US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1236: Review and evaluate all proficiency testing results, verify the accuracy of any unscored or unevaluated analyte, and at least twice a year verify the accuracy of every test not covered by an approved PT program, documenting all evaluation and verification

What does 1236 require?

The laboratory must review and evaluate the results it obtains on Subpart H proficiency testing. It must verify the accuracy of any analyte or subspecialty without regulated analytes that an approved PT program does not evaluate or score, and of any analyte, specialty or subspecialty whose PT score does not reflect performance (for example where the program failed to reach the agreement needed for scoring, or the laboratory scored zero for nonparticipation or late return). At least twice annually it must verify the accuracy of every test or procedure it performs that is not a regulated analyte under Subpart I, and of every regulated analyte for which no compatible PT samples are offered. All PT evaluation and accuracy verification activities must be documented.