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首页> 外文期刊>International journal of health care quality assurance >In control? IQC consensus and statutory regulation
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In control? IQC consensus and statutory regulation

机译：掌控之中？ IQC共识和法规

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Purpose - Internal quality control (IQC) represents an essential risk management tool within the total testing pathway (TTP) that contributes to the overall objective of assuring the quality of results produced in medical laboratories. Controlling analytical phase quality alone requires significant expertise and input by scientifically trained staff. This effort has escalated exponentially following the publication of the International Organisation for Standardisation (ISO)15189:2012 requirements for quality and competence in medical laboratories. The reported inconsistency and diversity to IQC approaches in diagnostic laboratories is definitive evidence that international guidance in IQC programme design and implementation is long overdue. The paper aims to discuss these issues. Design/methodology/approach - Herein, the authors define, describe and critically examine the essential elements four stages of an IQC programme and suggest a template to inform both design and ease of implementation. For practical application, the authors have stratified the proposed methodology into four stages: staff education and training; IQC material; IQC targets; and IQC procedure, and provide recommendations that meet ISO15189:2012 requirements. Findings - These recommendations are informed by the published literature together with the collective experience working in clinical biochemistry and diagnostic endocrinology laboratories. The authors note that the laboratory staff's effort on IQC is a continuous process, driven by changes within each IQC stage, in response to risk analysis, maximising economic value or through professional leadership and central to IQC programme implementation and delivery. Practical implications - The authors offer a template that laboratories can use to inform the design and implementation of their IQC programme. Originality/value - The proposed IQC programme is user friendly, flexible and pragmatic with the potential to harmonise practice. The authors have provided a template to potentially harmonise IQC practice nationally. Given the central and critical role that IQC practice plays in ensuring the quality of patient results' importance, the authors contend that the time has come for international consensus and statutory regulation regarding the minimally acceptable criteria for its implementation, monitoring and review.
机译：目的-内部质量控制（IQC）代表了总测试路径（TTP）中必不可少的风险管理工具，有助于实现确保医学实验室产生的结果质量的总体目标。仅控制分析相的质量就需要大量专业知识和经过科学培训的人员的投入。随着国际标准化组织（ISO）15189：2012对医学实验室质量和能力要求的发布，这项工作呈指数级增长。据报告，诊断实验室对IQC方法的不一致和多样性是权威的证据，表明国际上早就应该制定IQC程序设计和实施指南。本文旨在讨论这些问题。设计/方法/方法-作者在此处定义，描述和批判性地检验了IQC程序的四个阶段的基本要素，并提出了一个模板，以告知设计和易于实施的信息。为了实际应用，作者将所提出的方法分为四个阶段：员工教育和培训； IQC材料； IQC目标；和IQC程序，并提供符合ISO15189：2012要求的建议。发现-这些建议是根据已发表的文献以及在临床生物化学和内分泌诊断实验室工作的集体经验提供的。作者指出，实验室工作人员在IQC方面的工作是一个连续的过程，受IQC每个阶段的变化，对风险分析的响应，最大的经济价值或通过专业领导以及IQC计划实施和交付的核心驱动。实际意义-作者提供了一个模板，实验室可以使用该模板为IQC计划的设计和实施提供信息。原创性/价值-拟议的IQC程序用户友好，灵活且务实，具有协调实践的潜力。作者提供了一个模板，可以在全国范围内统一IQC惯例。鉴于IQC实践在确保患者结果质量的重要性方面起着至关重要的作用，因此作者认为，现在已经到了就其实施，监测和审查的最低可接受标准达成国际共识和法定法规的时候了。

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