David Remona E, Dobreanu Minodora
Clin Lab. 2016;62(6):1033-44. doi: 10.7754/clin.lab.2015.150931.
Development of quality measurement principles is a strategic point for each clinical laboratory. Preexamination process is the most critical and the most difficult to be managed. The aim of this study is to identify, quantify, and monitor the nonconformities of the pre-analytical process using quality indicators that can affect the patient's health safety in four different locations of a Romanian private clinical laboratory.
The study group consisted of all the analysis requests received by the departments of biochemistry, hematology, and coagulation from January through March 2015. In order to collect the pre-analytical nonconformities, we created a "Risk Budget", using the entries from the "Evidence notebook--non-conform samples" from the above mentioned departments. The laboratory established the quality indicators by means of the risk management technique in order to identify and control the sources of errors, FMEA (Failure Modes and Effects Analyses), which had been implemented and monitored for its purposes and special needs. For the assessment of the control level over the processes, the results were transformed on the Six Sigma scale, using the Westgard calculation method and being obtained in this way the frequency with which an error may occur. (https://www.westgard. com/six-sigma-calculators.htm).
The obtained results prove that the quantification and monitoring of the indicators can be a control instrument for the pre-analytic activities. The calculation of the Six Sigma value adds extra information to the study because it allows the detection of the processes which need improvement (Sigma value higher than 4 represents a well controlled process). The highest rates were observed for the hemolyzed and the lipemic samples, in the department of biochemistry and hemolyzed, insufficient sample volume, or clotted samples for the department of hematology and coagulation. Significant statistical differences between laboratories participating in the study have been recorded for these indicators.
The elaborated study between the four branches of a Romanian private clinical laboratory was a challenge, and it helped in choosing strategic decisions regarding the improvement of the patient's health safety in the institution, corresponding to the accreditation requirements in accordance with ISO 15189:2013.
制定质量衡量原则是每个临床实验室的战略要点。检验前过程是最关键且最难管理的环节。本研究的目的是使用质量指标识别、量化并监测分析前过程中的不符合项，这些指标可能会影响罗马尼亚一家私立临床实验室四个不同地点的患者健康安全。
研究组包括2015年1月至3月期间生物化学、血液学和凝血科收到的所有分析请求。为了收集分析前的不符合项，我们利用上述科室“证据笔记本——不合格样本”中的记录创建了一个“风险预算”。实验室通过风险管理技术建立质量指标，以识别和控制误差来源，即失效模式与效应分析（FMEA），该技术已针对其目的和特殊需求进行实施和监测。为了评估对过程的控制水平，使用韦斯特加德计算方法将结果转换为六西格玛尺度，从而得出误差可能发生的频率。（https://www.westgard.com/six-sigma-calculators.htm）
所得结果证明，指标的量化和监测可以作为分析前活动的控制手段。六西格玛值的计算为该研究增添了额外信息，因为它能检测出需要改进的过程（西格玛值高于4表示过程控制良好）。在生物化学科，溶血和脂血样本的发生率最高；在血液学和凝血科，溶血、样本量不足或样本凝固的情况发生率最高。参与研究的各实验室在这些指标上存在显著的统计学差异。
罗马尼亚一家私立临床实验室四个分支机构之间开展的这项精心研究是一项挑战，它有助于根据符合ISO 15189:2013的认可要求，就改善该机构患者健康安全问题做出战略决策。
