Quality assurance in the laboratory diagnosis of prostate cancer

Quality assurance in anatomic and clinical pathology plays a critical role in the management of patients with prostate cancer, integrating quality development, quality maintenance, and quality improvement to ensure valid test results. This report describes the current efforts to ensure and improve quality in the pathology laboratory as it relates to prostate cancer. Recent advances have been made by many regulatory groups to improve the quality of laboratory diagnosis in prostate cancer and other cancers. Advances include publication of practice protocols for prostate specimen handling and results reporting, comparative interlaboratory proficiency testing, and consensus on grading and diagnostic criteria. Despite these advances, numerous unsettled issues remain, including observer variability in pathologic staging and grading, lack of agreement on terminology, and interlaboratory reproducibility of assays, such as serum prostate specific antigen (PSA) determination. Current efforts in quality assurance in anatomic and clinical pathology are expected to improve the accuracy and validity of pathologic diagnosis, grading, staging, prediction of outcome in prostate cancer, and serum PSA assays. Cancer 1995;75:1994–9.