Kit: Thank you for saving my life World Blood Donor Day

THANK YOU FOR SAVING MY LIFE

WORLD HEALTH ORGANIZATION

The Clinical Use of Blood

AIDE-MEMOIRE for National Health Programmes Blood transfusion is an essential part of patient care. When used correctly, it saves lives and improves health. However, blood transfusion carries a potential risk of acute or delayed complications and transfusiontransmitted infections and should be prescribed only to treat conditions associated with significant morbidity or mortality that cannot be prevented or managed effectively by other means. Blood is a scarce human resource and ensuring its safety and clinical effectiveness requires investment – both human and financial. The national blood transfusion service (BTS) is responsible for ensuring the provision of an adequate supply of safe blood for all patients requiring transfusion. The national health programme should develop policies and strategies to reduce the need for transfusion, minimize unnecessary transfusions and ensure the safe and appropriate use of blood and blood products. These strategies should include: „ Prevention, early diagnosis and effective treatment of conditions that could result in the need for transfusion „ Use of good surgical and anaesthetic techniques, pharmaceuticals and medical devices to reduce blood loss „ Availability and use of simple alternatives for volume replacement, including intravenous replacement fluids (crystalloids and colloids) „ Appropriate prescribing of blood and blood products in accordance with national guidelines „ Safe pre-transfusion procedures „ Safe administration of blood and blood products. The national blood programme and clinical users of blood and blood products should work together to implement these policies and strategies.

Checklist Prerequisites

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Well organized, nationally coordinated blood transfusion service National blood policy and plan incorporating the clinical use of blood National committee on the clinical use of blood Quality system for the BTS, hospital blood banks and clinical departments Adequate resources Clinical and laboratory indications for the use of blood, blood products and alternatives to transfusion Information about available blood products and alternatives to transfusion Standard blood request form Guidance on the development of blood ordering schedule and standard operating procedures at hospital level Training of clinicians, nurses and BTS/ blood bank staff in: – Undergraduate and postgraduate programmes – In-service training – Continuing medical education Effective implementation of national guidelines Training of hospital staff Hospital blood ordering schedule Hospital standard operating procedures Monitoring and evaluation at hospital level Safety and adequacy of available blood and blood products and alternatives to transfusion Traceability of blood and blood products Compliance with national transfusion guidelines Patterns of blood usage and clinical transfusion practice Adverse events related to transfusion

National guidelines

Education and training

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Words of advice „ Secure government commitment and support for the development

Hospital transfusion committees

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and implementation of a policy to promote the safe, appropriate use of blood Ensure a safe and adequate supply of blood and blood products Ensure the availability and use of simple alternatives to transfusion Establish a national committee on the clinical use of blood Develop national guidelines on the clinical use of blood Involve professional bodies and patient associations in the establishment of systems to ensure the safe and appropriate use of blood Provide training for all clinicians, nurses, BTS/hospital blood bank staff and other personnel involved in the transfusion process Establish transfusion committees in each hospital in which transfusion takes place Establish a system to monitor and evaluate blood usage Establish a national haemovigilance system to monitor, report and investigate adverse events associated with transfusion

Monitoring and evaluation

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© 2003 World Health Organization. All rights reserved. WHO/EHT/04.07. Printed April 2004.

