Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the Mohs surgery patient log, patient specimen slides, Mohs maps, and test reports, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 02/22/2023, the laboratory failed to have a system in place to ensure the accuracy and reliability of Mohs surgery findings/results manually transcribed into patient electronic health records (EHR) for one out of three patients (Patient identifier A) reviewed from January 2023. The findings include: 1. Patient identifier A had Mohs surgery performed on 01/05/2023. 2. Review of the Mohs surgery patient log, patient specimen slides, and Mohs map for patient identifier A all showed the surgeon performed Mohs surgery in two stages. 3. The test report for patient identifier A listed one stage for Mohs surgery performed on 01/05/2023. Furthermore, documentation of stage one of the surgery did not include the findings of the slide review. 4. At the time of the survey, personnel identifier #1 confirmed that the test report for Mohs surgery performed on 01/05/2023 for patient identifier A should have included two stages total and the findings from the first stage of the surgery. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --