Transfusion Medicine: The French Model

210 Pages·2013·5.071 MB·English

by  Alain Beauplet, Remi Courbil, Jean-Marc Ouazan

TRANSFUSION MEDICINE
T
R
A
Edited by N TTRRAANNSSFFUUSSIIOONN
Alain Beauplet S
F
Rémi Courbil
U
Jean-Marc Ouazan
S
I
Founded on 1 January 2000 and placed under the authority of the Ministry O
of Health, the French Blood Establishment (EFS) is the sole public provider N MMEEDDIICCIINNEE

of national blood transfusion services in France. ISO 9001: 2008 certified M
and formed by seventeen regional establishments, the EFS manages the E
D
activities of collection, preparation, testing and distribution of labile blood I
C
products. Its role in maintaining the country’s self-sufficiency in labile I
N
blood products, whilst meeting the highest quality and safety standards, E
:
makes it a major contributor to public health in France.
Three major features set French transfusion medicine apart from other
international models:
(cid:51)(cid:1)(cid:33)(cid:38)(cid:1)(cid:17)(cid:42)(cid:25)(cid:38)(cid:27)(cid:29)(cid:5)(cid:1)(cid:26)(cid:36)(cid:39)(cid:39)(cid:28)(cid:1)(cid:28)(cid:39)(cid:38)(cid:25)(cid:44)(cid:33)(cid:39)(cid:38)(cid:1)(cid:33)(cid:43)(cid:1)(cid:45)(cid:38)(cid:28)(cid:29)(cid:42)(cid:40)(cid:33)(cid:38)(cid:38)(cid:29)(cid:28)(cid:1)(cid:26)(cid:48)(cid:1)(cid:30)(cid:39)(cid:45)(cid:42)(cid:1)(cid:30)(cid:39)(cid:45)(cid:38)(cid:28)(cid:33)(cid:38)(cid:31)(cid:1)(cid:40)(cid:42)(cid:33)(cid:38)(cid:27)(cid:33)(cid:40)(cid:36)(cid:29)(cid:43)(cid:13)(cid:1)
it is anonymous, voluntary, non-remunerated and not-for-profit.
“Ethical blood donation” is the foundation of the French model; Edited by
(cid:51)(cid:1)(cid:44)(cid:32)(cid:33)(cid:43)(cid:1)(cid:37)(cid:39)(cid:28)(cid:29)(cid:36)(cid:1)(cid:33)(cid:43)(cid:1)(cid:36)(cid:29)(cid:28)(cid:1)(cid:26)(cid:48)(cid:1)(cid:25)(cid:1)(cid:43)(cid:33)(cid:38)(cid:31)(cid:36)(cid:29)(cid:1)(cid:31)(cid:39)(cid:46)(cid:29)(cid:42)(cid:38)(cid:37)(cid:29)(cid:38)(cid:44)(cid:1)(cid:25)(cid:31)(cid:29)(cid:38)(cid:27)(cid:48)(cid:5)(cid:1)(cid:44)(cid:32)(cid:29)(cid:1)(cid:16)(cid:17)(cid:23)(cid:5)(cid:1)(cid:47)(cid:32)(cid:33)(cid:27)(cid:32)(cid:1)(cid:32)(cid:25)(cid:43)(cid:1)
Alain Beauplet
a monopoly over the distribution of labile blood products to ensure
constant availability across the country; Rémi Courbil
(cid:51)(cid:1)(cid:28)(cid:29)(cid:36)(cid:33)(cid:46)(cid:29)(cid:42)(cid:48)(cid:1)(cid:33)(cid:43)(cid:1)(cid:33)(cid:38)(cid:43)(cid:29)(cid:40)(cid:25)(cid:42)(cid:25)(cid:26)(cid:36)(cid:29)(cid:1)(cid:30)(cid:42)(cid:39)(cid:37)(cid:1)(cid:33)(cid:37)(cid:37)(cid:45)(cid:38)(cid:39)(cid:32)(cid:25)(cid:29)(cid:37)(cid:25)(cid:44)(cid:39)(cid:36)(cid:39)(cid:31)(cid:48)(cid:1)(cid:3)(cid:44)(cid:32)(cid:29)(cid:1)(cid:16)(cid:17)(cid:23)(cid:1)(cid:33)(cid:43)(cid:1)(cid:44)(cid:32)(cid:29)(cid:1)
Jean-Marc Ouazan
largest medical testing laboratory in France) and transfusion support,
which is also provided by the EFS, to guide the prescriber towards the
A
“right prescription” (the right product for the right patient). . B
e
a
u
p
Through the EFS, the French State is therefore responsible for self- le
t
sufficiency, health safety and the efficient management of the rare and , R
. C
precious commodity that is human blood. The French model is one of the ou
rb
feefwfic tieon pcryo.vide both “ethical blood donation” and internationally recognized il, J.M
. O
u
a
z
a
n
ISBN: 978-2-7420-1120-9
TRANSFUSION MEDICINE
T
R
A
Edited by N TTRRAANNSSFFUUSSIIOONN
Alain Beauplet S
F
Rémi Courbil
U
Jean-Marc Ouazan
S
I
Founded on 1 January 2000 and placed under the authority of the Ministry O
of Health, the French Blood Establishment (EFS) is the sole public provider N MMEEDDIICCIINNEE

