Summary:
Summary Statement of Deficiencies 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, 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 surveyor review of the Beckman Access 2 analyzer calibration records and interview with the technical consultant and the testing person, calibration of the Beckman Access 2 analyzer was not performed at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the analyzer. FINDINGS: 1) The Beckman Access 2 system creates and stores calibration data for each calibration run on the analyzer. Depending on the type of assay, the system generates an associated calibration curve or a cutoff. The laboratory's calibration policy and the manufacturer of the Beckman Access 2 analyzer require analyzer calibration to be performed and the calibration curve to be updated when prompted by the analyzer. This criteria was disregarded by the laboratory from 4/24/19 through 5/6/19 when it was flagged/prompted repeatedly by the analyzer. 2) On May 15, 2019 at approximately 11:30 AM the technical consultant and the testing person confirmed surveyor's findings that the analyzer calibration curve was expired from 4/24/19 through 5/6/19 for the following analytes: Free T4, Prostate Serum Antigen (PSA), Thyroid Stimulating Hormone (TSH), Vitamin B12, Vitamin A, testosterone, total T3, 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 -- and Folate. 3) Approximately 150 patient specimens were tested and reported for endocrinology analytes during the time period when analyzer was out of calibration. -- 2 of 2 --