State Operations Manual 
 
Chapter 6 - Special Procedures for Laboratories 
 
Table of Contents 
(Rev. 199, 01-17-20) 
 
Transmittals for Chapter 6 
 
 
Program Background and Actions Related to Certification 
6000 - Background 
6002 - CLIA Applicability 
6006 - Application and Certificate Process 
6006.1 - Certificate of Registration 
6006.2 - Certificate of Waiver 
6006.3 - Certificate for Provider-performed Microscopy (PPM) Procedures  
6006.4 - Certificate of Compliance 
6006.5 - Certificate of Accreditation 
6006.6  Effective Dates 
6006.7 - Verification of Laboratory Director Qualifications 
6008 - Assignment of CLIA Identification Numbers 
6010 - Regulatory Exceptions for a Multiple Site Certificate 
6010.1 - Mobile Laboratory Units and Temporary Testing Sites  
6010.1.1 - Mobile Laboratory Units 
6010.1.2 - Temporary Testing Sites 
6010.1.2.1 - Home Health Agencies (HHAs) and Hospices Temporary Testing Sites 
6010.2 - Laboratories Performing Limited Public Health Testing 
6010.3 - Laboratories within Hospitals 
6012 - Chemical Toxicity Public Health Laboratories Exceptions  
6014 - CLIA Certificate Status Changes  
6016 -Notification of Change in Laboratory Operations and Retention Requirements 
6016.1 - Change in Laboratory Operations 
6016.1.1 - Change in Laboratory Director for Certificate of Accreditation 
Laboratories 
           6016.2 - Retention Requirements 
6018 - Revised Certificates  
6020 - Fee Adjustments  
6022 - CLIA Data System  
 
  State Agency and Regional Office Roles and Relationships with 
other Federal Agencies 
6024 - Consultative CLIA Activities  
6026 - Regional Office (RO) Role  
6028 - Laboratories Under Direct RO Jurisdiction 
6030 - RO Review of State Agency (SA) Certification Activities 
6032 - State Agency (SA) Role  
6034 - CLIA Laboratories - Compliance With Civil Rights Requirements 
6036 - Referrals to the Office of Inspector General (OIG) for CLIA Violations (e.g.,  
          Testing without a CLIA Certificate) 
6038 - Transfusion Services Covered by CMS/FDA Memorandum of Understanding 
(MOU) 
6038.1  Inspections of Transfusion Services 
6040 - Transfusion-Related Fatalities 
6042 - Proficiency Testing (PT) 
 
Proficiency Testing 
 
6044 - PT Enrollment and CASPER System Reports  
6046 - PT Enrollment Information  
6048  PT Participation and Testing Requirements  
6050 - Monitoring of PT Scores 
6054 - Unsuccessful Performance in Proficiency Testing 
6056 - Excused Failure to Participate in a Testing Event for a Particular Analyte  
6060 - Reinstatement After Failure to Successfully Participate in Proficiency Testing 
6061 - PT Referral 
6062 - Onsite Observation of Proficiency Testing 
6063 - Survey Protocols for Compliance with Cytology Proficiency Testing 
6100 - The Survey Process - Emphasis, Components, and Applicability 
 
The Survey Process 
 
6101 - The Outcome-Oriented Survey Process (OOSP) 
6102 - Scheduling Surveys 
6102.1 - Scheduling priorities 
6102.2 - Survey Due to Unanticipated Events 
6102.3 - Change of Location of Laboratory 
6102.4 - Change of Testing Performed by a Laboratory 
6106  Announced and/or Unannounced Surveys  
6106.1 - Testing Outside the Certificate Type  
  6106.2 - Accredited Laboratories  
6106.3  CLIA-Exempt Laboratories  
6108 - Laboratory Refuses to Allow Survey   
6110 - Survey Team Size and Composition 
6112 - Pre-Survey Preparation 
6114 - Entrance Interview  
6116 - Information Gathering  
6116.1 - Organizing the Survey 
6116.2 - Observation of Facilities and Processes 6116.3 - Interviews 
6116.3 - Interviews 
6116.4 - Record Review 
6116.5 - Credentialing of Foreign Trained Laboratory Personnel  
6116.6 - During the Survey 
6116.7 - Assessing Outcome or Potential Outcome 
6120 - Completing the Survey Report (Form CMS-1557) 
6120.1 - Regulatory Compliance Decision  
6124 - Preparation for Exit Conference 
6126 - Exit Conference 
6126.1  Introductory Remarks 
6126.2  Ground Rules 
6126.3 - Presentation of Findings 
6126.4 - Closure 
6128 - Certification Actions Performed After Survey 
6130 - Statement of Deficiencies, Plan of Correction and Allegation of Compliance, Form 
CMS-2567 
6130.1 - Development of the Statement of Deficiencies  
6130.2 - Citing Standard-Level Deficiencies  
6130.3 - Citing Condition-Level Deficiencies  
  6130.4 - Choosing the Appropriate Condition  
            6130.5 - Mandatory Citations  
6132 - Certification Actions Performed After the Survey  
6132.1 - Generating the Statement of Deficiencies  
6132.2 - Plan of Correction (PoC) 
6132.3 - Allegation of Compliance (AoC) 
6134 - Review of Plan of Correction or Allegation of Compliance by State Agency  
6134.1 - - Strategy for Repeat Deficiencies  
6134.2 - Follow-Up on PoCs and Post-Survey Revisit  
6134.3 - Post-Survey Revisit Report, Form CMS-2567B  
6136 - Evaluation of Compliance   
           6136.1 - Compliance With all CLIA Conditions With No Deficiencies Identified  
  6136.2 - Compliance Based on an Acceptable PoC 
6136.3 - Noncompliance 
  6136.4 - Survey Report Documentation and Data Entry 
  6137 - Data Management 
6138 - Retention of CLIA Certification Records 
6138.1 - No Deficiencies Cited 
6138.2  Deficiencies Cited 
6138.3 - Exception 
6139 - Media Representatives Referred by the CMS Press Office 
6140 - Additional Information 
  6140.1 - Counting Tests 
  6140.2 - Conducting Surveys of Multiple Testing Sites under One Certificate  
  6140.3 - Conducting Surveys of Laboratories Performing Waived Tests 
6140.4 - Conducting Surveys of Laboratories with a Certificate of Waiver (CoW) 
or a Certificate for PPM Procedures 
  6140.5 - Complaints Involving Laboratories 
 
Sample Validation Surveys of Accredited Laboratories 
 
6150 - Background - CMS Approval of Accreditation Organizations (AO) 
6151 - Accredited Laboratories - Deemed Status 
6152 - Accreditation Validation Surveys - Citations and General Description 
6154 - Objective of Validation Surveys of Accredited Laboratories 
6156 - Selection of Sample for Validation Surveys of Accredited Laboratories 
6156.1 - Number of Validation Surveys 
6156.2 - Criteria for Validation Selection  
            6156.3 - Complaint Investigations Accepted for Validation Survey Target 
  
6158 - Preparing for Validation Surveys of Accredited Laboratories 
6162 - Accredited Laboratorys Refusal to Permit a Validation Survey 
6164 - Conducting Validation Surveys of Accredited Laboratories 
6164.1  SA Responsibilities 
6164.2 - Discrepancy With CLIA Data Information 
6166 - Results of Validation Surveys of Accredited Laboratories 
6166.1 - Condition-Level Deficiencies With Immediate Jeopardy 
6166.1.1  The SA 
6166.1.2  The RO 
6166.2 - Condition-Level Deficiencies With No Immediate Jeopardy 
6166.2.1  The SA 
6166.2.2  The RO 
6166.3 - No Condition-Level Deficiencies Found at the Time of Survey 
6166.3.1  The SA 
6166.3.2  The RO 
6170 - Completing Validation Survey Information in the CLIA Data System 
  6172 - Notification Requirements of Approved Accreditation Organizations 
6174 - Basis for Validation Surveys of Accredited Laboratories in Response to 
Substantial Allegations of Noncompliance 
6176 - RO Direction of Accredited Laboratory Complaint Investigation 
6178 - Conducting Complaint Validation Survey of an Accredited Laboratory 
6180 - Forwarding Investigation Report to RO 
6182 - Accredited Laboratory Found in Compliance Following a Complaint Survey 
6184 - Accredited Laboratory Found Not in Compliance Following a Complaint Survey 
 
Sample Validation Surveys of CLIA-Exempt Laboratories 
 
6200 - CMS Approval of State Laboratory Licensure Programs Citations and General 
Description 
6202 - Validation Surveys of CLIA-Exempt Laboratories - Citations and Objectives 
6204 - Number and Criteria for Selection of CLIA-Exempt Laboratories for Validation 
Surveys 
6204.1 - Number of Validation Surveys 
6204.2 - Selection of Validation Surveys 
6206 - Preparing for Sample Validation Survey of CLIA-Exempt Laboratories 
6208 - Conducting Validation Surveys of CLIA-Exempt Laboratories  
6210 - Results of the CLIA-Exempt Validation Survey - RO and SA Responsibilities 
6210.1 - Condition-Level Deficiencies With Immediate Jeopardy 
6210.1.1  The RO 
6210.1.2 - The Exempt State (ES) Program  
6210.1.3  The RO 
6210.2 - Condition-Level Deficiencies With No Immediate Jeopardy 
6210.2.1  The RO 
6210.2.2 - The Exempt State Program  
6210.2.3  The RO 
6210.3 - Deficiencies Found Below the Condition-level 
6210.3.1  The RO 
6210.3.2 - The Exempt State Program  
6212 - Processing Validation Survey Records 
6214 - Evaluation of Approved State Licensure Program 
6216 - Onsite Visit to Exempt-State Laboratory Program  
6218 - Notification Responsibilities of Approved State Licensure Program 
6220 - CLIA-Exempt Laboratory Complaint Investigations - General 
6222 - Review of CLIA-Exempt Laboratory Complaints 
6224 - Conducting Complaint Validation Survey for CLIA-Exempt Laboratories 
   
Validation Surveys Performed Simultaneously With  Accreditation 
Organization Inspections or  Approved State Program Inspections 
 
6226 - Simultaneous Validation Surveys - General 
6226.1 - Simultaneous Validation Survey - Definition 
6226.2 - Purpose 
6226.3 - Relationship to Comparative Validation Surveys  
6226.5  Team Size 
6227 - Scheduling Simultaneous Validation Surveys and Coordinating Pre-Survey 
Arrangements 
6227.1 - Importance of Coordinating Pre-Survey Arrangements 
6227.2  Surveyor  Responsibilities 
6227.3 - Pre-Survey Arrangements for Accredited Laboratories 
6227.3.1 - Coordinating With Accreditation Organization (AO) Contact 
Person 
6227.3.2 - Arrangements With Laboratory 
6227.3.3 - Coordinating With Accreditation Organization Inspector  
6227.4 - Pre-Survey Arrangements for CLIA-Exempt Laboratories 
6228 - Onsite Activities - Simultaneous Validation Surveys 
6228.1  Entrance Conference 
6228.2  Fact-Gathering 
6228.3 - Pre-Exit Discussion 
6228.4  Exit Conference 
 
Other Activities 
6230 - CLIA State Agency Performance Review (SAPR) 
6232 - CLIA Federal Monitoring Survey (FMS) Selection 
6234 - FMS of Laboratories - Definitions and Purpose 
6234.1 - Definition 
6234.2 - Purpose 
6234.3 - Scope of FMS  
6234.4 - CLIA-FMS Types Used to Assess Individual Surveyor Performance  
            6234.5 - Additional RO Responsibilities on FMS Surveys 
6236 - CLIA-FMS Procedures 
6236.1 - Scheduling of Surveys 
6236.2  Survey Findings 
            6236.3 - Feedback to the SA Surveyor and the SA Supervisor 
6238 - Completion of FMS Workload and Time Expenditures 
6240 - Other Special Purpose Federal Surveys - Definitions 
   
Adverse Actions 
6250 - Purpose of and Basis for Enforcement Action 
6250.1 - Purpose 
6250.2 - Basis for Enforcement 
6252 - Definitions/Terminology - Enforcement 
6254 - Enforcement Options for All Laboratories  
6256 - Sanction(s) - General  
            6256.1 - Choice of Sanction - Factors to Consider 
6256.2 - Number of Alternative Sanctions  
6256.3 - Principal Sanctions  
            6256.4 - Alternative Sanctions  
  6256.5 - Additional Sanctions  
  6256.6 - Civil Suit 
  6256.7 - Criminal Sanctions 
6258 - Denial of Form CMS-116 from Prospective Laboratory or Denial of Request to 
Test in New Specialties or Subspecialties 
6260 - Certificate Changes When Enforcement Action is Pending  
           6260.1 - Laboratory Gives Notification of Going Out of Business  
           6260.2 - Laboratory Gives No Notification of Going Out of Business  
           6260.3 - Voluntary Withdrawal When Enforcement   Action is Pending 
           6260.4 - Requests to Change Certificate Type When Enforcement Action is  
           Pending 
          6260.5 - Request to Change Accreditation Organization When Enforcement Action 
          is Pending     
6262 - Reissuance of Certificates to Laboratories Found Out of Compliance  
6264 - Sanction Notification Requirements  
           6264.1  Notice of Proposed Sanction(s)  All Sanctions 
           6264.2  Notice of Imposition of Sanction(s)  All Sanctions  
6266 - CLIA Conditions Not Met - Additional Sanctions Related to Medicare Payments  
Principal and Alternative Sanctions for Laboratories that Participate in Medicare  
6266.1 - Principal Sanction - Cancellation of Medicare Payments  
            6266.1.1 - Basis for Cancellation 
  6266.1.2 - Effective Date of Cancellation 
  6266.1.3 - Effect of Cancellation on Other Medicare Payment Sanctions 
  6266.1.4 - Effect of Cancellation of Medicare on Laboratorys Eligibility to       
            Receive Medicaid Payments 
6266.2 - Alternative Sanctions  Suspension of Part or All of Medicare Payments  
            6266.2.1 - Suspension of Part Medicare Payments 
           6266.2.2 - Suspension of All of Medicare Payments 
6268 - Adverse Action on Any Type of CLIA Certificate: Effect on Medicare Approval  
  6268.1 - Suspension or Revocation of Any Type of CLIA Certificate 
  6268.2 - Limitation of Any Type of CLIA Certificate 
  6270 - Effect on Medicaid Participation  
6272 - Failure to Furnish Notification of Changes  
6274.1 - Suspension or Limitation of CLIA Certificate 
6276 - Suspension, Limitation, or Revocation of Any Type of CLIA Certificate  
6276.1 - Adverse Actions Based on Actions of the Laboratorys Owner, Operator, 
or Employees  
 
6276.1.1 - Basis for Action 
6276.2 - Adverse Actions Based on Improper Referrals in Proficiency Testing  
6276.2.1 - Category 1 
6276.2.2 - Category 2 
                                       6276.2.3 - Category 3 
                 6276.2.4 - Carve-Out  
                                      6276.2.5 - RO Actions 
                        6276.3- Adverse Action Based on Exclusion from Medicare 
                6276.4 - Procedures for Suspension, Limitation, or Suspension:   
                                     Exceptions 
              6276.4.1 - Suspension or Limitation: Exceptions 
              6276.4.2 - Procedures for Revocation 
              6276.5 - Notice to Office of the Inspector General (OIG) 
6276.3 - Processing Directed PoC 
6276.4- Processing Directed Portion of PoC 
6278 - Unsuccessful Participation in PT  
6278.1 - Unsuccessful Participation in PT: Training and Technical Assistance     
               Option 
6278.2  Subsequent (Non-Initial) Unsuccessful Participation in PT  
6278.2.1 - Notice of Proposed Sanction(s) 
6278.2.2 - Notice of Imposition of Sanction(s) 
6278.3 - Duration of Sanction 
6280 - Alternative Sanctions  
            6280.1 - Alternative Sanctions:  Directed Plan of Correction 
  (dPoC) and Directed Portion of a Plan of Correction (dPPoC)  
          6280.1.1 - Basis for Action 
  6280.1.2 - Procedures for Directed PoC (dPoC) 
  6280.1.3 - Procedures for Directed Portion of PoC (dPPoC) 
6280.2 - Alternative Sanction: Civil Money Penalty (CMP)  
                        6280.2.1 - Scope and Basis 
  6280.2.2 - Amount of Penalty  
  6280.2.3 - Range of Penalty Amount  
  6280.2.4 - Notice of Intent 
  6280.2.5 - Accrual of Penalty  
  6280.2.6 - Duration of Penalty 
  6280.2.7 - Computation and Notice of Penalty Amount  
  6280.2.8 - Collection of Penalty Amounts 
  6280.2.9 - Settlement 
  6280.3 - Alternative Sanction: State Onsite Monitoring  
            6280.3.1 - Basis for Action 
             6280.3.2 - Duration of Sanction  
6280.4 - Duration of Alternative Sanctions  
6280.4.1 - Notice of Intent 
6280.4.2 - Accrual of Penalty 
6280.4.3 - Duration of Penalty 
6280.5 - Lifting of Alternative Sanctions  
6280.6 - Collection of Penalty Amounts 
6280.7 - Settlement 
6282 - Exception for Laboratories with Certificates of Waiver  
6282.1 - Processing Immediate Jeopardy Enforcement Actions 
6284 - Noncompliance With One or More Conditions  Immediate Jeopardy Exists  
6284.1 - Processing Immediate Jeopardy Enforcement Actions 
6286 - Noncompliance With One or More Conditions - No Immediate Jeopardy 
Exists  
6286.1 - Monitoring of Corrective Action(s) 
6286.2 - Deficiencies Corrected before Revisit 
6286.3 - Alternative Sanction Imposed - Failure to Correct Condition-level                                      
Deficiencies 
6286.4 - Condition-level Deficiencies Corrected but Other Deficiencies Remain -                            
12-Month Maximum for Correction 
6286.5 - Revocation of CLIA Certificate 
6286.6 - Acceleration of Timetable 
6288 - Condition-level Deficiencies Corrected but Other Deficiencies Remain - 12-Month 
  Maximum for Correction 
6289 - Deficiencies That Are Not At Condition Level  
6290 - Laboratory Found Not in Compliance Following Validation survey or Complaint 
Survey  
6290.1 - Allegation of Compliance  
6290.2 - Compliance With All CLIA Conditions After Correction of Deficiencies 
 
6290.2.1  Plan of Correction  
6290.2.2 - Compliance With All CLIA Conditions After Correction of 
Deficiencies 
6290.2.3 - Notification of Accreditation Organization 
6292 - Procedures for Noncompliant Federal and State Operated Laboratories  
6292.1  Initial Action 
6292.2 - Ensuring Timely Corrections 
6293 - Intervening Actions That Do Not Postpone or Delay Enforcement Timetable 
6294 - Enforcement - Additional Information  
                          6294.1 - Ensuring Timely Correction of Condition-level Deficiencies  
    6294.1.1 - Monitoring of Corrective Action(s) 
6294.1.2 - Acceleration of Timetable 
6294.2 - Intervening Actions That Do Not Postpone or Delay Enforcement  
Timetable  
6294.3 - Lifting of Sanctions - Compliance Achieved Before or During Date of 
Revisit 
6294.4 - Credible Allegation of Compliance Submitted During Adverse Action  
6294.5 - Entering Enforcement Cases in ASPEN Enforcement Management 
(AEM) 
 
6295 - Lifting of Alternative Sanctions 
6295.1  General Rule 
6295.2 - Credible Allegation of Compliance 
6295.3 - Compliance Achieved Before or During Date of Revisit 
6296 - Table 1- Required Sanction(s) When Specific Action(s) are Taken by CMS  
6296.1 - Suspension or Revocation of Any Type of CLIA Certificate 
6296.2 - Limitation of Any Type of CLIA Certificate 
6298 - Summary of RO Responsibilities during the CLIA Adverse Action Process 
6299 - CLIA Violations - OIG Excludes Laboratory From Medicare Participation - Effect 
on CLIA Certificate 
6300 - Application of Appeals Process  
6302 - Reconsideration 
6302.1 - Definition of Reconsideration 
6302.2 - Right to Reconsideration 
6302.3 - Request for Reconsideration: Manner and Timing 
6302.4 - Actions upon Receipt of Request for Reconsideration 
6302.5 - Withdrawal Requests and Extensions 
6304 - RO Notice of Reconsidered Determination 
6304.1 - Determination Reversal (Approval) 
6304.2 Denial Affirmed - Denial of Form CMS-2567 from Prospective     
Laboratory or Denial of Request to Test in New Specialties or 
Subspecialties 
6304.3 - Administrative Evidentiary Hearing 
6306 - Administrative Hearing 
6306.1 - Actions Which Are Appealable 
6306.2 - Actions Which Are Not Appealable  
6306.3 - Procedure for Requesting a Hearing  
6306.4 - Content of the Request for Hearing  
6306.5 - Relationship of Action on Laboratorys CLIA Certificate to Timing of Hearing 
6308 - Processing of Hearing Requests 
6310 - Timing of the Hearing  
                          
                 
6312 - Adverse Hearing Decisions by Administrative Law Judge (ALJ) 
6314 - Readmission to CLIA Program 
6316 - Laboratory Registry 
6318 - Freedom of Information Act (FOIA) 
 
 
Budget and Administration 
6400 - The CLIA Federal/State Relationship 
6402 - Federal Administrative Responsibilities 
6404 - Nature and Source of Payments to States 
6404.1 - Funds for Clinical Laboratory Improvement Act Related Activities 
6404.2 - Laboratory Remitted Funds 
6406 - State Agency Administrative Responsibilities 
6408 - State Agency Responsibility for Records and Reports 
6410 - State Agency Responsibility for Staff Training and Development 
6410.1   Staff Training 
6410.2 - In-Agency Training 
6410.3 - Outside-of-Agency Training 
6412 - Role of the CMS RO With State Agency Program Administration 
6414 - CLIA Budget - RO Procedures 
6414.1 - General 
6414.2 - Regional Administrative Responsibilities 
6416 - Budget Call - RO Procedures 
6418 - Regional Allocations 
6420 - The SA Agency Annual Activity Plan 
6422 - Planning the Annual Workload - SA Procedures 
6424 - Elements in the Annual Activity Plan - Planned Workload Report - SA Procedures 
6426 - Format for the Annual Activity Plan - SA Procedures 
6428 - Survey Team Composition and Workload Report-CMS-670 (Exhibit 74) - SA 
Procedures  
6430 - Basis for Determining CLIA-Related Costs - SA Procedures 
6432 - Promotional and Public Informational Activities - SA Procedures 
6434 - The State Budget Request 
6436 - State Budget Request, Clinical Laboratory Improvement Amendments Program, 
Form CMS-102 (Exhibit 116) 
Section A - Salaries 
Section B - Other Direct Costs 
Section C - Indirect Costs (Approved Rate X Base) 
Section D - Total Budget Requested 
  Section E - Hourly Rate Requested 
6438 - Form CMS-105, Planned Workload Report  CLIA (Exhibit 119) - SA Procedures 
 
6440 - Form CMS-1466, State Agency Schedule for Equipment Purchases (Exhibit 54) - 
SA Procedures  
6442 - Form CMS-1465A, State Agency Budget List of Positions (Exhibit 47) 
6444 - State Budget Request Submittal - Clinical Laboratory Improvement Amendments 
6444.1 - List of Materials and Order of Assembly 
6444.2 - Routing and Number of Copies 
6446 - Developing Budget Approval - RO Procedures 
6446.1 - Budget Request Package 
6446.2 - Basis for Budget Approval 
6446.3 - Line Item Negotiation and Approval 
6446.4 - Payable Reasonable Costs 
6446.5  Projected Workload 
6446.6 - CO Assistance 
6448 - RO State Agency Budget Review - Form CMS-102 
6450 - Employee Salaries and Wages - RO Procedures 
6450.1 - Distribution of Staff Time for Program Purposes 
6450.2 - Determination of Necessary Staff 
6452 - Retirement Contributions and Fringe Benefits - RO Procedures 
6454 - Travel - RO Procedures 
6454.1 - CLIA Laboratory Survey and Administrative Travel 
6454.2 - Travel Involving Multiple Program Activities 
6454.3 - Training and Conference Travel 
6456 - Communications and Supplies - RO Procedures 
6456.1 - Basis for Charges 
6456.2 - Communications 
6456.3 - Supplies 
6458 - Office Space - RO Procedures 
6458.1 - Cost of Office Space 
6458.2 - Standard of Comparable Rental 
6458.3 - Privately Owned Space 
6458.4 - Space in Publicly Owned Buildings 
6458.5 - Charges Based on Meeting Cost of Service and Maintenance 
6460 - Equipment - RO Procedures 
6462 -Training - RO Procedures 
6464 - Consultants - RO Procedures 
6466 - Subcontracts - RO Procedures 
6468 - Miscellaneous - RO Procedures 
6470 - Indirect Costs - RO Procedures 
  6472 - Hourly Rate Requested - RO Procedures 
6474 - Planned Workload Report - Form CMS-105 - RO Procedures 
6476 - Schedule for Equipment Purchases - Form CMS-1466 - RO Procedures 
6476.1 - Usage 
6476.2 - Completion of the Form 
6478 - Preparation of List of Positions - Form CMS-1465A - RO Procedures 
6478.1 - Usage 
6478.2 - Form Completion 
6480 - Line Item Approval for Personal Services - RO Procedures 
6482 - Need for Additional Funds - RO Procedures 
6482.1 - Adjustment in Quarterly Allotments 
6482.2  Supplemental Budgets 
6484 - Need for Additional CLIA Funds - SA Procedures 
6484.1 - Adjustment in Quarterly Allotments 
6484.2  Supplemental Budgets 
6486 - State Agency Accounts and Reporting 
6488 - Support for Expenditures - SA Procedures 
6490 - Certificate of Authority - SA Procedures 
6492 - Cash Basis - SA Procedures 
6494 - Limit on Expenditures - SA Procedures 
6496 - Periodic Analysis of Accounts - SA Procedures 
6498 - Cash Balances and Expenditure Authority - SA Procedures 
6500 - Unliquidated Obligations - SA Procedures 
6502 - Nothing to Report on a Given Line - SA Procedures 
6504 - SA Forwarding Materials to the RO 
6506 - State Agency Files Used for Case Control and Reporting 
6508 - SA Establishment of Case Controls 
6510 - Payment by Electronic Transfer of Funds - SA Procedures 
6512 - State Expense Reporting 
6514 - Employee Salaries and Wages - the Distribution of Staff Time for Program 
Purposes - SA Procedures 
6516 - Determination of Necessary Staff - SA Procedures 
6518 - Retirement Contributions and Fringe Benefits - SA Procedures 
6520 - Travel - SA Procedures 
6520.1 - CLIA Laboratory Survey and Administrative Travel 
6520.2 - Travel Involving Multiple Program Activities 
6520.3 - Training and Conference Travel 
6522 - Communications and Supplies - SA Procedures 
6522.1 - Communications 
6522.2 - Supplies 
  6522.3 - Basis for Charges 
6524 - Office Space - SA Procedures 
6526 - Privately-Owned Space - SA Procedures 
6526.1  Cancellation Clause 
6526.2 - Lease Not Exceeding One Year 
6526.3 - Consulting the RO 
6528 - Space in Publicly-Owned Buildings - SA Procedures 
6528.1  Actual Cost 
6528.2 - Cost After Building Amortization 
6528.3 - 75 Percent Rule 
6528.4 - Ratio of Charge-to-Rental Rates in Privately-Owned Space 
6528.5 - Charge Based on Cost of Initial Construction or Purchase 
6528.6 - Charges Based on Meeting the Cost of Service and Maintenance 
6530 - Repairs and Alterations - SA Procedures 
6530.1  Maintenance Repairs 
6530.2 - Major Repairs and Replacements 
6530.3 - Alterations 
6532 - Identifiable (Direct) Costs - SA Procedures 
6534 - Office Maintenance - SA Procedures 
6534.1 - Definition 
6534.2 - Basis for Charges 
6536 - Equipment - SA Procedures 
6536.1 - Definition and Quality of Office Equipment 
6536.2 - Title to and Accountability 
6536.3 - Purchase of Equipment 
6536.3.1  State Practice 
6536.3.2 - Purchases Related to Budget Process 
65363.3 - Items Deleted by CMS 
6536.3.4 - Purchase of Items Not Included in Budget Submittal 
6536.3.5  Reporting Equipment 
6536.4 - Rental of Equipment 
6538 - Retirement and Social Security - SA Procedures 
6538.1  Retirement Contributions 
6538.2 - Prorating Costs 
6540 - Other Expenses - SA Procedures 
6542 - Consultants - SA Procedures 
6544 - Training of State Agency Personnel - SA Procedures 
6544.1 - Funding 
6544.2  Requesting Apprpoval 
6544.3 - Justification for Attendance 
6544.4 - Fiscal and Reporting Considerations - the Amount Requested for Travel                           
Costs of Such Activity 
  6544.5 - Educational and Training Leave 
6544.6 - Agreements by Employees to Continue on the Job 
6546 - Miscellaneous - SA Procedure 
6546.1 - Bonding 
6546.2  Public Liability 
6548 - Goods, Facilities, Services From Other Staff or Local Agencies 
6548.1 - Definition 
6548.2 - Centralized State Services 
 
  Program Background and Actions Related to Certification 
In the event of a Condition-level noncompliance determination as a result of a random 
sample validation or complaint survey, a laboratory with a Certificate of Accreditation is 
subject to a full review by CMS or its designee.  A Certificate of Accreditation may be 
issued to an accredited laboratory that is out of compliance at the Condition-level 
provided an acceptable Plan of Correction (PoC) is received by CMS or its designee, and 
the compliance does not constitute immediate jeopardy, even if a hearing is pending. 
 
6000 - Background 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100- 
578, amended 353 of the Public Health Service Act (42 U.S.C. 263a), to extend 
jurisdiction of the Department of Health and Human Services (HHS) to regulate all 
laboratories that test human specimens for the purpose of providing information for 
diagnosis, prevention, or treatment of any disease or impairment of, or the assessment 
of the health of, human beings. Except as provided at 42 CFR 493.3, entities that meet 
the definition of a laboratory at 42 CFR 493.2 must meet applicable Federal 
requirements and have a CLIA certificate in order to operate. 
 
Regulations implementing CLIA are codified under 42 CFR Part 493. These regulations 
require that all laboratories or entities that perform laboratory testing: 
 
  Pay user fees as assessed by CMS to finance the entire cost of administering 
the CLIA program; 
 
  Submit specific information to HHS or its designee; 
 
  Comply with specific administrative and program requirements; 
 
  Submit to surveys to assess compliance with CLIA requirements; 
 
  Be subject to specified enforcement actions; and 
 
  Apply for CLIA certificates based on the complexity of testing performed in 
the laboratory or based on accreditation by a CMS-approved accreditation 
organization, or 
 
  Be licensed or approved in accordance with State requirements if located 
in a State with a CMS approved State laboratory licensure program. 
 
Section 6141 of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239, 
requires that laboratories participating in the Medicare program comply with CLIA 
requirements.  Therefore, all laboratories, with the exception of laboratories located in 
and licensed or approved by a State with a CMS-approved State laboratory licensure 
  program (CLIA-exempt laboratories) must obtain a CLIA certificate to operate and to be 
eligible for payment under Medicare and Medicaid. Although CLIA-exempt laboratories 
do not need a CLIA certificate to operate, they are assigned a CLIA identification 
number for Medicare and Medicaid payment purposes. 
 
6002 - CLIA Applicability 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-
20) 
 
The complexity or volume of testing conducted does not exclude an entity from being 
subject to CLIA, but these factors determine which requirements a laboratory must meet 
for CLIA certification, and the fees to be paid by the laboratory.  These requirements 
apply whether or not the laboratory or entity bills the patient for the services or is paid 
for the services by Medicare or Medicaid. 
 
Certain types of laboratories and laboratory tests are NOT subject to meeting CLIA 
requirements.  These include: 
 
  Any facility or component of a facility that performs testing strictly for 
forensic purposes; 
 
  Research laboratories that test human specimens but do not report patient 
specific results for the diagnosis, prevention or treatment of any disease or 
impairment of, or the assessment of the health of individual patients; 
 
  Components or functions of laboratories certified by the Substance Abuse 
and Mental Health Services Administration (SAMHSA), in which drug 
testing is performed that meets SAMHSA guidelines and regulations. 
(However, all other testing conducted by a SAMHSA certified laboratory is 
subject to this rule.); 
 
  Laboratories under the jurisdiction of the Department of Veterans Affairs; 
 
  Department of Defense (DoD) laboratories are subject to requirements that 
CMS has determined to be comparable to those in CLIA. The DoD is 
responsible for assuring compliance with these requirements and for oversight 
of its laboratories under a Memorandum of Understanding (MOU) between 
the Secretary of HHS and the Secretary of DoD. 
 
  Laboratory testing conducted in conjunction with the provision of home health 
or hospice care in an individuals home, where the home health agency or 
hospice employee merely assists the individual in performing a test, since tests 
performed by individuals in the home are not subject to CLIA; (See 
6010.1.2.1) 
   
  Laboratories located in and licensed or approved by a State with a CMS- 
approved State laboratory licensure program (i.e., CLIA-exempt as 
approved under 42 CFR part 493, Subpart E); 
 
  Facilities which serve only as collection stations. A collection station 
receives specimens to be forwarded to a laboratory performing diagnostic 
tests; 
  Radiological facilities that perform only imaging procedures 
(e.g., x-rays, ultrasounds, Magnetic Resonance Imaging, 
Computerized Tomography); 
 
  Facilities performing only physiological testing, e.g. spirometry, slit-lamp 
test for eyes, breath analysis, pulse oximetry; and 
 
  Any facility or component of a facility that performs substance use disorder 
testing (such as for alcohol and/or drugs) solely for employment purposes 
(such as disciplinary, administrative, or legal action). 
 
NOTE: Any entity (including any facility or component of a facility) 
performing substance use disorder testing (including drug or alcohol testing 
and/or screening) where the test results may be used for the purpose of 
offering, referring or making available treatment to the individual, must 
obtain an appropriate CLIA certificate and meet the applicable CLIA 
standards or cease testing. 
 
If a laboratory is performing testing subject to CLIA and does not obtain the 
appropriate certificate, it is in violation of Public Law 100-578, 353, and subject 
to specified penalties. Such cases or suspected cases should be forwarded to the 
RO for referral to the OIG. (See 6036.) 
 
6006 - Application and Certificate Process 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
It is the responsibility of the laboratory to obtain and submit the CLIA application (Form 
CMS- 
116, Exhibit 125) and necessary personnel information for a CLIA certificate. The CLIA 
application collects information about a laboratorys operation that is necessary to 
determine the fees to be assessed, to establish baseline data and to fulfill the statutory 
requirements for CLIA. The information will provide an overview of a facilitys 
laboratory operation. A laboratory cannot perform testing or claim Medicare and/or 
Medicaid payment for services performed without a CLIA certificate and/or valid CLIA 
identification number. (See Chapter 2, 2005, for additional information pertaining to 
Medicare Health Care Provider/Supplier Enrollment.) 
   
CMS (directly or through its agents or contractors) is responsible for providing, 
collecting, and processing CLIA applications; generating fee coupons; collecting 
certificate and inspection fees; and entering application and fee data into the CLIA 
database. A CMS contractor issues the CLIA certificate through the CLIA data 
system. 
 
6006.1  Certificate of Registration 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A Certificate of Registration is issued initially to any laboratory that applies for a 
Certificate of 
Compliance or Certificate of Accreditation and pays appropriate registration fee(s).  A 
Registration Certificate is valid for no more than a period of two years. When a 
laboratory applies for a Certificate of Compliance, the Certificate of Registration only 
indicates that the laboratory is registered with CMS and does not indicate approval or 
compliance with CLIA requirements. It permits the laboratory to operate until CMS or its 
designee determines through an inspection that all applicable requirements are met. A 
Certificate of Registration can be reissued if a laboratory requests an appeal of a sanction 
imposed as a result of noncompliance with one or more CLIA conditions, which does not 
pose immediate jeopardy. In such a case, a Certificate of Registration is reissued and 
remains effective until an Administrative Law Judge (ALJ) of the Department of Appeals 
Board (DAB) makes a decision. All sanctions imposed against the registration certificate 
carry forth when reissued. 
 
For laboratories applying for a Certificate of Accreditation, the Certificate of Registration 
indicates only that the laboratory is registered with CMS. It permits the laboratory to operate 
until CMS receives verification of accreditation approval. Laboratories must provide CMS 
with proof of accreditation by an approved accreditation program within 11 months of 
issuance of the Certificate of Registration. 
 
When a laboratory has been granted accreditation, a confirmation checkmark is 
entered into the CLIA data system by the approving AO along with the AO inspection 
date and inspection specialties information. 
 
6006.2  Certificate of Waiver 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A Certificate of Waiver (CoW) is issued to a laboratory that performs only tests 
categorized as waived tests and pays the appropriate fee. Waived tests are those that 
have been determined to be so simple that if performed incorrectly will pose no risk of 
harm. The initial list of tests approved for CoW status are listed at 42 CFR Part 493.15, 
however, the list has been extended and can be viewed at 
https://www.accessdata.fda.gov. 
   
A CoW is valid for a 2-year period. Upon certificate expiration, and after payment of 
appropriate fees, the laboratorys certificate will be renewed for another 2-year period. 
While the laboratory with a CoW is not subject to routine inspections, the laboratory 
must comply with CLIA registration and certificate requirements and follow the 
manufacturers instructions for test performance. 
 
6006.3  Certificate for Provider-performed Microscopy (PPM) 
Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A Certificate for Provider-performed Microscopy (PPM) procedures is issued to a 
laboratory in which a physician, midlevel practitioner, or dentist performs only the 
microscopy tests listed at 42 CFR 493.19(c) or performs only the listed microscopy 
tests in any combination with waived tests during a patients visit.  A certificate for 
PPM procedures is valid for a 2-year period. Upon certificate expiration, and after 
payment of appropriate fees, the laboratorys certificate will be renewed for another 2-
year period.  The laboratory that holds a PPM certificate is subject to quality system 
requirements  for  nonwaived  tests.  However,  such  a  laboratory  is  not  routinely 
inspected but may be included in an inspection sample of non-waived laboratories or a 
complaint inspection. 
 
6006.4  Certificate of Compliance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A Certificate of Compliance is issued to a laboratory after an inspection finds the 
laboratory to be in compliance with all applicable requirements. The certificate will 
reflect the effective date for each approved specialty/subspecialty.  A Certificate of 
Compliance may also be reissued to a laboratory that has one or more Condition-level 
deficiencies that do not pose immediate jeopardy (see 6262). 
 
If a Certificate of Compliance is due to expire prior to a hearing date, it may be reissued 
if CMS finds that conditions in the laboratory do not pose immediate jeopardy. The 
certificate remains effective while awaiting the hearing decision. All sanctions imposed 
against the certificate carry forth when the certificate is reissued. A Certificate of 
Compliance is valid for a period of two years. Upon certificate expiration, and after 
recertification and payment of appropriate fees, the laboratorys certificate will be 
renewed for another 2- year period. 
 
6006.5  Certificate of Accreditation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
A Certificate of Accreditation is issued to a laboratory after the accrediting organization 
certifies the laboratory according to its certification requirements. The Certificate of 
Accreditation will reflect the effective date for each specialty/subspecialty approved by 
  the accreditation organization. 
 
Upon a certificates expiration, and after payment of appropriate fees, the laboratorys 
certificate will be renewed with a new 2-year effective date unless CMS is notified by the 
accreditation organization of a laboratorys loss of accreditation status. 
 
In the event of a Condition-level noncompliance determination as a result of a random 
sample validation or complaint survey, a laboratory with a Certificate of Accreditation is 
subject to a full review by CMS or its designee.  A Certificate of Accreditation may be 
issued to an accredited laboratory that is out of compliance at the Condition-level 
provided a credible Allegation of Compliance (AoC) is received by CMS or its designee, 
and the non-compliance does not constitute immediate jeopardy, even if a hearing is 
pending. 
 
6006.6  Effective Dates 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The effective date of the initial Certificate for PPM procedures, 
Certificate of Registration, or a Certificate of Waiver for new 
laboratories is the date the CLIA application, Form CMS-116 (Exhibit 
125) is entered into the CLIA data system. 
 
The effective date of the Certificate of Compliance is the date the laboratory is 
surveyed and found in compliance with the CLIA requirements. 
 
The effective date of the Certificate of Accreditation is the date the organization 
verifies to CMS that the laboratory is accredited. This date can be no earlier than the 
accreditation organization initial approval date.  Once the effective dates are 
established, the laboratorys 2-year certificate cycle is set. 
 
6006.7  Verification of Laboratory Director Qualifications 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Laboratories applying for a Certificate of PPM procedures, Certificate of Compliance 
or Certificate of Accreditation must meet the qualifications of Laboratory Director as 
found in Sections 493.1357, 493.1405, 493.1406 and 493.1443. The SA is responsible 
for verifying that the Director meets the appropriate personnel qualifications. The SA 
may request the Director to provide the following documentation: evidence of meeting 
state licensure requirements (if applicable), copy of diploma, transcripts from an 
accredited institution, evidence of Continuing Medical Education (CME) credits in 
laboratory practice, appropriate laboratory experience, etc. 
 
Laboratories may choose to use primary source verification (PSV) to confirm personnel 
credentials and provide PSV documentation as evidence of compliance with the 
  personnel requirements stated in 42 CFR, Part 493, Subpart M.  The use of a PSV 
report as evidence of meeting CLIA personnel qualifications is optional for the 
laboratory.  The laboratory may provide both direct observation of documents, PSV 
documents, or a combination of both to achieve compliance. 
 
PSV is the process of confirming an applicant's credentials by verifying that a degree, 
certificate, or diploma was received; that licenses were granted; and, by confirming 
reported work history, such as company names and locations, dates, and positions 
held.  Verifications are obtained either directly from an institution, former employers, 
or their authorized agents. Refer to S&C 16-18 CLIA. 
 
6008 - Assignment of CLIA Identification Numbers 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CLIA identification numbers are shown under the CMS Certification Number 
(CCN) column in certain CMS data systems. 
 
CLIA identification numbers are 10-digit alphanumeric numbers issued by the CLIA data 
system.This is assigned at the time of initial entry of the CLIA application and included 
with the mailing of the remittance fee coupon.  The 10-digit number consists of the 
following fields: 
 
  Positions 1 and 2 identify the State in which the laboratory was located 
when it initially applied for a CLIA certificate. (A laboratory that 
relocates to another State retains its original CLIA number.); 
 
  Position 3 is the alpha letter D to identify the provider/supplier as 
a laboratory certified under CLIA; and 
 
  Positions 4 through 10 are the unique facility number identifiers. 
 
Laboratories which are CLIA-exempt and those designated as VA laboratories do 
not have a CLIA certificate, but are assigned a CLIA identification number. 
 
Once a laboratory is assigned a number, it retains this number even if it withdraws 
from CLIA, has its certificate revoked, changes its certificate type or ownership, 
location (i.e., relocates to another State), name, or operator.  A CLIA number will not 
be reassigned to another laboratory. 
 
6010 - Regulatory Exceptions for a Multiple Site Certificate 
Location 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Each location where laboratory tests are performed must file a separate application, 
  unless it meets one of the following exceptions as outlined in 42 CFR 
493.35(b)(1)-(b)(3), 493.43(b)(1)-(b)(3), or 493.55(b)(1)-(b)(3). 
 
6010.1 - Mobile Laboratory Units and Temporary Testing Sites 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Exception (b)(1): Laboratories that are not at a fixed location, that is, laboratories that 
move from testing site to testing site, such as mobile units providing laboratory testing, 
health screening fairs, or other temporary testing locations may be covered under the 
CLIA certificate and address of the designated primary site or home base. (42 CFR 
493.35(b)(1), 493.43(b)(1), or 493.55(b)(1)). 
 
Primary Site or Home Base: 
 
The regulations do not specify the types of facility that may be designated as the 
primary site or home base.  The primary site or home base is the location where the 
staff is based and records, equipment, supplies, etc. are maintained.  For example, 
the main office for an ambulance service. 
 
6010.1.1 - Mobile Laboratory Units 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  A mobile unit is generally considered to be a movable, self-contained 
operational laboratory with its own personnel, equipment, and records, 
with equipment installed and located permanently within the mobile 
unit. 
  If a vehicle is used solely to transport laboratory equipment from the 
primary site/home base to another site where testing is performed, the 
transporting vehicle is not a mobile unit. 
 
If a mobile laboratory operates in more than one State, the RO determines 
which state should perform an inspection. 
Each mobile laboratory that moves from testing site to testing site or has a temporary 
testing location, should provide the SA with the primary site/home base or central 
dispatch phone number, so that the SA can obtain an updated schedule of the 
location(s) of testing and the hours of operation.  Records may be maintained in the 
mobile vehicle or at the primary site/home base. Reports should reflect the primary 
site/home base address and indicate which mobile unit performed each test. The 
vehicle identification number may be used to distinguish mobile laboratory vans. 
 
6010.1.2 - Temporary Testing Sites 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A temporary testing site is where, at various intervals of time, an entity that is not at a 
fixed or permanent location performs laboratory testing.  The laboratory moves from 
  testing site to testing site.  The laboratorys certificate should be in the name of the 
designated primary site or home base. 
 
 
  The regulation specifies no restrictions on the number of visits to a 
particular site, the type of testing performed, or scheduling. 
  Records, files, etc. for temporary testing sites may be kept at the primary site or 
home base. The personnel, equipment, supplies, and reagents, etc. are not kept 
at a temporary testing site on a permanent basis. 
 
6010.1.2.1 - Home Health Agencies (HHAs) and Hospices Temporary 
Testing Sites 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Home Health Agencies 
A parent HHA with multiple branches may apply for one CLIA certificate as 
long as these sites are under one HHA provider number, i.e., parent and 
branch. Subunits that operate independently and have a unique provider 
number should each apply for a separate CLIA certificate. 
 
NOTE: The parent or provider location must perform laboratory testing.  Since 
branches cannot operate independently, the parent defines the services provided 
in the branches and is responsible for the day-to-day operation, supervision, and 
administration of laboratory testing, including the employment of qualified 
personnel. 
 
NOTE: If the health care worker only assists the patients and provides the patients self-
testing result to the health care provider, a certificate is not required. 
 
Hospices 
The guidance for HHAs applies to Hospices. The Medicare designated term for the 
hospice multiple sites is multiple locations instead of branches. 
 
6010.2 - Laboratories Performing Limited Public Health Testing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Exception (b)(2): Not-for-profit or Federal, State, or local government laboratories that 
engage in limited (not more than a combination of 15 moderately complex or waived 
tests per certificate) public health testing may file a single application. (42 CFR 
493.35(b)(2), 493.43(b)(2), or 493.55(b)(2)). 
 
  The facility must either be Not-for-profit, or a Federal, State or local 
government facility (e.g., Women, Infants and Children (WIC) 
clinics). 
  Not-for-profit status is a legal designation. 
o
    Limited public health testing is not defined in the regulation. 
  The testing is limited to 15 or fewer tests, and those fifteen tests must be 
listed on the license application.  Those fifteen tests may be solely 
comprised of moderate complexity tests, solely comprised of waived tests, or 
comprised of a combination of moderate and waived tests. 
  A Certificate of Waiver laboratory is eligible if it only performs 15 or 
fewer waived tests. 
  The various sites under this certificate may only perform tests within the 
15 tests listed on the certificate application. 
  An entity performing any high complexity testing cannot use this exception 
for a multi- site certificate. 
  The multi-sites cannot perform tests that are outside of those listed for the 
CLIA certificate they are operating under.  The name of the tests must be 
shown on the CLIA application for this exception. (Although certificates 
are currently issued by specialty/subspecialty, the tests must be verified 
and shown on the CLIA application Form CMS-116.) 
  The location designated as the primary site on the CLIA 
application/certificate must perform testing and hold the certificate. 
  The primary site must also identify the type of testing performed at each site.  
If any of the multi-site laboratories is located in more than one State, the State 
Agency (SA) contacts the Regional Office to determine which State conducts 
the inspection. 
 
6010.3 - Laboratories within Hospitals 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Exception (b)(3): Laboratories within a hospital that are located at contiguous 
buildings on the same campus and under common direction may file a single 
application or multiple applications for CLIA certificate(s) for the laboratory sites 
within the same physical location or street address. (42 CFR 493.35(b)(3), 
493.43(b)(3), or 493.55(b)(3)). 
 
  This exception applies only to laboratories within hospitals. This 
includes teaching hospitals of universities.  Other types of entities are 
not eligible. 
  Under common direction means that all of the multiple site 
laboratories must be under the direction of the same laboratory 
director. 
  Street address is the address assigned by the post office and is the physical 
location of the main laboratory.  The street address may be different from the 
mailing address, which can be a post office box or a billing address. 
  Where it is unclear whether laboratories in multiple sites on a campus meet 
the applicable criteria, such as with a hospital occupying multiple buildings 
on a university campus, the SA consults with the RO to determine if the 
hospital is eligible for a single certificate. 
  The fact that the laboratory is owned by a hospital does not necessarily make it a hospital 
laboratory for purposes of the multi-site exception.  In many of these cases, a multiple 
site certificate CANNOT be issued.  Additional information should be requested at each 
requirement under 42 CFR 493.35(b)(3), 493.43(b)(3), or 493.55(b)(3)) 
 
6012 - Chemical Toxicity Public Health Laboratories Exceptions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Centers for Disease Control and Prevention (CDC) worked with the Association of 
Public Health Laboratories (APHL) to establish and prepare the national Laboratory 
Response Network (LRN) to ensure that there are robust, adequate laboratory testing 
services available in the event of a chemical terrorism attack 
A CT PHL will be issued an effective CLIA certificate at their highest level of testing, 
regardless of whether they are testing human samples or not.  This policy applies to 
only the laboratories designated by APHL.  This allows the laboratory to operate within 
the scope of CLIA, ensure quality patient testing and avoid delays should an untoward 
event occurs.  These laboratories may hold either a certificate of compliance or 
certificate of accreditation depending upon whom they select as their survey agency, as 
do all enrolling laboratories.  A new CT PHL is surveyed immediately and within the 
surveyors availability using the CLIA Outcome Oriented Survey Process (OOSP).  
Subsequent surveys should be performed following the survey agencies routine 
biennial schedule.  If a CT PHL already has a CLIA certificate, but has added chemical 
terrorismtesting to its test menu since its last survey, the surveyors should visit and 
review only this testing in the interim until the next biennial survey. 
 
All CT PHL surveys will be entered into the CLIA database by the CLIA Regional 
Offices.  Survey findings are entered in to the Notes portion to identify these 
laboratories in the system, but do not identify them in any fields that could be observed 
externally. 
 
6014 - CLIA Certificate Status Changes 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Certificate of Waiver or Certificate of PPM 
Laboratories operating under a CoW or Certificate for PPM procedures must notify 
HHS or its designee prior to performing and reporting results for any test not covered 
under their certificate. To become certified to conduct the additional testing, the 
laboratory must submit a new CLIA application (Form CMS-116).  For specific 
instructions on the application process, see 6006.  A fee coupon will be system 
generated once the data is entered into the CLIA data system.  The certificate is issued 
once the appropriate fees are paid. 
 
  Certificate of Compliance to Certificate of PPM or Certificate of Waiver 
A laboratory operating under a Certificate of Compliance that is no longer performing 
nonwaived testing (excluding PPM procedures), may request to change to either a 
CoW or a certificate for PPM procedures.  The laboratory must submit a new CLIA 
application (Form CMS-116).  For specific instructions on the application process, see 
6006.  However, the laboratory is not required to change its certificate.  The 
laboratory may decide to retain its current certificate and change the type of certificate 
upon its certificate expiration.  If the laboratory elects to change the certificate, the 
data must be updated in the CLIA data system; therefore, a new certificate and fees 
will be system generated.  The certificate will be issued after the fees are paid. 
 
Certificate of Accreditation to Certificate of PPM 
When a laboratory that operates under a CLIA Certificate of Accreditation decides to 
conduct PPM procedures ONLY, the laboratory may downgrade its Certificate to a 
CLIA Certificate for PPM procedures.  The laboratory must submit a new CLIA 
application (Form CMS-116).  For specific instructions on the application process, see 
6006.  It may not continue to hold a Certificate of Accreditation.  (The laboratory may 
continue voluntarily to be accredited by an AO.  However, this accreditation would not 
be for CLIA purposes.) 
 
Certificate of Compliance to Certificate of Accreditation 
A laboratory requesting a change from a Certificate of Compliance to a Certificate 
of Accreditation must be in CLIA Condition-level compliance.  Once a credible AoC 
is received, and compliance is verified, the certificate change data may be entered 
into the CLIA data system.  A laboratory can elect to retain the Certificate of 
Compliance until the certificate expiration date and subsequently change the 
certificate status.  If the laboratory elects to change its certificate status prior to the 
expiration date of the current CLIA certificate, the data system must be updated.  The 
laboratory must submit a new CLIA application (Form CMS- 116).  For specific 
instructions on the application process, see 6006.  A new certificate will be 
generated once the data is entered into the data system; therefore, a Certificate of 
Registration and fees will be system generated.  The Certificate of Registration will 
be issued once the appropriate fees are paid.  The laboratory then continues the 
process for a Certificate of Accreditation. 
 
Certificate of Accreditation to Certificate of Compliance 
In order for a laboratory to request a change from a Certificate of Accreditation to a 
Certificate of Compliance, the laboratory must submit a new CLIA application (Form 
CMS-116) to the appropriate State Agency.  For specific instructions on the application 
process, see 6006.  The CLIA system must be updated and a Certificate of Registration 
with appropriate fees will be system generated.  The Certificate of Registration will be 
issued after the fees are paid.  The laboratory then continues the process for a 
Certificate of Compliance. 
 
 
  6016 - Notification of Change in Laboratory Operations and Retention 
Requirements 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When a laboratory provides written notification or, as necessary, a new Form CMS-116 
concerning changes listed in 6016.1, the SA enters the information into the CLIA data 
system and retains a copy of the laboratorys documentation (i.e., Form CMS-116).  The 
SA must not accept oral notices of change or intent to change. 
 
6016.1 - Change in Laboratory Operations 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
For information concerning change of ownership see Chapter 2, 2005. A new Form 
CMS-116 must be obtained when any of the following laboratory changes or events take 
place: 
 
  Initial Application 
  Survey, Initial or Recertification 
  Certificate Status Change other than to a Certificate of Waiver 
  Reinstatement of CLIA Certificate with a Gap in Certification 
  Laboratory Director Change (Provider-performed 
Microscopy (PPM); Certificate of Compliance) 
 
At a minimum, written notification must be obtained when any of the following 
laboratory changes take place: 
 
  Certificate Status change to Certificate of Waiver 
  Name of Laboratory 
  Location (Physical Location) 
  Location (Mailing Address) 
  Location (Corporate Address) 
  Ownership 
  Tax ID (EIN) 
  Specialty or Subspecialty change (Certificate of Compliance) 
  Telephone and Fax Numbers 
  Reinstatement - Activate without a Gap 
  Multiple Site 
  Change in Accreditation Organization 
  Voluntary Closure/Termination 
  Personnel-Technical Supervisor 
 
Written notification includes email, fax or hard copy.  The written notification must 
include the laboratorys name, CLIA number, the name of Laboratory Director and 
Owner, the change(s) being made, and the signature of the Laboratory Director or 
his/her designee. In lieu of written notification, a new Form CMS-116 is also 
  acceptable.  Please note, the Form CMS-116 must be completed in its entirety.  A 
revised certificate is reissued based on the requested changes. 
 
6016.1.1 - Change in Laboratory Director for Certificate of Accreditation 
Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Once a laboratory becomes accredited by an Accreditation Organization (AO) (as 
indicated by the confirmation checkmark in the ASPEN Web CMS 116 on the AO Info 
tab), and the laboratory pays all CLIA fees, the certificate type will change from a 
Certificate of Registration to a Certificate of Accreditation (CoA).  From this point on, 
the AO will be responsible for the qualification and entry of laboratory director changes 
into the CLIA data system.  The system has been programmed to automatically generate 
a replacement certificate showing the new laboratory director name to the CoA 
laboratory. 
 
Example 1:  A State Agency receives an initial application for a Certificate of 
Accreditation and the laboratory has marked one of the approved accrediting 
organizations as the AO to which they have applied for accreditation for CLIA 
purposes.  Does the indicated AO qualify the laboratory director and enter the name 
and title into the ASPEN Web CLIA 116? 
 
Response: No.  Initial applications are entered by State Agency (SA) personnel.  
This includes performing the qualification of the laboratory director and entry of 
the name and title. 
 
Example 2:  The laboratory has been entered into the ASPEN Web CLIA 116, has 
paid its registration fee and received its Certificate of Registration.  The laboratory 
has now requested to change the director.  Does the AO indicated on the initial 
application qualify and enter the new laboratory director? 
 
Response: No.  The SA remains responsible for qualifying any laboratory director and 
entering the name and title changes while the laboratory holds a Certificate of 
Registration. The SA should send a replacement Certificate of Registration after making 
the changes. 
 
Example 3:  The laboratory holds a Certificate of Compliance. The laboratory has 
requested a change in certificate type to a Certificate of Accreditation.   Does the AO 
indicated on the request for the certificate type change (also known as a status change) 
qualify and enter the laboratory director? 
 
Response: No.  The request for a status change is treated the same way as an initial 
application. 
 
Example 4:  Due to state laboratory licensing laws, the laboratory needs to 
know when a change in laboratory director is entered by an AO so that it can 
  qualify the new laboratory director per state regulations. Is there a report the 
laboratory can access to monitor such changes? 
 
Response: Yes.  There is a nationwide report in ASPEN Web CLIA 116 that can be 
accessed by date range.  CASPER report 104 can also be used.  Remember that due to 
the overnight upload of data from ASPEN to CASPER, the information in CASPER 
will be a day behind the report in ASPEN, which shows real time data.  The advantage 
to CASPER report 104 is that it can be accessed for an individual state or region. 
 
Example 5:  When a CoA laboratory sends in a Form CMS-116 with requested 
changes, including a laboratory director change, to the State Agency, is the Form 
CMS-116 forwarded to the AO or the Regional Office (RO)? 
Response: Neither.  The State Agency keeps the Form CMS-116 as documentation of 
the requested changes and notifies the laboratory that changes other than specialties 
and laboratory directors will be performed by the SA personnel, but that any changes to 
specialties and laboratory director should be handled by the laboratorys AO and the 
laboratory should use whatever form of documentation the AO requires to submit those 
changes. The AOs do not use government forms. 
 
Example 6: Can the AOs change the demographic information associated with the 
laboratory in ASPEN Web CLIA 116? 
 
Response: No.  While the demographic information is visible to the laboratorys 
confirmed AO, the AO user is restricted from entering changes to those fields. 
 
Example 7:  Will a replacement certificate be automatically generated if my SA 
personnel make a change to the laboratory director on a Certificate of Accreditation 
while it is still under its registration certificate? 
 
Response: No.  The CLIA data system is programmed to do that only for AO users 
because they do not have access to that field in ASPEN Web CLIA 116.  Remember AO 
users cant make laboratory director changes while the laboratory is still under a 
Certificate of Registration.  The SA should send a replacement certificate after making 
the changes. 
 
Example 8:  If a CoA laboratory fails to notify an SA about a laboratory director 
change as required by state licensure requirements, will an alert be sent to the SA? 
 
Response: No. The ASPEN Web CLIA 116 does not feature alerts, but the new 
Director Change search function on the ASPEN Web CLIA 116 search page or 
CASPER report 104 will allow the 
SA to find CoA laboratories that have had laboratory director changes. (Also see 
Example 4) 
 
Example 9:  Will the AO attach the Laboratory Director qualifications in the ASPEN 
Web CLIA 116? 
   
Response: No.  The AO does not have the security rights to save attachments to the 
ASPEN Web CLIA 116 record. The documentation used by the AO for the laboratory 
director qualification will be maintained by the AO in accordance with its own 
standards. 
 
6016.2 - Retention Requirements 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
According to Section XI of the CMS Records Schedule, Form CMS-116 needs to be kept 
by the SA/RO for at least seven years.  If State law states that the Form CMS-116 needs 
to be kept for a longer period or in specific formats, then the SA may maintain the forms 
for the duration and in the form mandated by State law. 
 
6018 - Revised Certificates 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
There is currently no fee for re-issuing lost certificates, or certificates with demographic 
revisions. 
 
