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 six (6) randomly selected Mohs patient testing records, Mohs log sheet, final reports, and an interview with the Mohs tech (MT) on November 13, 2025; the laboratory failed to follow established 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. The findings include: 1. Review of Mohs patient log for one (1) out of six (6) records reviewed revealed a discrepancy on the number of slides documented: the Mohs log documentation indicated for patient RM sample processed on 08/27/2024 consisted of four (4) sample slides processed and stained. The MT and laboratory staff located only three (3) slides processed and stained for Mohs during sample review. 2. No