State Operations Manual 
Chapter 5 - Complaint Procedures  
 
Table of Contents 
(Rev. 212, 02-10-23) 
 
Transmittals for Chapter 5 
 
Sections 5000 to 5080.1 relate to all Medicare/Medicaid-certified 
provider/supplier types. 
5000 - Management of Complaints and Incidents 
5000.1 - Purpose of the Complaint/Incident Process 
5000.2 - Overview 
5010 - General Intake Process 
5010.1 - Information to Collect From Complainant 
5010.2 - Information to Provide to Complainant 
5010.3 - Notification to the RO 
5050 - CMS Regional Office Responsibility for Monitoring SA Management of 
Complaints and Incidents 
5060 - ASPEN Complaints/Incidents Tracking System (ACTS)  
  5060.1-Data Entry 
  5060.2-Reports 
5070 - Priority Assignment for Nursing Homes, Deemed and Non-Deemed Non-Long 
Term Care Providers/Suppliers, and EMTALA 
5075 - Priority Definitions for Nursing Homes, Deemed and Non-Deemed Non-Long 
Term Care Providers/Suppliers, and EMTALA 
5075.1 - Immediate Jeopardy (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)  
5075.2 - Non-Immediate Jeopardy - High (for Nursing Homes and 
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers, and 
EMTALA) 
5075.3 - Non-Immediate Jeopardy - Medium (for Nursing Homes and 
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) 
5075.4 - Non-Immediate Jeopardy  Low (for Nursing Homes and 
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) 
5075.5 - Administrative Review/Offsite Investigation (for Nursing Homes 
and Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) 
5075.6 - Referral  Immediate (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)   5075.7 - Referral  Other (for Nursing Homes, Deemed and Non-Deemed 
Non-Long Term Care Providers/Suppliers, and EMTALA) 
5075.8 - No Action Necessary (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) 
5075.9 - Maximum Timeframes Related to the Federal Onsite 
Investigation of Complaints/Incidents 
5077 - State Monitoring Visits 
5078 - Pre-survey Activities 
5079 - Entrance Conference - Non-Long Term Care 
5080 - Investigation Findings and Reports 
5080.1 - Report to the Complainant 
5080.2 - Survey Exit Conference and Report to the Provider/Supplier 
 
Sections 5100 to 5170 relate to deemed providers/suppliers. 
5100 - Investigation of Complaints for Deemed Providers/Suppliers 
5100.1 - Basis for Investigation 
5100.2 - Initial Response to Complainant 
5110 - Post-Survey Procedures 
5110.1 - Substantial Compliance 
5110.2 - Condition-Level, IJ 
5110.3 - Condition-Level, Non-IJ 
5110.4 - Full Survey after Complaint Survey with Condition-level Deficiencies, 
When Authorized by the RO 
5120 - Life Safety Code Guidance for Deemed Providers/Suppliers 
5130 - Deemed Provider/ Supplier Hospital Refusal of Complaint Investigation Surveys 
5140 - Complaints Involving HIV-Infected Individuals 
5150 - Investigating Complaints Involving ESRD Services Provided by Deemed 
Hospitals or CAHs 
5160 - Investigating Complaints Against ESRD Suppliers 
 
Section 5170 Relates to Hospital Restraint/Seclusion Death Reporting 
and Investigation 
5170 - Hospital Restraints/Seclusion Death Reporting and Investigation 
5170.1 - Background 
5170.2 - Responsibilities 
5170.3 - Process 
 
Sections 5200 to 5240 relate to all non-deemed provider/supplier types, 
excluding nursing homes (SNFs/NFs).  5200 - Investigating Complaints for Non-Deemed Providers/Suppliers, Excluding 
Nursing Homes (SNFs/NFs)  
5200.1 - General Procedures 
5200.2 - Special Procedures for Psychiatric Hospitals 
5210- Processing of Complaints Originating with or Investigated by the RO 
5220 - Investigation Conducted Directly by the RO 
5230- Special RO Processing 
5240 - Complaints - HHA Hotline 
 
Sections 5300 to 5390 relate to nursing homes. 
5300 - Investigation of Complaints for Nursing Homes 
5300.1 - Task 1:  Offsite Survey Preparation 
5300.2 - Task 2:  Entrance Conference/Onsite Preparatory Activities 
5300.3 - Task 5:  Information Gathering 
5300.4 - Task 6: Information Analysis 
5300.5 - Task 7:  Exit Conference 
5310 - Action on Allegations of Resident Neglect and Abuse, and Misappropriation of 
Resident Property for Nursing Homes 
5310.1 - Written Procedures 
5310.2 - Review and Triage of Allegation 
5310.2 A-Immediate Jeopardy Priority 
5310.3 - Investigating Allegations 
5310.4 - Factors Beyond the Control of the Individual 
5320 - Reporting Findings of Abuse, Neglect, or Misappropriation of Property to the 
Nurse Aide Registry 
5320.1 - Notification Procedures- Preliminary Determinations 
5320.2 - Conduct of Hearing for Nurse Aides 
5320.3 - Reporting Findings 
5330 -  Reporting Abuse to Law Enforcement and the Medicaid Fraud Control Unit for 
Nursing Homes 
5340 - Post-Survey Certification Actions for Nursing Homes 
5350 - Data Entry 
5360 - Processing of Complaints Originating with or Investigated by the CMS RO 
5370 - Pre-Investigation Actions on Allegations Originating Through the RO 
5380 - RO Processing of RO Investigated Complaints 
5390 - RO Oversight of Complaint-Related Processes 
 
 
Sections 5400 to 5480.2 relate to alleged EMTALA violations   5400 - Investigations Involving Alleged EMTALA Violations 
5410 - EMTALA and Born-Alive Infants Protection Act of 2002 
5410.1 - Interaction of the Born-Alive Infant Protection Act and 
EMTALA 
5410.3 - Conduct of Investigations 
5420 - Basis for Investigation 
5430 - RO Direction of Investigation 
5430.1 - Evaluation of Allegation 
5430.2 - Request for Investigation of Allegations 
5440 - Conducting an Investigation 
5440.1 - Selecting the Team 
5440.2 - Scheduling the Investigation 
5440.3 - Guidelines for Surveyors Conducting Investigations 
5440.4 - Conducting the Investigation 
5440.5 - Exit Conference 
5450 - Forwarding Report of Investigation to the RO 
5460 - RO Review of Investigation 
5460.1 - Hospital Is In Compliance - No Past Violation 
5460.2 - Hospital Is In Compliance - Past Violation, No Termination 
5460.3 - Hospital Is Not in Compliance - Immediate Jeopardy to Patient 
Health and Safety 
5460.4 - Hospital Is Not in Compliance - Situation Does Not Pose an 
Immediate Jeopardy to Patient Health and Safety 
5465 - Procedures for the 5-day QIO Review of Alleged Violations of 42 CFR 489.24 
5470 - Termination Procedures for EMTALA Violations 
5470.1 - Procedures for Termination when the EMTALA Violation is an 
Immediate Jeopardy to Patient Health and Safety 
5470.2 - Procedures for Termination When the EMTALA Violation is Not 
Immediate Jeopardy to Patient Health and Safety 
5480 - Procedures for QIO Review of Confirmed EMTALA Violation 
5480.1 - Procedures for Coordinating 60 day QIO Review 
5480.2 - EMTALA Case Referral to OIG 
5480.3 - Releasing QIO Assessment 
 
Sections 5500 to 5590 relate CLIA. 
5500 - Complaints Involving Unaccredited Laboratories 
5500.1 - Control 
5500.2 - Acknowledgment 
5500.3 - Evaluation  5500.4 - Scheduling Investigations 
5500.5 - Conducting Investigations 
5500.6 - Conducting Investigations in a Laboratory with a Certificate of 
Waiver 
5500.7 - Conducting Investigations in a Laboratory with a Certificate for 
PPM Procedures 
5500.8 - Post Investigation Actions 
5500.9 - Resolution/Closeout 
5510 - CLIA-Exempt Laboratory Complaint Investigations - General 
5520 - Review of CLIA-Exempt Laboratory Complaints 
5530 - Conducting Complaint Investigations and Surveys for CLIA-Exempt Laboratories 
5540 - Complaint Investigations and Surveys of Accredited Laboratories Under CLIA 
5550 - RO Direction of Complaint Investigation of an Accredited Laboratory 
5560 - Conducting Complaint Survey of an Accredited Laboratory 
5570 - Forwarding Investigation Report to RO 
5580 - Accredited Laboratory Found in Compliance Following a Complaint Survey 
5590 - Accredited Laboratory Found Not in Condition-level Compliance Following a 
Complaint Survey  5000 - Management of Complaints and Incidents 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
NOTE: CMS Regional Office (RO) is used interchangeably with CMS location 
throughout this Chapter of the SOM. 
 
 
5000.1  Purpose of the Complaint/Incident Process 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Mission:  To protect Medicare/Medicaid beneficiaries from abuse, neglect, exploitation, 
inadequate care or supervision. 
 
The goal of the Federal complaint/incident process is to establish a system that will assist 
in promoting and protecting the health, safety, and welfare of residents, patients, and 
clients receiving health care services.  The complaint/incident management system has 
three objectives. 
 
1.  The first objective and priority for the complaint/incident management system is 
protective oversight.  This is accomplished by analyzing the complaint allegations 
and reported incidents received to identify and respond to those that appear to 
pose the greatest potential for harming beneficiaries (has caused or is likely to 
cause, serious injury, harm, impairment or death).  Complaints/incidents of this 
type that allege an immediate threat to the health, safety or welfare of individuals 
are investigated immediately. 
 
2.  The second objective is prevention.  Complaints/incidents that do not allege a 
threat of serious harm are investigated to determine if a problem exists that could 
have a negative impact on the healthcare services provided.  The investigation of 
these complaints/incidents is designed to identify and correct less serious 
complaints/incident to prevent the escalation of these problems into more serious 
situations that would threaten the health, safety and welfare of the individuals 
receiving the service. These complaints/incidents are also prioritized and 
investigated based on the seriousness of the allegations. 
 
Numerous or more frequent complaints/incidents may indicate systemic problems 
and therefore may be assigned a higher priority for investigation. 
 
3.  The third objective is to promote efficiency and quality within the health care 
delivery system.  Complaints/incidents that are not directly related to Federal 
requirements are forwarded to the appropriate agency(ies) for follow-up and 
investigation.  Complaints/incidents in this category may include but are not 
limited to Medicare/Medicaid fraud, complaints against individual licensed 
practitioners, and billing issues. 
 
  5000.2  Overview 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
All the procedures in this chapter are followed when complaints and reported incidents, 
including referrals from public entities, involve Medicare-certified providers/suppliers, 
Medicaid-certified providers/suppliers, or CLIA-certified laboratories.  The investigation 
and resolution of complaints are critical certification activities.  The CMS, the State 
Medicaid Agency (SMA), and the State survey agency (SA) are responsible for ensuring 
that participating providers/suppliers of health care services continually meet Federal 
requirements.  This requires that the SA promptly reviews complaints/incidents, conducts 
unannounced onsite investigations of reports alleging noncompliance, and informs the 
CMS Regional Office (RO) and/or the SMA any time certification requirements are 
found to be out of compliance. 
 
Since there are multiple activities associated with the management of complaints and 
incidents, responsibilities often cut across organizational lines.  Thus, the SA must 
demonstrate clear-cut accountability for each step of the process and a focal 
coordinating/controlling responsibility to assure timely and appropriate action. The SAs 
responsibilities cannot be delegated. 
 
5010 - General Intake Process 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
A complaint is an allegation of noncompliance with Federal and/or State requirements.  If 
the SA determines that the allegation(s) falls within the authority of the SA, the SA 
determines the severity and urgency of the allegations, so that appropriate and timely 
action can be pursued. Each SA is expected to have written policies and procedures to 
ensure that the appropriate response is taken for all allegations and is consistent with 
Federal requirements as well as with procedures in the State Operations Manual.  This 
structure needs to include response timelines and a process to document actions taken by 
the SA in response to allegations.  If a States time frames for the investigation of a 
complaint/incident are more stringent than the Federal time frames, the intake is 
prioritized using the States timeframes.  The SA is expected to be able to share the logic 
and rationale that was utilized in prioritizing the complaint/incident for investigation.  
The SA response must be designed to protect the health and safety of all residents, 
patients, and clients. 
 
Besides the SA, other public entities receive information and/or perform investigations.  
These entities include the office of the coroner or medical examiner, end-stage renal 
disease (ESRD) networks, quality improvement networks (QINs), law enforcement, the 
ombudsmans office, and protection and advocacy systems.  At times, these public 
entities will forward information to the SA if there are concerns about the health and 
safety of residents, patients, and clients.  The SAs are required to manage and investigate 
these referrals as complaints. 
  An allegation is an assertion of noncompliance with Federal health and safety 
regulations.  The point of receipt of the allegation is a critical fact-finding and decision-
making point.  The SA ensures that its complaint telephone number is listed in local 
directories.  Information regarding the care, treatment and services provided to 
beneficiaries can come from a variety of sources, including beneficiaries themselves, 
beneficiaries family members, health care providers, concerned citizens, public agencies, 
or media reports.  Report sources may be verbal or written. In some instances, the 
complainant may request anonymity. 
 
The SA and RO ensure the privacy and anonymity of every complainant.  Generally, the 
SA follows the disclosure procedures under chapter 3, 3308.  The SA discloses the 
complainants identity only to those individuals with a need to know who are acting in an 
official capacity to investigate the complaint. 
 
In addition to these Federal requirements, the SA abides by any State procedures not in 
direct conflict with CMS instructions.  The SA notifies the RO if State regulations 
conflict directly with any part of these complaint procedures. 
 
See also Section 5310.1 for information related to facility-reported incidents. 
 
5010.1 - Information to Collect From Complainant 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA collects information necessary to make important decisions about the allegations.  
In instances where written or verbal allegations are received, subsequent communication 
may be necessary to obtain additional information. 
 
Comprehensive information should be collected during the intake process to allow for 
proper prioritization, including the following: 
 
  Information about the complainant (e.g., name, address, telephone, etc.); 
 
  Individuals involved and affected; 
 
  Narrative/specifics of the complainants concerns including the date, and time of 
the allegation; 
 
  The complainants views about the frequency and pervasiveness of the allegation;  
 
  Name of the provider/supplier including location (e.g., unit, room, floor) of the 
allegation, if applicable;  
 
  How/why the complainant believes the alleged event occurred;  
    Whether the complainant initiated other courses of action, such as reporting to 
other agencies, discussing issues with the provider, and obtaining a 
response/resolution; and  
 
  The complainants expectation/desire for resolution/remedy, if appropriate. 
 
5010.2 - Information to Provide to Complainant 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The complaint intake process assists the complainant in resolving his/her conflicts.  As 
part of the intake process the SA provides the following: 
 
  Policies and procedures for handling intakes including the scope of the SAs 
regulatory authority and any considerations pertaining to confidentiality;  
 
  The course of action that the SA or RO will take and the anticipated time frames;  
 
  Information about other appropriate agencies that could provide assistance 
including the name and telephone number of a contact person, if available; and  
 
  A SA contact name and number for follow-up by the complainant. 
 
NOTE FOR DEEMED PROVIDERS/SUPPLIERS:  If a complaint does not allege 
condition-level noncompliance, the SA may: 1) advise the complainant to file the 
complaint to the accrediting organization (AO), or 2) ask for the complainant's 
permission to release the information to the AO. 
 
5010.3  Notification to the RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
1  Notification to the RO 
 
The SA immediately forwards allegations involving the following to the RO: 
 
  Deemed providers/suppliers; 
 
  Hospital and  psychiatric residential treatment facility (PRTF)  restraint/seclusion-
related deaths; 
 
  EMTALA complaints; 
 
  Fires resulting in serious injury or death in a Medicare/Medicaid-certified facility; 
 
  Federal facilities; 
    Religious Non-medical Health Care Institutions (RNHCIs)(evaluation performed 
by Region I, Boston, only); 
 
  CLIA-certified laboratories holding a certificate of accreditation.  (See Chapter 6). 
 
  CLIA-exempt laboratory.  (See Chapter 6); 
 
  Blood transfusion-related fatalities (See Chapter 6 and Appendix C); 
 
  Over-utilization or inappropriate utilization of services within the QIOs 
jurisdiction; 
 
  Civil rights violations; or 
 
  Medicare or Medicaid fraud 
 
2  Special Cases 
 
The SA considers whether notification to the RO is appropriate.  If a complaint is 
especially significant, sensitive, or attracting broad public or media attention, the SA 
informs the RO immediately.  Additionally, the SA needs to consider any other early 
notice requirements prescribed by other State or Federal policies or interagency 
agreements. 
 
5050 - CMS Regional Office Responsibility for Monitoring SA 
Management of Complaints and Incidents 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
CMS ROs are responsible for monitoring the SAs management of complaints and 
incidents to assure that the SAs are complying with the provisions set forth in Federal 
regulations, the SOM, and CMS policy memoranda.  As part of the monitoring process, 
the SAs will be evaluated in accordance with the criteria set forth by the State 
Performance Standard Review.  Many States have State laws and regulations that specify 
how to manage complaints and incidents.  Whenever possible, State and Federal 
requirements should be integrated to avoid unnecessary duplication.  CMS ROs should 
accept State requirements that meet or exceed the intent of the Federal requirements.  At 
a minimum, it is expected that noncompliance with Federal requirements resulting from a 
complaint or reported incident will receive follow-up and be documented in the Aspen 
Complaints Tracking System (ACTS). 
 
5060  ASPEN Complaints/Incidents Tracking System (ACTS) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The SA collects information related to complaints and facility-reported incidents and 
uses a system to track and monitor the receipt and disposition of complaint and incident 
intakes.   
The ASPEN Complaints/Incidents Tracking System (ACTS) is designed to track, 
process, and report on complaints and incidents reported against health care providers 
and suppliers regulated by CMS.  It is designed to manage all operations associated with 
complaint/incident processing, from initial intake and investigation through the final 
disposition. 
 
The ACTS must be used for the intake of all allegations against Medicare/Medicaid-
certified providers/suppliers and CLIA.  The ACTS is a Federal system and data entered 
into ACTS is subject to Federal laws governing disclosure and the protection of an 
individuals right to privacy. 
 
A complaint/incident record is created in ACTS based on how the allegation is received 
by the SA or RO.  For example, if one person calls with ten allegations about one 
provider/supplier, this is counted as one complaint record.  If six people call with the 
same allegation, this is counted as six telephone calls and is counted as six complaint 
records.  If one letter is received with one or many allegations and is signed by 20 people, 
this is counted as one complaint record. 
 
5060.1 - Data Entry 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The SAs and ROs are required to enter into ACTS: 
 
  All complaints gathered as part of Federal survey and certification 
responsibilities, regardless if an onsite survey is conducted [i.e., complaints 
related to noncompliance with the Federal condition(s) of participation (COPs), 
condition(s) for coverage (CFCs), condition(s) for certification, requirement(s) 
for participation (RFPs), or EMTALA requirement(s)]; and  
 
  For nursing homes, all self-reported incidents that are reported under Federal 
law and the requirements for participation [i.e., reporting to law enforcement of 
crimes occurring in LTC facilities  1150B of the Social Security Act and 
483.12(b)(5); alleged violations of abuse, neglect, exploitation or mistreatment, 
including injuries of unknown source and misappropriation of resident property  
483.12(c)(1) and (4)].  For non-long term care providers/suppliers, all self-
reported incidents that require a Federal onsite survey. 
 
Revisions related to the entry of self-reported incidents into ACTS will be implemented no 
later than October 1, 2024, in order to provide time for the SAs to prepare given the 
resource constraints in the SAs. 
 
The information recorded in ACTS reflects the allegation furnished by the 
complainant/provider/supplier at the time of the intake.  At a minimum, if the intake 
information requires an onsite survey and the allegation may involve both Federal and  State licensure requirements, a Federal onsite survey is completed and entered into 
ACTS. 
 
If an investigation finds one or more violations of Federal requirements, the findings 
must be cited under the appropriate tags and entered into the Federal system even if the 
information is entered into a State licensure data system.  Since this information is 
essential to the effective management of the survey and certification program, it is 
important that SAs complete the required fields in ACTS in a timely manner. 
 
Exhibit 23 defines the required fields in ACTS. 
 
Tracking of Referrals in ACTS 
 
The SAs are required to enter into ACTS all referrals from public entities that allege 
noncompliance with the Federal requirements.  For reporting purposes, the SAs should 
enter these cases as complaints (i.e., Intake Type=Complaint, Intake Subtype=Federal 
COPs, CFCs, RFPs, EMTALA). In order to more quickly identify which of these cases 
stem from a referral, the SAs are expected to check the appropriate category under the 
Source field.  For example, for referrals from the coroners office, states would check 
Coroner under the Source field for the intake. 
 
Tracking of State Monitoring Visits (See Section 5077) in ACTS 
 
When a State Monitoring Visit results in a Federal deficiency, the SA will identify the 
survey in ASPEN as complaint and create an intake and survey record in ACTS.  The 
data should be entered into ACTS as follows: 
 
  Intake Type = Complaint; 
  Intake Subtype = Federal COPs, CFCs, RFPs, EMTALA; 
  Source = State SA; 
  Priority = can vary; and 
  Allegation Type = State Monitoring. 
 
 
5060.2 - Reports 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The ACTS produces a variety of reports that may be used for analysis and evaluation of 
provider/supplier performance.  Complaint/incident reports are generated and displayed 
through menus that can be accessed in ACTS.  Reports may be produced for one 
provider/supplier, or reports may be combined and present information for multiple 
providers/suppliers.  Report filtering criteria is available through the Report 
Customization window, which allows the user to select criteria for the report to meet the 
users specifications.  Refer to the ACTS Procedures Guide for a list and description of 
the reports available in ACTS. 
   
NOTE: 
 
FOR ADDITIONAL INFORMATION ON SPECIFIC POLICIES RELATED TO: 
 
  DEEMED PROVIDERS AND SUPPLIERS, EXCLUDING CLIA, SEE 
SECTION 5100 
 
  NON-DEEMED PROVIDERS AND SUPPLIERS, SEE SECTION 5200 
 
  NURSING HOMES, SEE SECTION 5300 
 
  EMTALA, SEE SECTION 5400 
 
  CLIA LABORATORIES, SEE SECTION 5500 
 
  ESRD, SEE SECTION 5160 AND SECTION 5170 
 
5070 - Priority Assignment for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
This section does not apply to clinical laboratories subject to the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA).  See Sections 5500  5590 
for CLIA information. 
 
An assessment of each complaint or incident intake must be made by an individual who 
is professionally qualified to evaluate the nature of the problem based upon his/her 
knowledge of Federal requirements and his/her knowledge of current clinical standards of 
practice.    
 
From a complainants allegation(s) or an allegation from a facility-reported incident, the 
SA/CMS Location identifies potential concerns where the provider/supplier may not be in 
compliance with Federal requirements.  The SA/CMS Location must review the 
allegation(s) for all requirements that apply and should be investigated.  These 
requirements will be specific to each health care entity.  The surveyor then investigates 
each of those areas of concern and health care entity type.   
 
The role of the surveyor is not to validate whether the events contained in the allegation 
had occurred, but it is to determine whether the facility is in compliance with the Federal 
requirements for Medicare/Medicaid-certified providers/suppliers.  If CMS or the SA 
believes that the complaint or facility-reported incident should also be investigated under 
the jurisdiction of another entity, referrals should be made as appropriate (e.g., law 
enforcement for criminal activity, State licensing boards for health care practitioners, the 
Medicare Administrative Contractor (MAC) for billing issues). 
  In the case of nursing homes, in situations where a determination is made that immediate 
jeopardy may be present and ongoing, the SA must start the on-site investigation within 
three business days of receipt of the initial complaint or incident report.  Receipt of the 
initial complaint or incident report means when the report is received by the SA, whether 
it is received by the SA directly, or another State agency under arrangement or 
contractor that is receiving the report on behalf of the SA from the complainant or 
facility. Also, if a complaint or facility-reported incident is received after business hours, 
then it is considered to be received on the next business day, for purposes of calculating 
the investigation timeframe. For example, if a complaint is received on Saturday and the 
SA office is closed during the weekend, then the following Monday will be used to 
calculate the investigation timeframe.  Revisions related to the timeframes for 
investigating nursing home complaints and facility-reported incidents will be 
implemented no later than October 1, 2023, to provide time for the SAs to prepare given 
the resource constraints in the SAs.   
 
For non-long term care providers/suppliers, in situations where a determination is made 
that immediate jeopardy may be present and ongoing, the SA is required to start the on-
site investigation within two business days of receipt of the complaint or incident report, 
or, in the case of a deemed provider or supplier, within two business days of RO 
authorization for investigation.  The same process applies to EMTALA complaints or a 
survey related to a report of a hospital or CAH Distinct Part Unit patient death associated 
with the use of restraint or seclusion. The SAs investigation must be initiated within two 
business days of RO authorization for investigation.   
   
Generally, an alleged event occurring more than 12 months prior to the intake date would 
not require a complaint investigation.  However, the SA is not precluded from conducting 
a Federal investigation (with appropriate RO authorization, where required) to determine 
current compliance status based on the concerns identified in the complaint. 
 
For nursing homes, an onsite survey may not be required if there is sufficient evidence 
that the facility does not have continuing noncompliance and the alleged event occurred 
before the last standard survey. 
 
