WHO-EM/LAB/389/E

Strategic framework for blood safety

and availability

2016–2025
 WHO-EM/LAB/389/E

Strategic framework for blood

safety and availability 2016–2025
WHO Library Cataloguing in Publication Data

World Health Organization. Regional Office for the Eastern Mediterranean

Strategic framework for blood safety and availability 2016-2025/ World Health Organization. Regional
Office for the Eastern Mediterranean
p.
WHO-EM/ LAB/389/E
1. Blood Safety 2. Blood Transfusion I. Title II. Regional Office for the Eastern Mediterranean
(NLM Classification: WH 460)

© World Health Organization 2017

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Document WHO-EM/LAB/389/E
Contents

1. Introduction…………….. .......................................................................................... 5

2. Situation in the Region ............................................................................................ 7

2.1 Situation analysis……. ...................................................................................... 7

2.2 Leadership and governance ............................................................................. 7
2.3 Coordination and collaboration ....................................................................... 7
2.4 Provision of safe blood and blood products ................................................... 8
2.5 Clinical transfusion in patient management ................................................. 11
2.6 Quality system management throughout the blood transfusion chain....... 11

3. Strategic framework for blood safety and availability 2016–2025 .................... 12

3.1 Background and rationale .............................................................................. 12

3.2 Purpose and scope….. ..................................................................................... 13
3.3 Priority interventions of the strategic framework ........................................ 14
3.4 Implementation of the strategic framework ................................................. 17

4. The way forward…… .............................................................................................. 18

Annex 1. Resolution EM/RC63/R.5 ........................................................................... 20

Annex 2. Priority interventions ................................................................................. 25

Annex 3. Summary of the key elements of a national blood system ................... 35

3
4
1. Introduction

Blood transfusion is an essential component of health care that contributes to saving

lives and improving the quality of life for millions of people worldwide. Blood
transfusion is most commonly used in caring for women suffering from bleeding
associated with pregnancy and childbirth, children suffering from severe anaemia
due to malaria and malnutrition, and victims of trauma, emergencies, disasters and
accidents. It is also used to support advanced medical and surgical procedures,
including cardiovascular surgery and transplantation in countries with advanced
health care systems. Blood and blood products1 are essential in the treatment of
blood and bone marrow disorders, as well as immune deficiency conditions.
Universal and timely access to safe blood and blood products, and their appropriate
use, are essential components of good health care provision.

The demand for blood and blood products continues to grow as a result of several
factors, including the growth and aging of the population, and the availability of,
and access to, increasingly sophisticated medical and surgical procedures. Ministries
of health are responsible for meeting the increasing clinical needs of patients for safe
blood and blood products and for ensuring the quality, safety, availability and
equitable distribution of these products through the establishment of an effective
national blood supply and transfusion service that is integrated into the national
health system.

However, despite the availability of effective measures to ensure the quality and
safety of blood and blood products, there is still significant risk associated with their
clinical use, including adverse reactions and transmission of transfusion-transmitted
infection (TTI).

The safety and availability of blood transfusion depends on the:

• availability of a well-organized and adequately funded nationally coordinated

blood transfusion service, with an effective blood component programme under
well-defined regulatory oversight;
• collection of blood and blood components from voluntary, non-remunerated and
regular blood donors from low risk populations;

1
The term “blood products” is defined by the Expert Committee on Biological Standardization as follows: “any therapeutic
substances derived from human blood, including whole blood, labile blood components and plasma-derived medicinal
products” (WHA63.12 Availability, safety and quality of blood products).
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Strategic framework for blood safety and availability 2016–2025

• quality-assured testing of all donated blood, including screening for TTIs, ABO
and Rhesus D grouping, and compatibility testing;
• reduction in unnecessary transfusions through appropriate clinical use and safe
administration of blood and blood products; and
• implementation of effective quality systems in all areas, including quality
management, development and implementation of quality standards, effective
documentation systems, training of all staff and regular quality assessment,
including haemovigilance, based on a national quality policy and strategy.

WHO has been at the forefront of the movement to improve blood and blood
product safety and availability as mandated by successive World Health Assembly
resolutions, the earliest dating from 1975 (see WHA28.72 Utilization and supply of
human blood and blood products, WHA58.13 Blood safety: proposal to establish
World Blood Donor Day, WHA63.12 Availability, safety and quality of blood
products). In 1987, at its 34th session, the WHO Regional Committee for the Eastern
Mediterranean endorsed resolution EM/RC34/R.9 on the development of national
blood transfusion services in the countries of the Eastern Mediterranean Region.
However, significant challenges remain in providing access to sufficient, affordable
and sustainable supplies of blood and blood products, while ensuring the quality
and safety of these products in the presence of known and emerging threats to
public health.

In response to this situation, the strategic framework for blood safety and
availability (2016–2025) was endorsed by the 63rd Session of the Regional
Committee in 2016 in resolution EM/RC63/R.6 (see Annex 1). The strategic
framework is intended to guide countries in developing and strengthening national
blood systems to ensure the continuity, sufficiency, sustainability and security of
national supplies of safe and efficacious blood and blood components to meet
national needs. It was developed through broad consultation with national blood
transfusion service providers, regional and international organizations, and experts
working in the field. The strategic framework, with its accompanying framework for
action and priority interventions (see Annex 2), will guide countries in developing
and strengthening national blood systems to meet national needs.

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 Strategic framework for blood safety and availability 2016–2025

2. Situation in the Region

2.1 Situation analysis

WHO undertook a comprehensive situation analysis of blood transfusion services in

the Eastern Mediterranean Region using data collected from 18 countries and
verified by the directors of the national services. The findings, as described below,
indicate gaps in all areas of the key elements of a national blood system
(summarized in Annex 3), including leadership and governance, coordination and
collaboration, provision of safe blood and blood products, clinical transfusion in
patient management, and quality system management throughout the blood
transfusion chain. About a third of the countries have insufficient national blood
supplies to meet the needs of patients for transfusion and the vast majority of people
with bleeding disorders and immune deficiencies still have no, or very limited,
access to plasma-derived medicinal products.

2.2 Leadership and governance

Of the 18 countries that responded, 14 have a national blood policy, 13 have a

national strategic plan and 12 have constituted a national advisory committee (or
equivalent) for blood transfusion services. Where there are national advisory bodies
established, they are not empowered to take key technical decisions. A regulatory
mechanism for the registration, licensing, operation and inspection of the blood
transfusion service exists in nine countries and nine have legislation that covers the
safety and quality of blood and blood products.

Financing of blood transfusion services is often given low priority and many
countries report a lack of adequate, sustainable and specific funding by
governments. A dedicated budget for national blood donor and national blood
services is only provided for in eight countries. Nine countries report receiving extra
budgetary funding from bilateral or multilateral cooperation agencies and
development partners. Only seven countries have put in place a cost-recovery
system through health insurance schemes or direct payments, such as user fees, to
improve available funding.

