LABORATORY LABORATORY MANAGEMENTMANAGEMENT

REVIEW 2008REVIEW 2008

LABORATORY LABORATORY MANAGEMENTMANAGEMENT

REVIEW 2008REVIEW 2008

Adapted from Tim Hamill, M.D.Adapted from Tim Hamill, M.D.Adapted from Tim Hamill, M.D.Adapted from Tim Hamill, M.D.

Federal Agencies Impacting Federal Agencies Impacting LaboratoriesLaboratories

Federal Agencies Impacting Federal Agencies Impacting LaboratoriesLaboratories

• Department of Health & Human Services (DHHS)Department of Health & Human Services (DHHS)

• CLIACLIA

• Center for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Services (CMS) (Formerly HCFA)(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 Federal Occupational Safety & Health Administration (OSHA)Administration (OSHA)

• Department of Health & Human Services (DHHS)Department of Health & Human Services (DHHS)

• CLIACLIA

• Center for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Services (CMS) (Formerly HCFA)(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 Federal Occupational Safety & Health Administration (OSHA)Administration (OSHA)

CLIACLIAClinical Laboratory Improvement AmendmentClinical Laboratory Improvement Amendment

CLIACLIAClinical Laboratory Improvement AmendmentClinical Laboratory Improvement Amendment

• CLIA ‘67 came firstCLIA ‘67 came first

• Under HCFA (now CMS) recommendations the Under HCFA (now CMS) recommendations the federal government enacted CLIA ’88 federal government enacted CLIA ’88

• Took effect Sept. 1992Took effect Sept. 1992

• Regulations set forth in 42CFR493Regulations set forth in 42CFR493

• Set minimum standards under which ALL laboratories Set minimum standards under which ALL laboratories would operatewould operate

• Available on-line at: Available on-line at:

http://www.cdc.gov/clia/regs/toc.aspxhttp://www.cdc.gov/clia/regs/toc.aspx

• CLIA ‘67 came firstCLIA ‘67 came first

• Under HCFA (now CMS) recommendations the Under HCFA (now CMS) recommendations the federal government enacted CLIA ’88 federal government enacted CLIA ’88

• Took effect Sept. 1992Took effect Sept. 1992

• Regulations set forth in 42CFR493Regulations set forth in 42CFR493

• Set minimum standards under which ALL laboratories Set minimum standards under which ALL laboratories would operatewould operate

• Available on-line at: Available on-line at:

http://www.cdc.gov/clia/regs/toc.aspxhttp://www.cdc.gov/clia/regs/toc.aspx

CLIA LaboratoriesCLIA LaboratoriesCLIA LaboratoriesCLIA Laboratories• CLIA defines what a ‘Laboratory’ is and specifies those CLIA defines what a ‘Laboratory’ is and specifies those

labs that do not come under CLIAlabs 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 Research laboratories IFIF the results of tests are not released for the results of tests are not released for use in patient care decisionsuse in patient care decisions

• CLIA defines what a ‘Laboratory’ is and specifies those CLIA defines what a ‘Laboratory’ is and specifies those labs that do not come under CLIAlabs 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 Research laboratories IFIF the results of tests are not released for the results of tests are not released for use in patient care decisionsuse in patient care decisions

CLIA Test ComplexitiesCLIA Test ComplexitiesCLIA Test ComplexitiesCLIA Test Complexities

• Application of CLIA standards is based on Application of CLIA standards is based on the highest ‘complexity’ of testing the highest ‘complexity’ of testing performed by each laboratoryperformed 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 Application of CLIA standards is based on the highest ‘complexity’ of testing the highest ‘complexity’ of testing performed by each laboratoryperformed by each laboratory

• WaivedWaived

• Moderately complexModerately complex

• Provider performed microscopy (PPM)Provider performed microscopy (PPM)

• Highly complexHighly complex

2006 CLIA Laboratory Statistics2006 CLIA Laboratory Statistics2006 CLIA Laboratory Statistics2006 CLIA Laboratory Statistics

88% of labs perform ≤ 25,000 tests/yr88% of labs perform ≤ 25,000 tests/yr0.3% of labs perform > 1M tests/yr0.3% of labs perform > 1M tests/yr

Criteria Used to Evaluate Test Criteria Used to Evaluate Test Method Complexity Method Complexity (score 1-3 for each criteria)(score 1-3 for each criteria)

