Epiphany Dermatology Of New Mexico Llc

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on December 10, 2025, at Epiphany Dermatology of New Mexico LLC found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: D6128: TS Competency Evaluations Based on review of the Center for Medicare and Medicaid (CMS) 209 Personnel form and personnel competency records, the Technical Supervisor failed to assess competency for 1 of 2 testing personnel (TP) performing MOHs testing in 2024 and 2025. Findings include: 1. A review of the CMS 209 personnel form revealed 2 TP performing MOHs testing. 2. A review of personnel competency records indicated no competency assessment for MOHs testing was performed for TP1 in 2024 and 2025. 3. The laboratory was asked to provide MOHs competency records for TP1 for testing years 2024 and 2025, none was provided. 4. The laboratory reports 4500 MOHs tests annually. 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 The following deficiencies were cited during a recrtification survey completed on 1/11 /2018 for the federal requirements of 42 CFR Part 493 for Laboratories. 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 the lack of documentation, review of patient logs, patient reports, change of ownership documents and interview with the laboratory director, the laboratory failed to document the quality of the Hematoxylin and Eosin (H&E) stain for each batch of slides since April 14, 2017. The laboratory reported reading 1,383 H & E slides April 14, 2017- December 31, 2017. Findings are: Repeat deficiency from survey on 2/17 /2016. 1. Review of the electronic pathology log and associated patient medical records revealed that there was no documentation of stain quality either in the pathology log or in each patient test report. 2. Review of the laboratory's quality assurance records revealed no documentation of stain quality assessment or special stain quality control from the H & E processing laboratory. 3. According to the change of ownership documentation, the laboratory underwent a change of ownership effective April 14 2017. During interview on 1/08/2018 at 4:00 pm, the laboratory director stated he had been documenting the stain quality on each patient report since the last survey on 2/17/2016 until the implementation of a new electronic medical record system (EMR) by the new owner. He further stated the new EMR did not allow him to enter this information into each patient report. The laboratory director confirmed that he did not document the stain quality elsewhere in the laboratory. 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 --