Key elements Requirements for the appropriate clinical use of blood The national blood programme has the responsibility to ensure that blood and blood products provided for clinical use are safe, adequate to meet demand, clinically effective and produced consistently to appropriate standards. While responsibility for the decision to transfuse ultimately rests with individual clinicians, consistently effective clinical transfusion practice cannot be achieved unless the following are in place: „ A well organized, nationally coordinated blood transfusion service National clinical guidelines Transfusion guidelines should represent a consensus by clinical specialists, the BTS, pharmacists and professional bodies on the most effective treatments for specific conditions. They should be practical, comprehensive and relevant to local conditions. They should include: „ Clinical and laboratory indications for the use of blood, blood products and alternatives to transfusion „ Information on available blood products and alternatives to transfusion: dosage, storage conditions, risk of transfusion-transmissible infection, means of administration, contraindications and precautions „ Standard blood request form to provide full information about the patient and the need for transfusion „ Blood ordering schedule, as a guide to the number of units of blood and blood products that should normally be requested for each type of operation, with guidance on its adaptation by each hospital „ Instructions for the development of standard operating procedures at hospital level. The national committee on the clinical use of blood should work to ensure the effective implementation of the guidelines. Education and training The effective implementation of the national policy and guidelines requires education and training in clinical blood use and safe clinical transfusion procedures for clinicians, nurses, BTS/ blood bank staff and other personnel involved in transfusion, including: to ensure the availability of, and access to, safe blood and blood products „ National blood policy and plan incorporating the clinical use of blood, with appropriate supportive regulations „ National committee on the clinical use of blood within the national blood programme „ Availability of intravenous replacement fluids, and medical devices and pharmaceuticals to reduce blood loss „ Undergraduate and postgraduate „ Quality system for the BTS, hospital

blood banks and all clinical departments involved in transfusion, including: – Standard operating procedures – Documentation of requests for blood, blood sampling, the administration of blood and monitoring the transfused patient – Systems to monitor adverse events and errors related to transfusion – Clinical audit.

programmes in: – Medical schools and teaching hospitals – Medical laboratory technology training institutions – Schools of nursing – Paramedical schools „ In-service training for: – Clinicians – Nurses – Blood transfusion service and hospital blood bank staff „ Continuing medical education: – Hospital clinical meetings – Seminars and conferences – Medical publications. Hospital transfusion committees A transfusion committee should be established in each hospital to implement the national policy and guidelines and monitor the use of blood and blood products at the local level. The committee should have authority within the hospital structure to determine hospital policy in relation to transfusion and resolve any identified problems. The main functions of a hospital transfusion committee include: „ Developing systems for the implementation of the national guidelines within the hospital „ Liaison with the BTS to ensure the availability of required blood and blood products at all times „ Liaison with the relevant department to ensure a reliable supply of intravenous replacement fluids and other alternatives to transfusion at all times „ Developing a hospital blood ordering schedule

„ Developing hospital standard

operating procedures for all steps in the transfusion process „ Training all hospital staff involved in transfusion „ Monitoring the usage of blood and blood products within the hospital „ Monitoring and investigation of severe adverse effects or errors associated with transfusion, taking any corrective and preventive action required and reporting through the haemovigilance system to the national committee on the clinical use of blood. Monitoring and evaluation At national level, responsibility for monitoring and evaluation should be shared by the BTS, the national committee on the clinical use of blood and the department responsible for the supply of intravenous replacement fluids and other alternatives to transfusion. The monitoring system should cover: „ The safety, adequacy and reliability of the supply of blood, blood products and alternatives to transfusion „ The traceability of all blood and blood products, from blood collection to transfusion „ Compliance with the national guidelines on transfusion and the impact on prescribing practice „ Differences in blood usage within hospitals and between similar hospitals at regional, provincial and district level „ Haemovigilance – the monitoring, reporting and investigation of all adverse events related to transfusion.

Blood Transfusion Safety Department of Essential Health Technologies World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/eht

