Summary:
Summary Statement of Deficiencies D0000 An unannounced Clinical Laboratory Improvement Amendments (CLIA) complaint investigation (Complaint #VA00050411) was conducted at Dominion Family Care, doing business as (dba) American Family Care on January 12, 2021 by a Medical Facilities Inspector from the Virginia Department of Health, Office of Licensure and Certification. The laboratory holds a Certificate of Waiver and operates under CLIA # 49D2163038. Based on a tour, 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. 493.41 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 laboratory tour, review of written protocols, patient log sheet records and interviews, the laboratory failed to report SARS-CoV-2 negative test results as required for ninety (90) days reviewed (timeframe of October 1, 2020 to the date of the survey, January 12, 2021). Findings include: 1. During a tour on 1/12/21, at approximately 12:00 PM, the inspector noted that the laboratory utilized two (2) Sofia analyzers (Serial numbers 29018772 and 29018753) for rapid SARS-CoV-2 patient testing. The inspector requested to review the test procedures and evidence of results reporting to state agency. The testing personnel stated at approximately 12:30 PM: "We send the positive results on the Virginia Department of Health (VDH) website." The administrator stated concurrently: "We started testing the first of April last year. We manually submit results to VDH on their website". 2. Review the laboratory's 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 -- patient Sofia COVID-19 Test Log documentation and reporting protocols from 10/1 /20 to 1/12/21 revealed two thousand four hundred ninety (2,490) rapid SARS-CoV-2 patient tests were analyzed: One hundred eighty seven (187) positive SARS-CoV-2 results were assayed/resulted and reported to VDH. Two thousand three hundred three (2,303) negative SARS-CoV-2 results were assayed/resulted but were not reported as required. The practice manager stated on 1/12/21 at approximately 1:00 PM "We were not aware that we were to send negatives as well as positives." 3. The practice manager confirmed the above findings on 1/12/21 at approximately 1:30 PM. -- 2 of 2 --