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 interview the laboratory failed to report SARS-Co-V-2 negative test results to either the State or County Public Health Departments for January, February, and March of 2021. Findings include: 1. Review of SARS-CoV-2 testing documentation, ID NOW COVID-19 Procedural Control results and Patient Record, showed 32 negative test results for January, February, and March of year 2021. 2. The laboratory failed to provide documentation of reporting SARS-CoV-2 negative test results to either the State or County Public Health Departments for review. 3. Interview with the laboratory director (Chief Executive Officer) on 4/7 /2021 at 3:00 PM confirmed the laboratory failed to report negatives to either the State or County Public Health Departments. 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 --