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 policy and procedure manual, patient test results maintained in the Electronic Health Record (EHR) and interview with the facility personnel, the laboratory failed to follow the established policy and procedure to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (entered manually) to final report destination, in a timely manner. Findings include: 1. Patient-specific data and the final test result information for Mohs and Frozen Biopsy testing is manually transcribed by laboratory personnel into the patient's EHR. 2. The "Quality Assessment" procedure reviewed during the survey states: "A properly trained Mohs tech will perform the reviews for pre-analytic, analytic, and post-analytic chart reviews." 3. No documentation was presented for review during the survey conducted on 6/6/25 to indicate the laboratory had followed the established policy and procedure referenced above during 2024. 4. The testing personnel interviewed on 6/6/25 at 10:30 AM confirmed the laboratory failed to follow the established policy and procedure to verify the accuracy of patient-specific data and patient test results that are manually entered into the EMR during 2024. 5. The laboratory performs testing under the specialty of Histopathology with a reported annual test volume of 900. 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 --