2.3 Coordination and collaboration

Countries in the Region are at varying stages of development with respect to their
blood transfusion service. While some countries have established well-funded and

7
Strategic framework for blood safety and availability 2016–2025

well-developed services, in many countries services are still developing and

fragmented, with challenges of coordination and collaboration among different
stakeholders. In 12 countries, a specific unit or department responsible for blood
transfusion services exists within the ministry of health. In some countries, blood
transfusion services continue to be under the umbrella of laboratory services, which
are often not nationally coordinated. In countries that have blood banks in the
private sector, these work in isolation from public sector blood services and are
mostly unregulated.

In many countries there is a centralized system of evaluation and validation of test

kits and reagents. Stock management, as an integral part of the quality system and
its management, is ineffective, inadequate or even absent. Five countries report
interruption in the regular supply of test kits, reagents and consumables, often due
to insufficient budgetary allocation or to trade embargo. Interruption of this kind is a
major obstacle for the collection, screening and processing of blood donations.

National systems for standardized data collection and reporting encompassing all
activities from blood donation to distribution to hospitals, issuing to patients and the
recording of transfusions of blood and blood components to patients, are absent in
most countries. These are necessary to facilitate monitoring and evaluation of the
vein-to-vein transfusion chain, including traceability and surveillance
(haemovigilance). The current information management systems are not well
developed and are mainly laboratory-oriented and paper-based.

National policies, standards, regulations, guidelines and standard operating

procedures for biomedical waste management are inadequate and insufficient. Not
all blood services have access to personal protective equipment and not all countries
have a recognized immunization strategy for conventionally recognized infectious
agents, especially hepatitis B virus (HBV) and influenza, for all staff.

Strategic partnerships and collaborations with blood donor organizations, patient

associations, academic and research institutions, scientific and professional societies,
and industry, are not strong. In addition, there is an absence of linkages with key
health programmes, such as those for maternal and child health, HIV/AIDS and
hepatitis, infection control and patient safety.

2.4 Provision of safe blood and blood products

Many blood services in the Region are not provided with facilities and infrastructure
that have been adequately planned and constructed with respect to requirements for
space, design, utilities and waste disposal in line with good manufacturing practice

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 Strategic framework for blood safety and availability 2016–2025

(GMP) requirements. Adequacy of equipment is also not universal and is reported as

available in only half the countries.

There is a general shortage of trained specialized staff in blood transfusions services,

together with a lack of opportunities for professional development and inadequate
staff retention strategies and remuneration, which are not at the same level as other
health care workers. Trained biomedical engineers for maintenance and repair of
laboratory equipment and facilities are not available in many countries.
Coordination in the teaching curricula between the ministry of health and ministry
of education requires significant improvement. Only six countries have
undergraduate and postgraduate educational and training programmes in
transfusion medicine in place, and only 12 countries have opportunities for
continuing medical education and training.

Only 6% of the global blood supply is collected in the Region, while it has 9% of the
world’s population. The blood donation rates in the Region range from 0.42 to 26 per
1000 population. Eight countries reported collecting less than 10 whole blood
donations per 1000 population.

Sixteen countries in the Region have implemented strategies for donor motivation
and retention and have developed national donor selection criteria. The number of
voluntary non-remunerated whole blood donations increased by 28% from 2.52
million in 2004 to 3.24 million in 2011. The mean proportion of voluntary non-
remunerated whole blood donations is 59.2%; only two countries reported 100%
donation from voluntary non-remunerated donors, with some countries reporting
below 10%. Close to 40% of the blood collected is still from family replacement
donors, and also from (hidden) paid professional donors.

In all 18 countries, 100% of transfused units screen for HIV 1 and 2

(antigen/antibody), HBV (HBsAg), hepatitis C virus (HCV) and syphilis, using
enzyme-linked immuno assay (EIA), and eight countries use nucleic acid
amplification test (NAAT), in addition to conventional EIA testing. In five countries,
NAAT is carried out routinely in addition to EIA on all samples; while in three
countries, NAAT is used selectively, as and when considered necessary. One country
screens for syphilis using rapid plasma reagin. Screening for malaria is carried out in
four countries. Sixteen countries report collaboration with a national reference
laboratory for confirmation of HIV reactive samples.

Overall, 75% of whole blood collected is processed into components, with rates
varying among countries from 2% to 84%. There is a lack of capacity, expertise and
resources to produce components. Moreover, quality control procedures are not
consistently practised during component production. Prescribing clinicians are often
reluctant to utilize components because of a misguided preference for whole blood.

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Strategic framework for blood safety and availability 2016–2025

Large volumes of plasma recovered from whole-blood donations are currently

discarded because of concerns that quality, logistical and budgetary requirements
are not being met for contract plasma fractionation due to inadequate GMP. Out of a
total of approximately 28.7 million litres of plasma sent for fractionation globally in
2011, only 144 722 litres of recovered plasma from whole blood (0.5% of the global
plasma sent for fractionation) was from countries in the Region. Most countries
import plasma-derived medicinal products from international sources to meet the
needs of patients.

Current estimates suggest that there are 26 524 patients with bleeding disorders in
the Region, contributing 9% of the global reported disease burden. Among these,
17 430 have haemophilia (14 027 with haemophilia A, 3128 with haemophilia B and
209 with unknown type), 3605 have von Willebrand disease and 5489 have other
bleeding disorders.2 These figures underestimate the real magnitude of the problem.

Haemoglobin disorders, mainly comprising different types of haemoglobinopathies

(thalassaemia and sickle cell disorders), present a significant problem worldwide.
Around 7% of the global population has an abnormal haemoglobin gene and more
than half a million affected children are born each year. The countries of the Region
are almost all in the “thalassaemia belt”, which accounts for 35% of the global
estimate of children born with transfusion-dependent beta (β)-thalassemia. Sickle
cell disorders are also a problem in the Region and affect 0.84 per 1000 of births.3

In many countries, the blood cold chain system is not effective or is inadequate and
has no maintenance programme. The median percentage of total donations (whole
blood/red blood cells) discarded in 2011 was 6.5%. This is largely due to donations
with a reactive or positive TTI test. Incomplete collections and problems in
processing, storage, transportation and dates of expiry also contribute to the discard
and wastage of blood and blood components. Data is not available on donor
exclusions due to anaemia, underweight or other reason.

The safety and availability of blood and blood components is of great concern in the
Region, particularly for populations in humanitarian emergencies, where health
systems have been weakened or destroyed as a result of armed conflict,
displacement of populations and other complex emergencies. Nearly three quarters
of countries, and more than 76 million people in the Region, are currently affected by
humanitarian emergencies, including almost 16 million refugees or internally
displaced people.

2
World Federation of Hemophilia report on the annual global survey 2014. Montreal; World Federation of Hemophilia: 2015
(http://www1.wfh.org/publications/files/pdf-1627.pdf accessed 15 September 2016).
3
Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bull World Health Organ.
2008;86(6):417–496 (http://www.who.int/bulletin/volumes/86/6/06-036673/en/, accessed 15 September 2016).
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 Strategic framework for blood safety and availability 2016–2025

2.5 Clinical transfusion in patient management

Complete and accurate data on clinical transfusions and utilization of blood and
blood products are limited. However, information collected from some countries
suggests that transfusions are often given unnecessarily, with a preference to
transfuse whole blood rather than blood components. National guidelines on the
clinical use of blood are available in 13 countries. However, the guidelines are often
not adhered to by clinicians or may not be effectively distributed and updated.
Quality systems for clinical transfusion processes are not in place.

