Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory records, patient test reports, and interview with the laboratory representative; the laboratory failed to ensure the positive identification of a patient specimen for one of six Mohs histopathology surgical specimens reviewed between the specimen tracking log, the surgical map, and the final patient test report. Findings include: 1. Review of laboratory records revealed the Mohs logbook, which stated, for patient 25-322 (tested on 10/13/2025), under "Site", "Pretibial region, [Right] distal". 2. Review of laboratory records revealed Mohs histopathology surgical map document for patient 25-322, which indicated the location of Mohs surgical testing site as "Pretibial region, right Distal". 3. Review of the patient test report for patient 25-322, from 10/13/2025, revealed, under "Impression/Plan:", "Location: right lateral proximal pretibial region". 4. Interview with the laboratory representative on 01/27/2026, at 12:01 pm, confirmed the laboratory failed to ensure the positive identification of a patient specimen for one of six Mohs histopathology surgical specimens reviewed between the specimen tracking log, the surgical map, and the final patient test report. 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 --