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 negative test results for 26 of 29 days reviewed from January 2021 to June 2021. Findings include: 1. SARS-CoV-2 testing documentation "SOFIA 2 RAPID COVID" log was reviewed from January 7, 2021 through June 3, 2021. 2. SARS-CoV-2 test result reporting documentation was reviewed from January 7, 2021 through June 3, 2021. 3. Documentation revealed that SARS-CoV-2 test results were not reported as required for 7 days in January, 6 days in February, 5 days in March, 7 days in April, and 1 day in June. 4. 46 negative test results were not reported as required during the period of review. 5. The laboratory performed 59 SARS-CoV-2 tests during the period of review. 6. The laboratory director, SP#2, confirmed the findings on 7/7/2021 at 4: 55 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 --