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European Blood Alliance: mission, objectives, current activities


European Blood Alliance: mission, objectives, current activities Gilles Foll a, MD, PhD * EID: ABC actively participating Member consultation: ABC is ... – PowerPoint PPT presentation

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Title: European Blood Alliance: mission, objectives, current activities

European Blood Alliance mission, objectives,
current activities
Gilles Folléa, MD, PhD
  • Brief presentation of EBA
  • Mission and scope, strategic objectives
  • Membership, structure
  • Current activities and projects
  • Main achievements in 2011
  • Main projects for 2012
  • Discussion potential benefits for / from

EBA missions and scope
  • Blood and tissue supply
  • To contribute to the availability, quality,
    safety and cost-effectiveness of the blood and
    tissue supply for the citizens of Europe by
    developing and maintaining an efficient and
    strong collaboration amongst European blood and
    tissue services.
  • Voluntary and non-remunerated donation
  • To increase public and professional awareness of
    voluntary and non-remunerated donation of blood
    and blood components as an indispensable
    therapeutic means to help patients.
  • Performance
  • To assist European blood establishments to
    continuously improve their performance, based on
    scientific and ethical principles for the
    benefit of patients.

EBA strategic objectives
  • Performance
  • To improve performance through collaboration
  • Regulatory affairs
  • To engage in regulatory affairs to promote best
  • Networking
  • To facilitate information collection and
    knowledge exchange

  • EBA
  • an association of not for profit Blood
  • Creation
  • Created in 1998 with 9 members Be, UK, Fi, Fr,
    Irl, Lux, NL, Port, Scotl
  • Current members
  • 21 EU members Au, Be, Dk, Est, Fi, Fr, Ge, Hu,
    Irl, It, Lat, Lit, Lux, Mal, NL, Port, Rom,
    Slov, Sp, Swe, UK
  • 2 EEA members Nor, Switz
  • 1 observer ABC
  • 1 candidate member Cr
  • 4  dormant members  Cyp, Gr, Icl, Cz
  • Global partnership
  • Alliance of Alliances with ABC and Asia Pacific
    Blood Network

1. Austria 2. Belgium - 2 operators 3. (Czech
Republic 4.(Cyprus) 5. Denmark 6. Estonia 7.
Finland 8. France 9. Germany - 2 operators 10.
(Greece) 11. Hungary 12. (Iceland) 13.
Ireland 14. Italy 15. Latvia 16. Lithuania 17.
Luxembourg 18. Malta 19. The Netherlands 20.
Norway 21. Portugal 22. Romania 23. Slovenia 24.
Spain 25. Sweden 26. Switzerland 27. United
Kingdom - 4 operators
  • Population 450 M
  • Blood donations 18 M

Working structure
  • Executive Board 6 board members (elected, meet 4
    x per year)
  • President Jeroen de Wit (Sanquin, the
  • Vice President Philippe Vandekerckhove (Belgium,
    Red Cross Flanders)
  • Treasurer Andy Kelly (Ireland, IBTS)
  • Secretary Alex Aquilina (Malta BS)
  • Jørgen Georgsen (Denmark BS)
  • Erhard Seifried (Germany, German Red Cross BS)
  • Board all members (appointed, meets 2 x per
  • 2 seats and 1 vote per country
  • Permanent staff
  • 1 Executive Secretary (Willemijn Kramer,
  • 1 Executive Director (Gilles Folléa, Brussels)
  • Decision making based on consensus
  • Working language English

  • Mainly from members fees (calculated according
    to specific rules)
  • Other sources (under discussion)
  • Expenses (2011) 390 k
  • Basic principle to give the members value for

Current activities and projects to improve
performance through collaboration
  • Working groups / networks
  • EBA promoted EU funded projects
  • Emerging Infectious Disease
  • Monitor
  • Benchmarking
  • Joint procurement (EPG GPO)
  • Collaborative validations
  • Collaborative supplier audits
  • Tissues and Cells
  • Education and training
  • VNRD vs paid donations (2012)
  • SOP

EU Blood Inspection Systems (EUBIS)
  • 1st project that has brought regulators and
  • together to develop criteria and standards
  • Two manuals
  • EUBIS Common criteria for the inspection of Blood
  • EUBIS Audit/inspection training guide
  • Manuals and training sessions aimed to assist
  • BEs in need to optimise their quality system and
  • process/ EC directives
  • BEs to prepare for regulatory inspections by
  • CAs wishing to use the manual and training guide
    as a reference for implementation of EC
    legislation related to regulatory inspections

EU Optimal Blood Use Projecthttp//www.optimalblo
  • Manual aimed at promoting improvement in the
    quality of the clinical transfusion process,
    defined as Transfusion of the right unit of
    blood to the right patient at the right time, and
    in the right condition and according to
    appropriate guidelines.
  • The manual contains information to
  • Deliver QA of the clinical transfusion process
  • Promote best practice in blood transfusion
  • Comply with relevant EU directives

