Department of Laboratory Medicine and Center of Biomedical Research, University Hospital of Padova, Padova, Italy.
Clin Chem Lab Med. 2011 May;49(5):835-44. doi: 10.1515/CCLM.2011.128. Epub 2011 Feb 23.
The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required.
In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs.
The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.
质量指标（QIs）的采用促使人们开发了测量和评估实验室检测质量和效果的工具，最初是在医院环境中，随后在门诊和其他护理环境中。虽然检验医学在提供高质量护理方面发挥着重要作用，但目前尚未就专注于实验室总检测过程（TTP）所有步骤的 QIs 使用达成共识，因此需要在这一领域开展进一步研究。
为了减少实验室检测中的错误，国际临床化学联合会（IFCC）“实验室误差与患者安全”工作组（WG-LEPS）开发了一系列专门针对临床实验室的质量指标。在项目的第一阶段，确定了 TTP 关键流程的特定 QIs，包括所有分析前、分析中和分析后步骤。该项目的总体目标是基于标准化数据收集，为临床实验室创建一个通用报告系统，并为每个 QI 定义最先进的质量规范（QS），而不受以下因素的影响：a）组织规模和活动类型；b）开展的流程复杂性；以及 c）员工不同程度的知识和能力。本文旨在报告 2008 年 2 月至 2009 年 12 月期间参加实验室收集的数据结果，并确定初步的 QS。
结果表明，作为一种外部质量保证计划管理的质量指标模型可作为一种工具，用于监测和控制分析前、分析中和分析后活动。它还可以使临床实验室识别导致患者伤害的错误风险：识别和设计消除医疗错误的实践；共享信息和对临床及实验室团队进行减少或预防错误的实践教育；监测和评估改进活动。
