Master

Laboratory General
Checklist
CAP Accreditation Program

College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
www.cap.org

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Disclaimer and Copyright NoticeOn-site inspections are performed with the edition of the Checklists mailed to a facility at the completionof the application or reapplication process, not necessarily those currently posted on the website. The
checklists undergo regular revision and a new edition may be published after the inspection materials
are sent.
For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call
800-323-4040 or 847-832-7000 (international customers, use country code 001).
The Checklists used for inspection by the College of American Pathologists' Accreditation Programs
have been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying
and use of the checklists by CAP inspectors in conducting laboratory inspections for the Commission
on Laboratory Accreditation and by laboratories that are preparing for such inspections. Except aspermitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklists
constitutes infringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legal
action to protect these copyrights.
All Checklists are ©2016. College of American Pathologists. All rights reserved.

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Laboratory General
Checklist
TABLE OF CONTENTS

SUMMARY OF CHANGES....................................................................................................................5
UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS................................ 8
INTRODUCTION.................................................................................................................................... 8
DEFINITION OF TERMS....................................................................................................................... 8
QUALITY MANAGEMENT...................................................................................................................12
SPECIMEN COLLECTION, HANDLING, AND REPORTING............................................................. 23
SPECIMEN COLLECTION INSTRUCTIONS.................................................................................................................... 24
SPECIMEN COLLECTION AND LABELING.....................................................................................................................26
SPECIMEN TRANSPORT AND TRACKING.....................................................................................................................30
REQUISITIONS AND SPECIMEN RECEIPT/HANDLING/PROCESSING........................................................................33
RESULTS REPORTING AND REFERRAL OF TESTING................................................................................................ 37

DIRECT-TO-CONSUMER TESTING................................................................................................... 45
QUALITY OF WATER AND GLASSWARE WASHING..................................................................... 46
LABORATORY COMPUTER SERVICES........................................................................................... 47
COMPUTER FACILITY...................................................................................................................................................... 48
HARDWARE AND SOFTWARE........................................................................................................................................ 49
SYSTEM SECURITY......................................................................................................................................................... 51
PATIENT DATA................................................................................................................................................................. 52
AUTOVERIFICATION........................................................................................................................................................ 54
DATA RETRIEVAL AND PRESERVATION...................................................................................................................... 56
INTERFACES..................................................................................................................................................................... 57
TELEPATHOLOGY AND REMOTE DATA ASSESSMENT.............................................................................................. 58

WHOLE SLIDE IMAGING................................................................................................................... 60
PERSONNEL........................................................................................................................................61
SECTION DIRECTORS (TECHNICAL SUPERVISORS)/GENERAL SUPERVISORS..................................................... 63
TECHNICAL AND CLINICAL CONSULTANT................................................................................................................... 65
ALL PERSONNEL..............................................................................................................................................................67

PHYSICAL FACILITIES.......................................................................................................................74
SPACE............................................................................................................................................................................... 74
ENVIRONMENT................................................................................................................................................................. 75
COMMUNICATIONS.......................................................................................................................................................... 76
INVENTORY AND STORAGE OF SUPPLIES..................................................................................................................76
POWER.............................................................................................................................................................................. 76

LABORATORY SAFETY..................................................................................................................... 77
SAFETY POLICIES, PROCEDURES, AND RECORDS................................................................................................... 77
BLOODBORNE PATHOGENS.......................................................................................................................................... 79
OTHER INFECTIOUS HAZARDS..................................................................................................................................... 83
FIRE PREVENTION AND PROTECTION......................................................................................................................... 84
ELECTRICAL SAFETY...................................................................................................................................................... 86
CHEMICAL SAFETY..........................................................................................................................................................87
COMPRESSED GASES.................................................................................................................................................... 90
RADIATION SAFETY.........................................................................................................................................................91
ENVIRONMENTAL SAFETY............................................................................................................................................. 92

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OTHER HAZARDS............................................................................................................................................................ 93
WASTE DISPOSAL........................................................................................................................................................... 95

BIOREPOSITORY ACCREDITATION PROGRAM (BAP) ONLY:......................................................96
INTRODUCTION (BAP)..................................................................................................................................................... 96
POLICIES AND PROCEDURES (BAP).............................................................................................................................96
QUALITY MANAGEMENT (BAP)...................................................................................................................................... 99
PERSONNEL (BAP)........................................................................................................................................................ 103
DIRECTOR QUALIFICATIONS (BAP)...................................................................................................................... 104
DIRECTOR OVERSIGHT RESPONSIBILITEIS (BAP)............................................................................................. 104
DIRECTOR NOT ON-SITE FULL TIME (BAP)......................................................................................................... 106
OPERATIONAL LEADERSHIP/MANAGEMENT SECTION (BAP)........................................................................... 106
PHYSICAL FACILITIES (BAP)........................................................................................................................................ 109
SAFETY (BAP).................................................................................................................................................................112
GENERAL SAFETY (BAP)........................................................................................................................................113
BIOLOGICAL SAFETY (BAP)................................................................................................................................... 117
FIRE SAFETY (BAP).................................................................................................................................................121
CHEMICAL SAFETY (BAP)...................................................................................................................................... 124
RADIATION SAFETY (BAP)..................................................................................................................................... 128

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ON-LINE CHECKLIST AVAILABILITY
Participants of the CAP accreditation programs may download the checklists from the CAP website(www.cap.org) by logging into e-LAB Solutions. They are available in different checklist types and formatting
options, including:●●●

Master — contains ALL of the requirements and instructions available in PDF, Word/XML or Excel
formats
Custom — customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or
Excel formats
Changes Only — contains only those requirements with significant changes since the previous checklist
edition in a track changes format to show the differences; in PDF version only. Requirements that havebeen moved or merged appear in a table at the end of the file.

SUMMARY OF CHECKLIST EDITION CHANGES
Laboratory General Checklist
08/17/2016 Edition
The information below includes a listing of checklist requirements with significant changes in the current editionand previous edition of this checklist. The list is separated into three categories:
1. New
2. Revised:●
Modifications that may require a change in policy, procedure, or process for continued
compliance; or●
A change to the Phase
3. Deleted/Moved/Merged:●
Deleted●Moved — Relocation of a requirement into a different checklist (requirements that have been
resequenced within the same checklist are not listed)●
Merged — The combining of similar requirements
NOTE: The listing of requirements below is from the Master version of the checklist. The customized checklist
version created for on-site inspections and self-evaluations may not list all of these requirements.

NEW Checklist Requirements
Requirement
GEN.20361
GEN.20450
GEN.43040
GEN.50630
GEN.54025
GEN.74250
GEN.80000
GEN.80100
GEN.80200
GEN.80300
GEN.80400
GEN.80500
GEN.80700
GEN.81325
GEN.88040

Effective Date
07/28/2015
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REVISED Checklist Requirements
Requirement
GEN.20316
GEN.20335
GEN.20375
GEN.20377
GEN.26791
GEN.40016
GEN.40032
GEN.40125
GEN.40470
GEN.40490
GEN.40491
GEN.40492
GEN.40515
GEN.40530
GEN.40750
GEN.40942
GEN.41042
GEN.41096
GEN.41303
GEN.41304
GEN.41306
GEN.41310
GEN.41350
GEN.43033
GEN.43055
GEN.43325
GEN.43875
GEN.43881
GEN.50057
GEN.50614
GEN.51728
GEN.52842
GEN.52850
GEN.52900
GEN.53400
GEN.53600
GEN.53625
GEN.53650
GEN.54000
GEN.54400
GEN.54750
GEN.55450
GEN.55500
GEN.55525
GEN.60100
GEN.61750
GEN.66100
GEN.73300
GEN.73400
GEN.73600
GEN.73800
GEN.74100
GEN.74200
GEN.75500

Effective Date
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GEN.75900
GEN.76000
GEN.76100
GEN.76200
GEN.76700
GEN.77400
GEN.81350
GEN.81900
GEN.81950
GEN.82100
GEN.82500
GEN.82700
GEN.82900
GEN.83000
GEN.83600
GEN.85300
GEN.85400
GEN.85420
GEN.85700
GEN.85800
GEN.85900
GEN.86000
GEN.86130
GEN.86200
GEN.86300
GEN.86500
GEN.86600
GEN.87000
GEN.87020
GEN.87600
GEN.88300

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DELETED/MOVED/MERGED Checklist Requirements
Requirement
GEN.30070
GEN.43044
GEN.43088
GEN.43812
GEN.43850
GEN.43884
GEN.51171
GEN.85000

Effective Date
08/16/2016
07/27/2015
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UNDERSTANDING THE CAP ACCREDITATIONCHECKLIST COMPONENTS
All checklist requirements contain a requirement number, subject header, phase, and a declarative statement.
Some requirements also contain a NOTE and/or Evidence of Compliance.
The NOTE portion of a checklist requirement provides additional detail to assist in interpreting the requirement.
Evidence of Compliance (EOC) is intended to:●
Suggest specific examples of acceptable records; some elements are required●
Assist in inspection preparation and for managing ongoing compliance●
Drive consistent understanding of requirements
If a policy or procedure is referenced within a requirement, it is only repeated in the Evidence of Compliance
if such statement adds clarity. All policies or procedures covered in the CAP checklists must be a written
document. A separate policy or procedure may not be needed for items in EOC if it is already addressed by an
overarching policy.
The Master version of the checklist also contains references and the inspector R.O.A.D. instructions (Read,
Observe, Ask, Discover), which can provide valuable insight for the basis of requirements and on how
compliance will be assessed.

INTRODUCTION
The Laboratory General (GEN) Checklist applies to all sections or departments of the laboratory. It is
customized based on the services reported by the laboratory to the CAP on its application.
One copy of the GEN Checklist is provided to the inspection team. One or more inspectors may be assigned toinspect with the GEN Checklist; however, all inspectors must be familiar with the GEN Checklist requirements
and ensure that all areas are in compliance. For suggestions on how inspectors can assist the Laboratory
General inspector, please refer to the Laboratory General (GEN) section in the Laboratory Accreditation Manual.
Note for non-US laboratories: Checklist requirements apply to all laboratories unless a specific disclaimer of
exclusion is stated in the checklist.

DEFINITION OF TERMS
Addendum - Information appended to a final report without changing any of the language in the original report(original report is intact and unchanged).
Alternative assessment - A system for determining the reliability of laboratory examinations for which nocommercial proficiency testing products are available, are not appropriate for the method or patient population
served by the laboratory, or participation is not required by the accrediting organization.
Amended/amendment - Any change in the diagnosis, narrative text, or other content of a report that has been
issued (minor or major). The change in an anatomic pathology report is usually in the diagnosis or narrative, but
occasionally may involve a change in a number or some other quality.
Analytical validation - The process used to confirm with objective evidence that a laboratory-developed or
modified FDA-cleared/approved test method or instrument system delivers reliable results for the intended
application.

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Analytical verification - The process by which a laboratory determines that an unmodified FDA-cleared/
approved test performs according to the specifications set forth by the manufacturer when used as directed.
Annual - Every 12 calendar months
Biennial - Every 24 calendar months
Authority - The power to give orders or make decisions: the power or right to direct someone or control a
process
Calibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of theassay over time
Check - Examination to determine the accuracy, quality or presence of any attribute of a test system
Clinical validation - The determination of the ability of a test to diagnose or predict risk of a particular healthcondition or predisposition, measured by sensitivity, specificity, and predictive values
Commutable - The property of a reference material that yields the same numeric result as would a patient's
specimen containing the same quantity of analyte in that analytic method under discussion (i.e. matrix effects
are absent).
Confirmation - Substantiation of the correctness of a value or process
Corrected/correction - Errors in test results that may include incorrect patient identification, test results,
reference interval, interpretive information, or other significant information, but not minor typographical errors of
no consequence.
Corrective Action - Action taken to eliminate the cause of a detected nonconformity or other undesirable
situation
Correlation - Establishment of agreement between two or more measured values
Credentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to provide
care in a health care organization
Device - Any reagent, reagent product, kit, instrument, apparatus, equipment or related product, whether usedalone or in combination, intended by the manufacturer to be distributed for use in vitro for the examination ofhuman specimens
Digital image analysis - The computer-assisted detection or quantification of specific features in an image
following enhancement and processing of that image, including immunohistochemistry, DNA analysis,morphometric analysis, and in situ hybridization
Equipment - Single apparatus or set of devices or apparatuses needed to perform a specific task
Examination - In the context of checklist requirements, examination refers to the process of inspection oftissues and samples prior to analysis. An examination is not an analytical test.
FDA - In the context of checklist requirements, FDA should be taken to mean the national, state, or provincial
authority having jurisdiction over in vitro diagnostic test systems.
Function Check - Confirmation that an instrument or item of equipment operates according to manufacturer's
specifications before routine use, at prescribed intervals, or after minor adjustment (e.g. base line calibration,balancing/zero adjustment, thermometer calibration, reagent delivery).

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High complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on theirrisks to public health. Tests in this category are seen to have the highest risks to public health.
Instrument - An analytical unit that uses samples to perform chemical or physical assays (e.g. chemistry
analyzer, hematology analyzer)
Instrument platform - Any of a series of similar or identical analytical methods intended by their manufacturer
to give identical patient results across all models
Laboratory Director - The individual who is responsible for the overall operation and administration of
the laboratory, including provision of timely, reliable and clinically relevant test results and compliance withapplicable regulations and accreditation requirements. This individual is listed on the laboratory's CAP and CLIA
certificate (as applicable).
Maintenance - Those activities that prolong the life of an instrument or minimize breakdowns or mechanicalmalfunctions. Examples include cleaning, changing parts, fluids, tubing, lubrication, electronic checks, etc.
Moderate complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on
their risks to public health
Modification of manufacturer's instructions - Any change to the manufacturer's supplied ingredients ormodifications to the assay as set forth in the manufacturer's labeling and instructions, including specimen type,
instrumentation or procedure that could affect its performance specifications for sensitivity, specificity, accuracy,or precision or any change to the stated purpose of the test, its approved test population, or any claims related
to interpretation of the results
Nonwaived - Tests categorized as either moderately complex (including provider-performed microscopy) or
highly complex by the US Food and Drug Administration (FDA), according to a scoring system used by the FDA
Performance verification - The set of processes that demonstrate an instrument or an item of equipment
operates according to expectations upon installation and after repair or reconditioning (e.g. replacement ofcritical components)
Policy - 1) Set of basic principles or guidelines that direct or restrict the facility's plans, actions, and decisions;2) Statement that tells what should or should not be done
Preventive action - Action taken to eliminate the cause of a potential nonconformity or any other undesirable
potential situation
Primary source verification report - A document, usually prepared by a third party agent or company that
confirms that a job applicant's degree, certificate, or diploma is authentic, licenses were granted, and reported
work history (company names, locations, dates and positions held) is accurate. The confirmation is obtained
through direct contact with an institution, former employer, or their authorized agents.
Primary specimen - The body fluid, tissue, or sample submitted for examination, study or analysis. It may be
within a collection tube, cup, syringe, swab, slide, data file, or other form as received by the laboratory.
Procedure - 1) Specified way to carry out an activity of a process (also referred to by ISO as "work instructions";
2) Set of steps performed that tells "how to do it" to achieve a specified outcome, including decisions to be madeProcess - 1) Set of interrelated or interacting activities that transforms inputs into outputs; 2) Series of events,
stages, or phases that takes place over time that tells "what happens" or "how it works"
Proficiency testing - Evaluation of participant (laboratory or individual) performance against pre-establishedcriteria by means of interlaboratory comparisons. In some countries, the PT programs for clinical laboratories
are called "external quality assessment" programs.

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Reagent - Any substance in a test system other than a solvent or support material that is required for the target
analyte to be detected and its value measured in a sample.
Report errors - A report element (see GEN.41096) that is either incorrect or incomplete
Responsibility - A duty or task that an individual is required or expected to do
Secondary specimen - Any derivative of the primary specimen used in subsequent phases of testing. It may
be an aliquot, dilution tube, slide, block, culture plate, reaction unit, data extract file, image, or other form during
the processing or testing of a specimen. (The aliquots or images created by automated devices and tracked byinternal electronic means are not secondary specimens.)
Section Director - The individual who is responsible for the medical, technical and/or scientific oversight of a
specialty or section of the laboratory.
Semiannual - Every 6 calendar months
Subject to U.S. Regulations - Laboratories located within the United States and laboratories located outside of
the US that have obtained or applied for a CLIA certificate to perform laboratory testing on specimens collectedin the US for the assessment of the health of human beings.
Telepathology - The practice in which the pathologist views digitized or analog video or still image(s), andrenders an interpretation that is included in a formal diagnostic report or is recorded in the patient record.
Testing personnel - Individuals responsible for performing laboratory assays and reporting laboratory results
Test - A qualitative, semiqualitative, quantitative, or semiquantitative procedure for detecting the presence of, or
measuring an analyte
Test system - The process that includes pre-analytic, analytic, and post-analytic steps used to produce a test
result or set of results. A test system may be manual, automated, multi-channel or single-use and can include
reagents, components, equipment or instruments required to produce results. A test system may encompass
multiple identical analyzers or devices. Different test systems may be used for the same analyte.
Waived - A category of tests defined as "simple laboratory examinations and procedures which have an
insignificant risk of an erroneous result." Laboratories performing waived tests are subject to minimal regulatory
requirements.

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QUALITY MANAGEMENT
The laboratory must have a written quality management program to systematically ensure the quality oflaboratory services. In laboratories that are part of a larger institution (e.g. a hospital), the laboratory quality
management program must be integrated with the institutional program.
Although effective organization of the laboratory and appropriate delegation of duties are part of quality
management, these areas are addressed in the Team Leader Checklist. Quality management requirements
pertaining to all laboratory sections are addressed in the All Common Checklist.

Inspector Instructions:
●
●
●
●
●
●
●

●
●

●

CAP sign regarding the reporting of quality concerns●

How is the laboratory's QM performance communicated to other hospital
departments?
How was referring physicians'/clients'/or patients' satisfaction measured? What were
the results and what actions were taken as a result of the findings?
Is there a specific example when problems were identified that could have interferedwith patient care or safety?

●

●

●

●

GEN.13806

Policy for communication of employee concerns
Sampling of quality indicators with follow-up actions when targets are not achieved
Annual appraisal of effectiveness of the QM Program
Document control policy
Record/specimen retention policy
Error, complaint and incident logs with corrective/preventative actions
Device-related adverse patient event procedure and records of reporting (ifapplicable)
Results of the laboratory's self-evaluation and correction of deficiencies
Sampling of records of manufacturer's recalls and records of follow-up

If any problems are found during review of quality measurements, or when asking
questions, further evaluate the laboratory's investigation and resolution, including root
cause analysis and associated risk-reduction activities when applicable
If trends in negative feedback are identified in the satisfaction survey, further evaluate
investigation and corrective actions

QM Program

Phase II

The laboratory has a written quality management (QM) program.
NOTE: There must be a document that describes the overall QM program. The document neednot be detailed, but should spell out the objectives and essential elements of the QM program.
The QM plan may be based upon some reference resource such as CLSI QMS01-04; the ISO
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or it may be of the laboratory's own design. If the laboratory is part of a larger organization, thelaboratory QM program is coordinated with the organization's QM plan.
REFERENCES
1) Joint Commission on Accreditation of Healthcare Organizations. Using Performance Improvement Tools in Health Care Settings,
2)
3)
4)
5)
6)
7)

GEN.16902

Third Edition. Oakbrook Terrace, IL: JCAHO, 2006
ISO Standards compendium: ISO 9001:2000, Quality management systems -- Requirements. Geneva, Switzerland: International
Organization for Standardization, 2000
ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence. Geneva, Switzerland: International
Organization for Standardization, 2003
Clinical and Laboratory Standards Institute (CLSI). Quality Management System: A Model for Laboratory Services; Approved
Guideline—Fourth Edition. CLSI document QMS01-A4 (ISBN 1-56238-761-8 [Print]; ISBN 1-56238-762-6 [Electronic]). Clinical andLaboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2011.
Nakhleh RE, Fitzgibbons PL. Quality Management in Anatomic Pathology. Chicago, IL: CAP Press, 2005
Valenstein P. Quality Management In Clinical Laboratories. Chicago, IL: CAP Press, 2005
Berte L. Quality Manual Preparation Workbook for Blood Banking, 2nd edition. Bethesda, MD: AABB Press, 2005

QM Implementation

Phase IIFor laboratories that have been CAP accredited for more than 12 months, the QM plan is
implemented as designed and is reviewed annually for effectiveness.
NOTE: Appraisal of program effectiveness may be evidenced by an annual written report,
revisions to laboratory policies and procedures, or revisions to the QM plan, as appropriate.
Evidence of Compliance:✓
Evidence that the plan has been implemented as designed requires all of the following:●
quality measurements/assessments specified in the plan are being substantially carriedout;●
there is evidence of active review of quality measurements;●
if target performance levels are specified in the plan and the targets are not being met,
there are records of follow-up action;●
any interventions/changes to operations that are specified in the plan have been carriedout as scheduled, or the reason for delay recorded; AND●
any communication of information that is required by the plan have taken place
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)

GEN.20100

amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1249]
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1299]

QM Extent of Coverage

Phase IIThe QM program covers all areas of the laboratory and all beneficiaries of service.
NOTE: The QM program must be implemented in all areas of the laboratory (e.g. chemistry,
anatomic pathology, satellite, point-of-care, consultative services). The program must include all
aspects of the laboratory's scope of care, such as inpatient, outpatient, and referral laboratory
services.
GEN.20208

QM Patient Care Services

Phase IIThe QM program includes a process to identify and evaluate errors, incidents and otherproblems that may interfere with patient care services.
NOTE: There must be an organized process for recording of problems involving the laboratorythat are identified internally, as well as those identified through outside sources such ascomplaints from patients, physicians or nurses. The process must be implemented in all sectionsof the laboratory, and on all shifts. Any problem that could potentially interfere with patientcare or safety must be addressed. Clinical, rather than business/management issues, shouldbe emphasized. The laboratory must record investigation and resolution of these problems.

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Laboratories must perform root cause analysis of any unexpected event involving death orserious physical or psychological injury, or risk thereof (including “near misses” and sentinel
events). Laboratories must be able to demonstrate appropriate risk-reduction activities based onsuch root cause analyses.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments
2)
3)
4)
5)
6)
7)

of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1233]
ISO International Standard 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International
Organization for Standardization, 2003 (4.8)
College of American Pathologists. CAP Quality Management Education Resources. Root Cause Analysis [online course]. 2010.
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1249]
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1299]
Clinical and Laboratory Standards Institute (CLSI). Management of Nonconforming Laboratory Events; Approved Guideline. CLSI
document QMS11-A (ISBN 1-56238-651-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne,
Pennsylvania 19087-1898, USA, 2005.
Clinical and Laboratory Standards Institute. Nonconforming Event Management, 2Laboratory Standards Institute, Wayne, PA; 2015.

**REVISED** 08/17/2016
GEN.20316 QM Indicators of Qualitynd ed. CLSI guideline QMS11-Ed2. Clinical andPhase IIThe QM program includes monitoring key indicators of quality in the pre-analytic, analytic,
and post-analytic phases.
NOTE: Key indicators should monitor activities critical to patient outcome or that may affectmany patients. The laboratory must evaluate its indicators by comparing its performance against
available benchmarks. The laboratory should also evaluate the effectiveness of each corrective
action. The number of monitored indicators should be consistent with the laboratory's scope ofcare. Special function laboratories may monitor fewer indicators; full-service laboratories should
monitor multiple aspects of the testing process appropriate to their scope of service.
For laboratories that have implemented one or more individualized quality control plans (IQCPs),
the quality management program must include a review of the ongoing monitoring of theeffectiveness of each IQCP.
While there is no requirement to monitor any specific laboratory indicator, the following key
quality indicators have been commonly used to measure laboratory performance in a consistentmanner and are important to clinicians and patients as indices of care.
1. Patient/Specimen Identification: Percent of patient wristbands with errors, percent ofordered tests with patient identification errors, or percent of results with identification
errors
2. Test Order Accuracy: Percent of test orders correctly entered into a laboratorycomputer3. Specimen Acceptability: Percent of specimens accepted for testing
4. Stat Test Turnaround Time: Collection-to-reporting turnaround time or receiptin-laboratory-to-reporting turnaround time of tests ordered with a “stat” priority(e.g. emergency department or intensive care unit specimens), mean or medianturnaround time, or the percent of specimens with turnaround time that falls within an
established limit
5. Critical Value Reporting: Percent of critical results with written record that results
have been reported to caregivers; percent of critical results for which the primaryclinician cannot be contacted in a reasonable period of time
6. Customer Satisfaction: Standardized satisfaction survey tool with a reference
database of physician, nurse, or patient respondents
7. Corrected Reports – General Laboratory: Percent of reports that are corrected
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9. Surgical Pathology/Cytology Specimen Labeling: Percent of requisitions or specimen
containers with one or more errors of pre-defined type
10. Blood Component Wastage: Percentage of red blood cell units or other blood
components that are not transfused to patients and not returned to the blood
component supplier for credit or reissue
11. Blood Culture Contamination: Percent of blood cultures that grow bacteria that arehighly likely to represent contaminants
Performance of indicators should be compared with benchmarks, preferably from multiinstitutional studies conducted within ten years of the laboratory's use of the monitor, where such
surveys are available.
Both the College of American Pathologist's Q-TRACKS Program itself and publications of QTRACKS studies in the Archives of Pathology provide information regarding definitions of quality
indicators and demonstrate statistically valid peer-group performance standards.
For benchmark information on commonly used quality indicators, please refer to the Quality
Management Quality Indicator Monitoring Guidance Document posted on the CAP Website at thefollowing link: http://www.cap.org/apps/docs/laboratory_accreditation/qim.pdf
Evidence of Compliance:✓
Listing of quality indicators that include the following:●
indicators for pre-analytic, analytic, and post-analytic phases AND●
indicators to address the scope of testing and laboratory services AND●
frequency for monitoring each indicator AND●
defined benchmarks for the performance of each indicator AND✓
Quality management data and reports for quality indicator monitoring and evaluation,
including, comparison against benchmark data, and corrective action when targets are notmet
REFERENCES
1) http://www.cap.org/apps/docs/laboratory_accreditation/qim.pdf
2) Clinical Laboratory Improvement Amendments 42 CFR § 493.1701
3) Howanitz PJ, et al. Continuous wristband monitoring over 2 years decreases identification errors: a College of American Pathologists
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
21)

Q-TRACKS Study. Arch Pathol Lab Med. 2002; 126:809-815
Valenstein PN, Walsh MK, Stankovic AK. Accuracy of send-out test ordering: a College of American Pathologists Q-Probes study ofordering accuracy in 97 clinical laboratories. Arch Pathol Lab Med. 2008;132:206-210
Novis DA, et al. Biochemical markers of myocardial injury test turnaround time. Arch Pathol Lab Med. 2004; 128:158-164
Novis DA, Walsh MK, Dale JC, Howanitz PJ. Continuous monitoring of stat and routine outlier turnaround times: two College ofAmerican Pathologists Q-TRACKS monitors in 291 hospitals. Arch Pathol Lab Med. 2004;128:621-626
Wagar EA, Stankovic AK, Wilkinson DS, Walsh M, Souers RJ. Assessment monitoring of laboratory critical values. A College ofAmerican Pathologists Q-TRACKS study of 180 institutions. Arch Pathol Lab Med. 2007;131:44-49
Nakhleh RE, Souers R, Ruby SG. Physician satisfaction with surgical pathology reports: a 2-year College of American Pathologists
Q-TRACKS study. Arch Pathol Lab Med. 2008;132:1719-1722
Jones BA, Bekeris LG, Nakhleh RE, Walsh PK, Valenstein PN. Physician satisfaction with clinical laboratory services: a College ofAmerican Pathologists Q-Probes study of 138 institutions. Arch Pathol Lab Med. 2009;133:38-43
Bruce A. Jones MD, Molly K. Walsh PhD and Stephen G. Ruby MD. 2006: Hospital nursing satisfaction with clinical laboratory
services: a College of American Pathologists Q-Probes study of 162 institutions. Arch Pathol Lab Med. 2006;130:1756-1761
Raab S, Nakhleh RE, Ruby SG. Patient safety in anatomic pathology: measuring discrepancy frequencies and causes. Arch Pathol
Lab Med. 2005;129:459-466
Nakhleh RE, Idowu MO, Souers RJ, Meier FA, Bekeris LG. Mislabeling cases, specimens, blocks, and slides; a College of American
Pathologists study of 136 institutions. Arch Pathol Lab Med. 2011;135(8):969-97
Novis DA, et al. Quality indicators of fresh frozen plasma and platelet utilization. Arch Pathol Lab Med. 2002; 126:527-532
Bekeris LG, Tworek JA, Walsh MK, Valenstein PN. Trends in blood culture contamination: a College of American Pathologists QTRACKS study of 365 institutions. Arch Pathol Lab Med. 2005;129:1222-1225
Zarbo RJ, Jones BA, Friedberg RC, Valenstein PN, Renner SW, Schifman RB, Walsh MK, Howanitz PJ. Q-TRACKS: A College ofAmerican Pathologists Program of Continuous Laboratory Monitoring and Longitudinal Performance Tracking. Arch Pathol Lab Med.
2002;126:1036-1044
Raab SS, Jones BA, Souers R, Tworek JA. The effect of continuous monitoring of cytologic-histologic correlation data on cervicalcancer screening performance. Arch Pathol Lab Med. 2008;132:16-22
Raab SS, Tworek JA, Souers R, Zarbo RJ. The value of monitoring frozen section-permanent section correlation data over time. Arch
Pathol Lab Med 2006;130:337-342
Bonini P, et al. Errors in laboratory medicine. Clin Chem. 2002, 48:691-698
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1249]
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1299]
Clinical and Laboratory Standards Institute. Development and Use of Quality Indicators for Process Improvement and Monitoring ofLaboratory Quality; Approved Guideline. CLSI guideline QMS12-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2010.

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Employee and Patient Quality Communication

Phase II

The laboratory has a procedure for employees and patients to communicate concerns
about quality and safety to management.
NOTE: The investigation and analysis of employee and patient complaints and suggestions,with corrective or preventive action as appropriate, should be a part of the laboratory quality
management program and be specifically addressed in laboratory quality management records.
Evidence of Compliance:✓
Records of employee and patient complaints (if any) with appropriate follow up
GEN.20330

CAP Sign

Phase II

The laboratory posts the official CAP sign regarding reporting of quality concerns.
NOTE: The laboratory must prominently post the official CAP sign regarding the reporting of
quality concerns to CAP.
While personnel should report concerns to laboratory management, the laboratory must ensurethat all personnel know that they may communicate with CAP directly if they have a concern
not addressed by laboratory management, and that CAP holds such communications in strict
confidence. In addition, the laboratory must have a policy prohibiting harassment or punitive
action against an employee in response to a complaint or concern made to CAP or otherregulatory organization regarding laboratory quality or safety.
The dedicated, confidential CAP telephone line for quality or safety concerns is 866-236-7212(US, toll-free) and 847-832-7533 (international).
Official CAP signs may be obtained by calling 800-323-4040 option 1#.
**REVISED** 07/28/2015
GEN.20335 Customer Satisfaction

Phase IThe laboratory has measured the satisfaction of healthcare providers or patients withlaboratory services within the past two years.
NOTE: Satisfaction metrics are important for understanding the needs of clients (physicians,patients, referring laboratories, nurses, etc.) to improve laboratory services. Experience has
shown that surveys are more informative if they are conducted anonymously and allow for open
ended comments. The sample size should be adequate. A numeric satisfaction scale allows forcalculation of statistics.
Evidence of Compliance:✓
Records of the design and results of satisfaction surveys
REFERENCES
1) Kiechle FL, Funk DM, Rossler R, Sesok-Pizzini D. So You're Going to Collect a Blood Specimen. An Introduction to Phlebotomy,th
14 edition. Northfield, IL: College of American Pathologists, 2014.
2)
3)
4)
5)
6)
7)
8)

Steindel SJ, Howanitz PJ. Physician satisfaction and emergency department laboratory test turnaround time. Observations based on
College of American Pathologists Q-Probes studies. Arch Pathol Lab Med. 2001;125:863-871
Howanitz PJ, Cembrowski GS, Bachner P. Laboratory phlebotomy: College of American Pathologists Q-Probes study of patientsatisfaction and complications in 23783 patients. Arch Pathol Lab Med 991; 115:867-872.
Dale JC, Novis DA, Meier FA. Reference laboratory telephone service quality: College of American Pathologists Q-Probes study of
545 laboratories. Arch Pathol Lab Med. 2001; 125:608-612.
Zarbo RJ, Nakhleh RE, Walsh, M. Customer satisfaction in anatomic pathology: a College of American Pathologists Q-Probes studyof 3065 physician surveys from 94 laboratories. Arch Pathol Lab Med. 2003; 127:23-29.
Jones BA, Walsh MK, Rudy SG. Hospital nursing satisfaction with clinical laboratory services: a College of American Pathologists QProbes study of 162 institutions. Arch Pathol Lab Med. 2006; 130:1756-1761.
Nakhleh RE, Souers R, Ruby SG. Physician satisfaction with surgical pathology reports: a 2-year College of American Pathologists
Q-Tracks study. Arch Pathol Lab Med. 2008; 132:1719-1722.
Jones BA, Bekeris LG, Nakhleh RE, et al. Physician satisfaction with clinical laboratory services: a College of American Pathologists
Q-Probes study of 138 institutions. Arch Pathol Lab Med. 2009; 133:38-43.

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GEN.20340

Notifications From Vendors

08.17.2016

Phase II

The laboratory manages notifications from vendors of defects or issues with supplies orsoftware that may affect patient care.
NOTE: Notifications may take the form of product recalls, market withdrawals, or software
patches and upgrades. The laboratory should take action on those that have the potential toaffect testing results or laboratory services.
Evidence of Compliance:✓
Records of manufacturer's recalls received AND✓
Records of follow-up
GEN.20351

Adverse Patient Event Reporting

Phase II

The laboratory has a procedure for reporting device-related adverse patient events, as
required by the FDA.
NOTE: This checklist item does NOT apply to laboratories accredited under the CAP Forensic
Drug Testing program. Non-US laboratories are encouraged to comply with this checklist item,
either through reporting to the FDA in the US or to their national equivalent.
When information reasonably suggests that any laboratory instrument, reagent or other device(including all instruments in the central laboratory, satellite laboratories, point-of-care testing
programs, and accessory devices used for phlebotomy or specimen collection) has or may havecaused or contributed to a patient death or serious patient injury, the FDA requires hospitals andoutpatient diagnostic facilities, including independent laboratories, to report the event. If the event
is death, the report must be made both to the FDA and the device manufacturer. If the event isserious patient injury, the report may be to the manufacturer only, unless the manufacturer is
unknown, in which case the report must be submitted to the FDA. Reports must be submitted on
the FDA Form 3500A (or an electronic equivalent) as soon as practical but no later than 10 days
from the time medical personnel become aware of the event.
The FDA defines “serious patient injury” as one that is life threatening; or results in permanent
impairment of a body function or permanent damage to a body structure; or necessitates medicalor surgical intervention to preclude permanent impairment of a body function or permanent
damage to a body structure. Device malfunctions or problems that are reportable may relate
to any aspect of a test, including hardware, labeling*, reagents or calibration; or to user error(since the latter may be related to faulty instrument instructions or design). An adverse patient
event that may have resulted from inherent limitations in an analytic system (e.g. limitations ofsensitivity, specificity, accuracy, and precision) is not reportable.
The laboratory should have written procedures for 1) the identification and evaluation of adverse
patient events, 2) the timely submission of MDR (medical device reporting) reports, and 3)
compliance with record keeping requirements. A written record of participation in the overall
institutional MDR process is required of laboratories that are part of a larger organization (e.g.
hospital laboratories).
The laboratory should educate its personnel in the FDA MDR requirements.
The laboratory (or parent institution, as appropriate) must submit an annual report of devicerelated deaths and serious injuries to FDA, if any such event was reported during the previous
year. Annual reports must be submitted on Form 3419 (for hospital-based laboratories only, or anelectronic equivalent) or Form 3500 (for non-hospital-based laboratories) by January 1 of eachyear. The laboratory or institution must keep records of MDR reports for 2 years.
Additional information is available on the FDA website, at http:/www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/default.htm*In this context, “labeling” refers to all user instructions provided by the manufacturer.