Criteria Used to Evaluate Test Criteria Used to Evaluate Test Method Complexity Method Complexity (score 1-3 for each criteria)(score 1-3 for each criteria)

11 KnowledgeKnowledge

22 Training and experienceTraining and experience

33 Reagent and material preparationReagent and material preparation

44 Characteristics of operational stepsCharacteristics of operational steps

55 Calibration, QC, PT materialsCalibration, QC, PT materials

66 Test system troubleshootingTest system troubleshooting

77 Interpretation and judgmentInterpretation and judgment

*<=12 moderate complexity, >12 high complexity*<=12 moderate complexity, >12 high complexity

11 KnowledgeKnowledge

22 Training and experienceTraining and experience

33 Reagent and material preparationReagent and material preparation

44 Characteristics of operational stepsCharacteristics of operational steps

55 Calibration, QC, PT materialsCalibration, QC, PT materials

66 Test system troubleshootingTest system troubleshooting

77 Interpretation and judgmentInterpretation and judgment

*<=12 moderate complexity, >12 high complexity*<=12 moderate complexity, >12 high complexity

Waived TestingWaived TestingWaived TestingWaived 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 Tests using such simple and accurate

methodologies that the likelihood of erroneous methodologies that the likelihood of erroneous results is negligible”results is negligible”

• 1992: dip u/a, fecal occult blood, urine preg & 1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct 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 Tests using such simple and accurate

methodologies that the likelihood of erroneous methodologies that the likelihood of erroneous results is negligible”results is negligible”

• 1992: dip u/a, fecal occult blood, urine preg & 1992: dip u/a, fecal occult blood, urine preg & ovulation tests, ESR, home devices for blood ovulation tests, ESR, home devices for blood glucose, hgb by copper sulfate, spun hct glucose, hgb by copper sulfate, spun hct

Waived TestingWaived TestingWaived TestingWaived Testing

• 1997 Waived test program expanded – 1997 Waived test program expanded – result is 10-fold expansion in number of result is 10-fold expansion in number of waived tests waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):(http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):

• Any test listedAny test listed• Manufacturer may apply for waived status for Manufacturer may apply for waived status for

any test system that meets criteriaany 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 – 1997 Waived test program expanded – result is 10-fold expansion in number of result is 10-fold expansion in number of waived tests waived tests (http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):(http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf):

• Any test listedAny test listed• Manufacturer may apply for waived status for Manufacturer may apply for waived status for

any test system that meets criteriaany test system that meets criteria• Test systems cleared by FDA for home useTest systems cleared by FDA for home use

Waived TestingWaived TestingWaived TestingWaived Testing

• What does it mean if your physician office What does it mean if your physician office lab performs only waived testing? lab performs only waived testing? • No specific personnel or quality control No specific personnel or quality control

requirements other than to follow the requirements other than to follow the manufacturers’ directionsmanufacturers’ 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 What does it mean if your physician office lab performs only waived testing? lab performs only waived testing? • No specific personnel or quality control No specific personnel or quality control

requirements other than to follow the requirements other than to follow the manufacturers’ directionsmanufacturers’ directions

• No inspection unless there is a complaintNo inspection unless there is a complaint• Still need a waiver certificateStill need a waiver certificate

Waived & PPM Testing: Problems Waived & PPM Testing: Problems for the Hospital Clin Labfor the Hospital Clin Lab

Waived & PPM Testing: Problems Waived & PPM Testing: Problems for the Hospital Clin Labfor the Hospital Clin Lab

• Many/most POC tests are “waived”Many/most POC tests are “waived”

• Providers, clinics, OR, etc. want to perform Providers, clinics, OR, etc. want to perform these tests in their locationsthese tests in their locations

• If it is under our CLIA certificate, it is If it is under our CLIA certificate, it is subject to all of our requirements and subject to all of our requirements and inspections including state, VA, JC, CAP, inspections including state, VA, JC, CAP, FDA, etc. FDA, etc.

• Many/most POC tests are “waived”Many/most POC tests are “waived”

• Providers, clinics, OR, etc. want to perform Providers, clinics, OR, etc. want to perform these tests in their locationsthese tests in their locations

• If it is under our CLIA certificate, it is If it is under our CLIA certificate, it is subject to all of our requirements and subject to all of our requirements and inspections including state, VA, JC, CAP, inspections including state, VA, JC, CAP, FDA, etc. FDA, etc.

Moderately Complex TestsModerately Complex TestsModerately Complex TestsModerately Complex Tests

• Provider Performed Provider Performed MicroscopyMicroscopy• 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 Provider Performed MicroscopyMicroscopy• 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/ UA: automated w/ microscopicmicroscopic

• Automated hematologyAutomated hematology

• Automated ChemistryAutomated Chemistry

• UA: automated w/ UA: automated w/ microscopicmicroscopic

CLIA CertificatesCLIA CertificatesCLIA CertificatesCLIA Certificates

• Certificate of WaiverCertificate of Waiver

• For labs only performing waived tests For 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 tests For 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

CLIACertificate

CLIA CertificatesCLIA CertificatesCLIA CertificatesCLIA Certificates

• Certificate of Compliance:Certificate of Compliance: Issued by CMS after passing a Issued by CMS after passing a CLIA inspectionCLIA inspection

• Certificate of Accreditation:Certificate of Accreditation: Issued after passing an Issued after passing an inspection by a ‘deemed’ agencyinspection 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 American Association of Blood Banks (AABB) (blood banks and Transfusion centers only)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:Certificate of Compliance: Issued by CMS after passing a Issued by CMS after passing a CLIA inspectionCLIA inspection

• Certificate of Accreditation:Certificate of Accreditation: Issued after passing an Issued after passing an inspection by a ‘deemed’ agencyinspection 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 American Association of Blood Banks (AABB) (blood banks and Transfusion centers only)centers only)

• American Society for Histocompatibility and Immunogenetics (ASHI)American Society for Histocompatibility and Immunogenetics (ASHI)

• American Osteopathic Association (AOA)American Osteopathic Association (AOA)

Types of CLIA CertificationTypes of CLIA CertificationTypes of CLIA CertificationTypes of CLIA Certification

CLIA: PersonnelCLIA: PersonnelCLIA: PersonnelCLIA: Personnel

• Director, technical supervisor, clinical Director, technical supervisor, clinical consultant, general supervisor, testing consultant, general supervisor, testing personnelpersonnel

• Director: overall responsibility, must be Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role)(need MD in clinical consultant role)

• Clinical consultant: clinician or PhDClinical consultant: clinician or PhD

• Director, technical supervisor, clinical Director, technical supervisor, clinical consultant, general supervisor, testing consultant, general supervisor, testing personnelpersonnel

• Director: overall responsibility, must be Director: overall responsibility, must be MD/DO/podiatrist or PhD in some cases MD/DO/podiatrist or PhD in some cases (need MD in clinical consultant role)(need MD in clinical consultant role)

• Clinical consultant: clinician or PhDClinical consultant: clinician or PhD

CLIA: Proficiency TestingCLIA: Proficiency TestingCLIA: Proficiency TestingCLIA: Proficiency Testing

• Successful PT requirement for maintaining CLIA Successful PT requirement for maintaining CLIA certificate of compliancecertificate of compliance

• If no commercial PT available, must do split sample If no commercial PT available, must do split sample comparison with another internal method or outside labcomparison with another internal method or outside lab

• Minimum performance limits for each test in 3 PT events Minimum performance limits for each test in 3 PT events per yearper year

• PT samples must be treated same as patient samples: no PT samples must be treated same as patient samples: no referrals!referrals!

• PT failures: investigate and correctPT failures: investigate and correct• If you fail same analyte 2 of 3 consecutive PT events, If you fail same analyte 2 of 3 consecutive PT events,

subject to sanctions. After PT failure, must have 2 subject to sanctions. After PT failure, must have 2 successful surveys to be “out of danger”successful surveys to be “out of danger”

• Successful PT requirement for maintaining CLIA Successful PT requirement for maintaining CLIA certificate of compliancecertificate of compliance

• If no commercial PT available, must do split sample If no commercial PT available, must do split sample comparison with another internal method or outside labcomparison with another internal method or outside lab

• Minimum performance limits for each test in 3 PT events Minimum performance limits for each test in 3 PT events per yearper year

• PT samples must be treated same as patient samples: no PT samples must be treated same as patient samples: no referrals!referrals!

