Summary:
Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on review of centrifuge maintenance records, Standard Operating Procedures (SOPs), as well as interview with the Technical Consultant (TC), the laboratory failed to perform and document equipment Preventative Maintenance (PM). FINDINGS: 1. There was no documentation of centrifuge annual PM performance for three of four total centrifuges. 2. This is contrary to instructions indicated in the current, approved SOPs. 3. It was noted that the four respective centrifuges were loaned from a reference laboratory. 4. The TC confirmed the findings on May 30, 2025, at 12:00 P. M. 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 --