White Oak Urgent Care Randleman

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 manufacturers' instructions and observation 9/18/24, the laboratory failed to follow manufacturers' instructions and failed to discard supplies that had exceeded their expiration dates. Findings: 1. Review of the OSOM Mono Test product insert revealed "... KIT CONTENTS AND STORAGE ... Do not use the Test Sticks or reagents after their expiration dates. ..." During a tour of the laboratory at approximately 2:00 p.m., the surveyor observed 1 open OSOM Mono Test kit (lot #231345) with expiration date 8/31/24 on a shelf in the laboratory, available for use. 2. During a tour of the laboratory at approximately 2:00 p.m., the surveyor observed the following FOB (fecal occult blood) controls in the laboratory refrigerator, available for use: a. 1 bottle FOB Test Control Kit T1-TC01 Negative Control (lot #L0214229737) with expiration date 2/28/24; b. 1 bottle FOB Test Control Kit T1- TC01 Positive Control (lot #L0214229736) with expiration date 2/28/24. 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 --

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 3:15 p.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%. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, 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 -- traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions and review of 2017, 2018, and 2019 hematology records 11/12/19, the laboratory failed to perform and document calibration of the Medonic M-series hematology analyzer at least once every six months as required. The Medonic M-series User's Manual states "Section 7: Calibration ... Introduction ... It is recommended to calibrate the instrument every 6 months. ... " Review of 2017, 2018, and 2019 hematology records revealed the Medonic M-series analyzer was not calibrated at least once every six months as specified by the manufacturer. Calibration was performed on 11/30/17, 4/3/18, eight months later on 12/18/18, 3/21/19, and eight months later on 11/4/19. -- 2 of 2 --