Istituto Superiore di Sanit Italian National Institute of

Istituto Superiore di Sanità Italian National Institute of Health NATIONAL BLOOD CENTRE RELATIONS BETWEEN INSTITUTIONS AND BLOOD DONOR ASSOCIATIONS the Italian experience 8 th International Youth Forum of IFBDO Catania, Italy 29 th August 2008 Giuliano Grazzini, MD Director General National Blood Centre

Donation rate per 1, 000 population in the world 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: 224 s-240 s CNS

Global population and global blood supply HDI = Human Development Index Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005; 45: 224 s-240 s CNS

Global human development index (HDI) and blood supply Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005; 45: 224 s-240 s CNS

Paying for blood donations: still a risk? C. L. van der Poel, E. Seifried & W. P. Schaasberg Vox Sanguinis (2002) 83, 285– 293 Paid blood or plasma donors still have higher rates for infectious disease markers than unpaid donors CNS

Voluntary donors in Latin America (2003) Country Voluntary donors(%) Argentina Bolivia Brazil Chile Colombia Costa Rica Cuba Ecuador El Salvador Guatemala Honduras 18. 9 Mexico Nicaragua Panama Paraguay Peru Dominican Republic 18. 0 Uruguay Venezuela 8. 0 17. 5 50. 8 6. 0 41. 7 49. 0 100. 0 29. 9 10. 0 4. 0 3. 9 44. 8 1. 9 5. 7 5. 3 81. 4 4. 0 Sullivan P. Developing an administrative plan for transfusion medicine – a global perspective. Transfusion 2005; 45: 224 s-240 s CNS

BLOOD SAVE LIVES CNS

WHO strategy for blood safety CNS

Estimated use of Red Cells in the world CNS

WHO strategy for blood safety CNS

WHO strategy for blood procurement and blood safety REQUIREMENTS CNS

WHO strategy for blood safety Policy CNS

WHO strategy for blood safety Quality and safety CNS

WHO strategy for blood safety Quality and safety CNS

WHO strategy for blood safety Access CNS

WHO strategy for blood safety Use CNS

ITALIAN BLOOD SYSTEM 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 BTC s - Government and regional health authorities are strongly committed to promote voluntary, responsible, non-remunerated, periodical (repeat) blood donation - Blood donors: Ø ~ 1, 600, 000 Ø 2. 9 % of total population Ø 4. 5% of 18 -65 y Ø 42 / 1000 [18 -65] pop CNS

ITALIAN BLOOD SYSTEM 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) CNS

ITALIAN BLOOD SYSTEM ESSENTIAL DATA - 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. 1015%) CNS

Italian Regions WB/RBC donation index 2007 WB/RBC donations /1, 000 pop /year 58. 6 MAX > 50 40 -50 30 -40 25 < 30 MIN ITALY: 41. 5 CNS

ITALIAN BLOOD SYSTEM ESSENTIAL DATA - 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 CNS

Italian Regions Plasma for fractionation (contract manufacturing) 2007 19. 8 MAX Kg /1, 000 pop /year > 15 10 -15 5 -10 2. 2 < 5 Kg MIN ITALY: 10. 3 CNS

Plasma delivered to pharmaceutical industry (contract manufacturing) Italy 2000 -2007 CNS

Plasma derived products National estimates 2007

HEALTHCARE IN THE ITALIAN GOVERNMENTAL FRAMEWORK Healthcare issues to be applied nationwide REGIONAL GOVERNMENTS (Healthcare Departments) Organizational issues Local healthcare needs Regional laws & Regulatory acts Regional technical & scientific coordination Delivery of essential healthcare services CNS NATIONAL GOVERNMENT (Ministry of Health) Permanent Government Regions Conference Public safety issues Special national needs Agreements National laws & Regulatory acts National Laws & Regulatory acts National essential healthcare services National technical & scientific coordination Assessment, update, monitor adequate and appropriate delivery, of essential healthcare services

2005: birth of a new blood law in Italy ü ü ü 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 ü 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). CNS

NEW NATIONAL BODIES ENTRUSTED WITH THE CO-ORDINATION OF THE ITALIAN BLOOD SYSTEM CNS

NATIONAL BLOOD TECHNICAL CONFERENCE “Consulta tecnica permanente per il sistema trasfusionale” ü Settled at the Ministry of Health ü Chaired by the Minister of Health ü 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 ü 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 ü Co-operates with National Blood Centre CNS

