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 review of the Cell Dyn Emerald hematology calibration records from 3/1/18 through the day of survey, 12/19/19 and interview with testing personnel (TP) #2 listed on the CMS (Center for Medicare & Medicaid Services) form at 11:00 am on the day of survey, the laboratory failed to perform calibration on the Boule Medonic M Series hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Review of the Medonic M Series calibration records revealed calibration was performed at installation 3/1/18 and again on 4/3/19. This exceeds the 6 month mandatory calibration requirement by the manufacturer. 2. Interviews with TP #2 at 11:00 am on 12/19/19 confirmed that calibrations were not performed every 6 months as evidenced by the calibration records available the day of survey. 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 --