6020 - Fee Adjustments 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA data system is a computerized system that maintains demographic and 
CLIA user fee billing data on every laboratory that is certified to participate in the 
CLIA program. The data system supports CLIA program operations, including the 
entry and display of the CLIA application (Form CMS-116), the billing and 
collection of laboratory user fees and the issuance of certificates. 
 
Authorized users can query the CLIA data system to review CLIA certificate data and 
laboratory  accounts  data.    A  browse  feature  allows  users  to  view 
certificate/laboratory data and laboratory accounts data within the CLIA data system.  
A specific record from a list of available records or data for a specific laboratory 
within the data system may be selected.  Additional features (such as adding or 
updating information) are available based upon the security authorization of the 
individual user. 
 
Standard or user defined reports that provide general information are available 
through the CLIA data system reporting functions.  Consult with your supervisor or 
Regional Office to obtain specific instructions/training on how to use the CLIA data 
system, or any of the current available CLIA data system Users Guide(s). 
 
 
 
  6022 - CLIA Data System 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA data system is a computerized system that maintains demographic and 
CLIA user fee billing data on every laboratory that is certified to participate in the 
CLIA program. The data system supports CLIA program operations, including the 
entry and display of the CLIA application (Form CMS-116), the billing and 
collection of laboratory user fees and the issuance of certificates. 
 
Authorized users can query the CLIA data system to review CLIA certificate data and 
laboratory  accounts  data.    A  browse  feature  allows  users  to  view 
certificate/laboratory data and laboratory accounts data within the CLIA data system.  
A specific record from a list of available records or data for a specific laboratory 
within the data system may be selected.  Additional features (such as adding or 
updating information) are available based upon the security authorization of the 
individual user. 
 
Standard or user defined reports that provide general information are available 
through the CLIA data system reporting functions.  Consult with your supervisor or 
Regional Office to obtain specific instructions/training on how to use the CLIA data 
system, or any of the current available CLIA data system Users Guide(s). 
 
 
State Agency and Regional Office Roles and Relationships with other 
Federal Agencies 
 
6024 - Consultative CLIA Activities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Centers for Disease Control and Prevention (CDC) - provides scientific 
and technical assistance to CMS in the promulgation of CLIA regulations and 
CLIA related efforts. 
 
Clinical Laboratory Improvement Advisory Committee (CLIAC) - CLIAC is a 
committee that consists of experts knowledgeable in all scientific areas of the laboratory 
disciplines, the field of medicine, public health, manufacturers, clinical practice and 
consumers.  The authority for this committee is 42 U.S.C. 217a,  222 of the Public 
Health Service Act, as amended.  This committee provides scientific and technical advice 
and guidance to HHS regarding the need for, and the nature of: 
 
  Revisions to the standards under which clinical laboratories are regulated; 
 
  The impact on medical and laboratory practice of proposed 
revisions to the standards; and 
 
  The modification of the standards to accommodate technological advances. 
   
CDC oversees the CLIAC and provides CMS with any other required scientific 
and technical expertise. 
 
6026 - Regional Office (RO) Role 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CMS ROs are responsible for ensuring that CLIA laboratories provide appropriate 
quality services and the SAs operate in accordance with the 1864 agreement using CLIA 
policies and procedures.  Their major responsibilities are as follows: 
 
  Reviewing survey and certification reports submitted by the SA; 
  Initiating all adverse actions, imposing alternative sanctions in addition 
to or in lieu of principal sanctions, canceling or suspending all or part of 
the laboratorys approval to receive Medicare payments, as applicable, 
based on SA/RO recommendations, and issuing of final notices; 
 
  Monitoring and surveillance of SA expenditures and approval of SA 
budgets for the provision of cost efficient and effective survey and 
certification activities; 
 
  Assisting CO with training, projects, workgroups and policy 
development, and problem resolution; 
 
  Coordinating with the SA the orientation of all new CLIA 
surveyors and staff; 
 
  Performing validation and complaint surveys of laboratories in States 
whose laboratory licensure programs have been approved by CMS and 
accredited laboratories.  (See SOM Chapter 5 regarding additional 
information about complaint investigations of laboratories); 
 
  Conducting onsite surveys of federally and State-operated 
CLIA-certified laboratories; 
 
   Performing transfusion-related fatality surveys and 
investigations according to CMS policies and 
procedures; 
 
  Coordinating follow-up of complaints with SAs and AOs and 
communicating findings; 
 
  Notifying CO of training and policy needs, PT referrals and 
circumstances with significant impact to the public health, 
  media coverage, Federal/State Congressional or political 
concerns; 
 
  Performing State Agency Performance Reviews (SAPR) and 
Federal Monitoring Surveys (FMS) to ensure SA conformance with 
CMS policies and procedures; 
 
  Providing technical assistance to SAs and laboratories; 
 
  Implementing CMS CLIA policies and procedures in their 
respective States and ensuring consistent application by the 
SA; and 
 
  Identifying administrative/program problems at the State, 
regional or national level. 
 
6028 - Laboratories Under Direct RO Jurisdiction 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The following facilities may fall under the direct jurisdiction of the RO if they 
test human specimens and report out the results for purposes of diagnosis, 
assessment or treatment of the subject.  Where they do, all survey and 
certification activities are to be performed by RO staff. 
 
 Federal laboratories subject to CLIA 
 State laboratories within their region 
 Indian Health Service laboratories 
 
Since Indian health tribal facilities may or may not be under 
Federal jurisdiction, the RO determines whether the RO or the SA 
has jurisdiction. If they are run by the Department of the 
Interior/Bureau of Indian Affairs, they are considered federal 
laboratories and therefore are inspected by the RO. (See SOM 
Chapter 1, 1018A) 
 
The RO is also responsible for designating all federal jurisdictional laboratories as 
such in the CLIA data system. 
 
6030 - RO Review of State Agency (SA) Certification Activities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CLIA has a single set of regulations applicable to all types of laboratories or entities 
performing laboratory tests based on test complexity.  The RO is responsible for 
reviewing certification activity of the SA.  The primary objective of this review is to 
  ensure that the certification decision is supported by appropriate documentation that 
serves as sufficient evidence of the laboratorys compliance with the laws and 
regulations governing program participation. (See 6230) 
 
If the RO determination disagrees with the SA, the decision must be supported by 
evidence.  The RO justifies the determination in writing and attempts to resolve the 
disagreement.  To foster continuous quality improvement, the RO communicates the 
resolution to CO.  If a disagreement involves interpretive policy that cannot be 
resolved, it should be referred to the CO for resolution. 
 
6032 - State Agency (SA) Role 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
State agencies are responsible for CLIA survey and certification activities (including 
most data entry) for non-Federal laboratories within their respective States. Lists of 
laboratories ready to be inspected are available to SAs through the CLIA data system. 
 
The SA makes determinations of compliance with CLIA requirements based on survey 
findings. The policies and procedures for these actions are in the SOM Chapters 5 and 6. 
In the area of laboratories, they include but are not limited to: 
 
  Identifying and enrolling potential laboratory participants. 
 
  Communicating  effectively  and  timely  in  a  verbal  and  written 
manner with laboratories, peers, supervisors and ROs according 
to standard operating procedures (SOPs). 
 
  Managing the CLIA data base using CLIA system applications 
according to procedure. 
 
  Responding timely to complaints, as per RO direction. 
 
  Attending CO/RO training courses, as directed. 
 
  Developing internal systems and processes to effectively and efficiently 
perform CLIA related duties and meet the State Agency Performance 
Review (SAPR) requirements. 
 
  Providing technical assistance to laboratories concerning the regulations to 
enable laboratories to qualify for participation in the program (meet 
applicable requirements). 
 
  Scheduling, preparing for, conducting and appropriately following up 
surveys in which the State agency determines the laboratory's compliance 
with the CLIA requirements in accordance with the Outcome Oriented 
Survey Process (OOSP) and within stated timeframes. 
   
  Citing deficiencies according to CLIA Principles of Documentation (PoD) as 
needed using the most appropriate citation. 
 
  Soliciting and reviewing a PoC, recommending certification and 
recertification, and other follow-up actions. 
 
  Recommending sanctions to the RO if laboratories do not 
meet the CLIA requirements. 
 
  Conducting validation surveys of accredited laboratories per 
the SOM protocol. 
 
  Performing periodic PT desk review and corresponding follow ups. 
 
  Participating in federally directed efforts. 
 
6034 - CLIA Laboratories - Compliance With Civil Rights Requirement 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CLIA laboratories are required to comply with certain requirements enforced by the 
Office for Civil Rights (OCR), including the Americans with Disabilities Act, but are 
not subject to traditional pre-certification assurance investigations.  These 
requirements are enforced only on the basis of complaints.  The OCR makes any 
necessary investigations and determinations related to compliance with civil rights 
requirements.  The SA forwards complaints concerning a CLIA laboratorys 
noncompliance with Federal civil rights requirements to the RO.  The RO must not 
assess the validity of such complaints. Rather, it must forward such complaints to OCR 
for review and investigation.  As necessary, OCR forwards the complaint to the 
Department of Justice (DOJ) for evaluation, investigation, and disposition.  The RO 
does not investigate Federal civil rights complaints under any circumstances.  OCR or 
the DOJ is responsible for investigating Federal civil rights complaints.   CMS is not 
authorized to bill the laboratory for the cost of a complaint survey for noncompliance 
with civil rights as part of the laboratorys user fee obligation. 
 
6036 - Referrals to the Office of Inspector General (OIG) for CLIA 
Violations (e.g., Testing without a CLIA Certificate) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory is operating without a CLIA certificate, the SA or RO as applicable, 
notifies the laboratory that it is violating CLIA requirements and warns the laboratory 
of the consequences of such violations.  The laboratory is afforded an opportunity to 
respond within 14 days.  If it does not respond, or does not cease testing without a 
certificate within 30 days of the date of the notification to the laboratory, the RO will 
notify the OIG of the violation.  If applicable, the SA forwards documentation to the RO 
within 20 days of the date the violation notice was sent to the laboratory.  In addition, 
  the RO also refers to the OIG: 
  Cases of misrepresentation in obtaining a CLIA certificate; 
 
  Laboratories that perform or represent themselves as a laboratory entitled 
to perform tests not authorized by its CLIA certificate; and 
 
  Laboratories that violated or aided or abetted in the violation of any 
provision of CLIA and its implementing regulations. 
 
6038 - Transfusion Services Covered by CMS/FDA Memorandum of 
Understanding (MOU) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS and the FDA have a MOU concerning transfusion services. For the purposes of the 
MOU, a transfusion service is defined as an establishment which is engaged in the 
compatibility testing and transfusion of blood and blood components, but which neither 
routinely collects nor processes blood and blood components. Transfusion services are 
exempt from the FDA registration and are not routinely inspected by the FDA. 
 
Transfusion services are allowed to perform certain specified blood processing 
activities. Transfusion services may prepare Red Blood Cells or recovered plasma 
from Whole Blood, pool Platelets or Cryoprecipitated AHF for ease of transfusion, 
or issue bedside leukocyte reduction filters with blood components. 
 
However, if an establishment performs any other blood processing activity, including 
but not limited to freezing, deglycerolizing, washing, irradiating, rejuvenating, or 
leukocyte- reducing Red Blood Cells, it is not considered to be a transfusion service. 
Blood establishments performing these functions are required to register with the FDA 
and are routinely inspected by the FDA. 
 
NOTE: The definition of transfusion service for the purposes of the CMS/FDA 
MOU is different than the CLIA definition of transfusion service. (See SOM 
Appendix C, 493.1103) 
 
The scope of the CMS/FDA MOU is limited to transfusion services that are CLIA- 
certified and are exempt from the FDA registration as blood establishments. Facilities 
that are both CLIA-certified and registered with the FDA as blood establishments are 
outside the scope of the MOU. 
 
6038.1  Inspections of Transfusion Services 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA routinely conducts CLIA surveys of non-accredited immunohematology 
laboratories that meet the definition of a transfusion service under the CMS/FDA 
MOU. These transfusion services are not registered with the FDA and the FDA does 
  not routinely inspect these facilities. An example of this type of facility is a hospital 
transfusion service that obtains its blood products from an outside provider. 
 
Under the MOU, the SA must survey transfusion services for compliance with all 
applicable CLIA regulations, including those FDA regulations that are cited in 42 CFR 
Part 493, Subparts J and K. It is not required that the SA survey transfusion services 
for any other FDA regulations. 
 
Blood establishments that are registered with the FDA are routinely inspected by the 
FDA. Non-accredited immunohematology laboratories located within these blood 
establishments are also routinely surveyed by the SA for CLIA. Because these facilities 
receive inspections by both agencies, they are not covered by the CMS/FDA MOU. An 
example of this type of facility is a community blood center in which blood is collected, 
processed, tested and distributed to hospitals. 
The following table summarizes the different types of facilities: 
 
 
Non-  Blood Establishment  Surveyed  Inspected  Covered 
Accredited  by State  by FDA?  by MOU? 
 
Immuno  Registered  FDA  Agency for     
hematology  with FDA?  Registration  CLIA? 
Laboratory?  Exempt? 
Y  Y  N  Y  Y  N 
Y  N  Y  Y  N  Y 
 
 
6040 - Transfusion-Related Fatalities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Facilities, including laboratories, involved in the collection or transfusion of blood or 
blood products must report transfusion-related fatalities to the FDAs Center for 
Biologics Evaluation and Research (CBER), Office of Compliance and Biologics 
Quality.  The FDA notification process, including contact information, can be found at 
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/Transfus
ionDonat ionFatalities/. 
 
The FDA notifies CMS CO of all transfusion related fatalities.  (NOTE: The reports 
from the FDA are considered confidential and may only be shared within CMS or the 
SA. They may not be shared with any other party, including accreditation 
organizations.) CMS CO evaluates the information received from the FDA. As 
applicable, CO may request that a survey of the facility be performed. The request is 
made to the appropriate Regional Office. Depending on the circumstances of the fatality, 
a CLIA survey, a survey by another CMS program (e.g., hospital), or both, may be 
necessary. The surveys may be performed simultaneously or separately. Either the RO 
  or SA (including CLIA-exempt States) may perform the survey, but the survey may not 
be delegated to an accreditation organization. For investigations involving staff from 
more than one program unit (e.g., CLIA and hospital), it is important to work as a team 
to coordinate activities.  Within CLIA, the RO is the point of contact for coordinating 
the investigation. 
 
The investigation should also include a review of other transfusion reaction 
reports to ensure that proper procedures were followed and corrective actions 
implemented.  The RO should assure that all measures are taken to correct the 
situation which led to the death as well as any other serious deficiencies 
uncovered in the course of the survey. 
 
For CLIA purposes, transfusion-related fatalities that warrant surveys are considered to 
be complaints. The policies and procedures that apply to complaint investigations apply 
to transfusion-related fatality investigations. The investigations are entered and tracked in 
the ASPEN Complaints/Incidents Tracking System (ACTS). When performing 
investigations in accredited laboratories or laboratories in exempt states, follow standard 
policies and procedures for RO authorization, review of deficiencies, and communication 
with the laboratory, the accreditation organization, and the exempt state. 
 
The RO or SA will conduct the survey within 45 days of the notice from CO, with 
notification to CO when the survey is complete. The information entered in ACTS is 
sufficient for reporting to CO. Investigations of transfusion-related fatalities are 
generally announced, since the facility is aware of the possibility of a follow up after 
the report is made to the FDA. These investigations are an exception to the general 
policy that complaint surveys are not announced. However, if the report of the fatality 
originates with any other source, e.g., media or anonymous complaint, the SA or RO 
conducts an unannounced survey. 
 
The RO or SA will assess the facilitys compliance with applicable CLIA conditions 
and standards during the onsite review. If condition-level deficiencies are found, a full 
CLIA inspection is conducted. The survey may uncover problems that warrant 
investigation of departments outside the laboratory, e.g., Operating Room, Emergency 
Room, nursing services, or medical records, to follow up on problems that may have 
led to the fatality. Since CLIA is specific only to laboratory testing, the RO forwards 
relevant information to other programs, e.g., hospital, for follow up as necessary. 
(NOTE: When citing deficiencies related to a CLIA survey, only D-tags should be used 
on the 2567. A-tags and State tags should not be used on the 2567 given to the 
laboratory for the CLIA survey.) In addition, more than one location may be involved, 
for example, when the blood is tested in one facility and transfused in a different 
facility. 
 
The RO or the SA will issue deficiencies and document the survey in ACTS using 
standard policies and procedures.  Ensure that all documentation is included in ACTS. 
 
 
                                      Proficiency Testing 
 
6042 - Proficiency Testing (PT) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
42 CFR Part 493 Subpart H, Participation in Proficiency Testing for Laboratories 
Performing Non-waived Testing, provides laboratories with the PT requirements they 
must follow to comply with CLIA. The subpart specifies requirements for PT 
enrollment, testing, PT sample handling, and documentation.  The prohibition of 
referral of PT samples to another laboratory is found at 42 CFR Part 493.801(b)(4) 
and, if identified, carries one of the most severe sanctions in the CLIA law and 
regulations. The subpart also identifies successful participation in a CMS-approved PT 
program and how a laboratory may be reinstated when it has performed 
unsuccessfully. (Please see 42 CFR Part 493.2, Definitions, for unsatisfactory 
participation and unsuccessful participation.) 
 
NOTE:  The referral to another laboratory of a sample from a PT program by ANY 
laboratory of ANY certificate type is considered PT referral.  If a laboratory enrolls 
and participates in PT, regardless of certificate type, all rules related to PT referral 
apply.  
 Notify the RO if PT referral is identified.  For additional information on PT 
Referral, see 6061. 
 
PT Program Approval: Not-for-profit organizations or States may apply to CO to 
become a CMS-approved PT program for specific subspecialties and analytes. CO PT 
specialists perform an in-depth review of applications submitted for approval to 
determine whether the program meets the requirement of 42 CFR Part 493 Subpart I. 
The CLIA statute requires annual review of approved programs. Annual re-approval 
reviews are also conducted by CO specialists. Approved PT programs and the 
subspecialties and analytes for which they are approved are listed on the CMS CLIA 
Web site each year. 
 
6044 - PT Enrollment and CASPER System Reports 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA or RO has access to the following reports from the CASPER System: 
  CASPER Report 150 - PT program names, addresses and 
telephone numbers, program demographics and tests for which 
the program is approved; 
  CASPER Report 152 - Listing of corrected scores; 
  CASPER Report 153 - Listing of laboratories by state or region with 
unsuccessful performance; 
  CASPER Report 155 - An individual laboratorys PT scores; and 
  CASPER Report 157 - Laboratories requesting excused participation (See 
example of this exception at 42 CFR Part 493.841(c)(1)-(3)). 
   
To obtain directions on how to use the CASPER system, consult your 
supervisor or Regional office. 
 
6046 - PT Enrollment Information 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Title 42 CFR 493.801(a)(1) requires laboratories performing moderate and/or high 
complexity tests to enroll in one or more CMS approved PT programs for each 
specialty, subspecialty, analyte, or test listed in 42 CFR 493, Subpart I. The laboratory 
must designate a specific survey (as well as PT program) for each specialty, 
subspecialty, analyte, or test for regulatory purposes, so that only one score is 
considered for that area per testing event.  The specialty, subspecialty, analyte or tests 
for PT are listed in 42 CFR 493.909 through 493.959. A condition level deficiency (42 
CFR Part 493.801) is cited if a laboratory has not enrolled for even one of these tests if 
performed in the laboratory. If a laboratory fails to enroll and/or appropriately test PT 
samples, the RO may impose any of the sanctions described in 42 CFR 493, Subpart R. 
If a laboratory has not enrolled in an approved PT program, the technical assistance 
and training sanction cannot be imposed when noncompliance with the condition, 42 
CFR Part 493.801 is found, but instead the SA may recommend to the RO appropriate 
sanctions if the non-enrollment isnt corrected in a timely manner. 
 
Each calendar year the PT programs transmit enrollment records to the PT 
Monitoring System within the CLIA data system for each laboratory participating in 
their programs.  Laboratory demographics and every test for which the laboratory has 
enrolled are listed on CASPER Report 155, PT Individual Laboratory Profile.  This 
information is transmitted just prior to the first testing event of the year.  Additional 
enrollments (usually for new laboratories) are sent to the system as enrollment occurs 
throughout the year. The surveyor must verify that laboratories are correctly enrolled 
during the on-site survey.  If the SA or RO wishes to verify enrollment more frequently, 
they may print out CASPER Report 155 for the prior year and compare it to new 
enrollment for the current year.  If there are tests missing on the current years 
enrollment when compared to the prior year, the SA or RO should call the laboratory 
to ask for proof of enrollment for the missing tests or ask for a written statement from 
the laboratory director that it has discontinued performing the missing tests. 
 
6048 - PT Participation and Testing Requirements 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory must meet the CLIA regulatory requirements for enrollment, 
participation, and testing as specified in Subpart H at 42 CFR Part 493.801. The SA, 
adhering to the time frames and guidelines in Appendix C of the SOM, reviews all 
related documentation. If failure to meet the specific requirements of 42 CFR Part 493 
Subpart H is identified by the SA, appropriate actions may be initiated and sent to the 
RO for review and concurrence. 
   
If the SA identifies any information on survey or by any other means that indicates the 
possibility that any PT sample has been referred to another laboratory for testing prior to 
an event cut off date, the RO must be notified immediately. The RO will instruct and 
advise the SA surveyor of the appropriate actions the surveyor must take.  The RO may 
contact CO with any questions. 
 
All documentation to support the finding of any PT referral is forwarded to CO for 
review by the PT Referral Team who will recommend appropriate sanctions in 
accordance with Subpart R.  (See 6061.) 
 
6050  Monitoring of PT Scores  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA routinely monitors their states laboratory performance by reviewing CASPER 
Report 153, PT Unsatisfactory/Unsuccessful Report, from the PT Monitoring System. 
 
All SAs are required to conduct PT desk reviews for their Certificate of Compliance 
laboratories at least every 30-45 days using the PT Monitoring System Reports 153 and 
155.  The SA mustverify the scores using information from the PT provider and/or the 
laboratory prior to recommending an action, and take any necessary follow-up actions 
based on their findings in collaboration with their RO. 
 
PT must also be reviewed during the on-site survey. Prior to the on-site survey, the SA 
will review CASPER Report 155, PT Individual Laboratory Profile, which will display 
the individual laboratorys PT performance.  The SA may print the reports on prior 
individual laboratory performance to take with them on survey and compare any 
specific PT results that the PT system scores indicate as unsatisfactory or unsuccessful.  
The SA must ensure that the laboratory has effectively corrected all problems that lead 
to an unsatisfactory or unsuccessful PT performance and has taken steps to prevent a 
recurrence of the problem(s) that caused the unsatisfactory or unsuccessful 
performance.  The SA should also review quality control results with patient results 
during the period of time when the poor performance occurred. 
 
Unsuccessful participation in PT, unsatisfactory PT performance and unsuccessful 
PT performance are defined at 42 CFR Part 493.2, Definitions. 
 
Unsuccessful participation in PT is defined as any of the following: 
Unsatisfactory performance for the same analyte in two consecutive or two out of three 
testing events; repeated unsatisfactory overall testing event scores for two consecutive 
or two out of three testing events for the same specialty or subspecialty; or an 
unsatisfactory testing event score for those subspecialties not graded by analyte (i.e., 
bacteriology, mycobacteriology, virology, parasitology, mycology, blood compatibility, 
immunohematology, or syphilis serology) for the same subspecialty for two consecutive 
or two out of three testing events. 
 
  Unsatisfactory PT performance means failure to attain the minimum satisfactory 
score for an analyte, test, subspecialty, or specialty for a testing event. 
 
Unacceptable PT performance means unsatisfactory performance for a single 
analyte. Unacceptable performance is not used to describe an unsatisfactory score 
for a subspecialty (such as bacteriology or virology) that does not contain 
analytes. 
 
Unsuccessful performance may be used interchangeably with unsuccessful 
participation for non-cytology PT. 
 
A rolling time frame is used to determine unsuccessful PT performance wherein the 
laboratory incurs either two unsatisfactory scores for two of three consecutive testing 
events or two consecutive testing events, for an analyte, subspecialty, or specialty.  The 
time frame does not stop, nor does it re-set annually.  It will be based on information 
available in the CASPER reports. 
 
The SA will recommend sanctions or enforcement actions to the RO for failure to meet 
PT requirements for successful participation. This may only be done after the SA has 
verified the PT results from the PT program or from the laboratory. Specifically, SA 
follow-up action for unsuccessful PT performance should consist of: 
 
  Obtaining the results for each unsatisfactory analyte, subspecialty, or 
specialty that contributed to the laboratorys unsuccessful performance 
from the laboratory or from the PT program; and 
 
  Reviewing the PT performance reports and determining if the unsatisfactory 
results truly represent the laboratorys failure to perform and report the test(s) 
satisfactorily. For example, clerical errors and delays in reporting still 
constitute failure; however, an instrument failure, a PT program data input 
error, or a backorder of necessary reagents may not be within the laboratorys 
control. Careful reviews will provide a fair evaluation of the laboratorys 
performance and insight into the reason(s) for the PT failure. Problems 
regarding PT samples such as matrix effects and scoring are to be handled 
between the laboratory and the PT program. 
 
6054 - Unsuccessful Performance in Proficiency Testing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If it is determined that a laboratory has performed PT unsuccessfully, the SA follows the 
following procedures. 
 
All sanctions are imposed in accordance with 42 CFR Part 493 Subpart R and 
taken by the RO. 
 
  If an initial unsuccessful PT performance by a laboratory (that is, the laboratory has 
never performed unsuccessfully for the particular test, specialty, subspecialty, or 
analyte) is confirmed, the SA may recommend to the RO that the laboratory undertake 
additional training, obtain technical assistance, or both, rather than recommending 
the imposition of alternative or principal sanctions.  No on-site survey is necessary to 
initiate this action. 
 
NOTE: The SA may recommend training and/or technical assistance for 
an initial unsuccessful PT performance EXCEPT when one or more of 
the following exists: 
 
  There is immediate jeopardy to patient health or safety; 
 
  The laboratory fails to adequately correct the problem causing the 
unsuccessful performance; 
 
  The laboratory has a history of poor compliance with CLIA 
requirements. See 42 CFR Part 493.803(c) for regulatory 
specifications. 
 
If the RO agrees with the recommendation of technical assistance and/or training, a 
credible allegation of compliance to show that the laboratory corrected the problem that 
caused  the  unsuccessful  performance  should  be  obtained  from  the  laboratory.  
Documentation of the SA determinations and follow-up should be maintained.  For an 
initial  unsuccessful  PT  performance,  the  RO  may  allow  the  SA  to  request  that  a 
laboratory  undertake  training  and  technical  assistance  (T&TA)  provided:  1)  the 
laboratory has a good history of compliance; 2) there is no immediate jeopardy, no PT 
referral, no current significant quality problems; and 3) the laboratory has agreed to 
correct the problem causing the unsuccessful PT. 
 
  The SA must first verify that the PT scores are accurate by contacting 
either the PT program or the laboratory to review the results of the testing 
that caused the unsuccessful performance. After verification of the scores, 
the SA (with RO consent   
 
NOTE: This may be a blanket consent for SAs for all initial unsuccessful 
PT performance) sends the laboratory a letter proposing T&TA with a 
Form CMS-2567 citing the Condition-level deficiency.  The letter should 
also include the consequences of another PT failure. 
 
  The laboratory may continue testing during this period. 
 
  The laboratory must document completion of the T&TA and correction of 
the  problem(s)  that  caused  the  unsuccessful  PT  performance.  The 
documentation must be submitted promptly to the SA. 
 
    When the laboratory completes the T&TA and notifies the SA, it is 
documented as back into compliance by the SA. 
 
  These actions for the initial unsuccessful PT performance must be 
entered into the CLIA enforcement data base in a timely manner by the 
RO. 
 
For a non-initial unsuccessful PT performance, the SA must verify that the scores are 
accurate by contacting either the PT program or the laboratory to review the results of 
the testing that caused the unsuccessful performance. 
 
  If the subsequent unsuccessful PT performance is confirmed in a 
different analyte, subspecialty or specialty, the RO has the option, based 
on the laboratorys compliance history, SA recommendation, and the 
specific circumstances that caused the failure, to impose another T&TA 
rather than impose a sanction as specified in subpart R.  If the RO 
determines that another T&TA is warranted, follow the procedure noted 
above for an initial unsuccessful PT performance. 
 
  If the failure is for the same test, analyte, specialty or 
subspecialty, then a more stringent sanction, as noted below, 
is imposed. 
 
  If the imposition of a more stringent sanction is decided, the SA refers the 
Form CMS- 2567 with Condition-level noncompliance to the RO. 
 
  The RO then sends a letter along with the Form CMS-2567 citing the 
Condition-level  deficiency(ies)  to  the  laboratory  that  proposes 
sanctions, including, but not limited to, a limitation of the laboratorys 
certificate in the area of failure, and cancellation of their Medicare 
and/or Medicaid payment immediately for no less than six months in the 
area of failure.If the effective date of the sanctions is not delayed (such 
as in the case of immediate jeopardy) or laboratory does not appeal the 
sanctions, they are imposed. 
 
  In order to come back into compliance and remove the sanctions, the 
laboratory must obtain satisfactory scores in 2 consecutive re-
instatement PT events. 
 
  The  laboratory  may  choose  to  use  2  routine  PT  events  as  their 
reinstatement  PT  or  they  may  obtain  off-cycle  re-instatement  PT 
samples  from  their  PT  program  or  any  other  CMS-approved  PT 
program. 
 
  The scores of the re-instatement PT are entered into the CLIA PT data 
base as non-routine by the PT program and may be found at the 
  bottom of CASPER Report 155. The laboratory will receive copies of 
their  re-instatement  scores  from  the  PT  program  from  which  it 
purchased the two re-instatement events. 
 
To initiate the appropriate enforcement actions, use the guidance at Sections 6276- 
6280.  Please see the Notice of Proposed Limitation of the CLIA Certification and 
Suspensions of Medicare Payments When a Laboratory Has Failed to Participate 
Successfully in a Proficiency Testing Program. 
 
6056 - Excused Failure to Participate in a Testing Event for a Particular 
Analyte 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory has received a score of zero due to failure to participate in a testing 
event for an analyte or subspecialty without analytes, the laboratory may request 
excused participation. This request is usually made when instrumentation is inoperative 
or reagents for testing are unavailable during the testing event. (See 493.845(c)(1)-(3)) 
An excused participation may be granted only if: 
 
  Patient testing for the specialty, subspecialty, analyte was suspended 
during the time frame allotted for testing and reporting of PT results; 
 
  The laboratory notifies SA/RO and the PT program within the time frame 
for submitting PT results of the suspension of patient testing for that 
specialty, subspecialty, or analyte and of the circumstances that led to 
failure to perform testing on the PT samples; and 
 
  The laboratory participated in the previous two testing events for 
the specialty, subspecialty, or analyte. 
 
If the SA/RO accepts the circumstances given by the laboratory for not participating, the 
score of 100 percent given by the program is allowed to remain. If the SA/RO does not 
accept the circumstances given by the laboratory to justify its lack of participation, the 
SA/RO will notify the PT program to change the 100 percent score to a zero to indicate 
lack of participation.  Only the PT program can change a laboratorys PT score in the PT 
Monitoring System which will then be reflected in the CASPER reports. 
 
6060 - Reinstatement After Failure to Successfully Participate in 
Proficiency Testing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The laboratory must meet the requirements for reinstatement when: 
 
  A laboratory has been required to cease testing an analyte or 
subspecialty without analytes or a specialty; 
   
  The laboratorys certificate has been suspended or limited; or 
 
  The laboratory voluntarily withdraws testing of the 
unsuccessful area of participation. 
 
Reinstatement requires satisfactory performance on two consecutive PT events for the 
specialty, subspecialty, or analyte that the laboratory previously failed. Sustained 
satisfactory performance (two consecutive events) demonstrates that the laboratory has 
identified and corrected the area of failure that caused the original unsuccessful 
performance. A laboratory that has had its certificate suspended, limited or cancelled 
due to unsuccessful PT participation may not be reinstated or receive Medicare or 
Medicaid payments for a period of at least six months. The laboratory must re-apply to 
CMS to have the specialty, subspecialty, or analyte recertified. A revised application 
and certificate are necessary during the period of suspension or limitation. The 
laboratory may be required to pay a fee to cover the cost of issuing the revised 
certificate. 
 
The laboratory may voluntarily withdraw from testing prior to the RO sending the letter 
to impose (i.e., imposed sanction notice) a sanction or limitation to the laboratory if it 
notifies the SA that it has stopped testing the unsuccessful analyte(s), subspecialty, or 
specialty.  The laboratory must still complete the two consecutive re-instatement PT 
events with satisfactory scores and correct the problem that caused the unsuccessful 
performance. If the laboratory satisfactorily completes the two re-instatement events and 
has not received the imposed sanction notice, it will be considered as back in 
compliance. This may be completed in less than 6 months. The SA will monitor this in 
coordination with the RO and utilize the same procedure as indicated for all 
unsuccessful PT performance. 
 
Re-instatement (non-routine in the PT system) PT samples are NOT included in the 
grading for routine PT events that are sent 3 times per year and are, therefore, not 
counted toward a determination of PT performance. 
 
If a laboratory voluntarily stops testing in the area of failure, it may resume testing 
when it has demonstrated sustained satisfactory performance for two consecutive 
testing events; the PT samples may be tested as soon as the laboratory has identified 
and corrected the cause of theoriginal unsuccessful performance. Reinstatement 
samples (referred to as non-routine in the CASPER reports) should be purchased from 
the program in which the laboratory is enrolled for the failed analyte. If samples are not 
immediately available, the laboratory may purchase the samples from another approved 
program. The RO will make the final determination whether reinstatement requirements 
are met. 
 
 
 
  6061  PT Referral 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the SA identifies or suspects PT referral is occurring or has occurred, whether during 
an onsite survey, complainants allegations, PT desk review, or other means, contact the 
RO immediately.  If the RO directs the SA to investigate the potential PT referral, collect 
all information related to the PT referral including all records, interviews and 
observations and send the information to the RO immediately.  The RO will notify CO of 
the potential PT referral and send all documents to CO for review by the PT referral 
team.  The CO PT referral team will provide a recommendation for sanctions in 
accordance with Subpart R for all PT referral cases. See 6276.2 for enforcement and 
sanction information related to PT referral.   
 
Documentation forwarded to CO should include, at a minimum: 
 CMS-2567 
 SOP for PT and the specific analyte, test, specialty, or subspecialty 
approved at the time of the survey 
 Survey notes and evidence 
 PT submission forms 
 Any written communication between lab personnel 
 Instrument printouts 
 
If it is determined that PT samples or PT results have been referred to another 
laboratory, PT Referral is cited. The SA prepares a CMS-2567 including the 
deficiencies related to the PT referral at D2000 and D2013.  (Per Mandatory 
Citations). 
 
Do not solicit an Allegation of Compliance from a laboratory when it has been 
determined that the laboratory intentionally referred its PT samples to another laboratory 
for analysis and submitted the other laboratorys results as its own. 
 
The regulations divide the PT referral sanctions into three categories based on the 
severity and the extent of the referrals. 
1.  The first category is for the most egregious violations, encompassing cases of 
repeat PT referral or cases where the laboratory reports another laboratorys 
test results as its own. 
For example, a laboratory may have two distinct sites, Laboratory A and 
Laboratory B, that operate under different CLIA numbers.  Laboratory A has 
received PT samples to be tested as part of its enrollment in PT as required by the 
CLIA regulations. If Laboratory A were to refer PT samples to Laboratory B, 
receive test results back at Laboratory A from Laboratory B prior to the event 
  cutoff date, and report to the PT program those results obtained from Laboratory 
B, the scores for the PT event would not reflect the performance of Laboratory A 
but the performance of Laboratory B.  The PT scores would actually be reflective 
of the accuracy and reliability at Laboratory B rather than A, the purpose of the 
PT would be undermined. 
2.  The second category PT referral includes when a laboratory reports its own 
PT sample results, but obtains test results for PT samples from another 
laboratory on or before cut-off date. 
For example, a laboratory refers PT samples to a laboratory that operates 
under a different CLIA number before the PT event close date and, while the 
laboratory reports its own results to the PT program, it receives results from 
the second laboratory prior to the event close date.  Such a referral situation 
allows the referring laboratory an opportunity to confirm, check, or change its 
results prior to reporting its results to the PT program. 
3.  The third category of PT referral includes the scenario in which the referring 
laboratory does not receive test results from another laboratory prior to the 
event cut-off date and reports their own results. This category includes referral 
of confirmatory, distributive, and reflex PT samples. 
 
For example, a laboratory may place PT samples in an area where other 
patient specimens are picked up by a courier to take to a reference laboratory.  
The reference laboratory courier may take the PT samples along with the 
patients specimens.  The laboratory personnel notice that the PT samples are 
missing and contact the reference laboratory to inquire if they have received 
the PT samples along with the patients specimens.  The reference laboratory is 
instructed to discard the PT samples and not test them since they were picked 
up in error.  In this case, the referring laboratory realized the error, 
contacted the receiving laboratory, and did not receive results back for any of 
the PT samples. 
Laboratories experiencing poor performance for analytes using a PT program other than 
the one that is designated for CLIA compliance purposes or for analytes, tests, 
specialties and subspecialties not listed in Subpart I should address the failures via their 
own internal quality assurance protocol. 
 
To avoid implications of PT referral, laboratories using previously tested PT samples 
for competency assessment, training or other in-house purposes should wait until 
after the PT event cut-off date for reporting results to the PT program. 
 
If a laboratory chooses to use PT samples from a CMS-approved PT program for 
the purpose of meeting the quality assessment requirements at 42 CFR 
  493.1236(c) and intentionally refers those samples to another laboratory, as 
stated at 42 CFR 493.801(b)(4), it may have its certificate revoked as stated in 42 
CFR 493.1840.  This refers to ALL samples purchased from a PT program; 
samples for tests listed in subpart I AND samples for tests not listed in subpart I 
that must be checked for accuracy twice per year for quality assessment (QA) 
purposes. 
 
Laboratories with Certificates of Waiver are not exempt from the ban against 
referral of PT sample and other penalties required when PT referral has been 
substantiated. 
 
6062 - Onsite Observation of Proficiency Testing 
(Rev. 1, 05-21-04) 
 
RO/SA Surveyors may elect to observe PT performance onsite as part of the survey 
process or because of failure in PT by the CLIA laboratory. 
 
6063  Survey Protocols for Compliance with Cytology Proficiency 
Testing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Cytology laboratories and individuals must enroll and successfully participate in a CMS-
approved cytology PT program and achieve a passing score annually.  See 42 CFR 
493.855. 
 
Pathologists and cytotechnologists are tested individually with test sets composed of 
slides exhibiting a progression of abnormality from unsatisfactory to cervical cancer. 
There are at least four test opportunities annually. If an individual does not score at 
least 90% on the first test, he/she can test a second, third, or fourth time: 
 
  Initial Test - ten slides reviewed in two hours (If the individual does 
not obtain a score of at least 90%, they must be retested within 45 
days. The individual may continue to examine slides at this time.); 
  Second Test - ten slides reviewed in two hours (If the individual does 
not obtain a score of at least 90%, the laboratory must provide the 
individual with documented, remedial training and education in the 
area of failure, and assure every gynecologic slide examined 
subsequent to the notification of scoring less an 90% has been 
reexamined by an individual in the laboratory that has taken and 
scored at least 90% on their annual PT for the year until such time as 
the individual is retested; 
  Third test - 20 slides reviewed in 4 hours (if individual does not obtain 
a score of At least 90% they must cease testing until they obtain 35 
hours of documented, formally structured continuing education in 
diagnostic cytopathology, and are re- tested with a 20-slide test set 
and score at least 90%); and 
    Fourth test- 20 slides reviewed in 4 hours (if the individual does not 
obtain a score of 90% they must cease testing and obtain an additional 
35 hours of continuing education, and re-test). 
 
CMS monitors the cytology PT results and conducts appropriate follow up on 
enrollment and performance failures during survey reviews. 
 
During surveys, SAs must accomplish the following: 
 
  Enrollment:  Confirm by review of enrollment documentation that 
the individuals examining gynecologic cytology slides (Pap smears 
and liquid based 
technologies) are enrolled in a CMS-approved cytology PT program for 
the calendar year and that all individuals at all laboratory cytology testing 
sites are enrolled. 
 
  Testing:  Ask  the  laboratory  director  the  status  and  outcome  of  each 
individuals testing to ensure that the laboratory is following the regulatory 
protocol. Do not request copies of individual results. 
 
NOTE: Verification of Compliance: For laboratories that will not be surveyed in the 
current calendar year, CO will monitor their performance and provide additional 
guidance to the ROs. CO will also monitor the performance of individuals in accredited 
laboratories and CLIA-exempt laboratories and will notify the AO or approved State 
program of any necessary follow-up. 
 
  Approved State Programs (Exempt States) & Approved Accreditation 
Organizations (AOs): CLIA-exempt laboratories and accredited 
laboratories will be overseen by their respective State Agencies or AOs. 
 
  Systems of Testing: Individuals have multiple opportunities to take the 
proficiency test and any retest, if necessary. Initially, individuals are 
required to take a 10-slide test within 2 hours, provided in sets. 
 
o  If an individual passes the first 10-slide test, he/she has 
successfully participated for the year and need not be tested 
again until the following year. 
 
  Systems of Re-testing: 
 
o  Confirm that individuals who fail the initial proficiency test are 
being re-tested in a timely manner in conformance with 
the procedures at 493.855. 
 
    If the individual fails the first 10-slide test, he/she must 
o
take a 10- slide retest within 45 days after notification of 
test failure. Surveyors must confirm that the individual 
was retested within the 45 day time 
frame. 
 
  When an individual passes the second 10-slide test, he/she has 
successfully participated for the year and need not be tested again 
until the following year.  
 
  If the individual fails the 10-slide retest: 
 
  The individual must obtain documented, remedial training in the 
o
area of test failure, which will be noted on the test results letter. 
Confirm via review of laboratory documentation that remedial 
training did occur. 
 
  All Pap smears screened by the individual subsequent to the 
o
notification of failure must be reexamined. Surveyors should 
review the documentation of reexamined slides, and 
 
  The individual must successfully participate in a 20-slide 
o
proficiency test within 4 hours.  Confirmation of scheduled 
retesting must be reviewed. 
 
  If the individual fails the 20-slide test: 
 
  He/she must cease examining Pap smears immediately upon 
o
notification of failures. Surveyor confirmation of individual 
cessation of examining gynecologic cytology specimens is 
necessary; 
 
  The individual must obtain at least 35 hours of documented, 
o
formally structured, continuing education in diagnostic 
Cytopathology which focuses upon the examination of 
gynecologic cytology. Surveyor confirmation of continuing 
education is necessary; and 
 
  The individual must successfully participate in 
o
another 20-slide proficiency test. Confirmation of 
scheduled retesting must be reviewed. 
 
  This final cycle could continue until the individual successfully 
participates in another 20-slide proficiency test. 
 
  Enforcement Actions 
 
The RO, in conjunction with the SA, will initiate intermediate sanctions that may 
include Civil Money Penalties, limitation of the laboratorys CLIA certificate for 
cytology, and, if applicable and serious, suspension of the laboratorys Medicare and 
Medicaid payments for gynecologic cytology testing in accordance with Subpart R of 
the CLIA regulations if the laboratory fails to accomplish any of the following: (Also 
see 6250 Adverse Actions) 
 
  Ensure Enrollment: Fails to enroll all gynecologic cytology testing 
sites in a CMS-approved cytology PT program for each calendar 
year; 
 
  Ensure Testing: Fails to ensure that all individuals examining gynecologic 
cytology slides in the current calendar year are enrolled in a CMS-approved 
cytology PT program and are tested in a timely manner. The regulatory 
protocol under 493.855 identifies the extent to which additional testing, 
education or limitations must be put in place with regard to individuals who 
do not pass the test initially; 
  Ensure Retesting: Fails to ensure that an individual who fails a cytology PT 
test takes any required additional education or remedial actions, and is 
retested, as specified in the CLIA requirements, if such individual continues 
to examine slides for the laboratory; 
 
  Complete Testing: Fails to ensure that the testing for the current calendar 
year has been completed by April 2nd of the following calendar year. Please 
contact your RO in the event you identify any other questionable practices. 
 
                                    The Survey Process 
 
6100 - The Survey Process - Emphasis, Components, and Applicability 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Survey  protocols  and  Interpretive  Guidelines  provide  guidance  to  personnel 
conducting surveys of laboratories. Surveys are conducted using an outcome-oriented 
survey process, which places emphasis upon performance or outcome measurements 
to ensure accurate and reliable test results and other related activities.  The purpose of 
the protocols and guidelines is to provide suggestions, interpretations, and other tools 
to use in preparing for and conducting the survey and for analyzing and evaluating 
survey findings. Both the SA and RO use the same survey protocol. 
 
The SA/RO is responsible for conducting the on-site survey, and entering the 
information concerning the results of the survey into the Automated Survey Processing 
Environment (ASPEN), which includes ASPEN Central Office (ACO) and ASPEN 
Regional Office (ARO). 
   
Survey protocols and interpretive guidelines are intended to provide guidance to personnel 
conducting surveys of laboratories.  The protocols and guidelines clarify and/or explain the 
Federal requirements for laboratories and are required for use by all surveyors assessing 
laboratory performance based on these Federal requirements.  The same survey protocols 
are used by the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) 
and/or State Agency (SA) surveyors. 
 
The following protocols represent an outcome-oriented method to be used to conduct the 
survey.  The focus of the survey is to assess how the laboratory monitors its operations and 
ensures the quality of its testing.  The intended use of these protocols is to promote 
consistency in the approach to the survey process, and to ensure that a laboratorys 
operations are reviewed in a practical, efficient, and effective manner so that at the 
completion of the survey there is sufficient information to make compliance determinations.  
While the purpose of the protocols and guidelines is to provide direction in preparing for the 
survey, conducting the on-site survey, and analyzing, evaluating, and documenting survey 
findings, the surveyors professional judgment is the most critical element in the survey 
process. 
 
CMSs objective is not only to determine the laboratorys regulatory compliance but also 
to assist regulated laboratories in improving patient care by emphasizing those aspects of 
the regulatory provisions that have a direct impact on the laboratorys overall test 
performance.  CMS promotes the use of an educational survey process, especially on 
initial laboratory inspection, to help laboratoriesunderstand and achieve the quality 
system concepts. It is the surveyors objective, using professional judgment, to determine, 
based on observation of the laboratorys (past and current) practices, interviews with the 
laboratorys personnel, and review of the laboratorys relevant documented records, 
whether it is producing quality test results (i.e., accurate, reliable, and timely).   
 
Specifically, the primary objective of the survey process is to determine whether or not the 
laboratory meets the CLIA requirements.  The surveyor meets this objective by employing 
an outcome-oriented survey process or approach, the intent of which is to focus the 
surveyor on the overall performance of the laboratory and the way it monitors itself, 
rather than on a methodical evaluation of each standard-level regulatory requirement. 
 
Surveyors should make every effort to minimize the impact of the survey on laboratory 
operations, patient care activities, and to accommodate staffing schedules and departmental 
workloads as much as possible.  In facilities providing direct patient care (e.g., physician 
offices, clinics, residential care facilities, and hospitals), surveyors should avoid 
interrupting or interfering with patient care. 
Surveyors should respect patient privacy and confidentiality at all times in all survey settings. 
 
6101 - The Outcome-Oriented Survey Process (OOSP) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The principal focus of the outcome-oriented survey is the effect (outcome) of the 
laboratorys practices on patient test results and/or patient care.  The OOSP is intended to 
direct the surveyor to those requirements that will most effectively and efficiently assess the 
  laboratorys ability to provide accurate, reliable, and timely test results. 
 
In the outcome-oriented survey process, the surveyor reviews and assesses the overall 
functioning of the laboratory and evaluates the laboratorys ability to perform quality 
testing; that is, the surveyor evaluates the laboratorys quality system.  The quality 
system requirements in the Introduction to Subpart K and the General Laboratory, 
Preanalytic, Analytic, and Postanalytic Quality Assessment requirements are appropriate 
guides for the surveyor to organize the review. 
 
In the outcome-oriented survey process, emphasis is placed on the laboratorys quality 
system as well as the structures and processes throughout the entire testing process that 
contribute to quality test results.  The surveyor selects a cross-section of information from 
all aspects of the laboratorys operation for review to assess the laboratorys ability to 
produce quality results.  The surveyor reviews the cross-section of information to verify that 
the laboratory has established and implemented appropriate ongoing mechanisms for 
monitoring its practices, and identifying and resolving problems effectively. 
 
If the findings from the review of the laboratorys ongoing mechanisms for ensuring quality 
test results are sufficient to make the determination of compliance and if the evaluation 
does not warrant a more in-depth review, the surveyor concludes the survey and proceeds 
to the exit conference (see 6126). 
 
NOTE: Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and 
Laboratory Services, includes guidelines and instructions for the listed regulatory 
requirements and encompasses all types of laboratory facilities. Surveyors should take 
care, therefore, to only cite to the portions of this document that are applicable to the 
laboratory operations and the complexity of testing performed and are regulatory in nature.  
Guidelines and instructions are not to be cited. 
 
 
6102 - Scheduling Surveys 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
 
6102.1  Scheduling Priorities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When scheduling surveys use the following priorities: 
 
  Complaint surveys indicating possible immediate jeopardy; 
 
  Laboratories with other complaint investigations pending; 
 
  Follow-up surveys; 
 
  Initial surveys; 
   
  Recertification surveys; and 
 
  Validation (non-complaint) surveys. 
 
Scheduling surveys - There are three activities associated with scheduling surveys: 
 
  The intention to survey which is the in-office formulation of a workplan, 
  Announcing the surveys which is notifying the laboratory (when 
applicable) of the survey date and time, and 
  Performing the survey which is the actual on-site inspection. 
 
For efficiency when scheduling, attempt to cluster surveys geographically, to include 
initials, recertifications, complaints, and validations. Extenuating circumstances require 
RO review.  In instances where the State requires a laboratory survey at a different time 
frame than CLIA, the State must meet both survey scheduling requirements as efficiently 
as possible. 
 
For example: The State requires a survey before the laboratory can operate in that State. 
The SA can survey the laboratory for compliance with the State requirements, and return 
in the appropriate time frame to survey for compliance with the CLIA requirements. 
 
1.  Initial Surveys: In order to permit observation of actual testing during the 
initial survey, schedule the initial survey to occur at least 90 days after the 
data entry date of the Form CMS-116, but no later than 12 months after the 
data entry of the Form CMS-116. 
 
For example: Form CMS-116 data entry date is May 12, 2015. Initial survey should be 
conducted between August 10, 2015 (90th day after May 12, 2015) and May 11, 2016 
(365th day after May 12, 2015).  If after the 90 days a representative from the 
laboratory states that laboratory testing is not being performed because equipment is 
not ready, etc., advise the laboratory that the CLIA certificate will be terminated until 
such time testing is being performed. If there is suspicion that the laboratory is being 
operated in a manner that constitutes a risk to human health, schedule an unannounced 
survey.  An unannounced survey could be an option for either case. 
 
2.  Recertification Survey:  Schedule the recertification survey to occur at least 6 
months (180 days) prior to the expiration date of the laboratorys current 
certificate, but no earlier than 12 months prior to the expiration date of the 
current certificate. 
 
For example: Current certificate expiration date is December 31, 2014. Recertification 
survey should be conducted between December 31, 2013 and July 4, 2014. 
   
Establish a date and time for the survey once the schedule has been completed. If a 
laboratory operates more than one shift or location, schedule survey hours to 
include a representative cross-section of shifts or locations, as necessary. 
 
All surveys of accredited laboratories must have prior approval from the RO. 
 
To enhance survey effectiveness and efficiency, except in the case of complaints or other 
instances in which you would conduct an unannounced survey, consider mailing the 
following forms to the laboratories before the scheduled survey date.  Request that the 
laboratory complete the forms and either return them to the SA or hold them for review 
during the on-site survey. 
 
  Laboratory Personnel Report (CLIA), Form CMS-209 (required) with directions for 
completing or updating information, adding new personnel or changes in positions 
or status; and 
  Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, 
Form CMS-116 (required) printed from the CLIA data system with all the current 
values filed in by the system.  The laboratory should be asked to write changes on 
the form and once the survey begins the testing volumes should be corrected and the 
current owner/operator/director should sign the updated form.  (For counting test 
volumes, refer to SOM Appendix C, Survey Protocols, OOSP, Section IX: Additional 
Information.) 
 
Request the following information be accessible and retrievable at the time of survey: 
 
  Standard operating procedure manual with all test procedures (e.g., package inserts 
and supplemental information, as necessary); 
 
  Reference laboratories client services manual, if applicable; 
  Records of tests referred to other laboratories; 
 
  Personnel records, including: 
 
a. Diplomas, certificates, degrees; 
 
b. Training and experience; 
 
c. Continuing education; 
 
d. Competency assessment; 
 
e. Duties/responsibilities; 
   
f. Personnel changes; and 
 
g. Primary Source verification (PSV) reports if applicable. 
 
  Quality control records, including: 
 
a. Remedial action information; 
 
b. Calibration and calibration verification records; 
 
c. Statistical limits; and 
 
d. Instrument maintenance and function checks records. 
 
  All proficiency testing (PT) records, including: 
 
a. Test runs with PT results; 
 
b. Direct printouts; 
 
c. Remedial actions for unsatisfactory results; 
 
d. Copies of the signed PT attestation forms provided by the PT program; and 
 
e. For nonwaived tests and procedures that are not listed in Subpart I, 
verification of test or procedure accuracy twice yearly. 
 
  Quality system assessment plan and documentation:  
 
For each of the systems: 
a. Policies and procedures to monitor, assess, and correct identified 
problems; 
 
b. Documentation of ongoing assessment activities, including: 
1. Review of the effectiveness of corrective actions taken; 
2. Revision of policies and procedures to prevent recurrence of problems 
and address complaints; and 
3. Discussion of assessment reviews with staff. 
 
  Safety information; and 
 
  Patient testing records: 
 
a. Requisition (patient charts may be used); 
 
b. Work records (direct printouts); and 
   
c. Patient test reports (patient charts may be used) 
 
 
6102.2  Survey Due to Unanticipated Events 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA or RO conducts a survey at an earlier date than planned if there is reason to 
believe the laboratory is being operated in a manner that constitutes a risk to human 
health.  Possible reasons for this would be a complaint about deteriorating standards of 
operations, results of an accreditation survey of an accredited laboratory, loss of 
laboratory accreditation, substantial changes in managerial personnel, continued 
unsatisfactory PT performance, or a significant change (e.g., from moderate to high 
complexity) in the type of testing performed.  The decision to conduct a survey at an 
earlier date than originally planned depends upon whether there is likelihood that 
certification status could be changed.  Such surveys must be unannounced.  
 
6102.3  Change of Location of Laboratory 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Changes in location of a laboratory within a State do not ordinarily require a special on- 
site survey. The laboratory is expected to continue to uphold the standards of operation 
detailed in its most recent survey. An on-site survey is to be performed only when the 
relocation  raises  significant  questions  as  to  the  laboratorys  ability  to  maintain 
standards.  
 
In these situations, the SA considers when the last recertification survey was performed. 
If a recertification survey is due within the next six months, the SA advances the entire 
resurvey. If the recertification survey is not due, and an on- site visit is performed, the SA 
conducts a complaint survey focusing on the issues that led to question the laboratorys 
ability to maintain standards. The SA documents the justification for performing special 
on-site surveys and maintains this documentation in the laboratorys official file. 
 
6102.4  Change of Testing Performed by a Laboratory 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory, other than a laboratory with a Certificate of Waiver, begins to perform 
additional tests, a SA survey or resurvey may be required.  (For laboratories with a 
Certificate of Waiver that want to expand services to include nonwaived testing, see 
6014 and 6018) The regulations permit laboratories with a certificate to add services 
for 6 months prior to notification to CMS, although laboratories will not be eligible for 
Medicare or Medicaid payments until they have made the notification and their certificate 
has been revised. If a regularly scheduled survey occurs during the 6-month period a 
laboratory has added services but has not notified CMS, the SA surveys the added 
services. 
 
  6106 - Announced and/or Unannounced Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Section 353(g)(1) of the Public Health Service Act provides for either announced or 
unannounced surveys, but it is generally CMSs policy to use announced surveys.  
Complaint or revisit surveys must be conducted on an unannounced basis.  For either an 
initial CLIA survey or recertification CLIA survey, an unannounced survey may be 
performed after one appointment is cancelled by the laboratory. For announced surveys, 
allow up to two weeks notice. 
When applicable, the laboratory should be notified in writing (e.g. email, mail) and 
followed up by telephone.  Notification may include the actual date and time of the survey. 
Use this communication to notify the laboratory about the potential consequences of 
cancelling an appointment.  Request that the laboratory notify the RO or SA, as 
appropriate, if its laboratory operations are not conducted during usual hours of operation 
or only on specific days and times.  Surveys are to be conducted during the laboratorys 
routine hours of operation. Confirm the laboratorys certificate type and advise the 
laboratory to notify the SA of any changes that would necessitate a different certificate.  If 
the laboratory has applied for a certificate of accreditation, ask the laboratory to provide 
documentation (e.g., written verification from the accreditation organization) of its 
accreditation status prior to going on-site, when possible. 
 
Complaint or revisit/follow-up surveys must be conducted on an unannounced basis.  
Validation surveys of accredited or CLIA-exempt laboratories are typically 
announced, except for simultaneous validation surveys of laboratories accredited by 
certain accreditation organizations (See 6227.3.1 - 6227.3.2).  In cases where there 
is significant evidence of non-compliance in the survey findings of the accreditation 
organization or CLIA-exempt State agency, the RO has the latitude to treat such a 
survey as a complaint survey, which is unannounced. (See SOM Chapter 5 
Complaint Procedures for guidance regarding complaint investigations.) 
 
6106.1 - Testing Outside the Certificate Type 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In accordance with 42 CFR 493.1775, if it is verified that the laboratory that has been 
issued a Certificate of Waiver or a Certificate for Provider-performed Microscopy 
Procedures is testing outside of its certificate type, the laboratory is in violation of CLIA.  
The SA allows the laboratory the opportunity to submit a new Form CMS-116 requesting 
an appropriate certificate. If the laboratory fails to do so within 30 days, the SA enters a 
complaint survey into ACTS on the Medicare/Medicaid Certification and Transmittal 
(Form CMS-1539), and in Item 16 (State Survey Agency Remarks) recommends referral 
to the RO.  The SA completes a Statement of Deficiencies and Plan of Correction (Form 
CMS-2567), to indicate the findings of the survey, and solicits a PoC or AoC from the 
laboratory. The SA attaches any documentation that can be used in the adverse action 
process to substantiate the recommendation to the survey kit and puts a check mark in 
the kit as Release for CMS Review. The SA notifies the RO that the RO needs to 
review the kit for enforcement. The SA refers to 6014 if the laboratory wants to add 
nonwaived tests. 
   
6106.2 - Accredited Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Laboratories  accredited  by  a  CMS  approved  organization  are  deemed  to  meet  the 
requirements of  42  CFR  Part  493.    When  the  RO/SA  receives  notification  from  a 
laboratory, which was previously inspected by the RO/SA, that it has been accredited, 
the  SA  verifies  the  laboratorys  accreditation  status  by  asking  the  laboratory  for 
documentation of its application to the accreditation organization before removing the 
laboratory  from  the  RO/SAs  biennial  survey  schedule.   A  laboratory  requesting  a 
change from a Certificate of Compliance to a Certificate of Accreditation remains under 
CMS jurisdiction until the Condition-level deficiencies are corrected.  If any standard-
level deficiencies are pending, the SA discontinues any follow-up on the deficiencies and 
forwards the pending deficiencies to the laboratorys accreditation organization.  If the 
pending deficiencies are serious and represent a threat to the quality and reliability of 
the  laboratorys  testing,  i.e.,  Condition-level  non-compliance  exists,  the  matter  is 
referred to the RO.  A laboratorys accreditation cannot be recognized until it has 
corrected its Condition-level deficiencies. 
 
