Pediatric Associates Inc Of Brockton

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) scores and staff interview, the laboratory failed to investigate and perform

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) scores and staff interview, the laboratory failed to investigate and perform

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pediatric Associates of Brockton laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 record review and interview, the laboratory failed to provide documentation to verify that calibrations were performed following the manufacturer's test system instructions as evidenced by the following: The manufacturer's instructions for calibration of the CELL-DYN Emerald Hematology analyzer indicated that calibrations must be performed every six months according to the policy "Emerald User Guide and Policy and Procedure for Obtaining Hemoglobin and CBC." A review of calibration records from calendar years 2017, 2018, and 2019 revealed that calibrations were performed on 7/5/17, 4/4/18, and 4/16/19. Testing Person One interviewed on 9/4/19 at 10:45 AM confirmed that calibrations were not performed every 6 months per the test system's instructions. 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 --