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 surveyor observation, surveyor review of laboratory's procedure, and interview with testing personnel #1 (TP#1), as indicated on the CMS-209, the laboratory failed to perform annual calibration checks on one out of one pipette used in the laboratory. 1. Surveyor observation of the laboratory revealed one pipette in use. 2. Review of the laboratory's "Pipette Cleaning and Accuracy Check" procedure indicates "Semi-automated pipettes will be sent to an outside vendor for cleaning and for calibration checks annually." 3. Interview with TP #1, on 5/14/2026 at 10:13 AM, confirmed the laboratory failed to send their pipette to an outside vendor for cleaning and for calibration checks annually. 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 --