RELATIONS BETWEEN INSTITUTIONS RELATIONS BETWEEN INSTITUTIONS AND BLOOD DONOR ASSOCIATIONSAND BLOOD DONOR ASSOCIATIONS

the Italian experiencethe Italian experience

Giuliano Grazzini, MD Giuliano Grazzini, MD

Director General National Blood CentreDirector General National Blood Centre

Istituto Superiore di SanitàIstituto Superiore di SanitàItalian National Institute of HealthItalian National Institute of Health

NATIONAL BLOOD CENTRENATIONAL BLOOD CENTRE

88thth International Youth Forum of IFBDO International Youth Forum of IFBDOCatania, ItalyCatania, Italy

2929thth August 2008 August 2008

Donation rate per 1,000 population in the world

CNS

Donations per 1,000

0 - 10

10.1 - 20

20.1 - 30

30.1 - 40

40.1 - 90

No data

Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005;45:224s-240s

Global population and global blood supply

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Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005;45:224s-240s

HDI = Human Development Index

Global human development index (HDI)and blood supply

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Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005;45:224s-240s

Paying for blood donations: still a risk?C. L. van der Poel, E. Seifried & W. P. Schaasberg

Vox Sanguinis (2002) 83, 285–293

CNS

Paid blood or plasma donors still have higher rates for

infectious disease markers than unpaid donors

Voluntary donors in Latin America (2003)

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Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005;45:224s-240s

Country Voluntary donors(%)

Argentina 8.0Bolivia 17.5Brazil 50.8Chile 6.0Colombia 41.7Costa Rica 49.0Cuba 100.0Ecuador 29.9El Salvador 10.0Guatemala 4.0Honduras 18.9Mexico 3.9Nicaragua 44.8Panama 1.9Paraguay 5.7Peru 5.3Dominican Republic 18.0Uruguay 81.4Venezuela 4.0

BLOOD SAVE LIVES

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WHO strategy for blood safety

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Estimated use of Red Cells in the world

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WHO strategy for blood safety

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WHO strategy for blood procurement

and blood safety

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REQUIREMENTS

WHO strategy for blood safetyPolicy

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WHO strategy for blood safetyQuality and safety

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WHO strategy for blood safetyQuality and safety

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WHO strategy for blood safetyAccess

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WHO strategy for blood safetyUse

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ITALIAN BLOOD SYSTEMITALIAN BLOOD SYSTEMESSENTIAL DATA ESSENTIAL DATA

- The Italian blood system is exclusively public

- It is part of the National Health Service

- Blood Transfusion Centres (BTCs) are, by law, hospital-based services

- Blood collection may be outsourced to authorized/accredited blood donor associations under the technical direction of BTCs

- Government and regional health authorities are strongly committed to promote voluntary, responsible, non-remunerated, periodical (repeat) blood donation

- Blood donors:

~ 1,600,000 2.9 % of total population 4.5% of 18-65 y 42 / 1000 [18-65] pop

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ITALIAN BLOOD SYSTEMITALIAN BLOOD SYSTEMESSENTIAL DATA ESSENTIAL DATA

2007

- ~ 2.4 x 106 whole blood (41.5/1000 pop/year) and ~ 0.5 x 106 apheresis donations (trend: 3 x 106

overall donations)

- 49.5 donations (WB + apheresis) /1000 pop/year

- ~ 45% whole blood collection outsourced to authorized blood donors associations (~ 1,300 collection sites), under the technical supervision of BTCs

- ~ 6.5 x 106 BCs produced annually

- ~ 0.5 x 106 BCs exchanged among BTCs: 80% within regions, 20% inter-regionally (mostly from northern to southern regions)

- ~ 4 x 106 BCs transfused annually (~ 11,000 daily)

- RBCs transfused: ~ 39.5 / 1000 pop / year (regional range: 25 - 57)

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- National self sufficiency of labile products has been gained since 2003, through planned/occasional blood component transfer among regions

- As to self sufficiency, significant gaps exist among regions, being some southern and insular regions systematically sustained by others

- Thoroughly reliable data on regional RBC consumption has never been available from the old “National Blood & Plasma Registry”

- National data on interregional financial balance of healthcare services show that most self sufficient southern regions are not in need due to significantly lower general healthcare delivery capacity (a considerable number of patients seek healthcare in central and northern regions)

- In most central, southern and insular regions the number of first time donors is significantly higher than in the centre-north (25-35% vs. 10-15%)

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ITALIAN BLOOD SYSTEMITALIAN BLOOD SYSTEM ESSENTIAL DATA ESSENTIAL DATA

Italian RegionsItalian Regions

WB/RBC donation indexWB/RBC donation index20072007

> 50

40-50

30-40

< 30

ITALY: 41.5

WB/RBC donations /1,000 pop /year

CNS

58.6

25

MAX

MIN

- National self sufficiency of stable blood products is at different levels for each product

- In 2007, ~ 607,000 Kgs plasma were delivered to pharmaceutical industry for contract manufacturing albumin, IVIg, factor VIII, factor IX, prothrombin complex, antithrombin

- Considerable gaps exist among regions in the production of plasma for fractionation, all southern and insular regions being significantly if not dramatically below national average

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ITALIAN BLOOD SYSTEMITALIAN BLOOD SYSTEM ESSENTIAL DATA ESSENTIAL DATA

Italian RegionsItalian RegionsPlasma for fractionation (contract manufacturing)Plasma for fractionation (contract manufacturing)

20072007

> 15

10-15

5-10

< 5 Kg

ITALY: 10.3

Kg /1,000 pop /year

19.8 MAX

MIN

2.2

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Plasma delivered to pharmaceutical industryPlasma delivered to pharmaceutical industry(contract manufacturing)(contract manufacturing)

Italy 2000-2007Italy 2000-2007

400000

500000

600000

700000

2000 2001 2002 2003 2004 2005 2006 2007

Kgs

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Plasma derived productsPlasma derived productsNational estimates 2007National estimates 2007

Albumin(Kgs)

IVIg(Kgs)

Antithrombin

(UI x 106)

PD Factor VIII*

(UI x 106)

PD Fattore IX

(UI x 106)

PTC

(UI x 106)

Demand 2007 30,000 - 32,000 3,000 - 3,100 130 - 135 90 - 93 5.0 - 6.0 13 - 14

Demand / 106

pop / 2007510 - 545 51 - 54 2.2 - 2.3 1.5 - 1.6 0.08 - 0.1 0,2

Potential yields from

national plasma 2007

15,100 - 15,500 2,000 - 2,400** 100 -105 53 - 55*** > demand > demand

Actual national self sufficiency

rate~ 50% ~ 67% ~ 45%**** ~ 60% 100% 100%

Plasma derived productsEstimates

* Estimated demand includes all types of PD FVIII with MA in Italy** Pharmaceutical yields may vary depending on final product's purity*** Pharmaceutical yields critically depend on plasma FVIII content and characteristics of production process**** Limited by industry's production availability

Albumin(Kgs)

IVIg(Kgs)

Antithrombin

(UI x 106)

PD Factor VIII*

(UI x 106)

PD Fattore IX

(UI x 106)

PTC

(UI x 106)

Demand 2007 30,000 - 32,000 3,000 - 3,100 130 - 135 90 - 93 5.0 - 6.0 13 - 14

Demand / 106

pop / 2007510 - 545 51 - 54 2.2 - 2.3 1.5 - 1.6 0.08 - 0.1 0,2

Potential yields from

national plasma 2007

15,100 - 15,500 2,000 - 2,400** 100 -105 53 - 55*** > demand > demand

Actual national self sufficiency

rate~ 50% ~ 67% ~ 45%**** ~ 60% 100% 100%

Plasma derived productsEstimates

* Estimated demand includes all types of PD FVIII with MA in Italy** Pharmaceutical yields may vary depending on final product's purity*** Pharmaceutical yields critically depend on plasma FVIII content and characteristics of production process**** Limited by industry's production availability

