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 with the Laboratory Director (LD), the laboratory failed to report SARS-Co-V-2 test results as required for 27 days (February 26, 2021 to April 30, 2021) of 27 days of testing. Findings include: 1. A review of the laboratory's "Close To Home Assisted Living, LLC" protocol, revealed a lack of a process for reporting negative staff results for SARS-CoV-2 to the health department. 2. A review of the laboratory's testing records revealed the laboratory had performed SARS-CoV02 testing for 27 days (February 26, 2021 to April 30, 2021) of 27 days of testing since running the testing in-house. 3. An interview with the Laboratory Director on 5/06/2021 at 2:30 pm during a phone call revealed the laboratory did not report negative staff test results for SARS-CoV-2 to the health department on a routine basis, only during an outbreak. 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 --