Summary:
Summary Statement of Deficiencies D0000 The Westlake Dermatology & Cosmetic Surgery 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 09/11/2025 and recertification is recommended. Standard level deficiency was cited. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the patient visit notes, Mohs map, and slides, the laboratory failed to include a stage in the test report for one of four Mohs test reports reviewed from May 2024 - July 2025. Findings follow. A. Review of four randomly selected Mohs cases from May 2024 - July 2025 showed Mohs case HFW24-58 performed on 10/21 /2024 was missing a Stage in the visit notes which also served as the patient test report. Review of the visit notes for the Mohs Surgery only documented 1 stage. B. Review of the Mohs map showed there were 2 stages. C. Review of the case slides showed a total of four slides labeled for stages I and II. D. Interview with the histotechnologist on September 11, 2025 at 1435 hours in the Mohs lab confirmed the findings. 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 --