For all intakes concerning deemed status providers or suppliers where the intake involves 
allegations of substantial noncompliance (in other words, the allegation would result in a 
condition-level deficiency citation if found to be true and uncorrected), the SA must 
submit a request for RO approval of a complaint validation survey (i.e., substantial 
allegation validation survey).  The SA must obtain RO approval before conducting a 
substantial allegation validation survey.  The RO will authorize the SA to conduct the 
survey by issuing electronically via ACTS a Form CMS-2802, which will indicate the 
specific conditions for which the SA must assess compliance.  The RO must authorize 
assessment of compliance for a whole condition and not just for particular standards 
within a condition, unless the Form CMS-2802 for the applicable provider/supplier type 
permits selection of a specific standard, e.g., Life Safety Code. 
  All allegations of EMTALA violations related to a hospital (which also includes cancer, 
childrens, long term care, psychiatric and rehabilitation hospitals) or CAH, regardless of 
whether the hospital or CAH is deemed, must be referred to the RO.  The RO will 
determine whether the SA will conduct an EMTALA investigation.  
 
In cases where the SA or RO has noted a pattern of similar complaints about a specific 
provider or supplier, each of which on its own merits would be triaged at a medium or 
low level, the SA or RO has the discretion to assign a higher triage level to a current 
intake based on the noted pattern, in order to ensure timely investigation of the 
providers/suppliers compliance with the applicable requirements or Conditions. 
   
CMS expects SAs to prioritize complaints at the appropriate level that is warranted.  The 
timeframes in Section 5075 below represent maximum timeframes for investigation 
(Note: Revisions related to the timeframes for investigating nursing home complaints and 
facility-reported incidents will be implemented no later than October 1, 2023, to provide 
time for the SAs to prepare given the resource constraints in the SAs); the SA is not 
precluded from investigating complaints and facility-reported incidents within a shorter 
timeframe.  In addition, the SA is not precluded from taking other factors into 
consideration in its triage decision.  For example, the SA may identify a trend in 
allegations that indicates an increased risk of harm to residents or the SA may receive 
corroborating information from other complainants regarding the allegation. 
See also Section 5310.2 for requirements for nursing home facility-reported incidents.    
 
5075 - Priority Definitions for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
5075.1 - Immediate Jeopardy (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
General Provisions 
 
The regulations at 42 CFR 489.3 define immediate jeopardy as, A situation in which the 
providers noncompliance with one or more requirements of participation has caused, or 
is likely to cause, serious injury, harm, impairment, or death to a resident.  Appendix Q 
contains the Guidelines for Determining Immediate Jeopardy.  Intakes are assigned this 
priority if the alleged noncompliance indicates there was serious injury, harm, 
impairment or death of a patient or resident, or the likelihood for such, and there 
continues to be an immediate risk of serious injury, harm, impairment or death of a 
patient or resident unless immediate corrective action is taken.  In addition, for nursing 
homes, facility-reported incidents are assigned this priority if immediate jeopardy may 
have occurred, regardless of whether an immediate risk may continue to exist.  Examples 
of intakes that are assigned this priority include, but are not limited to, the following: 
    All intakes alleging abuse of a resident/patient/client and it is uncertain that they 
are adequately protected. 
  For nursing homes, all intakes alleging eviction of a resident to an unsafe 
location. 
  Intakes alleging EMTALA noncompliance may also be assigned this priority. 
  Any hospital self-reported incident of patient death associated with use of 
restraint or seclusion which the RO determines requires an on-site investigation is 
also assigned this priority. 
 
When the SA or RO makes the determination that a complaint or incident report suggests 
an immediate jeopardy may be present, the investigation is to be initiated in accordance 
with Section 5075.9. 
   
See also Section 5310.2A for additional guidance related to nursing home facility-
reported incidents. (Note: Revisions related to the timeframes for investigating nursing 
home complaints and facility-reported incidents will be implemented no later than 
October 1, 2023, to provide time for the SAs to prepare given the resource constraints in 
the SAs.) 
     
Fires Resulting in Serious Injury or Death 
 
Fires resulting in serious injury or death are prioritized as immediate jeopardy.  The 
following actions are taken when a report of a fire resulting in serious injury or death in a 
Medicare/Medicaid certified facility is received from any source: 
 
The SA 
 
  Enters the complaint or self-reported incident into ACTS (Priority = IJ, 
Allegation Category = Life Safety Code); 
 
  Informs the appropriate RO of fire resulting in serious injury or death no 
later than one working day after receipt of the intake;  
 
  Compiles information as needed to present a comprehensive picture of the 
situation surrounding the fire; 
 
  Takes appropriate action necessary to assist the Medicare/Medicaid-
certified provider/supplier to protect and/or relocate residents or patients 
from further harm; and 
 
  Performs the Life Safety Code investigation. 
 
  The RO 
 
  Informs CMS Central Office (CO) of the fire and planned actions, sending 
a copy of the alert to the Life Safety Code specialist;   
  Consults with the CO to determine whether there is an indication for CO 
participation in the survey for program evaluation purposes; 
 
  Reports any findings and actions taken by the SA to the CO at the end of 
the on-site survey; and  
 
  At its discretion, may accompany the SA during the on-site survey. 
 
The CO 
 
  Consults with the RO to determine whether or not issues are present that 
indicate further investigation to determine the adequacy of current 
standards and their application; and 
 
  In certain cases, CO staff may accompany regional and/or state personnel 
on the on-site survey. 
 
5075.2 - Non-Immediate Jeopardy - High Priority (for Nursing Homes 
and Deemed and Non-Deemed Non-Long Term Care 
Providers/Suppliers, and EMTALA) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Nursing Homes: 
 
Intakes are assigned a high priority if the alleged noncompliance with one or more 
requirements may have caused harm that negatively impacts the individuals mental, 
physical and/or psychosocial status and are of such consequence to the persons well- 
being that a rapid response by the SA is indicated.  Usually, specific rather than general 
information (such as:  descriptive identifiers, individual names, date/time/location of 
occurrence, description of harm, etc.) factors into the assignment of this level of priority. 
 
When the SA makes the determination that the alleged noncompliance may have caused 
actual physical and/or psychosocial harm to the resident(s), the SA must initiate an onsite 
survey within an annual average of 15 business days of receipt of the initial report, not to 
exceed 18 business days. Investigating nursing home complaints and facility-reported 
incidents according to these timeframes will be implemented no later than October 1, 
2023, to provide time for the SAs to prepare given the resource constraints in the SAs. 
 
NOTE:  Exhibit 22 provides additional guidance to distinguish between the priorities of 
immediate jeopardy and non-immediate jeopardy - high for nursing home 
complaints/incidents. 
 
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for 
information related to facility responses to alleged violations, including facility 
investigation, resident protection, and corrective actions.   
Non-Long Term Care Providers/Suppliers 
 
Intakes are assigned this priority if the alleged noncompliance with the applicable 
Conditions of Participation, Coverage or Certification, or EMTALA requirements, if 
found to be true and uncorrected, would not represent an IJ, but would result in a 
determination of substantial noncompliance, i.e., at least one condition-level deficiency. 
 
Intakes assigned this priority require an onsite survey to be initiated within 45 calendar 
days after intake prioritization for non-deemed providers/suppliers, and within 45 
calendar days after authorization of the investigation by the RO for deemed status 
providers/suppliers.  The RO has the discretion to request the onsite survey be initiated in 
less than 45 calendar days. 
 
5075.3 - Non-Immediate Jeopardy - Medium Priority (for Nursing 
Homes and Deemed and Non-Deemed Non-Long Term Care 
Providers/Suppliers) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Nursing Homes: 
 
Complaints are assigned a medium priority if the alleged noncompliance with one or 
more requirements caused no actual physical and/or psychosocial harm but there is the 
potential for more than minimal harm to the resident(s) (Severity Level 2).  Facility-
reported incidents are assigned a medium priority if the alleged noncompliance with 
one or more requirements caused no actual physical and/or psychosocial harm but there 
is the potential for more than minimal harm to the resident(s) (Severity Level 2) and the 
facility has not provided an adequate response to the allegation or it is not known 
whether the facility provided an adequate response. For complaints and facility-reported 
incidents that are assigned a medium priority, the SA must initiate an onsite survey 
within 45 calendar days of receipt of the initial report. Investigating nursing home 
complaints and facility-reported incidents according to this timeframe will be 
implemented no later than October 1, 2023, to provide time for the SAs to prepare given 
the resource constraints in the SAs. 
  
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for 
surveyor guidance related to facility responses to alleged violations, including facility 
investigation, resident protection, and corrective actions. 
 
Non-Long Term Care Providers/Suppliers 
 
Intakes are assigned this priority if the alleged noncompliance with one or more standards 
within a Condition of Participation, Condition for Coverage or Condition for Certification 
is limited in manner and degree and/or caused, or may cause, harm that is of limited 
consequence and does not impair the individuals mental, physical and/or psychosocial 
status or function.  In other words, the incident or complaint, if found to be true and  uncorrected, would not result in a determination of substantial non-compliance, i.e., there 
would not be any condition-level deficiency.  
 
For non-deemed providers/suppliers, intakes assigned this priority are scheduled in 
accordance with section 5075.9 for investigation no later than when the next on-site 
survey occurs. 
 
For deemed providers/suppliers, the SA (or RO, if the RO handled the intake) 
advises the complainant that the allegation does not meet the criteria for a Federal 
investigation and refers the complainant to the applicable accrediting 
organization(s)(AOs) in accordance with the provisions of section 5100.2. 
 
5075.4 - Non-Immediate Jeopardy  Low Priority (for Nursing Homes 
and Deemed and Non-Deemed Non-Long Term Care 
Providers/Suppliers) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Nursing Homes 
 Intakes are assigned a low priority if the alleged noncompliance with one or more 
requirements may have caused no actual harm with a potential for minimal harm 
(Severity Level 1).  The investigation is to be initiated in accordance with section 5075.9.  
Investigating nursing home complaints and facility-reported incidents according to 
section 5075.9 will be implemented no later than October 1, 2023, to provide time for the 
SAs to prepare given the resource constraints in the SAs. 
 
In addition, facility-reported incidents are assigned a low priority if the alleged 
noncompliance with one or more requirements may have caused no actual physical 
and/or psychosocial harm but there is the potential for more than minimal harm to the 
resident(s)(Severity Level 2) and the facility has provided a potentially adequate 
response to the allegation.  
 
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for 
information related to facility responses to alleged violations, including facility 
investigation, resident protection, and corrective actions. 
 
The SA reviews these intakes for tracking of possible trends in order to determine if there 
are common themes that suggest areas for focused attention when the next on-site survey 
occurs.  If the SA identifies a trend that suggests similar concerns, the SA either 
investigates the concerns during the next standard or complaint survey or initiates a 
complaint survey.   
  
Non-Long Term Care Providers/Suppliers 
 
Intakes are assigned this priority if the alleged noncompliance with one or more standards 
within a Condition of Participation, Coverage or Certification may have caused physical, 
mental and/or psychosocial discomfort that does not constitute injury or damage.     
For non-deemed providers/suppliers, the SA reviews these intakes for tracking of 
possible trends in the nature of complaints in order to determine if there are common 
themes that suggest areas for focused attention when the next on-site survey occurs.  
Individual investigations of each intake are not required, although the SA has the 
discretion to conduct a complaint survey if trending suggests a number of similar 
problems that might warrant an on-site investigation. 
   
For deemed providers/suppliers, the SA (or RO, if the RO handled the intake) advises 
the complainant that the allegation does not meet the criteria for a Federal investigation 
and refers the complainant to the applicable accreditation organization(s)(AOs) in 
accordance with the provisions of section 5100.2. 
 
 
5075.5 - Administrative Review/Offsite Investigation (for Nursing 
Homes and Deemed and Non-Deemed Non-Long Term Care 
Providers/Suppliers) 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
Nursing Homes 
 
Intakes are assigned an administrative review/offsite investigation priority if an onsite 
investigation is not necessary. However, the SA or RO conducts and documents in the 
provider file an offsite administrative review (e.g., written/verbal communication or 
documentation) to determine if further action is necessary.  Where an administrative 
review/offsite investigation is conducted by the SA, the SA may confirm the findings at 
the next onsite survey. 
 
Non-long Term Care Providers/Suppliers 
 
For non-long term care providers/suppliers, both deemed and non-deemed, administrative 
review or offsite investigation is generally not permitted.  Exceptions are usually limited 
to the following types of cases: 
 
  RO review of alleged noncompliance with provider agreement requirements found in 
42 CFR Part 489, such as:  
 
  Alleged discrimination against Medicare beneficiaries, or  
 
  Failure of a hospital to accept Medicare-like payment rates for treatment 
provided to a patient referred by an Indian Health Service or tribal facility. 
  
  RO review in the case of a CAH:  
 
  Of a notice by the MAC of failure of a CAH to maintain an average annual 
per patient length of stay not exceeding 96 hours, or    
  Whether a relocating CAH or an existing hospital seeking to convert to CAH 
status satisfies the CAH location requirements. 
 
The RO documents in the provider/supplier file the results of such administrative review 
or offsite investigation.  Note:  depending on RO practice, such administrative review 
cases may or may not be entered into ACTS. 
 
5075.6 - Referral  Immediate (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Intakes are assigned a Referral  Immediate priority if the nature and seriousness of a 
complaint/incident or State procedures requires the referral or reporting of this 
information for investigation to another agency, board, or ESRD network without delay.  
 
For example, if a complaint has criminal implications and the complainant has not 
reported the incident to law enforcement, the SA must report the suspected crime to law 
enforcement immediately (NOTE: In such cases, the referral is recorded in the 
Contact/Refer tab under the ACTS intake). This priority may be assigned in addition to 
one of the priorities in sections 5075.1 through 5075.5.  
 
When the SA refers the complaint/incident to another agency or entity (e.g., law 
enforcement, Ombudsman, licensure agency, etc.) for action, the SA must request a 
written report on the results of the investigation by the outside entity. Referral to an 
outside entity does not relieve the SA of the responsibility to assess compliance with 
Federal conditions or requirements, when applicable. The timeframes for investigation 
are not altered by the referral. (Expressed requests by law enforcement that the SA defer 
an onsite investigation should be discussed with the CMS RO, as appropriate.) 
 
 
5075.7 - Referral  Other (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
Intakes are assigned a Referral  Other priority when they are referred to another 
agency, board, or ESRD network for investigation or for informational purposes.  This 
priority may be assigned in addition to one of the priorities in sections 5075.1 through 
5075.5. 
 
When the SA refers the complaint/incident to another agency or entity (e.g., law 
enforcement, Ombudsman, licensure agency, etc.) for action, the SA must request a 
written report on the results of the investigation by the outside entity.  Referral to an 
outside entity does not relieve the SA of the responsibility to assess compliance with 
Federal conditions or requirements, when applicable. The time frames for investigation  are not altered by the referral.  (Expressed requests by law enforcement that the SA defer 
an onsite investigation should be discussed with the CMS RO, as appropriate.) 
 
5075.8 - No Action Necessary (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Intakes are assigned a No Action Necessary priority if the SA or RO determines with 
certainty that no further investigation, analysis, or action is necessary.  
 
For example, no action is necessary if the allegation is not related to any Federal COPs, 
CFCs, conditions for certification, RFPs, or EMTALA requirement(s); or situations in which 
a previous survey investigated the exact same event(s) and either did not find noncompliance, 
or noncompliance was previously identified and subsequently corrected by the 
provider/supplier.  
 
This category would also be used for intakes concerning an event that occurred more than 12 
months in the past, unless the SA (or the RO, in the case of a deemed status 
provider/supplier) determines that a complaint investigation is nevertheless warranted. 
 
Nursing Homes 
 
The following are examples of reports that require no further action or investigation by 
the SA/RO: 
 
1)  Facility-reported incidents that are not reportable events under Federal law or 
regulations; 
 
2)  Facility-reported incidents involving injuries where the resident was able to 
explain or describe how he/she received the injury as long as there is no other 
indication of abuse or neglect;  
 
3)  Facility-reported incidents involving lost items, which are found and no theft is 
suspected; and 
 
4)  The alleged event occurred before the last standard survey and there is sufficient 
evidence that the facility does not have continuing noncompliance since the last 
standard survey. 
 
NOTE: Sufficient evidence that the facility does not have continuing noncompliance may 
be indicated by a recent survey that reviewed the concern, no additional complaints or 
facility reported incidents have been received regarding the same issue, and interview 
with the Long-term Care Ombudsman which reveal no concerns. 
 
  5075.9 - Maximum Time Frames Related to the Federal Onsite Investigation of Complaints/Incidents 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
  Intake Prioritization 
Provider Type  Immediate Jeopardy (IJ)  Non-IJ High  Non-IJ Medium  Non-IJ Low 
Nursing home  SA must initiate an onsite survey  SA must initiate an onsite  SA must initiate an onsite  SA must track/trend for 
complaints   within 3 business days of receipt of  survey within an annual  survey within 45 calendar  potential focus areas during 
the initial report.  average of 15 business days  days of receipt of the initial  the next onsite survey, or 
of receipt of the initial report,  report.  initiate a new complaint 
not to exceed 18 business  survey. 
days. 
Nursing home  With inadequate resident protection,  SA must initiate an onsite  With an inadequate facility  With a potentially adequate 
incidents  SA must initiate an onsite survey  survey within an annual  response, SA must initiate an  facility response, SA must 
within 3 business days of receipt of  average of 15 business days  onsite survey within 45  track/trend for potential focus 
the initial report.  of receipt of the initial report,  calendar days of receipt of  areas during the next onsite 
  not to exceed 18 business  the initial report.  survey, or initiate a new 
With potentially adequate resident  days.    complaint survey. 
protection, SA must initiate an onsite   
survey within 7 business days of 
receipt of the initial report. 
See Section 5310.2A. 
Non-deemed non-long  SA must initiate an onsite survey  SA must initiate an onsite  SA must investigate no later  SA must track/trend for 
term care  within 2 business days of receipt.  survey within 45 calendar  than when the next onsite  potential focus areas during 
providers/suppliers  days of prioritization  survey occurs   the next onsite survey. 
Deemed  SA must initiate an onsite survey  SA must initiate an onsite  Complainant is referred to the  Complainant is referred to the 
providers/suppliers  within 2 business days of receipt of  survey within 45 calendar  applicable accrediting  applicable accrediting 
RO authorization  days of receipt of RO  organization(s)  organization(s) 
authorization. 
EMTALA  SA must initiate an onsite survey  SA must initiate an onsite  N/A  N/A 
within 2 business days of receipt of  survey within 45 calendar 
RO authorization.  days of receipt of RO 
authorization 
Death associated with  SA must initiate an onsite survey  N/A  N/A  N/A 
restraint/seclusion- within 2 business days of receipt of 
Hospitals  RO authorization. 
Fires resulting in  SA must initiate an onsite survey  N/A  N/A  N/A 
serious injury or death  within 2 business days of receipt.   
Investigating nursing home complaints and facility-reported incidents according to section 5075.9 will be implemented no later than 
October 1, 2023, to provide time for the SAs to prepare given the resource constraints in the SAs. 5077 - State Monitoring Visits 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
State monitoring visits refers to visits by the SA to oversee a providers/suppliers 
compliance status: 
 
  During bankruptcy, in those cases in which CMS has authorized such visits. 
 
  After a change of ownership, as authorized by the CMS RO. 
 
  During or shortly after removal of immediate jeopardy when the purpose of the 
visit is to ensure the welfare of the residents/clients/patients by providing an 
oversight presence, rather than to perform a structured follow-up visit. 
 
  In other circumstances, as authorized by the CMS RO. 
 
See Section 5060 for data entry requirements for this type of visit. 
 
5078  Pre-Survey Activities 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
To assist in planning the complaint investigation, prior to going on-site the SA should 
review the providers or suppliers prior compliance record and, as applicable, quality 
indicators, ESRD Outcome List and Data or supporting information received from other 
programs, such as the Ombudsman program or Protection and Advocacy program.  This 
process may require additional contact with the complainant.   More information on pre-
survey activities may be found in Section 5170 for ESRD facilities, Section 5300.1 for 
long term care facilities, in the provider/supplier-specific SOM appendices and in 
Appendix V concerning EMTALA of the SOM.)  
 
5079  Entrance Conference - Non-Long Term Care 
Providers/Suppliers 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
Onsite complaint investigations must always be unannounced. Upon entrance, advise the 
provider/supplier CEO or other senior official on duty of the general purpose of the visit.  
The SA explains the reason for the survey and avoids any impression that a 
predetermination has been made as to the validity of the allegation.  It is important to let 
the facility know why you are there, but to also protect the confidentiality of those 
involved in the complaint.  Do not release information that will cause opportunities to be 
lost for pertinent observations, interviews, and record reviews required for a thorough 
investigation. For example, in the case of a hospital, critical access hospital or ambulatory 
surgical center, if the complaint is that a patient developed a life-threatening infection in 
a post-surgical wound, do not tell the facility the exact complaint.  Rather, tell them it is a 
situation related to infection control for surgical patients.   Another example, in the case 
of a long term care facility, would be when a complaint that food that is intended to be 
  served hot is always served cold.  In this case, do not tell the provider the exact 
complaint. Rather, tell them it is a situation related to dietary requirements. 
 
(See Section 5300.2 for guidance on the entrance conference for long term care facilities 
as well as the provider/supplier-specific appendices of the SOM, and Appendix V of the 
SOM concerning EMTALA.) 
 
5080 - Investigation Findings and Reports 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Each SA establishes reporting policies, procedures and formats including report language 
targeted to specific audiences. 
 
5080.1 - Report to the Complainant 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The SA/CMS location provides the complainant a written report of the investigation 
findings as a summary record of the investigation. 
 
The following principles guide preparation of the report to the complainant: 
 
  Acknowledge the complainants concern(s);  
 
  Identify the SAs regulatory authority to investigate the complaint/incident and 
any statutory or regulatory limits that may bear on the authority to conduct an 
investigation;  
 
  Provide a summary of investigation methods (e.g., on-site visit, written 
correspondence, telephone inquiries, etc.);  
 
  Provide date(s) of investigation;  
 
  Provide an explanation of your SAs decision-making process (NOTE: CMS and 
the SA should avoid using terms such as substantiated and unsubstantiated);   
 
  Provide the complainant with information regarding whether or not 
noncompliance was identified during the complaint investigation. (NOTE:  To 
the extent possible, the summary should not compromise the anonymity of 
individuals, or include specific situations that may be used to identify individuals, 
when anonymity has been requested or is appropriate in the judgment of the SA);  
 
  Identify where the complainant may find the Statement of Deficiencies and Plan of 
Correction (e.g., posted at the nursing home, Nursing Home Care Compare, 
request the CMS-2567 from the SA); 
 
    Describe how the complainant may request a copy of the investigation report, 
subject to Federal and State disclosure requirements (e.g., see 42 CFR 488.325 
and FOIA requirements at 45 CFR Part 5); and  
 
  Identify appropriate referral information (i.e., other agencies that may be 
involved). 
 
5080.2 - Survey Exit Conference and Report to the Provider/Supplier 
(Rev. 155, Issued: 06-10-16, Effective: 06-10-16, Implementation: 06-10-16) 
 
Generally, the SA conducts an exit conference with the provider/supplier at the 
completion of the on-site portion of the complaint investigation survey. The SA informs 
the provider/supplier of the survey findings, including a general description of any 
deficiencies found.  The description should be detailed enough to inform the 
provider/supplier of the types of activities that require the providers/suppliers corrective 
action.  However, the SA must not comment on the scope and severity of the deficiencies 
identified for long term care facilities.  For non-long term care providers/suppliers, the 
SA must not comment on manner and degree, that is, whether the deficiencies identified 
were condition- or standard-level.  Surveyors must also not make reference to any Tags 
related to deficiencies identified in non-long term care as this identifies condition- or 
standard-level.  Instead identify the regulatory grouping where concerns exist.  See 
Section 2724 for additional information about presenting findings during the Exit 
Conference. 
 
For non-long term care providers/suppliers, the SA must not provide a list of patients 
interviewed, observed, or whose medical records were reviewed, and does not identify 
specific patients whose cases are associated with specific deficiencies.  (The 
provider/supplier has the right to request a copy of any documentation the surveyors copy 
to support deficiency findings; therefore the provider/supplier should have enough 
information after the exit conference to begin corrective actions.) 
 
The SA informs the provider/supplier that survey findings will be documented on Form 
CMS 2567, which will be sent to the provider/supplier and subsequently will be made 
available to the public under the disclosure of survey information provisions.  For 
deemed providers/suppliers, the SA informs the provider/supplier that the RO will be 
consulted and (depending on RO practice), either the RO or the SA will inform the 
facility of the results of the survey investigation via the Form CMS 2567. 
 
The SA/RO sends to the provider/supplier a written report of the investigation findings as 
a summary record of the investigation. At a minimum, this would include the Form CMS 
2567 and applicable notices.  For surveys of deemed providers/suppliers (not including 
EMTALA surveys), the RO sends a copy of the written report to the applicable 
accrediting organization(s), following the procedures specified in Section 5110.  At the 
ROs or SAs discretion, the materials may be sent to the accrediting organization via e-
mail. 
 
  (See Section 5300.5 for guidance on the exit conference for long term care facilities, 
Section 5440.5 for EMTALA investigations, as well as the provider/supplier-specific 
appendices of the SOM, and Appendix V of the SOM concerning EMTALA.) 
 
NOTE: Sections 5300 to 5390 relate to nursing homes. 
 
