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A comprehensive guide to each component of a quality assurance program for blood transfusion services, whether established in a small hospital blood bank or a large transfusion centre. Measures described are intended to ensure the maximum safety of all procedures for donors, recipients, and the staff themselves. Arguing that a system of quality assurance should be implemented in all transfusion services and blood banks, the book emphasizes the vital importance of strict quality control procedures at each stage of each procedure. The first chapter explains the importance of meticulous records and documents. Chapter two outlines nine elements that must be included in all standard operating procedures and sets out requirements for their implementation. Subsequent chapters describe measures for quality assurance in donor selection and blood collection. A chapter focused on the responsibilities of laboratories sets out, in tabular form, specific requirements for the quality control of ABO grouping, Rh(D) blood group reagents, HBsAg testing, anti-HIV testing and syphilis testing. The remaining chapters cover the testing and quality assurance of blood components and describe the roles of transfusion committees and audits.
"Blood transfusion is a life-saving intervention that has an essential role in patient management within health care systems. All Member States of the World Health Organization (WHO) endorsed World Health Assembly resolutions WHA28.72 (1) in 1975 and WHA58.13 (2) in 2005. These commit them to the provision of adequate supplies of safe blood and blood products that are accessible to all patients who require transfusion either to save their lives or promote their continuing or improving health." --Preface.
THE PHILOSOPHY OF QUALITY ASSURANCE IN THE BLOOD BANK H. F. Taswell One year before this symposium, Cees Smit Sibinga and I began to discuss an approach to quality assurance in the blood bank which we felt would be both important and practical and could serve as the basis for the choice of subjects to be presented in the symposium. As an introduction to this book, I would like to outline our approach, the subjects chosen and the rationale behind our choice. What is the fundamental purpose of a blood bank and trans fusion service? Simply stated, the purpose of a blood bank and transfusion service and of a quality assurance program in blood banking is, for the one to provide and, the other to assure safe and effective transfusion therapy. This objective is in contrast to that of other clinical laboratories. The objective in a clinical chemistry laboratory is to produce accurate test results which will be meaningful to the clinician taking care of his patient. In most clinical laboratories, therefore, the goals of a quality assurance program are largely quantitative, that is, to assure accurate numerical test results. In contrast, in the blood bank, the goals of quality assurance are primarily qualitative, that is, to assure safe and effective transfusion. As a result, two somewhat different approaches to quality assurance are necessary.
The use of blood components represents the only therapy available for many seriously-ill patients who suffer from acute or chronic diseases. To provide all those working in the field of transfusion medicine - from blood services to hospital departments to regulators - with a compendium of measures designed to ensure the safety, quality and efficacy of blood components, the Council of Europe has developed a guide as a technical annex to its Recommendation NA R (95) 15 on the preparation, use and quality assurance of blood components. The Guide contains recommendations on blood collection, blood components, technical procedures, transfusion practices and quality systems for blood establishments. It represents the basis for a large number of national regulations, as well as for the blood directives of the European Commission. This is the 17th edition of the Guide, compiled by leading European experts under the aegis of the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). This Steering Committee was created in 2007 by the Council of Europe to pursue its activities in the field of blood transfusion following the transfer of these activities to the EDQM.
The use of blood components represents the only therapy available for many seriously ill patients who suffer from acute or chronic diseases. To provide all those working in the field of transfusion medicine - from blood services to hospital departments to regulators - with a compendium of measures designed to ensure the safety, quality and efficacy of blood components, the Council of Europe has developed a guide as a technical annex to its Recommendation No. R (95) 15 on the preparation, use and quality assurance of blood components. The Guide contains recommendations for blood establishments on blood collection, blood components, technical procedures, transfusion practices and quality systems. It represents the basis for a large number of national regulations, as well as for the blood directives of the European Commission. This is the 19th Edition of the Guide, compiled by leading European experts under the aegis of the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). For matters dealing with the use of organs and tissues and cells, see the Council of Europe Guide to the quality and safety of organs for transplantation and Guide to the quality and safety of tissues and cells for human application, respectively.
The WHO guidelines on assessing donor suitability for blood donation have been developed to assist blood transfusion services in countries that are establishing or strengthening national systems for the selection of blood donors. They are designed for use by policy makers in national blood programmes in ministries of health, national advisory bodies such as national blood commissions or councils, and blood transfusion services.
The use of blood components represents the only therapy available for many seriously-ill patients who suffer from acute or chronic diseases. To provide all those working in the field of transfusion medicine - from blood services to hospital departments to regulators - with a compendium of measures designed to ensure the safety, quality and efficacy of blood components, the Council of Europe has developed a guide as a technical annex to its Recommendation NA R (95) 15 on the preparation, use and quality assurance of blood components. The Guide contains recommendations on blood collection, blood components, technical procedures, transfusion practices and quality systems for blood establishments. It represents the basis for a large number of national regulations, as well as for the blood directives of the European Commission. This is the 17th edition of the Guide, compiled by leading European experts under the aegis of the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). This Steering Committee was created in 2007 by the Council of Europe to pursue its activities in the field of blood transfusion following the transfer of these activities to the EDQM.
This is the 12 edition of this compendium of measures designed to ensure safety, efficacy and quality of blood components, and this guide forms the basis for many national guidelines in Europe and around the world. It describes the different blood components and gives information on their clinical indications and possible side effects, in accordance with the requirements under Article 29 of EU Directive 2002/98/EC.