Cairo Atmc 8 Prosp

Please visit us on www.ints.fr

Sophie Marechal-Francon, MA
Sr. Delegate for International Activities
+33 6 89 30 00 32

Institut National de la Transfusion Sanguine (INTS)
EuroNet-TMS, the European Network of Transfusion Medicine Societies
6, rue Alexandre Cabanel І F-75739 Paris Cedex 15 І France

Hilton Pyramids Golf Resort, Cairo (Egypt) – December 1 – 4, 2010 1


« Bismillahi Rahmani Raheem »

Dear ATMC 8 attendee,

First of all let me thank you for granting me the opportunity to introduce my institution, the French national
institute of blood transfusion and the research, reference and educational activities we deal with, which we
hope will be of interest to you.

I’m very keen to learn from your Blood Transfusion organization and requirements, the system of transfusion
medicine as implemented by the Ministry of Health in your country, and your educational system in blood
transfusion.

Undoubtdely our today’s discussion will help our institutions learn from each other, and I’m confident it will lay
the grounds for future collaboration project possibilities, for the sake of blood transfusion and blood donors.

I remain anytime at your disposal for any information complement.

With best regards.

Sophie Marechal-Francon
Sr. Delegate for International Activities, INTS



Introduction to the INTS and its Role

 The INTS is the French national institute of blood transfusion.

 It was founded in 1994 by the French authorities (under the aegis of two ministries: Ministry of Public
Health and Ministry of Education and Research) to break up with the mergers that had led to the infected
blood scandal which burst in France in 1991.

 The INTS is located in Paris, in the 15th arrondissement (Eiffel Tower area) and has a second site located in
Paris 11th arrondissement (near the Bastille), dedicated to the CNRGS (French national reference centre for
blood groups).

 INTS staff: 180 persons altogether

 A 3-fold assignment in Blood Transfusion: Research, Reference, and Education & Training.

 5 laboratories:
 Blood-transmissible infectious agents (reference lab. for B,C, Delta Hepatites and HIV)
 Platelet Immunology
 Human genetics
 Immunogenetics & applied molecular approaches (CNRGS: French reference centre for blood groups)
 Molecular genetics of blood groups, in association with the INSERM (French national institute for
health and medical research) entity located in our premises.



The CNRGS: Role and Specificities

 The CNRGS (French national reference centre for blood groups) is a unique structure in Europe in terms of
responsiveness. It guarantees 24/7 a close surveillance on biological and clinical red blood cell compatibility linked to
the 30 blood group systems currently identified, and more especially for rare blood types. Please kindly read the
enclosed specific CNRGS brochure to know more.

 The CNRGS receives blood samples from all over the world – for example, from the centre of armed forces in Riyadh,
Saudi Arabia - for complex immuno-haematology case-solving, including rare blood type screening.

 Highlights in 2009:

 Renewal of the Certification for CE type by G-MED/LNE (Paris) for the national reference red blood cell panel
(DMDIV marked CE, production laboratory certified NF EN ISO/13485)

 COFRAC approval for the renewal accreditation of the reagent batch control laboratory (check-up of reagent
batches as per European directive 98/79/CE Annex IIA, according to NF EN ISO/CEI 17025 standard).

 COFRAC approval for the accreditation of the specialized immuno-haematology laboratory as per NF EN ISO/CEI
17025 standard.

 Implementation of a BioArray® high throughput genotyping platform in response to a growing demand in
genotyping requests, in particular for Duffy, Kidd and MNS systems.

 Set up of a quality external appraisal program for the specialized immuno-haematology laboratory in
collaboration with the AFSSAPS (French national agency for health product safety).



International Presence & Development

 In 2002, Prof. Philippe Rouger, CEO to the INTS, founded EuroNet-TMS
(European network of Transfusion Medicine Societies):

 17 countries from scratch – over 30 countries in 2010
 Missionned by national health authorities to enquire on blood transfusion practices in Europe (for
example: pre-donation Hb testing, autologous transfusion, donor compensation, HTLV prevention, etc …)
 3 meetings a year in European cities to compile practices and field statistics to be reported to European
authorities for drafting Directives on blood transfusion recommendations and good practices.
 Editor of a white paper every 5 year: ‘Blood Transfusion in Europe: The White Book 2005’ ; we are
currently working on the 2011 edition in collaboration with the EBA (European Blood Alliance).