Good Policy Process for Blood Safety and Availability

AIDE-MÉMOIRE for National Health Policy Makers Ensuring the safety and availability of blood and blood products is an essential public health responsibility. Measures to ensure blood safety also play a major role in preventing the transmission of HIV, hepatitis viruses and other bloodborne pathogens in health-care settings. The safety and availability of blood and blood products continue to be of major concern, particularly in the developing world, where blood shortages and unsafe transfusion contribute significantly to the global burden of disease, especially among women and children, the most vulnerable populations. Through successive World Health Assembly Resolutions, national health authorities have expressed their commitment to ensuring equitable access to safe blood transfusion for patients who depend on it for their survival and well-being. The public health importance of blood safety issues necessitates that each country should establish a sustainable national blood programme with a well-formulated national blood policy and plan, a national blood transfusion service, legislative and regulatory mechanisms, and a structured process for policy making. National blood policies should address all issues that could affect the quality, safety, availability and accessibility of blood and blood products and should be reviewed regularly, particularly when new issues emerge that have implications for the national blood programme. The adoption of a set of principles that define a good policy process and a structured approach to policy formulation enhances the effectiveness of national decision-making by health policy makers. Since the issues affecting blood safety and availability – and the policy decisions to manage them – have ramifications across national borders, these should be addressed through an international framework of decision-making, with the following considerations: „ Enhanced commitment and support of national policy makers to the principles of good policy process for blood safety and availability „ Structured process of decision-making in accordance with national policies, the level of development of national blood programmes and available resources „ Improved quality of international communication and consultation on blood policy making as an ongoing, dynamic and interactive process. While many countries may be confronted with similar, often complex, policy decisions, the available policy options, priorities for intervention and the optimal allocation of resources will vary. Good policy process assists national health authorities to address known and emerging threats to blood safety and availability while ensuring the flexibility to address these issues according to varying national contexts, needs and resources. Additionally, a common framework for communicating the basis of national blood policy decisions improves the quality of international dialogue and collaboration on issues of common concern. The integration of scientific, economic, ethical and social considerations into public health policies is fundamental to good policy process. Surveillance procedures and haemovigilance systems are needed to monitor adverse events and known threats to blood safety and availability and to enable informed policy decisions to be taken in response to new challenges, threats and opportunities. Such policy decisions may include: „ Restructuring of a national blood transfusion service „ Introduction or modification of criteria for donor selection and deferral „ Introduction of a new strategy and/or technology to enhance the safety, quality, supply or use of blood and blood products.

Checklist Prerequisites ‰ Endorsement of government commitment and support ‰ National blood programme ‰ National blood commission/authority ‰ National blood policy and plan ‰ Legislative and regulatory frameworks ‰ Adequate funding ‰ National blood transfusion service with responsibility for the provision of blood and blood products and liaison with clinical services Principles of good policy process ‰ Decisions based on scientific, medical and epidemiological evidence ‰ Consideration of economic, ethical and social dimensions ‰ Efficiency and cost-effectiveness ‰ Partnership and active participation by relevant stakeholders ‰ Transparency ‰ Effective communication Structured policy-making process ‰ Situation analysis, definition of problem and risk identification ‰ Identification of policy alternatives ‰ Risk assessment and analysis ‰ Identification of preferred policy option and policy formulation ‰ Communication of policy decisions and risks ‰ Policy implementation ‰ Monitoring and evaluation ‰ Risk management Assessing policies ‰ Impact on health outcomes ‰ Access and fairness of policies ‰ Cost and value for money ‰ Scientific evidence to back policy ‰ Operational capacity of institutions involved ‰ Legal issues and international agreements ‰ Risks, public health and safety

Developed by WHO/Blood Transfusion Safety with the support of the Global Collaboration for Blood Safety, a WHO-hosted network. © 2008 World Health Organization. All rights reserved. WHO/EHT/08.02. Printed January 2008.

Key elements Principles of good policy process Policy decisions for blood safety and availability bloodborne pathogens and the crosscutting role of blood transfusion in should be based on up-to-date scientific, underpinning programmes of major public medical and epidemiological evidence, with health importance, including maternal and due consideration of economic, ethical and social factors. Decisions should be made in the child health, medical and surgical procedures, and in emergency and disaster interests of public health and promote situations. optimal use of available resources. Desired outcomes and goals should be clearly The establishment and endorsement of a identified. Authority, responsibility and good policy-making process is based on the accountability for the implementation of following principles: policy decisions, including structural and „ Evidence-based: maximization of health functional relationships, should be clearly outcomes when decision-making is defined. based on robust evidence Measures to ensure the safety, availability and „ Efficiency and cost-effectiveness: accessibility of blood transfusion should be prioritization of resource allocation in given a high priority within the health care the context of overall public health and system given the importance of preventing the prudent use of human, technical and the transmission of HIV, hepatitis and other financial resources Key questions for policy makers and stakeholders Policy making should be a structured, stepwise, cyclical process. Policy makers and stakeholders should address the following questions: „ What is the problem to be solved? „ What is the proposed intervention? „ What are the known and likely positive and negative effects of the intervention? „ Do the positive effects outweigh the negative effects? „ What is the cost of the proposed intervention? „ What is required to make the intervention work? „ How can equity and sustainability be assured? „ What options are lost if the intervention is adopted? „ How often and by what criteria will the intervention be reviewed? Situation analysis and problem definition Objective situation analysis is required at regular intervals. This should include: „ Definition of the problem and its causes „ Review of existing policy to identify limitations „ Assessment of strengths, weaknesses, opportunities and threats „ Review of scientific and medical evidence and epidemiological data „ Identification of actual and potential risks. Assessment of potential interventions The identification and assessment of potential interventions should include: „ Commitment to ethical principles, „ Participation and partnership: involve-

ment of relevant stakeholders in the policy process, under the umbrella of the national blood commission/authority, to ensure the legitimacy and effectiveness of policy; stakeholders include ministry of health, national blood transfusion service, regulatory agency, experts in blood transfusion, clinicians, blood donor organizations, nongovernmental organizations, patient associations and the media „ Transparency: clear and open policy process to help ensure the legitimacy and effectiveness of blood policy „ Proactive communication: to ensure public awareness of the needs, benefits and risks associated with blood policy issues. Policy implementation Policy implementation should use appropriate mechanisms to ensure maximum compliance with the policy. Government may choose to collaborate with, or entrust policy implementation entirely to, partners in civil society and the private sector. Assessing policies A policy can be systematically assessed using a range of methods to determine its impact, value and feasibility. The following issues could be used in assessing policies on blood safety and availability: „ Impact on health outcomes and public health: assessing improvements in the quality, safety and availability of blood and blood products „ Access and fairness: assessing the effects on access to safe blood and blood products and the impact on individuals and groups (e.g. region, gender, ethnic, socioeconomic) „ Cost and value for money: assessing costeffectiveness and correlation with impact „ Scientific evidence: assessing if credible scientific evidence supports the policy „ Operational capacity: assessing the operational capacity of the institutions involved and their compatibility with the requirements of the new policy „ Legal issues and international agreements: e.g. on the movement of blood and blood products across borders „ Risk, public health and safety: assessing implications for the public, including vulnerable groups and the environment, in relation to the provision and use of blood and blood products, infection control in health-care settings and management of biohazardous clinical waste.

including accountability and transparency „ Access to relevant information by relevant stakeholders and their inputs into the identification and review of policy alternatives „ Formal analysis of policy options, including: – Risk assessment, analysis and risk– benefit ratio – Cost-effectiveness and cost-benefit analysis – Feasibility: technical, administrative and political – Education and training requirements – Sustainability – Timeliness of options „ Evaluation of strategies to avoid or reduce risks. Preferred policy option and policy formulation The selection of the preferred policy option and policy formulation should be based on the formal analysis of alternative interventions as well as consideration of social and political factors, including the likely effects on public confidence. Communication The effective communication of the decision requires a systemic strategy that cuts through the entire policy process. In order to retain public confidence, a clear statement is required of the scientific, economic, social and political rationale for the decision and the benefits and risks associated with the policy. The opportunities and actions required by different stakeholders should be highlighted.

Blood Transfusion Safety Department of Essential Health Technologies World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety

Safe Blood Components AIDE-MÉMOIRE for National Health Authorities Safe blood may be used most effectively if it is divided into components prepared from whole blood donations or obtained by apheresis procedures. One unit of whole blood can be used to meet the needs of more than one patient and provide only that component that is required. In addition, the availability of blood components enables the provision of therapeutic support for patients with conditions such as disorders of haemoglobin, coagulation and bone marrow. An effective blood component programme requires a sustainable national blood programme, including a well-organized, nationally coordinated blood transfusion service (BTS), a stable base of suitable, voluntary non-remunerated blood donors, accurate testing systems, quality systems and a suitable regulatory mechanism. For this, the commitment and support of national health authorities and additional human, financial and technological resources are needed. Requirements for a blood component programme include: „ Effective strategies for the recruitment and retention of voluntary non-remunerated blood donors, including apheresis donors, where applicable, to ensure a safe, adequate and reliable source of blood for component preparation „ Centralization or regionalization of blood processing and testing to permit economies of scale and uniform standards of performance „ Systems and standardized procedures for donor selection, blood collection, processing, testing, storage and transportation to ensure the consistent quality, safety and efficacy of blood components „ Training of BTS staff in all activities related to the provision of safe blood components „ Training in appropriate blood component therapy for staff involved in the clinical transfusion process. Consideration should be given to the use of surplus plasma for the production of plasma-derived medicinal products through fractionation, utilizing facilities either within or outside the country.

