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 reviews of the Hematology calibration records, the Medonic M Series Operator's Manual, and an interview with Testing Personnel #1, the laboratory failed to follow the manufacturer's instructions to perform quality control after calibration, and before running patient samples. This was noted on one of five calibrations reviewed for 2020 - 2022. The findings include: 1. A review of Hematology records revealed the Medonic M Series instrument was calibrated on 03/02/2021 at 3:46 PM, however, quality control was not performed until 03/03/2021. A review of the 03/02 /2021 "All Sample Log" revealed two patient CBC's (Complete Blood Counts) were run after the calibration at 4:59 PM and 5:29 PM. 2. A review of the Medonic M Series Operator's Manual revealed under section 7.2 Calibration, " ...17. It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly. ...". 3. During an interview on 5/17/2022 at 1:00 PM, Testing Personnel #1 verified controls should be run after every calibration. Testing Personnel 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 -- confirmed two patient CBCs were performed after the calibration on 03/02/2021, and stated "It was the end of the day, and I just forgot." SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --