Uf Health Dermatology Deerwood Park

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UF Health Dermatology Deerwood Park on 9/2/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5028 493. 1219 Condition: Histopathology . D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the accuracy and reliability of its Mohs histopathology testing processes by failing to maintain positive specimen identification through reporting of patient test results (refer to D5203); failed to verify the accuracy of the Mohs histopathology procedure at least twice annually (refer to D5217); and failed to document cryostat operating temperatures on days when Mohs tissue sectioning was performed (refer to D5413). . 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on record review and interview, the laboratory failed to maintain positive specimen identification through reporting of results for 1 of 3 patient records reviewed (Patient #3 / Specimen #225), when the final laboratory report contained and accession number assigned to a different patient. Findings include: 1. On 9/2/2026, review of the laboratory's Mohs accession log and corresponding patient record for Patient #3 showed that the specimen collected on 7/20/2026 was assigned Specimen /Accession #225. Review of the final laboratory report issued for Patient #3 showed an accession number of #227. Review of the accession log showed that #227 had been assigned to a different patient. 2. During the interview on 9/2/2026 at 11:30 AM, Staff #A confirmed that the final report for Patient #3 was incorrect. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of 2 of 2 tests/procedures reviewed that were not included in Subpart I (Mohs histopathology and potassium hydroxide [KOH] wet mount microscopy). Findings include: 1. On 9/2/2026, review of the laboratory document titled "Mohs QA 2025" showed that only one accuracy verification for Mohs histopathology was documented during 2025, dated 5/5/2025. No documentation was provided showing that a second accuracy verification was completed during 2025. 1a. During the interview on 9/2 /2026 at 11:30 AM with Staff #A, it was confirmed that only one Mohs peer review was completed during 2025 and stated that the second set of slides was reviewed in 2026. 2. Review of 2025 peer review records for three testing personnel who perform KOH microscopy showed that Testing Person #D completed one documented KOH peer review during 2025; Testing Person #E completed one documented KOH peer review in 2025; and Testing Person #F had no documented KOH peer review during 2025. 2a. The interview with Staff #A on 9/2/2026 at 11:30 AM confirmed the twice annual peer review was not complete in 2025. . 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 document cryostat operating temperatures for 3 of 45 days reviewed in 2025 (05/19/2025, 12/17/2025, and 12/29/2025). Findings include: 1. A review of the laboratory's "Cryostat Maintence Log" on 09/02/2026 revealed that the laboratory failed to document the -- 2 of 3 -- daily operating temperature of the cryostat on the following three patient testing dates: 05/19/2025 12/17/2025 12/29/2025 2. A cross-reference of the laboratory's Mohs specimen logs confirmed that patient micrographic tissue sectioning was actively performed on the cryostat on each of those three dates. 3. In an interview on 09/02 /2026 at 11:30 AM, Staff #A (Laboratory Director) confirmed that the cryostat temperatures were not recorded on the specified dates. Staff #A acknowledged that the laboratory's protocol requires daily documentation of equipment temperatures prior to performing Mohs micrographic tissue processing . 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 observation and interview, the laboratory failed to ensure that staining solutions were not used for patient testing after their expiration date for 1 of 1 bottles of Chlorazol Black E observed. Findings include: 1. Observation in the laboratory on 09/02/2026 at 10:50 AM revealed an open bottle of Chlorazol Black E stain (Lot #3178) on the counter of the testing bench. Review of the manufacturer's label affixed to the bottle revealed an expiration date of 06/27/2025. 2. In an interview on 09/02 /2026 at 11:00 AM, Staff #A (Laboratory Director) acknowledged that the expired Chlorazol Black E stain was the only bottle of this specific stain in stock and was actively used for patient testing. Staff #A acknowledged that the reagent had exceeded its expiration date. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant failed to evaluate and document the annual competency assessments for 3 of 3 moderate complexity testing personnel reviewed (Testing Personnel D, E, and F) for the calendar years 2024 and 2025. Findings include: 1. A review of the laboratory's personnel records on 09/02 /2026 showed no documented annual competency evaluations for the calendar years 2024 and 2025 for the following moderate complexity testing personnel: Staff #D Staff #E Staff #F 2. In an interview on 09/02/2026 at 11:30 AM, Staff #A (Laboratory Director) confirmed that no annual competency assessments had been conducted or documented for Staff #D, Staff #E, or Staff #F. -- 3 of 3 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, UF Health Dermatology Deerwood Park 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, failed to ensure the cryostat temperature was documented for 3 of 4 days reviewed in June 2024. Findings include: Review of the laboratory document titled "Cryostat Maintenance" dated June 2024 showed documentation on 6/24/24 of the temperature of cryostat #1 and #2. Review of the Mohs log showed testing was performed on 6/3/24, 6/17/24, 6/20/24, and 6/24/24. During the interview on 8/1/24 at 3:30pm with the Department Director, it was confirmed the documentation was missing for the three days. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials 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 -- for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to maintain daily quality control (QC) slide documentation for Mohs testing for 2 out of 4 testing days reviewed in June 2024. Findings include: Record review of the Mohs Accession Log showed 6 cases of Mohs were tested on 6/3/24 and 6 cases of Mohs were testing on 6 /17/24. Review of the document titled "Daily Slide QA Log" showed QC documentation on 6/20/24, and 6/24/24. There was no QC documentation for 6/3/24 ad 6/17/24. During the interview with the Department Director on 8/1/24 at 2:45pm, it was confirmed the QC documentation was missing. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain complete Histopathology quality control documentation for 3 of 7 months reviewed in 2024. Findings include: The record review of quality control documentation showed there was no record of lot numbers and expiration dates for the Hematoxylin and Eosin (H&E) stains that were used on patient histopathology slides during processing in May, June, and July 2024. The interview with the Department Director on 8/1/24 at 3: 15pm confirmed that the laboratory was missing quality control logs that record the lot number and expiration dates for the H&E stains. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, UF Health Dermatology Deerwood Park 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 room temperature and humidity in the laboratory for 2 (2020-2022) out of 2 years reviewed. The findings include: The laboratory was unable to provide documentation showing room temperature and humidity of the laboratory was being monitored each day of patient testing. During an interview on 9/27/22 at 11:27 AM the Laboratory Director confirmed that room temperature and humidity were not being recorded. 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 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation and interview with laboratory staff, the facility failed to have potassium hydroxide that was not expired for 3 months in 2018. The findings include: During observation on 07/31/18 at 8:50 AM, the potassium hydroxide located in the patient exam rooms had an expiration date of April 2018. The interview on 7/31/18 at 8:50am with the laboratory testing personnel confirmed the potassium hydroxide was expired. 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 --