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 maintenance logs for the Vitros chemistry analyzer for 2019 and interview with the technical supervisor, the laboratory failed to perform the monthly maintenance for March 2019. Findings include: 1. The March 2019 monthly maintenance log print out from the Vitros chemistry analyzer did not indicate performance of 11 out of 11 monthly maintenance procedures. 2. The technical consultant acknowledged that there were no preventative maintenance procedures performed by Vitros technicians during the month of March 2019. 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 --