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 randomly selected patient records, review of the laboratory's quality assurance plan (QA), and staff interview, the laboratory failed to have an adequate system in place to ensure the accuracy of final patient test reports resulting in an incorrect site location listed on the MOHS procedure final test report for 1 of 4 patient reports reviewed in 2023. The findings include: 1. Review of the laboratory's surgical pathology report, MOHS Patient Tracking log, and final patient test report for the MOHS procedure on case number 230-001 (A2050405), reported on 01/24/23, revealed the following: a) Surgical Pathology Report listed both "Left Superior Posterior Helix" and "Left Inferior Posterior Helix" as biopsy locations. The "Left Inferior Posterior Helix" biopsy location was indicated for the MOHS surgical procedure. b) MOHS patient tracking log lists location for MOHS procedure as "L. Inferior Post. Helix" c) Final patient test report for the MOHS surgical procedure lists the location as "left superior posterior helix" 2. Review of the laboratory's QA plan revealed the plan did not include evaluation of final patient test reports for accuracy. 3. Interview on 7/25/23 at 12 p.m. with the laboratory director and quality manager Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- confirmed the laboratory failed to review accuracy of final patient test reports and the MOHS surgical location referenced on the final patient test report for case number 230-001 was incorrect. -- 2 of 2 --