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Evidence of Compliance:✓
Records of MDR reports for reportable events, if applicable
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). A Model for Managing Medical Device Alerts (Hazards and Recalls) for
Healthcare Organizations; Approved Guideline. CLSI document QMS10-A (ISBN 1-56238-590-9). Clinical and Laboratory Standards
Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087-1898, USA, 2005.

**NEW** 07/28/2015
GEN.20361 CLIA Certificate Type

Phase IIFor laboratories subject to US regulations performing patient testing subject to CLIA, thelaboratory has registered with the Centers for Medicare and Medicaid Services (CMS) andobtained a CLIA certificate that corresponds to the complexity of testing performed, asapplicable.
NOTE: This requirement does not apply to laboratories that are part of the Department of
Defense. Laboratories located in CLIA exempt states, such as Washington and New York, must
be able to show that they have obtained a CLIA number, when appropriate.
The CLIA regulations define a laboratory as a facility that performs testing on materials derived
from the human body for the purpose of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the health of, human beings.
Examples of laboratory activities that do not require registration with the CMS for a CLIA number
include:●Specimen collection●
Specimen preparation, including histology, tissue embedding, sectioning, and staining●
Forensic testing●
Research testing on human specimens where patient-specific results are not reported tothe clinician●
Drug testing meeting SAMHSA guidelines and regulations
Laboratories must obtain the CLIA certificate type that corresponds to their highest level ofcomplexity. The CLIA certificate types include:●
Certificate of Waiver - waived tests only*●
Certificate of Provider Performed Microscopy (PPM) Procedures - testing performed by aphysician, midlevel practitioner or dentist for specific microscopy procedures (moderatecomplexity) during the course of a patient's visit●
Certificate of Registration - nonwaived testing (moderate or high complexity) prior toinitial laboratory inspection●
Certificate of Compliance - nonwaived testing with inspection by the State Department of
Health (CLIA inspection)●
Certificate of Accreditation - nonwaived testing with inspection by a CMS-approved
accrediting organization, such as the CAP's accreditation programs.
For more information on the CMS requirements for CLIA certificates and typesof CLIA certificates, refer to Appendix C of the CMS Interpretive Guidelines forLaboratories (http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
Interpretive_Guidelines_for_Laboratories.html).
*Any modification from the manufacturer's instructions changes the test classification to
nonwaived and requires a different type of CLIA certificate.
GEN.20374

Federal/State/Local Regulations

Phase IThe laboratory has a policy for ensuring compliance with applicable federal, state andlocal laws and regulations.

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NOTE: Applicable federal, state and local requirements may include but are not limited to thefollowing areas: handling radioactive materials, shipping infectious or diagnostic materials,
personnel qualifications, retention of specimens and records, hazardous waste disposal, fire
codes, medical examiner or coroner jurisdiction, legal testing, acceptance of specimens only from
authorized personnel, handling controlled substances, patient consent for testing, confidentialityof test results, and donation of blood. The checklists contain specific requirements on theseareas.
The laboratory may obtain information on applicable federal, state and local laws and regulations
from multiple sources, including hospital management, state medical societies and state
departments of health.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2004(Oct 1): [42CFR493.1101(c)]**REVISED** 07/28/2015
GEN.20375 Document Control

Phase II

The laboratory has a document control system to manage policies, procedures, and forms
that are subject to CAP accreditation.
NOTE: This includes documents relating directly to laboratory testing, as well as others, such as
quality management, safety, specimen collection, personnel, and laboratory information systems.
The document control system must ensure that only current policies, procedures (including
derivative documents such as card files and summary charts), and forms are in use and thatrecords for approval, review, and discontinuance are available.
It is recommended that the laboratory maintain a control log listing all current policies,
procedures, and forms with the locations of copies. The control log may contain other information
as appropriate, such as dates when policies and procedures were placed in service, schedule ofreview, identity of reviewer(s), and dates when policies and procedures were discontinued and/or
superseded.
Additional requirements regarding procedure manuals are found in the All Common Checklist,
and in this checklist in the Collection Manual, Computer Services and Safety sections.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Development and Management of Laboratory
2)
3)

Documents; Approved Guideline - Sixth Edition. CLSI document QMS02-A6 (ISBN 1-56238-869-X). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2013.
ISO International Standard 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International
Organization for Standardization, 2003

st ed. CLSI guideline QMS16-Ed1. Clinical andClinical and Laboratory Standards Institute. Laboratory Personnel Management, 1Laboratory Standards Institute, Wayne, PA; 2015.

**REVISED** 08/17/2016
GEN.20377 Record/Specimen Retention

Phase II

Laboratory records and materials are retained for an appropriate time.
NOTE: Policies for retention of records and materials must comply with federal, state and local
laws and regulations and with the retention periods listed below, whichever is most stringent. For
testing on minors (under the age of 21), stricter state regulations may apply.
More specific requirements for certain laboratory records are found in the Anatomic Pathology,
Cytopathology, Cytogenetics, Molecular Pathology, Reproductive Laboratory Medicine, andTransfusion Medicine Checklists.

Type of Record/Material

Retention Period20 of 129
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Specimen requisitions (including thepatient chart or medical record if usedas the requisition)
Accession records
Quality management records
Validation/verification of method
performance specifications
Proficiency testing records
Policies and procedures

Quality control records
Individualized Quality Control Plan
(IQCP), including risk assessment andsupporting data, and approval of quality
control plan
Ongoing quality assessment data
Instrument maintenance* and function
check records
Personnel Records
Competency assessment records

08.17.2016

2 years

2 years
2 years
2 years after discontinuation of the test
2 years (5 years for transfusion
medicine)
At least 2 years following
discontinuance (5 years for transfusion
medicine)
2 years (5 years for transfusion
medicine)
2 years following discontinuation of the
IQCP

2 years
2 years

2 years (5 years for transfusion
medicine)

Training records
2 years (5 years for transfusion
medicine)
Patient Specimens (stored underappropriate conditions)
Serum, heparinized plasma, EDTA
plasma, CSF, and body fluids (except
urine)

48 hours

Not defined
Whole blood specimens, including blood
gas specimens
Urine
Clinical Pathology Slides
Blood Films
Permanently stained body fluid slides
Permanently stained microbiology
slides prepared from clinical specimens(including blood culture bottles)

24 hours; exceptions may be made atthe discretion of the laboratory director.
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Testing Records
Instrument printouts and worksheets ** 2 years
Patient test results and reports,
including original and corrected reports,
and referral laboratory reports
Direct-to-consumer testing results,
including reference ranges
Laboratory Computer Services
Computer system validation records

10 years

2 years beyond the life of the system

Records of changes to software, the test
library, and major functions of laboratory
information systems
Ongoing computer system checks (e.g. 2 years
calculation verification)* Laboratories may wish to retain instrument maintenance records for longer than the two-year
requirement (e.g. for the life of the instrument), to facilitate trouble-shooting.
** For data directly transmitted from instruments to the laboratory computer system via aninterface (on-line system), it is not necessary to retain paper worksheets, printouts, etc., so longas the computer retains the data for at least two years. Manual computer entry of patient result
data from worksheets, print-outs, etc. requires retention of all worksheets, printouts, etc. for atleast two years (digitized or photographic images are acceptable). For results that are manuallyentered into the computer from 1) observation of an electronic display, with no paper print-out
available, or 2) manually performed test methods without worksheets, the two-year retention
requirement applies to the data within the computer.
Evidence of Compliance:✓
Written policy for retention of records, specimens and slides
REFERENCES
1) College of American Pathologists. Guidelines for the retention of laboratory records and materials. Northfield, IL: CAP, current edition
2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement3)

GEN.20425

amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1105]
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1283(b)]Record Retention

Phase II

The laboratory has a policy to ensure that all records, slides, blocks, and tissues are
retained and available for appropriate times should the laboratory cease operation.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2005(Oct 1):1033 [42CFR493.1105(b)]**NEW** 08/17/2016
GEN.20450 Correction of Laboratory Records

Phase II

The laboratory follows a written policy for the management and correction of laboratory
records, including quality control data, temperature logs, and intermediate test results orworksheets.

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NOTE: Laboratory records and changes to such records must be legible and indelible. Original(erroneous) entries must be visible (i.e. erasures, white and correction fluid are unacceptable)or accessible (e.g. audit trail for electronic records). Corrected data, including the identity of theperson changing the record and when the record was changed, must be accessible to audit. Thisrequirement does not apply to changes to patient reports (refer to GEN.41310).
Evidence of Compliance:✓
Records of corrections to laboratory records following the policy
GEN.23584

Interim Self-Inspection

Phase II

The laboratory conducts an interim self-inspection and records efforts to correct
deficiencies identified during that process.
NOTE: The interim self-inspection is an important aspect of continuing education and laboratory
improvement. The use of a variety of mechanisms for self-inspection (residents, technologists
or others trained to perform inspections) is strongly endorsed. Self inspection by personnel
familiar with, but not directly involved in, the routine operation of the laboratory section to beinspected is a best practice. Records of performance of the interim self-inspection with correctionof deficiencies is a requirement for maintaining accreditation. The laboratory must have a record
to demonstrate that personnel responsible for each laboratory section have reviewed the findingsof the interim self-inspection.
Evidence of Compliance:✓
Written evidence of self-inspection findings with records of corrective action
REFERENCES
1) Clinical and Laboratory Standards Institute. Assessments: Laboratory Internal Audit Program; Approved Guideline. CLSI document
QMS15-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2013.

**REVISED** 07/28/2015
GEN.26791 Terms of Accreditation

Phase II

The laboratory has a policy that addresses compliance with the CAP terms ofaccreditation.
NOTE: The CAP terms of accreditation are listed in the laboratory's official notification ofaccreditation. The policy must include notification of CAP regarding the following:
1. Investigation of the laboratory by a government entity or other oversight agency, or
adverse media attention related to laboratory performance; notification must occur nolater than two working days after the laboratory learns of an investigation or adverse
media attention. For laboratories subject to US regulations, this notification must
include any complaint investigations conducted or warning letters issued by any
oversight agency (e.g. CMS, State Department of Health, The Joint Commission,
FDA, OSHA).
2. A facility must notify the CAP as soon as it finds itself to be the subject of a validation
inspection
3. Discovery of actions by laboratory personnel that violate national, state or local
regulations
4. Change in laboratory test menu prior to beginning that testing or the laboratory
permanently or temporarily discontinues some or all testing
5. Change in laboratory directorship, location, ownership, name, insolvency, orbankruptcy; notification must occur no later than 30 days prior to the change(s);or, in the case of unexpected changes, no later than two working days afterwards.
Laboratories subject to US regulations must also notify the US Department of Healthand Human Services.

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In addition, the policy must address:
6. Provision of a trained inspection team comparable in size and scope if requested by
CAP at least once every two-year accreditation period
7. Cooperation with CAP and HHS when the laboratory is subject to a CAP or HHS
complaint investigation or validation inspection
8. Adherence to the Terms of Use for the CAP Certification Mark of accreditation
9. For laboratories subject to US regulations, availability, on a reasonable basis of thelaboratory's annual proficiency testing results upon request of any person
Evidence of Compliance:✓
Records of notification, if applicableGEN.30000

Monitoring Analytic Performance

Phase II

There is a written quality control program that clearly defines policies and procedures formonitoring analytic performance.
NOTE: There must be a written overall quality control program for the entire laboratory. It must
include general policies and assignment of responsibilities. There must be clearly defined, written
procedures for ongoing monitoring of analytic performance, including (1) number and frequency
of controls; (2) establishment of tolerance limits for control testing; and (3) corrective actions
based on quality control data. Quality control records should be well-organized with a system topermit regular review by appropriate supervisory personnel (laboratory director, supervisor orlaboratory quality control coordinator).

SPECIMEN COLLECTION, HANDLING, AND REPORTING
Specimen collection, handling, and results reporting are critical. Specific instructions for the proper collection
and handling of specimens must be made available to laboratory personnel and to anyone collecting patient test
materials that are sent to the laboratory.

Inspector Instructions:●

Follow a patient specimen beginning with test ordering through patient identification,
phlebotomy/collection, labeling, transport, receipt and processing, delivery to testarea, analysis, result review, and reporting. Determine if practice matches related
policies and procedures.

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SPECIMEN COLLECTION INSTRUCTIONS
Inspector Instructions:●●●

Sampling of specimen collection policies and proceduresSpecimen handling policies and procedures for referral of testingSpecimen collection manuals (available)**REVISED** 07/28/2015
GEN.40016 Specimen Collection Procedure Review

Phase II

There are records of review of the specimen collection/handling procedures by the current
laboratory director or designee at least every two years.
**REVISED** 07/28/2015
GEN.40032 New Specimen Collection Procedure Review

Phase II

The laboratory director reviews and approves all new specimen collection and handlingprocedures, as well as substantial changes to existing procedures before implementation.
NOTE: Current practice must match written procedures.
GEN.40050

Distribution of Manuals

Phase IThe specimen collection manual is distributed to all specimen-collecting areas within thehospital (nursing stations, operating room, emergency room, out-patient areas) AND to
areas outside the main laboratory (such as physicians' offices or other laboratories).
NOTE: It is acceptable for this information to be electronically available to users rather than inbook format; there is no requirement for a paper-based specimen collection manual. Indeed,
electronic manuals have the advantage of more accurately reflecting current requirements.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(d)]GEN.40100

Specimen Collection Manual Elements

Phase II

The specimen collection manual includes instructions for all of the following elements, asapplicable.
1.
2.
3.
4.
5.

Preparation of the patient
Type of collection container and amount of specimen to be collected
Need for special timing for collection (e.g. creatinine clearance)
Types and amounts of preservatives or anticoagulants
Need for special handling between time of collection and time received by thelaboratory (e.g. refrigeration, immediate delivery)25 of 129
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6. Proper specimen labeling
7. Need for appropriate clinical data, when indicated
NOTE: Because of the importance of clinical information in the practice of surgical pathology
and cytopathology, requisitions for such specimens should include pertinent clinical data, as wellas pre-operative and/or post-operative diagnosis. Written instructions should be available for all
applicable tissue and cytologic specimens, including biopsies, resections, PAP tests, sputum
washings, brushings, body fluids, fine needle aspirations, etc. Instructions must include proper
fixation of slides and tissue specimens. A variety of tests in clinical pathology also require specificclinical information (e.g. maternal AFP screening, TDM peak and trough measurements, andantibiotic therapy) or special instructions for collection, preservation, and storage (e.g. timed or
24-hour urine specimens).
REFERENCES
1) Nakhleh RE, et al. Necessity of clinical information in surgical pathology. A College of American Pathologists Q-Probes study of 771
2)
3)
4)
5)

475 surgical pathology cases from 341 institutions. Arch Pathol Lab Med. 1999;123:615-619
Burton JL, Stephenson TJ. Are clinicians failing to supply adequate information when requesting a histopathological investigation? J
Clin Pathol. 2001;54:806-808
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Fed Register. 2003(Jan 24):3706[42CFR493.1251(b)(1)]Clinical and Laboratory Standards Institute (CLSI). Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved
Guideline—Third Edition. CLSI document GP15-A3 (ISBN 1-56238-679-4). Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2008.
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(a)]**REVISED** 07/28/2015
GEN.40125 Handling of Referred Specimens

Phase IIFor specimens sent to referral laboratories, the referring laboratory properly follows all
requisition, collection and handling specifications of the referral laboratory.
NOTE: Pre-analytic variables must be closely controlled to maintain specimen integrity. These
include specimen temperature, transport time, and the interval before separation of blood cells
from serum/plasma. For coagulation tests, important considerations include proper filling of thecollection tube, the use of waste tubes, and, if blood must be drawn through an indwelling line,
flushing of the line. For surgical pathology and cytopathology, specimens must be preservedby proper fixation or refrigeration. Twenty-four-hour urine specimens may require special
preservatives for specific tests. Also, it may be necessary to collect specific patient information
required by the testing laboratory (e.g. menstrual history for cytopathology, gestational age
for prenatal neural tube defect screening, preoperative diagnosis for surgical pathology, andbleeding history for specialized coagulation assays).
For microbiology specimens, guidelines for the timing of specimen collection, collection
techniques, and selection of appropriate collection devices and transport media must be followed
as stipulated by the referral laboratory.
For newborn screening specimens, the specimen collection, application and drying of blood
spots, and submission of specimens to the referral laboratory must follow the designated
newborn screening laboratory's instructions and be in compliance with the most recent editionof the CLSI Document NBS01 and state or local regulations. Specimens should be transported
after they are dry and no later than 24 hours after collection or following the instructions provided
by the designated newborn screening laboratory. Delays in specimen transportation from thecollection facility to the testing laboratory may compromise the integrity of the specimen andresults and could critically impact the newborn.
Evidence of Compliance:✓
Written procedure for submission of specimens to referral laboratories, consistent with thereferral laboratory collection and handling requirements
REFERENCES
1) Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry
accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150

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2)
3)
4)

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Narayanan S. The preanalytic phase. An important component of laboratory medicine. Am J Clin Pathol. 2000;113:429-452
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(a)]Clinical and Laboratory Standards Institute (CLSI). Blood Collection on Filter Paper for Newborn Screening Programs. CLSI Standard
NBS01-A6. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087-1898 USA

SPECIMEN COLLECTION AND LABELING
Accurate and precise laboratory data are dependent on properly collected clinical specimens.

Inspector Instructions:
●

●
●

●

●

GEN.40460

Specimen collection (patient identification, specimen labeling, correction of labeling,
and adverse event) policies and procedures
Sampling of phlebotomy/clinical specimen collection training records
Paternity/forensic collection policies and procedures
Sampling of phlebotomy supplies, collection devices, transport media (expiration
date, storage)
Specimen collection at one or more sites within the institution.

●

How is feedback related to specimen quality provided to the individuals collecting
patient specimens, including non-laboratory staff, as applicable?

●

If specimen collection errors are a recurring problem, further evaluate the laboratory's
investigation of how the errors occurred and the corrective actions that were
implemented

Specimen Collection Supplies

Phase IISpecimen collection supplies such as blood collection tubes and collection devices (e.g.
heel lancets, culture swabs, and transport media) are used within their expiration date andstored per manufacturer's instructions.
NOTE: For newborn screening collection cards, if the expiration date is not printed on theindividual cards, another mechanism, such as serial number, may be used for tracking.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Blood Collection on Filter Paper for Newborn Screening Programs. CLSI Standard
NBS01-A6. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087-1898 USA**REVISED** 07/28/2015
GEN.40470 Specimen Collection Training

Phase II

There are records that all personnel collecting patient specimens have been trained incollection techniques and in the proper selection and use of equipment/supplies and areknowledgeable about the contents of the specimen collection procedures.

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NOTE: This applies to laboratory employees, including those at remote sites that are owned andoperated by the laboratory.
It applies to all personnel who collect and test samples under the laboratory's CAP number,such as for point-of-care testing and for blood gas analysis. It does not apply to the collectionof specimens sent to the laboratory by hospital personnel or from outside sources. All types of
specimen collection techniques (e.g. phlebotomy, capillary, arterial, in-dwelling line, phlebotomy
during intravenous infusion), as well as non-blood specimens, must be included in the training
in accord with the individuals' duties. If the laboratory uses prepackaged kits for specimen
collection, any special instructions that accompany the kit must be part of the training.
REFERENCES
1) Galena HJ. Complications occurring from diagnostic venipuncture. J Fam Pract. 1992;34:582-584
2) Piton JD, Forstater AT. Recurrent asystole associated with vasovagal reaction during venipuncture. J Emerg Med. 1993;11:723-727
3) Becan-McBride K, et al. Phlebotomy. Collection, professionalism, and QA. Chicago, IL: ASCP Press, 1993
4) Strand CL, et al. Effect of iodophor versus iodine skin preparation on blood culture contamination rate. JAMA. 1993;269:1004-1006
5) Spitalnic SJ, et al. The significance of changing needles when inoculating blood cultures; a meta-analysis. Clin Infect Dis.
1995;21:1103-1106
Strasinger SK, di Lorenzo MA. Phlebotomy workbook for the multiskilled healthcare professional. Philadelphia: FA Davis, 1996
So You're Going to Collect a Blood Specimen. An Introduction to Phlebotomy. 12th edition. Northfield, IL: College of American
Pathologists, 2007
8) Gibb AP, et al. Reduction in blood culture contamination rate by feedback to phlebotomists. Arch Pathol Lab Med. 1997;121:50-507
9) Klosinki DD. Collecting specimens from the elderly patient. Lab Med. 1997;28:518-522
10) Brigden ML, et al. Prothrombin time determination: the lack of need for a discard tube and 24-hour stability. Am J Clin Pathol.
1997;108:422-426
11) Clinical and Laboratory Standards Institute. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved

6)
7)th ed. CLSI document H03-A6. Clinical and Laboratory Standards Institute, Wayne, PA, 2007.

Standard. 6

12) Larsson BA, et al. Venipuncture is more effective and less painful than heel lancing for blood tests in neonates. Pediatrics.
1998;101:882-886

13) Berns SD, Matchett JL. Effect of phlebotomy technique on serum bicarbonate values. Acad Emerg Med. 1998;5(1):40-44
14) Adcock DM, et al. Minimum specimen volume requirements for routine coagulation testing. Dependence on citrate concentration. Am
J Clin Pathol. 1998;109:595-599

15) Reneke J, et al. Prolonged prothrombin time and activated partial thromboplastin time due to underfilled specimen tubes with 109
mmol/l (3.2%) citrate anticoagulant. Am J Clin Pathol. 1998;109:754-757

16) Phelan S. Phlebotomy: review guide. Chicago, IL: ASCP Press, 199817) Dale JC. Preanalytic variables in laboratory testing. Lab Med. 1998;29:540-545
18) Dale JC, et al. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo
Clinic Rochester. Mayo Clin Proc. 1998;73:611-615

19) Pruett S. Needle-stick safety for phlebotomists. Lab Med. 1998;29:754-760
20) Dale JC, Hamrick HJ. Neonatal bilirubin testing practices. Reports from 312 laboratories enrolled in the College of American
Pathologists Excel proficiency testing program. Arch Pathol Lab Med. 2000;124:1425-1428

21) Burns ER, Yoshikawa N. Hemolysis in serum samples drawn by emergency department personnel versus laboratory phlebotomists.
Lab Med. 2002;33:378-380**REVISED** 08/17/2016
GEN.40490 Patient Identification

Phase II

The individual collecting the specimen positively identifies the patient before collecting a
specimen and labels the specimen in the presence of the patient.
NOTE: Personnel must confirm the patient's identity by checking at least two identifiers before
collecting a specimen. For example, an inpatient's wristband may be checked for name andunique hospital number; an outpatient's name and birth date may be used. The patient's room
number may not be used as an identifier. The patient's identity should be verified by asking thepatient to identify him- or herself, when it is practical to do so*. The intent of this requirement is toensure a written, consistently followed system for correct patient and specimen identification at
the point of collection.
*For example, verbal verification is not necessary if obtaining the services of a translator would
delay specimen collection.
Evidence of Compliance:✓
Written collection procedure, including criteria for patient identification
REFERENCES
1) Garza D, Becan-McBride K. Phlebotomy handbook, 2nd ed. Norwalk, CT: Appleton & Lange, 1989
2) Renner SW, et al. Wristband identification error reporting in 712 hospitals. A College of American Pathologists' Q-Probes study ofquality issues in transfusion practice. Arch Pathol Lab Med. 1993;117:573-577

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3)
4)
5)

08.17.2016

So You're Going to Collect a Blood Specimen. An Introduction to Phlebotomy. 12th edition. Northfield, IL: College of American
Pathologists, 2007
Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues inpatient identification. Lab Med. 1997;28:203-207
Clinical and Laboratory Standards Institute. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved

th

6)
7)
8)

Standard. 6 ed. CLSI document H03-A6. Clinical and Laboratory Standards Institute, Wayne, PA, 2007.
Howanitz PJ, et al. Continuous wristband monitoring over 2 years decreases identification errors. A College of American Pathologists
Q-Tracks study. Arch Pathol Lab Med. 2002;126:809-815
Clinical and Laboratory Standards Institute (CLSI). Accuracy in Patient and Sample Identification; Approved Guideline. CLSI
document GP33-A (ISBN 1-56238-721-9). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2010.
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1283(a)(2)]**REVISED** 08/17/2016
GEN.40491 Primary Specimen Container LabelingPhase II

All primary specimen containers are labeled with at least two patient-specific identifiers.
NOTE: A primary specimen container is the innermost container that holds the original
specimen prior to processing and testing. This may be in the form of a specimen collection
tube, cup, syringe, swab, slide or other form of specimen storage. Data files received fromother laboratories for analysis are considered a specimen and must contain acceptable patient
identifiers. Criteria for acceptable specimen labeling and the handling of sub-optimal specimensmust be defined in laboratory policy.
Examples of acceptable identifiers include but are not limited to: patient name, date of birth,
hospital number, social security number, requisition number, accession number, unique random
number. A location (e.g. hospital room number) is not an acceptable identifier. Identifiers may bein a machine readable format, such as a barcode.
In limited situations, a single identifier may be used if it can uniquely identify the specimen. For
example, in a trauma situation where a patient's identification is not known, a specimen may besubmitted for testing labeled with a unique code that is traceable to the trauma patient. Other
examples may include forensic specimens, coded or de-identified research specimens, or donor
specimens labeled with a unique code decryptable only by the submitting location.
Obtaining uniform compliance with this requirement may be difficult when specimens arecollected by non-laboratory personnel. The laboratory should 1) Provide a list of acceptable
identifiers to all specimen collectors; 2) Communicate with specimen collectors regarding
the importance of this requirement; and 3) Have a procedure for following up with specimen
collectors when inadequately labeled specimens are received. Communication and follow-up
may be through QM reports, written memoranda, phone calls, visits by client service personnel,
or other means of disclosure.
Evidence of Compliance:✓
Written policy with criteria for acceptable labeling of primary specimen containers AND✓
Specimen collection procedures with defined labeling specifications AND✓
Records of audits for compliance with specimen labeling policies and procedures
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved
2)
3)Standard. CLSI document AUTO12-A (ISBN 1-56238-748-0). Clinical and Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2011.
So You're Going to Collect a Blood Specimen. An Introduction to Phlebotomy, 12th edition. Northfield, IL: College of American
Pathologists, 2007
Clinical and Laboratory Standards Institute. Laboratory Automation: Bar Codes for Specimen Container Identification; Approvednd4)Standard. 2
ed. CLSI document AUTO02-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2006.
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(a)]**REVISED** 07/28/2015
GEN.40492 Specimen Label Correction

Phase II

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The laboratory has a written policy regarding correction of information on specimenlabels.
NOTE: If laboratory personnel become aware of a potential error in patient identification orother information (e.g. initials of individual collecting the specimen, date/time of collection) on a
specimen label, best practice is to recollect the specimen. However, there may be circumstances
when recollection is not possible or practical (e.g. for specimens that are impossible or difficult
to recollect, such as cerebrospinal fluid). The laboratory should define the circumstances
under which correction of the information on specimen labels is permitted. A record of all suchcorrections should be maintained. The laboratory should investigate errors in specimen labeling,
and develop corrective action as appropriate, including education of personnel who collectspecimens.
Evidence of Compliance:✓
Records of corrections to specimen labels and corrective action
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1283(a)(3)]

GEN.40493

Specimen Labeling for Pretransfusion Testing

Phase IIAll blood specimens collected for pretransfusion testing are labeled at the time of
specimen collection in the presence of the patient with:
1.
2.
3.
4.

Patient's first and last name
Unique identification number
Date of collection
A method to identify the individual collecting the specimen

NOTE: Blood specimens collected for pretransfusion testing must be positively and completely
identified and labeled before leaving the patient. Acceptable practices for positive identificationof patient and blood specimen labels must be defined in the procedure manual and may include
visual inspection and/or an electronic system to read the identifying information contained in bar
codes or radio-frequency identification (RFID) microchips or the patient's wristband. Acceptable
practices for generating specimen labels must be defined in the procedure manual and may
include electronic devices utilizing information encoded in bar codes or RFID microchips. There
must be a dependable method to identify the individual who collected the blood specimen, suchas initials or another identifier on the tube, or an electronic record.
Evidence of Compliance:✓
Written procedure defining labeling requirements of specimens for pretransfusion testingAND✓
Written procedure defining system identifying the individual collecting pretransfusion testing
specimens
REFERENCES
1) Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin
2)
3)
4)

GEN.40497

Pathol. 1997;107(suppl 1):S12-S16
Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues inpatient identification. Lab Med. 1997;28:203-207
Sandler SG, Langeberg A, Carty K, Dohnalek LJ. Bar codes and radio-frequency technologies can increase safety and efficiency ofblood transfusions. LabMedicine 2006;37:436-439
Sandler SG, Langeberg A, DeBandi L, Gibble J, Wilson C, Feldman CL. Radio-frequency identification technology can standardize
and document blood collections and transfusions. Transfusion 2007;47:763-70

Paternity/Forensic Data

Phase IIIf the laboratory collects specimens for paternity/forensic identity testing, the following
data are obtained:
1. Place and date of specimen collection
2. Identity of person collecting the specimen

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3. Photograph, or photocopy of a picture identification card for each individual
tested
4. Signed record of information (including name, race, relationship) for eachindividual tested
5. Date of birth of child
6. Synopsis of case history/investigation, sample source
7. Record of informed consent
NOTE: If the laboratory uses prepackaged kits for specimen collection, any additional instructions
that accompany the kit must be followed.
REFERENCES
1) Standards for Parentage testing laboratories. American Association of Blood Banks. Standards for parentage testing laboratories.
Bethesda, MD: 2003:5.2.4

GEN.40498

Specimen Labeling - Paternity/Forensic ID

Phase II

For paternity/forensic identity testing, the information about each individual and theaccuracy of the specimen label is verified by that individual or the legal guardian.
Evidence of Compliance:✓
Records of information and label verification by patient or legal guardian
GEN.40505

Specimen Collection Feedback

Phase I

There is a mechanism to provide feedback to the collectors of specimens on issues
relating to specimen quality and labeling.
NOTE: The accuracy of an analytic result depends upon the initial quality of the specimen.
Proper collection techniques are essential.
Evidence of Compliance:✓
Written procedure defining methods for providing feedback to specimen collectors AND✓
Records of communication of specimen collection issues, such as QM reports, staff meeting
minutes OR records of employee counselingGEN.40508

Phlebotomy Adverse Reaction

Phase II

The laboratory has procedures to care for patients who experience adverse reactions fromphlebotomy.
NOTE: Minor adverse reactions include hematomas, abrasions, nausea, and fainting. Serious
injuries include vomiting, nerve damage, seizures and injuries. Training of phlebotomists shouldemphasize injury prevention. Serious reactions must be recorded in an incident log.
Evidence of Compliance:✓
Written instructions to phlebotomists AND✓
Training records

SPECIMEN TRANSPORT AND TRACKING
This section applies to laboratories that send specimens to referral or other laboratories for testing, whether
or not the specimen collection is performed by the laboratory staff. It also applies to referral laboratories thatreceive specimens from other laboratories or remote locations outside of the facility for testing.

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While transportation of clinical specimens may not be the responsibility of personnel under the control of thelaboratory director, issues of tracking and specimen quality must be addressed to ensure quality laboratory
results.

Inspector Instructions:
●
●

●
●

GEN.40511

Sampling of specimen packing and shipping policies and procedures
Sampling of packaging and shipping of infectious materials training records

How do you know specimens sent from remote sites are actually received?
What is your course of action when specimens received from remote sites areunacceptable?

Specimen Tracking/LabelingPhase IIAll specimens are properly packaged and labeled to indicate the general nature of thematerials transported.
Evidence of Compliance:✓
Written procedure defining criteria for packaging and labeling
REFERENCES
1) World Health Organization, Division of Emerging and Other Communicable Diseases Surveillance and Control. Guidelines for the
2)
3)
4)

GEN.40512

safe transport of infectious substances and diagnostic specimens. Geneva, Switzerland: WHO/EMC/97.3, 1997
Department of Transportation. Research and Special Programs Administration. Hazardous materials table, special provisions,hazardous materials communication. General. Washington, DC: US Government Printing Office, 1998(Oct 1): [49CFR172]
Beckala HR. Regulations for packaging and shipping laboratory specimens. Lab Med. 1999;30:663-667
Tarapchak P. In 'shipping' shape. Advance/Lab. 2000;9(7):48-59

Infectious Material Packing/Shipping

Phase II

The laboratory packages and ships infectious material in accordance with applicable
federal, state and local regulations.
Evidence of Compliance:✓
Written procedures for packaging and shipping that comply with regulations
REFERENCES
1) World Health Organization, Division of Emerging and Other Communicable Diseases Surveillance and Control. Guidelines for the2)
3)

safe transport of infectious substances and diagnostic specimens. Geneva, Switzerland: WHO/EMC/97.3, 1997
Department of Transportation. Research and Special Programs Administration. Hazardous materials table, special provisions,hazardous materials communication. General. Washington, DC: US Government Printing Office, 1998(Oct 1): [49CFR172]

nd ed. CLSI

Clinical and Laboratory Standards Institute. Quality Control of Microbiological Transport Systems; Approved Standard. 2
Document M40-A2. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.

**REVISED** 07/28/2015
GEN.40515 Transport Personnel Training

Phase IITransport personnel are trained in appropriate safety and packaging procedures suitableto specimen type and distances transported, including training for personnel involved inpackaging and shipping infectious substances.
NOTE: Training should include issues such as adherence to regulations for transport ofbiohazards, use of rigid containers where appropriate, temperature control, notification
procedures in case of accident or spills, etc.

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All personnel who package infectious specimens for shipment must satisfactorily complete
training in these requirements. Federal and international regulations mandate the proper
packaging and transportation of infectious substances, also termed "etiologic agents." It is
the laboratory's responsibility to determine whether specimens that are to be shipped are
subject to the regulations, or are exempt. For US laboratories, specific requirements are set
forth by the US Public Health Service, the US Department of Transportation and the US Postal
Service. These apply to domestic transportation by land, air or sea, and to international airtransportation. Recurrent training is required every 3 years. The laboratory should check with its
local department of transportation or state health department for any recent revisions to theserequirements.
Laboratories outside of the US must comply with their national regulations.
These requirements for packaging and shipping of infectious substances do not apply to private
couriers.
The laboratory may send personnel to courses for training, or may obtain materials to train its
personnel in-house. Resources for training are available from many sources, including state
health departments, vendors of shipping materials, and the CDC National Laboratory Training
Network (NLTN).
Evidence of Compliance:✓
Records of training for all personnel involved in transport of specimens
REFERENCES
1) Title 49, Code of Federal Regulations, Part 172.704 Training Requirements
2) Clinical and Laboratory Standards Institute. Quality Control of Microbiological Transport Systems; Approved Standard. 2nd ed. CLSI
Document M40-A2. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.

