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 review of COVID testing records and interview with the Executive Director of this facility, the laboratory failed to report the results of COVID 19 assays to the Oregon Health Authority (OHA). Findings include: 1. During a virtual survey performed on 07/29/2021, it was revealed that this facility was not reporting any of their test results from the Abbott Binax Now Antigen test for COVID. 2. The Executive Director confirmed during virtual interview at approximately 1200 pm on 07/29/2021 and again in person on 08/03/2021 that they were not reporting any of the COVID test results to OHA. 3. For the months of January 2021 through July 2021, four hundred and nine (409) COVID tests were run using the Abbott Binax Now Antigen test at this facility. Of the 409 tests run, one (1) was positive and four hundred and eight (408) were negative. 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 --