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Details of CLIA Final QC Regulatory Changes

Details of CLIA Final QC Regulatory Changes. Division of Laboratory Services CMS. Overview. Consolidates Subpart J, K, and P into: J-Facility Administration for Nonwaived Testing. K-Quality System for Nonwaived Testing. Creates one set of Nonwaived requirements.

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Details of CLIA Final QC Regulatory Changes

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  1. Details of CLIA Final QC Regulatory Changes Division of Laboratory Services CMS

  2. Overview • Consolidates Subpart J, K, and P into: • J-Facility Administration for Nonwaived Testing. • K-Quality System for Nonwaived Testing. • Creates one set of Nonwaived requirements. • Parallels the flow of a specimen through the laboratory. • Reflects the Total Testing Process: • General Laboratory Systems • Preanalytic Systems • Analytic Systems • Postanalytic Systems

  3. Subpart AGeneral Provisions • Revisions: • Definitions for calibration, FDA-cleared or approved, reportable range & test system. • Replaced National Institute for Drug Abuse (NIDA) with Substance Abuse & Mental Health Services Administration (SAMHSA).

  4. Subpart IProficiency Testing • Revisions: • Changed consensus for PT program grading from 90% to 80%. • Reduces number of ungradables. • Permits labs to “get more for their money”. • Facilitates better laboratory education; e.g., error ID & correction.

  5. Subpart JFacility Administration • Revisions: • Applies to moderate & high testing. • Facility requirements. • Safety precautions are accessible. • Uni-directional workflow for molecular amplification procedures. • Comply w/ Federal, State & local laws.

  6. Subpart J Facility Administration • Revisions: • Transfusion Services • Report transfusion reactions/fatalities to laboratory & authorities. • Record/Specimen Retention • Preservation. • Record retention for closed facilities. • Keep test procedure & performance specifications for 2 years afteruse.

  7. Subpart KQuality System • Applies to moderate & high testing. • General Laboratory Systems. • Preanalytic Systems. • Analytic Systems. • Post analytic Systems. • Emphasizes Quality Assessment.

  8. Subpart KQuality System • Quality assessment (QA) requirements • Monitor and assess quality. • Correct problems. • Review effectiveness of correction. • Discuss with staff. • Document assessment activities. Included in each phase of testing

  9. Subpart KQuality System • General laboratory Systems: • Confidentiality of patient information. • Specimen identification & integrity. • Complaint investigations. • Communications. • Personnel Competency Assessment Policies. • Evaluation of PT performance.

  10. Subpart KQuality System • Evaluation of PT Performance: Verify accuracy of: • Tests w/ no evaluation or score. • Tests when PT score doesn’t reflect test performance. • Any test not included in Subpart I. • Regulated analytes for which compatible PT material isn’t available from PT providers twice a year.

  11. Subpart KQuality SystemPreanalytic Systems • Test request: • Solicit patient’s gender, age or DOB. • Solicit specimen source, when appropriate. • Specimen submission, handling and referral: • Date and time of receipt in laboratory.

  12. Subpart KQuality SystemAnalytic Systems • Procedure Manual: • Director must sign procedures & changes prior to use. • Retain test procedures with the dates of initial use and discontinuance.

  13. Subpart KQuality SystemAnalytic Systems • Test systems, equipment, instruments, reagents, materials, and supplies: • Removed the FDA product dating information to guidelines. • Follow manufacturer’s instructions for storage of reagents, specimens & test systems.

  14. Subpart KQuality SystemAnalytic Systems • Maintenance and function checks: • Follow manufacturer’s instructions for maintenance & function checks. • Calibration and calibration verifications: • Provides flexibility for calibration verification material.

  15. Subpart KQuality SystemsAnalytic Systems • Establishment and Verification of Performance Specifications: • Applies to new or modified nonwaived tests. • Verify/establish accuracy, precision, reportable range. • Verify/establish manufacturer’s normal values. • Determine calibration & control procedures. • Establish analytical sensitivity & specificity.

  16. Subpart KQuality SystemAnalytic Systems • Control Procedures: • Detect immediate errors and monitor over time. • Requires a control system capable of detecting reaction inhibition for molecular amplification. • Test 2 controls/day or acceptable alternative. • Use of calibrators as controls. • Rotate QC testing among all operators.

