Usa Mobile Diagnostic Center

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 Policies and Procedures, a review of Sysmex XN 1000 calibration records, and an interview with the Technical Consultant, the laboratory failed to perform and document one of two calibrations on the Sysmex XN 1000 in 2022. The findings include: 1. A review of Policies and Procedures revealed the following under "Sysmex XN-1000 Hematology Analyzer", "...The laboratory must verify calibration every six months...". 2. A review of Sysmex XN-1000 calibration records revealed calibrations on the instrument were performed on 4/28/2022 and 5/24 /2023. No evidence of a calibration performed in the second half of 2022 was available for review. 3. During an interview on 7/5/2023 at 12:00 PM, the Technical Consultant confirmed the above findings. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on reviews of proficiency testing (PT) records and an interview with the Technical Consultant, the surveyor determined the laboratory failed to implement procedures to ensure proficiency testing failures were effectively investigated to determine the cause. This was noted on four of four 2018-2019 Chemistry surveys with failing results. The findings include: 1. A review of the 2018 API (American Proficiency Institute) Chemistry PT records revealed the laboratory obtained failing scores of 20% for Pro-BNP (Beta Natriuretic Peptide) in the Event #2 and Event #3 surveys. [Note: The surveyor noted all Pro-BNP results showed a positive SDI (Standard Deviation Index) bias in both surveys, with no indication the laboratory had investigated this trend.] 2. A review of the laboratory's