Abstract

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.

摘要

长期以来，人们一直在寻求将患者的结果用作常规临床化学测试的质量控制的要求，这是由于无法获得合适的质量控制材料，成本以及合成材料的基质效应所致。血液学实验室是采用普通技术的较早采用者，主要是因为难以获得合适的，稳定的质量控制材料，而在化学实验室中，合成材料的优势和实用性超过了缺点。但是，临床化学测试量的增加以及计算机系统处理大型和复杂计算的能力现在使基于患者的质量控制算法的使用变得可行。人们越来越意识到通用的质量控制规则和分析频率可能无法检测出临床上显着的检测偏倚，这也推动了使用基于患者的质量控制的愿望。随着实验室寻求在整个地区乃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一个问题。这篇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集成在一起。随着实验室寻求在整个地区乃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一个问题。这篇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集成在一起。随着实验室寻求在整个地区乃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一个问题。这篇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集成在一起。