Summary:
Summary Statement of Deficiencies 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 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 patient test reports (Mohs maps) and interview with the Director of Clinical Development (DCD), the laboratory failed to include the address of the location where Mohs microscopic slide examinations were performed on 6 of 6 patient test reports reviewed from 01/17/2024 to the day of survey. Findings Include: 1. On the day of survey, 12/08/2025 at 12:15 pm, review of 6 of 6 patient test reports (Mohs maps) revealed the laboratory failed to ensure the addition of the address of the laboratory where Mohs microscopic slides were examined from 01/17/2024 to 12/08 /2025. 2. Review of the laboratory's Mohs test logs revealed the laboratory performed 396 Mohs microscopic slide examinations from 01/17/2024 to 12/08/2025. 3. The DCD confirmed the findings above on 12/08/2025 at 12:25 pm. 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 --