§493.1236. Standard: Evaluation of proficiency testing performance.
42 C.F.R. § 493.1236
The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part.
The laboratory must verify the accuracy of the following:
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.
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).
At least twice annually, the laboratory must verify the accuracy of the following:
Any test or procedure it performs that is not included in subpart I of this part.
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.
All proficiency testing evaluation and verification activities must be documented.
Notes, amendments, and revision history
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.