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, eight patient testing records from April 27, 2023 to August 14, 2026, log sheet, final reports, slides, Mohs map, and interviews with the regional manager and practice manager on September 17, 2026, the laboratory failed to follow their 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 eight patient records for Dermatopathology from April 27, 2023 through August 14, 2026, three discrepancies in the documented specimen site or location: a. Mohs case Z23-339, examined on November 30, 2023, was documented in the patient log and Mohs map as right nasal ala, while the final report documented right nasal sidewall. b. Mohs case Z25-008, examined on January 23, 2025, was documented in the patient log as left cheek, while the Mohs map and final report documented left central malar cheek. c. Mohs case Z26-005, examined on February 5, 2026, was documented in the patient log and slides as left pretibia, while the Mohs map and final report documented left distal pretibial region. 2. The regional manager and practice manager confirmed during interviews on September 17, 2026, at approximately 12:55 p.m., that records were discrepant and that a