Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted remotely at the Hanover II Operations, LL on 01/10/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Initial interview and CMS Letter to Director for the Focused Survey sent on 12/13/21 . Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D1002 - 42 C.F.R. 493-41 Condition: Reporting of SARS-CoV-2 Test Reports. 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, the lab failed to report SARS-CoV-2 negative test results for 79 of 79 testing dates from 04/01/20 through 01/10/22. Findings include: 1. An interview and review of available SARS-CoV-2 testing documentation with the lab director on 01/10/22 at 11:00 AM revealed the site performed Abbott BinaxNow Ag testing from 04/01/20 through 01/10/22 (79 days). 2. 119 negative results were not reported as required during the period of review. 3. The lab performed a total 122 COVID-19 tests during the period of review. 4. The lab director confirmed the findings on 01/10/22 at 11:30 AM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --