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LABORATORY MANAGEMENT REVIEW 2008 Adapted from Tim Hamill, M.D.

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Presentation on theme: "LABORATORY MANAGEMENT REVIEW 2008 Adapted from Tim Hamill, M.D."— Presentation transcript:

1 LABORATORY MANAGEMENT REVIEW 2008 Adapted from Tim Hamill, M.D.

2 Federal Agencies Impacting Laboratories Department of Health & Human Services (DHHS)Department of Health & Human Services (DHHS) CLIACLIA Center for Medicare & Medicaid Services (CMS) (Formerly HCFA)Center for Medicare & Medicaid Services (CMS) (Formerly HCFA) Office of the Inspector General (OIG)Office of the Inspector General (OIG) Food & Drug Administration (FDA)Food & Drug Administration (FDA) Federal Occupational Safety & Health Administration (OSHA)Federal Occupational Safety & Health Administration (OSHA) Department of Health & Human Services (DHHS)Department of Health & Human Services (DHHS) CLIACLIA Center for Medicare & Medicaid Services (CMS) (Formerly HCFA)Center for Medicare & Medicaid Services (CMS) (Formerly HCFA) Office of the Inspector General (OIG)Office of the Inspector General (OIG) Food & Drug Administration (FDA)Food & Drug Administration (FDA) Federal Occupational Safety & Health Administration (OSHA)Federal Occupational Safety & Health Administration (OSHA)

3 CLIA Clinical Laboratory Improvement Amendment CLIA 67 came firstCLIA 67 came first Under HCFA (now CMS) recommendations the federal government enacted CLIA 88Under HCFA (now CMS) recommendations the federal government enacted CLIA 88 Took effect Sept. 1992Took effect Sept Regulations set forth in 42CFR493Regulations set forth in 42CFR493 Set minimum standards under which ALL laboratories would operateSet minimum standards under which ALL laboratories would operate Available on-line at:Available on-line at:http://www.cdc.gov/clia/regs/toc.aspx CLIA 67 came firstCLIA 67 came first Under HCFA (now CMS) recommendations the federal government enacted CLIA 88Under HCFA (now CMS) recommendations the federal government enacted CLIA 88 Took effect Sept. 1992Took effect Sept Regulations set forth in 42CFR493Regulations set forth in 42CFR493 Set minimum standards under which ALL laboratories would operateSet minimum standards under which ALL laboratories would operate Available on-line at:Available on-line at:http://www.cdc.gov/clia/regs/toc.aspx

4 CLIA Laboratories CLIA defines what a Laboratory is and specifies those labs that do not come under CLIACLIA defines what a Laboratory is and specifies those labs that do not come under CLIA Laboratories operated by federal & state agenciesLaboratories operated by federal & state agencies Veterans AdministrationVeterans Administration MilitaryMilitary Public health laboratoriesPublic health laboratories SAMSHA (NIDA) drug testing laboratoriesSAMSHA (NIDA) drug testing laboratories Laboratories doing only forensic testingLaboratories doing only forensic testing Research laboratories IF the results of tests are not released for use in patient care decisionsResearch laboratories IF the results of tests are not released for use in patient care decisions CLIA defines what a Laboratory is and specifies those labs that do not come under CLIACLIA defines what a Laboratory is and specifies those labs that do not come under CLIA Laboratories operated by federal & state agenciesLaboratories operated by federal & state agencies Veterans AdministrationVeterans Administration MilitaryMilitary Public health laboratoriesPublic health laboratories SAMSHA (NIDA) drug testing laboratoriesSAMSHA (NIDA) drug testing laboratories Laboratories doing only forensic testingLaboratories doing only forensic testing Research laboratories IF the results of tests are not released for use in patient care decisionsResearch laboratories IF the results of tests are not released for use in patient care decisions

5 CLIA Test Complexities Application of CLIA standards is based on the highest complexity of testing performed by each laboratoryApplication of CLIA standards is based on the highest complexity of testing performed by each laboratory WaivedWaived Moderately complexModerately complex Provider performed microscopy (PPM)Provider performed microscopy (PPM) Highly complexHighly complex Application of CLIA standards is based on the highest complexity of testing performed by each laboratoryApplication of CLIA standards is based on the highest complexity of testing performed by each laboratory WaivedWaived Moderately complexModerately complex Provider performed microscopy (PPM)Provider performed microscopy (PPM) Highly complexHighly complex

6 2006 CLIA Laboratory Statistics 88% of labs perform 25,000 tests/yr 0.3% of labs perform > 1M tests/yr

7 Criteria Used to Evaluate Test Method Complexity (score 1-3 for each criteria) 1Knowledge 2Training and experience 3Reagent and material preparation 4Characteristics of operational steps 5Calibration, QC, PT materials 6Test system troubleshooting 7Interpretation and judgment * 12 high complexity 1Knowledge 2Training and experience 3Reagent and material preparation 4Characteristics of operational steps 5Calibration, QC, PT materials 6Test system troubleshooting 7Interpretation and judgment * 12 high complexity

8 Waived Testing Test methods waived from regulatory oversightTest methods waived from regulatory oversight Tests cleared by FDA for home useTests cleared by FDA for home use Tests using such simple and accurate methodologies that the likelihood of erroneous results is negligibleTests using such simple and accurate methodologies that the likelihood of erroneous results is negligible 1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct Test methods waived from regulatory oversightTest methods waived from regulatory oversight Tests cleared by FDA for home useTests cleared by FDA for home use Tests using such simple and accurate methodologies that the likelihood of erroneous results is negligibleTests using such simple and accurate methodologies that the likelihood of erroneous results is negligible 1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct

9 Waived Testing 1997 Waived test program expanded – result is 10-fold expansion in number of waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):1997 Waived test program expanded – result is 10-fold expansion in number of waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf): Any test listedAny test listed Manufacturer may apply for waived status for any test system that meets criteriaManufacturer may apply for waived status for any test system that meets criteria Test systems cleared by FDA for home useTest systems cleared by FDA for home use 1997 Waived test program expanded – result is 10-fold expansion in number of waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):1997 Waived test program expanded – result is 10-fold expansion in number of waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf): Any test listedAny test listed Manufacturer may apply for waived status for any test system that meets criteriaManufacturer may apply for waived status for any test system that meets criteria Test systems cleared by FDA for home useTest systems cleared by FDA for home use

10 Waived Testing What does it mean if your physician office lab performs only waived testing?What does it mean if your physician office lab performs only waived testing? No specific personnel or quality control requirements other than to follow the manufacturers directionsNo specific personnel or quality control requirements other than to follow the manufacturers directions No inspection unless there is a complaintNo inspection unless there is a complaint Still need a waiver certificateStill need a waiver certificate What does it mean if your physician office lab performs only waived testing?What does it mean if your physician office lab performs only waived testing? No specific personnel or quality control requirements other than to follow the manufacturers directionsNo specific personnel or quality control requirements other than to follow the manufacturers directions No inspection unless there is a complaintNo inspection unless there is a complaint Still need a waiver certificateStill need a waiver certificate

11 Waived & PPM Testing: Problems for the Hospital Clin Lab Many/most POC tests are waivedMany/most POC tests are waived Providers, clinics, OR, etc. want to perform these tests in their locationsProviders, clinics, OR, etc. want to perform these tests in their locations If it is under our CLIA certificate, it is subject to all of our requirements and inspections including state, VA, JC, CAP, FDA, etc.If it is under our CLIA certificate, it is subject to all of our requirements and inspections including state, VA, JC, CAP, FDA, etc. Many/most POC tests are waivedMany/most POC tests are waived Providers, clinics, OR, etc. want to perform these tests in their locationsProviders, clinics, OR, etc. want to perform these tests in their locations If it is under our CLIA certificate, it is subject to all of our requirements and inspections including state, VA, JC, CAP, FDA, etc.If it is under our CLIA certificate, it is subject to all of our requirements and inspections including state, VA, JC, CAP, FDA, etc.