Withdrawal or Denial of Laboratory Accreditation 
 
When an accreditation organization withdraws or denies a laboratorys accreditation, 
the RO will authorize the SA to conduct a complaint investigation to determine 
compliance with all CLIA requirements. (See SOM Chapter 5, Complaint 
Procedures). The RO takes appropriate enforcement action if deficiencies are found.  
If the laboratory is found to be in compliance with all CLIA requirements, the SA 
obtains an updated Form CMS-116 and processes the change in certification type. 
6106.3 - CLIA-Exempt Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Laboratories exempt through an approved State licensure program are subject to validation 
surveys conducted by the RO or its designee.  A validation survey of a CLIA-exempt 
laboratory is conducted to ensure that the exempt laboratory meets CLIA compliance.  
The RO laboratory surveyor applies the CLIA regulations during a validation survey.  
When Condition-level deficiencies are determined, CMS directs the State to take 
appropriate enforcement action. (See 6208) 
 
6108 - Laboratory Refuses to Allow Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Section 353(g) of the PHSA permits authorized officials to make announced or 
unannounced surveys of laboratories holding any type of CLIA certificate, at any time 
during the laboratorys normal hours of operation.  If access is refused, the SA 
documents the identity (name and title) of the individual refusing admission and the 
reasons given, and submits this documentation immediately to the RO, i.e., by email, 
  telephone or fax.  The CLIA regulations at 42 CFR 493.1771and 493.1773 permits 
the SA to cite the laboratory for refusal to allow a survey on a CMS Form 2567.  In 
addition, the regulation at 42 CFR 1001.1301 permits the OIG to exclude a laboratory 
from the CLIA program if it fails to grant immediate access upon reasonable request. 
The exclusion may be in effect up to a period equal to the sum of the length of the period 
during which immediate access was not granted, plus an additional 90 days.  The RO 
will make the referral to the OIG.  (See 6270.) 
 
6110 - Survey Team Size and Composition 
(Rev. 1, 05-21-04) 
 
Each SA surveyor must meet the education and training qualifications in 4009.  If more 
than one surveyor is performing the survey, all surveyors are to survey together during 
 
the same time interval. (See Appendix C, Survey Procedures and Interpretive 
Guidelines for Laboratories and Laboratory Services.) 
 
6112 - Pre-Survey Preparation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Prior to each survey, review the laboratorys file, including CLIA-database 
information.  To determine the size of the survey team and the expected time required 
for the survey, consider the number of sites under the certificate, the scope and 
volume of testing, and the test complexity. 
 
1.  Personnel - Consult the annual laboratory registry to assist with 
determining whether the director/owner has had a laboratory certificate 
revoked within the last two years. Include the completed or updated Form 
CMS-209 in each survey package.  Use this information during the on-site 
survey to evaluate positions currently held by employees in accordance 
with the requirements.  Focus on new personnel since the last survey. 
 
2.  Services Offered - Review the CLIA application, the list of tests and 
specialties/subspecialties, and any correspondence from the laboratory to 
determine the complexity of tests performed.  Ascertain whether the 
laboratory has changed analytes, specialties or subspecialties, or 
added/deleted tests or procedures since the last survey. 
 
3.  PT - Review PT records to ensure that the laboratory is enrolled and 
participating in an approved program for each PT listed in Subpart I, 
specialty, subspecialty, analyte or test for which testing is performed.  Note 
any unacceptable, unsatisfactory, or unsuccessful scores and any specialty, 
subspecialty, analyte or test that is not evaluated by the proficiency testing 
program provider.  Use this information to target particular tests for review 
during the survey. 
 
4.  File Review--Evaluate the laboratorys ability to maintain 
  compliance between surveys by reviewing its file for: 
 
 Previous survey results and plans of correction by noting 
patterns, number, nature of deficiencies, and dates of 
correction; 
 
 Enforcement action(s) taken or in progress, e.g., limitations of the 
certificate or voluntary withdrawal of a specialty, subspecialty, 
analyte or test due to unsuccessful proficiency testing or loss of 
qualified personnel; and 
 
 Complaint allegations noting frequency, significance, 
severity and, if substantiated, the resolution. 
 
5.  Initial Survey - Preparation for an initial survey may focus on the 
personnel qualifications, verification of data in the Form CMS-116, 
specialty/subspecialties, test volumes and any correspondence with the 
laboratory prior to the survey. 
6114 - Entrance Interview 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The entrance interview sets the tone for the entire survey.  Be prepared, positive, 
courteous, and make requests, not demands.  Upon arrival, present the appropriate 
identification, introduce other team members, inform the facilitys administrator, 
director, or supervisor of the purpose of the survey, the time schedule, and explain the 
survey process. Identify a contact person and establish a communication level based on 
the degree of technical knowledge of the contact person. 
 
If the laboratory consists of multiple testing sites, verify all information concerning 
testing performed at each site. If one or more sites do not meet the multiple site 
exceptions in the regulations (42 CFR 493.35(b), 493.43(b) and 493.55(b)), explain 
the reason and have the owner/operator/director complete Form CMS-116 for each 
applicable site. (Refer to Section IX for information concerning conducting surveys of 
multiple testing sites under one certificate.) 
 
Inform the laboratory that the survey will include a tour of the facility, record review, 
observation, and interviews with personnel involved in the preanalytic, analytic, and 
postanalytic phases of the testing process.  Establish personnel availability and discuss 
approximate time frames for survey completion.  Determine whether the deficiencies, 
when identified, are to be discussed with testing personnel, and explain that an exit 
conference may be held to discuss survey findings.  Refer to the SOM, Chapter 6, 
6124 and 6126, for additional information regarding the exit conference. 
 
Request that the laboratory collect any documents, records, or information that may be 
needed to complete the survey, and solicit and answer any questions the laboratory may 
  have concerning the survey process. 
 
6116 - Information Gathering 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The technique for information gathering includes observation, interviews, and record 
review and these are usually performed concurrently.  The information gathering 
process is critical in the determination of quality laboratory testing.  Gather sufficient 
information to evaluate the laboratorys operations without being overly intrusive or 
gathering excessive information.  As each laboratory is unique in the services offered, 
the order of gathering information may be different for each survey.  The timing for 
observing testing and the availability of staff for interview may determine the 
sequence of the survey. 
 
Consider the laboratorys compliance history (including, but not limited to, deficient 
practices and Plans of Correction).  Verify the correction of all previously cited 
deficiencies and continued compliance with CLIA regulations.  Pay particular attention 
to deficiencies that the laboratory has failed to correct.  Refer to enforcement 
requirements at 42 CFR Part 493, Subpart R, if needed. 
 
6116.1 - Organizing the Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Consider the following variables when making determinations for organizing the 
survey and the areas to be reviewed: 
 
 Purpose of the Survey: 
 
a. Initial or recertification: 
 
b. Complaint; 
 
c. Follow-up; and/or 
 
d. Validation. 
 
 Pre-Survey Information: 
 
a. Problematic PT; 
 
b. Previous survey deficiencies; 
 
c. Complaints; and/or 
 
d. Enforcement actions. 
 
   Size and Organization of the Laboratory: 
 
a. Type of instruments/test procedures; 
 
b. Type of information system(s); 
 
c. Number of supervisors and testing personnel; 
 
d. Number of testing sites; 
 
e. Scheduling of testing (e.g., Stat, daily, weekly shifts); 
f. Number of specialties/subspecialties; 
 
g. Test volume; 
 
h. Record availability; and/or 
 
i. Type of patients/clients served. 
 
6116.2 - Observation of Facilities and Processes 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Observe the laboratorys physical layout.  These observations should include specimen 
collection and processing, prep and clean-up areas, testing and reporting areas, 
and storage areas.  Whenever possible, observe specimen processing and test 
performance, noting information which would precipitate revisiting an area, 
interviewing personnel, or requesting records for review.  Observe and verify that 
reagents, kits, and equipment correlate with test menu, clients served and results 
reported. Also observe whether staffing and space appear adequate for test volume.  
Schedule the survey date/time to observe personnel performing specimen processing, 
testing, and reporting of results in each specialty/subspecialty of service. If it is not 
possible to observe testing, ask for a verbal walk-through of the procedure.  Do not 
distract staff when observing operations and personnel activities. 
 
Focus observations on: 
 
  Specimen integrity; 
 
  Quality control performance; 
 
  Skills and knowledge of personnel regarding: 
 
a. Performance of testing; 
 
b. Evaluation of test results; 
 
  c. Identification and resolution of problems; and 
 
 Interactions of personnel regarding: 
 
a. Availability of supervisor to staff; 
 
b. Communication among personnel at all levels within the laboratory and 
with clients; and 
 
c. Interaction of laboratory director in laboratorys operations. 
 
At all times respect patient privacy and do not interfere with patient care and 
confidentiality. 
 
6116.3 - Interviews 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Interview the staff to confirm observations and obtain additional information, as 
necessary. Obtain information to identify personnel interviewed, such as name or code. 
Ask open-ended questions, e.g., probes from the guidelines, and if necessary, repeat or 
restate the response given by the staff to confirm what was said. Information obtained 
through interviews can provide evidence to support a deficiency.  The surveyor must 
document who was interviewed and should note the specific date and time of the 
interview or confirmation. 
 
During the interview of personnel, evaluate their knowledge and skills for performing 
tests, identifying problems and the methods for corrective and remedial actions.  
Interviews should include as many staff members as necessary to form a judgment as to 
the ability of staff to perform their duties.  Determine the validity of any allegations 
prior to leaving the laboratory. Do not cite deficient practices without verification.  
Extend the original survey to investigate the allegation of non-compliance. 
 
6116.4 - Record Review 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Gather relevant information that will reflect the laboratorys ability to provide quality 
testing from all areas of the laboratory including records encompassing the time period 
since the last certification survey.  Determine all new tests, new test methods, and new 
equipment added since the prior survey and review documentation relevant to as many 
of these factors as possible when reviewing laboratory records.  The amount of records 
selected and reviewed is not intended to be statistically valid, but rather a 
representative cross-section of various records. 
 
Avoid predictable patterns of gathering information (e.g., same tests or time periods). 
Do not allow the laboratory to select the records for review.  Consider the types of 
clients and/or facilities that the laboratory serves, e.g., nursing homes, pediatric, 
  dialysis units, public health clinics, and cancer clinics.  Choose a variety of patient 
records across the laboratorys spectrum of clients.  When test information must be 
gathered from medical records, be considerate when handling these records, as they 
contain confidential information.  If possible, review medical records in the presence of 
office or laboratory personnel with consideration for confidentiality. 
 
Subpart K delineates the laboratorys responsibility for performing its own internal 
reviews. This is an excellent starting point for an outcome-oriented survey.  Review a 
cross-section of information selected from records of quality system assessment 
activities within each of the four systems.  Review a cross-section of information while 
simultaneously assessing the laboratorys ability to provide quality test results as well 
as its ability to identify and correct problems.  Refer to the quality system assessment 
portions of the regulations as a guide for organizing your selection and review of 
information to assess the laboratorys overall compliance.  Investigate further any 
problems identified but not addressed by the laboratorys quality system assessment. If 
the laboratory is failing to effectively monitor its own system and correct its problems, 
you can direct the laboratory to the requirements and the relevant sections for its 
particular setting. 
 
Make copies of any records needed to support deficient practice findings. 
 
Ensure that reviews of PT (Subpart H), Facility Administration (Subpart J), 
Quality System (Subpart K), and Personnel (Subpart M) include the following: 
 
1.  PT 
 
Laboratories must be appropriately enrolled and participating in a CMS approved 
PT program(s) for each Subpart I analyte, specialty and subspecialty that they 
perform. 
Laboratories also must perform biannual accuracy verification that meets 42 CFR 
493.1236(c)(1)  for  any  nonwaived  tests  that  they  conduct,  that  do  not  fall  under 
Subpart I.  Verify that both requirements have been met for the entire period of time the 
laboratory has been performing each test or procedure (not just shortly before the 
survey). 
 
If the laboratory has unacceptable PT scores or unsatisfactory performance in a 
specialty, subspecialty, analyte or test since the last survey, review the specific record, 
corrective action, and any other data such as education and training of staff associated 
with PT remediation. Include both patient test results and QC records which were 
assayed in the same run as the failed PT in the review. In addition: 
 
  Verify that the laboratory has reported results under the 
appropriate methodology/instrumentation used for test 
performance, e.g., automated vs. manual hematology; 
 
  Verify that the laboratory did not engage in inter-laboratory 
  communications regarding the PT sample(s) prior to the event 
cut-off date; 
 
  Verify that the laboratory did not refer its PT samples to another 
laboratory for testing prior to the event cut-off date; 
 
  Verify that PT samples were handled, prepared, processed, examined, 
tested, and reported, to the extent practical, in the same manner as 
patient samples. PT samples must not be sent to another laboratory 
for analysis prior to the event cut- off date; and 
 
  For tests where there is no PT available and/or those nonwaived 
tests performed by the laboratory that are not included in Subpart I, 
determine whether the laboratory verifies the accuracy of each test 
or procedure at least twice a year. 
 
2.  Facility Administration 
 
Review records for the appropriate retention times and ensure the laboratory adheres 
to appropriate safety, arrangement, space, ventilation, and contamination procedures. 
If the facility provides transfusion services, verify that the arrangement is current, the 
blood products are stored appropriately, and transfusion reactions are investigated 
and reported to the appropriate authorities in a timely manner. 
 
3. Quality System 
 
General Laboratory, Preanalytic, Analytic, and Postanalytic System Quality Assessment- 
 
Using the patient test requisitions, test records, test results, and test reports or, as 
applicable, patient charts, review all phases of the laboratory testing processes, 
including instructions for specimen storage.  If possible, when reviewing individual 
patient test results, correlate test requisition(s) or medical record information with 
final report(s). 
 
Refer to Postanalytic Systems Quality Assessment for guidance in reviewing and 
correlating patient test results.  After determining the patient population serviced by the 
laboratory, e.g., geriatrics, public health clinics, dialysis units, health fairs, and 
hospitals, review the following: 
 
 A cross-section of patient test results encompassing all specialties 
and subspecialties of testing performed in the laboratory in 
sufficient numbers to determine if results vary significantly from 
expected population norms; 
 
 Worksheets or instrument printouts, looking for outliers, trends, etc., 
when tests are performed in batches; 
   
 Several worksheets, instrument printouts, or medical records over 
time for tests performed at random; 
 
 Test results that are disproportionately abnormal or normal; and 
 
 The correlation of initial test results and/or test results of various 
analytes of a patient over time. 
 
Review QC practices and evaluate whether the laboratory is following its own QC 
protocols or those procedures specified by the manufacturer.  Review QC results, 
including outliers, shifts, trends, and corrective actions taken, when necessary. 
 
Refer to the establishment and verification of performance specifications at 42 CFR 
493.1253 for guidance in reviewing the laboratorys policies and criteria for 
adding a new method, test system or analyte to its test menu. 
 
Correlate reported patient test data with QC data and/or quality systems assessment 
records to ensure proper performance and documentation of controls. Review original 
test data (instrument printouts or computer files).  Verify that patient results have not 
been reported when QC data was unacceptable according to the laboratorys protocol. 
 
Consider the following in relation to the laboratorys patient population: 
 
 
  New methodologies and equipment; 
  QC and calibration materials used; 
  Source and availability of QC limits; 
  Evaluation and monitoring of QC data; and 
  Corrective action for QC failures. 
 
Personnel: 
 
Review personnel records to determine compliance regarding whether individuals in 
prescribed positions meet the CLIA personnel qualification and responsibility 
requirements stated in 42 CFR, Part 493, Subpart M. This includes the positions of 
laboratory director (LD), clinical consultant (CC), technical supervisor and consultant 
(TS, TC), general supervisor (GS), testing personnel (TP), cytology general supervisor 
(CGS), and cytotechnologist (CT). The process for verification of personnel 
qualifications requires surveyors to observe direct evidence of meeting academic 
requirements. Laboratories are required to complete the CMS-209 form listing all 
testing personnel, individuals in the above positions, and including any contract 
  personnel.  Refer to subpart M for additional information concerning personnel 
training, experience, competency, qualifications and responsibilities. 
 
General Qualification Guidance 
 
  When initially surveying the laboratory, surveyors evaluate the qualifications 
of the LD, TS or TC, CC, GS, CT, CGS, and a sample of TP (including point of 
care personnel and respiratory therapy technicians, if applicable). Surveyors 
are NOT required to evaluate qualifications for every TP. 
  For subsequent surveys, surveyors evaluate all changes to personnel (for the 
positions of LD, TS or TC, CC, GS, CT, CGS) that have occurred since the 
previous survey, in addition to another sample of TP (including point of care 
personnel). 
  Certain laboratory positions are NOT evaluated by the surveyor; 
examples include phlebotomists who do not perform testing, or 
individuals who do reagent preparation, specimen preparation, 
microbiology plating, etc., but no actual testing. 
  Request appropriate documents to be provided within a reasonable timeframe 
(such as the time it takes to complete a survey or within one week afterwards).  
Appropriate documents include, but are not limited to: academic credentials 
such as degrees and transcripts. 
  Qualifications need only be provided at the highest level of academic 
achievement applicable to CLIA for the position held by the individual. It is 
not necessary to review a high school diploma, for example, of an individual 
whose position requires an advanced degree. 
  Laboratories are required to maintain documentation on its personnel in 
addition to paper records on point-of-care testing personnel that perform 
testing throughout a medical facility. 
  Surveyors may not require an individual to test for and obtain a General 
Education Degree (G.E.D.).  If records for a high school diploma or G.E.D are 
not available and a high school diploma or G.E.D. is required, this individual 
is not qualified. 
  If a high school is closed, it is possible for the individual to solicit 
documentation from the local school board or State Board of Education to 
verify graduation. 
 
Primary Source Verification 
Primary source verification (PSV) is the process of confirming an applicant's 
credentials by verifying that a degree, certificate, or diploma was received; that licenses 
were granted; and, by confirming reported work history, such as company names and 
locations, dates, and positions held. Verifications are obtained either directly from an 
institution, former employers, or their authorized agents. 
 
Laboratories may choose to use PSV to confirm personnel credentials and provide 
surveyors PSV documentation as evidence of compliance with the personnel 
requirements stated in 42 CFR, Part 493, Subpart M. The use of a PSV report as 
  evidence of meeting CLIA personnel qualifications is optional for the laboratory.  
Surveyors will continue to accept direct observation of documents, and the laboratory 
may also achieve compliance through a combination of the two. 
 
  NOTE: The PSV company is NOT responsible for determining whether a 
given individual meets the personnel requirements under CLIA; PSV 
companies merely confirm that the asserted training, degrees and 
credentialing have been achieved or conferred. 
  It is always the responsibility of the laboratory to ensure that its personnel 
meet the CLIA requirements, and CMS, its agents and accreditation 
organizations retain full authority to determine compliance with those 
requirements.  The PSV report is one tool that can be used by the surveyor 
and laboratory to determine if the applicant meets the personnel 
requirements.  The laboratory is responsible for ensuring that individuals 
qualifications meet the personnel requirements. 
  CMS is not issuing standards to be applied to PSV companies - 
laboratories are responsible for assessing the services offered by 
PSV companies. 
  As needed, surveyors will continue to ask LDs to provide additional 
documentation on their employees qualifications when they find the PSV 
reports inadequate to confirm compliance. 
  If there are required elements in the personnel regulations that the PSV 
company does not verify, it is the LDs responsibility to ensure that these 
personnel qualifications are met by other means. 
  Each LD should collect and maintain documentation and records as may be 
necessary to provide any information that is not included in the PSV report.  
Laboratories electing to use the PSV option must maintain either paper or 
electronic reports from the PSV company. 
  NOTE: Not all personnel qualifications will be verifiable by a PSV 
company.  Based on our current understanding, PSV companies do not verify 
transcripts.  Laboratories need to be aware that, even if they choose to use 
PSV, personnel may still need to produce documentation that cannot be 
verified by PSV companies for those positions in which a transcript is 
necessary to qualify the individual.  Ultimately, the LD is responsible for 
making sure that personnel qualifications are met for each position and that 
there is available evidence of the qualifications. 
 
Additional Qualification Guidance 
 
  Professional Certification and State Licensure Requirements - An individuals 
professional certification, such as medical technology certification or nursing 
licenses, as the only type of documentation to meet the CLIA personnel 
requirements, documentation IS NOT necessarily considered sufficient evidence of 
meeting all applicable personnel qualifications. More detailed information, such as 
degrees, transcripts, or PSV documents verifying degrees and transcripts, are required. 
 
One exception to this exists where professional certification is required by the 
  CLIA regulations: for example, CT and cytology CGS positions may require 
American Society of Clinical Pathology (ASCP) certification, in addition to 
documentation of their highest level of academic achievement in education, 
training, and experiential requirements. 
 
When the CLIA regulations specify that the individual must possess a license 
for any personnel in Subpart M (e.g., laboratory director, testing personnel), if 
required by the State, such as a physician (M.D., D.O., DDS) Midlevel 
practitioner (as defined at 42 CFR 
493.2), testing personnel or otherwise, the laboratory need only produce a 
copy of the individuals State license or a report from a PSV company verifying 
the State license.  No further academic documentation, such as diploma or 
transcripts, is required. 
 
  Bachelor Degree in Nursing - A bachelors degree in nursing meets the 
requirement of having earned a bachelors degree in a biological science for 
high complexity testing personnel.  The laboratory may show a PSV report 
verifying that a bachelors degree in nursing was earned, a diploma with the 
type of degree earned, or transcripts as evidence of meeting the education 
personnel requirement. 
 
An associates degree in nursing meets the requirement of having earned an 
associates degree in a biological science for moderate complexity testing 
personnel. The laboratory may show a PSV report verifying that an associates 
degree in nursing was earned, a diploma with the type of degree earned, or 
transcripts as evidence of meeting the education personnel requirement. 
 
  Federal Laboratories - The regulation at 493.3(c) states that laboratories 
under the jurisdiction of an agency of the Federal Government are subject to the 
rules of this part, except that the Secretary may modify the application of such 
requirements as appropriate. Therefore, with respect to the employment of 
physicians and similar medical and scientific professionals in federal 
laboratories, the Secretarys noted discretion in applying CLIA regulations to 
federal laboratories would offer other federal agencies a means for adopting 
hiring criteria that only require possession of a valid license in one state in 
order to work in any federally operated laboratory. 
 
  Home Schooling - There is no standardized approach to home schooling 
across the country. Should a surveyor be presented with a home school 
diploma, in general, they would accept the home school diploma at face value 
and focus on the employees training and competency. At this time, CMS is not 
aware of any primary source verification company that verifies home school 
programs. 
 
  Military Training - Primary source verification companies are able to verify 
most military schooling and training. If the PSV company is unable to provide 
  verification of the successful completion of an official U.S. Military medical 
laboratory procedures training course of at least 50 weeks duration and that the 
applicant has held the military enlisted occupational specialty of Medical 
Laboratory Specialist (Laboratory Technician), (42 
CFR 493.1423(b)(3) for moderate complexity testing and 42 CFR 
493.1489(b)(4)(ii) for high complexity testing), the laboratory must present 
documentation that the testing personnel has the qualifications to meet the 
CLIA personnel requirements. 
 
  Regents Bachelors Degree (RBD) - An RBD is a baccalaureate degree 
program designed for adult students. The basic principle is that credit is 
awarded for what students know regardless of how that knowledge was 
obtained. In other words, students may earn college-equivalent credit for work 
and life experiences that can be equated to college courses. It is designed to 
provide students with a comprehensive general education. Many times, no 
specific courses are required for graduation, allowing students to design their 
own programs of study. This degree is usually awarded by a Board of Regents 
of an accredited institution. CLIA regulations require that a bachelors degree 
be from an accredited institution. The RBD may meet this requirement. 
However, CLIA also requires that the bachelors degree be in a chemical, 
physical, biological, or clinical laboratory science, or medical technology... 
The RBD without the designation of one of the above majors does not meet this 
requirement, as it is a general education degree.  These individuals transcripts 
can be evaluated in order to qualify as high complexity testing personnel at 42 
CFR 493.1489(b)(2) or general supervisor at 42 CFR 493.1461(c)(2)(i). 
 
Compliance with Personnel Requirements 
 
If the surveyor identifies potentially serious isolated or pervasive test quality problems 
that may be attributed to unqualified or untrained individuals performing or directing 
the laboratorys testing, the surveyor may request such documentation as may be 
necessary for the surveyor to confirm compliance with the personnel requirements. 
 
Mandatory Citations 
 
A laboratory is considered to be non-compliant if: a required position is not filled, if an 
individual does not meet the required qualifications for that position (such as 
education, training and experience), or if an individual does not fulfill the 
responsibilities of the position. 
 
Noncompliance with personnel regulations must be cited at the condition level if not 
met; i.e., the individual does not meet the required education, training, or experience, 
the position is not filled, or the corresponding responsibilities of that position are not 
met at the time of survey.  The list of mandatory citations is at 6130.5.  As indicated in 
the list, both the condition level AND standard level deficiencies must be cited. 
 
  Practical Application of the Personnel Qualification Determinations 
 
Surveyors are instructed to cite the most appropriate mandatory deficiency(s) if the 
laboratory does not meet the personnel requirements for the CLIA position categories 
which are included on Forms CMS-1557 and CMS-209.  Some examples are included 
here, though this is not an exhaustive list. 
 
Example 1: A CLIA surveyor is evaluating a sample of TP qualifications in a moderate 
complexity laboratory and is presented with a home school diploma as evidence of 
compliance. What would the surveyor do? 
Answer: Surveyor would accept the diploma at face value and focus on the testing 
personnels training and competency. 
Example 2: A CLIA surveyor is evaluating a sample of TP qualifications in a high 
complexity laboratory and is presented with proof of a medical technology degree 
from an accredited institution.  Does this degree satisfy the personnel requirement 
or are transcripts needed? 
Answer: Yes, a medical technology degree from an accredited institution is 
sufficient. A PSV report verifying a medical technology degree from an accredited 
institution would also meet the requirement. 
Example 3: If a laboratory is applying for a CLIA certificate and the LD is not board 
certified, but is board eligible, what evidence is needed for CMS to issue a Certificate of 
Registration? 
Answer: If an LD is only eligible to be board certified, the PSV Company may not be 
able to verify eligibility status. The LD would need to provide the documentation of 
training and experience required by the board to be eligible to take such examinations. 
Example 4: A laboratory is hiring a military trained medical laboratory technician.  
What evidence is needed for the laboratory to maintain compliance with CLIA 
personnel qualifications? Answer: Primary source verification companies are able to 
verify most military schooling and training. If the PSV company cannot verify the 
successful completion of an official U.S. military medical laboratory procedures 
training course of at least 50 weeks duration and that the applicant has held the 
military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory 
Technician), the laboratory must present documentation that the testing personnel has 
the qualifications to meet the requirement. 
Example 5:  A CLIA surveyor evaluating qualifications of a nurse performing 
moderate complexity laboratory testing is presented with a nursing license as evidence 
of compliance. What would the surveyor do? 
Answer: CLIA surveyors do not accept nursing licenses as evidence of compliance. An 
associates or bachelors degree in nursing meets the requirement of having earned a 
degree in a biological science for moderate complexity testing personnel. The 
laboratory must provide the surveyor with a PSV report verifying the type of degree 
earned, a diploma showing the type of degree earned, or transcripts as evidence of 
meeting the personnel requirement. 
 
  Example 6: A CLIA surveyor is evaluating a sample of TP qualifications in a high 
complexity laboratory and is presented with a report from a primary source verification 
company. The report verifies that the TP has a degree in Medical Technology from an 
accredited university and that the TP has worked for 3 years as a medical technologist 
at a hospital. Does this report satisfy the personnel requirement or are transcripts 
needed? 
Answer: Yes, the PSV company report is sufficient; no further evidence is needed. 
 
Example 7: A CLIA surveyor is evaluating a sample of TP qualifications in a high 
complexity laboratory located in a state that requires licensure for medical 
technologists. The surveyor is presented with a PSV company report that verifies the 
TPs State license as evidence of meeting the personnel requirement. Does the surveyor 
also need to see further evidence of education, such as degrees or transcripts? 
Answer: No. It is acceptable for the laboratory to present the surveyor with a PSV report 
verifying State licensure. The State license would also be acceptable. For laboratories in 
states that require licensure, no further academic documentation, such as diploma or 
transcripts, is required. 
Example 8a: A CLIA surveyor is evaluating LD qualifications in a high complexity 
laboratory located in a state that requires licensure.  The surveyor is presented with 
a PSV report verifying the LDs State license as evidence of meeting the personnel 
requirement. Does the surveyor also need to see further evidence of education, such 
as degrees or transcripts? 
Answer: No.  It is acceptable for the laboratory to present the surveyor with only a PSV 
report verifying State licensure.  The State license would also meet the requirement.  For 
laboratories in states that require licensure, no further academic documentation, such 
as diploma or transcripts, is required. 
Example 8b: A CLIA surveyor is evaluating LD qualifications in a high complexity 
laboratory located in a state that requires licensure. The LD is a foreign trained 
physician. The surveyor is presented with a PSV company report verifying the LDs State 
medical license as evidence of meeting the personnel requirement. Does the LD also need 
to produce foreign educational equivalencies? 
Answer: No.  It is acceptable for the laboratory to present the surveyor with only a 
PSV report verifying State medical licensure. The State medical license would also 
meet the requirement. Foreign trained physicians (MD, DO, DPM or DDS) who are 
licensed to practice medicine in the State in which the laboratory is located do not 
need to produce educational equivalencies. The state medical license is also sufficient 
proof of academic achievement. 
Example 9: A CLIA surveyor is evaluating TP qualifications in a high complexity 
laboratory. The surveyor is presented with a bachelors of science in nursing diploma as 
evidence of compliance. 
Does this satisfy the personnel requirement? 
Answer: Yes.  A bachelors degree in nursing meets the requirement of having earned a 
bachelors degree in a biological science for high complexity testing personnel. The 
laboratory must show a PSV report verifying the degree, a diploma showing the type of 
degree earned, or transcripts as evidence of meeting the personnel requirement. 
  Example 10: A CLIA surveyor is evaluating TP qualifications in a high complexity 
laboratory. The surveyor is presented with a PSV report verifying that the TP received 
a bachelors degree from an accredited university in 2008. Is this sufficient evidence of 
meeting the personnel requirement? 
Answer: No.  Regulation 493.1489(b)(1) states that high complexity testing personnel 
will have earned a ...bachelors degree in a chemical, physical, biological, or clinical 
laboratory science, or medical technology... The documentation in the PSV report did 
not state the type of BS degree earned.  The surveyor would need to look for additional 
evidence of the type of bachelors degree earned, a diploma showing the type of degree 
earned, or transcripts. Just having evidence of a BS degree does not meet the personnel 
requirement. 
 
6116.5 - Credentialing of Foreign Trained Laboratory Personnel 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Personnel employed in laboratories subject to CLIA that perform tests of moderate 
and/or high complexity must meet specific education, training, and experience 
requirements.  Individuals who attended foreign schools must have an evaluation of their 
credentials determining equivalency of foreign to United States education. 
 
Nationally recognized evaluation organizations and their affiliates should perform the 
academic credential evaluation on a course-by-course basis.  Nationally recognized 
evaluation organizations include, but are not limited to the National Association 
Credential Evaluation Services, Inc. (NACES) (http://www.naces.org) and the 
Association of International Credential Evaluators, Inc. (AICE) (http://www.aice-
eval.org).  Other organizations may be available, and may be able to be confirmed 
through research on the Internet (See Appendix C). 
 
The laboratory should maintain a copy of the course-by-course foreign-trained 
equivalency evaluation/determination in the laboratory records. 
 
Laboratories may also choose to use a primary source verification company for verifying 
foreign trained personnel, so long as the PSV relies on the same type of course-by-course 
evaluation to confirm and document the foreign degrees equivalency to the personnel 
qualifications. 
 
  Foreign trained personnel that have a PhD equivalent must hold current 
HHS-approved board certification or meet the regulation at 42 CFR 
493.1405(b)(3) or 42 CFR 493.1405(b)(3) or 42 CFR 493.1433(b)(3). 
  Foreign trained physicians (M.D., D.O., DDS) who are licensed to practice 
medicine in the State in which the laboratory is located do not need to produce 
educational equivalencies. A valid State medical license is sufficient proof of 
academic achievement. 
  With the exception of licensed physicians, other moderate and high 
complexity testing personnel who attended a foreign school still need to 
have foreign equivalencies done. 
    Each person examining cytology slide preparations must (1) meet the 
qualifications of 42 CFR 493.1449(b) or (k), or (2) possess a current license 
as a cytotechnologist issued by the State in which the laboratory is located, if 
such licensing is required, and meet one of several sets of requirements.  One 
set of requirements states that on or before September 1, 1994 
cytotechnologists examining cytology slide preparations must have full-time 
experience of at least two years or equivalent examining cytology slide 
preparations within the preceding five years in the United States under the 
supervision of a physician qualified under 42 CFR 493.1449(b) or (k)(1), and 
on or before September 1, 1995, have met the requirements in 42 CFR 
493.1483(b)(1) or (2). 
 
6116.6 - During the Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The surveyors should allow laboratory personnel to accompany them during the tour of 
the facility.  The tour of the facility should include observation, record review and 
interviews with personnel involved in preanalytic, analytic and postanalytic phases of 
testing.  Managerial staff generally should not be present during staff interviews. The 
SA should exercise discretion in each case. Laboratory personnel may be helpful, 
answer questions, or point out certain things of concern to the surveyors.  The surveyor 
should use such assistance if it is helpful to the survey and makes the process easier.  
Laboratory personnel should give the surveyors privacy as needed when the surveyors 
discuss their survey findings.  Conversely, if the laboratory personnel harass 
surveyor(s), argue about observed problems, and make the survey more difficult, the 
surveyor should remove themselves from the difficult and or hostile environment. 
 
6116.7 - Assessing Outcome or Potential Outcome 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the information gathered indicates that the laboratory has established, implemented, and 
maintained appropriate ongoing mechanisms for ensuring quality test results by 
monitoring, evaluating, and resolving any problems in its practices, and findings do not 
warrant a more in-depth review, conclude the survey.  However, if an assessment of the 
laboratorys performance cannot be made based on the cross-section of information 
collected, it may be necessary to expand the cross-section (e.g., number of sites, 
observations, or number of records).  If the findings reveal potential problem areas with 
any test procedures, ensure the review is sufficient in breadth and depth to substantiate 
whether a negative or potentially negative outcome exists. 
 
If a problem or potential problem related to patient test results is found, determine the 
nature and seriousness of the problem. 
 
The OOSP allows the freedom to increase or decrease the number and types of 
records reviewed, the personnel interviewed, and the observations made as individual 
needs are identified. 
   
Analyze the findings for the degree of severity, pervasiveness, comparison with 
historical survey results, frequency of occurrence, and impact on delivery of services, 
i.e., accuracy, reliability, and timeliness of test results.  A single occurrence of a 
deficiency directly related to a potential adverse impact on patient testing may be cited.  
On the other hand, some preliminary findings may have so slight an impact on outcome 
that they do not warrant a citation.  However, there are four CLIA Condition-level 
requirements the surveyor must cite if non-compliance is found, regardless of the 
presence or absence of any negative outcome or potential harm (see 6130.5 
Mandatory Citations). 
 
Figure 4-1, steps one through four, presents the decision process for whether or not to 
cite deficiencies during a survey.  After a preliminary finding is established by the 
surveyor, the first step is to determine whether or not it is a mandatory citation.  If yes, 
go to step #5; if no, go to step #2. Step 2 is to determine if the problem or potential 
problem is related to laboratory testing.  If the answer is no, then no deficiency is cited.  
On the other hand, if the answer to this question is yes, then the third step is to 
determine if the identified problem does or could potentially impact patient test results.  
If the surveyor determines there is no impact or potential impact to patient test results, 
then the surveyor uses the OOSP to determine whether deficiencies should be cited.  If 
the surveyor concludes that there is an impact or potential impact to patient test results, 
then the fourth step is to determine if the problem may be the result of, or otherwise 
related to, noncompliance with CLIA regulatory requirements.  If yes, then the surveyor 
must cite a deficiency.  If no, then consult with the RO on whether other Federal 
regulations are applicable.  If the laboratory is subject to a State Licensure Program, 
consult with the State Agency supervisor for further instruction. 
 
NOTE: Any condition-level deficiency is an actionable deficiency.  Any standard-
level deficiency that has an impact or potential impact on patient test results is also 
an actionable deficiency. 
 
6120 - Completing the Survey Report (Form CMS-1557) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form (CMS-1557) is the vehicle for documenting general laboratory information and 
is designed to facilitate electronic data entry of survey findings. 
 
The information required to complete Form CMS-1557 (Exhibit 12) is collected at the 
time of the survey, and includes survey data that must be entered into ASPEN. It 
includes information used in preparing the Statement of Deficiencies and Plan of 
Correction,  Form  CMS-2567.  Electronic  data  input  in  ASPEN  also  includes  the 
Federal Surveyor ID number of the surveyors on the CMS Form 670, as well as the 
determination of compliance with program requirements. 
 
When completing the Form CMS-1557 during the survey, the surveyor should pay 
  particular attention to Personnel and the Specialties/Subspecialties.  For molecular 
diagnostics or genetic testing, select the specialty/subspecialty that fits the specific gene 
being analyzed.  For those genetic tests described by CPT codes, refer to the laboratory 
codes (LC) mentioned in the CPT-4 and HCPCS Codes Subject to CLIA Edits list.  The 
LC codes that are CLIA applicable to non- microbiology molecular genetic testing are: 
  010 - Histocompatibility, 
  210 - General Immunology, 
  310 - Chemistry, 
  400 -  Hematology, or 
  900 - Cytogenetics. 
 
Personnel - Prior to completing the personnel section of the Form CMS-1557, complete 
a Laboratory Personnel Report (CLIA), Form CMS-209 that requires more detailed 
information concerning the qualification of the laboratorys personnel. Only persons 
listed on a Form CMS- 209 are to be included in the classification totals on the Form 
CMS-1557.  The surveyor reviews a sample of testing personnel qualifications, which 
should include any new personnel added since the last survey, to verify the 
documentation on the Form CMS-209. 
 
Specialties/Subspecialties - The surveyor indicates all categories where at least 
one test is performed in a specialty or subspecialty, and notes additions, 
deletions and appropriate effective dates on the form.  The surveyor must verify 
the estimated test volume(s) for each specialty/subspecialty; for example, the 
surveyor can review daily or monthly logs or other data. 
 
6120.1 - Regulatory Compliance Decision 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
After all necessary information has been collected and the surveyor determines 
whether any identified laboratory testing-related problems do (or could) negatively 
impact patient test outcomes, and, if so, whether such problems are due to non-
compliance with CLIA, the surveyor will need to determine whether CLIA-related non-
compliance driven issues constitute a condition- level deficiency.  Review the findings 
and decide if additional information and/or documentation are necessary to 
substantiate and document a standard- or condition-level deficient practice.  The 
number of deficiencies generally does not correlate to whether a laboratory should be 
found out of compliance with a standard or condition.  Standard-level deficiencies 
require: (1) the documentation of the nature and extent of the deficiencies, if any, with 
respect to a particular function, i.e., the creation of a list of the deficient practices; and 
(2) the surveyor to assess the need for improvement in relation to the prescribed 
conditions, i.e., review standard-level deficiencies to determine condition-level non-
compliance.  With the exception of the four mandatory condition- level citations 
discussed in subsection VII.D. below, consider a condition out of compliance as a 
result of one or more deficiencies if, in your judgment, the deficiency(ies) constitutes a 
significant or a serious problem that adversely affects patient test results/patient care, 
  or has the potential for adversely affecting patient test results/patient care. 
 
Determining Immediate Jeopardy 
 
Immediate Jeopardy (IJ) represents a situation in which laboratory noncompliance has 
placed the health and safety of recipients in its care at risk for serious injury, serious 
harm, serious impairment or death.  These situations must be accurately identified by 
surveyors, thoroughly investigated, and resolved by the entity as quickly as possible. In 
addition, noncompliance cited at IJ is the most serious deficiency type, and carries the 
most serious sanctions for laboratories.  An immediate jeopardy situation is one that is 
clearly identifiable due to the severity of its harm or likelihood for serious harm and the 
immediate need for it to be corrected to avoid further or future serious harm. 
Immediate jeopardy is defined in 42 CFR 493.2 as a situation in which immediate 
corrective action is necessary because the laboratorys noncompliance with one or 
more condition-level requirements has already caused, is causing, or is likely to 
cause, at any time, serious injury or harm, or death, to individuals served by the 
laboratory or to the health or safety of the general public. 
The regulatory definitions form the basis for identifying three key components that 
are essential for surveyors to use in determining the presence of IJ. These 
components include: 
 
  Noncompliance: An entity has failed to meet one or more federal 
health, safety, and/or quality regulations; 
 
AND 
 
  Serious Adverse Outcome or Likely Serious Adverse Outcome: As a 
result of the identified noncompliance, serious injury, serious harm, 
serious impairment or death has occurred, is occurring, or is likely to 
occur to one or more identified recipients at risk; 
 
AND 
 
  Need for Immediate Action: The noncompliance creates a need for 
immediate corrective action by the provider/supplier to prevent 
serious injury, serious harm, serious impairment or death from 
occurring or recurring. 
 
(See 42 CFR 493.1812 providing the enforcement actions to be taken when 
deficiencies pose immediate jeopardy.)  Refer to Figure 4-1 for guidance in 
determining whether to issue condition (and/or standard) citations and what 
enforcement actions to pursue. 
 
The number of deficiencies does not necessarily relate to whether or not a Condition 
  is found out of compliance, but rather the impact or potential impact the 
deficiency(ies) has (have) on the quality of laboratory services and the results 
reported. 
 
Figure 4-1, steps four through six, presents the decision steps for citing deficiencies in 
relation to patient outcome. In step four, the surveyor cites applicable CLIA Conditions, 
Mandatory CLIA Citations and/or supporting CLIA Standards that are not met by the 
laboratory.  Upon citing Condition(s), step five is to determine whether the situation 
already caused, is causing, or likely to cause serious injury, harm or death. If yes, step 6 
is to proceed with citing Immediate Jeopardy (IJ) along with the Condition-level non-
compliance. If the surveyor concludes no IJ is present, proceed with citing Condition(s) 
as identified under Step four. 
 
When determining if the Condition-level noncompliance reaches the level of immediate 
jeopardy. The surveyors should ask themselves: 
 
Do the deficient practices result in inaccurate or the high probability of inaccurate, 
unreliable, or untimely test results? 
 
  Is the situation one in which immediate corrective action is necessary because 
the laboratorys noncompliance has already caused or is likely to cause 
serious injury, harm, or death to individuals served by the laboratory? 
  Does the laboratorys continued activity(ies) constitute a significant 
hazard to individuals served by the laboratory or to the public health 
or safety of the general public? 
  Do the deficiencies warrant immediate limitation or suspension of the 
laboratorys CLIA certificate? 
  Is there information or data not available at the time of the survey, or 
within a reasonable time frame, that must be provided by the laboratory in 
order to determine if the deficient practice has already caused, is causing, 
or is likely to cause, at any time, serious injury or harm, or death? 
 
In summary, the steps for regulatory considerations include: 
 
1.  Are CLIA regulatory deficiencies identified? 
2.  Does the deficiency(ies) constitute(s) Condition-level non-compliance? 
-  Do the deficiencies prevent certification? 
3.  Does the Condition-level non-compliance pose an immediate jeopardy to 
patient health and safety? 
-  Is there an option for other enforcement remedies? 
 
Refer to QSOG-19-9-ALL, Revisions to Appendix Q, Guidance on Immediate Jeopardy, 
for further information. 
 
   
 
 
 
 
 
 
 
  6124 - Preparation for Exit Conference 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Prior to the exit conference, the surveyor(s) review findings and come to a 
consensus on the seriousness and extent of the deficiencies and whether the number, 
character, or combination interferes with accurate and reliable laboratory test 
results.  Deficiencies found in more than one Condition or standard may be 
cumulative and interrelated and result in general, pervasive inadequacies in 
determining test results. 
 
6126 - Exit Conference 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The purpose of the exit conference is to provide an overview of your findings with the 
laboratory. It is not meant to be an exhaustive discussion of your findings.  It is the 
continuation of the survey process and is the first opportunity for the laboratory to 
present additional information in response to the findings.  Acknowledge staff 
cooperation and operational support, as appropriate, before addressing the non-
compliance issues.  The exit conference is also the beginning of the period during 
which corrective action can be taken if the laboratory is to be subject to a corrective or 
an enforcement action. 
 
If immediate jeopardy or condition-level deficiencies are identified, inform the 
laboratory of the seriousness of the problem(s)/finding(s) and indicate that they are 
not final until receipt of the written statement of deficiencies Form (CMS-2567).  In 
this or any other instance where adverse action is anticipated, the surveyor explains 
the implications, making it clear that only compliance will stop the action. 
 
If the surveyor(s) calls IJ at the time of the onsite survey, the IJ Template in Appendix 
Q must be used. If the surveyor(s) determines that IJ exists after leaving the onsite 
survey, upon review of the information and evidence collected at the onsite survey, the 
completed template must be given to the laboratory at the time IJ is determined. This 
may be done electronically.  CLIA surveyors are not required to return to the 
laboratory to deliver the completed template (see CLIA subpart of Appendix Q for 
sections that do not apply to CLIA). The laboratory will still be notified of the IJ, via 
written notice, when the Form CMS-2567 is sent to the laboratory requesting an 
Allegation of Compliance (AoC). 
 
Refer to QSOG-19-9-ALL, Revisions to Appendix Q, Guidance on Immediate 
Jeopardy, for further information. 
 
The surveyor advises the laboratory that a revisit to verify correction of deficiencies 
occurs only when the laboratory submits a credible AoC. If the laboratory does not 
provide the RO/SA with a credible AoC, no revisit will be made and the adverse action 
process will continue.  Consider the following when conducting an exit conference: 
 
    Conduct the exit conference with the facilitys administrator, 
director, consultant, or supervisor, and/or other invited staff; 
 
  Describe the laboratory practices that fail to be in compliance 
with 
the regulatory requirements and the findings that substantiate these potential 
deficiencies.  In presenting findings, the surveyors cite problems that clearly 
violate regulatory requirements and provide an explanation to the laboratory 
concerning the deficiency in specific terms (without using data tags or 
regulation citations) to allow the laboratory to understand why the 
requirement is not met. Frequently, the explanation will imply the action 
needed to correct the problem. Because there may be several possible causes 
for any deficiency, it is not the surveyors responsibility to sift through 
various alternatives to suggest an acceptable remedy.  For example, if a 
laboratory was cited for maintaining incomplete patient specimen records, 
the surveyor specifies what is missing, not why it is missing or what process 
is best for ensuring that the records are complete in the future.  If asked for 
the regulatory basis, the surveyor provides the regulatory basis for 
noncompliance; 
 
  Provide the laboratory an opportunity to discuss and provide additional 
information regarding potential deficiencies. It is the laboratorys 
responsibility to determine the corrective action(s) necessary to remedy the 
problem(s); 
 
  Inform the laboratory that they will receive a written statement of 
deficiencies (Form CMS-2567) with the final deficiencies cited; 
 
  A team member should indicate that the official findings are presented in 
writing on the Form CMS-2567 and will be forwarded to the laboratory 
within 
10 calendar days. The laboratory must also be informed they are to return the 
PoC or credible AoC in 10 calendar days; 
 
  Given the complexity of the regulations and nature of the survey, the surveyors 
must indicate to the laboratory that the specific regulatory reference will be 
found in the Form CMS-2567 report that will be issued to them.  The 
laboratory is informed that the information discussed in the exit interview is 
preliminary and the lab management will have an opportunity at the exit 
interview to talk in general about the issues that were found; 
 
  Inform the facility of your intended recommendation to the RO to certify, 
recertify, or deny certification of the laboratory. In an initial survey, the 
surveyor tells the laboratory to expect notification from CMS of their initial 
approval (issuance of a certificate). For subsequent biennial surveys, the 
surveyor explains that CMS issues an updated certificate reflecting any 
changes in approved services; and 
   
  At the exit interview, inform the laboratory 
(director/administrator/supervisor) of changes in test volumes which may 
result in fee changes. 
 
Although it is CMS general policy to conduct an exit conference, the surveyor should 
be aware of situations that would justify a refusal to conduct or continue an exit 
conference. For example: 
 
  If counsel represents the laboratory (all participants in the exit conference 
should  identify  themselves),  the  surveyor  should  refuse  to  continue  the 
conference if the lawyer tries to turn the exit conference into an evidentiary 
hearing. 
 
  Any time the laboratory creates an environment that is hostile, intimidating, 
or inconsistent with the informal and preliminary nature of an exit 
conference, the surveyors should refuse to continue the exit conference. 
 
  If the laboratory wishes to audio tape the conference, the surveyor should 
refuse to continue the conference unless the laboratory agrees to tape the 
entire meeting and provide surveyor(s) with a copy of the tape at the 
conclusion of the conference. Videotaping is also permitted if it does not 
intimidate the surveyors or disrupt the conference, and a copy is provided at 
the conclusion of the conference.  Use discretion in deciding whether to 
permit videotaping. (See 
2724.) 
 
The survey team should establish and maintain control throughout the exit conference. 
The survey team presents the findings but should refrain from arguing.  The surveyors 
should be mindful that laboratory staff may disagree with the survey findings. The 
laboratory representatives have a right to disagree with survey findings and to present 
information to refute them and the team should be receptive to such disagreements. If 
the laboratory representatives present information to negate any of the survey findings, 
the surveyor(s) should indicate willingness to reevaluate the findings before leaving the 
laboratory. If deficiencies are corrected before the completion of the survey, the surveyor 
should acknowledge the corrections and explain how this situation will be documented. 
 
6130 - Statement of Deficiencies, Plan of Correction and Allegation of 
Compliance, Form CMS-2567 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form CMS-2567 (Exhibit 7) serves several important functions. They 
are as follows: 
 
  Documents that specific deficiencies were found.  If there are no citations, 
  the surveyor(s) indicates this in the left-hand column of the Form CMS-
2567; 
 
  Documents the laboratorys receipt of the deficiency notice; 
  Discloses to the public the laboratorys deficiencies and what is being 
done to remedy them; 
 
  Provides an opportunity for the laboratory to refute survey findings and to 
furnish documentation that requirements are met; and 
 
  Documents the laboratorys plans and time frames for correcting the 
deficiencies. 
 
6130.1 - Development of the Statement of Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Choose the most appropriate regulatory citation and corresponding D-tag when 
documenting a deficiency.  For example, if deficient practices are a result of failure of 
the laboratory to properly perform quality assessment, cite the deficiency using the 
quality assessment requirements.  Note, however, where a laboratory does not have a 
quality assessment program, one should cite the quality assessment requirements and 
the laboratory director at D6021and/or D6094 for not ensuring that the quality 
assessment programs are established and maintained to ensure the quality of laboratory 
services provided.  If deficient practices are the result of a laboratorys failure to 
perform (or perform correctly) certain specific tasks or requirements, then cite the 
deficiency in the specific area of the regulation such as personnel, general laboratory 
systems, preanalytic systems, analytic systems or postanalytic systems.  Supporting 
information for documenting deficiencies should be complete, clear, and concise.  Write 
deficiency statements in terms that allow a reasonably knowledgeable person to 
understand the aspects of the requirements that are not met. Avoid writing the same 
deficiency in several places.  Write your statement of evidence following the format 
described in the Principles of Documentation Guidelines 
(http://www.cms.gov/Regulations-and- 
Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html). 
 
For some cited deficiencies, the Automated Survey Processing Environment (ASPEN) 
system may require that you list the appropriate specialty or subspecialty identifier 
code(s) and test complexity (moderate, high or both) for each D-tag.  Use the list 
provided on Form CMS-1557 that identifies the code number for each specialty and 
subspecialty (e.g., the code number for the specialty of hematology is 400).  This is 
applicable to standard and condition-level deficiencies. 
 
6130.2 - Citing Standard-Level Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If standard-level noncompliance has been identified, cite the most specific 
  standard available.  For instance, if the deficient practice(s) is related to control 
procedures: 
 
  Cite the appropriate D-tag (D5501 - D5773) for the specialty/subspecialty 
standards under 42 CFR 493.1261 through 493.1278, which are 
Bacteriology,Mycobacteriology, Mycology, Parasitology, Virology, Routine 
Chemistry, Hematology, Immunohematology, Histopathology, Cytology, Clinical 
Cytogenetics, and Histocompatibility if such standard is available; OR 
 
  Use the appropriate D-tag (D5401 - D5485; D5775 - D5793) for 42 CFR 
493.1251 through 493.1256 and 42 CFR 493.1281 through 493.1289, 
if an appropriate D-tag is NOT available in the specialty/subspecialty 
standards. 
 
EXAMPLE: A laboratory performs fluid cell counts using a hemocytometer. Use D5543. 
 
EXAMPLE: A rheumatologist performs rheumatoid factor (RF) titers. Use D5451.  
Where there are underlying standards, condition-level deficiencies can only be cited 
when standard-level deficiencies have been identified.  Remember to cite to standard-
level deficiencies when such deficiencies support a finding of condition-level deficiencies. 
 
6130.3 - Citing Condition-Level Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When the deficient practice is of such a serious nature that correction is a condition for 
allowing the laboratory to continue with patient testing, cite the most appropriate 
condition and document the finding using the format in the Principles of 
Documentation.  As stated in the Principles of Documentation, the laboratory must 
correct all standard-level deficiencies that are used to support the condition-level 
noncompliance finding before the laboratory can be found back in compliance with the 
condition. 
 
Options within Subpart K 
 
  Specialty and Subspecialty conditions--Use these conditions when serious 
deficiencies are identified within the specialty or subspecialty. D5002 - 
D5042. 
 
  General Laboratory Systems--Use this condition when serious 
deficiencies are identified within general laboratory systems. D5200. 
 
  Preanalytic--Use this condition when serious deficiencies are identified 
within the preanalytic phase of testing. D5300. 
 
  Analytic--Use this condition when serious deficiencies are identified 
within the analytic phase of testing. D5400. 
   
  Postanalytic--Use this condition when serious deficiencies are identified 
within the postanalytic phase of testing. D5800. 
 
NOTE: A serious deficiency is based on the nature and extent of the deficient practice. 
 
6130.4 - Choosing the Appropriate Condition 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Review the regulatory language at each of the conditions, noting the requirements that 
must be met for the condition to be in compliance.  For example: The condition of 
Bacteriology at 42 CFR 493.1201 (D5002) states the laboratory must meet the 
requirements at 42 CFR 493.1230 (D5200) through 493.1256 (D5485), 493.1261 
(D5501 - D5507) and 493.1281 (D5775) through 493.1299 (D5893) (covering General 
Laboratory Systems, Preanalytic Systems, Analytic Systems, and Postanalytic Systems). 
Serious problems in one or more of these areas can cause the condition of Bacteriology 
to be out of compliance. 
 
In comparison, the condition statement for Preanalytic Systems at 42 CFR 493.1240 
(D5300) states the laboratory must meet the requirements at 42 CFR 493.1241 
(D5301 - D5309), 493.1242 (D5311 - D5317), and 493.1249 (D5393) for each specialty 
or subspecialty of testing. Serious preanalytic deficiencies that are pervasive 
throughout the laboratory (not related to specific specialties or subspecialties) could 
cause the condition of Preanalytic Systems to be out of compliance.  Caution: An 
enforcement action based on noncompliance with the condition of General Laboratory 
Systems, Preanalytic Systems, Analytic Systems or Postanalytic Systems could be a 
revocation or a suspension of the CLIA certificate and would not necessarily be a 
limitation of the CLIA certificate for one or more specialties. 
 
Standard-level deficiencies written in one subpart cannot be the basis for a condition in 
another subpart. Deficiencies in Proficiency Testing or Personnel would not be the 
basis for the condition of Bacteriology to be out of compliance. It is not uncommon for 
a surveyor to identify issues that crossover between subparts of the regulations.  Cite 
deficiencies at the appropriate area of the regulations that describes the problem.  For 
example, failures in proficiency testing may be caused by an error in specimen 
identification, test system malfunction, or lack of training for staff.  Consider citing the 
most appropriate citation for the laboratory to come into compliance.  Avoid citing 
multiple citations for the same deficiency unless each citation focuses on a different 
aspect of the deficiency (instrument malfunction vs. staff training, or quality system vs. 
laboratory director responsibilities, as discussed above). 
 
The surveyor must consider the deficiencies cited when determining the conditions out 
of compliance, and also the potential enforcement actions should the laboratory not 
correct the deficiencies.  The organization of the regulations and conditions allows the 
surveyor to write a condition out of compliance according to specialty/subspecialty or 
to the Systems of testing (General Laboratory Systems, Preanalytic Systems, Analytic 
  Systems, or Postanalytic Systems). 
 
EXAMPLE 1: 
 
A laboratory has one or more standard-level deficiencies related to Bacteriology testing 
in Preanalytic Systems 42 CFR 493.1241 through 493.1249 (D5301-D5393), Quality 
Control Procedures 42 CFR  493.1256 (D5441-D5485) and the Bacteriology 
subspecialty 
42 CFR  493.1261 (D5501-D5507). The surveyor may determine the condition of 
Bacteriology 42 CFR  493.1201 (D5002) is out of compliance based on the deficiencies 
written under all three systems, Preanalytic, Analytic and Postanalytic. Even though the 
laboratory conducts testing in other specialty or subspecialty areas, by citing the 
deficiencies under the condition of Bacteriology, the certificate could be limited for the 
subspecialty of Bacteriology instead of the entire CLIA certificate being affected. 
 
EXAMPLE 2: 
 
A laboratory is cited for one or more standard-level deficiencies in Preanalytic Systems 
42 CFR 493.1241 through 493.1249 (D5301-D5393) and the deficiencies are related 
to practices in all the specialties and subspecialties offered by the laboratory. The 
surveyor determines the condition of Preanalytic Systems is out of compliance. If the 
laboratory does not correct the condition-level deficiency in Preanalytic Systems, the 
enforcement action is against the certificate and not a limitation of a specialty or 
subspecialty. 
 
EXAMPLE 3: 
 
A laboratory has deficiencies in Bacteriology in the Control Procedures 42 CFR 
493.1256 (D5441-D5485), the Bacteriology subspecialty 42 CFR 493.1261 (D5501-
D5507), and Routine Chemistry deficiencies in the Control Procedures 42 CFR 
493.1256 (D5441- D5485).  All deficiencies are within the Analytic System. 
 
The surveyor may determine the condition of Bacteriology 42 CFR 493.1201 (D5002) 
is out of compliance based on the deficiencies cited in Control Procedures 42 CFR 
493.1256 (D5441-D5485) and also deficiencies in subspecialty areas for Bacteriology 
42 CFR 493.1261 (D5501-D5507). 
 
And the surveyor may determine the condition of Routine Chemistry 42 CFR 
493.1210 (D5016) is out of compliance based on deficiencies cited related to Control 
Procedures 42 CFR 493.1256 (D5441-D5485).  Even though the D-tags used to 
determine condition- level noncompliance in Routine Chemistry are cited in the 
Control Procedures area, the appropriate condition to mark out of compliance is the 
applicable subspecialty of Routine Chemistry. 
 
If the laboratory performs testing in only the subspecialties of Bacteriology and 
Routine Chemistry, and if the deficient practices are pervasive, the surveyor may 
write the condition of Analytic Systems 42 CFR 493.1250 (D5400) out of 
  compliance. 
 
When a specialty or subspecialty condition is out of compliance, the enforcement action 
chosen may be a limitation to the certificate for the specialty or subspecialty out of 
compliance.  This approach allows the laboratory to continue testing in those specialties 
and subspecialties in which compliance was determined. A condition-level deficiency in 
one of the Systems (General Laboratory Systems, Preanalytic Systems, Analytic Systems, 
or Postanalytic Systems) indicates a pervasive situation through all specialties and 
subspecialties offered by the laboratory. 
 
6130.5 - Mandatory Citations 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
There are four CLIA Condition-level requirements the surveyor must cite if non-
compliance is found, regardless of the presence or absence of any negative outcome or 
potential harm. The four CLIA Condition-level requirements are: proficiency testing 
enrollment, proficiency testing referral, unsuccessful proficiency testing participation 
and issues related to personnel qualifications. 
 
The Mandatory Citations table provides guidance to surveyors for citing the four 
mandatory CLIA Condition-level citations.  Citations should include the Condition 
citation and the corresponding D-tag.  Where appropriate, surveyors should also 
provide any Standard -level citations under the condition as well as the standard-level 
D-tag for those standard-level citations. 
 