**REVISED** 07/28/2015
GEN.40530 Specimen Tracking

Phase IIFor specimens submitted to the laboratory from remote sites, there is a tracking system
and record to ensure that all specimens are actually received.
NOTE: Records should include time of dispatch and receipt, as well as condition of specimens
upon receipt. An example of an acceptable tracking system is submission of a packing list
(prepared by the client or courier) with each batch of client specimens, which may be checkedagainst the specimens received by the laboratory. Some laboratory tests (e.g. coagulation
assays) have limitations on time and temperature conditions between collection and analysis.
This requirement applies to couriers/transportation systems that are within the laboratoryorganization or are contracted by it. It does not apply to couriers unrelated to the laboratory.
Evidence of Compliance:✓
Specimen shipping/transport logs AND✓
Records of follow up for specimens not received
GEN.40535

Specimen Transport QM

Phase I

There is a process for monitoring the quality of submitted specimens, correcting
problems identified in specimen transportation, and improving performance of clients orsites that frequently submit specimens improperly.
Evidence of Compliance:✓
Records of corrective action OR communications with clients that frequently submit
specimens incorrectly
GEN.40545

Newborn Screening Specimen Tracking

Phase I

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For specimens being submitted to a remote testing laboratory for newborn screening
for congenital disorders, there is a tracking system and records to ensure that all
specimens are submitted in compliance with timing requirements and that a result orother appropriate notification is received indicating that the specimens were actually
received.
NOTE: Tracking records should include time of dispatch and condition of specimens upon
submission. An example of an acceptable tracking system is the use of a packing list (preparedby the submitting site or courier) with each batch of specimens that is checked against the
specimens received by the remote testing laboratory. Newborn screening laboratory specimens
have limitations with time and humidity conditions between collection and analysis. Thisrequirement applies to couriers/transportation systems that are part of the laboratory organizationand to outside courier systems.
Evidence of Compliance:✓
Records showing results/notifications received on all specimens AND✓
Records of follow up for specimens not received at the remote laboratory

REQUISITIONS AND SPECIMEN RECEIPT/HANDLING/PROCESSING
Inspector Instructions:
●
●
●

●

●
●

●

GEN.40700

Sampling of specimen receipt and handling policies and procedures
Sampling of specimen requisitions
Sampling of temperature logs (refrigerator, freezer)

How do you know what date/time a specimen is received in your laboratory? How are
specimens accessioned once received by the laboratory?
What is your course of action regarding verbal orders?
How do you know your specimen containers do not contribute to analyticinterference?
If lost specimens are a recurring problem, further evaluate the laboratory's
investigation of where/how in the process the specimen was lost and the corrective
actions that were implemented

Requisitions

Phase IIAll specimens are accompanied by an adequate requisition.
NOTE: In computerized settings, there may not be a paper requisition that is physically attachedto the specimen container.
REFERENCES
1) Valenstein P, Howanitz PJ. Ordering accuracy: a College of American Pathologists Q-Probes study of 577 institutions. Arch Pathol
2)
3)

GEN.40725

Lab Med. 1995;119:117-122
Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry
accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1241(a)]Requisition Data Entry

Phase II

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Test requisition data elements are entered accurately into the laboratory information orrecord system.
NOTE: Data elements include patient demographic data; the name and location of the individual
or entity ordering the test, as well as other elements needed for the final report (see GEN.41096).
The laboratory must have an ongoing mechanism to ensure the accuracy of manual entries. For
test orders crossing an interface to the LIS, requirements for interface integrity apply.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1241(e)]**REVISED** 07/28/2015
GEN.40750 Requisition Elements

Phase II

The paper or electronic requisition includes all of the following elements, as applicable.
1. Adequate patient identification information (e.g., name, registration number
and location, or a unique confidential specimen code if an alternative audit trail
exists)
2. Patient sex
3. Patient date of birth or age
4. Name and address (if different than the receiving laboratory) of the physician,legally authorized person ordering the test, or name and address of thelaboratory referring the specimen
5. Tests requested
6. Last menstrual period (for gynecologic specimens)
7. Date of specimen collection, and if appropriate, time of collection
8. Source of specimen, when appropriate
9. Clinical information, when appropriate
NOTE: Specimen source may be particularly important for microbiology, surgical pathology,
and cytopathology specimens. Surgical pathology specimens must be labeled and requisitions
prepared in the room where the surgical procedure is performed. The patient's chart or medical
record may be used as the test requisition or authorization.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)3)

GEN.40825

amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1241(c)]Valenstein P, Howanitz PJ. Ordering accuracy: a College of American Pathologists Q-Probes study of 577 institutions. Arch Pathol
Lab Med. 1995;119:117-122
Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry
accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150

Specimen ID

Phase II

There is a system to positively identify all patient specimens, specimen types, andaliquots at all times.
NOTE: Each specimen container must identify the patient uniquely. This may be text-based,
numeric, bar-coded, etc. The form of this system is entirely at the discretion of each laboratory,
so long as all primary collection containers and their aliquots have a unique label which one
can audit back to full particulars of patient identification, collection date, specimen type, etc.
Practical considerations of container size may limit the extent of such details. There must be an
appropriate, consistently applied accessioning system.
REFERENCES
1) Clinical and Laboratory Standards Institute. Laboratory Automation: Bar Codes for Specimen Container Identification; Approvednd ed. CLSI document AUTO02-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2006.
Standard. 2

GEN.40900

Specimen Date Received

Phase II

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The date (and time, if appropriate) that the specimen was received by the laboratory isrecorded.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)

GEN.40930

amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(b)]Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1283(a)(2)]

Authorized Requestor

Phase IThe laboratory has a mechanism to ensure that specimens are analyzed only at therequest of an authorized person.
NOTE: The laboratory must perform tests only at the written or electronic request of an
authorized person. In some US states and other countries, individuals may order some laboratory
tests without a physician's referral (direct-to-consumer testing).
Evidence of Compliance:✓
Written policy requiring test orders by authorized persons, if applicable in the jurisdiction inwhich the laboratory is located
REFERENCES
1) Shulze. Microscope on Washington. Direct-access testing: a state-by-state analysis. Lab Med. 1999;30:371-373
2) Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry
accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150

GEN.40932

Verbal Test Authorization

Phase IIFor laboratories subject to US regulations, the laboratory solicits written or electronic
authorization for verbal orders within 30 days.
NOTE: The laboratory must retain the written authorization or record of efforts made to obtaina written authorization. In a managed office where the staff assistants are not employees of thephysician/clinician, the staff should not sign a test requisition for the physician without some typeof provider services agreement. This agreement must specify how the clinician has accepted
responsibility for the tests ordered from the off-site laboratory. (This situation is different from thehospital environment, where the physician has personally signed the order sheet.)
Evidence of Compliance:✓
Records of follow-up to obtain written order
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)3)

GEN.40935

amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1241(a),1241(b)]Shulze. Microscope on Washington. Direct-access testing: a state-by-state analysis. Lab Med. 1999;30:371-373
Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry
accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150

Test Order Read Back

Phase II

The laboratory has a policy that personnel receiving verbal or phone orders read back theentire order to verify accuracy of transcription.
GEN.40938

Unclear Test Order

Phase IThe laboratory has a policy on confirmation of test orders that may be unclear (e.g. orders
using non-standard or non-specific terms).
**REVISED** 07/28/2015
GEN.40942 Specimen Container Analytic Interference

Phase II

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The laboratory director or designee evaluates significant changes to specimen containers
to ensure that they do not contribute to analytic interference in the assays to be
performed and approves them for use.
NOTE: Significant changes include new container types, a different container type (e.g. a plain
container to one with an additive), and when changing to a different vendor. To ensure that the
specimen containers do not contribute to analytic interference, the laboratory director or designee
must review clinical literature, as available, and evaluate information from specimen collection
container and instrument/method manufacturers. Based on the information reviewed and the test
systems that will be impacted, the laboratory director or designee determines whether verificationby the laboratory is indicated.
Manufacturers of collection containers must perform studies to demonstrate safety and efficacyof the product prior to marketing their products. However, it is not feasible for manufacturers
to evaluate all assays on all instrument and methods. The CLSI Guideline GP34-A, Validation
and Verification of Tubes for Venous and Capillary Blood Specimen Collection, recommends
performing a comparative tube evaluation when changing to a different type of tube (e.g. gel,additive, different vendor). A sample protocol for end user evaluation is provided in the CLSI
guideline.
Evidence of Compliance:✓
Records of specimen container evaluation for analytic interference with approval for use
REFERENCES
1) Herr RD, Swanson RT. Pseudometabolic acidosis caused by underfill of Vacutainer tubes. Ann Emerg Med. 1992;21:177-180
2) Pewarchuk W, et al. Pseudopolycythemia, pseudothrombocytopenia, and pseudoleukopenia due to overfilling of blood collection
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)

GEN.41017

tubes. Arch Pathol Lab Med. 1992;116:90-92
Bartlett WA, et al. Vacutainer system can lead to inaccurate results. Brit Med J. 1993;307:868
Banfi G. State of the art of preanalysis in laboratories in Italy performing endocrinologic tests. Eur J Clin Chem Clin Biochem.
1995;33:99-101
Bonini PA, et al. "La fase preanalitica" bibliografia. Biochem Clin. 1995;19:206-216
Newman RS, Fagin AR. Heparin contamination in coagulation testing and a protocol to avoid it and the risk of inappropriate FFPtransfusion. Am J Clin Pathol. 1995;104:447-449
Kallner A. Preanalytical procedures in the measurement of ionized calcium in serum and plasma. Eur J Clin Chem Clin Biochem.
1996;34:53-58
Farkas DH, et al. Specimen collection and storage for diagnostic molecular pathology investigation. Arch Pathol Lab Med.
1996;120:591-596
Wenk RE. Disposables as sources of preanalytical contamination and misdiagnosis. Am J Clin Pathol. 1997;107:395-397
Dasgupta A, et al. Stability of therapeutic drug measurement in specimens collected in Vacutainer plastic blood-collection tubes. Ther
Drug Monit. 1996;18:306-309
Li W, et al. Adsorption of tricyclic antidepressants to arylic and polyester separator gels in blood collection tubes. Clin Chem.
1996;42:S224
Sampson M, et al. Positive interference in lithium determinations from clot activator in collection container. Clin Chem.
1997;43:675-679
Yared M, et al. Time dependent absorption of drugs by the barrier gel of the Greiner Vacuette blood collection tubes: impact on
therapeutic drug monitoring. Am J Clin Pathol. 2000;114:302
Frank E, et al. Effects of anticoagulants and collection containers on aluminum, copper, and zinc results. Am J Clin Pathol.
2000;114:313
Gaillard C, Strauss F. Eliminating DNA loss and denaturation during storage in plastic microtubes. Am Clin Lab. 2001:20(2);52-54
Salem RO, et al. Effect of specimen anticoagulant and storage on measurement of serum and plasma fatty acid ethyl ester
concentrations. Clin Chem. 2001;47:126-127
Kessler HH, et al. Effects of storage and types of blood collection tubes on hepatitis C virus level in whole blood samples. J Clin
Microbiol. 2001;39:1788-1790
Hashim IA. Blood samples collected in serum-separator tubes give higher free tri-iodothyronine levels using the Immulite assay. Clin
Chem. 2001;47(suppl):A14
Clinical and Laboratory Standards Institute (CLSI). Validation and Verification of Tubes for Venous and Capillary Blood Specimen
Collection; Approved Guideline. CLSI document GP34-A (ISBN 1-56238-739-1). Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2010.

Centrifuge Operating Speeds

Phase II

The operating speeds of centrifuges are checked at least annually as needed for theintended use, and this is done in a safe manner.
NOTE: For centrifuges having a safety mechanism preventing the opening of the lid while inoperation, the checks of rpm should be performed only by an authorized service representative of
the manufacturer or an appropriately trained clinical engineer.

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Evidence of Compliance:✓
Records of verification of operating speeds at least annually
REFERENCES
1) Clinical and Laboratory Standards Institute. Laboratory Instrument Implementation, Verification, and Maintenance; Approved
Guideline. CLSI Document GP31-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2009.

**REVISED** 08/17/2016
GEN.41042 Refrigerator/Freezer Temperatures

Phase II

Refrigerator/freezer temperatures are checked and recorded daily using a calibrated
thermometer.
NOTE: This checklist requirement applies to refrigerators/freezers containing reagents or patient/client specimens. “Daily” means every day (7 days per week, 52 weeks per year). The laboratory
must define the acceptable temperature ranges for these units. If temperature(s) are found to beoutside of the acceptable range, the laboratory must record appropriate corrective action, which
may include evaluation of contents for adverse effects.
Temperatures may be recorded either manually, or using a recording device or system by: 1)
recording the numerical temperature, or 2) placing a mark on a graph that corresponds to anumerical temperature. If temperatures are recorded manually, the identity of the individual
recording the temperature(s) must be recorded (the initials of the individual are adequate).
If an automated (including remote) temperature monitoring system is used instead of manual
temperature monitoring, laboratory personnel must have ongoing immediate access to thetemperature data, so that appropriate corrective action can be taken if a temperature is outside of
the acceptable range. System records must demonstrate the daily functionality of the system.
If a minimum/maximum thermometer is used to perform continuous monitoring of temperatures
between daily temperature readings or following a laboratory downtime (e.g. laboratory closure
for weekend or holiday), both the low and high temperatures must be recorded. To ensure
correct temperature readings, the minimum/maximum thermometer device must be reset prior tothe monitoring period.
A frost-free freezer may be used to store reagents and controls provided that the function ofthese materials is not compromised. Storage conditions must remain within the specifications of
the manufacturer of the reagent or control. Temperatures may be recorded using a continuous
monitoring system or a maximum/minimum thermometer. Thermal containers within the freezer
may be used.
Patient samples may be stored in frost free freezers only if protected from thawing. The
laboratory must maintain records showing that the temperatures stay within the defined range.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1252(b)(2)]

RESULTS REPORTING AND REFERRAL OF TESTING
The laboratory must provide useful clinical data. Data must be legible, accurate, reported in clearly designatedunits of measurement, and promptly reported to persons authorized by law to receive and use medical
information.
A referral laboratory is any outside location to which the referring laboratory submits specimens or material for
testing [CLSI guideline QMS05-A2]. In the requirements that follow, the phrase "referral laboratory" means an
independent, external enterprise. The phrase "off-site location" is used when part of the testing essential fora final result is performed at a closely affiliated or satellite laboratory. Off-site locations include offices whereimages or data files are reviewed and interpreted with frequency (i.e. recurrent or on a regular basis). The

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addition of an electronic signature to a final report is not off-site laboratory testing, nor is the rendering of aconsultative opinion that does not involve a specimen submitted for testing.

Inspector Instructions:
●
●
●
●

●

●
●

●
●
●

●

GEN.41067

Sampling of reporting policies and procedures
Sampling of paper or electronic laboratory reports
Sampling of referral laboratory's patient reports
Patient confidentiality policies and procedures
How does the laboratory director ensure that the content of laboratory reports
effectively communicates patient test results?
How does the laboratory protect patient information?
What is your course of action if laboratory testing is delayed? How frequently does
this occur?
What is your process for selecting referral laboratories?
How does your laboratory determine who is authorized to receive results?
How does your laboratory archive test results for comparison with later results?
If instances of delayed test reporting are frequent, further evaluate laboratory director
leadership's investigation, corrective actions, and resolution

Content/Format Report Review

Phase IAn individual meeting CAP laboratory director qualifications reviews and approves thecontent and format of paper and electronic patient reports at least every two years.
NOTE: The laboratory director (or a designee who meets CAP qualifications for laboratory
director) must review and, at least every two years, approve the content and format of laboratory
patient reports (whether paper or computer screen images) to ensure that they effectively
communicate patient test results, and that they meet the needs of the medical staff. Further
details on review of electronic reports are given in GEN.48500.
GEN.41077

Reporting Outside Results

Phase I

There is a policy for laboratory director input regarding whether outside laboratory results
are reported through the primary reporting system (i.e. the laboratory information systemor the institution's electronic medical record).
NOTE: At times patients may bring test results from outside laboratories to their physicians.
Patients' physicians may request, or institutional policy may dictate, that such results (or othertest results from outside laboratories) be integrated into the laboratory's primary reporting
system (i.e. the LIS or the institution's electronic medical record). The laboratory director should
be aware of whether results from outside laboratories are reported through the laboratory
information system or the electronic medical record system. It is recognized that the laboratory
director may not be in a position to prohibit entry of outside laboratory results into the electronic
medical record system.
However, if such results are integrated, the name and address of the outside laboratory must be
available in the primary reporting system, and there must be an indication available to the person
viewing such results that the results originated from an outside laboratory. Criteria for inclusionof such results might include whether the quality of the outside laboratory has been evaluated by39 of 129
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the laboratory director; CLIA licensure or equivalent; whether reference ranges and/or units ofmeasurement differ from in-house tests; whether units of measurement and reference range areincluded; and possession of an official report.
If the laboratory director believes that certain test results should not be integrated into the primary
reporting system, one option is to include such results in a section of the electronic medical
record other than the laboratory database.
**REVISED** 07/28/2015
GEN.41096 Report Elements

Phase II

The paper or electronic report includes the following elements.
1. Name and address of testing laboratory (see note below)
2. Patient name and identification number, or unique patient identifier
3. Name of physician of record, or legally authorized person ordering test, as
appropriate
4. Date of specimen collection, and if appropriate, time of collection
5. Date of release of report (if not on the report, this information should be readily
accessible)
6. Time of release of report, if applicable (if not on the report, this information
should be readily accessible)
7. Specimen source, when applicable
8. Test result(s) (and units of measurement, when applicable)
9. Reference intervals, as applicable
10. Conditions of specimen that may limit adequacy of testing
NOTE: All of the above data elements, as applicable, must be available in the laboratory
information system or in paper records, and must be in the report that is available/sent to theclinician, whether electronic or paper, including electronic reports in systems interfaced to
the laboratory information system directly or through middleware or an interface engine. (Forelectronic reports, data elements need not all be present on one screen, but must be readily
available.)
The paper or electronic report must include the name and address of referral laboratories where
patient testing was performed. For laboratories subject to US regulations, a “referral laboratory”
includes outside referral laboratories as well as any affiliated or special function laboratory that is
separately accredited and has a different CLIA registration number than the referring laboratory.
For electronic reports, the name and address of referral laboratories need not all be present on
the same screen(s) as the results but must be available to the clinician in the information system.
Under some circumstances it may be appropriate to distribute lists or tables of reference intervals
to all users and sites where reports are received. This system is usually fraught with difficulties,
but if in place and rigidly controlled, it is acceptable.
Patient reports must state the name of the physician (or other legally authorized person) ordering
the test(s) or a physician of record. In those institutions where there are multiple ordering
physicians and/or frequent changing of attending physicians, the ordering physician should be
easily identifiable through a computer audit trail or other records of the test order.
Referral laboratories accredited by the CAP must provide a copy of the results to the referringlaboratory (Exceptions to this requirement may be made under special circumstances or for
special categories of testing, such as drugs of abuse or employee drug testing. The laboratory
director may make these exceptions.). Results may be reported to the ordering physician ofrecord (or other legally authorized person) by either the referral laboratory or the referringlaboratory.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments
2)of 1988; final rule. Fed Register. 2003(Jan 24):3713 [42CFR493.1291(c)]Grasbeck R, Alstrom T, eds. Reference values in laboratory medicine. The current state of the art. New York: Wiley, 1981

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3)
4)
5)
6)
7)

GEN.41300

08.17.2016

Statland BE. Clinical decision levels for lab tests. Oradell, NJ: Medical Economics Books
Rochman H. Clinical pathology in the elderly. New York: Karger, 1988:207216
Tietz NW, ed. Clinical guide to laboratory tests. Philadelphia: WB Saunders, 1990
Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory- Approved Guideline- Third Edition - CLSI Document EP28-A3c. (ISBN 1-56238-682-4) Clinical and Laboratory Standards Institute,
940 West Valley Road, Suite 2500, Wayne, PA, 19087-1898, USA, 2010.
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(h)(i)(3)] and [42CFR493.1283(a)(1)]

Report Retention and Retrieval

Phase II

Copies or files of reports are legible and retained by the laboratory in a manner that
permits prompt retrieval of the information.
NOTE: The length of time that reported data are retained in the laboratory may vary; however,
the reported results must be retained for that period encompassing a high frequency of requests
for the data. In all circumstances, a hospital laboratory must have access to the patient's chart
where the information is permanently retained.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments
2)of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(b)]Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7163 [42CFR493.1291(j)]**REVISED** 07/28/2015
GEN.41303 Patient Confidentiality

Phase II

The laboratory ensures that internal and external storage and transfer of data maintains
patient confidentiality and security.
NOTE: Written procedures must address patient confidentially during transfer of data to externalreferral laboratories or other service providers. This must include cloud based computing (e.g. forstorage of confidential data), as appropriate
The laboratory must audit compliance with the procedures at least annually.
Evidence of Compliance:✓
Records of patient privacy audit for compliance with the Health Insurance Portability andAccountability Act (HIPAA)
REFERENCES
1) Title 45 – Code of Federal Regulations – Parts 160, 162, and 164, Health Insurance Reform: Security Standards; Final Rule, Federal
Register, Published Feb. 20, 2003.

**REVISED** 07/28/2015
GEN.41304 Patient Data Accessibility

Phase II

There is a written policy to ensure that patient data are accessible in a timely manner only
to those individuals who are authorized to review test results.
NOTE: Only those healthcare personnel authorized to review a patient's test results should haveaccess to those results. Laboratories subject to US regulations must provide final test results
to the patient or the patient's personal representative upon request. For completed tests, theseresults must generally be provided no later than 30 days after such a request.
Under the HIPAA Privacy Rule, only the patient or a personal representative, defined as anindividual who has authority under applicable law to make health care decisions for the patient,can be given access to a patient's personal health data. Laboratories must take reasonable steps
to verify the identity of the patient and the authority of a personal representative to have accessto an individual's protected health information. The Rule also allows for the release of test reports
to authorized persons responsible for using the test reports and to the laboratory that initiallyrequested the test, if applicable.

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For additional information see Department of Health and Human Services, Medicare andMedicaid Services, "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports;
Final Rule." Fed Reg 79:7290 (2014); 45CFR164.502(g); 45CFR164.514.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2014(Feb 6):7289 [42CFR493.1291(l)]**REVISED** 08/17/2016
GEN.41306 Analyst Tracking ID

Phase II

There is a system whereby the identity of the analyst performing or completing the test
and the date of the test can always be established.
NOTE: If results are released using autoverification, the system must be capable of identifying
those test results that have been autoverified. In addition, the laboratory should be able toidentify the technologist responsible for the instrument producing the result, such as through daily
bench assignment charts, instrument set-up logs, or electronic audit trail.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)

GEN.41307

amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1283(a)(4)]Clinical and Laboratory Standards Institute. Autoverification of Clinical Laboratory Test Results; Approved Guideline. CLSI document
AUTO10-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2006.

Report Errors

Phase II

When errors are detected in patient test reports, the laboratory promptly notifies
responsible clinical personnel or referring laboratory as applicable and issues a correctedreport.
NOTE: Notification should include the department of health or other legal entity as required by
local regulations.
Evidence of Compliance:✓
Records of report error notification and corrected report
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2004(Oct 1):1048 [42CFR493.1291(k)]**REVISED** 08/17/2016
GEN.41310 Corrected Report

Phase II

All corrected reports of previously reported, incorrect patient results are identified ascorrected, and both the corrected and original data are clearly identified as such.
NOTE: 1. As clinical decisions or actions may have been based on the previous report, it isimportant to replicate previous information (test results, interpretations, reference intervals)
for comparison with the corrected information. The previous information and the corrected
information must be identified as such, and the original data must be present in the correctedreport (for paper reports), or linked electronically or logically to the corrected information (inelectronic reports).
2. This requirement applies to electronic reports in the laboratory information system and to
the data systems interfaced to the laboratory information system either directly or throughmiddleware or an interface engine (but not to systems that are further downstream in theinterface chain).
3. Displays in an electronic medical record (EMR) downstream from the laboratory should include
the original report as well as the corrected report. The report elements listed in GEN.41096
should be included in the EMR.

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4. The correction should add explanatory language if an explanation would be helpful to the user.
For example, a comment about transport or sample storage conditions uncovered post-analysis
can help frame an original, invalid result.
5. For changes to anatomic pathology and cytopathology reports, refer to ANP.12185 andCYP.06475.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(k)(3)]

GEN.41312

Multiple Corrections

Phase II

When there are multiple sequential corrections of a single test result, all corrections arereferenced in sequential order on subsequent reports.
NOTE: When there are multiple sequential corrections of a previously reported result, it isconsidered inappropriate to note only the last correction made, as the clinician may have madea clinical decision based upon erroneous data rather than the "true" result. All corrections should
be referenced in the patient report.
GEN.41316

Infectious Disease Reporting

Phase II

There is a policy regarding the timely communication, and documentation thereof, ofdiagnoses of infectious diseases of particular significance (e.g. human immunodeficiency
virus and tuberculosis).
NOTE: The laboratory should have a policy to ensure that diagnoses of humanimmunodeficiency virus infection and other serious infections (for example, tuberculosis) arecommunicated to the responsible clinician in a timely manner.
The intent of this checklist item is NOT to require that these diagnoses be treated as criticalresults (this decision is up to the laboratory director); rather, the intent is that the laboratory
assures that its reporting system is effective.
GEN.41325

Newborn Screening Results

Phase II

There must be a procedure for handling invalid and positive newborn screening results
for samples submitted to other laboratories for testing.
NOTE: This requirement applies to the testing of whole blood heel stick samples from thenewborn after birth on filter paper collection devices for the routine screening of congenital
disorders. Positive results include those results that are outside of the expected range oftesting results established for a particular condition. Invalid results include situations where
the laboratory is unable to complete the screening process due to an unsuitable specimen,
test, or incomplete information. Due to the urgent nature of newborn screening test results,
procedures must include a process to track requests for repeat testing so that repeat specimens
are submitted within the follow-up/recollection timeframe specified by the testing laboratory.
REFERENCES
1) Clinical and Laboratory Standards Institute. Newborn Screening Follow-up. CLSI document NBS02-A2. Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA

GEN.41345

Turnaround Time

Phase II

The laboratory has defined turnaround times (i.e. the interval between specimen receipt
by laboratory personnel and results reporting) for each of its tests, and it has a policy for
notifying the requester when testing is delayed.

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NOTE: This does NOT imply that all instances of delayed reporting for all tests must lead toformal notification of clinical personnel. Rather, clinicians and laboratory must have a jointly
agreed upon policy for when such notification is important for patient care.
Evidence of Compliance:✓
Written policy defining test reporting turnaround time and process for communication ofdelays in turnaround time
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
2)
3)
4)

amendments of 1988; final rule. Fed Register. 2003(Jan 24):7166 [42CFR493.1291(h)]Winkelman JW. How fast is fast enough for clinical laboratory turnaround time? Measurement of the interval between result entry andinquiries for reports. Am J Clin Pathol. 1997;108:400-405
Manor PG. Turnaround times in the laboratory: a review of the literature. Clin Lab Sci. 1999;12(2):85-89
Eggert AA, et al. Using detailed computer tracking to monitor and improve outpatient phlebotomy service and overall test turn-aroundtime. Clin Chem. 2000;46:A71**REVISED** 08/17/2016
GEN.41350 Referral Laboratory Selection

Phase II

The laboratory has a written procedure for the selection and evaluation of laboratories towhich it refers specimens or materials for testing.
NOTE:
1. The laboratory director, in consultation with the institutional medical staff or physician
clients (where appropriate), is responsible for selecting referral laboratories
2. Selection of referral laboratories must be based primarily upon the quality of
performance of such laboratories
3. Specimens or materials for testing include intermediate processing such as histologic
and cytologic processing, preliminary analysis such as flow cytometry, and the useof distributive testing in next-generation sequencing. It also includes the referral ofimages or data files to an off-site location for interpretation.
4. For laboratories subject to US regulations: for tests in disciplines covered by CLIA,
specimens and materials for testing must be referred only to a CLIA-certified
laboratory or a laboratory meeting equivalent requirements as determined by CMS;
this includes off-site locations where images or data files are frequently referred forreview and interpretation. Laboratories that are part of the Department of Defense*
must meet the referral policies of the Clinical Laboratory Improvement Program(CLIP). With respect to patients on research protocols, whose tests are referred to a
research laboratory: if those test results are used for patient management decisions,the research laboratory must be CLIA-certified, or meet equivalent requirements asdetermined by CMS.
5. For disciplines not covered by CLIA (e.g. histology), laboratories subject to US
regulations must refer specimens to a laboratory accredited by CAP or a CAPaccepted organization.*
6. For non-US laboratories, whenever possible, specimens and materials for testingshould be referred to a laboratory accredited by CAP; accredited to an establishedinternational standard from a recognized organization; or certified by an appropriate
government agency. The inspector may need to exercise judgment with respect todetermining if a referral laboratory is acceptable.
7. It is the responsibility of the laboratory director or designee to monitor the turnaroundtime and quality of test results received from referral laboratories.
*For overseas US military laboratories only, an exception to this requirement is acceptable if bothof the following conditions are met:
1. Rapid turnaround time (TAT) is required to prevent either a delay in patient
treatment/diagnosis or specimen degradation, and an acceptable TAT cannot beprovided by a CAP-accredited or CLIA-certified laboratory.

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2. The laboratory director has determined that the alternative testing site meetsrequirements that are equivalent to those of a CLIP or CLIA-certified laboratory as
stipulated in the CLIP/CLIA Manual (11-32(8)c). This assessment must be recorded.
Evidence of Compliance:✓
Records of the monitoring of referral laboratory services (e.g. problem log, review of reports)
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
2)
3)
4)
5)
6)

GEN.41430

amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(c)]Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Qualifying, Selecting and Evaluating a Referral
Laboratory Approved Guideline—Second Edition. CLSI document QMS05-A2 (ISBN I-56238-855-X [Print], ISBN I-56238- 856- 8[Electronic]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2012.
Caro B. Department dollars. Planning a referral testing service program. Advance/Lab. 1999;8(4):22-24
Brooks B. Cost considerations of esoteric testing. Advance/Lab. 1999:8(6):59-68
Carter JE, Bennett B. Laboratory "send out" test review by pathology house staff: cost-cutting strategy. Am J Clin Pathol.
1999;112:572
Department of Defense instructions 6440.2, Clinical Laboratory Improvement Program, April 20, 1994.

Referral Laboratory Report Retention

Phase IIFor samples referred to another laboratory, the original or an exact copy of the testinglaboratory's report is retained by the referring laboratory.
NOTE: The report may be retained on paper or in electronic format. Exceptions to thisrequirement may be made under special circumstances or for special categories, such as drugsof abuse or employee drug testing. The laboratory director may make these exceptions.
Evidence of Compliance:✓
Retained original referral laboratory reports OR direct access to referral laboratory reports via
electronic transmission from the referral laboratory
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(h)(i)(2)]

GEN.41440

Referral Laboratory Results Reporting

Phase II

The essential elements of referred test results are reported by the referring laboratory
as received from the referral laboratory, without alterations that could affect clinicalinterpretation.
NOTE: If the laboratory transcribes results from the referral laboratory report, the test result(s),interpretation, and information directly related to the interpretation must be copied as reported by
the referral laboratory This does not mandate that the referring laboratory report every word nor
retain the exact format of the referral laboratory report. There is no requirement to fully replicate
the complete content of the referral laboratory report beyond the results and interpretation.
Suggestions for follow-up testing may, for example, be omitted at the discretion of the laboratory
director.
Evidence of Compliance:✓
Patient results from the referral laboratory consistent with laboratory-issued patient reports
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7163 [42CFR493.1291(h)(i)(1)]

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DIRECT-TO-CONSUMER TESTING
NOTE: Direct-to-consumer (DTC) tests are defined as tests that are requested or ordered by the consumer.
All applicable requirements in other areas of the checklists apply to direct-to-consumer testing. This checklist
section applies only to laboratories subject to US regulations. This checklist section does not apply to healthfairs.

Inspector Instructions:●●GEN.41460

Direct-to-consumer testing policies and procedures
Sampling of direct-to-consumer laboratory reports

DTC Jurisdiction

Phase II

The laboratory performs DTC testing and reports results of DTC tests only in jurisdictions
where such testing is lawful.
NOTE: No less than every two years, the laboratory must verify which jurisdictions permit DTC
testing if it provides direct-to-consumer testing.
Evidence of Compliance:✓
Record that the laboratory has reviewed applicable laws/regulations
GEN.41475

DTC Report

Phase II

The test report includes test results, reference range, interpretation as applicable, andlimitations of the test, as applicable, in language readily understandable by a lay person.
GEN.41485

DTC Report

Phase II

The test report includes information that enables the consumer to contact a licensed
heath care professional about the clinical significance of the test result.
NOTE: This information may consist of the name, phone number, and email address of a healthcare professional. Alternatively, it may be the phone number of an office at the laboratory or
medical center that can provide contact information to the consumer.
The practitioner or designee should be reasonably available during normal business hours.
GEN.41497

DTC Result Retention

Phase II

The laboratory retains the results of DTC tests and reference ranges for at least 10 years
after testing.
NOTE: This requirement applies only to DTC tests performed after June 15, 2009.

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QUALITY OF WATER AND GLASSWARE WASHING
Inspector Instructions:●●●GEN.41500

Water quality policies and procedures
Water quality test records

How does your laboratory clean glassware?

Defined Water Types

Phase II

The laboratory defines the specific type of water required for each of its testingprocedures and water quality is tested at least annually.
NOTE: The laboratory should define the type of water necessary for each of its procedures,and should have an adequate supply of same. The current edition of CLSI Guideline GP40A4-AMD defines the following grades of water: Clinical Laboratory Reagent Water (CLRW),
suitable for most laboratory procedures; Special Reagent Water (SRW), defined by a laboratory
for procedures that need different specifications than CLRW; Instrument Feed Water, specified
by IVD manufacturers as suitable for use with their measurement systems; and Commercially
Bottled Purified Water that may be suitable for certain laboratory procedures.
CLRW is not required if the laboratory is able to record reliable results with an alternate grade ofwater.
The following specification for CLRW is adapted from this guideline and should be met at time of
in-house production:
Bacteria may inactivate reagents, contribute to total organic contamination, or alter opticalproperties of test solutions. Resistivity provides a nonspecific measure of the ion content.
Particulate matter includes organic carbon from biofilms and inorganic aggregates that can varyover time both in nature of the contamination and the effect on the laboratory use.
The CLSI Guideline provides testing information for microbial content, and resistivity, as well as
total organic carbon; earlier specifications for silicates have been removed. It gives instructions
for the preparation of the various types of water. It also addresses the use of purchased water,
the effects of storing water, and the monitoring of stored water.
The quality (specifications) of the laboratory's water, whether prepared in-house or purchased,must be checked and recorded at least annually. The frequency and extent of checking mayvary, according to the quality of source water and specific laboratory needs. Corrective action
must be recorded if water does not meet acceptability criteria.
For CLRW, minimum monitoring includes resistivity and microbiology cultures. Other criteria,such as pH, endotoxin/pyrogens, silicates and organic contaminants are at the discretion of thelaboratory, testing for these substances must be recorded only if the laboratory finds that they
adversely affect specific test methods.
The laboratory must determine the level of testing necessary for other grades of water in use.

