Summary:
Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality assessment (QA) policy and procedure, seven randomly chosen patient test records from 2024 to 2026, and interviews with the histology technician (HT) and laboratory director (LD) on April 2, 2026, it was determined that the laboratory failed to address errors in patient records prior to finalizing reports. The findings include: 1. The surveyor reviewed seven randomly selected patient test records for Dermatopathology dated from March 18, 2024 to March 18, 2026, two out of seven had a mismatch of patient information from several documentation checked such as the patient log, electronic chart notes, Mohs map, and slides. a. Patient MM06, evaluated on March 18, 2024, was recorded in the patient log, Mohs map, and slides as Stage III but was reported as Stage IV. b. Patient MM8615, examined on November 18, 2025, was documented in the patient log, Mohs map, and slides as Stage II but was reported as Stage III. 2. There was a lack of