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 and staff interview, the laboratory failed to report, the laboratory failed to report 757 negative SARS-CoV-2 patient test results, as required, for 33 weeks of testing reviewed (1/20/21 to 9/8/21). The findings were: 1. Review of the laboratory's documentation showed 507 SARS-CoV-2 patient tests were performed using the Access Bio CareStart test system from 1/20/21 to 9/8/21 and 360 SARS-CoV-2 patient tests were performed used the BioFire Diagnostics Respiratory Panel 2.1-EZ from 6/4/21 to 9/8/21. There was no evidence the 757 negative patient test results had been reported to the State Public Health Laboratory. 2. Interview with the laboratory director on 9/8/21 at 1:25 PM confirmed the negative SARS-CoV-2 patient test results had not been reported to the State Public Health Laboratory. In addition, the laboratory director stated the laboratory had not developed a policy and procedure for reporting SARS-CoV-2 to the appropriate state agencies. 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 --