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 Harmony Collection At Roanoke on 10 /13/21 and 10/14/21 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 review of COVID-19 process occurred during the recertification survey of adjacent Certificate of Compliance (CoC) CLIA number 49D0861146. The sites share inventory of COVID-19 test methods. The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), manufacturer's instructions for use (IFU), policy and procedures (P&P), lack of documentation, and interviews, the laboratory failed to have a written policy for reporting patient SARS-CoV-2 (COVID-19) positive and negative results to the State agency from 10/20/20 and up to the date of survey on 10/14/21. Findings include: 1. Review of the CMS 116 application revealed the laboratory performs COVID-19 testing. An interview with the technical consultant on 10/14/21 at approximately 11 AM revealed the lab began patient testing with the BD Veritor Rapid Detection of SARs-CoV-2 Antigen kits and the Abbott Binax Now Antigen COVID-19 kits on 10/20/20. 2. Review of the manufacturer's IFU's revealed the following statements: Abbott Binax Now Antigen COVID-19 - "Conditions of Authorization for Laboratory and Patient Care Setting", 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 -- "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." BD Veritor Rapid Detection of SARs-CoV-2 Antigen- "Conditions of Authorization for the Laboratory", "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 3. Review of the P&P revealed lack of documentation of policy or procedure for reporting patient COVID- 19 positive and negative test results to the local health department. 4. An exit interview with the technical consultant on 10/14/21 at approximately 2:00 PM confirmed the findings. -- 2 of 2 --