White Oak Urgent Care Asheboro

Summary Statement of Deficiencies 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: Based on review of manufacturer's instructions, review of the FDA (Food and Drug Administration) website, and interview with the laboratory supervisor 9/15/22, the laboratory failed to include Fact Sheets with patient Quidel Sofia SARS Antigen FIA test reports. Manufacturer's instructions for the Quidel Sofia SARS Antigen FIA test state on page 15 "... Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. ..." Review of the FDA website revealed a "FACT SHEET FOR PATIENTS" and a "FACT SHEET FOR HEALTHCARE PROVIDERS". During interview at approximately 8:45 a.m., the laboratory supervisor confirmed that the Fact Sheets were not given to patients with their laboratory's results. She stated they did not know it was required. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions and review of the laboratory's 2017, 2018, and 2019 temperature and humidity logs 11/12/19, the laboratory failed to establish an acceptable range for room humidity that was consistent with manufacturer's instructions for operation of the Medonic M-series hematology analyzer. Review of the Medonic M-series User's Manual revealed the manufacturer specifies that the analyzer be operated in an environment with a humidity less than or equal to 80%, noncondensing. Review of the laboratory's 2017, 2018, and 2019 temperature and humidity logs revealed an acceptable range for humidity of 15-85%. 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 --