Transcription
APHL GUIDE FORCLIA INTERNAL AUDITSRELATED TO HIGH COMPLEXITY TESTINGJANUARY 2022
CONTENTSIntroduction.36. Analytic—Testing.266.1 Procedure Manual. 26Acknowledgments.3APHL Workgroup. 3APHL Staff. 3CDC . 36.2 Analytic Systems—Verification and Validation(establishment of performance specifications). 297. Analytic—Quality Control.31CMS CLIA. 37.1 QC—General. 31List of Assessors by CLIA RegulatoryRequirement.47.3 QC—Mycobacteriology. 377.2 QC—Bacteriology. 367.4 QC—Mycology. 377.5 QC—Parasitology. 381. Facilities & Safety.57.6 QC—Virology. 387.7 QC—Other than Microbiology. 382. Personnel.72.1 General CLIA Personnel Requirements (LaboratoryDirector Responsibilities Not Covered Elsewhere). 72.2 Qualifications. 88. Proficiency Testing (PT) &Alternative Assessment.398.1 PT—Enrollment. 392.3 Responsibilities. 98.2 PT—Testing of Samples. 392.4 Training. 118.3 PT—Evaluation of Performance. 412.5 Competency Assessment. 128.4 Comparison of Test Results. 423. Pre-analytic & Post-analyticSystems.159. General Laboratory Systems &Retention Requirements.433.1 Pre-analytic Systems. 159.1 General Laboratory Systems §493.1230. 433.2 Post-analytic. 174. Analytic—Test Systems, Reagents,Materials & Supplies.215. Analytic—Equipment Maintenance,Function Checks & Calibration.2310. Quality Assessment & CorrectiveAction.4410.1 Quality Assessment. 4410.2 Corrective Action. 47APHL CLIA Audit Checklist 2
INTRODUCTIONThis document was developed as a quality improvement tool for internal “self” assessments of CLIA laboratory activities.Throughout the guide, State Operations Manual (SOM)/Code of Federal Regulations (CFR) numbers are hyperlinked within thetables for a full explanation of each requirement. Access the full documents: SOM: State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and LaboratoryServices (Rev. 166, 02/03/17) CFR: Electronic Code of Federal Regulations (Title 42: Public Health, Part 493 – Laboratory Requirements)The information and content in this document reflects the CFR requirements in place on March 31, 2021. APHL makes norepresentations of any kind, express or implied about the completeness, accuracy, reliability, or suitability of this checklist withrespect to ongoing updates to reflect amendments to the eCFR website. Therefore, the use of this document is strictly at yourown risk. However, the eCFR website link provided in this document is hyperlinked to the current eCFR website version.ACKNOWLEDGMENTSAPHL would like to acknowledge the following individuals and organizations for their contributions, feedback and expertise to thisproject:APHL WorkgroupCDC Hyder Al Janabi Nancy Anderson, MMSc, MT(ASCP) Mary Bonifas, BS, CQA(ASQ) Víctor R. De Jesús, PhD Bonita Bryant, MT(ASCP) Marie Earley, PhD Leann Covington Meredith Korth, CQA (ASQ), Booz Allen Hamilton Gillian Edwards Atis Muehlenbachs, MD, PhD, FCAP Laurie Gregg, MT(ASCP) Marranda S. Scott, MLS(ASCP) Analiza Gross, MBA, MT(ASCP) Angela Thompson, MS, MT(ASCP) Lydia Mikhail Laura Naught, PhD, NRCC(TC) Rajesh ParmarCMS CLIA Kathy Ross Deborah Severson, MT(ASCP)Laboratory Systems and Standards committeechair Kimyatta Smith, MS Tamara Theisen, MT(ASCP)APHL Staff Kuki Hansen, BVMS, MPH, DACVPM Lorelei Kurimski, MS Tina Su, MPH Andrea WrightAPHL CLIA Audit Checklist 3
LIST OF ASSESSORS BY CLIA REGULATORY REQUIREMENTCategory of CLIA Regulatory Requirements Assessed1. Facilities & Safety2. Personnel2.1 General CLIA Personnel Requirements2.2 Qualifications2.3 Responsibilities2.4 Training2.5 Competency Assessment3. Preanalytic & Postanalytic Systems3.1 Preanalytic Systems3.2 Postanalytic Systems4. Analytic—Test Systems, Reagents, Materials & Supplies5. Analytic—Equipment Maintenance, Function Checks & Calibration6. Analytic—Testing6.1 Procedure Manual6.2 Verification and Validation7.Analytic—Quality Control8. Proficiency Testing & Alternative Assessment8.1 Enrollment8.2 Testing of samples8.3 Evaluation of performance8.4 Comparison of test results9. General Laboratory Systems & Retention Requirements10. Quality Assessment & Corrective Action10.1 Quality Assessment10.2 Corrective ActionAPHL CLIA Audit Checklist 4Assessor