of national blood transfusion services in France. ISO 9001: 2008 certified M
and formed by seventeen regional establishments, the EFS manages the E
D
activities of collection, preparation, testing and distribution of labile blood I
C
products. Its role in maintaining the country’s self-sufficiency in labile I
N
blood products, whilst meeting the highest quality and safety standards, E
:
makes it a major contributor to public health in France.
Three major features set French transfusion medicine apart from other
international models:
(cid:51)(cid:1)(cid:33)(cid:38)(cid:1)(cid:17)(cid:42)(cid:25)(cid:38)(cid:27)(cid:29)(cid:5)(cid:1)(cid:26)(cid:36)(cid:39)(cid:39)(cid:28)(cid:1)(cid:28)(cid:39)(cid:38)(cid:25)(cid:44)(cid:33)(cid:39)(cid:38)(cid:1)(cid:33)(cid:43)(cid:1)(cid:45)(cid:38)(cid:28)(cid:29)(cid:42)(cid:40)(cid:33)(cid:38)(cid:38)(cid:29)(cid:28)(cid:1)(cid:26)(cid:48)(cid:1)(cid:30)(cid:39)(cid:45)(cid:42)(cid:1)(cid:30)(cid:39)(cid:45)(cid:38)(cid:28)(cid:33)(cid:38)(cid:31)(cid:1)(cid:40)(cid:42)(cid:33)(cid:38)(cid:27)(cid:33)(cid:40)(cid:36)(cid:29)(cid:43)(cid:13)(cid:1)
it is anonymous, voluntary, non-remunerated and not-for-profit.
“Ethical blood donation” is the foundation of the French model; Edited by
(cid:51)(cid:1)(cid:44)(cid:32)(cid:33)(cid:43)(cid:1)(cid:37)(cid:39)(cid:28)(cid:29)(cid:36)(cid:1)(cid:33)(cid:43)(cid:1)(cid:36)(cid:29)(cid:28)(cid:1)(cid:26)(cid:48)(cid:1)(cid:25)(cid:1)(cid:43)(cid:33)(cid:38)(cid:31)(cid:36)(cid:29)(cid:1)(cid:31)(cid:39)(cid:46)(cid:29)(cid:42)(cid:38)(cid:37)(cid:29)(cid:38)(cid:44)(cid:1)(cid:25)(cid:31)(cid:29)(cid:38)(cid:27)(cid:48)(cid:5)(cid:1)(cid:44)(cid:32)(cid:29)(cid:1)(cid:16)(cid:17)(cid:23)(cid:5)(cid:1)(cid:47)(cid:32)(cid:33)(cid:27)(cid:32)(cid:1)(cid:32)(cid:25)(cid:43)(cid:1)
Alain Beauplet
a monopoly over the distribution of labile blood products to ensure
constant availability across the country; Rémi Courbil
(cid:51)(cid:1)(cid:28)(cid:29)(cid:36)(cid:33)(cid:46)(cid:29)(cid:42)(cid:48)(cid:1)(cid:33)(cid:43)(cid:1)(cid:33)(cid:38)(cid:43)(cid:29)(cid:40)(cid:25)(cid:42)(cid:25)(cid:26)(cid:36)(cid:29)(cid:1)(cid:30)(cid:42)(cid:39)(cid:37)(cid:1)(cid:33)(cid:37)(cid:37)(cid:45)(cid:38)(cid:39)(cid:32)(cid:25)(cid:29)(cid:37)(cid:25)(cid:44)(cid:39)(cid:36)(cid:39)(cid:31)(cid:48)(cid:1)(cid:3)(cid:44)(cid:32)(cid:29)(cid:1)(cid:16)(cid:17)(cid:23)(cid:1)(cid:33)(cid:43)(cid:1)(cid:44)(cid:32)(cid:29)(cid:1)
Jean-Marc Ouazan
largest medical testing laboratory in France) and transfusion support,
which is also provided by the EFS, to guide the prescriber towards the
A
“right prescription” (the right product for the right patient). . B
e
a
u
p
Through the EFS, the French State is therefore responsible for self- le
t
sufficiency, health safety and the efficient management of the rare and , R
. C
precious commodity that is human blood. The French model is one of the ou
rb
feefwfic tieon pcryo.vide both “ethical blood donation” and internationally recognized il, J.M
. O
u
a
z
a
n

