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 negative test results for 17 of 17 days reviewed from 12-15-20 to 2-24-21 date. Findings included: 1. SARS-Co-V-2 test log was reviewed from 12-15-20 to 2-24-21. 2. SARS-Co-V-2 test result reporting documentation was reviewed from 12-15-20 to 2-24-21. 3. Documentation revealed that SARS-Co-V-2 negative test results were not reported as required for six days in December, 2020, 10 days in January 2021, and one day in February 2021. 4. 26 negative test results were not reported as required during the period of review. 5. The laboratory performed 27 SARS-Co-V-2 tests during the period of review. 6. In interview on 4-28-2021 at 3:00 PM, SP1, Infection Prevention, confirmed the laboratory did not report negative SARS-Co-V-2 test results between 12-15-20 and 2-24-21, as required. 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 --