Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Mayo Medical Practice, LLC on April 26, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included an entrance interview with the practice's Primary Care Provider-Nurse Practitioner Hospitalist on 04/25/22. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as the following: 42 CFR part 493 CLIA Regulation: D1002- 42 CFR. 493.1100 Condition Reporting of SARS-CoV-2 test results. 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 of procedures and test logs, lack of documentation, and interviews, the laboratory failed to report twenty-two (22) SARS-Co-V-2 test results as required for nineteen (19) of 19 days reviewed from May 21, 2021 through March 11, 2022. Findings include: 1. Review of the laboratory's SARS-CoV-2 testing procedure documentation revealed that the office utilized AccessBio CareStart COVID-19 Antigen and Quidel QuickVue SARS Antigen test kits during the timeframe of May 2021 and up to the date of the inquiry, April 25, 2022. 2. SARS- CoV-2 patient test result logs/documentation was reviewed for timeframe of 05/21/21 through 03/11/22. 3. Review of test records revealed that SARS-CoV-2 test results were not reported to the state agency for the following test dates in calendar year 2021: 5/21, 8/4, 8/16, 9/2, 9/3, 9/16, 9/17, 10/18, 11/18, 11/30, 12/27, 12/28, 12/29. SARS-CoV-2 test results were not reported for the following test dates in calendar 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 -- year 2022: 1/6, 1/12, 1/24, 2/3, 2/10, 3/11. The inspector requested to review evidence of reporting for the 19 days outlined above. No records were available to review. The Primary Care Provider-Nurse Practitioner Hospitalist stated on 4/26/22 at approximately 3:00 PM "We did not submit any SARS-CoV-2 test results to the state agency". 4. The laboratory performed 22 SARS-CoV-2 tests on 19 testing days during the period of review outlined above: six (6) positive, sixteen (16) negative. 5. An exit interview with the lab director on 4/26/22 at approximately 4:30 PM confirmed the above findings. -- 2 of 2 --