The quest for quality blood banking program in the new millennium the American way.

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.