Only 11 countries have established hospital transfusion committees, which are

variably active and suffer from lack of support from hospital management and
clinical staff. In general, communication is weak between the blood services, hospital
blood banks and hospitals/clinicians (clinical interface), and there are shortcomings
in compatibility testing and issue of blood, appropriate clinical use of blood and
blood products, safe transfusion practice at the bedside, and patient monitoring and
follow-up. Training of clinicians, nurses, midwives and laboratory technical staff on
clinical transfusion has only been carried out in six countries.

2.6 Quality system management throughout the blood transfusion

chain

Quality management programmes have been initiated in the blood transfusion

systems in many countries, but have not been subsequently followed up. Standards
and standard operating procedures have been developed, but are not applied
uniformly within countries. There are challenges in the development of complete
and accurate records and systems for controlling documents. Training of blood
transfusion service and clinical staff on quality and quality systems has been
conducted. Thirteen countries participate in a national external quality assessment
scheme for TTI testing and 11 for blood group serology and compatibility testing,
while only five countries report participation in an international external quality
assessment scheme and only 10 have protocols for reporting adverse transfusion
events and for post-transfusion management of patients.

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Strategic framework for blood safety and availability 2016–2025

3. Strategic framework for blood safety

and availability 2016–2025

3.1 Background and rationale

Despite the recognition that universal and timely access to safe blood and blood
products is essential for good health care provision and the progress made in
developing blood transfusion services in many countries in the Region, significant
challenges remain that affect the availability, safety, quality, affordability and clinical
efficacy of blood and blood products. Approximately 30% of countries in the Region
have insufficient or unsustainable national blood supplies, with a median blood
donation rate of less than 10 per 1000 population. Moreover, although plasma-
derived medicinal products for the treatment of coagulation factor deficiencies and
immune deficiency diseases were added to the WHO Model List of Essential
Medicines in 1979, the vast majority of people with bleeding disorders and immune
deficiencies in the Region still have very limited or no access to these products.

The safety and availability of blood and blood products has a vital role in the
implementation of essential interventions for reproductive, maternal, newborn and
child health, the delivery of universal health coverage, and the achievement of the
strategic priorities for public health in the Region. It is also a critical element in
achieving Sustainable Development Goal 3 targets to reduce maternal deaths, end
preventable deaths of newborns and children under 5 years of age, end the AIDS
epidemic, combat hepatitis, reduce the number of deaths and injuries from road
traffic accidents and achieve universal health coverage by 2030.

The strategic framework for blood safety and availability 2016–2025 has been
developed to address the challenges identified in the regional situation analysis and
to improve the health of the nearly 583 million people in the 22 countries of the
Region. The strategic framework will guide countries over the next 10 years (2016–
2025) in developing and strengthening national blood transfusion systems, which
will ensure the continuity, sufficiency, sustainability and security of national
supplies of safe and efficacious blood and blood products to meet the needs of their
populations.

The strategic framework will also play an important role in integrating blood
transfusion services into health care systems as a cross-cutting service and in support
of the implementation of: World Health Assembly resolutions WHA28.72,
WHA58.13 and WHA63.12, and Regional Committee resolution EM/RC34/R.9, on
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 Strategic framework for blood safety and availability 2016–2025

the safety, quality and availability of blood and blood products; Executive Board
decision EB136(2) on principles for global consensus on the donation and
management of blood, blood components and medical products of human origin;
World Health Assembly resolutions WHA63.18 and WHA67.6 on hepatitis;
WHA59.20 on sickle-cell anaemia; and Executive Board decision EB118.R1 on
thalassemia and other haemoglobinopathies.

3.2 Purpose and scope

The goal of the strategic framework is to improve the availability, safety,

affordability and accessibility of blood and blood products in the Eastern
Mediterranean Region in order to reduce mortality and morbidity in countries.

The objectives of the strategic framework are to support countries in:

• ensuring access to a safe and sufficient supply of blood and blood products;
• achieving complete reliance on regular voluntary non-remunerated donors for
blood and blood components;
• preventing transfusion transmitted infections (TTIs) through quality-assured
screening of all donated blood and blood components, and ensuring quality-
assured testing for blood grouping and compatibility (immunohaematology);
• developing quality and quality management systems throughout the blood
transfusion chain; and
• promoting appropriate clinical use of blood and blood products.

A framework for action (Annex 1) outlines the priority interventions and actions
needed from countries to achieve the following targets by 2025.

• All countries will have developed or reviewed and implemented a national blood
policy and strategic plan for a nationally coordinated blood transfusion service;
• All countries will have developed and implemented an appropriate framework
for regulatory mechanisms for the registration, licensing, operation and
inspection of blood transfusion services;
• All countries will have achieved 100% voluntary non-remunerated donations
from low risk populations;
• All countries will have achieved or maintained 100% quality-assured testing of
donated blood for TTIs;
• All countries will have processed at least 75% of whole blood collected into
components within a quality system;
• All countries will have developed and implemented national guidelines on the
clinical use of blood;
• All countries will have a functioning and sustainable hospital transfusion
committee in at least 80% of hospitals;

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Strategic framework for blood safety and availability 2016–2025

• All countries will have implemented national quality management systems at

all levels of the blood services; and
• All countries will have established a national haemovigilance system.

3.3 Priority interventions of the strategic framework

Strengthen leadership and governance of the national blood transfusion service

This will be achieved through:

• establishing or strengthening a specific organization, unit or department with

overall responsibility for the national blood transfusion service, as appointed and
approved by the ministry of health/national health authority;
• appointment of a competent leader or strengthening of the existing leadership;
• the development, or updating, and implementation of a national blood policy
and strategic plan;
• the development, or updating, and implementation of an appropriate framework
for a regulatory mechanism for the registration, licensing, operation and
inspection of the national blood transfusion service;
• establishing and strengthening a national blood advisory body for advising the
ministry of health/national health authority on the safety and adequacy of the
national blood supply, and appropriate clinical use;
• setting national standards for quality blood and blood products, services,
processes and systems; and
• ensuring adequate and sustainable financing for the national blood transfusion
service through mechanisms such as a specific fiscal budget, cost-recovery
through health insurance, economies of scale and cost-effectiveness, or a
combination of these based on the necessary integration of blood supply and
consumption in the health care system, in both the private and public sector.

