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Quality Systems: Theory and Practice 䊱 Tania L. Motschman, MS, MT(ASCP)SBB, CQA(ASQ); Betsy W. Jett, MT(ASCP), CQA, CQM/OE(ASQ); and Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB, CQA(ASQ)
P R I M A R Y G O A L O F transfusion medicine, cellular therapies, and clinical diagnostics is to promote high standards of quality in all aspects of patient care, production, and service. This commitment to quality is reflected in standards of practice set forth by the AABB. AABB standards use a “quality system” as the framework for quality. A quality system includes the organizational structure, responsibilities, policies, processes, procedures, and resources established by executive management to achieve and maintain quality. (A glossary of quality terms used in this chapter is included in Appendix 1-1.) The establishment of a formal quality assurance program is required by regulation under the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA)1 and the Food and Drug Administration (FDA) current good manufacturing practice (cGMP).2-4 The FDA
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regulations in the Code of Federal Regulations (CFR) Title 21, Part 211.22 require an independent quality control or quality assurance unit that has responsibility for the overall quality of the facility’s finished product and authority to control the processes that may affect this product3 (see frequently used CFR quality-related citations in Appendix 12). Professional and accrediting organizations, such as the AABB,5 The Joint Commission [formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)],6 College of American Pathologists (CAP),7 and Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS)8,9 have also established requirements and guidelines to address quality issues. The International Organization for Standardization (ISO) quality management standards (ISO 9001) are generic to any industry and describe the important minimum elements of a quality
Tania L. Motschman, MS, MT(ASCP)SBB, CQA(ASQ), Quality Manager, Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota; Betsy W. Jett, MT(ASCP), CQA, CQM/OE(ASQ), Chief Operations Officer, Department of Transfusion Medicine, National Institutes of Health, Bethesda, Maryland; and Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB, CQA(ASQ), Deputy Director, Hoxworth Blood Center, Cincinnati, Ohio The authors have disclosed no conflicts of interest.
1 Copyright © 2008 by the AABB. All rights reserved.
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