Fort Worth Dermatology Associates

Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was completed on 09/05 /2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. 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 review of patient final reports, surveyor direct observation, and interview, the laboratory failed to establish its own policy for positive patient identification to ensure optimum integrity of patient samples from collection to reporting of results for six of six patients randomly reviewed in April 2025. Findings include: 1. Review of patient final reports determined the following patients had Mohs testing performed: a. ID: 36209 DOB: 08/27/1942 Date: 04/29/2025 b. ID: 36225 DOB: 12/30/1972 Date: 04/29/2025 c. ID: 36102 DOB: 08/15/1955 Date: 04/29/2025 d. ID: 20345 DOB: 10 /24/1938 Date: 04/29/2025 f. ID: 36238 DOB: 02/10/1948 Date: 04/29/2025 e. ID: 09032 DOB: 10/27/1965 Date: 04/30/2025 2. On 09/05/2025 at 1400 hours, the surveyor observed patient Mohs slides that were provided with the patient final reports, handwritten with the following information (see patient alias list): Last name, first initial Date of service Mohs stage(s) 3. On 09/05/2025 at 1416 hours, the surveyor asked the laboratory for the laboratory's policy for positive patient identification to ensure optimum integrity of patient samples from collection to reporting of results for six of six patients randomly reviewed in April 2025. On 09/05 /2025 at 1417 hours, the Laboratory Director (as listed on the CMS-209 form) stated a 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 -- policy has been in use for positive patient identification in the past, but "may have been misplaced when moving to the new location." The Laboratory Director confirmed the laboratory did not have a policy for positive patient identification during an interview on 09/05/2025 at 1420 hours in the laboratory. Key: DOB - Date of Birth CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient testing logs and interview, the laboratory failed to document their testing records for frozen section biopsies for dermatopathology interpretations for two of two years reviewed. Findings follow. A. The log for frozen section biopsies was requested on June 28, 2023 at 1430 hours but not provided. B. Interview with the Laboratory Director on June 28, 2023 at 1430 hours confirmed they had a Mohs log, but not a log for frozen section biopsies. He estimated he performed fewer than ten per year. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) 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 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, Mohs maps, and interview, the laboratory failed to include the key on the Mohs map for the symbols indicating the marking dyes on the sections used on ten of ten Mohs maps reviewed over 18 months. Findings follow. A. Review of the laboratory's Policies and Procedures For Mohs Lab binder included a page for Tissue Colors for Sectioning and was a guide to the marker dyes and showed a solid line _____ designated RED dye, the dash line . . . . . . designated BLUE dye, the - - - - - - symbol designated GREEN dye, and the ooooo symbol designated black dye. B. Random review of ten Mohs maps from 05/18 /23 - 10/28/21 showed symbols for the marking dyes used, but there was no key on the map to show what colors the symbols were, as listed by date of service and accession number: Date of Service Mohs case # 1. 05/18/23 400-23 2. 03/28/23 255- 23 3. 02/20/23 144-23 4. 12/12/22 994-22 5. 09/15/22 734-22 6. 07/19/22 548-22 7. 04 /19/22 329-22 8. 03/02/22 183-22 9. 12/20/21 989-21 10. 10/28/21 844-21 C. Interview with the Laboratory Director on June 28, 2023 at 1540 hours confirmed the he used symbols on the Mohs map, and there was no key on the map for the symbols used. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Laboratory Director and Histotechnician were at the entrance conference conducted 01/17/2020. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the Laboratory Director on 01/17/2020. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiency cited was discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 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 review of laboratory policy, quality control (QC) logs, patient records, and confirmed in interview, the laboratory failed to define for each day of use, test staining materials for intended reactivity to ensure the predictable staining characteristics for the Hematoxylin and Eosin (H&E) QC for 15 of 15 days in 2018 (12 /2018), 33 of 33 days in 2019 (11/2019, 12/2019) and 9 of 9 days in 2020 (01/2020). Findings: 1. Review of the laboratory's H&E staining policy revealed: "Quality Control: 1. Laboratory director shall review the first slide prepared each day for adequacy of stain." The procedure failed to define the staining characteristics for intended reactivity of the H&E stain. 2. A random review in 2018, 2019 and 2020 of "MOHS FORZEN SECTION DAILY TECHNICAL QUALITY ASSURANCE REPORT" revealed the following: The log had a row for "Stain Quality," each day 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 -- stain quality was documented as "SATISFACTORY" or "UNSATISFACTORY" by placing a "checkmark" in the corresponding column. The bottom of the log was initialed by the laboratory director as the reviewer. The log did not specify if "SATISFACTORY" or "UNSATISFACTORY" was indicated for H&E intended reactivity to ensure predictable staining characteristics. The following dates were observed to be documented with "SATISFACTORY": 2018 December: 3, 4, 5, 6, 10, 11, 12, 13, 17, 18, 19, 20, 26, 27, 28 2019 November: 4, 5, 6, 7, 11, 12, 13, 14, 16, 18, 19, 20, 21, 26, 27 December: 2, 3, 4, 5, 9, 10, 11, 12, 14, 16, 17, 18, 19, 23, 26, 27, 30, 31 2020 January: 2, 6, 7, 8, 9, 13, 14, 15, 16 The laboratory failed to document the intended reactivity to ensure predictable H&E characteristics for the above dates. 3. The laboratory had an annual test volume of 1500 cases. 4. During an interview on 01 /17/2020 at 12:05 pm, the laboratory director confirmed the above findings. -- 2 of 2 --