Support coordination and collaboration

This will be achieved through:

• improving national coordination of the blood transfusion service to promote

uniform standards, appropriate economies of scale, consistency in the quality and
safety of blood and blood products, and best transfusion practices;
• developing effective mechanisms to assist in the selection, procurement and
maintenance of equipment, devices and consumables;
• strengthening coordination and collaboration with blood donor and patient
associations, academic and research institutions, scientific and professional

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 Strategic framework for blood safety and availability 2016–2025

societies, and industry (public and private), and establishing links with other
health programmes (national, regional and international);
• improving biomedical waste management and occupational safety as part of a
comprehensive health and safety policy in blood transfusion services;
• developing an effective national system for the collection and management of
data, monitoring and evaluation, and research and development; and
• strengthening blood supply contingency planning for preparedness and response
to emergencies, threats and natural disasters.

Strengthen provision of safe blood and blood products to meet patients’ needs

This will be achieved through:

• establishing a sustainable voluntary (non-remunerated and regular) blood donor

panel from low risk populations through effective public education and donor
motivation, recruitment/mobilization and retention programmes, including
converting family replacement donors to regular voluntary non-remunerated
blood donors;
• ensuring safe blood collection processes, including donor selection and deferral,
donor care, notification, counselling, referral and confidentiality;
• strengthening quality-assured testing of blood using the most appropriate and
effective methodologies for mandatory screening for HIV 1 and 2, HBV, HCV and
syphilis;
• where appropriate and cost-effective, considering other health care priorities,
implementing screening strategies using NAAT and other risk-reduction
technologies such as pathogen inactivation;
• promoting quality blood component production;
• establishing a mechanism for the coordination and integration of blood and
plasma collection programmes aimed at optimizing the use of recovered and
source plasma for contract fractionation and minimizing wastage;
• establishing or strengthening an information management system to collect,
monitor and ensure the accuracy, transparency and traceability of all data on
blood and blood products; and
• developing mechanisms for human resource development through education
and training of staff working throughout the transfusion chain.

Promote appropriate clinical use of blood and blood products

This will be achieved through:

• the development, or updating, and implementation of national guidelines on the

clinical use of blood and blood products;
• the establishment of mechanisms, such as hospital transfusion committees, to
assess current and future needs, monitor trends and improve clinical practice
through clinical audits;

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Strategic framework for blood safety and availability 2016–2025

• setting up systems, processes and procedures for compatibility testing and issue
of blood, safe transfusion practice at the bedside, and patient monitoring and
follow-up;
• ensuring availability of critical supplies for alternatives to transfusion,
compatibility testing and blood administration; and
• training for clinicians, nurses, midwives and laboratory scientists/technical staff
on safe transfusion practice.

Strengthen quality system management throughout the blood transfusion chain

This will be achieved through:

• ensuring management commitment to establishing appropriate quality systems

and standardized procedures in the national transfusion service for the collection,
testing, processing, storage, distribution and use of blood and blood products;
• developing, or strengthening, and implementing a quality policy, appointing a
national quality manager, and appropriate national quality and technical
standards;
• developing, or strengthening, an appropriate and comprehensive documentation
system captured in a quality manual including process descriptions, standard
operating procedures, equipment operating procedures, complete and accurate
records, and a system for document control to manage the quality system;
• capacity-building (education, teaching and training) of blood transfusion service
staff and other health care professionals involved in blood transfusion medicine
and quality management;
• participating in assessment programmes and accreditation; and
• establishing and strengthening national haemovigilance systems for monitoring
all aspects of clinical transfusion practices, including adverse events occurring in
the vein-to-vein transfusion chain.

See Annex 2 for more detailed actions and targets.

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 Strategic framework for blood safety and availability 2016–2025

3.4 Implementation of the strategic framework

The implementation of the strategic framework at country level is a collective

endeavour that will require concerted and coordinated actions by all stakeholders,
national and international, under the leadership of the Ministry of Health. These
actions should be adapted to and aligned with each country’s specific context,
political and socioeconomic environment, available resources and capacities, and
overarching health and development strategies, laws and regulations.

The following actions will have a critical role for implementation and are common
for most countries regardless of national context.

• Conduct a thorough assessment of the current blood transfusion service.

• Use the results of the assessment to mobilize high-level political commitment and
cross-sectoral support for the strengthening of the blood transfusion service.
• Develop a national blood policy and strategic plan through an inclusive
consultative process and consensus-building with relevant stakeholders, and
officially endorse/enact the policy and plan through appropriate country
mechanisms and channels.
• Mobilize the necessary resources, including human, technical and financial
resources.
• Establish a national mechanism for monitoring and evaluation of the
performance of the blood transfusion service and the implementation of the
national blood policy and strategic plan.

The monitoring of the strategic framework should be undertaken annually, by each

country, to enable necessary adjustments to be made on time. At the regional level,
progress reports will be developed and disseminated every two years. A mid-term
review will be conducted after five years of implementation of the strategic
framework (2020) and reports on the status of blood safety availability in the Eastern
Mediterranean Region will be developed and published.

Data on blood safety and availability indicators will be collated annually for the
WHO Global Database on Blood Safety, and each country will in addition define
monitoring indicators based on its specific situation that will be used to assess its
own progress.

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Strategic framework for blood safety and availability 2016–2025

4. The way forward

Universal and timely access to safe blood and blood products and their appropriate
use are essential components of good health care provision. With the goal of
ensuring universal access to safe blood and blood products, WHO has been at the
forefront of the movement to improve safety and availability as mandated by
successive World Health Assembly and Regional Committee resolutions. However,
countries in the Region still face major challenges in providing access to sufficient,
affordable and sustainable supplies of blood and blood products, while also
ensuring the quality and safety of these products in the presence of known and
emerging threats to public health.

The strategic framework has been developed to address the challenges identified in
the situation analysis and to guide countries over the 10 year period 2016–2025 in
developing and strengthening national systems. This will ensure the continuity,
sufficiency, sustainability and security of national supplies of safe and efficacious
blood and blood products to meet the needs of patient populations.

The following recommendations are proposed for Member States.

• Implement the proposed actions as outlined in the strategic framework, adapted

to national priorities, regulations and specific context through a broad-based
partnership with national and international partners and stakeholders
• Use the strategic framework to guide the development/review of national blood
policies and strategic plans, based on the findings of a sound situation analysis
and inclusive priority-setting, aligned with the overarching national health plan
and national development strategy, and synchronized with national financial
policy cycles.
• Ensure provision of adequate financial, human, infrastructural and technical
resources for implementation of national blood policies and strategic plans
through sound resource planning and programme budgeting, leveraging the
support available from domestic and international sources.
• Build and expand the mechanisms and institutional base for monitoring and
evaluation of blood transfusion services and of the progress towards
implementation of national blood policies and strategic plans.

Countries should carry out a review of their blood transfusion services regularly and
develop their own strategic and operational plans, guided by the strategic
framework, to address country-specific needs in accordance with their existing
resources.
18
 Strategic framework for blood safety and availability 2016–2025

A framework for action (see Annex 2) has been developed to summarize priority
interventions and actions by countries with support from WHO, along with
indicators and a baseline (2015), including targets for 2020 and 2025, and to assist
monitoring of implementation.

WHO will continue to provide support to Member States at regional and country
level in their efforts to improve their health blood transfusion services in a cross-
cutting and comprehensive manner.