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Typically, "sterile (pharmaceutical) water" is not manufactured to meet the specifications of
CLRW, and should not be used as its equivalent.
For commercial instrument-reagent systems, the laboratory must use a specific type of water
recommended by the manufacturer. Although routine commercial methods are typically designed
to work with laboratory reagent grade water, higher-quality water systems exist and may berequired for specific methods or if analytical imprecision or inaccuracy has been traced to thequality of in-lab water.
CLRW
Maximum microbial content (CFU/mL)

10

Minimum resistivity (megohm-cm)

10 (in-line)

Particulate matter

0.22 um filter

Evidence of Compliance:✓
Record of corrective action when water quality does not meet specifications
REFERENCES
1) Gabler R, et al. Degradation of high-purity water on storage. J Liquid Chromatogr. 1983;6:2565-2570
2) Mather J, et al. The effects of water purity and addition of common water contaminants on the growth of cells in serum-free media.
3)
4)
5)
6)

BioTechniques. 1986;4:56-63
Gould MJ. Evaluation of microbial/endotoxin contamination using the LAI test. Ultrapure Water. 1993;10:43-47
Huang YH, et al. Comparison of Milli-Q PF Plus water to DEPC-treated water in the preparation and analysis of RNA. BioTechniques.
1995;19:656-661
Paul DH. Ion exchange primer. Ultrapure Water. 1997;14:63-66
Clinical and Laboratory Standards Institute. Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved

th

7)
8)

GEN.41770

Guideline. 4 ed. CLSI document GP40-A4-AMD. Clinical and Laboratory Standards Institute, Wayne, PA, 2012.
Srikanth B. Ultraviolet light: recent advancements in UV technology yield enhanced TOC reduction performance. Ultrapure Water.
1998;15:40-46
Stewart BM. The production of high-purity water in the clinical laboratory. Lab Med. 2000;31:605-611

Glassware Cleaning

Phase II

There are written procedures for handling and cleaning glassware, including methods fortesting for detergent removal.
NOTE: Special instructions for micropipettes, cuvets, acid washing, etc. must be included.
A simple procedure to check for detergent residue uses bromcresol purple (0.1 g bromcresol
purple in 50 mL ethyl alcohol). Pipette approximately 5 cm (2 inches) distilled water into a
representative, washed, glassware item. Add two to three drops bromcresol solution. A purple
color reveals residual detergent. A yellow color indicates satisfactory rinsing.
Evidence of Compliance:✓
Records of detergent residue testing
REFERENCES
1) Clinical and Laboratory Standards Institute. Laboratory Instrument Implementation, Verification, and Maintenance; Approved
Guideline. CLSI Document GP31-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2009.

LABORATORY COMPUTER SERVICES
Multiple solutions for laboratory information systems (LIS) exist. Traditional systems have a local “host”
database (i.e. the computer hardware and software) serving the information needs of the laboratory; thelaboratory is the only “user.” In the current environment, the host is often physically remote from the laboratory
and in fact the host may have multiple user laboratories. Many of the Computer Services requirements
may apply to host, user, or both, depending on how information services are organized in the laboratory.
The laboratory is responsible for ensuring that the provider of host functions meets CAP requirements (seeGEN.42195, below).

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The requirements in this section do NOT apply to the following:
1. Desktop calculators
2. Small programmable technical computers
3. Purchased services such as the Quality Assurance Service or Laboratory Management Index
Service of the College of American Pathologists
4. Micro computers used solely for word processing, spreadsheets, or similar single user functions
5. Dedicated microprocessors or workstations that are an integral part of an analytic instrument

Inspector Instructions:●GEN.42195

CAP accreditation certificate of remote site or records that the host site is incompliance with this section of the checklist

Remote LIS

Phase II

If components of the LIS are located at a facility other than the one under this CAP
accreditation number, there is evidence that the remote facility complies with CAP
requirements for host LIS functions.
NOTE: This requirement does not apply if all components of the LIS are under the laboratory's
CAP number. This requirement may be addressed by a copy of the CAP accreditation certificate
from other sites, or evidence that the computer facility has been provided a copy of this Checklist,
and has satisfactorily addressed the contents of the Computer Facility section, and all otherpertinent requirements, with records provided to the laboratory director and the CAP inspector.

COMPUTER FACILITY
This section applies to laboratories where the computer facilities are housed.

Inspector Instructions:●●GEN.42750

Computer facility equipment and location (clean, ventilated, protected against power
surges)Fire extinguishers/equipment

Computer Facility MaintenancePhase IThe computer facility and equipment are clean, well-maintained and adequately ventilatedwith appropriate environmental control.
NOTE: The computer facilities should be clean, well maintained and in a location that isenvironmentally controlled, as required by the most restrictive vendor specifications.
GEN.42800

LIS Fire Equipment

Phase II

Fire-fighting equipment (extinguishers) is appropriate for electrical components available.

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NOTE: Acceptable fire-fighting equipment/extinguishers in areas with information technology
equipment may include:
1.
2.
3.
4.

Automatic sprinkler systems that are valved separately from other systems
Gaseous clean agent extinguishers systems
Listed portable fire extinguishers of carbon dioxide or halogenated agent type
Listed extinguishers with a minimum rating of 2-A for ordinary combustible material(paper and/or plastics)
5. Gaseous agent inside units or total flooding systems when there is critical need, e.g.
to protect data in process, reduce equipment damage and to facilitate a return toserviceDry chemical extinguishers are not recommended because of the corrosive damage theycause. In the instance where no other extinguisher is available and there is imminent danger topersonnel or property however, a dry extinguisher may be used.
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204
2) National Fire Protection Association Standard 75: Protection of Information Technology Equipment, 2013 edition. Chapter 8.
3) Occupational Safety and Health Administration. Portable fire extinguishers. Hydrostatic testing. Washington, DC: US Government
Printing Office, 2002(Jul 1): [29CFR1910.157(f)]GEN.42900

LIS Power

Phase II

The computer system is adequately protected against electrical power interruptions andsurges.
NOTE: Protection from electrical surges and interruptions must be adequate to prevent lossof data. An uninterruptible power system (UPS) or similar protective device (e.g. isolationtransformer) must be considered. Periodic testing of this protective equipment to ensure
protection of data and proper shutdown of computer equipment is considered best practice.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1252(b)(4)]

HARDWARE AND SOFTWARE
Inspector Instructions:●

Sampling of computer training records●

How does your laboratory verify the LIS following a hardware or software failure?
Who do you notify when there is a computer malfunction?

●

GEN.43022

LIS Testing

Phase II

There are records that programs are adequately tested for proper functioning when first
installed and after any modifications, and that the laboratory director or designee has
approved the use of all new programs and modifications.

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NOTE: Computer programs must be checked for proper performance when first installed
and after any changes or modifications. Any changes or modifications to the system must berecorded, and the laboratory director or designee must approve all changes, additions anddeletions in programs, the test library, and major computer functions before they are released.
Records must be retained for at least two years beyond the service life of the system.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information System: Approved Guideline.
CLSI document AUTO8-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006.

**REVISED** 07/28/2015
GEN.43033 Custom LIS

Phase I

Customized software, and modifications to that software, are appropriately documented
and records allow for tracking to identify persons that have added or modified thatsoftware.
NOTE: The purpose of the computer program, the way it functions, and its interaction with otherprograms must be clearly stated. The level of detail should be adequate to support troubleshooting, system modifications, or additional programming.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information System: Approved Guideline.
CLSI document AUTO8-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006.

**NEW** 07/28/2015
GEN.43040 LIS Policy and Procedure Approval

Phase II

The laboratory director or designee reviews and approves all new LIS policies andprocedures, as well as substantial changes to existing documents before implementation.
NOTE: Procedures should be appropriate to the level of use of the system, and must encompass
the day-to-day activities of the laboratory staff as well as the daily operations of the Information
Technology staff.
**REVISED** 07/28/2015
GEN.43055 Computer System Training

Phase II

There are records for training of all users of the computer system initially, after systemmodification, and after installation of a new system.
NOTE: Review of LIS policies and procedures relevant to the scope of duties must be
incorporated into the training.
GEN.43066Computer Malfunction Notification

Phase II

There is a written procedure with instructions for contacting a responsible person (e.g.
Computer System Manager) in case of computer malfunction.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
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SYSTEM SECURITY
The following requirements concern unauthorized users. If a system is vulnerable, steps should be taken toprevent unauthorized access.

Inspector Instructions:●GEN.43150

Sampling of computer security policies and procedures

Access Patient Data

Phase II

There are explicit written policies that specify who may use the computer system to enteror access patient data, change results, change billing or alter programs.
NOTE: Policies must define those who may only access patient data and users who are
authorized to enter patient results, change results, change billing, or alter computer tables orprograms. If data in other computer systems can be accessed through the LIS (e.g. pharmacy or
medical records), policies must prevent unauthorized access to the data through the LIS.
REFERENCES
1) Clinical and Laboratory Standards Institute. Information Technology Security of in vitro Diagnostic Instruments and Softwarend ed. CLSI document AUTO11-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2014.
Systems; Approved Standard. 2

GEN.43200

Computer Access Codes

Phase II

Computer access codes (security codes, user codes) are in place to confine individuals'
access to those functions they are authorized to use, and the security of access codes ismaintained (e.g. inactivated when employees leave, not posted on terminals).
NOTE: The laboratory should establish security (user) codes to permit only specificallyauthorized individuals to access patient data or alter programs. A system that allows different
levels of user access to the system based on the user's authorization is desirable and usuallyprovides effective security. Examples of best practices include: periodic alteration of passwords
by users; minimum character length for passwords; password complexity requirements (e.g. a
combination of alphanumeric characters); recording of failed log-on attempts with user lock-out
after a defined number of unsuccessful log-on attempts.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information System: Approved Guideline.
2)

CLSI document AUTO8-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006.
Clinical and Laboratory Standards Institute. Information Technology Security of in vitro Diagnostic Instruments and Softwarend ed. CLSI document AUTO11-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2014.

Systems; Approved Standard. 2

GEN.43262

Unauthorized Software Installation

Phase I

There are written policies and procedures that govern installation of software on any
computer used by the laboratory.
NOTE: Laboratory computers often serve multiple functions. Many of these computers areconnected in a network. The security of the system should be sufficient to prevent the casual52 of 129
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user from installing software. Such unauthorized installation may cause instability of theoperating system or introduce other unwanted consequences. Many operating systems allow
procedures to restrict certain users from installing software.
REFERENCES
1) Clinical and Laboratory Standards Institute. Information Technology Security of in vitro Diagnostic Instruments and Softwarend ed. CLSI document AUTO11-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2014.
Systems; Approved Standard. 2**REVISED** 07/28/2015
GEN.43325 Public Network Security

Phase IIIf the facility uses a public network, such as the Internet as a data exchange medium,
there are network security measures in place to ensure confidentiality of patient data.
NOTE: Information sent over a public domain such as the Internet or stored in "the cloud," isconsidered in the public domain. Thus it is potentially accessible to all parties on that network.
Systems must be in place to protect network traffic, such as "fire walls" and data encryption
schemes.
Evidence of Compliance:✓
Written policy defining mechanism for data protection
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information System: Approved Guideline.
2)

CLSI document AUTO8-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006.
Clinical and Laboratory Standards Institute. Information Technology Security of in vitro Diagnostic Instruments and Softwarend ed. CLSI document AUTO11-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2014.

Systems; Approved Standard. 2

PATIENT DATA
Inspector Instructions:●

Records of the review of patient results containing calculated data●

How are absurd values detected?
How does the technologist electronically enter comments regarding specimen
quality?
How does your laboratory verify manual and automated result entry?

●●

GEN.43450

Calculated Patient Data Verification

Phase II

Calculated values reported with patient results are reviewed every two years or when asystem change is made that may affect the calculations.
NOTE: This checklist requirement applies only to calculations based on formulas modifiable by
the user.
Errors can be inadvertently introduced into established computer programs. Calculations
involving reportable patient results must be rechecked to ensure accuracy and records retained.
This requirement applies to laboratory information systems, middleware, and analyzers. Morefrequent checks may be required for certain specific calculations, as delineated elsewhere in the
checklists (e.g. INR).

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When calculations are performed by an LIS shared by multiple laboratories, this review only
needs to be done at one location and each individual laboratory must have access to a copy of
the review records. However, any calculations specific to an individual laboratory's methodology
must be reviewed by that laboratory and the record of that review must be available.
Evidence of Compliance:✓
Records of validation of calculated test results
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(a)]GEN.43750

Specimen Quality Comment

Phase II

The system provides for comments on specimen quality that might compromise theaccuracy of analytic results (e.g. hemolyzed, lipemic).
Evidence of Compliance:✓
Patient reports
GEN.43800

Data Input ID

Phase II

There is an adequate system to identify all individuals who have entered and/or modified
patient data or control files.
NOTE: When individual tests from a single test order (e.g. multiple tests with same accession
number) are performed by separate individuals and the test result is entered into the LIS,
the system must provide an audit trail to record each person involved. For example, a single
accession number having orders for electrolytes and a lipid panel may have testing done by two
or more individuals. The laboratory should be able to identify the responsible personnel who
performed each test and posted the data. This includes sequential corrections made to a single
test result. If autoverification is used, then the audit trail should reflect that the result was verified
automatically at a given time.
With point-of-care testing, if the individual performing the test is different than the individual
entering test data into the LIS, both should be uniquely identified by the system and retrievableby audit trail.
REFERENCES
1) Jones JB. The importance of integrating POCT data into an organized database. Advance/Laboratory. 1999;8(9):8-10
2) Halpern NA, Brentjens T. Point of care testing informatics. The critical care-hospital interface. Crit Care Med. 1999;15:577-591

GEN.43825

Result Verification

Phase II

Manual and automated result entries are verified before final acceptance and reporting by
the computer.
NOTE: Data entered into the computer system either manually or by automated methods must
be reviewed by an authorized individual who verifies the accuracy of the input data before
final acceptance and reporting by the computer. An example of best practices for this step ischecking the result against the reportable range and critical results for the test. Depending on thelocal environment, this may or may not require a second person. Verification procedures must
generate an audit trail.
This checklist requirement does not apply to autoverification procedures (see below).
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(a)]GEN.43837

Downtime Result Reporting

Phase II

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There are written procedures to ensure reporting of patient results in a prompt and usefulfashion during partial or complete downtime and recovery of the system.
REFERENCES
1) Valenstein P, et al. Laboratory computer availability. A College of American Pathologists Q-Probes study of computer downtime in
422 institutions. Arch Pathol Lab Med. 1996;120:626-632

AUTOVERIFICATION
Autoverification is the process by which patient results are generated from interfaced instruments and sent
to the LIS, where they are compared against laboratory-defined acceptance parameters. If the results fallwithin these defined parameters, the results are automatically released to patient reporting formats without
any additional laboratory staff intervention. Any data that fall outside the defined parameters are reviewed bylaboratory staff prior to reporting.

Inspector Instructions:●●

Autoverification policies and procedures
Autoverification validation records**REVISED** 07/28/2015
GEN.43875 Autoverification Validation

Phase II

There is documentation that the autoverification process was validated initially, and istested at least annually and whenever there is a change to the system that could affect the
autoverification logic.
NOTE: The range of results for which autoverification is acceptable must be defined for all patient
tests subject to autoverification.
Validation of autoverification must include a process to confirm that the autoverification algorithm
decision rules are functioning properly, including the use of previously assayed specimens withresults that challenge the algorithm. Examples of specimens that may be needed to validate
the autoverification algorithm decision rules may include specimens with analyte concentrations
within the normal reference limit, above or below the reference limits, above or below theanalytic measurement range, and in the critical range. Specimens with known interferences andspecimens that require calculations should also be used, when applicable.
When changes are made that might affect the autoverification decision algorithm, validation
appropriate to the scope and nature of the change must be performed.
Evidence of Compliance:✓
Records of autoverification validation studies, including laboratory director approval AND✓
Records of ongoing retesting of the autoverification process at least annually and at changes
to the system
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Autoverification of Clinical Laboratory Test Results: Approved Guideline. CLSI
document AUTO10-A (ISBN 1-56238-620-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2006.

GEN.43878

Autoverification QC Samples

Phase II

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For all test results subject to autoverification, the laboratory ensures that applicablequality control samples have been run within an appropriate time period, with acceptable
results.
NOTE: This requirement may be met by, 1) the computer system automatically checking
quality control status prior to autoverification, or, 2) manually disabling autoverification after any
unacceptable QC result, or when QC has not been run within the required time interval.
Evidence of Compliance:✓
Procedure defining the QC process AND✓
QC data to show that QC was performed at defined intervals**REVISED** 07/28/2015
GEN.43881 Autoverification Results

Phase II

Results are compared with an appropriate range of acceptable values and flags or
warnings reviewed prior to autoverification.
NOTE: Appropriate comparisons include checking patient results against absurd and criticalresults requiring manual intervention (repeat testing, dilution, telephone notification of results,
etc.)
The mere presence of a flag may not disqualify a result from autoverification, but any flag that is
not specifically recognized by the autoverification program must cause the flagged result to beheld for manual review.
Evidence of Compliance:✓
Records of system rules including comparison of patient results against absurd and criticalvaluesGEN.43887

Autoverification Audit Trail

Phase IThe audit trail in the computer system identifies all test results that were autoverified, andthe date/time of autoverification.
GEN.43890

Autoverification Delta Checks

Phase IThe autoverification process includes all delta checks that the laboratory performs prior
to manual release of test results.
NOTE: This requirement does not require delta-checking for all autoverified results, but
the laboratory's delta-checking procedures should be the same for manually released andautoverified test results.
Evidence of Compliance:✓
Records of system rules including the use of delta checks when appropriate
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Fed Register. 2003(Jan 24):
[42CFR493.1281(b)(1-5)]

GEN.43893

Autoverification Suspension

Phase II

The laboratory has a procedure for rapid suspension of autoverification.
NOTE: Laboratory personnel should be able to suspend autoverification in the event of a problem
with a test method, analytic instrument or the autoverification program.

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DATA RETRIEVAL AND PRESERVATION
Inspector Instructions:GEN.43900●

Data preservation policies and procedures●

If there are indications that the computer system is inadequate to meet the patientneeds of the organization, further evaluate laboratory/LIS leadership's responses,
corrective actions, and resolutions

Archived Test Result

Phase II

A complete copy of archived patient test results can be retrieved, including originalreference ranges and interpretive comments, including any flags or footnotes that were
present in the original report, and the date of the original report.
NOTE: Stored patient result data and archival information must be easily and readily retrievable
within a time frame consistent with patient care needs.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments
2)

GEN.43920

of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(b)]Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7163 [42CFR493.1291(j)]Multiple Analyzer ID

Phase I

When multiple identical analyzers are used, they are uniquely identified such that a test
result may be appropriately traced back to the instrument performing the test.
NOTE: Best practice is to store these data in the LIS.
GEN.43946

Data Preservation/Destructive Event

Phase II

There are written procedures for the preservation of data and equipment in case of an
unexpected destructive event (e.g. fire, flood), software failure and/or hardware failure,
and these procedures allow for the timely restoration of service, including data integrity
check.
NOTE: Procedures must 1) be adequate to address scheduled and unscheduled interruptions of
power or function; 2) be tested periodically for effectiveness; and 3) include systems to backup
programs and data.
These procedures can include, but are not limited to, 1) steps to limit the extent of the destructive
event, 2) periodic backing up and storing of information, 3) off-site storage of backup data, and
4) restoring information from backed up media. The procedures should specifically address therecoverability of patient information. Changes to hardware and software commonly require review
and reevaluation of these written procedures. These procedures must specifically address thephysical environment and equipment and are often addressed by the organization's disaster plan.

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REFERENCES
1) Valenstein P, et al. Laboratory computer availability. A College of American Pathologists Q-Probes study of computer downtime in
2)
3)

422 institutions. Arch Pathol Lab Med. 1996;120:626-632
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1252(b)(4)]Clinical and Laboratory Standards Institute. Planning for Laboratory Operations During a Disaster; Approved Guideline. CLSI
document GP36-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.

INTERFACES
Inspector Instructions:●●●GEN.46000

Interface systems policies and procedures
Sampling of reports transmitted to each interfaced system (laboratory data entry of
results match patient reports, including reference ranges and comments)

How does your laboratory verify the accuracy of data transmission from the LIS tointerfaced systems?

Reference Range/Units Transmission

Phase I

As applicable, reference ranges and units of measure for every test are transmitted withthe patient result across the interface.
NOTE: The reference range, including units of measure, may be specific for a given patient result
and should be attached to that result such that it will be displayed along with the patient result.
GEN.48500

Interface Result Integrity

Phase II

There is a procedure to verify that patient results are accurately transmitted from the pointof data entry (interfaced instruments and manual input) to patient reports (whether paperor electronic).
NOTE: Verification must be performed prior to implementation of an interface (i.e. pre go-live),and every 2 years thereafter. This includes evaluation of data transmitted from the LIS to othercomputer systems and their output devices. Reference ranges and comments, as well as actual
patient results and report formats, must be evaluated.
Verification of accurate data transmission from the LIS to other systems must be performed byreviewing data in the first downstream (or interfaced) system in which the ordering clinician/client(e.g. referring laboratory) may be expected to routinely access patient data. This requirement canbe met by printing screen shots or by other methods that record that a verification procedure has
been performed. If the LIS has separate interfaces to multiple receiving systems in which patient
data can be accessed by clinicians, then reports from each receiving system must be validated.
However, where multiple sites use the same recipient system (e.g. the same installed instance ofan electronic medical record system), validation need only occur for the interface (i.e. at one of
the sites) and not for each individual site that is served by that single installed system.
At implementation of a new interface, or change to an existing interface, validation of at least
2 examples of reports from each of the following disciplines, where applicable, satisfies theintent of this checklist requirement. Subsequently, at least 2 examples of reports from at least

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4 of these disciplines should be validated every 2 years. Not all of these report types will beapplicable to every laboratory:
1. Surgical pathology reports
2. Cytopathology reports (preferably gynecologic and non-gynecologic)
3. Clinical laboratory textual reports (e.g. molecular, protein electrophoresis,
coagulation panel interpretation)
4. Quantitative results (e.g. chemistry, hematology, or coagulation)
5. Qualitative or categorical results (e.g. serology)
6. Microbiology reports (e.g. culture and antimicrobial sensitivity)
7. Blood bank reports (e.g. type and screen)
Interface validation should include examples of individual results, test packages or batteries,
abnormal flags, and results with comments/footnotes. Initial interface validation should include
verification that corrected results for clinical laboratory and anatomic pathology results arehandled accurately in the receiving system.
Evidence of Compliance:✓
Records of verification
REFERENCES
1) Cowan DF, et al. Validation of the laboratory information system. Arch Pathol Lab Med. 1998;122:239-244
2) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments
3)

GEN.48750

of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(a)]Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information System: Approved Guideline.
CLSI document AUTO8-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006

LIS Interface Shutdown/Recovery

Phase II

There are procedures for changes in laboratory functions necessary during partial orcomplete shutdown and recovery of systems that interface with the laboratory information
system.
NOTE: These procedures must ensure integrity of patient test data. Procedures must include
verifying recovery of interfaced systems, and replacement or updating of data files, as necessary.
REFERENCES
1) Valenstein P, et al. Laboratory computer availability. A College of American Pathologists Q-Probes study of computer downtime in2)

422 institutions. Arch Pathol Lab Med. 1996;120:626-632
Clinical and Laboratory Standards Institute. Information Technology Security of in vitro Diagnostic Instruments and Softwarend ed. CLSI document AUTO11-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2014.

Systems; Approved Standard. 2

TELEPATHOLOGY AND REMOTE DATA ASSESSMENT
This section applies to telepathology, including the practice of pathology and cytology, in which a pathologist
examines digitized or analog video, still image(s), or other data files (e.g. flow cytometry files, Sanger
sequencing data) at an off-site or remote location and an interpretation is rendered that is included in a formal
diagnostic report or in the patient record. It also includes the review of images by a cytotechnologist whena judgment of adequacy is recorded in the patient record. This section may be applied to, but is not limited
to the disciplines of anatomic pathology, cytopathology, hematopathology, cytogenetics, flow cytometry,
histocompatibility, and molecular pathology.
Telepathology modes include:■
Static telepathology – interpretation based on pre-selected still image(s)■Dynamic telepathology - viewing real-time images (includes robotic microscopy, video streaming, anddesktop sharing)■
Virtual slides/whole slide imaging

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This checklist section applies to:■Primary diagnoses made by telepathology■
Frozen section diagnoses■
Formal second-opinion consultations■
Ancillary techniques in which the pathologist participates in interpretation of images■
Real-time evaluation of FNA specimens for triaging and preliminary diagnosis
This checklist section is NOT applicable to:■Informal reviews without formal reporting■
Educational or research use of these systems
References:
Pantanowitz L, Dickinson K, Evans AJ, Hassell LA, Henricks WH, Lennerz JK, et al. American Telemedicine
Association clinical guideline for telepathology. J Pathol Inform. 2014;5:39.

Inspector Instructions:●●

Sampling of telepathology policies and procedures
Sampling of reports generated from reviews of images/slides and data files performedby telepathology**REVISED** 08/17/2016
GEN.50057 Slide/Image ID

Phase II

There is a method for the individual reviewing cases to ensure that correct patient
identification and slides/images and data files are submitted for review.
NOTE: There are multiple ways to accomplish positive patient identification, including verbal
communications, images of slide identifier, etc.
Evidence of Compliance:✓
Written procedure defining mechanism to positively identify slides/images and data files**REVISED** 08/17/2016
GEN.50614 Clinical Information Access

Phase IThe individual reviewing cases has access to pertinent clinical information at the time ofslide/image(s) or data file review.
NOTE: Typically this information includes at least the information on the surgical pathology or
cytology requisition form.
**NEW** 08/17/2016
GEN.50630 Telepathology System Validation

Phase IThe laboratory validates telepathology systems used for clinical diagnostic purposesby performing its own validation studies, including approval for use by the laboratory
director (or designee who meets CAP director qualifications) before the technology isused for the intended diagnostic purpose(s).
NOTE: The specific components of the validation study are left to the discretion of the laboratory.
As general guiding principles, the validation process should:●
Closely emulate the real-world clinical environment and involve specimen
preparation types and clinical settings relevant to the intended use(s).

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Be carried out by a pathologist(s) adequately trained to use the system.

Refer to GEN.52920 for requirements on validation of whole slide imaging.
Evidence of Compliance:✓
Records of completed validation study with review and approval**REVISED** 08/17/2016
GEN.51728 Telepathology Training

Phase IThe lab has a procedure addressing training requirements for all users of thetelepathology system.
NOTE: The training procedure should be role-specific, as defined in the approved laboratory
procedures. Retraining may be required when significant system changes are made.
Evidence of Compliance:✓
Records for telepathology training in personnel files**REVISED** 08/17/2016
GEN.52842 Telepathology and Patient Confidentiality

Phase II

There are procedures in place to ensure that sites engaging in telepathology provide
reasonable confidentiality and security.
NOTE: Procedures might include message security, system and user authentication, activity
logs, encryption, and access restrictions. These security considerations must be particularly
adhered to when using mobile devices in public places.
For laboratories subject to US regulations, the procedures must be in conformance with HIPAA
requirements.
**REVISED** 07/28/2015
GEN.52850 Telepathology Result Records

Phase I

The telepathology records include diagnoses made and statements of adequacy
assessment, preliminary diagnosis, or recommendations for additional studies provided
at the time of evaluation.
NOTE: Such records are not required to be included on the patient report.
Evidence of Compliance:✓
Reports generated from reviews of images/slides and data files performed by telepathology
GEN.52860

Quality Management Program

Phase I

Telepathology services are included in the laboratory's quality management program.
NOTE: For example, the laboratory might monitor the frequency of deferral cases, comparison to
on-site evaluation, or consultation using traditional glass slide microscopy.

WHOLE SLIDE IMAGING
This section applies to laboratories using whole slide imaging systems for diagnostic purposes (primary and/or
consultation).

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Inspector Instructions:●●

Sampling of training records
System validation records**REVISED** 08/17/2016
GEN.52900 Whole Slide Imaging User Training

Phase I

There are records showing that all users of the whole slide imaging system have been
trained.
NOTE: Users of the whole slide imaging system include individuals responsible for slide scanningand digital slide quality assessment, as well as pathologists. The training procedure should
include role-specific training, as defined in the approved laboratory procedures. Retraining may
be required when significant system changes are made.
Evidence of Compliance:✓
Records for whole slide image training in personnel files
GEN.52920

Whole Slide Imaging System Validation

Phase IThe laboratory validates whole slide imaging systems used for clinical diagnostic
purposes by performing its own validation studies, including approval for use by thelaboratory director (or designee who meets CAP director qualifications) before thetechnology is used for the intended diagnostic purpose(s).
NOTE: The specific components of the validation study are left to the discretion of the laboratory.
As general guiding principles, the validation process should:●
Closely emulate the real-world clinical environment and involve specimen preparation
types and clinical settings relevant to the intended use(s);●Be carried out by a pathologist(s) adequately trained to use the system;●
Assess intraobserver concordance between digital and glass slides;●
Encompass the entire whole slide imaging system, with reevaluation if a significant
change is made to a previously validated system.
Evidence of Compliance:✓
Records of completed validation study with review and approval
REFERENCES
1) Pantanowitz et al, Validating whole slide imaging for diagnostic purposes in pathology: Guideline from the College of American

2)

Pathologists Pathology and Laboratory Quality Center. ARPA, 2013
http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2013-0093-CP
http://www.cap.org/apps/docs/membership/wsi_faqs.pdf
Validation of Digital Pathology in Healthcare Environment: A Whitepaper from the Digital Pathology Association, 2011
http://digitalpathologyassociation.org/_data/files/DPA-Healthcare-White-Paper--FINAL_v1.0.pdf

PERSONNEL
The laboratory must have personnel policies, and job descriptions that define qualifications and duties for all
positions. Personnel files must contain records of educational qualifications (e.g. copies of diplomas, transcripts,
primary source verification reports), laboratory personnel licenses (where required), training and continuing
education for each employee. Ideally, these files should be located in the laboratory. If they are retained outside

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08.17.2016of the laboratory, they must be readily available to the inspector on the day of inspection. The inspector reviews
the personnel files using the Laboratory Personnel Evaluation Roster.

Inspector Instructions:
●
●
●

●

●

Sampling of personnel policies and procedures
Organizational chart or narrative description
Sampling of competency assessments for assessment of all six elements ofcompetency for each nonwaived test system, six month competency for new
employees, and assessments done by qualified individuals based on complexity of
testing performed
Sampling of technical personnel files for educational qualifications, (e.g. diplomas,
transcripts, primary source verification reports), laboratory personnel licenses (whererequired), training, and continuing education records for testing personnel, section
directors/technical supervisors, supervisors/general supervisors, and consultants
using the table below
Records of diploma/transcript equivalency evaluation for non-US trained personnel by
a foreign credentialing agency (for laboratories subject to US regulations)

Sampling to include a mix of the following: 1) laboratory personnel (including MD, DO, PhD,
technicians and technologists) and non-laboratory personnel (e.g. POC, PPT, Radiology,
Respiratory); 2) full and part-time employees on all shifts and throughout all departments; 3)
supervisory staff and testing personnel.
All newly hired personnel for the last two years must be reviewed (if applicable), bothlaboratory and non-laboratory.
If any documents are missing from the personnel files, record the appropriate deficiency on
the Inspector's Summation Report, noting the specific instances of non-compliance.
DO NOT allow laboratory staff to select which personnel records to review. Randomly selectspecific individuals from the Laboratory Personnel Evaluation Roster following sampling
instructions described above. Use the following criteria to determine the number of personnel
records to be reviewed:
Total Number of Personnel (bothlaboratory and non-laboratory)

Number of Personnel
Records to Sample**Records of all technical personnel
hired within the last two years must be
reviewed

Up to 10

Review all personnel

11 - 100

8 -10

101 - 250

10 -12251 - 400

13 - 15401 - 500

16 - 18

More than 500

18 - 20●●●

Do you have a specific example of an employee who demonstrated unacceptablecompetency assessments? What were the corrective actions?
What continuing education classes are available to employees?
If primary source verification reports are used, what is your process to ensure that thereports contain the required elements?

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How are records of educational qualifications (e.g. diploma or transcript) maintainedfor point of care and other testing personnel performing nonwaived testing outside of
the main laboratory?

SECTION DIRECTORS (TECHNICALSUPERVISORS)/GENERAL SUPERVISORSThis section applies to laboratories performing one or more highly complex tests. The individuals fulfilling theseroles must be identified on the CAP's Laboratory Personnel Evaluation Roster form.
The term "section director" may be considered synonymous to the technical supervisor in the checklist
requirements. The term "supervisor" may be considered synonymous to the general supervisor in the checklist
requirements. Within the laboratory's organizational structure, the actual position titles may be different. A
qualified laboratory director may serve as the section director and general supervisor, and may set position
requirements more stringent than defined in the checklist.
**REVISED** 08/17/2016
GEN.53400 Section Director (Technical Supervisor) Qualifications/Responsibilities

Phase II

Section Directors/Technical Supervisors of high complexity testing meet definedqualifications for the specialties supervised and fulfill the expected responsibilities.
NOTE: For high complexity testing, one or more individuals qualified as a technical supervisor
must be identified on the CAP's Laboratory Personnel Evaluation Roster form.
Requirements for the section directors of clinical cytogenetics, histocompatibility and transfusion
medicine services are more stringent and are found in the Cytogenetics, Histocompatibility andTransfusion Medicine Checklists, respectively.
The technical supervisor must meet the following requirements:
1. MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is
located with certification in anatomic pathology or clinical pathology by the American
Board of Pathology or the American Osteopathic Board of Pathology or possess
qualifications equivalent to those required for certification.
●
If responsible for anatomic pathology or cytopathology must be board certified inanatomic pathology or possess equivalent qualifications●
If responsible for clinical pathology must be board certified in clinical pathology or
possess equivalent qualifications●
If responsible for anatomic pathology and/or cytopathology, and clinicalpathology, must be board certified in both anatomic and clinical pathology or
possess equivalent qualifications OR
2. For specialties other than Anatomic Pathology and Cytopathology, an individual willmeet the qualifications of a technical supervisor providing the following qualifications
are met:●MD or DO licensed to practice (if required) in the jurisdiction where the laboratory
is located with at least one year of training and/or experience in high-complexity
testing*; or●Doctoral degree in chemical, physical, biological or clinical laboratory sciencefrom an accredited institution with at least one year of laboratory training and/or
experience in high complexity testing*; or●Master's degree in a chemical, physical, biological, or clinical laboratory scienceor medical technology from an accredited institution with at least two years oflaboratory training and/or experience in high complexity testing*; or64 of 129
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Bachelor's degree in a chemical, physical, or biological science or medical
technology from an accredited institution with at least four years of laboratory
training and/or experience in high complexity testing*.

*The technical supervisor's training and experience must be in the designated specialty or
subspecialty area of service for which the individual is responsible.
For laboratories subject to US regulations, alternate qualifications for the following
specialty areas can be found in Fed Register. 1992 (Feb 28): 7177-7180 [42CFR493.1449]:
bacteriology, mycobacteriology, mycology, parasitology, virology, cytology, ophthalmic
pathology, dermatopathology, oral pathology, and radiobioassay.
If more stringent state or local regulations are in place for supervisory qualifications, including
requirements for state licensure, they must be followed.
For laboratories subject to US regulations, credentials for all personnel trained outside of the US
must be reviewed and recorded to ensure that their training and qualifications are equivalent to
CLIA requirements. The equivalency evaluations should be performed by a nationally recognizedorganization.
The section director, as designated by the laboratory director, must be accessible to thelaboratory as needed for on-site, telephone, or electronic consultation and is responsible forthe technical and scientific oversight of the laboratory. The section director is responsible for
performing and recording competency assessment for high complexity testing. The duties for
performing the competency assessment may be delegated, in writing, to individuals meeting
general supervisor qualifications for high complexity testing. Other responsibilities of the technicalsupervisor include:●
Selection of test methodology●
Establishment or verification of laboratory test performance specifications●
Enrollment and participation in proficiency testing●
Establishment of a quality control program to monitor ongoing test performance●
Resolution of technical problems and ensuring that remedial actions are taken●
Ensuring that patient results are not reported until corrective actions are taken and test
systems are functioning properly●
Identification of training needs
For functions that are delegated, such as review of quality control data, assessment ofcompetency, or review of proficiency testing performance, delegation must be in writing and thetechnical supervisor is responsible to ensure that those functions are properly carried out by aqualified individual.
Evidence of Compliance:✓
Records of qualifications including degree, transcript, equivalency evaluation, or current
license (if required) AND✓
Certification/registration (if required) and work history in related field AND✓
Description of current duties and responsibilities AND✓
Record of delegation of duties
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 1992(Feb 28):7180 [42CFR493.1451]**REVISED** 08/17/2016
GEN.53600 General Supervisor Qualifications/Responsibilities

Phase II

Supervisors/general supervisors meet defined qualifications and fulfill expected
responsibilities.
NOTE: For high complexity testing, one or more individuals qualified as a general supervisor
must be defined on the CAP's Laboratory Personnel Evaluation Roster form.

