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 a surveyor's review of hematology calibration records and interview with the general supervisor, the laboratory failed to perform a calibration of the hematology analyzer at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the Beckman Coulter analyzer. FINDINGS: 1. The general supervisor confirmed, on September 14, 2018 at approximately 10:30 AM, the surveyor's findings that the Coulter AcT Diff was not calibrated at the six month requirement in 3/2018. 2. The last available calibration records for review was 9 /11/2017. The hematology analyzer was therefore out of calibration from 3/11/2018 through survey date. 3. Approximately 254 patient specimens were tested and reported for hematology during the above time period when analyzer was out of calibration. 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 --