5100 - Investigation of Complaints for Deemed Providers/Suppliers 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
Sections 5100 - 5130 apply to all deemed providers and suppliers, with the exception 
of clinical laboratories subject to the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA).  See Sections 5500  5590 for CLIA information, 
including investigation of complaints related to accredited laboratories. 
 
5100.1 - Basis for Investigation 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
Sections 1864(c) and 1865 of the Social Security Act (the Act) provide the basis for 
conducting substantial allegation validation  i.e., complaint investigation - surveys of 
deemed providers/suppliers.  Before the SA may conduct a complaint investigation 
survey at a deemed provider/supplier, it must receive authorization to do so from the RO.  
In accordance with 42 CFR 488.7, the RO may authorize a complaint investigation only 
in response to a substantial allegation of noncompliance.  A substantial allegation of 
noncompliance is defined at 42 CFR 488.1 as a complaint from any of a variety of 
sources, including complaints submitted in person, by telephone, through written 
correspondence, or in news media articles, that, if substantiated, would have an impact on 
the health and safety of patients, and that raises doubts as to a providers or suppliers 
compliance with any Medicare condition.   In other words, the complaint, if verified and 
uncorrected at the time of the survey, would result in a condition-level deficiency 
citation.  The SA survey conducted in response to a substantial allegation is one type of 
validation survey.   
 
NOTE:  Deemed status is irrelevant for EMTALA complaints.  Hospitals and CAHs may 
not be deemed to be in compliance with EMTALA requirements at 42 CFR 489.24 and 
the related requirements at 42 CFR 489.20, since these requirements are not part of an 
approved Medicare hospital or CAH Medicare accreditation program.  SAs must refer all 
EMTALA-related allegations concerning a hospital or CAH to the RO, regardless of 
whether the hospital or CAH is deemed or not.  The provisions of Section 5100 do not 
apply to EMTALA investigations. 
 
The SA must notify the RO of all complaints/incidents it receives which, if substantiated, 
would by their manner and degree suggest condition-level noncompliance.  The RO 
authorizes the SA to conduct a complaint investigation if it concurs that the nature of the 
allegation, if it were true and uncorrected, suggests condition-level noncompliance.  If the 
RO does not concur that the allegation rises to this level, either the RO will change the 
prioritization of the intake in ACTS to the appropriate level or it will instruct the SA to 
  do so.  Regardless of who makes the change in ACTS, the RO instructs the SA to refer 
the complainant to the applicable accrediting organization, following the procedures in 
section 5100.2 
 
The RO communicates its authorization to conduct a complaint investigation of the 
deemed provider/supplier by completing the applicable Form CMS 2802 (See Exhibit 33) 
in ACTS, indicating which Conditions of Participation or Conditions for Coverage or 
Certification are to be investigated by the SA.  Absent RO authorization, the SA may not 
conduct a Federal complaint investigation of the deemed provider/supplier.  The SA may 
have authority under State law to conduct its own non-Federal investigation.  
 
The RO completes the Form CMS 2802 in ACTS even if the SA received an initial verbal 
authorization from the RO to initiate the complaint survey of a deemed provider/supplier.  
Since ACTS allows the RO to authorize a complaint survey electronically it is not 
necessary for the RO to send a signed hard copy of the Form CMS 2802 to the SA via fax 
or U.S. Postal Service.  Once the SA receives the authorization, it may begin its 
complaint investigation of a deemed provider/supplier.  Whether the survey is of one or 
all Medicare conditions, it will be treated as a complaint survey under ACTS rather than a 
re-certification survey, since the complaint/incident is the basis for the survey.  
 
If the RO learns directly of a complaint/incident concerning a deemed provider/supplier, 
it will review the complaint/incident to assign a priority consistent with Section 5075.  If 
the complaint/incident is found to be a substantial allegation of noncompliance, 
prioritized for investigation as either immediate jeopardy or non-IJ high, the RO 
authorizes the SA to conduct a complaint investigation or, in a limited number of cases, 
the RO conducts the complaint investigation.  
 
There may be occasions during the course of a State-only activity in a deemed 
provider/supplier when State surveyors observe a situation they believe may constitute IJ 
or other substantial noncompliance with a Medicare condition.  In such circumstances, 
the State must contact the RO by telephone or e-mail, explain the situation, and request 
authorization to conduct a Federal complaint survey.  CMS authorizes the investigation 
as a complaint validation (i.e., substantial allegation validation) survey if it concurs that 
there may be condition-level noncompliance. The complaint is entered into ACTS at the 
earliest possible opportunity. 
 
5100.2  Initial Response to Complainant 
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14) 
 
  If the SA concludes that a complaint represents a substantial allegation of 
noncompliance (i.e., it is appropriately triaged as an IJ or non-IJ high), it requests 
authorization in ACTS from the RO to conduct a survey.  If the RO authorizes a 
survey, the SA acknowledges receipt of the complaint by a letter to the complainant, 
and advises that a SA investigation will be initiated.   The acknowledgment letter also 
advises that the complainant may also wish to file a complaint with the applicable 
accrediting organization (AO), naming the AO and attaching a current list of AOs and 
  their contact information.  This list may be found at:  
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-
Complaint-Contacts.pdf    
 
  If the SA concludes that a complaint does not represent a substantial allegation of 
noncompliance (i.e., it is appropriately triaged as non-IJ medium or low) the SA 
sends the complainant a letter indicating that the complaint does not meet the criteria 
for a Federal on-site investigation of an accredited health care facility.  The letter also 
advises the complainant which AO(s) accredit the provider/supplier for Medicare 
participation purposes and provides the above AO contact information, should the 
individual wish to pursue a complaint with the AO.   
 
If the RO directly receives a complaint, it is responsible for sending the complainant a 
letter which acknowledges the receipt of the complaint and advises the complainant in the 
same manner as indicated above for complaints received by the SA. 
 
5110 - Post-Survey Procedures 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
5110.1 - Substantial Compliance 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
If a condition-level deficiency is not cited at a survey, the provider/supplier is in 
substantial compliance with the Federal requirements.  The SA certifies its survey 
findings in ACTS within 30 calendar days after the completion of the survey.  A Form 
CMS 2567 is prepared in all cases.  Even if no deficiencies were cited, the Form CMS 
2567 is issued with a statement that a survey was conducted to evaluate compliance with 
the listed requirements identified on the CMS-2802 and that no deficiencies were 
identified in these areas. 
 
The RO randomly selects several Form CMS 2567s with standard-level deficiencies for 
review to determine if the RO concurs with the SAs finding of substantial compliance.   
 
  For all cases not selected for review of the Form CMS 2567, the RO completes 
the processing in ACTS of the complaint investigation Form CMS 562 and other 
applicable items in ACTS, and then, depending on RO practice, either the SA or 
RO uploads the complaint survey package into CASPER, the CMS National 
Reporting System. 
 
  For cases selected for review of the Form CMS 2567: 
 
  If the RO concurs with the finding, the RO completes the processing in 
ACTS of the complaint investigation Form CMS 562 and other applicable 
items in ACTS, and then, depending on RO practice, either the SA or RO 
  uploads the complaint survey package into CASPER, the CMS National 
Reporting System. 
 
  If the RO does not concur with the SAs findings of substantial 
compliance, the RO discusses with the SA any revisions needed on the 
Form CMS 2567 and, after the revisions are made, follows the procedures 
for a survey finding substantial noncompliance.  (See Section 5110.2 or 
5110.3, as applicable.) 
 
The RO either issues a notice, or authorizes the SA in ACTS to issue the 
provider/supplier a notice of its compliance status.  The RO or SA, as applicable, issues 
this notice to the provider/supplier, along with a copy of the Form CMS 2567containing 
the survey findings. The notice indicates that the provider/supplier was found to be in 
substantial compliance even though there may, or may not, also be standard-level 
deficiencies cited.  In such circumstances, the provider/supplier is not required to submit 
a plan of correction for any cited standard-level deficiencies, but may choose to do so 
because the Form CMS 2567 is available to the public.  The SA and RO do not review 
any plan of correction the provider/supplier submits; no revisit survey is conducted.  The 
RO promptly sends a copy of the notice letter and Form CMS 2567 to the applicable 
AO(s).  At the ROs or SAs discretion, the materials may be sent to the AO via e-mail. 
 
5110.2 - Condition-Level, IJ 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
1.  IJ Removed while the SA is On-site 
 
If deficiencies pose an IJ and the IJ is removed while the SA is on-site, deficiency 
citations are made at the condition-level.  Follow the procedure for condition-level 
noncompliance, non-IJ, in Section 5110.3 below. 
 
Note:  The Form CMS 2567 must state at the beginning that an IJ was cited, regardless of 
the fact that it was removed while the SA was on-site.   An entry in ASPEN/ACTS must 
also be made by the RO indicating that there was an IJ citation before the survey can be 
uploaded to the national database, the CMS National Reporting System (CASPER).  The 
ASPEN/ACTS systems will prompt the RO whenever a survey includes condition-level 
deficiencies to indicate whether there was also an IJ. 
 
Details of the IJ situation and the actions taken by the provider/supplier to remove the IJ 
must also be documented on the Form CMS 2567.  Even though the IJ was removed 
while the SA was on-site, the provider or supplier must still be cited for condition-level 
noncompliance for the applicable Condition of Participation, Condition for Coverage, or 
Condition for Certification that is cited for non-compliance related to the IJ.  The 
documentation must also include the date the surveyors verified that the IJ was removed 
prior to completion of the survey.  
 
 
  2.  IJ not Removed while the SA is On-site 
 
If condition-level deficiencies pose an IJ and the IJ is not removed while the SA is on-
site, the SA certifies its findings in ACTS within 2 working days after the completion of 
the survey. 
 
If the RO concurs with the SAs findings, the deemed provider/supplier is placed on a 23 
calendar-day termination track.  The RO sends the provider/supplier the Form CMS 
2567, notifies the provider/supplier of the proposed termination action and effective date, 
which is 23 calendar days after the date of the ROs notice, and requests submission of an 
acceptable plan of correction to the RO within 5 calendar days of the notice.  The 
provider/supplier is advised it will be surveyed after receipt of an acceptable plan of 
correction and prior to the termination date.  The notice also contains a statement that 
removes the deemed status of the provider/supplier and places it under SA 
jurisdiction. 
 
The RO sends a copy of the notice to the SA and a copy of the notice and Form CMS 
2567 to the applicable AO(s).  At the ROs discretion, the materials may be sent to the 
AO via e-mail. 
 
Note:  Although deemed status technically has been removed and the provider/supplier is 
placed under SA jurisdiction, because it is expected that deemed status will be restored 
once corrections are made and verified, no change is made in ASPEN to the 
providers/suppliers deemed status.  However, periods during which the 
provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.  Further, 
the AO may also conduct a survey of the facility, so long as it continues to accredit the 
provider/supplier under its approved Medicare accreditation program. 
 
When the RO receives a timely and acceptable plan of correction from the 
provider/supplier, it directs the SA to conduct either a full survey or an IJ follow-up 
survey, which is a focused, revisit-type survey, before the scheduled termination date in 
order to confirm that the IJ has been removed and that the provider/supplier is in 
substantial compliance.  See Section 5110.3 for a discussion of factors the RO should 
consider when deciding whether a full survey is needed.  If the RO authorizes a full 
survey, see Section 5110.4 for procedures to follow, except that the full survey must be 
conducted prior to the 23-day termination date. 
 
i.  No Acceptable Plan of Correction Submitted 
 
No revisit is necessary if the provider/supplier fails to submit a timely and 
acceptable plan of correction.  CMS will proceed to terminate a provider/supplier 
if it does not submit a timely and acceptable POC.  See SOM Section 3254F.  The 
public notice must be published 15 calendar days prior to the termination date.  
The RO notifies the applicable Medicare Administrative Contractor (MAC) via 
the Form CMS 2007 of the termination of the provider/suppliers Medicare 
agreement, including the effective date of the termination. 
   
The RO completes the processing in ACTS of the complaint investigation Form 
CMS 562 and other applicable items in ACTS and then, depending on RO 
practice, either the SA or RO uploads the complaint survey package into 
CASPER, the CMS National Reporting System. 
 
The RO sends a copy of the termination letter to the applicable AO(s).  At the 
ROs discretion, the copy may be sent to the AO via e-mail. 
 
ii.  Post-IJ First Revisit:  IJ Not Removed 
 
At least 5 calendar days in advance of the scheduled termination date, the SA 
certifies to the RO in ACTs its findings, based on on-site verification, that the IJ 
has not been removed, and recommends that the termination action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO completes the processing in ACTS of the complaint 
investigation Form CMS 562 and other applicable items in ACTS and then, 
depending on RO practice, either the SA or RO uploads the complaint survey 
package into the CMS National Reporting System (CASPER).  The termination of 
the providers/suppliers Medicare agreement is processed in ASPEN. 
 
The RO sends the provider/supplier a final termination letter and publishes a 
public notice, in accordance with the termination process in Section 3010B. The 
provider/supplier is terminated from the Medicare program.  The RO notifies the 
applicable Medicare Administrative Contractor (MAC) via the Form CMS 2007 
of the termination of the provider/suppliers Medicare agreement, including the 
effective date of the termination. 
 
The RO sends a copy of the termination notice and the Form CMS 2567 to the 
applicable AO(s).  At the ROs discretion, the materials may be sent to the AO via 
e-mail. 
 
iii.  Post-IJ First Revisit:  IJ Removed, Substantial Compliance 
 
The termination action is rescinded if the IJ has been removed and substantial 
compliance has been achieved prior to the effective date of the termination, i.e., 
there are no condition-level deficiencies identified during the follow-up survey by 
the SA. The SA certifies its findings to the RO via ACTS at least 5 calendar days 
in advance of the scheduled termination date, and recommends that the 
termination action be rescinded. 
 
The RO randomly selects several Form CMS 2567s with standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding of 
substantial compliance.  If the RO concurs, and in all other cases where the Form 
CMS 2567 is not reviewed by the RO, the RO completes the processing in ACTS 
  of the complaint investigation Form CMS 562 and other applicable items in 
ACTS, and then, depending on RO practice, either the SA or RO uploads the 
complaint survey package into CASPER, the CMS National Reporting System.  If 
the RO does not concur with the SAs finding, the RO discusses with the SA any 
revisions needed on the Form CMS 2567 and, after the revisions are made, 
follows the procedures for substantial noncompliance.  
 
When substantial compliance is achieved, the RO either issues a notice, or 
authorizes the SA in ACTS to issue the provider/supplier a notice of its 
compliance status, restoring its deemed status.  The RO or SA, as applicable, 
issues this notice to the provider/supplier, along with a copy of the Form CMS 
2567 containing the survey findings.  
 
In addition, the RO sends a copy of the notice letter to the applicable AO(s).  At 
the ROs discretion, the copy may be sent to the AO via e-mail. 
  
Although the follow-up survey found the provider/supplier to be in substantial 
compliance, it may have resulted in citation(s) of standard-level deficiencies of 
the Form CMS 2567.  Because deemed status has been restored, the 
provider/supplier is not obligated to submit a plan of correction to the SA, nor are 
any further revisits conducted.  The provider/supplier may voluntarily choose to 
submit a plan of correction because the Form CMS 2567 will be made available to 
the public.   The SA and RO do not review any plan of correction the 
provider/supplier submits; no further revisit survey is conducted. 
 
iv.  Post-IJ First Revisit:  IJ Removed, Substantial Noncompliance Remains 
 
If the IJ has been removed but substantial noncompliance (i.e., condition-level 
deficiencies), remain, the SA certifies its findings to the RO in ACTS within 10 
working days after the survey completion date.  The SA certifies that the IJ has 
been removed and recommends rescission of the 23 calendar-day IJ termination 
action, but continuation of the termination action on a 90 calendar-day 
termination track. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO gives the provider/supplier up to 67 additional calendar 
days, or a total of 90 calendar days (23 plus 67) to achieve substantial compliance.  
The resulting revised termination date is 90 calendar days after the date of the 
ROs original 23-day notice.  The RO sends the CMS Form 2567 from the follow-
up survey to the provider/supplier with notice of the new termination date, and 
requests that an acceptable POC be provided to the SA within 10 calendar days of 
the notice. 
 
Post-IJ Second Revisit:  The SA conducts the second revisit survey by the 60th 
calendar day after the date of the ROs original 23-day termination notice.  Unlike the 
post-IJ first revisit survey, advance authorization from the RO is not required. 
   
(i)  Post-IJ Second Revisit Survey Findings:  Substantial Compliance 
 
The termination action is rescinded if substantial compliance (i.e., no 
condition-level deficiencies) is achieved and documented through the onsite 
verification at the revisit survey.  There may or may not be standard-level 
deficiencies cited.  Within 10 working days after the completion of the revisit 
survey, the SA certifies to the RO its findings via ACTS and recommends that 
the termination action be rescinded. 
 
The RO randomly selects some Form CMS 2567s with only standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding 
of substantial compliance.  If the RO concurs, and in all other cases where the 
Form CMS 2567 is not reviewed by the RO, the RO completes the processing 
in ACTS of the complaint investigation Form CMS 562 and other applicable 
items in ACTS and then, depending on RO practice, either the SA or the RO 
uploads the complaint survey package into CASPER, the CMS National 
Reporting System.  If the RO does not concur, the RO discusses with the SA 
revisions needed on the Form CMS 2567 and, after the revisions are made, 
follows the procedures for substantial noncompliance. 
 
The RO either issues a notice, or authorizes the SA in ACTS to issue a notice 
to the provider/supplier of its compliance status and that its deemed status is 
restored.  The RO or SA, as applicable, issues this notice to the 
provider/supplier, along with a copy of the Form CMS 2567 with the survey 
findings.  
 
The RO sends a copy of the notice and Form CMS 2567 to the applicable 
AO(s).   At the ROs discretion, the materials may be sent to the AO via e-
mail. 
 
i.  Post-IJ Second Revisit Survey Findings:  Substantial Noncompliance 
 
If the second revisit shows that the provider/supplier fails to demonstrate 
substantial compliance (i.e., condition-level deficiencies are identified through 
on-site verification by the SA), the SA certifies to the RO its findings within 
10 calendar days after the survey completion date, and recommends that the 
termination action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO sends the provider/supplier a final termination letter 
and publishes a public notice 15 calendar days prior to the termination date. 
The provider/supplier is terminated from the Medicare program.  The RO 
notifies the applicable Medicare Administrative Contractor (MAC) via the 
Form CMS 2007 of the termination of the provider/suppliers Medicare 
agreement, including the effective date of the termination. 
   
The RO completes the processing in ACTS of the complaint investigation 
Form CMS 562 and other applicable items in ACTS and then, depending on 
RO practice, either the SA or RO uploads the complaint survey package into 
CASPER.  The providers or suppliers Medicare agreement is terminated in 
ASPEN. 
 
The RO sends a copy of the final termination notice and Form CMS 2567 to 
the applicable AO(s).  At the ROs discretion, the materials may be sent to the 
AO via e-mail. 
 
5110.3 - Condition-Level, Non-IJ 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
If the provider/supplier fails to demonstrate substantial compliance, i.e., condition-level 
deficiencies are identified by the SA, but they do not pose an IJ, the SA certifies its 
findings to the RO via ACTS within 10 working days after the survey completion date. 
 
The RO reviews the SAs findings, and if it concurs with the SAs recommendation, the 
RO either places the deemed provider/supplier on a 90 calendar-day termination track or 
it requires a full survey after a complaint survey. 
 
In determining whether to exercise its discretion to require a full survey for deemed 
providers and suppliers, the RO may consider factors including, but not limited to, the 
following: 
 
  The manner and degree of noncompliance identified as a result of the complaint 
investigation; 
 
  The providers/suppliers compliance history; 
 
   Recent changes in the providers/suppliers ownership or management; 
 
  The length of time since the providers/suppliers last accreditation survey; 
 
  The availability of SA resources at the time required to conduct a full survey; 
and/or 
 
  The advantages associated with conducting a more extensive survey compared to 
the advantages associated with the faster enforcement (and thus a faster potential 
corrective action) that result when proceeding directly to enforcement action after 
the complaint survey. 
 
Paragraph a) below discusses the procedures when the RO does not require a full 
survey after the complaint survey; paragraph b) discusses the procedures to follow 
when the RO directs the SA to conduct a full survey. 
   
a)  No full survey  proceed directly to termination track based on the complaint 
survey 
 
If the RO places the deemed provider/supplier on a 90 calendar-day termination track 
as a result of the complaint investigation, it sends the provider/supplier the Form 
CMS 2567, notifies the provider/supplier of the proposed termination action and 
effective date, which will be 90 calendar days after the date of the ROs notice.  The 
RO requests submission of an acceptable plan of correction to the SA within 10 
calendar days.  The notice also contains a statement that removes the deemed 
status of the provider/supplier and places it under SA jurisdiction. 
 
The RO sends a copy of the notice to the SA and a copy of the notice and Form CMS 
2567 to the applicable AO(s).  At the ROs discretion, the materials may be sent to 
the AO via e-mail. 
 
NOTE:  Although deemed status has technically been removed and the 
provider/supplier is placed under SA jurisdiction, because it is expected that deemed 
status will be restored once corrections are made and verified, no change is made in 
ASPEN to the providers/suppliers deemed status.  However, periods during which 
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.  
Further, the AO may also conduct a survey of the facility so long as it continues to 
accredit the provider/supplier. 
 
The SA conducts a complaint survey revisit after the SA has received a timely and 
acceptable plan of correction, but no later than the 45th calendar day after the notice 
to the provider/supplier. 
 
1)  No Timely, Acceptable Plan of Correction Submitted 
 
If the provider/supplier fails to submit a timely and acceptable plan of correction 
to the SA and as a result the SA is unable to conduct a timely revisit before the 
termination date, the SA notifies the RO and the RO may proceed with 
termination.  See SOM Section 3254F.  The RO publishes a public notice 15 days 
prior to the termination date.  The RO notifies the applicable Medicare 
Administrative Contractor (MAC) via the Form CMS 2007 of the termination of 
the provider/suppliers Medicare agreement, including the effective date of the 
termination. 
 
The RO approves the complaint investigation Form CMS 562 and other 
applicable items in ACTS and then, depending on RO practice, either the SA or 
RO uploads the complaint survey package into the CMS National Reporting 
System (CASPER).  The providers or suppliers Medicare agreement is 
terminated in ASPEN. 
 
  Additionally, the RO sends a copy of the notice of termination letter to the 
applicable AO(s).   
 
2)  First Revisit Survey Findings:  Substantial Compliance 
 
The termination action is rescinded if substantial compliance (i.e., no condition-
level deficiencies) is achieved and documented through the onsite verification at 
the first revisit survey.  There may or may not be standard-level deficiencies cited.  
Within 10 working days after the completion of the revisit survey, the SA certifies 
to the RO in ACTS its findings and recommends that the termination action be 
rescinded. 
 
The RO randomly selects several Form CMS 2567s with standard-level 
deficiencies for review to determine if the RO concurs with the SAs finding of 
substantial compliance. 
 
  For all cases not selected for review of the Form CMS 2567, the RO 
completes the processing in ACTS of the complaint investigation Form CMS 
562 and other applicable items in ACTS, and then, depending on RO practice, 
either the SA or RO uploads the complaint survey package into CASPER, the 
CMS National Reporting System. 
 
  For cases selected for review of the Form CMS 2567: 
 
  If the RO concurs with the finding, the RO completes the processing in 
ACTS of the complaint investigation Form CMS 562 and other 
applicable items in ACTS, and then, depending on RO practice, either 
the SA or RO uploads the complaint survey package into CASPER, 
the CMS National Reporting System. 
 
  If the RO does not concur with the SAs findings of substantial 
compliance, the RO discusses with the SA any revisions needed on the 
Form CMS 2567 and, after the revisions are made, follows the 
procedures for a survey finding substantial noncompliance.  (See 
Section 5110.2 or 5110.3, as applicable.) 
 
The RO either issues a notice, or authorizes the SA in ACTS to issue a notice to 
the provider/supplier of its compliance status and that its deemed status is 
restored.  The RO or SA, as applicable, issues this notice to the provider/supplier, 
along with a copy of the Form CMS 2567 with the survey findings.  
 
The RO sends a copy of the notice and Form CMS 2567 to the applicable AO(s).  
At the ROs discretion, the materials may be sent to the AO via e-mail. 
 
3)  First Revisit Survey Findings:  Substantial Noncompliance 
 
  If the SA finds during the first revisit survey that the provider/supplier is not in 
substantial compliance with one or more Medicare conditions, the SA consults 
with the RO on its findings and whether to conduct a second revisit.  If the RO 
agrees that condition-level deficiencies remain, the RO considers whether the 
survey findings warrant a second revisit or proceeding immediately to 
termination.  Generally the RO authorizes a second revisit, but the RO has 
discretion to make an exception, based on the facts of the situation.  For example, 
if the SA and RO determine that an immediate jeopardy was present during the 
first revisit, the RO might find it prudent to proceed to termination without a 
second revisit. 
 
If the RO agrees that condition-level deficiencies remain and does not authorize a 
second revisit, the RO and SA follow the procedures outlined in paragraph 3ii. 
below. 
 
If a second revisit is authorized by the RO, the SA sends the provider/supplier the 
Form CMS 2567 for the first revisit with notice that substantial noncompliance 
remains, the 90-day termination date remains in effect, a new acceptable plan of 
correction is required, and that an additional revisit will be conducted prior to the 
termination date.  The SA conducts the second revisit no later than 60 calendar 
days after the date of the termination notice.  
 
i.  Second Revisit Survey Findings:  Substantial Compliance 
 
If substantial compliance is achieved by the provider/supplier (i.e., no 
condition-level deficiencies are identified through the on-site verification by 
the SA), the SA certifies its findings to the RO via ACTS within 10 working 
days after the survey completion date, and recommends that the termination 
action be rescinded. 
 
The RO randomly selects some Form CMS 2567s with only standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding 
of substantial compliance.  If the RO concurs, and in all other cases where the 
Form CMS 2567 is not reviewed by the RO, RO completes the processing in 
ACTS of the complaint investigation Form CMS 562 and other applicable 
items in ACTS and then, depending on RO practice, either the SA or RO 
uploads the complaint survey package into CASPER, the CMS National 
Reporting System.  If the RO does not concur, the RO discusses with the SA 
revisions needed on the Form CMS 2567 and, after the revisions are made, 
follows the procedures for substantial noncompliance. 
 
The RO either issues a notice, or authorizes the SA in ACTS to issue the 
provider/supplier a notice letter of its compliance status and that its deemed 
status is restored.  The RO or SA, as applicable, forwards this notice to the 
provider/supplier, along with a copy of the Form CMS 2567 with the survey 
findings.  
   
Additionally, the RO sends a copy of the notice and the Form CMS 2567 to 
the applicable AO(s).  At the ROs discretion, the materials may be sent to the 
AO via e-mail. 
 
ii.  Second Revisit Survey Findings  Substantial Noncompliance 
 
If the second revisit survey shows that the provider/supplier fails to 
demonstrate substantial compliance (i.e., condition-level deficiencies are 
identified through on-site verification by the SA), the SA certifies its findings 
to the RO via ACTS within 10 calendar days after the survey completion date, 
and recommends that the termination action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO sends the provider/supplier a final termination letter 
and publishes a public notice at least 15 calendar days prior to the termination 
date, consistent with the requirements of Section 3012. The provider/supplier 
is terminated from the Medicare program.  The RO notifies the applicable 
Medicare Administrative Contractor (MAC) via the Form CMS 2007 of the 
termination of the provider/suppliers Medicare agreement, including the 
effective date of the termination. 
 
The RO completes the processing in ACTS of the complaint investigation 
Form CMS 562 and other applicable items in ACTS and then, depending on 
RO practice, either the SA or RO uploads the complaint survey package into 
CASPER, the CMS National Reporting System.  The providers or suppliers 
Medicare agreement is terminated in ASPEN.   
 
Additionally, the RO sends a copy of the termination notice and the Form 
CMS 2567 to the applicable AO(s).  At the ROs discretion, the materials may 
be sent to the AO via e-mail.   
 
b)  Full Survey After the Complaint Survey 
 
If the RO directs the SA to conduct a full survey following the complaint survey, it 
sends the Form CMS 2567 for the complaint survey to the provider/supplier in 
addition to a notice letter indicating that it is removing the providers/suppliers 
deemed status and that a full survey will be conducted on an unannounced basis.   
The provider/supplier is not required to submit a plan of correction in response to the 
complaint survey findings, but may choose to do so. 
 
The RO completes the processing in ACTS of the complaint investigation Form CMS 
562 and other applicable items in ACTS and then, depending on RO practice, either 
the SA or RO uploads the complaint survey package into CASPER, the CMS 
National Reporting System. 
 
  Additionally, the RO sends a copy of the notice letter and Form CMS 2567 for the 
complaint survey to the applicable AO(s).  At the ROs discretion, the materials may 
be sent to the AO via e-mail.  
 
NOTE:  Although deemed status technically has been removed and the 
provider/supplier is placed under SA jurisdiction, because it is expected that deemed 
status will be restored once corrections are made and verified, no change is made in 
ASPEN to the providers/suppliers deemed status.  However, periods during which 
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.  
Further, the AO may also conduct a survey of the facility so long as, since it 
continues to accredit the provider/supplier. 
 
The full survey must be conducted within 60 calendar days after the ROs notice 
to the provider/supplier of the complaint survey results and removal of deemed 
status.  The RO and SA follow the procedures in Section 5110.4. 
 
5110.4 - Full Survey after Complaint Survey with Condition-level 
Deficiencies, When Authorized by the RO 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
If the RO authorizes the SA to conduct a full survey after the complaint survey, the 
timeframes and procedures described in this section apply. 
 
Timeframe 
 
The full survey must be conducted within: 
 
  23 days after the ROs notice to the provider/supplier, if the complaint survey 
involved an IJ that was not removed while the survey team was on-site; or 
 
  60 calendar days after the ROs notice to the provider/supplier in all other cases.   
 
Procedures following the full survey with findings of: 
 
a)  Full Survey Findings:  Substantial Compliance 
 
If the SA full survey finds the deemed provider or supplier to be in substantial 
compliance, the SA and RO follow the same procedures and timeline as at Section 
5110.1.  In addition, since the RO had removed deemed status, the RO either issues a 
notice, or authorizes the SA to issue a notice to the provider or supplier of its compliance 
status and that its deemed status is restored, along with a copy of the Form CMS 2567 
with the survey findings.  
 
The RO sends a copy of the notice and Form CMS 2567 to the applicable AO(s).   At the 
ROs discretion, the materials may be sent to the AO via e-mail. 
 
  b)  Full Survey Findings:  Condition-Level, IJ 
 
1.  IJ Removed while the SA is On-site 
 
  If deficiencies pose an IJ and the IJ is removed while the SA is on-site, deficiency 
citations are made at the condition-level.  Follow the procedure for condition-
level noncompliance, non-IJ, in Section 5110.4c below. 
 
  Note:   The Form CMS 2567 must state at the beginning that an IJ was cited, 
regardless of the fact that it was removed while the SA was on-site.   An entry in 
ASPEN must also be made by the RO indicating that there was an IJ citation 
before the survey can be uploaded to the national database, the CMS National 
Reporting System (CASPER).  The ASPEN systems will prompt the RO 
whenever a survey includes condition-level deficiencies to indicate whether there 
was also an IJ. 
 
  Details of the IJ situation and the actions taken by the provider/supplier to remove 
the IJ must also be documented on the Form CMS 2567.  Even though the IJ was 
removed while the SA was on-site, the provider or supplier must still be cited for 
condition-level noncompliance for the applicable Condition of Participation or 
Condition for Coverage that is cited for non-compliance related to the IJ.  The 
documentation must also include the date the surveyors verified that the IJ was 
removed prior to completion of the survey.  
 
2.  IJ not Removed while the SA is On-site 
 
  If condition-level deficiencies pose an IJ and the IJ is not removed while the SA is 
on-site, the SA certifies its findings to the RO within 2 working days after the 
completion of the survey.   
 
  If the RO concurs with the SAs findings, the deemed provider/supplier is placed 
on a 23 calendar-day termination track.  The RO sends the provider/supplier the 
Form CMS 2567, notifies the provider/supplier of the proposed termination action 
and effective date, which is 23 calendar days after the date of the ROs notice, and 
requests submission of an acceptable plan of correction to the RO within 5 
calendar days of the notice. 
 
  The RO sends a copy of the notice to the SA and a copy of the notice and Form 
CMS 2567 to the applicable AO(s).  At the ROs discretion, the materials may be 
sent to the AO via e-mail. 
 
  When the RO receives a timely and acceptable plan of correction from the 
provider/supplier, it directs the SA to conduct an IJ follow-up survey before the 
rescheduled termination date in order to confirm that the IJ has been removed and 
that the provider/supplier complies with the conditions previously cited for 
noncompliance. 
   
2.1 First Revisit after Full Survey with IJ 
 
i.  No Acceptable Plan of Correction Submitted 
 
No revisit is necessary if the provider/supplier fails to submit a timely and 
acceptable plan of correction.  CMS will proceed to terminate a provider/supplier 
if it does not submit a timely and acceptable POC.  See SOM Section 3254F. The 
public notice must be published 15 calendar days prior to the termination date.  
The RO notifies the applicable Medicare Administrative Contractor (MAC) via 
the Form CMS 2007 of the termination of the provider/suppliers Medicare 
agreement, including the effective date of the termination. 
 
The SA and RO complete the processing in ASPEN of the survey kit and then, 
depending on RO practice, either the SA or RO uploads the complaint survey 
package into CASPER, the CMS National Reporting System.    
 
  The RO sends a copy of the termination letter to the applicable AO(s).   At the 
ROs discretion, the copy may be sent to the AO via e-mail. 
 
ii.  First Revisit Survey Findings:  IJ Not Removed 
 
  At least 5 calendar days in advance of the scheduled termination date, the SA 
certifies to the RO its findings, based on on-site verification, that the IJ has not 
been removed, and recommends that the termination action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the  SA and RO complete the processing of the survey kit in 
ASPEN and then, depending on RO practice, either the SA or RO uploads the 
survey package into the CMS National Reporting System (CASPER).  The 
termination of the providers/suppliers Medicare agreement is processed in 
ASPEN. 
 
  The RO sends the provider/supplier a final termination letter and publishes a 
public notice, in accordance with the termination process in Section 3010B.  The 
provider or supplier is terminated from the Medicare program.   The RO notifies 
the applicable Medicare Administrative Contractor (MAC) via the Form CMS 
2007 of the termination of the provider/suppliers Medicare agreement, including 
the effective date of the termination. 
 
  The RO sends a copy of the termination notice and the Form CMS 2567 to the 
applicable AO(s).  At the ROs discretion, the materials may be sent to the AO via 
e-mail. 
 
iii.  First Revisit Survey Findings:  IJ Removed, Substantial Compliance 
 
    The termination action is rescinded if the IJ has been removed and substantial 
compliance has been achieved prior to the effective date of the termination, i.e., 
there are no condition-level deficiencies identified during the first revisit survey 
by the SA. The SA certifies its findings to the RO at least 5 calendar days in 
advance of the scheduled termination date, and recommends that the termination 
action be rescinded. 
 
  The RO randomly selects several Form CMS 2567s with standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding of 
substantial compliance.  If the RO concurs, and in all other cases where the Form 
CMS 2567 is not reviewed by the RO, depending on RO practice, either the SA or 
RO uploads the survey package into CASPER, the CMS National Reporting 
System.  If the RO does not concur with the SAs finding, the RO discusses with 
the SA any revisions needed on the Form CMS 2567 and, after the revisions are 
made, follows the procedures for substantial noncompliance. 
 
  When substantial compliance is achieved, the RO either issues a notice, or 
authorizes the SA to issue the provider/supplier a notice of its compliance status, 
restoring its deemed status, along with a copy of the Form CMS 2567containing 
the survey findings.  
 
  In addition, the RO sends a copy of the notice letter to the applicable AO(s).  At 
the ROs discretion, the copy may be sent to the AO via e-mail. 
  
  Although the revisit survey found the provider/supplier to be in substantial 
compliance, it may have resulted in citation(s) of standard-level deficiencies of 
the Form CMS 2567.  Because deemed status has been restored, the provider or 
supplier is not obligated to submit a plan of correction to the SA, nor are any 
further revisits conducted.  The provider or supplier may voluntarily choose to 
submit a plan of correction because the Form CMS 2567 will be made available to 
the public.   The SA and RO do not review any plan of correction the 
provider/supplier submits; no further revisit survey is conducted. 
 
iv.  First Revisit Survey Findings:  IJ Removed, Substantial Noncompliance 
Remains 
 
If the IJ has been removed but substantial noncompliance (i.e., condition-level 
deficiencies), remains, the SA certifies its findings to the RO within 10 working 
days after the survey completion date.  If the RO concurs that the IJ has been 
removed but that condition-level deficiencies remain, the RO considers whether 
the survey findings warrant a second revisit or proceeding immediately to 
termination.  At this point the provider/supplier will have been surveyed three 
times, including the preceding complaint survey, with continued substantial 
noncompliance found in each survey and at least one IJ.  Generally the RO 
authorizes a second revisit, but the RO has discretion to make an exception, based 
on the facts of the case, including the risks to patients associated with the 
  remaining deficiencies versus providing the provider/supplier further opportunity 
to correct its problems in a timely manner. 
 
If the RO does not authorize a second revisit, it follows the procedures in 
paragraph ii above. 
 
If the authorizes a second revisit, the RO gives the provider/supplier up to 67 
additional calendar days, or a total of 90 calendar days (23 plus 67) from the date 
of the notice of the IJ, to achieve substantial compliance.  The resulting revised 
termination date is 90 calendar days after the date of the ROs original 23-day 
termination notice.  The RO provides the provider/supplier the Form CMS 2567 
for the revisit with notice of the new termination date, and requests that an 
acceptable POC be provided to the SA within 10 calendar days of the notice. 
 
2.2 Second Revisit after Full Survey with IJ 
 
The SA conducts the second revisit survey no later than 60 calendar days after the date of 
the ROs 23-day termination notice to the provider or supplier.   
 
i. Second Revisit Survey Findings:  Substantial Compliance 
 
If substantial compliance is achieved by the provider/supplier (i.e., no condition-
level deficiencies are identified through the on-site verification by the SA) during 
the second revisit survey, the SA certifies its findings to the RO within 10 
working days after the survey completion date, and recommends that the 
termination action be rescinded. 
 
The RO randomly selects some Form CMS 2567s with standard-level deficiencies 
for review, to determine if the RO concurs with the SAs finding of substantial 
compliance.  If the RO concurs, and in all other cases where the Form CMS 2567 
is not reviewed by the RO, depending on RO practice, either the SA or RO 
uploads the survey kit into CASPER, the CMS National Reporting System.  If the 
RO does not concur, the RO discusses with the SA revisions needed on the Form 
CMS 2567 and, after the revisions are made, follows the procedures for 
substantial noncompliance. 
 
The RO also either issues a notice, or authorizes the SA to issue the 
provider/supplier a notice, of its compliance status and that its deemed status is 
restored, along with a copy of the Form CMS 2567 with the survey findings.  
 
Additionally, the RO sends a copy of the notice and the Form CMS 2567 to the 
applicable AO(s).  At the ROs discretion, the materials may be sent to the AO via 
e-mail. 
 
ii. Second Revisit Survey Findings:  Substantial Noncompliance 
 
  If the second revisit shows that substantial noncompliance (i.e., condition-level 
deficiencies) remain, the SA certifies to the RO its findings within 10 calendar 
days after the survey completion date, and recommends that the termination 
action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO sends the provider or supplier a final termination letter 
and publishes a public notice 15 calendar days prior to the termination date. The 
provider or supplier is terminated from the Medicare program.   The RO notifies 
the applicable Medicare Administrative Contractor (MAC) via the Form CMS 
2007 of the termination of the provider/suppliers Medicare agreement, including 
the effective date of the termination. 
 
The SA and RO complete the processing in ASPEN of the survey kit and, 
depending on RO practice, either the SA or RO uploads the survey package into 
CASPER.  The providers or suppliers Medicare agreement is terminated in 
ASPEN. 
 
The RO sends a copy of the final termination notice and Form CMS 2567 to the 
applicable AO(s).  At the ROs discretion, the materials may be sent to the AO via 
e-mail. 
 
c)  Full Survey Findings:  Condition-Level, Non-IJ 
 
If the results of the full survey indicate there is substantial noncompliance (i.e., condition-
level deficiencies), but the deficiencies do not constitute an IJ, the SA certifies its 
findings to the RO within 10 working days after the survey completion date. 
 
The RO reviews the SAs findings, and if it concurs with the SAs recommendation, the 
RO places the provider or supplier on a 90 calendar-day termination track as a result of 
the full survey.  The RO sends the provider or supplier the Form CMS 2567 and notifies 
it of the proposed termination action and effective date, which will be 90 calendar days 
after the date of the ROs notice.  The RO requests submission of an acceptable plan of 
correction to the SA within 10 calendar days of the notice. 
 
Additionally, the RO sends a copy of the notice of termination letter to the applicable 
AO(s).   
 
1.  First Revisit:  The SA conducts the first revisit survey no later than the 45th calendar 
day after the date of the ROs termination notice to the provider or supplier.     
 
i.  First Revisit Survey Findings:  Substantial Compliance 
 
The termination action is rescinded if substantial compliance (i.e., no condition-
level deficiencies) is achieved and documented through the onsite verification at 
the revisit survey.  There may or may not be standard-level deficiencies cited.  
  Within 10 working days after the completion of the revisit survey, the SA certifies 
to the RO its findings and recommends that the termination action be rescinded. 
 
The RO randomly selects some Form CMS 2567s with only standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding of 
substantial compliance.  If the RO concurs, and in all other cases where the Form 
CMS 2567 is not reviewed by the RO, the RO completes the processing of the 
survey kit in ASPEN and then, depending on RO practice, either the SA or the 
RO uploads the survey package into CASPER, the CMS National Reporting 
System.  If the RO does not concur, the RO discusses with the SA revisions 
needed on the Form CMS 2567 and, after the revisions are made, follows the 
procedures for substantial noncompliance. 
 
The RO either issues a notice, or authorizes the SA to issue a notice to the 
provider or supplier of its compliance status and that its deemed status is restored, 
along with a copy of the Form CMS 2567 with the survey findings.  
 
The RO sends a copy of the notice and Form CMS 2567 to the applicable AO(s).  
At the ROs discretion, the materials may be sent to the AO via e-mail. 
 
ii.  First Revisit Survey Findings:  Substantial Noncompliance 
 
If the SA confirms during the first revisit survey that the provider/supplier is not 
in substantial compliance with one or more Medicare conditions, the SA consults 
with the RO on its findings and whether to conduct a second revisit.  If the RO 
concurs that condition-level deficiencies remain, the RO considers whether the 
survey findings warrant a second revisit or proceeding immediately to 
termination.  At this point the provider/supplier will have been surveyed three 
times, including the complaint survey, the full survey and the first revisit, with 
substantial noncompliance found on each survey.  Generally the RO authorizes a 
second revisit, but the RO has discretion to make an exception, based on the facts 
of the case, including the risks to patients associated with the remaining 
deficiencies versus providing the provider/supplier further opportunity to correct 
its problems in a timely manner. 
  
If the RO does not authorize a second revisit, the RO and SA will follow the 
procedures outlined in paragraph 2(ii). below. 
 
If the RO authorizes a second revisit, the SA sends the provider/supplier the Form 
CMS 2567 for the first revisit with notice that substantial noncompliance remains, 
the 90-day termination date remains in effect, a new acceptable plan of correction 
is required, and that an additional revisit will be conducted prior to the 
termination date. 
 
2.  Second Revisit:  The SA conducts the second revisit survey no later than 60 calendar 
days after the date of the termination notice to the provider or supplier. 
   
(i)  Second Revisit Survey Findings:  Substantial Compliance 
 
If substantial compliance is achieved by the provider/supplier (i.e., no 
condition-level deficiencies are identified through the on-site verification by 
the SA) during the second revisit survey, the SA certifies its findings to the 
RO within 10 working days after the survey completion date, and 
recommends that the termination action be rescinded. 
 
The RO randomly selects some Form CMS 2567s with standard-level 
deficiencies for review, to determine if the RO concurs with the SAs finding 
of substantial compliance.  If the RO concurs, and in all other cases where the 
Form CMS 2567 is not reviewed by the RO, the RO completes the processing 
in ASPEN of the survey kit and then, depending on RO practice, either the SA 
or RO uploads the complaint and revisit surveys into CASPER, the CMS 
National Reporting System.  If the RO does not concur, the RO discusses with 
the SA revisions needed on the Form CMS 2567 and, after the revisions are 
made, follows the procedures for substantial noncompliance. 
 
The RO also either issues a notice, or authorizes the SA in ACTS to issue the 
provider or supplier a notice, of its compliance status and that its deemed 
status is restored, along with a copy of the Form CMS 2567 with the survey 
findings.  
 
Additionally, the RO sends a copy of the notice and the Form CMS 2567 to 
the applicable AO(s).  At the ROs discretion, the materials may be sent to the 
AO via e-mail.  
 
(ii)  Second Revisit Survey Findings:  Substantial Noncompliance 
 
If the second revisit shows that the provider or supplier has substantial 
noncompliance (i.e., condition-level deficiencies are identified through on-site 
verification by the SA), the SA certifies to the RO its findings within 10 
calendar days after the survey completion date, and recommends that the 
termination action proceed. 
 
The RO reviews the SAs findings, and if it concurs with the SAs 
recommendation, the RO sends the provider/supplier a final termination letter 
and publishes a public notice 15 calendar days prior to the termination date. 
The provider or supplier is terminated from the Medicare program.  The RO 
notifies the applicable Medicare Administrative Contractor (MAC) via the 
Form CMS 2007 of the termination of the provider/suppliers Medicare 
agreement, including the effective date of the termination. 
 
The RO completes the processing in ASPEN of the survey kit and then, 
depending on RO practice, either the SA or RO uploads the survey package 
  into CASPER.  The providers or suppliers Medicare agreement is terminated 
in ASPEN. 
 
The RO sends a copy of the final termination notice and Form CMS 2567 to the 
applicable AO(s).  At the ROs discretion, the materials may be sent to the AO via e-
mail. 
 
5120 - Life Safety Code Guidance for Deemed Providers/Suppliers 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
In most States, an engineer or other fire safety specialist surveys for compliance with the 
Life Safety Code (LSC) standard and others survey the remaining standards in the 
Physical Environment Condition.  If the allegation pertains only to LSC requirements, it 
is not necessary to survey the remainder of the Physical Environment Medicare 
condition. 
 
5130  Deemed Provider/ Supplier Refusal of Complaint Investigation 
Surveys 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
The SA informs the provider/supplier that refusal to allow a complaint investigation 
survey is a basis for termination and exclusion from the Medicare program, in accordance 
with Section 1128(b)(12) of the Social Security Act.  The SA notifies the RO 
immediately of a refusal to allow a complaint investigation survey. 
 
5140 - Complaints Involving HIV-Infected Individuals 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
As direct recipients of Federal funds, providers and suppliers are subject to provisions of 
Section 504 of the Federal Rehabilitation Act of 1973.  Symptomatic and asymptomatic 
individuals who are infected with the human immunodeficiency virus (HIV), or AIDS 
virus, are protected by the Rehabilitation Act as individuals with handicaps.  
Therefore, HIV-infected individuals who are provided services, are employed, or are to 
be employed by providers and suppliers in Federally-conducted or financed programs or 
activities would be treated like anyone else in the workforce, so long as these individuals 
do not, on a case-by-case basis, pose a substantial health and safety risk to others, or pose 
a performance problem, and are otherwise qualified. 
 
A provider participating in the Medicare or Medicaid programs cannot discriminate 
against individuals who are HIV-infected so long as these individuals do not, on a case-
by-case basis, pose a substantial health and safety risk to others and so long as the 
provider provides comparable services and care to non HIV-infected individuals. 
 
The SA or the RO refers discrimination complaints to the Office of Civil Rights (OCR), 
which is the authority to determine whether Medicare or Medicaid providers and 
suppliers comply with this non-discrimination statute. 
   
5150 - Investigating Complaints Involving ESRD Services Provided by 
Deemed Hospitals or CAHs 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
Many of the hospitals or CAHs participating in the ESRD program are deemed to meet 
the Medicare Conditions of Participation on the basis of their accreditation by a CMS-
approved Medicare accreditation program.  Deemed status applies only to the 
hospitals or CAHs approval as a provider, not to its status as a supplier of ESRD 
transplantation or dialysis services.  The SA investigates all complaints and allegations 
related solely to ESRD services since ESRD services fall outside the purview of 
accreditation. 
 
5160 - Investigating Complaints Against ESRD Suppliers 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
1. General 
 
Refer to the guidance for investigation of complaints against non-deemed providers and 
suppliers.  See SOM 5200. 
 
The ESRD Networks are required to have a complaint /grievance resolution system.  
Networks (NW) and the SA are frequently contacted by the same complainant with the 
same or similar allegations.  If the allegations require an onsite investigation or allege 
potential risk to patient health or safety, the SA is responsible for the investigation.  If the 
allegations are primarily focused on relationship or communication issues, the NW may 
assume primary responsibility for the investigation.  If the focus of the allegations is a 
medical practice issue, the SA and NW may need to collaborate on the investigation.  The 
NWs and SA are encouraged to communicate and collaborate to reduce or prevent 
redundant investigations. 
 
2. Conducting the ESRD Investigation 
 
The SA surveyors must use the ESRD survey protocol in Appendix H to investigate 
complaints.  The allegations of the complaint will determine the tasks needed.  For 
example, an allegation of inadequate patient care staffing would require use of the 
following tasks, at a minimum: 
 
  Pre survey activities; 
 
  Entrance Conference:  Provide an overview of the complaint allegations and the 
planned agenda for your survey time; 
 
  Tour and observations; 
 
  Patient interviews; 
   
  Staff interviews; 
 
  Record reviews; 
 
  Review of quality management materials; and  
 
  Exit conference. 
 
Conduct each of the identified survey tasks in Appendix H, Guidance to Surveyors:  
End-Stage Renal Disease Facilities. 
 
3. Pre-survey Task for ESRD Complaint Investigations 
 
Review the allegations of the complaint to identify needed survey tasks.  Review the 
State Outcomes List and the Dialysis Facility Report to determine if there are data 
outliers related to the allegations.  For example, if the complaint alleges staff members do 
not wash their hands, the surveyor should review the facilitys rate of hospitalization and 
hospitalizations related to septicemia, and consider this information in the survey process. 
 
