Regional Committee for the Eastern Mediterranean
Sixty-fifth session
Provisional agenda item 3(f)
EM/RC65/INF.DOC.5
August 2018
Progress report on implementation of the regional strategic framework for blood safety and availability 2016–2025
Introduction
1. In October 2016, the Sixty-third session of the Regional Committee for the Eastern Mediterranean
adopted resolution EM/RC63/R.5 endorsing the regional strategic framework for blood safety and availability
2016–2025 and its framework for action.
2. In the resolution, the Committee urged Member States to: (a) take the necessary steps to establish
effective and sustainable blood transfusion services, with appropriate legislation and regulatory mechanisms
and dedicated budget lines, and to develop national strategic and operational plans based on the strategic
framework; (b) establish effective coordination and collaboration mechanisms among all relevant
stakeholders in the public and private sectors; (c) establish, implement and support a national quality
management system throughout the blood transfusion chain; (d) take the necessary steps to ensure regular
voluntary non-remunerated donation of blood and blood components, and to improve public education, donor
motivation, mobilization and retention and all other elements to ensure a safe and sustainable donor
programme; (e) develop competent human resource capacity through the provision of initial and continuing
education and training of all staff involved in the vein-to-vein chain; and (f) establish a mechanism for the
integration of blood and plasma programmes, aimed at optimizing the use of recovered and source plasma for
fractionation.
3. The Committee also requested WHO to: (a) provide support to Member States to develop national
strategic and operational plans based on the strategic framework; (b) foster coordination and collaboration
with all relevant stakeholders and partners; and (c) monitor the progress achieved in implementing the
strategic framework and report on it to the Regional Committee on a biennial basis.
4. The regional strategic framework identified a set of strategic interventions to improve blood safety and
availability in five priority areas: leadership and governance; coordination and collaboration; provision of
safe blood and blood products to meet patients’ needs all the time, including during humanitarian
emergencies; appropriate clinical use of blood and blood products; and quality system management
throughout the blood transfusion chain.
5. This report provides a progress update on implementation of the regional strategic framework by
Member States and WHO during the first two years of the ten-year framework.
Progress update
6. Recognizing the many challenges in ensuring blood safety and availability, implementation has focused
on priority interventions. These include generating information for evidence-based planning and monitoring,
fostering coordination and collaboration among relevant partners, strengthening leadership and governance
of the blood system and improving access to quality-assured blood and blood products at all times, including
during humanitarian emergencies.
Strengthening leadership and governance of national blood systems
7. Strengthening blood regulatory systems was one of the priority interventions. Currently, nine countries
reported having in place blood legislation and a regulatory mechanism for the registration, licensing,
operation and inspection of blood supply and transfusion systems. WHO has reviewed existing blood
legislation in these countries and developed template legislation that countries can adapt to foster adherence
to good manufacturing principles and harmonization across the Region. Two national consultations were
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conducted in Pakistan to review, update and strengthen blood regulatory systems. In line with the regional
strategic framework, WHO supported Sudan to develop a national blood policy and a strategic plan for
strengthening its national blood system.
Supporting coordination and collaboration
8. Progress has been made in strengthening coordination and collaboration with relevant units and
departments within WHO and WHO Collaborating Centers. In addition, several collaborative activities were
conducted with the Arab Authority for Blood Transfusion Services, the International Federation of Red Cross
and Red Crescent Societies, professional societies such as the Arab Transfusion Medicine Forum, national
professional societies, the Asian Association of Transfusion Medicine, the International Society of Blood
Transfusion, the American Association of Blood Banks, the International Haemovigilance Network, blood
donor organizations such as the International Federation of Blood Donor Organizations and its national
chapters, patient organizations such as the World Federation of Haemophilia, the Haemophilia Eastern
Mediterranean Network and the Thalassemia International Federation, and the International Plasma
Fractionation Association.
Strengthening the provision of safe blood and blood products to meet patients’ needs
9. In order to improve access to a safe and sufficient supply of blood and blood products through regular
voluntary non-remunerated blood donations, WHO initiated and promoted the establishment of blood donor
management programmes. Regional and national workshops on blood donor management were conducted in
Egypt, Jordan and Pakistan to address gaps in relevant knowledge and skills identified through a
comprehensive assessment.
10. Recognizing the gaps in quality-assured testing and processing of blood donations, regional workshops
on good manufacturing practices and immunohaematology were conducted in the Islamic Republic of Iran
with participants from countries in the Region.1
11. The availability and safety of blood transfusion during humanitarian emergencies remains a major
concern in the Region. Assessment conducted in affected countries2 showed an increase in the demand for
blood transfusion and identified challenges in providing transfusion services. The need to build stronger and
more resilient national blood systems that can meet the increased demand for blood during emergencies was
one of the recommendations of the regional consultation on the availability and safety of blood transfusion
during humanitarian emergencies held in 2016.3 In this regard, WHO has provided technical assistance to
affected countries to implement the recommendations of the consultation.
