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 review of the Abbott ID Now COVID-19 Product Insert, COVID-19 patient testing records for November and December 2021 and interviews with the District Manager and Certified Store Manager, the laboratory failed to report COVID-19 test results for 561 of 561 patients. Findings: 1. Review of the Abbott ID Now COVID-19 Product Insert states, "Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories." 2. Review of COVID-19 patient test records for November and December 2021 showed 479 COVID-19 tests were performed in November 2021 and 82 COVID-19 tests were performed in December 2021. The laboratory could not provide documentation to show the laboratory reported COVID-19 results obtained during November and December to the appropriate health officials. 3. Interview with the District Manager and Certified Store Manager on January 4, 2022 at 10:30 AM confirmed the laboratory failed to report all COVID-19 tests. 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 --