Facilities & SafetyLaboratory Director:Date:1. FACILITIES & SAFETY#SOM/CFR*RequirementExamples of ComplianceNotes1.1D3001Does the laboratory have adequatespace, ventilation and utilities necessaryfor conducting all phases of the testingprocess? Make laboratory floor plans available. Observe during laboratory tours(space: crowded; ventilation: check airflow strips; adequate lighting; fumes;availability of electrical outlets). Ask about backup power. Arrange work areas to minimizeproblems in specimen handling,examination and testing, and thereporting of test results. Place instruments, equipment andcomputer systems in locations wheretheir operation is not adverselyaffected by physical or chemicalfactors, such as heat, direct sunlight,vibrations, power fluctuations.Requirement met?Laboratory Director Responsibility(cannot be delegated): Assure there are quality systems inplace. Ask about any safety incident(s) in thelaboratory and what was done.Requirement met?Observe during the lab tour:Requirement met?§493.1101(a)(1)1.2D6083, D6084§493.1445(e)(2)Does the Laboratory Director ensure thatthe physical plant and environmentalconditions of the laboratory:YesNoYesNoNotes:See CLIA Personnel Review Worksheet Tool.Notes: Are appropriate for the testingperformed? Provide a safe environment in whichemployees are protected from physical,chemical, and biological hazards?1.3D3003§493.1101(a)(2)Is the laboratory space maintained tominimize contamination of specimens,equipment, instruments, reagents,materials and supplies? Lab is clean and uncluttered Eyewash or hand wash facilities areaccessible Ventilation is clear Power strips are acceptable to use, butextension cords are notYesNoYesNoYesNoNotes:Lab bench decontamination log isavailable.1.4D3005§493.1101(a)(3)Is lab space used for molecularamplification procedures arranged toprovide unidirectional workflow withseparate areas for: Specimen prep, amplification anddetection? Reagent preparation (as applicable)? Mechanism to detect crosscontamination of patient specimens?1.5D3007§493.1101(b)Does the laboratory have appropriateand sufficient equipment, instruments,reagents, materials and supplies for thetype and volume of testing performed? Observe unidirectional workflow (noworkarounds) Environmental swipe test and blank forcontamination Evidence of blank controls (NTCs) fromQC logs or run sheets.Requirement met?Observe during lab tour or assessthrough staff discussions about essentiallaboratory equipment, (e.g. autoclave,centrifuge, scales, correct reagentsfor instrumentation, equipment list,inventory list, etc.)Requirement met?Notes:Notes:Is there a purchasing process in placeand is it sufficient?Table Key:Laboratory Director (LD)Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist 5Technical Supervisor (TS)Return to Table of Contents
Facilities & SafetyLaboratory Director:Date:#SOM/CFR*RequirementExamples of ComplianceNotes1.6D3009The laboratory must be in compliancewith applicable federal, state and locallaboratory requirements. Ask for the current certificates or statelicensure documents. Ask for the laboratory’s policy oncompliance with these requirementeven if there is no state licensure orcertificates.Requirement met?Are safety procedures established,accessible and observed to ensureprotection from physical, chemical,biochemical and electrical hazards, andbiohazardous materials?Check that findings from any laboratory’ssafety survey report have been corrected.Requirement met?Are records and, as applicable, slides,blocks, and tissues maintained andstored under conditions that ensureproper preservation?How are records stored? What is yourrecord retention policy? What is yourpolicy for the temperature and humiditycontrol for the records? What is your offsite archive and retrieval policy?§493.1101(c)1.7D3011§493.1101(d)1.8D3027, 3029,3031, 3033,3037, 3039, and3041§493.1101(e)Table Key:Laboratory Director (LD)Laboratory specific documentation—including the biosafety manual, wastemanagement plan, chemical hygieneplan and, if applicable, the laboratory’sbloodborne pathogen exposure controlplan and training documents—arereviewed during the annual safety survey.YesNoYesNoNotes:This includes all types of laboratories(e.g., permanent, mobile, temporary, etc.)Notes:Requirement met?YesNoNotes:Check state requirements as applicable—go with most stringent.Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist 6Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:2. PERSONNEL2.1 General CLIA Personnel Requirements (Laboratory Director ResponsibilitiesNot Covered Elsewhere)Refer to the CLIA Personnel Review Worksheet Tool for more information on each of the following Examples of ComplianceNotes2.1.aD6079Is the laboratory director responsible forthe overall operation and administrationof the laboratory, including:If a new CLIA director:Requirement met?