CHINA 凝血测试中的质量保证和质量控制

Inaccurate and imprecise 不正确和不精确
This assay is inaccurate and imprecise 这个检测既不正确也不精确
Inaccurate but precise 不正确但是精确
This assay is inaccurate but precise The assay is said to have a positive ‘BIAS’
Quality Assurance & Quality Control in Coagulation Testing 凝血测试中的质量保证和质量
控制
QUALITY ASSURANCE质量保证
A term used to describe all activities undertaken to improve and maintain a laboratory’s standard of performance 该术语用于描述为了改进和维持实验室操作标准所 进行的所有活动
Internal Quality Control Material 内部质量控制品
• Continual monitoring by laboratory staff of the reproducibility of test results
• 实验室工作人员持续监控测试结果的重现性
• Used in internal QC to check reproducibility of a test or assay • 用于内部质量控制，以检查一项测试或检验的重现性 • The true value of the material need not be known precisely • 质控品的真值不需要知道的很精确 • It must be stable over the time period for which it is intended for
确保报告结果的精确性和一致性
EQA外部质量评估
retrospective analysis comparing results
between laboratories and between methods
比较实验室间和实验方法间结果的回顾性分析
• Laboratory used incorrect calculation to determine INRs 实验室使用错误的计算方法计算INRs
• Internal Quality Control (IQC) 内部质量控制 • External Quality Assessment (EQA) 外部质量评估 • Use of Standard Materials 标准品的使用 • Setting up of procedures (SOP) 操作步骤的建立 • Staff Training and Appraisal 员工培训和评价 • Accreditation 鉴定认证
Quality Assurance质量保证 measures taken to ensure the reliability of laboratory sampling, testing and reporting
确保实验室取样、检测、报告可靠的方法
IQC内部质量控制
ensures precision and consistency of results for reporting
should be established 如果改变了所用的仪器或是试剂，应建立新的参考范围 • wherever possible assays should be reported with reference to
International Standards • 无论何地的检测结果都应该参考国际标准进行报告
这个检测不正确但是精确，可是说存在正向“偏倚”
Accurate and imprecise 正确但不精确
This assay is accurate but imprecise
这个检测正确但是不精确
Accurate and precise正确又精确
The assay producing the results shown is both accurate (i.e. no positive or negative bias) and precise (i.e. very little scatter of results about the mean value) 这个检测产生的结果既正确（无正向或负向偏倚）又精确（结果距离平 均值的离散度很小，几乎没有）
• Laboratory did not employ an Abnormal IQC sample 实验室没有使用异常的IQC标本
IQC and EQA:内部质量控制和外部质量评估 Precision and Accuracy精确性和正确性
• IQC is required to ensure results are precise. Consistent over time (from day to day etc)
• 932 patients in an 8 week period given the wrong INR 在8周内，有932个患者获得错误的INR报告
• At least 2, possibly 5 patients died as a result of overdosing 至少有2位，可能有5位患者由于用药过度死亡
Analytical variables 分析变量
• reference ranges are applicable only to specific machine and reagent combinations
参考范围只能用于特定仪器和设备的组合 • if either machine or reagent is changed newቤተ መጻሕፍቲ ባይዱreference ranges
• IQC要求确保结果精确，结果始终保持一致性（如 每天的结果保持一致）
• EQA is required to confirm that results are accurate. Results are in agreement with those in other centres.
• EQA要求确保结果的正确性。结果与其他中心的 要一致。