Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 final test result information for Mohs maintained in the Electronic Health Record (EHR) and interview with the facility personnel on June 30, 2026 at 12: 05 PM, the laboratory failed to accurately report Mohs test results in the patient's EHR for one out of three patient records reviewed from February 2025 through June 2026. Findings include: 1. The final test result information for Mohs is manually transcribed by laboratory personnel into the patient's EHR. 2. One out of three Mohs cases reviewed (Patient #1) failed to include the correct test result in the patient's EHR. The Mohs test result information maintained in the EHR stated, "Stage 2: Frozen section analysis showed: residual tumor seen." The documentation on the Mohs map indicated the tumor was cleared at Stage 2. 3. The facility personnel interviewed on 6 /30/26 at 12:05 PM acknowledged the Mohs test result for Patient #1 was incorrectly entered into the EHR by laboratory staff, and confirmed that the Mohs map listed the correct test result. 4. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 853. 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 --