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-Co-V-2 test results as required for 219 of 219 days reviewed from November 15, 2020 through June 22, 2021. Findings include: 1. SARS-CoV-2 testing documentation "SARS COVID 19 Antigen Patient Log" was reviewed from November 15, 2020 through June 22, 2021. 2. SARS-CoV-2 test result reporting documentation was reviewed from November 15, 2020 through June 22, 2021. 3. Documentation revealed that SARS-CoV-2 test results were not reported as required for 15 days in November 2020, 31 days in December 2020, 31 days in January 2021, 28 days in February 2021, 31 days in March 2021, 30 days in April 2021, 31 days in May 2021, and 22 days in June 2021. 4. 1,437 test results were not reported as required during the period of review. 5. The laboratory performed 1,437 SARS-CoV-2 tests during the period of review. 6. The laboratory director and SP-1 (Director of Quality) confirmed the findings on 6/24/2021 at 6:20 pm. 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 --