LABORATORY MANAGEMENT REVIEW 2008

1. LABORATORY MANAGEMENTREVIEW 2008 Adapted from Tim Hamill, M.D.

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

3. CLIAClinical Laboratory Improvement Amendment • CLIA ‘67 came first • Under HCFA (now CMS) recommendations the federal government enacted CLIA ’88 • Took effect Sept. 1992 • Regulations set forth in 42CFR493 • Set minimum standards under which ALL laboratories would operate • 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 CLIA • Laboratories operated by federal & state agencies • Veterans Administration • Military • Public health laboratories • SAMSHA (NIDA) drug testing laboratories • Laboratories doing only forensic testing • Research 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 laboratory • Waived • Moderately complex • Provider performed microscopy (PPM) • Highly 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) • Knowledge • Training and experience • Reagent and material preparation • Characteristics of operational steps • Calibration, QC, PT materials • Test system troubleshooting • Interpretation and judgment *<=12 moderate complexity, >12 high complexity

8. Waived Testing • Test methods waived from regulatory oversight • Tests cleared by FDA for home use • “Tests 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 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): • Any test listed • Manufacturer may apply for waived status for any test system that meets criteria • Test systems cleared by FDA for home use

10. 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’ directions • No inspection unless there is a complaint • Still need a waiver certificate

11. Waived & PPM Testing: Problems for the Hospital Clin Lab • Many/most POC tests are “waived” • Providers, 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.

12. Moderately Complex Tests • Provider Performed Microscopy • KOH • Wet mount • Urine sediment • Qualitative semen • Ferning • Post-coital exams • Pinworm • Nasal Leukocytes • Fecal Leukocytes • Automated hematology • Automated Chemistry • UA: automated w/ microscopic

13. CLIA Certificate CLIA Certificates • Certificate of Waiver • For labs only performing waived tests • Good for 2 years • Certificate of PPM • For labs performing PPM and/or waived tests • Certificate of Registration • Good for 24 months or until inspected • Not required for Labs doing only waived tests or PPM

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

15. Types of CLIA Certification

16. CLIA: Personnel • Director, 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) • Clinical consultant: clinician or PhD

17. CLIA: Proficiency Testing • Successful PT requirement for maintaining CLIA certificate of compliance • If 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 year • PT samples must be treated same as patient samples: no referrals! • PT 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 danger”

18. Case: Proficiency Testing

19. CLIA: Quality Systems • Maintain quality in preanalytical, analytical, and postanalytical phases of testing • “Establish 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 inspection • SOPs must be available for all testing procedures • 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, reporting

21. CLIA: Test Validation • Applicable to tests placed into use after 9/1/92 • FDA approved test: • Accuracy • Precision • Reportable range • Verify manufacturer’s normal (reference) range • Test performs as expected at your site

22. Test Validation • Modified FDA or “Home Brew” (LDA) • Accuracy • Precision • Analytic sensitivity • Analytic specificity • Reportable range • Reference range • Other performance characteristics • Specimen Stability • Interferences • Establish that modification has not changed test characteristics or performance

23. Test Validation Checklist

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

25. CLIA: Quality Control • Should detect immediate problems and monitor accuracy and precision over time • Perform & document Quality Control • 2 levels every 8 hrs or with each run for all quantitative tests • Positive & negative controls with each run for all qualitative tests • Titered: include titered reactivity control • Extraction process: include extraction controls • Molecular tests: include inhibition controls • Microbiology: control checks on media, stains, discs, etc. • After reagent changes and before testing patient samples • As 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 trends

26. “Equivalent or Alternate QC” • Recognition that 1992 QC regulations were out of date • 2004 new alternate QC proposed: • Combine Moderate & High complexity QC as ‘Non-Waived’ QC • Tests systems identified by FDA as applicable for alternate QC • Manufacturer instructions

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

28. CLIA: Inspection • Sites performing nonwaived testing must be inspected every two years • “Deemed” organizations: CAP, JC, COLA, AABB

29. Proficiency testing Gen. Lab success rate 80%, Blood bank 100%, Cytology 90% Applies to all non-waived tests introduced after 1992 Quality Control Changed in 2004 - “Equivalent QC” Other: Facilities Test methods & equipment Reagents, materials, supplies Procedure 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 CLIA ‘88

30. Inspection Agencies • College of American Pathologists • Joint Commission for Accreditation of Hospital Organizations • Commission on Laboratory Accreditation • American Association of Blood Banks

31. Workplace safety Sharps Universal Precautions Blood Bourne Pathogen Standard Engineering Practices Work Practice Controls Personal Protective Equipment Exposure Control Plan Housekeeping Hepatitis B vaccine Special Situations Signs Training Chemical Hygiene Plan CalOSHA OSHA

32. Safety • Safety manual • MSDS • Exits & maps • Fire drills & extinguishers • Eyewashes • Protective gear • How to call for help

33. Food & Drug Administration • Oversight of instruments or test kits that are ‘marketed’ to labs for testing • Pre-market approval process • Incomplete assays • Bulk reagents • Analyte specific reagents (ASR’s) • Lab Developed Assays (LDA’s) • IVDMIA’s

34. CMS office of the Inspector General (OIG) • OIG Model Compliance Plan for Laboratories • Written Compliance plan • Compliance Officer • Staff education & training programs • Audits to monitor compliance • Corrective actions • Compliance Committee • Billing • Annual Notices • Utilization monitoring • Training • Advanced Beneficiary Notice

35. Human Resources • Staffing Levels • Benchmarking • Internal v. Peer group • Variable v. Fixed • FTE monitoring reports • New programs

36. Hiring • Search process* • Screen Resumes • Conduct Interviews • Complete Reference Checks • Complete Background Checks • License Validation • Job Offer & Negotiations

37. Labor Relations • Probationary Period • Performance Evaluations • Disciplinary Actions • Terminations • Unions

38. Personnel • Job descriptions • Initial training • 6 month competency for new employees • Competency assessment including direct observation