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: Based on surveyor review of laboratory urine microscopy procedures, observation of the centrifuge used for urinalysis testing, and interview with the laboratory director, the laboratory did not perform function checks to ensure one of one urine centrifuge met the procedure defined requirements for preparation of urine samples for microscopic analysis. Findings include: 1. Review of the procedure, "Urinalysis - Microscopic" showed instructions for urine centrifugation, "centrifuge for 5 minutes at NCCLS recommendation of approximately 1800 RPM" (revolutions per minute). 2. Observation of the urine centrifuge on July 16, 2024, at 1:15 PM revealed the centrifuge showed function checks were due in January 2024. The centrifuge label showed samples were spun at 25 x 100 RPM. 3. Interview with the laboratory director on July 16, 2024, at 1:30 PM confirmed the centrifuge function checks were past due and the laboratory had not ensured the centrifuge met the procedural requirements the laboratory defined for processing urine samples for microscopic examination. 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 --