Donor Management in Europe (DOMAINE)
  • Objectives
  • Maintaining a safe and sufficient blood supply
    for the European community through effective
    donor management
  • Putting together individual experiences
  • Cooperation of BEs to facilitate solutions
  • Translating knowledge and experience into Good
    Donor Management
  • Successive steps
  • Survey (2008)
  • Manual presented at ISBT meeting 2010,
    accessible at http//
  • Training programme first in 2011
  • Workshop on donor selection in 2012

To engage in regulatory affairs to promote best
practice lobbying EU Institutions
  • Bringing expertise to EU Directorate General of
    Health and
  • Consumers (DG SANCO, EU regulator for health
  • eg EC survey on VNRD, monitoring/surveying WNV
  • Presenting the information in a practical way to
    European Institutions, e.g. EUBIS, EUOBUP,
    DOMAINE manuals
  • Influencing the preparation of the future EU
    Blood and Tissues
  • Directives/regulations, eg EC guidance for next
    WNV outbreaks,
  • VNRD vs paid donors (blood, T C) EC, EU
  • Supporting the growing influence of the European
    Committee on
  • Blood Transfusion of Council of Europe (CoE, 37
    countries) on EC
  • for future Blood regulations, eg chapter on
    Quality Assurance of the CoE
  • Blood Guide, now only recommendations, will
    become binding in 2013

Main Achievements 2011 networking more effective
and visible (including ABC ABO)
  • EID Monitor monitoring EIDs, sharing preventive
    measures, bringing expertise to members and
    regulators (monthly teleconferences EBA
  • Member consultations conclusive and discussed
    with Board (eg blood supply management,
    organisation in case of major disasters, donors
    RBC grouping/typing)
  • On line tools Basecamp (web based community
    tool), Webinars (web tel conferences)
  • Managed Convergence Lisbon meeting on Apheresis
    Connector Safety with BEs (ABO), suppliers
    (Eucomed, Advamed), regulators (EC, FDA, AFSSaPS)

Managed convergence
  • Initiated by ABO/ Advamed / Eucomed/ Edma 2005
  • Objective to streamline the movement of devices
    and diagnostics from product conception to
    regular sales across regulatory boundaries
  • Beneficiaries of the Project
  • Patients safer products being licensed quicker
  • BEs making safe healthcare provision more cost
    effective and thus potentially more readily
  • Manufacturers reducing cost of bringing a
    product to market
  • Regulators helping to cut out redundant process
    and speed up safe healthcare provision

Cooperating in the global blood supply chain
the managed convergence
  • Collaborative work
  • Blood Establishments
  • Hospitals
  • Technology supplying Companies
  • Regulators

Large scale implementation
  • Conception of innovative technologies to improve
  • Blood safety
  • Blood use

Collaborative Validation
Apheresis connector safety a constructive
partnership (ABO Suppliers CA), a pilot for
  • Death of an apheresis donor (France, SEP 2009)
    human error (confusing AC and saline) but
    avoidable if specific connectors available.
  • Misconnections identified as a broader global
    problem since years
  • Creation of a WG (chaired by EBA) gathering
  • Experts from BEs (EBA)
  • Experts from suppliers (EUCOMED)
  • Representative from 1 CA (AFSSaPS)
  • Elaboration of a harmonized solution for
    connectors of apheresis disposables to improve
    donors safety implemented in France (2011)
  • After the Lisbon meeting, a more sustainable
  • (specific connector for AC) is currently built
    up by involved suppliers
  • (Eucomed, Advamed) with ABO Members and
  • 1st step agreement of suppliers on common
    specifications (2012)
  • 2nd step ISO standardisation (2014)

Main Achievements 2011 improving member
efficiency and lobbying
  • New EBA rules to reinforce collaboration on
    agreed priorities (eg one Executive liaison for
    each WG)
  • Benchmarking WG
  • Workshop on processing
  • Flying Squad (experts in Lean) visits to Malta
    and Estonia
  • Expertise brought to EC (DG SANCO)
  • Report on VNRD corrections requested by EBA
    partly accepted (definition of VNRD)
  • Expertise brought by EID Monitor accepted WNV
    survey 2010, WNV information sharing 2011

Main projects for 2012 (including ABC and ABO)
  • Benchmarking Workshop on Donor selection (Feb)
  • Joint purchasing Eurobloodpack JP (2012-13), GPO
  • EID Monitor contribution to EC WNV 2012
    preparedness and follow up
  • ABO document on the value of Cell Therapy
    activities for Blood Establishments (Apr)
  • Managed convergence (ABO) progressing on
    standardisation of aph. connectors, new subjects
    (eg dialogue between blood MD vigilances),
    giving a home to MC
  • Developing good practices of blood supply
    management (with CoE WG, ISBT WP, ABO Think Tank)
  • Reformulating and updating evidence to promote
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