Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory Technical Consultant (TC), the laboratory failed to perform manufacturer required biennial maintenance on the Sysmex XN-530 hematology analyzer in use. Findings include: 1. Record review on 11/6/2025 of the Sysmex required maintenance logs May 2023 - October 2025, revealed no "air pump" replacement as required by the manufacturer "once every 2 years". 2. Record review on 11/6/2025 of the laboratory's "Equipment Maintenance" policy revealed, "All equipment used in the laboratory will be maintained according to manufacturer's recommendations." 3. Interview with the TC on 11/6/2025 at 11:00am confirmed the findings above. 4. The laboratory performs 29,716 tests per year in the specialty of hematology. 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 --