42 CFR § 493.1100 - Condition: Facility administration.
---
identifier: "/us/cfr/t42/s493.1100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1100 - Condition: Facility administration."
title_number: 42
title_name: "Public Health"
section_number: "493.1100"
section_name: "Condition: Facility administration."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "493"
part_name: "LABORATORY REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17)."
regulatory_source: "55 FR 9576, Mar. 14, 1990, unless otherwise noted."
cfr_part: "493"
---
# 493.1100 Condition: Facility administration.
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]
[68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020]