Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Office Manager, the laboratory failed to establish and follow SARS-COVID-19 reporting policies from 08 /31/2021 to 07/26/2022. Findings Include: 1. On the day of survey, 07/26/2022 at 12: 02 pm, the laboratory could not provide procedures for reporting pateint SARS- COVID-19 antigen test results to the appropriate agencies. 2. The laboratory performed 649 SARS-COVID-19 antigen tests from 01/01/2022 to 02/28/2022. 3. The Office Manager confirmed the findings above on 07/26/2022 around 12:30 pm. 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 Office Manager (OM), the laboratory failed to report SARS-Co-V-2 (COVID 19) test results as required for 59 of 59 days reviewed from January through February 2022. Findings include: 1. On the day of survey, 07/26/2022 at 12:02 pm, the laboratory was unable to provide documentation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of reporting SARS-CoV 2 antigen test results to local/state agencies performed on the QuickVue SARS Antigen Test and the INDICAID COVID-19 Rapid Antigen Test kits for 649 of 649 patients tested from 01/01/2022 to 02/28/2022. 2. The Office Manager confirmed the findings above on 07/26/2022 around 12:30 pm. -- 2 of 2 --