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 the laboratory failed to report SARS-CoV-2 test results for 5 of 18 days reviewed from February 11 to February 28, 2022. Findings include: 1. In interview, on 3/18/2022 at 12:03 pm SP2, Operations Manager, indicated SARS-CoV-2 testing using the Indicaid Rapid Antigen tests occured from February 11. 2022 to February 28, 2022 and 38 patients were tested during this time. 2. In email, on 3/18/2022 at 8:27 pm, ERC1, Indiana Epidemiology Resource Center contact, confirmed 27 results (25 negative and 2 positives) had been reported to the stated from 2/18/2022 to 2/28/2022. 3. Review of excel sheets labeled "ISDH_SARS_CoV_2_Data" indicated 11 patient's (PT 1-11) SARS-CoV-2 test results were not reported as required for 5 days in February. 4. 1 positive test and 10 negative tests were not reported as required during the period of review. 5. The laboratory performed 38 SARS-CoV-2 tests during the period of review. 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 --