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 negative test results for two of two days reviewed from the start of patient testing, November 23, 2020 through August 10, 2021 consisting of 262 days of patient testing. Findings include: 1. SARS- CoV-2 patient testing documentation spreadsheet was randomly reviewed for the testing period of November 23, 2020 through Augut 10, 2021. 2. Documentation revealed that SARS-CoV-2 negative test results were not reported as evident in the random review of two days (November 25, 2020 and February 08, 2021) reviewed from the total of two of 262 days of SARS-CoV-2 patient testing. 3. 90 negative test results were not reported as required during the period of review. 4. The laboratory performed 118 total SARS-CoV-2 tests during the period of review. 5. The laboratory owner confirmed the findings on 08.13.2021 at 8:07 am. =================================== 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 --