Checklist Organizational requirements

‰ Nationally-coordinated BTS with centralized/ ‰ Assessment of clinical demand and regionalized processing and testing feasibility of blood component programme and waste management system

‰ Adequate, sustainable finances ‰ Suitable premises, working environment ‰ Appropriate infrastructure ‰ Suitable regulatory mechanism ‰ Sufficient number of trained staff ‰ Appropriate technology, equipment and ‰ ‰

materials for blood collection, testing and processing Effective quality systems, including standardized procedures and good manufacturing practices Documentation of all processes and accurate labelling

Blood donors and blood collection deferral

‰ Panel of regular voluntary blood donors ‰ National criteria for donor selection and ‰ Donor call-up and blood collection planned ‰ Suitable blood collection bag systems ‰ Specifications for blood components, equipment and materials including labelling to meet component preparation targets

Component preparation, testing and distribution

‰ System for quarantine, release and recall, ‰ Quality monitoring of blood components Storage and transportation

‰ Correct storage and transportation of blood ‰

Words of advice „ Assess the clinical demand for blood components and the feasibility „

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bags, donor specimens, collected units, blood components, reagents and materials Separate storage areas for untested, quarantined and available units Suitable temperature-monitored equipment

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of a component preparation programme Develop a programme that complies with regulatory requirements and is appropriate to the level of the health care system, including the diagnostic and medical services available Allocate adequate human and financial resources to ensure the sustainability of the programme Build a stable base of regular, voluntary non-remunerated blood donors to meet collection targets for blood components Consolidate blood processing and testing within major centres Strengthen the interaction between the BTS and hospitals and promote appropriate blood component therapy

Blood component stock management

‰ Agreements between the BTS and

‰ Monitoring and evaluation of availability, utilization and outdating of components

hospitals on stocks, order and supply

Blood component therapy

‰ Guidelines on use of blood and blood products ‰ Hospital transfusion committees ‰ Training of clinical staff involved in transfusion ‰ Accurate transfusion records ‰ Haemovigilance system ‰ Ongoing assessment of need for components

© World Health Organization, 2005. All rights reserved. WHO/EHT/05.01.

Key elements Organizational requirements for an effective blood component programme Before a blood component programme is established, a systematic assessment of its feasibility and scope is required. The scale and level of development of the programme should be determined by the clinical demand for components, including the availability of medical and diagnostic services, and the capacity of the BTS. If the clinical demand for component therapy cannot fully be met from components prepared from whole blood, consideration might be given to developing an apheresis programme. A blood component programme should be accessible and sustainable. The BTS should be allocated adequate financial resources to meet the additional costs of component preparation, including: „ Suitable premises that comply with good manufacturing practices Blood donors and blood collection A reliable base of regular voluntary nonremunerated blood donors is a prerequisite for a safe and effective blood component programme that can meet the transfusion requirements of all patients. Effective donor recruitment, call-up and retention strategies are needed to promote regular donation by suitable donors. This requires: „ National donor selection and deferral criteria, including criteria specific to component preparation „ Mechanism for setting blood collection targets to meet component preparation targets and clinical demand. Effective blood collection requires: „ Systematic planning and preparation for fixed and mobile sessions „ Planning of number and type of collections per session from whole blood/apheresis donors „ Appropriate staffing, equipment and materials, including blood bags. Component preparation, testing and distribution The centralization or regionalization of blood processing and testing in major centres permits more efficient, costeffective use of technology and resources. It also facilitates uniform standards of performance, resulting in improved quality and safety. Safe component preparation requires: „ Preparation of components only from whole blood or apheresis donors who meet standard selection criteria Sufficient number of trained staff Specialized equipment for blood collection, processing, testing, storage and transportation and a preventive maintenance system „ Reliable supply of blood collection bags and reagents. BTS infrastructural requirements include: „ Suitable working environment for donor selection, blood collection, processing, testing and storage „ Reliable water and power supplies with back-up systems „ Waste management system „ Reliable transportation systems „ Effective communication systems. „ „