§493.1445(a)(b)Note:Also covered in2.3.c2.1.bD6080§493.1445(c)Note:D6144, D6145and D6146§493.1463(a)(1-2) are coveredin 5(e)(10)2.1.eD6101§493.1445(e)(11)Table Key: Employment of personnel who arecompetent to perform test procedures,record and report test resultspromptly, accurately and proficiently,and for assuring compliance with theapplicable regulations? Delegation of qualified personnelto perform the duties of TechnicalSupervisor, Clinical Consultant,General Supervisor, and TestingPersonnel? Ensuring all duties delegated areproperly performed? Ask for educational records,competency records, transcripts,certificates, diplomas, laboratoryorganizational charts, etc. Identify technical supervisors andpolicy on delegation of duties.Is the laboratory director accessibleto the laboratory to provide onsite,telephone or electronic consultation asneeded?Documentation addressed in othersections.Requirement met?Cannot be delegated:Does the laboratory director ensurethat testing systems developed andused for each of the tests performedin the laboratory provide qualitylaboratory services for all aspects oftest performance, which includes thepre-analytic, analytic, and post-analyticphases of testing?Documentation addressed in othersections.Requirement met?Cannot be delegated:Does the laboratory director ensurethat a general supervisor provideson-site supervision of high complexitytest performance by testing personnelqualified under §493.1489(b) (4)?Documentation addressed in othersections.Requirement met?Cannot be delegated:Does the laboratory director ensure theemployment/assignment of a sufficientnumber of laboratory personnel withappropriate education and eitherexperience or training to provideappropriate consultation, properlysupervise and accurately perform testsand report test results?Documentation addressed in othersections.Requirement met?Laboratory Director (LD)Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist Notes:Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:2.2 Qualifications#SOM/CFR*RequirementExamples of ComplianceNotesFor each person acting in the followingpersonnel roles, are qualificationsdocumented?Since the previous internal audit/inspection, the items below must becurrent for new employees:Requirement met?YesNoYesNoNotes: Diploma indicating degree in achemical, physical, biological,clinical laboratory science or medicaltechnology, if applicable Transcript, if diploma does notspecify area of study (transcriptswere requested by CMS inspectorsfor degrees in public health, zoology,epidemiology, forestry and veterinarymedicine) Foreign degree equivalency ifeducational requirement is from aforeign institution Professional training recordsConsult regulations for specifics.2.2.aD6078Laboratory Director§493.14432.2.bD6111Technical Supervisor§493.14492.2.cD6135Certificate or (state) license to indicatequalification to direct the laboratory,degree (MD or PhD) or other additionalcertifications.Requirement met?The laboratory director can also be thetechnical supervisor.Requirement met?Someone with a BS and MS degree withyears of experience can be the technicalsupervisor with written designation.Clinical ConsultantMDs: License to practice medicinefrom any US state or territory or boardcertification by a CMS-approved board.§493.1455Note: No further documentation isrequired (no need to produce foreigneducational equivalency), but the medicallicense must be current and active (mustnot be expired).See CLIA Personnel Review Worksheet ToolNotes:YesNoSee CLIA personnel forms: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel FormNotes:Requirement met?YesNoSee CLIA personnel forms: CLIA Personnel Review Worksheet Tool Clinical Consultant Personnel FormNotes:PhDs: Degree in a chemical, physical,biological or clinical laboratory science,plus active certification by a HHSapproved board (e.g., ABMM or ABB).Note: Further documentation may beneeded to produce foreign educationalequivalency of the PhD.Table Key:Laboratory Director (LD)Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist 8Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:#SOM/CFR*RequirementExamples of ComplianceNotes2.2.dD6143General SupervisorDocumentation of two years laboratorytraining or experience is required.Requirement met?§493.1461YesNoSee CLIA personnel forms: CLIA Personnel Review Worksheet Tool General Supervisor Personnel FormNotes:2.2.eD6171Testing Personnel§493.1489Documentation of a degree (doctoral,master’s or bachelor’s) in a chemical,physical, biological or clinical laboratoryscience, or medical technology from anaccredited institution.Requirement met?YesNoYesNoNotes:2.3 Responsibilities#SOM/CFR*RequirementExamples of ComplianceNotes2.3.aD6107Has the laboratory director specified inwriting the responsibilities and dutiesfor all:Written documentation, policies,procedures or forms for all CLIApersonnel signed by the laboratorydirector or designee:Requirement met?