Summary:
Summary Statement of Deficiencies D0000 Based on an on-site initial certification survey conducted on December 4, 2025, deficiencies were cited for Summit Dermatology, PC laboratory located in Colorado Springs, Colorado. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with the Mohs Technician during the survey, the laboratory failed to not use reagents when they have exceeded their expiration date. Findings include: 1. A tour of the laboratory on December 4, 2025, at approximately 12:00 PM, revealed multiple reagents exceeded their expiration dates. These reagents are Hematoxylin (lot: 1828515, expired 10/17/2020), Scott's Tap Water Substitute (lot: 2427219, expired 10/11/2025), Eosin Y Stain (lot: 2104313, expired 02/18/2023), Mineral Oil (expired 6/21/2025), Optic Mount and Mounting Medium (expired 2023-2024) 2. An interview with the Mohs Technician on December 3, 2025, at approximately 12:30 PM confirmed that multiple reagents have exceeded their expiration dates. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory documents and an interview with the Mohs Technician during the survey, the laboratory failed to document the maintenance activities on the Cryostat and the microscope. Findings include: 1. A review of the laboratory documents on December 4, 2025 at approximately 11:00 AM, revealed there were no documented maintenance for the cryostat and the microscope for the year 2022, 2023, 2024, and 2025. 2. An interview with the Mohs Technician on December 3, 2025, at approximately 12:30 PM confirmed there were no documentation of maintenance for the cryostat and the microscope for the year 2022, 2023, 2024, and 2025. -- 2 of 2 --