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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 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).
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.
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.
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 KQuality System
Applies to moderate & high testing.– General Laboratory Systems.– Preanalytic Systems.– Analytic Systems.
– Post analytic Systems.• Emphasizes Quality Assessment.
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
Subpart KQuality System
General laboratory Systems: – Confidentiality of patient information.– Specimen identification & integrity.– Complaint investigations.– Communications.– Personnel Competency Assessment Policies.– Evaluation of PT performance.
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.
Subpart KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality System
Analytic Systems
Parasitology:– No changes.
Virology:– No changes.
Routine Chemistry:– No changes.
Subpart KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 KQuality 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 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.
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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