The safety, quality, availability, affordability and clinical efficacy of blood

transfusion remain a serious challenge for countries in the Eastern Mediterranean
Region. This strategic framework examines the weaknesses of the blood transfusion
services in the Region and proposes a framework for action in order to foster timely
progress in this vital sector.

19
Strategic framework for blood safety and availability 2016–2025

20
 Strategic framework for blood safety and availability 2016–2025

Annex 1. Resolution EM/RC63/R.5

REGIONAL COMMITTEE FOR THE EM/RC63/R.5

EASTERN MEDITERRANEAN October 2016

Sixty-third Session

Strategic framework for blood safety and availability 2016–2025

The Regional Committee,

Having considered the technical paper on the strategic framework for blood safety
and availability 2016–20254;

Recalling resolutions WHA 28.72 on utilization and supply of human blood and
blood products, WHA58.13 on blood safety: proposal to establish World Blood
Donor Day, WHA63.12 on availability, safety and quality of blood products and
EM/RC34/R.9 on the development of national blood transfusion services in the
countries of the Eastern Mediterranean Region;

Acknowledging blood transfusion as an essential component of health care;

Noting the status of blood transfusion services in Member States of the Region and
the progress made so far, and the continuing gaps in providing access to sufficient,
affordable and sustainable supplies of safe and quality blood and blood products;

1. ENDORSES the strategic framework for blood safety and availability 2016–
2025 and its framework for action (annexed to this resolution);

2. URGES Member States to:

2.1 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;

4
EM/RC63/6 Rev.1.

21
Strategic framework for blood safety and availability 2016–2025

2.2 Establish effective coordination and collaboration mechanisms among all

relevant stakeholders in the public and private sectors;

2.3 Establish, implement and support a national quality management system

throughout the blood transfusion chain;

2.4 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;

2.5 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;

2.6 Establish a mechanism for the integration of blood and plasma

programmes, aimed at optimizing the use of recovered and source plasma
for fractionation;

3. REQUESTS the Regional Director to:

3.1 Provide support to Member States to develop national strategic and

operational plans based on the strategic framework;

3.2 Foster coordination and collaboration with all relevant stakeholders and
partners;

3.3 Report to the Regional Committee every two years, starting from 2018, on
the progress in implementation of the regional strategic framework for
blood safety and availability 2016−2025.

22
 Strategic framework for blood safety and availability 2016–2025

Annex to Resolution EM/RC63/R.5

Framework for action for blood safety and availability 2016–2025

Priority interventions Action by countries Progress indicator

Strengthen Establish a specific organization, unit or department with overall Country has:
leadership and responsibility for the national blood transfusion service implemented a national
governance of the Develop or update and implement a national blood policy and blood policy and strategic
national blood strategic plan plan for a nationally
transfusion service Develop or update and implement an appropriate framework for coordinated blood
a regulatory mechanism for the registration, licensing, operation transfusion service
and inspection of the national blood transfusion service implemented an
Establish and strengthen the national blood advisory body to appropriate framework for a
advise the Ministry of Health on the safety and adequacy of the regulatory mechanism for
national blood supply and appropriate clinical use the national blood
Set national standards for quality blood and blood products, transfusion service
services, processes and systems
Ensure adequate and sustainable financing for the national blood
transfusion service

Support Improve national coordination of the blood transfusion service to Country has:
coordination and promote uniform standards, appropriate economies of scale, established a centralized
collaboration consistency in the quality and safety of blood and blood products national blood information
and best transfusion practices management system a
Develop effective mechanisms to assist in the selection, blood supply contingency
procurement and maintenance of equipment, devices and plan included in the
consumables national emergency
Strengthen coordination and collaboration with blood donor and preparedness and
patient associations, academic and research institutions, response plan
scientific and professional societies, and industry (public and
private) and establish links with other health programmes
Develop an effective national system for the collection and
management of data, monitoring and evaluation, research and
development
Strengthen blood supply contingency planning for preparedness
and response to emergencies, threats and natural disasters

Strengthen Establish a sustainable voluntary (non-remunerated and regular) Country has:

provision of safe blood donor panel from low risk populations achieved 100% voluntary
blood and blood Ensure safe blood collection processes, including donor selection non- remunerated
products to meet and deferral, donor care, notification, counselling and referral and donations from low risk
patients’ needs confidentiality populations
Strengthen quality assured testing of blood using the most processed at least 75% of
appropriate and effective methodologies for mandatory screening whole blood collected into
for HIV 1 and 2, HBV, HCV and syphilis and implement other components within a quality
risk-reduction technologies where appropriate and cost-effective system
Promote quality blood component production started using plasma for
Establish a mechanism for the coordination and integration of fractionation
blood and plasma collection programmes
Establish or strengthen an information management system to
collect, monitor and ensure the accuracy, transparency and
traceability of all data on blood and blood products
Develop mechanisms for human resource development through
education and training of staff

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Strategic framework for blood safety and availability 2016–2025

Promote Develop, or update, and implement national guidelines on the Country has:
appropriate clinical clinical use of blood and blood products developed and
use of blood and Establish mechanisms, such as HTCs, to assess current and implemented national
blood products future needs, monitor trends and improve clinical practice guidelines on the clinical
through clinical audits use of blood
Set up systems, processes and procedures for compatibility a functioning and
testing and issue of blood, safe transfusion practice at the sustainable hospital
bedside and patient monitoring and follow up transfusion committee in at
Ensure availability of critical supplies for alternatives to least 80% of hospitals
transfusion, compatibility testing and blood administration
Train clinicians, nurses, midwives and laboratory
scientists/technical staff on safe transfusion practice

Strengthen quality Ensure management commitment to establish appropriate quality Country has:
system systems and standardized procedures in the national transfusion implemented national
management service for the collection, testing, processing, storage, distribution quality management
throughout the and use of blood and blood products systems at all levels of the
blood transfusion Develop or strengthen implementation of quality policy, blood services established
chain a national haemovigilance
appointing a national quality manager, and appropriate national
quality and technical standards system (in all areas of
transfusion medicine,
Develop or strengthen an appropriate and comprehensive
documentation system captured in a quality manual including including donor and
processes descriptions, standard operating procedures (SOPs), patient adverse events)
equipment operating procedures (EOPs), complete and accurate
records and a system for document control to manage the quality
system
Build capacity of blood transfusion service staff and other health
care professionals involved in blood transfusion medicine and
quality management
Participate in assessment programmes and accreditation
Establish and strengthen national haemovigilance systems for
monitoring all aspects of clinical transfusion practices, including
adverse events occurring in the vein-to-vein transfusion chain

