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 Office Manager, the laboratory failed to report SARS-Co-V-2 test results as required for 4 of 4 patient tests performed since the laboratory opened on 12/3/20. Findings include: 1. The surveyor requested the facility's SARS-CoV-2 patient test results and documentation of reporting via email correspondence on 3/4/21 at 1:15 pm. 2. An interview with the Office Manager on 3/9 /21 at 9:00 am via a Teams meeting revealed the laboratory had performed a total of 4 patient tests with the BD Veritor System for Rapid Detection of SARS-CoV-2 test system and they did not report those results to the health department. 3. The Office Manager confirmed the findings on 3/9/21 at 1:15 pm via a phone call. 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 --