42 CFR 493.1100

§ 493.1100 Condition: Facility administration.

United States · 42 CFR — Public Health · Status: effective

Cite this

Citation: 42 CFR 493.1100, § 493.1100 Condition: Facility administration, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/207806
Permanent ID: ys:prov:207806@1
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Full text

Each laboratory that performs nonwaived testing must meet the applicable requirements under §§ 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results. During the Public Health Emergency, as defined in § 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a “SARS-CoV-2 test”) must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. (b) [Reserved]

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.