blood collection and component preparation. A quality system should be in place in all areas to ensure good manufacturing and laboratory practices. This should include: „ Specifications for blood components, equipment and materials „ Validation of processes, procedures, equipment and materials „ Regular maintenance and calibration of equipment to ensure quality and minimize down-time „ Standardized procedures „ Hygiene and safety of environment, equipment, blood donors and staff „ Documentation of all processes and accurate labelling to ensure traceability „ Ongoing training of staff „ Monitoring of all activities to ensure continuous quality improvement. „

An effective planning and communication system should be established to set and evaluate targets for donor recruitment, „

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Testing of all donated units and discard of all blood and components that test positive for any transfusiontransmissible infection Quality system and good manufacturing practices for all aspects of component preparation and distribution Compliance with specifications for components, equipment and materials Labelling system for untested, quarantined and available stock Mechanisms for quarantine and release System for recall of defective components Cleaning and maintenance of all areas and equipment to minimize the risk of contamination of components Quality monitoring of components, including statistical process control. Storage and transportation

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Monitoring and recording of temperatures in all blood cold chain equipment Corrective and preventive action in cases of deviation from specified temperature ranges and time limits. Blood component stock management

Efficient stock management systems are needed in the BTS and hospitals, including: „ Formal agreement and ongoing communication between the BTS and hospitals on optimum stocks, order and supply „ Monitoring and evaluation of component availability and utilization, including shortfalls and outdating. Blood component therapy The optimum use of blood as a scarce national resource requires: „ National and hospital guidelines on the use of blood and blood products and alternatives to blood transfusion „ Hospital transfusion committees to develop local policies and guidelines, and monitor component utilization „ Training of clinical staff involved in the prescription and administration of components „ Accurate transfusion records to ensure the traceability of component usage „ Haemovigilance system for monitoring, investigation and reporting of adverse transfusion events „ Ongoing assessment of current and future clinical needs for components.

Correct storage and transportation conditions are required at all times for blood donations and specimens, blood bags, reagents and other materials, especially in extremes of temperature. This entails: „ Storage and transportation of collected units and specimens to processing centres and testing laboratories within prescribed temperature and time limits „ Separate storage areas for untested, quarantined and available units „ Suitable areas and equipment for storage and transportation that meet specifications for time and temperature

Blood Transfusion Safety, Department of Essential Health Technologies World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety

Developing a National Blood System

Aide-Mémoire

for Ministries of Health Blood transfusion contributes to saving millions of lives every year, improves life expectancy and the quality of life of patients suffering from life-threatening conditions, and supports complex medical and surgical procedures. Every country should put in place policies, systems and structures to ensure the safety, quality, accessibility and timely availability of blood and blood products to meet the needs of all patients who require transfusion. The ministry of health (MoH) should provide effective leadership and governance in developing a national blood system that is fully integrated into the health-care system. Essential functions of a national blood system include policy formulation and standard setting, strategic and operational planning, provision of resources and national coordination and management to ensure an adequate supply of blood and blood products and safe clinical transfusion. The structure of the national blood system will depend on the organization and level of development of the health-care system. However, all critical activities within a national blood system should be coordinated at national level to promote uniform standards, economies of scale, consistency in the quality and safety of blood and blood products and best transfusion practices. Core components of a national blood system include:  Specific unit within the ministry of health for coordination, programme management and monitoring of the blood system throughout the country  Advisory body which brings together the major stakeholders to assist the ministry of health in formulating policy and plans, setting standards and advising on key issues  Blood transfusion service/s (BTS) involved in donor recruitment, blood and plasma collection, and the testing, processing, storage and distribution of blood and blood products. Common service delivery models include: — A single service provider, either governmental or delegated to a not-forprofit, nongovernmental organization — Multiple service providers, including governmental and nongovernmental organizations, and private institutions  Hospital blood banks, clinical transfusion services and transfusion committees for the timely provision of compatible blood and its safe and appropriate use. An effective national blood system requires coordination and collaboration with relevant government ministries, national reference laboratory and agencies and institutions for public health, surveillance, regulation, accreditation and plasma fractionation.

