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 and quality assurance records, and an interview with Testing Personnel (TP) #6, the surveyor determined the laboratory failed to follow the manufacturer's instructions in the performance frequency of calibrations in 2016 - 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) 9/29/2016: Documentation of an acceptable calibration B) 7 /24/2017: Documentation of a calibration performed ten months after the previous calibration 3. A review of quality assurance records revealed a note from the Technical Consultant on a 6/30/2016 Calibration Report, asking "Where is 12-16 cal [calibration]?" The Technical Consultant had also made a note directing the testing personnel to check with Abbott Service for documentation of a calibration. 4. During the exit summation interview and review of the records on 6/7/2018 at approximately 3:00 PM, TP #6 was asked if the laboratory had documentation of any Hematology 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 -- calibrations performed between 9/29/2016 and 7/24/2017 (ten months later). TP #6 confirmed she had been unable to find any other calibrations for that period. When asked how often the Emerald Hematology analyzer should be calibrated, TP #6 stated, "Every six months". Thus, the above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --