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 239 of 239 days reviewed from December 08, 2020 through August 04, 2021. Findings include: 1. SARS-CoV-2 testing documentation was reviewed from December 08, 2020 through August 04, 2021. 2. SARS-CoV-2 test result reporting documentation was reviewed from December 08, 2020 through August 04, 2021. 3. Documentation revealed that SARS-CoV-2 test results were not reported as required for 23 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, 22 days in June 2021, 31 days in July 2021, and 4 days in August 2021. 4. 179 test results were not reported as required during the period of review. 5. The laboratory performed 179 SARS-CoV-2 tests during the period of review. 6. The laboratory director (SP-1) confirmed the findings on 8/16/2021 at 2:10 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 --