1 / 38

LABORATORY MANAGEMENT REVIEW 2008

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

edith
Download Presentation

LABORATORY MANAGEMENT REVIEW 2008

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related