• PT failures: investigate and correctPT failures: investigate and correct• If you fail same analyte 2 of 3 consecutive PT events, If you fail same analyte 2 of 3 consecutive PT events,

subject to sanctions. After PT failure, must have 2 subject to sanctions. After PT failure, must have 2 successful surveys to be “out of danger”successful surveys to be “out of danger”

Case: Proficiency TestingCase: Proficiency Testing

CLIA: Quality SystemsCLIA: Quality SystemsCLIA: Quality SystemsCLIA: Quality Systems

• Maintain quality in preanalytical, analytical, Maintain quality in preanalytical, analytical, and postanalytical phases of testingand postanalytical phases of testing

• ““Establish and maintain written policies and Establish and maintain written policies and procedures that implement and monitor procedures that implement and monitor quality systems”quality systems”

• Maintain quality in preanalytical, analytical, Maintain quality in preanalytical, analytical, and postanalytical phases of testingand postanalytical phases of testing

• ““Establish and maintain written policies and Establish and maintain written policies and procedures that implement and monitor procedures that implement and monitor quality systems”quality systems”

CLIA: Procedure ManualCLIA: Procedure ManualCLIA: Procedure ManualCLIA: Procedure Manual

• Failure to follow manufacturers’ directions is #1 Failure to follow manufacturers’ directions is #1 deficiency in any inspectiondeficiency 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 Manufacturer product insert may be used to

partially meet requirement, but…partially meet requirement, but…• Include: patient prep, specimen collect, Include: patient prep, specimen collect,

instrument calibration, reportable range, qc, instrument calibration, reportable range, qc, reference intervals (range), panic values, reportingreference intervals (range), panic values, reporting

• Failure to follow manufacturers’ directions is #1 Failure to follow manufacturers’ directions is #1 deficiency in any inspectiondeficiency 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 Manufacturer product insert may be used to

partially meet requirement, but…partially meet requirement, but…• Include: patient prep, specimen collect, Include: patient prep, specimen collect,

instrument calibration, reportable range, qc, instrument calibration, reportable range, qc, reference intervals (range), panic values, reportingreference intervals (range), panic values, reporting

CLIA: Test ValidationCLIA: Test Validation CLIA: Test ValidationCLIA: 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 manufacturer’s normal (reference) rangeVerify manufacturer’s 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 manufacturer’s normal (reference) rangeVerify manufacturer’s normal (reference) range

• Test performs as expected at your siteTest performs as expected at your site

Test ValidationTest ValidationTest ValidationTest 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

Test Validation ChecklistTest Validation ChecklistTest Validation ChecklistTest Validation ChecklistVersion Date 6/7/07

NEW TEST APPROVAL SIGN -OFF DATE SUBMITTED FOR REVIEW: _______________ TEST: __________________________________________________________________________ CIRCLE ONE: FDA APPROVED FDA MODIFIED HOME BREW ATTACH COPIES OF ALL VALID ATION DATA REVIEW AND APPROVAL: INDICATE APPROVAL OF ITEMS WITH ŅOKÓ, DATE AND INTIAL WHEN REVIEW WAS PERFORMED ACCURACY PRECISION LINEARITY RPT RNG REF RNG PROCEDURE DAT E INITIALS SECTION DIRECTOR

TECHNICAL DIRECTOR

QC SPEC

LABORATOR Y DIRECTOR

SENSITIVITY SPECIFICITY INTERFERENC E STABILITY REPORTS/

UCARE CAP TEST

MENU CHG FORM

DAT E INITIALS

SECTION DIRECTOR

TECHNICAL DIRECTOR

QC SPEC

LABORATOR Y DIRECTOR

DUPLICATE ALL VA LIDATION DATA AND THIS REVIEW SHEET WHEN COMPLETE. ONE COPY TO BE RETAINED BY THE TESSTING SECTION AND THE OTHER BY THE QC DEPARTMENT FOR THE ENTIRE TIME THE ASSAY IS IN USE PLUS 3 YRS.