 All our heads of departments are authors of multiple international publications and are regularly invited to
deliver state of the art lectures in their specific fields in transfusion medicine events all over the world.

 Every year since 1992, the INTS set up a 2-day international symposium in Paris focusing on specific scientific
and technological advances in transfusion where high-flying experts from all over the world meet and display
their experiences and practices. The event program is issued by a dedicated scientific committee.

2010 The role of blood antigens and associated molecules in red cell biology: from molecular approaches to clinical applications (with INSERM)
2009 Molecular Biology of red cells : from research to diagnosis (with SFTS)
2008 Adhesion molecules in red cell-endothelium interaction: impact on sickle cell and malaria
… the complete list of our international symposia is available from our website www.ints.fr



International Presence & Development
INTS international involvement in 2009:
 74 collaborations in Europe, USA, Asia, Africa, Near-East
57% INTS-INSERM and CNRGS, 19% Virology, 13% Platelet Immunology, 11% molecular biochemistry.

 49 invitations to deliver lectures in Europe, USA, Asia, Canada and Brazil
72% INTS-INSERM and CNRGS, 12% molecular biochemistry, 10% Platelet immunology, 6% Virology.

 For 5 years, Prof. Jean-Jacques Lefrère, head of our Virology Dept, has been involved in WHO-supported
collaborative projects for implementing 70 research laboratories (of which 10 implemented so far) and quality
control policies in 15 African countries in partnership with the Institut Pasteur.

 Also, during the ISBT Congress in Berlin last June, the INTS received from countries in the MENA area a
growing demand for educational services, transfusional advice, quality and continuous improvement policy
implementation, blood groups, etc …

 So we have decided to emphasize our visibility:

 In creating and implementing an English website developing promotion tools (eg INTS BreakingNews) to keep our
contacts aware of our scientific developments, our participation in international events so we can anticipate on
meetings and better answer their requirements.

 In taking part as exhibitors/lecturers in international events: Hyderabad, Amsterdam, Tehran, Lisbon (ISBT),
Abidjan are featured in the INTS 2010/2011 agenda.

 In setting up visits of potential foreign partners in their country in order to analyze their project developments and
requirements and try to find out matching possibilities with our range of services.



First Education & Training structure for Blood Transfusion in France

 Whatever for blood transfusion professionnals, healthcare staff, or the personnel in
biological and medical analysis laboratories, the INTS proposes training curricula and
methods of quality matching all requirements.

 On 15 March 2006, the INTS was granted the HAS (French High Health Authority)
approval for EPP (practice appraisal) and for CME on 15 May 2007. To comply with
new MOH regulations in 2010 (especially the HPST Hospital-Patient-Safety-Territory
public health reforming law), both activities have now merged into the CPD
(Continuous Professional Development).

 Over 3,000 CME trainees in 2009 - 200 teachers from various entities
(Universities, French Blood Establishment (EFS), hospital haematologists, qualiticians, transfusion experts wishing
to share a field experience and knowledge).

 The INTS Documentation & Information Centre is the unique French thesaurus for
blood transfusion and related regulations in hematology, immuno-hematology,
virology, biochemistry, molecular biology, genetics, public health, quality.
A library of 3,000 books and manuals, 700 PhD theses, 100 periodicals and an
internet station are at the disposal of trainees and blood transfusion professionals.




HIGHER EDUCATION

 The first higher education courses in blood transfusion in France were delivered in
1975 by the CNTS (predecessor of the INTS).

 Affiliated to Pierre et Marie Curie University (Paris VI), René Descartes (Paris V),
Denis Diderot (Paris VII) and Jules Verne-Amiens, the INTS delivers 6 higher
degrees:

 Transfusion Technology Capacity (CTT)
 Specialized degree in haemobiology-transfusion (DESC)
 Blood Transfusion Higher (University) Degree (DUTS)
 Inter-university degree for ‘therapeutic principles in transfusion technology’ (D3T)
 Higher degree for quality and safety in blood components (DUQSP)
 Higher degree for Continuous Improvement and Quality implementation (DFQ)



