Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Dermatology Group on 4/6/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that room temperature and humidity were monitored and documented for 6 days of patient testing in 2026, and failed to ensure that cryostat internal temperatures were documented for 15 days of patient testing in 2025 & 2026. Findings include: 1. A review of the "Mohs Lab Room Temp & Humidity Log" for the February 2026 revealed that the laboratory failed to document the daily room temperature and humidity on the following six dates: 2/11, 2/12, 2/16, 2/18, 2/23, and 2/25. 2. A review of the "Equipment Quality Control - Maintenance Record" for the cryostat revealed the following missing documentation of required temperature checks: In September 2025, internal cryostat temperatures were not documented for nine dates: 9 /3, 9/4, 9/8, 9/10, 9/15, 9/17, 9/22, 9/24, and 9/29. In February 2026, internal cryostat temperatures were not documented for six dates: 2/11, 2/12, 2/16, 2/18, 2/23, and 2 /25. 3. A review of the laboratory's patient testing logs on 4/6/2026 confirmed that 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 -- patient Mohs histopathology specimens were processed and tested on all of the dates listed above. 4. In an interview on 4/6/2026 at 11:45AM, Testing Person #8 confirmed that the room temperature, humidity, and cryostat temperature logs were incomplete. -- 2 of 2 --