Robert Cater Md Pc

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 a review of the Hematology records, the manufacturer's user manual, and an interview with the Laboratory Director, the Laboratory failed to perform calibrations on the Medonic M series Hematology analyzer every six months as per the manufacturer's instructions. The laboratory failed to perform two of five calibrations due in 2021 and 2022. The findings include: 1. A review of the Hematology calibration records revealed the Medonic M series was calibrated 10/28/2021 and then ten months later on 8/18/2022. There was no documentation of a calibration the first half of 2021 and 2022. 2. A further review of the Medonic user manual revealed on page 60, "It is recommended to calibrate the instrument every 6 months." 3. During an interview on December 21, 2022, at 10:41 AM, the Laboratory Director confirmed the calibrations due in April 2021 and April 2022 were not performed. 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 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the Hematology quality control (QC) records and the patient logs, and an interview with the Laboratory Director, the laboratory failed to perform at least two levels of QC each day of patient testing. The surveyor noted three days in 2020 when the laboratory failed to perform QC prior to patient CBC (Complete Blood Count) testing. The findings include: 1. A review of the 2020 monthly cumulative QC records and patient logs for the Medonic Hematology analyzer revealed no documentation of QC on three days of patient CBC's testing, as follows: A) 5/8/2020: 1 patient CBC B) 8/7/2010: 4 patient CBC's C) 9/3/2020: 8 patient CBC's 2. A review of