---
kind: "section"
citation: "42 C.F.R. § 493.1100"
title: "42"
number: "493.1100"
heading: "Condition: Facility administration."
url: "https://uscodex.org/cfr/42/493.1100"
---

# §493.1100. Condition: Facility administration.


Each laboratory that performs nonwaived testing must meet the applicable requirements under [§§ 493.1101 through 493.1105](/cfr/42/493.1101..493.1105.md), 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](/cfr/42/400.200.md) 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]

## Notes

### Amendments

[68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020]

### Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020]