European Blood Alliance:
Corporate presentation
July 2013
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Working structure
• Executive Board: 6 members (elected, meet 4 x per year)
• Board: all members (appointed, meets 2 x per year)
– 2 seats and 1 vote per country
• Permanent staff:
– Executive Director: Gilles Folléa (Brussels)
– Communications & Administrations officer: Willemijn Kramer
(Amsterdam)
– PA: Desanka Heidsieck (Amsterdam)
• Decision making: the Board Members Meeting decide by
majority vote but preferably in consensus
• Working language: English
• Funding: Mainly members fee, budget €390K
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EBA purpose, mission and scope (statutes):
“To contribute to the safety, security and cost
effectiveness of the blood and tissue and cell
supply for the citizens of Europe by developing
and maintaining an efficient and strong
collaboration amongst European blood and
tissue and cell services”.
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EBA strategic objectives (1 of 2)
1. Safe and secure self-sufficiency from VNRD.
Increase public and professional awareness of, and further
promote voluntary non-remunerated donations (VNRD) of
blood and blood components and self-sufficiency from
VNRD.
2. Performance improvement through collaboration.
Assist European blood and tissue and cell services to
improve their performance, based on scientific and ethical
principles – for the benefit of patients. Encourage joint
activities and projects between members to enhance the
capability of the members.
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EBA strategic objectives (2 of 2)
3. Support to national and European authorities to
promote best practice.
Provide technical and professional support to national and
European authorities, particularly those involved in
preparation / revision of regulations, standards,
recommendations, guidelines, to promote best practice.
4. Information exchange and dissemination.
Exchange information on developments in the field of blood
transfusion and tissue and cell transplantation, and
disseminate relevant information on relevant issues.
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Strategic Objective 1:
Safe and secure self-sufficiency
from VNRD
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Safe and Secure Self-Sufficiency (1 of 4):
Improving Blood supply management (BSM)
• Leading role in the Council of Europe ‘TS003’ WG:
– Survey on BSM (2012, 39 countries)
– Self-assessment questionnaire and SWOT based method:
succesfully used by 12 countries.
– CoE Symposium on BSM (Oct 2012)
– Currently spread with ISBT WP on BSM.
• Work from TS003 WG and symposium expected to
be presented in a CoE manual: executive summary;
symposium report; TS003 study; Good practices of
BSM.
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Safe and Secure Self-Sufficiency (2 of 4):
Professional and effective donor management
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 BE’s to facilitate solutions
• Translating knowledge and experience into Good Donor Management’
Successive steps:
• Survey (2008)
• Manual: presented at ISBT meeting 2010, accessible at
www.domaine-europe.eu
• Training courses: 2011, 2013
• Recommended by ISBT Working Party on donors in 2012
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Safe and Secure Self-Sufficiency (3 of 4): Management
of Emerging Infectious Diseases ‘EID Monitor’
Objectives
• monitoring EIDs, sharing preventive measures, bringing expertise to
members and regulators
Method
• monthly teleconferences (EBA + AU+CA+US), email exchanges, meetings
with SANCO, European Centre for Disease Control (ECDC)
Main outcomes
• Regular monitoring and experience / expertise exchange shared with EBA
(ABO) members
• Contribution to EC preparedness plan on WNV
• Position on malaria in Greece
• EID M experts recruited for assessment of EUFRAT (ECDC) and another risk
assessment tool (Utrecht University)
• Positions sent to CoE for 17th version of the Blood Guide: integrated in
either 17th or 18th edition.
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Safe and Secure Self-Sufficiency (4 of 4):
Use of blood components and plasma derivatives
‘EU Optimal Blood Use Project’
• 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:
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Deliver QA of the clinical transfusion process
Promote best practice in blood transfusion
Comply with relevant EU directives
Manual accessible at www.optimalblooduse.eu
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VNRD: Now more important than ever (1 of 2)
• Context: continuing debate about donor remuneration and related threats
to the blood supply and safety
• EBA updated evidence for VNRD (EBA book):
– Blood safety for patients
– Continuity of blood supply
– Donor safety
– Ethical / legal reasons for donors:
• Dignity
• Non-maleficence and beneficence
• Compromised Autonomy: Coercion/Pressure
• Justice
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VNRD: Now more important than ever (2 of 2)
• EBA recommendations
– Clarification of the current definition of VNRD (complementary
definitions from Nuffield Council on Bioethics)
– Complementary tools to help objectively assess VNRD and impact for
patients’ and donors’ safety (presented at EMA)
– Label blood components with the origin VNRD or paid
– Collection of blood: Service of General Economic Interest
• Ongoing steps 2013
– EBA recommendations submitted to GTS and DH Bio
– New questionnaire for EC surveys on VNRD submitted to SANCO
– EBA recommendations submitted to WHO, IFFRC
– EBA recommendations to be presented to EU Parliament
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Strategic Objective 2:
Performance improvement through
collaboration
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Current activities and projects
to improve performance through collaboration
Working groups / networks:
EBA promoted EU funded projects:
• Benchmarking
• Joint procurement: EPG + GPO
• Collaborative quality management
(validation + supplier audits)
• Tissues and Cells
• Education and training
• VNRD versus paid donations
• Plasma from VNRD (2013)
• SOP
• EUBIS
• EUOBUP
• DOMAINE
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Performance improvement through collaboration:
EBA Benchmarking
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KPI monitoring and sharing (confidentially): 18 members
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Inter-members visits
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Workshops on collection efficiency, processing efficiency,
donor deferral, platelet supply chain
– With follow ups to assess effectiveness
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Flying Squad (experts in Lean)
– Visits to Malta and Estonia 2011: positive outcomes
– Visits to Finland and Belgium (FR speaking): 2012
– Visit to Ireland: 2013
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Performance improvement through collaboration:
Joint procurement
• Objective: saving money for members, improving quality of MDs,
alternate source of funding for EBA
• Eurobloodpack (EPG) WG: UK, IE + NL. Proof of concept
– First bags purchasing expected in 2013
– Significant savings (IE, UK, not NL)
– Benefits from collaboration for common specification, supplier audits,
validation
• Grouped Purchasing Organisation (GPO)
– DGP survey (2012): EBA members globally agree
– Negometrix survey (2012): no legal obstacle
– Creation of an EBA GPO: accepted in principle, expected to be effective in
2013
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Performance improvement through
collaboration: Collaborative Quality Management
• Collaboration between EBA members to audit suppliers of
critical goods within the framework of an agreed policy and
standard process.
