PATHOLOGY SUPPORT FOR THE NTP QUALITY ASSESSMENT

由国家毒理学计划(NTP)开展的病理学同行评审已成为确保啮齿动物生物检测中产生的病理数据有效性的标准手段。NTP在这方面的努力的主要部分包含在病理质量保证合同中。《NTP的病理学支持--质量保证》(QA)。根据本合同，病理材料(幻灯片、图块等)对质量(染色等)进行评估和完整性(幻灯片、块匹配、组织的存在等)。此外，大多数内部研究和在与NTP签约的实验室进行的所有NTP研究的病理诊断都由另一名病理学家核实。目前，病理表是以电子方式接收的，并经过格式化以供质量保证病理学家使用。研究病理学家和QA病理学家之间的所有差异都在QA叙述中突出显示，该叙述与幻灯片一起提交给NTP。这些差异由病理工作小组(PWG)主席评估，他负责挑选有代表性的病例进行PWG审查。QA病理学家和其他专家参与PWG同行审查，其中选定的病例在不知道研究或QA病理学家诊断的情况下进行检查。

Pathology peer review as carried out by the Natioal Toxicology Program (NTP) has become a standard means of assuring the validity of the pathology data generated in the rodent bioassays. A major portion of the NTP effort in this regard is contained in the contract for pathology quality assurance. "Pathology support for the NTP-Quality Assurance" (QA). Under this contract, pathology materials (slides, blocks, etc.) are evaluated for quality (staining, etc.) and integrity (slide, block match, presence of tissues, etc.). Also, the pathology diagnosis for most in- house studies and all NTP studies carried out in the laboratories under contract to the NTP are verified by a second pathologist. Currently, the pathology tables are received electronically and formatted for use by the QA pathologists. All discrepancies between the study pathologist and the QA pathologists are highlighted in a QA narrative which is submitted together with the slides to the NTP. The discrepancies are evaluated by the Pathology Working Group (PWG) chairperson who is responsible for selecting representative cases for PWG review. The QA Pathologist and other Experts participate in the PWG Peer Review where selected cases are examined without knowing either the study or QA Patholgists diagnosis.