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 reviews of the Abbott Cell Dyn Emerald Hematology analyzer Operator's Manual, calibration records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to follow the manufacturer's instructions in the performance frequency of calibrations in 2017. The findings include: 1. A review of the Abbott Cell Dyn Emerald Hematology analyzer Operator's Manual on page 6-3 revealed the following instructions, "When to Calibrate ... At least every six months...". 2. A review of the Hematology records revealed the following: A) 5/10 /2017: Documentation of a valid calibration B) 2/21/2018: Documentation of a calibration performed approximately nine months after the previous calibration 3. During an interview and review of the records on 3/20/2019 at 1:20 PM, TP #1 was asked about calibration frequency, and whether the laboratory had performed a calibration the second half of 2017. TP #1 confirmed the testing personnel were taught calibrations were required every six months, however the staff had missed performing the calibration due in late 2017. SURVEYOR ID #32558 Licensure and Certification Surveyor 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 --