Romagosa Barron Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Romagosa Barron Dermatology on March 25, 2026 to April 8, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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, interview, review of the laboratory procedure manual and safety data sheets (SDS), the laboratory failed to ensure protection from chemical hazards used in their Tissue Tek Vacuum Infiltration Processor (VIP) and Hematoxylin and Eosin (H&E) stain from 02/02/2024 to 03/25/2026. Findings: 1. During a tour of the laboratory on 03/25/2026 at 9:45 AM, two containers used to store chemical waste used in their H&E stain in the Mohs lab were seen in a cabinet in the laboratory and one large container used to store chemical waste used in their H&E stain and in the Vacuum Infiltration Processor (VIP) was seen on the floor of the pathology laboratory. 2. Review of the procedure titled, Tissue Tek VIP Vacuum Infiltration Processor - Processing Program, signed and dated by the Laboratory Director on 02/18/2026, revealed the pathology laboratory used the following reagents in their VIP processors: Formalin, 50% Reagent Alcohol, 70% Reagent Alcohol, 95% Reagent Alcohol, 100% Reagent Alcohol, and Xylene. 3. Review of the procedure titled Routine Hematoxylin and Eosin Staining (H&E) by the Leica Autostainer XL Procedure, signed and dated by the Laboratory Director on 02/18/2026, revealed the Pathology laboratory used the following reagents for the H&E stain: Xylene, 100% Reagent Alcohol, 95% Reagent Alcohol, Harris Hematoxylin, Clarifier, Bluing Reagent, and Eosin. 4. Review of the procedure titled, Hematoxylin and Eosin Stain 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 -- (Automatic Timetable), signed and dated by the Laboratory Director on 02/18/2026, revealed the Mohs laboratory used the following reagents for the H&E stain: 100% Reagent Alcohol, Hematoxylin, Eosin, and Histo-Clear. 5. Review of the SDSs for Avantik Reagent Alcohol 100%, Avantik Gill 3 Hematoxylin, Avantik Alcoholic Clarifier, Avantik Eosin Y, Stat Lab 100% Reagent Alcohol stain, and Stat Lab Xylene noted, "Store locked up." 6. Review of the SDSs for Avantik Eosin Y, Stat Lab Eosin - Y - Alcohol 0.25%, Stat Lab 95% Reagent Alcohol, Stat Lab Xylene, and Stat Lab Harris Hematoxylin noted, "Keep in fireproof place." 7. Review of the SDSs for Avantik Reagent Alcohol 100%, Avantik Gill 3 Hematoxylin, Avantik Alcoholic Clarifier, Avantik Eosin Y, Stat Lab 100% Reagent Alcohol, Stat Lab Xylene, Stat Lab Eosin - Y - Alcohol 0.25%, and Stat Lab 95% Reagent Alcohol revealed each SDS had the symbol for flammable. 8. During an interview on 03/25/2026 at 9:45 PM, the Mohs Technician acknowledged the flammable chemical waste was not locked up or in a fireproof place. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of the procedure manual, record review, and interview, the laboratory failed to document acceptability of the Hematoxylin and Eosin (H&E) quality control (QC) slide from 01/30/2024 to 08/19/2024. Findings: 1. Review of the procedure titled, H&E Quality Control Procedure, signed and dated on 02/18/2026 by the Laboratory Director noted, "If the slide meets the criteria for proper interpretation, the reviewer will then sign the "Path Lab H&E Staining Quality Control Log" and /or report any issues." 2. Review of Path Lab H&E Staining Quality Control Log Suite #204 revealed, the Dermatopathogist (Technical Supervisor B) failed to document the acceptability of the H&E stain for 124 of 124 days from 01/30/2024 to 08/19/2024. 3. During an interview on 03/25/2026 at 1:30 PM, Testing Personnel E acknowledged the stain quality control logs were not signed by the Dermatopathologist. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the procedure manual, review of personnel records, and interview, the Technical Supervisor (Laboratory Director) failed to document competency evaluation for two (Testing Personnel B and C) of three (Laboratory Director, and Testing Personnel B and C) Mohs Surgeons in 2024 and 2025. Findings included: 1. -- 2 of 3 -- Review of the procedure titled, Competency Assessments and Annual Review signed and dated by the Laboratory Director on 02/18/2026 noted, "All Romagosa Baron Dermatology laboratory employees will be subject to competency assessments." 2. Review of the personnel records for Testing Personnel B and C revealed there was no documentation of annual competency evaluations on the Mohs Surgeons for 2024 and 2025. 3. During an interview on 03/25/2026 at 12:39 PM, the Mohs Technician revealed they did not have competency assessments performed on the Mohs Surgeons. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 1/23/2024 to 2/2/2024. Romagosa Barron Dermatology clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to have unexpired mineral oil in use for scabies testing for 1 out of 1 scabies patient reviewed. Findings Included: On 1/23/2024 at 1 PM, one bottle of mineral oil with expiration date of 8/2021 in a cabinet. Review of procedure policy revealed there was no policy for how to perform scabies and no policy for reagent storage and expiration. Review of scabies patient records revealed patient 1 was tested for scabies on October 9th, 2023. On 1/25/2024 at 4:45 PM, MOHS Lab Manager and IHC Lab Manager confirmed the mineral oil used for Scabies testing was expired for 1 out of 1 scabies patient reviewed. 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 D0000 A recertification survey was conducted on August 25, 2021. Romagosa Barron Dermatology clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually from 10/04/2019 to 08/25/2021. Findings: The laboratory used peer review to verify the accuracy of the reading and interpretation of H&E stain for their biopsy slides. Review of the Maintenance Logs showed the first date of biopsy testing was 10/04/2021. Review of the laboratory's records showed peer review was not performed on the Dermatopathologist. Review of the histopathology procedure manual signed by the Laboratory Director on 08/06/2021, showed there was no procedure on proficiency testing for the Dermatopathologist.. On 08/25/2021 at 12:20 PM, Testing Personnel G stated the first day of testing was 10/04/2021. On 08/25 /2021 at 3:43 PM, Testing Personnel G stated peer review was not performed on the Dermatopathologist.. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)