The Italian National Blood Centre (CNS) performs coordination and technical-scientific control activities in matters governed by Law no. 219 of 21st October 2005, “New regulations for transfusion activities and national production of blood derivatives” acting according to governance principles. The latter develops from the twofold need, national and international, to support the development of a systematic approach to identifying and understanding which factors affect global public health, and then to persuade the State to take collective action to mitigate and eliminate actual and potential health risks, while guaranteeing tangible protection. This approach is achieved through the proactive participation of the CNS in meetings of numerous institutional bodies and technical working groups of various European and international organisations (European Union, World Health Organisation, Council of Europe, European Blood Alliance, Alliance of Blood Operators, etc.). European Union (EU):
- HEALTH AND CONSUMERS DIRECTORATE-GENERAL – Directorate D4 “Substances of Human Origin and Tobacco Control”. European Commission (EC): Meetings of the Competent Blood Authorities of all EU Member States at which the state of the art of national blood systems is discussed and evaluated in terms of transposition of European Directives and achievement of their objectives, proposals for revision of European legislation, co-funded projects, updates on vigilance and surveillance (Zika virus, WNV, etc.), collaboration with the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), the World Health Organisation (WHO) and the Council of Europe
- Experts Sub-Group on Haemovigilance, which bring together national experts and contact persons for haemovigilance. Activities include the production of the annual European Serious Adverse Reactions and Events reports on blood and blood components and the evaluation of the EC Rapid Alert (RAB) platform, with possible proposals for management improvements.
- Working Group on the Exchange of Surplus Blood between EU Member States, which formulates proposals to ensure traceability and identification requirements for blood and blood component units and donors and recipients, as well as labelling and data recording requirements.
Council of Europe:
- European Directorate for the Quality of Medicines & HealthCare (EDQM). The European Committee on Blood Transfusion (CD-P-TS), – consisting of institutional representatives of the national competent authorities whose main objective is to study the ethical, legal and organisational aspects of blood transfusion. This includes ensuring its quality and safety, increasing the availability of blood and blood components while avoiding wastage, ensuring the optimal use of blood stocks and analysing the possible ethical and organisational impact of new scientific developments.
Then there are five technical working groups:
- Guide to the Preparation, Use and Quality Assurance of Blood Components (GTS): The Guide is a compendium of measures to ensure the safety, efficacy and quality of blood products and is primarily addressed to blood service operators. The Group drafts and updates the document annually.
- Good practice guidelines for blood establishments and hospital blood banks required to comply with EU Directive 2005/62/EC: In cooperation with the EU Commission, it defines and updates good practice guidelines, in particular on quality systems, for all blood transfusion services.
- Plasma Supply Management (TS093 PSM): The main objective is the sharing of experiences between participating countries and identifying elements of “good practice” in plasma supply management.
- Sexual Risk Behaviour (TS100 SRB): This group monitors adopted policies related to SRB, evaluates scientific data, and defines and proposes standardised approaches for donor deferral.
- Blood Proficiency Testing Scheme (B-PTS): EDQM designs and organises an external quality assessment programme based on the “ISO/IEC 17043:2010 Conformity Assessment – General Requirements for proficiency testing” standards. Participation in the programme requires laboratories to assess and demonstrate the reliability of their data. This helps to build mutual trust between European blood systems, which is vitally important to ensure common quality control of blood donations.
World Health Organisation:
- When requested, the CNS attends both the General Assembly, which is the decision-making body, and the Executive Board, the body composed of national technical representatives in the field of healthcare.
Two working groups:
- Expert Working Group on Self-sufficiency: This group drafts documents that guide and support states in their pursuit of self-sufficiency (Global Status Report, Aide-Mémoire for national blood system planning, etc.)
- Ebola Blood and Plasma Working Group: It drafts position papers (e.g. Community Engagement and Education, Recruitment and Retention of People Recovered from Ebola as Potential Donors for Convalescent Whole Blood and Plasma; Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from Ebola Virus Disease for Transfusion, as an Experimental Treatment during Outbreaks).
European Blood Alliance (EBA):
- The EBA is the decision-making body composed of representatives from 25 European and non-European countries. Its mission is to help European Blood Establishments (BEs) continuously improve their work, based on scientific and ethical principles for the benefit of patients, and to contribute to the availability, quality and safety of the blood and blood component supply for European citizens by developing and maintaining an efficient and strong collaboration between BEs and competent authorities.
Seven working groups:
- Benchmarking: At its board meetings, the member states submit their annual data that provide an up-to-date snapshot of the “state of the art” of national blood systems.
- Blood Directives: It evaluates the current four European blood directives and makes recommendations for their revision/update.
- Collaborative Quality Management: This group produces quality system validation models and develops supplier audit standards on policies, procedures, pre-audit questionnaires, audit plans and reports.
- Collaborative Procurement Projects: It develops procurement activities addressed to stakeholders in order to improve best practices, promote collaboration between states, and increase the effectiveness of blood, tissues and cells for European citizens (e.g. the “Eurobloodpack 1” project on whole-blood collection systems).
- Emerging Infectious Disease (EID) Monitor: The purpose of the collaboration between the EBA and the ABO (Europe + Australia, Canada, and the United States of America) is to monitor emerging infectious diseases, assess their threat to blood safety and discuss the safety measures to be taken.
- Contingency planning: The main topics are contingency planning and the ability to respond to a crisis. In particular, this group studies and proposes approaches and actions to manage an emergency affecting several European countries based on lessons learned and shared within the group.
- VNRD Definition: It formulates proposals relating to the definition of voluntary unpaid donation.