Sirchia G, Rebulla P, Lecchi L, Mozzi F, Crepaldi R, Parravicini A
Milano Cord Blood Bank, Centro Trasfusionale e di Immunologia dei Trapianti, IRCCS Ospedale Maggiore, Italy.
J Hematother. 1998 Feb;7(1):19-35. doi: 10.1089/scd.1.1998.7.19.
Although placental blood has recently become a new source of hematopoietic progenitors for marrow replacement, limited attention has been given to systems suitable to ensure the short-term and long-term quality of placental blood units used for transplantation. In this article, we describe a quality system for placental blood banking developed in accord with ISO 9002 norms at Milano Cord Blood Bank. The quality system is the organizational structure, procedures, processes, and resources needed to implement quality management. ISO 9002 is a model for quality assurance in production, installation, and servicing, which includes a number of clauses providing guidance for the implementation of the quality system. The quality system was started by the bank medical director with step 1: the general quality plan, which included (a) the written description of mission, objectives, technical and organizational policies, and staff organization chart of the placental blood bank, (b) the definition and acquisition of adequate financial, human, and structural resources, (c) the appointment of a quality system head independent from the production laboratory and reporting directly to the medical director. Tasks of the quality system head were (a) to identify the placental blood banking process together with the placental blood bank personnel, (b) to implement a documentation plan finalized at the production and maintenance of (i) the quality manual, which provides a summary on how the bank operates with a quality system in compliance with the ISO 9002 clauses, (ii) the general procedures (or quality system procedures), which provide more detail on selected clauses, including at least those prescribed by the ISO 9002 standard, (iii) the operative procedures (or process procedures), which describe in detail the process of placental blood banking and how technical activities must be performed, (iv) the work instructions, which provide stepwise descriptions of individual activities, (v) records/forms for data collection and storage, (c) to identify quality indicators, (d) to start a regular internal audit, (e) to report audit results to the medical director for review. This was followed by step 2: the job descriptions, staff training, and qualification; step 3: the documentation plan; step 4: the internal audit plan; step 5: the launch of the quality system, and step 6: the assessment by an external team from an accredited third-party organization and final certification for compliance to ISO 9002. The quality system, which must be maintained and undergo external audit at regular intervals so that certification is confirmed, ensures the high probability that placental blood units provided to clinicians conform regularly to predefined levels of quality.
尽管胎盘血最近已成为用于骨髓替代的造血祖细胞的新来源，但对于适合确保用于移植的胎盘血单位的短期和长期质量的系统却很少有人关注。在本文中，我们描述了米兰脐带血库按照ISO 9002规范建立的胎盘血库质量体系。质量体系是实施质量管理所需的组织结构、程序、流程和资源。ISO 9002是生产、安装和服务中的质量保证模式，其中包括一些为质量体系的实施提供指导的条款。该质量体系由血库医学主任启动，第一步是制定总体质量计划，其中包括：(a)胎盘血库的使命、目标、技术和组织政策以及人员组织结构图的书面描述；(b)确定并获取充足的财务、人力和结构资源；(c)任命一名独立于生产实验室且直接向医学主任汇报的质量体系负责人。质量体系负责人的任务包括：(a)与胎盘血库工作人员共同确定胎盘血库流程；(b)实施一个文件计划，最终形成并维护以下文件：(i)质量手册，它总结了血库如何按照符合ISO 9002条款要求的质量体系进行运作；(ii)通用程序（或质量体系程序），它对选定条款提供了更详细的说明，至少包括ISO 9002标准规定的那些条款；(iii)操作程序（或流程程序），它详细描述了胎盘血库的流程以及技术活动必须如何进行；(iv)工作指导书，它逐步描述了各项具体活动；(v)用于数据收集和存储的记录/表格；(c)确定质量指标；(d)启动定期内部审核；(e)向医学主任汇报审核结果以供审查。接下来是第二步：岗位描述、员工培训和资格认定；第三步：文件计划；第四步：内部审核计划；第五步：质量体系启动；第六步：由认可的第三方组织的外部团队进行评估并最终获得符合ISO 9002的认证。该质量体系必须持续维护并定期接受外部审核以确认认证，它确保了提供给临床医生的胎盘血单位有很高的概率能持续符合预先定义的质量水平。