To facilitate meeting the requirement of surveying each ESRD facility every 3 years, the 
SA evaluates all available information (outcome list rank, Dialysis Facility Report, time 
since last survey, complaint history, NW information, etc.) to determine whether a 
recertification survey should be conducted at the time of the complaint investigation. 
 
5170  Hospital Restraints/Seclusion Death Reporting and Investigation 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
This section applies to both deemed and non-deemed hospitals, as well as to deemed and 
non-deemed CAH distinct part psychiatric and rehabilitation units.   
 
5170.1 - Background 
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
The Medicare hospital restraint and seclusion requirements are found under the Patients 
Rights provisions at 42 CFR 482.13(e),(f) and (g).   
 
Hospitals are required to report a death associated with the use of restraint/seclusion to 
their CMS RO in accordance with 42 CFR 482.13(g)(1). 
 
The interpretive guidelines found in the Hospital Appendix A at 42 CFR 
482.13(e)  (g) discuss in detail what is considered a restraint or seclusion, the 
requirements governing hospital use of restraint or seclusion, and these reporting 
requirements. 
 
5170.2 - Responsibilities 
  (Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13) 
 
Regional Offices (ROs) 
 
The RO receives Hospital Restraint/Seclusion Death Reports which hospitals are required 
to submit in accordance with 42 CFR 482.13(g)(1).   The RO is responsible for 
communicating with hospitals in its region whether the required reports are to be 
submitted electronically by facsimile and/or e-mail, providing appropriate addresses or 
fax numbers, or whether it will also accept mail submissions. 
 
The RO is also responsible for data entry of reports received into the Automated Survey 
Processing Environment (ASPEN) Complaint Tracking System (ACTS) Hospital 
Restraint/Seclusion Death Module and for maintenance in ACTS of information related 
to disclosures to Protection and Advocacy Agencies. (See Process discussion below.) 
 
Each RO designates one contact person and a backup person who serves as the hospital 
point of contact regarding reporting, and who is responsible for coordinating the review 
of reports received, and authorization of complaint surveys when appropriate. 
 
State Agencies (SAs) 
 
Hospitals report patient deaths associated with restraint or seclusion to their CMS RO, 
not to the SA.  Any hospital patient restraint or seclusion death report received by a SA 
directly from a hospital (or other source) must be forwarded immediately by the SA to its 
RO. 
 
The SA conducts a complaint investigation related to a patient death associated with a 
hospitals use of restraints or seclusion only when the RO authorizes the investigation.  
The investigation must be completed no later than five working days after RO 
authorization. 
 
SAs assist ROs in educating the hospitals in their State about their obligation to report to 
their RO any death that meets the reporting requirements found at 42 CFR 482.13(g)(1).  
Upon request, SAs are to provide hospitals with the applicable RO contact information, 
as well as the hospital reporting procedures contained in this policy. 
 
The SAs respond to requests from Protection and Advocacy (P&A) 
organizations, or any other parties, for information on survey findings related to 
specific cases identified by the requestor.  The SAs handle these requests in 
accordance with standard CMS policy on disclosure of Federal survey 
information. 
 
5170.3 - Process 
(Rev. 191, Issued: 07-19-19, Effective: 07-19-19, Implementation: 07-19-19) 
 
  The RO evaluates the information required to be reported by the hospital or CAH DPU 
under 42 CFR 482.13(g)(1) to determine whether the situation might involve a violation 
of 42 CFR 482.13(e) through 42 CFR 482.13(g) and authorizes an on-site investigation if 
there appears to be a possible violation. 
 
Using the information provided by the hospital or CAH DPU in the worksheet, the RO 
evaluates whether the case warrants an on-site investigation.   If the RO determines that 
the restraint/seclusion death report requires on-site investigation, within two business 
days of receiving the report, the RO enters the reported information into the ACTS 
restraint/seclusion module and immediately notifies the SA to authorize a complaint 
survey to investigate the hospitals or CAH DPUs compliance with the Patients Rights 
requirement at 42 CFR 482.13(e), (f), and (g), including the reported case.  The SA 
accesses the ACTS restraint/seclusion module to see the information reported by the 
hospital or CAH DPU prior to conducting the on-site investigation.  The SA is expected 
to be onsite to initiate the investigation within two business days of receipt of survey 
authorization from the RO. 
 
Notice to Protection and Advocacy Organizations 
 
At the same time that the RO notifies the SA that it authorizes the on-site survey, 
consistent with the ACTS Notice of a Modified or Altered System of Records (SOR) (71 
FR 29643, May 23, 2006, SOR 09-70-0565), the RO also provides written notification, 
by mail or email, to the appropriate Protection and Advocacy Organization (P&A) within 
the State where the hospital is located, only if the P&A has a current Data Use 
Agreement (DUA) with CMS. The RO may contact CMS Central Office for a list of 
P&As with current DUAs. The names and addresses for each States P&A can be 
located at the following website, at the drop down menu entitled Get Help in Your 
State: www.ndrn.org .  Notification is provided only in those cases for which an on-
site survey is authorized. 
 
The RO provides the following information to the P&A:  hospital or CAH DPU name, 
hospital or CAH DPU address, name of the deceased, and a copy of the 
restraint/seclusion death report submitted by the hospital or CAH DPU.  An entry must 
be made on the intake in ACTS indicating the name of the P&A to which the 
restraint/seclusion death report data was sent and the date it was sent. 
 
The P&A must have an approved CMS Data Use Agreement (DUA), Form CMS-R-
0235, (Exhibit 292) in place before restraint/seclusion death report data may be disclosed 
to it.  In order to get an approved DUA, the P&A must complete and submit a signed 
CMS DUA, Form CMS-R-0235, including an initialed DUA ACTS SOR- P&A 
Attachment (Exhibit 293) to the Director, Division of Information Security and Privacy 
Management (DISPM), Centers for Medicare and Medicaid Services, Mailstop N2-04-27, 
7500 Security Boulevard, Baltimore, MD 21244-1850.  DISPM will review the DUA, 
assign a unique DUA identifier and expiration date to it, and return a signed copy to the 
P&A, including an expiration date.  CMS Central Office Survey and Certification will 
maintain and make available to ROs a list of P&As with DUAs. 
When completing the Form, P&As must note the following in particular: 
   
  Line 5 of the DUA must state Restraint/Seclusion Hospital Death Reports. The 
Years and System of Record columns should be left blank; 
 
  Line 12 must state CMS DUA: ACTS SOR Attachment  P&A; 
 
  The DUA must be signed by the P&A official whom the P&A designates as 
Custodian, i.e., the individual who will have actual possession of and 
responsibility for the data released under the DUA; and 
 
  A P&A may designate more than one Custodian, but if it does so, each individual 
must complete and sign a Multi-Signature Addendum Form (Exhibit 294). 
 
When approved, the DUA will have an expiration date.  DISPM will alert an organization 
with a DUA of its upcoming expiration date and will give the organization the option of 
requesting a one-year DUA extension via e-mail, or to close the DUA with a DUA 
destruction certificate.  DISPM has set up a DUA resource email box which accepts all 
expired DUA resolution requests at DataUseAgreement@cms.hhs.gov. 
 
Custodians may be added or deleted over the life of the primary DUA. To add a new 
Custodian under an existing DUA, the P&A must submit the following to CMS/DISPM: 
a letter from the P&A describing the activities planned for the new Custodian and the 
length of time over which the Custodian will serve, and a Multi-Signature Addendum 
signed by the appropriate official from the P&A.  The Multi-Signature Addendum must 
show the DUA number of the existing primary P&A DUA.  The P&A must assign a case 
number to all Multi-Signature Addendums beginning with 1 and adding consecutively 
thereafter.  CMS/DISMP will use this number to track the number of Custodians in each 
P&A.  When a P&A seeks to delete an existing Custodian, it must send the CMS/DISPM 
a letter to this effect.  CMS/DISPM will strike out the name of the deleted Custodian 
from the DUA or Multi-Signature Addendum that added that Custodian, dating and 
initialing the deletion. 
 
The DUA process described in this section applies to disclosure of hospital and CAH 
DPU restraint/seclusion death reports by CMS to P&As in those cases where the P&A 
did not first make a request specific to an identified patient; a DUA is not required for 
other disclosures of information in ACTS to a P&A when permitted in accordance with 
the ACTS System of Records Notice. 
 
  A P&A may request information about an on-site survey by submitting its request 
to the SA. The SA will process this request and release information to the P&A in 
accordance with standard CMS policy for disclosure of Form CMS 2567, 
Statement of Deficiencies and Plan of Correction. 
 
If the P&A identifies a particular patient, hospital, and approximate date or dates when 
the patient was in that hospital or CAH DPU, and if the P&A makes a request for 
additional information, beyond the Form CMS 2567, related to use of restraint or 
  seclusion on that patient, the request is forwarded to the RO.  The RO may, in accordance 
with the ACTS System of Records Notice, release additional information to the P&A. 
 
NOTE:  Sections 5200 to 5240 relate to all non-deemed 
provider/supplier types, excluding nursing homes (SNFs/NFs). 
 
5200 - Investigating Complaints for Non-Deemed Providers/Suppliers, 
Excluding Nursing Homes (SNFs/NFs) 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
5200.1 - General Procedures 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
For complaint surveys on non-deemed providers/suppliers, the SA uses the appropriate 
survey protocol and interpretive guidelines.  A focus survey is conducted on the specific 
regulatory requirements related to the allegation.  Based on an initial assessment or other 
observations, if significant problems are identified, the SA expands the scope of review 
as necessary to determine compliance or noncompliance.  The SA does not refer 
complaints regarding non-deemed providers/suppliers to the RO. 
 
If deficiencies are cited, the SA documents the deficiencies on Form CMS-2567 and 
obtains an acceptable POC. If non-compliance with the Medicare conditions is identified, 
the SA will follow the appropriate termination procedures and document and report as 
required.  (See SOM Chapter 3, 3010-3028 for termination procedures.) 
 
5200.2 - Special Procedures for Psychiatric Hospitals 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The special conditions for psychiatric hospitals cannot be deemed to meet the Medicare 
requirements.  The remaining conditions for hospitals apply to psychiatric hospitals, and 
a hospital may be deemed to meet those conditions. 
 
When the SA receives a complaint allegation against a psychiatric hospital under the 
general conditions of participation, it must determine whether or not the hospital is 
deemed.  If the hospital is deemed, the SA follows the appropriate survey protocol for 
deemed facilities.  If the hospital is not deemed, the SA investigates the complaint if 
appropriate under these procedures listed above in 5200.1. 
 
If the complaint allegation concerns the special conditions for psychiatric hospitals, the 
SA may conduct an investigation if it has appropriate qualified personnel or refer it to the 
RO.  If the complaint is referred to the RO, the RO will evaluate and refer it to the CO as 
required. 
 
5210- Processing of Complaints Originating with or Investigated by the 
RO 
  (Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO establishes procedures and clear organizational accountability to ensure that 
complaints are properly evaluated, documented, acknowledged, and handled timely and 
appropriately.  The RO uses ACTS to ensure timely and appropriate action on all 
allegations originating with or investigated by the RO.  The extent and nature of the RO 
involvement with a given complaint varies depending on the nature of the allegation and 
the receiving organization. 
 
Most complaints originate through the SA and are recorded and controlled by the SA.  
When a complaint is filed directly with the RO, the RO assumes those initial SA 
responsibilities.   
 
5220- Investigation Conducted Directly by the RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
This less frequent class of complaints includes allegations retained by the RO or 
forwarded to the RO by the SA for investigation.  The ROs responsibilities vary based 
on the type of complaint. 
 
The RO uses the appropriate survey protocol and interpretive guidelines for the 
provider/supplier.  These procedures apply when a direct RO investigation is conducted, 
such as for Federal facilities, Religious Non-Medical Health Care Institutions (RNHCIs), 
or special situations.  When directly investigating, the RO begins by ensuring that it or 
the SA has met all initial data collection and acknowledgement requirements. 
 
If the allegation involves an IJ, the RO investigates within two working days.  Otherwise, 
the RO schedules the investigation based on the severity of the allegation. (See 5075.9 
for time frames related to Federal onsite investigations.) 
 
5230 - Special RO Processing 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The following types of allegations are subject to special RO handling: 
 
1.  Over-Utilization or Inappropriate Utilization of Services- The RO refers to the 
local QIO for investigation, and documents the providers files as for other 
allegations.  The RO acts, as necessary, on any findings returned by the QIO; 
 
2.  Civil Rights Violations- The RO refers to the regional OCR for investigation.  
The RO documents the providers files as for other allegations.  The RO acts as 
necessary on any findings returned by OCR; and 
 
3.  Medicare/Medicaid/CLIA fraud- The RO refers to the RO of the Inspector 
General/DHHS for investigation.  The RO documents the providers files as for 
other allegations. 
   
In each of the above instances, the RO ensures that the complainant and SA are notified 
of any findings. 
 
5240 - Complaints - HHA Hotline 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Each State has a Medicare home health hotline that can be called by patients who are 
dissatisfied with the home health services they are receiving or by other individuals with 
a complaint about a specific HHA. Under the Medicare COPs for Patient Rights at 42 
CFR 484.10, HHAs are required to provide their patients with the hotline number for 
their state. Concerns about an HHA not complying with the COPs, or reports that an 
HHA is misinforming beneficiaries or inappropriately terminating care for patients, can 
be referred to the SA for investigation via the home health hotline. Concerned consumers 
may also call the SA directly. A violation of the COPs or the provider agreement could 
lead to termination of the HHA from the Medicare program. 
 
As part of the patient rights COPs, the HHA is required to investigate complaints made 
by a patient or the patients family or guardian regarding treatment or care that is, or fails 
to be, furnished, and to document both the existence of the complaint and resolution of 
the complaint. 
 
Surveyors, as part of their investigation of the HHAs compliance of the COPs, may ask 
to review complaints received by the HHA and the resolution of these complaints. The 
HHA must permit examination of these records by or on behalf of CMS, or risk 
termination from the Medicare program. 
 
NOTE:  Sections 5300 to 5390 relate to nursing homes. 
 
5300 - Investigation of Complaints for Nursing Homes 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Section 42 CFR 488.332 provides the Federal regulatory basis for the investigation of 
complaints about nursing homes. 
 
The survey agency must review all complaint allegations and conduct a standard or an 
abbreviated standard survey to investigate complaints of violations of requirements if its 
review of the allegation concludes that: 
 
  A deficiency in one or more of the requirements may have occurred; and 
 
  Only a survey can determine whether a deficiency or deficiencies exist. 
 
The survey agency does not conduct a survey if the complaint raises issues that are 
outside the purview of Federal participation requirements. 
 
  Complaint investigations follow, as appropriate, the pertinent survey tasks, and 
information gathered is recorded on the appropriate survey worksheets.  However, if the 
documentation required is minimal, use Form CMS-807 to record information during the 
complaint investigation.  Record deficiencies on Form CMS-2567 and/or, the Statement 
of Isolated Deficiencies Which Cause No Harm with Only a Potential for Minimal Harm 
for SNFs and NFs . The completed Form CMS-2567 must be made a part of the 
complaint record. 
 
If necessary, a specialized team may be used to investigate complaints.  Team members 
may include, but are not limited to, an attorney, auditor, and appropriate health 
professionals.  The specialized team is not necessarily composed of qualified surveyors.  
However, specialized team members provide unique talents and expertise that assist at 
least one qualified surveyor in identifying, gathering, and preserving documented 
evidence.  Further information regarding the composition of the survey team is provided 
in Chapter 7. 
 
The timing, scope, duration and conduct of a complaint investigation are at the discretion 
of the SA, except when a determination is made that immediate jeopardy may be present 
and ongoing or a higher level of actual harm may be present.  If the complaint concerns 
conditions on a certain day (e.g., on weekends), or on a certain shift (e.g., 11 p.m. - 7 
a.m.), the SA should make an attempt to investigate it at the relevant time.  In most cases, 
the following tasks, or portion of tasks, should be performed during a complaint 
investigation. 
 
5300.1 - Task 1:  Offsite Survey Preparation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Review any information about the facility that would be helpful to know in planning the 
investigation.  Contact the ombudsman to discuss the nature of the complaint and whether 
there have been any similar complaints reported to and substantiated by the ombudsman. 
 
Review the related regulatory requirements or standards that pertain to the complaint.  
For example, if it is a complaint about abuse, review the requirements at 42 CFR 483.13. 
 
Plan the investigation.  Before going to the nursing home, plan what information to 
obtain during the complaint investigation based on the information already acquired.  
Consider practical methods to obtain that information. 
 
5300.2 - Task 2:  Entrance Conference/Onsite Preparatory Activities 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Onsite complaint investigations should always be unannounced.  Upon entrance, advise 
the facilitys Administrator of the general purpose of the visit.  The SA explains the 
reason for the survey and avoids any impression that a predetermination has been made 
as to the validity of the allegation.  It is important to let the facility know why you are 
there, but protect the confidentiality of those involved in the complaint.  Do not release 
  information that will cause opportunities to be lost for pertinent observations, interviews, 
and record reviews required for a thorough investigation.  For example, if the complaint 
is that food that is intended to be served hot is always served cold, do not tell the facility 
the exact complaint.  Rather, tell them it is a situation related to dietary requirements. 
 
5300.3 - Task 5:  Information Gathering 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The order and manner in which information is gathered depends on the type of complaint 
that is being investigated.  Conduct comprehensive, focused, and/or closed record 
reviews as appropriate for the type of complaint.  Generally, it is not necessary to review 
records and information from more than one year ago.  However, the SA is not precluded 
from doing so if concerns identified during the investigation indicate it is necessary in 
order to determine current compliance.  It is very important to remember that the 
determination of whether the complaint happened is not enough.  The surveyor needs to 
determine noncompliant facility practices related to the complaint situation and which, if 
any, requirements are not met by the facility. 
 
Perform information gathering in order of priorities, i.e., obtain the most critical 
information first.  Based on this critical information about the incident, determine what 
other information to obtain in the investigation. 
 
Observations, record review and interviews can be done in any order necessary.  As 
information is obtained, use what has been learned to determine what needs to be 
clarified or verified as the investigation continues. 
 
Observe the physical environment, situations, procedures, patterns of care, delivery of 
services to residents, and interactions related to the complaint.  Also, if necessary, 
observe other residents with the same care need.  After determining what occurred, i.e., 
what happened to the resident and the outcome, investigate what facility practice(s) or 
procedures affected the occurrence of the incident. 
 
EXAMPLE 
 
It was verified through the investigation that a resident developed a pressure sore/ulcer 
which progressed to a Stage IV, became infected and resulted in the resident requiring 
hospitalization for aggressive antibiotic therapy.  Observe as appropriate: dressing 
changes, especially to any other residents with Stage III or IV pressure sores; infection 
control techniques such as hand washing, linen handling, and care of residents with 
infections; care given to prevent development of pressure sores (e.g., turning and 
repositioning, use of specialized bedding when appropriate, treatments done when 
ordered, keeping residents dry, and provision of adequate nutritional support for wound 
healing). 
 
Record Review:  If a specific resident is involved, focus on the condition of the resident 
before and after the incident. If there are care issues, determine whether the appropriate 
  assessments, care planning, implementation of care, and evaluations of the outcome of 
care have been done as specified by the regulatory requirements. 
 
EXAMPLE 
 
For a complaint of verbal and physical abuse, review the record to determine the 
residents mood and demeanor before and after the alleged abuse.  Determine if there are 
any other reasons for the change in the residents demeanor and behavior.  Determine 
whether an assessment has been done to determine the reason for the change in mood and 
behavior.  Does the record document any unexplained bruises and/or complaints of pain, 
and whether they occurred in relation to the alleged incident? 
 
Interviews:  Interview the person who made the complaint.  If the complainant is not at 
the facility at the time of the survey, he/she should be interviewed by telephone, if 
possible.  Also, interview the person the complaint is about.  Then, interview any other 
witnesses or staff involved.  In order to maintain the confidentiality of witnesses, change 
the order of interviews if necessary.  It may not always be desirable to interview the 
person who made the complaint first, as that may identify the person as the complainant 
to the facility.  Interview residents with similar care needs at their convenience. 
 
As interviews proceed, prepare outlines needed for other identified witnesses and revise 
outlines as new information is obtained. 
 
During information gathering to investigate a complaint about the care and services 
provided to residents in a nursing home, findings of past noncompliance may be 
identified.  Before considering a citation of past noncompliance with a specific regulatory 
tag, surveyors must determine if current compliance with the specific regulatory tag 
exists.  Similar to verifying correction of current noncompliance on a revisit, surveyors 
should use a variety of methods to determine whether correction of the past 
noncompliance occurred and continues.  This may include, but is not limited to, the 
following: 
 
  Interviews with facility staff, such as the administrator, nursing staff, social 
services staff, medical director, quality assessment and assurance committee 
members, and/or other facility staff, as indicated, to determine what procedures, 
systems, structures, and processes have been changed. 
 
  Reviewing through observation, interview and record review, how the facility 
identified and implemented interventions to address the noncompliance.  
Examples of interventions may include, but are not limited to: 
 
  The facilitys review, revision, or development of policies and/or 
o
procedures to address the areas of concerns; 
 
  The provision and use of new equipment, as necessary; 
o
 
    The provision of staff training required to assure ongoing compliance for 
o
the implementation and use of new and/or revised policies, procedures, 
and/or equipment, especially with new and/or temporary staff; 
 
  The provision of additional staffing, changes in assignments or 
o
deployment of staff, as needed; and 
 
  The provision of a monitoring mechanism to assure that the changes made 
o
are being supervised, evaluated, and reinforced by responsible facility 
staff. 
 
  Evaluating whether the facility has a functioning quality assessment and 
assurance committee whose responsibilities include the identification of quality 
issues; providing timely response to ascertain the cause; implementing corrective 
action; implementing monitoring mechanisms in place to assure continued 
correction and revision of approaches, as necessary, to eliminate the potential risk 
of occurrence to other residents and to assure continued compliance. 
 
A citation of past noncompliance must meet all of the criteria described in Task 6 below. 
 
5300.4 - Task 6: Information Analysis 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Review all information collected.  If there are inconsistencies, do additional data 
collection as needed, to resolve the inconsistencies.  Determine if there is any other 
information still needed. 
 
Determine whether: 
 
  The allegations are substantiated or unsubstantiated;  
 
  The facility failed to meet any of the regulatory requirements; and 
 
  The facility practice or procedure that contributed to the complaint has been 
changed to achieve and/or maintain compliance. 
 
To cite past noncompliance with a specific survey data tag (F-tag or K-tag), all of the 
following three criteria must be met: 
 
1)  The facility was not in compliance with the specific regulatory requirement(s) (as 
referenced by the specific F-tag or K-tag) at the time the situation occurred; 
 
2)  The noncompliance occurred after the exit date of the last standard recertification 
survey and before the survey (standard, complaint, or revisit) currently being 
conducted; and 
 
  3)  There is sufficient evidence that the facility corrected the noncompliance and is 
in substantial compliance at the time of the current survey for the specific 
regulatory requirement(s), as referenced by the specific F-tag or K-tag. 
 
A nursing home does not provide a plan of correction for a deficiency cited as past 
noncompliance as the deficiency is already corrected; however, the survey team 
documents the facilitys corrective actions on Form CMS-2567. 
 
5300.5 - Task 7:  Exit Conference 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
Conduct an Exit Conference related to a complaint survey in accordance with the process 
described in the Exit Conference section located in the Long-Term Care Survey Process 
(LTCSP) Procedure Guide (https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html).  Do not inform the 
nursing facility of confidential information unless the individual who provided the 
information specifically authorizes you to do so. 
 
If a deficiency is not present now, but was present and has been corrected, notify the 
facility orally and in writing that the complaint was substantiated because deficiencies 
existed at the time that the complaint situation occurred.  (See SOM Chapter 7, Survey 
and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities, for 
specific information about citing past noncompliance.) 
 
If the complaint is unsubstantiated, (i.e., the surveyor(s) cannot determine that it occurred 
and there is no indication of deficient practice), notify the facility of this decision. 
 
5310 - Action on Allegations of Resident Neglect and Abuse, and 
Misappropriation of Resident Property for Nursing Homes  
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
 
5310.1 - Written Procedures 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The State must develop and implement written procedures for the timely review and 
investigation of allegations of resident abuse and neglect, and misappropriation of 
resident property, including both complaints and facility-reported incidents.  The States 
policies and procedures must be consistent with Federal requirements as well as with 
procedures in the State Operations Manual. 
 
Nursing homes send the following types of incidents to the State Survey Agency: 
 
  All alleged violations involving abuse, neglect, exploitation or mistreatment, 
including injuries of unknown source and misappropriation of resident property; 
 
    The results of all facility investigations involving alleged violations of abuse, 
neglect, exploitation or mistreatment, including injuries of unknown source and 
misappropriation of resident property; and 
 
  Reasonable suspicions of crimes against nursing home residents.  
 
NOTE: If the SA receives information that a suspected crime may have 
occurred in a facility and there is indication that it has not been reported or 
the SA cannot verify that a report was made to law enforcement, then the SA 
forwards the information from the initial report immediately to law 
enforcement.  The SA must follow applicable laws and regulations related to 
information disclosures, privacy and confidentiality, as it makes referrals.  
The SA may also contact the CMS Location office for more information. 
 
