Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on January 8, 2026, deficiencies were cited for Colorado Dermatology Group, PLLC laboratory located in Fort Collins, Colorado. 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 a review of the Avantik QS12 manual, a review of the laboratory maintenance records and an interview with the laboratory director during the survey, the laboratory failed to perform the recommended annual preventative maintenance for the Avantik QS12 cryostat. Findings include: 1. A review of the Avantik QS12 manual revealed that the manufacturer recommends preventative maintenance to be performed on the instrument at least once a year by a qualified service technician. 2. A review of the laboratory maintenance records revealed that the laboratory did not perform annual maintenance for Avantik QS12 in 2025. 3. An interview with the laboratory director on January 8, 2026 at approximately 11:30 AM confirmed that the laboratory did not perform annual maintenance for Avantik QS12 in 2025. 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 --