Summary:
Summary Statement of Deficiencies D1002 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 record review and interview, the laboratory failed to report SARS-CoV-2 test results as required for four out of four days reviewed in the month of January for 15 patients. Findings include: 1. National Collegiate Athletic Association (NCAA) official's test list from January 23, 2021 through January 30, 2021 and Standing Order procedure for COVID-19 procedure were reviewed. 2. The official's test list revealed SARS-CoV-2 tests were performed and not reported on four days during the week of January 23rd thru 30th of 2021. 3. 15 test results were not reported as required during the period of review. 4. The laboratory failed to include in its COVID-19 procedure the requirement to report all SARS-CoV-2 test results to the appropriate Public Health agency. 5. On a remote survey conducted on 09/01/2021 at 10:15 AM, the laboratory staff confirmed the above findings. 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 --