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 20 of 20 days reviewed from January 31, 2021 through May 4, 2021. Findings included: 1. SARS-Co-V-2 testing documentation "COVID-19 Virus Test Result" was reviewed from January 31, 2021 through May 4, 2021. 2. SARS-CoV-2 test result reporting documentation was requested from January 31, 2021 through May 4, 2021. 3. In interview on 5-3-2021 at 9:45 AM, Staff Person #14, Laboratory Director, confirmed the laboratory did not report SARS-Co-V-2 test results as required. 4. Review of patient records and lack of documentation revealed that SARS-Co-V-2 test results were not reported as required for two days in January, 2021; four days in February, 2021; 8 days in March, 2021, 5 days in April, 2021, and one day in May, 2021. 5. 38 tests were not reported, as required, during the period of review. 6. The laboratory performed 38 SARS-Co-V-2 tests during the period of review. 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 --