Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Commonwealth Senior Living at Cedar Manor on June 21, 2021 by the Virginia Department of Health's Office of Licensure and Certification. Specific Condition deficiency cited is: 42 CFR part 493 CLIA Regulation: 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, patient log sheet records, and lack of documentation, the facility failed to report sixty-eight (68) negative COVID-19 results to the state public health department per the facility's policy on two (2) testing dates reviewed from February 1, 2021 to June 21, 2021. Findings include: 1. During an interview with the executive director on 06/21/21, at approximately 10:00 AM, the inspector was informed that the facility had utilized Abbott BinaxNOW COVID-19 Ag Cards for rapid SARS-CoV-2 patient testing from February 2021 to the date of the survey. The inspector requested to review the test procedure, policy related to SARS- CoV-2 test reporting, and evidence of reporting results to the state agency. 2. The facility's policy (COVID-19 Testing) stated: "Report results to your state or local public health department". 3. A review of the available BinaxNOW patient test logs from 2/1/21 to 6/21/21 revealed 2 dates of testing with no evidence of reporting as required: 02/02/21- three (3) negative results; 02/11/21- sixty-five (65) negative results. The inspector requested evidence of reporting the 68 negative results outlined 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 -- above. No documentation was available for review. The executive director stated on 6 /21/21 at approximately 4:30 PM: "It does not look like these tests were reported to our local health department." 4. The executive director confirmed the above findings on 06/21/21 at approximately 4:30 PM. -- 2 of 2 --