Summary:
Summary Statement of Deficiencies D0000 An announced focused survey for compliance with SARS-CoV-2 test result reporting requirements was conducted virtually for Summit Health and Rehabilitation Center on October 14, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included interviews and remote record review with the facility's Director of Nursing, Corporate Director of Clinical Applications, and the Laboratory Information Systems Team Lead on 10/14/21, 10/15/21, 10/18/21 respectively. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as the following and include: 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, test records, and lack of documentation, the facility failed to report nine hundred twenty-eight (928) negative COVID-19 results to the state public health department on 60 of 60 test dates reviewed during the timeframe of March 8, 2021 to October 14, 2021. Findings include: 1. During an interview with the director of nursing on 10/14/21 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 March 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 director of nursing stated on 10/14/21 at approximately 11:00: "Our policy to date has been to report COVID-19 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 -- test results to the state or local public health department. Our staff members were trained to utilize our owner's (Centra Hospital) Cerner LIS (laboratory information system) to enter COVID-19 results. The LIS has an interface to report to the health department." 3. A review of the available BinaxNOW resident test logs from 03/8/21 to 10/15/21 revealed nine hundred thirty-nine (939) test results were reported on 60 days. The inspector noted that three (3) of the 939 tests were resulted as positive. The inspector requested evidence of the facility reporting the 3 positive and 928 negative results to the health department. No documentation was available for review. The director of nursing stated on 10/14/21 at approximately 11:30 AM: "We will have to reach out to the LIS team to provide the reporting evidence." 4. During a follow up interview with Centra's Corporate Director of Clinical Applications on 10/15/21 at approximately 3:00 PM, the inspector inquired regarding the process of reporting Summit Health and Rehabilitation Center's COVID-19 results from the LIS to the state agency. The director stated: "We are not yet set up for the ELR (Electronic Lab Reporting). We are still in the process of setting this up. The results would have been submitted manually. Our Laboratory Information Systems Team Lead can provide assistance once returned from vacation on 10/18/21". 5. An interview with the LIS team lead on 10/18/21 at approximately 4:00 PM revealed that Summit Health's positive COVID-19 results were faxed by Centra's infection control department to the state health department on the following dates of testing: 07/29/21 - Accession number 21-210-05891; 08/11/21 - Accession number 21-223-02379; 08/12/21 - Accession number 21-222-02857. The LIS Team Lead stated: "There is no documentation that the negative results were faxed to the health department." 6. The director of nursing and LIS team lead confirmed the above findings on 10/19/21 at approximately 10:00 AM. -- 2 of 2 --