Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Southeast Saint Augustine on 4/27/2026. 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 monitor and document room temperature and humidity and equipment temperatures (cryostat) for 2 days (10 /02/2025 and 02/23/2026) on which patient testing was performed, across five months of records reviewed. Findings include: 1. A review of the laboratory's "Hematoxylin & Eosin Quality Control & Maintenance Linistat Linear Stainer" logs on 4/27/2026 for the months of September 2025, October 2025, January 2026, February 2026, and March 2026 revealed that the laboratory failed to record the following required data: On 10/02/2025: There were no documented entries for room temperature, room humidity, or the internal temperature of the cryostat. On 02/23/2026: There were no documented entries for room temperature, room humidity, or the internal temperature of the cryostat. 2. A review of the laboratory's patient testing logs on 4/27/2026 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 -- confirmed that Mohs histopathology specimens were processed and tested on both 10 /02/2025 and 02/23/2026. 3. In an interview on 4/27/2026 at 9:45am, Mohs Technician (MT) #A confirmed that patient testing occurred on 10/02/2025 and 02/23 /2026. MT #A acknowledged that the room temperature, humidity, and cryostat temperatures were not documented for those dates as required. -- 2 of 2 --