Dermatology Center Of Steamboat Springs

Summary Statement of Deficiencies 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 records review and an interview with the Lead Mohs Nurse (not included on CMS-209 form), the laboratory failed in 2022 and 2023 to perform twice annual verification testing for: Mohs histopathology slide interpretation, and Potassium Hydroxide (KOH) preparations. The laboratory performs approximately 2,500 Mohs histopathology procedures, and approximately 10 KOH preparations per year. Findings include: 1. Records review revealed that the laboratory failed to perform twice annual accuracy verification for Mohs histopathology slide interpretation, and Potassium Hydroxide (KOH) preparations for years 2022 and 2023. 2. An interview with the Lead Mohs Nurse (not included on CMS-209 form) at approximately 10:00 AM on April 5, 2024, confirmed that the laboratory failed to perform twice annual accuracy verification for Mohs histopathology slide interpretation, and Potassium Hydroxide (KOH) preparations for years 2022 and 2023. 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 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 quality control records and staff confirmation, the laboratory failed to document the quality of the hematoxylin and eosin stain on biopsy slides for intended reactivity each day of use in 2018 and 2019 and approximately 3000 histopathology slides stained 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 --