§493.1445(e)(15) Clinical consultants?Technical supervisors?General supervisors?Testing personnel? Clinical consultantsTechnical supervisorsGeneral supervisorsTesting personnelTypes of documentation: Position descriptionsCompetency documentsTraining recordsSOPs and authorizationsSee CLIA personnel forms: Clinical Consultants Technical Supervisors General Supervisors Testing Personnel Supervisor Competency AssessmentProcedure CLIA Supervisory CompetencyAssessment for General Supervisor Form CLIA Supervisory CompetencyAssessment for Clinical Consultant Form CLIA Supervisory CompetencyAssessment for Technical SupervisorFormNotes:2.3.bD6107§493.1445(e)(15)For testing personnel, is theredocumentation that specifies: Testing procedures the individual isauthorized to perform? Whether supervision is requiredfor specimen processing, testperformance or result reporting? Whether supervisory or director reviewis required prior to reporting patienttest results?Written documentation, policies,procedures or forms for all testingpersonnel signed by the laboratorydirector or designee indicating the teststhe individual is authorized to performwithout supervisionLaboratory Director (LD)Clinical Consultant (CC)YesNoSee CLIA Testing Personnel FormNotes:Note: supervisory review is requiredbefore patient test results are reportedfor all testing personnel.Types of documentation: Table Key:Requirement met?Position descriptionsCompetency documentsTraining recordsSOPs and authorizationsGeneral Supervisor (GS)APHL CLIA Audit Checklist 9Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:#SOM/CFR*RequirementExamples of ComplianceNotes2.3.cD6079Laboratory Director Responsibility:Is the laboratory director responsible forthe overall operation and administrationof the laboratory, including:Written documentation ofreapportionments.Requirement met?§493.1445(a)(b)Note: Alsocovered in 2.1.a2.3.d2.3.e2.3.fClinical Consultant Responsibility:Does the laboratory have a clinicalconsultant available to provide:§493.1457(a)(b)(d) Consultation to submitters? Assist submitters to ensureappropriate test are ordered? Communicate with submitters aboutthe quality of test results reported andtheir interpretation concerning specificpatient conditions?D6144, D6145and D6146General Supervisor Responsibility:§493.1463(a)(1-2) Provide day-to-day supervision of highcomplexity test performance? Remain accessible to testingpersonnel at all times testingis performed to provide on-site,telephone or electronic consultationto resolve technical problemsin accordance with policies andprocedures established either bythe laboratory director or technicalsupervisor?D6080§493.1445(c)Note: Alsocovered in 2.1.a2.3.gD6174§493.1495(a)Table Key:NoNotes: Employing personnel who arecompetent to perform test procedures;record and report test results promptly,accurately and proficiently; andassure compliance with the applicableregulations? Delegating qualified personnel toperform the duties of technicalsupervisor, clinical consultant, generalsupervisor and testing personnel? Ensuring all duties delegated areproperly performed?D6136, D6137,D6138 andD6140Note: Alsocovered in 2.1.bYesSee CLIA Personnel Review Worksheet ToolDoes the general supervisor:Communication log that shows theclinical consultant provides consultationwith submitters.Evidence of day-to-day review of records,such as QC record or organizationalcharts that display reporting lines.NoRequirement met?YesNoSee: CLIA Personnel Review Worksheet Tool General Supervisor Personnel FormNotes:Overall review of system compliance.Testing Personnel Responsibility:Is there documented evidence thattesting person-nel limit patient testing toonly those tests which they have beenauthorized to per-form by the laboratorydirector?Review test results to ensure performedby an authorized testing personnel, ortrain-ing and competency assessmentrecords.Clinical Consultant (CC)YesSee: CLIA Personnel Review Worksheet Tool Clinical Consultant Personnel FormNotes:Laboratory Director Responsibility:Is the laboratory director accessibleto the laboratory to provide onsite,telephone or electronic consultation asneeded?Laboratory Director (LD)Requirement met?Requirement met?YesNoSee CLIA Personnel Review Worksheet ToolNotes:General Supervisor (GS)APHL CLIA Audit Checklist 10Requirement met?YesNoSee CLIA Personnel Review Worksheet ToolNotes:Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:2.4 Training#SOM/CFR*RequirementExamples of ComplianceNotes2.4.aD6102Technical Supervisor Responsibility(Delegated by LD):Does the technical supervisor ensurethat, prior to testing patients’ specimens,all personnel: Personnel qualification records(e.g., transcripts, diplomas, foreignevalutions, equivalency records,training records, competencyassessment records, etc.). LD or designee indicates TSresponsibilities in writing.Requirement met?Personnel training records.Requirement met?