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 surveyor review of laboratory records and interview with the Technical Consultant, testing personnel did not perform routine maintenance on the Aution Max AX-4030 analyzer every three days as required on the laboratory's maintenance log in three of three months reviewed. Findings include: 1. Review of the 'Aution Max AX- 4030 Maintenance Log' from January through March 2024 showed routine maintenance included washing the introduction tray, cleaning the strip feeders, and cleaning the test strip stopper every three days. Further review of the maintenance logs showed testing personnel did not document these maintenance steps between the following dates: January 11 - 15, 18 - 22, 25 - February 1, February 1 - 5, 8 - 12, 29 - March 4, and March 7 - 11. 2. Interview with the Technical Consultant on December 3, 2024, at 12:30 PM confirmed testing personnel had not performed the identified maintenance tasks on the Aution Max AX-4030 analyzer every three days as required on the maintenance log for the analyzer. 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 --