The mandatory Condition-level citations and D-tags and the Standard-level citations 
and D-tags that correspond to the three mandatory PT conditions are: 
 
1. Enrollment in Proficiency Testing (D2000) (42 CFR 493.801) 
 
No minimum standard-level D-tag required. This is the ONLY mandatory Condition-
level  citation  where  no  Standard-level  D-tag  is  cited  in  conjunction  with  the 
Condition-level D- tag. 
 
2. Proficiency Testing Referral (D2000) (42 CFR 493.801) 
 At a minimum cite the Standard at D2013 (42 CFR 493.801(b)(4)) 
 
3. Successful Participation in Proficiency Testing 
(D2016) (42 CFR 493.803) 
 At a minimum cite the Standard at any of the following as 
applicable: D2028, D2037, D2046, D2055, D2064, D2074, D2084, 
D2085, D2096, D2097, D2107, D2108, D2118, D2119, D2130, D2131, 
D2162, D2163, D2172, D2181, D2190 or D2191. 
 
The mandatory Condition-level citations and D-tags, and the potential standard-level 
citations and D-tags that correspond to the Condition-level personnel qualifications, 
  are: 
 
1. Laboratory Director PPM (D5980) (42 CFR 493.1355) 
 At a minimum cite the Standard at D5981(42 CFR 493.1357) 
 
2. Testing Personnel PPM (D5990) (42 CFR 493.1361) 
 At a minimum cite the Standard at D5991(42 CFR 493.1363) 
 
3. Laboratory Director Moderate Complexity Testing (D6000) (42 CFR 
493.1403) 
 At a minimum cite the Standard at D6003(42 CFR 493.1405) 
4. Technical consultant Moderate Complexity Testing (D6033) (42 CFR 
493.1409) 
 At a minimum cite the Standard at D6035(42 CFR 493.1411) 
 
5. Clinical Consultant Moderate Complexity Testing (D6056) (42 CFR 
493.1415) 
 At a minimum cite the Standard at D6057(42 CFR 493.1417) 
 
6. Testing Personnel Moderate Complexity Testing (D6063) (42 CFR 493.1421) 
 At a minimum cite the Standard at D6065(42 CFR 493.1423) 
 
7. Laboratory Director High Complexity Testing (D6076) (42 CFR 493.1441) 
 At a minimum cite the Standard at D6078(42 CFR 493.1443) 
 
8. Technical Supervisor High Complexity Testing (D6108) (42 CFR 493.1447) 
 At a minimum cite the Standard at D6111(42 CFR 493.1449) 
 
9. Clinical Consultant High Complexity Testing (D6134) (42 CFR 493.1453) 
 At a minimum cite the Standard at D6135(42 CFR 493.1455) 
 
10.  General Supervisor High Complexity Testing (D6141) (42 CFR 
493.1459) 
 At a minimum cite the Standard at D6143(42 CFR 493.1461) 
 
11.  Cytology General Supervisor (D6153) (42 CFR 493.1467) 
 At a minimum cite the Standard at D6155(42 CFR 493.1469) 
 
12.  Cytotechnologist (D6162) (42 CFR 493.1481) 
 At a minimum cite the Standard at D6164(42 CFR 493.1483) 
 
13.  Testing Personnel High Complexity Testing (D6168) (42 CFR 493.1487) 
 At a minimum cite the Standard at D6171(42 CFR 493.1489(b)) 
 
 
  MANDATORY CITATIONS 
 
  YOU  MUST  AT  YOU MUST AT LEAST 
IF YOU FIND  LEAST  CITE  THE  CITE THE 
NON-COMPLIANCE WITH. . .  STANDARD  AT  D- CONDITION AT D-
Non-enrollment in Proficiency        D2000    
Testing 42 CFR  493.801 
Proficiency Testing  D2013  D2000 
Referral 42 CFR  
Unsuccessful   D2028, D2037,  D2016 
Participation in  D2046, D2055, 
Proficiency Testing  D2064, D2074, 
42 CFR  493.803  D2084, D2085, 
D2096, D2097, 
D2107, D2108, 
D2118, D2119, 
D2130 D2131 
Laboratory Director  D5981  D5980 
PPMP     
Testing Personnel  D5991     D5990 
M  PPMP 
     
t  Laboratory Director  D6003  D6000 
r
a Moderate  Complexity 
p
b TTechinic al Consultant  D6035  D6033 
u
S Moderate  Complexity 
-  T i  
s  Clinical Consultant  D6057  D6056 
n Moderate  Complexity 
o
i T i  
at Testing Personnel  D6065  D6063 
c Moderate  Complexity 
i
lif TLaboira tory Director  D6078  D6076 
a
u High  Complexity Testing 
Q
  Technical Supervisor  D6111  D6108 
l
e High  Complexity Testing 
n
on Clinical Consultant  D6135  D6134 
s High  Complexity Testing 
r
e
P General Supervisor  D6143  D6141 
High  Complexity Testing 
Cytology General Supervisor  D6155  D6153 
Cytotechnologist  D6164  D6162 
Testing Personnel  D6171  D6168 
High  Complexity Testing 
   
   
6132 - Certification Actions Performed After the Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The post-survey certification processes are summarized as follows: 
 
  The surveyor completes survey documents. (see 6136.4 Survey Report 
Documentation and Data Entry); and 
  The Form CMS-2567 is sent to the laboratory requesting a PoC or 
credible AoC, if appropriate. A PoC is required for all deficiencies, 
except in cases of immediate jeopardy where limitations or 
suspension of the certificate may be imposed prior to an opportunity 
for a hearing. 
 
The SA sends (e. g. emails, mails, fax) the laboratory a copy of the Form CMS-2567 
within 10 calendar days of completing the survey.  If there are citations, the SA 
allows the laboratory 10 calendar days to complete and return a PoC or credible 
AoC. If immediate jeopardy is identified, the SA follows the time frames in 6284. 
 
The Form CMS-2567 may be disclosed to the public in accordance with the 
instructions in Chapter 3, Additional Program Activities. Refer to the SOM 
Chapter 3  3304, 3308, 3308A, 3310, 3312, 3314, 3316 and 3318 for 
information on disclosure. 
Information that may be disclosed to the Public by the SA: 
1.  Whether a facility participates in the 
Medicare/Medicaid/CLIA program; 
2.  The official Medicare/Medicaid/CLIA report of a survey with the 
following redactions: 
 The name of any patient; 
 
 Medical information about any identifiable patient; 
 
 The identity of a complainant; 
 
 The address of anyone other than an owner of the facility; or 
 
 Information which could be defamatory toward any identifiable person. 
 
NOTE: The SA reviews the report of survey, and if it contains any of the 
above elements, it deletes the information from the report by blocking it 
out fully prior to release of the report.  (See 42 CFR 401.118) 
NOTE: Prior to release, the laboratory must have had an opportunity to review 
  the report (not exceeding 60 days) and offer comments.  The disclosure must be 
made within 90 days following completion of the survey by the SA. 
 
3.  Citations of deficiencies that have been conveyed to the provider following 
a survey, except to the extent the report contains any of the identifiable 
information listed above. The SA blocks this information out prior to release of 
the statement of deficiencies; 
4.  PoC and pertinent comments submitted by the provider relating to 
Medicare/Medicaid/CLIA deficiencies cited following a survey, except to the 
extent the PoC or comments contain any of the identifiable information listed 
above.  The SA blocks this information out prior to release of the PoC; 
5.  Official notices of involuntary provider termination; 
 
6.  Reports and information about a laboratorys performance in proficiency 
testing  programs  (NOTE:  information  about  any  individual  persons 
performance may not be released); 
7.  Information contained within the CMS manuals distributed to the 
SAs, intermediaries, carriers, providers, or suppliers; and 
8.  Statistical data on provider characteristics that do not identify any 
specific provider or individual. 
9.  Form CMS-116, CLIA Application for Certification; however, the name 
of the laboratory director and tax ID must be blocked prior to the release of 
the application. 
10.  Form CMS-209, Laboratory Personnel Report (CLIA), may not be released. 
 
Paper or electronic copies of these Federal electronic documents may be released by 
the SA.  Again, any individual identifiers (other than patient/resident or staff 
alphanumeric identifiers) must be deleted from the information prior to release. 
See 6318 for further information on the Freedom of Information Act (FOIA). 
 
NOTE: Standard and User-Defined CASPER reports may also be released by the SA. 
 
6132.1 - Generating the Statement of Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form CMS-2567 can be generated using the appropriate module in the ASPEN 
suite (e.g., ACO, ARO, ACTS, ASE-Q).  Direct references to regulations are shown 
with a corresponding D-tag (data tag) number. In the summary statement column at 
  the appropriate D-tag number, the surveyor includes the regulatory citation along 
with the description of the laboratorys deficient practices.  The surveyor should 
refer to the Principles of Documentation manual for preparing a defensible citation. 
The SA must always obtain and maintain thorough and comprehensive documentation 
to support the survey findings and certification decisions to sustain the action in the 
event of a hearing or judicial review. The SA must use all available sources of 
information to assist with completing the Form CMS-2567. 
 
6132.2 - Plan of Correction (PoC) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The laboratory enters its planned action to correct the deficiency and the expected 
completion date opposite the appropriate data tag on Form CMS-2567.  
Alternatively, the laboratory may enter its disagreement with a finding and may 
furnish documentation that requirements are met.  If a deficiency has been corrected 
since the survey, the laboratory should indicate this on the form along with the date 
of correction. 
 
The PoC is a plan which contains records (documentary materials) that outlines how 
the laboratory is going to fix the standard-level deficiency(s) therefore, the PoC may 
have future dates (i.e., after the date of submission).  A record includes all recorded 
information, regardless of form or characteristics, made or received by a federal agency 
under federal law or in connection with the transaction of public business and preserved 
or appropriate for preservation by that agency or its legitimate successor as evidence of 
the organization, functions, policies, decisions, procedures, operations, or other 
activities of the US Government or because of the informational value of data in them. 
44 U.S.C Chapter 33, Section 3301.  All records must be kept the period defined by the 
federal requirements at DAA-0440-2015-0008, which is 7 years, or by State 
requirements, if more stringent than federal requirements. 
There are four elements that are required to be submitted with a PoC. Those four 
elements are: 
a.  Documentation describing the corrective actions that have been taken 
for  patients that were identified by the survey and subsequent analysis 
as having been  affected by the deficient practice(s); 
b. An explanation as to how the laboratory has identified other patients who 
may have been affected by the deficient practice(s); 
c. A description of the correction(s) that have been put into place and/or the 
systemic changes that have been made to ensure that the deficient practice 
does not recur; and 
d.  A description of how the corrective actions are being monitored to 
ensure the deficient practice does not recur. 
 
All deficiencies may not be corrected at the time the plan of correction is submitted to 
the SA or RO, but it must have corrected dates that are within 12 months after the 
  date survey completed listed on the CMS-2567 and must be reasonable in 
timeframe and content. 
The plan must be specific and time frames stated and realistic, stating exactly: 
 
  How the deficient practice will be corrected or how it was corrected; 
 
  What corrective action(s) have been taken for patients found to have been 
affected by the deficient practice; 
 
  How the laboratory has identified other patients having the potential to be 
affected by the same deficient practice and what corrective action(s) has been 
taken; 
 
  What measure has been put into place or what systemic changes have been 
made to ensure that the deficient practice does not recur; and 
 
  How the corrective action(s) is being monitored to ensure the deficient 
practice does not recur. 
The laboratory director or other authorized official, (i.e. owner, operator and/or 
laboratory director) must sign and date the Form CMS-2567 on which the laboratorys 
PoC is written. 
 
If the laboratory director requests additional time to develop the plan, the SA 
explains that a preliminary PoC must be submitted within 10 days, as precisely as 
present information permits, and that it may be followed with a more specific plan 
as early as possible.  Also, the SA advises that a future contact or revisit to verify 
correction of deficiencies will occur only when the laboratory makes an 
acceptable PoC. 
 
After completing the PoC, if the Form CMS-2567 was generated using ASPEN, the SA 
instructs the laboratory to retain a copy and return the original to RO/SA within 10 
days of receipt. If the response attempts to refute a citation, the SA contacts the 
laboratory to resolve the disagreement. If not resolved, the laboratory should put its 
protest in writing in a form suitable for disclosure, but must still provide its plan and 
time frame for correction. 
 
If the laboratory corrects a cited deficiency before the completion of the survey, the 
SA documents the deficiency on the Form CMS-2567 and explains to the laboratory 
director that when the laboratory receives the Form CMS-2567, it is to indicate the 
correction as of that date. 
 
It is not acceptable, under any circumstances, for a laboratory to allude in any way to 
another laboratory or to malign an individual on a publicly disclosable Form CMS-
2567. The SA should request an amended PoC from the laboratory. 
 
  6132.3 - Allegation of Compliance (AoC) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When Condition-level noncompliance is determined by the RO or State Agency surveyor, 
an AoC is requested. 
 
An AoC is an assertion (i.e., allegation) from the laboratory that they are in compliance; 
hence, no future dates of correction are acceptable for any condition-level deficiency as 
well as standard-level deficiencies included in the condition on the Form CMS-2567. 
For any standard-level deficiencies that are not included in the condition, future dates 
are acceptable.  The AoC contains records (documentary materials) that describe or 
support the laboratorys compliance.  A record includes all recorded information, 
regardless of form or characteristics, made or received by a federal agency under 
federal law or in connection with the transaction of public business and preserved or 
appropriate for preservation by that agency or its legitimate successor as evidence of 
the organization, functions, policies, decisions, procedures, operations, or other 
activities of the US Government or because of the informational value of data in them. 
44 U.S.C Chapter 33, Section 3301. All records must be kept the period defined by the 
federal requirements at DAA-0440-2015-0008, which is 7 years, or by State 
requirements, if more stringent than federal requirements. 
 
There are four elements that are required to be submitted with an AoC. Those four 
elements are: 
a. Documentation describing the corrective actions that have been taken 
for patients that were identified by the survey and subsequent analysis as 
having been  affected by the deficient practice(s); 
b. An explanation as to how the laboratory has identified other patients who 
may have been affected by the deficient practice(s); 
c. A description of the correction(s) that have been put into place and/or the 
systemic changes that have been made to ensure that the deficient practice 
does not recur; and 
d. A description of how the corrective actions are being monitored to 
ensure the deficient practice does not recur. 
 
In addition to the above four elements, the AoC is a statement or documentation that is: 
a. Made by a representative of a laboratory with a history of having 
maintained a commitment to compliance and taking corrective action 
when required; 
b. Realistic in terms of the possibility of the corrective action being 
accomplished between the date of the survey and the date of the 
allegation: and, 
c. Indicates resolution of the problem(s). 
 
 
 
 
  6134 - Review of Plan of Correction or Allegation of Compliance by State 
Agency 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA reviews the laboratorys PoC or AoC and accompanying documentation 
for appropriateness, legibility, completeness, and timeliness. 
The SA verifies the evidence contains: 
 
1.  Corrective action(s) have been taken for patients found to have been 
affected by the deficient practice. 
2.  How the laboratory has identified other patients having the potential to be 
affected by the same deficient practice and what corrective action(s) have 
been taken. 
3.  Measures has been put into place or systemic changes have been made to 
ensure that the deficient practice does not recur. 
4.  Corrective action(s) are being monitored to ensure the deficient practice 
does not recur. 
5.  Identify the signature of the laboratory director or designee. 
 
If not properly completed or there is a question about the PoC or AoC, the SA 
contacts the laboratory representative to obtain clarification or appropriate 
modification of the plan or allegation.  The SA retains a copy of the Form CMS-
2567, the laboratorys written PoC or AoC and the laboratorys accompanying 
documentation in the SAs file with the certification packet. 
 
All records must be kept the period defined by the CMS Records Schedule at DAA-0440- 
2015-0008, which is 7 years, or by State requirements, if more stringent than CMS 
Records Schedule. 
 
6134.1 - Strategy for Repeat Deficiencies 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15-19) 
 
A repeat deficiency is defined as a deficient practice cited on a current Form CMS-
2567, Statement of Deficiencies that was also cited during a prior CLIA survey of the 
laboratory. If during a recertification, complaint, or validation survey of the laboratory 
it is determined that a repeat deficiency exists, use the following strategy to help ensure 
the receipt of an acceptable plan of PoC or a credible AoC that will result in effective, 
meaningful, and sustained corrective actions by the laboratory. 
 
Laboratories must not be given multiple opportunities to correct repeat deficiencies. If 
repeat deficiencies are not corrected quickly, the SA should refer the laboratory to the 
RO for possible enforcement action. (This strategy may not be applicable to certain 
  repeat deficiencies, e.g., the laboratorys failure to have appropriately qualified 
laboratory personnel in rural areas.) 
 
Strategy for Repeat Deficiencies: 
 
1.  Cite each repeat deficiency and, if found, all other deficient practices on 
Form CMS-2567. Principles of Documentation do not preclude the 
surveyor from identifying a deficient practice as a repeat deficiency on 
Form CMS-2567. 
 
2.  Using the routine process, request the laboratory to submit an acceptable 
PoC or a credible AoC. 
3.  Review the submitted plan of correction or allegation of compliance and 
determine whether the laboratorys submission meets the criteria for an 
acceptable plan of correction or a credible allegation of compliance. Based on 
established criteria, if the plan of correction is not acceptable or the 
allegation of compliance is not credible, give the laboratory no more than one 
additional opportunity to provide an acceptable or credible submission, or 
forward the case to the Regional Office for possible enforcement action. 
Consideration should be made to the laboratorys compliance history, 
seriousness of the deficient practice, and the degree to which the laboratorys 
submission has met established criteria. 
 
4.  If the laboratorys submission meets established criteria for an acceptable plan 
of correction or a credible allegation of compliance, compare the currently 
submitted plan of correction or allegation of compliance for the repeat 
deficiency to the plan of correction or allegation of compliance the laboratory 
submitted when the deficiency was previously cited. If the currently submitted 
plan of correction or allegation of compliance for the repeat deficiency is the 
same as the previously submitted plan of correction or allegation of 
compliance, the plan of correction is not acceptable or the allegation of 
compliance is not credible. Give the laboratory no more than one additional 
opportunity to provide an acceptable or credible submission, or forward the 
case to the Regional Office for possible enforcement action.  Consideration 
should be made to the laboratorys compliance history, seriousness of the 
deficient practice, and the degree to which the laboratorys current submission 
is the same as the laboratorys previous submission. 
 
5.  If the laboratorys submission for the repeat deficiency is different from the 
plan of correction or allegation of compliance submitted by the laboratory for 
the prior survey, consider whether the laboratorys current submission resolves 
the underlying cause of the problem and is adequate to prevent recurrence of 
the deficient practice.  If it is determined that the laboratorys current 
submission does resolve the underlying cause of the problem or is not adequate 
to prevent the deficient practice from recurring, give the laboratory no more 
than one additional opportunity to provide an appropriate submission, or 
  forward the case to the Regional Office for possible enforcement action.  
Consideration should be made to the laboratorys compliance history, 
seriousness of the deficient practice, and the degree to which the laboratorys 
current submission is likely to resolve the underlying cause of the problem(s) 
and prevent recurrence of the deficient practice. 
 
6.  If it is determined that the laboratorys current submission resolves the 
underlying cause of the problem and is adequate to prevent the deficient 
practice from recurring, review evidence from the laboratory to ensure that the 
corrective/remedial action has been implemented before determining that the 
laboratorys submission is acceptable or credible. 
 
 
The above strategy is summarized in the following flow chart: 
 
 
  6134.2 - Follow-Up on PoCs and Post-Survey Revisit 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If possible, the Post Survey revisit is to be conducted by a member of the survey 
team that made the findings.  When a laboratory has failed to comply with one or 
more CLIA conditions, the SA follows up on all citations cited on the Form 2567 
only after the laboratory makes a credible AoC and submits acceptable evidence of 
correction. In some cases, the citations may be of such nature that an electronic 
transmission, mail or telephone contact may suffice in lieu of an on-site visit, e.g., 
the laboratory agreed to amend its written policies. An electronic transmission, 
mail or telephone contact is acceptable, as long as there has been no reason to 
question the validity of the reported corrections. When conducting a post survey 
revisit, the SA is verifying that the evidence of correction as documented in the AoC 
is authentic. If documentary or on- site verification is warranted, the SA obtains 
appropriate verification before reporting a citation as corrected and completes a 
post- Certification Revisit Report, Form CMS- 2567B. 
 
When the deficiencies are below the Condition-level for which the laboratory has 
submitted a PoC, the SA may certify a laboratory based on an acceptable PoC. The SA 
is certifying that the laboratory is able to furnish test results without hazard to the 
health and safety of patients, that the PoC will likely result in compliance within the 
time frame indicated, and that the time frame is acceptable. The SA conducts a revisit 
survey when only Standard-level deficiencies were cited within 12 months of the 
original survey. This required post-survey revisit is normally conducted by electronic 
transmission, mail or telephone contact. On-site post-survey revisits are not normally 
conducted when the only deficiciencies cited are Standard-level deficiencies. On- site 
verification of standard-level deficiencies is warranted in rare circumstances where the 
documentation or correction provided by the laboratory alone does not verify 
correction of the deficiency and/or the documentation provided is indicative of 
potential risk to the quality of patient test results. 
The SA may consult with the RO for a determination regarding cases that are unclear. 
The SA obtains appropriate documentary verification (or on-site verification if 
warranted) before reporting a citation as corrected and completes a Form CMS-2567B. 
 
If, at the time of the revisit, some deficiencies have not been corrected, the SA 
completes another Form CMS-2567 summarizing the deficiencies not corrected by 
using the appropriate data prefix tag number. The SA must ask the laboratory to 
provide a revised PoC or AoC with a new completion date. The SA sends a copy of the 
Form CMS-2567 and allows the laboratory 10 calendar days to complete and return a 
PoC or AoC for any remaining deficiency(ies). The SA inputs the revised data into the 
ASPEN system. If failure to correct deficiencies results in the laboratory no longer 
being in compliance, the SA documents the case for enforcement action and forwards 
the case to the RO. 
 
In any event, the SA must record the survey findings in ASPEN within 45 days from the 
date of the survey; post-survey revisit information can be entered into ASPEN at any 
  time thereafter. 
 
6134.3 - Post-Survey Revisit Report, Form CMS-2567B 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS Form 2567-B is only required between the SA and the RO. At the time of the 
follow-up visit or when corrections are verifiable by electronic transmission, 
telephone contact, or mail, the SA completes a Form CMS-2567B for the deficiencies 
previously reported which have been corrected.  Form CMS-2567B includes:  
 
1.  Laboratory identification information; 
2.  Date of the revisit ; 
3.  Prefix tag; 
4.  Corresponding regulatory reference cited on the original Form CMS-2567; and 
5.  Date the correction was completed. 
The use of the CMS Form 2567-B is to become an internal document between the SAs 
and the ROs. The SAs are no longer required to complete the CMS Form 2567-B for 
provider/supplier notification to inform facilities that they have come back into 
compliance; however, SAs are required to produce the CMS 2567-B to the ROs. 
 
Revisit determines that all deficiencies have been corrected, and no new deficiencies 
are cited. 
  A CMS Form 2567-B is issued by the SA to the RO only, listing all 
deficiencies corrected and dates that the corrections were completed. 
o  The box at the bottom of the form entitled Check for any 
uncorrected deficiencies is not checked. 
  The cover letter accompanying the CMS Form 2567-B states that all 
deficiencies were found to be corrected at revisit. 
  No CMS Form 2567 is issued. 
 
6136 - Evaluation of Compliance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA requirements establish a single set of Conditions and standards for 
all laboratories. CLIA certification is required for payment for laboratory 
services under the Medicare and Medicaid programs. 
 
During the laboratory survey, the SA compiles all information required to determine 
compliance, and completes all official reports of survey findings. Survey findings under 
CLIA requirements are determinations made by surveyors. When the survey reports and 
  a Medicare/Medicaid Certification and Transmittal, Form CMS-1539 are entered into 
the CLIA data system, an official determination of CLIA compliance is made. There are 
three types of compliance for any laboratory: 
 
6136.1 - Compliance With all CLIA Conditions With No Deficiencies 
Identified 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
This indicates that there are no deficiencies identified. The laboratory is sent a Form 
CMS-2567 stating there are no deficiencies on the date(s) of the survey. It is optional 
for the laboratory director to sign the Form CMS-2567 when no deficiencies were 
cited. The laboratory is issued the appropriate CLIA certificate and is eligible to 
participate in the Medicare and Medicaid programs. 
 
6136.2 - Compliance Based on an Acceptable PoC 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Compliance based on an acceptable PoC reflects the findings that all applicable 
Conditions are met, but there are deficiencies below the Condition level for which 
the laboratory has submitted an acceptable PoC. The surveyor is certifying that the 
laboratory is able to furnish test results without hazard to the health and safety of 
patients. Laboratories having deficiencies must correct them within an acceptable 
time frame (no later than 12 months after the date surveys completed).  Compliance 
based on an acceptable PoC varies with the level, nature and seriousness of the 
deficiencies. 
 
In reviewing the PoC, the SA evaluates whether or not the corrective action will result 
in compliance within the time frame indicated and whether that time frame is 
acceptable. If the laboratory does not submit an acceptable PoC or if it fails to correct 
its deficiencies, the SA/RO withdraws the laboratorys approval to receive Medicare 
and Medicaid payment and revokes its certificate, as appropriate.  (See 6284.) 
 
6136.3 - Noncompliance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In situations where it is determined that a laboratory has failed to comply with one or 
more CLIA conditions, the SA requests an AoC and acceptable evidence of correction. If 
the laboratory fails to submit a credible AoC and acceptable evidence of correction, the 
SA notifies the RO of the noncompliance and recommends to the RO sanction action by 
completing Form CMS-1539.  (See 6262.) 
 
6136.4 - Survey Report Documentation and Data Entry 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Following the survey, enter into the CLIA database any revisions, additions, or deletions 
  to the application (Form CMS-116) information. Refer to the CLIA Systems Users Guide 
for specific information and instruction. Enter into the data system the Certification Kit, 
which consists of: 
 
Form CMS-1539, Certification and Transmittal; 
Form CMS-1557, Survey Report Form (CLIA) - pages 1 and 2; 
 
Form CMS-2567, Statement of Deficiencies and Plan of Correction; 
and Form CMS-670, Survey Team Composition and Workload 
Report. 
Enter into the data system, when applicable:  
 
             Form CMS-562, Medicare/Medicaid/CLIA Complaint Form. 
 
Form CMS-668B has been developed to assess the survey process from the viewpoint 
of the laboratory. Leave this form with all laboratories that receive an on-site survey. 
The laboratory will complete this form and return it to CO. 
 
6137 - Data Management 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The following CLIA data entry actions contain reasonable time frames that should be 
adhered to: 
 
  Form CMS-116 entered up to 30 days after receipt by the SA. (Before 
entering the Form CMS-116 data into the system, the SA verifies that the 
laboratory director is qualified.  (See 6006.7) 
 
  Form CMS-2567, Form CMS-670, and Form CMS-1557 entered up to 45 
days after the survey. 
 
  Certificate changes and updates entered up to 45 days after receipt by the SA. 
 
6138 - Retention of CLIA Certification Records 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Essential data from all CLIA forms can be captured electronically in the CMS 
mainframe data system, and will maintain the data for 7 years following the year in 
which the record is created, pursuant to Subpart R of the Federal Acquisition 
Regulations (incorporated by reference in Article XII.A of the 1864 agreement). The 
1864 agreement and Subpart R do not preclude limiting data captured to essential 
elements. For example, the deficiency codes and correction dates from the Form CMS-
2567 are essential, but the narrative description of deficiencies or corrections are not. 
  Article XII.A of the 1864 agreement requires retention of survey and certification 
records for three years following the year in which the record is created. This 
provision permits retention of the records in electronic form. 
 
Additional expectations are found in the CMS Records Schedule, which provides 
record descriptions and mandatory disposition instructions for the retention, transfer, 
retirement or destruction of Agency records as approved by the National Archives & 
Records Administration.  See Section XI for specific CLIA-related information. 
 
However, where State law requires retention of records for a longer period or in 
specific formats, only the state actor is bound by the State law. 
 
The following sections specify record retention requirements for different compliance 
situations. 
 
6138.1 - No Deficiencies Cited 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Upon completion of a survey in which no deficiencies are cited, the SA enters all 
applicable CLIA survey forms (see Appendix C) into the CLIA data system. 
 
6138.2 - Deficiencies Cited 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Upon completion of a survey where deficiencies are cited, the SA enters all forms into the 
CLIA data system in the time frame specified above, regardless of whether the PoC or 
AoC are yet verified. 
 
6138.3 - Exception 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Form CMS-209 is completed at the time of the survey. This form is currently not 
available in electronic form in ASPEN. The SA either retains a hard copy or scans a 
copy of the Form CMS-209 (Exhibit 106) until updated or revised at the next survey to 
prevent evaluation of the same personnel on two consecutive surveys as part of the 
survey sample of personnel. 
 
6139 - Media Representatives Referred by the CMS Press Office 
(Rev. 1, 05-21-04) 
 
The CMS Press office has primary responsibility for media liaison; however, there may 
be occasional instances when the Press Office refers a media representative to a CLIA 
program representative.  The following policy statement is provided for your reference if 
the media representatives inquiry is related to individually identifiable health 
information.  
 
  CLIA program representatives are pleased to discuss the CLIA requirements with 
media representatives referred by the CMS Press Office.  It is the policy of CMS, 
however, not to comment on the health information of an individual, including 
laboratory test results, or the impact of a laboratorys services on the treatment or 
health outcome of a specific individual. 
Sample Validation Surveys of Accredited Laboratories 
 
6140 - Additional Information 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6140.1 - Counting Tests 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Total annual volume for waived tests, if any, should be recorded on the CLIA 
application (Form CMS-116) in the waived testing section. The total annual volume for 
nonwaived tests, including PPM procedures, should be reported on the form in the 
Nonwaived Testing section by specialty and subspecialty. Only tests that are ordered 
and reported should be included in the laboratorys test volume(s). Calculations (e.g., 
A/G ratio, MCH, MCHC, HCT, and T7), QC tests, and PT assays should not be 
counted. 
 
  For chemistry tests, each non-calculated analyte is counted separately 
(e.g., Lipid Panel consisting of a total cholesterol, HDL cholesterol, LDL 
cholesterol and triglycerides equals 4 tests). 
 
  For complete blood counts, each measured individual analyte that is 
ordered and reported is counted separately. Differentials count as one 
test. 
 
  For urinalysis, microscopic and macroscopic examinations each count as 
one test.  Macroscopics (dipsticks) are counted as one test regardless of the 
number of reagent pads on the strip. For screening drug tests (e.g. dipsticks, 
cups, cards) count as one test regardless of the number of drugs tested. 
  For microbiology, susceptibility testing is counted as one test per group of 
antibiotics used to determine sensitivity for one organism.  Cultures are 
counted as one per test request from each specimen regardless of the extent 
of identification, number of organisms isolated, and number of 
tests/procedures required for identification.  Each gram stain or acid-fast 
bacteria (AFB) smear requested from the primary source is counted as one.  
For example, if a sputum specimen has a routine bacteriology culture and 
gram stain, a mycology test, and an AFB smear and culture ordered, this 
would be counted as five tests.  For parasitology, the direct smear and the 
concentration and prepared slide are counted as one test. 
  For allergy testing, each allergen is counted as one test. 
 
    For flow cytometry, each measured individual analyte (e.g. T cells, B cells, 
CD4, etc.) that is ordered and reported should be counted separately. 
 
  For manual gynecologic and nongynecologic cytology, each slide (not case) 
is counted as one test. Refer to D5643 for counting non-gynecological slide 
preparations using liquid-based slide preparatory techniques. Refer to 
D5665 for counting gynecologic cytology slide preparations when using 
automated and semi-automated screening devices. 
 
  For immunohematology, each ABO, Rh, antibody screen, cross 
match, or antibody identification is counted as one test. 
 
  For histocompatibility, each HLA typing (including disease associated 
antigens) is counted as one test, each HLA antibody screen is counted as 
one test and each HLA cross match is counted as one test. For example, a B-
cell, a T-cell, and an auto-crossmatch between the same donor and recipient 
pair would be counted as 3 tests. 
 
  For histopathology, each block (not slide) is counted as one test. Autopsy 
services are not included.  For those laboratories that perform special 
stains on histology slides, the test volume is determined by adding the 
number of special stains, including immunohistochemistry, performed on 
slides to the total number of specimen blocks prepared by the laboratory. 
 
  For cytogenetics, the number of tests is determined by the number of 
specimen types processed on each patient (e.g., a bone marrow and a 
venous blood specimen received on one patient are counted as two tests).  
 
NOTE: For all other genetic tests, the number of tests is determined by the 
number of results reported in the final report. 
 
  Genetics tests should be placed in the specialty or subspecialty where 
they fit best, according to the methodology of the test. 
 
6140.2 - Conducting Surveys of Multiple Testing Sites under One 
Certificate 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
1.  Multiple sites are permitted to operate under a single certificate when 
the sites meet one of the multiple site exceptions at 42 CFR  493.35(b), 
493.43(b), or 493.55(b).  Each site performing testing under a single 
certificate must meet all applicable requirements of 42 CFR Part 493.  
Each site is subject to a survey; however, the primary site or home base, as 
applicable, should be one of the locations included in the initial CLIA 
certification survey. Select a representative portion of the remaining 
  locations for on-site survey. 
When choosing the representative sample for multiple site surveys, consider the 
following: 
 
  Types of testing performed; 
 
  Types of clients and/or facilities served, e.g., pediatric, 
geriatric, residential/emergency care, or health assessment 
screens; 
 
  Location(s) participating in PT; and 
 
  Problems or complaints identified either at the primary or other 
testing sites. 
 
2.  Temporary testing sites, including mobile units, should be inspected using 
the criteria listed above. Refer to the SOM Chapter 6, 6010.1 to assist with 
determining what constitutes a mobile unit and for temporary testing sites.  
Every effort should be made to schedule the survey to coincide with testing at 
temporary locations. (Refer to 42 CFR 
493.35(b)(1),493.43(b)(1),493.55(b)(1)) 
 
a. Home Health and Hospice laboratory testing with multiple sites 
should generally be inspected using the criteria listed above (Refer 
to CFR 493.35(b)(1),493.43(b)(1), 493.55(b)(1)) Refer to SOM 
Chapter 6  6010.1.2.1. 
 
Many Home Health Agencies (HHAs) may be certified with multiple 
sites under one certificate.  A parent HHA may apply for one CLIA 
certificate as long as these sites meet the applicable requirements. 
Medicare designates these multiple locations using the term parent 
location for the main location and the term branches for the 
additional sites.  Hospices may also be certified with one certificate 
for multiple sites.  Refer to the SOM Chapter 6, 6010.1.2.1 for 
additional information on HHAs and hospices. 
 
3.  Refer to the SOM Chapter 6, 6010.2 for additional information on 
laboratories performing limited public health testing. These entities should be 
inspected using the above criteria (Refer to 42 CFR  493.35(b)(2), 
493.43(b)(2), 493.55(b)(2)) 
 
4.  In a hospital laboratory, multiple test sites under one certificate should 
generally be inspected using the criteria listed above. (Refer to 42 CFR  
493.35(b)(3), 493.43(b)(3), 493.55(b)(3)).  Refer to SOM Chapter 6 6010.3. 
 
 
  A laboratory having multiple sites under one certificate is required to enroll in only one 
PT program(s) for the primary test system/procedure for each specialty, subspecialty, 
analyte or test used under that certificate even though the same specialty, subspecialty, 
analyte or test may be used at multiple locations using different test systems or 
procedures and different personnel.  Ensure that PT records indicate the location at 
which the tests were performed, and that all other locations have been compared with 
the system selected for PT, as specified in 42 CFR 493.1281(a). 
 
A condition may be considered out of compliance even if deficiencies are only found 
at a subset of the sites operating under the single certificate. 
 
6140.3 - Conducting Surveys of Laboratories Performing Waived Tests 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In any laboratory holding a CLIA certificate, waived tests are generally not subject 
to routine survey.  If the SA is surveying a CoC or CoA and finds cause that points 
towards problems in waived testing, the SA should investigate the problem(s). 
 
6140.4 - Conducting Surveys of Laboratories with a Certificate of Waiver 
(CoW) or a Certificate for PPM Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
As provided at 42 CFR 493.1775 of Subpart Q Inspection, a laboratory that has 
been issued a CoW certificate or a PPM certificate is not subject to biennial 
inspections. 
However, a survey may be conducted as specified in Subpart Q (i.e., randomly) during 
its hours of operation on authorization by the RO for any or all of the following to: 
  Determine if the laboratory is testing outside its certificate; 
  Collect information regarding the appropriateness of tests specified as 
waived or PPM; 
  Investigate a complaint from the public; and 
  Determine if the laboratory is operating and if testing is performed in a 
manner that does not constitute an imminent and serious risk to public 
health. 
 
Please note that in those instances in which you are performing a survey on a 
laboratory with a certificate for PPM procedures, the appropriate requirements in 42 
CFR Part 493 Subparts H, J, K, M and Q will apply.  Furthermore, regardless of the 
certificate held, in instances in which a survey is occurring in a laboratory with a 
Certificate of Compliance or a Certificate of Accreditation, which has conducted PPM 
procedures, that PPM testing may be included in the sample for the patient testing 
review portion of the survey. 
 
 
 
 
  6140.5 - Complaints Involving Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA/RO investigates allegations of non-compliance that are related to CLIA 
requirements in laboratories.  A complaint about a laboratory should be reported to 
the appropriate SA or RO contact.  The complete list of SA/RO contacts can be found 
on the CLIA website at: https://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA/index.html.  The RO is responsible for coordinating the 
responses to all complaints. (See SOM Chapter 5, 5500-5590, Complaint 
Procedures for guidance regarding complaint investigations). 
 
Sample Validation Surveys of Accredited Laboratories 
 
6150 - Background - CMS Approval of Accreditation Organizations 
(AO) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Section 353(e) of the PHSA permits the Secretary to approve private nonprofit 
accreditation organizations and thereby determine that laboratories accredited by the 
approved accreditation organization are deemed to meet CLIA requirements. An 
accreditation organization may be approved for a maximum of 6 years and must re-
apply for each succeeding approval. When CMS approves an accreditation 
organization, a notice is published in the Federal Register stating the name of the 
organization, the specialties and subspecialties for which it is approved, and the basis 
for the approval of that accreditation organization.  If it is later determined that the 
accreditation organization no longer meets the applicable requirements set forth in 42 
CFR Part 493, Subpart E of the regulations, CMS will publish a notice in the Federal 
Register containing a justification of the basis for removing deeming authority from 
an accreditation organization. 
 
The approved organizations are: 
 
  AABB; 
 
   American Association for Laboratory Accreditation (A2LA); 
 
  Accreditation Association for Hospitals/Health Systems/Healthcare Facilities 
Accreditation Program (AAHHS/HFAP); (formerly AOA) 
 
  American Society for Histocompatibility and Immunogenetics (ASHI); 
 
  COLA; 
 
  College of American Pathologists (CAP); and 
 
 
   The Joint Commission (TJC). 
 
6151 - Accredited Laboratories - Deemed Status 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
An accredited laboratory is a laboratory that has voluntarily applied for and been 
accredited by a private, nonprofit accreditation organization approved by CMS.  By virtue 
of its accreditation, an accredited laboratory that meets the requirements of 493.61 is 
deemed to meet CLIA condition-level requirements. 
 
6152 - Accreditation Validation Surveys - Citations and General 
Description 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The statutory basis for validation surveys of accredited laboratories is found in 
353(e)(2)(D) of the PHSA. This section requires the Secretary to evaluate and report to 
Congress annually on the performance of each approved accreditation organization.  
Further, it requires the Secretary to evaluate the performance of each organization by: 
 
  Surveying a sufficient number of laboratories accredited by the 
organization to allow a reasonable estimate of performance by the 
organization, and 
 
  Using such other means as the Secretary determines appropriate. 
 
Regulations authorizing such surveys are found at 42 CFR Part 493, Subpart E, 
Accreditation by a Private, Nonprofit Accreditation Organization or Exemption under 
Approved State Laboratory Programs. Section 493.563 provides that validation 
surveys may be conducted on a representative sample basis, (sample validation 
survey) or in response to a substantial allegation of noncompliance (complaint). The 
SA performs all validation surveys of accredited laboratories except accredited federal 
laboratories, which are performed by the RO. The SA and RO conduct the validation 
surveys according to established procedures for certification surveys of non-accredited 
laboratories (see Appendix C) in order to assure a fair basis for comparing the 
effectiveness of the accreditation organizations programs. Validation surveys cover all 
CLIA conditions in the specialties and subspecialties listed on the CLIA certificate for 
which the organization is approved.  Sample validation surveys are performed no later 
than 90 calendar days after the accreditation organizations inspection.  As part of the 
validation review process, CMS may conduct onsite visits at the accreditation 
organizations headquarters to verify administrative integrity. 
 
6154 - Objective of Validation Surveys of Accredited Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Validation program is designed to evaluate the premise that a laboratory that 
  receives accreditation is in fact meeting CLIA requirements.  By comparing the CLIA 
findings on each validation survey to the accreditation organizations inspection results, 
calculating the disparity rate as prescribed by the regulations, and reporting the results to 
Congress annually, CO fulfills the statutory responsibility.  The results of the validation 
surveys provide: 
  On a laboratory-specific basis, insight into the effectiveness of the 
accreditation organizations program, and 
 
  In the aggregate, an indication of the organizations capability to assure 
laboratory performance equal to or more stringent than that required by 
CLIA. 
 
6156 - Selection of Sample for Validation Surveys of Accredited 
Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The number of validation surveys and criteria for selection are indicated in the 
sections below. A complaint investigation of an accredited laboratory can also be 
counted toward the validation target.  (See 6156.3 below). 
 
6156.1 - Number of Validation Surveys 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Each fiscal year the number of validation surveys to be performed is specified in the 
annual budget.  Monies are allocated proportionately in the SA budgets for this purpose.  
 
6156.2 - Criteria for Validation Selection 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CO forwards annual inspection schedules for each accreditation organization to 
each RO. The RO, with SA input about travel schedules and other administrative 
matters, selects laboratories to receive validation surveys using the following criteria: 
 
  Select from small, medium and large volume laboratories to encompass, to 
the extent possible (in whole or in part), the entire range of specialty and 
subspecialty testing; 
 
  Select laboratories that are geographically dispersed and generally 
proportionate to the number of laboratories located in urban and rural areas; 
and 
 
  Selections of laboratories from each accreditation organization should be 
proportionate to the total number of accredited laboratories in the 
State. 
 
    Avoid selecting a facility that received a CLIA validation survey during the 
previous survey cycle year. 
 
The RO and SA confirm validation selections and survey schedules using the monthly 
inspection schedules sent directly from each of the accreditation organizations to the RO. 
 
6156.3 - Complaint Investigations Accepted for Validation Survey Target 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A complaint investigation can be counted towards the validation survey target 
specified in the annual budget call letter if it meets the following criteria: 
  Conducted by the SA no later than 90 calendar days after the 
accreditation inspection; and 
 
  Covers the entire laboratory, i.e., all specialties and subspecialties listed on 
the CLIA certificate, even if the complaint is limited to particular areas or 
practices of the laboratory. 
 
Complaint investigations that meet the above criteria are included in the pool for 
validation review by CO. (See SOM Chapter 5 for additional information 
regarding complaint investigation(s) involving an accredited laboratory). 
 
NOTE: Complaint surveys of laboratories practices in Cytology, which are 
performed by outside contractors, are not counted toward the validation survey target 
or included in the validation review. In the contractor surveys, the time frame is 
expanded, slides are reviewed and the survey process is much more detailed.  Those 
surveys would not serve as a fair basis for evaluating the effectiveness of the 
accreditation organization. 
 
6158 - Preparing for Validation Surveys of Accredited Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A validation survey is initiated when the RO approves the survey in the CLIA data 
system and notifies the SA.  When scheduling the survey, the SA verifies the 
accreditation organizations inspection date to ensure that the validation survey takes 
place no later than 90 calendar days after the inspection. If the survey cannot be 
performed, the SA should notify the RO immediately. 
 
Validation surveys may be performed simultaneously with accreditation organization 
inspections.  (See 6226-6228 for pre-survey arrangements and simultaneous survey 
procedures.) 
 
Validation surveys are typically announced unless performed simultaneously with an 
AO survey, which may be unannounced (See6106).  The SA must ascertain the hours 
when testing is conducted in the laboratory to assure that the survey is conducted at a 
  time when the laboratory is normally functioning. 
In States with more than one laboratory surveyor, the SA rotates the validation 
survey assignments among all surveyors, whenever possible. 
 
Within budgetary constraints and whenever possible, the SA coordinates validation 
surveys with other survey types. 
 
At its discretion, the RO may plan to accompany the SA on the validation survey in 
order to assist in the survey process or as part of an observational or participatory 
Federal Monitoring Survey (FMS). 
 
6162 - Accredited Laboratorys Refusal to Permit a Validation Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory selected for validation fails to permit a survey, the RO notifies 
the laboratory, by letter, informing that: 
 
  It will be subject to a full review and survey, 
  It no longer meets the CLIA requirements by virtue of its accreditation 
in an approved accreditation program, and 
  Is subject to suspension, revocation or limitation of its CLIA 
certificate of accreditation. 
 
The RO will send a copy of the letter to the accreditation organization, SA and CO. An 
accredited laboratory will be considered deemed to meet the CLIA Conditions when: 
 
  It withdraws any prior refusal to authorize its accreditation organization to 
release to CMS or a CMS agent, a copy of the laboratorys current 
accreditation inspection, PT results, or notification of any adverse actions 
resulting from PT failure; 
 
  It withdraws any prior refusal to allow a validation survey; and 
 
  CMS finds that the laboratory meets all condition-level requirements.  
 
6164 - Conducting Validation Surveys of Accredited Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA performs validation surveys according to established survey procedures. (See 
6100.) The surveyor refrains from reviewing any inspection results of the accreditation 
organization that may be available on site until the validation survey is completed, so that 
compliance status is independently determined. In that manner, a fair basis will be 
maintained for evaluating the effectiveness of the accreditation organization. In instances 
where the survey is conducted by more than one CLIA surveyor, all team members 
  should participate in the entrance and exit conferences, if they individually cannot be on 
site for the entire survey. 
 
6164.1 - SA Responsibilities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  Upon receipt of approval from the RO, scheduling validation 
survey(s) to take place no later than 90 calendar days after the 
accreditation organizations survey; 
 
  Assignment of surveyors on a rotating basis to perform the validation 
survey, as available; 
 
  Perform the validation survey (complete survey of all specialties per 
certificate) using the same survey process and the same objectivity as in a 
survey of a non- accredited laboratory; 
 
  Perform an exit conference which outlines the survey findings and 
informs the laboratory of any follow-up actions or correspondence; 
 
  Upon completion of the survey, documents all required information 
in the CLIA data system that includes: 
 
  Form CMS-2802A (Exhibit 242) - Request for 
Complaint Investigation or Validation Survey of 
Accredited Laboratory; 
 
  Form CMS-1539 (Exhibit 9) - Certification and Transmittal; 
 
  Form CMS-1557 (Exhibit 12) - Survey Report Form; 
 
  Form CMS-209 (Exhibit 106) - Laboratory Personnel Report; 
 
  Form CMS-2567  (Exhibit 7) - Statement of Deficiencies 
 
  Form CMS-670 (Exhibit 74) - Survey Team 
Composition and Workload Report. 
 
Any additional information/forms pertinent to the survey should be forwarded to the RO 
by attaching them to the survey in the CLIA data system or by other means acceptable to 
the RO, e.g., CMS-209 - Laboratory Personnel Report; Form CMS-116 CLIA 
Application for Certification; correspondence with the laboratory. 
 
Include the following forms in the data system, when applicable: 
 
    Form CMS-2567B (Exhibit 8) - Post-Certification Revisit Report, and 
 
  Form CMS-562 (Exhibit 75) -
Medicare/Medicaid/CLIA Complaint Form. 
 
 
6164.2 - Discrepancy With CLIA Data Information 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If, during the course of a validation survey in an accredited laboratory, the laboratory 
is found to be performing more or less tests and/or specialties than reflected in the 
CLIA data system, i.e., the laboratory is in a higher or lower survey specialty test 
volume schedule, the discrepancy must be noted in the Validation survey kit. (See 
Appendix C.) 
 
The SA ensures the laboratory completes the Form CMS-116 to include test volumes and 
signature of the laboratory director or designee. The SA completes the Form CMS-1557 
tab in the validation kit designating whether there are discrepancies in the specialties, 
test volumes, or both. 
A notation is made on the new Form CMS-116 clearly indicating it is for a change 
in test volume only.  The SA notifies the RO of test volume information. 
 
6166 - Results of Validation Surveys of Accredited Laboratories 
(Rev. 1, 05-21-04) 
 
6166.1 - Condition-Level Deficiencies With Immediate Jeopardy 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6166.1.1 - The SA 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  At the exit conference, the SA CLIA surveyor informs the laboratory of its 
noncompliance status; its recommendation to the RO that the laboratory no 
longer meets the CLIA Condition-level requirements by virtue of 
accreditation; and that the laboratory is subject to the same enforcement 
actions as non-accredited laboratories; (See 6126) 
 
  Prepares a Statement of Deficiencies, Form CMS-2567 (Exhibit 7) and clearly 
documents the nature of the jeopardy and notifies the RO (within 2 days) of the 
recommended action. 
 
  Within three working days of the survey exit date, completes all 
required information in the CLIA data system and attaches any 
  additional information pertinent to the survey for RO review.  (See 
6164.) 
 
6166.1.2 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
NOTE: For accredited laboratories, the RO rather than the SA is responsible for 
processing the enforcement actions listed in 6290. 
 
  Receives the SA recommendations and determines the appropriate actions 
according to the policies outlined in 6284. The RO initiates immediate action 
to suspend or limit the laboratorys certificate of accreditation, and may also 
impose one or more alternative sanctions as necessary to encourage 
compliance. 
 
  Promptly notifies the laboratory by written communication (e.g., overnight 
mail, facsimile, e-mail) of the immediate jeopardy situation and of the 
actions being initiated (Exhibit 237).  A copy of this communication is sent 
to the SA, CO, and the applicable accreditation organization. 
 
  On or before the 23rd day, the RO assures that the immediate jeopardy has 
been removed and follows procedures for Condition-level deficiencies with 
no immediate jeopardy. If the immediate jeopardy has not been removed, 
the RO follows the procedure for immediate jeopardy enforcement actions 
in 6284. The RO also updates the AO regarding the immediate jeopardy 
situation and/or findings. 
 
  Ensures copies of selected documents and correspondence are available to 
CO in the data system for performing the validation review.  (See 6170.) 
 
6166.2 - Condition-Level Deficiencies With No Immediate Jeopardy 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6166.2.1 - The SA 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  At the exit conference, informs the laboratory of its Condition-level 
noncompliance status and its recommendation to the RO that the laboratory 
no longer meets the applicable CLIA Condition-level requirements by virtue 
of accreditation. The laboratory is advised that it retains its CLIA certificate 
of accreditation at this point, however, it becomes subject to the same 
requirements and same enforcement procedures applied to non-accredited 
laboratories found out of compliance and the laboratory is monitored until it 
achieves Condition- level compliance or until its certificate of accreditation 
is revoked. 
   
  Explains that the Form CMS-2567 (Exhibit 7) will be sent by the RO to the 
laboratory in approximately 10 calendar days. A plan of correction or 
allegation of compliance is due within 10 calendar days of receiving the Form 
CMS-2567. Also explains that the accreditation organization will receive 
copies of all correspondence to the laboratory.  In addition, the laboratory may 
wish to consult with the organization regarding its efforts to correct the 
deficiencies. 
 
  Prepares a Form CMS-2567, completes all required information in the 
CLIA data system, and attaches any additional information pertinent to 
the survey for RO review within 10 calendar days from the survey exit 
date. (See 
6164.) 
 
6166.2.2 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
NOTE: For accredited laboratories, the RO rather than the SA is responsible for 
processing the enforcement actions listed in 6290. 
  Routinely copies all correspondence with the laboratory to the SA and 
the accreditation organization. 
 
  Receives the SA recommendations and determines the appropriate actions to 
take, according to the policies outlined in 6290. 
 
  Notifies the laboratory that it is not in Condition-level compliance and it is no 
longer deemed to meet the CLIA conditions by virtue of its accreditation 
Wwithin approximately 10 calendar days of receipt of the Form CMS-2567 
and any additional information pertinent to the validation survey from the 
State Agency. 
 
  Requests the laboratory to submit an allegation of compliance (AoC) within 10 
calendar days of receiving the letter and informs the laboratory that there will 
be follow-up with the laboratory to determine whether Condition-level 
compliance has been achieved. 
 
  After consulting with the SA, as appropriate, determines if the laboratorys 
response constitutes a credible AoC.  Documents that verify corrective action 
may include, but are not limited to, the following: verification of proficiency 
testing enrollment, personnel qualifications, and quality assessment activities. 
 
  If, in 45 calendar days of the laboratorys receipt of the letter, the RO has 
not received acceptable evidence of correction, or the RO has determined 
  that the laboratory has failed to provide a credible AoC, the RO follows the 
established enforcement actions. (See 6290.) 
  If, in 45 calendar days, the RO has received acceptable evidence of 
correction and the RO has determined the laboratory provided a 
credible AoC, the RO notifies the laboratory that it continues to meet 
CLIA Condition-level requirements by virtue of its accreditation. 
 
  Ensures copies of selected documents and correspondence are available 
to CO in the data system for performing the validation review. (See 
6170.) 
 
 
6166.3 - No Condition-Level Deficiencies Found at the Time of Survey 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
  
6166.3.1 - The SA 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  At the exit conference, informs the laboratory that it is in 
Condition-level compliance. 
 
  If standard-level deficiencies were cited, informs the laboratory 
that it will receive a Form CMS-2567 (Exhibit 7), which is subject 
to public disclosure within 90 calendar days of the survey. While 
not required to complete the plan of correction, the laboratory may 
wish to submit it for the record. 
 
  Explains to the laboratory that the accreditation organization will 
receive a copy of the Form CMS-2567 and the correspondence. 
 
  Prepares a Form CMS-2567 and notifies the RO when the validation survey 
documentation is available in the CLIA data system. (See 6164.) 
 
6166.3.2 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  Forwards the CMS-2567 to the laboratory. 
 
  Notifies the laboratory that the CMS-2567 is disclosable to the public 
within 90 calendar days along with any PoC the laboratory provides. 
  Copies all correspondence with the laboratory to the SA and accreditation 
organization. 
 
  Ensures copies of selected documents and correspondence are available 
to CO in the data system for performing the validation review.  (See 
  6170.) 
 
6170 - Completing Validation Survey Information in the CLIA Data 
System 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When the validation survey of an accredited laboratory and the follow-up activities 
have been completed, the RO will ensure the following forms and other survey 
information are complete and available in the CLIA data system for use by the CO 
CLIA component in the annual validation review: 
 
  Form CMS-2802A(Exhibit 242); 
 
  Form CMS-1557(Exhibit 12); 
 
  Form CMS-2567 (Exhibit 7) - include AoC when there are 
Condition-level deficiencies; 
 
  Form CMS-2567B (Exhibit 7) completed for revisits, if any; and 
 
  Copies of all correspondence to the laboratory related to the validation 
survey such as compliance determination, follow-up regarding 
corrections, etc. 
 
6172 - Notification Requirements of Approved Accreditation 
Organizations 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Responsibilities of each approved accreditation organization include notifying CMS, on 
an ongoing basis, when certain situations occur. This information must be 
communicated in writing by the accreditation organizations within a specific time frame 
as required by the regulations and include the laboratory name, CLIA number, 
deficiencies identified, if applicable, and dates of identification or of any actions taken.  
The RO will record the date of receipt of the accreditation organizations notification. 
 
The following describes those situations that should be communicated to the RO: 
 
  Immediate jeopardy situations (within 10 days); 
 
  Newly accredited laboratories using the accreditation organizations program 
for CLIA compliance, including specialty and subspecialty information 
(within 30 days); 
 
  Data related to unsuccessful PT performance and actions taken (within 30 
days); 
    Any adverse actions taken by the organization, i.e., denial, temporary loss, 
suspension, or withdrawal of accreditation, limitation of 
specialty/subspecialty, etc. (within 30 days); and 
 
  Revisions in specialty/subspecialty testing (additions or deletions) in 
existing accredited laboratories (within 30 days). 
 
Information relative to laboratories whose accreditation has been withdrawn or 
revoked will be helpful when assembling information for the annual laboratory 
registry. In addition, it may be used as a basis for a complaint or validation survey, as 
appropriate. 
 
When accreditation has been removed from a facility, it then comes under CMS 
jurisdiction for CLIA purposes. The other mechanism by which a laboratory is no longer 
deemed to meet the CLIA requirements is when the RO removes the certificate of 
accreditation due to Condition-level noncompliance that has not been corrected.  [See 
493.569(a)]. 
 
6174 - Basis for Validation Surveys of Accredited Laboratories in 
Response to Substantial Allegations of Noncompliance 
(Rev. 1, 05-21-04) 
 
The statutory basis for validation surveys of accredited laboratories in response to 
substantial allegations of noncompliance is found in 353(e)(2)(D) of the PHSA.  
Regulations authorizing such surveys are found at 42 CFR, Part 493, Subpart E.  Title 42 
CFR 493.563 provides that validation surveys may be conducted in response to a 
substantial allegation of noncompliance. Complaints can be received in person, by 
telephone, through written correspondence, from newspaper or magazine articles or other 
sources. A substantial allegation of noncompliance, which is defined in 42 CFR 493.2 of 
the regulations, has two elements: 
 
  Harmful or potentially harmful impact on the health and safety of the general 
public or the individuals served by the laboratory; and 
 
  Raises doubt as to the laboratorys compliance with one or more CLIA 
conditions. 
 
For the handling of complaints against accredited laboratories see Chapter 5. 
 
 
  Sample Validation Surveys of CLIA-Exempt Laboratories 
 
6200 - CMS Approval of State Laboratory Licensure Programs 
Citations and General Description 
(Rev. 1, 05-21-04) 
 
Section 353(p) of the PHSA permits the Secretary to exempt from CLIA all laboratories 
in any State that has demonstrated that its licensure laws or regulations related to 
laboratory requirements are equal to or more stringent than those requirements imposed 
by CLIA. The 42 CFR Part 493, Subpart E of the regulations, permits CMS to approve or 
remove approval from specific State laboratory programs dependent upon specific criteria 
met.  When CMS approves a State laboratory program, a notice is published in the 
Federal Register, indicating the State for which an approval was granted, and the 
rationale for the decision. An approved State laboratory program may be exempt for a 
maximum of six years; the State must re-apply for each approval period. During the 
approval period, all laboratories in that State that are subject to the approved licensure 
program are exempt from the CLIA requirements.  A partial CLIA exemption may be 
granted to an approved laboratory licensure program in a State that does not license all of 
its facilities performing laboratory testing.  If a State does not have a universal, all-
inclusive licensure law, laboratories licensed by the State are exempt from the CLIA 
requirements, and laboratories not licensed by the State remain under CLIA jurisdiction. 
 
6202 - Validation Surveys of CLIA-Exempt Laboratories - Citations 
and Objectives 
(Rev. 1, 05-21-04) 
 
Regulations authorizing validation surveys are found at 42 CFR Part 493, Subpart E, 
Accreditation By a Private, Nonprofit Accreditation Organization or Exemption Under 
an Approved State Laboratory Program.  Title 42 CFR 493.563(b) and (c), respectively, 
provide that validation surveys will be conducted on a representative sample basis or in 
response to a substantial allegation of noncompliance. 
 
The RO conducts CLIA-exempt laboratory validation surveys to ensure that laboratories 
under the jurisdiction of the approved State laboratory program are continually meeting 
requirements equal to or more stringent than the CLIA requirements. 
 
The results of the validation surveys are used to validate the appropriateness of the 
exemption of the States laboratories from the CLIA program requirements. (See 6214.) 
 
  6204 - Number and Criteria for Selection of CLIA-Exempt Laboratories 
for Validation Surveys 
(Rev. 1, 05-21-04) 
 
6204.1 - Number of Validation Surveys 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The number of CLIA-exempt laboratories to be validated is approximately 5 percent of 
State-licensed laboratories.  (Refer to the annual budget call letter.) 
 
