Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 review of the Sysmex XP-300 hematology analyzer Instructions for Use and Sysmex XP-300 hematology analyzer maintenance logs from 3/21/2023 through 7/31 /2024, the laboratory failed to document, as performed, weekly maintenance for fifty- two of seventy weeks and monthly maintenance for nine of sixteen months, as defined by the manufacturer and with at least the frequency specified by the manufacturer. Findings include: 1. The Sysmex XP-300 hematology analyzer Instructions for Use defines the following weekly and monthly maintenance procedures: Weekly Maintenance Clean SRV tray. Monthly Maintenance (1) Clean RBC and WBC transducer. (2) Clean Waste Chamber. 2. Review of Sysmex XP-300 hematology analyzer maintenance logs from the last survey, on 3/21/2023, through 7/31/2024 revealed the laboratory failed to document, as performed, the weekly maintenance procedure for 52 weeks, of 70 weeks, during this time frame. 3. Review of Sysmex XP-300 hematology analyzer maintenance logs from the last survey, on 3/21/2023, through 7/31/2024 revealed the laboratory failed to document, as performed, the two monthly maintenance procedures for 9 months, of 16 months, during this time frame. 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 --