GroundRules
42 CFR 493.1236: Standard: Evaluation of proficiency testing performance.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER G—STANDARDS AND CERTIFICATION
- PART 493—LABORATORY REQUIREMENTS
- Subpart K—Quality System for Nonwaived Testing
(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part.
(b) The laboratory must verify the accuracy of the following:
(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program.
(2) Any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return of results).
(c) At least twice annually, the laboratory must verify the accuracy of the following:
(1) Any test or procedure it performs that is not included in subpart I of this part.
(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program.
(d) All proficiency testing evaluation and verification activities must be documented.
Collected 2026-08-27T02:26:11Z. Source file · JSON