12 Moderately Complex Tests Provider Performed MicroscopyProvider Performed Microscopy KOHKOH Wet mountWet mount Urine sedimentUrine sediment Qualitative semenQualitative semen FerningFerning Post-coital examsPost-coital exams PinwormPinworm Nasal LeukocytesNasal Leukocytes Fecal LeukocytesFecal Leukocytes Provider Performed MicroscopyProvider Performed Microscopy KOHKOH Wet mountWet mount Urine sedimentUrine sediment Qualitative semenQualitative semen FerningFerning Post-coital examsPost-coital exams PinwormPinworm Nasal LeukocytesNasal Leukocytes Fecal LeukocytesFecal Leukocytes Automated hematologyAutomated hematology Automated ChemistryAutomated Chemistry UA: automated w/ microscopicUA: automated w/ microscopic Automated hematologyAutomated hematology Automated ChemistryAutomated Chemistry UA: automated w/ microscopicUA: automated w/ microscopic

13 CLIA Certificates Certificate of WaiverCertificate of Waiver For labs only performing waived testsFor labs only performing waived tests Good for 2 yearsGood for 2 years Certificate of PPMCertificate of PPM For labs performing PPM and/or waived testsFor labs performing PPM and/or waived tests Certificate of RegistrationCertificate of Registration Good for 24 months or until inspectedGood for 24 months or until inspected Not required for Labs doing only waived tests or PPMNot required for Labs doing only waived tests or PPM Certificate of WaiverCertificate of Waiver For labs only performing waived testsFor labs only performing waived tests Good for 2 yearsGood for 2 years Certificate of PPMCertificate of PPM For labs performing PPM and/or waived testsFor labs performing PPM and/or waived tests Certificate of RegistrationCertificate of Registration Good for 24 months or until inspectedGood for 24 months or until inspected Not required for Labs doing only waived tests or PPMNot required for Labs doing only waived tests or PPM CLIA Certificate

14 CLIA Certificates Certificate of Compliance: Issued by CMS after passing a CLIA inspectionCertificate of Compliance: Issued by CMS after passing a CLIA inspection Certificate of Accreditation: Issued after passing an inspection by a deemed agencyCertificate of Accreditation: Issued after passing an inspection by a deemed agency Joint Commission on Accreditation of Healthcare Organizations (JCAHO)Joint Commission on Accreditation of Healthcare Organizations (JCAHO) College of American Pathologists (CAP)College of American Pathologists (CAP) Commission on Laboratory Accreditation (COLA)Commission on Laboratory Accreditation (COLA) American Association of Blood Banks (AABB) (blood banks and Transfusion centers only)American Association of Blood Banks (AABB) (blood banks and Transfusion centers only) American Society for Histocompatibility and Immunogenetics (ASHI)American Society for Histocompatibility and Immunogenetics (ASHI) American Osteopathic Association (AOA)American Osteopathic Association (AOA) Certificate of Compliance: Issued by CMS after passing a CLIA inspectionCertificate of Compliance: Issued by CMS after passing a CLIA inspection Certificate of Accreditation: Issued after passing an inspection by a deemed agencyCertificate of Accreditation: Issued after passing an inspection by a deemed agency Joint Commission on Accreditation of Healthcare Organizations (JCAHO)Joint Commission on Accreditation of Healthcare Organizations (JCAHO) College of American Pathologists (CAP)College of American Pathologists (CAP) Commission on Laboratory Accreditation (COLA)Commission on Laboratory Accreditation (COLA) American Association of Blood Banks (AABB) (blood banks and Transfusion centers only)American Association of Blood Banks (AABB) (blood banks and Transfusion centers only) American Society for Histocompatibility and Immunogenetics (ASHI)American Society for Histocompatibility and Immunogenetics (ASHI) American Osteopathic Association (AOA)American Osteopathic Association (AOA)

15 Types of CLIA Certification

16 CLIA: Personnel Director, technical supervisor, clinical consultant, general supervisor, testing personnelDirector, technical supervisor, clinical consultant, general supervisor, testing personnel Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role)Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role) Clinical consultant: clinician or PhDClinical consultant: clinician or PhD Director, technical supervisor, clinical consultant, general supervisor, testing personnelDirector, technical supervisor, clinical consultant, general supervisor, testing personnel Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role)Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role) Clinical consultant: clinician or PhDClinical consultant: clinician or PhD

