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 remote record review and phone interview with the assistant athletic trainer, the laboratory failed to report SARS-Co-V-2 negative test results for 18 of 18 specimens tested from May 4, 2021 through July 28, 2021. Findings: 1. The assistant athletic trainer provided the following documents for review: 1) excel spread sheet with test results, 2) 18 instrument printouts showing the final report, and 3) a policy for reporting SARS-CoV-2 test results on 08/13/2021 at 1:00 PM. 2. The documents were reviewed. The policy for reporting SARS-CoV-2 test results stated: "For the duration of the public health emergency (PHE) all SARS-CoV-2 test results (positive and negative test) must be reporting to the Maryland Health Department in accordance with regulation 493.41." 3. During a phone interview on 8/13/2021 at 4:45 PM, the assistant athletic trainer stated that the laboratory only performed the SARS-CoV-2 test on 18 specimens and the results were all negative. He confirmed that since the results were all negative, they were not reported to the Maryland Health Department. The laboratory failed to follow the policy for reporting all positive and negative test results to the Maryland Health Department in accordance with the regulations. 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 --