§493.1445(e)(12) Have the appropriate education andexperience? Receive the appropriate training forthe type and complexity of servicesoffered? Have demonstrated that they canperform all testing operations reliablyto provide and report accurate results?2.4.bD6120§493.1451(b)(7)Technical Supervisor Responsibility:Does the technical supervisor ensurethat staff training needs are identifiedand that all testing personnel receiveregular in-service training and education?D6151§493.1463(b)(3)General Supervisor Responsibility(If delegated by LD or TS):Does the general supervisor provideorientation to all testing personnel?NoNotes:YesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel FormNotes:Note: This responsiblility can be delegatedin writing to GS (see 2.4.c).2.4.cYesSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel FormPersonnel training records, onboardingchecklist.Requirement met?YesNoSee: CLIA Personnel Review Worksheet Tool General Supervisor Personnel FormNotes:Table Key:Laboratory Director (LD)Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist 11Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:2.5 Competency Assessment#SOM/CFR*RequirementExamples of ComplianceNotes2.5.aD6087Technical Supervisor Responsibility(Delegated by LD): Does the technicalsupervisor ensure that laboratorypersonnel are performing the testmethods as required for accurate andreliable results? Competency assessment (CA) records Training records Quality assurance recordsRequirement met?§493.1445(e)(3)(iii)Note: This responsibility can be delegatedin writing to GS (see 2.5.e).2.5.bD6103§493.1445(e)(13)Technical Supervisor Responsibility(Delegated by LD): Does the technicalsupervisor: Ensure that policies and proceduresare established for monitoringindividuals who conduct pre-analytical,analytical and post-analytical phasesof testing to assure that they arecompetent and maintain theircompetency to process specimens,perform test procedures and reporttest results promptly and proficiently? Identify needs for remedial training orcontinuing education to improve skills?YesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel Form CLIA Testing Personnel Test SystemAuthorization FormNotes: CA records Policy and procedure documents Documents where staff haveacknowledged that they understandthe policies and procedures (signaturepage—digitally, electronically, manually,attestation, etc.)Requirement met? CA records: Are easy to follow, organized andstandardized Have a summary of the schedule forall personnel in the front of the CArecords (recommended).Requirement met?YesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel Form CLIA Testing Personnel Test SystemAuthorization FormNotes:Note: This responsibility can be delegatedin writing to GS (see 2.5.e).2.5.cD6120§493.1451(b)(8)Technical Supervisor Responsibility:Does the technical supervisor ensurepolicies and procedures are establishedto evaluate the competency of alltesting personnel and assure that staffmaintain their competency to performtest procedures and report test resultspromptly, accurately and proficiently?Note: This responsibility can be delegatedin writing to GS (see 2.5.e).Table Key:Laboratory Director (LD)Clinical Consultant (CC) Review policies and proceduresrelated to compentencies. Competency records.General Supervisor (GS)APHL CLIA Audit Checklist 12YesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel Form CLIA Testing Personnel Test SystemAuthorization FormNotes:Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:#SOM/CFR*RequirementExamples of ComplianceNotes2.5.dD6121–D6126Technical Supervisor Responsibility:Do competency assessments includeeach of the following methods:CA records:Requirement met?