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Supervisors who do not qualify as a laboratory director or section director/technical supervisor
must qualify as testing personnel and possess the minimum of a:
1. Bachelor's degree in a chemical, physical, biological or clinical laboratory scienceor medical technology with at least one year of training and/or experience in highcomplexity testing; or
2. Associate degree in a laboratory science or medical technology with at least two
years of training and/or experience in high complexity testing; or
3. Have previously qualified or could have qualified as a general supervisor prior to
2/28/1992
Requirements for the supervisors/general supervisors of cytopathology and histocompatibility are
more stringent and are found in the Cytopathology and Histocompatibility Checklists.
If more stringent state or local regulations are in place for supervisory qualifications, including
requirements for state licensure, they must be followed.
For laboratories subject to US regulations, credentials for all personnel trained outside of the US
must be reviewed and recorded to ensure that their training and qualifications are equivalent to
CLIA requirements. The equivalency evaluations should be performed by a nationally recognizedorganization.
The supervisor of high-complexity testing must be accessible to the laboratory as needed foron-site, telephone, or electronic consultation and is responsible for day-to-day supervision or
oversight of the laboratory operation and personnel performing testing and reporting test results.
Individuals meeting the qualifications of a general supervisor for high complexity testing mayassess the competency of high complexity testing personnel, if this duty is delegated, in writing,by the section director. Other responsibilities of the general supervisor include:●
Resolution of technical problems in accordance with policies and procedures establishedby the laboratory director or technical supervisor●
Monitoring of test performance●
Ensuring that remedial actions are taken when test systems deviate from the laboratory's
established performance specifications●
Providing orientation of testing personnel
Evidence of Compliance:✓
Records of qualifications including degree, transcript, equivalency evaluation, or current
laboratory personnel license (if required) AND✓
Certification/registration (if required) and work history in related field AND✓
Description of current duties and responsibilities
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 1992(Feb 28):7182 [42CFR493.1463]

TECHNICAL AND CLINICAL CONSULTANT
The individuals fulfilling these roles must be identified on the CAP's Laboratory Personnel Evaluation Roster
form.
Within the laboratory's organizational structure, the actual position titles may be different. A qualified laboratory
director may also serve as the technical and clinical consultant, and may set position requirements more
stringent than defined in the checklist.
**REVISED** 08/17/2016
GEN.53625 Technical Consultant Qualifications/Responsibilities

Phase II

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Technical consultants meet defined qualifications and fulfill expected responsibilities.
NOTE: This requirement applies to laboratories performing moderate complexity testing, but nothigh complexity testing. For moderate complexity testing, one or more individuals qualified asa technical consultant must be identified on the CAP's Laboratory Personnel Evaluation Roster
form (for high complexity testing, refer to GEN.53400).
The technical consultant (including the laboratory director who serves as a technical consultant)must be qualified by education and experience by one of the following combinations:●
MD or DO, licensed to practice medicine in the jurisdiction where the laboratory is
located (if required), with certification in anatomic and/or clinical pathology by theAmerican Board of Pathology or the American Osteopathic Board of Pathology, or
possess qualifications equivalent to those required for certification; or●MD, DO, or DPM, licensed to practice in the jurisdiction where the laboratory is located (ifrequired), with at least one year of training and/or experience in nonwaived testing*; or●Doctoral or master's degree in a chemical, physical, biological or clinical laboratory
science from an accredited institution with at least one year of training and/or experiencein nonwaived testing*; or●Bachelor's degree in a chemical, physical, biological or clinical laboratory science ormedical technology from an accredited institution with at least two years of training and/or experience in nonwaived testing*.
*The technical consultant's training and experience must be in the designated specialty or
subspecialty area of service for which the individual is responsible.
If more stringent state or local regulations are in place for supervisory qualifications, including
requirements for state licensure, they must be followed.
The technical consultant is responsible for the technical and scientific oversight of the laboratory.
The technical consultant must be available to the laboratory as needed for telephone, electronic
and on-site consultation. Individuals meeting the qualifications of a technical consultant may
assess the competency of personnel performing moderate complexity testing, if this duty isdelegated, in writing, by the laboratory director. Other responsibilities of the technical consultant
include:●Establishment or verification of laboratory test performance specifications●
Selection of test methodology●
Enrollment and participation in proficiency testing●
Establishment of a quality control program to monitor ongoing test performance●
Resolution of technical problems and ensuring that remedial actions are taken●
Ensuring that patient results are not reported until corrective actions are taken and test
systems are functioning properly●
Identification of training needs
Evidence of Compliance:✓
Records of technical qualifications including degree, transcript, equivalency evaluation, or
current license (if required) AND✓
Certification/registration (if required) and work history in related field AND✓
Description of current duties and responsibilities
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2004(Oct 1):101053 [42CFR493.1411] and 2003(Oct 1) 1053-54 [42CFR493.1413]**REVISED** 08/17/2016
GEN.53650 Clinical Consultant Qualifications/Responsibilities

Phase II

Clinical consultants meet defined qualifications and fulfill expected responsibilities.

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NOTE: This requirement applies to laboratories performing moderate complexity testing and/or high complexity testing. One or more individuals qualified as a clinical consultant must be
identified on the CAP's Laboratory Personnel Evaluation Roster form.
Clinical consultants must be an MD, DO, DPM licensed to practice medicine in the jurisdiction
where the laboratory is located (if required) or doctoral scientist certified by an HHS-approved
board.
The clinical consultant must be available to provide and ensure that consultation is available on
test ordering, and interpretation of results relating to specific patient conditions, and for mattersrelating to the quality of test results reported. The clinical consultant must also ensure that patientreports include pertinent information required for interpretation. See TLC.10440, TLC.10500, andTLC.10700.
Evidence of Compliance:✓
Records of clinical consultant qualifications (i.e. a valid medical license AND✓
Written job description or contract AND✓
Records of activities performed by the consultant during visits consistent with the job
description (e.g. meeting minutes, activity logs, signed summaries or data with evidence ofreview)
REFERENCES
1) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1415], [42CFR493.1417], [42CFR493.1419]

ALL PERSONNEL**REVISED** 08/17/2016
GEN.54000 Organizational Chart

Phase II

There is an organizational chart for the laboratory, or a narrative description that
describes the reporting relationships among the laboratory's owner or management, thelaboratory director, section director(s)/technical supervisor(s), technical consultant(s),clinical consultant(s), and supervisor(s)/general supervisor(s), as appropriate.
**NEW** 08/17/2016
GEN.54025 Laboratory Personnel Evaluation Roster

Phase II

The Laboratory Personnel Evaluation Roster is current and accurate and is audited by
the laboratory director or designee at least annually for nonwaived testing personnel andpersonnel fulfilling supervisor roles.
NOTE: The laboratory's audit of the laboratory personnel evaluation roster must include a review
of a mixture of the following types of personnel:●
All nonwaived testing personnel hired within the last 12 months (laboratory and nonlaboratory)●
Laboratory and non-laboratory (POC, PPT, Radiology, Respiratory, etc.) personnel●
Full and part-time nonwaived testing personnel on all shifts and throughout all
departments●
Personnel fulfilling supervisory roles (e.g. laboratory director, technical supervisor, staff
pathologist)
Personnel performing any CLIA-defined duty must be listed on the roster. Personnel performing
waived testing only or whose duties are limited to phlebotomy, clerical work or specimen
processing are not required to be listed on the Laboratory Personnel Evaluation Roster. Histology
personnel that do not perform high-complexity testing are also excluded. All grossing performed
in histology is considered high-complexity testing.

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Evidence of Compliance:✓
Records of completed rosters accurately reflecting personnel AND✓
Records of annual audits performed by the laboratory director or designee
GEN.54200

Continuing Education

Phase I

There is a functional continuing laboratory education program adequate to meet theneeds of all personnel.
Evidence of Compliance:✓
Written policy for continuing laboratory education
REFERENCES
1) Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI Document2)
3)

QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.
Krienitz DR. Safety education in the laboratory. Lab Med. 1996;27:823-827
Nguyen AND, et al. A web-based teaching program for laboratory diagnosis of coagulation disorders. Arch Pathol Lab Med.
2000;124:588-593**REVISED** 08/17/2016
GEN.54400 Personnel Records

Phase II

Personnel files are maintained on all current technical personnel and personnel records
include all of the following, as applicable:
1. For nonwaived testing personnel, copy of academic diploma , transcript, or
primary source verification reports confirming credentials (Refer to NOTE 2 foruse of primary source verification reports)
2. Laboratory personnel license, if required by state, province, or country
3. Summary of training and experience
4. Certification, if required by state or employer
5. Description of current duties and responsibilities as specified by thelaboratory director: a) Procedures the individual is authorized to perform, b)
Whether supervision is required for specimen processing, test performance or
result reporting, c) Whether supervisory or section director review is required
to report patient test results
6. Records of continuing education
7. Records of radiation exposure where applicable (such as with in vivo radiation
testing), but not required for low exposure levels such as certain in-vitro
testing
8. Work-related incident and/or accident records
9. Dates of employment
NOTE 1: All records, in either electronic or paper form, must be readily available for review by theinspector at the time of the CAP inspection.
NOTE 2: For laboratories subject to US regulations:●
The file must include records demonstrating that each individual meets the required
educational qualifications for the position(s) held, such as a copy of the academic
diploma, transcript, or primary source verification (PSV) report.
●
If PSV reports are used, the laboratory must have a defined system for reviewing thereports, with written criteria for acceptance. PSV is typically performed by a third-party
agent or company that directly contacts institutions and former employers to verify
training and experience, such as diplomas, board certification, licensure, and reported
work history. PSV reports confirming the required qualifications may be retained inlieu of obtaining paper copies of these records. If there are required elements for thequalifications that the PSV report does not adequately verify (e.g. transcripts, educational
equivalency for personnel trained outside of the US, or reports lacking the type of degree
earned), there must be records showing that qualifications are met using other means.

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●

●

●

●

08.17.2016

The credentialing systems used by the Department of Veterans Affairs (i.e. VetPro
Credentialing System) and Department of Defense may be used to document
educational qualifications. Records must be available upon request.
If the laboratory is located in a state that requires laboratory personnel licensure,the license may be used instead of the diploma or transcript to show that educational
qualifications were met. Licensure records for any other discipline, such as nursing,
respiratory therapy, or radiology is not required, and cannot be used to meet educational
qualifications for non-waived laboratory testing. These individuals must have all required
educational and training records in their files.
While certification of technical personnel by a professional organization, such as
ASCP or AMT, is highly desirable, records of the certification alone are not consideredadequate to demonstrate that educational qualifications have been met.
The training and qualifications of all personnel trained outside of the US must be
evaluated to determine equivalency of their education to an education obtained in
the United States, with records of the evaluation available in the personnel file. The
equivalency evaluations should be performed by a nationally recognized organization.
For Department of Defense laboratories, the equivalency must be performed using aprocess approved by the Center for Laboratory Medicine Services.

NOTE 3: Laboratories not subject to US regulations may authenticate educational achievement
according to prevailing governmental rules.
Evidence of Compliance:✓
Copies of diplomas, transcripts, equivalency evaluation, or current laboratory personnel
licensure (if required) accessible at the laboratory OR✓
Policy for use of primary source verification reports, with criteria for acceptance, if used AND✓
Primary source verification reports with required elements
REFERENCES
1) Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI Document
2)
3)
4)

QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.
Harmening DM, et al. Defining roles of medical technologists and medical laboratory technicians. Lab Med. 1995;26:175-178
Ward-Cook K, et al. Medical technologist core job tasks still reign. Lab Med. 2000;31:375-379

st ed. CLSI guideline QMS16-Ed1. Clinical andClinical and Laboratory Standards Institute. Laboratory Personnel Management, 1Laboratory Standards Institute, Wayne, PA; 2015.

**REVISED** 08/17/2016
GEN.54750 Testing Personnel Qualifications

Phase II

All testing personnel meet the following requirements.
1. Personnel performing high complexity testing must have a minimum of one of
the following:●
Bachelor's degree in a chemical, physical, biological or clinical laboratory
science or medical technology from an accredited institution; or●Associate degree in a laboratory science (chemical or biological science)or medical laboratory technology from an accredited institution, or
equivalent laboratory training and experience meeting the requirements
defined in the CLIA regulation 42CFR493.1489 (see NOTE 2).
2. Personnel performing moderate complexity testing, including non-laboratory
personnel, must have a minimum of one of the following:●
Associate degree in a chemical, physical, or biological science or medicallaboratory technology from an accredited institution; or●High school graduate or equivalent and have successfully completed an
official military medical laboratory procedures course and have held themilitary enlisted occupational specialty of Medical Laboratory Specialist; or●High school diploma or equivalent and have a record of training defined in
the CLIA regulation 42CFR493.1423 (see NOTE 4)

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NOTE 1: Laboratory and non-laboratory (e.g. nurses, respiratory therapists, radiologic
technologists, and medical assistants) testing personnel must meet the qualifications appropriate
to the complexity of testing performed. GEN.54400 contains the specific requirements for thetypes of records that must be maintained in the personnel file to demonstrate compliance.
Additional information for assessing personnel qualifications is available at the following link:
CAP Personnel Requirements by Testing Complexity.
NOTE: 2: For high complexity testing, equivalent laboratory training and experience includes thefollowing:●
60 semester hours or equivalent from an accredited institution that, at a minimum,
includes either 24 semester hours of medical laboratory technology courses, OR 24
semester hours of science courses that include six semester hours of chemistry, sixsemester hours of biology, and 12 semester hours of chemistry, biology or medicallaboratory technology in any combination; AND●
Laboratory training including either completion of a clinical laboratory training programapproved or accredited by the ABHES, NAACLS, or other organization approved by
HHS (note that this training may be included in the 60 semester hours listed above),
OR at least three months documented laboratory training in each specialty in which theindividual performs high complexity testing.
NOTE 3: For US Department of Defense laboratories, effective May 29, 2014, newly hired highcomplexity testing personnel must have either:●A minimum of an associate degree in a biological or chemical science or medicallaboratory technology from an accredited institution AND be certified by the ASCP, AMT
or other organization deemed comparable by OASD(HA) or their designee (CCLM) as an
MLT or MT/MLS; OR●
Successfully completed an official U.S. military medical laboratory procedures training
course of at least 50 weeks duration and currently hold the military enlisted occupational
specialty of medical laboratory specialist (laboratory technician).
NOTE 4: For moderate complexity testing personnel qualifying with a high school diploma or
equivalent qualifications only, training records must demonstrate skills for the following:●Specimen collection, including patient preparation, labeling, handling, preservation,
processing, transportation, and storage of specimens, as applicable;●
Implementation of all laboratory procedures;●
Performance of each test method and for proper instrument use;●
Preventive maintenance, troubleshooting and calibration procedures for each test
performed;●
Working knowledge of reagent stability and storage;●
Implementation of quality control policies and procedures;●
An awareness of interferences and other factors that influence test results; and●Assessment and verification of the validity of patient test results, including theperformance of quality control prior to reporting patient results.
NOTE 5: Students gaining experience in the field must work under the direct supervision of aqualified individual.
NOTE 6: If more stringent state or local regulations are in place for personnel qualifications,
including requirements for state licensure, they must be followed.
Evidence of Compliance:✓
Records of qualifications including diploma, transcript, equivalency evaluation, or current
laboratory personnel license (if required) AND✓
Work history in related field
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 1992(Feb 28):7175 [42CFR493.1423], 7183 [42CFR493.1489]

2)

Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3
QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.

rd ed. CLSI document

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GEN.55400

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Visual Color Discrimination

Phase I

Personnel are tested for visual color discrimination.
NOTE: Personnel performing testing or other tasks that require color discrimination should be
evaluated for difficulty with visual color discrimination. Evaluation is not required for personnel
who do not perform such functions. Evaluation limited to discrimination of those colored items
pertinent to the job is sufficient.
Evidence of Compliance:✓
Record of color discrimination testing OR functional assessment, if indicated**REVISED** 08/17/2016
GEN.55450 Initial Training

Phase II

There are records that all laboratory personnel have satisfactorily completed initialtraining on all instruments/methods applicable to their designated job.
NOTE: The records must cover all testing performed by each individual. Training records must be
maintained for a minimum of two years (five years for transfusion medicine). After the initial twoyear (or five-year) period, records of successful ongoing competency assessment may be used
to demonstrate compliance with this requirement.
Retraining must occur when problems are identified with personnel performance.
REFERENCES
1) Clinical and Laboratory Standards Institute. Training and Competence Assessment; Approved Guideline. 3rd ed. CLSI Document2)

QMS03-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2009.
Clinical and Laboratory Standards Institute (CLSI). Establishing Molecular Testing in Clinical Laboratory Environments: CLSI
document MM19-A. Clinical and Laboratory Standards Institute, Wayne, PA, 2011.

**REVISED** 08/17/2016
GEN.55500 Competency Assessment of Testing Personnel

Phase II

The competency of each person performing patient testing to perform his/her assigned
duties is assessed.
NOTE: Prior to starting patient testing and prior to reporting patient results for new methods or
instruments, each individual must have training and be evaluated for proper test performance as
required in GEN.55450. Retraining and reassessment of employee competency must occur whenproblems are identified with employee performance.
For waived testing:●Competency assessment must be performed at least annually (semiannual assessment
not required)●
The laboratory may select which elements to assess for each test system●
The qualifications of individuals assessing competency of waived testing personnel shallbe determined by the laboratory director●
If more stringent state or local regulations are in place for competency assessment of
waived testing, they must be followed
For nonwaived testing:●During the first year of an individual's duties, competency must be assessed at least
semiannually●
After an individual has performed his/her duties for one year, competency must be
assessed at least annually●
Competency assessment must include all six elements described below for eachindividual on each test system during each assessment period, unless an element is notapplicable to the test system
Elements of competency assessment include but are not limited to:72 of 129
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1. Direct observations of routine patient test performance, including, as applicable,
patient identification and preparation; and specimen collection, handling, processing
and testing
2. Monitoring the recording and reporting of test results, including, as applicable,
reporting critical results
3. Review of intermediate test results or worksheets, quality control records, proficiency
testing results, and preventive maintenance records
4. Direct observation of performance of instrument maintenance and function checks
5. Assessment of test performance through testing previously analyzed specimens,
internal blind testing samples or external proficiency testing samples; and6. Evaluation of problem-solving skills
The laboratory must identify the test systems that an employee uses to generate patient test
results. Competency must be evaluated and recorded for all testing personnel for each test
system. A TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic
steps used to produce a test result or set of results. A test system may be manual, automated,
multi-channel or single use and can include reagents, components, equipment or instruments
required to produce results. A test system may encompass multiple identical analyzers ordevices. Different test systems may be used for the same analyte. In many situations, tests
performed on the same analyzer may be considered one test system; however, if there are
any tests with unique aspects, problems or procedures within the same testing platform (e.g.
pretreatment of samples prior to analysis), competency must be assessed as a separate test
system to ensure staff are performing those aspects correctly.
Many of the elements of competency assessment are performed during routine review of an
employee throughout the year. Records of these elements, including adherence to laboratory
policies and procedures, observation of test performance, results reporting, instrument
maintenance, review of worksheets, recording QC, performance of PT, and demonstrationof taking appropriate corrective actions are examples of daily activities that can be used todemonstrate competency. If elements of competency are assessed by routine review, thecompetency procedure must outline how this routine review is used to evaluate competency.
Competency assessment during routine review may be recorded using a checklist.
The laboratory director must ensure that the individuals performing competency assessments
are qualified through education and experience to meet the defined regulatory requirements
associated with the complexity of the testing.
●Testing personnel performing high complexity testing must be assessed by the section
director, or individual meeting general supervisor requirements if delegated in writing by
the section director.
●
Testing personnel performing moderate complexity testing must be assessed by anindividual meeting the qualifications of a technical consultant.
Evidence of Compliance:✓
Records of competency assessment for new and existing testing personnel reflecting thespecific skills assessed, the method of evaluation AND✓
Written procedure defining the method and frequency for assessing competency
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
2)
3)
4)
5)
6)
7)
8)

amendments of 1988; final rule. Fed Register. 2003(Oct 1):1065-66 [42CFR493.1451(b)], 1053-54 [42CFR493.1413], 1992 (Feb 28)7184 [42CFR493.1713]
Clinical and Laboratory Standards Institute (CLSI) Training and Competence Assessment; Approved Guideline—Third Edition. CLSI
document QMS03-A3 (ISBN 1-56238-531-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne,
Pennsylvania 19087-1898 USA, 2009.
Boone DJ. Assessing laboratory employee competence. Arch Pathol Lab Med. 2000;124:190-191
Howanitz PJ, et al. Employee competence and performance-based assessment. A College of American Pathologists Q-Probes studyof laboratory personnel in 522 institutions. Arch Pathol Lab Med. 2000;124:195-202
Church DL, et al. Effects of restructuring on the performance of microbiology laboratories in Alberta. Arch Pathol Lab Med.
2000;124:357-361
Ward-Cook K, et al. Medical technologist core job tasks still reign. Lab Med. 2000;31:375-379
Haun DE, et al. Assessing the competence of specimen-processing personnel. Lab Med. 2000;31:633-637
Schiffgens J, Bush VA. Four-part approach to competency assessment. Lab Med. 2001;32:431-435

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9)

08.17.2016

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Brochure #10. What Do I Need
to Do to Assess Personnel Competency. November 2012. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
CLIA_Brochures.html**REVISED** 07/28/2015
GEN.55525 Performance Assessment of Supervisors/Consultants

Phase II

The performance of section directors/technical supervisors, general supervisors, andtechnical consultants is assessed and satisfactory.
NOTE: All responsibilities of section directors (as technical supervisors in laboratories performing
high complexity testing) and technical consultants (in laboratories performing moderatecomplexity testing, but not high complexity testing) must be delegated by the laboratory director
in writing. Unsatisfactory performance must be addressed in a corrective action plan.
The assessment may take the form of a checklist or other written record of performance of
responsibilities, as defined by the individual's job description. If assessment of these individuals
is not performed or there are inadequate or inconsistent records, a deficiency should also becited for TLC.11425 (Director Responsibility - Delegation of Functions) in the Team Leader
Assessment of Director and Quality Checklist.
If the individuals in these roles are also performing nonwaived patient testing, competency
assessment requirements for testing personnel (GEN.55500) also apply, including all six
elements of competency.
Evidence of Compliance:✓
Job descriptions that list regulatory responsibilities AND✓
Records of performance assessment
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement2)3)

GEN.57000

amendments of 1988; final rule. Fed Register. 2003(Oct 1): [42CFR493.1235], [42CFR493.1407(b)], [42CFR493.1445(b)]Clinical and Laboratory Standards Institute (CLSI) Training and Competence Assessment; Approved Guideline—Third Edition. CLSI
document QMS03-A3 (ISBN 1-56238-531-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne,
Pennsylvania 19087-1898 USA, 2009.
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Brochure #10. What Do I Need
to Do to Assess Personnel Competency. November 2012. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
CLIA_Brochures.html

Competency Corrective Action

Phase IIIf testing personnel fail to demonstrate satisfactory performance on the competency
assessment, the laboratory follows a plan of corrective action to retrain and reassess
competency.
NOTE: If it is determined that there are gaps in the individual's knowledge, the employee
should be re-educated and allowed to retake the portions of the assessment that fell below thelaboratory's guidelines. If, after re-education and training, the employee is unable to satisfactorily
pass the assessment, then further action should be taken which may include, supervisory review
of work, reassignment of duties, or other actions deemed appropriate by the laboratory director.
Evidence of Compliance:✓
Records of corrective action to include evidence of retraining and reassessment ofcompetency✓
Written procedure for competency assessment corrective action

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PHYSICAL FACILITIESInspector Instructions:●

All Sections, including technical work areas, administrative space, storage areas,
patient phlebotomy areas, etc. (adequate space, acceptable temperature/humidity,
areas clean, adequate storage areas, adequate emergency power)●

Is the work area sufficient for you to perform your duties safely and accurately?

SPACE
Deficiencies in space should be recorded so there is incentive to improve. Deficiencies in space are regarded
as minor unless they are so severe as to interfere with the quality of work or quality control activities or safety,
in which case they become a Phase II deficiency. As laboratory operations expand over time, Phase I space
deficiencies may become Phase II deficiencies by the time of the next inspection.
GEN.60000

Adequate Space

Phase II

The general laboratory has adequate, conveniently located space so the quality of work,safety of personnel, and patient care services are not compromised.
REFERENCES
1) Koenig AS. Medical laboratory planning and design. Northfield, IL: College of American Pathologists, 1992
2) Guidelines for construction and equipment for hospital and medical facilities. Washington, DC: American Institute of Architects Press,
3)
4)
5)
6)
7)
8)

1993
Cooper EC. Laboratory design handbook. London: CRC Press, 1994
Mortland KK, Reddick JH. Laboratory design for today's technologies and marketplace. Lab Med. 1997;28:332-336
Clinical and Laboratory Standards Institute (CLSI). Laboratory Design; Approved Guideline - Second Edition. CLSI Document
QMS04-A2. (ISBN 1-56238-631-X). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, PA
19087-1898, USA, 2007.
Mortland KK, Mortland DB. Lessons learned in lab renovation. Advance/Lab. 1999;8(6):92-98
Hazlett SO. Perspectives in pathology. The newly designed morgue. Advance/Lab. 2000;9(1):10-11
Mortland KK, Mortland DB. Lab design: an architect's perspective. Advance/Lab. 2000;9(8):49-52**REVISED** 07/28/2015
GEN.60100 Adequate Space

Phase I

All of the following areas have sufficient space and are located so there is no hindrance tothe work.
1.
2.
3.
4.
5.
6.
7.

Laboratory director
Staff pathologists and residents
Clerical staff
Section supervisors
Outpatient/ambulatory waiting and reception
Lavatories
Library, conference and meeting room

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8. Personnel lounge and lockers
GEN.60150

Adequate Space

Phase I

There is adequate space for:
1.
2.
3.
4.
5.
6.
7.
8.

Technical (bench) work
Instruments and equipment
Storage (records, slides, tissue, etc.)
Refrigerator/freezer storage
Media preparation, as applicable
Accessioning of potentially biohazardous specimens, as applicable
Radionuclide storage, as applicable
Microscopy and imaging, as applicable

ENVIRONMENT
Ambient or room temperature and humidity must be controlled to minimize evaporation of specimens andreagents, to provide proper growth conditions for room temperature incubation of cultures, and not to interferewith the performance of electronic instruments.
GEN.60250

Working Environment

Phase IThe following are adequate for the facility.
1.
2.
3.
4.
5.
GEN.61300

Lighting
Water taps, sinks, drains
Electrical outlets
Ventilation
Gas and suction, when applicable

Climate Control

Phase IThe room temperature and humidity are adequately controlled in all seasons.
Evidence of Compliance:✓
Temperature and humidity records, if specific ranges are required for instrument and/or
reagent use
GEN.61350

Direct Sunlight

Phase I

Exposure to direct sunlight is minimized.
NOTE: Direct sunlight should be avoided because of its extreme variability and the need for low
light levels necessary to observe various computer consoles, etc. Lighting control should besectionalized so general levels of illumination can be controlled in areas of the room, if desired.
GEN.61400

Hallway Obstructions

Phase II

Passageways are unobstructed.
GEN.61500

Environment MaintenanceFloors, walls and ceilings are clean and well-maintained.

Phase I

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GEN.61600

Environment Maintenance08.17.2016

Phase I

Bench tops, cupboards, drawers and sinks are clean and well-maintained.

COMMUNICATIONSCommunications within the laboratory should be appropriate for the size and scope of the laboratory. Messages
should be transferred efficiently to all sections.
**REVISED** 07/28/2015
GEN.61750 Hand-Off Communication

Phase IThe laboratory implements a procedure for effective “hand-off” communication.
NOTE: The laboratory must have a procedure for communicating information about pending
specimens, tests and patient care issues when responsibility is “handed off” from one person toanother, such as at a change in shift, or when the responsibility for a case is transferred fromone pathologist to another. The procedure should include provision for asking and responding toquestions.
Evidence of Compliance:✓
Logs or message boards showing communication between shifts
GEN.61800

Telephone/Computer Locations

Phase I

Telephones and computer terminals are conveniently located.

INVENTORY AND STORAGE OF SUPPLIES
GEN.61900

Inventory Control

Phase I

There is an effective supply inventory control system in operation.
NOTE: An effective inventory control system minimizes emergency requisitions and shortages ofsupplies.
REFERENCES
1) Chapman J. Saving money with computerized materials management. Advance/Lab. 1999:8(9):16-18

GEN.62000

Intralaboratory Storage

Phase IThe intralaboratory storage area is sufficient and free of clutter.

POWER**REVISED** 07/28/2015
GEN.66100 Emergency Power
Emergency power is adequate for the functioning of the laboratory.

Phase I

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NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc.,
to ensure preservation of patient specimens. Depending on the type of testing performed in
the laboratory, emergency power may also be required for the preservation of reagents, theoperation of laboratory instruments, and the functioning of the data processing system.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1252(b)(4)]

LABORATORY SAFETY
Requirements in this section cover the general safety program for the entire laboratory and must be answered
for all laboratory sections. Non-compliance with any of these requirements in any one section of the laboratory
represents a deficiency for the entire laboratory. Requirements related to safety features specific to an individual
section will be found in the checklist for that section.
With respect to fire safety, if a checklist requirement conflicts with regulations of the Authority Having
Jurisdiction (i.e. state and local fire codes), the regulations of the Authority Having Jurisdiction take precedence.

SAFETY POLICIES, PROCEDURES, AND RECORDS
Inspector Instructions:●

Sampling of safety policies and procedures●

Adequate emergency lighting●

How are your laboratory's safe work practices reviewed?
Is there a specific example of an occupational injury or illness that required medical
treatment? What steps were taken to address the incident?

●●

GEN.73200

For any occupational injury or illness that required medical treatment, further evaluate
laboratory leadership's responses, corrective actions, follow-up procedures, andadditional measures taken to ensure safety in the workplace

Safety Policy and Procedure Approval

Phase II

The laboratory director or designee reviews and approves all changes to the safety
policies and procedures before implementation.

78 of 129
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GEN.73300 Safety Policy and Procedure Training

08.17.2016

Phase II

There are records for the training of all laboratory workers in safety policies andprocedures.
NOTE: A system to ensure that all personnel have read the policies and procedures is required
and must form a portion of the orientation program for new personnel. Posting of specificwarnings or hazards as appropriate is urged.
Evidence of Compliance:✓
Records of personnel review of safety policies and procedures
REFERENCES
1) Montgomery L. Health and safety guidelines for the laboratory. Chicago, IL: American Society of Clinical Pathologists Press, 1995
2) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document3)

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Krienitz DR. Safety education in the laboratory. Lab Med. 1996;27:823-827**REVISED** 07/28/2015
GEN.73400 Safe Work Practices Review

Phase II

There are records of periodic review (at least annually) of safe work practices to reduce
hazards.
NOTE: Review must include bloodborne hazard control and chemical hygiene. If the review
identifies a problem, the laboratory must investigate the cause and consider if modifications areneeded to the safety policies and procedures to prevent reoccurrence of the problem or mitigate
potential risk.
Evidence of Compliance:✓
Safety committee minutes OR records of regular safety inspections OR incident reports andstatistics OR another method defined by the laboratory director
GEN.73500

Lab Accidents

Phase II

There are written policies and procedures for the reporting and recording of all laboratory
accidents resulting in property damage or involving spillage of hazardous substances.
**REVISED** 07/28/2015
GEN.73600 Occupational Injuries

Phase II

There are written policies and procedures for the reporting of all occupational injuries orillnesses that require medical treatment (except first aid).
NOTE: For US laboratories subject to OSHA regulations, all workplace fatalities must be reported
to the Occupational Safety and Health Administration (OSHA) within eight hours and work-related
in-patient hospitalizations, amputations, or losses of an eye within 24 hours.
REFERENCES
1) Fed Register. 1986;50(137):29102-29113;2) 29CFR1904.8, current edition

GEN.73700

Occupational Injury Evaluation

Phase IIAn evaluation of laboratory accident and occupational injury/illness reports isincorporated into the laboratory's quality management program to avoid recurrence.
Evidence of Compliance:✓
Records of report evaluation OR committee minutes with records of discussion

79 of 129
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GEN.73800 Disaster Preparedness

Phase II

There are written policies and procedures defining the role and responsibilities of thelaboratory in internal and external disaster preparedness.
REFERENCES
1) Clinical and Laboratory Standards Institute. Planning for Laboratory Operations During a Disaster; Approved Guideline. CLSI
document GP36-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.

GEN.73900

Evacuation Plan

Phase II

There is a written comprehensive and workable evacuation plan specific for thelaboratory.
NOTE: 1. This plan must cover all employees, patients and visitors, and must address the special
needs of persons with disabilities. Evacuation routes must be clearly marked (Posting evacuationroutes is optional). 2. Emergency lighting is adequate for safe evacuation of the laboratory.
REFERENCES
1) Occupational Safety and Health Administration. Exit routes, emergency action plans, and fire prevention plans: standard, 2002
2)

[29CFR1910.38]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

BLOODBORNE PATHOGENS
Inspector Instructions:●●●GEN.74000

Sampling of safety policies and procedures
Sampling of records of hepatitis B vaccination or records declining the vaccination
Sampling of personnel safety education records●

PPE usage●

What has your laboratory done to reduce or eliminate exposure to bloodborne
pathogens during phlebotomy and laboratory testing?

