临床生化实验室Na+、K+的内部质量控制

Modibo Coulibaly, Jean Luis Konan, Mary Laure Hauhouot Attoungbre, Dagui Monnet
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The pre-pre-analytical quality indicators depending on the physician’s order, the pre-analytical quality indicators and the post-analytical indicators under the control of the laboratory and based on the NF standard ISO 15189 version 2012 have been determined. Data were captured into Microsoft Access [Microsoft Corporation, Redmond, WA] and then imported and analyzed using QI Macros SPC Software for Excel®. The monthly dispersion parameters of the Exatrol Normal were used to establish the Levey-Jennings diagram and the Wesgard’s rules were used for the interpretation. Results: a total of 112 electrolytes analysis order were received. For the pre-pre-analytical phase, the analysis of these requests revealed that 81 (72.3%) requests carried no clinical information. The non-compliance of the samples were mainly represented by the sampling under tight tourniquet 4 (3.6%), followed by the non-respect of the succession tubes during multiple sampling 3 (2.7%). For the analytical phase, the monthly Levey-Jennings diagram showed a dispersion of the Exatrol-Normal® values ​​between the mean plus or minus 2 standard deviations [m ± 2SD]: 139.34 ± 2.84 mmol/L for sodium (Na+). For the potassium (K+), the values ​​of Exatrol-Normal® were between [m± SD]: 4.2±0.78 mmol/L. The interpretation of the two Levey-Jennings diagrams by Wesgard’s rules did not found any statistically significant mistake with regard to the distribution of Na+ and K+ levels. For clinical samples, isolated hyponatremia was the most common disturbance (30.4%) followed by isolated hypokalemia (12.5%). At the post-analytical phase we observed a mean turnaround time of 34 minutes with extremes ranging from 23 to 95 minutes. One case (0.9%) of transcription error was noted. Conclusion: the internal quality control process is applied in the clinical biochemistry laboratory at the Institute of Cardiology, Abidjan. 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引用次数: 0

摘要

背景:血液电解质分析是一项常规的实验室检查,正确的执行将有助于诊断水电解质紊乱。我们负责评估从分析前到分析后阶段钠和钾的质量。材料和方法:这是一项横断面研究,于2009年3月1日至3月31日在科特迪瓦阿比让心脏病研究所生物化学实验室进行。用火焰光度计测定了Biolabo®公司生产的内控品艾曲洛和临床样品的钠、钾电解质水平。根据医师医嘱确定分析前、分析前质量指标,根据NF标准ISO 15189 version 2012确定实验室控制下的分析前、分析后质量指标。数据被捕获到Microsoft Access [Microsoft Corporation, Redmond, WA]中,然后使用QI Macros SPC Software for Excel®进行导入和分析。采用Exatrol Normal的月频散参数建立Levey-Jennings图,并采用Wesgard规则进行解释。结果:共收到112份电解质分析单。在预-预分析阶段,对这些请求的分析显示,81份(72.3%)请求没有临床信息。样本不符合的主要表现为紧止血带下取样4(3.6%),其次是多次取样时连续管不符合3(2.7%)。在分析阶段,月度levy - jennings图显示Exatrol-Normal®值在平均值正负2个标准差(m±2SD)之间的分散:钠(Na+)为139.34±2.84 mmol/L。对于钾(K+), Exatrol-Normal®的值在[m±SD]: 4.2±0.78 mmol/L之间。用韦斯加德规则解释两个利维-詹宁斯图时,没有发现关于Na+和K+水平分布的统计学上的重大错误。在临床样本中,孤立性低钠血症是最常见的障碍(30.4%),其次是孤立性低钾血症(12.5%)。在分析后阶段,我们观察到平均周转时间为34分钟,极端时间从23分钟到95分钟不等。转录错误1例(0.9%)。结论:该内部质量控制流程适用于阿比让心脏病研究所临床生物化学实验室。分析过程不同阶段的系统验证系统可以识别分析过程所有层次的错误,并在必要时采取纠正措施。要求电解质分析的临床医生和执行分析的生物学家之间更好的合作是必要的,以改善预-预-分析阶段,除此之外,更好的病人护理。
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Internal quality control of Na+ and K+ at clinical biochemistry laboratory
Background: the blood electrolyte analysis is a routine laboratory test, the proper execution of which would help in the diagnosis of hydro-electrolyte disorders. We undertook to assess the quality of the sodium and potassium from the pre-pre-analytical phase to the post-analytical phase. Material and Methods: This was a cross-sectional study which took in the laboratory of biochemistry at the Institute of Cardiology, Abidjan, Ivory Coast from March 1st to March 31, 2009. We used the flame photometer to measure the sodium and potassium electrolytes level in the internal control Exatrol-Normal from Biolabo® and those of the clinical samples. The pre-pre-analytical quality indicators depending on the physician’s order, the pre-analytical quality indicators and the post-analytical indicators under the control of the laboratory and based on the NF standard ISO 15189 version 2012 have been determined. Data were captured into Microsoft Access [Microsoft Corporation, Redmond, WA] and then imported and analyzed using QI Macros SPC Software for Excel®. The monthly dispersion parameters of the Exatrol Normal were used to establish the Levey-Jennings diagram and the Wesgard’s rules were used for the interpretation. Results: a total of 112 electrolytes analysis order were received. For the pre-pre-analytical phase, the analysis of these requests revealed that 81 (72.3%) requests carried no clinical information. The non-compliance of the samples were mainly represented by the sampling under tight tourniquet 4 (3.6%), followed by the non-respect of the succession tubes during multiple sampling 3 (2.7%). For the analytical phase, the monthly Levey-Jennings diagram showed a dispersion of the Exatrol-Normal® values ​​between the mean plus or minus 2 standard deviations [m ± 2SD]: 139.34 ± 2.84 mmol/L for sodium (Na+). For the potassium (K+), the values ​​of Exatrol-Normal® were between [m± SD]: 4.2±0.78 mmol/L. The interpretation of the two Levey-Jennings diagrams by Wesgard’s rules did not found any statistically significant mistake with regard to the distribution of Na+ and K+ levels. For clinical samples, isolated hyponatremia was the most common disturbance (30.4%) followed by isolated hypokalemia (12.5%). At the post-analytical phase we observed a mean turnaround time of 34 minutes with extremes ranging from 23 to 95 minutes. One case (0.9%) of transcription error was noted. Conclusion: the internal quality control process is applied in the clinical biochemistry laboratory at the Institute of Cardiology, Abidjan. A systematic verification system of the different phases of the analytical process makes it possible to identify errors at all levels of the analytical process and to take corrective action if necessary. Better collaboration between clinicians requesting electrolyte analysis and biologists performing the analysis is necessary to improve the pre-pre-analytical phase and, beyond that, better patient care.
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