Epiphany Dermatology Of Montana, Llc

Summary Statement of Deficiencies 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. (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 an interview with the site manager (not listed on the CMS- 209 (Laboratory Personnel Report) Form), the laboratory failed to either perform a quality control (QC) slide of known reactivity with each day of Hematoxylin and Eosin (H&E) staining of patient slides or document the reactions of the control slide for twelve out of twelve days of testing from August 4, 2023, to January 5, 2024. Findings: 1. A review of Mohs patient logs and QC logs revealed a QC slide was not performed on the following dates of service: 8/4/23, 9/15/23, 10/13/23, 10/30/23, 11/6 /23, and 1/5/24. 2. A review of QC logs revealed Mohs testing personnel failed to document the reactions of the control slide for H&E staining on 8/7/23, 8/14/23, 8/28 /23, 9/18/23, 11/13/23, and 12/18/23. 3. An interview with the site manager (not listed on the CMS-209 Form) on August 13, 2024, at 3:15 PM confirmed the laboratory failed to either perform a QC slide of known reactivity with each day of H&E staining of patient slides or document the reactions of the control slide from August 4, 2023, to January 5, 2024. 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 D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of procedures, patient records and slides, and interview with medical assistant (MA) #1, (not listed on the CMS-209 Laboratory Personnel Report), the laboratory failed to follow written procedures to assess, and correct problems identified for five out of five patients' Micrographic Surgery-Operative Map and Pathology Reports and for 37 out of 37 patients entered into the Mohs Surgery Log Sheet as part of the preanalytic systems from January 1, 2021 to November 16, 2022. Findings: 1. A review of Mohs Surgery and Frozen Section Analysis, Quality Assessment, Test Records procedure revealed the laboratory failed follow their procedures as stated, "2. Results reports in the form of Mohs maps or Frozen Section forms will include the following information: Patient name; Unique identifier (date of birth and Mohs surgery or Frozen Section accession number), Tests name, Date of specimen collection; Test results and interpretation (diagnosis); Date and time reported; Units of measure and Suggested course of action." 3. A review of patient Micrographic Surgery-Operative Map and Pathology Report (Mohs map) revealed the laboratory failed to document the date of birth (DOB) for MT22-208, MT22-215, MT22-303 and MT22-245; and failed to provide the correct diagnosis description for MT22-244. 4. A review of the Mohs Surgery Log Sheet revealed the laboratory failed to provide information for either DOB, Site description and/or Diagnosis for MT21- 55, MT22-001 - 017, MT22-018 - 029, MT22-42, MT22-208, MT22-215, MT22-245, MT22-294, MT22-303; and documented the information incorrectly for MT22-336 and MT22-244. 5. The Micrographic Surgery-Operative Map and Pathology Report's template lacks a place to record time reported and the laboratory failed to record the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- time surgery started and finished. 6. No documentation of