ValidationValidation

• 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 Formalized testing using “scripts” to ensure that

performance of each function is as expectedperformance 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 Check that it performs per manufacturers specifications in manualmanual

CLIA: Quality ControlCLIA: Quality ControlCLIA: Quality ControlCLIA: Quality Control

• Should detect immediate problems and monitor accuracy and precision over Should detect immediate problems and monitor accuracy and precision over timetime

• 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 For quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trendsand standard deviation must be monitored over time to detect trends

• Should detect immediate problems and monitor accuracy and precision over Should detect immediate problems and monitor accuracy and precision over timetime

• 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 For quantitative controls compare values to statistically derived mean and standard deviation must be monitored over time to detect trendsand standard deviation must be monitored over time to detect trends

““Equivalent or Alternate QC”Equivalent or Alternate QC”““Equivalent or Alternate QC”Equivalent or Alternate QC”

• Recognition that 1992 QC regulations were out of Recognition that 1992 QC regulations were out of datedate

• 2004 new alternate QC proposed:2004 new alternate QC proposed:

• Combine Moderate & High complexity QC as ‘Non-Combine Moderate & High complexity QC as ‘Non-Waived’ QCWaived’ QC

• Tests systems identified by FDA as applicable for Tests systems identified by FDA as applicable for alternate QCalternate QC

• Manufacturer instructionsManufacturer instructions

• Recognition that 1992 QC regulations were out of Recognition that 1992 QC regulations were out of datedate

• 2004 new alternate QC proposed:2004 new alternate QC proposed:

• Combine Moderate & High complexity QC as ‘Non-Combine Moderate & High complexity QC as ‘Non-Waived’ QCWaived’ QC

• Tests systems identified by FDA as applicable for Tests systems identified by FDA as applicable for alternate QCalternate QC

• Manufacturer instructionsManufacturer instructions

““Equivalent or Alternate QC”Equivalent or Alternate QC”““Equivalent or Alternate QC”Equivalent or Alternate QC”

• Example Option 1: Systems w/internal system to Example Option 1: Systems w/internal system to check check allall analytic components 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 Test external controls 1x per month and daily internal

checkcheck

• Example Option 1: Systems w/internal system to Example Option 1: Systems w/internal system to check check allall analytic components 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 Test external controls 1x per month and daily internal

checkcheck

CLIA: InspectionCLIA: InspectionCLIA: InspectionCLIA: Inspection

• Sites performing nonwaived testing must be Sites performing nonwaived testing must be inspected every two yearsinspected every two years

• ““Deemed” organizations: CAP, JC, COLA, Deemed” organizations: CAP, JC, COLA, AABBAABB

• Sites performing nonwaived testing must be Sites performing nonwaived testing must be inspected every two yearsinspected every two years

• ““Deemed” organizations: CAP, JC, COLA, Deemed” organizations: CAP, JC, COLA, AABBAABB

CLIA ‘88CLIA ‘88CLIA ‘88CLIA ‘88• Proficiency testingProficiency testing

• Gen. Lab success rate 80%, Gen. Lab success rate 80%, Blood bank 100%, Cytology Blood bank 100%, Cytology 90%90%

• Applies to all non-waived tests Applies to all non-waived tests introduced after 1992introduced after 1992

• Quality ControlQuality Control• Changed in 2004 - “Equivalent Changed in 2004 - “Equivalent

QC”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%, Gen. Lab success rate 80%,

Blood bank 100%, Cytology Blood bank 100%, Cytology 90%90%

• Applies to all non-waived tests Applies to all non-waived tests introduced after 1992introduced after 1992

• Quality ControlQuality Control• Changed in 2004 - “Equivalent Changed in 2004 - “Equivalent

QC”QC”

• Other:Other:• FacilitiesFacilities• Test methods & equipmentTest methods & equipment• Reagents, materials, suppliesReagents, materials, supplies• Procedure manualProcedure manual

• Method performanceMethod performance• FDA* vs. Modified or Home FDA* vs. Modified or Home

BrewBrew• Accuracy*Accuracy*• Precision*Precision*• Analytic sensitivityAnalytic sensitivity• Reportable range*Reportable range*• Reference range*Reference range*• StabilityStability• InterferenceInterference

• CalibrationCalibration• Quality improvementQuality improvement• Certification & inspectionsCertification & inspections• Maintenance ChecksMaintenance Checks• Comparability of ResultsComparability of Results

• Method performanceMethod performance• FDA* vs. Modified or Home FDA* vs. Modified or Home

BrewBrew• Accuracy*Accuracy*• Precision*Precision*• Analytic sensitivityAnalytic sensitivity• Reportable range*Reportable range*• Reference range*Reference range*• StabilityStability• InterferenceInterference

