Kirchner Maria Jesus Alsina, Funes Virtudes Alvarez, Adzet Carme Biosca, Clar Maria Vicenta Doménech, Escuer Mercè Ibarz, Girona Joana Minchinela, Barellas Rosa Maria Pastor, Alsina Carmen Perich, Aguilá Carmen Ricós, Isern Gloria Trujillo, Navarro Conrad Vilanova
Laboratori Clínic Barcelonès Nord i Vallès Oriental, Badalona, Spain.
Clin Chem Lab Med. 2007;45(5):672-7. doi: 10.1515/CCLM.2007.122.
The aim of this study was to identify process indicators for the three phases of laboratory activity and their corresponding quality specifications in our setting (primary care centers, and second- and third-level hospitals that provide public healthcare services in Catalonia).
Every 2 months, working group members met to present data obtained for quality indicators for the current processes in their laboratories. The results collected were for indicators recorded monthly from 2005 and for indicators recorded less frequently from 2004. The medians of the results obtained in all laboratories were calculated and the values obtained were established as the current specifications for the corresponding indicators.
The laboratories participating in this working group use 12 indicators for the key processes (three for preanalytical steps, four for analytical steps and five for postanalytical steps). The preanalytical indicators are erroneous request, erroneous sample, and samples not taken, with specifications of 4.1%, 5.0% and 1.7%, respectively. A new indicator for the analytical step is the percentage of external controls exceeding the specification (0.8%); specifications for the other three well-recognized indicators (imprecision, bias and total error) are not the subject of this study. For the postanalytical phase, the indicators (and specifications) include duplicate hard copies of reports sent to centers or clinical units (1.6%), failure in critical value reporting (0.5%), reports exceeding delivery time (0.7%), reports from referred tests that exceed delivery time (8.9%), and incidents related to the data processing network between centers (25 events per year).
The process indicators reflect the state-of-the-art of the laboratories comprising our working group. Current performance for the analytical phase is satisfactory because it is entirely in the hands of the laboratory, while the main problems in extra-analytical phases reside in activities performed outside the laboratory (sample collection and transport, as well as non-electronic report delivery).
本研究的目的是确定实验室活动三个阶段的过程指标及其在我们所处环境（加泰罗尼亚提供公共医疗服务的基层医疗中心以及二级和三级医院）中的相应质量规范。
每两个月，工作组成员会面，汇报各自实验室当前流程质量指标所获取的数据。收集的结果包括2005年起每月记录的指标以及2004年记录频率较低的指标。计算所有实验室所得结果的中位数，并将所得值确定为相应指标的当前规范。
参与该工作组的实验室在关键流程中使用12项指标（分析前步骤3项、分析步骤4项、分析后步骤5项）。分析前指标为错误申请、错误样本和未采集样本，其规范分别为4.1%、5.0%和1.7%。分析步骤的一项新指标是超出规范的外部对照百分比（0.8%）；其他三项公认指标（不精密度、偏差和总误差）的规范并非本研究的主题。对于分析后阶段，指标（及规范）包括发送至各中心或临床科室的报告硬拷贝重复件（1.6%）、危急值报告失败（0.5%）、报告超出交付时间（0.7%）、转诊检测报告超出交付时间（8.9%）以及各中心之间数据处理网络相关事件（每年25起）。
过程指标反映了构成我们工作组的各实验室的最新情况。分析阶段的当前表现令人满意，因为这完全由实验室掌控，而分析外阶段的主要问题存在于实验室外部开展的活动（样本采集与运输以及非电子报告交付）中。
