Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted by the Wyoming CLIA state agency at Cedars Health located at 428 South Durbin Street, Suite 104, in Casper, WY on 9/28/26. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(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 (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(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 lack of documentation, review of the manufacturer's operator's manual, and staff interview, the laboratory failed to follow the Sysmex XP-300 manufacturer's instructions to perform an instrument calibration once every 6 months for 4 out of 4 years reviewed (2023, 2024, 2025, 2026). The laboratory performed approximately 1,600 complete blood count patient tests per year. The findings were: 1. Review of the laboratory's hematology records showed the last certificate of calibration was dated 1 /26/23. 2. Review of the Sysmex XP-300 operator's manual showed calibration frequency was a minimum of every 6 months or after major maintenance or part replacement. 3. Interview with the laboratory director on 9/28/26 at 4:30 PM confirmed there was no documentation to show the Sysmex XP-300 had been calibrated since 1/26/23. 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 --