NATIONAL BLOOD CENTRE “Centro Nazionale Sangue” ü Settled at the Italian National Institute of Health (INIH), in autonomous position ü Directed by a Director General (must be a MD with suitable experience in transfusion medicine and healthcare management) ü Executive board chaired by the Director, composed of: § § § President of the INIH 3 regional blood coordinators 3 representatives of blood donor associations ü 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 ü Co-operates with National Blood Technical Conference CNS

BLOOD TRANSFUSION SERVICES IN ITALY NBC CNS

THE ITALIAN BLOOD SYSTEM According to 21 st October 2005 Law “New discipline for blood transfusion activities and national production of blood derivatives” SELF SUFFICIENCY Professionals Scientific Societies QUALITY University Pharmaceutical Industries Ministry of Health National Blood Technical Conference National Blood Centre CNS Regional Blood Coordinating Centres Blood Donors R&D APPROPRIATENESS SAFETY Transfusion Services Health Trusts TECH. ASS.

A 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. CNS

NATIONAL BLOOD CENTRE - TASKS NBC is entrusted with technical and scientific control of all transfusion medicine issues ruled by national laws and European directives and recommendations, particularly : ü blood and blood product self sufficiency ü blood quality and safety ü appropriate utilization of blood resources ü accreditation of transfusion medicine activities ü national blood information system ü technology assessment ü external quality assessment ü national haemovigilance network ü coordination of ITCBN (Italian Cord Blood Network) ü control of medicinal products deriving from human plasma ü audits and controls of plasma product industries ü education and scientific research in transfusion medicine ü promotion of voluntary, responsible, repeat blood donation CNS

Italian Blood System PRIORITIES - 1 ü 2008 annual self sufficiency program ü National blood & plasma 2008 -2010 plan ü Implement national information system ü Define new authorisation and accreditation requirements, implement regional & national inspection and control systems ü Modify and launch national haemovigilance system ü Create national reference organization for blood safety & TTIs surveillance and issue relevant guidelines ü Identify reference labs/organizations for technology assessment and EQA ü Issue national guidelines for appropriate utilization of blood components and blood products ü Issue national guidelines on appropriate BTCs organizational models ü Coordinate ITCBN - Italian Cord Blood Network (cooperation with the National Transplant Centre) CNS

Italian Blood System PRIORITIES - 2 ü Promote long life education in transfusion medicine and new approaches in academic education ü Training programs for auditors participating in BTCs license/accreditation processes ü Promote research projects on some “hot” topics: o o o CNS TTIs (emerging viruses, bacterial contamination) Risk management of transfusion procedures Plasma product optimal use Blood donor recruitment Ex vivo RBC production from HSC …………………. .

Italian Blood System 219/2005 Law, article 14 Annual national self sufficiency program ü 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 ü The Minister of Health, upon the indications of the National Blood Centre, annually issues a national self sufficiency program CNS

21 st October 2005 Law ANNUAL NATIONAL SELF SUFFICIENCY PROGRAMME Ministry of Health NAT. BLOOD TECHN. CONFERENCE Healthcare plans & programs National Institute of Health Blood Donors Associations NATIONAL BLOOD CENTRE REGIONAL BLOOD CO-ORDINATING CENTRES TRASFUSION MEDICINE SERVICES ANNUAL SELF SUFFICIENCY PROGRAMME LABILE BLOOD COMPONENTS CNS STABLE BLOOD PRODUCTS

Italian Blood System RBC procurement and demand 2007 & 2008

Italian Blood System Plasma for fractionation 2007 & 2008

Italian Blood System Blood Donor Associations participation in the blood system governance ü 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 ü Within CIVIS agreements are taken among the 4 Associations on blood donation policies, promotional campaigns, educational actions/plans ü 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 ü CIVIS represents a fundamental “resource” for interactions among BD Associations and political and legislative Institutions CNS

Italian Blood System Blood Donor Associations participation in the blood system governance NATIONAL LEVEL WHERE: ü National Blood Technical Conference ü National Blood Centre WHAT: Ø Ø Ø Ø CNS 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 System Blood Donor Associations participation in the blood system governance REGIONAL LEVEL WHERE: ü ü Regional blood committees / boards Regional blood centres (institutional coordinating bodies for transfusion activities) WHAT: Ø Ø Ø Ø Ø CNS 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 System Blood Donor Associations participation in the blood system governance LOCAL/HOSPITAL LEVEL WHERE: ü ü ü 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: Ø Ø Ø Ø CNS 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

Istituto Superiore di Sanità Italian National Institute of Health NATIONAL BLOOD CENTRE Thanks for listening Giuliano Grazzini, MD Director General National Blood Centre CNS