17 CLIA: Proficiency Testing Successful PT requirement for maintaining CLIA certificate of complianceSuccessful PT requirement for maintaining CLIA certificate of compliance If no commercial PT available, must do split sample comparison with another internal method or outside labIf no commercial PT available, must do split sample comparison with another internal method or outside lab Minimum performance limits for each test in 3 PT events per yearMinimum performance limits for each test in 3 PT events per year PT samples must be treated same as patient samples: no referrals!PT samples must be treated same as patient samples: no referrals! PT failures: investigate and correctPT failures: investigate and correct If you fail same analyte 2 of 3 consecutive PT events, subject to sanctions. After PT failure, must have 2 successful surveys to be out of dangerIf you fail same analyte 2 of 3 consecutive PT events, subject to sanctions. After PT failure, must have 2 successful surveys to be out of danger Successful PT requirement for maintaining CLIA certificate of complianceSuccessful PT requirement for maintaining CLIA certificate of compliance If no commercial PT available, must do split sample comparison with another internal method or outside labIf no commercial PT available, must do split sample comparison with another internal method or outside lab Minimum performance limits for each test in 3 PT events per yearMinimum performance limits for each test in 3 PT events per year PT samples must be treated same as patient samples: no referrals!PT samples must be treated same as patient samples: no referrals! PT failures: investigate and correctPT failures: investigate and correct If you fail same analyte 2 of 3 consecutive PT events, subject to sanctions. After PT failure, must have 2 successful surveys to be out of dangerIf you fail same analyte 2 of 3 consecutive PT events, subject to sanctions. After PT failure, must have 2 successful surveys to be out of danger

18 Case: Proficiency Testing

19 CLIA: Quality Systems Maintain quality in preanalytical, analytical, and postanalytical phases of testingMaintain quality in preanalytical, analytical, and postanalytical phases of testing Establish and maintain written policies and procedures that implement and monitor quality systemsEstablish and maintain written policies and procedures that implement and monitor quality systems Maintain quality in preanalytical, analytical, and postanalytical phases of testingMaintain quality in preanalytical, analytical, and postanalytical phases of testing Establish and maintain written policies and procedures that implement and monitor quality systemsEstablish and maintain written policies and procedures that implement and monitor quality systems

20 CLIA: Procedure Manual Failure to follow manufacturers directions is #1 deficiency in any inspectionFailure to follow manufacturers directions is #1 deficiency in any inspection SOPs must be available for all testing proceduresSOPs must be available for all testing procedures Manufacturer product insert may be used to partially meet requirement, but…Manufacturer product insert may be used to partially meet requirement, but… Include: patient prep, specimen collect, instrument calibration, reportable range, qc, reference intervals (range), panic values, reportingInclude: patient prep, specimen collect, instrument calibration, reportable range, qc, reference intervals (range), panic values, reporting Failure to follow manufacturers directions is #1 deficiency in any inspectionFailure to follow manufacturers directions is #1 deficiency in any inspection SOPs must be available for all testing proceduresSOPs must be available for all testing procedures Manufacturer product insert may be used to partially meet requirement, but…Manufacturer product insert may be used to partially meet requirement, but… Include: patient prep, specimen collect, instrument calibration, reportable range, qc, reference intervals (range), panic values, reportingInclude: patient prep, specimen collect, instrument calibration, reportable range, qc, reference intervals (range), panic values, reporting

21 CLIA: Test Validation Applicable to tests placed into use after 9/1/92Applicable to tests placed into use after 9/1/92 FDA approved test:FDA approved test: AccuracyAccuracy PrecisionPrecision Reportable rangeReportable range Verify manufacturers normal (reference) rangeVerify manufacturers normal (reference) range Test performs as expected at your siteTest performs as expected at your site Applicable to tests placed into use after 9/1/92Applicable to tests placed into use after 9/1/92 FDA approved test:FDA approved test: AccuracyAccuracy PrecisionPrecision Reportable rangeReportable range Verify manufacturers normal (reference) rangeVerify manufacturers normal (reference) range Test performs as expected at your siteTest performs as expected at your site