Transfusion medicine:
the French model

Transfusion medicine:
the French model
Coordinated by
Alain Beauplet,
Rémi Courbil,
Jean-Marc Ouazan
ISBN: 978-2-7420-1120-9
Éditions John Libbey Eurotext
127 Avenue de la République
92120 Montrouge, France
Tel: [phone]
Email: [email protected]
http://www.jle.com
John Libbey Eurotext
42-46 High Street
Esher
KT10 9QY
United Kingdom
©
2013 John Libbey Eurotext. All rights reserved.
No part of this publication may be reproduced without the permission of the publisher or the Centre Français d’Exploitation du
Droit de Copie, 20 Rue des Grands-Augustins, 75010 Paris.
Preface
Transfusionmedicine
Blood transfusion is an essential, and irreplaceable, component of healthcare, underpinning modern medicine and
surgery.
Over time, blood transfusion practice has evolved, leading to the emergence of transfusion medicine as we know
it today –multidisciplinary and involving a series of complex processes.
Transfusion medicine now includes promoting donation, collecting blood from donors, and preparing and testing
products. These activities are followed by distribution and delivery, which are closely associated with immunohae-
matology or possibly histocompatibility testing and transfusion support, to ensure the appropriate use of blood
transfusion in patient management.
Safety is maintained through vigilance, monitoring and assessment processes targeting continual improvement in
quality, which also entails training, research and development.
TheFrenchmodel
To optimize the provision of this aspect of healthcare, responsibility for blood transfusion services is clearly divided
in France, with separation between:
– the producer of labile blood products (LBP): this role has been allocated to the French Blood Establishment
(EFS),acentralgovernmentagency(établissementpublicdel’État),whichhashadamonopolyoverthecollection,
preparation, testing and distribution of LBP since 1January 2000;
– the LBP user, i.e. health facilities (ES), whether public, private, semi-private or military, which transfuse the
products to patients.
Three major features set French transfusion medicine apart from other international models:
• in France, blood donation is underpinned by four founding principles: altruism, voluntarism, anonymity
and absence of profit, which are upheld by the EFS. These principles contribute to increased safety levels for
donors and recipients.
“Ethical blood donation” is the basis for the non-ownership and non-commercialization of the human body and
products derived therefrom, principles that are now enshrined in bioethics law.
It is also the unshakeable foundation of French society through the related concepts of generosity, solidarity and
selflessness;
• French lawmakers opted to give the EFS a monopoly over the distribution of LBP to guarantee across the
country:
–homogeneousdistributionofLBPtoalltypesofES(public,private,etc.)andareasofactivity(medicine,surgery,
obstetrics, etc.),
– optimal access to LBP meeting the individual needs of each recipient (specific processing or testing) and avoiding
the dispersion of stocks of these rare, precious and perishable products,
V
Transfusionmedicine:theFrenchmodel
– records of recipients enabling permanent traceability of the donor-donation-product-patient chain,
– self-sufficiency in LBP at all times, for which a single government agency is clearly and solely accountable;
• the strong link between immunohaematology, delivery and transfusion support, which is essential for health
safetyandisthecoreoftheFrenchbloodtransfusionmodel.Immunohaematologyisinseparablefromtheselection
of blood components and its sole purpose is to ensure appropriate delivery: the right product to the right patient.
The EFS also provides transfusion support to guide prescribers towards the “right prescription”, i.e. consistent
with current professional guidelines, the medical condition in question and patient characteristics. Transfusion
support is an essential component of optimal LBP management for optimal recipient safety.
And because the EFS is financed by the State, efficiency is a major strategic objective alongside self-sufficiency
and safety.
TheFrenchBloodEstablishment
The EFS, which was founded under the authority of the Ministry of Health on 1January 2000 by the Act of
1July 1998 and was ISO 9001 certified in 2008, is the sole public provider of national blood transfusion
services in France. Its role is to maintain the country’s self-sufficiency in LBP, whilst meeting the highest quality
and safety standards. Formed by 17regional establishments (14on the mainland and 3in overseas départements),
theEFSisamajorcontributortopublichealthinFrance,managingthecollection(in2011:3.2milliondonations
weremadeinits151permanentsitesand50,000annualmobilesessions),preparation,testing(withits17technical
platforms) and distribution of LBP (in 2011: 2.4 million packed red blood cells, 380,000 therapeutic plasmas and
29,000platelet concentrates) and delivery, for each patient, from its 156sites (in 2011: over 560,000 recipients
transfused in more than 1,900ES).
The EFS is also France’s largest medical testing laboratory with recognized expertise in immunohaematology (in
2011: 376million tests conducted) and histocompatibility (in 2011: 106million tests conducted). Finally, in
addition to its core purpose, the EFS provides treatments and conducts research in innovative areas such as engi-
neering and cell and tissue therapy.
The mapping of EFS processes (Figure1) shows the extent and complexity of its activities.
Every day, continuity in public transfusion services is ensured through the commitment and professionalism of
nearly 10,000EFS employees.
FrançoisToujas
ChairmanoftheEFS
VI
Preface
Figure1.MappingofEFSprocesses.
LBP:labilebloodproducts;IVDD:invitrodiagnosticmedicaldevices.
VII