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 hematology maintenance records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 2: 30 pm on 07/24/2018, the laboratory failed to perform and document maintenance every two weeks on the Sysmex Poch-100i hematology instrument for six out of 14 time periods from 01/05/2018 to 07/24/2018. The findings include: 1. Review of the Poch-100i maintenance log indicated the laboratory must clean the transducer every two weeks. 2. The laboratory performed and documented maintenance on the following dates: 01/12/2018, 02/15/2018, 03/16/2018, 04/05/2018, 04/17/2018, and 07 /13/2018. 3. At the time of the survey, the laboratory did not have additional maintenance records. 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 --