6 Higher Degrees in Transfusion Medicine in France

Degree How long ? For Whom ?
Transfusion Technology Capacity 1 year MDs
(CTT) (120 hours)
Blood Transfusion University Degree (DUTS) 1 year MDs
(220 hours) PharmDs
Scientists
Specialized Higher Degree in Haemobiology- 4 + 1 years MDs
Transfusion (DESC) Residents
Inter-University Degree for Therapeutic 1 year MDs
Principles in Transfusion Technology (D3T) (100 hours) PharmDs
Scientists
Higher Degree for Quality and Safety of Blood 1 year MDs
Components (DUQSPS)
(180 hours PharmDs
+ a 3-week training)
Higher Degree for Continuous Improvement 1 year Biologists
and Quality Implementation (DFQ)
(140 hours) Qualiticians




CONTINUING MEDICAL EDUCATION (CME)

 Our panel of some 50 training modules encompasses all transfusion activities of all
professional categories wishing to maintain or develop their knowledge and skills.

 5 years ago, 100,000 was the estimated number for transfusion medicine
professionals in France. So the INTS has decided to put the emphasis on its CME
activity across a 3-fold organization: INTS in-house courses, remote teaching with
regional partnerships, and e-learning.

 Trainees’ occupations: 54% technicians, 25% MDs, 11% nurses, 4% PharmDs, 3%
clerks, 2% others.

 Constantly updating its pedagogical methodologies to best comply with latest quality
standards, the INTS delivers theoretical academic classes, monitored progress
sessions, practical exercises, knowledge appraisal, access to the Documentation &
Information Centre.





 The INTS graduating sessions are non-university graduating trainings composed of several
modules teaching blood transfusion newcomers with the necessary job skills. These training
sessions have seen their graduation level certified with the following regulations:
 Decree on 12 May 2000, validating the graduation level of some of our training sessions
meant for blood transfusion professionals.

 Decree on 3 December 2007, as regards qualifications for certain blood repository
personnels, featuring a list of training sessions meant for these personnels.

 Regulatory graduating training sessions at the INTS:
Erythrocyte immuno-haematology (levels 1 and 2) - blood-transmissible infectious agents - good
practices of labile blood product delivery (in-house course) - biological qualification of blood
donations - preparation of labile blood products - quality approach in blood transfusion - blood
collections in France: ethics, quality, safety – management of a blood repository (in-house
course) – management of an emergency / intermediate blood repository (e-learning + in situ
practical training + in-house appraisal) – good practices of labile blood product delivery (e-
learning + in-house).




CONTINUING MEDICAL EDUCATION (CME) - E-learning

 Since January 2009, e-learning training sessions were implemented and delivered at
the INTS in its quality of CME-accredited education and training institution, on the
request of applicants wishing for easier update thanks to a flexible learning method.

 Our e-learning curricula are initiated, drafted, reviewed and constantly updated by
experts in their respective fields. Their variety of origins and positions made it
possible to build comprehensive and high-quality programmes recognized as such.

 4 e-learning programmes in 2010/2011:
 EF01: Management of an emergency and/or intermediate blood repository
 EF02: Transfusion process and controls
 EF03: Good practices for the delivery of labile blood products
 EF04: Operation processes in an emergency and/or intermediate blood repository.





 Partnering & Remote Training Sessions:
Thanks to its partnerships with the EFS (French Blood Establishment), CTSA (transfusion centre of armed forces),
healthcare agencies, regional hospitals, other education & training facilities sharing the same objectives, the INTS
implemented a skill-sharing synergy to better fulfil its public assignments and to address the requirements of
regional professionals by setting up on-site training sessions.

For example, a large number of regulatory training sessions meant for blood repository personnels have been
delivered across multiple French regions for 2 years.

 Continuing Medical Education (CME)
Current regulations stipulate that MDs should earn 250 credits every 5 year, based on the following scale system:

 In-house training as delivered by approved structures: category 1 (8 credits/day)
 Individual and remote training: category 2, limited to 40 credits
 Formative professional situations: category 3, limited to 100 credits
 Practice appraisal: category 4, limited to 100 credits.





 Practice appraisal:
- A regulatory obligation for all MDs (Decree 2005-346 on 14 April 2005 and Decree 2006-653 on 2
June 2006) in response to a healthcare and public safety requirement.

= 100 to 250 credits every MD should earn within 5 years at the latest.

- For so doing, the INTS implemented:
- an innovative remote management site for practice appraisal in partnership with the STIC
Santé laboratory at Nice-Sophia Antipolis University,
- a remote coaching-based follow-up system driven by a mentor, expert in this specific
course and conversant with this process-oriented online technology.