• Pilot: 4 audits
– Positive response from suppliers (satisfactory corrective
action plans)
– Reports shared by 13 BEs
– Cost effectiveness established
• Manuscript submitted to peer reviewed journal (2013).
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Performance improvement through collaboration:
Tissues and Cells
• Objectives:
• Harmonization of practices: benchmarking in collaboration
with the initial EBA Benchmarking Working Group
• Expertise to relevant EU bodies (EU Parliament
resolution on VNRD for T&C, 09/2012)
• Education programme to help improving practices
• Contributed to the EBA Book: Tissues and Cells from Human
Origin
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Improving performance through Collaboration:
Education and Training
• Project of training and Post Graduate Diploma in Donor
Health Management, led by Sanquin, with EU funding
• Kick-off meeting (Dec)
• Application file submission (Jan 2013)
• EMTACT Course: “European Blood Alliance (EBA): The
transfusion’s challenges of tomorrow” (available on EMTACT
website)
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Strategic Objective 3:
Support to national and European
authorities to promote best
practice
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Support to national and European authorities
to promote best practice
• Bringing expertise to EU Directorate General of Health and
Consumers (DG SANCO): eg EIDs, VNRD
• Presenting the information in a practical way to European
Institutions: manuals, EBA book
• Influencing the preparation of the future EU Regulation:
– EU Parlement resolution on VNRD for T&C (EBA – CoE 2012)
– MD & IVD Regulations: ongoing
– Blood (EBA WG 2013) and Tissues Directives/regulations (expected)
• Supporting the European Committee on Blood Transfusion of
CoE (CD-P-TS) influence on EC for future Blood regulations:
the chapter on Quality Assurance of the CoE Blood Guide will
become binding in 2015 (18th edition of CoE Blood Guide)
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EU Blood Inspection Systems:EuBIS
www.eubis-europe.eu
• First project that has brought regulators and manufacturers
together to develop criteria and standards jointly.
• Two manuals:
– EUBIS Common criteria for the inspection of Blood Establishments
– EUBIS Audit/inspection training guide
• Manuals and training sessions aimed to assist:
– BE’s to optimise their quality system and self-inspection process / to
prepare for regulatory inspections by CA’s
– CA’s to use the manual as a reference for implementation of EC
legislation related to regulatory inspections
– Common practice, expertise, mutual knowledge
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Strategic Objective 4:
Information exchange and
dissemination
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Internal communication and information
management for/from members-partners
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Regular mail exchanges, Q/A through EBA office
Information/experience sharing: active in each WG
Member consultations: followed by report and conclusions
Community based web-tool to facilitate exchanges: Basecamp
Web conferences for EBA WG/Members/Staff
EBA blogs
Coordination of WGs: forum of EBA WG chairs (2013)
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Leveraging influence of EBA on policy and decision
makers - improving stakeholder engagement
• EBA book (2013): Blood, tissues and cells from human origin:
the European Blood Alliance Perspective. Accessible at
issuu.com/ebloodalliance
• EBA publications in peer reviewed journals (ex)
– Donor cycle and donor segmentation: new tools for improving blood
donor management. Vox Sang. 2013
– Renewed considerations on ethical values for blood and plasma
donations and donors. Blood Transfus 2013.
• Participation in the stakeholder engagement sub-group of
the ABO Risk Based Decision Making WG
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Developing international Collaboration
• Council of Europe
– Blood supply management (TS003); EU report on blood landscape ;
VNRD; Plasma supply management
• Alliance of Blood Operators (ABO) and America’s Blood
Centers (ABC)
– Regulatory managed convergence / apheresis connector
standardisation; Horizon scanning
• WHO
– Self-sufficiency from VNRD; Essential Medicine Lists
• ISBT
– working party on blood supply management; VNRD
• Asia Pacific Blood Network
– information exchange.
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Thanks for your attention!
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