22 Test Validation Modified FDA or Home Brew (LDA)Modified FDA or Home Brew (LDA) AccuracyAccuracy PrecisionPrecision Analytic sensitivityAnalytic sensitivity Analytic specificityAnalytic specificity Reportable rangeReportable range Reference rangeReference range Other performance characteristicsOther performance characteristics Specimen StabilitySpecimen Stability InterferencesInterferences Establish that modification has not changed test characteristics or performanceEstablish that modification has not changed test characteristics or performance Modified FDA or Home Brew (LDA)Modified FDA or Home Brew (LDA) AccuracyAccuracy PrecisionPrecision Analytic sensitivityAnalytic sensitivity Analytic specificityAnalytic specificity Reportable rangeReportable range Reference rangeReference range Other performance characteristicsOther performance characteristics Specimen StabilitySpecimen Stability InterferencesInterferences Establish that modification has not changed test characteristics or performanceEstablish that modification has not changed test characteristics or performance

23 Test Validation Checklist

24 Validation Validate proceduresValidate procedures You wrote it, can somebody else follow?You wrote it, can somebody else follow? Validate computer softwareValidate computer software Formalized testing using scripts to ensure that performance of each function is as expectedFormalized testing using scripts to ensure that performance of each function is as expected Document (print) and saveDocument (print) and save Validate equipmentValidate equipment Install after biomed engineering checksInstall after biomed engineering checks Check that it performs per manufacturers specifications in manualCheck that it performs per manufacturers specifications in manual

25 CLIA: Quality Control Should detect immediate problems and monitor accuracy and precision over timeShould detect immediate problems and monitor accuracy and precision over time Perform & document Quality ControlPerform & document Quality Control 2 levels every 8 hrs or with each run for all quantitative tests2 levels every 8 hrs or with each run for all quantitative tests Positive & negative controls with each run for all qualitative testsPositive & negative controls with each run for all qualitative tests Titered: include titered reactivity controlTitered: include titered reactivity control Extraction process: include extraction controlsExtraction process: include extraction controls Molecular tests: include inhibition controlsMolecular tests: include inhibition controls Microbiology: control checks on media, stains, discs, etc.Microbiology: control checks on media, stains, discs, etc. After reagent changes and before testing patient samplesAfter reagent changes and before testing patient samples As patient samples and rotate among operatorsAs patient samples and rotate among operators For quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trendsFor quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trends Should detect immediate problems and monitor accuracy and precision over timeShould detect immediate problems and monitor accuracy and precision over time Perform & document Quality ControlPerform & document Quality Control 2 levels every 8 hrs or with each run for all quantitative tests2 levels every 8 hrs or with each run for all quantitative tests Positive & negative controls with each run for all qualitative testsPositive & negative controls with each run for all qualitative tests Titered: include titered reactivity controlTitered: include titered reactivity control Extraction process: include extraction controlsExtraction process: include extraction controls Molecular tests: include inhibition controlsMolecular tests: include inhibition controls Microbiology: control checks on media, stains, discs, etc.Microbiology: control checks on media, stains, discs, etc. After reagent changes and before testing patient samplesAfter reagent changes and before testing patient samples As patient samples and rotate among operatorsAs patient samples and rotate among operators For quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trendsFor quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trends

26 Equivalent or Alternate QC Recognition that 1992 QC regulations were out of dateRecognition that 1992 QC regulations were out of date 2004 new alternate QC proposed:2004 new alternate QC proposed: Combine Moderate & High complexity QC as Non- Waived QCCombine Moderate & High complexity QC as Non- Waived QC Tests systems identified by FDA as applicable for alternate QCTests systems identified by FDA as applicable for alternate QC Manufacturer instructionsManufacturer instructions Recognition that 1992 QC regulations were out of dateRecognition that 1992 QC regulations were out of date 2004 new alternate QC proposed:2004 new alternate QC proposed: Combine Moderate & High complexity QC as Non- Waived QCCombine Moderate & High complexity QC as Non- Waived QC Tests systems identified by FDA as applicable for alternate QCTests systems identified by FDA as applicable for alternate QC Manufacturer instructionsManufacturer instructions

