Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of 2021, 2022, and 2023 Coulter AcT diff hematology quality control and maintenance records, review of 2021, 2022, and 2023 quality assessment records, and interview with the TC (technical consultant) 5/3/23, the laboratory failed to discard hematology quality control material that exceeded the expiration date. Review of 2021, 2022, and 2023 hematology quality control records revealed the laboratory used Coulter 4C-ES quality control material lot #068900 low/078900 normal/088900 high with expiration date 1/31/22 from 2/1/22 to 2/28/22. Review of the February 2022 Coulter maintenance log revealed the following notation dated 5/5 /22 and signed by the TC: "Expired QC all month but in range. Reviewed w/ (the laboratory director) & left pt. summary with him to review." Review of quality assessment records revealed the TC instructed the laboratory to have the laboratory director review all patient results for tests completed during the use of expired controls, but there was no documentation that a patient review was performed. During interview at approximately 1:15 p.m., the TC confirmed that the patient review had not been completed. 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 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 -- 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, 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 2020, 2021, 2022, and 2023 Coulter AcT diff hematology calibration records and review of 2020, 2021, 2022, and 2023 quality assessment records 5/3/23, the laboratory failed to perform and document calibration at least once every six months. Findings: Review of 2020, 2021, 2022, and 2023 Coulter AcT diff hematology calibration records revealed the laboratory performed calibration on the following dates: 2/19/20, 9/30/20, 2/15/21, 10/14/21, 10/22/21, 5/12/22, 11/11/22, and 3/2/23. Calibrations performed 10/14/21, 10/22/21, 5/12/22, and 11/11/22 were not successful. Review of 2020, 2021, 2022, and 2023 quality assessment records revealed: 1. The calibration factors were not saved for the calibration performed 5/12 /22. The "List of Issues" from the 8/10/22 TC visit stated "Cal Coulter and get this updated as soon as possible." There was no documentation that service was contacted. 2. The calibration performed 11/11/22 failed and was not repeated. There was no documentation that service was contacted. The "List of Issues" from the 11/28/22 TC visit stated "Do not use the machine until Calibration is repeated." The "List of Issues" from the 2/28/23 TC visit stated "Calibrate ASAP and document