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 interview with the Facility Administrator and the lack of test reporting records requested to be reviewed during virtual survey 2/22/2023, the laboratory failed to report COVID 19 test results (positive or negative) beginning February 2021. Finding includes 1. This surveyor requested documentation of reporting positive cases of COVID 19 to the Oregon Health Authority from February 2021 until February 2023. No evidence of such reporting could be provided during the survey 02/22/2023. 2. Interview with the Facility Administrator during survey 02/22/2023 at approximately 0930 am confirmed that the facility was not reporting any COVID 19 test results to the Oregon Health Authority since they began testing in February of 2021. 3. The laboratory had no EUA FDA letter for the Abbott Binax NOW test kit used at this facility during survey 2/22/2023. This was confirmed by the Facility Administrator during interview at approximately 9:45 am. 4. The laboratory had no Abbott Binax NOW IFU available for review during survey 2/22/2023. This was confirmed by the Facility Administrator during interview at approximately 9:45 am. 5. The laboratory had no record of training for testing personnel performing the Abbott Binax NOW test for COVID 19. This was confirmed by the Facility Administrator during interview at approximately 9:45 am. 6. COVID testing began 2/2021 and is currently still being conducted at time of interview. During the time period between 2 /2021 and survey conducted 2/22/2023, the laboratory conducted 2338 COVID tests, of which 1077 were positive and 1261 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 --