• CalibrationCalibration• Quality improvementQuality improvement• Certification & inspectionsCertification & inspections• Maintenance ChecksMaintenance Checks• Comparability of ResultsComparability of Results

Inspection AgenciesInspection AgenciesInspection AgenciesInspection Agencies

• College of American PathologistsCollege of American Pathologists

• Joint Commission for Accreditation of Joint Commission for Accreditation of Hospital OrganizationsHospital 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 Joint Commission for Accreditation of Hospital OrganizationsHospital Organizations

• Commission on Laboratory AccreditationCommission on Laboratory Accreditation

• American Association of Blood BanksAmerican Association of Blood Banks

OSHAOSHAOSHAOSHA

• Workplace safetyWorkplace safety• SharpsSharps• Universal PrecautionsUniversal Precautions• Blood Bourne Blood Bourne

Pathogen StandardPathogen Standard• Engineering PracticesEngineering Practices• Work Practice Work Practice

ControlsControls• Personal Protective Personal Protective

EquipmentEquipment

• Workplace safetyWorkplace safety• SharpsSharps• Universal PrecautionsUniversal Precautions• Blood Bourne Blood Bourne

Pathogen StandardPathogen Standard• Engineering PracticesEngineering Practices• Work Practice Work Practice

ControlsControls• Personal Protective Personal Protective

EquipmentEquipment

• Exposure Control PlanExposure Control Plan

• HousekeepingHousekeeping

• Hepatitis B vaccine Hepatitis B vaccine Special SituationsSpecial Situations

• SignsSigns

• TrainingTraining

• Chemical Hygiene Chemical Hygiene PlanPlan

• CalOSHACalOSHA

• Exposure Control PlanExposure Control Plan

• HousekeepingHousekeeping

• Hepatitis B vaccine Hepatitis B vaccine Special SituationsSpecial Situations

• SignsSigns

• TrainingTraining

• Chemical Hygiene Chemical Hygiene PlanPlan

• CalOSHACalOSHA

SafetySafetySafetySafety

• Safety manualSafety manual• MSDSMSDS• Exits & mapsExits & maps• Fire drills & Fire drills &

extinguishersextinguishers• EyewashesEyewashes• Protective gearProtective gear• How to call for helpHow to call for help

Food & Drug AdministrationFood & Drug AdministrationFood & Drug AdministrationFood & Drug Administration

• Oversight of instruments or test kits that are Oversight of instruments or test kits that are ‘marketed’ to labs for testing ‘marketed’ to labs for testing • Pre-market approval processPre-market approval process

• Incomplete assaysIncomplete assays• Bulk reagentsBulk reagents• Analyte specific reagents (ASR’s)Analyte specific reagents (ASR’s)

• Lab Developed Assays (LDA’s)Lab Developed Assays (LDA’s)• IVDMIA’sIVDMIA’s

• Oversight of instruments or test kits that are Oversight of instruments or test kits that are ‘marketed’ to labs for testing ‘marketed’ to labs for testing • Pre-market approval processPre-market approval process

• Incomplete assaysIncomplete assays• Bulk reagentsBulk reagents• Analyte specific reagents (ASR’s)Analyte specific reagents (ASR’s)

• Lab Developed Assays (LDA’s)Lab Developed Assays (LDA’s)• IVDMIA’sIVDMIA’s

CMS office of the Inspector CMS office of the Inspector General (OIG)General (OIG)

CMS office of the Inspector CMS office of the Inspector General (OIG)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

Human ResourcesHuman ResourcesHuman ResourcesHuman 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

HiringHiringHiringHiring

• 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

Labor RelationsLabor RelationsLabor RelationsLabor Relations

• Probationary PeriodProbationary Period

• Performance EvaluationsPerformance Evaluations

• Disciplinary ActionsDisciplinary Actions

• TerminationsTerminations

• UnionsUnions

• Probationary PeriodProbationary Period

• Performance EvaluationsPerformance Evaluations

• Disciplinary ActionsDisciplinary Actions

• TerminationsTerminations

• UnionsUnions

PersonnelPersonnel

• Job descriptionsJob descriptions• Initial trainingInitial training• 6 month 6 month

competency for competency for new employeesnew employees

• Competency Competency assessment assessment including direct including direct observationobservation