Simundic Ana-Maria, Church Stephen, Cornes Michael P, Grankvist Kjell, Lippi Giuseppe, Nybo Mads, Nikolac Nora, van Dongen-Lases Edmee, Eker Pinar, Kovalevskaya Svjetlana, Kristensen Gunn B B, Sprongl Ludek, Sumarac Zorica
Clin Chem Lab Med. 2015 Aug;53(9):1321-31. doi: 10.1515/cclm-2014-1053.
An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines.
A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart.
Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6-43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy.
The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.
欧洲临床化学与检验医学联合会分析前阶段工作组（EFLM WG - PRE）在12个欧洲国家开展了一项观察性研究，以评估CLSI H3 - A6指南的遵循情况。
创建了一份包含29项内容的结构化检查表，以评估欧洲静脉穿刺程序对CLSI H3 - A6指南的遵循情况。根据观察到的每个指南关键问题的错误频率和危害严重程度，绘制了个体静脉穿刺步骤的风险发生图。使用该风险发生图对静脉穿刺过程中出现的错误严重程度进行分级。
12个欧洲国家参与了研究，每个国家的审核中位数为33次（18 - 36次），总计336次审核。静脉穿刺总程序的错误率中位数为26.9%（10.6 - 43.8），表明总体上对CLSI推荐指南的遵循程度较低。患者识别和试管标记被确定为概率与潜在危害风险组合最高的关键指南问题。行政人员在静脉穿刺过程中未遵守患者识别程序，而医生未遵守试管标记政策。
发现12个欧洲国家的静脉穿刺程序对CLSI H3 - A6指南的遵循程度低得令人无法接受。在所调查国家中，最需要立即关注的关键步骤是患者识别和试管标记。