24
 Annex 2. Priority interventions
1. Strengthen leadership and governance of the national blood transfusion service

Intervention components Action by countries Action by WHO Progress indicator Baseline Target Target
2015 2020 2025
1.1 Organizational structure Establish a clearly defined organizational Disseminate aide-memoire on Number of countries 12 21 22
structure and management for the national developing a national blood system with a specific
blood transfusion service (Arabic, English, French) organization, unit or
Establish a specific organization, unit or Provide assistance when and where department for
department with the necessary authority from requested national blood
ministry of health/national health authority transfusion service
with overall responsibility for the national
blood transfusion service, separate from
laboratory services
1.2. National blood policy Develop or update and implement a national Support countries in developing, Number of countries 14 22 22
blood policy through active participation of all updating and implementing national with endorsed
stakeholders blood policy (updated) national
blood policy
1.3. National strategic plan Conduct situation and SWOT analysis Support countries in developing, Number of countries 13 22 22
Develop or update a realistic and practical updating and implementing national with endorsed
national strategic plan with defined targets strategic plan (updated) national

Strategic framework for blood safety and availability 2016–2025

and timelines strategic plan
Implement national strategic plan in a
stepwise approach
1.4. Regulatory mechanism Develop legislation for the national blood Technical support for countries in Number of countries 9 18 22
transfusion service where it does not exist developing, updating and implementing with an established
and ensure it covers all activities a regulatory mechanism for national and operational
Develop an independent, effective and blood transfusion service regulatory body
appropriate regulatory body or strengthen Advocate, promote and support
the existing regulatory mechanism for the countries to develop competent
registration, licensing, operation and regulatory body
inspection of blood transfusion service in Identify a suitable collaborating centre
public, nongovernmental and private health in the Region for training of regulators
sectors and inspectors/auditors
Identify and define the roles of regulators
and inspectors/auditors
Assess and develop the competency of
regulators, inspectors/auditors and operators

25
25
26

Strategic framework for blood safety and availability 2016–2025

Intervention components Action by countries Action by WHO Progress indicator Baseline Target Target
2015 2020 2025
1.5. National blood transfusion Establish and/or strengthen a national blood Support countries in establishing and/or Number of countries 12 20 22
service executive board services executive management board, strengthening a functional national with national blood
which provides information and advice to the blood services executive management transfusion service
ministry of health on policies and strategies board executive board (or
for key national issues, with representation of Establish WHO regional expert advisory equivalent)
the ministry of health/national health panel for blood and transfusion safety
authority and all other major stakeholders
Countries are advised and urged to review
the membership of existing national advisory
committees to select suitable members from
these bodies and society who can contribute
to the establishment of a sustainable and
effective functioning executive management
board
1.6. Financial resources Allocate a specific budget based on a cost Respond to request for assistance in Number of countries 8 14 22
analysis for a sustainable national blood developing a costing tool for national with a specific and
transfusion service linked to the national blood transfusion service financial sustainable budget
health financing plan management allocation for blood
Introduce strategies and mechanisms for Assist in mobilization of funds and transfusion service
sustainable financing of the national blood supplies from international partners,
transfusion service (e.g. cost-recovery, bilateral and/or donor agencies
health insurance, efforts to introduce
economies of scale and cost-effectiveness)
1.7. Human resources Develop a national human resources and Respond to requests to support Number of countries 10 18 22
development plan to include number of staff, countries in the development of national with human resources
deployment, training needs, continuing human resource and development plan plan for blood
professional development, remuneration, for blood transfusion service transfusion service
incentives, retention mechanisms and career Support countries in integrating hospital
development options blood banking and transfusion medicine
Develop curriculum for induction and in pre-service curriculum
orientation of new staff, and pre-service
training of staff categories working
throughout the transfusion chain
Advocate and develop academic degrees
and scientific diplomas for staff working in
blood transfusion either at university level or
postgraduate level for medical, nursing and
technical staff, to create career prospects
and recruit more human resources to work in
this field
 2. Support coordination and collaboration

Intervention components Action by countries Action by WHO Progress indicator Baseline Target Target
2015 2020 2025
2.1. National coordination Establish national coordination of the blood Support countries in coordinating with Number of countries 3 14 22
transfusion service with partners and other blood partners that meet plasma
providers at various levels to promote uniform Organize regional consultations on quality requirements
standards, economies of scale, consistency in optimization of recovered plasma
the quality and safety of blood and blood collection and integration of plasma
products and best transfusion practices collection targets in overall blood
Calculate the national needs of plasma-derived programmes
medicinal products and the estimated plasma Support countries in addressing plasma
targets required and plasma-derived medicinal products
Address availability and safety of plasma and requirements in their national blood
plasma-derived medicinal products in the policy, national strategic plan and
national blood policy, national strategic plan, regulatory mechanisms
regulatory mechanisms and implementation of
the national blood transfusion service
2.2. Procurement and supply Establish and promote centralized bulk Support countries in the development of Number of countries 5 0 0

Strategic framework for blood safety and availability 2016–2025

management procurement of equipment, test kits, reagents, national procurement and supply reporting stock out of
consumables based on pre-validation management system reagents and supplies
(sensitivity, specificity), expiry dates, shelf-life Support countries in developing a
and cost system for planned preventive
Improve stock management and cold chain maintenance, repair and replacement of
control measures for transportation, and equipment, facilities and vehicles
traceability
Improve planned preventive maintenance and
repair of equipment, facilities, and vehicles
Develop approved suppliers list
27

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Strategic framework for blood safety and availability 2016–2025

Intervention components Action by countries Action by WHO Progress indicator Baseline Target Target
2015 2020 2025
2.3. Partnerships Develop and implement stakeholder’s analysis Establish a regional network of blood Number of countries 11 20 22
Support blood donor organizations, patient donor organizations with functional national
associations and develop mechanisms to Strengthen patient associations in the blood donor
improve partnership with the community region organizations
Establish working relationships with academic
and research institutions, scientific and
professional societies and industry
Establish links with health programmes such as
maternal and child health, HIV, hepatitis,
surgery, trauma care, centres for accident,
emergency and road traffic injuries, haemophilia,
thalassemia and sickle cell disease
Celebrate World Blood Donor Day and/or
national blood donor days

2.4. Occupational safety and Develop a national biomedical waste Support countries in developing and Number countries with 13 20 22
biomedical waste management management policy for blood transfusion service implementing national strategies and appropriate physical
Provide appropriate infrastructure, facilities, guidelines on biosafety, waste structure and
environment and equipment for biomedical management and infection control equipment for
waste management Organize regional training for blood biomedical waste
Develop and implement standard operating transfusion service staff on biosafety, management
procedures for biomedical waste management waste management and infection
Procure and distribute equipment and control
commodities for biomedical waste management
Improve access to personnel protective
equipment and immunization for pre- and post-
exposure prophylaxis
Train staff on biomedical waste management
and health and safety at work in blood
transfusion service
Establish policies and procedures for reporting
and management of sharp and needle-stick
injuries

28
 Intervention components Action by countries Action by WHO Progress indicator Baseline Target Target
2015 2020 2025
2.5. Information management system Develop a national centralized blood information Adaptation and translation of blood Number of countries 8 19 22
management system to collect, monitor and information management system with centralized
ensure the accuracy, transparency, traceability guidelines national blood
and confidentiality of all data on blood and blood Technical support in setting up national information
products from the donor to the recipient with blood information management system management system
data backup system
Develop national guidelines on archiving that
specify legal requirements and the length of time
that reports, records and data are to be
maintained

