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 manager, the laboratory failed to report all SARS-CoV-2 test results as required for 12 of 12 patients tested since the laboratory started testing patients for SARS-CoV-2 on 9/11/21. Findings include: 1. The surveyor requested documentation of the laboratory's attempts to report all SARS- CoV-2 testing results using its Abbott BinaxNOW SARS-CoV-2 antigen testing system on 3/10/22 at 1:35 pm and it was not made available. 2. A phone interview on 3 /10/22 at 9:55 am with the manager revealed the laboratory had not reported SARS- CoV-2 patient test results to the health department as required. 3. Email correspondence from the manager on 3/16/22 indicated the laboratory started testing on 9/11/21 and tested 12 patients to date. 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 --