Summary:
Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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 results and interview with the lead medical assistant the laboratory failed to report all results to the Oregon Health Authority (OHA) since the laboratory began testing for SARS CoV-2 on August 17, 2021. Findings include: 1. 08 /17/2021 one out of one patient tested, result not reported to OHA. 2. 09/01/2021 two out of two patients tested, results not reported to OHA. 3. 09/03/2021 three out of three patients tested, results not reported to OHA. 4. 09/07/2021 one out of one patient tested, result not reported to OHA. 5. 09/09/2021 one out of one patient tested, result not reported to OHA. 6. 09/22/2021 two out of two patients tested, results not reported to OHA. 7. 09/23/2021 two out of two patients tested, results not reported to OHA. 8. 09/24/2021 one out of one patient tested, result not reported to OHA. 9. 09/30/2021 one out of one patient tested, result not reported to OHA. 10. 10/08/2021 one out of one patient tested, result not reported to OHA. 11. Interview with the lead medical assistant concur with these findings on 12/30/2021 at 14:00 PM. 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 --