Summary:
Summary Statement of Deficiencies D0000 THE LABORATORY IS IN COMPLIANCE WITH THE REQUIREMENTS OF 42 CFR PART 493, REQUIREMENTS FOR CLINICAL LABORATORY. D3000 FACILITY ADMINISTRATION CFR(s): 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). (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. This CONDITION is not met as evidenced by: Based on laboratory personnel remote questioning and the responses provided, the laboratory failed to report patient SARS-CoV-2 test results as required since the laboratory began patient SARS-CoV-2 testing on April 30, 2020 through April 16, 2021. Findings include: a. According to testing personnel, the laboratory began patient SARS-CoV-2 testing on April 30, 2020. On April 16, 2021, the laboratory was granted access to the State's SARS-CoV-2 test reporting portal. b. According to laboratory personnel, patient SARS-CoV-2 test results were not reported to the State's SARS-CoV-2 test reporting portal as required during this period of patient testing, April 30, 2020 through April 16, 2021. c. According to testing personnel, 1,262 patient SARS-CoV-2 test results were performed from April 30, 2020 through April 16, 2021. d. Testing and laboratory personnel confirmed these findings on April 12/20 /2021 at 12:35 pm (San Francisco time). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --