Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Morningside of Williamsburg on March 25, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included an entrance interview conducted on 03/12/21. Based on a review of documents and interviews, the inspector found that the laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: 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 interviews, review of procedures, result log sheet records, and lack of documentation, the facility failed to report SARS-CoV-2 test results as required on two (2) days during the review timeframe of October 1, 2020 through December 2020. Findings include: 1. During an entrance interview with the Executive Director on 03/12/21 at approximately 1:00 PM, the inspector was informed that the facility utilized Abbott BinaxNOW for rapid COVID -19 (SARS-CoV-2) testing. 2. The inspector requested to review the facility's test procedures, result logs, and evidence of COVID-19 result reporting to the state agency during the virtual survey conducted on 03/25/21. Review of the facility's result log documentation and reporting protocols from October 1, 2020 through December 2020 revealed that the facility performed six (6) COVID -19 tests during the timeframe. 6 of 6 COVID -19 test results performed were not reported to the state agency as required on the following 2 test dates: one (1) positive on 12/03/20 and four (4) positives, 1 negative on 12/07/20. The inspector 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 -- requested to review documentation that the results outlined above were reported to the state agency. The Executive Director stated at approximately 2:30 PM: "We were unaware that we should be reporting to the state. It was a very chaotic time." 3. The Executive Director confirmed the above findings on 03/25/21 at 5:00 PM. -- 2 of 2 --