A. Initial Reporting of Facility-Reported Incidents  
 
The information collected during intake is critical in determining what may be 
occurring in a facility and the effect(s) that it may have on residents.  While 
States have discretion in how they collect information from facilities (e.g., 
through electronic submission), at a minimum, the State Survey Agency must 
provide instructions to the facility and collect sufficient information to 
determine how the incident should be prioritized.  See also Exhibit XX for 
sample instructions with examples of information and Appendix PP, Tag 
F609. If the facility has not provided sufficient information, the SA should take 
this into consideration as it triages the incident. 
 
1.  Facility Reported Incidents  Initial Report  
     
The facility must provide in its report sufficient information to describe the 
alleged violation and indicate how residents are being protected [See 
483.12(c)(3)]. It is important that the facility provide as much 
information as possible, to the best of its knowledge at the time of 
submission of the report, so that state agencies can initiate action 
necessary to oversee the protection of nursing home residents.  See Exhibit 
XX for a sample form for initial reporting with examples of information 
and see also Appendix PP, Tag F609.   
 
B. Reporting of Investigation Findings for Facility-Reported 
Incidents  
 
For alleged violations of abuse, neglect, exploitation or mistreatment, 
including injuries of unknown source and misappropriation of resident 
property, the facility is required to submit a report of the results of the 
investigation within 5 working days to the State Survey Agency (See 42 C.F.R. 
483.12(c)(4), Tag F609 of Appendix PP of the State Operations Manual).  
  While States have discretion in how they collect information from facilities 
(e.g., through electronic submission), at a minimum, the State Survey Agency 
must provide instructions to the facility and collect sufficient information to 
determine how the incident should be prioritized.   
 
5-Day Final Report of Suspected Allegation 
 
Within 5 working days of the incident, the facility must provide in its report 
sufficient information to describe the results of the investigation, and indicate 
any corrective actions taken, if the allegation was verified. It is important that 
the facility provide as much information as possible, to the best of its 
knowledge at the time of submission of the report, so that State agencies can 
initiate action necessary to oversee the protection of nursing home residents 
[see 483.12(c)(4)]. See Exhibit XX for a sample form for the investigation 
report with examples of information, and see also Appendix PP, Tag F609.  
 
5310.2 - Review and Triage of Allegations 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
The State reviews all allegations of resident neglect and abuse and misappropriation of 
resident property regardless of the source. 
 
5310.2A-Immediate Jeopardy Priority 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
In cases where the initial report indicates the following, the SA must initiate an onsite 
survey within three business days of receipt of the initial report: 
 
1)  The alleged noncompliance may have caused, or may likely cause, serious injury, 
harm, impairment, or death to a resident, and  
2)  The facility has not implemented adequate protection for all residents or the SA 
has not received sufficient evidence to conclude that residents are adequately 
protected. 
 
For these cases, the SA will enter into ACTS: Intake Type=Incident; Priority = IJ; and 
Investigate Within X Days = 3 Working Days. 
 
In cases where the initial report indicates the following, the SA must initiate an onsite 
survey within seven business days of receipt of the initial report:  
 
1)  The alleged noncompliance may have caused, or may likely cause, serious injury, 
harm, impairment, or death to a resident, and  
 
2)  The facility has potentially implemented adequate protection for all residents. 
 
  For these cases, the SA will enter into ACTS: Intake Type=Incident; Priority = IJ; and 
Investigate Within X Days = 7 Working Days. 
 
NOTE: See Appendix Q of the State Operations Manual for guidance related to 
immediate jeopardy situations. 
 
Investigating nursing home facility-reported incidents according to these timeframes will 
be implemented no later than October 1, 2023, to provide time for the SAs to prepare 
given the resource constraints in the SAs. 
 
Depending on the nature of the allegation, the facility would be expected to take 
immediate action(s) to ensure the protection of residents.  Information provided by the 
facility may assist the SAs in determining whether there are potentially adequate 
protections provided to the resident.   Examples of such information include, but are not 
limited to: 
 
  Monitoring of the alleged victim and other identified residents who are at risk, 
such as conducting unannounced management visits at different times and shifts; 
  Evaluation of whether the alleged victim feels safe and if he/she does not feel 
safe, taking immediate steps to alleviate the fear, such as a room relocation, 
increased supervision, etc.; 
 
  Providing social services (e.g., emotional support and counseling) to the 
resident, as needed; 
 
  Immediate assessment of the alleged victim and provision of medical treatment 
as necessary; 
 
  Provision of goods and/or services that are necessary to avoid serious injury, 
harm, impairment, or death to a resident;  
 
  Immediate notification of the alleged victims physician and the resident 
representative, when there is injury or a change in condition or status; 
 
  If the alleged perpetrator is staff- Removal of access by the alleged perpetrator 
to the alleged victim and other residents and assurance that ongoing safety and 
protection is provided for the alleged victim and other residents 
 
  If the alleged perpetrator is a resident or visitor- Removal of access by the 
alleged perpetrator to the alleged victim and, as appropriate, other residents and 
assurance that ongoing safety and protection is provided for the alleged victim 
and other residents 
 
  Notification of the alleged violation to other agencies or law enforcement 
authorities, within timeframes as specified under Federal or State law or 
regulations; and 
   
  Whether administrative staff, including the administrator, were informed and 
involved as necessary in the investigation. 
   
Below are examples that indicate that a resident(s) may not be protected in the facility: 
 
  The alleged perpetrator continues to have access to the alleged victim and/or 
other residents; 
 
  Retaliation occurs against a resident who reports an alleged violation; 
 
  A resident who repeatedly fondles other residents is moved to another unit, 
where he/she continues to exhibit the same behaviors to other residents; and 
 
  A resident with a history of striking a resident is left unsupervised with a resident 
who has been targeted in the past. 
 
The SA may contact the resident/representative to determine whether adequate 
protections are provided to the resident 
 
 
5310.3 - Investigating Allegations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If there is reason to believe, either through oral or written evidence, that an individual 
used by a facility to provide services to residents could have abused or neglected a 
resident or misappropriated a resident's property, the State must investigate the allegation.  
During the investigation, the SA should evaluate how the facility developed policies and 
procedures to prevent the abuse, and after the abuse occurred, how the facility took action 
to report and investigate the allegations while ensuring the safety of the residents. 
 
5310.4 - Factors Beyond the Control of the Individual 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The State must not make a finding that an individual neglected a resident if the individual 
demonstrates that such neglect was caused by factors beyond the control of the 
individual. 
 
EXAMPLE:  A nurse aide could not be found negligent for not providing clean bed and 
bath linens to a resident if the facility had no clean bed and bath linens available.  
However, the facility is responsible for providing clean bed and bath linens to residents. 
 
5320  Reporting Findings of Abuse, Neglect, or Misappropriation of 
Property to the Nurse Aide Registry 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
   
5320.1 - Notification Procedures - Preliminary Determinations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the State makes a preliminary determination, based on oral or written evidence and its 
investigation, that resident neglect, abuse, or misappropriation of property has occurred, 
the State completes the following notification procedures: 
 
1.  Individuals Notified - The State notifies the following individuals in writing 
within 10 working days of the investigation: 
 
a.  Individual(s) implicated in the investigation; and 
 
b.  The current administrator of the facility in which the incident occurred. 
 
2.  Notice Information - The following information is included in the notice: 
 
a.  Nature of the allegation (specific facts); 
 
b.  Date and time of the occurrence; 
 
c.  A statement that the individual implicated in the investigation has a right to a 
hearing and must request the hearing within 30 days from the date of the 
notice.  Provide the individual with the specific information needed to request 
a hearing, such as the name and address of a contact in the State to request a 
hearing; 
 
d.  Statement that if the individual fails to request a hearing, in writing, within 30 
days from the date of the notice, the presumed substantiated findings is 
reported to the nurse aide registry or the appropriate licensure authority; 
 
e.  The intent to report findings substantiated by a hearing in writing to the nurse 
aide registry and/or to the appropriate licensure authority; 
 
f.  Consequences of waiving the right to a hearing; 
 
g.  Consequences of a finding through the hearing process that the resident abuse 
or neglect, or misappropriation of property did occur; and 
 
h.  Right of the accused individual to be represented by an attorney at the 
individuals own expense. 
 
5320.2 - Conduct of Hearing for Nurse Aides 
 
1- Time frame to Complete the Hearing 
 
  The State must complete the hearing and the hearing record within 120 days from the day 
it receives the request for a hearing. 
 
2 - Hearing Location 
 
The State must hold the hearing in a manner consistent with State practice at a reasonable 
place and time convenient for the individual. 
 
5320.3 - Reporting Findings 
 
1 - Reporting to Entities 
 
If the individual waives the right to a hearing or the time to request a hearing has expired, 
or if the hearing finding is that the individual neglected or abused a resident or 
misappropriated a residents property, the substantiated findings must be reported in 
writing within 10 working days to: 
 
a.  The individual; 
 
b.  Current administrator of the facility in which the incident occurred; 
 
c.  The administrator of the facility that currently employs the individual, if it is not 
the same facility in which the incident occurred; 
 
d.  Applicable licensing authorities; and 
 
The nurse aide registry for nurse aides as specified in 42 CFR 483.156(c) and discussed 
in 4141.  Section 4141 discusses the function of the registry, the information contained 
in the registry, and responsibility for the registry. 
 
2 - Information Submitted to the Nurse Aide Registry 
 
The following information must be included and remain in the registry permanently, 
unless the finding was made in error, the individual was found not guilty in a court of 
law, or the State is notified of the individuals death.  See 4141.B. 
 
a.  Documentation of the investigation, including the nature of the allegation and the 
evidence that led to the conclusion that the allegation was valid; 
 
b.  The date of the hearing, if the individual chose to have one, and its outcome; and 
 
c.  A statement by the individual disputing the allegation if the individual chose to 
make one. 
 
3 - Information Retained in the Nurse Aide Registry Permanently 
 
  The registry must remove entries for individuals who have performed no nursing or 
nursing-related services for 24 consecutive months, unless the individuals registry entry 
includes documented findings of abuse, neglect, or misappropriation of property. 
 
5330 - Reporting Abuse to Law Enforcement and the Medicaid Fraud 
Control Unit for Nursing Homes 
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22) 
 
If the SA receives information that a suspected crime may have occurred in a facility and 
there is indication that it has not been reported or the SA cannot verify that a report was 
made to law enforcement, the SA must report the suspected crime to law enforcement 
immediately.    
 
Verifying that a complainant, facility, and/or covered individual(s) has made a report to 
law enforcement would include review and confirmation of the following information: 
 
  Who submitted the report to law enforcement, including name and contact 
information; 
 
  Who did the reporter contact, including law enforcement entity, name, and 
contact information; 
 
  Date/Time that the report was filed; 
 
  Any copies of the report made to law enforcement, if available; 
 
  What information was conveyed to law enforcement; and 
 
  The police report number provided by law enforcement. 
 
When the SA or RO substantiates a finding of abuse, the SA or RO must report the 
substantiated findings to local law enforcement and, if appropriate, the Medicaid Fraud 
Control Unit. 
 
NOTE: Covered individual is defined in section 1150B(a)(3) of the Act as anyone who 
is an owner, operator, employee, manager, agent or contractor of the facility 
(483.12(b)(5)(i)).   
 
5340 - Post-Survey Certification Actions for Nursing Homes 
(Rev. 155, Issued: 06-10-16, Effective: 06-10-16, Implementation: 06-10-16) 
 
Following the investigation, the survey team records any findings on Form CMS-2567, 
the SA conducts a supervisory review of the CMS-2567 form and sends the provider a 
copy.  The SA requests a POC for any uncorrected deficiencies.  See 2728. 
 
When Federal deficiencies are identified, the SA initiates certification actions as follows: 
   
1. Noncompliance that Constitutes Immediate Jeopardy to Resident Health 
and Safety - The SA initiates procedures in accordance with 7307 to 7309. 
 
2.  Noncompliance that Does Not Constitute Immediate Jeopardy to Resident 
Health and Safety - The SA initiates procedures in accordance with 7311 to 
7316. 
 
3.  In Substantial Compliance - The SA initiates procedures in accordance with 
7319. 
 
5350  Data Entry 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA enters survey information into the ASPEN system (via ASPEN Central Office or 
ACTS), including Forms CMS-670 and CMS-2567.  
 
5360 - Processing of Complaints Originating with or Investigated by the 
CMS RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO establishes procedures and clear organizational accountability to ensure that any 
complaint is properly evaluated, documented, acknowledged, and handled timely and 
appropriately.  The RO uses ACTS to ensure timely and appropriated action on all 
allegations originating with or investigated by the RO. 
 
The extent and nature of RO involvement with a given complaint varies depending on the 
nature of the allegation and the receiving organization.  The following procedures address 
the major variants of RO involvement. 
 
5370 - Pre-Investigation Actions on Allegations Originating Through 
the RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Most complaints originate through the SA and are recorded and controlled by the SA.  
When a complaint is filed directly with the RO, however, the RO assumes those initial 
SA responsibilities. 
 
5380 - RO Processing of RO Investigated Complaints 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
This less frequent class of complaints includes allegations retained by the RO or 
forwarded to the RO by the SA for investigation or special processing.  The RO 
responsibilities vary based on the type of complaint. 
 
  1 - Direct RO Investigation 
 
These procedures apply when a direct RO investigation is conducted.  When directly 
investigating, the RO begins by ensuring that it or the SA has met all intake, 
acknowledgment, and priority assignment requirements in 5010 to 5020. 
 
2 - Conducting the Investigation 
 
The RO follows the procedures for investigation in 5300. 
 
3  RO Certification Actions  
 
When Federal deficiencies are identified, the RO initiates certification actions as follows: 
 
a.  Noncompliance that Constitutes Immediate Jeopardy to Resident Health and 
Safety - The RO initiates procedures in accordance with 7307 to 7309.  The RO 
performs the SA responsibilities described in these sections. 
 
b.  Noncompliance that Does Not Constitute Immediate Jeopardy to Resident Health 
and Safety - The RO initiates procedures in accordance with 7311 to 7316. 
 
c.  In Substantial Compliance - The RO initiates procedures in accordance with 
7319. 
 
4 - Reporting 
 
The RO should report survey information into the ASPEN system (via ASPEN Central 
Office or ACTS), including Forms CMS-670 and CMS-2567. 
 
5390  RO Oversight of Complaint-Related Processes 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
1.  The RO considers any complaint data in targeting look-behind surveys or reviews. 
 
2.  The RO monitors data in summary form - either through a log or data system.  See 
5060. 
 
These records should include: 
 
  Identification of region or State-wide patterns; 
 
  Pinpointing of problem providers or States; 
 
  Evaluation of SA processing times, workloads, performance, etc.; and 
 
    Identification of overall SA workloads, including unsubstantiated and Medicaid-
only complaint volumes. 
 
3.  Based on needs identified from oversight activities, the RO provides SA training and 
technical assistance. 
 
NOTE:  Sections 5400 to 5480.2 relate to alleged EMTALA violations. 
 
5400 - Investigations Involving Alleged Emergency Medical Treatment 
and Labor Act (EMTALA) Violations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Section 1866 of the Act, Agreements with Providers of Services, specifies that for a 
hospital, or any provider of services, to qualify for participation in the Medicare program, 
it must enter into an agreement with the Secretary of HHS.  Effective August 1, 1986, 
participating hospitals with emergency departments must comply with the requirements 
of 1867 of the Act as a condition of their provider agreement. 
 
The following Medicare provider agreement requirements, which closely parallel 
provisions contained in 1866of the Act, must be met by Medicare participating hospitals 
with emergency departments: 
 
  42 CFR 489.20(l) requires a hospital to comply with the requirements of 42 CFR 
489.24.  Section 1866(a)(1)(I) of the Act requires a hospital to have and enforce 
policies to ensure compliance with the requirements of 1867; 
 
  42 CFR 489.20(m) requires a hospital to report to CMS or the SA any time it has  
reason to believe it may have received an individual who has been transferred in 
an unstable emergency medical condition (EMC) from another hospital in 
violation of the requirements of 42 CFR  489.24(e); 
 
  42 CFR 489.20(q) requires a hospital to post conspicuously a sign(s) specifying 
the rights of individuals, under 1867 of the Act, with respect to examination and 
treatment for emergency medical conditions and women in labor and to indicate 
whether or not the hospital participates in the Medicaid program.  The letters 
within the signs must be clearly readable at a distance of at least 20 feet or the 
expected vantage point of the emergency department clients.  The wording of the 
sign(s) must be clear and in simple terms and language(s) that are understandable 
by the population served by the hospital; 
 
  42 CFR 489.20(r)(1) requires a hospital to maintain medical and other records 
related to individuals transferred, including discharges, to or from the hospital for 
a period of five years from the date of transfer; 
 
    42 CFR 489.20(r)(2) requires a hospital to maintain a list of physicians who are 
on call to provide treatment necessary to stabilize an individual with an 
emergency medical condition; 
 
  42 CFR 489.20(r)(3) requires a hospital to maintain a central log on each 
individual who comes seeking assistance and whether he or she refused treatment, 
was refused treatment, or whether the individual was transferred, admitted and 
treated, stabilized and transferred, or discharged. 
 
When hospitals do not conform to the requirements of 1867 of the Act, the practice is 
commonly called dumping.  A hospital with a dedicated emergency department is 
defined in 42 CFR 489.24(b) as a hospital that offers services for emergency medical 
conditions within its capacity to do so.  The regulations at 42 CFR 489.24 parallel the 
provisions of 1867 of the Act and contain the following requirements that a hospital 
with a dedicated emergency department must meet: 
 
  42 CFR  489.24(a) General.  Applicability of provisions of this section. 
 
  42 CFR 489.24(b) Definitions. As used in this section. 
 
  42 CFR 489.24(c) Use of dedicated emergency department for non-emergency 
services. 
 
  42 CFR 489.24(d) Necessary stabilizing treatment for emergency medical 
conditions. 
 
  42 CFR 489.24(d)(1) General.  Subject to the provisions of paragraph (d)(2). 
 
  42 CFR 489.24(d)(2) Exception: Application to inpatients. 
 
  42 CFR 489.24(d)(3) Refusal to consent to treatment. 
 
  42 CFR 489.24(d)(4) Delay in examination or treatment. 
 
  42 CFR 489.24(d)(5) Refusal to consent to transfer. 
 
  42 CFR 489.24(e) Restricting transfer until the individual is stabilized. 
 
  42 CFR 489.24(e)(1) General. 
 
  42 CFR 489.24(e)(2) Appropriate transfer to another medical facility. 
 
  42 CFR 489.24(e)(3) Provides whistleblower protection to physicians and 
qualified medical personnel. 
 
    42 CFR 489.24(f) Recipient hospital responsibilities. 
 
  42 CFR 489.24(g) Termination of provider agreement. 
 
  42 CFR 489.24(h) Consultation with Quality Improvement Organization (QIO). 
 
  42 CFR 489.24(i) Release of QIO Assessment. 
 
  42 CFR 489.24(j) Availability of on-call physicians. 
 
  42 CFR 489.24 (j)(1) On-call list. 
 
  42 CFR 489.24 (j)(2) Hospital on-call policy and procedures. 
 
If a hospital fails to meet these requirements, CMS may terminate the provider agreement 
in accordance with 42 CFR 489.53.  The Office of the Inspector General (OIG) has the 
responsibility and authority to assess civil monetary penalties (CMPs) or to exclude 
physicians from the Medicare program when a hospital or physician violates these 
requirements.  Additionally, individuals suffering personal harm and medical facilities 
suffering financial loss as a result of a violation of these provisions can bring civil action 
against the offending hospital and physicians.  Filing for such civil action is limited to a 
period of 2 years after the date of the alleged violation.  This legislation does not preempt 
any State or local laws, except to the extent that State or local requirements directly 
conflict with a requirement of this legislation. 
 
5410  EMTALA and Born-Alive Infants Protection Act of 2002 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
5410.1 - Interaction of the Born-Alive Infant Protection Act and 
EMTALA 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
With the definition of the terms person and individual codified at 1 U.S.C. 8, it is 
clear that there are circumstances where EMTALA protections are applicable to an infant 
who is born alive, as that term is defined in 1 U.S.C. 8(b). 
 
For example, assume that a hospitals labor and delivery department meets the definition 
of a dedicated emergency department. If an infant was born alive in that dedicated 
emergency department, and a request was made on that infants behalf for screening for a 
medical condition, (or if a prudent layperson would conclude, based on the infants 
appearance or behavior, that the infant needed examination or treatment for an 
emergency medical condition and that a request would have been made for screening) the 
hospital and physician could be liable for violating EMTALA for failure to provide such 
a screening examination. The born-alive infant is a person and an individual under 1 
U.S.C.  8(a) and the screening requirement of EMTALA applies to any individual 
who comes to the emergency department. 
   
Another example is a case of an infant born alive elsewhere on the hospitals campus 
(i.e., not in the hospitals dedicated emergency department) and a prudent layperson 
observer concluded, based on the born-alive infants appearance or behavior, that the 
infant was suffering from an emergency medical condition. In such a circumstance, the 
hospital and its medical staff are required to perform a medical screening examination on 
that infant to determine whether or not an emergency medical condition existed. If the 
hospital or its medical staff determined that the infant was suffering from an emergency 
medical condition, the hospital has an obligation to admit the infant, or to comply with 
either the stabilization requirement or the transfer requirement of EMTALA. The born-
alive infant is a person and an individual, as described above, and the stabilization 
and transfer requirements of EMTALA apply to any individual who comes to the 
hospital. 
 
Finally, a third example is when the hospital admits a born-alive infant. EMTALA does 
not apply to inpatients. If a bornalive infant is admitted to the hospital, EMTALA would 
not apply to protect the infant in most circumstances. However, the Medicare COPs 
would apply to the infant once he or she was admitted to the hospital as an inpatient. 
 
5410.2 - Conduct of Investigations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If a complaint indicates that a born-alive infant has been denied a screening examination, 
stabilizing treatment, or an appropriate transfer, the complaint is prioritized as an alleged 
EMTALA violation. It is not necessary to determine that the hospital acted with an 
improper motive in any failure to provide a screening examination, stabilizing treatment, 
or an appropriate transfer in order to conclude that an EMTALA violation has occurred. 
The Supreme Court of the United States has held that a finding of improper motive is not 
required to conclude that an EMTALA violation has occurred. 
 
5420 - Basis for Investigation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA enters alleged EMTALA violations into ACTS.  The RO approves or disapproves 
requests for EMTALA investigations in ACTS. 
 
5430 - RO Direction of Investigation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
5430.1 - Evaluation of Allegation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO evaluates all complaints and refers to the SA those that warrant SA investigation.  
The SA or the RO sends a letter to the complainant acknowledging the complaint and 
informing the complainant of whether an investigation is warranted.  The SAs 
  responsibility is to verify whether a violation of 42 CFR 489.24 and/or the related 
requirements at 42 CFR 489.20 occurred, and if there were other violations. 
 
5430.2 - Request for Investigation of Allegations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO gives an initial verbal authorization to the SA to investigate the EMTALA 
allegation, and then completes Form CMS-1541A in ACTS.  If the RO identifies 
Medicare conditions or standards it wants the SA to survey, related to the EMTALA 
allegation at a deemed hospital, the RO completes Form CMS-2802 in ACTS.  If the RO 
identifies conditions or standards it wants the SA to survey related to the EMTALA 
allegation at a non-deemed hospital, it directs the SA to conduct a survey by completing 
Form CMS-1541A in ACTS. 
 
5440 - Conducting an Investigation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
5440.1 - Selecting the Team 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA selects surveyors with a background in the profession or area to be investigated.  
Preferably, the surveyors should have acute care training and experience. All surveyors 
must be adequately trained in the evaluation of 42 CFR 489.24 cases.  Physicians should 
have experience in peer review. 
 
5440.2 - Scheduling the Investigation 
(Rev. 191, Issued: 07-19-19, Effective: 07-19-19, Implementation: 07-19-19) 
 
Allegations of EMTALA violation against a non-deemed or deemed hospital or CAH 
may represent a probable immediate jeopardy to the next individual who comes to the 
hospital requesting examination and treatment for an emergency medical condition.  
Therefore, when triaged as IJ by the RO, initiate the investigation within two business 
days after receipt of the authorization from the RO.  The onsite investigation must be 
conducted on consecutive business days.  The survey must be completed promptly and is 
not to be interrupted by other activities.  DO NOT ANNOUNCE ANY 
INVESTIGATIONS. 
 
Based on review of the complaint allegations by the RO, the EMTALA complaint may 
also be prioritized as Non-IJ High.  In these situations, the investigation must be initiated 
within 45 business days of RO authorization.  The onsite investigation must be conducted 
on consecutive business days.  The survey must be completed promptly, should not be 
interrupted by other activities, and must be unannounced. 
 
5440.3 - Guidelines for Surveyors Conducting Investigations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
  Attention to Procedures 
 
The purpose of conducting the investigation is to ascertain whether or not the hospital 
violated the EMTALA requirements. The survey must be in accordance with applicable 
survey procedures and policies.  Review instructions in Appendix V, before beginning 
the investigation. The guidelines provide a detailed interpretation of the regulations. 
 
Involvement of Complainants 
 
Complainants, if known, receive a letter of acknowledgment from the SA or RO.  Do not 
disclose the identity of complainants.  When information obtained during the 
investigation appears to be in conflict with the information supplied by the complainant, 
consult with the complainant, if this can be done without disclosing the persons identity. 
 
