Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Percentric Physician Partners on May 11, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is 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 a record review of procedures and test logs, lack of documentation, and interviews, the laboratory failed to report twenty-two (22) positive SARS-Co-V-2 test results as required for thirteen (13) of 13 days during the review timeframe of January 2021 through the date of the survey on May 11, 2022. Findings include: 1. Review of the laboratory's SARS-CoV-2 testing procedure documentation revealed that the office utilized Sofia SARS and BD Veritor COVID-19 Antigen test kits during the timeframe of January 2021 and up to the date of the inquiry, May 11, 2022. 2. SARS- CoV-2 patient test result logs/documentation was reviewed for timeframe of January 2021 through 5/11/22. 3. Review of available monthly test records revealed that nine hundred nine (909) patient SARS-CoV-2 tests were performed/resulted during the timeframe of January 2021 through 5/11/22. Of the 909 test results, 22 patient results were positive. The laboratory failed to report to the the state agency 22 positive SARS- CoV-2 tests on the following 13 testing days during the review timeframe: 3/18/21, 4 /22/21, 10/11/21, 11/18/21, 11/29/21, 12/13/21, 12/16/21, 1/18/22, 1/21/22, 2/3/22, 2/9 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 -- /22, 3/8/22, and 4/20/22. The inspector requested to review evidence of reporting the positive results outlined above to the state agency. No records were available to review. The director stated on 5/11/22 at approximately 12:00 PM "We did not submit any SARS-CoV-2 test results to the state agency." 4. An exit interview with the lab director on 5/11/22 at approximately 1:30 PM confirmed the above findings. -- 2 of 2 --