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 17 negative SARS-CoV-2 patient test results, as required, for 8 months of testing (January 2021 through August 2021). The findings were: 1. Review of the laboratory's documentation showed 22 SARS-CoV-2 tests were performed using the BD Veritor test system since January 2021. There was no evidence the 17 negative SARS-CoV-2 patient results had been reported to the State Public Health Laboratory. 2. Review of the laboratory's procedure titled SARS-CoV-2 waived testing showed "...In the event of a positive result:...4. A Wyoming Department of Health Infectious Disease Report shall be generated immediately and filed using the system developed by the Wyoming Department of Health." There was no procedure for reporting the negative patient test results. 3. Interview with laboratory director on 8/30/21 at 11:45 AM confirmed the negative SARS-CoV-2 patient 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 --