27 Equivalent or Alternate QC Example Option 1: Systems w/internal system to check all analytic componentsExample Option 1: Systems w/internal system to check all analytic components Successful daily internal checksSuccessful daily internal checks Successful testing of 2 levels of control each day x 10 daysSuccessful testing of 2 levels of control each day x 10 days Change QC to:Change QC to: Test external controls 1x per month and daily internal checkTest external controls 1x per month and daily internal check Example Option 1: Systems w/internal system to check all analytic componentsExample Option 1: Systems w/internal system to check all analytic components Successful daily internal checksSuccessful daily internal checks Successful testing of 2 levels of control each day x 10 daysSuccessful testing of 2 levels of control each day x 10 days Change QC to:Change QC to: Test external controls 1x per month and daily internal checkTest external controls 1x per month and daily internal check

28 CLIA: Inspection Sites performing nonwaived testing must be inspected every two yearsSites performing nonwaived testing must be inspected every two years Deemed organizations: CAP, JC, COLA, AABBDeemed organizations: CAP, JC, COLA, AABB Sites performing nonwaived testing must be inspected every two yearsSites performing nonwaived testing must be inspected every two years Deemed organizations: CAP, JC, COLA, AABBDeemed organizations: CAP, JC, COLA, AABB

29 CLIA 88 Proficiency testingProficiency testing Gen. Lab success rate 80%, Blood bank 100%, Cytology 90%Gen. Lab success rate 80%, Blood bank 100%, Cytology 90% Applies to all non-waived tests introduced after 1992Applies to all non-waived tests introduced after 1992 Quality ControlQuality Control Changed in Equivalent QCChanged in Equivalent QC Other:Other: FacilitiesFacilities Test methods & equipmentTest methods & equipment Reagents, materials, suppliesReagents, materials, supplies Procedure manualProcedure manual Proficiency testingProficiency testing Gen. Lab success rate 80%, Blood bank 100%, Cytology 90%Gen. Lab success rate 80%, Blood bank 100%, Cytology 90% Applies to all non-waived tests introduced after 1992Applies to all non-waived tests introduced after 1992 Quality ControlQuality Control Changed in Equivalent QCChanged in Equivalent QC Other:Other: FacilitiesFacilities Test methods & equipmentTest methods & equipment Reagents, materials, suppliesReagents, materials, supplies Procedure manualProcedure manual Method performance FDA* vs. Modified or Home Brew Accuracy* Precision* Analytic sensitivity Reportable range* Reference range* Stability Interference Calibration Quality improvement Certification & inspections Maintenance Checks Comparability of Results Method performance FDA* vs. Modified or Home Brew Accuracy* Precision* Analytic sensitivity Reportable range* Reference range* Stability Interference Calibration Quality improvement Certification & inspections Maintenance Checks Comparability of Results

30 Inspection Agencies College of American PathologistsCollege of American Pathologists Joint Commission for Accreditation of Hospital OrganizationsJoint Commission for Accreditation of Hospital Organizations Commission on Laboratory AccreditationCommission on Laboratory Accreditation American Association of Blood BanksAmerican Association of Blood Banks College of American PathologistsCollege of American Pathologists Joint Commission for Accreditation of Hospital OrganizationsJoint Commission for Accreditation of Hospital Organizations Commission on Laboratory AccreditationCommission on Laboratory Accreditation American Association of Blood BanksAmerican Association of Blood Banks

31 OSHAOSHA Workplace safetyWorkplace safety SharpsSharps Universal PrecautionsUniversal Precautions Blood Bourne Pathogen StandardBlood Bourne Pathogen Standard Engineering PracticesEngineering Practices Work Practice ControlsWork Practice Controls Personal Protective EquipmentPersonal Protective Equipment Workplace safetyWorkplace safety SharpsSharps Universal PrecautionsUniversal Precautions Blood Bourne Pathogen StandardBlood Bourne Pathogen Standard Engineering PracticesEngineering Practices Work Practice ControlsWork Practice Controls Personal Protective EquipmentPersonal Protective Equipment Exposure Control Plan Housekeeping Hepatitis B vaccine Special Situations Signs Training Chemical Hygiene Plan CalOSHA Exposure Control Plan Housekeeping Hepatitis B vaccine Special Situations Signs Training Chemical Hygiene Plan CalOSHA

