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 Physician Assistant, the laboratory failed to report all positive SARS-CoV-2 test results as required for 24 of 123 patients that tested positive since the laboratory started testing for SARS-COV-2 on February 10, 2022. Findings include: 1. An interview on 10/4/22 at 12:30 pm with the Physician Assistant revealed the laboratory started testing February 10, 2022. 2. A review of the laboratory's "Pure Health Urgent Care COVID Positive Results" log revealed 123 total patients had tested positive by the laboratory for SARS-CoV-2 and 24 had a lack of documentation showing the positive results were sent to the health department. 3. A review of the laboratory's "Reporting Policy for COVID Testing" revealed a section stating, "All test results must be logged into the MDSS within 24 hours." 4. The surveyor requested documentation of the laboratory's attempts to report the 24 positive SARS-CoV-2 results using its SARS-CoV-2 antigen test systems to the health department on 10/4/22 at 12:30 pm and it was not made available. 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 --