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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >Detecting failed WBC-reduction processes: a quality assurance program introduced in a blood center.
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Detecting failed WBC-reduction processes: a quality assurance program introduced in a blood center.

机译：检测失败的白细胞减少过程：血液中心引入的质量保证程序。

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BACKGROUND: Pragmatic yet statistically valid quality assurance (QA) programs are necessary so that blood centers can select, validate, and monitor their WBC-reduction processes. A QA system for WBC-reduction processes based on the practical application of statistical theory within a large blood center was developed. The system identifies parameters for procedure and component evaluation and provides sample size and formatting suggestions. STUDY DESIGN AND METHODS: Analyses of both procedure and component performance were undertaken during the purchase, validation, and control of filtration and apheresis WBC-reduction processes at Blood Centers of the Pacific from 1997 through 1999. QA analysis was categorized on the basis of whether the process was new to the organization or was a modification of a previously validated system. The numbers of samples necessary to consistently detect failure in platelet yield, unit volume, pH, and WBC count was statistically determined by parametric and nonparametric techniques. RESULTS: Parametric analysis (power analysis) of the mean +/- SD of smaller numbers of samples was highly sensitive to shifted distributions, but only if the shift was normally distributed. Nonparametric analysis, necessary when the nature of the underlying distribution is unknown, suggested a minimal sample of 40 was required to achieve high confidence that significant bimodal failure (a secondary population with WBCs 5% above the cutoff) would be detected. CONCLUSION: A QA system, developed for the evaluation of new or revised WBC-reduction processes, was based on statistical analysis of normally and non-normally distributed process failure. The number of samples was determined that allowed the achievement of confidence and tolerance levels considered appropriate within the blood center. Suggestions for outlier evaluation and a format for performance documentation have also been developed. To better define blood center quality goals, further research is necessary on donor and component biologic variability and the most significant modes of WBC-reduction process failure.
机译：背景：务实但在统计上有效的质量保证（QA）程序是必需的，以便血液中心可以选择，验证和监视其减少WBC的过程。基于统计理论在大型血液中心的实际应用，开发了一种用于白细胞减少过程的QA系统。该系统识别用于过程和组件评估的参数，并提供样本量和格式建议。研究设计和方法：在1997年至1999年期间，在太平洋血液中心购买，验证和控制过滤和单采白细胞减少WBC的过程中，对过程和组件性能进行了分析。对质量检查分析的依据是该过程对于组织来说是新的，或者是对先前已验证系统的修改。通过参量和非参量技术统计确定持续检测血小板产量，单位体积，pH和WBC计数失败所需的样品数量。结果：数量较少的样本的平均值+/- SD的参数分析（功效分析）对偏移分布高度敏感，但前提是偏移量呈正态分布。当基本分布的性质未知时，非参数分析是必要的，建议需要最少40个样本才能实现高可信度，即可以检测到严重的双峰故障（WBC高于临界值5％的次要人群）。结论：为评估新的或修订的白细胞减少过程而开发的质量保证系统，是基于对正态分布和非正态分布过程故障的统计分析。确定的样本数量可以在血液中心内达到合适的置信度和耐受水平。还提出了有关异常值评估的建议以及性能文档的格式。为了更好地定义血液中心质量目标，需要进一步研究供体和成分的生物变异性以及减少WBC减少过程失败的最重要模式。

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