US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart H: participation in proficiency testing for nonwaived testing (sections 493.801 to 493.865), with Subpart I program approval as context – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 801(b): Test proficiency testing samples exactly as patient specimens, within the routine workload by the staff who normally test, the same number of times, with no inter-laboratory communication or referral of PT samples before the reporting deadline, with the analyst and director attesting to routine integration and all records kept for two years

What does 801(b) require?

PT samples must be examined or tested in the same manner as patient specimens: integrated into the regular patient workload, by personnel who routinely perform the test, using the laboratory's routine methods, the same number of times patient samples are tested, with microbiology identifications reported to the level the laboratory reports for patients, and, where patient testing would normally stop at the point of referral for reflex, distributive or confirmatory testing elsewhere, stopping at that point. The analyst and the laboratory director must attest to that routine integration on the PT program's attestation statement. Until the program's reporting deadline for the event, no communication about PT results may take place with another laboratory or across the laboratory's own sites, and no PT sample or portion may be sent to another laboratory for any analysis the laboratory is certified to perform; intentional referral leads to revocation of the certificate for at least a year, and a laboratory receiving another laboratory's PT sample must tell CMS. The laboratory must document handling, preparation, processing, examination and each testing and reporting step for every PT sample and keep those records, including the program report forms and signed attestation, for at least two years from the event. PT is required only for the primary method used for patient testing during the event.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Subpart H: participation in proficiency testing for nonwaived testing (sections 493.801 to 493.865), with Subpart I program approval as context – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.