Favaloro Emmanuel J
Department of Haematology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, New South Wales, Australia.
Semin Thromb Hemost. 2007 Apr;33(3):290-7. doi: 10.1055/s-2007-971816.
There are many benefits to the overall process of standardization for tests of hemostasis and thrombosis. Nevertheless, it should also be recognized there are several specific problems and limitations to this process, as highlighted in this review. Some of the issues are formidable, but it is hoped that they are not insurmountable. Sometimes, clinical pressures drive diagnostic test processes before they are formally proven to be of clinical value. Such clinical pressures drive diagnostic changes in the hemostasis laboratory, including the incorporation of new and emerging technologies, which in turn drives the need for evolving and effective external quality assurance. Incorporated into the diagnostic or test-performance process are a large number of organizations involved in driving standardization, with the ultimate intention of improving diagnostics, but this process will also have unintended potential for adverse outcomes. Although this review notes many of the benefits to the process, it focuses primarily on those negative factors that are often less obvious but still require attention and process review.
止血和血栓形成检测的标准化整体过程有诸多益处。然而，如本综述所强调的，也应认识到这一过程存在若干具体问题和局限性。其中一些问题颇为棘手，但希望并非无法克服。有时，临床压力会在诊断测试过程尚未正式证明具有临床价值之前就推动其发展。这种临床压力促使止血实验室的诊断发生变化，包括采用新出现的技术，这进而推动了对不断发展且有效的外部质量保证的需求。参与推动标准化的大量组织被纳入诊断或测试执行过程，其最终目的是改善诊断，但这一过程也可能产生意想不到的不良后果。尽管本综述指出了该过程的诸多益处，但主要关注的是那些往往不太明显但仍需关注和过程审查的负面因素。
