Summary:
Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on physical inspection of the COVID Clinic temporary testing site in Happy Valley, OR, the Laboratory failed to post the correct CLIA certificate. Findings include: 1. During physical/visual on site inspection of the laboratory testing site located in the parking lot at 12000 SE 82nd Avenue in Happy Valley, OR, the facility failed to display the correct CLIA certificate for this site. 2. The CLIA certificate displayed in the testing area is for this COVID Clinic is the certificate for the site located in Tigard, OR at Washington Square Mall. 38D2205598 3. During interview with testing personnel (TP) #1 on 3/23/2022 at approximately 1230 pm, she said did not know anything about the certificates and that there was no other certificate that she was aware of. D1001 CERTIFICATE OF WAIVER TESTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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: Based on review of written laboratory records and interview with Testing Personnel (TP) during survey 03/23/2022, the laboratory failed to follow the manufacturer's instructions for performing COVID testing. Findings include: 1. The COVID Clinic testing site under investigation in this complaint is located at 12000 SE 82nd Ave. Suite 1093, Happy Valley (Portland), OR 97266 2. The Instructions for use (IFU) using the Accula rapid PCR test state "Testing site personnel must provide a physical or digital copy of the Self-Collection Quick Reference Guide to the patient prior to collection". No written or digital copy of the Self Collection Quick guide is/was given to patients prior to collection. This was confirmed during interview with testing personnel (TP) #1 at approximately 1130 am on 03/23/2022. 3. The IFU for the Accula rapid PCR test system states "Store reagents at room temperature (15C to 30C or 59F to 86F). Do not refrigerate or freeze". Upon review of the temperature charts for storage of reagents and testing supplies at this location for February and March 2022 revealed that the temperature was out of acceptable range (lower than 59 degrees F or 15 degrees C) five (5) out of ten (10) days in February 2022 and eight (8) out of seventeen (17) days in March of 2022. The temperature logs were approved as acceptable by a Site Supervisor 03/15/2022 with no