32 SafetySafety Safety manualSafety manual MSDSMSDS Exits & mapsExits & maps Fire drills & extinguishersFire drills & extinguishers EyewashesEyewashes Protective gearProtective gear How to call for helpHow to call for help

33 Food & Drug Administration Oversight of instruments or test kits that are marketed to labs for testingOversight of instruments or test kits that are marketed to labs for testing Pre-market approval processPre-market approval process Incomplete assaysIncomplete assays Bulk reagentsBulk reagents Analyte specific reagents (ASRs)Analyte specific reagents (ASRs) Lab Developed Assays (LDAs)Lab Developed Assays (LDAs) IVDMIAsIVDMIAs Oversight of instruments or test kits that are marketed to labs for testingOversight of instruments or test kits that are marketed to labs for testing Pre-market approval processPre-market approval process Incomplete assaysIncomplete assays Bulk reagentsBulk reagents Analyte specific reagents (ASRs)Analyte specific reagents (ASRs) Lab Developed Assays (LDAs)Lab Developed Assays (LDAs) IVDMIAsIVDMIAs

34 CMS office of the Inspector General (OIG) OIG Model Compliance Plan for LaboratoriesOIG Model Compliance Plan for Laboratories Written Compliance planWritten Compliance plan Compliance OfficerCompliance Officer Staff education & training programsStaff education & training programs Audits to monitor complianceAudits to monitor compliance Corrective actionsCorrective actions Compliance CommitteeCompliance Committee BillingBilling Annual NoticesAnnual Notices Utilization monitoringUtilization monitoring TrainingTraining Advanced Beneficiary NoticeAdvanced Beneficiary Notice OIG Model Compliance Plan for LaboratoriesOIG Model Compliance Plan for Laboratories Written Compliance planWritten Compliance plan Compliance OfficerCompliance Officer Staff education & training programsStaff education & training programs Audits to monitor complianceAudits to monitor compliance Corrective actionsCorrective actions Compliance CommitteeCompliance Committee BillingBilling Annual NoticesAnnual Notices Utilization monitoringUtilization monitoring TrainingTraining Advanced Beneficiary NoticeAdvanced Beneficiary Notice

35 Human Resources Staffing LevelsStaffing Levels BenchmarkingBenchmarking Internal v. Peer groupInternal v. Peer group Variable v. FixedVariable v. Fixed FTE monitoring reportsFTE monitoring reports New programsNew programs Staffing LevelsStaffing Levels BenchmarkingBenchmarking Internal v. Peer groupInternal v. Peer group Variable v. FixedVariable v. Fixed FTE monitoring reportsFTE monitoring reports New programsNew programs

36 HiringHiring Search process*Search process* Screen ResumesScreen Resumes Conduct InterviewsConduct Interviews Complete Reference ChecksComplete Reference Checks Complete Background ChecksComplete Background Checks License ValidationLicense Validation Job Offer & NegotiationsJob Offer & Negotiations Search process*Search process* Screen ResumesScreen Resumes Conduct InterviewsConduct Interviews Complete Reference ChecksComplete Reference Checks Complete Background ChecksComplete Background Checks License ValidationLicense Validation Job Offer & NegotiationsJob Offer & Negotiations

37 Labor Relations Probationary PeriodProbationary Period Performance EvaluationsPerformance Evaluations Disciplinary ActionsDisciplinary Actions TerminationsTerminations UnionsUnions Probationary PeriodProbationary Period Performance EvaluationsPerformance Evaluations Disciplinary ActionsDisciplinary Actions TerminationsTerminations UnionsUnions

38 Personnel Job descriptionsJob descriptions Initial trainingInitial training 6 month competency for new employees6 month competency for new employees Competency assessment including direct observationCompetency assessment including direct observation


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