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(a): Enrol in a CMS-approved proficiency testing program for every specialty, subspecialty and regulated analyte the laboratory is certified to perform, designate the program used for each, stay with it for a year before changing, and authorise release of PT data to HHS

What does 801(a) require?

Each laboratory performing nonwaived testing must enrol in one or more proficiency testing (PT) programs approved under Subpart I covering each specialty and subspecialty for which it seeks certification, notify HHS of the program chosen, and, where it uses more than one program, designate which program is used for each specialty, subspecialty and analyte for compliance purposes. For tests it performs that are not regulated analytes under Subpart I, the laboratory must establish and maintain the accuracy of its testing through the twice-yearly verification required by section 493.1236(c). The laboratory must participate in the designated program for one year before designating a different one and must notify CMS before any change, and must authorise the PT program to release to HHS all data needed to determine compliance and to make PT results public as the Public Health Service Act requires.

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.