Florida Center For Dermatology Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Florida Center for Dermatology Laboratory on 3/6/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure protection from chemical hazards by storing bulk flammable reagents in a non-rated laboratory cabinet rather than a designated flammable storage cabinet, and by failing to maintain a sanitary storage environment for 20 of 20 1-gallon reagent containers observed. Findings include: During a tour of the laboratory at 11:15 am on 3/6/2026, the following bulk flammable reagents were observed stored inside a standard wood- laminate laboratory cabinet located under a counter: Fifteen (15) 1-gallon bottles of 95% reagent grade alcohol; Two (2) 1-gallon bottles of Eosin Y solution; and Three (3) 1-gallon bottles of 100% alcohol. The manufacturer's labels on the bulk alcohol and Eosin Y containers displayed the "flame" pictogram, indicating the contents were highly flammable and required appropriate hazardous material storage. Observation of the interior of the storage cabinet on 3/6/2026 revealed a lack of sanitary maintenance and protection from contamination. The cabinet shelves were heavily soiled with various colored stains, and the reagent bottles were observed sitting in pools of pink and purple liquids. In an interview on 3/6/2026 at 12:05 PM, the Mohs technician confirmed the laboratory possessed a designated flammable storage cabinet; however, 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 -- further confirmed that the standard laboratory cabinet was also being used to store these bulk flammable chemicals. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the positive identification of patient specimens from the time of receipt through the reporting of results for 88 of 88 Mohs surgery cases reviewed between July 17, 2025, and August 1, 2025, where the accession numbers recorded in the laboratory's primary log did not match the accession numbers documented on the corresponding surgical maps and patient slides. Findings include: A review of the laboratory's 2025 "MOHS LOG" revealed extensive manual edits and renumbering of patient case numbers for five testing days. The original accession numbers were crossed out or obscured, and a new numerical sequence was substituted. The number of patient records renumbered on the primary log included: 7/17/2025: 20 patient records; 7/29/2025: 17 patient records; 7 /30/2025: 13 patient records; 7/31/2025: 19 patient records; and 8/1/2025: 19 patient records. A comparative review of the primary log pages against the clinical surgical maps and prepared patient slides for these 88 cases confirmed that the accession numbers did not match. For example, for Patient #1 on 7/17/2025, the Mohs slide and Mohs Map identified the specimen with Accession #FCDm25-1291, but the primary laboratory log showed that the entry for Accession #1291 had been crossed out and edited to Case #1301. A review of the remaining 87 Mohs surgery cases (Patients #2 through #88) revealed similar discrepancies where the renumbered Case #s in the primary log did not match the original accession numbers preserved on the surgical maps and slides. In an interview on 3/6/2026 at 12:30 PM, the Mohs Technician confirmed that the accession numbers on the surgical maps and slides for those specific dates in 2025 did not match the renumbered entries in the primary log. During an interview with the Laboratory Director via phone on 3/6/2026 at 12:35 PM, he acknowledged the identification error and stated that the laboratory would implement

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Florida Center for Dermatology was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 staff interview, the laboratory failed to document the humidity of the laboratory for two of two years reviewed (2018-2019), and failed to ensure the required cryostat temperature on the "Cryostat Maintenance Policy" matched what was documented on the Cryostat Temperature Log for two of two years reviewed (2018-2019). Findings include: 1. Review of the temperature/humidity logs for 2018 and 2019 showed the room temperature was documented but the humidity was not. During an interview on 2/13/20 at 10:50am with the MOHs technician, it was confirmed that only room temperature was documented and not humidity. 2. The policy titled "Cryostat Maintenance Policy" states "The cryostats should be maintained at -21C to no colder than -26C for best sectioning". The cryostat temperature logs for 2018-2019 show an acceptable temperature range is -20C to -30 C. The average temperature range documented each day of testing is -28C to -30C which is out of range of the policy. The interview with the MOHs technician on 2/13 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 -- /30 at 10:50am confirmed the temperature range for the cryostats in the laboratory is around -28C to -30C and the policy was incorrect. -- 2 of 2 --