2.6. Research and development Review existing information (including WHO Strengthen and support WHO Number of countries 16 22 22
Global Database on Blood Safety) and identify collaborating centres to conduct submitted complete
priority research topics operational research data to WHO Global
Collaborate with academic and research Prepare biennial regional progress Database on Blood
institutions, scientific and professional societies reports on blood safety and availability Safety
and industry to conduct operational and basic
research

Strategic framework for blood safety and availability 2016–2025

2.7. Contingency planning Create awareness of the need for ensuring Organize regional consultations on Number of countries 15 22 22
adequate blood supply during humanitarian blood transfusion during humanitarian with blood supply
emergencies and outbreaks of emerging emergency situations contingency plan
infections Technical support in developing included in national
Include blood supply contingency plan in the guidelines for rapid response for emergency
national emergency preparedness and response emerging infections, surveillance and preparedness and
plan to provide a framework for a rapid and reporting system response plan
coordinated response to emergencies Technical support in developing
Review the supply of blood and blood products national/regional guidelines for rapid
during emergencies and outbreaks of emerging response during humanitarian
infections (when applicable) emergencies, disasters and
regional/global threats

29
29
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Strategic framework for blood safety and availability 2016–2025

3. Strengthen provision of safe blood and blood products to meet patients’ needs

Intervention components Action by countries Action by WHO Indicator Baseline Target Target
2015 2020 2025
3.1. Blood donor programme Establish voluntary non-remunerated and regular Translate to Arabic and distribute WHO Number of countries 2 17 22
blood and blood component donor education, guidelines for donor selection and collecting 100% of their
motivation, mobilization and retention donor counselling blood supply from
programme Organize World Blood Donor Day as a voluntary non-
Designate a public education, blood donor regional event remunerated donors
motivation and retention unit within blood Provide technical support in developing
transfusion services relevant information, education and
Develop national guidelines and perform quality communication materials
assurance for donor selection, deferral, safe Provide technical support in translation
blood collection process, donor care (including of documents and information,
donor vigilance), notification, counselling and education and communication material
referral
Collaborate with the media, blood donor
organizations and other community
organizations to promote the culture of voluntary
non-remunerated and regular (repeat) donation
Convert family replacement donors to voluntary
non-remunerated donors
Educate and train blood bank staff on public
education, motivation, recruitment, retention and
safe blood collection procedures
Translate documents in local languages
3.2. Quality assured testing Develop strategies for screening for transfusion- Translate to Arabic and disseminate Number of countries 18 22 22
transmitted infections (TTIs) based on WHO guidelines on screening donated with 100% quality-
epidemiology, capacity of laboratories and a blood for TTIs assured and
cost-benefit analysis Facilitate regional EQAS uninterrupted testing of
Convert step-wise from rapid test to enzyme- donated blood for TTIs
Organize regional training on testing
linked immunoassay and consider and selection of appropriate screening
appropriateness of introduction of screening and testing algorithms
strategies using nucleic acid amplification test
and other risk-reduction technologies such as
pathogen inactivation as appropriate
Collaborate with national, regional or global
reference laboratories for evaluation of assays,
investigation of infection transmission cases and
confirmation of test results
Provide required infrastructure, equipment and
maintenance, financial resources, and
competent staff
 Intervention components Action by countries Action by WHO Indicator Baseline Target Target
2015 2020 2025
Ensure availability of quality control material,
procedures and participation in External Quality
Control System (EQAS)

3.3. Component production Implement a step-wise component production Disseminate aide-memoire on safe Number of countries 12 18 22
programme based on needs and feasibility blood components processing at least
Procure equipment and supplies required for Support countries in strengthening 75% of whole blood
component production, storage and distribution quality blood component collection and collected into
(cold chain) production components
Train staff on component production, cold chain
management and component therapy
3.4. Fractionation Integrate plasma programmes in the national Explore feasibility of fractionation Number of countries 3 3 5
blood transfusion service to optimize the use of programmes on a regional or national using plasma for
recovered plasma and minimize wastage level (including contract or loan fractionation
Introduce and implement the necessary fractionation)
operational and quality systems to produce
adequate volumes of qualified plasma for
fractionation
Include plasma-derived medicinal products in

Strategic framework for blood safety and availability 2016–2025

national list of essential medicines
31

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 Strategic framework for blood safety and availability 2016–2025
32

4. Promote appropriate clinical use of blood and blood products

Intervention components Action by countries Action by WHO Indicator Baseline Target Target
2015 2020 2025
4.1. National guidelines on Develop and implement guidelines on Provide technical support for the Number of countries 13 20 22
appropriate clinical use of blood appropriate clinical use of blood and blood development and implementation of with endorsed national
and blood products products by consensus with clinicians and the guidelines on appropriate clinical use of guidelines on the
blood transfusion service blood and blood products appropriate clinical use
Procure and distribute critical supplies for of blood and blood
alternatives to transfusion, compatibility testing products
and blood administration
4.2. Hospital transfusion committees Establish and support hospital transfusion Provide technical support in Number of countries 11 18 22
committees in all hospitals with clearly defined establishing hospital transfusion with at least 80% of
terms of reference committees hospitals having
Conduct annual review of the activities of functional hospital
hospital transfusion committees transfusion committees
4.3. Clinical transfusion Establish systems, processes and procedures Develop or adapt tools for estimating Number of countries 8 12 22
for compatibility testing and issue of blood, safe blood needs implemented the
transfusion practice at the bedside and patient Provide technical support for national guidelines on
monitoring and follow-.up implementation of the guidelines on appropriate clinical use
Assign transfusion officers and train staff to appropriate clinical use of blood and of blood and blood
monitor patient transfusions and report any blood products products
adverse reactions
4.4. Education and training Conduct education and training for clinicians, Support countries in planning and Number of countries 10 21 22
nurses, midwives, pharmacists and laboratory implementing training activities on conducted national
technical staff on appropriate clinical use of appropriate clinical use of blood and training on appropriate
blood and blood products and safe transfusion blood products and patient blood clinical use of blood
practice management and blood products
Conduct regular clinical audits to monitor and
train clinical staff including clinicians, nurses,
laboratory staff and any other staff involved in
the transfusion chain
 5. Strengthen quality system management throughout the blood transfusion chain

Intervention components Action by countries Action by WHO Indicator Baseline Target Target
2015 2020 2025
5.1. Organizational management Develop national quality policy and plan Provide technical support for Number of countries 14 18 22
Assign quality managers at national and facility developing national quality policy and with quality policy and
levels plan plan
Designate a quality section/team in each blood
bank and hospital
5.2. Standards Develop or update quality and technical Provide technical countries in Number of countries 14 18 22
standards on the management and operational developing and updating standards with blood transfusion
processes for blood transfusion service and Develop an electronic resource service standards
clinical transfusion, supported and based on including all national standards
legislation
Include quality and quality management in the
regulatory mechanism for registration, licensing,
operation and inspection of blood transfusion
service
Ensure standards cover all critical processes
and products vein-to-vein, are agreed by all
stakeholders and followed by all facilities

