Details of CLIA Final QC Regulatory Changes

Details of CLIA Final QC Regulatory Changes

Division of Laboratory ServicesCMS

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.


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


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


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.


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.


Analytic Systems

Procedure Manual:– Director must sign procedures & changes prior

to use.– Retain test procedures with the dates of initial

use and discontinuance.


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.


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.


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.


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


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


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


Analytic Systems

Parasitology:– No changes.

Virology:– No changes.

Routine Chemistry:– No changes.


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).


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.


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.


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.


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.


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.


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)

http://www.cms.hhs.gov/

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Details of CLIA Final QC Regulatory Changes

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