6204.2 - Selection of Validation Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO obtains the laboratory licensure survey schedule from the approved State and 
verifies the date that the approved State completed the inspection, so that the validation 
survey can be simultaneous or be conducted no later than 90 calendar days after the 
State licensure inspection. The RO selects the sample of laboratories to be validated 
using the following criteria: 
 
  Select from small, medium, and large laboratories, to the extent possible 
(in whole or in part), the entire range of specialty and subspecialty 
testing; and 
 
  Select laboratories that are geographically dispersed. 
 
 
6206 - Preparing for Sample Validation Survey of CLIA-Exempt 
Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Validation surveys are typically announced unless performed simultaneously with an AO 
that is recognized and operates within an exempt State (ES), which has policies of 
unannounced surveys. (See 6227.3.1 for complete guidance on when to refrain from 
announcing CLIA validation surveys.) The RO laboratory surveyors should conduct 
validation surveys, to the extent possible, on a rotating basis so that no one surveyor 
conducts all the validation surveys. 
 
The RO completes the survey in approximately the same time frame required for a 
laboratory of similar size and complexity undergoing a CLIA certification survey. To 
permit an independent compliance decision, the RO does not obtain a copy of the 
licensure survey findings until the validation survey is completed. 
 
If a laboratory representative refuses to permit a validation survey, the RO requests the 
State to explain the protocol to the laboratory. If the laboratory still refuses, the RO 
requests the State to take enforcement action under their licensure program. 
   
 
6208 - Conducting Validation Surveys of CLIA-Exempt Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO has direct responsibility for the entire validation survey process for CLIA- 
exempt laboratories, unless CO utilizes a CMS designated contractor, e.g., survey of 
cytology. The RO surveyor conducts the survey according to established procedures 
for certification surveys (See 6100). At the exit conference the RO surveyor informs 
the laboratory of any Condition-level findings and the CLIA compliance 
determination. The validation survey may be conducted simultaneously with the State 
licensure inspection, however, the RO surveyor makes an independent CLIA 
compliance determination and completes all necessary documentation and survey 
forms. The RO sends to the State Program a notification of determination (letter) with 
Form CMS-2567 (Exhibit 7), and a copy of both to the laboratory. See, 6210.2.1 and 
6210.3.1 for specifics related to the type of deficiencies. 
 
NOTE:  A State Program may recognize a CMS-approved accreditation organization 
in lieu of State licensure. If so, a laboratory accredited by an approved 
accreditation organization may be subject to validation by the State 
Program to validate the accreditation organization in the same manner as 
an accredited laboratory (non CLIA-exempt) is subject to a CLIA 
validation survey. In that case, the State uses State licensure requirements 
to validate the accredited laboratory. At the ROs discretion, the RO may 
accompany the State on these surveys to observe the State Programs 
validation activities. 
 
6210 - Results of the CLIA-Exempt Validation Survey - RO and SA 
Responsibilities 
 
(Rev. 1, 05-21-04) 
 
6210.1 - Condition-Level Deficiencies With Immediate Jeopardy 
 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If the deficiencies identified are Condition-level and pose immediate jeopardy to the 
health and safety of individuals served by the laboratory or that of the general public: 
 
6210.1.1 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
  At the exit conference, informs the laboratory of its Condition-level 
noncompliance status, explains to the laboratory that it does not meet the 
CLIA Condition-level requirements and is subject to sanctions imposed by 
the State program. 
   
NOTE:  If onsite simultaneously with the State inspection, assures that 
the laboratory is fully aware of the deficiencies that pose 
immediate jeopardy and is subject to State sanctions; 
 
  Within 2 working days of the survey, the RO sends to the State program 
a notification of determination (letter) that clearly explains the nature of 
the jeopardy, and directs the State to take appropriate action under its 
approved licensure program. A Form CMS-2567 (Exhibit 7) with 
summary of the findings is an enclosure with the notification of 
determination. The RO sends to the laboratory a copy of the letter, 
including the Form CMS-2567 enclosure. 
 
6210.1.2 - The Exempt State (ES) Program 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  Takes the appropriate enforcement actions based on the enforcement policies 
of its approved licensure program. Within 10 calendar days of the survey, 
notifies the RO of the action taken. 
 
6210.1.3 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
   
Follows up with the State within 15 calendar days if not notified of the action taken or 
notified that the jeopardy situation has been corrected. If the State program is unwilling 
or unable to take enforcement action appropriate (as determined by the RO) to the 
jeopardy situation, the RO may request CO to either contact the State or attempt other 
resolution to eliminate the jeopardy.  (See 42 CFR 493.557(b)(13).) 
 
6210.2 - Condition-Level Deficiencies With No Immediate Jeopardy 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6210.2.1 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  At the exit conference informs the laboratory of its Condition-level 
noncompliance and explains to the laboratory that it does not meet the 
CLIA Condition-level requirements and is subject to sanctions and 
follow-up by the State program; 
 
NOTE:  If onsite simultaneously with the State licensure inspection, assures 
that the laboratory is fully aware of the Condition-level deficiencies 
and follow-up by the State. 
 
  Within 10 calendar days of completing the survey, sends to the State a 
  notification of determination (letter) that explains the Condition-level 
deficiencies and directs the State to take appropriate action under its 
approved licensure program. A Form CMS-2567 (Exhibit 7) with summary 
of the findings is an enclosure with the notification letter. The RO sends to 
the laboratory a copy of the letter, including the Form CMS-2567 
enclosure.  (See Exhibit 232.) 
 
6210.2.2 - The Exempt State Program 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Takes the appropriate enforcement actions based on the policies of its licensure program. 
Within 30 calendar days, the State program notifies the RO of the action taken. 
 
6210.2.3 - The RO 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15-19) 
 
Follows up with the State Program within 45 calendar days if not notified of the action 
taken. If the State Program has not taken appropriate enforcement action, (as 
determined by the RO) and/or the Condition-level noncompliance remains, the RO 
contacts the State Program to seek resolution/take action so that the laboratory comes 
into Condition-level compliance. 
 
6210.3 - Deficiencies Found Below the Condition-Level 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6210.3.1 - The RO 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  At the exit conference, informs the laboratory that it is in Condition-level 
compliance with the CLIA requirements, but that standard level deficiencies 
are identified. 
 
  Prepares a Form CMS-2567 (Exhibit 7) and sends it to the State Program as 
an attachment to a notification of determination (letter), within 10 calendar 
working days of the survey. Sends to the laboratory a copy of the letter, 
including the attachment (Form CMS-2567). 
 
6210.3.2 - The Exempt State Program 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Monitors the correction of the cited deficiencies based on the policies of its 
licensure program. 
 
 
  6212 - Processing Validation Survey Records  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO inputs the survey information into the CLIA data system within 45 calendar 
days of completing the survey. The applicable documents should be completed and 
processed (see 6100). 
 
6214 - Evaluation of Approved State Licensure Program 
(Rev. 1, 05-21-04) 
 
The RO not only performs the validation surveys as described above, but also prepares 
and forwards to CO an annual evaluation of the States licensure program operations.   
The report includes a comparison of the State programs findings with validation survey 
findings at the Condition-level.  It also includes summary information about the States 
laboratory universe, adverse actions, complaints, surveyor staffing, proficiency testing 
review, financial resources and any other information pertinent to the ongoing 
acceptability of the program exemption as an alternative to CLIA survey and certification 
activities. 
 
6216 - Onsite Visit to Exempt-State Laboratory Program 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Title 42 CFR 493.563 (d)(2) allows CMS to conduct visits to the States laboratory 
program offices and operations. The purpose of the visits is to gather information 
about the State laboratory licensure program operations, including any verifications 
needed about the representations made by the State in their application for CLIA 
exemption. 
Additionally, the RO may assess the States compliance with its own policies and 
procedures as approved by CMS. 
 
An onsite visit may include, but is not limited to, an evaluation of the following: 
 
  Survey workload; 
  Enforcement activities; 
 
  Complaint management; 
 
  Validation surveys of accredited facilities (if accredited facilities are 
deemed to meet the State Licensure requirements); 
 
  Surveyor competency; 
 
  Surveyor training and continuing education; 
 
  Proficiency testing monitoring; 
   
  Internal quality improvement activities; and 
 
  Financial management. 
 
Data may be gathered through employee interviews, documentation review, meeting 
attendance, or other means. Refusal by the State to allow an onsite visit or poor 
performance in the management of the above activities may jeopardize the renewal of 
a States CLIA exemption. 
 
6218 - Notification Responsibilities of Approved State Licensure 
Program  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Responsibilities of each approved State laboratory licensure program include notifying 
CMS, on an ongoing basis, when certain situations occur, as listed below. This 
information must be communicated in writing by the State program within a specific 
time frame (specified below). Include the laboratory name, CLIA number, deficiencies 
identified, if applicable, and dates of identification or of any actions taken. The RO 
records the date of the States notification of the information. 
 
The following describes those situations that the approved State program 
communicates to the RO: 
 
1.  Immediate jeopardy situations (within 10 calendar days); 
 
2.  Newly licensed laboratories, including specialty and subspecialty 
information (within 30 calendar days); 
 
3.  Data related to unsuccessful PT performance and actions taken (within 30 
      calendar days); 
 
4.  Any sanctions taken by the State i.e., denial, withdrawal, or revocation of 
State licensure, limitation of specialty/subspecialty, etc. (within 30 
calendar days); and 
 
5.  Revision in specialty/subspecialty testing (additions, deletions) in existing 
CLIA- exempt laboratories (within 30 calendar days). 
 
Information relative to laboratories whose licensure has been withdrawn or revoked 
will be helpful when the RO assembles information for the annual laboratory registry 
and for use in the evaluation report of the States operations. 
 
  Validation Surveys Performed Simultaneously With  
Accreditation Organization Inspections or  
Approved State Program Inspections  
 
6226 - Simultaneous Validation Surveys - General 
(Rev. 1, 05-21-04) 
 
6226.1 - Simultaneous Validation Survey - Definition 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A validation survey of an accredited or CLIA-exempt laboratory in which the CLIA 
surveyor accompanies the accreditation organization or approved State program 
inspector during the inspectors fact-gathering, and uses the outcome-oriented survey 
principles (see 6100) to determine whether the laboratory meets the CLIA Condition-
level requirements. 
 
6226.2 - Purpose 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The main purpose of the simultaneous validation survey is the same as any CLIA 
validation survey: to verify that the laboratory meets all applicable CLIA 
conditions. While determining the laboratorys Condition-level compliance status, 
the CLIA surveyor gains insight into accreditation or State program processes. 
 
6226.3 - Relationship to Comparative Validation Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The simultaneous survey offers an additional approach for conducting validation 
surveys. Like the validation survey performed after the AO or State inspection date, the 
simultaneous focuses on the laboratorys compliance status, however, the timing is 
different. Instead of performing the validation survey up to 90 calendar days after the 
accreditation organization or approved State program inspection, the surveyor performs 
the survey while accompanying the AO or State inspector. 
 
6226.5 - Team Size  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA may increase the number of CLIA surveyors when the accreditation inspection 
is performed by a team.  Additional surveyors may be from the SA or RO, as available. 
 
 
  6227 - Scheduling Simultaneous Validation Surveys and Coordinating 
Pre-Survey Arrangements  
(Rev. 1, 05-21-04) 
 
6227.1 - Importance of Coordinating Pre-Survey Arrangements 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Well-coordinated pre-survey arrangements, open communication and flexibility are key 
to promoting a successful survey experience by all parties - the accreditation organization 
or State program inspector, the CLIA surveyor, and the laboratory.  With this foundation: 
 
  Both teams can conduct their activities in the usual professional manner; 
 
  Both teams can focus on the quality of the laboratory practices and testing 
outcomes; and 
 
  The laboratory operations can continue, minimally impacted by the survey. 
 
6227.2 - Surveyor Responsibilities 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA surveyor promotes professional and collegial communication during pre- 
survey and onsite activities. Direct contact by the surveyor with the accreditation 
organization or State program representatives is necessary in order to enhance CLIA 
surveyor/AO inspector coordination, an essential element in a smooth-flowing survey. 
 
6227.3 - Pre-Survey Arrangements for Accredited Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When a laboratory is selected for a simultaneous validation survey, the special tasks 
listed below are performed in addition to the usual survey scheduling tasks, in order to 
fully coordinate among all the parties. 
 
6227.3.1 - Coordinating With Accreditation Organization (AO) Contact 
Person 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The surveyor contacts the accreditation organizations designated contact person (current 
names and contact information can be obtained from the RO.)  The surveyor: 
 
  Verifies the date of the organizations inspection; and 
 
  Obtains contact information of the AO inspector. 
 
NOTE: ALWAYS VERIFY WITH THE AO CONTACT PERSON WHETHER 
  THEIR INSPECTION WILL BE ANNOUNCED OR UNNANOUNCED. If 
unannounced, DO NOT CONTACT THE LABORATORY. 
 
6227.3.2 - Arrangements With Laboratory  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The surveyor verifies that the laboratory received the SA notification about the 
validation survey and apprises the laboratory that it will be performed simultaneously 
with the accreditation inspection. 
 
EXCEPTION: Do not have any pre-survey contact (written, electronic or oral) with a 
laboratory accredited by an AO with a policy of unannounced inspections. (See 
6227.3.1). 
 
6227.3.3 - Coordinating With Accreditation Organization Inspector 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Every effort should be made to perform these pre-entrance activities with the 
AO inspector in all simultaneous validation surveys, irrespective of the AOs 
policy of announcing/not announcing inspections to the laboratory. 
 
  The CLIA surveyor contacts the AO inspector. In addition to verifying 
the time and date of inspection, the surveyor arranges to meet with the 
inspector briefly before entering the laboratory. 
 
  The CLIA surveyor and the AO inspector have a pre-entrance 
meeting to coordinate for a smooth-flowing survey. 
 
The following activities are performed at the pre-entrance meeting: 
 
  Mutual agreement on the content of the opening conference (see 6228), as 
well as the inspector and surveyor roles, recognizing that the accreditation 
inspector has the lead; 
 
  Orientation of the CLIA surveyor on the inspectors planned flow through 
the laboratory, so that CLIA survey fact-gathering can be coordinated 
accordingly, thereby minimizing interruption to laboratory operations and 
duplication of inquiry; 
 
  Orientation of the accreditation inspector, as appropriate, to the basics of the 
CLIA outcome-oriented survey protocol, and assurance that the CLIA 
surveyors role is to conduct an evaluation of the laboratorys compliance 
with CLIA, not a performance evaluation of the inspector or a comparison of 
the accreditation standards with the CLIA requirements. 
 
   
6227.4 - Pre-Survey Arrangements for CLIA-Exempt Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The  RO  CLIA  surveyor  coordinates  pre-survey  arrangements  for  simultaneous 
validation surveys in CLIA-exempt laboratories. The surveyor adapts the procedures 
for  pre-survey  arrangements  with  the  laboratory,  the  RO  and  the  State  program 
inspector,  (see  preceding  sections)  as  appropriate,  to  coordinate  pre-survey 
arrangements  with  the  laboratory,  State  program  official,  and  the  State  program 
inspector. 
 
6228 - Onsite Activities - Simultaneous Validation Surveys 
(Rev. 1, 05-21-04) 
 
6228.1 - Entrance Conference 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA surveyor ensures that the laboratory officials are presented the 
following information: 
 
  The purpose of the validation survey; 
 
  The planned flow through the laboratory; and 
 
  The CLIA surveyor/AO inspector conveys their intent to coordinate 
fact- gathering as much as possible in order to minimize disruption to 
laboratory operations and avoid duplication of inquiry. 
 
6228.2 - Fact-Gathering 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The accreditation/State program inspector sets the flow of the fact-gathering. The 
surveyor accompanies the inspector, and at the same time determines if sufficient 
information is obtained to evaluate compliance with CLIA Conditions, using the 
outcome-oriented survey principles. (See 6100.) The surveyors approach may be 
tailored to the facility and circumstances, based on professional judgment and survey 
experience. If the fact-gathering and discussions with the inspector do not result in 
sufficient information to make a CLIA compliance determination, the CLIA surveyor 
and the inspector mutually agree on the next course of action. The CLIA survey need 
not end at the same time as the accreditation/State program inspection, however, there 
may be blocks of time, such as the inspectors period for administrative tasks, when the 
surveyor can gather sufficient additional information to make the compliance 
determination. 
 
  6228.3 - Pre-Exit Discussion 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The CLIA surveyor should plan to have a pre-exit meeting with the inspector (away from 
laboratory personnel) to discuss each others findings, share the CLIA compliance 
determination, and to coordinate the exit presentations to the laboratory.  There may be 
instances where the surveyors conclusions differ from the inspectors.  Acknowledge 
this as you coordinate on the exit conference agenda.  Should the inspector be concerned 
about the discrepancies in findings, refrain from debating the merits of each one, and 
draw attention to the mutual interest in quality of laboratory practices and outcomes.  
Explain, as appropriate, that a laboratory holding a CLIA Certificate of Accreditation has 
an ongoing responsibility to meet the applicable CLIA Conditions, irrespective of the 
accreditation inspection findings or the laboratorys agreement with the accreditation 
organization.  
 
NOTE:  The CLIA surveyor should be mindful that each set of accreditation and State 
program requirements was approved by CMS as being equivalent (not 
necessarily identical) to the CLIA Conditions, taken as a whole.  Clarify, 
accordingly, for concerns about apparent dissimilarities in the requirements or 
discrepancies in findings that may be raised at the pre-exit discussion or the 
exit conference.  Also clarify, as appropriate, that the surveyors role is to 
evaluate the laboratory under CLIA, not compare the two sets of 
requirements, or comment on the merits of the accreditation inspection 
findings.  
 
6228.4 - Exit Conference 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
As coordinated with the accreditation/State program inspector, the surveyor presents the 
CLIA findings.  The surveyor also explains that the laboratory will be informed in 
writing of the CLIA compliance determination, the laboratorys responsibility for 
responding, if necessary, and the time frames involved.  If the information gathered was 
insufficient to make a CLIA compliance determination, the surveyor advises the 
laboratory accordingly and after the exit conference arranges to complete the remainder 
of the survey.  In instances where the laboratory raises questions about discrepancies in 
the accreditation inspection and CLIA survey results, or apparent dissimilarities in 
requirements, refer to the guidance in the section above (Pre-Exit Discussion), as 
appropriate. 
 
After the survey is completed, follow the procedures in 6166. 
  Other Activities 
 
6230 - CLIA State Agency Performance Review (SAPR) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA SAPR is an evaluation by the RO each fiscal year of each State Agencys 
(SAs) performance of its survey and certification responsibilities under the CLIA 
Program, as specified in the Section 1864 Agreement. The primary goal of the CLIA 
SAPR is to educate and support the SA while working as a team to promote optimal 
performance by the SA and implement improvements.  Sustained proficiency is 
recognized and areas of improvement are identified for corrective action by the SA.  
The RO retains its overarching responsibility for program oversight; however, its 
primary role in the SAPR is education and support for SA improvement, with 
flexibility to address the variation in SA sizes and operations. 
 
The CLIA SAPR is a comprehensive review of the SAs survey and certification 
activities and may include, but is not limited to: workload completion, survey process 
(including the results of the CLIA Federal Monitoring Survey (FMS), proficiency desk 
review, writing and evaluating statements of deficiencies, handling complaints, 
financial management, and enforcement.  CO will make the determination which 
criteria are evaluated each fiscal year.  The CLIA SAPR is structured to evaluate and 
report SA performance in an objective and consistent manner.  The CLIA SAPR is 
distinguished from the CLIA Federal Monitoring Survey (FMS) (see 6232) by its 
scope.  The SAPR focuses on the SA activities, in aggregate, related to its survey and 
certification responsibilities while the FMS focuses on individual surveyors. 
 
SA Responsibilities 
 
The SA has the following responsibilities in regard to the SAPR process: 
 
  Implement internal systems to organize, complete and track survey and 
certification responsibilities. 
  Monitoring and reviewing the SAPR requirements to ensure their programs 
meet the SAPR criteria. 
  Hire qualified staff to implement the CLIA program. 
  Provide a Corrective Action Plan (CAP) or Quality Improvement Plan (QIP) 
when required to improve SA performance. 
RO Responsibilities 
SAPRs are conducted either onsite or remotely via document review, or a combination of 
both, in collaboration with the SA.  The RO will ask the SA to submit documentation on 
how the SA has fulfilled each criterion.  The RO has the following responsibilities in 
regards to the SAPR process: 
    Overall program oversight of the SA. 
  Educational and supportive role to the SA. 
o  Recognize strengths 
o  Identify areas needing improvement 
o  Identify SA personnel training needs 
  Prepare for a SAPR review that provides an efficient and timely assessment of 
SA CLIA program responsibilities. 
  Utilizing CASPER reports to augment the documentation provided by the SA. 
 
CO Responsibilities 
 
CO has the following responsibilities in regard to the SAPR process: 
 
  Select criteria to be evaluated for each fiscal year (FY). 
  Issue the Administrative Info Memo. 
  Review any changes, new processes for next FY with ROs. 
  Review SAPR drafts submitted by ROs prior to issuing to SAs. 
  Track receipt and storage of all drafts, finals, CAPs, QIPs. 
  Provide clarification to ROs as needed. 
  Utilize the data to update and clarify policy and to determine national training 
needs. 
 
6232  CLIA Federal Monitoring Survey (FMS) Selection 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The primary purpose of the FMS system is to monitor each SA surveyors use and 
performance of the CLIA Outcome-oriented Survey Process (OOSP) to: determine 
training needs, provide timely feedback for surveyor education and improve survey 
process performance.  The ROs FMS strategy should be consistent with this approach. 
Actual monitoring survey targets and allocation requirements will be established at the 
beginning of each fiscal year through a CO component negotiation process.  In general, 
the expectations for the FMS targets are one percent sample of laboratories surveyed 
during the year.  As a basic rule, however, the RO does not include in the FMS sample 
selection any facility against which adverse action has been initiated by the State survey 
agency. 
 
6234 - FMS of Laboratories - Definitions and Purpose 
(Rev. 1, 05-21-04) 
 
6234.1 - Definition 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
An FMS is any survey in which an RO Representative accompanies or follows the SA 
survey to monitor the surveyors use and performance of the CLIA OOSP.  Laboratories 
  under direct Federal jurisdiction are exempt, from the CLIA FMS process (see 6028). 
 
6234.2 - Purpose  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO performs the survey for the following reasons: 
 
  Monitoring and improving SA performance in interpreting and applying 
CLIA requirement(s), applying survey policies and procedures; 
 
  Identifying training/or technical assistance needs of surveyors such as 
issues pertaining to test results and patient outcome; 
 
  Identifying problems that surveyors and/or laboratories 
encounter in implementing Federal regulations and survey 
procedures; and 
 
  Providing documented feedback to the RO, SA and Central Office (CO) on 
selected surveys that are performed as an Observational (O), Comparative 
(C), or Participatory (P) FMS in individual States. 
 
NOTE: New surveyors work products (e.g., survey packages) are reviewed and/or 
verified, and signed off with supervisory review prior to the new surveyor being 
released to independently perform surveys.  Upon completion of the CLIA Orientation 
Program and CLIA Surveyor Training, the RO can use the CLIA FMS as a supplement 
to training until the surveyor has completed the formal Surveyor Training Module(s). 
 
 
6234.3 - Scope of FMS Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
1.  Full Survey - This is a survey of all applicable CLIA Conditions and/or 
standards for laboratories. 
 
2.  Partial Surveys - This is a survey of selected CLIA Conditions and/or 
standards for laboratories. 
 
6234.4 - CLIA-FMS Types Used to Assess Individual Surveyor 
Performance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
A description of the three types of CLIA-FMS is as follows: 
 
  The Observational CLIA-FMS is a survey in which the RO surveyor 
accompanies the SA surveyor and interacts as necessary during the survey 
  process. The interaction is also intended to provide guidance at the 
appropriate times during the survey process.  The RO surveyor and SA 
surveyor communicate about findings, observations, decisions and regulatory 
interpretations during the survey in a collaborative and cooperative 
environment.  The RO surveyor serves as a resource to enable the SA 
surveyor to strengthen skills, knowledge base, and adherence to the CLIA 
regulations, policies, and the OOSP.  It is important that the RO surveyor 
communicates and interacts in a neutral non-judgmental manner, providing 
objective and constructive feedback about the SA surveyors strengths and 
weaknesses.  The SA surveyor prepares the Form CMS-2567 after discussing 
the deficiencies with the RO surveyor.  The RO hours are not included in the 
SAs CMS-670 form in the SA certification kit. 
 
  The Participatory CLIA-FMS is a survey in which the RO surveyor observes 
the SA surveyor and participates in the survey.  The Participatory survey 
facilitates a collaborative relationship between the RO and SA.  As in the 
Observational FMS, the RO surveyor serves as a resource to enable the SA 
surveyor to strengthen skills, knowledge base, and adherence to the CLIA 
OOSP, regulations, and policies.  The Participatory FMS also affords an 
opportunity for the RO surveyor to demonstrate a different survey approach 
when deemed necessary.  The goal is to jointly identify deficiencies by the RO 
and the SA surveyor.  Both the SA and RO surveyor collaborate on a final 
compliance determination when there are different conclusions.  The ROs 
hours are included in the SAs CMS-670 form in the SAs certification kit as 
well as any deficiency citations written by the RO surveyor. 
 
  The Comparative CLIA-FMS is a survey in which the RO surveyor 
surveys the laboratory after the SA surveyor, preferably within 30 days but 
no later than 60 days from when the SA performs its survey.  The deficiency 
citations of the RO surveyor are compared to those of the SA surveyor.  
When assessing comparability, the RO surveyor must keep in mind the 
possibility that deficiencies may not have been present in the laboratory at 
the time of separate surveys.  If an issue arises, then the RO surveyor must 
contact the SA surveyor for clarification.  The ROs hours are not included 
in the SAs CMS-670 form in the SAs certification kit. 
 
 
6234.5 - Additional RO Responsibilities on FMS Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Regional Offices (RO) role is to obtain sufficient information to make an 
appropriate determination regarding the surveyors' adherence to CLIA policies and 
procedures.  An additional aid for the RO to determine skill and training needs for the 
SA surveyor(s) are the 4 skill sets which can be used as a guide for improvement, not 
only for the RO, but also for the SA and surveyors.  The RO may identify other 
applicable skills during their FMS reviews and should apply good judgment in their 
  recommendations to the SA in these supplemental areas for improvement on education 
and/or training.  The skill sets include organization, communication, information 
gathering, and investigation and are summarized below.  Each of the 4 types of basic 
skill sets are interrelated and are part of performing the various CLIA survey 
functions/activities effectively.  All 4 skills need not be separately observed; rather a 
single situation may demonstrate one or more skills simultaneously. 
 
Organization Skill: 
Although organization lends itself to certain variables from person to person, the SA 
surveyor should make efficient use of costly survey time by demonstrating an ability 
to function in an orderly and structured fashion.  For example, the surveyors ability 
to organize his/her survey notes and survey information would facilitate his/her 
decision on the laboratorys compliance with a particular requirement. 
 
Communication Skills: 
The surveyor(s) should demonstrate the ability to communicate effectively to all 
appropriate parties throughout the entire OOSP.  Surveyors should demonstrate 
effective communication skills in active listening, appropriate body language and 
diplomatically handling difficult people and/or situations.  Communicating positive 
feedback on the laboratorys commendable practices also adds to the surveyors 
credibility and serves as a foundation of success on which the laboratory can build.  
Communicate and clarify findings with the personnel directly involved in the issues 
being investigated.  All interview questions should be clear, concise, open-ended, and 
non-threatening. 
 
Information Gathering Skill: 
This skill enables the surveyors to identify the information needed to determine the scope, 
pervasiveness, and seriousness of problems that may have an impact on the laboratorys 
compliance.  A cross section of information is gathered, reviewed and verified in an 
orderly and logical manner.  To maximize the use for costly on-site time, the surveyor 
limits his/her inquiry to issues that are pertinent and within the scope of the CLIA 
requirements.  The preliminary findings are made from the information obtained by 
observation, interviews, facts, events, or documentation reviews.  Sources of information 
may be observation of techniques or equipment, review of records (QC, PT, QA, 
calibration, etc.), interviews, etc. Effective interviews are conducted in a clear concise 
manner to obtain facts or specific and relevant information, not impressions, conclusions, 
judgments, etc. 
 
Investigative Skills: 
The investigative skills are techniques surveyors use to gather, preserve, or create 
various forms of information, in a manner that results in valid conclusions.  The 
surveyor should make a systematic inquiry or examination into the laboratorys 
practices, conditions, and environment to either support or deny compliance 
determinations.  The surveyor should remain focused on relevant monitors and 
information.  The surveyor must carefully record the information obtained.  Surveyors 
must have the knowledge of the regulations and how to apply them in order to relate 
deficient practice(s) to their findings to determine if the findings have identified a true 
  symptom of a failed system. The surveyor is able to make decisions by evaluating 
findings in the context of public health responsibilities and recommend appropriate 
actions when patient health is at risk regarding laboratory test outcomes. 
 
6236 - CLIA-FMS Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Modifications updating procedures used to perform Comparative, Observational, 
and/or Participatory FMS are included as needed annually through national policy 
memoranda. 
 
6236.1 - Scheduling of Surveys 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Scheduling of surveys can occur as far in advance as the RO needs to organize its 
workload in consideration of survey priorities.  Public Law 100-578(g) permits 
inspections of laboratories on an announced or unannounced basis during regular 
hours of operation.  The RO conducts FMS on an announced or unannounced basis.  
In the case of an announced Observational or Participatory FMS, the SA notifies the 
laboratory of the upcoming survey with a maximum of 2 weeks advanced notice of the 
CLIA survey and that the RO surveyor will accompany the SA surveyor.  In the case 
of an announced Comparative FMS, the RO notifies the facility of the upcoming 
CLIA survey.  Complaint surveys/investigations are always unannounced regardless of 
the type of laboratory circumstances.  Refer to Chapter 5, Complaint Procedures, for 
additional information about complaint investigations in a laboratory. 
 
 
6236.2 - Survey Findings 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The  SA  and  RO  end  each  Federal  survey  with  a  standard  exit  conference  with 
appropriate facility staff and discuss findings in general terms as well as specify any 
deficiencies that could significantly affect the health and safety of individuals or result 
in adverse action. 
 
If the RO determines that CLIA Conditions are out of compliance, see 6250-6294 
for enforcement process.  The RO is responsible for subsequent enforcement actions 
under these circumstances.  However, the RO may request that the SA conducts any 
necessary follow-up visits except for Federal jurisdictional surveys.  The RO forwards 
to the SA the survey findings and copies of all correspondence with the entity. 
 
The RO requests that the SA obtain a PoC from the facility, and monitors the SAs 
follow-up activities.  The RO may wish to work with the facility and the SA directly if the 
seriousness of the findings warrant such action. 
 
  6236.3 - Feedback to the SA Surveyor and the SA Supervisor 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO surveyor must provide verbal feedback to the SA surveyor at the conclusion of 
every Observational/Participatory/Comparative CLIA-FMS.  Written feedback is 
provided by the RO surveyor after an observational, participatory, and comparative 
FMS. 
1.  Verbal Feedback. The RO surveyor provides the SA surveyor with objective 
remarks on strengths and areas for improvement noted in the comment section of the 
CLIA Federal Monitoring Survey Assessment (FMSA) Worksheet; i.e., effective use of 
OOSP and Principles of Documentation (PoD).  Following a Comparative survey, the 
RO should contact the SA surveyor regarding specifics noted in the FMSA Worksheet. 
 
2.  Written Feedback.  No later than 60 calendar days after the survey, the RO surveyor 
sends written feedback to the CLIA SA supervisor and a courtesy copy to the surveyor.  
The written feedback includes the ROs assessment based on the FMSA Technical Skills 
Criteria and any recommendations to the SA and reflects the verbal feedback given to 
the surveyor following the survey. 
 
  For Observational and Participatory surveys, the summary report must 
include specific comments regarding the surveyors training needs and 
specific recommendations where appropriate in relationship to the 
minimum FMSA Technical Skills Criteria, Principles of Documentation, 
and the CLIA OOSP. 
 
  For Comparative surveys, the summary report must include specificity about 
only those criteria that can be assessed without the SA surveyor present, as 
well as the results of the comparison of deficiency citations. 
 
6238  Completion of FMS Workload and Time Expenditures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
To provide accurate information on both the number and types of monitoring surveys 
the RO completes the Form CMS-670 which is entered into the system for each 
survey performed, regardless of the type or extent of the survey, or the size of the 
survey team. For CLIA surveys, the Form CMS-670 will generally capture SA time, 
RO time, CO (administrative) time, and appeals time expenditures.  This more 
comprehensive accounting of time is necessary to meet the self-funding requirement 
of CLIA.  The RO hours are not included in the SAs CMS-670 in the SAs 
certification kit for the Observational and the Comparative surveys, but are entered 
by the RO into the ASPEN record for FMS Surveys.  For the Participatory survey, the 
ROs hours are included in the CMS-670 in the SA certification kit as well as any 
deficiency citations written by the RO surveyor. 
 
   
6240 - Other Special Purpose Federal Surveys - Definitions 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15-19) 
 
  Federal jurisdictional survey is a Federal survey to assess laboratory 
performance and to determine whether a laboratory meets all CLIA 
requirements for the tests that the laboratory conducts.  It is used as the basis 
for approving a laboratory where CMS has indicated that the SA should not 
have jurisdiction over the laboratory.  Surveys conducted by Federal 
personnel include federally operated laboratories and State operated 
laboratories.  When conducting these surveys, the RO performs all functions 
performed by the SA for CLIA laboratories, including ensuring that the 
laboratory is enrolled in an approved PT program and monitoring their 
performance in the PT program.  CO will determine whether or not a 
laboratory outside the U.S. should be surveyed under CLIA if the laboratory 
performs laboratory tests on human specimens referred to it by a laboratory 
in the U.S. or its territories.  CO has regulatory oversight of CLIA certified 
international laboratories. Surveys of international laboratories are handled 
by an RO assigned to perform the survey by CO.  SAs do not have 
jurisdiction over international laboratories and should refer all inquiries to 
CO with a copy to their RO.  CO also has regulatory oversight over CLIA-
accredited international laboratory--related complaints and validations. 
 
  Complaint survey is a survey conducted to investigate an allegation of 
laboratory noncompliance with one or more CLIA requirements.  The SA or 
RO may conduct complaint surveys. Refer to Chapter 5, Complaint 
Procedures, for additional information about complaint investigations in a 
laboratory. 
 
  Follow-up survey is conducted to determine the status of corrective action, 
based on deficiencies cited on the Form CMS-2567 (Exhibit 7).  If 
appropriate, a contact (i.e., telephone or mail) in lieu of an on-site follow-up 
survey may be conducted to ascertain the status of a facility that has received 
notice from the RO or SA and has alleged correction of the deficiency or 
deficiencies. 
Adverse Actions 
 
6250 - Purpose of and Basis for Enforcement Action 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Laboratories holding any type of CLIA certificate are subject to enforcement actions 
under the authority of 353 of the Public Health Service Act (PHSA) and 1846 of 
the 
Social Security Act (the Act). Title 42 CFR Part 493, Subpart R, sets forth the 
  enforcement procedures for laboratories. 
 
 
6250.1 - Purpose 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The enforcement process serves the following purposes: 
 
  To protect all individuals served by a laboratory against substandard testing of 
specimens; 
 
  To safeguard the general public against health and safety hazards that might result 
from laboratory activities; and 
 
  To motivate laboratories to comply with CLIA requirements so that they can 
provide accurate and reliable test results. 
 
6250.2 - Basis for Enforcement 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CLIA enforcement actions are based on: 
 
  Deficiencies found during an onsite laboratory survey or 
through review of materials submitted by the laboratory (e.g., 
personnel qualifications, PT referral, failure to comply with 
notification requirements); and 
 
  Unsuccessful participation in PT. 
 
6252 - Definitions/Terminology - Enforcement 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  Confirmatory testing means testing performed by a second 
analytical procedure that could be used to substantiate or bring 
into question the result of an initial laboratory test. 
 
Example:  Pos HIV screen or Pos Lyme  Western Blot 
 
  Credible Allegation of Compliance - A credible allegation is 
a statement or documentation that: 
 
o  Is made by a representative of a laboratory with a history 
of having maintained a commitment to compliance and 
taking corrective action when required; 
o  Is realistic in terms of the possibility of the corrective 
  action being accomplished between the last day of the 
survey and the date of the allegation; and 
 
o  Indicates that the problem has been resolved. 
 
  Day - Unless otherwise stated, day always means calendar day. 
 
  Distributive testing means laboratory testing performed on the same 
specimen, or an aliquot of it, that requires sharing it between two or more 
laboratories to obtain all data required to complete an interpretation or 
calculation necessary to provide a final reportable result for the originally 
ordered test. When such testing occurs at multiple locations with different 
CLIA certificates, it is considered distributive testing. 
 
Example: Protein Electrophoresis - Lab A does electrophoresis, Lab B 
does Total Protein 
 
  International Laboratories - CLIA-certified laboratories 
operating outside the United States or its territories. 
 
NOTE: All enforcement actions on international laboratories are 
handled by the CMS Central Office. 
 
  Lifting a sanction - Generally, sanctions are not lifted until a 
laboratorys compliance with all condition level requirements is 
verified; in other words, sanctions are imposed for a period of 
time and then end when condition-level compliance is confirmed. 
 
  PT Scores - The CMS approved PT program will determine the 
overall and individual analyte scores following the grading 
criteria defined in 42 CFR Part 493, Subpart I. 
 
  PT Survey - A module or grouping of samples marketed as a unit 
by PT programs. Programs typically offer several survey kits that 
include different samples for the same specialty, subspecialty, 
analyte, or test. 
 
  Reflex testing means confirmatory or additional laboratory testing 
that is automatically requested by a laboratory under its standard 
operating procedures for patient specimens when the laboratory's 
findings indicate test results that are abnormal, are outside a 
predetermined range, or meet other pre-established criteria for additional 
testing. 
 
  Examples:  Pos Hep A screen  Total vs IgM, Pos E.coli  
serotyping 
 
  Repeat proficiency testing referral means a second instance in 
which a proficiency testing sample, or a portion of a sample, is 
referred, for any reason, to another laboratory for analysis prior 
to the laboratory's proficiency testing program event cut-off date 
within the period of time encompassing the two prior survey 
cycles (including initial certification, recertification, or the 
equivalent for laboratories surveyed by an approved 
accreditation organization). 
 
  Rescinding a sanction - Generally, sanctions may be withdrawn if 
they have been imposed when information, which was not 
previously known to CMS, comes to CMSs attention that the 
sanction should not have been imposed. 
 
  Testing Event - This is a PT programs scheduled submission to a 
laboratory of survey samples for a regulated specialty, subspecialty, 
analyte, or test.  A minimum of two testing events per year are 
required for the mycobacteriology subspecialty.  All other 
specialties, subspecialties, analytes, and tests require three testing 
events per annum except cytology. 
 
 
6254 - Enforcement Options for All Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may impose one or more of the sanctions specified in this section on any 
laboratory that is out of compliance with one or more CLIA condition-level 
requirements. 
ALL MODEL LETTERS FOR ADVERSE ACTIONS MAY BE FOUND AT: 
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ 
 
NOTE: Due to the additional administrative process which requires a cytology 
contractor to send survey findings to the RO once the cytology survey is completed, 
the effective date of any adverse action imposed against a laboratory based on a 
cytology contractors survey begins on the date the RO receives the official survey 
report. 
 
6256 - Sanctions(s) - General 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
   
 
6256.1 - Choice of Sanction - Factors to Consider 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS is required to impose those sanctions that are most likely to bring laboratories 
into compliance in the shortest possible time from the date of determination of 
deficiencies. The RO considers a number of factors when choosing a sanction. These 
factors include, but are not limited to: 
 
 Whether the deficiencies pose immediate jeopardy; 
 
 The nature, incidence, severity, and duration of the 
deficiencies or noncompliance; 
 
  Whether the same Condition-level deficiencies have been identified 
repeatedly; 
 
  The accuracy and extent of the laboratorys records (e.g., remedial 
action) in regards to the noncompliance and their availability to 
the SA, to other CMS agents, and to CMS; 
 
  The relationship of one deficiency or group of deficiencies to other 
deficiencies; 
 
 The overall compliance history of the laboratory, including but not 
limited to any period of noncompliance that occurred between 
certifications of compliance; 
 
 The corrective and long term compliance outcomes that 
would be achieved through application of the chosen 
sanction or sanctions; 
 
  Whether the laboratory has made any progress toward 
improvement following a reasonable opportunity to correct 
deficiencies; and 
 
  Any recommendation by the SA as to which sanction would be appropriate. 
 
6256.2 - Number of Alternative Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A separate alternative sanction may be imposed for each Condition-level deficiency 
or a single alternative sanction may be imposed for all Condition-level deficiencies 
that are interrelated and subject to correction by a single course of action. 
   
6256.3 - Principal Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may impose any of the three principal CLIA sanctions, which are: 
 
  Limitation of the CLIA certificate; 
 
  Suspension of the CLIA certificate; or 
 
  Revocation of the CLIA certificate. 
 
A limitation of the CLIA certificate means the laboratory is not permitted to perform 
testing in the areas limited, and will be unable to bill Medicare or Medicaid for the 
laboratory work in the applicable specialty or subspecialty as a result of that limitation.  
The laboratory may continue to conduct all other testing permitted under the non-
limited portions of its CLIA certificate. 
 
A suspension of the CLIA certificate means that the laboratory cannot report out the 
results of testing of human specimens for diagnostic, treatment, or assessment purposes 
during the period of suspension. 
 
A revocation of the CLIA certificate means that the laboratory cannot report out the 
results of testing of human specimens for diagnostic, treatment or assessment purposes 
following during the period of the revocation. 
 
6256.4 - Alternative Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may impose one or more of the following alternative sanctions on any laboratory 
in lieu of or in addition to imposing a principal sanction: 
 
  Directed PoC (dPoC) and directed portion of a PoC (dPPoC); 
 
  State onsite monitoring; and/or 
 
  Civil money penalty (CMP). 
 
EXCEPTION: Alternative sanctions may not be imposed on a laboratory that has a 
certificate of waiver because there are no Condition-level requirements for the waived 
tests. These laboratories are not inspected for compliance with Condition-level 
requirements. 
 
 
 
  6256.5 - Additional Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
For laboratories approved to receive Medicare payment, sanctions also include: 
 
  Cancellation of the laboratorys approval to receive Medicare 
payment; 
 
  Suspension of part of Medicare payment; or 
 
  Suspension of all of Medicare payment. 
 
6256.6 - Civil Suit 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may bring suit in the appropriate U.S. District Court to enjoin continuation of any 
specific activity that is causing a significant hazard, or to enjoin the continued 
operation of the laboratory itself, including a CLIA-exempt laboratory, if CMS believes 
that continuation of the specific activity or laboratory operations would constitute a 
significant hazard to the public health.  Upon proper showing, the court issues a 
temporary injunction or restraining order without bond against continuation of the 
activity or operations. 
 
6256.7 - Criminal Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
An individual who is convicted of intentionally violating any CLIA requirement may be 
imprisoned or fined. An intentional violation is knowing and willful noncompliance 
with any CLIA requirement. The RO refers suspected instances of intentional 
violations to the Office of Inspector General (OIG). 
 
6258 - Denial of Form CMS-116 from Prospective Laboratory or Denial of 
Request to Test in New Specialties or Subspecialties 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the Form CMS-116 for any CLIA certificate is denied, the RO prepares a notice to 
the laboratory outlining: 
  The decision and the reason for the denial, citing 
provisions of the law or implementing regulations not met; 
 
  The laboratorys appeal rights; 
 
  The fact that the laboratory cannot operate or receive payment 
under Medicare or Medicaid unless the denial is overturned at the 
conclusion of the administrative appeals process and a CLIA 
  certificate is issued; and 
 
  The procedures to follow for a reconsideration. 
 
If a laboratory is requesting the addition of a new specialty or subspecialty, the 
laboratory may not report patient test results or receive payment under Medicare or 
Medicaid for those additions unless the denial is overturned.  However the 
laboratory may continue to report patient test results and bill for the already 
approved specialties and subspecialties. 
 
The denial notice must be signed by the RO in accordance with the Delegations 
of Authority. 
 
6260 - Certificate Changes When Enforcement Action is Pending 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6260.1 - Laboratory Gives Notification of Going Out of Business 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory not facing enforcement action may voluntarily withdraw from all 
testing, and, therefore, relinquish its CLIA certificate and go out of business by 
notifying the RO or SA of its intent, in writing.  The SA completes the necessary 
actions.  If the SA learns that a laboratory facing enforcement action intends to 
close, the SA notifies the RO in writing (e.g., email), including the projected date of 
closure.  Any correspondence received from the laboratory and any other pertinent 
document(s) are submitted to the RO. 
 
6260.2 - Laboratory Gives No Notification of Going Out of Business 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory not facing enforcement action voluntarily withdraws from all testing, 
and refuses new requests for testing, it voluntarily relinquishes its CLIA certificate.  If 
the SA learns that a laboratory may be going out of business, it verifies the situation 
and completes the necessary actions.  If the SA learns and verifies that a laboratory 
facing enforcement action has closed, the SA notifies the RO in writing (e.g., email). 
 
6260.3 - Voluntary Withdrawal When Enforcement Action Is Pending 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO should proceed with the enforcement action despite the laboratorys 
withdrawal, particularly if the RO decides that the laboratorys performance warrants 
inclusion on the annual Laboratory Registry and public notification, actions that are 
triggered by imposition of the adverse action. 
If the RO decides to proceed with the enforcement action, it prepares a notice to the 
  laboratory explaining that, although it has withdrawn from the CLIA program, its CLIA 
certificate will remain active until the enforcement action takes effect so that CMS may 
exercise its right to take its enforcement action to conclusion.  The RO will restate in the 
notice the laboratorys appeal rights mentioned in the notice of sanction. 
 
If the RO decides to discontinue the revocation, it notifies the SA to process the 
withdrawal. 
 
6260.4 - Requests to Change Certificate Type When Enforcement Action is 
Pending 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO proceeds with the enforcement action proposed against a laboratorys existing 
certificate if the laboratorys deficiencies warrant it. 
 
If the RO proceeds with the enforcement action, the RO notifies the laboratory that 
its  current  certificate  will  remain  active  until  the  enforcement  action  becomes 
effective, at which time the request will be acted upon. 
 
If the enforcement action is discontinued, the RO or SA proceeds with the change of 
certificate type. 
 
6260.5 - Request to Change Accreditation Organization When 
Enforcement Action is Pending 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO proceeds with the enforcement action proposed against a laboratorys existing 
certificate if the laboratorys deficiencies warrant it.If the RO proceeds with the 
enforcement action, the RO notifies the laboratory that its current certificate will remain 
active until the enforcement action becomes effective, at which time the request may be 
acted upon.  In addition, the RO notifies the laboratory that the laboratory may not 
change accreditation organizations during an enforcement action. If, during the 
enforcement action, the accreditation organization revokes the laboratorys 
accreditation, the laboratory will continue to hold a certificate of accreditation 
throughout the duration of the enforcement action. 
 
If the enforcement action is discontinued, the RO or SA proceeds with the change of AO.  
 
6262 - Reissuance of Certificates to Laboratories Found Out of 
Compliance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory that has been found out of compliance with one or more CLIA 
Condition(s) may be reissued a CLIA certificate before the expiration date 
when: 
   
  Alternative sanctions, or training and technical assistance, or both 
are imposed; or 
 There is no immediate jeopardy to individuals served by the laboratory 
or to the general public health and a principal sanction or civil money 
penalty has been imposed and the laboratorys appeal of that sanction, 
including revocation, is pending when its current certificate expires. 
 
A Certificate of Compliance or Certificate of Accreditation may also be 
administratively extended for a laboratory that has been found out of 
compliance if the laboratorys certificate has been subject to a principal 
sanction or civil money penalty and the laboratorys appeal of that sanction is 
pending when its current certificate expires. 
 
Any certificate issued under any of these circumstances is subject to all principal 
and alternative sanctions. 
 
6264 - Sanction Notification Requirements 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6264.1 - Notice of Proposed Sanction(s) - All Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO provides written notice of the proposed sanction(s) and gives the laboratory 
at least 10 calendar days to respond. 
 
6264.2 - Notice of Imposition of Sanction(s) - All Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO provides written notice of the imposed sanction(s) at least five days before the 
effective date in immediate jeopardy situations, and at least 15 days before the 
effective date in situations that do not pose immediate jeopardy. 
 
6264.2 - Alternative Sanctions 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6266 - CLIA Conditions Not Met - Additional Sanctions Related to 
Medicare Payments - Principal and Alternative Sanctions for Laboratories 
that Participate in Medicare 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
NOTE: This section and its subsections are Medicare Provisions enforced under the 
Medicare Program Authority, not CLIA. 
 
CLIA certification is mandatory for all laboratories that report out test results 
  on human specimens for diagnosis, treatment or assessment purposes. CLIA 
obligations are not dependent on the payment source for the testing.  
However, CLIA certification is required for payment under Medicare and 
Medicaid. 
 
The Medicare program has for many years required that noncompliant suppliers, 
including laboratories, be subject to enforcement actions under the Medicare statute, 
in most cases, before there is an opportunity for a hearing on the alleged CLIA 
infractions. CLIA also permits imposition of alternative sanctions other than a civil 
money penalty prior to a hearing on the alleged CLIA infractions, and also permits 
the suspension or limitation of the CLIA certificate prior to a hearing if: 
 
  Immediate jeopardy exists; 
 
  The laboratory has refused a reasonable request for information, 
materials, or work (e.g., failure to conduct PT) on materials 
necessary to determine compliance with CLIA; or 
 
 The laboratory has refused CMS or its agent(s) permission to 
conduct a survey. 
 
Although the Federal health and safety requirements are now the same for Medicare 
and CLIA, failure to meet CLIA requirements may result in additional enforcement 
actions under Medicare, since both the Public Health Service Act and the Social 
Security Act apply to these facilities.  These Medicare sanctions are described below. 
 
6266.1 - Principal Sanction - Cancellation of Medicare Payments 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may cancel the laboratorys approval to receive Medicare payment for its services. 
 
6266.1.1 - Basis for Cancellation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS always cancels a laboratorys approval to receive Medicare payment for its 
services if CMS suspends or revokes the laboratorys CLIA certificate. 
Cancellation of Medicare approval to receive Medicare payment for its services is 
applied to those specialties and subspecialties that are affected by a limited CLIA 
certificate. 
 
CMS may cancel the laboratorys approval to receive Medicare and Medicaid payment 
for its services under any of the following circumstances: 
 
  The laboratory is out of compliance with a Condition including 
failure to meet PT requirements; 
   
 The laboratory fails to submit an AoC or PoC within an appropriate 
time frame; or 
 
  The laboratory fails to correct all its deficiencies within the time 
frames specified in the PoC. For deficiencies not at the condition 
level, correction of deficiencies cannot extend beyond 12 months 
from the last date of survey that identified the deficiencies. 
 
6266.1.2 - Effective Date of Cancellation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Medicare cancellation takes effect after proper written notice to the laboratory (at least 
5 days before the effective date of the sanction for immediate jeopardy and at least 15 
days before the effective date if there is no immediate jeopardy), which includes the 
opportunity to respond. The cancellation is not delayed because the laboratory has 
appealed and the hearing or hearing decision is pending. 
 
6266.1.3 - Effect of Cancellation on Other Medicare Payment Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Cancellation of Medicare approval terminates any other Medicare payment sanction, 
i.e., suspension of all or part of Medicare payments, regardless of the time frames 
originally specified for the other sanction. 
 
6266.1.4 - Effect of Cancellation of Medicare on Laboratorys Eligibility 
to Receive Medicaid Payments 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Except  as  otherwise  provided  in  1902(a)(9)(C)  of  the  Act,  payment  for 
laboratory services may be made under the State plan only if those services are 
furnished by a laboratory that meets CLIA requirements or is licensed by a State 
whose licensure program has been approved for CLIA exemption by CMS. 
 
6266.2 - Alternative Sanctions - Suspension of Part or All of Medicare 
Payments 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6266.2.1 - Suspension of Part of Medicare Payments 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS may impose this sanction in the following situations: 
 
  The laboratory has Condition-level deficiencies with respect to tests in 
  one or more specific specialties or subspecialties; and 
 
  The laboratory agrees not to charge Medicare beneficiaries, their private 
insurance carriers, the fiscal intermediary (FI), or carrier for those services 
for which payment is suspended. The laboratory may choose to make this 
agreement in return for not having its Medicare approval canceled 
immediately. 
 
After proper written notification, the RO will instruct the appropriate Medicare carrier, 
intermediary, or Medicare Administrative Contractors (MACs) to suspend Medicare 
payment for services furnished on and after the effective date of the sanction for those 
specialties or subspecialties for which the laboratory is out of compliance. The sanction 
remains in effect until the laboratory corrects the Condition-level deficiencies or CMS 
cancels the laboratorys approval to receive Medicare payment, but never beyond 12 
months from the last date of the survey that identified the deficiencies; one or the other 
must occur. In this situation, the SA and RO should be in communication throughout 
the process so that any enforcement action can be timely. 
 
If the laboratory corrects all Condition-level deficiencies, the RO instructs the MAC to 
resume Medicare payment effective for all services furnished on or after the date the 
deficiencies are corrected. If all deficiencies are not corrected within the time frames 
specified in the AoC or PoC (corrections cannot exceed 12 months for a PoC), the RO 
cancels the laboratorys approval to receive Medicare payment for its services. 
 
If the sanction of suspension of Medicare payment is recommended, the RO includes in 
the notice a statement asking the laboratory whether or not it intends to continue 
charging Medicare beneficiaries, their private insurance, fiscal intermediary, or carrier 
for those specialties and subspecialties for which testing is being limited. The RO informs 
the laboratory that if it agrees not to charge its Medicare beneficiaries, their private 
insurance, fiscal intermediary, or carrier, it will have its payment for affected Medicare 
covered laboratory services suspended on the effective date of the sanction. 
 
6268 - Adverse Action on Any Type of CLIA Certificate: Effect on 
Medicare Approval 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6268.1 - Suspension or Revocation of Any Type of CLIA Certificate 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When the RO suspends or revokes any type of CLIA certificate, the laboratorys 
approval to receive Medicare payment for its services is canceled concurrently. 
 
 
 
 
  6268.2 - Limitation of Any Type of CLIA Certificate 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When  the  RO  limits  any  type  of  CLIA  certificate,  it  concurrently  amends  the 
laboratorys  approval  to  receive  Medicare  payment  to  only  those  specialties  or 
subspecialties that are authorized by the laboratorys limited certificate. 
 
6270 - Effect on Medicaid Participation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Payment for laboratory services may be made under the State plan only if those 
services are furnished by a laboratory that has a CLIA certificate or is licensed by a 
State whose licensure program has been approved by the Secretary. 
 
6272 - Failure to Furnish Notification of Changes 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory fails to meet the notification of change requirements as outlined in the 
regulations (42 C.F.R 493.39(b), 493.51(a), 493.53(b), 493.63(a)), the RO may 
impose a principal sanction. (Refer to 6256.3). 
 
Refer to Notification sections for timelines earlier in the SOM. 
 
6276 - Suspension, Limitation, or Revocation of Any Type of CLIA 
Certificate 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6276.1 - Adverse Actions Based on Actions of the Laboratorys Owner, 
Operator or Employees 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6276.1.1 - Basis for Action 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO may initiate adverse action to impose principal sanctions (i.e., 
suspension, limitation, revocation) on any CLIA certificate if CMS finds that a 
laboratory owner, operator or one of its employee has: 
 
  Been found (e.g., through findings during the survey process, or 
through documents submitted to CMS, the RO or the SA) to have 
potentially made a misrepresentation which was materially 
relevant to the laboratory having obtained or maintained a CLIA 
certificate; 
 
    Performed, or represented the laboratory as entitled to perform, 
a laboratory examination or other procedure that is not within a 
category of laboratory examinations or other procedures 
authorized by its CLIA certificate; 
 
  Failed to comply with CLIA certificate requirements and performance 
standards (e.g., failed to comply with notification of change 
requirements); 
 
  Failed to comply with reasonable requests by the RO or CMS agent for 
any information or work on materials that the RO or CMS agent 
conclude is necessary to determine the laboratorys continued eligibility 
for its CLIA certificate or continued compliance with performance 
standards set by CMS (no hearing necessary before the action); 
 
  Refused  a  reasonable  request  by  the  RO  or  CMS  agent  for 
permission to inspect the laboratory and its operation and pertinent 
records  during  the  hours  that  the  laboratory  is  in  operation  (no 
hearing necessary before the action); 
 
  Violated or aided and abetted in the violation of any provisions of CLIA 
and its implementing regulations; 
 
  Failed to comply with an alternative sanction previously imposed; or 
 
  Within the proceeding 2-year period, owned or operated a laboratory that 
had its CLIA certificate revoked. (This provision applies only to the owner 
or operator, not to all other laboratorys employees.) 
 
If the RO determines that any of the above CLIA violations have occurred, the RO 
imposes a principal sanction. 
 
Also, the RO notifies the OIG in cases of: 
 
  Misrepresentation in obtaining a CLIA certificate; 
 
  Performance, or representation by the laboratory as entitled to perform, 
an examination or other procedure that is not authorized by its CLIA 
certificate; 
 
  Violation or aiding and abetting in of any provisions of CLIA 
and its implementing regulations; and 
 
  Adverse action based on improper PT referral. 
 
   
6276.2  Adverse Actions Based on Improper Referrals in Proficiency 
Testing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If CMS determines that a laboratory has intentionally referred its proficiency 
testing to another laboratory for analysis, CMS will categorize the PT referral 
into one of three categories (see 6276.2.1-6276.3).  What is meant by 
intentional is the intent to act, regardless of motive; that is, a knowing and 
willful act. 
 
The PT referral regulations provide a specific framework for application of 
sanctions for PT referral cases taking into account circumstances of the referral. 
The process for review of PT referral cases is as follows - when a possible case of 
PT referral is found by the RO or the SA, it is forwarded to the PT Referral Team 
at CO. 
 
6276.2.1  Category 1 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory that refers its proficiency testing samples to another laboratory for 
analysis, and reports out that other laboratorys proficiency testing results, or 
has a repeat PT referral regardless of category, will be considered Category 1 
PT referral. 
 
In these instances, the RO: 
 
  Must impose - Revocation of the CLIA certificate and 
owner/operator/laboratory director prohibition for at least 1 year, 
and 
  May impose - CMP. 
 
NOTE: The owner may be exempt from the owner/operator ban if, after review, 
CMS finds that there is no evidence that patients would be put at risk by owner 
being exempted from the ban, that the owner was not complicit in the PT 
referral, and that the laboratory has either not received PT samples from 
another laboratory in 2 previous survey cycles, or, if it did, it reported the 
receipt to CMS or to the CMS- approved AO.  This determination is made on a 
lab-by-lab basis. 
 
6276.2.2 - Category 2 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory that refers its proficiency testing samples to another laboratory for 
analysis and obtains test results for PT samples from that other lab on or before 
  proficiency testing event cutoff date, but reports its own PT sample results, will 
be considered a Category 2 PT referral. 
 
In these instances, the RO: 
 
  Must impose - Suspension/limitation for less than 1 year 
and alternative sanctions, as appropriate, but will always 
impose a CMP and dPoC which includes training of staff. 
 
6276.2.3 - Category 3 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A laboratory that refers its proficiency testing samples to another laboratory 
for analysis and obtains test results for PT samples from another laboratory 
after the cut-off, will be considered a Category 3 PT referral. 
 
In these instances, the RO: 
 
  Must impose - Alternative sanctions, as appropriate, but will 
always impose a CMP and dPoC which includes training of 
staff. 
 
6276.2.4 - Carve-Out 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If CMS determines that a proficiency testing sample was referred to another 
laboratory for analysis, but the requested testing was limited to reflex, distributive 
or confirmatory testing that, if the sample were a patient specimen, would have 
been in full conformance with written, legally accurate and adequate standard 
operating procedures for the laboratorys testing of patient specimen, and if the 
proficiency testing referral is not a repeat proficiency testing referral, CMS will 
consider the referral improper, but not intentional, and potentially subject the 
subject the laboratory to alternative sanctions in accordance with 493.1804(c). 
 
