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: Through a review of the Sysmex XP-300 maintenance requirements, a review of the XP-300 Maintenance Logs for 2021 and 2022, and through interviews with laboratory staff, it was determined the laboratory failed to document weekly and monthly maintenance for the Sysmex XP-300 hematology analyzer as required by the manufacturer. Survey findings include: A. A review of the Sysmex maintenance requirements for the XP-300 hematology analyzer revealed that the laboratory is required to clean the SRV tray weekly and clean the RBC/WBC transducer and the waste chamber monthly. B. Through a review of the XP-300 Maintenance Logs for January 1 2021 through October 18, 2022 it was determined the laboratory failed to document weekly maintenance 28 of 52 weeks in 2021 and 30 of 40 weeks in 2022 and the laboratory failed to document monthly maintenance 1 of 12 months in 2021 and 5 of 10 months reviewed in 2022. C. In an interview, at 11:32 a.m. on 10/18/2022, the laboratory director (as listed on the form CMS-209) confirmed the laboratory had not documented weekly and monthly maintenance as required by the manufacturer. 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 --