cairo atmc 8 prosp

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

Please visit us on www.ints.fr

Sophie Marechal-Francon, MASr. 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 Societies6, rue Alexandre Cabanel І F-75739 Paris Cedex 15 І France

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http://www.ints.fr/�



« 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 wehope 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 bloodtransfusion.

Undoubtdely our today’s discussion will help our institutions learn from each other, and I’m confident it will laythe 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-FranconSr. Delegate for International Activities, INTS

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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 infectedblood 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.

Introduction to the INTS and its Role

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The CNRGS: Role and Specificities

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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 reagentbatches 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).




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 Europeanauthorities 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 scientificand 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

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INTS international involvement in 2009:

74 collaborations in Europe, USA, Asia, Africa, Near-East57% INTS-INSERM and CNRGS, 19% Virology, 13% Platelet Immunology, 11% molecular biochemistry.

49 invitations to deliver lectures in Europe, USA, Asia, Canada and Brazil72% 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-supportedcollaborative projects for implementing 70 research laboratories (of which 10 implemented so far) and qualitycontrol 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 policyimplementation, 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 ourcontacts 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.

International Presence & Development

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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 withnew MOH regulations in 2010 (especially the HPST Hospital-Patient-Safety-Territorypublic 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 wishingto 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.

First Education & Training structure for Blood Transfusion in France

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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 higherdegrees:

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)

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6 Higher Degrees in Transfusion Medicine in France

Degree How long ? For Whom ?Transfusion Technology Capacity(CTT)

1 year(120 hours)

MDs

Blood Transfusion University Degree (DUTS) 1 year(220 hours)

MDsPharmDsScientists

Specialized Higher Degree in Haemobiology-Transfusion (DESC)

4 + 1 years MDsResidents

Inter-University Degree for Therapeutic Principles in Transfusion Technology (D3T)

1 year(100 hours)

MDsPharmDsScientists

Higher Degree for Quality and Safety of Blood Components (DUQSPS)

1 year(180 hours

+ a 3-week training)

MDsPharmDs

Higher Degree for Continuous Improvement and Quality Implementation (DFQ)

1 year(140 hours)

BiologistsQualiticians

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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 medicineprofessionals 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 withregional 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 qualitystandards, the INTS delivers theoretical academic classes, monitored progresssessions, practical exercises, knowledge appraisal, access to the Documentation & Information Centre.

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The INTS graduating sessions are non-university graduating trainings composed of severalmodules 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 repositorypersonnels, 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 blooddonations - preparation of labile blood products - quality approach in blood transfusion - bloodcollections 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).


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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 itpossible 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.

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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.


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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 STICSanté laboratory at Nice-Sophia Antipolis University,

- a remote coaching-based follow-up system driven by a mentor, expert in this specificcourse and conversant with this process-oriented online technology.

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


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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 qualityand safety, better consideration for public health priorities, medical-driven control on healthexpenditures.

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

a scientific committee, a steering committee and an appraisal committee on a shared basis with learnedsocieties 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.


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The Cognitive Circles of Today’s Medical Practice

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ContinuingMedical

Education(CME)

ContinuousProfessional

Development(CPD)

Competences

Qualifications

Accreditation

Certification




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.

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The Transfusion Medicine Education Systemin the European Union

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

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Initial Medical Training for MDs in Europe

Training period : 4 to 6 years

University cursus : specialty or not

Teaching of Transfusion Medicineincluded in the Undergraduate Curriculum

AUT

BEL

CHE

DEU

DNK

ESP

FIN

FRA

ENG

GRC

IRE

ITA

LUX

NLD

NOR

PRT

SWE

√ √ √ √ √ - √ √ √ √ - - √ √ - √

Transfusion Medicine included as a Medical Specialty

√ - - √ - - - √ √√/-

- - - √ √ √ √

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Requirement for MDs & Scientists in Europe

Fellowship Programme in Transfusion MedicineAUT

BEL

CHE

DEU

DNK

ESP

FIN

FRA

ENG

GRC

IRE

ITA

LUX

NLD

NOR

PRT

SWE

- - - √ - - - √ - - - - - √ √ √ √

Requirements for Board Certification

√ - - √ - nc - √ - - - - - √ √ √ -

Requirements for Continuing Education

√ √ √ - - √ - √ √ - - √ - √ - √ -

Requirements for a CME Credit System

√ √ √ √ - nc - √ √ √ √ √ - - - - -

nc : no comment

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Training and Education for Nurses in Europe

Official Programmes for Nursesin Phlebotomy or Transfusion Practices

AUT

BEL

CHE

DEU

DNK

ESP

FIN

FRA

ENG

GRC

IRE

ITA

LUX

NLD

NOR

PRT

SWE

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

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

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

- - √ - - nc √ √ √ - √ √ - - - - -

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So what with Technologists ? Three issues

What role in the Transfusion field ?

No specific programduring the Initial Medical Training

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

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Categories of Personnel involved in Europe

Categories of Personnel involved in PhlebotomyAUT

BEL

CHE

DEU

DNK

ESP

FIN

FRA

ENG

GRC

IRE

ITA

LUX

NLD

NOR

PRT

SWE

DN N N

DN/N

nc N N NIHS

N/T nc N N nc nc N

N/T

Component Preparation

N T TDN/N

ncT N T

IHS

N/T

CS T

QT

nc nc N/T T

Laboratory Work

T T T Tnc T/

N T T CS

N/T

CS T T

nc ncT T

Testing

T T T T ncT/N T T C

ST

CS T T nc nc T T

DN : Doctor Nurse N : Nurse IHS : in home trained staffCS : Clinical Scientist QT : Qualified by Training T : Techniciannc : no comment

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cairo atmc 8 prosp

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