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 medical assistant (MA), the laboratory failed to report positive SARS-CoV-2 antigen test results as required for 20 of 50 patients tested since the laboratory started testing patients for SARS-CoV-2 on 5 /04/2022. Findings include: 1. The surveyor requested documentation of the laboratory's attempts to report positive SARS-CoV-2 testing results using its "Celltrion Dia Trust COVID-19 Ag Rapid Test" system on 9/07/2022 at 2:21 pm during a phone interview. 2. A phone interview on 9/07/2022 at 2:21 pm with the MA revealed the laboratory had not reported positive SARS-CoV-2 patient test results to the health department as required. 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 --