Reflex, distributive and confirmatory testing is prohibited for PT unless it is performed by 
the same laboratory that performed the initial testing, is included in that laboratorys 
standard operating procedure, and the results are reported as part of the proficiency 
testing program.  NOTE: Any CLIA-certified laboratory that receives a proficiency 
testing sample from another laboratory for testing must notify CMS of the receipt of that 
sample regardless of whether the referral was made for reflex, distributive or 
confirmatory testing, or any other reason. 
 
 
 
  6276.2.5 - RO Actions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the RO determines that any of the above CLIA violations have occurred after 
consultation with CO, the RO imposes the appropriate sanction(s).  Also, the RO 
determines whether referral to OIG is necessary. 
  
6276.3 - Adverse Action Based on Exclusion from Medicare 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the Inspector General (OIG) excludes a laboratory from participation in Medicare, 
CMS will suspend the laboratorys CLIA certificate for the period of time the OIG 
excludes the laboratory. 
 
The notice of suspension should be sent immediately after the RO learns that the 
exclusion was imposed.  While subject to appeal, the effective date of the Medicare 
cancellation is not delayed pending the hearing decision.  A change of laboratory 
ownership may not release a laboratory from its exclusion from Medicare and the 
suspension.  (See 6294.2) 
 
6276.4 - Procedures for Suspension, Limitation, or Suspension: 
Exceptions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6276.4.1 - Suspension or Limitation: Exceptions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS generally may not suspend or limit a CLIA certificate until after an ALJ hearing 
decision that upholds the suspension or limitation.  However, CMS may suspend or limit 
a CLIA certificate prior the ALJ hearing if any of the following circumstances exist: 
 
  The laboratorys deficiencies pose immediate jeopardy; 
  The laboratory has refused a reasonable request for information or work on 
materials; or 
  The laboratory has refused permission for CMS or a CMS agent to inspect 
the laboratory or its operations. 
 
6276.4.2 - Procedures for Revocation 
Procedures for Revocation 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS does not revoke any type of CLIA certificate until after an ALJ hearing (if one 
is requested) that upholds the revocation.  CMS may revoke a CLIA certificate after 
the  hearing  decision  even  if  it  had  not  previously  suspended  or  limited  that 
  certificate. 
 
6276.5 - Notice to Office of the Inspector General (OIG) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In addition to imposing sanctions, the RO refers to OIG, within 30 days, for action any 
situation in which the RO determines: 
 
  The owner, operator, or one of the laboratorys employees is 
guilty of misrepresentation in obtaining a CLIA certificate; 
 
  The owner, operator, or one of the laboratorys employees performed or 
represented the laboratory as entitled to perform a laboratory examination 
or other testing not included in the laboratorys CLIA certificate; 
 
  The owner, operator, or one of the laboratorys employees violated or 
aided and abetted in the violation of any CLIA provisions and its 
implementing regulations; or 
 
  The laboratory intentionally referred PT samples to another 
laboratory for analysis. (See 6260.2.1, Category 1) 
 
6278 - Unsuccessful Participation in PT 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6278.1 - Unsuccessful Participation in PT: Training and 
Technical Assistance Option 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
For a laboratorys initial unsuccessful participation in PT, the RO may require the 
laboratory to undertake special training of its personnel, or to obtain necessary technical 
assistance, or both.  This action is separate from all other principal and alternative 
sanctions available for all laboratories.  The authority to impose this remedy in lieu of, 
or in addition to, other sanctions is discretionary with the RO.  The RO may allow the SA 
to require the laboratory to obtain training and technical experience; however, in this 
instance, the SA must report this information to the RO. 
 
This only applies to initial unsuccessful participation. Any non-initial (i.e., subsequent) 
unsuccessful participation for PT must be immediately forwarded to the RO by the SA. 
 
Training and technical assistance is not an option in the following situations: 
  Immediate jeopardy; 
  Laboratory fails to provide satisfactory evidence that it has corrected 
the problem which caused the unsuccessful PT performance; 
    Laboratory has poor compliance history 
 
6278.2 - Subsequent (Non-Initial) Unsuccessful Participation in PT 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory fails to successfully participate in PT for a specialty, subspecialty 
or analyte, the RO will suspend or limit the CLIA certificate as well as cancel or 
suspend the laboratorys ability to receive Medicare payments for a period of no 
less than 6 months.  However, if the laboratory agrees to stop testing in the 
specialty, subspecialty, or analyte prior to the written notification proposing 
sanctions, the laboratory may demonstrate satisfactory performance on two 
consecutive events (either regularly schedule or off-cycle or a combination) and 
be reinstated prior to the 6 month suspension or limitation. 
 
6278.2.1  Notice of Proposed Sanction(s) 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The RO provides written notice of the proposed sanction(s) and gives the laboratory at 
least 10 days to respond.  [See updated sample letters at http://www.cms.hhs.gov/clia].  
 
6278.2.2  Notice of Imposition of Sanction(s) 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The RO provides written notice of the imposed sanction(s) at least five days before the 
effective date in immediate jeopardy situations, and at least 15 days before the effective 
date in situations that do not pose immediate jeopardy.  [See updated sample letters at 
http://www.cms.hhs.gov/clia]. 
 
6278.3 - Duration of Sanction 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Once imposed, onsite monitoring continues until the laboratory demonstrates that it is 
capable of ensuring compliance with all Condition-level requirements. 
 
If a revisit or other written documentation confirms that the laboratory has not corrected 
its deficiencies within 12 months from the survey date, the RO cancels the laboratorys 
approval to receive Medicare payment for its services and the RO notifies the laboratory 
of its intent to impose a principal sanction against the laboratorys CLIA certificate.  If 
the laboratory still does not correct its deficiencies, the Medicare sanction will continue 
until the principal sanction against the laboratorys CLIA certificate is effective. 
 
6280 - Alternative Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  6280.1 - Alternative Sanctions: Directed Plan of Correction (dPoC) 
and Directed Portion of a Plan of Correction (dPPoC) 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15- 
 
6280.1.1 - Basis for Action 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO may impose a directed PoC for a laboratory that has Condition-level 
deficiencies.  Under this sanction, the laboratory is directed to take specific 
corrective action within specific time frames in order to compel the laboratory to 
achieve compliance.  The laboratory must correct every deficiency addressed in the 
directed PoC.  If the RO does not impose a directed PoC as an alternative sanction, 
it at least imposes a directed portion of a PoC when any of the following 
alternative sanctions are imposed: 
 
 State onsite monitoring; 
 
  Civil money penalty; or 
 
  Suspension of all or part of Medicare payments. 
 
6280.1.2 - Procedures for Directed PoC (dPoC) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When imposing this sanction, the RO takes the following action: 
 
  Specific Corrective Action and Time Frames - Directs the 
laboratory to take specific corrective action within specified 
time frames. 
 
  Duration and Effect of Sanction - If a revisit or other 
documentation confirms that the laboratory has not corrected its 
deficiencies within 12 months from the survey date, the RO 
cancels the laboratorys approval to Medicare payment for its 
services and notifies the laboratory of its intent to impose a 
principal sanction against its CLIA certificate.  The directed 
PoC remains in effect until the effective date of the principal 
sanction against the laboratorys CLIA certificate. 
 
6280.1.3 - Procedures for Directed Portion of PoC (dPPoC) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
It may be necessary to notify clients, i.e., physicians, providers, and suppliers, and in 
  some cases, individual patients, of a sanctioned laboratory, because of the seriousness 
of the noncompliance (e.g., immediate jeopardy) or for other reasons.  In these cases, 
the RO directs the SA to notify the laboratorys clients.  When the RO imposes this 
sanction, the following procedures apply: 
 
  The RO directs the laboratory to submit to the SA, within 10 days after 
the date of its notice, a list of the names and addresses of all 
physicians, providers, suppliers, and other clients who have utilized 
some or all of the laboratorys services since the last survey or within any 
other time frame the RO specifies. 
 
  Within 30 days of the date the SA receives this information, the RO may 
direct the SA to provide a notice to each of the laboratorys clients 
which contains the following: 
 
o  The name and address of the laboratory; 
 
o  The nature of the noncompliance; and 
 
o  The type and effective date of the alternative 
sanction or principal sanction. 
 
The notice will also indicate that the client may contact the SA if additional 
information is needed.  It is the SAs responsibility to obtain information or needed 
clarification in order to respond to clients concerns about making an informed 
decision regarding patient notification and retesting or the use of another 
laboratorys services. 
 
6280.2 - Alternative Sanction: Civil Money Penalty (CMP) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6280.2.1 - Scope and Basis 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO determines if a CMP will be based on a per day of noncompliance or per 
violation.  When a laboratory has Condition-level deficiencies, the RO may generally 
impose a civil money penalty in lieu of, or in addition to, imposing a principal sanction 
against the laboratorys CLIA certificate.  Civil money penalties may only accrue, but 
may not be collected prior to a hearing (if one is requested).  The penalty is collected 
according to the procedures outlined below.  CMP fees are tracked by the RO in the 
Civil Money Penalty Tracking System (CMPTS) tab of the AEM system. 
 
NOTE: See 6276.2 for requirements related to CMPs in cases of PT referral. 
 
 
  6280.2.2 - Amount of Penalty 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The following factors are considered in determining the amount of penalty: 
 
  The nature, scope, severity, and duration of the noncompliance; 
 
  Whether the same Condition-level deficiencies have been identified 
during three consecutive surveys; 
 
 The laboratorys overall compliance history, including, but not limited to, 
any period of noncompliance that occurred between certifications of 
compliance; 
 
  The laboratorys intent or reason for noncompliance; and 
 
  The accuracy and extent of laboratory records and their availability to 
RO or CMS agent. 
 
NOTE: Per the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, 
adjustments to the civil money penalties are expected to be published annually.  These 
adjustments will be published in the Federal Register and located at 45 CFR Part 102. In 
addition, CMP amounts for laboratories will also be posted on the Survey and Certification 
website at https://www.cms.gov/Medicare/Provider-Enrollment-and- 
Certification/SurveyCertificationGenInfo/Civil-Monetary-Penalties-Annual-
Adjustments.html. 
Once the effective date of new CMP levels occurs, the new amounts shall be used to impose 
any CMPs, regardless of when noncompliance is identified.  For example, if a survey 
identifies noncompliance prior to the effective date of new CMP levels, but the CMP is 
imposed after that effective date, the new CMP levels shall be used to calculate the CMP 
imposed. These new amounts shall be used until the next effective date occurs. 
 
6280.2.3 - Range of Penalty Amount 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
As of 2017, the amounts were as follows: 
 
1.  Immediate Jeopardy (Higher Range) - The penalty will range from $6,134 to 
$20,111 per day of noncompliance or per violation. 
 
2.  No Immediate Jeopardy (Lower Range) - The penalty will range from $101 to 
$6,033 per day of noncompliance or per violation. 
 
  3.  Changes in Penalty Amount 
 
  If a civil money penalty is proposed for immediate jeopardy and the 
immediate jeopardy is subsequently removed, but the Condition- level 
deficiency continues, the penalty amount may be shifted to the lower 
range. 
 
  Conversely, if deficiencies cited during the survey did not pose immediate 
jeopardy and the RO proposed a penalty in the lower range, the RO may before the 
hearing, propose an increase in the penalty amount to the higher range when 
deficiencies become sufficiently serious to pose immediate jeopardy. 
 
6280.2.4 - Notice of Intent 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO will notify the laboratory in writing of its intent to impose a civil money penalty 
at least five days before the effective date when immediate jeopardy exists and at least 
15 days before the effective date of the sanction if there is no immediate jeopardy.  The 
notice includes the following information: 
 
 
  The statutory basis for the penalty; 
 
  The proposed daily or per violation amount of the penalty; 
 
  The factors considered in determining the penalty amount; 
 
  The  laboratorys  opportunity  to  respond  within  ten  days  of 
receipt of the notification, which includes the opportunity to 
submit  additional  information  or  a  credible  allegation  of 
compliance; and 
 
  The laboratorys appeal rights, including the criterion that, if the 
laboratory does not request a hearing, RO may reduce the 
proposed penalty amount by 35 percent. 
 
 
6280.2.5 - Accrual of Penalty 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The civil money penalty begins accruing five days after the date of the notice of intent if 
immediate jeopardy is cited.  In no immediate jeopardy cases, the penalty begins 
accruing 15 days after the notice of intent. 
 
 
 
  6280.2.6 - Duration of Penalty 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The penalty continues to accrue until the earliest of the following occurs: 
 
 Condition-level compliance is verified, based on a revisit or evidence 
presented by the laboratory in its credible allegation of compliance.  
If a revisit finds compliance and the laboratory presents no credible 
evidence that compliance was achieved before the revisit, the civil money 
penalty stops accruing as of the last day of the revisit; 
 
 The laboratory presents credible evidence at the time of the revisit 
that establishes that the laboratory achieved compliance with all 
Conditions before the revisit.  In this instance, the civil money 
penalty stops accruing as of the date of compliance; or 
 
  The laboratorys CLIA certificate is suspended, limited, or revoked. 
 
6280.2.7 - Computation and Notice of Total Penalty Amount 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
After the laboratorys compliance is verified or its CLIA certificate has been suspended, 
limited, or revoked, the RO computes the total penalty amount due.  This computation 
occurs: 
 
  After the 60-day period for requesting a hearing has expired and 
the laboratory has not requested a hearing or 
  If the laboratory has waived its right to a hearing; or 
  When an ALJ issues a hearing decision that upholds imposition of 
the CMP 
 
NOTE: If the laboratory does not request a hearing, the RO may reduce the proposed 
penalty amount by 35 percent. 
 
The RO sends a written notice to the laboratory informing it of the daily or per-
violation penalty amount, the number of days or violations for which the penalty is 
imposed, the total amount due, and the due date for payment of the penalty.  Payment is 
due 15 days from the date of the notice.  At the ROs option, it may choose to approve a 
plan allowing the laboratory to pay the penalty, plus interest, over a period of up to one 
year from the original due date.  The RO computes interest in accordance with 42 CFR 
Part 405.378(d). [See updated sample letters at https://www.cms.gov/CLIA]. 
 
 
 
 
  6280.2.8 - Collection of Penalty Amounts 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The penalty amount due may be deducted from any monies then or later owed the 
laboratory by the Federal Government.  Interest accrues on the unpaid balance of the 
penalty beginning on the due date, and is based on the rate specified in 42 CFR Part 
405.378(d). 
 
6280.2.9 - Settlement 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CMS has the authority to settle any case at any time before the ALJ issues a 
hearing decision. 
 
6280.3 - Alternative Sanction: State Onsite Monitoring 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6280.3.1 - Basis for Action Basis for Action 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Continuous or intermittent monitoring by the SA may be required to ensure the 
laboratory implements its AoC or PoC and makes the corrective actions necessary to 
bring it into compliance with the Condition-level requirements.  The monitors 
responsibility is to oversee whether deficiencies are being corrected and whether 
compliance is achieved. 
The State onsite monitor has no management authority, i.e.; the monitor cannot hire or 
fire staff, obligate funds, or otherwise dictate how the laboratory operates. 
 
The laboratory must pay for the costs of onsite monitoring by the SA. The costs of 
onsite monitoring are computed by multiplying the number of hours of onsite 
monitoring in the laboratory by the hourly rate negotiated by the RO and each State.  
The hourly survey rate as negotiated during the budget process includes salary, fringe 
benefits, travel, and other direct and indirect costs negotiated by the RO and the State. 
Form CMS-670 is used to collect this data. 
 
6280.3.2 - Duration of Sanction 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15-19) 
 
Once imposed, State onsite monitoring continues until the laboratory demonstrates 
that it is capable of ensuring compliance with all Condition-level requirements. 
 
6280.4 - Duration of Alternative Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
An alternative sanction continues until the earlier of the following occurs: 
   
  The laboratory corrects all Condition-level deficiencies; or 
 
  A principal sanction against the laboratorys CLIA certificate 
becomes 
effective. 
 
If an alternative sanction is imposed for Condition-level noncompliance that does 
not pose immediate jeopardy, and a revisit verifies that the laboratory has not 
corrected all deficiencies within 12 months from the survey date, the RO takes the 
following action: 
 
  Cancels the laboratorys approval to receive Medicare payment 
for  its  services,  and  discontinues  any  Medicare  alternative 
sanctions as of the date the cancellation is effective; 
 
  Notifies the laboratory of its intent to impose a principal 
sanction against the laboratorys CLIA certificate and of its 
right to a hearing; and 
 
  Imposes (or continue to impose) any alternative sanctions that do 
not pertain to Medicare payments.  Sanctions imposed against the 
CLIA certificate may continue for more than 12 months from the 
date of survey while a hearing on the proposed limitation, 
suspension, or revocation of the laboratorys CLIA certificate is 
pending. 
 
6280.4.1 - Notice of Intent 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
The RO will notify the laboratory in writing of its intent to impose a civil money penalty 
at least 15 days before the effective date of the sanction if there is no immediate jeopardy 
situations and at least five days before the effective date when immediate jeopardy exists.  
The notice includes the following information [see updated sample letters at 
http://www.cms.hhs.gov/clia]: 
 
  The statutory basis for the penalty;  
 
  The proposed daily or per violation amount of the penalty;  
 
  The factors considered in determining the penalty amount; 
 
  The laboratorys opportunity to respond within ten days of receipt of the 
notification, which includes the opportunity to submit additional information or a 
credible allegation of compliance; and 
   
  The laboratorys appeal rights, including the criterion that, if the laboratory does 
not request a hearing, RO may reduce the proposed penalty amount by 35 percent. 
 
6280.4.2 - Accrual of Penalty 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The civil money penalty begins accruing five days after the date of the notice of intent if 
immediate jeopardy is cited.  In no immediate jeopardy cases, the penalty begins accruing 
15 days after the notice of intent. 
 
6280.4.3 - Duration of Penalty 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The penalty continues to accrue until the earliest of the following occurs: 
 
  Condition-level compliance is verified, based on a revisit or evidence presented 
by the laboratory in its credible allegation of compliance.  If a revisit finds 
compliance and the laboratory presents no credible evidence that compliance was 
achieved before the revisit, the civil money penalty stops accruing as of the last 
day of the revisit; 
 
  The laboratory presents credible evidence at the time of the revisit that establishes 
that the laboratory achieved compliance with all Conditions before the revisit. In 
this instance, the civil money penalty stops accruing as of the date of compliance; 
or  
 
  The laboratorys CLIA certificate is suspended, limited, or revoked. 
 
6280.5-Lifting of Alternative Sanctions 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Alternative sanctions are not lifted until compliance with all Condition-level 
requirements is verified. 
 
6280.6 - Collection of Penalty Amounts 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The penalty amount due may be deducted from any monies then or later owed the 
laboratory by the Federal Government.  Interest accrues on the unpaid balance of the 
penalty beginning on the due date, and is based on the rate specified in 42 CFR Part 
405.378(d). 
 
  6280.7 - Settlement 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The RO has the authority to settle any case at any time before the ALJ issues a hearing 
decision.  
 
6282 - Exception for Laboratories With Certificates of Waiver 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Alternative sanctions are not imposed on laboratories with certificates of waiver that 
receive Medicare payments for their services, because there are no Condition-level 
requirements for these tests.  However, the fact that a deficiency is not at the 
Condition- level does not preclude taking adverse action based on the provisions 
contained in 42 CFR Part 493.1840.  For example, if a laboratory is not following a 
manufacturers instructions it is not considered to be meeting the requirements in 
subpart B and the certificate can be suspended or revoked.  If the SA finds that a a 
laboratory is performing nonwaived tests under its certificate of waiver, the SA must 
notify the RO.  The RO may take action against the laboratorys s certificate (i.e., 
suspension or revocation).  When a laboratorys certificate of waiver is revoked or 
suspended, its approval to receive Medicare payment for its services is concurrently 
canceled. 
 
6282.1 - Processing Immediate Jeopardy Enforcement Actions 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
When immediate jeopardy is documented, the RO completes enforcement procedures 
within 23 calendar days.  The RO does not postpone or stop the procedure unless the 
removal of the immediate jeopardy is achieved and verified. 
 
1.  Survey Date - The survey date is the date on which the entire onsite survey 
process is completed. 
 
2.  Second Working Day - No later than 2 working days following the survey date, 
the SA will telephone the RO to advise that it is making a determination of 
noncompliance and that immediate jeopardy exists. 
 
3.  Third Working Day - No later than three working days following the survey 
date:  
 
  The SA sends written notice, i.e.,  a warning letter (see updated sample letters 
at http://www.cms.hhs.gov/clia)  to the laboratory (by overnight mail or 
facsimile) which includes the following: 
 
  The Conditions out of compliance and their determination that these 
deficiencies constitute immediate jeopardy; 
 
    The sanction or sanctions recommended.  The sanction(s) must consist of 
at least suspension or limitation of the laboratorys CLIA certificate and 
may include one or more alternative sanctions.  If the laboratory 
participates in Medicare, all (or, in the case of the limitation of a CLIA 
Certificate, part of) Medicare payments must be canceled or suspended.  If 
the laboratory unsuccessfully participated in PT, the training and technical 
assistance requirement may also be imposed.  If a civil money penalty is 
recommended, the daily or per violation amount recommended must also 
be specified;  
 
  The rationale for the proposed sanction(s); 
 
  The projected effective date and duration of the proposed sanction(s); 
 
  The authority for the proposed sanction(s); 
 
  The time allowed (ten calendar days from the date of the notice) for the 
laboratory to respond to the notice, which includes the opportunity to 
submit additional information or a credible allegation of compliance to the 
RO (see updated sample letters at http://www.cms.hhs.gov/clia); 
 
  The CMS authority at 42 CFR 493.643(b) to assess additional fees for 
costs incurred to verify compliance;  
 
  The opportunity for the laboratory to notify the RO and/or the SA 
immediately if the jeopardy has been removed or the deficiencies have 
been corrected and there is evidence to support the allegation of 
compliance and; 
 
  The intent for the RO to publish a public notice in the local newspaper; 
and 
 
  The SA forwards all supporting documentation to the RO by overnight 
mail. 
 
6284 - Noncompliance With One or More Conditions - Immediate 
Jeopardy Exists 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When a laboratorys deficiencies pose immediate jeopardy, the RO requires the 
laboratory to take immediate action to remove the jeopardy and it may also impose one 
or more principal and/or alternative sanctions as necessary to encourage compliance.  
If the RO has reason to believe that continuation of any activity by the laboratory 
(either by the entire laboratory operation or in any specialty or subspecialty of testing) 
would constitute a significant hazard to the public health, it may bring suit and seek a 
temporary injunction or restrainiFng order against the continuation of that activity by 
  the laboratory, regardless of the type of CLIA certificate the laboratory has or whether 
it is a CLIA-exempt laboratory. 
 
If the laboratory agrees to voluntarily cease testing in the area related to the IJ, then the 
laboratory may be able to abate the IJ; however, IJ cannot be removed until the 
laboratory provides the evidence and documentation to show that they are in condition-
level compliance. 
 
If the laboratory has not removed the immediate jeopardy, the RO notifies the 
laboratory that CMS will suspend or limit its CLIA certificate.  In instances of 
immediate jeopardy, a suspension or limitation of the laboratorys CLIA certificate is 
not delayed because the laboratory has appealed and the hearing or hearing decision is 
pending. The laboratorys suspended CLIA certificate may be revoked following a 
hearing, when one is requested, if the ruling is in CMS favor. 
 
6284.1 - Processing Immediate Jeopardy Enforcement Actions 
 (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When immediate jeopardy is documented, the RO completes enforcement 
procedures within 23 calendar days.  The RO does not postpone or stop the 
procedure unless the removal of the immediate jeopardy is achieved and verified. 
 
1.  Survey Date - The survey date is the date on which the survey 
process is completed by the SA or RO. 
 
2.  Second Working Day - No later than 2 working days following the survey 
date, the SA will notify the RO to advise that it is making a determination of 
noncompliance and that immediate jeopardy exists. 
 
3.  Third Working Day - No later than three working days following the 
survey date: 
 
The SA sends written notice (e.g., overnight mail, facsimile followed by 
mail, email) notifying the laboratory of the IJ and requesting an AoC as 
well as the Form CMS-2567 to the laboratory.  In some cases, the RO 
may combine the request for an AoC along with the Form CMS-2567 and 
proposed sanctions in lieu of the SA sending the letter and Form CMS-
2567.  The letter which accompanies the Form CMS-2567 includes the 
following: 
 
  The Conditions which are out of compliance and the 
determination that these deficiencies constitute immediate 
jeopardy; 
 
  The sanction or sanctions recommended; if the letter is sent by the 
  SA, the SA letter will clearly state that if condition-level compliance 
is not achieved, the case will be referred to CMS for sanction action.  
CMS will make the final determination and will advise the 
laboratory in writing of the sanction(s) to be imposed and/or 
enforcement action(s) that will be taken and will also notify the 
laboratory of their appeal rights at that time.  The sanction(s) must 
consist of at least suspension or limitation of the laboratorys CLIA 
certificate and may include one or more alternative sanctions.  If the 
laboratory participates in Medicare, all (or, in the case of the 
limitation of a CLIA Certificate, part or all of Medicare) payments 
must be canceled or suspended. 
 
 The rationale for the possible proposed sanction(s); 
 
 The projected effective date and duration of the proposed sanction(s) 
(RO only); 
 
  The authority for the proposed sanction(s); 
 
  The time allowed (ten calendar days from the date of the notice) for 
the laboratory to respond to the notice; 
 
  The CMS authority at 42 CFR 493.643(b) to assess additional fees 
for costs incurred to verify compliance; 
 
  The opportunity for the laboratory to notify the RO and/or the SA 
immediately if the jeopardy has been removed or the deficiencies have 
been corrected and there is evidence to support the allegation of 
compliance and; 
 
  The intent for the RO to post a public notice on the CMS website 
should the sanction(s) be imposed (RO only with proposed 
sanction(s)); 
 
The SA forwards an electronic copy of the Form CMS-2567 and all supporting 
documentation to the RO or attaches all the documentation to the survey kit in 
the CLIA data system. 
 
RO Responsibilities 
  Credible AoC is received, and alleges conditional-level compliance 
and removal of IJ: 
o  RO authorized SA to perform an onsite revisit to verify 
compliance; and 
o  If condition-level compliance and removal of IJ is verified, the 
RO sends a letter to the laboratory notifying them of the 
condition-level compliance and removal of IJ; or 
o  If condition-level compliance and removal of IJ is not verified, 
  the RO sends a letter to the laboratory notifying them that 
condition- level compliance has not been achieved and IJ has 
not been removed. 
o  In either case, the RO will also notify the laboratory if any of 
the proposed sanction(s) will be imposed. 
 
6286 - Noncompliance With One or More Conditions - No Immediate 
Jeopardy Exists 
Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When condition-level deficiencies are identified, but immediate jeopardy does not exist, 
and an enforcement action is warranted, the RO completes enforcement procedures 
within 90 calendar days.  The RO does not postpone or stop the procedure unless 
compliance is achieved and verified. 
 
1.  Survey Date - The survey date is the date on which the survey 
process is completed. 
 
2. Tenth Calendar Day - No later than ten days following the survey date, the 
SA will notify (e.g., overnight mail, facsimile, email) the laboratory in writing 
of the cited deficiencies, including Condition-level noncompliance The SA will 
inform the laboratory that the enforcement process provides the opportunity for 
correction and that, if compliance is achieved, the laboratory is to notify the SA 
immediately and furnish evidence to support its allegation.  The SA will state 
that they will make a determination of compliance within 45 days of the survey, 
if a credible allegation of compliance is received and verified. 
 
3. Twentieth Calendar Day - The laboratory must submit a credible AoC to the SA. 
 
4. Forty-Fifth Calendar Day to the Fifty-Fifth Day - If the laboratory has 
submitted a credible allegation of compliance, the SA will determine whether 
compliance must be verified by an onsite revisit or whether compliance can be 
verified based on evidence presented by the laboratory (e.g., paper revisit for PT 
enrollment and personnel qualifying documentation).  If compliance can be 
verified without an onsite revisit, the SA will certify compliance, notify the 
laboratory, and will notify the RO to unflag (L32, L33) in the certification kit.  If 
the SA determines that the AoC is credible and the evidence supports the AoC, 
but cannot verify compliance without an onsite review, the SA will conduct a 
revisit.  RO must approve subsequent SA onsite revisits which usually occur 
between the 45th and 55th day. 
 
If the laboratory fails to submit a credible allegation of compliance, a revisit is not 
required.  The SA will notify the RO that enforcement actions need to be initiated.  In 
these cases, and those in which a revisit found continued noncompliance, the SA or 
RO will prepare and send written notification to the laboratory which includes the 
  following information: 
 
  The cited deficiencies, including the Condition-
level noncompliance identified; 
 
  The sanctions recommended for imposition against the laboratory 
(SA) or proposed sanction(s) (RO); 
 
  The rationale for the proposed sanction(s); 
 
  The projected effective date and duration of the proposed sanction(s) 
(RO only); 
 
  The authority for the proposed sanction(s); 
 
  For alternative sanctions, the time allowed (at least ten calendar days 
from the date of the notice) for the laboratory to respond to the notice 
and the instructions for the laboratory to notify the SA or RO if the 
deficiencies have been corrected and there is evidence to support the 
allegation; 
 
  The CMS authority at 42 CFR 493.643(b) to assess additional fees 
for costs incurred to verify compliance; 
 
  The sanction(s) which will take effect if compliance is not achieved 
(RO only); and 
 
  The intent to post a public notice on the CMS website (RO only). 
 
5. Sixtieth to Seventieth Calendar Day - The SA will review any response 
received from the laboratory or from the revisit and determine whether 
compliance has been achieved.  If compliance can be verified on the basis of 
evidence presented by the laboratory or from the revisit, the SA will certify 
compliance and will notify the RO to unflag (L32, L33) in the certification kit. 
 
If compliance cannot be verified on the basis of evidence submitted by 
the laboratory or from the revisit, the SA will notify the RO that the 
laboratory has not achieved compliance.  If a credible AoC is not 
received, and compliance cannot be verified, the RO will prepare a 
proposed sanction notice.  If the submitted AoC cannot be verified as 
implemented based on the revisit, the SA will prepare the Form CMS-
2567 which includes those deficient practices which have not been 
corrected as well as any new deficient practices found on the revisit. 
The SA will also notify the RO of their determination and forward the 
Form CMS-2567 and supporting documentation as well as sanction 
  recommendations to the RO. 
 
6. The RO sends an official enforcement action notice (i.e., proposed sanction(s)) 
to the laboratory which includes the following information 
 
  The cited deficiencies, including the Condition-level 
noncompliance identified; 
 
  The outcome of the ROs review of any evidence presented by the 
laboratory as the result of the SAs warning letter and/or any 
revisit conducted by the SA; 
 
  The sanctions it proposes to impose against the laboratory. If a 
civil money penalty is recommended, the per day or per violation 
amount proposed will be specified; 
 
  The rationale for imposing the sanction(s); 
 
  The projected effective date and duration of the sanction(s), and 
the effective date of the sanction(s) if Condition-level compliance is 
not achieved; 
 
  The authority for imposing the sanction(s); 
 
  The opportunity for the laboratory to notify the RO immediately if the 
Condition-level deficiencies have been corrected and there is evidence 
to support the allegation; 
 
  The CMS authority at 42 CFR 493.643(b) to assess additional fees 
for costs incurred to verify compliance; 
 
  The laboratorys right to appeal; and 
 
  The intent to post a public notice on the CMS website. 
 
NOTE: The post on the CMS website must at least explain the reasons for the adverse 
action as well as the effective date and effect of the action.  When the CLIA certificate is 
limited, if the laboratory participates in Medicare, the notice must specify the specialties 
and subspecialties of tests that the laboratory is no longer authorized to perform, and, 
therefore, are no longer approved for payment under Medicare. 
 
If the laboratory makes a credible allegation of compliance, the RO determines 
whether the SA can certify compliance on the basis of the evidence presented by the 
laboratory in its allegation or if a revisit must be made to verify that the laboratory 
has, in fact, achieved compliance. If the RO determines a revisit is needed, it instructs 
  the SA to conduct it prior to the effective date of the sanction. The RO also instructs 
the SA to notify it of the outcome immediately upon completion of the revisit. 
 
If the RO concurs on the basis of evidence presented or the outcome of a revisit that 
there are no remaining Condition-level deficiencies, it certifies compliance (i.e., unflag 
(L32, L33) in the certification kit). The RO advises the laboratory that compliance has 
been achieved. If the laboratory fails to make a credible allegation of compliance, no 
revisit is necessary and enforcement procedures continue. 
 
7. Ninetieth Calendar Day - If compliance has not been achieved, the 
CLIA proposed sanctions will be imposed, however, the Medicare 
sanctions must take effect on the 90th day or effective date. If a principal 
sanction is imposed, the RO arranges to publish a public notice 
immediately. 
 
a.  Laboratory Participated in Medicare, Has Its Certificate Limited, and Does 
Not Agree Not to Charge Medicare Beneficiaries, Their Private Insurance, 
the Fiscal Intermediary (FI), or Carrier - Payment for all Medicare-covered 
laboratory services is canceled on the effective date of the sanction. 
 
b.  Laboratory Participated in Medicare, Has Its Certificate Limited, and Agrees 
Not to Charge Medicare Beneficiaries, Their Private Insurance, the FI, or 
Carrier 
 
(1) Suspension of All Medicare Payment - Payment for all Medicare covered 
laboratory services is suspended on the effective date of the sanction, if the 
laboratory agrees not to charge Medicare beneficiaries, their private insurance, 
the FI, carrier, or MAC for services for which Medicare payment is suspended, 
i.e., specialties, subspecialties out of compliance. The laboratory may choose to 
make this agreement in return for not having its Medicare approval canceled 
immediately. 
 
(2) Duration and Effect of Sanction - The sanction remains in effect until the 
laboratory corrects all Condition-level deficiencies, but never beyond 12 
months from the last date of the survey which identified the deficiencies. 
 
If the laboratory corrects all Condition-level deficiencies and participates in Medicare, 
the RO resumes Medicare payment effective for all services furnished on or after the 
date the deficiencies are corrected. If all deficiencies are not corrected by the end of the 
12- month period specified above, the RO cancels the laboratorys approval to receive 
Medicare payment for its services. The RO may impose a principal sanction against the 
laboratorys CLIA certificate.  The RO notifies the laboratory in writing of the 
sanction(s) that CMS is proposing to impose and its right to due process. 
 
  6286.1 - Monitoring of Corrective Action(s) 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The RO may direct the SA to revisit the laboratory or conduct a follow-up at any time to 
evaluate progress and at the end of the enforcement period to determine whether all 
corrections have been made. 
 
6286.2 - Deficiencies Corrected before Revisit 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If a laboratory produces credible evidence that it achieved compliance before the revisit, 
the RO lifts the sanctions as of that earlier date. 
 
6286.3 - Alternative Sanction Imposed - Failure to Correct Condition-
level Deficiencies 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If a revisit verifies that the laboratory has not corrected its Condition-level deficiencies 
within the period specified in the approved PoC, the RO initiates action to impose a 
principal sanction against the laboratorys CLIA certificate. 
 
Alternative sanctions may continue for more than 12 months from the date of the survey 
while a hearing on the proposed principal sanction against the CLIA certificate is 
pending.  If a hearing decision upholds the proposed principal sanction against the 
laboratorys CLIA certificate, the RO lifts the alternative sanction as of the day the 
principal sanction is effective. 
 
6286.4 - Condition-level Deficiencies Corrected but Other Deficiencies 
Remain   12-Month Maximum for Correction 
-
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
At the end of the PoC period, if all Condition-level deficiencies have been corrected, but 
there are standard level deficiencies that remain uncorrected, the SA will request a 
revised PoC from the laboratory that addresses these remaining deficiencies.  The SA will 
not accept a revised PoC that extends beyond 12 months from the date of the survey that 
originally identified the deficiencies. 
 
If a revisit at the end of the 12-month period verifies that the laboratory has not corrected 
its deficiencies, the RO imposes a principal sanction against the laboratorys CLIA 
certificate and cancels the laboratorys Medicare approval. 
 
Alternative sanctions may continue for more than 12 months from the date of the survey 
while a hearing on the proposed principal sanction against the CLIA certificate is pending 
and while Condition-level as well as lower-level deficiencies remain uncorrected.  If a 
hearing decision upholds the proposed principal sanction against the laboratorys CLIA 
  certificate, the RO lifts the alternative sanction as of the day the principal sanction is 
effective. 
 
6286.5 - Revocation of CLIA Certificate 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
If the RO decides to revoke a noncompliant laboratorys CLIA certificate, it may do so 
within the time frames that the RO communicate to the laboratory in the notice of 
sanction if the laboratory does not request a hearing.  If the laboratory requests a hearing, 
the CLIA certificate may not be revoked until the decision is rendered by the ALJ. 
 
6286.6 - Acceleration of Timetable 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The RO switches from the no immediate jeopardy procedures to the accelerated 
procedures of 6282 at any point that it determines immediate jeopardy to patient health 
or safety exists. 
 
6288 - Condition-level Deficiencies Corrected but Other 
Deficiencies Remain - 12-Month Maximum for Correction 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If all Condition-level deficiencies have been corrected, and standard level deficiencies 
remain uncorrected at the end of 12 months from the date of the survey that originally 
identified the deficiencies, the SA will recommend to the RO that principal sanctions be 
imposed against the laboratorys CLIA certificate as well as cancelling the 
laboratorys approval to receive Medicare payments.  This applies when the SA has 
received a PoC which was acceptable in content and time frame, but based on a revisit, 
the SA has determined that the laboratory has not corrected the Standard level 
deficiencies.  The SA will not accept a revised PoC that extends beyond 12 months. 
 
6289  Deficiencies That Are Not At Condition Level 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a laboratory has deficiencies that are not at the Condition level, the following 
rules apply. 
 
  The laboratory must submit a PoC that is acceptable in terms of both its 
contents and the time frames for correction.  For the PoC to be acceptable, 
it must show that the laboratory can achieve compliance and that the 
compliance can be verified within 12 months from the survey date. 
 
  If a laboratory fails to submit an acceptable PoC, and subsequent requests 
  for an acceptable PoC are unsuccessful, the RO may cancel the 
laboratorys approval to receive Medicare payment for its services in 
accordance with 42 CFR 493.1842(a)(2)(ii).  In addition, the RO may 
consider the laboratorys failure to comply with reasonable requests for 
information for purposes of 42 CFR 493.1840(a)(4) and may initiate a 
principal sanction on the basis of this failure. 
 
  If the laboratory has not corrected its deficiencies within 12 months 
after the last date of the survey that identified the deficiencies, the 
RO cancels the laboratorys approval to receive Medicare payment 
for its services and imposes a principal sanction against the 
laboratorys CLIA certificate.. 
 
6290 - Laboratory Found Not in Compliance Following Validation 
Survey or Complaint Survey 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
NOTE: Refer to SOM Chapter 5, Complaint Procedures regarding additional 
information about complaint investigations/surveys. 
 
If deficiencies identified are Condition-level and pose immediate jeopardy to the health 
and safety of individuals served by the laboratory or that of the general public, the RO 
follows the adverse action procedures described in 6284. 
If it is documented that the laboratory is out of compliance with one or more CLIA 
conditions, but the deficiencies do not pose immediate jeopardy to the health and safety 
of individuals served by a laboratory or that of the general public, the RO follows the 
adverse action procedures described in 6286.  The RO notifies the laboratory that it 
has been found out of compliance with a Condition(s) and is, therefore, placed under 
CMS jurisdiction. 
 
The laboratory is placed under CMS jurisdiction, while continuing to retain its 
Certificate of Accreditation, until it reaches CLIA Condition-level compliance or until 
such time as it loses its Certificate of Accreditation.  Accredited laboratories found out 
of compliance at the Condition-level on a validation or complaint survey, and do not 
provide a credible AoC, are subject to the same enforcement procedures applied to 
non-accredited laboratories. 
For any cases that may have national media implications, CO should also be 
notified of enforcement actions proposed and/or imposed against accredited 
laboratories. 
 
NOTE: The RO should provide notices and documentation related to enforcement 
actions to the appropriate AOs. 
 
  6290.1 - Allegation of Compliance 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the RO, in conjunction with the SA, determines that the AoC is credible, the RO 
sends written notification to the laboratory and to the accreditation organization. 
 
If the RO, in conjunction with the SA, determines that the AoC is not credible, the RO 
sends written notification to the laboratory requesting an amended AoC, and also 
notifies the accreditation organization of their actions. 
 
6290.2 - Compliance With All CLIA Conditions After Correction of 
Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When an accredited laboratory is determined to be in compliance with all CLIA 
conditions, the RO notifies the laboratory and the accrediting organization 
accordingly. 
 
6290.2.1 - Plan of Correction 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If the RO concurs with the SAs recommendation of an acceptable PoC, the RO sends 
written notification to the laboratory and to the accreditation organization.  (See updated 
sample letters at http://www.cms.hhs.gov/clia.)  Where the SA has found the PoC 
unacceptable and the RO concurs with the SAs recommendation, the RO notifies the 
laboratory accordingly and requests an amended acceptable PoC. 
 
6290.2.2 - Compliance With All CLIA Conditions After Correction of 
Deficiencies 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When an accredited laboratory is determined to be in compliance with all CLIA 
conditions, the RO notifies the laboratory and the accrediting organization accordingly.  
(See updated sample letters at http://www.cms.hhs.gov/clia.)  The RO informs the SA in 
writing to cease monitoring activities.  Revisits are never authorized after an accredited 
laboratory has been notified that it is in Condition-level compliance with all CLIA 
conditions. 
 
6290.2.3 - Notification of Accreditation Organization 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
The RO will notify the Division of Laboratory Services at CO and the appropriate 
representative of the laboratorys accreditation organization within 60 days of completion 
of the survey when the laboratory is placed under your monitoring jurisdiction.  The RO 
copies all written communications to CO and the accreditation organization.  The 
  laboratory continues to be accredited.  However, it is subject to the same requirements, 
survey, and enforcement procedures applied to nonaccredited laboratories found out of 
compliance following a survey.  The facility is monitored until it reaches Condition-level 
compliance or when its certificate of accreditation is revoked. 
 
6292 - Procedures for Noncompliant Federal and State Operated 
Laboratories 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the RO surveys a Federal or State operated laboratory and finds Condition-level 
noncompliance, the RO will function as both the SA and the RO and follow the 
enforcement procedures outlined in the section. 
 
6292.1 - Initial Action 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
The laboratory must submit a PoC that is acceptable in terms of both its contents and the 
time frames for correction. 
 
For the PoC to be acceptable, it must show that the laboratory can achieve compliance 
and that compliance can be verified within 12 months from the survey date. 
 
If a laboratory fails to submit an acceptable PoC, and subsequent requests for an 
acceptable PoC are unsuccessful, the RO may cancel the laboratorys approval to receive 
Medicare payment for its services in accordance with 42 CFR Part 493.1842(a)(2)(ii).  In 
addition, the RO may consider the laboratorys failure to comply with reasonable 
requests for information for purposes of 42 CFR 493.1840(a)(4) and may initiate a 
principal sanction, i.e., suspension, limitation, revocation of the CLIA certificate, on the 
basis of this failure. 
 
6292.2 - Ensuring Timely Corrections 
(Rev. 45, Issued: 05-08-09, Effective: 05-08-09, Implementation: 05-08-09) 
 
If the laboratory has not corrected its deficiencies within 12 months after the last date of 
the survey that identified the deficiencies, the RO cancels the laboratorys approval to 
receive Medicare payment for its services and imposes a principal sanction against the 
laboratorys CLIA certificate. 
 
6293 - Intervening Actions That Do Not Postpone or Delay Enforcement 
Timetable 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Only correction of noncompliance can stop an enforcement action.  
 
(S&C-01-22) 
   
A change of ownership does not affect completion of an enforcement action.  However 
the RO or SA does not solicit a PoC from the new owner.  Court-appointed receivership 
is not a basis for cessation of the sanction process.   
 
6294 - Enforcement - Additional Information 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6294.1 - Ensuring Timely Correction of Condition-level Deficiencies 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
6294.1.1 - Monitoring of Corrective Action(s) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO may direct the SA to revisit the laboratory or conduct a follow-up at any time to 
evaluate progress and at the end of the enforcement period to determine whether all 
corrections have been made. 
 
6294.1.2 - Acceleration of Timetable 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO may switch from the no immediate jeopardy procedures to the accelerated 
procedures of 6284 at any point that it determines immediate jeopardy to patient 
health or safety exists. 
 
6294.2 - Intervening Actions That Do Not Postpone or Delay Enforcement 
Timetable 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Only verified correction of noncompliance can stop an enforcement action. (S&C-01-22) 
 
A change in the laboratory director does not affect completion of an enforcement 
action. However the RO or SA does not solicit an AoC or PoC from the new 
laboratory director. 
 
Changes in ownership does not affect completion of an enforcement action. 
Court- appointed receivership is not a basis for cessation of the sanction 
process. 
 
6294.3 - Lifting of Sanctions - Compliance Achieved Before or During 
Date of Revisit 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If compliance can be verified on the basis of an AoC or PoC and supporting 
  evidence submitted by the laboratory or by a revisit, the RO may lift the 
sanction(s) as of the date of compliance. 
 
If a laboratory is in compliance at the time of the revisit and it produces credible 
evidence that it achieved compliance before the revisit, the RO may lift the sanction(s) 
as of that earlier date.  If the revisit finds compliance and there is no credible evidence 
presented by the laboratory that compliance was achieved before the revisit, the RO may 
lift the sanction(s) as of the last day of the revisit. 
 
6294.4 - Credible Allegation of Compliance Submitted During Adverse 
Action 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
When a sanctioned laboratory submits a credible allegation of compliance, the 
RO determines whether: 
  Compliance can be verified on the basis of evidence submitted 
by the laboratory in its allegation or other written 
documentation; or 
  A revisit is necessary to verify whether compliance has been achieved. 
 
If compliance can be verified on the basis of evidence submitted, the RO lifts the 
sanction as of the date of compliance supported by the evidence. 
 
6294.5 - Entering Enforcement Cases in ASPEN Enforcement 
Management (AEM) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
It is the ROs responsibility to enter all information related to enforcement cases in AEM. 
 
6295 - Lifting of Alternative Sanctions  
(Rev. 1, 05-21-04) 
 
6295.1 - General Rule  
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Alternative sanctions are not lifted until compliance with all Condition-level 
requirements is verified. 
 
6295.2 - Credible Allegation of Compliance 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
   
  When a sanctioned laboratory submits a credible allegation of compliance, the RO 
determines whether: 
 
  Compliance can be verified on the basis of evidence submitted by the 
laboratory in its allegation or other written documentation; or 
 
  A revisit is necessary to verify whether compliance has been achieved. 
 
If compliance can be verified on the basis of evidence submitted, the RO lifts the sanction 
as of the date of compliance supported by the evidence.  
 
6295.3 - Compliance Achieved Before or During Date of Revisit 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If a laboratory is in compliance at the time of the revisit and it produces credible evidence 
that it achieved compliance before the revisit, the RO lifts the sanction as of that earlier 
date. If the revisit finds compliance and there is no credible evidence presented by the 
laboratory that compliance was achieved before the revisit, the RO lifts the sanction as of 
the last day of the revisit. 
 
6296 - Table 1 - Required Sanction(s) When Specific Action(s) are Taken 
by CMS 
(Rev. 195, Issued: 11-15-19, Effective: 11-15-19, Implementation: 11-15-19) 
 
If CMS...  CMS Must...  Regulatory Reference 
Concurrently cancel the laboratorys 
Suspends or Revokes any  42 C.F.R 
approval to receive Medicare payments for 
type of CLIA certificate  493.1808(a) 
its services 
  Concurrently limit Medicare approval to   
Limits any type of CLIA  only those specialties or subspecialties that  42 C.F.R 
certificate  are authorized by the laboratorys limited  493.1808(b) 
certificate 
  Cancel the laboratorys approval to   
Finds that deficiencies  receive Medicare payments AND notify the   
are not corrected within  laboratory of its intent to suspend, limit, or  42 C.F.R 493.1816 
12 months  revoke the CLIA certificate and its appeal 
rights 
Does not impose a dPoC  Impose a dPPoC when it imposes any of   
when a laboratory has  the following: State onsite monitoring,  42 C.F.R 
condition level  CMP, suspension of all or part of Medicare  493.1832(a) 
deficiencies  payments 
   
6296.1 - Suspension or Revocation of Any Type of CLIA Certificate 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When the RO suspends or revokes any type of CLIA certificate, the laboratorys approval 
to receive Medicare payment for its services is canceled concurrently. 
 
6296.2 - Limitation of Any Type of CLIA Certificate 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When the RO limits any type of CLIA certificate, it concurrently cancels the laboratorys 
approval to receive Medicare payment to only those specialties or subspecialties that are 
authorized by the laboratorys limited certificate. 
 
6298 - Summary of RO Responsibilities during the CLIA Adverse 
Action Process 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
During an adverse action or civil suit against a laboratory, the RO has the 
following responsibilities: 
 
 Notifies the laboratory of the exact enforcement action to be 
imposed against it, the authority for the action, and the 
effective dates; 
 
 Generates revised CLIA certificates, if necessary; 
 
 Suspends or limits the CLIA certificate if a 
laboratorys noncompliance poses immediate 
jeopardy; 
 
 Assists in the collection of evidence and other 
information related to criminal actions by the 
laboratories; 
 
 Notifies carriers and fiscal intermediaries or MACs of 
Medicare payment sanctions imposed against laboratories; 
and 
 
 Provides appropriate notice to Medicaid State Agencies. 
 
  6299 - CLIA Violations - OIG Excludes Laboratory From Medicare 
Participation - Effect on CLIA Certificate  
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If the OIG excludes a laboratory from participation in the Medicare program, the RO 
suspends the laboratorys CLIA certificate for the period during which the laboratory is 
excluded. 
 
The notice of suspension should be sent immediately after the RO learns that the 
exclusion takes effect.  The laboratory is entitled to a hearing before the suspension is 
imposed, but may only appeal whether the OIG exclusion did take effect.  A change of 
laboratory ownership may not release a laboratory from its exclusion from Medicare and 
the suspension. 
 
6300 - Application of Appeals Process  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The procedures under the CLIA program for reconsiderations, hearings and appeals, 
and civil actions outlined in this section apply to all laboratories that meet the 
definition for a laboratory under CLIA and, where indicated, prospective 
laboratories.  These procedures are set forth in 42 CFR Part 493.1844 and are 
explained in the following sections.  
 
6302 - Reconsideration  
(Rev. 1, 05-21-04) 
 
6302.1 - Definition of Reconsideration 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
A reconsideration is a thorough, independent review by CMS of a prior decision by CMS. 
The entire body of evidence, including any new information presented is reviewed. 
 
6302.2 - Right to Reconsideration 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A reconsideration may be given only to a prospective laboratory (i.e., a laboratory that 
is applying for a CLIA certificate (or for both a CLIA certificate and approval to 
receive Medicare/Medicaid payment for its services) or to a laboratory that applies to 
test in new specialties or subspecialties. The RO reconsiders only initial determinations 
as outlined below and in 42 CFR Part 493.1844(b). Appeals of initial determinations of 
laboratories that already hold a CLIA certificate and/or have previously been approved 
to participate in Medicare/Medicaid are submitted directly to an ALJ. There is no 
reconsideration given at RO level for these types of cases. 
 
The following are the initial determinations applicable to prospective laboratories, 
  and, therefore, are valid reasons for which prospective laboratories may provide the 
SA (or the RO directly) with a written request for a reconsideration: 
 
  The denial of a laboratorys request for a CLIA certificate; 
 
  The denial of a laboratorys request for additional specialties or 
subspecialties; and 
 
  The denial of a laboratorys request for approval to receive Medicare payment 
for its     services. 
 
In 42 CFR Part 493.1844(c), there is a list of administrative actions that are not 
initial determinations and are, therefore, not appealable and not subject to a 
reconsideration. 
Previously approved laboratories are not given reconsideration determinations. 
 
6302.3 - Request for Reconsideration: Manner and Timing 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
A request for reconsideration is any written expression of dissatisfaction with the ROs 
initial determination with regard to a CLIA certificate.  The request may be in the form of 
a letter, statement, or submittal of a new request for Medicare approval or a CLIA 
certificate, must be submitted within 60 days of the initial determination, and must 
include a statement of the issues with which the prospective laboratory disagrees, with 
the reasons for the disagreement. 
 
6302.4 - Actions upon Receipt of Request for Reconsideration 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The RO or the SA will document the date that the request was received, and promptly 
acknowledge the request. A copy of the request and the letter of acknowledgment will 
be forwarded immediately to the RO from the SA. Any additional information the SA 
subsequently receives from the prospective laboratory that may affect the 
reconsideration or hearing will be forwarded to the RO. All reports of onsite visits and 
telephone contact with the prospective laboratory will also be sent to the RO from the 
SA. 
 
6302.5 - Withdrawal Requests and Extensions 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If the affected party files a written notice to withdraw its request for reconsideration, the 
RO will approve the withdrawal request if it is received prior to its mailing the notice of 
reconsidered determination. 
 
If the prospective laboratory is unable to file a request for reconsideration within 60 days, 
it may file a written request for an extension to the RO, stating the reasons why the 
  request was not filed timely.  The RO is responsible for deciding whether good cause for 
missing the filing deadline existed.  If the affected party has not shown good cause for the 
late filing, the RO should dismiss the reconsideration request.  It may also dismiss a 
request for reconsideration from a prospective laboratory if it does not involve an initial 
determination, as defined in 42 CFR Part 498.3. 
 
6304 - RO Notice of Reconsidered Determination 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If the initial reconsideration is denied, the RO prepares a notice to the 
laboratory outlining: 
 
  The decision and the reason for the denial, citing provisions of the 
law or implementing regulations not met; 
 
  The laboratorys appeal rights; 
 
  The fact that the laboratory cannot operate or receive payment under 
Medicare or Medicaid unless the denial is overturned at the conclusion of 
the administrative appeals process and a CLIA certificate is issued; and 
 
  The procedures to follow for a reconsideration. 
 
The denial notice must be signed by the RO in accordance with the Delegations of 
Authority.  All information related to the reconsideration should be recorded in AEM on 
the specialty tab. 
 
6304.1 - Determination Reversal (Approval) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
If a reconsideration is requested and a laboratorys application is subsequently 
approved, the RO notifies the laboratory within 20 days of approving the 
prospective laboratorys application to participate in the CLIA program.  After 
confirming that the Form CMS-116 (Exhibit 125) is correct, the RO enters the 
application into the CMS-116 database and a CLIA ID number is assigned.  The 
reconsideration decision should be documented and attached, along with the Form 
CMS-116, to the laboratory CLIA number in the CMS-116 database.  The 
laboratory is then billed, and issued, a Certificate of Registration, Certificate of 
Waiver, or Certificate of PPM, as applicable. 
 
6304.2 - Denial Affirmed - Denial of Form CMS-116 from Prospective 
Laboratory or Denial of Request to Test in New Specialties or 
Subspecialties 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
   
The RO notifies the laboratory, via written notification, of the decision which includes 
a listing of each statutory and regulatory requirement with which the prospective 
laboratory is not in compliance and why.  If the ARA did not sign the initial denial 
notice, he or she should sign the reconsidered denial notice. 
 
6304.3 - Administrative Evidentiary Hearing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Any prospective laboratory dissatisfied with a reconsidered determination under 42 CFR 
493.1844(e)(1) or a revised reconsidered determination under 42 CFR 498.30 may 
submit a written request for an administrative evidentiary hearing by the Departmental 
Appeals Board (DAB). 
 
6306 - Administrative Hearing 
(Rev. 1, 05-21-04) 
 
6306.1 - Actions Which Are Appealable 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The following actions are initial determinations and are, therefore, subject to appeal in 
accordance with 42 CFR 493.1844: 
 
  The suspension, limitation, or revocation of the laboratorys CLIA 
certificate because of noncompliance with CLIA requirements; 
 
  Denial of a CLIA certificate; 
 
  The imposition of alternative sanctions under 42 CFR 493.1806 - 1807 
(but not the determination as to which alternative sanction(s) to impose); 
and 
 
  Denial or the cancellation of the laboratorys approval to receive 
Medicare payment for its services. 
 
6306.2 - Actions Which are Not Appealable 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The following actions are not initial determinations and are, therefore, not 
subject to appeal in accordance with 42 CFR 493.1844: 
  The finding that a laboratory accredited by a CMS-approved 
accreditation organization is no longer deemed to meet the 
conditions set forth in subparts H, J, K, M, and Q of this part. 
However, the suspension, limitation or revocation of a certificate 
of accreditation is an initial determination and is appealable. 
    The finding that a laboratory determined to be in compliance 
with condition-level requirements but has deficiencies that are 
not at the condition level. 
  The determination not to reinstate a suspended CLIA certificate 
because the reason for the suspension has not been removed or there 
is insufficient assurance that the reason will not recur. 
  The determination as to which alternative sanction or sanctions to 
impose, including the amount of a civil money penalty to impose per 
day or per violation. 
  The denial of approval for Medicare payment for the services 
of a laboratory that does not have in effect a valid CLIA 
certificate. 
  The determination that a laboratory's deficiencies pose 
immediate jeopardy. 
  The amount of the civil money penalty assessed per day or for 
each violation of Federal requirements. 
 
If the RO decides to impose principal and/or alternative sanctions on laboratorys CLIA 
certificate, it may do so within the time frames that the RO communicates to the 
laboratory in the notice of sanction(s).  If the laboratory does not request a hearing, the 
RO will finalized the sanctions after the appeal period has expired which is at least 60 
days. If the laboratory requests a hearing, in general, principal sanctions and CMPs 
may not be finalized until the decision is rendered by the ALJ.  However, in certain 
cases, the suspension or limitation of the laboratorys CLIA certificate may be imposed 
prior to the hearing (see 42 C.F.R.  493.1840(d) and 493.1842(b)(2)). 
 
In addition, alternative sanctions may continue for more than 12 months from the last 
day of inspection while a hearing on the proposed principal sanction against the CLIA 
certificate is pending.  If a hearing decision upholds the principal sanction against the 
laboratorys CLIA certificate, the RO lifts the alternative sanction as of the day the 
principal sanction is effective. 
 
6306.3 - Procedure for Requesting a Hearing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Any laboratory or prospective laboratory dissatisfied with a request of reconsideration 
or an initial determination is entitled to an administrative hearing before an ALJ of the 
DAB. 
 
If laboratory does not believe the determination to impose sanctions against its CLIA 
certificate is correct, the laboratory may request a hearing before an ALJ of the DAB 
in accordance with 42 C.F.R.  493.1844 and 498.40 through 498.78.  A request for 
hearing must be filed electronically no later than sixty (60) calendar days after the 
date that the laboratory is notified of the imposition of sanctions.  Instructions for 
filing an appeal are outlined in the imposition of notification letters.  In order to 
request a hearing, the laboratory, prospective laboratory or its legal representative 
  must file a request for an appeal with the Civil Remedies Division (CRD) of the DAB 
within 60 days of its receipt of the notice of initial, reconsidered, or revised 
determination.  All requests for an appeal must be filed electronically unless an 
exemption is granted by the CRD. 
 
If the affected laboratory shows good cause why the request for a formal 
hearing was not filed timely, the ALJ is responsible for granting the filing 
extension. 
 
Hearings are conducted in accordance with Subpart D of 42 CFR Part 498. If the 
laboratory requests a hearing prior to receiving a notice of sanction or a notice of a 
reconsidered determination, the RO explains in writing to the laboratory why the 
request for an appeal is premature and provides instructions to the laboratory or 
prospective laboratory explaining the procedures for correctly filing the appeal. 
 
6306.4 - Content of the Request for Hearing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The request for a hearing must contain the following information: 
 
  Specific issues or findings with which the laboratory disagrees; and 
 
  Specification of the basis for contending that the findings are incorrect. 
 
6306.5 - Relationship of Action on Laboratorys CLIA Certificate 
to Timing of Hearing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In cases where a laboratorys deficiencies do not constitute immediate jeopardy, 
action against a laboratorys CLIA certificate occurs after the administrative hearing 
if one is requested.  In cases of immediate jeopardy, a CLIA certificate may be 
suspended or limited prior to an ALJ hearing.  Civil money penalties, which accrue 
during periods of noncompliance prior to the hearing, are collected following a 
hearing decision favorable to CMS.  Alternative sanctions other than civil money 
penalties and cancellation of the laboratorys Medicare/Medicaid approval may be 
imposed prior to an ALJ hearing. 
 
