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Background and Objectives Alloimmune antibodies against red-blood-cell (RBC) antigens induced in susceptible individuals (responders) by transfusion, pregnancy or transplantation may have serious clinical consequences. The aim of this study was to investigate association of alloimmunization against selected RBC antigens with HLA-Class II. Materials and Methods A total of 230 responders (106 monoresponders and 124 multiresponders) were enrolled into the study. HLA-DRB1 and HLA-DQB1 variants were determined by PCR-SSO and their frequencies compared between the patients (patient subgroups) and 375 ethnically and regionally matched controls. Results Development of multiple RBC antibodies was associated with HLA-DRB1*15 and HLA-DQB1*06 allelic groups in the patients, with the relationship being particularly apparent in those with anti-C+D antibodies. Furthermore, DRB1*13 and DQB1*06 were more frequent in multiresponders with anti-E+c antibodies and DRB1*03 and DQB1*02 in those with anti-E+Cw. Conclusion For the first time, we confirmed the association of HLA-DRB1*15 with RBC antibody multiresponder status and found HLA-Class II associations for three frequent RBC antibody combinations. Our data support the concept that HLA restriction plays an important role in the response to RBC alloantigens.

EuBIS, the European blood inspection system, is a collaborative effort of 27 representatives from 19 Member States (MS), including governmental institutions, blood establishments and competent authorities. EuBIS has been initiated by co-funding through the Public Health Programme (Directorate General Sanco) of the European Commission bringing together regulators (competent authorities) and manufacturers (blood establishments) to jointly develop criteria and standards aimed to assist: 1 blood establishments in need to optimize their quality system and self-inspection process and to prepare for regulatory inspections by competent authorities and 2 competent authorities, who wish to use the manual and training guide as a reference for the implementation process of legislative requirements related to regulatory inspections. These standards and criteria have been published in a EuBIS Manual and a EuBIS Training Guide. The structure of the EuBIS training guide follows critical aspects of quality management to be addressed to achieve good/best practice. For each of the quality related critical points, a criterion description, examples evidence and references to relevant international standards (GMP, PIC/S and CoE/EDQM CD-P-TS) and legislative requirements based on the European blood directives are given. Using ‘fishbone’ diagrams, quality indicators for risk assessment can be easily developed in a systematic fashion covering all relevant activities of a blood establishment. Chapter 3·5 refers to Blood collection, testing and processing with detailed subchapters on blood collection, processing and validation, labelling and release of blood and blood components. Additional quality requirements are described in Chapter 3·3 for Premises (Collection, Processing, Storage and Distribution), Chapter 3·4 Equipment and Chapter 3·8 non-conformance. Based on these standards and criteria, quality management systems have been nationally adapted to include reporting systems for risk analysis, prevention and acceptance based on deviations of processes, non conforming products and/or adverse events as well as non-compliances from audits and regulatory inspections.

Background and Objectives The Public Health Programme (Directorate General Sanco) gave impetus to the need for equivalent recognition of inspections of blood establishments among European Member States (MS) through the development and implementation of commonly accepted criteria and standards by funding the European Blood Inspection Project (EuBIS) (HYPERLINK “http://www.eubis-europe.eu”http://www.eubis-europe.eu). EuBIS is a collaborative effort of 27 representatives from 19 MS, including governmental institutions, blood establishments and competent authorities. It has cooperative working partnerships with five organisations, three projects, and is supported by the European Blood Alliance (EBA). Materials and Methods EuBIS is the first project that has brought together regulators (competent authorities) and manufacturers (blood establishments) to jointly develop criteria and standards aimed to assist: • blood establishments in need to optimise their quality system and self-inspection process • blood establishments to prepare for regulatory inspections by competent authorities • competent authorities, which wish to use the manuals and training guide as a reference for the implementation process of legislative requirements related to regulatory inspections. Results These standards and criteria have been finalised and published in a EuBIS Manual and Training Guide. The manual and training guide are available through the EuBIS homepage. In addition, EuBIS has developed educational material and to be used for seminars and courses. Based on regulatory standards applicable within the European Union (EU), the manual and training guide give references to commonly used internationals standards, such as GMP standards, the PIC/S guideline and the CoE (EDQM) guide. Thus, the EuBIS material should also be useful for those working in the field of quality management in other countries/areas world wide. In order to give practical assistance, the structure of the EuBIS guide follows critical aspects of quality management systems to be addressed in order to achieve good practice. For each of these critical points, a criterion description, examples evidence and references to relevant standards and legislative requirements are given. Conclusion The EuBIS manuals have been used by its partners organising national and international seminars, experimental and regulatory audits assisting the national implementation and further harmonisation of quality standards. In some member states elements of EuBIS have been adapted to national or local quality management systems. The implementation of good practice will improve the quality of blood and ensure that patients receiving blood transfusions are given safe blood.

The European blood legislation has defined several key quality elements to achieve Good Manufacturing Practice (GMP) in the field of blood transfusion. During the recent years, the blood legislation is in the process of implementation throughout its member states. Following the Directive 2002/98/EC, Directive 2005/62/EC has given further requirements for quality-management systems to be fulfilled by blood establishments. In addition, GMP/Good Laboratory Practice (GLP) and ISO standards are used inter alia by blood establishments. In order to support the implementation of the blood legislation, the European Public Health Work Plan (2005/2007) has cofunded two projects, led by the German Red Cross and supported by the European Blood Alliance, delivering a common European Standard Operating Procedure (SOP) methodology (EU-Q-Blood-SOP) and criteria and standards for the inspection of blood establishments (EUBIS). The EU-SOP manual will assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU Directive 2002/98/EC and its technical annexes. The standards and criteria for inspection of blood establishments will cross-reference existing quality standards to the directive requirements and define requirements for the structure of quality-management systems based on the directive 2002/98/EC and its technical annexes. Based on these requirements, inspection standards and criteria are developed to assist in the independent assessment of quality systems established by individual blood establishments. These assessments are done in relation to the requirements defined by the European Union legislation on blood, in order to safeguard the quality of blood and to achieve continuous improvement of its quality throughout Europe.