Elias Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ELIAS DERMATOLOGY LLC from 06/05/2025 to 06/09/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5805 TEST REPORT CFR(s): 493.1291(c) (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) 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 Dermatopathology patient reports review and staff interview, the laboratory failed to ensure that the patient reports had the current laboratory address for four out of four reports with collection dates after the laboratory moved from the previous location on 12/06/2024. Findings included: 1-Review of four final patient reports: P#1 (collection date 12/17/2024), P#2 (collected 01/06/2025), P#3 (collected 01/09/2024) and P#4 collected (05/07/2025), revealed that the reports failed to list the current address of the laboratory that did the Dermatopathology testing. 2-During an interview on 06/05/2025 at 03:30 PM, with the laboratory technician, he confirmed that the final reports reviewed failed to show the current address of the laboratory that performed the Dermatopathology testing for the test reports 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 July 10, 2019. Elias Dermatology LLC was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 interview, the laboratory failed to document and maintain a record of the open dates for reagents used in their Hematoxylin & Eosin (H&E), Periodic Acid Schiff (PAS) and Acid- Fast Bacilli (AFB) stains. Findings: Record review of the laboratory's logs titled "Laboratory Reagent Log" showed that the laboratory failed to record when the reagents where opened from 7/30/17 to 7/30/19. During an interview on 7/30/19 at 2:03 PM, the Testing Personnel B confirmed they didn't record the open date for their reagents on the log. 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 --