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 an interview with the supervisor, 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 14, 2023, to July 12, 2025. One out of five records contained discrepancies in the following: a. Patient MRN# MM3283 was scheduled for Mohs surgery on January 15, 2024 under case# 24-010, as indicated on the patient log sheet. However, the final report documented in the elctronic medical record (EMR) was listed as case#24-011. Additionally, the patient's name was recorded differently on the patient log compared to the EMR, slides, and Mohs map. 2. The laboratory's protocol involved daily check of patient information recorded across all documentation. However, MM3283 was missed to be corrected upon its occurence. No documentation for