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 Sysmex XP-300 hematology analyzer maintenance records and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 4:30 pm on 12/15/2020, the laboratory failed to document weekly maintenance as defined by the manufacturer for 10 out of 13 weeks of patient testing from March- May 2020. The findings include: 1. The XP-300 maintenance log indicated that the following task is to be performed and documented weekly: Clean SRV Tray. 2. Review of the XP-300 maintenance log revealed that the laboratory documented weekly maintenance on the following dates: 03/04/20, 04/03/20 and 04/15 /20. 3. At the time of the survey, personnel identifier #3 confirmed that the laboratory did not document weekly maintenance during the following weeks from March- May 2020: 03/09/20, 03/16/20, 03/23/20, 04/06/20, 04/20/20, 04/27/20, 05/04/20, 05/11 /20, 05/18/20, and 05/25/20. 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 --