§493.1451(b)(8)(i-vi) Direct observation of testing? Monitoring the recording and reportingof results? Review of intermediate results, QC, PTand PM? Direct observation of maintenance andfunction checks? Assessment of test performancethrough repeat, blind or external PTtesting? Assessment of problem solving skills?Note: This responsibility can be delegatedin writing to GS (see 2.5.e).2.5.eD6151§493.1463(b)(4)General Supervisor Responsibility(if delegated by LD or TS):Does the general supervisor annuallyevaluate and document the performanceof all testing personnel. Are performed by an individual whohas supporting documents andqualifications to do so (either GS or TS) Have details of what test wasassessed, including dates for each ofthe six methods of assessment Include the results of test performanceand evaluation including worksheets(if PT was used, specifics for PT eventmust be included or a copy of the PTevent records) Show evidence of supervisory review Include documentation of successfulretraining as necessaryYesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel FormNotes:Note: All six competencies must beassessed within the same calendar year,but not necessarily at the same time.Annual competency assessment records,to include dates.Requirement met?YesNoSee: CLIA Personnel Review Worksheet Tool General Supervisor Personnel Form CLIA Testing Personnel Test SystemAuthorization FormNotes:2.5.fD6179§493.1495(b)(5)Testing Personnel Responsibility:Is there documented evidence thattesting per-sonnel are capable ofidentifying problems that may adverselyaffect test system per-formance? Corrective action reportsEvent logsRoot cause analysisInstrument logsRequirement met?YesNoSee CLIA Personnel Review Worksheet ToolNotes:Note: Documentation may be used asevidence for competency assessment.2.5.gD6175§493.1495(b)(1)Table Key:Testing Personnel Responsibility:Is there documented evidence thattesting personnel follow laboratoryprocedures for:Review of run reports with raw data,sample rejection logs, quality controllogs, corrective action reports, review ofresult reports. Specimen handling and processing? Test analyses? Reporting and maintaining records ofpatient test results?Note: Documentation may be used asevidence for competency assessment.Laboratory Director (LD)Clinical Consultant (CC)General Supervisor (GS)APHL CLIA Audit Checklist 13Requirement met?YesNoSee CLIA Personnel Review Worksheet ToolNotes:Technical Supervisor (TS)Return to Table of Contents
PersonnelLaboratory Director:Date:#SOM/CFR*RequirementExamples of ComplianceNotes2.5.hD6177Testing Personnel Responsibility:Is there documented evidence thattesting personnel adhere to qualitycontrol policies and document allquality control activities, instrument andprocedural calibrations and maintenanceperformed? Requirement met?§493.1495(b)(3)Quality control recordsInstrument recordsMaintenance recordsDocuments where staff haveacknowledged that they understandthe policies and procedures (signaturepage—digitally, electronically, manually,attestation, etc.)YesNoSee CLIA Personnel Review Worksheet ToolNotes:Note: Documentation may be used asevidence for competency ical Supervisor Responsibility:Are testing personnel competencyassessments conducted anddocumented: Semiannually during the first year theindividual tests patient specimens? Annually thereafter? When a new method or instrumentchange is introduced, individualis reevaluated to include the useof the new test methodology orinstrumentation prior to reportingpatient test results?2.5.jD5209§493.1235As specified in the personnelrequirements in Subpart M—Personnelfor Nonwaived Testing, the laboratorymust establish and follow written policiesand procedures to assess employee and,if applicable, consultant competency.Competency assessment records—maybe delegated in writing to GS (see 2.5.e). Check for new testing personnel CLIAtesting start date and ensure thelaboratory has records of two competency assessments during the 12months following this start date, withat least one assessment within thefirst six months. Check existing personnel records fornew methods authorized to perform. If the testing methodology changed,retraining will be needed at least onceand documented as necessary. Ensure there are records of annualcompetency assessment for existingpersonnel. Records must show evidence ofsupervisory review. Policies or procedures in place toassess personnel performing preanalytical (accessioning), analytical orpost-analytical (reporting) Documents where staff haveacknowledged that they understandthe policies and procedures (signaturepage—digitally, electronically, manually,attestation, etc.)Requirement met?YesNoSee: CLIA Personnel Review Worksheet Tool Technical Supervisor Personnel FormNotes:Requirement met?YesNoSee CLIA Testing Personnel Te
APHL CLIA Audit Checklist 3 INTRODUCTION This document was developed as a quality improvement tool for internal "self" assessments of CLIA laboratory activities. Throughout the guide, State Operations Manual (SOM)/Code of Federal Regulations (CFR) numbers are hyperlinked within the . tables for a full explanation of each requirement.
