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. Parallels the flow of a specimen through the laboratory. Reflects the Total Testing Process: General Laboratory Systems Preanalytic Systems Analytic Systems Postanalytic Systems

Subpart A General 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).

Subpart I Proficiency 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.

Subpart J Facility 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.

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 after use.

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

Subpart K Quality 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

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

Subpart K Quality 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.

Subpart K Quality System Preanalytic 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.

Subpart K Quality System Analytic Systems Procedure Manual: Director must sign procedures & changes prior to use. Retain test procedures with the dates of initial use and discontinuance.

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic Systems Maintenance and function checks: Follow manufacturer’s instructions for maintenance & function checks. Calibration and calibration verifications: Provides flexibility for calibration verification material.

Subpart K Quality Systems Analytic 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.

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic 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

Subpart K Quality System Analytic 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. Each day of use check all reagents, test procedures for mycobacterial identification using positive and negative acid-fast organisms.

Subpart K Quality System Analytic 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

Subpart K Quality System Analytic Systems Parasitology: No changes. Virology: Routine Chemistry:

Subpart K Quality System Analytic 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).

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic 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.

Subpart K Quality System Analytic 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.

Subpart K Quality Systems Analytic 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.

Subpart K Quality System Postanalytic 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.

Subpart M Personnel 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.

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)

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