5440.4 - Conducting the Investigation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
A complete investigation consists of assessment of the following components: 
 
  Completeness, adequacy and enforcement of policies and procedures which 
address the provisions of 42 CFR 489.24; 
 
  Prompt reports to the SA or CMS of receipt of an improperly transferred 
individual by the receiving hospital; 
 
  Presence and completeness of signs posted in emergency departments specifying 
the rights of individuals under 42 CFR 489.24, and information indicating 
whether the hospital participates in the Medicaid program; 
 
  Maintenance of medical and other records related to individuals transferred to or 
from the hospital for a period of five years from the date of transfer, including 
discharged patients; 
 
  Maintenance of a list of physicians who are on call to provide necessary 
stabilizing treatment; 
 
  Maintenance of a central log on each individual who comes to the hospital 
seeking emergency services; 
 
  Provision of an appropriate medical screening examination sufficient to determine 
the presence of an emergency medical condition; 
 
  Provision of necessary stabilizing treatment; 
 
  Provision of no delay in examination or treatment in order to inquire about 
insurance status or capability for payment; 
   
  Provision of an appropriate transfer to another medical facility/provider; 
 
  Provision of whistleblower protections; and 
 
  Adequacy of responsibilities of the recipient hospital with specialized capabilities 
(nondiscrimination). 
 
The survey tasks are listed below for easy reference.  See Appendix V for detailed 
guidance. 
 
  Task 1:  Entrance Conference; 
 
  Task 2:  Case Selection Methodology; 
 
  Task 3:  Record review; 
 
  Task 4:  Interviews; 
 
  Task 5:  Exit Conference; 
 
  Task 6:  Professional Medical Review; and 
 
  Task 7:  Assessment of Compliance and Completion of the Deficiency Report. 
 
After the investigation is concluded, complete a Form CMS-1541B (Exhibit 137).  If one 
or more of the provisions of EMTALA are not met, complete Form CMS-2567, using 
Principles of Documentation.  Describe in detail the facts of each individual case.  In 
addition, specify whether the hospital was aware of the problem and took steps to remedy 
it prior to the survey.  If a SA physician was a member of the investigation team, include 
the medical review of the case.  Use the Physician Review Outline for Emergency Care 
Obligations of Medicare Hospitals, (Exhibit 138) for this purpose.  In addition, complete 
Form CMS-562.  All the forms must be signed, showing the professional titles of all 
participating surveyors, and dated. 
 
A hospital may have multiple sites listed under its Medicare provider number. These sites 
may not be in close proximity of each other and each site may have its own dedicated 
emergency department (DED). In cases where the alleged EMTALA violation is against 
a specific site of the hospital, the surveyors should focus their survey investigation at the 
hospital site mentioned in the complaint intake.  However, the surveyors should review 
all EMTALA related Policies and Procedures of all sites of the hospital. The surveyors 
need to survey the other sites of the hospital if the survey findings indicate that the 
potential EMTALA violation maybe widespread. 
 
5440.5 - Exit Conference 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
   
It is usually desirable and appropriate to conduct an exit conference. The surveyor(s) may 
outline the basic facts uncovered during the onsite investigation.  However, the 
surveyor(s) must inform the hospital that the RO makes the final compliance 
determination, and the determination is often made with information obtained after the 
onsite investigation.  Do not reveal the complainant and do not venture an opinion on 
what determination the RO might make.  The exit conference should include a 
description of the process that is followed if the RO determines that a violation has 
occurred. 
 
5450 - Forwarding Report of Investigation to the RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Transmit the results of the investigation and your recommendations to the RO through 
ACTS within 10 working days following completion of the onsite survey, if it appears 
there may be an EMTALA violation.  If there appears to be no violation, this time frame 
may be extended to 15 working days, in order to allow the SA additional processing time. 
 
Transmit the following materials to the RO through ACTS: 
 
  Form CMS-562,Medicare/Medicaid/CLIA Complaint Form; 
 
  Form CMS-1541B, Responsibilities of Medicare Participating Hospitals in 
Emergency Cases Investigation Report.  Recommend one or more of the actions 
below on the form: 
 
  None - This means the complaint was not substantiated;  
o
 
  In Compliance, but Previously Out of Compliance - This means that the 
o
hospital identified the problem on its own and took effective corrective 
action prior to the investigation.  In addition to this recommendation, 
document on the Form CMS-2567 when the hospital identified the 
violation or a similar problem, the corrective action taken, and the date of 
such action.  Also, document that the hospital has had no violations or 
similar problems for at least the past 6 months; 
 
  Recommend Termination (23 calendar day track) - This means that the 
o
hospital is out of compliance with 42 CFR 489.24 or the related 
requirements at 42 CFR 489.20(l), (m), (q) or (r) and the violation presents 
an immediate jeopardy to patient health and safety; 
 
  Recommend Termination (90 calendar day track) - This means that the 
o
hospital is out of compliance with 42 CFR 489.24 or the related 
requirements at 42 CFR 489.20(l), (m), (q) or (r), but the violation does 
not present an immediate jeopardy to patient health and safety;  
 
    Request Physician Review. This means that it is recommended that the 
o
RO obtain a medical review of the case; 
 
  Possible Discrimination. This means that it is believed that 
o
discrimination occurred based on financial status, race, color, nationality, 
handicap, or diagnosis. 
 
  Form CMS-670, Survey Team Composition and Workload Report; 
 
  Form CMS-2567, Statement of Deficiencies and POC; 
 
NOTE:  If the hospital had identified the deficiency and took corrective action 
prior to the investigation, indicate on the Form CMS-2567 that the 
requirement was not met.  However, indicate on the Form CMS-2567 
and the narrative report that the hospital took corrective action prior to 
the investigation, what action was taken, and for how long the hospital 
has been in compliance. 
 
  Physician Review Outline for Emergency Care Obligations of Medicare Hospital 
(if physician review was done by SA); 
 
  Complaint investigation narrative; 
 
  Copies of pertinent hospital policies and procedures that relate to the identified 
deficiencies; 
 
  Summary listing of all patients comprising the sample, including an explanation 
of how and why the cases were selected for review;  
 
  Summary of interviews. 
 
Transmit the following to the RO by overnight mail: 
 
  Copies of medical records for substantiated cases, medical records of individuals 
named in the complaints, and other medical records for which a QIO review is 
requested; 
 
  Certification of benefits versus risks of the transfer, if this is a transfer case. 
 
5460 - RO Review of Investigation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Upon receiving the case from the SA, the RO has 10 working days to review the 
investigation findings.  The RO requests a 5-day advisory medical review of the case by 
the QIO to determine if there is an EMTALA violation. The RO has 5 working days to 
review the case upon return from the QIO.  With this information, and any other 
  additional information, the RO determines whether the hospital complied with the 
EMTALA requirements and determines whether the violation constitutes an immediate 
jeopardy to patient health and safety. 
 
Prior to determining compliance or noncompliance, the RO is encouraged to confer with 
the State Agency, and may confer with the hospitals representatives. The RO shares as 
much data as possible in accordance with current Privacy Act requirements. 
 
5460.1 - Hospital Is In Compliance - No Past Violation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the RO determines that the allegation is not substantiated and that the hospital is in 
compliance with 42 CFR 489.24 and/or the related requirements at 42 CFR 489.20, the 
RO notifies the hospital and forwards a copy of the letter to the SA.  If the SA received 
the complaint, it notifies the complainant that the complaint was not substantiated.  If the 
RO received the complaint, the RO notifies the complainant. 
 
5460.2 - Hospital Is In Compliance - Past Violation, No Termination 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the RO determines that the allegation was substantiated, but the hospital had identified 
the violation on its own, took effective corrective action prior to the investigation, and 
has had no EMTALA violations for at least the past 6 months, termination action is not 
initiated.  The RO notifies the hospital via a Past Violation - No Termination Letter. 
The SA receives a copy of the letter through ACTS.  The RO or SA sends a letter to the 
complainant regarding the outcome of the investigation.  Although no termination action 
is taken, the RO refers past violations of 42 CFR 489.24 to the OIG for assessment of 
civil monetary penalties (CMPs) if warranted. 
 
5460.3 - Hospital Is Not in Compliance - Immediate Jeopardy to Patient 
Health and Safety 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the RO determines that the hospital is not in compliance and the violation represents an 
immediate jeopardy to patient health and safety, the RO follows a 23 calendar-day 
termination process. The termination procedures in 3010 are followed.  Uncorrected 
deficiencies that resulted in a violation of 42 CFR 489.24 may pose an immediate 
jeopardy to people seeking emergency care.  The RO notifies the complainant that the 
complaint was substantiated.  It also informs the hospital in writing of the specific 
violations via a preliminary determination letter, and sends the hospital a copy of Form 
CMS-2567.  The SA receives a copy of the letter through ACTS. 
 
5460.4 - Hospital Is Not in Compliance - Situation Does Not Pose an 
Immediate Jeopardy to Patient Health and Safety 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
   
If the RO determines that the hospital is not in compliance with the EMTALA 
requirements, but the violation does not pose an immediate jeopardy to patients health 
and safety, or the hospital took corrective action after the investigation to remove the 
immediate jeopardy, the RO follows a 90 calendar-day termination process.  The 
termination procedures in 3012 are followed.  The RO notifies the complainant that the 
complaint was substantiated.  The RO informs the hospital, in writing, of the specific 
violations via a preliminary determination letter and sends the hospital a copy of Form 
CMS-2567.  The SA receives a copy of the letter through ACTS. 
 
Examples of noncompliance that usually do not pose an immediate jeopardy: 
 
1.  A transfer which was appropriate, but not signed or dated by the physicians; 
 
2.  An appropriate, functioning, central log that on one particular day is not fully 
completed; and 
 
3.  A written hospital policy that is missing, but is nonetheless being implemented. 
 
The fact that the hospital has completed a POC should not be interpreted to mean that the 
hospital admits violating the EMTALA requirements. However, the hospital is included 
on the log of facilities with EMTALA violations, with the notation that an acceptable 
POC was received by CMS, and termination action was stopped. 
 
5465 - Procedures for the 5-day QIO Review of Alleged Violations of 42 
CFR 489.24 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Prior to terminating a hospital from the Medicare program because of possible 
violation(s) of EMTALA, the RO requests the QIO to assess whether the individual 
involved was provided an appropriate medical screening examination, stabilizing 
treatment, or an appropriate transfer as required by EMTALA. 
 
The QIO 5-day review is mandatory if the RO determines that a case involves a possible 
violation of 42 CFR 489.24 to support possible termination action against a hospital if in 
fact it violated EMTALA. The RO is responsible for providing the QIO with all 
information relevant to the case that is within its possession and control.  The RO sends 
the Physician Review Outline for Emergency Care Obligations of Medicare Hospitals, 
(Exhibit 138) to capture this information. The QIO completes the review within 5 
working days upon the receipt of ROs request. The QIO sends the case file back to the 
RO including a copy of the review report. It is not required that the physician reviewer 
give the hospital and/or the physician an opportunity to respond to the allegations at this 
time.  If the affected physician and/or hospitals have questions concerning the case, they 
are to consult with the RO. 
 
  The QIO Review is not required in cases where a delay in effecting a sanction would 
jeopardize the health and safety of individuals or in situations where medical review is 
inappropriate (e.g., cases where the individual was denied a medical screening 
examination).  The QIO 5-day review is required to seek medical expertise on whether 
the individual was adequately screened, examined and treated. 
 
The RO shall release upon request the 5 day QIO review to the affected physician and/or 
hospital, after the RO has made a determination as to whether the hospital violated or is 
in compliance with EMTALA.  In addition, the RO may release the QIO review to the 
complainant or his/her representative upon request. The physician reviewers identity is 
confidential, therefore, when releasing the QIO report the physicians identity is not to be 
disclosed unless he or she consents to the release of their identity in accordance with the 
disclosure regulations at 42 CFR 480.132 and 480.133. 
 
The cases in which the RO determined that the hospital was in compliance with 42 CFR 
489.24 but in violation of 42 CFR 489.20 of the EMTALA regulation do not need to be 
forwarded to the QIO for review. The RO takes action as warranted. 
 
5470 - Termination Procedures for EMTALA Violations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
5470.1 - Procedures for Termination when the EMTALA Violation is an 
Immediate Jeopardy to Patient Health and Safety 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
In cases where the RO determined that an immediate jeopardy existed, after a 5-day QIO 
advisory review has been completed, the RO follows the termination procedures in 
3010.  The processing timeframes are the maximum allowed. The termination 
procedures are not postponed or stopped unless evidence of correction of the deficiencies 
or proof that the violation did not exist is provided by the hospital to the RO.  The RO 
forwards the supporting documents to the QIO (for a 60 day QIO review) in order to 
provide a medical opinion on the case.  The RO refers the case to the OIG that has the 
responsibility for assessment of CMPs against the hospital and/or physician and 
physician exclusion provisions for violations of 42 CFR 489.24. The case is also referred 
to the Office for Civil Rights (OCR) because OCR may take action under the Hill-Burton 
Subpart G Community Services regulations at 42 CFR 124.603(b) (1). 
 
The termination track starts on the date that the RO makes the determination of 
noncompliance with 42 CFR 489.24.  It is the date of the preliminary determination 
letter. The letter is forwarded to the hospital by the fastest method available (fax, e-mail 
or telephone).  In addition, a written letter follows up by mail.  The preliminary 
determination letter informs the hospital of: 
 
  The ROs findings based on the investigation and the results of medical review; 
 
    The projected termination date (the 23rd calendar day from the date of the 
preliminary determination letter); 
 
  The date on which the RO issues a Notice of Termination Letter and notifies the 
public (at least two calendar days, but no more than four calendar days prior to 
the termination date); and 
 
  That the hospital may avoid the termination action and notice to the public by 
either providing acceptable POCs for the deficiencies or by successfully showing 
that the deficiencies did not exist. In either case, the necessary information must 
be furnished to the CMS RO in time for the SA to verify the corrections before 
the projected termination date. 
 
If, during the resurvey, the SA finds that the provider had implemented systems and 
processes to ensure that the likelihood of further violation is remote and there is adequate 
evidence that the provider is in compliance with the requirements, the termination action 
is rescinded and the provider is put back in compliance. 
 
If, during the resurvey, the SA finds that the provider has not adequately implemented 
systems and processes to ensure compliance, the RO gives the hospital an additional 67 
days or a total of 90 days (23 plus 67) to achieve compliance. 
 
This allows the hospital time to prove that the corrective action is good for the long-term 
(i.e., the corrective action is adequate to ensure that no further violations will occur).  The 
RO directs the SA to conduct a second survey by the 60th calendar day.  On the resurvey, 
the surveyor(s) reviews patients emergency department (ED) records and other relevant 
documents for the period since the last survey to assess continued compliance. If the 
hospital fails to achieve compliance, it is terminated from the Medicare program.  The 
RO sends the complainant a letter reporting the final results of the investigation. 
 
If the termination takes place and the hospital desires to become re-certified as a 
Medicare provider, the hospital must provide reasonable assurance that compliance will 
be maintained. The procedures at 2016 are followed. 
 
5470.2 - Procedures for Termination When the EMTALA Violation is 
Not Immediate Jeopardy to Patient Health and Safety 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
In cases where the RO determined that a violation existed but not an immediate jeopardy, 
after a 5-day QIO advisory review has been completed when it was warranted, the RO 
follows the termination procedures in 3012 The processing timeframes are the 
maximum allowed. The termination procedures are not postponed or stopped unless 
evidence of correction of the deficiencies or proof that the violation did not exist is 
provided to the RO by the hospital.  If warranted, the RO forwards supporting documents 
to the QIO (for a 60 day QIO review) in order to provide a medical opinion on the case. 
The RO refers the case to the OIG, if warranted, that has the responsibility for assessment 
  of CMPs against the hospital and/or physician and physician exclusion provisions for 
violations of 42 CFR 489.24 The case is also referred to the Office for Civil Rights 
(OCR) because OCR may take action under the Hill-Burton Subpart G Community 
Services regulations at 42 CFR 124.603(b)(1) 
 
The termination track starts on the date that the RO makes the determination of 
noncompliance with 42 CFR 489.24 and/or the related requirements at 42 CFR 489.20.  It 
is the date of the preliminary determination letter. 
 
5480 - Procedures for QIO Review of Confirmed EMTALA Violation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Before imposing sanctions under 1867 of the Act for violations of 42 CFR 489.24, 42 
CFR 489.24(h) requires that CMS obtain consultation from the QIO.  The OIG holds the 
authority to assess CMPs against the hospital or physicians or to exclude physicians from 
the Medicare program for violations of 42 CFR 489.24. 
 
5480.1 - Procedures for Coordinating 60 day QIO Review 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO requests the QIO to provide a medical opinion on EMTALA violation cases 
within 60 calendar days. The cases referred for 60-day QIO review are outlined in 
5480B. The RO uses the Model Letter Requesting QIO Review of a Confirmed 
Violation of 42 CFR 489.24 for Purposes of Assessing Civil Monetary Penalties or 
Excluding Physicians, (Exhibit 212).   The QIO provides the physician and the hospital 
reasonable notice of its review a reasonable opportunity for discussion, and an 
opportunity for the physician and hospital to submit additional information before issuing 
its report.  (Instructions on notice of review and opportunity for discussion, and 
additional information that follow the regulatory requirements in 42 CFR 489.24(h) are 
found in 9100-9150 of the QIO Manual.) 
 
The RO is responsible for providing the QIO with all information relevant to the case that 
is within its possession and control.  The RO sends the Physician Review Outline for 
Emergency Care Obligations of Medicare Hospitals, (Exhibit 138) to capture this 
information.  This outline is helpful for organizing the review of the medical record.  The 
specialty of the reviewing physician should be matched to the specialty of the physician 
who attended the patient and/or the individuals medical condition.  If the patient was not 
seen by a physician, the QIO uses the diagnosis of the patient or the usual physician 
assignment practice of the hospital to determine the specialty of the physician reviewer. 
 
Within 60 calendar days of receiving the case, the QIO must submit to the RO a report on 
its findings.  The report provides an expert medical opinion regarding whether the 
individual involved had an emergency medical condition, whether the individuals 
emergency medical condition was stabilized, whether the individual was transferred 
appropriately, and whether there are any medical utilization or quality of care issues 
  involved in the case.  Upon request, the RO provides copies of the QIO report to the 
affected physician and/or hospital after all investigative activity has been completed. 
 
When there was no screening examination or when a delay would jeopardize the health or 
safety of individuals, QIO Review is not required before the OIG may impose CMPs or 
exclude a physician from the Medicare program.  In addition, if the QIO determines, after 
a preliminary review, that there was an appropriate medical screening examination and 
the individual did not have an emergency medical condition, the QIO returns the case to 
the RO with its documented opinion. The RO will close the case and no referral to OIG is 
necessary. 
 
When the RO determines that a hospital was non-compliant with the requirements of 42 
CFR 489.24, one of its notice requirements is to notify the OIG that the violation was 
confirmed and that termination action was initiated.  (See Exhibit 208.) The RO 
completes the notification after receipt of the QIO 60-day review report.   If the QIO 
report does not support an EMTALA violation, the RO closes the case without referring 
it to the OIG. 
 
The RO forwards the following documents to the OIG: 
 
  Form CMS-1541B; 
 
  Form CMS-2567; 
 
  Medical record; 
 
  Summary of interviews; 
 
  Explanation of sample selection; 
 
  Copies of pertinent hospital policies and procedures related to the identified 
deficiencies; 
 
  Complaint investigation narrative; 
 
  Certification of benefits versus risks of the transfer (if this is a transfer case);  
 
  Copy of the 5 working-day advisory QIO Review, and  
 
  Copy of the 60 calendar-day advisory QIO Review.  
 
The RO sends the above information and any other pertinent documentation in its 
possession to the OIG at the following address: 
 
Office of Inspector General  
Office of Counsel to the Inspector General 
  Department of Health and Human Services 
Room 5527, Cohen Building 
330 Independence Avenue SW 
Washington, D.C. 20201 
 
5480.2 - EMTALA Case Referral to OIG 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
CMS refers appropriate cases to the OIG for investigation.  Periodically, OIG will advise 
us of the criteria they would prefer CMS to use in referring cases.  Examples of the types 
of cases that may be referred include: 
 
1.  Financial Screening - The hospital and/or responsible physician refused to 
examine or treat a person based on the persons insurance status or inability to pay 
a fee.  The financial basis for the decision must be clearly supported by evidence 
in the file, e.g., documented policy, interview reports. 
 
2.  Patient with Trauma or Acute Emergency Condition - The hospital and/or 
responsible physician (including an on-call physician who failed to come to the 
hospital) failed to screen, stabilize, or appropriately transfer (or, in the case of a 
hospital with specialized capabilities or facilities, refused to accept an appropriate 
transfer of) a person with trauma, e.g., a severe head injury, or other acute 
emergency condition, e.g., heart attack or stroke, requiring immediate and 
substantial medical intervention. 
 
3.  High Risk Event (such as Birth) Occurs Prior to Arrival at Another Hospital 
- The hospital and/or responsible physician discharged or refused to screen/treat a 
person who gave birth (or is subject to another high risk medical event) prior to 
arriving at another hospital (especially if transport is by private vehicle). 
 
4.  Death or Serious Harm Results from Dump - The evidence in the file 
(including the QIO Review) demonstrates that the dumping violation caused 
serious medical harm or death to the victim of the violation. 
 
5.  Egregious Violation Prioritized by CMS - CMS concludes that a CMP is 
appropriate because of the seriousness of the violation (the person must have had 
an emergency medical condition) and other relevant factors, e.g., long history of 
noncompliance, hospital policy resulting in violations, pattern of serious 
violations, knowing and willful violation. This category is for those cases that 
CMS determines are very serious and merit a CMP but do not fit within other 
categories identified by OIG. 
 
5480.3 - Releasing QIO Assessment 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
  Upon request, the RO may release QIO assessment(s) to the physician and/or hospital or 
the affected individual, or his/her representative.  The QIO physicians identity is 
confidential unless he/she consents to its release. The QIO Review may be released 
pursuant to the requirements of 42 CFR 480.132 and 480.133. 
 
Sections 5500 to 5590 relate CLIA. 
 
5500 - Complaints Involving Unaccredited Laboratories 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
NOTE:   This section applies to complaints against laboratories that hold a CLIA 
certificate of compliance, certificate of waiver (COW), and certificate of PPM  
(See 5540-5590 for complaints regarding accredited laboratories). 
 
A complaint is an allegation that could result in citing noncompliance with CLIA 
requirements. A complaint may be substantiated or unsubstantiated as a result of an 
investigation or survey.  A substantiated complaint is one resulting in a finding of 
noncompliance at the time of the investigation, or a finding that noncompliance was 
proven to exist, but was corrected prior to the investigation.  An unsubstantiated 
complaint is an allegation where sufficient evidence could not be found to conclude that 
noncompliance with CLIA requirements existed during the investigation or at the time of 
the alleged violation.  A complaint may be received in either the SA or the RO.  The 
receiving organization should follow the procedures outlined below. 
 
The SA obtains the following information for every complaint: 
 
  Complainants name, address, and telephone number, unless the complainant 
requests anonymity; 
 
  Laboratorys name and address; and  
 
  Description of problem, (e.g., personnel, places, and dates of occurrence). 
 
5500.1 - Control 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA establishes a file for the complaint and logs the action in a control system.  The 
system may be manual or automated, but must facilitate tracking and control of the 
complaint. 
 
5500.2 - Acknowledgment 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the complainant is known, the SA promptly issues written acknowledgment that the 
complaint is being investigated.  The SA should not delay acknowledgment pending an 
investigation unless the investigation takes place within three working days.  The SA 
  must take appropriate precautions to protect the complainants anonymity and privacy.  
The SA maintains a copy or record of the notification with the complaint documentation. 
 
5500.3 - Evaluation 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA evaluates any complaint to determine whether it should be investigated by the 
SA, or whether it should be forwarded to the RO for investigation or referral to the 
appropriate authority (e.g., OCR, OSHA, RO).  The SA assesses the complaint to 
determine if an immediate survey is necessary.  While the SA will perform most 
complaint surveys, complaints involving State-operated facilities are the responsibility of 
the RO.  When the SA does not have jurisdiction, it should forward the complaint to the 
RO within three working days.  If referral is not necessary, the SA considers whether or 
not any special notification is appropriate.   
 
If a complaint is especially significant, sensitive, or attracting broad public or media 
attention, the SA informs the RO immediately. 
 
5500.4 - Scheduling Investigations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA investigates within two working days of receiving the complaint and focuses on 
the specific problem area if the complaint involves possible immediate jeopardy to 
patient health and safety.  Otherwise, the SA follows procedures for prioritizing and 
investigating certification-related complaints.  Laboratories with complaints pending are 
identified and given priority in scheduling of regular certification surveys. 
 
5500.5 - Conducting Investigations 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The SA investigates complaints by means of an onsite survey, by telephone, by electronic 
communication, by letter, or by a documentary review.  Complaint investigations are 
unannounced. 
 
For onsite complaint investigations, the SA performs a full or partial survey based on the 
allegations. If a complaint alleges generalized inappropriate laboratory practices, the SA 
evaluates compliance with applicable requirements or conducts a full survey, as needed.  
If the complaint is of a specific nature, the SA performs a survey focused on areas 
relevant to the complaint. 
 
5500.6 - Conducting Investigations in a Laboratory with a Certificate of 
Waiver 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO authorizes an unannounced complaint survey of a laboratory holding a certificate 
of waiver only if it is based on a substantial allegation of noncompliance.  The fact that a 
  deficiency is not at the Condition-level does not preclude taking adverse action based on 
provisions contained in 42 CFR 493.1840.  As with other laboratories, the SA 
investigates complaints made against laboratories with a certificate of waiver by means of 
an onsite survey, by telephone, letter, or by a review of documents. 
 
