Romagosa Barron Dermatology

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)