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 laboratory personnel, the laboratory failed to report SARS-Co-V-2 negative test results for 128 of 128 days reviewed from December 2020 through September 2021. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing at multiple testing locations using the BD Veritor System for Rapid Detection of SARS-CoV-2 as confirmed by the Laboratory Director (LD) during the entrance interview at 2:05 p.m. on 09/27/21. 2. In the interview at 2: 05 p.m. on 09/27/21, the LD indicated negative SARS-CoV-2 results had not been reported to the appropriate health authorities. 3. The Covid-19 POC Test Record spreadsheet, provided by the LD via email on 09/28/21, included test record and result reporting documentation for all locations from test implementation to date of survey, 12/02/20 - 09/27/21. The documentation indicated SARS-CoV-2 negative test results were not reported as required. Days of non-reporting are indicated below. 2020 Days not reported December 13 2021 Days not reported January 17 February 13 March 16 April 14 May 11 June 14 July 9 August 11 September 10 4. 501 negative SARS-CoV- 2 test results were not reported as required from 12/02/21 through 09/27/21 as indicated on the Covid-19 POC Test Record spreadsheet. 5. The laboratory performed 504 SARS-CoV-2 tests between 12/02/21 and 09/27/21. 6. The laboratory director confirmed the above finding via email on at 12:04 p.m. on 10/01/21. 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 --