Parvin Curtis A, Baumann Nikola A
1 Bio-Rad Laboratories, Plano, TX, USA.
2 Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, MN, USA.
J Diabetes Sci Technol. 2018 Jul;12(4):786-791. doi: 10.1177/1932296818758768. Epub 2018 Feb 16.
Current laboratory risk management principles emphasize the importance of assessing laboratory quality control (QC) practices in terms of the risk of patient harm. Limited practical guidance or examples on how to do this are available.
The patient risk model described in a published laboratory risk management guideline was combined with a recently reported approach to computing the predicted probability of patient harm to produce a risk management index (RMI) that compares the predicted probability of patient harm for a QC strategy to the acceptable probability of patient harm based on the expected severity of harm caused by an erroneously reported patient result.
Measurement procedure capability and quality control performance for two instruments measuring HbA1c in a laboratory were assessed by computing the RMI for each instrument individually and for the laboratory as a whole.
This assessment provides a concrete example of how laboratory QC practices can be directly correlated to the risk of patient harm from erroneously reported patient results.
当前实验室风险管理原则强调，从患者受到伤害的风险角度评估实验室质量控制（QC）实践的重要性。关于如何进行此项评估的实用指南或示例有限。
将已发表的实验室风险管理指南中描述的患者风险模型与最近报道的计算患者伤害预测概率的方法相结合，得出一个风险管理指数（RMI），该指数将质量控制策略下患者伤害的预测概率与基于错误报告的患者结果所造成伤害的预期严重程度得出的患者伤害可接受概率进行比较。
通过分别计算实验室中两台测量糖化血红蛋白（HbA1c）仪器以及整个实验室的RMI，评估了测量程序能力和质量控制性能。
该评估提供了一个具体实例，说明实验室质量控制实践如何能直接与错误报告患者结果导致的患者伤害风险相关联。
