Summit Pediatrics

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Sysmex XP-300 Hematology Quality Control (QC) records and an interview with Testing Personnel #2, the laboratory failed to implement a mechanism to monitor the accuracy and precision of test performance over time. This was noted from 7/27/2022 to the date of the current survey, 4/3/2024. The findings include: 1. A review of Sysmex XP-300 QC records revealed only daily QC print outs from the instrument were retained. No evidence of Levy Jennings charts or peer group data was available for review at the time of survey. 2. During an interview on 4/3 /2024 at 10:45 AM, Testing Personnel #2 confirmed that the laboratory had not printed and reviewed Levy Jennings charts for the Sysmex XP-300 and had not implemented any other method to monitor shifts and trends over time. 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 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 calibration records, policy and procedures manual, and an interview with Testing Personnel #1, the laboratory failed to calibrate the Sysmex XP- 300 Hematology analyzer every six months as per laboratory procedure. The laboratory failed to perform two of two calibrations due in 2021. The findings include: 1. A review of the calibration records revealed a calibration was performed on 10/8 /2020 and the next calibration was performed 05/4/2022, a year and seven months after the previous calibration. 2. A review of the policy and procedures manual revealed on page 4 "...Sysmex will come in to calibrate every 6 months...". 3. During an interview on May 10, 2022 at 11:45 AM, Testing Personnel #1 confirmed Sysmex did not perform calibrations in 2021 due to lapse in service contract. 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 --