RCPA Quality Assurance Programs, St Leonards, Australia.
Institut für Klinische Chemie und Pathobiochemie Klinikum, Münich, Germany.
Crit Rev Clin Lab Sci. 2020 Dec;57(8):532-547. doi: 10.1080/10408363.2020.1765731. Epub 2020 Jun 2.
The quest to use patient results as quality control for routine clinical chemistry testing has long been driven by issues of the unavailability and cost of suitable quality control material and the matrix effects of synthetic material. Hematology laboratories were early adopters of average of normals techniques, primarily because of the difficulty in acquiring appropriate, stable quality control material, while in the chemistry laboratories, the perceived advantages and availability of synthetic material outweighed the disadvantages. However, the increasing volume of testing in clinical chemistry plus the capability of computer systems to deal with large and complex calculations has now made the use of patient-based quality control algorithms feasible. The desire to use patient-based quality control is also driven by increasing awareness that common quality control rules and frequency of analysis may fail to detect clinically significant assay biases. The non-commutability of quality control material has also become a problem as laboratories seek to harmonize results across regions and indeed globally. This review describes the history of patient-based quality control in clinical chemistry, summarizes the various approaches that can be implemented by laboratory professionals, and discusses how patient-based quality control can be integrated with traditional quality control techniques.
长期以来，人们一直致力于将患者的检测结果用作常规临床化学检验的质量控制手段，这主要是因为合适的质量控制材料无法获得且成本高昂，以及合成材料的基质效应。血液学实验室是常规平均值技术的早期采用者，主要是因为难以获得合适、稳定的质量控制材料，而在化学实验室中，人们认为合成材料的优势和可用性超过了其缺点。然而，临床化学检测量的不断增加，加上计算机系统处理大量复杂计算的能力，现在使得使用基于患者的质量控制算法成为可能。使用基于患者的质量控制算法的愿望还源于人们日益认识到，常见的质量控制规则和分析频率可能无法检测到临床上有意义的检测偏差。由于实验室试图在区域内甚至全球范围内协调结果，质量控制材料的不可互换性也成为了一个问题。本综述描述了临床化学中基于患者的质量控制的历史，总结了实验室专业人员可以实施的各种方法，并讨论了如何将基于患者的质量控制与传统质量控制技术相结合。
