Sanova Dermatology-Bee Cave

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were 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: I. Based on review of laboratory policy and procedure, accuracy assessments, pre- survey paperwork, and interview, the laboratory failed to perform twice per year accuracy assessments for Mohs in 2023 for one of three events reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency Testing for Mohs Micrographic Surgery, approved 10/10/2024, under Procedure For Mohs stated, "Three random cases will be chosen, at least biannually..." B. Review of accuracy assessments from 2023 and 2024 showed one accuracy assessment in 2023. Additional accuracy assessments were requested on May 9, 2025 at 1050 hours but not provided. C. Review of the pre-survey paperwork showed approximately 400 Mohs blocks were performed per year. D. Interview with the histotechnologist on May 9, 2025 at 1050 hours in the breakroom confirmed they were missing an accuracy assessment in 2023. II. Based on review of laboratory policy and procedure, accuracy assessments, pre-survey paperwork, and interview, the laboratory failed to verify the accuracy of its KOH (potassium hydroxide) for fungal elements at least twice annually for KOH in 2023 for one of four events reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency Testing Standards for PPM, approved 10/10/2024, under Procedure atated, "1. Proficiency Testing by Physician Review a. Slides are chosen at random for biannual review. b. The physician reviews the slides and indicates the result on the PPM Test Log. c. A Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- separate physician will also review the slides and indicate if they agree or disagree with the initial result. This is indicated on the PPM Test Log. d. Any

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient testing log, patient test report, and interview, the laboratory failed to ensure the correct result was reported for KOH (potassium hydroxide) test for fungal elements for 1 of 3 test reports reviewed from Oct 2022 - March 2023. Findings follow. Review of the patient testing log from 10/12/22 - 03/17 /23 against the patient test report showed 1 of 3 with the incorrect result. Review of the KOH log showed patient tested on 03/17/2023, MRN TK4GOytgNr2B, was reported as negative. Review of the patient's chart on 03/17/2023 showed the KOH was reported as branching hyphae. Interview with the Mohs technologist by phone on March 24, 2023, at 1610 hours confirmed the result was negative and incorrectly reported as positive in the chart by a medical assistant. 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 --