HEALTHCARE IN THE ITALIAN HEALTHCARE IN THE ITALIAN GOVERNMENTAL FRAMEWORKGOVERNMENTAL FRAMEWORK

Agreements

REGIONAL GOVERNMENTS(Healthcare Departments)

National Laws & Regulatory acts

Permanent Government -Regions Conference

Healthcare issues to be applied nationwide

National essential healthcare services

Organizational issuesLocal healthcare needs

Regional laws &Regulatory acts

Public safety issuesSpecial national needs

National laws &Regulatory acts

NATIONAL GOVERNMENT(Ministry of Health)

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Regional technical & scientific coordination

Delivery of essential healthcare services

National technical & scientific coordination

Assessment, update, monitor adequate and

appropriate delivery, of essential healthcare

services

Since its implementation in 2001, it was deemed that the federalist governmental framework could exert negative effects on the national vision of self sufficiency of blood and blood products, and on the establishment of homogeneous standards of quality and safety nationwide

A long lasting demand existed for a substantial renewal of the 1990 blood law

Several regulatory aspects concerning transfusion medicine activities needed to be updated and made consistent with European directives

HENCE

A new legislative pathway was implemented in 2002, focusing on the need for a renewed, nationally coordinated blood system, complying with regional authorities’ organizational and legislative autonomy and with European directives (and recommendations).

2005: birth of a new blood law in Italy2005: birth of a new blood law in Italy

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NEW NATIONAL BODIES ENTRUSTED WITH THE NEW NATIONAL BODIES ENTRUSTED WITH THE

CO-ORDINATION OF THE ITALIAN BLOOD SYSTEMCO-ORDINATION OF THE ITALIAN BLOOD SYSTEM

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Settled at the Ministry of Health

Chaired by the Minister of Health

Composed of:

the 21 regional blood coordinators 4 representatives of blood donor associations 4 representatives of transfusion medicine scientific

societies 2 representatives of patients’ associations national secretariat c/o Dpt of Prevention Ministry of

Health

Consultation body for the Minister of Health for legislative/regulatory provisions, allowing relevant acts to be shared among the blood system’s institutional stakeholders, before issue

Co-operates with National Blood Centre

NATIONAL BLOOD TECHNICAL CONFERENCENATIONAL BLOOD TECHNICAL CONFERENCE“Consulta tecnica permanente per il sistema trasfusionale”“Consulta tecnica permanente per il sistema trasfusionale”

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Settled at the Italian National Institute of Health (INIH), in autonomous position

Directed by a Director General (must be a MD with suitable experience in transfusion medicine and healthcare management)

Executive board chaired by the Director, composed of:

President of the INIH 3 regional blood coordinators 3 representatives of blood donor associations

Hub of the national blood network, responsible for coordinating the 21 regional spokes, and for technical and scientific control of all transfusion medicine issues ruled by national laws and European directives and recommendations

Co-operates with National Blood Technical Conference

NATIONAL BLOOD CENTRENATIONAL BLOOD CENTRE“Centro Nazionale Sangue”“Centro Nazionale Sangue”

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BLOOD TRANSFUSION SERVICES IN ITALYBLOOD TRANSFUSION SERVICES IN ITALY

CNS

NBC

SELF SUFFICIENCY

SAFETYQUALITY

APPROPRIATENESS

National Blood Centre

National Blood Technical

Conference

Ministry of

Health

RegionalBlood

CoordinatingCentres

HealthTrusts

Blood Donors

Professionals

TransfusionServices

University

ScientificSocieties

Pharmaceutical

IndustriesR & DTECH. ASS.