If a laboratorys CLIA certificate is due to expire prior to the hearing date, CMS will 
administratively extend the certificate in order for the laboratory to remain 
operational and the CLIA certificate to be active for the duration of the enforcement 
process except in cases of immediate jeopardy or when the criteria at 42 CFR 
493.1840(a)(4) or (a)(5) are not met. 
 
6308 - Processing of Hearing Requests 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
   
Any laboratory or prospective laboratory dissatisfied with an initial, reconsidered or 
revised determination may file an electronic request for an administrative hearing 
before an ALJ. This request must be filed within 60 days of the laboratorys receipt of 
the notice of the sanction(s). The RO sends all hearing requests that are sent to it, or 
received by the SA and forwarded to the RO, to the DAB (see 6306.3). 
 
If the laboratory requests a hearing prior to receiving a notice of sanction or a 
notice of reconsidered determination, the RO explains in writing to the laboratory 
why the request for an appeal is premature and provides instructions to the 
laboratory or prospective laboratory explaining the procedures for correctly filing. 
 
6310 - Timing of the Hearing 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Any laboratory, regardless of whether it is approved under Medicare, will receive one 
administrative evidentiary hearing by the DAB.  The Medicare principal sanction 
(cancellation of Medicare approval) may take place prior to the hearing, while the 
principal sanctions authorized under CLIA are imposed after the hearing, unless: 
immediate jeopardy exists; the laboratory has refused a reasonable request for 
information; or has refused permission to inspect the laboratory. 
 
6312 - Adverse Hearings Decisions by Administrative Law Judge (ALJ) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Any laboratory or prospective laboratory dissatisfied with the ALJs decision may, 
within 60 days from the receipt of the notice of the ALJs decision, file a written 
request for review in accordance with Subpart E of 42 CFR Part 498. The authority to 
change a decision rests solely with the DAB. If the SA receives the request, it transmits 
the request immediately to the RO.  The RO will keep the SA apprised of action on 
such cases. 
 
NOTE: After the CLIA administrative appeal process is exhausted, a laboratory 
dissatisfied with the final decision to impose a CMP or principal sanctions may file a 
petition for judicial review with the U.S. Court of Appeals of the circuit in which the 
laboratory has its principal place of business. (See 42 CFR 493.1846(f)(3).) 
 
6314 - Readmission to CLIA Program 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
If an administrative hearing decision upholds CMS determination to revoke a 
laboratorys CLIA certificate, the owner and operator of the laboratory may not own 
or operate a laboratory for 2 years as outlined at 42 CFR 493.1840(a)(8). If the 
laboratory is taken over by another owner and/or operator who does not meet the 
criteria in 42 CFR 
493.1840(a)(8), the laboratory must submit another CLIA application according to the 
  procedures outlined at 42 CFR 493.45. 
 
When a previously sanctioned laboratory seeks readmission or reinstatement, it may be 
necessary to survey the laboratory prior to reissuance (or reinstatement) of a CLIA 
certificate, regardless of the certificate type. The purpose of the survey would be to 
establish reasonable assurance that the prior deficient practices which resulted in 
the sanction action have been corrected and will not recur. 
 
6316 - Laboratory Registry 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The CLIA statute and 42 CFR 493.1850 require CMS to make information available 
to physicians and to the general public that is useful in evaluating the performance of 
laboratories. The laboratory registry is compiled for the calendar year preceding the 
date the information is made available and includes appropriate explanatory 
information to aid in the interpretation of the data.  The categories included in the 
registry are: 
 
  A list of laboratories that have been convicted under Federal or State laws 
relating to fraud and abuse, false billing or kickbacks; 
 
  A list of laboratories that have had their CLIA certificates suspended, 
limited, or revoked, and the reason for the adverse actions; 
 
  A list of persons who have been convicted of violating CLIA requirements, 
as specified in 353(1) of the PHSA, together with the circumstances of 
each case and the penalties imposed; 
 
  A list of laboratories on which alternative sanctions have been imposed, 
showing: 
 
1. The effective date of the sanctions; 
 
2. The reasons for imposing them; 
 
3. Corrective action taken by the laboratory; and 
 
4.  If the laboratory has achieved compliance, the verified date of 
compliance; 
 
  A list of laboratories whose accreditation has been withdrawn or revoked and 
the reasons for the withdrawal or revocation; 
  All appeals and hearing decisions; 
  A list of laboratories against which CMS has brought suit under 42 CFR 
493.1846 and the reasons for the actions; and 
    A list of laboratories that have been excluded from participation in Medicare 
and Medicaid and the reasons for the exclusion. 
 
6318 - Freedom of Information Act (FOIA) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
FOIA provides the public the right to request access to records from any federal 
agency and is often described as the law that keeps citizens in the know about their 
government. Requests can be made by any person, US citizen or not, for any agency 
record and federal agencies are required to disclose any information requested under 
the FOIA unless it falls under one of nine exemptions. 
A request does not require agencies to create new records or to conduct research, 
analyze data, or answer questions when responding. The response format of records 
may be specified by requestor. 
 
If the SA receives a FOIA request, the SA must determine if it is for federal documents 
or State documents.  If the SA receives a FOIA request for federal documents, they must 
contact the RO for guidance.  The SA must contact their FOIA office, or State 
equivalent, in order to determine requirements for releasing State documents to the 
public. 
 
The following records are directly releasable by the State Agency WITHOUT a 
FOIA Request: 
 
  Form CMS-2567 
o  Prior to release, the lab must have had an opportunity to respond 
(not exceeding 60 days); if a credible AoC or acceptable PoC is 
received, immediately releasable (only applies for surveys 
performed by the SA; surveys performed by RO/CO must go 
through FOIA process) 
o  Disclosure must be made within 90 days following completion of the 
survey 
o  Individual identifiers must be redacted prior to release (this does not 
include identifiers used by surveyors as part of their coding system) 
  Standard enforcement notices, once agency confirms receipt by the laboratory 
(only applies for surveys performed by the SA; surveys performed by RO/CO 
must go through FOIA process) 
  Form CMS-116 - name of LD must be redacted prior to release (NOTE: 
Form CMS-209 may not be released) 
  Whether a lab participates in the CLIA program 
  Reports/information about a laboratorys performance in proficiency 
testing programs 
  Statistical data on laboratory characteristics that do not identify a specific 
laboratory 
 
  NOTE: If a laboratory labels any CLIA documentation or record that it falls under 
FOIA and that it is confidential, the SA, RO, and/or CO must contact the FOIA officer 
even if the document or record can be directly released per policy.  All documents 
forwarded to the FOIA office must not be redacted - the FOIA office is responsible for 
redaction prior to release. 
 
 
Budget and Administration 
 
6400 - The CLIA Federal/State Relationship 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578) continue to 
foster a close and integrated relationship between the Federal government and SAs 
charged with the implementation, maintenance and enforcement of Federal 
requirements. Regulations and guidelines developed are the interpretative 
documentation that both State and Federal agencies will follow as we jointly seek to 
assure that the clinical laboratory improvements mandated by Congress are initiated 
properly and fulfilled in the most effective manner possible. 
 
The SA is the key local interface and representative of CMS with the clinical 
laboratories that are not State or Federally owned. Although CLIA has expanded the 
Federal governments oversight role to virtually all laboratories in the country that do 
testing for diagnostic purposes, it is through the SAs or their agents that virtually all 
non-Federal CLIA oversight of laboratories occurs. SAs or their agents are responsible 
for hiring, training and managing personnel needed to fully implement and assure the 
ongoing effective conduct of regulations promulgated for CLIA in accordance with 
contractual provisions in the 1864 Agreement. 
The law further mandates that CLIA be a self-funded program. Fees for compliance 
determination and oversight covering all CLIA-related expenses must be established and 
collected. There are no other funds available from any source other than from those 
laboratories subject to CLIA requirements. Therefore, for CLIA laboratories, workload 
planning and budgeting are key features in the CLIA Federal/State administrative 
partnership.  This is a negotiated process that closely involves the SA, each States 
budget process, the laboratory surveys and related workloads and the cost to accomplish 
the required workload. The SA is the responsible State organization in this process. The 
RO is the Federal governments representative for helping the States develop acceptable 
work plans and appropriate budgets to accomplish the required workload targets. For 
CLIA-exempt and accredited laboratories, payment of the initial fees and fees covering 
the Federal oversight activities constitutes the main exchange between the State and 
CMS in the budget process. The CLIA-exempt State or accrediting body may make 
additional charges to individual laboratories. 
 
The budget process begins with the State preparation of the Planned Workload Report 
(with its narrative activity work plan) and a Budget Request that is forwarded to 
  CMS.  Next comes budget approval and the advancement of CLIA funds.  Survey 
Team Composition and Workload Reports are prepared and submitted for each 
completed survey and related support activity, and quarterly reports of work 
completed are filed for Federal payment for SA completed work on the CLIA 
workload. 
 
6402 - Federal Administrative Responsibilities 
(Rev. 1, 05-21-04) 
 
Among the responsibilities of the parties are obligations imposed upon the Federal 
government.  The following are delegated to the Regional Offices: 
 
  Setting policy and policy interpretations; 
 
  Providing consultation to necessary agencies involved in administering the 
Federal requirements; 
 
  Paying the appropriate and allowable costs of the SA functions relating to the 
administration of regulations and guidelines for CLIA; 
 
  Making determinations of allowable State costs submitted for Federal payment; 
and  
 
  Controlling payment of funds to appropriate State agencies for costs incurred in 
administering CLIA. 
 
6404 - Nature and Source of Payments to States 
(Rev. 1, 05-21-04) 
 
6404.1 - Funds for Clinical Laboratory Improvement Act Related 
Activities 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) mandates that the 
CLIA program be self-funded.  Program participants (laboratories that do clinical testing 
of human specimens for diagnostic purposes) bear all financial burden for 
implementation, day-to-day operations, enforcement and other Federal/State oversight 
expenses of the program.  The funds needed to run the program come from the variety of 
mechanisms put in place to administer the program.  The sources include: 
 
  Certificate of Registration fees, from the start-up period, that are to accompany 
the initial registration;  
 
  Certificate fees for Federal administration of the program; and 
    Compliance determination and enforcement fees to cover the costs incurred by the 
State and Federal government to ensure program requirements are met.  
 
6404.2 - Laboratory Remitted Funds 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When a lock-box contractor receives these laboratory-remitted funds, they are deposited 
into a CMS CLIA account where they are available for State advances and payments for 
CLIA work.  The States bill CMS for payment for surveys, visits or re-contacts, 
complaint visits, follow-ups and other CLIA work, by preparing a Form CMS-670 , 
Survey Team Composition and Workload Report, (Exhibit 74) and a Form CMS-102, 
Budget Requests, Clinical Laboratory Improvement Amendments Program, (Exhibit 
116).  The Form CMS-670 for CLIA is intended to capture the total time expended on a 
laboratory survey, or other CLIA-related workload from beginning to end.  All work 
performed, including all discussions, report preparation and similarly related work 
expenditures for all employees involved in the process are to be reported.  Payments to 
States under 1864 of the Act are made from user fees collected from the laboratories at 
registration.  These fees pay for administrative expenses (including advances or payment 
to States under 1864) as authorized for expenditure from the CLIA user fee account. 
 
As surveys and related CLIA work are performed, actual expenditures are determined 
and forwarded to the RO for review and action.  They are then forwarded to CMS CO or 
their representative for approval.  An end of year reconciliation and balancing of accounts 
will occur between CMS and each State.  Actual expenses data will then be used by CMS 
as a basis for determining and setting future fee schedules for the participating 
laboratories. 
 
6406 - State Agency Administrative Responsibilities 
(Rev. 1, 05-21-04) 
 
The SA is responsible for: 
 
  Establishing and maintaining organizational relationships with other State and 
local governmental groups, as necessary, for attaining program or related program 
goals; 
 
  Knowing the needs of laboratories in the State which affect their ability to comply 
with program standards, and devising and executing plans to address those needs; 
 
  Advising the RO of program needs and trends, and of responsive actions which 
have been taken; 
 
  Providing the material, equipment, and the training and support of personnel to 
perform the above functions; and 
 
    Furnishing necessary records and accounting to justify costs claimed for payment 
by CMS. 
 
6408 - State Agency Responsibility for Records and Reports 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
SAs are to establish and maintain basic records and prepare operating reports in the form 
of the Form CMS-670, (Exhibit 74), and the Form CMS-102, (Exhibit 117).  These report 
the essential administrative and fiscal information, records and reports which will help to 
provide an: 
 
  Evaluation of the effectiveness of program operations; 
 
  Analysis of workloads and degree of accomplishment; 
 
  Identification of administrative or technical problem areas; 
 
  Development and justification of payments; and 
 
  Documentation to support the expenditure of CLIA funds for compliance 
determination surveys and oversight activities. 
 
SAs are responsible for maintaining records and reports, on a continuing or special 
request basis, which are pertinent to the managing of agency operations and reflect the 
agencys workload.  Records and reports are to be designed to fit within the framework of 
the SA operations.  The design of those records and report mechanisms need not be 
limited to paper applications; it is acceptable for all parties to strive to use good modern 
management practices and tools to support the CLIA effort.  Computer formats of CMS 
forms and reports have been developed for State use.  The CMS requirement for a 
minimum of specific records and reports is not intended to limit in any way SAs fiscal 
and administrative practices.  Reasonable costs to facilitate the implementation of quality 
modern databases and information systems are to be available for CLIA funding.  
However, if a States fiscal and administrative requirements are in excess of the CLIA-
mandated requirements, then expenses for work done above and beyond that prescribed 
by CLIA is not normally to be borne by the laboratories nor the CLIA program.  
However, the State has the authority to charge those laboratories in their CLIA-exempt 
program according to any fee schedule they determine is appropriate.  Federal surveys of 
a sample of the CLIA-exempt laboratories will be billed according to the Federal fee 
schedule in 42 CFR Part 493, Subpart F.  SAs will not be paid for work done in excess of 
that prescribed by CLIA. 
 
  6410 - State Agency Responsibility for Staff Training and Development 
(Rev. 1, 05-21-04) 
 
6410.1 - Staff Training 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA is responsible for providing continuing education to employees.  In conjunction 
with, and subject to, the approval of the Regional Training Administrator (RTA), SAs 
must have a procedure for identifying the training needs of the surveyors.  That procedure 
must insure that SOM revisions, RO instructional letters, and the results of regular and 
Federal Monitoring Surveys (FMS) are included in the training agenda.  Training may be 
provided in a variety of forms: in-service training; formal education; State, regional or 
national conferences; seminars or workshops.  Costs for all courses and training must be 
within approved fiscal limitations.  
 
6410.2 - In-Agency Training 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA must have its own program of staff development which responds to the needs of 
new employees for orientation and basic training, and to the needs of experienced 
employees for continuing development and education. 
 
6410.3 - Outside-of-Agency Training 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
In evaluating the appropriateness of any outside training activity for CLIA funding, SAs 
and the RO must consider the degree to which the trainees will benefit when carrying out 
the CLIA survey and certification program.  
 
6412 - Role of the CMS RO With State Agency Program Administration 
(Rev. 1, 05-21-04) 
 
The RO is the CMS representative at the regional level for all CLIA survey and 
certification functions.  The RO is responsible for: 
 
  Reviewing and recommending action on each budget submittal; 
 
  Furnishing program guidance and policy interpretation;  
 
  Coordinating communications with the SA representatives, accredited providers, 
and laboratories on CLIA survey and certification activities; and   
 
  Consulting on a regular basis with the SA, contractors or representatives for 
mutual assessment of program activities, achieving stated objectives, and 
establishing future goals.  
   
Before approving each State budget submittal, the RO evaluates all information available 
and determines answers to the following questions: 
 
  Is the plan of program activities appropriate to national CLIA annual and biennial 
goals? 
 
  Do the workload and activity plans and staffing estimates properly place emphasis 
on fulfilling program goals?  
 
  Does the budget request represent a consistent application and understanding of 
approved principles of reasonable cost to the SAs specific circumstances? 
 
6414 - CLIA Budget - RO Procedures 
(Rev. 1, 05-21-04) 
 
6414.1 - General 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
CLIA is a self-funded program.  Fees from compliance determination and oversight 
covering all CLIA-related expense must be established and collected.  There are no other 
funds available from any source to administer the program other than from those 
laboratories subject to CLIA requirements. 
 
6414.2 - Regional Administrative Responsibilities 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The ROs have the primary responsibility for the efficient and effective administration of 
the CLIA program in the States in their respective regions.  It is the ROs responsibility 
to: 
 
  Issue the budget call letter to each State; 
 
  Furnish the SA with administrative, budget and program guidance, policy 
interpretation, and leadership; 
 
  Review, negotiate, and recommend action on each SA budget and subsequent 
quarterly expenditure reports; 
 
  Coordinate communications relating to CLIA between the SAs and other CMS 
components;  
 
  Consult with SAs to develop mutual agreement on the conduct of program 
activities, the achievement of stated objectives, and the establishment of future 
goals; 
   
  Make determinations of allowable State costs submitted for Federal payment; and  
 
  Control payment of funds to SA for costs incurred in administering CLIA. 
 
Before approving each State budget submittal, the RO considers the following questions: 
 
  How does the plan of program activities appropriately address the pertinent 
priorities and program emphases? 
 
  Does the workload activity plan and the staffing estimate reflect the proper 
emphasis needed to fulfill the priorities listed in the budget call letter? 
 
  Has the RO approved all appropriate reasonable costs that are peculiar to each 
SAs specific circumstances?  If not, has the RO communicated this and a proper 
explanation to all concerned parties? 
 
  Do all approved SA budgets reflect a consistent application and understanding of 
the programmatic, administrative, and fiscal principles and guidelines set forth in 
the SOM and the budget call letter? 
 
6416 - Budget Call - RO Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Each fiscal year, CO issues a budget call letter. This letter serves as official notification 
to begin the budget process with each State for the coming fiscal year. The call letter 
provides national program emphasis including the workloads to be accomplished during 
the next fiscal year and should be adhered to closely. 
 
Upon receipt of the budget call letter, the RO prepares State call letters to inform the 
States of the national and regional goals and priorities for CLIA. Upon receipt of each 
States proposed budget, the RO records the date received. This is the actual beginning 
of the negotiated budget process between the SAs and the RO.  
 
Each budget submission requires close attention and proper scrutiny.  It is imperative 
that the RO manage the SAs CLIA activity, including budgets, aggressively for 
efficiency and productivity. Contracts and purchases planned by the SAs and approved 
by the RO, especially large purchases of computer hardware and software, must be 
guided by the latest Office of Management and Budget (OMB) circulars and CMS 
standards, policies, and guidelines.  It is imperative that costs be contained and 
appropriately managed.  Therefore, when the RO encounters any unusual plans or 
purchases, it assures that they are supported by adequate written justification and that 
the RO is convinced of the actual need to support efficiency and productivity. 
 
It is important that the RO question and challenge unsupported spending levels, or 
supported requests that the RO does not feel are needed or the program cannot afford. 
  Aggressive monitoring throughout the year can help to lower the cost of managing the 
CLIA program. Questions or problems the RO has regarding State budgets may be 
directed to the CO budget staff. 
 
It is important that CLIA budget requests, funding requirements and expenditure 
reports be submitted separate from those for the Medicare and Medicaid programs. 
CLIA specific forms have been developed and must be used for CLIA program 
expenditures. 
 
6418 - Regional Allocations 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CO provides State-specific budget allocations to the Regions. The allocations reflect 
both the needs and special priorities of each program workload, as well as national 
and regionally-specific priorities. The RO must be aware of and apply these 
constraints and priorities when negotiating the CLIA budget with the States and during 
the review and approval of subsequent quarterly expenditure reports. It is important 
that the required workload be accomplished within the approved budget. The RO 
should communicate significant problems or changes to the CO as soon as they are 
identified. 
 
6420 - The SA Agency Annual Activity Plan 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In accordance with established yearly schedules, the SA completes the Form CMS-102 
(Exhibit 116), and forwards it to the RO. Include a description of planned program 
activities for the ensuing fiscal year and a Form CMS-105, Planned Workload Report, 
Clinical Laboratory Improvement Amendments Program, (Exhibit 119).  Working 
with SA and CMS CO, the RO assesses the amount of activity planned and the 
proposed cost to conduct the work by each State and helps to keep the costs in line for 
the nation as a whole. From this information and in discussions with the State and CO, 
the RO will be able to determine the adequacy and appropriateness of the programs 
planned by each State as they relate to the legislatively mandated goals and budget 
estimates. The information on the activity plan should agree with the State budget 
request. 
 
6422 - Planning the Annual Workload - SA Procedures 
(Rev. 1, 05-21-04) 
 
The need for professional skills and additional personnel can only be ascertained after the 
workload is identified and a plan for accomplishing the work is outlined.  Since the 
survey and certification program requires that laboratories be inspected within a biennial 
timeframe, the SA sets goals by categories of laboratory.  The SA establishes schedules 
for surveys of the laboratories.  The activity plan is to establish a program which permits 
survey and certification work to be done on an orderly basis throughout the year and with 
an even workload distribution over the 1- and 2-year cycle. 
   
6424 - Elements in the Annual Activity Plan - Planned Workload 
Report - SA Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Planned Workload Report lays out the SA Plan to conduct the surveys and other 
related activities for the fiscal year by laboratory schedule as it relates to workload 
volume and based on the yearly CLIA Budget Call Letter.  The SA then translates this 
workload into narrative staffing and activity plans and project related costs. 
 
The workload to be reflected in the State CLIA workload plan is to include initial 
surveys, re-visits, follow-up visits, and complaint visits for the various schedules of 
laboratories. The narrative plan is to conform to and confirm the numerical counts 
planned. Form CMS-105 is to be used in developing CLIA SA workload plans. 
 
For CLIA survey budgeting purposes, there are two types of certificates provided to 
laboratories.  These are Certificates of Compliance, and Certificates of Accreditation. 
Those holding a Certificate of Compliance are inspected once every two years.  Those 
holding a Certificate of Accreditation are inspected at an administrative goal of five 
percent biennially. The specific validation surveys are assigned by the RO.  If 
complaints are received about any laboratory, a survey can be scheduled to investigate 
the complaint. 
6426 - Format for the Annual Activity Plan - SA Procedures 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA uses any format for presentation of the SA annual activity plan.  The SA includes 
the topics essential to the ROs management and budget review that are: 
 
a.   A narrative explanation (as necessary) for significant figures included on the 
workload data sheet. 
 
b.  A plan for using professional staff in survey and certification activities when more 
than one surveyor is required: 
 
  Division of responsibilities for survey; 
 
  Deployment of teams in relation to specific areas of workload; and  
 
  Geographic deployment. 
 
c.  A plan for meetings with appropriate special interest groups, e.g., informational 
and educational programs for Ombudsmen, consumer groups, State and county 
laboratory and medical societies, to discuss issues and concerns regarding CLIA 
implementation. 
 
  d.  A list of CLIA activities delegated to personnel organizationally located outside 
the SA. 
 
e.  The names and health professions or specialties of currently qualified surveyors.  
 
f.  A description of the States use of any laboratory testing or evaluation program in 
connection with CLIA activities. 
 
g.  An outline of program training planned for the staff: 
 
  Staff training meetings;  
 
  Formal courses attended;  
 
  Seminars;  
 
  In-service training programs; and 
 
  Special problems of decentralized agencies. 
 
 
6428 - Survey Team Composition and Workload Report-CMS-670     
(Exhibit 74) - SA Procedures  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form CMS-670 (Exhibit 74) is intended to provide CMS with the work-power 
utilization information needed to determine the total number of hours spent on each 
type of CLIA laboratory survey-related activity.  From this and combined with other 
CLIA cost information, CMS can compute the costs of performing the CLIA-related 
work and can compute the amount of money to be paid to a given SA to pay for the 
work performed.  Laboratory surveyors, other State employees or contractors and 
others, including RO employees, involved in the CLIA-related processes must keep 
an accurate record of the number of hours spent working on a given laboratorys 
survey or similar CLIA activities.  All payment to the State for survey work-power 
costs will be matched against the CMS-670 data.  Once the Form CMS-670 data has 
been received, CMS computes the cost of survey-related activities and initiates any 
necessary action to create a bill for costs not already paid for by the laboratory.   
 
REMINDER: Hours spent performing State required activities that are in excess of 
those activities mandated by CLIA are not billed to CLIA.  The SA does not 
complete a Form CMS-670 for those hours.  
 
The SA prepares the Form CMS-670 for every type of CLIA survey-related activity 
including:  
   
  Initial surveys;   
  
  Recertification surveys;  
  
  Recontacts;  
  
  Complaint surveys;  
  
  Re-visits;  
  
  Validation surveys;  
  
  Sanction activities; and   
  
  Hearings/appeals.  
 
For the most part, the SA completes a Form CMS-670 after concluding all survey-
related activities, including follow-up contacts and resolution of corrective action.  
The SA includes time spent on each activity and based upon employee records, 
beginning with the pre-survey preparation time and ending with the closeout of the 
survey activities, on the Form CMS-670.  (See Exhibit 74.) 
 
Time spent by the RO staff conducting the oversight sample reviews of accredited 
and CLIA-exempt laboratories will be billed based upon the charges set forth in 42 
CFR Part 493, Subpart F.   
 
6430 - Basis for Determining CLIA-Related Costs - SA Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Public Law 100-578 mandates that the CLIA program be completely funded by the 
laboratories being regulated.  The total cost of the work expended by all CLIA 
personnel, both Federal and State, is to be paid by the regulated laboratories.  More 
specifically, each laboratory is to pay all costs incurred in regulating that laboratory, 
including the costs of survey, complaint investigation, hearings and appeals (if the 
SA and CMS are sustained) or other related CLIA outlays such as administrative and 
enforcement overhead.  
 
There are circumstances in which the specific laboratory may not be specifically 
billed for the cost of the CLIA work-power expenditure, e.g., if a laboratory appeals 
an action and the ALJ sustains the laboratory or a settlement in favor of the 
laboratory is reached prior to the official hearing, the appeal-related work-power 
outlay (Federal and State) are entered on a CMS-670 (Exhibit 74), but the laboratory 
is not billed directly for these expenses.  The SA prepares a Form CMS-670 for the 
  nonappeal-related work-power outlays and a separate Form CMS-670 is prepared for 
those work hours spent in preparation for the appeal, hearing and related expenses.  
In either case, the SA and CMS are paid for all CLIA work-power expenditures.  The 
laboratory is billed for the survey related costs that preceded the decision leading to 
the appeal, but not for the appeal costs.   
 
If the SA and CMS are sustained in the ALJ hearing or the laboratory agrees to the 
findings or settles prior to the hearing in a SA/CMS favorable decision, the SA 
documents on the Form CMS-670 all costs related to the action, e.g., hearing 
preparation, documentation, staff preparation time including the time spent preparing 
the Form CMS-670.  The laboratory is billed for those costs and the State is paid 
from the funds received.  Unsubstantiated complaint costs are not be billed to the 
laboratory by CMS, but rather are paid from the administrative funds of CLIA.  In 
such cases, the Form CMS-670 that the SA submits initiates payment.  No bill goes 
to the laboratory.   
 
As the SA schedules each laboratory survey, it maintains a record of the time spent in 
preparing for and conducting and closing out the survey, including the monitoring 
and recontacts involved in resolution and the preparation for an administrative 
hearing of a laboratory appeal.  As each CLIA survey or support activity is 
performed, the SA records the time spent on the activity.  Thus, any time spent 
preparing for a laboratory survey and time spent in follow-up contacts to ensure 
compliance are shown for all CLIA SA or RO personnel involved.  Telephone 
discussions, report preparation, on-site visits and even the time spent preparing the 
Form CMS-670, are chargeable work-power expenditures.  The SA reports the total 
time consumed for each laboratory action in hours at the close of the action in a 
Form CMS-670, identifying the type of action that precipitated the work-power 
expenditure.  CMS records and stores the data when received.  CMS then multiplies 
the total hours reported by the dollar hourly rate computed for each State CLIA 
budget for that fiscal year.  The computed dollar figure becomes the amount of the 
bill that is submitted to the laboratory involved in the specific CLIA action and 
which the SA claims payment.  
 
Use the Form CMS-670 for reporting CLIA work-power expenses by both State and 
Federal oversight personnel.  It is the mechanism for generating a laboratory bill and 
a State claim for payment for work-power expended.    
 
6432 - Promotional and Public Informational Activities - SA Procedures 
(Rev. 1, 05-21-04) 
 
The 1864 agreement assigns significant responsibilities to the SA for conducting public 
information (PI) activities.  Similar activities are carried out by CMS.  The SA answers 
queries about CLIA when at all possible.  CLIA queries are referred to the RO only if the 
information being requested is not available at the SA level or if it is clearly one that 
must be responded to by appropriate CMS authorities.   
 
  Certain other professional relations activities fall into the dual categories of public 
information and public relations.  SA personnel are to develop and maintain ongoing 
relationships with members of the health professions and their organizations.  The SA 
should encourage employees to participate as speakers, panelists, or consultants at 
meetings of professional organizations (laboratory or medical technologist associations, 
hospital associations, and medical societies) in the interest of furthering compliance with 
CLIA standards and objectives.  These costs may be reasonable costs subject to CLIA 
funding. 
 
6434 - The State Budget Request 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In the CLIA budget process, CMS CO and RO staffs obtain input from the States 
and laboratories to develop the baseline data needed to formulate each State budget.  
This data is used to develop the CLIA workload estimates, expenditure, time 
parameters, and hourly rates.  This is a negotiated process that starts with CMS 
preparation of the Budget Call Letter.  Input for the Budget Call Letter includes an 
estimated unit cost of each workload, time parameters, and a derived hourly dollar 
rate for the staff conducting agreed-to work.  
 
The RO forwards the Budget Call Letter to the States which develop workload 
estimate and corresponding budgets by completing the Form CMS-102 (Exhibit 
116); Form CMS-105 (Exhibit 119); Form CMS-1465A, State Agency Budget List 
Of Positions, (Exhibit 47); and CMS Form-1466 State Agency Schedule For 
Equipment Purchases, (Exhibit 54).  The completed Form CMS-102, Form CMS-
105, Form CMS-1465A, and Form CMS-1466 and the narrative supporting 
documentation are forwarded to the RO which analyzes the data presented and works 
with the SA to assure that the workload estimates are accurate and reasonable for 
each of these workloads: Initial Surveys; Resurveys, Follow-up Visit/Surveys, 
Complaint Surveys/Visits estimates.  Once agreement on the workload estimates is 
achieved the number of Full Time Equivalent (FTE) employees is computed.  
Though the SA does not perform the oversight surveys for State-exempt laboratories, 
it is possible that SA may incur some related costs.  If such costs do arise, it is 
important that they be identified to the RO so the RO can determine their 
appropriateness and advise the SA accordingly.  
As the SA conducts CLIA work, the surveys are completed.  The SA prepares the 
Form CMS-670 (Exhibit 74), to begin the laboratory billing and State payment 
processes.  Each quarter the SA completes the Form CMS-102 detailing expenditures 
for the elapsed quarter and for the budget year to date.  Analysis of this data will 
provide a complete status of revenues expended that can be compared to the total 
State approved budget.  The SA should identify shortfalls and, if necessary prepare a 
Form CMS-102 and submit it for processing and approval.  
 
Funds provided agencies as a result of the budget request are used only for necessary 
expenses and only for CLIA-related expenses.  The SA may shift funds from one 
  expenditure category to another, except equipment or laboratory surveyor training 
funds that may only be reprogrammed with prior approval.  
 
6436 - State Budget Request, Clinical Laboratory 
Improvement Amendments Program, Form CMS-102 
(Exhibit 116) 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The budget request is a detailed estimate of CLIA survey program costs. The SA 
classifies such costs according to the category of the proposed expenditure. Explanations 
for the specific categories of expense are essential in both budget preparation and 
subsequent analysis. Therefore, the SA should make sure the budget request contains 
complete rationale regarding each line item. The detail in which these statements are 
developed makes possible a close estimate of financial needs and enables the RO to make 
more rational adjustments in the total operating budget.  Line item justification consists 
of narrative statements providing specific rationale for budgetary needs. 
 
The basis for estimating line item expenditures will be the number of laboratories the 
SA intends to survey in one year and the number of work hours needed. The SA 
includes in the estimates the number of surveys to be initiated due to complaints; for 
enforcement purposes, such as to verify the correction of action items identified during 
a prior survey; and follow-up contacts or discussions required to close out a survey-
related workload item. 
 
  RO Assistance - RO personnel are available to assist in preparing budget 
requests. The SA should consult with appropriate RO staff on any problem 
with the budget preparation process.  Begin consultations as early as possible 
and submit the budget in accordance with the due date provided by the RO.  
Timely submissions help assure timely CMS completion of the budget 
approval process. 
 
The Form CMS-102 (Exhibit 116) is a multipurpose form designed to budget 
for and capture line item expenditures by State agencies for laboratory survey 
activity. The State agencies will complete and certify the Form CMS-102 
prior to the start of each Fiscal Year as part of its yearly budget submission. 
This data, when reviewed and approved by CMS regional and central offices, 
will serve as the approved state budget for the fiscal year. 
 
  Agency - Insert the name of your State. 
 
  Region/State Code - Insert the CMS Regional Office to which the 
State is assigned. 
 
  FY Quarter Ending - Leave blank for initial budget submission; complete 
only when reporting actual expenditures. 
   
  Budget Period - Insert the fiscal year for which the budget request is being 
made. 
 
  Request - Indicate if the submission is a regular, i.e., whole year 
budget submission, or a supplemental budget request for additional 
funds for the remainder of the fiscal year. 
 
Section A - Salaries 
 
1 (a,b,c), 2, 3 
 
The budget justification is to describe the type of staff being employed in the conduct of 
the CLIA workload, broken into the two categories, Professional (surveyor, non- 
surveyor, and supervisor) and Clerical. The SA estimates the number of staff years in 
full-time equivalents. This will provide the actual work years of personnel involved in 
the CLIA workload. Place the number of FTEs in column (a), and STAFF YEARS, and 
the yearly salary cost column in (b), AMOUNT. The SA adds the estimated staff years 
and the estimated yearly salaries and inserts those amounts in the respective column next 
to Total Salaries. 
 
Section B - Other Direct Costs 
4, 5 - Rate / Retirement Contributions and Fringe Benefits 
 
Enters the computed rate and dollar value of retirement contributions and fringe benefits 
mandated by State/Federal law, Union/Management or Employee/Management 
agreements or other legally binding contracts/agreements. Explains the computation in 
the budget request narrative. 
 
6 - Travel 
 
Enters the estimated travel costs for CLIA personnel, including where appropriate, the 
per diem or the subsistence in lieu of per diem, applicable to the CLIA survey program. 
Derives estimated costs based on provisions of State law, regulation and administrative 
procedures applicable to travel of State employees. Indicate in the narrative budget 
justification an estimate of the expected number, type and extent of trips. For out-of- 
State travel, indicate the number of trips, purpose and basis for charges to the CLIA 
program. Include the basis for charges for all out-of-State travel other than to meetings 
arranged by CMS. 
 
7 -  Communications 
 
Enters the estimated costs to be incurred for telephone services, including costs for 
teleconferences, mail (including express mail), special handling, postage and postage 
stamps, postage meters, insurance on mailed items, postage due-charges, FAX costs and 
  other communication-related expenses. 
8 - Office Supplies 
 
Enters the estimated cost of office supplies to be used by CLIA personnel only. Include 
the costs of paper, pencils, pens, envelopes, clips, pencil sharpeners and other usual 
desk materials, file baskets, books and other required desk reference materials, 
photocopier supplies, FAX supplies, computer equipment-related supplies, and other 
reasonable CLIA-related supplies. 
 
9 - Office Space 
 
(See 6524-6534.) Enters the costs of office space, considering possible variations, 
and describe as follows: 
 
a.Agency in Identifiable Space 
 
Enters the costs of space that can be attributed to CLIA personnel use only. Analysis of 
the budget request and estimates must contain the following elements for each location: 
 
b.  Total rental cost/pro rata cost of CLIA space; 
 
c.  Square feet of space/CLIA-related square footage; 
 
d.  Cost per square foot; and 
 
e.  Services included in the rental. 
 
The SA identifies, also, office space that is State-owned and includes it either 
separately or as part of the States indirect cost rate. 
 
f.  Office Space - Agency in Shared Space - Analysis of base period 
expenditures and the budget estimate must contain these elements: 
 
i.  Total cost of space to the agency; 
 
ii.  Basis of proration; 
 
iii.  Locations where CLIA staff are housed; and 
 
iv.  Estimate of square feet allocated to all State programs and those used 
by CLIA personnel. 
 
State-owned space should be identified as such. 
 
g.  Office Maintenance - Includes in the budget estimate narrative, a breakout of 
the major items of expense, e.g., light, heat, janitorial service, machine repair. 
  If office maintenance, in whole or in part, is included in the rental contract, 
the SA notes this fact.  The SA need not separate the amount. 
 
9 - Equipment 
Enters the reasonable costs of equipment to support CLIA-specific positions such as 
desks, chairs, computers and computer-related equipment, file cabinets, tables, and other 
machines (FAX machines, photocopiers, etc.) necessary for CLIA operational, 
administrative or management needs. Equipment authorized in the present fiscal year, 
which will not be purchased by the end of the fiscal year, must be requested in the 
budget for the succeeding fiscal year if the SA still needs it. In addition to line item 
justification, the SA documents the budget estimate through the use of the Form CMS-
1466 (Exhibit 54). 
 
10 - Training 
 
The budget estimate should provide for the cost of training CLIA personnel.  The SA 
uses the number of employees to be trained rather than FTEs when computing this 
figure and includes the cost of the courses to be taken, the cost of travel and per diem 
associated with training sessions. The narrative justification should indicate the types of 
courses to be taken by employee type and by number of employees to be trained. 
 
11 - Consultants 
 
Provides the estimated cost of consultants or those who are not State employees but who 
are used on a part-time, temporary, or fee-for-service basis to perform CLIA-related 
work. 
 
12 - Subcontracts 
 
Provides the estimated cost of subcontracts to be employed in the conduct of CLIA- 
related work. Subcontract costs attributable to CLIA survey activities are allowable 
and payable. The budget justification should provide in detail, the reasons for, and 
approximate cost of each separate subcontract. 
 
13 - Miscellaneous 
 
Provides the estimated cost of other items that have not been reported in any of the 
preceding classifications, breaking them into compatible groups of expenses (sections 
a, b, c, and d), if possible. The SA uses narrative justification to explain all proposed 
expenditures. 
 
14 - Total Other Direct 
Costs Enters the total of 
lines 4-14.  
  16 - Total Direct Costs 
Enters the total of lines 1-15. 
 
Section C - Indirect Costs (Approved Rate X Base) 
 
17 and 18 
 
Provides the rate negotiated and approved by the HHS Division of Cost Allocation 
for use during the fiscal year, together with the line item base it is applied against.  
Expenditures included in this category must not be duplicated under direct costs. 
 
Section D - Total Budget Requested 
 
19 
 
Enters the sum total of lines 16 and 17. 
 
20 
 
Leave blank for initial budget submission. Data entry is only required when reporting 
actual expenditures during the fiscal year (amounts to be reported and non-cumulative, 
i.e., report only the current balance as of the quarter ending). 
 
Section E - Hourly Rate Requested 
 
Divides the Total Budget Requested by the Total Number of Staff Years and divide again 
by the Hours Available per Staff Year to derive Hourly Rate, as in the example. 
 
Example: 
Budget Amount..  ..$100,000 
Divided by Staff Years     2 
Equals.  ...$ 50,000 per Staff Year 
 
$50,000 divided by 1,600 hours in the Staff Year Formula equals a $31.25 hourly rate.  
6438 - Form CMS-105, Planned Workload Report - CLIA (Exhibit 119)- 
SA Procedures  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form CMS-105 (Exhibit 119) provides the States estimate of the number of 
laboratory surveys it expects to perform in a budget period.  The workload plan will list 
by laboratory type the number of surveys to be conducted in the Fiscal Year.  (This form 
also accompanies the States quarterly and cumulative expenditure reports.) 
   
The SA uses the Form CMS-105 only to estimate the laboratory survey workload under 
CLIA.  The SA provides an estimate of the planned workload for each laboratory 
schedule.  The laboratory schedule can be found in the CLIA user fee regulation. 
 
A completed Form CMS-105 should accompany a Form CMS-102 (Exhibit 116) and an 
analytical budget justification narrative anytime a CLIA budget request or supplemental 
budget request is submitted to the RO.  It is essential that the estimates of planned 
workloads be as accurate as possible.  Accurate workload estimates can be developed 
from prior workload history, where one exists, and results in a more accurate and timely 
budget approval. 
The SA: 
 
Heading - Inserts State name and Federal fiscal year in the appropriate boxes. 
Column (a), Number of Sites - In reviewing the workload plans for the year, determines 
the number of separate laboratory sites that will be visited for surveys, follow-up visits 
and complaints. 
 
Column (b), Initial Visits - Enters the planned number of initial compliance 
determination surveys (laboratory surveys) to be conducted for each type of laboratory. 
(See 42 CFR 493.638ff for the schedule of laboratories and fees to be charged.)  
Include a five percent sample of those that hold a Certificate of Accreditation since a 
sample of those laboratories are to be inspected for compliance in accordance with the 
SA oversight role and responsibility. 
 
Column  (c),  Resurvey  Visits  -  Enters  the  total  number  of  non-initial  compliance 
surveys planned. This figure is to reflect the number of other than first time laboratory 
surveys to be conducted in a fiscal year. 
 
Column (d), Follow-up Visits - Enters the number of follow-up surveys planned for 
the fiscal year. These are visits to verify compliance or to verify a completed plan of 
corrective action or for some other enforcement purpose.  Prior history may indicate 
that a portion of all laboratories require actual follow-up visits as opposed to re-contact 
via telephone or mail to finalize the laboratory compliance survey report.  Follow-up 
visits are not routinely required by CLIA. 
 
Column (e), Complaint Visits - Enters the number of complaint surveys planned for 
the fiscal year. 
 
Column (f), Total Visits - Provides the totals to column (f) and computes the totals at the 
bottom of the form.  Signs and dates the form and submits it with the Form CMS-102. 
 
6440 - Form CMS-1466, State Agency Schedule for Equipment 
Purchases (Exhibit 54) - SA Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
  Usage - This form has a 2-fold purpose: The SA uses it when requesting budget approval 
of equipment purchases, and completes and submits it to the RO when an actual 
purchase has been completed.  The form is applicable for CLIA, LTC and non-LTC 
equipment requests and purchases.  A separate form must be prepared for equipment 
purchase for each program. When equipment is actually purchased, the SA prepares and 
forwards a Form CMS-1466 (Exhibit 54) with the appropriate programs budget 
expenditure report. 
 
The SA: 
 
Heading - Inserts the official name of the agency and the State name in the designated 
spaces.  Indicates the period for which equipment funds are requested.  Indicates if this 
is accompanying a regular budget submission or a supplemental budget submission. 
Column (a), Description of Equipment - Enters the items of equipment being 
requested or reported as purchased.  Uses an asterisk or other notation to note items 
previously approved by the RO but which are being re-budgeted or requested again.  On 
the bottom or reverse of the form explains why the purchase was not completed in the 
prior budget period. 
 
Column (b), Number of Items on Hand - Lists the number of similar items on hand in 
the State CLIA survey unit at the time the form is prepared.  If a new and different item 
is being shown, shows None in this column. 
 
Columns (c) and (d), Number of Units (Additional-c) or (Replacement-d) - Lists 
the number of units being requested in the appropriate column, (c) or (d). 
 
Column (e), Unit Cost - Enters the unit cost of each item in column (a). 
 
Column (f), Gross Cost - Computes and enters the gross cost for each item in column (a) 
by multiplying the number of units in columns (c) or (d) by the unit cost, column (e). 
 
Column (g), Trade in Value if Replacement Item - Computes and enters the trade-in- 
value of item identified in column (d) as a replacement for existing equipment. 
 
Column (h), Net Cost - Enters the amount shown in column (f) for each item listed 
in column (a), less any amount shown in column (g). 
 
Total Net Cost of Equipment - Enters the sum of all amounts shown in column (g) 
above. For CLIA, enters this amount on the Form CMS-102 (Exhibit 116), item 6. 
 
Date, Signature, Title - Dates and signs the Form CMS-1466.  Shows the title of 
the individual signing the schedule. 
 
6442 - Form CMS-1465A, State Agency Budget List of Positions - 
(Exhibit 47) 
  (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Usage - The SA uses the Form CMS-1465A (Exhibit 47) for all program position 
approvals. Separate forms and approvals are required for each of the programs:  
Title 
XVIII NON-LTC, Title XVIII LTC, Title XIX and CLIA.  The SA uses the most recently 
approved form or computer form format to assure proper information collection. 
 
The SA: 
 
Heading Information:  
Name of Agency - Inserts official name of the agency. 
 
State - Enters name of State. 
Fiscal Year - Enters the Federal period for which funds are being requested. 
 
Position Title/Name - Lists each position type employed and the names of each 
employee actually occupying each position type.  This will help the SA distinguish 
between the number of positions it has filled as opposed to the number allocated. 
Differences could mean substantially different approved budget levels.  This 
information may prove useful when determining the number of employees that require 
training in a given discipline.  Remember that individual employees are trained, not the 
number of full-time equivalents employees. 
 
City Where Located - Provides this for all position types and employees.  
Monitors differences and changes in staffing levels by location. 
 
No. of Pos. (Number of Positions) - After completing the Position Title/Name columnar 
entries for all positions, enters the number of actual allocations for each position, e.g., the 
actual number of employees occupying that position title. 
 
Staff Years - Computes the actual number of staff-years by Position Title. 
Representations of full and part-time employees are no longer necessary. Rather, it is 
important to compute the number of work or staff years using the work hours employed 
by each Position Title.  Includes anticipated overtime usage by all categories of 
positions in this computation. 
 
Funds Required - For each Position Title, computes the budget dollars required by 
multiplying the total work years for each Position Title times (X) the total dollar figure 
computed for and relevant to that Position Title.  Includes overtime in the calculations 
for all the positions listed. 
 
If possible, the SA discerns from the Position Titles which are professional and which are 
clerical positions.  If the SA cannot, do whatever is necessary to clarify and classify all 
positions accordingly.  Once the SA has classified the positions into the two types, total 
the staff years and dollar amount for each of the two categories. 
   
6444 - State Budget Request Submittal - Clinical Laboratory 
Improvement Amendments 
(Rev. 1, 05-21-04) 
 
6444.1 - List of Materials and Order of Assembly 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA assembles the budget documents in descending order, as follows: 
 
  Form CMS-102, Budget Request, Clinical Laboratory Improvement 
Amendments Program, (Exhibit 16); 
 
  Form CMS-105, Planned Workload Report, Clinical Laboratory Improvement 
Amendments Program, (Exhibit 119); 
 
  Form CMS-1465A, State Agency Budget List of Positions, (Exhibit 47); 
 
  Form CMS-1466, State Agency Schedule for Equipment 
Purchases, (Exhibit 54); 
 
  State justification arranged in line item order; and 
 
    Any exhibit referred to in the line item justification. 
 
6444.2 - Routing and Number of Copies 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA forwards the proposed budget package (the original and one copy of each 
document) to the RO.  The SA submits the budget in accordance with the due date 
provided by the RO but no later than July 30 preceding the Federal fiscal year to be 
funded.  The deadline ensures that CMS can complete the budget approval process in 
time to prevent an interruption in cash flow when one fiscal year ends and the succeeding 
year begins.  
 
Effective October 2002, State Agencies are required to use the automated Survey and 
Certification / CLIA reporting system to submit their final negotiated yearly budgets to 
the CMS regional offices.  State Agency users will enter negotiated budget data into the 
various records and formats of the system.  Once negotiations with the regional office are 
complete, the State certifying official will review the data, finalize the record, then certify 
the record, which will act as an electronic signature.  The certifying official is the 
executive officer of the state agency charged with the duties of administering (or 
supervising the administration of) the CLIA program.  
 
  6446 - Developing Budget Approval - RO Procedures 
(Rev. 1, 05-21-04) 
 
6446.1 - Budget Request Package 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In response to the budget call letter, the RO receives a CLIA budget submittal from 
each SA using the automated Survey and Certification / CLIA Reporting System. The 
data is transmitted electronically, from State to RO, RO to CO. The automated copy of 
the data should be certified by the approved State certifying official using the approved 
electronic signature feature of the system.  Each budget package should contain: 
 
  Form CMS-102, State Agency Budget Request, Clinical 
Laboratory Improvement Amendments Program, (Exhibit 116); 
 
  Form CMS-105, Planned Workload Report, Clinical Laboratory 
Improvement Amendments Program, (Exhibit 119); 
 
  Form CMS-1466, State Agency Schedule For Equipment Purchases, (Exhibit 
47); 
 
  Form CMS-1465A, State Agency Budget List of Positions, (Exhibit 54); and 
 
  The narrative budget plan that explains hiring, training plans, equipment 
purchases, budget exceptions, and variances or omissions in general. 
Documentation should be sufficient to support the budget plan. Narratives 
should be retained within the regional office and made available to CO only 
upon request. 
 
6446.2 - Basis for Budget Approval 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
State budget proposals must be submitted to the region in accordance with the approved 
automated Survey and Certification / CLIA  reporting system procedures.  Regional 
offices may approve State budget submissions only after proper certification by the 
approved State certifying official.  The RO approving official must obtain Central Office 
clearance prior to taking any approval action on a State budget request.  RO approval 
schedules should be developed to ensure that budget approvals are completed on or prior 
to September 30 of the fiscal year to ensure that funding authority can be made available 
to the State prior to the start of the upcoming fiscal year. The basis for approving the line 
item budget is the number of facilities to be surveyed and the amount of staff and money 
needed to survey them.  The 1988 amendments to CLIA mandate that all laboratories be 
surveyed every two years.  Thus, the budget plan should address itself to the basic 
question of how the SA will accomplish this goal.  It is important that the RO evaluate 
the accomplishments of the past performance period to determine the goals that need to 
  be set and accomplished for the next performance period.  Budget constraints or 
unexpected revisions may affect hiring or any of the myriad of budget line items.  
Revised national and regional priorities may also impact upon workload plans and 
accomplishments, so the RO should be flexible and diplomatic in subsequent negotiations 
with the SA.  The RO should not rely solely on written justification when approving a 
States CLIA budget. 
 
6446.3 - Line Item Negotiation and Approval 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The budget approval is a detailed concurrence or revision to State estimated survey 
program costs. The RO negotiates the budgets by line item, according to the category of 
the proposed expenditure. The approval process is between the RO and the SA.  The RO 
should be able to explain any adjustments and the method used to compute each amount. 
 
The RO should caution the State that funds provided agencies, as a result of the budget 
approval, must be used only for necessary expenses and that financial shortfalls may 
occur that would dictate reduction of budget allocations to each State after approval.  
This will reduce the potential for adverse consequences should there be a need to reduce 
expenditures. 
 
6446.4 - Payable Reasonable Costs 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA is entitled to receive advances to and payment of all reasonable costs for 
performing the CLIA survey workload.  CLIA funds cannot be used to pay the SA for 
any non-CLIA related expenses incurred.  Though CLIA-dedicated support staff will 
better facilitate the computation of CLIA-related expenses for budgeting purposes, it is 
possible that shared staff, who are involved in supporting multiple programs, may be 
employed.  Since CLIA will pay States only for CLIA-related expenses, proper proration 
of expenses is mandatory. 
 
Reasonable costs include all necessary expenses in accordance with the standards and are 
described in the manual.  Any class or kind of administrative expenditure that is properly 
chargeable to Federal CLIA funds under approved plans may be funded by CLIA 
revenues.  SAs are expected to exercise due care in the expenditure of funds, 
understanding that the funds must be used only for CLIA-approved activities and 
procurement.  
 
6446.5 - Projected Workload 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The projected workload, program emphases, the SAs hiring and training plans, and the 
experience of the 12-month preceding period, if appropriate, are the primary factors for 
the RO to consider when approving the line item budget.  The RO uses these factors as a 
guide, negotiate the budget in a fashion that assures that national and regional goals are 
  met.  When the RO makes changes to the States proposal, it provides the rationale for 
the proposed change.  The RO rationale should include: 
 
  The revised estimate; 
 
  The rationale for the change; and 
 
  The basis for computing the revised estimate.  
 
6446.6 - CO Assistance 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
CO personnel are available to assist with negotiating budget approvals.  The RO may 
consult with CO staff on any issues that are troublesome.  The RO should raise concerns 
or issues as early as possible in the budget process.  Prompt consultation can minimize 
the impact of many problems. 
 
How the SA establishes and maintains controls is less important than the fact that a 
control system is in place for the CLIA workload.  A by-product of the control system 
should be management information that is useful in managing the pending workload.  
Thus, some ability to capture data about workloads scheduled, pending and completed by 
laboratory schedule and employee type (to the extent possible) should exist in whatever 
system or mechanism the SA chooses to use.  Whatever form the controls take, it is 
important that documentation of actions involving the laboratories be retained in a 
retrievable format that allows for review of the data, if necessary.  Individual laboratory 
case records should be permanent case records that are accessible for review and analysis 
at a later date.  It is also essential that the RO maintain the laboratory action control 
records so that they can be readily accessed should the need arise. The RO uses 
established controls for following up on pending CLIA actions, scheduling surveys or 
complaint visits, PoC follow-up visits, and other CLIA-related activities.   
 
6448 - RO State Agency Budget Review - Form CMS-102 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
A review of the line items in the Form CMS-102 (Exhibit 116) should reveal that they 
conform to the guidelines that follow.  It is important that the RO obtain an explanation 
of all line items that contain no money amounts.  Blanks or zeros in items such as office 
space, communications, and supplies or equipment should be explained in writing.  If 
the cost for one or more line items is included in the indirect cost allocation rate reported 
on the form, it should be so stated and explained. 
 
  6450 - Employee Salaries and Wages - RO Procedures 
(Rev. 1, 05-21-04) 
 
6450.1 - Distribution of Staff Time for Program Purposes 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
CLIA funds may be used to pay CLIA-only program expenditures.  However, some 
personnel may be involved in multiple program activities.  The RO should determine that 
a method for capturing the appropriate manpower split by program is developed when 
such time-sharing occurs.  The proper pro-rata splits must be employed and documented 
to facilitate proper budget preparation, approval, and execution.  Distribution of shared 
staff time to the appropriate separate program areas of State activity is required.  
 
In the event staff are shared, the RO requests that periodic studies be conducted that will 
determine the proper prorate formula.  A prorated portion of the cost of such studies, 
work sampling, data recording, and reporting is also a necessary and reasonable CLIA-
related expense. 
 
6450.2 - Determination of Necessary Staff 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The following method may be used by the SA to determine a proper split of costs for 
CLIA versus other State program administration costs:  
 
  Determine the number of inspections and related manpower needed to fulfill the 
requirements of the CLIA laboratory inspection program; and 
 
  Determine manpower requirements which are related to the requirements of other 
programs.   
 
The ratio of countable CLIA activities to the sum total of the countable activities of all 
programs can be applied to the cost of the total multi-program activity.   
 
Using this prorate method is acceptable when miscellaneous costs cannot be specifically 
identified as a CLIA or other program-specific expense.  However, specific applications 
of this general principle will have to be developed jointly by the SA and the RO.  This 
method permits adjustments for circumstances a particular agency may encounter.  
However, it is possible that such difficult to identify charges may already be accounted 
for in the indirect cost allocation rate and should not be included here.  If the RO is in 
doubt as to whether all or part of a line item is already included in the indirect cost 
allocation rate, contact CO.  They will contact the Office of Assistant Secretary for 
Management and Budget, HHS, to determine if such is the case.  There are instances in 
which commonly-shared personnel, such as a typing pool, may be covered by agreement 
with the Department in the indirect cost allocation.  If it were included in the Indirect 
Cost Allocation, inclusion in another line item would create double billing for this item.  
  Since no two indirect cost allocation agreements are exactly the same, the RO should not 
presume that what goes for one SA goes for the others in its region.   
 
All such SA proposals to use sampling or prorate formulas must be approved by the RO 
before charges can be made under them.  The RO may conduct studies, or direct that the 
SA conduct them to verify results. 
 
6452 - Retirement Contributions and Fringe Benefits - RO Procedures 
(Rev. 1, 05-21-04) 
 
Retirement and fringe benefits that are in accordance with State and Federal laws are 
acceptable as CLIA reimbursable expenses.  It is possible that these charges may already 
be accounted for in the indirect cost allocation rate and should not be included here.  If in 
doubt, the RO should contact CO.  CO will contact the Office of Assistant Secretary for 
Management and Budget, HHS to determine if these costs should be included here. 
 
6454 - Travel - RO Procedures 
(Rev. 1, 05-21-04) 
 
The cost of travel, including, where appropriate, per diem or subsistence, in lieu of per 
diem, may be charged to CLIA.  The travel must be done in accordance with the States 
laws, regulations, and administrative procedures applicable to travel by State employees. 
 
6454.1 - CLIA Laboratory Survey and Administrative Travel 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Laboratory survey travel includes travel to and from a facility: 
 
  To conduct laboratory inspections; 
 
  For revisits or to verify PoC/AoCs; 
 
  To perform laboratory complaint or oversight inspections; and 
 
  For meetings with CMS personnel on CLIA-related activities. 
 
  Administrative travel is defined as travel for management purposes related to 
the CLIA laboratory inspection program: 
 
  To attend agency administrative staff meetings related to CLIA; 
 
  To attend State CLIA program meetings or activities conducted or sponsored 
by CMS; and 
 
  For planning or liaison visits to other agencies concerning certification. 
   
Travel to participate in sanction meetings or negotiations or to appear before an ALJ in a 
hearing (to provide testimony or support for a sanction activity against an alleged non- 
compliant laboratory) may also be charged to CLIA. 
 
6454.2 - Travel Involving Multiple Program Activities 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Travel expenses for an employee performing multiple program activities 
(Medicare/Medicaid and CLIA) for the State should be prorated in accordance with the 
distribution of direct personal service time spent on each program involved in and 
recorded for each trip.  Alternatively, such trip records may be accumulated for an 
accounting period and prorated accordingly.  For example, if at the end of the period such 
records showed that two-thirds of the employees productive time while in travel status 
was devoted to the State survey and certification program, and one-third of the time was 
devoted to CLIA activities, then the agency would charge one-third of the total travel cost 
to CLIA (including transportation, per diem, etc.) and the other two-thirds to the other 
appropriate program funds. 
 
6454.3 - Training and Conference Travel 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
This category of travel includes that travel which is not directly related to the line 
operations of surveying laboratories, consultation, and administration, as described 
above.  Examples of travel performed are: 
 
  Incident to orientation and basic training of new employees; and 
 
  For meeting the needs of experienced employees for retraining. 
 
  Also included is travel relating to: 
 
  Conferences; 
 
  Meetings; 
 
  Training; 
 
  Workshops; and 
 
  Seminars if the agenda material is directly related to the laboratory survey 
functions of the agency. 
 
Travel for such purposes may be funded by CLIA. 
 
  It is possible that some common travel charges may already be included for payment by 
the indirect cost allocation and should not be included here.  If in doubt as to whether all 
or part of a line item is already included in the indirect allocation rate, the RO should 
contact CO.  They will contact the Office of Assistant Secretary for Management and 
Budget, HHS, to determine if such is the case. 
 
6456 - Communications and Supplies - RO Procedures 
(Rev. 1, 05-21-04) 
 
6456.1 - Basis for Charges 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Communications and supplies should be direct CLIA charges if separable from other 
program costs and identifiable as to unit cost.  These expenses may be charged on a 
prorata basis if used for multiple program purposes.  For example, if long distance calls 
are routed through a switchboard or can otherwise be identified as to program, the CLIA 
calls can be made a direct charge.  Otherwise, all long distance charges should be 
prorated, using an identifiable and justifiable method or formula.  It is neither equitable 
nor legal to charge the CLIA program for installation and rental of telephones used 
exclusively by other programmatic State staff.  If CLIA and non-CLIA personnel share 
lines and telephones, payment must be on a prorata basis.  The SA method of proration or 
the formula used must be included in their budget supporting documentation.  Any blank 
or zero in this item must be explained.  If it is included in the indirect cost allocation rate, 
it should be so stated. 
 
6456.2 - Communications 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Such items as services including teleconferences (except such items as are payable on 
travel expense accounts), postage, postage meter charges, printed stamped envelopes, 
registry and special delivery or express mail fees, insurance charges on fourth class mail, 
or postage due charges for CLIA employees and CLIA-program related activities are 
chargeable to CLIA. 
 
