Hyltoft Petersen P, Hørder M, Blaabjerg O, Jørgensen P J
Scand J Clin Lab Invest Suppl. 1984;172:65-9.
Quality assurance in clinical chemistry is based on statistical control procedures designed to maintain a certain level of quality. Decisions about acceptance or rejection of analytical series are made primarily from measurements of quality control materials. Such materials are most often of non-human origin; this may lead to false decisions due to non-identity of patient samples and quality control material. We have investigated the significance of non-identity between patient and control materials by running two separate quality control systems in parallel. A regular system used for acceptance or rejection of series, and a parallel system used for registration of the actual quality of the analytical routine work. The results from the latter system have not been available for the operator handling the control system used in routine work. Our study has confirmed the validity of an internal quality control system to achieve a certain level of analytical stability as expressed by the short-term and long-term precision. However, because ideal control materials are not always available, additional procedures to control accuracy, specificity, and detectability may be necessary. The usefulness of such procedures to properly handle error signals from quality control systems has been demonstrated.
临床化学中的质量保证基于旨在维持一定质量水平的统计控制程序。关于分析批次的接受或拒绝的决策主要基于质量控制材料的测量结果。此类材料大多并非源自人体；这可能因患者样本与质量控制材料不一致而导致错误决策。我们通过并行运行两个独立的质量控制系统，研究了患者材料与对照材料不一致的影响。一个常规系统用于批次的接受或拒绝，另一个并行系统用于记录分析日常工作的实际质量。后一个系统的结果对于处理日常工作中使用的控制系统的操作人员不可用。我们的研究证实了内部质量控制系统对于实现一定水平的分析稳定性（以短期和长期精密度表示）的有效性。然而，由于理想的控制材料并非总是可得，可能需要额外的程序来控制准确性、特异性和可检测性。此类程序对于正确处理来自质量控制系统的错误信号的有用性已得到证明。
