Levels of quality management of blood transfusion services in Europe

Seidl, Christian; Brixner, V.; Müller-Kuller, Thea; Sireis, Walid; Costello, Philip; Čermáková, Zuzana; Delaney, F.; Douglas, Angus Mcmillan; Nightingale, M. J.; Galen, Julie; O'connell, Marie; Siegel, William C.; Sobaga, L.; Wit, Jeroen de; Seifried, Erhard

doi:10.1111/j.1751-2824.2008.00182.x

Cited by 5 publications

(7 citation statements)

References 4 publications

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“…The sixth section summarized the objectives and deliverables of the EuBIS project itself. The results of a comparative analysis of the survey, in combination with Directive 2002 ⁄ 98 ⁄ EC and its technical requirements, were used to establish the basic structure for the quality systems and pan-European blood inspection standards [12].…”

Section: The Eubis Manual and Training Guide For The Inspection Of Blmentioning

confidence: 99%

“…The EuBIS manual will give practical assistance in implementing the EU blood legislation. A survey between its participants has shown that legislation requirements given by the technical Directives of the blood legislation will need further modifications for national inspection systems to address all the requirements in the EC Directives [12] (Table 1).…”

Section: Quality Systems Of Blood Establishments Following the Europementioning

confidence: 99%

“…EuBIS develop pan-European standards and criteria for the inspection of blood establishments summarized in a manual and guide [11]. These requirements are intended for use not only by those responsible for the operation of blood establishments but by those in charge of inspecting them, in compliance with relevant European Union (EU) legislation (http://www.eubis-europe.eu) [12].…”

Section: Introductionmentioning

confidence: 99%

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The EuBIS manual and training guide. Guidelines and standards for quality management and inspection of blood establishments

Seidl¹,

Kaltenbrunner-Bernitz

Skrablin³

et al. 2011

ISBT Science Series

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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.

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Section: The Eubis Manual and Training Guide For The Inspection Of Blmentioning

confidence: 99%

Section: Quality Systems Of Blood Establishments Following the Europementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The EuBIS manual and training guide. Guidelines and standards for quality management and inspection of blood establishments

Seidl¹,

Kaltenbrunner-Bernitz

Skrablin³

et al. 2011

ISBT Science Series

Self Cite

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“…In view of the occurrence of some of these infectious diseases in certain European countries, the continuous presence of immigrants from endemic countries, and the extent of international travel, these risks may not have received sufficient attention.'' 8 Third, exclusion criteria might run counter to EU regulations that not only seek to promote mobility but also adhere to the principle of nondiscrimination. Although some countries have explicitly excluded certain risk groups from donation, as noted previously, a few member states have not.…”

Section: Possible Problemsmentioning

confidence: 99%

Governance in the European Union: The European Blood Directive as an Evolving Practice

Hansen-Magnusson¹

2010

Clinics in Laboratory Medicine

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This article reconstructs governance practices related to blood policy that have developed within in the European Union (EU) over the last 15 years. It describes core aspects of the policy and argues that, despite an integrated cooperative approach between policy-makers and practitioners, this policy remains an open and evolving process. The European Blood Directive (2002/98/EC) and its subsequent directives managed, for the first time, to create an overarching framework for transfusion procedures. This framework consists of a number of standard definitions as well as detailed standard operating procedures, yet leaves room for interpretation and different practices between EU member states. A recently published report on the progress of transposition of the Directives into national legislation reveals different standards, suggesting a lack of uniformity of safety and quality requirements. Further, gaps in the directives amount to practical medical problems, while increased mobility among EU citizens may add further problems to achieving the objective of a self-sufficient supply of blood and blood products. This might undermine public confidence in the quality of blood products and the health protection of donors, which, in turn, must be countered by a cooperative effort of policy-makers and blood establishments.

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“…Thus, integrated QMSs including standards on other fields will therefore be ever more employed in the future [1]. The results of the survey performed between the participants of the European Union (EU) co‐funded project EuBIS revealed several standards and guidelines, which are commonly used by blood establishments in EU member states [2]. Compatibility of these systems with Directive 2005/62/EC (applying basic principles of GMP and ISO 9000) [3] was investigated.…”

Section: Introductionmentioning

confidence: 99%

Quality management in blood establishments

2009

ISBT Science Series

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Transfusion medicine has a specific position relative to other fields of medical science. A series of laboratory and clinical medicine activities and pharmaceutical-like manufacture, with tight interaction of various professionals are involved in the complex chain of transfusion medicine, from the promotion of blood donation through the utilization of blood products. Maintaining constant high quality and safety of the products and services required by blood donors, patients and public at large are the prime and foremost goals to be pursued in transfusion medicine. These supreme goals can only be achieved through efficient quality management in all segments and with due support from all those involved in this complex system. Recognizing quality as a necessity, transfusion services all over the world have introduced or are just being introducing quality management systems according to particular standards and regulations. In EU countries, quality management in blood establishments is legal obligation defined by the 2005/62/EC Directive. Only a comprehensive and integrated quality management system can guarantee quality in a continuous way. Standard requirements and specifications of such an integrated system based on GMP and ISO 9000 series standards are elaborated in this paper.

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Levels of quality management of blood transfusion services in Europe

Cited by 5 publications

References 4 publications

The EuBIS manual and training guide. Guidelines and standards for quality management and inspection of blood establishments

The EuBIS manual and training guide. Guidelines and standards for quality management and inspection of blood establishments

Governance in the European Union: The European Blood Directive as an Evolving Practice

Quality management in blood establishments

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