THE ITALIAN BLOOD SYSTEMAccording to 21st October 2005 Law

“New discipline for blood transfusion activities and national production of blood derivatives”

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A NEW DEALA NEW DEAL

The national governance of the Italian transfusion network has been recently implemented. It is expected to represent the fundamental element for a new deal of the Italian Blood System, aimed at continuous improvement of blood policies and plans, tailored to guarantee high standards of quality and safety in transfusion medicine nationwide, complying with national and European legislative provisions.

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NBC is entrusted with technical and scientific control of all transfusion medicine issues ruled by national laws and European directives and recommendations, particularly:

blood and blood product self sufficiency

blood quality and safety

appropriate utilization of blood resources

accreditation of transfusion medicine activities

national blood information system

technology assessment

external quality assessment

national haemovigilance network

coordination of ITCBN (Italian Cord Blood Network)

control of medicinal products deriving from human plasma

audits and controls of plasma product industries

education and scientific research in transfusion medicine

promotion of voluntary, responsible, repeat blood donation

NATIONAL BLOOD CENTRE - TASKSNATIONAL BLOOD CENTRE - TASKS

CNS

2008 annual self sufficiency program

National blood & plasma 2008-2010 plan

Implement national information system

Define new authorisation and accreditation requirements, implement regional & national inspection and control systems

Modify and launch national haemovigilance system

Create national reference organization for blood safety & TTIs surveillance and issue relevant guidelines

Identify reference labs/organizations for technology assessment and EQA

Issue national guidelines for appropriate utilization of blood components and blood products

Issue national guidelines on appropriate BTCs organizational models

Coordinate ITCBN - Italian Cord Blood Network (cooperation with the National Transplant Centre)

Italian Blood SystemItalian Blood SystemPRIORITIES - 1PRIORITIES - 1

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Promote long life education in transfusion medicine and new approaches in academic education

Training programs for auditors participating in BTCs license/accreditation processes

Promote research projects on some “hot” topics:

o TTIs (emerging viruses, bacterial contamination)o Risk management of transfusion procedureso Plasma product optimal useo Blood donor recruitmento Ex vivo RBC production from HSCo …………………..

Italian Blood SystemItalian Blood SystemPRIORITIES - 2PRIORITIES - 2

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Blood and blood product self sufficiency is a national goal aimed at homogeneous quality and safety conditions of blood transfusion nationwide, overcoming local and regional situations, while respecting regional organizational autonomy

The Minister of Health, upon the indications of the National Blood Centre, annually issues a national self sufficiency program

Italian Blood System219/2005 Law, article 14

Annual national self sufficiency program

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Healthcare plans& programs

National Institute of Health NATIONAL BLOOD CENTRE

REGIONAL BLOOD CO-ORDINATING CENTRES

TRASFUSION MEDICINE SERVICES

LABILE BLOOD COMPONENTS

Ministry of Health NAT. BLOOD TECHN. CONFERENCE

Blood Donors Associations

ANNUAL SELF SUFFICIENCY PROGRAMME

STABLE BLOOD PRODUCTS

2121st st October 2005 LawOctober 2005 LawANNUAL NATIONAL SELF SUFFICIENCY PROGRAMMEANNUAL NATIONAL SELF SUFFICIENCY PROGRAMME

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Italian Blood SystemItalian Blood SystemRBC RBC procurement and demand 2007 & 2008procurement and demand 2007 & 2008

