Citations checked against 42 CFR Part 493 on 11 November 2026Independent publisher. Not affiliated with CMS, CDC or any accreditation organization.
CLIA Templates

Verification log

This page records each time we check the kits against the federal regulation and CMS guidance, and what changed as a result.

Citations checked against 42 CFR Part 493 on 11 November 2026

DateSource checkedResultStatus
2026-11-1142 CFR 493.1233, 493.1234, 493.1235, 493.1249Full text read. Kit wording matches. No change needed.Checked
2026-11-11CMS IQCP FAQs (Aug 2016) and CMS IQCP page (updated 24 Aug 2026), which interpret Appendix CIQ-01 revised: pathology exclusion, director approval cannot be delegated, shared risk assessment across locations, review frequency set by the director.Revised
2026-11-1042 CFR 493.1413, 493.1451, 493.1463 (competency assessment, delegation)Read in full. Six procedures and frequency confirmed. Delegation citation in CA-04 corrected to 493.1463(b).Checked
2026-11-1042 CFR 493.801 and 493.1236 (proficiency testing)Read in full on eCFR (text current to 22 Oct 2026). PT-01 corrected: attestation signers, and testing up to the point of referral.Checked
2026-11-1042 CFR 493.15(e), 493.39 (waived testing)Read in full. 30-day change notification added to WT-06.Checked
2026-11-1042 CFR 493.1105 (record retention)Read in full. Retention wording in IR-02 aligned.Checked
2026-11-1042 CFR 493.1239, 493.1251, 493.1255, 493.1256, 493.1281, 493.1282, 493.1289, 493.1299, 493.1773Read in full. No change needed.Checked
2026-11-10CMS brochure "Assessing Personnel Competency" (revised May 2025)Read in full. Scope of the Competency Assessment and Waived Testing kits set from it.Checked
2026-11-10Proposed rule on personnel, proficiency testing and remote review (published 8 Oct 2026; comments due 7 Dec 2026)Not final. Kits follow the rules in force. Would affect CA-05, PT-01 and IR-01 if finalized.Watching
2026-11-10Revised CLIA application, Form CMS-116 (required from 9 Nov 2026)Noted for the Waived Testing and Inspection Readiness kits.Watching

How the check works

Once a month we compare the current text of 42 CFR Part 493 with the text the kits were written against, read new final rules in the Federal Register, and read new CMS guidance for laboratories and surveyors.

If nothing affecting a kit has changed, the verification date moves forward and the log says so. If something has changed, the affected documents are revised, the version number goes up and the change is described here.

The check covers federal requirements. It does not track state law or accreditation checklists, which change on their own schedules.