Alpine Dermatology Clinic

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. 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 a record review of Mohs bi-annual verification and an interview with the facility administrator on 5/8/2025, the laboratory failed to verify the accuracy of Mohs slide examinations at least twice annually in 2023 and 2024. The findings include: 1. A record review of bi-annual verification identified that the laboratory failed to verify the accuracy of Mohs slide examinations twice in 2023 and once in 2024. 2. An interview with the facility administrator on 5/8/2025 at 10:11 am confirmed that the laboratory did not verify the accuracy of Mohs slide examination twice annually for 2023 and 2024. 3. The laboratory reports performing 200 Mohs slide examinations annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Based on a direct observation and an interview with the facility administrator on 5/8 /2025, the laboratory failed to discontinue the use of expired reagents. The findings include: 1. A direct observation of the laboratory's reagents on 5/8/2025 identified that the laboratory failed to discontinue the use of the following reagents prior to the expiration: Avantik tissue marking dye-green lot 156625 expiration 2024-08-31 Avantik tissue marking dye-green lot 144651 expiration 2024-03-31 Avantik tissue marking dye-green lot 112722 expiration 2022-12-31 Avantik tissue marking dye-red lot 089147 expiration 2021-08-31 Avantik tissue marking dye-red lot 112131 expiration 2022-12-31 Avantik tissue marking dye-red lot 168107 expiration 2025-02- 28 Avantik tissue marking dye-blue lot 087417 expiration 2021-09-30 Avantik tissue marking dye-blue lot 113806 expiration 2022-12-31 Avantik tissue marking dye- yellow lot 111915 expiration 2022-12-31 Avantik tissue marking dye-black lot 112649 expiration 2022-12-31 Delasco 20% KOH w/DMSO lot K163M6 expiration March 2019 INC Wash Buffer lot 20200817 expiration 2022-08-06 2. An interview with the facility administrator on 5/8/2025 at 9:34 am confirmed the above finding. 3. The laboratory reports performing 300 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a direct observation and an interview with the laboratory lead on 5/15/2023, the laboratory failed to discontinue the use of expired potassium hydroxide (KOH) with DMSO. The findings include: 1. During the laboratory tour on 5/15/2023 a direct observation identified that the laboratory failed to discontinue the use of expired 20% KOH with DMSO used in KOH slide examinations. Delasco 20% KOH with DMSO lot K20354 expiration 3-31-2023 Delasco 20% KOH with DMSO lot K163M6 expiration 3-31-2019 2. An interview with the laboratory lead on 5/15/2022 at 2:37 pm confirmed the above findings. 3. The laboratory reports performing 100 KOH slide examinations annually. 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 a review of the laboratory quality control (QC) log, Mohs log and an 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 -- interview with the laboratory lead on 5/15/2023, the laboratory failed to have document the quality of Hematoxylin and Eosin (H&E) stain daily. The findings include: 1. A review of the laboratory's H&E QC log identified that the laboratory failed to have a qualified testing person review and document the quality of the H&E stain daily for Mohs surgery procedures for 13 of 13 documented testing days in 2023. 2. A review of the laboratory's H&E QC log and Mohs log identified that the laboratory failed to document the quality of the H&E stain for Mohs surgery procedures for two (2) testing days, 1/18/2023 and 2/8/2023. 3. An interview with the laboratory lead on 5/15/2023 at 2:11 pm confirmed the above findings. 4. The laboratory reports performing 200 Mohs surgery procedures annually -- 2 of 2 --