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 the laboratory's policies and procedures, patient testing records, log sheet, final reports, slides and interviews with the practice manager (PM) and office manager (OM) on February 18, 2026, 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 Dermatopathology and identified two discrepancies: a. Case#24-021 had the patient's last name inconsistent across various records, including the patient log, Mohs map, slides, and patient chart. b. Case#25-112 was incorrectly transcribed on the visit note /final report as Case#25-111, which was assigned to another patient examined on the same day. 2. No