Bloodborne Pathogens

Phase II

The laboratory has written policies and procedures for infection control that comply withnational, state, and local guidelines on occupational exposure to bloodborne pathogens
and to the institution's exposure control plan.
NOTE: Universal or standard precautions must be used when handling all blood and body
fluid specimens. The term "universal precautions" refers to a concept of bloodborne disease
control requiring all human blood and other potentially infectious materials to be treated as if
infectious for HIV, HBV, HCV or other bloodborne pathogens, regardless of the perceived "lowrisk" status of a patient or patient population. Alternative concepts in infection control are called80 of 129
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Body Substance Isolation (BSI) and Standard Precautions. These latter terms define all body
fluids and substances as infectious. All health care workers must routinely use appropriate barrier
precautions to prevent skin and mucous membrane exposure when contact with blood or otherbody fluids is anticipated. For laboratories subject to US regulations, policies and proceduresmust comply with the OSHA Standard on Bloodborne Pathogens.
Evidence of Compliance:✓
Safety manual AND✓
Records of universal precaution training for all personnel expected to have contact with body
fluidsREFERENCES
1) Ipolito G. The risk of occupational human immunodeficiency virus infection in health care workers. Arch Intern Med.
2)
3)
4)
5)
6)
7)

1993;153:1451-1458
Howanitz PJ, Schifman RB. Safety practices and infectious risks for laboratory phlebotomists. Am J Clin Pathol. 1994;102:553
Krienitz DR. Safety education in the laboratory. Lab Med. 1996;27:823-827
The Hospital Infection Control Practices Advisory Committee, Centers for Disease Control and Prevention, Public Health Service.
Guidelines for isolation precautions in hospitals. Part II. Recommendations for isolation precautions in hospitals. February 1996
McGovern PM, et al. Laboratory professionals' compliance with universal precautions. Lab Med. 1997;28:725-730
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline. 4th ed. CLSI Document M29-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2014**REVISED** 08/17/2016
GEN.74100 PPE Provision and Usage

Phase II

Appropriate personal protective equipment (gloves, gowns, masks and eye protectors,etc.) is provided and maintained in a sanitary and reliable condition in all technical work
areas in which blood and body substances are handled and in circumstances during
which exposure is likely to occur.
NOTE: 1. Appropriate personal protective equipment (PPE) are items that do not permit bloodor other potentially infectious materials to pass through to the skin or reach the employee's
work clothes, skin, footwear, etc. In addition to fluid-resistant gowns, aprons may be required if
exposure to large volumes of body fluids is anticipated. 2. OSHA requires gloves to be worn witheach patient contact and changed after contact when performing vascular access, except whendrawing voluntary blood donors. Hands must be cleaned after glove removal using an effective
antimicrobial method.
REFERENCES
1) Centers for Disease Control. Guidelines for prevention of transmission of human immunodeficiency virus and hepatitis B virus to
2)
3)
4)
5)

health-care and public-safety workers. MMWR. 1989:38(suppl S-6):1-37
Krienitz DR. Safety education in the laboratory. Lab Med. 1996;27:823-827
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Prinz Luebbert P. Q&A. Wearing laboratory coats during break. Lab Med. 1999;30:710
Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005**REVISED** 08/17/2016
GEN.74200 PPE Instruction

Phase II

Personnel are instructed in the proper use of personal protective clothing/equipment (e.g.
gloves, gowns, masks, eye protectors, footwear) and records are maintained.
NOTE: The required elements of training in the use of gloves include (a) Proper fitting ofgloves; (b) Replacing gloves immediately when torn or contaminated; (c) Not washing or
disinfecting gloves for reuse; (d) Using hypoallergenic gloves when indicated by patient or
health care provider history; (e) Decontamination of hands after glove removal using an effective
antimicrobial method.

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Evidence of Compliance:✓
Written policy for the use of PPE for specific tasks AND✓
Records of personnel training for PPE
REFERENCES
1) Murray RL. Keep wearing your gloves. Med Lab Observ. 1994(Mar):80
2) Krienitz DR. Safety education in the laboratory. Lab Med. 1996;27:823-827
3) Prinz Luebbert P. Q&A. Wearing laboratory coats during break. Lab Med. 1999;30:710
4) Rego A, Roley L. In-use barrier integrity of gloves: latex and nitrile superior to vinyl. Am J Infect Control. 1999;27:405-410
5) Department of Labor, Occupational Safety and Health Administration, Occupational Safety and Health Standards. Bloodborne
6)
7)

pathogens. Fed Register. 2002(July 1): [29CFR1910.1030(d)(3)(i)]Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the
Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR
2002;51.
World Health Organization. WHO Guidelines on Hand Hygiene in Health-Care, 2009. http://apps.who.int/iris/
bitstream/10665/44102/1/9789241597906_eng.pdf, accessed 12/5/2015.

**NEW** 08/17/2016
GEN.74250 Hand Cleaning

Phase II

All personnel remove gloves and clean hands using an effective antimicrobial method
after manipulating biological samples or after each patient contact.
REFERENCES
1) Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the2)

GEN.74300

Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR
2002;51.
World Health Organization. WHO Guidelines on Hand Hygiene in Health-Care, 2009. http://apps.who.int/iris/
bitstream/10665/44102/1/9789241597906_eng.pdf, accessed 12/5/2015.

Manual Manipulation of Needles

Phase II

There is a written policy that prohibits the recapping, purposeful bending, breaking,removing from disposable syringes, or other manual manipulations of needles.
NOTE: Resheathing instruments or self-sheathing needles may be used to prevent recapping of
needles by hand.
REFERENCES
1) Jagger J, et al. Rates of needlestick injury caused by various devices. New Engl J Med. 1988;319:284-288
2) Whitby M, et al. Needlestick injury: impact of a recapping device and an associated education program. Infect Control Hosp
3)
4)
5)
6)
7)

Epidemiol. 1991;12:220-225
Bush VJ, et al. Advancements in blood collection devices. Lab Med. 1998;29:616-622
Dale JC, et al. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo
Clinic Rochester. Mayo Clin Proc. 1998;73:611-615
Charney E. Retractable safety syringe activation study. J Healthcare Safety Compliance Infect Control. 1998;2(9):413-415
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline. 4

GEN.74400

th ed. CLSI Document M29-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2014

Eating/Mouth Pipetting

Phase II

There is a written policy that prohibits smoking, eating, drinking, application of cosmetics
and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work
areas.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document2)

GEN.74500

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]

Specimen Transport Procedures

Phase II

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There are written procedures for the procurement, transportation, and handling of patient
specimens (e.g. blood, body fluids, tissue) to ensure that all specimens are submitted
in an appropriately labeled and well-constructed container with a secure lid to prevent
leakage during transport.
NOTE: Specimens sent through pneumatic tube systems must be sealed in fluid-tight bags.
If pneumatic tube systems are used for transporting specimens, the laboratory must haveprocedures to respond to a spill within the tube, including appropriate decontamination
measures.
REFERENCES
1) Centers for Disease Control and Prevention. Evaluation of safety devices for preventing percutaneous injuries during phlebotomy
2)

GEN.74600

procedures. MMWR. 1997;46(2):1
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]

Spill HandlingPhase II

There are written procedures for handling spills of blood and other body fluids.
GEN.74700

Hepatitis B Vaccinations

Phase II

Personnel reasonably expected to have direct contact with body fluids are identified andoffered hepatitis B vaccinations free of charge.
Evidence of Compliance:✓
Written policy offering the hepatitis B vaccination to employees AND✓
Records of vaccination OR records signed by employees declining the vaccine
REFERENCES
1) Centers for Disease Control. Protection against viral hepatitis: recommendations of the Immunization Practices Advisory Committee
2)

GEN.74800(ACIP). MMWR. 1990;39:#RR-2
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]

Viral Exposure

Phase II

There is a policy for follow-up after possible and known percutaneous, mucous membraneor abraded skin exposure to HIV, HBV or HCV that includes the following elements.
1. HIV, HBV and HCV testing of the source patient after consent is obtained
2. Appropriate clinical and serologic evaluation of the healthcare worker
3. Consideration of appropriate prophylaxis for personnel acutely exposed toHIV, HBV or HCV, based upon medical indications, the serologic status and theinformed consent of the health-care worker
4. Reporting of the exposure as required by law
Evidence of Compliance:✓
Records of exposure follow-up consistent with policy
REFERENCES
1) Alpert LI. Managing needlestick accidents in the lab. Northfield, IL: College of American Pathologists CAP Today 1991(Jun);5(6):49
2) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
3)
4)
5)
6)
7)

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Dale JC, et al. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo
Clinic Rochester. Mayo Clin Proc. 1998;73:611-615
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]4)
Tarapchak P. Taking care of 'risky' business. Advance/Lab. 1999:8(7):69-73
Shen C, et al. Risk of needle stick and sharp object injuries among medical students. Am J Infect Control. 1999;27:435-437
Bryce EA, et al. Sharps injuries: defining prevention priorities. Am J Infect Control. 1999;27:447-455

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OTHER INFECTIOUS HAZARDS
Inspector Instructions:●●GEN.74900

Sampling of safety policies and procedures
Sampling of sterilizing device monitoring records

TB Exposure Plan

Phase II

The laboratory has a written tuberculosis exposure control plan.
NOTE: This plan must include an exposure determination at defined intervals for all employees
who may have occupational exposure to tuberculosis. Additional elements of the plan include
engineering and work practice controls for hazardous activities that potentially may aerosolize
Mycobacterium tuberculosis. Such activities include the handling of unfixed tissues in surgicalpathology or autopsies, and processing of specimens in the microbiology section from patientswith suspected or confirmed tuberculosis.
If respiratory protection is needed because of potential exposure to an infectious agent by
aerosol or droplet, personnel must use either a properly fit-tested filter respirator (N-95 or higher)
or a powered air-purifying respirator (PAPRS) equipped with high efficiency particulate air(HEPA) filters. Accurate fit testing is a key component of effective respirator use.
For laboratories subject to US requirement, the filter respirator must be NIOSH-approved.
REFERENCES
1) Centers for Disease Control and Prevention/National Institutes of Health. Biosafety in microbiological and biomedical laboratories.
2)

GEN.75000

Washington, DC: US government printing office, Feb 2007
CDC. Guidelines for preventing transmission of Mycobacterium tuberculosis in health care settings. Morb Mortal Weekly Reports.
2005;54(RR17):1-141.

Sterilizing Device Monitoring

Phase IIAll sterilizing devices are monitored periodically with a biologic indicator (or chemical
equivalent) for effectiveness of sterility under conditions that simulate actual use.
NOTE: Each sterilizing device must be monitored periodically with a biologic indicator to measure
the effectiveness of sterility. Chemical indicators that reflect sporicidal conditions may be used.
The test must be performed under conditions that simulate actual use. One recommended
method is to wrap the Bacillus stearothermophilus spore indicator strip in packaging identicalto that used for a production run, and to include the test package with an actual sterilization
procedure. Weekly monitoring is recommended.
Evidence of Compliance:✓
Written procedure for monitoring sterilizing devices AND✓
Records of monitoring at defined frequency

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FIRE PREVENTION AND PROTECTION
Inspector Instructions:
●
●
●

●
●
●
●
●

GEN.75100

Sampling of safety policies and procedures
Sampling of employee fire safety training records
Sampling of employee fire extinguisher training records

Automatic fire extinguisher systems, if required
Two exit access doors, if required
Audible automatic fire detection and alarm system
Fire alarm station
Portable fire extinguishers, where appropriate

Fire Prevention Policies and Procedures

Phase II

Policies and procedures are written and adequate for fire prevention and control.
NOTE: Fire safety plans must include the use of alarms, response to alarms, isolation of the fire,evacuation of the area, extinguishment of the fire, and the responsibilities of laboratory personnel
for those elements.
REFERENCES
1) Stern A, et al. Fire safety in the laboratory: part I. Lab Med. 1993;24:275-277
2) Stern A, et al. Fire safety in the laboratory: part II. Lab Med. 1993;24:350-352
3) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document4)

GEN.75200

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204

Fire Separation

Phase II

The laboratory is properly separated from inpatient areas and/or provided with automatic
fire extinguishing (AFE) systems.
NOTE: For those facilities with no inpatients, no AFE is required.
For those facilities with inpatients, where the laboratory is separated by two-hour construction(rated at 1.5 hours) and Class B self-closing doors (SCD), no AFE system is required. An
AFE system is required for those laboratories separated from inpatient areas by one-hour
construction and class C SCD if flammable and combustible liquids are stored in bulk. An AFE
system is always required if there are unattended laboratory operations employing flammable or
combustible reagents. "Stored in bulk" means more than two gallons (7.5 L) of Class I, II, and IIIA
liquids in safety cabinets and safety cans per 100 ft² (9.2 m²), or half that amount if not in safetycontainers. The following are the definitions of these Classes:
Class I flammable: any liquid that has a closed-cup flash point below 37.8°C and a Reid vapor
pressure not exceeding 2068.6 mm Hg at 37.8°C as determined by ASTM D 323
Class II combustible: any liquid that has a flash point at or above 37.8°C and below 60°C
Class IIIA combustible: any liquid that has a flash point at or above 60°C but below 93°C
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204
2) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

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GEN.75300

Fire Exit

08.17.2016

Phase II

Each room larger than 1000 ft² (92.9 m²), or in which major fire hazards exist, has at least
two exit access doors remote from each other, one of which opens directly into an exit
route.
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204
2) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

GEN.75400

Fire Safety Training

Phase II

Fire safety training is performed for new employees, with a fire safety review conducted atleast annually.
NOTE: Fire safety training must be recorded for all employees to show that they have been
instructed on use and response to fire alarms and to execute duties as outlined in the fire safety
plan. While fire exit drills are not required, physical evaluation of the escape routes must be
performed annually, to ensure that fire exit corridors and stairwells are clear and that all fire exit
doors open properly (i.e., not rusted shut, blocked or locked). Paper or computerized testingof an individual's fire safety knowledge on the fire safety plan is acceptable; all personnel must
participate at least once a year.
Evidence of Compliance:✓
Records of participation for all employees in fire safety plan review at least annually (e.g.
employee roster with dates of participation)
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204
2) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

**REVISED** 07/28/2015
GEN.75500 Fire Detection/Alarm

Phase II

There is an automatic fire detection and alarm system.
NOTE: 1. The system must connect to the facility's overall system, where such a system exists.
It must sound an immediate alarm in the event of smoke or fire. 2. The fire alarm is audible inall parts of the laboratory, including storage areas, lavatories, and darkrooms. 3. Laboratories
employing hearing-impaired persons must have other means to alert these individuals, such as avisual alarm system.
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204

GEN.75600

Fire Alarm Station

Phase II

There is a fire alarm station in or near the laboratory.
NOTE: Alarm stations must be visible, unobstructed, and accessible.
REFERENCES
1) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204
2) National Fire Protection Association. NFPA 45: Standard on Fire Protection for Laboratories Using Chemicals, Chapter 6. Quincy,3)

GEN.75700

MA: NFPA, 2004
National Fire Protection Association Standard 72: National Fire Alarm and Signaling Code, 2013 edition, Chapter 27.6

Fire Extinguishers

Phase II

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Appropriate portable fire extinguishers are provided for all areas in which flammable andcombustible liquids are stored or handled.
NOTE: If gallon bottles of such materials are used, the minimum rating for Class B extinguishers
is 10-B or higher. These are best located near or outside of doors leading to the area having
solvent fire hazards.
REFERENCES
1) National Fire Protection Association Standard 10: Standard for Portable Fire Extinguishers, 2013 edition
2) Stern A, et al. Fire safety in the laboratory. Part I. Lab Med. 1993;24:275-277
3) Stern A, et al. Fire safety in the laboratory. Part II. Lab Med. 1993;24:350-352
4) Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204

GEN.75800

Fire Extinguishers

Phase IIIf the fire safety plan includes laboratory staff use of fire extinguishers, personnel are
instructed in the use of portable fire extinguishers.
NOTE: It is strongly recommended that instruction include actual operation of extinguishers thatmight be used in the event of a fire, unless prohibited by the local fire authority.
Evidence of Compliance:✓
Records for fire extinguisher training
REFERENCES
1) Stern A, et al. Fire safety in the laboratory: part I. Lab Med. 1993;24:275-277
2) Stern A, et al. Fire safety in the laboratory: part II. Lab Med. 1993;24:350-352
3) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
4)5)

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
National Fire Protection Association Standard 10: Standard for Portable Fire Extinguishers, 2013 edition
Hoeltge GA, et al. Accidental fires in clinical laboratories. Arch Pathol Lab Med. 1993;117:1200-1204

ELECTRICAL SAFETY
Inspector Instructions:●

Sampling of electrical grounding records, if applicable**REVISED** 07/28/2015
GEN.75900 Electrical Grounding

Phase II

There are records that all laboratory instruments and appliances are adequately grounded
and checked for current leakage before initial use, after repair or modification, and when aproblem is suspected.
NOTE: Exceptions to these requirements are as follows:
1. Devices protected by an approved system of double insulation or its equivalent. Suchdevices must be distinctively marked
2. Devices connected to wall receptacles or circuit breakers with ground-fault circuit
interrupter (GCFI) protection built-in need not be checked for current leakage
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Verification of electrical safety is required whenever the electrical/electronic systems of apowered device has been removed or altered. Hospital laboratories may follow ground checks
and current leakage checks as performed in patient locations.
In addition, the US Occupational Safety and Health Administration (OSHA) requires that powercords of portable electrical equipment be visually inspected for external defects wheneverrelocated. Grounding configurations may not be bypassed by, for example, an adapter thatinterrupts the continuity of the grounding. If manufacturer's recommendations for grounding areavailable, they must be followed.
REFERENCES
1) Occupational Safety and Health Administration. Electrical. Use of equipment. US Government Printing Office, 1999(Jul 1):[29CFR1910.334]

CHEMICAL SAFETY
Inspector Instructions:
●
●

●
●
●
●

Sampling of chemical safety policies and procedures
Sampling of SDS (formerly MSDS) sheets

Flammable and combustible liquids (properly stored)
Acids and bases (properly stored)
Sampling of hazardous chemicals (labeling)
PPE usage**REVISED** 07/28/2015
GEN.76000 Chemical Hygiene Plan

Phase II

The laboratory has a Chemical Hygiene Plan (CHP) that defines the safety policies andprocedures for all chemicals used in the laboratory.
NOTE 1: The laboratory director or designee must ensure that the laboratory has a written
chemical hygiene plan (CHP) that defines the safety policies for all chemicals used in thelaboratory. The plan must include evaluation of carcinogenic potential, reproductive toxicity, andacute toxicity. The plan must include specific handling requirements for all hazardous chemicals
used in the laboratory.
The purpose of the CHP is to ensure that the hazards of all chemicals are evaluated, and that
information concerning their hazards is transmitted to employers and employees. This transmittalof information is to be accomplished by means of comprehensive hazard communication
programs, which are to include container labeling and other forms of warning, safety data sheetsand employee training. An acceptable CHP contains the following elements:
1.
2.
3.
4.
5.
6.
7.

Responsibilities of the laboratory director and supervisors
Designation of a chemical hygiene officer
Policies for all operations that involve chemicals
Criteria for the use of personal protective equipment and control devices
Criteria for exposure monitoring when permissible levels are exceeded
Provisions for medical consultations and examinations
Provision for training anyone working in the laboratory on the elements of the CHP

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8. A copy of the OSHA Laboratory Standard, for laboratories subject to US regulations,or (for non-US laboratories) a copy of appropriate local standard
9. Evaluation of the carcinogenic potential, reproductive toxicity and acute toxicity for
all chemicals used in the laboratory. The product label, safety data sheet (SDS), orfor chemicals purchased prior to June 1, 2015 with no appropriate SDS, records ofinvestigation by the safety officer may be used for this evaluation.
10. Specific handling requirements for all hazardous chemicals used in the laboratory
NOTE 2: For laboratories subject to US regulations, chemicals that must be handled as potential
carcinogens include those defined by OSHA as "select carcinogens." OSHA defines selectcarcinogens as any substance that is:
1. Regulated as a carcinogen by OSHA, has been classified as "known to becarcinogenic" by the NTP, or listed as a group I carcinogen by the IARC
2. Has been classified as "reasonably anticipated to be carcinogenic" by the NTP or
listed as a group 2A or 2B carcinogen by the IARC if it meets the toxicological criteria
listed in the January 31, 1990 Fed Register, pages 3319-3320
OSHA also requires special containment procedures for substances that are reproductive toxinsor are acutely hazardous.
Authoritative sources include (but are not limited to) OSHA (Code of Federal Regulations. Title
29, Part 1910.1200 and 1450); NIOSH (Registry of Toxic Effects of Chemical Substances); theNational Toxicology Program; the International Agency for Research on Cancer, and Safety Data
Sheets.
Evidence of Compliance:✓
Written evaluation of chemicals used in the laboratory for carcinogenic potential, reproductive
toxicity and acute toxicity AND✓
Written procedure for chemical fume hood function verification AND✓
Records of testing
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances hazard communication: standard. 2012:
2)
3)
4)
5)

[29CFR1910.1200]
Occupational Safety and Health Administration. Occupational exposures to hazardous chemicals in laboratories: standard. 2012:[29CFR1910.1450]
Karcher RE. Is your chemical hygiene plan OSHA-proof? Med Lab Observ. 1993(Jul):29-36
Occupational Safety and Health Administration. Occupational exposure to methylene chloride: standard. 1997:[29CFR1910;1915;1926]
Prinz Luebbert P. Q&A. Wearing laboratory coats during break. Lab Med. 1999;30:710**REVISED** 07/28/2015
GEN.76100 Chemical Safety Document Access

Phase II

Employees have access to all of the following documents.
1. Current Safety Data Sheets (formerly MSDS) and other references that list thedetails of hazards and the precautions for safe handling and storage
2. Chemical Hygiene Plan of the laboratory
3. Code of Federal Regulations, Title 29 part 1910.1450 and its appendices(laboratories subject to US regulations only)
NOTE: It is acceptable for SDS information to be electronically available to users, rather than inbook format; there is no requirement for paper-based information. Indeed, electronic manuals
have the advantage of more accurately reflecting current requirements. The central point isimmediate availability to all personnel at all times.
**REVISED** 07/28/2015
GEN.76200 Chemical Precautionary Labels

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Precautionary labels are present on the containers of all hazardous chemicals, indicatingtype of hazard and what to do if accidental contact occurs.
NOTE: The laboratory may use signs, placards, process sheets, batch tickets, operatingprocedures, or other such written materials in lieu of affixing labels to individual stationary
process containers, as long as the alternative method identifies the containers to which it isapplicable and conveys the information otherwise required to be on a label. The written materials
shall be readily accessible to the employees in their work area throughout each work shift. It is
not required to label portable containers into which hazardous chemicals are transferred fromlabeled containers, and which are intended only for the immediate use of the employee who
performs the transfer. Existing labels on incoming containers of hazardous chemicals shall not be
removed or defaced, unless the container is immediately marked with the required information.
Additional requirements for the labeling and expiration date of chemicals used for the preanalytic
and analytic testing process, such as reagent preparation, are included in the Reagents
section of the All Common Checklist. Deficiencies cited relating to the labeling and expiration ofchemicals are cited in the checklist section where the chemicals are used.
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Hazard communication. Washington, DC: US
Government Printing Office, 2007(Jan 1): [29CFR1910.1200]

GEN.76300

PPE And Hazardous Materials

Phase II

Personnel use the proper personal protective devices when handling corrosive,
flammable, biohazardous, and carcinogenic substances.
NOTE: Such devices may include gloves of appropriate composition, aprons, and eye protection.
Shoes or shoe covers must protect the entire foot in areas where splashing is expected.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

GEN.76400

Chemical Hazard Emergencies

Phase II

Explicit instructions are posted, and appropriate supplies available, for the emergency
treatment of chemical splashes and injuries and the control of chemical spills wherever
major chemical hazards exist.
NOTE: Spill kits must be handled in accordance with manufacturer's instructions. If no expiration
date is assigned, the spill kit must indicate the date it was put into service and the laboratory
director or designee must periodically assess its usability.
REFERENCES
1) Occupational Safety and Health Administration. Hazardous materials. Hazardous waste operations and emergency response. US
2)

GEN.76500

Government Printing Office, 1999(Jul 1): [29CFR1910.120]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

Flammable Storage

Phase II

Supplies of flammable and combustible liquids are reasonable for the laboratory's needs,
and are properly stored.
NOTE: 1. In each laboratory area, up to one gallon (3.7 L) of Class I, II and IIIA liquids may
be stored outside of fire-resistant cabinets for each 100 ft² (9.2 m²) of space defined by fireresistant walls/doors. Up to two gallons (7.5 L) of Class I, II, and IIIA liquids may be stored insafety cans and safety cabinets for each 100 ft² (9.2 m²).These amounts may be doubled if
there is an automatic fire suppression system (e.g. sprinklers). For example: a 1000 ft² (92.9

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08.17.2016m²) laboratory defined by fire resistant walls/doors can store 10 gallons (37.8 L) outside a safetycabinet and 20 gallons (75.7 L) inside a safety cabinet and double those numbers if there is an
automatic fire suppression system. 2. Safety cans should be used for bulk storage of flammableand combustible liquid (National Fire Protection Association classes I and II). Metal or DOTapproved plastic containers provide an intermediate level of hazard containment between glassand safety cans. One pint (0.4 L) of a highly volatile solvent such as isopentane, stored in glass
has about the same ignitability risk as two gallons (7.5 L) stored in safety cans. Safety cansshould be used instead of glass bottles if the purity required does not mandate glass storage.
REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

GEN.76600

Volatile Solvent Ventilation

Phase II

Storage areas and/or rooms where volatile solvents are used are adequately ventilated.
NOTE: Areas where flammable liquids are used must be ventilated for protection of employee
health, as well as fire prevention. Areas where flammable liquids are stored should be ventilated
primarily for fire protection. Storage cabinets do not need to be vented, but if they are vented theduct system must be explosion proof.
REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition**REVISED** 07/28/2015
GEN.76700 Acid/Base Storage

Phase II

Supplies of concentrated acids and bases are stored safely.
NOTE: 1) Storage must be below eye level. Storage near the floor is recommended. 2) Strong
acids and bases must not be stored under sinks, where contamination by moisture may occur.
3) Storage containers of acids and bases should be adequately separated to prevent a chemical
reaction in the event of an accident/spill/leak. 4) Bottle carriers are used to transport all glass
containers larger than 500 mL that contain hazardous chemicals.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

COMPRESSED GASES
Inspector Instructions:●GEN.76800

Gas cylinders (properly stored and secured)Gas Cylinder Storage

Phase II

Compressed gas cylinders are secured to prevent accidental falling and damage to thevalve or regulator.
GEN.76900

Flammable Gas Cylinders

Phase II

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Flammable gas cylinders, if inside a health care facility, are stored properly.
NOTE: Proper storage practices include:
1. Storage in a separate, ventilated room or enclosure
2. Cylinders are positioned well away from open flame or other heat sources, not in
corridors and not within exhaust canopies
REFERENCES
1) National Fire Protection Association Standard 55: Compressed Gases and Cryogenic Fluids Code, 2013 edition

RADIATION SAFETY
Inspector Instructions:●GEN.77000

Sampling of radiation safety policies and procedures

Radiation Safety Manual

Phase II

There are written policies and procedures adequate for radiation safety.
NOTE TO INSPECTOR: The following requirement applies to laboratories that do not perform anatomic
pathology on-site, and for whom the Anatomic Pathology checklist is not used.
GEN.77100

Radioactive Material HandlingPhase II

There are specific policies and procedures for the safe handling of tissues that may
contain radioactive material (e.g. sentinel lymph nodes, breast biopsies, prostate "seeds",etc.).
NOTE: These policies and procedures should be developed in conjunction with the institutionalradiation safety officer, and must comply with any state regulations for the safe handling oftissues containing radionuclides. The policies and procedures should distinguish between low
radioactivity specimens such as sentinel lymphadenectomy and implant devices with higher
radiation levels.
REFERENCES
1) Glass EC, et al. Editorial: radiation safety considerations for sentinel node techniques. Ann Surg Oncol. 1999:6:10
2) Miner TJ, et al. Guideline for the safe use of radioactive materials during localization and resection of sentinel lymph nodes. Ann Surg
3)
4)
5)
6)

Oncol. 1999;6:75-82
Cibull ML. Handling sentinel lymph node biopsy specimens. A work in progress. Arch Pathol Lab Med. 1999;123:620-621
Pfeifer JD. Sentinel lymph node biopsy. Am J Clin Pathol. 1999;112:599-602
Barnes CA. False-negative frozen section results. Am J Clin Pathol. 2000;113:900
Fitzgibbons PL, et al. Recommendations for handling radioactive specimens obtained by sentinel lymphadenectomy. Am J Surg
Pathol. 2000;24:1549-1551

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ENVIRONMENTAL SAFETY
Inspector Instructions:GEN.77200●

Ergonomic evaluation●

Emergency eyewash available and tested properly●

How does your laboratory prevent workplace-related musculoskeletal disorders?

Ergonomics

Phase II

There is a written ergonomics program to prevent musculoskeletal disorders (MSDs) in
the workplace through prevention and engineering controls.
NOTE: The program may include training of employees about risk factors, identifying physicalwork activities or conditions of the job commonly associated with work-related MSDs, andrecommendations for eliminating MSD hazards. Laboratory activity, workplace and equipment(e.g. chairs, laboratory workstations, computer keyboards, and displays) should be designed toreduce the risks of ergonomic distress disorders and accidents.
Evidence of Compliance:✓
Records of ergonomic evaluation including recommendations for eliminating MSD hazards
and appropriate corrective action based on assessment findings
REFERENCES
1) Gile TJ. Ergonomics in the laboratory. Lab Med. 2001;32:263-267
2) U.S. Dept. of Labor, Occupational Safety and Health Administration. Ergonomic safety and health program management guideline.
54 Fed Register 3904 (1989), modified at 29CFR1910)

GEN.77300

Excessive Noise

Phase II

The laboratory has a policy to protect personnel from excessive noise levels.
NOTE: The laboratory should provide protection against the effects of noise exposure whensound levels equal or exceed an 8-hour time-weighted average sound level of 85 decibels. The
laboratory should monitor noise exposure if there is an indication that excessive noise levels arepresent (for example, when noise levels exceed 85 decibels, people have to shout to be heard).
REFERENCES
1) U. S. Department of Labor, Occupational Safety & Health Administration: http://www.osha.gov/pls/oshaweb/
owadisp.show_document?p_id=9735&p_table=STANDARDS**REVISED** 07/28/2015

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GEN.77400

Emergency Eyewash

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Phase II

The laboratory has adequate plumbed or self-contained emergency eyewash facilities inevery area where there are hazardous chemicals as defined by the laboratory's chemical
hygiene plan (e.g. chemicals that are irritating, corrosive, toxic by contact or absorption).
Testing records are maintained.
NOTE 1: The eyewash facility includes the following:
1. No greater than 10 seconds travel distance from areas in the laboratory where
hazardous chemicals are present
2. Capable of delivering 1.5 L per minute for 15 minutes
3. Flow is provided to both eyes simultaneously
4. Nozzles or covers to protect from airborne contaminants
5. Hands-free flow once activated
6. Signage for location of eyewash
7. Unobstructed path with unlocked doors opening in the direction of the eyewash
8. Plumbed systems are protected from unauthorized shut off
9. Tepid fluid temperature (Water temperature should be between 15°C and 37°C (60°F
and 100°F). Actual temperature recording is not required.)
10. Plumbed systems are activated weekly
11. Self-contained units are visually examined weekly
NOTE 2: The manufacturer's specifications should be available.
REFERENCES
1) American National Standards Institute. Emergency eyewash and shower equipment. New York, NY: ANSI, 20049;Z358.1
2) Occupational Safety and Health Administration. Medical and first aid. Medical services and first aid. US Government Printing Office,1998(June 18):[29CFR1910.151(c)]OTHER HAZARDS
Inspector Instructions:GEN.77500●

Sampling of safety policies and procedures●

UV light signage

Liquid Nitrogen

Phase II

Adequate policies, procedures, and practices are in place for the use of liquid nitrogen.
NOTE: Practices for the safe handling of liquid nitrogen include:
1. The mandatory use of appropriate gloves, shielding of all skin and the use of a faceshield when decanting or entering an open container of LN
2. Storage and use of all containers of LN only in well-ventilated areas
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REFERENCES
1) OSHA Quick Facts: Laboratory Safety Cryogens and Dry Ice. Occupational Safety and Health Administration Website. https://www.osha.gov/Publications/laboratory/OSHAquickfacts-lab-safety-cryogens-dryice.pdf. Reviewed October 2011. Accessed
11/24/2015.

GEN.77600

UV Light Exposure

Phase II

There are written policies and procedures to prevent or reduce ultraviolet light exposure
from instrument sources.
NOTE: UV light may cause corneal or skin burns from direct or deflected light sources. Wherever
UV light sources are used, suitable and adequate personal protective equipment must be
provided, and appropriate approved signage displayed. Laboratories may obtain information on
safety from manufacturers of devices that emit UV light.
A suggested sign for display is: Warning: This device produces potentially harmful ultraviolet(UV) light. Protect eyes and skin from exposure.
Evidence of Compliance:✓
Warning signage on source equipment AND✓
Suitable PPE available, as required
REFERENCES
1) Fleming DO, et al. Laboratory safety. Principles and practices, 2nd ed. Washington, DC: American Society for Microbiology, 1995

GEN.77700

Latex Allergy

Phase II

The laboratory has a written program to protect personnel and patients from allergic
reactions from exposures to natural rubber latex in gloves and other products.
NOTE: The latex program should address at least the following elements:
1. Selection of products and implementation of work practices that reduce the risk ofallergic reactions. If latex gloves are used, the employer should provide reduced
protein, powder-free gloves to protect workers from infectious materials
2. Provision of education programs and training materials about latex allergy
3. Evaluation of current prevention and control strategies whenever a worker isdiagnosed with latex allergy
Evidence of Compliance:✓
Records of employee education/training on latex allergies AND✓
Records of evaluation of the plan, when appropriate
REFERENCES
1) Bauer X, et al. Health risk in hospitals through airborne allergens for patients pre-sensitized to latex. Lancet. 1993;342:1148-1149
2) Yassin ME, et al. Latex allergy in hospital employees. Ann Allergy. 1994;72:245-249
3) Tomazic VJ, et al. Cornstarch powder on latex products is an allergen carrier. J Allergy Clin Immunol. 1994;93:751-758
4) Yunginger JW, et al. Extractable latex allergens and proteins in disposable medical gloves and other rubber products. J Allergy Clin
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)

Immunol. 1994;93:836-842
Mendyka BE, et al. Latex hypersensitivity: an iatrogenic and occupational risk. Am J Crit Care. 1994;3:198-201
Valentino VM, et al. Latex-induced asthma in four healthcare workers in a regional hospital. Occup Med. 1994;44:161-164
Tarlo SM, et al. Control of airborne latex by use of powder-free latex gloves. J Allergy Clin Immunol. 1994;93:985-989
Personius CD. Patients, health care workers, and latex allergy. Med Lab Observ. 1995;27(3):30-32
Vandenplas O, et al. Latex gloves with a lower protein content reduce bronchial reactions in subjects with occupational asthma
caused by latex. Am J Respir Crit Care Med. 1995;151:887-891
Thomson CM. The potential risks of latex. Brit Med J. 1996;6(5):12-14
Ownby DR, et al. The prevalence of anti-latex IgE antibodies in 1000 volunteer blood donors. J Allergy Clin Immunol.
1996;97:1188-1192
Kaczmarek RG, et al. Prevalence of latex-specific IgE antibodies in hospital personnel. Allergy Asthma Immunol. 1996;76:51-56
Liss GM, et al. Latex allergy: epidemiological study of 1351 hospital workers. Occup Environ Med. 1997;54:335-342
Leung R, et al. Prevalence of latex allergy in hospital staff in Hong Kong. Clin Exp Allergy. 1997;27:167-174
The National Institute for Occupational Safety and Health (NIOSH). Alert. Preventing allergic reactions to natural rubber latex in theworkplace. Washington, DC: DHHS publication 97-135, Jun 1997
Sussman GL, et al. Incidence of latex sensitization among latex glove users. J Allergy Clin Immunol. 1998;101:171-178
Sainato D. The irritation of latex allergy. Labs should be aware of causes and solutions. Clin Chem News. 1999;25(7):1-10

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08.17.201618) Graves PB. Latex allergy: a laboratory view. Amer Clin Lab. 2000;19(2):16-17
19) Carroll P, Celia F. What you need to know about latex allergy. Med Lab Observ. 2000;32(7):64-66

WASTE DISPOSAL
Inspector Instructions:●

Sampling of waste disposal policies and procedures●

How does your laboratory dispose of sharps?
How does your laboratory dispose of hazardous chemicals?

