James A Coggi, Md, Pc

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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:45 am on 03/07 /2024, the laboratory failed to take and document

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 laboratory's calibration policy, calibration records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 02/21/2020, the laboratory failed to perform and document calibration procedures on the Abbott Cell-Dyn Emerald hematology instrument (complete blood counts) every six months for two out of two time periods in 2019. The findings include: 1. The laboratory's calibration procedure stated that the laboratory would perform a calibration on the Abbott Cell-Dyn Emerald hematology analyzer every six months. 2. Calibration records revealed that the laboratory last calibrated the hematology instrument on 11/30/2018. 3. At the time of the survey, laboratory personnel identifier #2 confirmed that the laboratory had not calibrated the hematology instrument since 11/30/2018 and did not have calibration records for 2019. 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 --