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: A. Based on review of laboratory records and interview with the Mohs Technician, the laboratory failed to ensure two out of ten patient test reports for Mohs testing was accurately transcribed into the electronic medical record. Findings Include: 1. Review of two of ten patient test reports for Mohs testing found the laboratory failed to include the Accession number for the histopathology slides in the laboratory's test report for patient six (P6), MRN: MM0000046579 and patient ten (P10), MRN: 5429M27472. 2. On survey date 03-20-2023, at 11:13 am, the Mohs Technician confirmed the patient test reports for Mohs were missing the Accession numbers. B. Based on review of laboratory records and interview with the Mohs Technician, the laboratory failed to ensure three out of three patient test reports for frozen pathology testing was accurately transcribed into the electronic medical record. Findings Include: 1. Review of frozen pathology testing found: a. Two of three patient test reports found the laboratory failed to include the Accession number for the frozen pathology slides in the laboratory's test report for patient twelve (P12), MRN: 5429M7367 and patient thirteen (P13), MRN: MM0000093881. b. One out of three patient test report for frozen pathology testing found the laboratory failed to include the correct Frozen Section Diagnosis for patient eleven (P11), MRN: 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 -- MM0000000730. The test report for P11 reports Neoplasm of Uncertain Behavior-left superior helix for the Frozen Section Diagnosis, but should state Basal Cell Carcinoma. 2. On survey date 03-20-2023, at 11:13 am, the Mohs Technician confirmed the patient test reports for frozen pathology were missing the Accession numbers and one had the incorrect diagnosis. -- 2 of 2 --