Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lynchburg Nephrology Physicians, PLLC on February 22, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a tour of the laboratory, review of manufacturer's guidelines, maintenance records, and an interview, the laboratory failed to perform and document centrifuge function checks as defined by the manufacturer in 2016 and 2017. Findings include: 1. During a tour of the laboratory, the inspectors noted two (2) Unico Power Spin LX centrifuges in use for the preparation of patient serum and plasma samples. 2. Review of the Unico Power Spin LX centrifuge manufacturer's guidelines revealed the following statement for calibration: "It is recommended that your centrifuge's RPM be calibrated at least every six (6) months. This period is suggested by both the FDA and CLIA guidelines. Simply check the RPM using a stroboscope or tachometer and the small circular window on the lid." 3. During a review of the laboratory maintenance records, the inspector requested centrifuge calibration records. No records were available for review. 4. An interview with the laboratory director and primary testing personnel at approximately 3:30 PM confirmed that both centrifuges had not been calibrated per the manufacturer's guidelines in calendar years 2016 and 2017. 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 --