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Title 42 Part 493 → Subpart K → §493.1236

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1236

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1236

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1236


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing


§493.1236   Standard: Evaluation of proficiency testing performance.

(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.