Internal Quality Control in the Hemostasis Laboratory

Internal Quality Control in the Hemostasis Laboratory
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止血实验室的内部质量控制

DOI:
10.1002/9781444303575.ch5
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发表时间:
2009
期刊:
影响因子:
--
通讯作者:
J. Olson
J. Olson
中科院分区:
--
文献类型:
--
作者:
S. Kitchen;F. Preston;J. Olson

文献摘要

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在凝血实验室进行的许多检测对于家族性和获得性出血和血栓形成疾病患者的准确诊断和安全处理至关重要。尤其重要的是,当进行调查以确定可能的家族性止血障碍时,结果是准确和可靠的。实验室错误可能导致误诊,无论错误导致受试者被误诊为患有或不患有家族缺陷,都可能造成严重的临床后果。适当的内部质量控制程序是质量管理体系的关键部分,该体系旨在确保检测结果安全发布,供患者管理决策使用。本章讨论与止血试验有关的内部质量控制材料的性质及其性能,包括对此类材料的制备和储存的讨论。测试频率参考已发布的指南以及超限IQC结果部分进行了说明。提醒读者,IQC测试和对所获得结果的定期检查只应是质量保证和质量管理计划的一个组成部分,质量控制是一个持续的过程,是止血实验室所有各级工作人员的责任。
Many tests performed in coagulation laboratories are vital for the accurate diagnosis and safe management of patients with familial and acquired bleeding and thrombotic disorders. It is particularly important that results are accurate and reliable when investigations are undertaken to determine possible familial disorders of hemostasis. A laboratory error may lead to misdiagnosis, and whether an error leads to a subject being misdiagnosed as having, or not having, a familial defect, there could be serious clinical consequences. Adequate internal quality control procedures are a critical part of the quality management system that seeks to ensure that test results are safe to release for patient management decisions. This chapter addresses the nature of internal quality control materials and their properties in relation to hemostasis testing, including a discussion of preparation and storage of such materials. The frequency of testing is described with reference to published guidelines as well as sections on out of limits IQC results. Readers are reminded that IQC testing and regular scrutiny of results obtained should be merely one component of the quality assurance and quality management program, and that quality control is a continuous process and is the responsibility of all staff at all levels in the hemostasis laboratory.