Clinical Laboratory Reports in Molecular Pathology (Cap Laboratory Improvement Program)
The physician who orders a molecular test expects the laboratory report to state what test was done and the result that was obtained. Many clinicians find it helpful if the report further describes what the result means for their patient based on analytic and clinical performance characteristics of the test in correlation with the clinical setting in which the test was done. (1-3) This is true regardless of whether the report is a stand-alone molecular pathology report or part of a larger surgical pathology or hematopathology report in which molecular data is integrated with histologic examination and other tests done on the same specimen. (4,5) The College of American Pathologists (CAP) has developed recommendations for composing laboratory reports. Many of these recommendations are outlined in the checklists that are used by inspectors to evaluate compliance as part of the laboratory accreditation process. The Laboratory General checklist summarizes guidelines that are common to every laboratory report, whereas the subspecialty checklists such as those for molecular pathology, microbiology, cytogenetics, anatomic pathology, and human leukocyte antigen (HLA) contain additional elements specific to the molecular testing done in specialized areas of the clinical laboratory. These checklists may be downloaded from the CAP Web site (www.cap.org). Some report components are federal requirements for tests performed in the United States, whereas others are recommendations or requirements for accreditation by the CAP. In this article, current reporting guidelines are summarized and additional recommendations are made to improve content and format of clinical laboratory reports.