Summary:
Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A review of the laboratory's policies, review of equipment maintenance records during 2022, and an interview with the lab manager revealed that the laboratory failed to follow their policy regarding regular function checks for the centrifuge that is used to prepare specimens for chemistry testing. The laboratory performs approximately 1200 chemistry tests annually. Findings include: 1. A review at 11:45 AM on 4/10/23 of the laboratory's policy titled, "General Specimen Collection and Handling," stated that when "heparinized plasma is to be used for testing, centrifuge the collection tube for 10 minutes at 3000 RPM (rotations per minute)." 2. A review at 11:45 AM on 4/10 /23 of the laboratory's policy titled, "General Maintenance Program," contained directions for the centrifuge maintenance that stated "RPM and timer check biannually." 3. A review of equipment maintenance records at approximately 11:50 AM on 4/10/23 revealed that records of maintenance and function checks during 2022 for the centrifuge RPM and timer, as outlined in the laboratories policies, were not available at the time of survey. 4. An interview with the lab manager at approximately 12:00 PM on 4/10/23 confirmed that records of maintenance and function checks during 2022 for the centrifuge RPM and timer, as outlined in the laboratories policies, were not available at the time of survey. 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 --