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 document review and interview, the laboratory failed to report SARS-Co-V- 2 test results as required for 121 of 142 days reviewed from December 2020 through May 2021. Findings included: 1. SARS-Co-V-2 testing logs were reviewed from December 2020 through date of survey. 2. SARS-Co-V-2 test result reporting documentation was reviewed from December 2020 to date of survey. 3. Documentation revealed that SARS-Co-V-2 test results were not reported as required for 14 days in January 2021, 28 days in February 2021, 31 days in March 2021, 30 days in April 2021, and 18 days in May 2021. 4. 1558 test results were not reported as required during the period of review. 5. The laboratory performed 2,283 SARS-Co-V- 2 tests during the period of review. 6. In interview on 5-19-2021 at 11:23 AM, SP3, Director of Marketing, confirmed SARS-Co-V-2 test results were not reported as required between January 16, 2021 and May 18.2021. 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 --