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) 803-807: Participate successfully in proficiency testing for each specialty, subspecialty and analyte certified, take remedial action when an individual fails gynecologic cytology, and, after a failure-based suspension or withdrawal, demonstrate satisfactory performance on two consecutive events before reinstatement

What does 803-807 require?

Each laboratory performing nonwaived testing must successfully participate in the CMS-approved PT program for every specialty, subspecialty and analyte or test for which it is certified, with success defined per specialty in sections 493.821 to 493.865. Unsuccessful participation, or failing to take remedial action when an individual fails gynecologic cytology PT, leads to Subpart R sanctions, although for an initial failure CMS may direct training or technical assistance instead unless there is immediate jeopardy, the laboratory cannot show it has corrected the problem, or its compliance history is poor. Where a certificate is suspended or limited, Medicare or Medicaid approval cancelled or payments suspended because of PT failure, or the laboratory voluntarily withdraws certification for the failed specialty, subspecialty or analyte, the laboratory must then show sustained satisfactory performance on two consecutive PT events, one of which may be on site, before CMS considers reinstatement, and the cancellation or suspension lasts at least six months.

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.

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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)

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