2007 2008 Incr % 2007 2008 Incr % 2007 2008

01 - Valle d'Aosta 5.867 5.984 2,0 4.818 4.896 1,6 1.049 1.088

02 - Piemonte 223.000 225.305 1,0 195.122 198.900 1,9 27.878 26.405

03 - Liguria 71.439 73.250 2,5 70.097 72.000 2,7 1.342 1.250

04 - Lombardia 441.500 442.000 0,1 428.168 428.000 0,0 13.332 14.000

05 - PA Trento 19.390 19.500 0,6 19.071 19.150 0,4 319 350

06 - PA Bolzano 24.186 24.200 0,1 23.295 23.295 0,0 891 905

07 - Friuli Venezia Giulia 67.346 68.000 1,0 63.076 63.700 1,0 4.270 4.300

08 - Veneto 243.317 248.000 1,9 225.957 230.581 2,0 17.360 17.419

09 - Emilia R. 245.224 254.000 3,6 240.000 246.000 2,5 5.224 8.000

10 - Toscana 159.418 164.201 3,0 159.660 164.450 3,0 -242 -249

11 - Umbria 39.663 41.249 4,0 39.360 40.602 3,2 303 647

12 - Marche 67.950 70.000 3,0 65.401 66.000 0,9 2.549 4.000

13 - Lazio 166.316 173.400 4,3 195.346 196.898 0,8 -29.030 -23.498

14 - Sardegna 69.500 71.000 2,2 105.700 106.000 0,3 -36.200 -35.000

15 - Abruzzo 47.800 49.200 2,9 48.150 49.400 2,6 -350 -200

16 - Campania 143.000 150.000 4,9 141.790 150.000 5,8 1.210 0

17 - Molise 13.423 14.348 6,9 12.891 13.582 5,4 532 766

18 - Puglia 136.000 145.000 6,6 135.000 143.000 5,9 1.000 2.000

19 - Basilicata 21.750 22.750 4,6 20.250 21.250 4,9 1.500 1.500

20 - Calabria 60.402 62.000 2,6 59.800 61.000 2,0 602 1.000

21 - Sicilia 170.000 173.400 2,0 180.000 192.000 6,7 -10.000 -18.600

22 - Forze Armate 3.988 4.180 4,8 867 795 -8,3 3.121 3.385

ITALIA 2.440.479 2.500.967 2,5 2.433.819 2.491.499 2,4 6.660 9.468

Unità di GR

Bilancio produzione/consumo

Regioni e Province Autonome

Produzione Consumo

Italian Blood SystemItalian Blood System Plasma for fractionation 2007 & 2008Plasma for fractionation 2007 & 2008

