Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the surveyor's review of patient testing records, log sheet, final reports, and an interview with the supervisor on November 4, 2025; it was determined that the laboratory failed to follow established policies and procedures to ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. The findings include: 1. The surveyor reviewed ten patient records for Histopathology and found the following discrepancies: a. Patient E24-8, examined on 1/2/2024 had a mismatch on the last name in the Mohs log sheet, differing from the electronic chart, slides, and Mohs map documentation. b. Patient J25-781, examined on 7/25/2025, was recorded in the Mohs log as stage III, while the electronic chart, slides, and Mohs map documented it as stage II. 2. No