Summary:
Summary Statement of Deficiencies 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, review of the laboratory's policy and procedure, and staff interview, the laboratory failed to report 840 negative SARS-CoV-2 resident and staff test results, as required, for 32 weeks of testing reviewed (2/4/21 to 9/15/21). The findings were: 1. Review of the laboratory's documentation showed 841 resident and staff tests were performed using the Abbott Binax Now COVID-19 test system from 2 /4/21 to 9/15/21. There was no evidence the 840 negative SARS-CoV-2 resident and staff results had been reported to the State Public Health Laboratory. 2. Review of the laboratory's procedure titled "Testing/Reporting for COVID-19" last revised 11/6/20 showed no procedure for reporting negative resident and staff test results. 3. Interview with the laboratory director on 9/21/21 at 9:30 AM confirmed the negative SARS- CoV-2 resident and staff test results had not been reported to the State Public Health Laboratory. 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 --