Popolazione

% popolaz regione / popolaz totale

Plasma 2007*

Plasma 2008

Incremento%

2007-2008

Kg / 1000 abitanti 2007

Kg / 1000 abitanti

2008

1 Valle d'Aosta 123.978 0,21 1.710 2.000 16,96 13,79 16,13

2 Piemonte 4.341.733 7,39 59.496 63.500 6,73 13,70 14,63

3 Liguria 1.610.134 2,74 17.978 18.500 2,90 11,17 11,49

4 Lombardia 9.475.202 16,13 123.877 131.000 5,75 13,07 13,83

5 P.A. Trento 502.478 0,86 5.008 5.300 5,83 9,97 10,55

6 P.A. Bolzano 482.650 0,82 5.686 6.100 7,28 11,78 12,64

7 Friuli Venezia Giulia 1.208.278 2,06 23.900 24.500 2,51 19,78 20,28

8 Veneto 4.738.313 8,06 74.692 77.000 3,09 15,76 16,25

9 Emilia Romagna 4.187.557 7,13 72.749 75.000 3,09 17,37 17,91

10 Toscana 3.619.872 6,16 57.963 60.300 4,03 16,01 16,66

11 Umbria 867.878 1,48 7.393 8.100 9,56 8,52 9,33

12 Marche 1.528.809 2,60 20.935 22.000 5,09 13,69 14,39

13 Lazio 5.304.778 9,03 19.600 23.000 17,35 3,69 4,34

14 Sardegna 1.655.677 2,82 9.775 10.100 3,32 5,90 6,10

15 Abruzzo 1.305.307 2,22 12.840 13.600 5,92 9,84 10,42

16 Campania 5.790.929 9,86 12.643 20.000 58,19 2,18 3,45

17 Molise 320.907 0,55 2.340 3.000 28,21 7,29 9,35

18 Puglia 4.071.518 6,93 28.359 30.000 5,79 6,97 7,37

19 Basilicata 594.086 1,01 4.136 4.500 8,80 6,96 7,57

20 Calabria 2.004.415 3,41 10.479 11.500 9,74 5,23 5,74

21 Sicilia 5.017.212 8,54 34.919 37.000 5,96 6,96 7,37

22 Forze Armate 812 850 4,68

58.751.711 100 607.290 646.850 6,51 10,34 11,01

Regioni e Province Autonome

ITALIA* Dati consuntivi 2007 in corso di validazione

The main Blood Donor Associations (AVIS, FIDAS, FRATRES, CRI) are nationally associated in a coordination body (CIVIS), gathering common interests and positions in the field of blood donation

Within CIVIS agreements are taken among the 4 Associations on blood donation policies, promotional campaigns, educational actions/plans

The institutional participation of BD Associations in the governance of the Blood System at the various levels (national, regional and local) is the main goal

CIVIS represents a fundamental “resource” for interactions among BD Associations and political and legislative Institutions

Italian Blood SystemItalian Blood SystemBlood Donor AssociationsBlood Donor Associations

participation in the blood system participation in the blood system governancegovernance

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NATIONAL LEVEL

WHERE:

National Blood Technical Conference

National Blood Centre

WHAT:

Consultation on and proposition of blood donation (BD) policies Donor recruitment policies and BD promotional programs and campaigns Improvement plans (e.g.: reduction elimination of “occasional” BD;

multiethnic development of BD, etc.) Active participation in national planning of blood and plasma collection Promotion of blood safety and continuous education of donors for blood

safety (e.g.: education on blood transfusion risks, “postponed” BD, etc.) Cooperative promotional programs (e.g.: blood, organs and tissues

donation) Promotion of appropriate utilization of blood Scientific and sociological research on BD

Italian Blood SystemItalian Blood SystemBlood Donor AssociationsBlood Donor Associations

participation in the blood system participation in the blood system governancegovernance

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REGIONAL LEVEL

WHERE:

Regional blood committees / boards Regional blood centres (institutional coordinating bodies for transfusion

activities)

WHAT:

Consultation on and proposition of blood donation (BD) policies Donor recruitment policies and BD promotional programs and campaigns Improvement plans (according to regional needs, plans, epidemiology;

development of specific projects for the promotion of safe and repeat multiethnic BD)

Active participation in regional planning of blood and plasma collection, according to national plans and programs

Application of blood safety procedures (e.g.: “postponed” BD) Cooperative promotional programs (according to regional needs,

problems, plans) Participation in regional committees for optimal use of blood and blood

products Regional coordination / management of blood collection activities Regional experimentations and research projects for the optimal use of

resources (logistic, technical, human) in blood collection activities

Italian Blood SystemItalian Blood SystemBlood Donor AssociationsBlood Donor Associations

participation in the blood system participation in the blood system governancegovernance

CNS

LOCAL/HOSPITAL LEVEL

WHERE:

Local Health Trusts / Hospitals Health Trust / Hospital committees for blood collection and transfusion

medicine planning and management Health Trust / Hospital committees for optimal use of blood and blood

resources

WHAT:

Consultation on and proposition of blood donation (BD) policies Consultation on adequacy of resources allocated for blood collection

(logistic, technical, human) Management of blood collection units (under the technical control of the

hospital BTC) Improvement plans (according to local needs, problems, epidemiology) Active participation in local planning of blood and plasma collection,

according to regional and national plans and programs Active participation in the hospital transfusion committees Application of methods for the optimal use of resources in blood collection

activities

Italian Blood SystemItalian Blood SystemBlood Donor AssociationsBlood Donor Associations

participation in the blood system participation in the blood system governancegovernance

CNS

Thanks for listeningThanks for listening

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Giuliano Grazzini, MD Director General National Blood Centre

Istituto Superiore di SanitàIstituto Superiore di SanitàItalian National Institute of HealthItalian National Institute of Health

NATIONAL BLOOD CENTRENATIONAL BLOOD CENTRE