Coastal Hills Dermatology

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 interview with Laboratory Director (LD), Nine (9) random patient sampling, and review of laboratory's Proficiency Testing (PT) records on March 26, 2025, it was determined that the Laboratory failed to ensure that the accuracy of the Histopathology test was verified at least twice annually for the years 2022, 2023 and 2024. The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery, which is not listed in the subpart I of the 42 CFR part 493. For the test procedure not listed in subpart I the laboratory must verify the accuracy of the test procedure twice annually. 2. On March 26, 2025, at approximately 11:30 a.m., the LD affirmed that the laboratory maintained no documentation to show it verified the accuracy of Histopathology test at least twice annually for 3 of 3 years. 3. The laboratory's testing declaration form, signed by the laboratory director on March 25, 2025, stated that the laboratory had performed 300 histopathology tests annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures manuals, proficiency testing 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 -- records, review of Nine(9) randomly selected patient test results and interview with Laboratory Director (LD) on March 26, 2025, it was determined that the Laboratory director of high complexity testing failed to ensure that the quality assessment programs maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings include: According to the laboratory's written procedures for Quality Assurance Program, the laboratory randomly selects 2 Mohs cases twice annually for peer review by a board-certified dermatologist. on March 26, 2025, at approximately 11:30 am, the LD affirmed that the laboratory maintained no documentation to show it verified the accuracy of Histopathology test at least twice annually for 3 of 3 years. See D5217 -- 2 of 2 --

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 the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 9 /9/2020 between 10 am and 11:30 am, it was determined that the laboratory failed to at least twice annually, document their quality assurance/proficiency testing. Findings include: 1. On 9/9/2020, an inspection was conducted between 10 am and 11:30 am. 2. During a review of the laboratory documentation, it was noted at approximately 10: 45 am that the laboratory failed to document proficiency testing for MOHS Histopathology in 2018 and 2019. The LP recognized that this documentation was missing. 3. An administrative procedure approved by the director did exist indicating that two times per year, 5 MOHS cases would be pulled for a peer review; with results posted to a worksheet for review. This procedure was not followed during 2018 and 2019. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records for evaluation of proficiency testing 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 -- performance for MOHS reporting, and an interview with laboratory personnel (LP) on 9/9/2020, it was determined that the laboratory director failed to ensure that the quality assessment programs were provided and maintained. 1. Activities to assess and monitor quality and accuracy were not performed (see D-5217). -- 2 of 2 --