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]