Summary:
Summary Statement of Deficiencies D0000 A special survey of COVID Clinic Tigard, located at 9585 SW Washington Square Road in Tigard, OR was performed on 02/01/2022. The Laboratory was found to be in substantial compliance with the CLIA Condition-level regulation (42 CFR, Part 493.41) pertaining to COVID-19 reporting requirements. No deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Surveyor: 37006 Based on review of written temperature records for this site and discussion with the Compliance Nurse on site at the time of survey 02/01/2022, the laboratory failed to follow the manufacturer's package insert for Accula rPCR and Indicaid rapid antigen COVID testing. Findings include: 1. The Phase Indicaid rapid antigen test for COVID 19 Information for Use (IFU) states: "Authorized laboratories that receive your product must notify the relevant public health authorities of their intent to run your product prior to initiating testing". As of 02/01/2022, COVID Clinic Tigard has not informed Oregon Health Authority to date of it's intention to run this test for COVID antigen. 2. The Accula IFU states: "Store reagents at room temperature (15C to 30C, 59F to 86F). Do not refrigerate or freeze". Upon review of the written temperature logs for December 2021 and January 2022 at this site, it was noted that the temperature in the temporary testing site chamber was out of temperature range five (5) days out of thirty one (31) days in December 2021 and one (1) day out of thirty one (31) days in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- January 2022. No written