●GEN.77800

Hazardous Chemical Waste Disposal

Phase II

Written policies and procedures are adequate for hazardous chemical waste disposal.
NOTE: 1. The laboratory is responsible for all real or potential hazards of wastes at all stagesof disposal including transportation and final disposition. 2. The method for the disposal of
all solid and liquid wastes is in compliance with local, state and federal regulations. (Whether
or not laboratory management is responsible for waste disposal, the laboratory should havedocumentation that the facility is in compliance with all applicable regulations. Prevailing local,
state and federal (EPA) regulations should be reviewed by the laboratory director, safety officer
or hospital engineer to ensure that the laboratory is in compliance with regulations.)
Evidence of Compliance:✓
Records of review of regulations for compliance
REFERENCES
1) Ornelas D, et al. The laboratory's role in reducing hazardous waste. Lab Med. 1998;29:287-290
2) Ornelas D, et al. The role of recycling and chemical substitution in pollution prevention programs. Lab Med. 1998;29:356-359
3) Reinhart DR, McCreanor PT. Medical waste management: where does the solid waste go? Lab Med. 2000;31:141-145
4) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

GEN.77900

Biohazard Disposal Containers

Phase II

All infectious wastes (e.g. glassware, blood collection tubes, microbiologic and tissue
specimens) and other solid or liquid waste or refuse are discarded into "biohazard"labeled containers that do not leak and have solid, tight-fitting covers that are applied
before transport from the laboratory work area for storage and disposal.
NOTE: All infectious wastes must be incinerated or appropriately decontaminated before being
sent to a sanitary landfill. Stool and urine waste may be discarded into the sanitary seweragesystem.
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
2)

Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

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Sharps Disposal

Phase II

Sterile syringes, needles, lancets, or other blood-letting devices ("sharps") that arecapable of transmitting infection are used once only, and all waste sharps are discardedin puncture-resistant containers that are easily accessible, located in areas where needles
are commonly used, and properly labeled to warn handlers of the potential hazard.
NOTE: Shearing or breaking of contaminated sharps is prohibited. Bending, recapping, or
removing contaminated needles is prohibited as a general practice. Needles are expected to be
used and immediately discarded, un-recapped, into accessible sharps containers.
REFERENCES
1) Bush VJ, et al. Advancements in blood collection devices. Lab Med. 1998;29:616-622
2) Dale JC, et al. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo
3)
4)
5)

Clinic Rochester. Mayo Clin Proc. 1998;73:611-615
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Occupational Safety and Health Administration. Enforcement procedures for the occupational exposure to bloodborne pathogens.
Washington, DC: U.S. Government Printing Office, OSHA Directive CPL 2-2.44D, 1999 (Nov 5)
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

BIOREPOSITORIESINTRODUCTION
The General Checklist applies to all sections of the biorepository. An inspection of a biorepository section or
department will include the Biorepository Checklist.
The requirements in this section only apply to biorepositories enrolled in the Biorepository Accreditation
Program.

POLICIES AND PROCEDURES
Inspector Instructions:
●

●
●

●
●
●
●
●

Representative sample of procedures for completeness and biorepository director
review. Current practice must match contents of policies and procedures.
Document control policy
Privacy and confidentiality policies and procedures
How do you access procedures?
What procedure has most recently been implemented or modified?
How do you ensure all copies of procedures are up to date?
How are changes in procedures recorded and communicated to staff?
How does the facility protect patient information?

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Identify a newly implemented procedure in the prior two years and follow the steps
through authoring, director review and staff training**NEW** 08/17/2016
GEN.80000 Procedure Manual

Phase II

A complete procedure manual is available in a paper-based, electronic, or web-basedformat at the workbench or in the work area.
NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a procedure
manual. However, such inserts may be used as part of a procedure description, if the insert
accurately and precisely describes the procedure as performed in the biorepository. Any variationfrom this printed or electronic procedure must be detailed in the procedure manual. In all cases,
appropriate reviews must occur.
NOTE 2: A manufacturer's procedure manual for an instrument/reagent system may be
acceptable as a component of the overall departmental procedures. Any modification to or
deviation from the procedure manual must be clearly recorded and approved.
NOTE 3: Card files or similar systems that summarize key information are acceptable for use as
quick reference at the workbench provided that:■
A complete manual is available for reference■
The card file or similar system corresponds to the complete manual and issubject to document control
NOTE 4: Electronic manuals accessed by computer are fully acceptable. There is no requirement
for paper copies to be available for the routine operation of the biorepository as long as theelectronic versions are readily available to all personnel and personnel have been trained on
how to access them. However, procedure manuals must be available to biorepository personnel
when the electronic versions are inaccessible (e.g. during biorepository information system or
network downtime); thus, the biorepository must maintain paper copies, electronic copies on CDor other digital media, or have an approved alternative mechanism to access web-based files
during network downtimes. All procedures, in either electronic or paper form, must be readily
available for review by the inspector at the time of the CAP inspection.
Electronic procedure manuals and electronic copies of procedures are subject to proper
document control (see GEN.80600), and there must be records of biennial review. Records ofreview of electronic procedures may include statements such as “reviewed by [name of reviewer]on [date of review]” in the electronic record. Alternatively, paper review sheets may be used torecord review of electronic procedures. Record of review by a secure electronic signature is NOT
required.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Development and Management of Laboratory
Documents; Approved Guideline - Sixth Edition. CLSI document QMS02-A6 (ISBN 1-56238-869-X). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2013.

**NEW** 08/17/2016
GEN.80100 Policy/Procedure - Confidentiality

Phase II

Policies and procedures are in place to minimize the risk to individuals from whom thespecimens and data were obtained and to protect their privacy and confidentiality.
**NEW** 08/17/2016
GEN.80200 Policy and Procedure Review

Phase II

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There are records of review of all technical policies and procedures by the current director
or designee at least every two years.
NOTE: Only technical policies and procedures are addressed in this requirement. Biennial review
is not required for other controlled documents.
The director must ensure that the collection of policies and procedures is complete, current,and has been thoroughly reviewed by a knowledgeable person. Technical approaches mustbe scientifically valid and clinically relevant. To minimize the burden on the biorepository andreviewer(s), it is suggested that a schedule be developed whereby roughly 1/24 of all policies
and procedures are reviewed monthly. Paper/electronic signature review must be at the level ofeach procedure, or as multiple signatures on a listing of named procedures. A single signature ona Title Page or Index is not a sufficient record that each policy or procedure has been carefully
reviewed. Signature or initials on each page of a policy or procedure is not required.
**NEW** 08/17/2016
GEN.80300 New Procedure Review

Phase II

The director reviews and approves all new policies and procedures, as well as substantialchanges to existing documents, before implementation.
NOTE: Current practice must match the policy and procedure documents.
**NEW** 08/17/2016
GEN.80400 New Director Procedure Review

Phase IIIf there is a change in directorship of the biorepository, the new director ensures (overa reasonable period of time) that biorepository procedures are well documented andundergo appropriate review.
**NEW** 08/17/2016
GEN.80500 Knowledge of Policies and Procedures

Phase II

The biorepository has a defined process and records indicating that all personnel areknowledgeable about the contents of the policies and procedures (including changes)
relevant to the scope of their biorepository activities.
NOTE: This does not specifically require annual procedure sign-off by testing personnel. The
form of this system is at the discretion of the director.
Evidence of Compliance:✓
Relevant quizzes and results OR record confirming competency AND✓
Systems to record policy and procedure changes AND✓
Records of receipt/training in either paper or electronic format
GEN.80600

Document Control

Phase II

The biorepository has a document control process to manage policies, procedures, andforms that are subject to CAP accreditation.
NOTE: The document control system must ensure that only current policies, procedures, andforms are in use.
It may be helpful for some biorepositories to maintain a control log listing all current policies,
procedures, and forms with the locations of copies. The control log may contain other information
as appropriate, such as dates when policies and procedures were placed in service, schedule99 of 129
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of review, identity of reviewer(s), and dates when policies and procedures were discontinued orsuperseded.
Evidence of Compliance:✓
Electronic documents on a shared file OR commercial document system OR a biorepository
developed organized system
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Development and Management of Laboratory
2)

Documents; Approved Guideline - Sixth Edition. CLSI document QMS02-A6 (ISBN 1-56238-869-X). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2013.
ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence. Geneva, Switzerland: International
Organization for Standardization, 2003**NEW** 08/17/2016
GEN.80700 Discontinued Procedure

Phase II

When a procedure is discontinued or replaced, a paper or electronic copy is maintained
for at least two years, recording initial date of use, and retirement date.

QUALITY MANAGEMENT
The biorepository must have a written quality management program to systematically ensure the qualityof services. In biorepositories that are part of a larger institution (e.g. a hospital), the biorepository quality
management program may be integrated with the institutional program.

Inspector Instructions:
●
●
●
●
●

●

CAP sign regarding the reporting of quality concerns●

How are IRB and client concerns and recommendations addressed? What were theresults and what actions were taken as a result of the findings?
Is there a specific example when problems were identified that could have interferedwith participant/client care or safety?

●●

GEN.81000

Sampling of QM policies and procedures
Procedure for communication of employee concerns
Sampling of quality indicators with follow-up actions when targets are not achieved
Annual appraisal of effectiveness of the QM Program
Records of instructions/recommendations from IRBs and clients

If any problems are found during review of quality measurements, or when asking
questions, further evaluate the biorepository's investigation and resolution, including
root cause analysis and associated risk-reduction activities when applicable

Written QM Program
The biorepository has a written quality management (QM) program.

Phase II

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NOTE: There must be a document that describes the overall QM program. The document neednot be detailed, but should spell out the objectives and essential elements of the QM program.
If the biorepository is part of a larger organization, the biorepository QM program is coordinatedwith the organization's QM plan.
REFERENCES
1) ISO Standards compendium: ISO 9001:2000, Quality management systems -- Requirements. Geneva, Switzerland: International
2)

GEN.81100

Organization for Standardization, 2000
ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence. Geneva, Switzerland: International
Organization for Standardization, 2003

QM Implementation

Phase IIThe QM plan is implemented as designed and is reviewed annually by the director for
effectiveness.
NOTE: 1) This requirement pertains to biorepositories that have been CAP accredited for morethan 12 months. 2) Appraisal of program effectiveness may be evidenced by an annual written
report, revisions to policies and procedures, or revisions to the QM plan, as appropriate.
Evidence of Compliance:✓
Evidence that the plan has been implemented as designed requires all of the following:●
quality measurements and assessments specified in the plan are being substantially
carried out;●
there is evidence of active review of quality measurements;●
any interventions or changes to operations that are specified in the plan have been
carried out as scheduled, or the reason for delay recorded; AND●
any communication of information that is required by the plan have taken place
GEN.81200

QM Error and Incident Management

Phase IIThe QM system includes a program to identify and evaluate errors, incidents, and otherproblems that may interfere with functions of the biorepository.
NOTE: There must be an organized program for recording of problems involving thebiorepository that are identified internally, as well as those identified through outside sources
such as complaints from other study collaborators or researchers. Any problem that could
potentially interfere with research result integrity or safety must be addressed. Scientific impact,
rather than business or management issues, should be emphasized.
The biorepository must:
1. Record investigation and resolution of these problems
2. Perform root cause analysis of any unexpected sentinel events
3. Be able to demonstrate any appropriate risk-reduction activities based on such root
cause analyses
REFERENCES
1) ISO International Standard 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International
2)

GEN.81300

Organization for Standardization, 2003 (4.8)
ISO International Standard 14971: Medical devices—Application of risk management to medical devices. Second edition, 2007-03-01

QM Indicators of Quality

Phase IIThe QM program includes monitoring key indicators of quality.
NOTE: Key indicators are those that reflect activities critical to expected outcome or that havebeen problematic in the past. The biorepository must record comparison of performance of
selected indicators against a benchmark, where available and applicable. New programs orservices should be measured to evaluate their impact on service. The number of monitored101 of 129
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indicators should be consistent with the biorepository's scope of service. Action plans should be
developed for any indicator in which the biorepository falls outside a predetermined level.
**NEW** 08/17/2016
GEN.81325 Correction of Biorepository Records

Phase II

The biorepository follows a written policy for the management and correction ofbiorepository records, including quality control data, temperature logs, and intermediate
test results or worksheets.
NOTE: Biorepository records and changes to such records must be legible and indelible. Original(erroneous) entries must be visible (i.e. erasures, white and correction fluid are unacceptable)or accessible (e.g. audit trail for electronic records). Corrected data, including the identity of theperson changing the record and when the record was changed, must be accessible to audit.
Evidence of Compliance:✓
Records of corrections to biorepository records following the policy**REVISED** 07/28/2015
GEN.81350 Hand-Off Communication

Phase IThe biorepository implements a procedure for effective “hand-off” communication.
NOTE: The biorepository must have a procedure for communicating information about pending
processes, quality or operational issues when responsibility is “handed off” from one person toanother, such as at a change in shift, or when the responsibility for a case is transferred fromone pathologist to another. The procedure should include provision for asking and responding toquestions.
Evidence of Compliance:✓
Logs or message boards showing communication between shifts or departments
GEN.81400

Employee Quality Communication

Phase II

The biorepository has a procedure for employees, participants, and researchers tocommunicate concerns about research misconduct, quality, and safety to management.
NOTE: The biorepository must have a procedure that encourages employees to communicate
any concerns or complaints with respect to the research misconduct, quality and safety. The
investigation and analysis of employee complaints and suggestions, with corrective or preventive
action as appropriate, should be a part of the quality management program and be specificallyaddressed in quality management records.
Evidence of Compliance:✓
Records of employee complaints (if any) with appropriate follow up
GEN.81500

CAP Sign

Phase II

The biorepository posts the official CAP sign regarding reporting of quality concerns.
NOTE: The biorepository must prominently post the official CAP sign regarding the reporting of
quality concerns to CAP.
While personnel should report concerns to biorepository management, the biorepository mustensure that all personnel know that they may communicate with CAP directly if they have aconcern not addressed by biorepository management, and that CAP holds such communications
in strict confidence. In addition, the biorepository must have a policy prohibiting harassment or102 of 129
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punitive action against an employee in response to a complaint or concern made to CAP or otherregulatory organization regarding biorepository quality or safety.
The dedicated, confidential CAP telephone line for quality or safety concerns is 866-236-7212(US, toll-free) and 847-832-7533 (international).
Official CAP signs may be obtained by calling 800-323-4040 option 1#.
GEN.81600

Customer Satisfaction

Phase I

Customer satisfaction with biorepository services was measured within the past 2 years.
Evidence of Compliance:✓
Records of physician/client satisfaction survey OR referral statistics OR complaint rates
GEN.81700

Notifications From Vendors

Phase II

The biorepository manages notifications from vendors of defects or issues with supplies
or software that may affect biobanking related efforts.
NOTE: Notifications may take the form of product recalls, market withdrawals, or software
patches and upgrades. The biorepository should take action on those that have the potential toaffect biorepository services.
Evidence of Compliance:✓
Records of manufacturer's recalls received AND✓
Follow-up records
GEN.81800

State/Local Regulations

Phase II

The biorepository has a policy for ensuring compliance with applicable international,
federal, state, and local laws and regulations.
NOTE: Applicable international, federal, state, and local requirements may include but are notlimited to the following areas: handling radioactive materials, shipping infectious or diagnostic
materials, personnel qualifications, retention of specimens and records, hazardous waste
disposal, fire codes, medical examiner or coroner jurisdiction, legal testing, acceptance ofspecimens only from authorized personnel, handling controlled substances, participant consent,
confidentiality of results, storing and handling Select Agents, proper storage of flammablematerials, donation of blood, complying with all safety issues for storage of bulk fuels, e.g.
diesel and liquid nitrogen, and whether a Material Transfer Agreement is needed. The checklists
contain specific requirements on these areas.
The biorepository may obtain information on applicable laws and regulations from multiple
sources, including hospital management, state medical societies, and state departments ofhealth.
**REVISED** 07/28/2015
GEN.81900 Terms of Accreditation

Phase II

The biorepository has a policy that addresses compliance with the CAP terms ofaccreditation.
NOTE: The CAP terms of accreditation are listed in the biorepository's official notification ofaccreditation. The policy must include notification of CAP regarding the following:
1. Investigation of the biorepository by a government entity or other oversight agency,
or adverse media attention related to biorepository performance; notification

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must occur no later than two working days after the biorepository learns of aninvestigation or adverse media attention. This notification must include any complaintinvestigations conducted or warning letters issued by any oversight agency (i.e. FDA,
OSHA, FAA).
2. Change in biorepository test menu (notification must occur prior to implementing
scope of service changes)
3. Change in location, ownership or directorship of the biorepository; notification mustoccur no later than 30 days prior to the change(s); or, in the case of unexpectedchanges, no later than two working days afterwards
Evidence of Compliance:✓
Records of notification, if applicable**REVISED** 07/28/2015
GEN.81950 Selection and Evaluation of Services

Phase II

There is a written procedure for evaluating and selecting biospecimen source sites,
contracted services, or referral laboratories, to ensure that specimens and test results aremanaged in a quality environment.
NOTE:
1. A written qualification process suitable for the process being performed is in place,e.g. vendor qualification, a system for the biorepository director to approve theservice provider.
2. Specimens used for patient treatment decisions, including those from clinical trials,
should be obtained or sent to a laboratory accredited by CAP, accredited to an
established international standard from a recognized organization, or certified by anappropriate government agency.
3. It is the responsibility of the biorepository director or designee to monitor the qualityof test results received from contracted services or referral laboratories.
Evidence of Compliance:✓
Records of evaluation or qualification (e.g. certification, publications, audits or biorepository
director-approved records of acceptable quality)

PERSONNEL
The biorepository should have an organizational chart, personnel policies, and job descriptions that define
qualifications and duties for all positions. Personnel files should contain records of educational qualifications,references, training, competency assessments, health records and continuing education records for each
employee. Ideally, these files should be located in the biorepository. However, they may be kept in the
personnel office or health clinic if the biorepository has ready access to them (i.e. they are easily available to theinspector).

Inspector Instructions:●●●

Sampling of personnel policies and procedures
Organizational chart or narrative description
Sampling of all personnel files

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Do you have a specific example of an employee who demonstrated unacceptablecompetency assessments? What were the corrective actions?
What continuing education classes are available to employees?

DIRECTOR QUALIFICATIONS
GEN.82000

Director Qualifications

Phase II

The qualifications of director of the biorepository are appropriate for the scope ofactivities.
NOTE: The organization's leadership must have defined the appropriate training, experience,
and/or educational credentials. The director's experience and qualifications must meet theinstitutional policy for the degree of responsibility acceptable to operate and manage the scope ofthe biorepository.
**REVISED** 08/17/2016
GEN.82100 Delegation of Functions

Phase I

Delegation of the biorepository director's functions or responsibilities is in writing.
NOTE: Functions that may be delegated include duties, such as review of QC processes,
ensuring that IRB protocols are followed, and implementation of the quality management plan.
The biorepository director remains responsible that all persons performing delegated functions
are qualified to do so and that delegated functions are properly carried out.
Functions that may not be delegated include provision of appropriately trained supervisory andtechnical staff and the identification of their responsibilities. The biorepository director must
document personal, on-site assessment of physical and environmental conditions and theadequacy of staffing.
The responsibilities and duties of supervisors, consultants, and personnel involved in thebiorepository services must be defined in writing, with records of authorization to perform theservices and the level of supervision required, as applicable.
If there are multiple occasions when delegated duties are not being properly performed by thedesignee and there is a lock of consistency in performing corrective action, the team leader
should cite this requirement as a deficiency, in addition to the specific checklist requirement(s)that relates to the duty not being performed (e.g. QC review). This may be overarching rather
than a single issue.
Evidence of Compliance:✓
Policy or statement signed by the biorepository director authorizing individuals by name or
job title to perform tasks on behalf of the biorepository director AND✓
Records showing that delegated tasks are performed by the designee, as required

DIRECTOR OVERSIGHT RESPONSIBILITIES
GEN.82200

Director Responsibility/Authority

Phase II

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The biorepository director has sufficient responsibility and authority to implement andmaintain the standards of the College of American Pathologists.
NOTE: Examples of how the team leader may obtain information on the director's responsibility
and authority include: interviews with the biorepository director, institution's administration,biorepository management and biorepository supervisory staff, review of the biorepositoryorganizational chart, and review of minutes of quality management and other biorepository
meetings.
GEN.82300

Effective QM

Phase II

The biorepository director ensures an effective quality management program for thebiorepository.
NOTE: The biorepository director must be involved in the design, implementation, and oversightof the biorepository's quality management program. The program must include monitoring of
key indicators, investigation of problems, with corrective and preventive actions as appropriate;
maintenance of safety; and ensuring the quality data.
Evidence of Compliance:
Written QM plan covering all areas of the biorepository and addressing all phases of testing
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Management of Nonconforming Laboratory Events; Approved Guideline. CLSI
document QMS11-A (ISBN 1-56238-651-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne,
Pennsylvania 19087-1898, USA, 2005.

GEN.82400

Policy and Procedure Development

Phase II

The biorepository director is involved in development of all policies and procedures.
**REVISED** 07/28/2015
GEN.82500 Director's Responsibilities

Phase II

The biorepository director must have policies to safeguard that:
1.
2.
3.
4.

GEN.82600

IRB protocols and policies are upheld
HIPAA is not violated
Clinical care is not compromised in the process of procuring biospecimens
Basic ethical standards related to biospecimen collection and distribution are
upheld (e.g. no selling tissues for a profit on the side)

Director Responsibility - Education/R&D

Phase II

The biorepository director ensures provision of educational programs, strategic planning,
and research and development appropriate to the needs of the biorepository.
**REVISED** 07/28/2015
GEN.82700 Director Responsibility - Personnel

Phase II

The biorepository director ensures that there are sufficient personnel with adequate
training and experience to meet the needs of the biorepository, and that such training andexperience is recorded.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Training and Competence Assessment; Approved Guideline—Third Edition.
CLSI Document QMS03-A3. (ISBN 1-56238-531-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500,
Wayne, PA 19087-1898 USA, 2009.

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GEN.82800

Director Responsibility - Safe Environment

08.17.2016

Phase II

The biorepository director ensures implementation of a safe environment in compliancewith good practice and applicable regulations.
NOTE: The biorepository director must ensure compliance with OSHA and state/local
regulations, as well as other applicable safety regulations.

DIRECTOR NOT ON-SITE FULL TIMENOTE TO THE TEAM LEADER: The following requirements apply to biorepository directors who are not present
full-time at the biorepository.
**REVISED** 08/17/2016
GEN.82900 Director Off-Site

Phase II

There is a written agreement defining the frequency of, and responsibilities for, activities
to be performed by the biorepository director during on-site visits and remotely, withrecords of the director's completed activities.
Evidence of Compliance:✓
Records that show the frequency of on-site visits AND✓
Meeting minutes showing director participation**REVISED** 08/17/2016
GEN.83000 Director Visit

Phase II

The involvement of the biorepository director in the biorepository's activities conductedduring on-site visits or remote consultation follows the written policy or agreement and isconsidered adequate by the biorepository staff and the inspection team.
NOTE: The requirement is not met if the biorepository management and staff identify inadequate
oversight by the biorepository director. If activities are conducted remotely, the biorepository
director must ensure that there is an effective communication mechanism in place between thebiorepository director and biorepository management and staff.
Evidence of Compliance:✓
Minutes from meetings with staff OR✓
Records of conformance with specified director responsibilities

OPERATIONAL LEADERSHIP/MANAGEMENT SECTION
GEN.83100

Leadership/Management Qualifications

Phase II

Leadership/management have qualifications equal to the expertise of the level of serviceof the biorepository.
GEN.83200

Organizational Chart

Phase I

There is an organizational chart for operational leadership, or a narrative description that
describes the reporting relationships among the owner or management, the biorepository
director, and management/leadership staff, as appropriate.

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Description of Duties

Phase I

Duties for all staff are described in writing so that it is clear who is responsible forconsent, banking, transport, inventory, triage, and release on any given day.
GEN.83400

Staff Qualifications

Phase II

The biorepository director must define the minimum qualifications for each role in thebiorepository based on the level of service of the biorepository.
Evidence of Compliance:✓
Written description of minimum qualifications
GEN.83500

Continuing Education

Phase I

There is a functional, continuing biorepository education program adequate to meetthe needs of the biorepository's mission and/or goals as outlined by the biorepository
director.
NOTE: Continuing education may take place within the institution or at an offsite presentation.
Evidence of Compliance:✓
Written policy for continuing education
REFERENCES
1) VonNeeda P. Keep everyone keen on continuing education. Med Lab Observ. 1979(May):117-126**REVISED** 08/17/2016
GEN.83600 Personnel Records

Phase II

Personnel files are maintained on all current technical personnel and personnel records
include all of the following items, as applicable.
1. Copy of academic diploma , transcript, or primary source verification (PSV)
reports confirming credentials, if applicable (Refer to the NOTE for use of PSVreports)
2. Personnel license, if required by state
3. Summary of training and experience
4. Certification, if required by state or employer
5. Description of current duties and responsibilities as specified by thebiorepository director: a) Procedures the individual is authorized to perform, b)
Whether supervision is required for specimen processing, test performance or
result reporting, c) Whether supervisory or director review is required to report
participant results
6. Records of continuing education
7. Records of radiation exposure where applicable (such as with in vivo radiation
testing), but not required for low exposure levels such as certain in-vitro
testing
8. Work-related incident and/or accident records
9. Dates of employment
NOTE: All records in either electronic or paper form must be readily available for review by theinspector at the time of the CAP inspection.
If PSV reports are used, the biorepository must have a defined system for reviewing the reports,
with written criteria for acceptance. PSV is typically performed by a third-party agent or company
that directly contacts institutions and former employers to verify training and experience, such as
diplomas, board certification, licensure, and reported work history. PSV reports confirming therequired qualifications may be retained in lieu of obtaining paper copies of these records. If there108 of 129
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are required elements for the qualification that the PSV report does not adequately verify (e.g.
transcripts, educational equivalency for personnel trained outside of the US, or reports lacking
the type of degree earned), there must be records showing that qualifications are met using othermeans.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Training and Competence Assessment; Approved Guideline—Third Edition.
CLSI Document QMS03-A3. (ISBN 1-56238-531-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500,
Wayne, PA 19087-1898 USA, 2009.

GEN.83700

Initial Training

Phase II

There are records of satisfactory completion of initial training of all staff on all
instruments/methods applicable to their designated job.
NOTE: The records must show that training specifically applies to the duties performed by eachindividual.
Retraining must occur when problems are identified with employee performance.
GEN.83800

Competency Assessment

Phase II

The competency of each person to perform his/her assigned duties is assessed.
NOTE: Prior to the initiation of job duties and the performance of new duties, each individual
must have training and be evaluated for proper performance of duties as required in GEN.83700.
After an individual has performed his/her duties for one year, competency must be assessedannually. Retraining and reassessment of employee competency must occur when problems are
identified with employee performance. Elements of competency assessment include but are notlimited to:
1. Direct observations of routine process and procedure performance, including as
applicable, participant identification and preparation; and specimen collection,
handling, processing
2. Review of results or worksheets, quality control records, and preventive maintenancerecords
3. Direct observation of performance of instrument maintenance and function checks,
as applicable, and
4. Evaluation of problem-solving skills
Many of the elements of competency assessment are performed during routine supervisory
review of an employee throughout the year. Records of these elements, including adherence
to biorepository policies and procedures, observation of test performance, results reporting,
instrument maintenance, review of worksheets, recording QC, and demonstration of taking
appropriate corrective actions are examples of daily activities that can be used to demonstratecompetency. If elements of competency are assessed by routine supervisory review, thecompetency procedure must outline how this routine review is used to evaluate competency.
Competency assessment by routine supervisory review may be recorded using a checklist.
Evidence of Compliance:✓
Records of competency assessment for new and existing employees reflecting the specificskills assessed, the method of evaluation
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Training and Competence Assessment; Approved Guideline—Third Edition.
CLSI Document QMS03-A3. (ISBN 1-56238-531-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500,
Wayne, PA 19087-1898 USA, 2009.

GEN.83900

Competency Corrective Action

Phase II

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If an employee fails to demonstrate satisfactory performance on the competency
assessment, the biorepository follows a plan of corrective action to retrain and reassess
competency.
NOTE: If it is determined that there are gaps in the individual's knowledge, the employee
should be re-educated and allowed to retake the portions of the assessment that fell below
the biorepository's guidelines. If, after re-education and training, the employee is unable tosatisfactorily pass the assessment, then further action should be taken which may include,
supervisory review of work, reassignment of duties, or other actions deemed appropriate by thebiorepository director.
Evidence of Compliance:✓
Records of corrective action to include evidence of retraining and reassessment ofcompetency✓
Written procedure for competency assessment corrective action

PHYSICAL FACILITIESDeficiencies in space should be recorded so there is incentive to improve. Deficiencies in space are regarded
as minor unless they are so severe as to interfere with the quality of work or quality control activities and safety,
in which case they become a Phase II deficiency. As biorepository operations expand over time, Phase I space
deficiencies may become Phase II deficiencies by the time of the next inspection.
Ambient or room temperature and humidity must be controlled to minimize evaporation of specimens andreagents, to provide proper growth conditions for room temperature incubation of cultures, and not to interferewith the performance of electronic instruments.

Inspector Instructions:
●
●
●

●

●

●

GEN.84000

Floor plan and equipment locations
Overview of Building Automation System (BAS), if available
Sampling of electrical grounding records, if applicable

Physical facility (adequate space, acceptable temperature/humidity, areas clean,adequate storage areas, adequate emergency power)
Perimeter security and access security to specific specimen collections

Is the work area sufficient for you to perform your duties safely and accurately?

Restricted Access

Phase I

Access to the biorepository is restricted to authorized individuals.
NOTE: This may be accomplished through the use of access codes (security codes, user codes)that limit individuals' access to those areas they are authorized to enter or use. Authorization isrequired for access to the:110 of 129
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1. Biorepository
2. Specimens, aliquots and any extracts thereof
3. Participant/client and study records
Access codes/user codes must be maintained and current (e.g. inactivated when employment of
an authorized individual's employment ends).
GEN.84100

Adequate Space

Phase II

The general biorepository has adequate, conveniently located space so the quality ofwork, safety of personnel, and patient care services are not compromised.
REFERENCES
1) Mortland KK, Reddick JH. Laboratory design for today's technologies and marketplace. Lab Med. 1997;28:332-336
2) Clinical and Laboratory Standards Institute (CLSI). Laboratory Design; Approved Guideline - Second Edition. CLSI Document
QMS04-A2. (ISBN 1-56238-631-X). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, PA
19087-1898, USA, 2007.

GEN.84200

Adequate Space

Phase I

All of the following areas have sufficient space and are located so there is no hindrance tothe work.
1. Biorepository director
2. Staff pathologists and researchers
3. Biorepository technicians
4. Clerical staff
5. Chief technologist/biorepository manager
6. Section supervisors
7. Freezer storage area
8. Ambient temperature storage
9. Lavatories
10. Library, conference and meeting room
11. Personnel lounge and lockers
GEN.84300

Climate Control

Phase IThe room temperature and humidity are adequately controlled in all seasons.
Evidence of Compliance:✓
Temperature and humidity records, if specific ranges are required for instrument and/or
reagent use
GEN.84400

HVAC

Phase I

HVAC units, if present, are properly serviced and functioning to maintain appropriatecompressor activity.
Evidence of Compliance:✓
Records of maintenanceGEN.84500

Hallway Obstructions

Phase II

Passageways are unobstructed.
GEN.84600

Environment MaintenanceFloors, walls and ceilings are clean and well-maintained.

Phase I

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Environment Maintenance08.17.2016

Phase I

Bench tops, cupboards, drawers and sinks are clean and well-maintained.
GEN.84800

Environment MaintenancePhase II

There are oxygen sensors or sufficient airflow to prevent asphyxiation in areas whereliquid nitrogen is used.
GEN.85100

Inventory Control

Phase I

There is an effective supply inventory control system in operation.
NOTE: An effective inventory control system minimizes emergency requisitions and shortages ofsupplies.
Evidence of Compliance:✓
A written procedure detailing relevant personnel, when to order supplies and levels of buffer
stock required
REFERENCES
1) Chapman J. Saving money with computerized materials management. Advance/Lab. 1999:8(9):16-18

GEN.85200

Intrabiorepository Storage

Phase IThe intrabiorepository storage area is sufficient and free of clutter.
**REVISED** 07/28/2015
GEN.85300 Emergency Power

Phase II

Emergency power is adequate for the functioning of the biorepository.
NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc., toensure preservation of specimens.
**REVISED** 07/28/2015
GEN.85400 Emergency Power Load Testing

Phase II

Load testing is performed to ensure that emergency power is adequate for the functioningof the biorepository.
NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc. toensure preservation of specimens.
**REVISED** 07/28/2015
GEN.85420 Electrical Grounding

Phase II

There are records that all instruments and appliances are checked for adequate grounding
and current leakage before initial use, after repair or modification, and when a problem issuspected.
NOTE: Exceptions to these requirements are as follows:
1. Devices protected by an approved system of double insulation or its equivalent. Suchdevices must be distinctively marked.
2. Devices connected to wall receptacles or circuit breakers with ground-fault circuit
interrupter (GFCI) protection built-in need not be checked for current leakage

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3. Equipment operating at 240 v must be checked for ground integrity only
Verification of electrical safety is required whenever the electrical/electronic systems of apowered device has been removed or altered.
In addition, the US Occupational Safety and Health Administration (OSHA) requires that powercords of portable electrical equipment be visually inspected for external defects wheneverrelocated. Grounding configurations may not be bypassed by, for example, an adapter thatinterrupts the continuity of the grounding. If manufacturer's recommendations are available, theymust be followed.
REFERENCES
1) Occupational Safety and Health Administration. Electrical. Use of equipment. US Government Printing Office, 1999(Jul 1):[29CFR1910.334]

GEN.85500

Contingency Plans

Phase II

Contingency plans are in place in the event that the back-up generator is not operational
and if there is not enough fuel present to operate the generator.
Evidence of Compliance:✓
Written contingency plan AND✓
Schedule of fuel deliveries

SAFETY
Requirements in this section cover the general safety program for the entire biorepository.

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GENERAL SAFETY
Inspector Instructions:
●
●
●

●
●
●

●
●

●

GEN.85600

Sampling of safety policies and procedure
Ergonomic evaluation
Sampling of personnel safety education records

Adequate emergency lighting
Flammable and combustible liquids (properly stored)
Emergency eyewash available and tested properly

How are your biorepository's safe work practices reviewed?
Is there a specific example of an occupational injury or illness that required medical
treatment? What steps were taken to address the incident?

For any occupational injury or illness that required medical treatment, further evaluate
leadership's responses, corrective actions, follow-up procedures, and additional
measures taken to ensure safety in the workplace

Safety Policy and Procedure Approval

Phase II

The biorepository director or designee reviews and approves all changes to the safety
policies and procedures before implementation.
**REVISED** 07/28/2015
GEN.85700 Safety Policy and Procedure Availability

Phase II

There are records for the training of all laboratory workers in safety.
NOTE: A system to ensure that all personnel have read the policies and procedures is required
and must form a portion of the orientation program for new personnel. Posting of specificwarnings or hazards as appropriate is urged.
Evidence of Compliance:✓
Records of personnel review of safety policies and procedures
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

**REVISED** 07/28/2015
GEN.85800 Safe Work Practices Review

Phase II

There are records of periodic review (at least annually) of safe work practices to reduce
hazards.

