Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Envoy of Williamsburg, LLC on January 25, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included interviews/remote record review with the facility's Director of Nursing, Regional Director of Nursing, and the Regional Vice President of Operations on 1/26/22. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: 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, testing record reviews, and lack of documentation, the facility failed to report negative and positive COVID-19 results to the state public health department on sixty four (64) days during the review timeframe of October 2020 to the date of the inspection on January 25, 2022. Findings include: 1. During an interview with the facility's Director of Nursing, Regional Director of Nursing, and Regional Vice President of Operations on 1/25/22, at approximately 10:00 AM, the inspector confirmed that the facility had utilized BD Veritor and Abbott BinaxNOW Ag Cards for rapid SARS-CoV-2 testing from May 2020 and up to the date of the survey. The inspector requested to review the test procedures, testing personnel training records, policy related to SARS-CoV-2 test reporting, and evidence of reporting results to the state agency. 2. Review of the available rapid COVID-19 result logs from 10/01/20 to 1/25/22 revealed 6,936 negative and 42 positive results 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 -- were performed/reported by the facility testing personnel. The inspector requested evidence that the facility reported the rapid COVID-19 results to the state agency. The Regional Vice President of Operations stated on 1/25/22 at approximately 10:30 AM: "Our protocol was to report COVID-19 test results to the state or local public health department via online reporting but we had leadership changes along with staffing shortages that resulted in a delay in reporting. The staff member who was responsible for entering the reports is no longer with us." No documentation of reporting to the state agency was available for the following dates of six thousand nine hundred thirty- six (6,936) negative COVID-19 results: 10/01/20 (75), 10/29/20 (2), 11/12/20 (147), 11/19/20 (137), 11/26/20 (157), 12/03/20 (157), 12/10/20 (141), 12/17/20 (178), 12/24 /20 (88), 12/31/20 (69), 01/07/21 (59), 01/14/21 (138), 01/21/21 (159), 01/28/21 (90), 01/07/21 (59), 01/14/21 (138), 01/21/21 (55), 01/28/21 (90), 02/04/21 (108), 02/11/21 (112), 02/18/21 (80), 02/25/21 (150), 03/04/21 (156), 03/11/21 (76), 03/18/21 (72), 03 /25/21 (239), 04/01/21 (165), 04/08/21 (200), 04/15/21 (185), 04/22/21 (145), 04/29 /21 (148), 05/06/21 (156), 05/13/21 (8), 05/20/21 (7), 07/08/21 (30), 07/15/21 (10), 07 /22/21 (171), 07/29/21 (172), 08/04/21 (168), 08/11/21 (169), 08/18/21 (22), 08/25/21 (23), 09/01/21 (197), 09/15/21 (166), 09/22/21 (219), 09/29/21 (207), 10/06/21 (201), 10/13/21 (170), 10/20/21 (33), 10/27/21 (43), 11/03/21 (39), 11/10/21 (43), 11/17/21 (43), 11/24/21 (28), 12/01/21 (18), 12/08/21 (23), 12/15/21 (86), 12/22/2021 (26), 12 /29/21 (151), 01/05/22 (213), 01/12/22 (196), and 01/19/22 (123). No documentation of reporting to the state agency was available for the following dates of forty-two (42) positive COVID-19 results: 1/26/21 (1), 02/11/21 (1), 03/25/21 (5), 04/01/21 (1), 04 /08/21 (5), 04/15/21 (13), 07/15/21 (1), 09/01/21 (4), 09/15/21 (1), 09/22/21 (3), 09/29 /21 (4), 12/03/21 (1), 12/10/21 (1), and 12/22/21 (1). 3. An exit interview with the facility's Director of Nursing, Regional Director of Nursing, and the Regional Vice President of Operations on 1/26/22 at approximately 12:30 PM confirmed the above findings. -- 2 of 2 --