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 with the laboratory director, the laboratory failed to report SARS-CoV2 negative patient test results from October 8, 2020 through September 1, 2021. Findings include: 1. Based on a random record review of the laboratory's COVID-19 test tracking spreadsheet revealed 89 of 90 negative patient SARS-CoV2 test results were not reported to the health department on January 8, 2021. 2. Interview with the laboratory director on September 1, 2021 at 2:00 p.m. confirmed the laboratory failed to report 89 of 90 patient negative SARS-CoV2 patient test results on January 8, 2021 to the health department and confirmed the laboratory failed to report all negative SARS-CoV2 test from October 8, 2020 through September 1, 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 --