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 160 of 191 days reviewed from September 13, 2021, to March 23, 2022. Findings include: 1. In interview, on 3/23/2022 at 12:45 pm, SP3, Regional Manager, indicated SARS-CoV-2 testing using the Indicaid Rapid Antigen tests and Accula SARS-CoV2 Tests started on September 13, 2021, and continues through March 23, 2022. SP2 was unable to provide a number of how many patients had been tested using the rapid SARS-CoV-2 tests. 2. In email, on 3/24/2022 at 2:25 pm, SP4, Territory Director, indicated that since opening the site has conducted 1,918 rapid covid tests. 3. In email, on 3/25/2022 at 9:01 pm, ERC1, Indiana Epidemiology Resource Center contact, confirmed 125 results had been reported to the state as of March 23, 2022. The laboratory began reporting on February 24, 2022, and the earliest test date submitted was February 20, 2022. 3. The laboratory performed 1,918 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 --