Abstract
The concept of formal quality assessment (QA) or “peer review” in animal toxicity testing began within the National Cancer Institute in the late 1970s. Although there is not a QA requirement in the U.S. regulatory agencies, QA has become widespread within government and private industry. The importance of QA in assuring the accuracy of pathology data has been well documented. Additional benefits of QA are the promotion of standardized nomenclature, and provision of continuing education for the pathologists involved. QA may be used to review a single target organ and/or lesion, or to review an entire study. If a study is particularly complex, or if discrepancies cannot be resolved, then a panel review or Pathology Working Group (PWG) can be convened. The PWG, under the guidance of a chairperson, examines slides “blindly” and records a consensus opinion. In both the QA review and in the PWG, a written report summarizes the findings of each review. Although there may be many sources of disagreement between pathologists, it should be emphasized that QA is not a pathology audit or a process for determining the competency of a pathologist.