For services such as satellite training or conferences, the SA has been advised to contact 
the RO to determine if the expense is a reasonable expense.  The RO weighs the facts on 
an individual basis when such an inquiry is received.  If found to be reasonable and 
necessary, it may be incorporated in the CLIA-approved budget.  Expenses that, in some 
instances, may be justifiable as reasonable are those for: 
 
  Cell phones, 
 
  Modems, and 
 
  FAX machines and other communication related expenses.  
 
  If the RO concurs that the circumstances do indeed substantiate such an expense, the RO 
may include it in the approved budget computations.  It is incumbent upon the SA to be 
in close consultation to assure that any planned unusual expenses are approved. 
 
6456.3 - Supplies 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The items that follow are payable by CLIA if they are used to support CLIA personnel 
and CLIA-related activities: 
 
  Such general office supplies as paper, pencils, folders, unstamped envelopes, 
clips, etc.; 
  Non-consumable items such as staplers, pencil sharpeners, file baskets, books, 
electronic calculators and planners, computers not purchased as part of a major 
computer system, etc., which do not exceed Departmental and/or OMB dollar 
guidelines for cost-per-unit procurements; 
 
  Printing or duplicating expenses and the cost of procuring forms such as printed 
or duplicated general office forms; and 
 
  Costs of transportation or shipment of any of the above items. 
 
The cost-per-unit above shall apply unless a different amount is specified by State law, in 
which case the amount so specified shall control.  If purchases are co-mingled with other 
than CLIA program purchases of the same nature, documentation and justification of the 
expenses, on a prorata basis is necessary. 
 
It is possible that some common communication and supply charges are included for 
payment in the indirect cost allocation agreement negotiated by the State or SA with 
HHS.  If so, they should not be included here.  If in doubt as to whether all or part of a 
line item is already included in the indirect cost allocation rate, the RO should contact 
CO.  They will contact the Office of Assistant Secretary for Management and Budget, 
HHS, to determine if such is the case. 
 
6458 - Office Space - RO Procedures 
(Rev. 1, 05-21-04) 
 
6458.1 - Cost of Office Space 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The cost of office space for CLIA laboratory survey functions is a proper charge against 
CLIA funds.  The rules governing all such rentals and leases are the same for CLIA as 
they are for all other CMS rentals and leases.  These guidelines replicate those rules and 
guidelines.  Such charges may take the form of: 
 
  Rent, service, and maintenance cost in privately owned buildings;  
   
  Monthly rental charges based on the cost of initial construction or purchase of 
publicly owned buildings; or 
 
  Meeting the costs of service and maintenance in lieu of rent in publicly owned 
buildings. 
 
In addition, charges may be made for repairs and alterations to either privately or publicly 
owned buildings.  Payment usually should be made only for periods of occupancy.  If 
unusual situations arise and no precedent exists, the RO consults with CO before the RO 
approves the State request. 
 
6458.2 - Standard of Comparable Rental 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Charges against CLIA funds for office space must follow other CMS guidelines and may 
not exceed the rental rate of comparable privately owned space in the same or similar 
locality.  Because the rental rate of comparable privately owned space is not a fixed 
amount for any particular locality, the rental rates may vary within a locality as well as 
between localities.  However, a realistic determination of the rental rate of comparable 
privately owned space must be made. 
 
The basis and documentation for the establishment of the rental rate of comparable 
privately owned space should be kept on file in the SA.  The RO may want to obtain a 
copy of the documentation in any precedent setting situation. 
 
6458.3 - Privately Owned Space 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Charges  against  CLIA  funds  for  privately  owned  space,  including  expenses  of 
services and maintenance, repairs, and alterations, must not exceed the rental rate of 
equivalent space and facilities in the same or similar locality. 
 
6458.4 - Space in Publicly Owned Buildings 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The following standards apply to charges for office space in a publicly owned building: 
 
  Actual Cost which is the amount charged for office space in a publicly owned 
building must not exceed actual costs over a long-run period.  The SA is required 
to produce records of actual costs if the RO wishes to examine them; and 
 
  75% Rule which is the amount charged for office space in a publicly owned 
building may not exceed 75% of the lowest comparable rental for privately owned 
space unless there are special considerations justifying a greater charge.  Use of 
this standard should be used only as an interim measure in the absence of actual 
  cost data.  This allows the SA to claim costs that are not in excess of 75% of the 
lowest cost of privately owned space.  The SA is allowed to do this without prior 
review or approval by the RO. 
 
When a monthly rental charge based on the cost of initial construction or purchase of 
publicly owned buildings exceeds 75% of lowest comparable rental for privately owned 
space or when the cost of service and maintenance in lieu of rent in publicly owned 
buildings exceeds 75%, the SA is required to obtain prior approval from your office.  The 
RO may wish to consult with CO prior to granting approval for such expenditures. 
 
It is possible that some common space charges are included for payment in the indirect 
cost allocation agreement negotiated by the State or SA with HHS.  If so, they should not 
be included here.  If in doubt as to whether all or part of a line item is already included in 
the indirect cost allocation rate, the RO should contact CO.  CO will contact the Office of 
Assistant Secretary for Management and Budget, HHS, to determine if such is the case. 
 
6458.5 - Charges Based on Meeting Cost of Service and Maintenance 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When the total charges for service and maintenance in a publicly owned building exceed 
75% of the lowest comparable rental for privately owned space, the SA must submit, 
prior to its claim, the following data for review and approval by CMS: 
 
  Total useable floor space and the amount of space allocated to the CLIA 
laboratory inspection program personnel;   
 
  Total costs of service and maintenance and the portion to be charged to CLIA 
funds; 
 
  The elements of cost; and 
 
  The rental cost of comparable privately owned space with at least three statements 
of appraisals. 
 
6460 - Equipment - RO Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Form CMS-1466 (Exhibit 54) should be attached to the budget package the RO is 
reviewing.  Purchases planned should conform to the latest CMS hardware and 
software acquisition guidelines.  Documentation to support the proposed purchases 
should be complete.  Reasonable purchases of equipment to support CLIA specific 
positions are permitted.  Such purchases may include computer systems and computer-
related equipment, office furniture and file cabinets, and other machines (Fax machines, 
photocopiers, etc.) necessary for CLIA operational, administrative, or management 
needs. 
   
When the RO reviews the Form CMS-1466, it checks to see that the SA has included 
appropriate details and reasonable requirements.  If purchasing new computer 
systems, peripherals, such as printers, being planned should appear on this form.  If 
printers are not shown, the RO should question what the SA would use to print 
products.  Software being purchased in conjunction with the hardware purchase would 
not be included on this form, but rather would show up as a miscellaneous item on the 
Form CMS-102 (Exhibit 116).  It is wise for the RO to review the software being 
considered.  It should comply with CMS guidelines and software standards.  
Consultation with both the SA and CO may be necessary and is advisable if plans for 
unusual purchases are noted. 
 
Equipment authorized in the present fiscal year that will not be purchased by the end of 
the fiscal year must be requested in the budget for the succeeding fiscal year if still 
needed by the SA.  If hiring constraints are going to restrict staffing plans, it is 
advisable that the RO and the SA reevaluate the timing of planned equipment 
purchases.  Planning equipment purchases sufficient to provide for those to be hired 
should be considered. 
 
6462 -Training - RO Procedures 
(Rev. 1, 05-21-04) 
 
The budget request should provide for the cost of training CLIA personnel.  The SA 
should use the number of employees to be trained, rather than full time equivalents 
(FTEs) when computing this figure.  Included should be the cost of the courses to be 
taken, the cost of travel and per diem associated with training sessions.  A narrative 
justification should indicate the types of courses to be taken by employee type and by 
number of employees to be trained. 
 
It is possible that some training costs may have been included in the indirect cost 
allocation agreement negotiated by the State or SA with HHS.  If so, they should not be 
included here.  If in doubt as to whether all or part of a line item is already included in the 
indirect cost allocation rate, the RO contacts CO.  CO will contact the Office of Assistant 
Secretary for Management and Budget, HHS, where copies of the agreements are 
maintained, to determine if such is the case. 
 
6464 - Consultants - RO Procedures 
(Rev. 1, 05-21-04) 
 
The SA should include the proposed cost of hiring consultants who are not State 
employees but who are used on a part-time, fee-for-service, or temporary basis to 
perform CLIA-related work. 
 
  6466 - Subcontracts - RO Procedures 
(Rev. 1, 05-21-04) 
 
The SA should include projected cost of subcontracts to be employed in the conduct of 
CLIA-related work.  Subcontract costs attributable to CLIA survey activities are 
allowable and payable.  The SA budget justification should provide the RO with the 
specific details, the reasons for, and approximate cost of each separate subcontract.  
 
6468 - Miscellaneous - RO Procedures  
(Rev. 1, 05-21-04) 
 
Reported in these spaces should be any unusual budgeted items that have not been 
reported in any of the preceding classifications.  To facilitate decision making, the SA 
should have attached to the budget package a narrative justification that explains all 
proposed expenditures.  The RO should consult CO as necessary to resolve any 
questions. 
 
6470 - Indirect Costs - RO Procedures  
(Rev. 1, 05-21-04) 
 
The indirect costs provided would be the rate negotiated and approved by the HHS 
Division of Cost Allocation for use during the fiscal year, together with the line item base 
it is applied against (approved rate x base).  The Department negotiates these rates with 
States, SAs, or programs.  The rate negotiated may be for a whole State or for each 
program or grant in a State.  It is probable that no two rate formulas include the same 
provisions.  It is important that CLIA not pay the SA for anything that the SA is going to 
be paid for by any other program or provision.  Where doubt exists, the RO questions any 
budget item and assure that an investigation is initiated.  If the SA is unfamiliar with what 
is included in the indirect cost allocation and cannot get clarification for the RO from 
their financial experts, the RO contacts CO.  Provide as much detail as the RO can as 
early in the budget process as possible so that the Office of the Assistant Secretary for 
Management and Budget can be queried for an answer. 
 
6472 - Hourly Rate Requested - RO Procedures 
(Rev. 1, 05-21-04) 
 
The dollar amount of the hourly rate of payment requested by the State is usually 
computed by dividing the total budget cost by the agreed upon number of available hours 
for actual survey-related activities.  
 
6474 - Planned Workload Report - Form CMS-105 - RO Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Form CMS-105 (Exhibit 119) provides the States estimate of the number of laboratory 
surveys it expects to perform in the budget period.  The workload plan will list by 
laboratory type (schedule) the number of surveys to be conducted in the fiscal year.  The 
  workload report should reveal in detail how the SA plans to do the work.  The State is 
required to survey every laboratory that does not have a certificate of waiver, a certificate 
for PPM procedures, or is under Federal jurisdiction every two years.  It is essential that 
the estimates of planned workloads be as accurate as possible and be at the levels 
mandated by national and regional goals.  The RO will be able to determine the propriety 
of the workload plans by review of prior workload history, where they exist, and 
evaluation against regional and national goals.  The workload plan submitted should be 
supported by the other parts of the budget plan.  If it does not provide sufficient detail 
from which the RO can determine that the work paid for will be accomplished, the RO 
must obtain the needed information or clarification.  Negotiate discrepancies to 
acceptable levels. 
 
6476 - Schedule for Equipment Purchases - Form CMS-1466 - RO 
Procedures 
(Rev. 1, 05-21-04) 
 
 
6476.1 - Usage 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The Form CMS-1466 (Exhibit 54) serves two purposes: it is used when requesting initial 
budget approval of equipment purchases and is completed and submitted to the RO when 
an actual purchase has been completed.  When equipment is actually purchased, the 
State should prepare and forward a revised Form CMS-1466 with the quarterly 
expenditure report, Form CMS-102 (Exhibit 116). 
 
6476.2 - Completion of the Form 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Name of Agency - The official name of the agency and the State will be inserted 
automatically when the State selects the type of form and the period for which equipment 
funds are requested.   
 
Column (a), Description of Equipment - Entered here are the items of equipment being 
requested or reported as purchased.  Items previously approved but which are being 
rebudgeted should be included and noted by the SA.  The State submission for approval 
will include supporting comments on the bottom or reverse of the form.  It should also 
explain why a purchase was not completed in the prior budget period, if such is the case.  
If this justification is missing, the RO obtains the justification from the SA. 
 
Column (b), No. of items on hand - The number of similar items on hand (in the SAs 
inventory) at the time the form was prepared should be listed.  SA equipment planning 
for one program should not be co-mingled with those of another.  If sharing is taking 
place, the equipment costs should be prorated. 
 
  If this purchase represents a new and different item, None should be shown in this 
column. 
 
Columns (c) and (d), Number of Units (Additional) or (Replacement) - The number 
of units approved by the SA should be listed.  Are these to be replacement units or 
additional units?  Is employee sharing of equipment done currently?  Is equipment 
sharing a realistic and manageable option?  Do not arbitrarily dismiss such options as 
viable alternatives to one-for-one equipment purchases. 
 
Column (e), Unit Cost - The unit cost for each item listed in column (a) should be 
entered here. 
 
Column (f), Gross Cost - The SA computes and enters the gross cost for each item in 
column (a) by multiplying the number of units in columns (c) and/or (d) by the unit cost, 
column (e).  Column c + column d (x) column e = gross cost, column (f). 
 
Column (g), Net Cost - Shown here should be a summarized total amount for each item 
listed in column (a).  This may be the same figure as that shown in column (f).  If there 
are reductions that should be applied to the gross cost, thus increasing or lowering the net 
cost, the reduction should be explained and the proper Net Cost should be entered in 
column (g).  
 
Total Net Cost of Equipment - This is the sum of all amounts shown in column (g) 
above. The SA should have entered this amount on the CMS-102, item 9.  If the RO 
approves this amount, it enters the figure on the CMS-104 (Exhibit 7), item 6, column 
(c).  
 
Date, Signature, Title - The form must be dated and signed by the SA.  The title of the 
individual signing the schedule should be shown. 
 
6478 - Preparation of List of Positions - Form CMS-1465A - RO 
Procedures 
(Rev. 1, 05-21-04) 
 
6478.1 - Usage 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Form CMS-1465A (Exhibit 47) is to be used for all program position approvals. 
Separate forms and approvals are required for each of the following programs: 
 
  Title XVIII NON-LTC; 
 
  Title XVIII LTC; 
 
  Title XIX; and 
 
     CLIA. 
It is important that the SA use the most recently approved form to assure proper 
information collection. 
 
6478.2 - Form Completion 
Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Name of Agency - The official name of the agency and the State will be inserted 
automatically when the State selects the type of form and the period. 
 
Fiscal Year - The SA enters the period for which funds are being requested. 
 
Position Title/Name - The State should list each position type employed and the names 
of each employee actually occupying each position type.  This will help the RO 
distinguish between the number of positions the SA has filled as opposed to the number 
they have allocated.  Differences could mean substantially different approved budget 
levels.  This information may prove especially useful when determining the number of 
employees that require training in a given discipline.  Remember to count the number 
of employees who require training, not the number of FTEs. 
 
City Where Located - This must be provided for all position types and employees.  This 
will help the RO monitor differences and changes in staffing levels by location and may 
prove to be a source of information about the existence of multiple locations that may 
have larger program implications. 
 
Number of Positions - After completing the position title/name columnar entries for all 
positions, the SA should enter the number of actual number of employees occupying 
that position title. 
 
Staff Years - The State should have computed the actual number of FTEs by position 
title.  Representations of full and part-time employees are no longer necessary.  Rather, it 
is important to compute the number of work or staff years using the work hours 
employed by each position title.  Overtime usage anticipated by all categories of 
positions should be included in this computation. 
 
Funds Required - For each position title, the SA computes the budget dollars required by 
multiplying the total FTEs for each position title times the total dollar figure computed for 
and relevant to that position title and includes overtime in the calculations for all the 
positions listed. 
 
The RO should be able to discern from the position titles, which are professional and 
which are clerical positions.  If the RO cannot, it should do whatever is necessary to 
clarify and classify all positions accordingly.  Once the RO has classified the positions 
into the two types, the RO may wish to total the staff years and dollar amounts for 
each of the two categories.  If needed, the RO may transfer the totals to the appropriate 
  lines of the Form CMS-102 (Exhibit 116). 
 
6480 - Line Item Approval for Personal Services - RO Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
In negotiating budgets, it is advisable to set a limit on the number of full-time equivalents 
chargeable to the CLIA program budget. With limits in place, a SA cannot exceed the 
approved full-time staff levels without prior consultation and authorization. This will 
enable the RO to monitor staffing, (all disciplines), especially the actual number of on- 
board surveyors, and allow the RO to better analyze State requests and requirements for 
additional support staff. 
6482 - Need for Additional Funds - RO Procedures 
(Rev. 1, 05-21-04) 
 
SAs should periodically check their current rate of expenditure.  If it appears that 
expenditures may exceed the budget approved or the current allotment, the SAs should 
consult with the RO as soon as possible.  
 
6482.1 - Adjustment in Quarterly Allotments 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
During the first three-quarters of the fiscal year (October - June), if the agency concludes 
that expenditures will exceed the current allotment, an information statement should be 
submitted to the RO.  This statement should explain in which line items the SA believes 
additional funds will be needed and give the agencys reason for this conclusion.  SAs 
may request an adjustment in the quarterly allotment schedule to make additional funds 
available at this time.  A supplemental budget should be submitted when it appears funds 
will be exhausted before close of the fourth quarter of the fiscal year. 
 
6482.2 - Supplemental Budgets 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
At the beginning of July each year, SAs should review their fiscal requirements for the 
balance of the fiscal year.  If at this time it appears that additional funds will be required, 
the SA should submit a supplemental budget.  The supplemental budget should be 
completed for the full fiscal year and include a statement concerning the anticipated 
expenditures in each category and the net additional amount needed.  The supplemental 
request should be prepared on the same form(s) and in the same number of copies as a 
regular budget request.  Supporting information comparable to the kind found on regular 
requests should accompany the supplemental budget. 
 
Even though no supplemental budget is submitted at the time of the July review, SAs 
should continue to check their expenditure rate for the balance of the fiscal year.  An end 
of year reconciliation and balancing of accounts will occur between CMS and each State.  
Actual expenses data will then be used by CMS as a basis for setting future fee schedules 
for the participating laboratories.  
   
 
6484 - Need for Additional CLIA Funds - SA Procedures 
(Rev. 1, 05-21-04) 
 
Periodically, the SA should check its current rate of expenditure.  If it appears that 
expenditures may exceed the budget approved or the current allotment, it should consult 
with the RO.  The SA should take full advantage of line-item flexibility (see 6434) 
before concluding that additional funds are needed. 
 
6484.1 - Adjustment in Quarterly Allotments 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
During the first three-quarters of the fiscal year (October - June), if the SA concludes that 
expenditures will exceed the current allotment, it submits an informational statement to 
the RO.  This statement should explain in which line-items the SA believes additional 
funds are needed and give its reason(s) for this conclusion.  The SA requests an 
adjustment in the quarterly allotment schedule to make additional funds available at this 
time and submits a supplemental budget when it appears funds will be exhausted before 
the close of the fourth quarter of the fiscal year. 
 
6484.2 - Supplemental Budgets 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
At the beginning of July of each year, the SA reviews its fiscal requirements for the 
balance of the fiscal year.  If at this time it appears that additional funds are required, the 
SA submits a supplemental budget that should be completed for the full fiscal year, and 
include a statement explaining the anticipated shortfall for each category and the net 
additional amount needed.  The SA prepares the supplemental request on the same 
form(s) and in the same number of copies as a regular budget request and includes 
supporting information comparable to the kind found on regular requests. 
 
Even though no supplemental budget may need to be submitted at the time of the July 
review, the SA continues to check its expenditure rate for the balance of the fiscal year. 
 
6486 - State Agency Accounts and Reporting 
(Rev. 1, 05-21-04) 
 
The SA ensures that all estimates and reports of expenditures and other reports are 
prepared in accordance with appropriate budgetary and accounting methods and 
administrative practices adopted by the Secretary. 
 
It is CMS desire and intent to accept State practice in the manner in which funds 
received from the Federal government are handled and accounted for, and in a States 
choice of a depository, subject to the general accountability required under Section C, 
Fiscal, of the agreement.  However, funds advanced to a State must be identifiable on a 
  States records.  Establishing a separate account usually does this.  The Fiscal and 
Reports Sections, along with instructions established by CMS for receiving advances of 
funds and submitting reports, have been drafted with a view to following State patterns to 
the fullest extent possible. 
 
6488 - Support for Expenditures - SA Procedures 
(Rev. 1, 05-21-04) 
 
The SA must provide, through SA accounting and statistical records, support for all 
expenditures incurred in connection with survey and certification activities.  No particular 
kind of accounting record, method or procedure is required.  The States accounting 
records and supporting documents must permit verification by Federal fiscal audit and 
CMS administrative review of all charges, together with the status of the advances made 
to the State. 
 
If the SA is receiving grants-in-aid administered by HHS in connection with its regular 
program, it uses the accounting and procurement methods and procedures described in 
SA approved plan for such grant-in-aid programs.  The SA is responsible for securing the 
necessary data from local or district offices, and assuring the validity of all data used for 
budgetary and other purposes. 
 
6490 - Certificate of Authority - SA Procedures 
(Rev. 1, 05-21-04) 
 
A certificate is placed on file with CMS stating the official title of the State person 
authorized to submit an estimate of funds, to certify fiscal documents and to represent the 
SA in fiscal matters. 
 
The SA forwards two copies of the certificate to the RO.  If the authority passes to a new 
office, or the scope of the authorization is changed, the SA submits a new certificate. 
 
6492 - Cash Basis - SA Procedures 
(Rev. 1, 05-21-04) 
 
The method of financial reporting recommended is the cash basis.  Thus, the data is 
based upon cash accounting which requires that charges against CMS CLIA funds be 
entered on SA records when formal vouchers, electronic transactions or other documents 
that may initiate payment are prepared. 
 
6494 - Limit on Expenditures - SA Procedures 
(Rev. 1, 05-21-04) 
 
The total amount approved in the SA annual budget shall be the limit on expenditures for 
the fiscal year. 
 
  6496 - Periodic Analysis of Accounts - SA Procedures  
(Rev. 1, 05-21-04) 
 
Since total expenditures for a fiscal year may not exceed the amount approved for that 
period, the SA reviews the status of accounts at least once each month.  This allows the 
SA to observe expenditure trends as they occur and helps the SA to avoid both over-
expenditure of funds and over-accumulation of large amounts of unliquidated obligations.  
It also provides early identification of any need for supplemental funds. 
 
6498 - Cash Balances and Expenditure Authority - SA Procedures 
(Rev. 1, 05-21-04) 
 
Unexpended funds on hand at the end of each quarter are available for expenditure in the 
succeeding quarter without formal reallotment.  However, this is NOT applicable if the 
succeeding quarter is in  a new fiscal year - no new obligations may be incurred after the 
last day (September 30) of the fiscal year.  This provision applies to all funds on hand 
whether they were received in a CMS advance or from other sources.  Formal reallotment 
is not a prerequisite for expenditure of any funds on hand. 
 
6500 - Unliquidated Obligations - SA Procedures 
(Rev. 1, 05-21-04) 
 
Fiscal controls should provide current information on unliquidated obligations.  For 
purposes of CMS financial reporting, unliquidated obligations are defined as bills 
received, but not yet prepared for transmission to the State fiscal officer for payment, or 
obligations incurred for which there is acceptable evidence of a commitment or promise 
to pay for goods, facilities, or services in any category of expenditure, whether or not the 
goods or services have been received or a bill rendered.  Examples of unliquidated 
obligations are: 
 
  Equipment which had been ordered, but not paid for (whether or not received); 
and 
 
  Items charged on a semi-annual or annual basis.  For example, for an item 
charged for an annual basis, the unliquidated obligation reported for the first 
quarter in the year would represent one quarter of the estimated annual charge.  
The unliquidated obligation reported in the second quarter would represent one-
half of the estimated annual charge.  Should the obligation not be paid off at the 
expected time, the SA continues to report the accumulated amount due. 
 
6502 - Nothing to Report on a Given Line - SA Procedures 
(Rev. 1, 05-21-04) 
 
If there is nothing to report on a given line, the SA should so indicate by the use of a 
dash ( - ) or a zero (0). 
 
  6504 - SA Forwarding Materials to the RO 
(Rev. 1, 05-21-04) 
 
The RO may request that the SA forward documentation to the RO supporting the SA 
laboratory survey-related activities.  If required to do so, the SA retains a copy of the 
materials for SA records and sends the original to the RO.  Copies of all material must be 
legible and must contain the appropriate signatures. 
 
6506 - State Agency Files Used for Case Control and Reporting 
(Rev. 1, 05-21-04) 
 
The RO may also need more specific information about some aspect of SA CLIA 
operations, or may need other special tabulations and reports concerning an area of 
program activity.  RO may need: 
 
  The number of applications pending for various lengths of time; 
 
  Laboratory survey schedules; and 
 
  The progress made through consultation with a facility. 
 
The SA may use this additional data for SA own purposes as well.  All such data is to be 
readily available from SA records.  
 
Many States are employing their own unique filing system and finding improved methods 
of control and ways of incorporating additional data such as licensure information, details 
on the improvements in the quality of service through consultative efforts.  The SA may 
use any technique as long as it affords a positive control over pending cases and provides 
for adequate tallying and documentation of certification activities.  The data extracted 
from the system for RO reports is rudimentary and easily tallied.  Therefore, the case 
control system probably does not warrant employing data processing equipment.  In some 
cases, the SA already use data storage and retrieval equipment, so it would actually be 
less expensive and simpler to employ existing equipment than to use a manual case 
control system. 
 
6508 - SA Establishment of Case Controls 
(Rev. 1, 05-21-04) 
 
It is of utmost importance that the SA initiate and maintain proper workload controls.  A 
good workload control system helps to encourage good management practices.  Though 
this section uses the word system to describe a mechanism that can help track workload 
pending and accomplishments, it does not arbitrarily categorize such as a computer-based 
control system.  A simple manual case control system may be something as 
unsophisticated as a card system that can be used to track the progress of each CLIA 
workload.  Most States already have control systems in place which track other 
programmatic (survey) workloads.  Many are quite sophisticated and computerized.  
  Similar mechanisms may be adapted to CLIA or new more responsive systems may need 
to be designed to accommodate the CLIA workload.  The type of physical system used is 
less important than the actual capture of the basic information needed to establish and 
maintain management control over the workload.  The SA should make sure any control 
system considered, whether manual or automated, is able to facilitate the establishment, 
update and storage of the basic control data.  It must also provide the controls that allow 
for management of pending workloads, laboratories to be surveyed, resurveyed, and 
hearings pending.  Data retention capability should be for a minimum of three years.  
 
6510 - Payment by Electronic Transfer of Funds - SA Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
All State agencies with an approved budget will be paid by electronic transfer of funds 
through the use of DHHS, Division of Federal Assistance Financings Payment 
Management System known as SMARTLINK II.  The SMARTLINK II Users Manual 
details the equipment the SA need to implement the system, provides guidelines for 
maintaining security to the system and explains how the SA request payment using the 
system.  It also provides the information the SA need about installing the DHHS-
supplied KERMIT communications package and other system specific procedures. 
 
6512 - State Expense Reporting  
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
CLIA requires that certification fees be sufficient to cover the costs of implementing 
and administering this oversight program.  There are no exceptions.  Funds to run the 
program come from billing laboratories for all costs related to administering all aspects 
of the CLIA program, including payment of all Federal and State CLIA-related program 
expenditures. The SA is entitled to receive advances to and payment of all reasonable 
costs for performing CLIA-related work, including the cost of the personnel required 
to perform the CLIA-related work. CLIA funds cannot be used to pay the SA for any 
non- CLIA-related expenses incurred. To administer the CLIA program, it is probable 
that each SA will employ CLIA dedicated staff. CLIA laboratory compliance surveys 
will be performed by CLIA approved and dedicated surveyors. Though CLIA dedicated 
support staff will better facilitate the computation of CLIA related expenses for 
budgeting purposes, it is possible that shared staff involved in supporting multiple 
programs may be employed. CLIA will pay States only for CLIA-related expenses, so 
proper proration of expenses is mandatory. 
 
Reasonable costs include all necessary expenses that are in accord with these 
standards and within the limits of the approved SA CLIA budget.  CLIA revenues will 
fund any class or kind of administrative expenditure that is properly chargeable to 
Federal CLIA funds under plans approved by the DHHS. Allowable costs are further 
defined in Code of Federal Regulations Title 2, Part 200 Uniform Requirements, Cost 
Principals and Audit Requirements for Federal Awards.  The SA should exercise due 
care in the expenditure of funds, understanding that the funds must be used only for 
CLIA-approved activities and procurement. The completed Form CMS-102 (Exhibit 
  116), is to accompany the Form CMS-105 (Exhibit 119), and the budget plan and 
documentation, as a budget request package that is forwarded to the RO in response to 
the yearly Budget Call Letter. The Form CMS-102 line items are addressed in general 
and specifically in the following procedures. 
 
States are required to submit their quarterly expenditure reports, via the automated 
reporting system, to their respective regional offices no later than 45 days following 
the end of each fiscal quarter. Final adjustments, when necessary, to quarterly 
expenditure reports are due to the region no later than 60 days following the end of 
each fiscal year. Regional offices will approve both quarterly as well as year-end final 
adjustments to quarterly expenditure reports within 15 days following submission of 
reports by the State. 
 
6514 - Employee Salaries and Wages - the Distribution of Staff Time for 
Program Purposes - SA Procedures 
(Rev. 1, 05-21-04) 
 
CLIA funds are to be used only to pay CLIA program expenditures.  However, it is 
recognized that some personnel may be involved in multiple program activities.  Though 
the magnitude and scope of the CLIA program is such that time-sharing may not occur or 
even be readily possible, it may by necessity, occur.  Thus, an important administrative 
goal must be to assure that a method for capturing the appropriate work-power split by 
program is developed, when such time-sharing occurs.  The SA should employ the 
approved methods for determining the proper pro-rata splits and document them to 
facilitate budget preparation, approval, and execution.  It is necessary for the SA to 
distribute shared staff time to the appropriate separate program areas of State activity. 
 
In the event staff is shared and a cost proration is necessary to determine the related costs 
for each program, a prorated portion of the cost of such studies, work sampling, data 
recording, and reporting is a necessary CLIA-related expense.  Studies determined 
necessary or requested by the RO are a necessary and reasonable CLIA expense. 
 
6516 - Determination of Necessary Staff - SA Procedures 
(Rev. 1, 05-21-04) 
 
The SA may use the following method to determine a proper split of costs for CLIA 
versus other State program administration costs.  The SA should determine the number of 
surveys that are planned for each program and determine the amount of staff needed for 
CLIA surveys and survey-related activity.  Workload plans should fulfill the specific 
requirements of the CLIA laboratory survey program.  The SA determines commonly 
shared staff and estimates the staff requirements for each program.  The ratio of 
countable CLIA activities to the sum total of the countable activities of all programs can 
be applied to the cost of the total multi-program activity.  Using the ratio derived is 
acceptable when miscellaneous costs cannot be specifically identified as a CLIA or other 
program-specific expense.  However, the SA should develop specific applications of this 
general principle jointly with the RO, to allow for circumstances a particular agency may 
  encounter, and ensure the comparability of such activities between programs.  Such tools 
for deriving SA staffing estimates must be approved by the RO before charges for 
payment can be made.  Studies may be conducted to verify the comparability of the 
activities or to validate the proposed formula for adjustments made in charging expenses 
to CLIA. 
 
6518 - Retirement Contributions and Fringe Benefits - SA Procedures 
(Rev. 1, 05-21-04) 
 
Retirement benefits and fringe benefits that are reasonable costs and in accordance with 
State and Federal laws are acceptable and payable under CLIA. 
 
6520 - Travel - SA Procedures 
(Rev. 1, 05-21-04) 
 
The cost of travel, including, where appropriate, per diem, or subsistence in lieu of per 
diem, is charged to CLIA in accordance with provisions of State law, regulations, and 
administrative procedure applicable to travel of State employees. 
 
6520.1 - CLIA Laboratory Survey and Administrative Travel 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Laboratory survey travel includes travel to a facility: 
 
  To conduct laboratory surveys;  
  For re-visits or recontacts with a facility about compliance action items, or plans 
of actions;  
 
  To perform laboratory complaint or oversight surveys; and 
 
  For meetings with CMS personnel on CLIA-related activities. 
 
Administrative travel is defined as travel within the State: 
 
  For management purposes related to the CLIA laboratory survey program; 
 
  To attend agency administrative staff meetings related to CLIA; 
 
  To attend State CLIA program meetings or activities conducted or sponsored by 
CMS; and  
 
  For planning or liaison visits to other agencies having to do with certification.  
 
  Travel to participate in sanction meetings or negotiations, or to appear before an ALJ in a 
Hearing (to provide testimony or support for a sanction activity against an alleged non-
compliant laboratory) may also be charged to CLIA. 
 
6520.2 - Travel Involving Multiple Program Activities 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Travel expenses for an employee performing multiple program activities 
(Medicare/Medicaid and CLIA) for the State is to be prorated on the basis of direct 
personal service based upon time spent on each program involved in and recorded for 
each trip.  Alternatively, such trip records may be accumulated for an accounting period 
and prorated accordingly. For example, if at the end of the period records showed that 2/3 
of the employees productive time while in travel status was devoted to the 
Medicare/Medicaid survey and certification program, and 1/3 of the time devoted to 
CLIA activities, then the agency would charge 1/3 of the total travel cost to CLIA 
(including transportation, per diem) and the other 2/3 to the Medicare/Medicaid survey 
and certification program funds. 
 
6520.3 - Training and Conference Travel 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
This category includes travel not directly related to the line operations of inspecting 
laboratories, consultation, and administration, as described above.  Examples are travel 
performed (1) Incident to orientation and basic training of new employees in areas 
appropriate to SA activities in the laboratory survey and certification program; and (2) 
For meeting the needs of experienced employees for retraining.  Also included is travel 
relating to conferences, meetings, training institutes, workshops, and seminars if the 
agenda material is directly related to the laboratory survey functions of the agency.  
Travel for such purposes may be funded by CLIA. 
 
6522 - Communications and Supplies - SA Procedures 
(Rev. 1, 05-21-04) 
 
6522.1 - Communications 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Telephone services chargeable to CLIA include:  
 
  Teleconferences;  
 
  Postage; 
 
  Postage meter charges; 
 
  Printed stamped envelopes; 
 
    Registry and special delivery or express mail fees; 
 
  Insurance charges on fourth class mail; or  
 
  Postage due charges incurred by CLIA employees and for CLIA program-related 
activities.  
 
For services such as satellite training or conferences, contact the RO to determine if the 
expense is a reasonable expense that is payable in accordance with the CLIA-approved 
budget.  Expenses for cell phones, modems, FAX machines and other communication-
related expenses may, in some instances, be justifiable, and, thus, chargeable to CLIA in 
accordance with the previously approved budget.  The SA should consult with the RO to 
assure payment. 
 
6522.2 - Supplies 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The following items are chargeable to CLIA if they are used to support CLIA personnel 
and CLIA-related activities:  
 
  General office supplies such as paper, pencils, folders, unstamped envelopes, 
clips; 
 
  Non-consumable supplies such as staplers, pencil sharpeners, file baskets, books, 
which do not exceed a $50 per unit cost;  
 
  Printing and duplicating expense and the cost of procuring forms such as printed 
or duplicated general office forms; and  
 
  Costs of transportation or shipment of any of the above items. 
 
The $50 unit cost for non-consumable items shall apply unless state law specifies a 
different amount, in which case the amount so specified shall control.  If purchases are 
commingled with other than CLIA program purchases of the same nature, the SA 
documents and justifies the expenses on a prorated basis. 
 
6522.3 - Basis for Charges 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Communications and supplies should be direct CLIA charges if separable from other 
program costs and identifiable as to unit cost.  The SA charges these expenses on a 
prorated basis if used for multiple program purposes.  For example, if long distance calls 
are routed through a switchboard or can otherwise be identified as to program, the CLIA 
calls can be made a direct charge.  Otherwise, all long distance charges are to be prorated, 
using an identifiable and justifiable method or formula.  It would not be equitable to 
charge the CLIA program for installation and rental of telephones used exclusively by 
  other State staff.  If CLIA and non-CLIA personnel share lines and telephones, payment 
is computed on a pro-rata basis.  If an employee is engaged in multiple program 
activities, including CLIA-related activities, CLIA is to be billed only on a prorated share 
basis.  The SA includes the documentation of the method of proration or the formula 
used. 
 
6524 - Office Space - SA Procedures 
(Rev. 1, 05-21-04) 
 
The cost of office space essential for CLIA laboratory survey functions is a proper charge 
against CLIA funds.  The rules governing all such rentals and leases are the same for 
CLIA as they are for all other CMS rentals and leases.  These guidelines replicate those 
rules and guidelines.  Such charges may take the form of: 
 
  Rent, service, and maintenance cost in privately-owned buildings;  
 
  Monthly rental charges based on the cost of initial construction or purchase of 
publicly-owned buildings; and 
 
  Meeting the costs of service and maintenance in lieu of rent in publicly-owned 
buildings. 
 
In addition, charges may be made for repairs and alterations to either privately or 
publicly-owned buildings.  Payment will be made only for periods of occupancy unless 
approval is received from CMS for payment for periods of nonoccupancy. 
 
Charges against CLIA funds for office space must follow other CMS guidelines and thus, 
may not exceed the rental rate of comparable privately-owned space in the same or 
similar locality.  Although the rental rate of comparable privately owned space is not a 
fixed amount for any particular locality, and the rental rates may vary within a locality as 
well as between localities, it is expected that a realistic determination of the rental rate of 
comparable privately-owned space be made.  The basis and documentation for 
establishing the rental rate of comparable privately-owned space is to be kept on file. 
 
6526 - Privately-Owned Space - SA Procedures 
(Rev. 1, 05-21-04) 
 
Charges against CLIA funds for privately-owned space, including expenses of services 
and maintenance, repairs, and alterations, must not exceed the rental rate of equivalent 
space and facilities in the same or similar locality. 
 
In negotiating a lease for privately-owned space, the SA includes cancellation or 
conditional clauses in rental agreements.  The following guides are applicable with 
respect to the rental of space in privately-owned buildings when renewing an existing 
lease or when obtaining new or additional space under a lease: 
 
  6526.1 - Cancellation Clause 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When executing or renewing leases, the SA should make every effort to include a 
reasonable right of cancellation (30 days, if possible) in favor of the State, if such right 
can be included in light of rental rates, probable permanency of occupancy, and other 
pertinent factors.  The SA should attempt to secure a cancellation clause in all rental 
agreements covering space for more than 1 year. 
 
6526.2 - Lease Not Exceeding One Year 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When the SA is unsuccessful in securing a cancellation clause, it should make an attempt 
to secure leases not to exceed one years duration, if possible, with an annual renewal 
option for an extended period, such as three years or longer. 
 
6526.3 - Consulting the RO 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Where neither of the above is possible, the SA consults the RO at least 30 days in 
advance of the date the lease is to be signed. 
 
6528 - Space in Publicly-Owned Buildings - SA Procedures 
(Rev. 1, 05-21-04) 
 
The following standards apply to charges for office space in a publicly-owned building: 
 
6528.1 - Actual Cost 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The amount charged for office space in a publicly-owned building must not exceed actual 
costs over a long-run period.  The SA is required to produce records of actual costs for 
examination as necessary.  The SA will: 
 
  Not include the cost of land as part of the cost of initial construction or the 
purchase of publicly-owned buildings in deriving the rental charges.  This 
exclusion is based on the fact that land has no actual physical depreciation.  The 
State would always have the land as an asset long after the building had become 
obsolete or been demolished, and value could be realized. 
 
  Establish the estimated useful life of the building if depreciation is included as an 
element of cost.  In case the building is vacated before the end of its useful life, 
adjust past claims for amortization to a reasonable depreciation basis. 
 
  6528.2 - Cost After Building Amortization 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
After the initial cost of a building has been amortized, the SA charges only the costs of 
service and maintenance. 
 
6528.3 - 75 Percent Rule 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The amount charged for office space in a publicly-owned building may not exceed 75 
percent of the lowest comparable rental for privately-owned space unless there are special 
considerations justifying a greater charge.  The use of this standard as an expedient 
interim measure in the absence of actual cost data, enables the SA to claim costs that are 
not in excess of 75 percent of the lowest cost of privately-owned space without prior 
review or approval by the RO. 
 
6528.4 - Ratio of Charge-to-Rental Rates in Privately-Owned Space 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Experience gained in analyzing the elements of rental rates in privately-owned space 
shows that approximately 75 percent of the rate represents the expense of service, 
maintenance, and depreciation.  The portion in excess of 75 percent of the rental rate of 
comparable privately-owned space generally represents taxes and profit on investment 
that would ordinarily accrue.  Therefore, whenever a charge is made for space in a 
publicly-owned building that is not in excess of 75 percent of the lowest cost of 
comparable privately-owned space in the same or similar locality, the SA assumes that 
such charge is reasonably related to the expense of service, maintenance, and 
depreciation.  The SA verifies the reasonable relationship of such charges to actual costs 
over a long-run period.  When a monthly rental charge based on the cost of initial 
construction or purchase of publicly-owned buildings exceeds 75 percent of lowest 
comparable rental for privately-owned space or when the cost of service and maintenance 
in lieu of rent in publicly-owned buildings exceeds 75 percent, the SA obtains prior 
approval from CMS. 
 
6528.5 - Charge Based on Cost of Initial Construction or Purchase 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When rental charges are based on costs of initial construction or purchase of a publicly-
owned building and such charges exceed 75 percent of the lowest comparable rent for 
privately-owned space, the SA submits justification for review and approval by CMS 
prior to acquisition or occupancy of the space.  
 
  6528.6 - Charges Based on Meeting the Cost of Service and Main-
tenance 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
When the total charges for service and maintenance in a publicly-owned building exceed 
75 percent of the lowest comparable rental for privately-owned space, prior to the SAs 
claim, the SA submits the following data for review and approval by CMS: 
 
  Total useable floor space and the amount of space allocated to the CLIA 
laboratory survey program personnel; 
 
  Total costs of service and maintenance and the portion to be charged to CLIA 
funds; 
 
  The elements of cost; and  
 
  The rental cost of comparable privately owned space, with at least three 
statements of appraisals. 
 
6530 - Repairs and Alterations - SA Procedures 
(Rev. 1, 05-21-04) 
 
Charges may be made for repairs and alterations in privately or publicly-owned space 
necessary to the maintenance of proper facilities for efficient administration of the State 
survey unit. 
 
6530.1 - Maintenance Repairs 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA includes maintenance repairs such as painting, repairs to plaster, patching roofs 
and minor repairs to doors, elevators and electrical equipment in the rate for service and 
maintenance. 
 
6530.2 - Major Repairs and Replacements 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Major repairs and replacements, such as structural changes in buildings, new roofs, and 
new heating systems may be amortized over a period of years provided the total cost for 
space on an annual basis does not exceed lowest comparable rental, or in the case of 
publicly-owned buildings, 75 percent of the lowest comparable rental for privately-
owned space.  If the cost is amortized, the repairs and alterations must be of a permanent 
nature.  Repairs and alterations that remain the property of the agency are usually 
classified as moveable equipment. 
 
  6530.3 - Alterations 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Normally, quarters completely adequate for the SA should be obtainable from the lessor, 
and the cost of necessary alterations would be borne by the landlord.  However, where 
the landlord is unwilling to bear the cost of necessary alterations, CMS funds can be 
authorized to meet the cost of alterations provided the proposed alterations are needed for 
better utilization of the space, and the improvements are not obligations of the lessor 
under the terms of the lease.  In some situations, lessors will not agree to make necessary 
alterations but will offer space at a relatively low rental rate.  In such cases, the SA 
should try to negotiate an arrangement under which the lessor would make necessary 
alterations and the SA would amortize the cost by an increase in rent for a stipulated 
length of time.  Before agreeing to an arrangement providing for repair or alteration, the 
SA should secure approval from the RO. 
 
6532 - Identifiable (Direct) Costs - SA Procedures 
(Rev. 1, 05-21-04) 
 
When locating program personnel in extra identifiable space, the SA charges CLIA for 
the cost of such space. 
 
Where SA CLIA program personnel share space with the SA regular personnel, the SA 
apportions the cost of such space between the programs.  The apportionment is based 
upon the SA proration plan and must be approved by CMS.  The method approved will 
apply only to rental fees paid for locations where SA program personnel share occupan-
cy.  The SA should re-evaluate the basis for prorating rental costs when changes in 
physical facilities or other conditions may result in inequitable cost sharing. 
 
The SA submits the SAs rental cost apportionment plan each year as part of the budget 
documentation.  Approval of the budget constitutes approval of the plan of 
apportionment. 
 
6534 - Office Maintenance - SA Procedures 
(Rev. 1, 05-21-04) 
 
6534.1 - Definition 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Office maintenance includes services such as light, heat, time clock and water service, 
towel and janitor service, and machine repair service prorated on the same basis as rent, 
provided such services are not already included in rental costs. 
 
  6534.2 - Basis for Charges 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
If associated office maintenance costs, in whole or in part, are included in the SAs rental 
contract, the SA does not separate them; however, it notes their inclusion.  The SA 
charges maintenance costs that are not included in rentals on the same basis as rental 
costs. 
 
6536 - Equipment - SA Procedures 
(Rev. 1, 05-21-04) 
 
6536.1 - Definition and Quality of Office Equipment 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Items which are of a non-expendable nature, i.e., they have a life expectancy of one year 
or more and a probable resale, salvage, or trade-in value, are classified as office 
equipment if they have a unit cost in excess of 50 dollars.  However, if State law specifies 
a different amount, the amount so specified shall apply.  The quality of items should not 
exceed the quality of similar office equipment in general use in other SA offices. 
 
6536.2 - Title to and Accountability 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Title to and accountability for office equipment purchased for State survey program 
purposes, or for shared use with other State or Federal programs, shall rest with the State.  
However, the purchase price(s) of individual pieces of office equipment may be shared 
with other State or Federal programs.  Where the costs of equipment are prorated 
between Medicare and other programs such as CLIA, the SA should use the same 
proration in crediting residual value to the Medicare, or CLIA program for all disposed 
equipment.  Where Medicare-only, CLIA-only, or Medicaid-only funds are used to fully 
fund equipment, the SA credits 100 percent of the residual value to the appropriate 
funding program, either Medicare, Medicaid or CLIA, but not all. 
 
6536.3 - Purchase of Equipment 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
6536.3.1- State Practice 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA follows established State law or regulations for procurement of equipment for the 
State survey program. 
 
  6536.3.2 - Purchases Related to Budget Process 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Funds for equipment purchases are to be requested by State agencies and approved by 
CMS as part of the budget process.  The SA should try to predict SA equipment needs 
during pre-budget planning, and request all needed equipment in the budget submittal.  
To estimate equipment needs, the SA determines the condition of equipment on hand and 
the appropriateness of the equipment for the tasks to be performed.  The SA should also 
consider proposed staffing increases in SA budget projections. 
 
The total expended for equipment during the budget period cannot exceed the total funds 
allocated for equipment for that period without prior approval of the RO.   
 
6536.3.3 - Items Deleted by CMS 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
After reviewing an agencys estimate for equipment, CMS may delete an item or restrict 
the purchase of an item.  If upon review of the CMS deletions, the SA want to resubmit 
the request it should do so.  The SA submits the request with added supporting 
information.  However, until the restriction is removed, the item cannot be purchased 
with Federal funds. 
 
6536.3.4 - Purchase of Items Not Included in Budget Submittal 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Although the SA is expected to anticipate the bulk of its equipment needs, the SA may 
occasionally find a need for equipment that was not included in its budget submittal.  The 
SA must secure approval of the RO before purchasing such items of equipment.  
However, if sufficient uncommitted funds are available, the SA may purchase items not 
included in the budget approval without prior RO approval when the unit cost of the item 
is 50 dollars or less, and the item is of a kind approved in any previous budget period, 
e.g., tables, chairs, and coat racks.  The SA lists such items and identifies them in the 
equipment schedule submitted at the end of the quarter in which purchased. 
 
6536.3.5 - Reporting Equipment 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
The SA maintains an inventory of equipment, following usual State inventory practices, 
and makes an annual physical count of equipment items for comparison against the 
inventory records.  In the event of equipment loss or substantial damages due to theft or 
fire, the SA submits a statement concerning such losses to the RO as soon as possible. 
 
  6536.4 - Rental of Equipment 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Situations may occur where it will be advisable to rent certain office equipment instead of 
purchasing it.  The rental of office equipment is allowable if it is not contrary to State law 
or regulations.  Expenditures for equipment rental are considered necessary if: 
 
  The rental is for a short period of time; 
 
  The equipment is not available for purchase (leased telephone lines, electrostatic 
photocopy machines, etc.); or 
 
  It can be shown that renting rather than purchasing an item of equipment is 
advantageous in terms of cost. 
 
Secure prior approval from the RO if the SA wishes to rent equipment for more than 90 
days. 
 
6538 - Retirement and Social Security - SA Procedures 
(Rev. 1, 05-21-04) 
 
6538.1 - Retirement Contributions 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Retirement contributions include SA cost (not employees share) of contributions to 
retirement funds such as State retirement or social security. 
 
6538.2 - Prorating Costs 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Where SA prorate personal services costs of State survey personnel, it prorates the 
retirement costs for these personnel. 
 
6540 - Other Expenses - SA Procedures 
(Rev. 1, 05-21-04) 
 
 Other expenses include expenditures that can be properly charged to the State survey 
program, but have not been provided for in any of the preceding classifications.  
Examples of such items are discussed below by category. 
 
  6542 - Consultants - SA Procedures 
(Rev. 1, 05-21-04) 
 
Consultant services are generally defined as being furnished by persons who are not State 
employees, but who will be used on a part-time, temporary, or fee-for-service basis to 
provide needed skills to the State survey program. 
 
6544 - Training of State Agency Personnel - SA Procedures 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The reasonable costs of training personnel engaged in CLIA survey and related 
activities are chargeable to the CLIA program when the training is related to its 
responsibility for survey, certification and related enforcement activities.  Training may 
include attendance at job-related meetings, conferences, seminars, workshops, and 
satellite training conferences or training courses. Training is to be related to SA CLIA-
related responsibilities. Examples of professional meetings for which attendance may 
be justified and funded, subject to prior RO approval are periodic and annual meetings 
of regional or national laboratory and medical technologist professional societies and 
organizations such as, but not limited to, the American Society of Clinical Pathologists 
(ASCP), the American Society of Clinical Laboratory Science (ASCLS), American 
Medical Technologists (AMT), American Clinical Laboratory Association (ACLA), 
American Society for Cytotechnology (ASC), College of American Pathologists (CAP), 
and the Clinical Laboratory Management Association (CLMA). 
 
6544.1 - Funding 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
CMS will fund the entire cost of approved training of all employees.  Funding for SA 
training is subject to the following considerations: 
 
  Out-of-State attendance must be in accord with established State rules and 
regulations. 
 
NOTE:  When Federal requirements mandate that the training is necessary, SA 
travel policy for out-of-State travel is not an excuse for non-
participation in the Federal training. 
 
  Federal funds may not be used to attend any meetings or events if the attendee is 
paid by the sponsoring organization to attend or to speak or render other services 
in connection with the meeting. 
 
  Attendance will not significantly impair work activities. 
 
   
6544.2 - Requesting Approval 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
Funds for conferences and short-term training activity is normally requested, in 
advance, in the annual budget submittal.  The SA submits any training that has not 
received prior CMS approval in the approved budget, in advance, to the RO for 
approval.  Approval is to be on a case-by-case basis. 
 
At the SAs request, CMS will include a dollar authorization for short-term training 
activity over and above the cost of attendance at CMS-sponsored meetings within 
the funds approved for each fiscal year.  This authorization covers travel, per diem, 
admission fees, and any other costs related to attendance at the meetings. 
 
If the SA believes it necessary to exceed the allotment, see 6546.  The SA can make 
expenditures for short-term training activities without consulting the RO for specific 
authorization provided the following conditions are met: 
 
  No single meeting is attended for more than 5 working days; 
 
  The proposed attendees are State CLIA employees who regularly perform 
CLIA- related functions; 
 
  The training is related to your CLIA-related responsibilities; 
 
  The SAs do not charge a higher percentage of the cost of the CLIA-related 
portion than is appropriate.  The appropriate portion attributable to 
Medicare/Medicaid or other programs is to be charged to those programs; 
 
  A Form CMS-102 (Exhibit 116) is submitted as a supplemental budget request, 
in advance, if the event was not previously approved in the budget process.  If 
the employee entered on duty during that quarter or later, the SA charges the 
percentage applicable to the employee in the budget approval; and 
 
  Ensures that there is adequate documentation of every expenditure, following 
State practice, for subsequent audit. 
 
Where one or more of the preceding conditions are not met with respect to any 
particular meeting, the SA furnishes detailed justification well in advance of the planned 
training/event date. 
 
The authorization of funds for short-term training is in addition to the cost of attending 
any meetings called by CMS.  The SA should consult with the RO for budget 
information about proposed CMS meetings as part of the process of preparing the budget 
submittal. 
  6544.3 - Justification for Attendance 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Where it is necessary to furnish detailed justification for attendance at short-term 
meetings, either in the original budget or later on in the fiscal year to the RO, (because, 
for example, the criteria in subsection B above are not met or the allotment is exhausted), 
the SA provides the following information: 
 
  Name, position and title of each person proposed for attendance; 
 
  A list of previous out-of-State training meetings attended by each proposed 
attendee during the current fiscal year (other than CMS-sponsored meetings) 
which were charged to Federal funds; 
  An itemized listing of proposed expenditures for attendance, including travel, per 
diem, and admission fees; and  
 
  Name, location, and dates of the meeting and a copy of the course announcement 
or bulletin, if available.  Also, the SA submits a copy of the agenda or a list of the 
subject matter on the agenda and the name and address of the sponsoring 
organization.  Where the description of the subject matter does not clearly es-
tablish that it relates to CLIA responsibilities, the SA provides an explanation of 
how the subject matter relates to CLIA responsibilities. 
 
6544.4 - Fiscal and Reporting Considerations - the Amount Requested 
for Travel Costs of Such Activity 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The SA shows the total amount approved on the Form CMS-104 (Exhibit 118) for the 
CLIA program (the State Agency Budget Expenditure Report, Form CMS-435(Exhibit 
45) for the Medicare and Medicaid programs). 
The SA does not break down the amounts expended for specific meetings, conferences 
or events.  However, the SA maintains detailed records of all expenditures for audit 
purposes. 
 
6544.5 - Educational and Training Leave 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Educational leave is leave granted for specialized professional or technical study in an 
accredited educational institution.  Training leave is leave granted to an employee for 
attendance at short-term courses that will run longer than five working days, outside the 
agency.  Approval of educational or training leave can only be granted if it is for 
purposes related to carrying out CLIA responsibilities.  Additionally, State rules, 
regulations and practice must permit the taking of leave for such purposes.  The SA 
obtains approval of training or educational leave, in advance, from the RO.  Such 
  proposals are evaluated individually and specific circumstances and special problems are 
given proper consideration. The SA includes the following in its requests: 
 
  Employees name, type of appointment held, position and grade (salary), length of 
service with the SA, previous experience and education; 
 
  Description of any other specialized training or courses taken by the employee 
within the previous 24 months; 
 
  Name and location of training institution; 
 
  Title and description of training in sufficient detail to demonstrate its scope, 
content, and how it relates to CLIA responsibilities.  A copy of the training course 
announcement may help to fulfill this requirement; 
 
  A statement indicating how this training will benefit the employees work and 
improve the agencys activity; 
 
  The training period showing the number of days and hours the employee will be 
absent from duty; 
 
  A statement from the supervisor dealing with the ability of the unit to forego the 
services of the trainee during the training period; and 
 
  The cost of tuition, fees, and books in detail.  A copy of the training course 
announcement may help to fulfill this requirement. 
 
6544.6 - Agreements by Employees to Continue on the Job 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
In order to discourage resignation of an employee for whom there has been a 
considerable expenditure for formal training, some States require the employee to sign an 
agreement that she/he will remain on the job for a certain length of time (e.g., six months) 
after completing the training.  If State regulation or practice provide for such agreements, 
the SA has the selected employee sign such an agreement after having obtained CMS 
approval for the activity. 
 
6546 - Miscellaneous - SA Procedure 
(Rev. 1, 05-21-04) 
 
Items illustrative of this category, for example, are: 
 
  Bonding and public liability; 
 
  Equipment rental; 
 
    SA cost (not employees share) of workmens compensation; 
 
  Group insurance; 
 
  Unemployment insurance; and  
 
  Proportionate share of merit system of civil service charges.  
Multi-program pro ration of costs always applies. 
 
6546.1 - Bonding 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
Where a new bond or an amendment to an existing bond is required in relation to 
receiving and handling CLIA funds, the cost of the bond, when borne by the State, or the 
additional cost attributable to an amended bond, is a proper charge. 
 
6546.2 - Public Liability 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
An appropriate share of the cost to protect against financial responsibility for injury to 
person or property is properly charged to CMS when such expenses are in the form of 
premiums for public liability or property damage insurance.  The cost of awards, 
judgments, or settlements arising from injury to person or property are not chargeable to 
CMS.  
 
The share of public liability and property damage insurance costs properly chargeable to 
CMS, in the case of motor pool or personally-owned vehicles used in the discharge of SA 
official business, is proportionate to that share of all travel of personnel of the agency 
which is devoted to activities directly concerned with the CLIA program. 
 
The other items mentioned above may be prorated or charged directly as appropriate.  If 
prorated, the method of prorating should be appropriate and acceptable to the State and to 
CMS.  Thus, the costs of workmens compensation, group insurance, or unemployment 
insurance would usually be charged directly for employees whose salary costs are 
prorated in the same ratio as the salary costs. 
 
6548 - Goods, Facilities, Services From Other Staff or Local Agencies  
(Rev. 1, 05-21-04) 
 
6548.1 - Definition 
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) 
 
The definitions of the terms goods, facilities, and services and the criteria for 
application of the standards are those in effect for SA grant-in-aid relationship with the 
Department of Health and Human Services. Additional definitions are covered within 
the Federal Acquisition Regulations (subpart 31.6, Contract with State, Local, and 
  Federally Recognized Indian Tribal Governments) and Code of Federal Regulations 
Title 2, Part 200 Uniform Requirements, Cost Principals and Audit Requirements for 
Federal Awards. 
 
6548.2 - Centralized State Services 
(Rev. 35; Issued:  04-18-08; Effective/Implementation Dates:  04-18-08) 
 
In some States services of an administrative nature (including certain commodities) such 
as accounting, printing, civil service, or central purchasing are furnished to various 
operating agencies of the State by specialized service departments outside the health 
department or other agency having an agreement or State plan with DHHS under 1864 
or 1903 of the Act.  The SA allocates an equitable part of such charge to the State CLIA 
program if the services are necessary and are ones from which the program derives a 
benefit similar to that accruing to other units of the agency, and provided: 
 
  The pro-rata charge to the CLIA program does not include costs attributable to the 
general expense of State government in carrying out the coordinating, fiscal, and 
administrative functions of government;  
 
  The charge is based on reasonable cost; and  
 
  The costs are extra, identifiable, and readily ascertainable either by segregation or 
as a prorated share of the cost of such facilities or services.   
 
The SA describes the basis of the service agencys charge, including the method of 
proration and the services provided and submits it for prior approval.  The SA identifies 
such costs separately in the CLIA budget submittal. 
  Transmittals Issued for this Chapter 
 
Rev #  Issue Date  Subject  Impl Date  CR# 
R199SOM 01/17/2020  Revisions to State Operations Manual (SOM)  01/17/2020 N/A 
Chapter 6 - Special Procedures for 
Laboratories and Chapter 9 Exhibits 
R195SOM 11/15/2019  Revisions to State Operations Manual (SOM)  11/15/2019 N/A 
Chapter 6 - Special Procedures for 
Laboratories and Chapter 9 Exhibits- 
Rescinded and replaced by Transmittal 
199 
R45SOM  05/08/2009  Revisions to Chapter 6 - Special Procedures  05/08/2009 N/A 
for Laboratories 
R35SOM  04/18/2008  Revisions to Chapter 6 - Special Procedures  04/18/2008 N/A 
for Laboratories 
R01SOM  05/21/2004  Initial Issuance of Pub 100-07  N/A  N/A