12. A workshop on plasma fractionation was organized in 2018 with the aim of optimizing the use of plasma
for fractionation, reducing its wastage and facilitating the integration of blood and plasma programmes.4
Promoting appropriate clinical use of blood and blood products
13. Inappropriate use of blood, unsafe transfusion practices and a lack of effective patient blood management
programmes continue to be major concerns in the Region. WHO and the International Society of Blood
Transfusion are updating the guidelines on the clinical use of blood to meet the need for appropriate guidance.
Efforts are ongoing to establish a mechanism for clinical governance of the blood transfusion service at
hospital level through the establishment of hospital transfusion committees.
1 Participants from Afghanistan, Islamic Republic of Iran, Iraq, Morocco, Oman and Sudan. 2 Participants from Afghanistan, Iraq, Libya, Pakistan, Palestine, Somalia, Sudan, Syrian Arab Republic and Yemen. 3 Summary report on the Regional consultation on the availability and safety of blood transfusion during humanitarian emergencies, Tunis, Tunisia, 15–16 May 2016.
(http://apps.who.int/iris/bitstream/handle/10665/249542/IC_Meet_Rep_2016_EN_18967.pdf?sequence=1&isAllowed=y). 4 Participants from Algeria, Libya, Mauritania, Morocco and Tunisia.
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Strengthening quality system management throughout the blood transfusion chain
14. Ensuring the commitment of management to establishing appropriate quality systems and standardized
procedures in the blood supply and transfusion systems, including participation in assessment programmes
and accreditation, was given due attention in the reporting period. Regional external quality assessment
(EQA) programmes for testing of transfusion-transmitted infections and blood group serology were initiated
in collaboration with WHO Collaborating Centers in the Islamic Republic of Iran and Tunisia, respectively.
The number of participating countries is growing steadily.
15. As part of work on quality systems, establishing and strengthening haemovigilance systems for
monitoring all aspects of clinical transfusion practice was prioritized in the reporting period. WHO convened
a regional consultation on haemovigilance to launch the WHO guidance document on establishing national
haemovigilance systems and to identify the way forward in implementing the guidance.5 Subsequently, six
countries have designated national focal persons for haemovigilance and initiated implementation of
recommendations from the consultation.6 In addition, technical support was provided to Oman to strengthen
its haemovigilance system.
Challenges
16. The current status of blood safety and availability, including the challenges that need to be addressed,
have been documented in the regional status report on blood safety and availability, published in 2017.7
17. One major challenge is the low priority given to establishing effective and sustainable blood supply and
transfusion systems, with appropriate regulatory mechanisms and proper organization, at the national level.
18. Furthermore, inadequate attention is being given to the role of access to affordable and quality-assured
blood and blood products at all times, including during humanitarian emergencies, for achieving universal
health coverage.
19. Insufficient efforts are being made to ensure regular voluntary non-remunerated donation of blood and
blood components, and to establish effective and sustainable blood donor management programmes.
20. In addition, there is continued wastage of recovered plasma due to a lack of integration of blood and
plasma programmes and absence of national or regional mechanisms for plasma fractionation in most
countries.
The way forward
21. Member States are urged to continue taking action to accelerate implementation of the regional strategic
framework with a focus on updating the organization of the blood system and establishing appropriate
regulatory systems for the management of blood and blood products. These are essential medicines and an
integral part of efforts toward universal health coverage.
22. Member States should continue promoting and supporting the establishment of effective blood donor
management programmes and promoting regular voluntary non-remunerated donations, including converting
family replacement donors to regular voluntary non-remunerated donors.
23. In collaboration with WHO and partners, Member States should facilitate the development of national
and regional capacity for plasma fractionation to optimize the use of plasma and reduce its wastage.
5 Summary report on the Regional consultation on haemovigilance, Amman, Jordan, 4–5 December 2016. (http://apps.who.int/iris/bitstream/handle/10665/254703/IC_Meet_Rep_2017_EN_19555.pdf?sequence=1&isAllowed=y). 6 The six countries are Afghanistan, Bahrain, Morocco, Oman, Qatar and Saudi Arabia. 7 Regional status report on blood safety and availability 2016. (http://apps.who.int/iris/bitstream/handle/10665/258923/EMROPub_2017_EN_18907.pdf?sequence=1&isAllowed=y).
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24. WHO will continue to provide Member States with guidance and technical support to scale up
implementation of the regional strategic framework, and will provide the next progress report during the
Sixty-seventh session of the Regional Committee.