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 a review of the Hematology Sysmex XP-300 maintenance records, a review of the Sysmex XP-300 Instructions For Use, and an interview with Testing Personnel #1, the laboratory failed to document quarterly maintenance. This was noted from August 2020 (when patient testing started) to July 2021. The findings include: 1. A review of the Hematology maintenance records revealed a place to document quarterly maintenance on the Sysmex XP-300 Maintenance Log and this was left blank from August 2020 to July 2021. During this time period quarterly maintenance should have been documented at least three times. 2. A review of the Sysmex XP-300 Instructions For Use revealed in section 12, page 12-12 under Clean SRV, "When the main power switch is turned ON, and if either the counter value exceeds 4,500, or if 3 months have passed since the last maintenance, a message will appear prompting the operator to perform periodic maintenance (SRV cleaning)...". 3. During an interview on 08/12/2021 at 1:21 PM, Testing Personnel #1 confirmed the above findings, and was not aware of performing this maintenance since she started in April 2021. 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 --