- Especially meant for MDs practising in blood transfusion and wishing to perform practice appraisal
within a CPD (Continuous Professional Development) process.





 CPD (Continuous Professional Development)
A new combination of CME + practice appraisal as per the 2009 HPST regulations

 Definition: a continuous process of lifelong development and learning with 3 orientations:
medical expertise, risk management, professional values and responsibility.

 Currently mandatory for MDs, soon to be for technicians and nurses.

 Objectives: practice appraisal, knowledge enhancement, improvement of healthcare quality
and safety, better consideration for public health priorities, medical-driven control on health
expenditures.

 INTS method: to gain efficaciousness and boost its CME and practice appraisal system within
the CPD, the INTS implemented:

 a scientific committee, a steering committee and an appraisal committee on a shared basis with learned
societies involved in transfusion technology and medicine (SFTS, SFVTT, SFH, SFBTC).

 2 operational structures for CME and Practice appraisal, controlling the adequacy to requirements and
quality of our service offer within the Education and Training Department.



The Cognitive Circles of Today’s Medical Practice

Continuing
Medical Competences Accreditation
Education
(CME)

Continuous
Professional
Qualifications Certification
Development
(CPD)



Conclusion

 Training is all the more important as it is a basic element for quality assurance
system, accreditation and certification procedures.

 The development of ‘Training & Information’ is the key to efficacy in safe
transfusion at every stage of the chain, from the donor to the recipient.

 ‘Lifelong’ learning is the best guarantee to secure stable medical activities and
placing ‘the right person in the right job’ for the best efficaciousness and transfusion
safety for the patients.

 We, at the INTS, are ready and willing to share with all countries interested in
improving the safety of blood transfusion, the best of our knowledge and experience
in honor of all voluntary, benevolent, anonymous and non remunerated donors
generously giving their blood to save people’s lives.

Thank you for your attention.



The Transfusion Medicine Education System
in the European Union

Source: ‘Blood Transfusion in Europe: The White Book 2005’



Initial Medical Training for MDs in Europe

 Training period : 4 to 6 years
 University cursus : specialty or not

Teaching of Transfusion Medicine
included in the Undergraduate Curriculum
A B C D D E F F E G I I L N N P S
U E H E N S I R N R R T U L O R W
T L E U K P N A G C E A X D R T E

√ √ √ √ √ - √ √ √ √ - - √ √ - √

Transfusion Medicine
included as a Medical Specialty

√ - - √ - - - √ √ √/-
- - - √ √ √ √



Requirement for MDs & Scientists in Europe

Fellowship Programme in Transfusion Medicine
- - - √ - - - √ - - - - - √ √ √ √

Requirements for Board Certification

√ - - √ - nc - √ - - - - - √ √ √ -

Requirements for Continuing Education

√ √ √ - - √ - √ √ - - √ - √ - √ -

Requirements for a CME Credit System

√ √ √ √ - nc - √ √ √ √ √ - - - - -

nc : no comment



Training and Education for Nurses in Europe

Official Programmes for Nurses
in Phlebotomy or Transfusion Practices

- - - - - - √ - - √ √ √ - - √ - -
Training Programmes for Transfusion Nurse Specialists

- - - - - - - - - - - - - - - - -
Requirements of a Certification System

- - - - - nc - - - - - √ - - - - -
Requirements for Continuing Education

- - √ - - nc √ √ √ - √ √ - - - - -



So what with Technologists ? Three issues

What role in the Transfusion field ?

No specific program
during the Initial Medical Training

No certification,
e.g. ‘Specialist in Blood Banking Technology’



Categories of Personnel involved in Europe

Categories of Personnel involved in Phlebotomy

D
D IH N/ N/
N N N/ nc N N N nc N N nc nc N
N S T T
N

Component Preparation
D
N/ nc IH N/ C Q nc nc N/
N T T T N T S T S T T T T
N

Laboratory Work
nc T/ N/ C nc nc
T T T T N T T C T S T T T T
S

Testing
T/ C
T T T T nc N T T C T S T T nc nc T T
S

DN : Doctor Nurse N : Nurse IHS : in home trained staff
CS : Clinical Scientist QT : Qualified by Training T : Technician
nc : no comment


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