Clear Creek Dermatology Marble Falls

Summary Statement of Deficiencies D0000 The Clear Creek Dermatology- Marble Falls laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on 09/10/2025 and recertification is recommended. Standard level deficiencies were cited. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. Preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of slide retention and interview, the laboratory failed to retain slides from its Mohs cases for at least 10 years for one out of seven cases reviewed from June 2024 - August 2025. Findings follow. A. Review of retention of slides for the frozen section biopsy case number FB24-06 performed on 11/04/2024 was missing the frozen section biopsy slide. B. Interview with the Office Manager on September 10, 2025 at 1135 hours confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) (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 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 -- 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 Mohs test report and interview, the laboratory failed to include the correct address of the facility on the Mohs map for one of five cases reviewed from June 2024 - August 2025. Findings follow. A. Review of the Mohs maps showed an incorrect address of the facility where the testing was performed as listed by case number and date of service: M25-352 08/04/2025. B. Interview with the Office Manager on September 10, 2025 at 1140 hours confirmed the findings. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, pre-survey paperwork, laboratory records, and interview, the technical supervisor failed to evaluate the competency at least semi-annually during the first year the individual tested patient specimens for one of one testing personnel that performed Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance Manual (no origination/approval date), stated, "It is the policy of this laboratory that all personnel implicitly adhere to the policies and procedures as published by this laboratory. The laboraory director or techncial supervisor can perform competency assessments. Personnel assessment of competency is required semiannually for the first year and annually thereafter." And, under Personnel Assessment stated, "If the laboratory has employees, the Laboratory Director will use personal observation to perform an ongoing evaluation of all employees of the laboratory to ensure competency in job performance." B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #1 (as listed on the CMS form 209), began Mohs testing on 10/16/2023. C. Review of the laboratory records showed one semi-annual competency evaluation was performed 05/25/2024. A second semi- annual competency evaluation was requested on 09/10/2025 at 1005 hours but not provided. D. Interview with the Office Manager on September 10, 2025 at 1005 hours confirmed the findings. -- 2 of 2 --

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 Mohs test report and interview, the laboratory failed to include the name and address of the facility on the Mohs map for eight of eight cases for a period of five months reviewed. Findings follow. A. Review of the Mohs maps showed no name and address of the facility where the testing was performed. The following reports were reviewed as listed by case number and date of service: 1. 09/18 /2023 M23-026 2. 10/02/2023 M23-058 3. 10/23/2023 M23-091 4. 11/14/2023 M23- 144 5. 01/08/2024 M24-010 6. 01/29/2024 M24-039 7. 02/12/2024 M24-075 8. 03/04 /2024 M24-113 B. Interview with the histotechnologist on March 21, 2024 at 1040 hours acknowledged she had removed the name and address on the Mohs maps when they added facility locations for ease of document revisions. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, pre-survey paperwork, laboratory records, and interview, the technical supervisor failed to evaluate the competency at least semi-annually during the first year the individual tested patient specimens for one of one new hires that performed Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance Manual (no origination/approval date), stated, "It is the policy of this laboratory that all personnel implicitly adhere to the policies and procedures as published by this laboratory. Personnel assessment of competency is required semiannually for the first year and annually thereafter." And, under Personnel Assessment stated, "If the laboratory has employees, the Laboratory Director will use personal observation to perform an ongoing evaluation of all employees of the laboratory to ensure competency in job performance." B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #2 (as listed on the CMS form 209), began Mohs testing on 8 /22/2023 (elapsed time: 7 months). C. Review of the laboratory records showed no semi-annual competency evaluation performed. A competency evaluation was requested on 3/21/2024 at 1040 hours but not provided. D. Interview with the histotechnologist on March 21, 2024 at 1040 hours confirmed they had not performed a competency evaluation. -- 2 of 2 --