The SA performs the onsite investigation based on the allegation and determines whether 
a laboratory is performing only waived tests and if the laboratory is following the 
manufacturers instructions for performing the tests (See Appendix C). 
 
5500.7 - Conducting Investigations in a Laboratory with a Certificate 
for PPM Procedures 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO authorizes an unannounced complaint survey of a laboratory holding a certificate 
for PPM procedures only if based on a substantial allegation of noncompliance.  This 
survey should not differ from a complaint survey done in any other laboratory performing 
non-waived testing, as all requirements for moderate complexity apply except routine 
survey. 
 
Substantial indication that a laboratory is performing tests that do not appear on the PPM 
procedures test list; e.g., through billing procedures, should prompt a complaint survey of 
a certificate for PPM procedures laboratory followed by either proper registration or 
appropriate sanctions. 
 
5500.8 - Post Investigation Actions 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Following the investigation, the SA records any deficiencies on a Form CMS-2567 and 
provides it to the facility using regular procedures.  Subsequent actions depend on the 
severity and nature of the deficiencies cited and the facilitys willingness or ability to 
correct them. 
 
When deficiencies are identified, the SA initiates actions as follows: 
 
1.  Condition-Level Deficiencies - Immediate Jeopardy - Certifies noncompliance 
and initiates procedures to recommend imposing alternative and principal 
sanctions. 
 
2.  Condition-Level Deficiencies - No Immediate Jeopardy; Facility Provides an 
Acceptable POC - Certifies noncompliance and initiates procedures to 
recommend imposing alternative sanctions based on the severity and nature of the 
deficiencies found. 
 
3.  Lower Level Deficiencies - Facility Provides an Acceptable POC - Certifies 
compliance based upon an acceptable POC and assembles documentation for RO 
review. 
   
4.  Lower Level Deficiencies - Facility Unable or Unwilling to Provide 
Acceptable POC - A facility with deficiencies may not participate without an 
acceptable POC.  The SA recommends sanction action to the RO. 
 
When no deficiencies are identified, no certification action is required. 
 
5500.9 - Resolution/Closeout 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
1 - Unsubstantiated 
 
The SA enters the unsubstantiated complaint into ACTS and documents the facilitys 
certification file. 
 
2 - Substantiated 
 
The SA reports substantiated complaints using the Form CMS-2567 and any appropriate 
supporting documentation.  The SA logs summary information in the control system and 
files a copy of the complaint documents in the facilitys certification file.  The SA enters 
complaints into ACTS. The laboratory will be charged a fee to cover the cost of the 
survey if noncompliance is documented. 
 
The SA closes out all complaints with a follow-up notice to the complainant with the 
findings and disposition of the complaint.  The SA should send this notice soon after the 
investigation and retains a copy with the complaint record. 
 
The SA provides follow-up reports, as necessary, to any other appropriate parties such as 
the State Medicaid agency and/or initial referring agencies.  The SA must be sure to 
protect the anonymity and privacy of the complainant. 
 
The SA inputs the investigation information into ACTS within 45 days of the completion 
of the complaint survey. 
 
5510 - CLIA-Exempt Laboratory Complaint Investigations - General 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
Complaints may be from any source, including verbal, written, electronic or in the media. 
 
Complaints are investigated if they meet the following criteria: 
 
  If substantiated, would have an impact on the health and safety of the general 
public or individuals served by the laboratory, and 
 
  Would raise doubt as to the laboratory's compliance with one or more CLIA 
Conditions and/or requirements. 
   
An attempt to maintain the anonymity of the complainant should always be made. 
 
There are a number of entities that must address laboratory complaints including: CMS 
Central and Regional Offices, the state agencies (including those with state licensure 
programs), approved states, and accreditation organizations.  Each of these entities shares 
a strong interest in ensuring the quality of patient care and the services provided by 
laboratories. When the complaint involves more than one of these entities, there should 
be coordination and communication to ensure an effective and timely resolution of the 
issue. 
 
5520 - Review of CLIA-Exempt Laboratory Complaints 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the RO receives a complaint against a CLIA-exempt laboratory, the RO determines 
what action is appropriate.  The RO may do any of the following: 
 
  Determine the severity of the complaint; 
 
  Send the information to the approved State for their action; 
 
  Conduct a survey (full or partial); 
 
  Investigate the complaint during the course of a validation survey (full survey), if 
it is conducted within 45 days of the laboratorys licensure survey and the 
complaint does not present immediate jeopardy concerns. 
 
  If the seriousness of the complaint or the circumstances warrant, the RO should 
invoke the Rapid Response Alert Protocol. 
 
NOTE:  Transfusion-related fatality investigations must be conducted by the RO.  They 
may not be delegated to the approved State; however, the approved State may 
accompany the RO on the investigation. In either case, there must be 
coordination and communication between the RO and the State.  Where State 
laws apply to transfusion-related incidents, the approved State program should 
follow its established procedures and coordinate with the RO. 
 
The RO Reviews the approved State programs complaint activities as part of the overall 
annual review.  The RO has the discretion to maintain its own complaint tracking system 
for those that have been forwarded to the approved State program. However, this 
information should be an integral part of the States annual review. 
 
If the approved State program receives a complaint against a CLIA-exempt laboratory, 
the approved State program determines what action is appropriate.  If the approved State 
sanctions a CLIA-exempt laboratory in any way (e.g., licensure is withdrawn), it must 
notify the RO within 30 days. 
   
If the laboratory against which the complaint is alleged is accredited, the State must also 
notify the accreditation organization. 
 
5530 - Conducting Complaint Investigations and Surveys for CLIA-
Exempt Laboratories 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO will complete the Medicare/Medicaid/CLIA Complaint Form, Form CMS-562, 
for every complaint investigation it performs in a CLIA-exempt laboratory. When an 
investigation can be conducted via telephone (e.g., personnel credentials), the RO should 
do so.  The RO obtains the following information for every allegation: 
 
  Complainants name and address, unless complainant requests anonymity.  Do not 
disclose the identity of the complainant to the laboratory; 
 
  Laboratorys name and address; and 
 
  Description of problem, involving names, places, and dates. 
 
The RO follows the same procedures for control and acknowledgement indicated in 
5500. Complaints involving potential immediate jeopardy will be investigated by the 
RO within 2 working days of receipt. Complaints not involving potential immediate 
jeopardy are investigated within 45 days. All complaint surveys are unannounced. 
 
If a laboratory representative refuses to permit a complaint survey, the RO contacts the 
State and requests that it contact the laboratory to explain the protocol and, if necessary, 
suggest that the State take enforcement action against the CLIA-exempt laboratory.  The 
RO conducts the complaint survey in accordance with the survey protocol and uses the 
appropriate survey forms specified in Exhibit 63 and the outcome-oriented protocol 
found in Appendix C. 
 
Initially, the RO focuses the survey only on the Condition(s) or requirement(s) related to 
the complaint area(s).  If the complaint is substantiated or if additional deficiencies are 
found during the course of the investigation, the RO expands the scope of the survey to 
include additional standards, conditions, and other CLIA requirements.  If the complaint 
is not substantiated, the RO notifies the laboratory that it is in compliance with the CLIA 
Condition(s) (Exhibit 243).  The RO also notifies the approved State program of the 
Condition-level compliance (Exhibit 244). 
 
At the exit conference, the RO informs the laboratory of the deficiencies found.  If the 
deficiencies pose immediate jeopardy to the health and safety of individuals served by a 
laboratory or that of the general public, the RO notifies the approved State program and 
the laboratory within two working days by overnight mail and includes a copy of the 
Form CMS-2567.  The RO directs the State program to take the appropriate enforcement 
action.  (See Exhibits 231 and 228).  The RO follows-up with the State program within 
  15 working days of its notification to the laboratory to verify that the enforcement action 
has either been taken against the laboratory or that the laboratory has achieved 
compliance with CLIA requirements. 
 
If  the State program fails to take appropriate enforcement action for an immediate 
jeopardy case within 23 days of the ROs notification, and the laboratory has not 
achieved Condition-level compliance, the RO may request CO to either contact the State 
or attempt other resolution to eliminate the jeopardy. 
 
If 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 prepares a Form CMS-2567 
and forwards a letter along with the Form CMS-2567 to the laboratory and to the State 
program within 10 working days of completing the survey.  The State program is 
responsible for taking any enforcement action, if necessary, monitoring the correction of 
the deficiencies, and providing a report to the RO.  (See Exhibit 231.) 
 
The RO completes a Survey Team Composition and Workload Report, Form CMS-670, 
for all complaint surveys and related activity. 
 
If the approved State program fails to take appropriate enforcement action in non-
immediate jeopardy situations, the RO documents its files accordingly and notifies CO.  
Failure to take and document the necessary enforcement action may subsequently 
jeopardize current or future approval of the State's laboratory licensure program. 
 
5540 - Complaint Investigations and Surveys of Accredited 
Laboratories Under CLIA 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
There are a number of entities that must address laboratory complaints including: CMS 
Central and Regional Offices, the state agencies (including those with state licensure 
programs), approved states, and accreditation organizations.  Each of these entities shares 
a strong interest in ensuring the quality of patient care and the services provided by 
laboratories. When the complaint involves more than one of these entities, there should 
be coordination and communication to ensure an effective and timely resolution of the 
issue. 
 
The statutory basis for conducting surveys of accredited laboratories based on allegations 
of noncompliance is found in 353(e)(2)(D) of the Public Health Service Act (PHSA).  
Since accreditation organization (AO) requirements are equivalent to CLIA requirements, 
a complaint may affect the laboratorys accreditation status as well. 
 
Complaints are investigated if they meet the following criteria: 
 
  If substantiated, would have an impact on the health and safety of the general 
public or individuals served by the laboratory, and 
 
    Would raise doubt as to the laboratory's compliance with one or more CLIA 
Conditions and/or requirements. 
 
The RO should evaluate the complaint and take appropriate investigatory action.  If the 
seriousness of the complaint or the circumstances warrant, the RO should invoke the 
Rapid Response Alert Protocol. Every effort should be made to secure a written form of 
the complaint, while maintaining anonymity, if requested. 
 
All complaint surveys are unannounced and conducted according to outcome-oriented 
survey principles (See Appendix C). If an investigation can be conducted by letter or 
telephone, in lieu of an onsite survey, those means should be utilized. 
 
Upon receipt, all complaints are logged and tracked and the same information as for CMS 
certified laboratories is collected, monitored and maintained (see Section 5500). 
 
5550 - RO Direction of Complaint Investigation of an Accredited 
Laboratory 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
The RO has primary responsibility for the coordination of all activities involving 
complaints relating to an accredited laboratory. 
 
This includes: 
 
  Ensuring that all pertinent information concerning the complaint is obtained; 
 
  Assessing the level of severity of the complaint; 
 
  Determining actions required for investigation; 
 
  Determining whether multiple AOs may be involved; and 
 
  When warranted (e.g., in cases potentially involving media coverage, 
Federal/State Congressional or political interest, legal intervention, etc.), 
informing and coordination with all affected parties, including AO's, State 
Agencies and Central Office. 
 
Although the RO has the lead role in directing the investigation of complaints involving 
accredited laboratories, all affected entities (i.e., State Agencies, AO's, Central Office) 
share responsibility in ensuring timely and effective action is taken. 
 
Complaints received by the SA: 
 
If the SA receives a substantial allegation of noncompliance directly from a complainant 
about an accredited laboratory, it promptly acknowledges receipt of the complaint and 
advises the complainant that it is being forwarded to the RO for action.  The SA forwards 
  a copy of the acknowledgment letter and the complaint to the RO.  This includes SAs 
with a State laboratory licensure program. 
 
Complaints received by the RO: 
 
If the complaint is received directly by the RO, the RO will promptly send a letter to the 
complainant acknowledging the complaint and advising the complainant of the intended 
course of action, and subsequently the results of any investigation, if appropriate, and of 
the corrective action taken. 
 
In either case (complaint received by SA or RO), the RO evaluates the complaint and has 
the lead in determining the course of action.  The RO determines whether the RO, the 
SA, or the AO, including multiple AOs if circumstances so warrant, will investigate the 
complaint.  The RO will also determine whether one or multiple AOs may be impacted 
by the complaint and, if so, alert them of the pending action.  In certain instances the RO 
may enlist CO support to help determine the most effective course of action. 
 
If the RO determines that the SA should investigate the complaint, the RO prepares a 
Request for Complaint Investigation or Validation Survey of Accredited Laboratory, 
Form CMS-2802A, (See Exhibit 107) and a Medicare/Medicaid/CLIA Complaint, 
Form CMS-562, and forwards them to the SA along with a copy of the complaint and 
notifies the AO.  If the RO authorizes the SA to perform a full survey (all specialties and 
subspecialties covered by the certificate), and the survey can be performed within 90 days 
of the AOs inspection, the survey can be counted in the SAs validation workload. 
 
If the RO determines that the complaint involves a potential immediate jeopardy to the 
individuals served by the laboratory, or to the general public, the SA investigates the 
complaint within two working days of receiving it from the RO.  Otherwise, the RO will 
direct the SA to investigate non-Immediate Jeopardy complaints within 45 days and 
report their findings to the RO and AO at the conclusion of the survey. 
 
Complaints investigated by AOs: 
 
If the RO determines that the accreditation organization should carry out its own 
investigation, it promptly forwards the complaint to the accreditation organization for 
immediate attention.  The RO will request to be notified of the results of any investigative 
action taken.  The RO will then notify the SA and, if warranted, CO. 
 
NOTE:  Transfusion-related fatality investigations must be conducted by the RO or 
SA.  Transfusion-related fatality investigations must not be referred to an 
accreditation organization for action. However, the AO or multiple AOs, 
as appropriate, should be notified when such an investigation is taking 
place. 
 
Complaints received by AOs: 
 
  Complaints received directly by AOs will be investigated under each AOs own standards 
and procedures. If multiple AOs are potentially impacted, the AO receiving the complaint 
will promptly inform the other AOs and a determination should be reached regarding the 
need for coordinated action.  In cases potentially involving media coverage, Federal/State 
Congressional or political interest, legal intervention, etc., the SA, RO and CO should be 
promptly alerted by the AO receiving the complaint and consulted concerning 
appropriate action. 
 
5560 - Conducting Complaint Survey of an Accredited Laboratory 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If an onsite survey is warranted, the SA will conduct an unannounced survey of an 
accredited laboratory based on the substantial allegation of noncompliance. The SA 
conducts the complaint survey in accordance with outcome-oriented principles (see 
Appendix C).  The SA conducts a focused complaint survey, as instructed by the RO on 
Form CMS-2802A.  If the SA finds additional deficiencies during the course of the 
complaint investigation, it may expand the scope of the survey with RO approval. 
 
At the exit conference, the SA informs the laboratory director of the deficiencies found 
and the procedures to respond to them.  If the deficiencies do not pose an immediate 
jeopardy to the health and safety of individuals served by a laboratory, or to the general 
public, the SA prepares a Form CMS-2567 and requests that the laboratory submit a POC 
for all Condition-level deficiencies.  Condition level deficiencies must be corrected; 
those at the standard level are optional.  The SA informs the laboratory that the Form 
CMS-2567 will be made available to the public under the disclosure of survey 
information provisions.  The SA indicates to the laboratory that the Statement of 
Deficiencies (Form CMS-2567) will be forwarded to the laboratory within 10 working 
days and that the POC must be returned to the SA within 10 calendar days.  Upon receipt 
of the survey information and POC, the RO makes a determination of whether or not 
sanctions will be imposed against the laboratory and notifies the AO. 
 
5570  Forwarding Investigation Report to RO 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If non-immediate jeopardy is found, the SA will submit the appropriate information as 
specified in the List of Documents in the Certification Packet (see Exhibit 63) to the RO, 
or through an update to ACTS within 45 days of completing the survey and notifies the 
RO of the entry.  If the laboratory chooses not to submit a POC when deficiencies are 
found, the SA reports any known information about the laboratorys efforts to correct 
deficiencies to the RO and AO. 
 
5580 - Accredited Laboratory Found in Compliance Following a 
Complaint Survey 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
  If after review of the documentation the RO determines that the accredited laboratory is 
in compliance with all CLIA Condition-level requirements, it officially notifies the 
laboratory and forwards a copy of this letter to the SA and the AO.  This letter advises 
that the accreditation organization may contact the laboratory about correcting any 
deficiencies below Condition-level. 
 
5590 - Accredited Laboratory Found Not in Condition-level Compliance 
Following a Complaint Survey 
(Rev. 18, Issued:  03-17-06; Effective/Implementation Dates:  03-17-06) 
 
If the deficiencies found pose an immediate jeopardy to the health and safety of 
individuals, the SA prepares the Form CMS-2567, (which is included as part of the List 
of Documents in the Certification Package, See Exhibit 63) and notifies the RO and sends 
Form CMS-2576 to the laboratory within 2 working days. RO will notify the AO. Based 
on the information forwarded, and the laboratorys POC, the RO determines if sanctions 
are to be imposed against the laboratory. The RO will then notify the AO. 
 
Should the immediate jeopardy situation be corrected before the adverse action is taken 
or completed, the SA will advise the laboratory that it will revisit it to inspect all 
remaining Conditions not in compliance.  The RO will notify the AO. 
 
If non-immediate jeopardy is found, the SA will submit the appropriate information as 
specified in the List of Documents in the Certification Packet (See Exhibit 63) to the RO, 
or through an update to ACTS within 45 days of completing the survey and notifies the 
RO of the entry. The POC should also be forwarded to the RO. If the laboratory chooses 
not to submit a POC when deficiencies are found, the SA reports any known information 
about the laboratorys efforts to correct deficiencies to the RO and the RO will notify the 
AO and the laboratory that the laboratory is out of compliance and has been placed under 
SA monitoring jurisdiction (see Exhibit 241). The laboratory is monitored by the SA, RO, 
and/or AO until it reaches Condition-level compliance or its certificate of accreditation is 
revoked.  A copy of all correspondence is provided to the accreditation organization by 
the RO. 
 
For standard only deficiencies, responsibility rests with the AO to follow-up and pursue 
corrective action.  The laboratory continues to be accredited by its accreditation 
organization and retains its CLIA certificate of accreditation during this monitoring 
period; however, it becomes subject to the same CLIA requirements, survey and 
enforcement procedures as applied to non-accredited laboratories found out of 
compliance. 
  CROSSWALK TO THE OLD CHAPTER 5 
 
A crosswalk from sections of the State Operations Manual Chapter Five published 5-
21-2004 to the revised chapter five is as follows: 
 
 
Name of Old Section  Old  New  Name of New Section 
Section  Section 
Number  Number 
Management of Complaints and  5000  5000  Management of Complaints and 
Incidents  Incidents 
Intake Process  5010  5010  Intake Process 
Triage and Priority Assignment  5020  5070  Priority Assessment for  Nursing 
Homes, Deemed and Non-Deemed 
Providers/Suppliers, and EMTALA 
Priority Definitions  5030  5075  Priority Definitions for Nursing 
Homes, Deemed and Non-Deemed 
Providers/Suppliers, and EMTALA 
Investigation Findings and  5040  5080  Investigation Findings and Reports 
Reports 
CMS Regional Office  5050  5050  CMS Regional Office 
Responsibility for Monitoring  Responsibility for Monitoring SA 
SA Management of Complaints  Management of Complaints and 
and Incidents  Incidents 
 
Aspen Complaints/Incidents  5060  5060  ASPEN Complaints/Incidents 
Tracking System (ACTS)  Tracking System (ACTS) 
Investigation of Complaints  5100  5100  Investigation of Complaints for 
Against Accredited/Deemed  Deemed Providers/Suppliers 
Providers and Suppliers 
Basis for Investigation of  5110  5100.1  Basis for Investigation 
Complaints Against 
Accredited/Deemed Providers 
and Suppliers 
RO Direction of Accredited  5120  5210  Processing of Complaints 
Hospital Complaint Investigation  Originating with or Investigated by 
RO 
Conducting an Accredited  5130  5050  CMS RO Responsibility for 
Hospital Complaint Validation  Monitoring SA Management of 
Survey  Complaints and Incidents 
Forwarding Investigation Report  5140  5050  CMS RO Responsibility for 
to RO  Monitoring SA Management of 
Complaints and Incidents 
Accredited Hospital Found in  5150  5100  Investigation of Complaints for 
Compliance Following  Deemed Providers/Suppliers 
Complaint Validation Survey 
Accredited Hospital Found Not  5160  5100  Investigation of Complaints for 
in Compliance Following  Deemed Providers/Suppliers 
Complaint Validation Survey 
Reinstatement to Accreditation  5170  5100.2  Post-Survey Procedures 
Organization Jurisdiction 
Termination of Accredited  5180  5100.2  Post-Survey Procedures 
Hospital 
  Investigating Complaints  5190  5160  Investigating Complaints Involving 
Involving ESRD Services  ESRD Services Provided by 
Provided by Accredited  Deemed Hospitals 
Hospitals 
Investigation of Complaints  5200  5200  Investigating Complaints for Non-
Against Other Than  Deemed Providers/Suppliers, 
Accredited/Deemed Providers  Excluding Nursing Homes 
and Suppliers 
SA Processing of General,  5210  5010  General Intake Process 
Certification-Related Complaints 
Hospital Restraints/Seclusion  5240  5140  Hospital Restraints/Seclusion 
Death Reporting and  Death Reporting and Investigation 
Investigation 
Complaints Involving HIV- 5250  5150  Complaints Involving HIV-
Infected Individuals  Infected Individuals 
Investigations Involving Alleged  5300- 5400- Investigations Involving Alleged 
EMTALA Violations  5400  5500  EMTALA Violations 
Complaints Involving  5500- 5500- Complaints Involving 
Unaccredited Laboratories  5590  5590  Unaccredited Laboratories  
 
  Chapter Five State Operations Manual 
 
Acronyms 
 
(Rev. 18, 03-17-06) 
 
 
ACTS   ASPEN Complaint Tracking System 
 
AIDS    Auto-immune deficiency syndrome 
 
AO    Accreditation Organization 
 
the ACT  Social Security Act 
 
CFC    Conditions for Coverage 
 
CFR    Code of Federal Regulations 
 
CLIA    Clinical Laboratory Improvement Amendments 
 
CMP    Civil Monetary Penalties 
 
CMS    Center for Medicare and Medicaid Services 
 
CO    Central Office 
 
CoP    Conditions of Participation 
 
COW    Certificate of Waiver 
 
DED    Dedicated Emergency Department 
 
DHHS   Department of Health and Human Services 
 
EMS    Emergency Medical System 
 
EMTALA  Emergency Medical Treatment and Labor Act 
 
ESRD   End-Stage Renal Disease 
 
FDA    Food and Drug Administration 
 
HHA    Home Health Agency 
 
HIV    Human Immunodeficiency Virus 
   
IJ    Immediate Jeopardy 
 
JCAHO  Joint Commission on Accreditation of Healthcare Organizations 
 
LSC    Life Safety Code 
 
NF    Nursing Facility 
 
NW    Networks 
 
OCR    Office of Civil Rights 
 
OIG    Office of Inspector General 
 
OSHA   Occupational Safety and Health Administration 
 
P & A   Protection and Advocacy Group 
 
PHSA   Public Health Service Act 
 
POC    Plan of Correction 
 
PPM    Provider Perform Microscopy (PPM) Procedures 
 
PRTF    Psychiatric Residential Treatment Facility 
 
QIO    Quality Improvement Organization 
 
RFP    Requirements for Participation 
 
RNHCI  Religious Non-Medical Health Care Institutions 
 
RO    Regional Office 
 
SA    State Agency 
 
SMA    State Medicaid Agency 
 
SNF    Skilled Nursing Facility 
 
SOM     State Operations Manual 
 
USC    United States Code 
 
  Transmittals Issued for this Chapter 
 
Rev #  Issue Date  Subject  Impl Date  CR# 
R212SOM  02/10/2023  Revisions to State Operations Manual (SOM)  10/24/2022 N/A 
Chapter 5 
R208SOM  10/21/2022  Revisions to State Operation Manual (SOM),  10/24/2022 N/A 
Appendix PP Guidance to Surveyors for Long 
Term Care Facilities 
R191SOM  07/19/2019  Revisions to the State Operations Manual  07/19/2019 N/A 
(SOM) Chapter 5 and Appendix V 
R155SOM  06/10/2016  Revisions to State Operations Manual (SOM)  06/10/2016 N/A 
Chapter 5 
R120SOM  09/19/2014  Revisions to State Operations Manual (SOM)  09/19/2014 N/A 
Chapter 5 
R88SOM  08/27/2013  Revisions to State Operations Manual (SOM)  07/19/2013 N/A 
Chapter 5 
R86SOM  07/19/2013  Revisions to State Operations Manual (SOM)  07/19/2013 N/A 
Chapter 5  Rescinded and replaced by 
Transmittal 88 
R50SOMA 07/10/2009  Revisions to Chapter 5, "Complaint  07/10/2009 N/A 
Procedures" 
R18SOMA 03/17/2006  Revisions to Chapter 5, "Complaint  03/17/2006 N/A 
Procedures" 
R01SOM  05/21/2004  Initial Issuance of Pub 100-07  N/A  N/A 
 
SOM Chapter 5 - Page 103