---
kind: "section"
citation: "42 C.F.R. § 493.1236"
title: "42"
number: "493.1236"
heading: "Standard: Evaluation of proficiency testing performance."
url: "https://uscodex.org/cfr/42/493.1236"
---

# §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](/cfr/42/subpartI.md) 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.

## Notes

### Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.