  17. Subpart KQuality SystemAnalytic Systems • Bacteriology: • Check each batch, lot number and shipment of reagents, disks, stains, antisera, and identification systems when prepared or opened for positive and negative reactivity (and graded reactivity, if applicable). • Less stringent for catalase, Cefinase,Tm coagulase, oxidase, bacitracin, optochin, ONPG, X,V and XV disks or strips • Check each batch, lot number and shipment of antisera for positive and negative reactivity when prepared or opened, and once every 6 months thereafter. • Less stringent

  18. Subpart KQuality SystemAnalytic Systems • Mycobacteriology: • Check fluorochrome acid-fast stains for positive and negative reactivity each time of use. • More stringent • Check acid-fast stains for positive and negative reactivity each day of use. • More stringent • Each day of use check all reagents, test procedures for mycobacterial identification using positive and negative acid-fast organisms. • More stringent

  19. Subpart KQuality SystemAnalytic Systems • Mycology: • Check each batch, lot number and shipment of reagents and fungal identification tests (germ tube) when prepared or opened for positive and negative reactivity (and graded reactivity, if applicable). • Less stringent - frequency • More stringent - added negative control • Check each batch, lot number and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s). • Less stringent

  20. Subpart KQuality SystemAnalytic Systems • Parasitology: • No changes. • Virology: • No changes. • Routine Chemistry: • No changes.

  21. Subpart KQuality SystemAnalytic Systems • Syphilis Serology and Immunology: • Control testing reduced to each day of testing. • Hematology: • Reduced automated hematology QC to once/day. • Manual hematology requires QC each 8 hours of testing. • No change to QC for coagulation (manual or automated).

  22. Subpart KQuality SystemAnalytic Systems • Immunohematology: • Includes only specific cites for FDA BB (21 CFR) requirements under CLIA. • Histopathology: • Check immunohistochemical stains for positive & negative reactivity each time of use. • Allows individuals trained in neuromuscular pathology to report neuromuscular path results.

  23. Subpart KQuality SystemAnalytic Systems • Cytology: • Workload limit for liquid-based slide preparatory techniques reduced from 200 to 100 for gynecologic preparations. • Provision for automated, semi-automated screening devices added to require manufacturer’s instructions (including individual workload limits) be followed.

  24. Subpart KQuality SystemAnalytic Systems • Clinical Cytogenetics: • Resolution is appropriate for type of tissue or specimen & study required based on clinical information provided. • Requires full chromosome analysis for sex determination. • Utilize the International System of Cytogenetic Nomenclature on report.

  25. Subpart KQuality SystemAnalytic Systems • Histocompatibility: • Requires in-house prepared reagent typing inventory to indicate reagent specificity. • Requires a technique that detects HLA specific antibody w/ a specificity equivalent or superior to the basic microlymphocytotoxicity assay. • Requires using a method that distinguishes antibodies to HLA class II antigens from antibodies to Class I antigens.

  26. Subpart KQuality SystemAnalytic Systems • Histocompatibility cont’d: • Have available monthly specimens for periodic antibody screening & crossmatch on all potential transplant recipients; and develop a policy consistent w/ clinical transplant protocols for frequency of such antibody screening. • Define test protocols for each type of cell, tissue or organ to be transfused or transplanted.

  27. Subpart KQuality SystemsAnalytic Systems • Histocompatibility cont’d: • Follow policies that address when HLA testing & final crossmatches are required for pre-sensitized non-renal transplant recipients. • Establish technique to optimally define HLA Class I & II specificity. • Eliminates monthly evaluation of a specimen as an unknown by each testing person.

  28. Subpart KQuality SystemPostanalytic Systems • Test Report: • State date of test report on report & include specimen source, if applicable. • Include name & ID no. or unique patient identifier & ID no.

  29. Subpart MPersonnel • Applies only to doctoral degree (non-MD) qualifications: • Represents only remaining complexity-dependent requirements. • As of 2/24/03 “grandfathers” individuals currently as high complexity directors. • Requires board certification for new directors. • Approved Boards to be listed in Appendix C of Surveyor Guidelines and on website.

  30. CLIA FINAL QC REGULATIONS • CONTACT INFORMATION: • CMS WEB SITE: www.cms.hhs.gov/clia • CMS LAB DIVISION: 410-786-3531(phone) 410-786-1224 (fax)

  31. THE ENDTHANK YOU!! QUESTIONS????

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