Kim Dae Un
Saint Barnabas Medical Center, Livingston, New Jersey, USA.
Int J Hematol. 2002 Aug;76 Suppl 2:258-62. doi: 10.1007/BF03165126.
For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in implementing practices that assure quality and compliance with cGMP. AABB and CAP are granted "deemed status" as accrediting organizations under the CLIA '88 program by CMS, as well as JCAHO and some states. The International Standards Organization (ISO) has established international standards in most fields. The U.S. is represented in ISO by the American National Standards Institute (ANSI), and the National Committee for Clinical Laboratory Standards (NCCLS), as a global organization headquartered in the U.S., is a member of ANSI. The FDA and the AABB had begun incorporating many ISO principles into their own regulations and standards. The AABB's 10 QSEs are rooted in the 20 clauses of ISO 9000 series and compatible with their standards. In a Maslow-type model quality hierarchy by Tsiakals, so far the bottom three of the five progressive levels, Quality Control for method control, Quality Assurance for process control, and Quality System for system control have been implemented just to meet the regulatory and accrediting requirements. The next higher level, Quality Management for financial control, and the ultimate highest level, Total Quality Management for strategic control, should be our quest in this new millennium, and with the help of the AABB, ISO, FDA and all other organizations, we will achieve it. We should change our approach to quality issues from detection to prevention. We should improve the quality in transfusion practice itself by effective utilization of blood as a therapeutic resource with clear indication, maximum surgical blood order schedule, alternative transfusion such as autologous transfusion, hemodilution, and intra/post-operative blood salvage, surgical hemostasis, pharmacological hemostasis, and synthetic erythropoietin. Most importantly, implementation of the Quality Program should be something that we want to do rather than simply a burden that we have to do. A well-managed Quality Program is an effective and cost-efficient operation for the blood banks and transfusion services, and will enable us to better serve the patients for whom we exist.
对于一个行业来说，要取得成功并满足其客户需求，“质量”必须是首要目标。自血库行业诞生以来，质量就一直是其核心要素。自1937年美国第一家血库在库克县医院开业以来，质量计划不断发展。在随后的几十年里，血液保存、过滤器、病毒和血型检测、交叉配血、自动化以及包括条形码等在内的计算机化等方面的持续科学进步，都为血液制品和输血服务的质量与安全做出了贡献。然而，随着艾滋病时代的到来，日益敏感且信息灵通的公众不断要求在提供所有血液制品的所有过程中都要达到并维持最高质量水平。美国食品药品监督管理局（FDA）提出了“零风险血液供应”的概念作为行业目标。此外，成本控制和资源受限的环境改变了质量实践的复杂性。诸如FDA、医疗保健财务管理局[HCFA，该机构于2001年7月更名为医疗保险和医疗补助服务中心（CMS）]以及州卫生部等监管机构，还有诸如美国血库协会（AABB）、美国病理学家学会（CAP）以及医疗保健组织认证联合委员会（JCAHO）之类的认证机构，都要求血库和输血服务机构建立并遵循质量控制和质量保证计划，以获得许可、认证和认可。每个实验室都必须遵守由CMS实施的1988年《临床实验室改进修正案》（CLIA '88）的质量要求。FDA指南协助各机构遵守现行良好生产规范（cGMP）。AABB的质量体系要素（QSE）基于这些规范，并在实施确保质量和符合cGMP的实践方面提供额外指导。根据CLIA '88计划，AABB和CAP被CMS以及JCAHO和一些州授予认可组织的“认定地位”。国际标准化组织（ISO）在大多数领域都制定了国际标准。美国在ISO中的代表是美国国家标准学会（ANSI），而总部位于美国的全球组织美国国家临床实验室标准委员会（NCCLS）是ANSI的成员。FDA和AABB已开始将许多ISO原则纳入其自身的法规和标准中。AABB的10项QSE源于ISO 9000系列的20条条款，并与其标准兼容。在齐亚卡尔斯提出的马斯洛式质量层次模型中，到目前为止，五个递进层次中的底部三个层次，即方法控制的质量控制、过程控制的质量保证和系统控制的质量体系，只是为了满足监管和认可要求而实施的。下一个更高层次，即财务控制的质量管理，以及最终的最高层次，即战略控制的全面质量管理，应该是我们在这个新千年里追求的目标，并且在AABB、ISO、FDA和所有其他组织的帮助下，我们将会实现这一目标。我们应该将处理质量问题的方法从检测转变为预防。我们应该通过有效利用血液作为一种具有明确适应症的治疗资源、制定最大手术用血计划、采用替代输血方式如自体输血、血液稀释以及术中/术后血液回收、手术止血、药物止血和合成促红细胞生成素等，来提高输血实践本身的质量。最重要的是，实施质量计划应该是我们想要做的事情，而不仅仅是我们不得不承担的负担。一个管理良好的质量计划对于血库和输血服务机构来说是一项有效且具有成本效益的运营方式，并且将使我们能够更好地为我们所服务的患者提供服务。
