Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 the surveyor's review of the laboratory's policies and procedures, preventive maintenance (PM) documentation, six (6) patient records, and interviews with the laboratory's director of training (DT) and Regional Manager (RM); the laboratory failed to establish and follow a policy and procedure in place for the calibration of the thermometers as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings include: 1.The laboratory failed to provide PM documentation for the years 2023, 2024, and 2025 for the digital thermometers used in the laboratory according to manufacturer's requirements, to be performed annually. 2. No