Stamm D
Z Lebensm Unters Forsch. 1986 May;182(5):372-84. doi: 10.1007/BF01844233.
The introduction of statistical quality control of clinical chemical analyses has not only provided documentation of the reliability of analytical results and led to improvements in reliability, it has also led to marked improvements in the methods, reagents, calibration materials, control specimens and equipment used. Beyond this, the availability of reliable analytical results has enabled further development of the theoretical concepts underlying thought and action in clinical chemistry. The present paper provides an overview of developments in quality control in the Federal Republic of Germany since 1964. The uniform basic program for quality control with control specimens, as set forth in the Guidelines of the Medical Society of West Germany and required in all states of the country since 1971, is described and our experience with it discussed. Internal quality control consists of separate precision control and accuracy control procedures. External quality control in the form of short-term interlaboratory surveys with control specimens provides an objective check on accuracy. The assigned values for the required accuracy control specimens are determined under routine conditions in particularly well-equipped and well-staffed laboratories headed by particularly highly qualified individuals. The laboratories are independent of the manufacturers of control specimens, calibration materials, reagents and equipment. Over the years, the assigned value determinations have also provided valuable information about the structure of the data and about the reliability criteria for the analytical results. Based on the experience gained with this system, a new concept for quality control was developed in which the method-dependent assigned values are replaced by method-independent reference method values. The requirements for quality control, i.e., the maximum acceptable imprecision and the maximum acceptable deviation of the analytical results from the reference method value or the assigned value, are specified after consideration of the clinical requirements, that is, their effects on medical decision-making.
临床化学分析中统计质量控制的引入，不仅提供了分析结果可靠性的文件记录并提高了可靠性，还显著改进了所使用的方法、试剂、校准材料、控制标本和设备。除此之外，可靠分析结果的可得性推动了临床化学中思想和行动所依据的理论概念的进一步发展。本文概述了自1964年以来德意志联邦共和国质量控制的发展情况。描述了西德医学协会指南中规定并自1971年起该国所有州都要求的使用控制标本的统一质量控制基本程序，并讨论了我们在此方面的经验。内部质量控制包括单独的精密度控制和准确度控制程序。以控制标本进行短期实验室间调查形式的外部质量控制对准确度进行客观检验。所需准确度控制标本的赋值是在由特别高素质人员领导的设备特别精良、人员配备充足的实验室的常规条件下确定的。这些实验室独立于控制标本、校准材料、试剂和设备的制造商。多年来，赋值测定还提供了有关数据结构和分析结果可靠性标准的宝贵信息。基于该系统获得的经验，开发了一种新的质量控制概念，其中依赖方法的赋值被独立于方法的参考方法值所取代。在考虑临床要求，即它们对医疗决策的影响后，规定了质量控制要求，即分析结果相对于参考方法值或赋值的最大可接受不精密度和最大可接受偏差。