Strategic framework for blood safety and availability 2016–2025

Review and revise standards at regular intervals
5.3. Documentation Develop a quality manual including the quality Provide technical support for Number of countries 11 18 22
policy, standards and procedures developing a national quality manual with quality manual
Produce and use appropriate, comprehensive
documents for all activities, including standard
operating and equipment procedures, forms,
labels and any other documents required
Develop a system for document control and
records for storage and traceability
5.4. Education (teaching and training) Conduct competency-based training for blood Provide technical support for quality Number of countries 6 15 22
transfusion service and clinical staff in general management training with undergraduate
principles of quality, the quality system, Identify and support regional centre that and postgraduate
documentation and use of quality monitoring can provide exchange visits to promote training programmes in
tools quality models for best practice blood banking and
Assess competency of staff regularly transfusion medicine
Advocate and contribute in updating or
developing curricula for undergraduate and
postgraduate education in blood banking and
transfusion medicine

33
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 Strategic framework for blood safety and availability 2016–2025
34

Intervention components Action by countries Action by WHO Indicator Baseline Target Target
2015 2020 2025
5.5. Assessment Conduct validation of all processes, procedures, Provide technical support for validation, Number of countries 11 18 22
equipment and reagents audits, assessment and accreditation participating in EQAS
Conduct regular internal and external audits of schemes for TTI screening and
operational and quality systems immunohaematology
Develop a system for reporting and analysis of
errors and non-conformities with corrective and
preventive action
Participate in external quality assessment
schemes
Participate in accreditation programmes
(national, regional or international)
Develop a risk assessment system
5.6. Haemovigilance Assign a national haemovigilance focal person Establish regional programmes for Number of countries 10 19 22
Develop a system for monitoring and vigilance, rapid alert and information with a national
investigating adverse events in clinical sharing for emerging infections haemovigilance system
transfusion Translate to Arabic and disseminate for donor and patient
Develop systems of surveillance on the aide-memoire and the guide on adverse events
incidence and prevalence of TTIs in blood establishing a national haemovigilance
donors and general population and for follow-up system
investigation of infection transmission cases Organize regional consultation on
Develop a system to monitor incidence, haemovigilance
prevalence, follow-up and look-back Provide training on haemovigilance
investigation of TTIs
Collaborate with public health agencies in
surveillance of diseases that have impact on
blood safety and supplies
Encourage hospitals to enrol in a regional or
international voluntary haemovigilance initiatives
(e.g. the Arab Haemovigilance Network of the
Arab Transfusion Medicine Forum)

34
 Strategic framework for blood safety and availability 2016–2025

Annex 3. Summary of the key elements

of a national blood system 5

Leadership and governance

The ministry of health/national health authority has ultimate responsibility for

ensuring an adequate national supply of safe blood and blood products and their
safe and appropriate clinical use. The ministry of health/national health authority
should establish a sustainable national blood transfusion service that is authorized
and recognized through the formulation and implementation of a national blood
policy and strategic plan, defining the roles, responsibilities and accountability of
institutions and organizations, which comprise a coordinated national blood service,
setting national standards for blood and blood products, services, processes and
systems, and establishing appropriate regulatory mechanisms for the registration,
licensing, operation and inspection of blood transfusion services. It should also
demonstrate its commitment through the establishment of systems and structures,
including a specific organisation, unit or department with overall responsibility for
the national blood service. Furthermore, the ministry of health/national health
authority should provide a mechanism for the appointment of a national blood
advisory committee to provide expert guidance on areas of improvement in the
blood service and clinical transfusion practice, as and when necessary. It should also
provide adequate, sustainable financing for the national blood service, which is
integrated within the financial structure of the national health care system.

Coordination and collaboration

The national blood transfusion service should be organized and coordinated by the
body approved by ministry of health/national health authority in a manner that
ensures the most efficient and cost-effective use of all resources. Blood transfusion
services may operate, in a coordinated manner, either under a single service
provider or through multiple organizations and institutions. Whichever service
delivery model is in place, blood transfusion services should be coordinated at
national, regional and provincial levels, with critical activities, such as blood
screening and processing, consolidated in cost-effective and strategic locations.

Source: Adapted from Developing a national blood system: aide mémoire for ministries of health [website]. Geneva: World
Health Organization; 2016 (http://www.who.int/bloodsafety/publications/am_developing_a_national_blood_system.pdf,
accessed 15 September 2016).
35
Strategic framework for blood safety and availability 2016–2025

Provision of safe blood and blood products

Blood transfusion services should comply with national policies, strategies and plans to
ensure the implementation of standards to meet targets for the provision of safe blood and
blood products. In order to perform their functions efficiently, blood transfusion services
should have an adequate number of qualified, skilled and experienced personnel in human
resource management, finance and administration, quality systems, transfusion medicine,
blood donor programmes, laboratory testing and blood processing, and suitable infrastructure
and facilities in all centres in which blood collection, testing, processing and storage of blood
and blood products take place.

The most robust and safe national blood services that ensure the continuity, sufficiency,
sustainability and security of national supplies are based on the principle of voluntary non-
remunerated donations of blood and blood components donated by regular blood donors from
low-risk populations. Sustainable public education, donor motivation, recruitment,
mobilization and retention programmes, and a safe blood collection process, including donor
selection and deferral, and donor care, notification, counselling, referral and confidentiality,
are the foundations of an effective blood donor programme.

Testing and processing using the most appropriate and effective methodologies and best
laboratory practices, efficient inventory management system for optimum blood stocks, and
effective blood cold chain for safe storage and distribution of blood and blood products are
key requirements to ensure the safety and availability of blood and blood products and to
reduce wastage.

Clinical transfusion in patient management

Hospitals and other health facilities that perform transfusion should liaise and work
closely with the national blood transfusion service. National and hospital authorities
should allocate sufficient resources to optimize blood transfusion for patient health.
Cooperation of national blood transfusion services with hospitals in the
implementation of transfusion guidelines, staff training and participation in national
haemovigilance are of paramount importance to improve clinical transfusion.
Hospital transfusion committees with clear terms of reference and responsibility for
implementing transfusion guidelines and monitoring transfusion practices are key
institutional mechanisms to improve clinical transfusion.

Quality system management throughout the blood transfusion

chain

A quality system addressing organizational management, standards for quality

systems, documentation, training and assessment is a key requirement for provision
of safe blood and blood products in patient management. In an effective quality
system all activities are performed in a quality-focused way and are continuously
monitored.
36
The strategic framework for blood safety and availability (2016–2025), with its accompanying
framework for action and priority interventions, is intended to guide countries in developing
and strengthening national blood systems to ensure the continuity, sufficiency, sustainability
and security of national supplies of safe and efficacious blood and blood components to meet
national needs. It was developed through broad consultation with national blood transfusion
service providers, regional and international organizations, and experts working in the field.