Transcript 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.
– 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.
• More stringent – Each day of use check all reagents, test procedures for mycobacterial identification using positive and negative acid-fast organisms.
• More stringent
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:
– No changes.
Routine Chemistry:
– No changes.
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)