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 patient testing log records and interview with the staff, the laboratory failed to report all SARS CoV-2 results to the Oregon Health Authority (OHA). Finding includes: 1. Review of patient testing log records revealed the following testing dates using the Abbott BinaxNow Rapid Antigen Test Cards. a) February 15, 2021 the laboratory performed 35 SARS CoV-2 testing. These test results were not reported to OHA. b) March 8, 2021 the laboratory performed 32 SARS CoV-2 testing. These test results were not reported to OHA. c) May 12, 2021 the laboratory performed 107 SARS CoV-2 testing. 1 positive test result was reported to Multnomah County Health Dept. 106 test results were not reported to OHA. d) June 8, 2021 the laboratory performed 3 SARS CoV-2 testing. These test results were not reported to OHA. e) July 12, 2021 the laboratory performed 3 SARS CoV-2 testing. These test results were not reported to OHA. 2. The Abbott BinaxNow Rapid Antigen Test Cards Emergency Use Authorization (EUA) and Package Inserts (PI) instructs all laboratory users to report all results to the State or Local Health Department. 3. Interview with the Laboratory Director and the Administrator on 08/04/2021 @ 09:45, they both confirmed that they failed to follow the Abbott BinaxNow Rapid Antigen Test Card EUA and PI , by not reporting negative results to Oregon Health Authority. 4. Onsite special survey concluded on 08/04/2021 @ 09:50AM.. 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 --