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 an a failure to provide a test result reporting procedure, test result records, state reporting records and interview, the laboratory failed to report SARS-CoV-2 test results to KDHE or local health department from March 1, 2021 to April 27, 2021. Findings: 1. An offsite survey request was made for test result reporting procedure, test result records and state reporting records. No reporting procedure, test result records or state reporting records were provided during the time period of the survey. 2. The Laboratory Director (LD) stated she considered the Binax Now Rapid Antigen to be a screen and not a test. 3. An email from the LD on April 27, 2021 stated Binax NOW use began on March 1, 2021. A total of 60 rapid screens have been performed as of April, 27, 2021. All results were negative. Sixty of 60 results were not reported as required. 4. In email and phone interview the LD, Valerie Lopez-Finley on April 27, 2021 at 4:41 p.m. confirmed, the laboratory failed to report SARS-CoV-2 test results to KDHE or county health department from March 1, 2021 to April 27, 2021. 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 --