Epiphany Dermatology Of New Mexico, Llc

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on December 19, 2024, 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. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the Laboratory: Quality Assessment Plan, quality control logs, and interview with the manager, the laboratory failed to follow its own policy for the frequency of monitoring the room temperature and humidity in the laboratory in 2024 Finding included: 1. A review of the Laboratory: Quality Assessment Plan under, Environment, Instruments, Reagents, Materials, and Supplies stated, "The testing environment (room temperature, humidity) must be monitored each day to ensure that it meets Epiphany Dermatology or the manufacturer's stricter specifications." 2. A review of the quality control logs from 2024 revealed the laboratory failed to record room temperature and humidity on non-Mohs (micrographic surgery) testing days. 3. In an interview on 12/19/2024 at 11:30 am with the manager they stated, room temperature and humidity is only being documented on the quality control logs and currently only on days of Mohs testing", confirming the above findings. 4. The laboratory reported performing 600 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 An onsite recertification survey conducted on 11/29/2023, at Epiphany Dermatology of New Mexico LLC found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 review of the laboratory's Annual Test Volume & Proficiency Testing Programs Worksheet, Mycology and Parasitology log, KOH Quiz Score Summation, and confirmed in staff interview, the facility failed to perform twice annual accuracy of Potassium Hydroxide (KOH) Testing for 2 of 5 events from January 2021 through June 2023. Findings included: 1.Record review of the Annual Test Volume & Proficiency Testing Programs Worksheet, showed proficiency testing is completed by laboratory online quizzes and graded for accuracy. 2. Record review of KOH Quiz Score Summation showed no quiz scores for event 3 January through June 2022 and event 4 July through December 2022. The facility asked to provide scores, none were provided. 3. Review of Mycology and Parasitology Log showed the facility performed 5 KOH patient tests in 2022. 4. Interview with Mohs tech on 11/29/2023 at 10:03 am confirmed the findings. 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 --