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NOTE: Review must include bloodborne hazard control and chemical hygiene. If the review
identifies a problem, the biorepository must investigate the cause and consider if modifications
are needed to safety policies and procedures to prevent reoccurrence of the problem or mitigate
the potential risk.
Evidence of Compliance:✓
Safety committee minutes OR records of regular safety inspections OR incident reports andstatistics OR another method defined by the biorepository director
GEN.85820

Ergonomics

Phase II

There is a written ergonomics program to prevent musculoskeletal disorders (MSDs) in
the workplace through prevention and engineering controls.
NOTE: The program may include training of employees about risk factors, identifying physicalwork activities or conditions of the job commonly associated with work-related MSDs, andrecommendations for eliminating MSD hazards. Biorepository activity, workplace and equipment(e.g. chairs, workstations, computer keyboards, and displays) should be designed to reduce therisks of ergonomic distress disorders and accidents.
Evidence of Compliance:✓
Records of ergonomic evaluation including recommendations for eliminating MSD hazards
and appropriate corrective action based on assessment findings
REFERENCES
1) U.S. Dept. of Labor, Occupational Safety and Health Administration. Ergonomic safety and health program management guideline.
54 Fed Register 3904 (1989), modified at 29CFR1910)**REVISED** 07/28/2015
GEN.85900 Accidents

Phase II

There are written policies and procedures for the reporting and recording of all accidents
resulting in property damage or involving spillage of hazardous substances.
GEN.85920

Gas Cylinder Storage

Phase II

Compressed gas cylinders are secured to prevent accidental falling and damage to thevalve or regulator.
GEN.85940

Flammable Gas Cylinders

Phase II

Flammable gas cylinders are stored properly.
NOTE: Proper storage practices include:
1. Storage in a separate, ventilated room or enclosure
2. Cylinders are positioned well away from open flame or other heat sources, not in
corridors and not within exhaust canopies
REFERENCES
1) National Fire Protection Association Standard 55: Compressed Gases and Cryogenic Fluids Code, 2013 edition

GEN.85960

Liquid Nitrogen and Dry Ice

Phase II

Adequate policies, procedures, and practices are in place for the use of liquid nitrogenand dry ice.
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1. The mandatory use of appropriate gloves, shielding of all skin and the use of a faceshield when decanting or entering an open container of LN2
2. The mandatory use of insulated loose-fitting gloves, dry ice tongs or scoop, andsafety goggles/glasses when handling dry ice
3. Storage and use of all containers of LN2 and dry ice only in well-ventilated areas
4. Availability of a Safety Data Sheet
REFERENCES
1) OSHA Quick Facts: Laboratory Safety Cryogens and Dry Ice. Occupational Safety and Health Administration Website. https://www.osha.gov/Publications/laboratory/OSHAquickfacts-lab-safety-cryogens-dryice.pdf. Reviewed October 2011. Accessed
11/24/2015.

**REVISED** 07/28/2015
GEN.86000 Occupational Injuries

Phase II

There are written policies and procedures for the reporting of all occupational injuries orillnesses that require medical treatment (except first aid).
NOTE: For US facilities subject to OSHA regulations, all workplace fatalities must be reported to
the Occupational Safety and Health Administration (OSHA) within eight hours and work-related
in-patient hospitalizations or losses of an eye within 24 hours.
REFERENCES
1) Fed Register. 1986;50(137):29102-29113;2) 29CFR1904.8, current edition

GEN.86100

Occupational Injury Evaluation

Phase IIAn evaluation of these reports of biorepository accidents and occupational injury/
illnesses is incorporated into the biorepository's quality management program to avoid
recurrence.
Evidence of Compliance:✓
Records of report evaluation OR committee minutes with records of discussion
GEN.86120

Excessive Noise

Phase II

The biorepository has a policy to protect personnel from excessive noise levels.
NOTE: The biorepository should provide protection against the effects of noise exposure whensound levels equal or exceed an eight-hour time-weighted average sound level of 85 decibels.
The biorepository should monitor noise exposure if there is an indication that excessive noiselevels are present (for example, when noise levels exceed 85 decibels, people have to shout tobe heard).
REFERENCES
1) U. S. Department of Labor, Occupational Safety & Health Administration: http://www.osha.gov/pls/oshaweb/
owadisp.show_document?p_id=9735&p_table=STANDARDS**REVISED** 07/28/2015
GEN.86130 Emergency Eyewash

Phase II

The biorepository has adequate plumbed or self-contained emergency eyewash facilities
in every area where there are hazardous chemicals as defined by the biorepository's
chemical hygiene plan (e.g. chemicals that are irritating, corrosive, toxic by contact orabsorption). Testing records are maintained.
NOTE 1: The eyewash facility includes the following:

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1. No greater than 10 seconds travel distance from areas in the biorepository where
hazardous chemicals are present
2. Capable of delivering 1.5 L per minute for 15 minutes
3. Flow is provided to both eyes simultaneously
4. Nozzles or covers to protect from airborne contaminants
5. Hands-free flow once activated
6. Signage for location of eyewash
7. Unobstructed path with unlocked doors opening in the direction of the eyewash
8. Plumbed systems are protected from unauthorized shut off
9. Tepid fluid temperature (water temperature should be between 15°C and 37°C
(60-100°F). Actual temperature recording is not required)
10. Plumbed systems are activated weekly
11. Self-contained units are visually examined weekly
NOTE 2: The manufacturer's specifications should be available.
REFERENCES
1) American National Standards Institute. Emergency eyewash and shower equipment. New York, NY: ANSI, 2004;Z358.1
2) Occupational Safety and Health Administration. Medical and first aid. Medical services and first aid. US Government Printing Office,1998(June 18):[29CFR1910.151(c)]GEN.86140

UV Light Exposure

Phase II

There are written policies and procedures to prevent or reduce ultraviolet light exposure
from instrument sources.
NOTE: UV light may cause corneal or skin burns from direct or deflected light sources. Wherever
UV light sources are used, suitable and adequate personal protective equipment must be
provided, and appropriate approved signage displayed. Laboratories may obtain information on
safety from manufacturers of devices that emit UV light.
A suggested sign for display is: Warning: This device produces potentially harmful ultraviolet(UV) light. Protect eyes and skin from exposure.
Evidence of Compliance:✓
Warning signage on source equipment AND✓
Suitable PPE available, as required**REVISED** 07/28/2015
GEN.86200 Disaster Preparedness

Phase II

There are written policies and procedures defining the role and responsibilities of thebiorepository in internal and external disaster preparedness.
REFERENCES
1) Clinical and Laboratory Standards Institute. Planning for Laboratory Operations During a Disaster; Approved Guideline. CLSI
document GP36-A. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.

**REVISED** 07/28/2015
GEN.86300 Evacuation Plan

Phase II

There is a written comprehensive and workable evacuation plan specific for the facility.
NOTE: 1) This plan must cover all employees and visitors, and must address the special needsof persons with disabilities. Evacuation routes must be clearly marked (Posting evacuation routes
is optional). 2) Emergency lighting is adequate for safe evacuation of the biorepository.
REFERENCES
1) Occupational Safety and Health Administration. Exit routes, emergency action plans, and fire prevention plans: standard, 2002
2)

[29CFR1910.38]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

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BIOLOGICAL SAFETY
Inspector Instructions:
●
●
●

●
●

●

●

GEN.86400

Sampling of safety and waste disposal policies and procedures
Sampling of sterilizing device monitoring records
Sampling of records of hepatitis B vaccination or records declining the vaccination

PPE usage
Biohazard disposal bins

What has your facility done to reduce or eliminate exposure to bloodborne
pathogens?
How does your biobank dispose of sharps?

Bloodborne Pathogens

Phase II

The biorepository has written policies and procedures for infection control that comply
with the OSHA Standard on occupational exposure to bloodborne pathogens and to theinstitution's exposure control plan.
NOTE: Universal or standard precautions must be used when handling all blood and body
fluid specimens. The term "universal precautions" refers to a concept of bloodborne disease
control requiring all human blood and other potentially infectious materials to be treated as if
infectious for HIV, HBV, HCV or other bloodborne pathogens, regardless of the perceived "lowrisk" status of a participant or participant population. Alternative concepts in infection control arecalled Body Substance Isolation (BSI) and Standard Precautions. These latter terms define allbody fluids and substances as infectious. All health care workers must routinely use appropriate
barrier precautions to prevent skin and mucous membrane exposure when contact with blood orother body fluids is anticipated. Policies must comply with the OSHA Standard on Bloodborne
Pathogens.
Evidence of Compliance:✓
Safety manual AND✓
Records of universal precaution training for all personnel expected to have contact with body
fluidsREFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
2)

Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline. 4th ed. CLSI Document M29-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2014**REVISED** 08/17/2016
GEN.86500 PPE Provision and Usage

Phase II

Appropriate personal protective equipment (gloves, gowns, masks and eye protectors,etc.) is provided and maintained in a sanitary and reliable condition in all technical work

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areas in which blood and body substances are handled and in circumstances during
which exposure is likely to occur.
NOTE: 1) Appropriate personal protective equipment (PPE) are items that do not permit bloodor other potentially infectious materials to pass through to the skin or reach the employee's
work clothes, skin, footwear, etc. In addition to fluid-resistant gowns, aprons may be required if
exposure to large volumes of body fluids is anticipated. 2) OSHA requires gloves to be worn witheach participant or subject contact and changed after contact when performing vascular accessprocedures. Hands must be cleaned after glove removal using an effective antimicrobial method.
REFERENCES
1) Centers for Disease Control. Guidelines for prevention of transmission of human immunodeficiency virus and hepatitis B virus to2)
3)

health-care and public-safety workers. MMWR. 1989:38(suppl S-6):1-37
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline. 4th ed. CLSI Document M29-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2014**REVISED** 08/17/2016
GEN.86600 PPE Instruction

Phase II

Personnel are instructed in the proper use of personal protective clothing/equipment (e.g.
gloves, gowns, masks, eye protectors, footwear).
NOTE: The required elements of training in the use of gloves include (a) Proper fitting ofgloves; (b) Replacing gloves immediately when torn or contaminated; (c) Not washing or
disinfecting gloves for reuse; (d) Using hypoallergenic gloves when indicated by patient or
health care provider history; (e) Decontamination of hands after glove removal using an effective
antimicrobial method.
Evidence of Compliance:✓
Written policy for the use of PPE for specific tasks AND✓
Records of personnel training for PPE
REFERENCES
1) Department of Labor, Occupational Safety and Health Administration, Occupational Safety and Health Standards. Bloodborne
2)
3)

GEN.86620

pathogens. Fed Register. 2002(July 1): [29CFR1910.1030(d)(3)(i)]Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the
Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR
2002;51.
World Health Organization. WHO Guidelines on Hand Hygiene in Health Care, 2009. http://apps.who.int/iris/
bitstream/10665/44102/01/9789241597906_eng.pdf, accessed 12/5/2015.

Latex Allergy

Phase II

The biorepository has a written program to protect personnel and participants/clientsfrom allergic reactions from exposures to natural rubber latex in gloves and otherproducts.
NOTE: The latex program should address at least the following elements.
1. Selection of products and implementation of work practices that reduce the risk ofallergic reactions. If latex gloves are used, the employer should provide reduced
protein, powder-free gloves to protect workers from infectious materials.
2. Provision of education programs and training materials about latex allergy
3. Evaluation of current prevention and control strategies whenever a worker isdiagnosed with latex allergy
Evidence of Compliance:✓
Records of employee education/training on latex allergies AND✓
Records of evaluation of the plan, when appropriate

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GEN.86630

Manual Manipulation of Needles

08.17.2016

Phase II

There is a written policy that prohibits the recapping, purposeful bending, breaking,removing from disposable syringes, or other manual manipulations of needles.
NOTE: Resheathing instruments or self-sheathing needles may be used to prevent recapping of
needles by hand.
REFERENCES
1) Jagger J, et al. Rates of needlestick injury caused by various devices. New Engl J Med. 1988;319:284-288
2) Whitby M, et al. Needlestick injury: impact of a recapping device and an associated education program. Infect Control Hosp
3)
4)
5)
6)
7)

Epidemiol. 1991;12:220-225
Bush VJ, et al. Advancements in blood collection devices. Lab Med. 1998;29:616-622
Dale JC, et al. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo
Clinic Rochester. Mayo Clin Proc. 1998;73:611-615
Charney E. Retractable safety syringe activation study. J Healthcare Safety Compliance Infect Control. 1998;2(9):413-415
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline. 4

GEN.86640

th ed. CLSI Document M29-A4. Clinical and Laboratory Standards Institute, Wayne, PA; 2014

Sharps Disposal

Phase II

Sterile syringes, needles, lancets, or other blood-letting devices ("sharps") that arecapable of transmitting infection are used once only, and all waste sharps are discardedin puncture-resistant containers that are easily accessible, located in areas where needles
are commonly used, and properly labeled to warn handlers of the potential hazard.
NOTE: Under US law, shearing or breaking of contaminated sharps is prohibited. Bending,recapping, or removing contaminated needles is prohibited as a general practice. Needles are
expected to be used and immediately discarded, un-recapped, into accessible sharps containers.
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
2)
3)

GEN.86650

Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Occupational Safety and Health Administration. Enforcement procedures for the occupational exposure to bloodborne pathogens.
Washington, DC: U.S. Government Printing Office, OSHA Directive CPL 2-2.44D, 1999 (Nov 5)
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

Eating/Mouth Pipetting

Phase II

There is a written policy that prohibits smoking, eating, drinking, application of cosmetics
and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work
areas.
NOTE: The biorepository must define the technical work area in particular when there is space
sharing.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document2)

GEN.86700

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]

Specimen Transport Procedures

Phase II

There are written procedures for the procurement, transportation, and handling of
biospecimens (e.g. blood, body fluids, tissue) to ensure that all specimens are submitted
in an appropriately labeled and well-constructed container with a secure lid to prevent
leakage during transport.
NOTE: Specimens sent through pneumatic tube systems must be sealed in fluid-tight bags.
If pneumatic tube systems are used for transporting specimens, the biorepository must

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have procedures to respond to a spill within the tube, including appropriate decontamination
measures.
REFERENCES
1) Centers for Disease Control and Prevention. Evaluation of safety devices for preventing percutaneous injuries during phlebotomy
2)

GEN.86800

procedures. MMWR. 1997;46(2):1
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]

Spill HandlingPhase II

There are written procedures for handling spills of blood and other body fluids.
GEN.86900

Hepatitis B Vaccinations

Phase II

Personnel reasonably expected to have direct contact with body fluids are identified andoffered hepatitis B vaccinations free of charge.
Evidence of Compliance:✓
Written policy offering the hepatitis B vaccination to employees AND✓
Records of vaccination OR records signed by employees declining the vaccine
REFERENCES
1) Centers for Disease Control. Protection against viral hepatitis: recommendations of the Immunization Practices Advisory Committee
2)(ACIP). MMWR. 1990;39:#RR-2
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]**REVISED** 07/28/2015
GEN.87000 Viral Exposure

Phase II

There is a policy for post-exposure follow-up after possible and known percutaneous,mucous membrane or abraded skin exposure to HIV, HBV or HCV that includes thefollowing elements:
1. HIV, HBV and HCV testing of the source subject after consent is obtained
2. Appropriate clinical and serologic evaluation of the health-care worker
3. Consideration of appropriate prophylaxis for personnel acutely exposed toHIV, HBV or HCV, based upon medical indications, the serologic status and theinformed consent of the health-care worker
4. Reporting of the exposure as required by law
Evidence of Compliance:✓
Records of exposure follow-up
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document2)

GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
Government Printing Office, 1999(Jul 1): [29CFR1910.1030]4)**REVISED** 08/17/2016
GEN.87020 Biohazard Disposal

Phase II

All infectious wastes (e.g. glassware, blood collection tubes, microbiologic and tissue
specimens) and other contaminated materials are discarded into "biohazard"-labeledcontainers that do not leak and have solid, tight-fitting covers that are applied before
transport from the work area for storage and disposal.
NOTE: Waste disposal must be in accord with all regulations and disposed of with minimum
danger to professional, technical, and custodial personnel.

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All infectious wastes must be incinerated or appropriately decontaminated before being sent to asanitary landfill.
Evidence of Compliance:✓
Written procedure for waste disposal in accordance with local regulations
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Bloodborne pathogens. Washington, DC: US
2)

GEN.87100

Government Printing Office, 1999(Jul 1): [29CFR1910.1030]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

TB Exposure Plan

Phase II

The biorepository has a written tuberculosis exposure control plan.
NOTE: This plan must include an exposure determination at defined intervals for all employees
who may have occupational exposure to tuberculosis. Additional elements of the plan include
engineering and work practice controls for hazardous activities that potentially may aerosolize
Mycobacterium tuberculosis. Such activities include the handling of unfixed tissues in surgicalpathology or autopsies.
If respiratory protection is needed because of potential exposure to an infectious agent by
aerosol or droplet, personnel must use either a properly fit-tested NIOSH-approved filter
respirator (N-95 or higher) or a powered air-purifying respirator (PAPRS) equipped with highefficiency particulate air (HEPA) filters. Accurate fit testing is a key component of effective
respirator use.
REFERENCES
1) Centers for Disease Control and Prevention/National Institutes of Health. Biosafety in microbiological and biomedical laboratories.
2)

GEN.87125

Washington, DC: US government printing office, Feb 2007
CDC. Guidelines for preventing transmission of Mycobacterium tuberculosis in health care settings. Morb Mortal Weekly Reports.
2005;54(RR17):1-141.

Sterilizing Device Monitoring

Phase IIAll sterilizing devices are monitored periodically with a biologic indicator (or chemical
equivalent) for effectiveness of sterility under conditions that simulate actual use.
NOTE: Each sterilizing device must be monitored periodically with a biologic indicator to measure
the effectiveness of sterility. Chemical indicators that reflect sporicidal conditions may be used.
The test must be performed under conditions that simulate actual use. One recommended
method is to wrap the Bacillus stearothermophilus spore indicator strip in packaging identical tothat used for a production run, and to include the test package with an actual sterilization activity.
Weekly monitoring is recommended.
Evidence of Compliance:✓
Written procedure for monitoring sterilizing devices AND✓
Records of monitoring at defined frequency

FIRE SAFETY
With respect to fire safety, if a checklist requirement conflicts with regulations of the Authority Having
Jurisdiction (i.e. state and local fire codes), the regulations of the Authority Having Jurisdiction take precedence.

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Inspector Instructions:
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●

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GEN.87200

Sampling of safety policies and procedures
Sampling of employee fire safety training records

Automatic fire extinguisher systems, if required
Two exit access doors, if required
Audible automatic fire detection and alarm system
Fire alarm station
Portable fire extinguishers, where appropriate

Fire Prevention Policies and Procedures

Phase II

Policies and procedures are written and adequate for fire prevention and control.
NOTE: Fire safety plans must include the use of alarms, response to alarms, isolation of thefire, evacuation of the area, extinguishment of the fire, and the responsibilities of biorepository
personnel for those elements.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

GEN.87420

Fire Separation

Phase IIIf the biorepository stores flammable materials, it is properly separated from inpatientareas and/or provided with automatic fire extinguishing (AFE) systems.
NOTE: For those facilities with no inpatients, no AFE is required.
Where the biorepository is separated by two-hour construction (rated at 1.5 hours) and Class B
self-closing doors (SCD), no AFE system is required. This applies to biorepositories that residewithin a hospital or patient-care facility. An AFE system is required for those biorepositories
separated from inpatient areas by one-hour construction and Class C SCD if flammable andcombustible liquids are stored in bulk. An AFE system is always required if there are unattended
biorepository operations employing flammable or combustible reagents. "Stored in bulk" means
more than two gallons (7.5 L) of Class I, II, and IIIA liquids in safety cabinets and safety cans per
100 ft² (9.2m²), or half that amount if not in safety containers. The following are the definitions ofthese Classes:
Class I flammable: any liquid that has a closed-cup flash point below 37.8°C and a Reid vapor
pressure not exceeding 2068.6 mm Hg at 37.8°C as determined by ASTM D 323
Class II combustible: any liquid that has a flash point at or above 37.8°C and below 60°C
Class IIIA combustible: any liquid that has a flash point at or above 60°C but below 93°C
REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

GEN.87430

Fire Exit

Phase II

Each room larger than 1000 ft² (92.9m²), or in which major fire hazards exist, has at least
two exit access doors remote from each other, one of which opens directly into an exit
route.

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REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

GEN.87440

Fire Safety Training

Phase II

Fire safety training is performed for new employees, with fire safety review conducted atleast annually.
NOTE: Fire safety training must be recorded for all employees to show that they have been
instructed on use and response to fire alarms and to execute duties as outlined in the fire safety
plan. While fire exit drills are not required, physical evaluation of the escape routes must be
performed annually, to ensure that fire exit corridors and stairwells are clear and that all fire exit
doors open properly (i.e., not rusted shut, blocked or locked). Paper or computerized testingof an individual's fire safety knowledge on the fire safety plan is acceptable; all personnel must
participate at least once a year.
Evidence of Compliance:✓
Records of participation for all employees in fire safety plan review at least annually (e.g.
employee roster with dates of participation, sign-in sheet, etc.)GEN.87442

Fire Detection/Alarm

Phase II

There is an automatic fire detection and alarm system.
NOTE: 1) The system must connect to the facility's overall system, where such a system exists.
It must sound an immediate alarm in the event of smoke or fire. 2) The fire alarm is audible inall parts of the biorepository, including storage areas and lavatories. 3) Facilities employing
hearing-impaired persons must have other means to alert these individuals, such as a visual
alarm system.
GEN.87444

Fire Alarm Station

Phase II

There is a fire alarm station in or near the biorepository.
NOTE: Alarm stations must be visible, unobstructed, and accessible.
REFERENCES
1) National Fire Protection Association Standard 72: National Alarm and Signaling Code, 2013 edition, Chapter 27.6

GEN.87450

Fire Extinguishers

Phase II

Appropriate portable fire extinguishers are provided for all areas in which flammable andcombustible liquids are stored or handled.
NOTE: If gallon bottles of such materials are used, the minimum rating for Class B extinguishers
is 10-B or higher. These are best located near or outside of doors leading to the area having
solvent fire hazards.
REFERENCES
1) National Fire Protection Association Standard 10: Standard for Portable Fire Extinguishers, 2013 edition

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CHEMICAL SAFETY
Inspector Instructions:
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●
●
●

●
●
●

●

Sampling of chemical safety policies and procedures
Sampling of SDS (formerly MSDS) sheets
Sampling of formaldehyde vapor monitoring records
Sampling of chemical waste disposal policies and procedures
Acids and bases (properly stored)
Sampling of hazardous chemicals (labeling)
PPE usage

How does your biobank dispose of hazardous chemicals?

**REVISED** 07/28/2015
GEN.87600 Chemical Hygiene Plan

Phase II

The biorepository has a Chemical Hygiene Plan (CHP) that defines the safety policies andprocedures for all chemicals used in the biorepository.
NOTE 1: The biorepository director or designee must ensure that the biorepository has awritten chemical hygiene plan (CHP) that defines the safety policies and procedures for all
chemicals used in the biorepository. The plan must include evaluation of carcinogenic potential,
reproductive toxicity, and acute toxicity. The plan must include specific handling requirements for
all hazardous chemicals used in the biorepository.
The purpose of the OSHA regulations is to ensure that the hazards of all chemicals areevaluated, and that information concerning their hazards is transmitted to employers andemployees. This transmittal of information is to be accomplished by means of comprehensive
hazard communication programs, which are to include container labeling and other forms of
warning, safety data sheets and employee training. An acceptable CHP contains the following
elements.
1.
2.
3.
4.
5.
6.
7.

Responsibilities of the biorepository director and supervisors
Designation of a chemical hygiene officer
Policies for all operations that involve chemicals
Criteria for the use of personal protective equipment and control devices
Criteria for exposure monitoring when permissible levels are exceeded
Provisions for medical consultations and examinations
Provision for training anyone working in the biorepository on the elements of the
CHP
8. A copy of the OSHA Laboratory Standard
9. Evaluation of the carcinogenic potential, reproductive toxicity and acute toxicity for all
chemicals used in the biorepository. The product label, safety data sheets (SDS), orfor chemicals purchased prior to June 1, 2015 with no appropriate SDS, records ofinvestigation by the safety officer may be used for this evaluation.

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10. Specific handling requirements for all hazardous chemicals used in the biorepository
NOTE 2: Chemicals that must be handled as potential carcinogens include those defined by
OSHA as "select carcinogens." OSHA defines select carcinogens as any substance that is:
1. Regulated as a carcinogen by OSHA, has been classified as "known to becarcinogenic" by the NTP, or listed as a group I carcinogen by the IARC
2. Has been classified as "reasonably anticipated to be carcinogenic" by the NTP or
listed as a group 2A or 2B carcinogen by the IARC if it meets the toxicological criteria
listed in the January 31, 1990 Fed Register, pages 3319-3320
OSHA also requires special containment procedures for substances that are reproductive toxinsor are acutely hazardous.
Authoritative sources include (but are not limited to) OSHA (Code of Federal Regulations. Title
29, Part 1910.1200 and 1450); NIOSH (Registry of Toxic Effects of Chemical Substances); theNational Toxicology Program; the International Agency for Research on Cancer, and Safety Data
Sheets.
Evidence of Compliance:✓
Written evaluation of chemicals used in the biorepository for carcinogenic potential,
reproductive toxicity, and acute toxicity AND✓
Written procedure for chemical fume hood function verification AND✓
Records of testing
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances hazard communication: standard. 2012:
2)
3)
4)

GEN.87700[29CFR1910.1200]
Occupational Safety and Health Administration. Occupational exposures to hazardous chemicals in laboratories: standard. 2012:[29CFR1910.1450]
Karcher RE. Is your chemical hygiene plan OSHA-proof? Med Lab Observ. 1993(Jul):29-36
Occupational Safety and Health Administration. Occupational exposure to methylene chloride: standard. 1997:[29CFR1910;1915;1926]

Chemical Safety Document Access

Phase IIFor US biorepositories, employees have access to all of the following documents.
1. Current Safety Data Sheets (formerly MSDS) and other references that list thedetails of hazards and the precautions for safe handling and storage
2. Chemical Hygiene Plan of the biorepository
3. Code of Federal Regulations. Title 29, part 1910.1450 and its appendices
NOTE: It is acceptable for SDS information to be electronically available to users, rather than inbook format; there is no requirement for paper-based information. Indeed, electronic manuals
have the advantage of more accurately reflecting current requirements. The central point isimmediate availability to all personnel at all times.
GEN.87800

Chemical Precautionary Labels

Phase II

Precautionary labels are present on the containers of all hazardous chemicals, indicatingtype of hazard and what to do if accidental contact occurs.
NOTE: The biorepository may use signs, placards, process sheets, batch tickets, operatingprocedures, or other such written materials in lieu of affixing labels to individual stationary
process containers, as long as the alternative method identifies the containers to which it isapplicable and conveys the information otherwise required to be on a label. The written materials
shall be readily accessible to the employees in their work area throughout each work shift. It is
not required to label portable containers into which hazardous chemicals are transferred fromlabeled containers, and which are intended only for the immediate use of the employee who

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performs the transfer. Existing labels on incoming containers of hazardous chemicals shall not be
removed or defaced, unless the container is immediately marked with the required information.
REFERENCES
1) Occupational Safety and Health Administration. Toxic and hazardous substances. Hazard communication. Washington, DC: US
Government Printing Office, 2007(Jan 1): [29CFR1910.1200]

GEN.87900

PPE And Hazardous Materials

Phase II

Personnel use the proper personal protective devices when handling corrosive,
flammable, biohazardous, and carcinogenic substances.
NOTE: Such devices may include gloves of appropriate composition, aprons, and eye protection.
Shoes or shoe covers must protect the entire foot in areas where splashing is expected.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

GEN.88000

Chemical Hazard Emergencies

Phase II

Explicit instructions are posted, and appropriate supplies available, for the emergency
treatment of chemical splashes and injuries and the control of chemical spills wherever
major chemical hazards exist.
NOTE: Spill kits must be handled in accordance with manufacturer's instructions. If no expiration
date is assigned, the spill kit must indicate the date it was put into service and the director must
periodically assess its usability.
REFERENCES
1) Occupational Safety and Health Administration. Hazardous materials. Hazardous waste operations and emergency response. US
2)

GEN.88020

Government Printing Office, 1999(Jul 1): [29CFR1910.120]
Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Safety; Approved Guideline, Third Edition. CLSI document
GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-56238-798-7 (Electronic)]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.

Hazardous Chemical Waste Disposal

Phase II

Written policies and procedures are adequate for hazardous chemical waste disposal.
NOTE: 1) The biorepository is responsible for all real or potential hazards of wastes at all stagesof disposal including transportation and final disposition. 2) The method for the disposal of allsolid and liquid wastes is in compliance with local, state and federal regulations. (Whether or
not biorepository management is responsible for waste disposal, the biorepository should havedocumentation that the facility is in compliance with all applicable regulations. Prevailing local,
state and federal (EPA) regulations should be reviewed by the biorepository director, safety
officer or facilities manager to ensure that the biorepository is in compliance with regulations.)
Evidence of Compliance:✓
Records of review of regulations for compliance
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI
document GP05-A3 (ISBN 1-56238-744-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2011.

**NEW** 08/17/2016
GEN.88040 Formaldehyde and Xylene Safety

Phase II

Formaldehyde and xylene vapor concentrations are maintained below the following
maxima, expressed as parts per million, in all areas of the biorepository whereformaldehyde or xylene are used.

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NOTE: Formaldehyde and xylene vapor concentrations must be monitored in all areas wherethese reagents are used: e.g. surgical pathology gross dissection room, histology laboratory,
etc. Initial monitoring involves identifying all employees who may be exposed at or above theaction level or at or above the STEL and accurately determining the exposure of each employee
identified. Further formaldehyde monitoring is mandated at least every six months if resultsof the initial monitoring equal or exceed 0.5 ppm (8 hr time-weighted exposure, the “actionlevel”) or at least once per year if the results exceed the short term exposure limit (STEL) 2.0
ppm. The laboratory may discontinue periodic formaldehyde monitoring if results from twoconsecutive sampling periods taken at least seven days apart show that employee exposure
is below the action level and the short-term exposure limit, and 1) no change has occurred in
production, equipment, process or personnel or control measures that may result in new oradditional exposure to formaldehyde, and 2) there have been no reports of conditions that may
be associated with formaldehyde exposure.
Formaldehyde monitoring must be repeated any time there is a change in production, equipment,
process, personnel, or control measures which may result in new or additional exposure
to formaldehyde for any employee involved in the activity. If any personnel report signs or
symptoms of respiratory or dermal conditions associated with formaldehyde exposure, thelaboratory must promptly monitor the affected person's exposure.
Xylene must be monitored initially, but there is no requirement for periodic monitoring of xylene.
Repeat monitoring should be considered when there is a change in production, equipment,
process, personnel, or control measures likely to increase exposure levels.
8 hr Time-Weighted
Exposure Limit in ppm

Action Level( 8 hr TimeWeighted
Exposure)
in ppm

15 min Short-Term
Average Exposure
Limit (STEL) in ppm

Formaldehyde

0.75

0.5

2.0

Xylene100

150

Evidence of Compliance:✓
Written procedure for formalin and xylene safety including action limits, criteria for
discontinuation of monitoring and criteria for resumption of monitoring AND✓
Record of initial formalin and xylene monitoring and repeat monitoring when indicated AND✓
Records of corrective action when exposure limits are exceeded
REFERENCES
1) Montanaro A. Formaldehyde in the workplace and in the home. Exploring its clinical toxicology. Lab Med. 1996;27:752-757
2) Goris JA. Minimizing the toxic effects of formaldehyde. Lab Med. 1997;29:39-42
3) Wenk PA. Disposal of histology stains. Lab Med. 1998;29:337-338
4) Occupational Safety and Health Administration. 29CFR1910.1048 and 1450, revised July 1, 1998

GEN.88100

Flammable Storage

Phase II

Supplies of flammable and combustible liquids are reasonable for the biorepository's
needs, and are properly stored.
NOTE: 1) In each biorepository area, up to one gallon (3.7 L) of Class I, II and IIIA liquids may
be stored outside of fire-resistant cabinets for each 100 ft² (9.2m²) of space defined by fireresistant walls/doors. Up to two gallons (7.5 L) of Class I, II, and IIIA liquids may be stored insafety cans and safety cabinets for each 100 ft² (9.2m²).These amounts may be doubled if
there is an automatic fire suppression system (e.g. sprinklers). For example: a 1000 ft² (92.9m²)
laboratory defined by fire resistant walls/doors can store 10 gallons (37.7 L) outside a safetycabinet and 20 gallons (75.7 L) inside a safety cabinet and double those numbers if there is an
automatic fire suppression system. 2) Safety cans should be used for bulk storage of flammableand combustible liquid (National Fire Protection Association classes I and II). Metal or DOT-

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approved plastic containers provide an intermediate level of hazard containment between glassand safety cans. One pint (0.4 L) of a highly volatile solvent such as isopentane, stored in glass
has about the same ignitability risk as two gallons (7.5 L) stored in safety cans. Safety cansshould be used instead of glass bottles if the purity required does not mandate glass storage.
REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition

GEN.88200

Volatile Solvent Ventilation

Phase II

Storage areas and/or rooms where volatile solvents are used are adequately ventilated.
NOTE: Areas where flammable liquids are used must be ventilated for protection of employee
health, as well as fire prevention. Areas where flammable liquids are stored should be ventilated
primarily for fire protection. Storage cabinets do not need to be vented, but if they are vented theduct system must be explosion proof.
REFERENCES
1) National Fire Protection Association Standard 45: Standard on Fire Protection for Laboratories Using Chemicals, 2011 edition**REVISED** 07/28/2015
GEN.88300 Acid/Base Storage

Phase II

Supplies of concentrated acids and bases are stored in cabinets near floor level.
NOTE: 1) Strong acids and bases must not be stored under sinks, where contamination bymoisture may occur. 2) Storage containers of acids and bases should be adequately separated
to prevent a chemical reaction in the event of an accident/spill/leak. 3) Bottle carriers are used totransport all glass containers larger than 500 mL that contain hazardous chemicals.
GEN.88310

Evacuation/Clean-up Plan

Phase II

The biorepository has a plan for evacuation and clean-up in the event of an LN2 or liquid
CO2 spill from a bulk source.
GEN.88325

Emergency Treatment - Toxic Fumes

Phase II

The biorepository has a plan for the immediate treatment of an individual overcome by
toxic fumes.

RADIATION SAFETY
GEN.88340

Radiation Safety Manual

Phase IIIf the biorepository handles specimens that are known to be radioactive, there are written
policies and procedures adequate for radiation safety.
GEN.88350

Radioactive Material HandlingPhase IIIf the biorepository handles specimens that are known to be radioactive, there are specificpolicies and procedures for the safe handling of tissues that may contain radioactive
material (e.g. sentinel lymph nodes, breast biopsies, prostate "seeds", etc.).
NOTE: These policies and procedures should be developed in conjunction with the institutionalradiation safety officer, and must comply with any state regulations for the safe handling of

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tissues containing radionuclides. The policies and procedures should distinguish between low
radioactivity specimens such as sentinel lymphadenectomy and implant devices with higher
radiation levels.
REFERENCES
1) Glass EC, et al. Editorial: radiation safety considerations for sentinel node techniques. Ann Surg Oncol. 1999:6:10
2) Miner TJ, et al. Guideline for the safe use of radioactive materials during localization and resection of sentinel lymph nodes. Ann Surg
3)
4)
5)
6)

Oncol. 1999;6:75-82
Cibull ML. Handling sentinel lymph node biopsy specimens. A work in progress. Arch Pathol Lab Med. 1999;123:620-621
Pfeifer JD. Sentinel lymph node biopsy. Am J Clin Pathol. 1999;112:599-602
Barnes CA. False-negative frozen section results. Am J Clin Pathol. 2000;113:900
Fitzgibbons PL, et al. Recommendations for handling radioactive specimens obtained by sentinel lymphadenectomy. Am J Surg
Pathol. 2000;24:1549-1551