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 policy /procedure, five Dermatopathology patient records, and interviews with the administrator and manager, it was determined that the laboratory failed to correctly document patient information upon its occurrence. The findings include: 1. The surveyor reviewed five Dermatopathology patient records dated from October 19, 2022, to April 22, 2025. Three out of five records contained discrepancies in the following: a. Patient M22-078, examined on October 19, 2022, recorded site at right temple on the patient log sheet, actual patient photos, and slides. However, final notes reviewed in the electronic medical record (EMR) documented right forehead. b. Patient M23-014, serviced on February 27, 2023, the patient log sheet noted examination up to stage II, whereas the EMR and Mohs map only reflected documentation up to stage I, despite slides showing information up to stage III. c. Patient M24-014, scheduled last March 4, 2024, recorded site at left proximal dorsal middle finger on the patient log sheet, Mohs map, and EMR. However, the slides omitted the anatomical distinction. 2. The laboratory's protocol involved daily checks of patient information recorded across all documentation. However, the discrepancies mentioned in statement #1 had no documentation of