§493.1100. Condition: Facility administration.
42 C.F.R. § 493.1100
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).
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.
[Reserved]
Notes, amendments, and revision history
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]