Checklist Leadership and governance

 National blood policy and strategic plan  Legislative framework  Standards  Financial sustainability  Risk assessment and management  Expertise on medical, scientific, financial and  Regulatory mechanism Coordination and collaboration ethical issues

 Efficient organizational structure  Consolidation of critical activities  Coordination of institutions and organizations involved in: — Voluntary blood donation — Provision of blood and blood products, including plasma derivatives  Coordination with hospitals and facilities involved in blood transfusion  Human resource management, including education, training and career development  Surveillance and haemovigilance  Procurement and supply systems  Data collection and reporting  Collaboration and partnerships  Monitoring and evaluation

Provision of safe blood and blood products

 Adequate qualified, trained staff  Suitable infrastructure and facilities  Quality system  Donor education, recruitment and retention  Donor selection, blood collection and donor  Donor counselling and referral  Blood processing and testing  Waste management  Blood storage and inventory management  Blood cold chain and distribution  Liaison with hospital transfusion services Clinical transfusion in patient management management

Words of advice  Provide effective leadership and governance for the development of a sustainable national blood system  Develop an effective programme for the achievement of 100 per cent voluntary non-remunerated blood donation  Establish a mechanism for the coordination of all public, private and voluntary sector institutions, organizations and agencies involved in the national blood system  Establish an efficient, cost-effective organizational structure for blood transfusion services with an optimal level of consolidation of critical activities  Create an effective mechanism for regulatory oversight of the blood system © World Health Organization, 2011. All rights reserved. WHO/EHT/11.01.

 Hospital standards and guidelines  Education and training  Estimation of blood requirements  Blood storage and handling  Blood stock management  Patient’s involvement in treatment  Patient and product identification  Quality systems  Hospital transfusion committees  Haemovigilance

Key elements Leadership and governance The MoH has ultimate responsibility for ensuring an adequate supply of safe blood and blood products and their safe and rational use. The MoH should establish a sustainable national blood system which is recognized through a national blood policy, strategic plan and appropriate legal instruments. The MoH should demonstrate its commitment, leadership and governance through the establishment of systems and structures, including a specific unit or department with overall responsibility for the national blood system. Key functions include:  Formulate and oversee the implementation of the national blood policy and strategic plan  Define the roles, responsibilities and accountability of institutions and Coordination and collaboration The national blood system should be organized and coordinated by the MoH in a manner that ensures the most efficient and cost-effective use of all resources. Blood transfusion services may operate either under a single service provider, such as a national blood transfusion service (NBTS), 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 strategic locations. In countries with a single service provider, the coordination role of the MoH may be undertaken by the NBTS. Requirements include:  Coordination of all organizations and institutions providing blood transfusion services to harmonize approaches, foster joint planning and collaboration, optimize use of resources, avoid duplication and wastage  Mechanism to ensure the uniform implementation of national standards  Efficient procurement and supply chain systems to ensure the continuity of supplies in all blood centres and hospital blood banks  National system for standardized data collection and reporting  Systems for traceability, surveillance and haemovigilance  Policies, standards and systems in blood transfusion services and hospitals for the management of waste from transfusionrelated activities  Monitoring and evaluation of the national blood system  Strategic partnerships with organizations involved in voluntary NR blood donation  Collaboration with academic and research institutions, scientific and professional societies, blood donor and patient associations, and industry  Linkages with health programmes such as maternal and child health, HIV/AIDS and hepatitis, infection control and patient safety. organizations that comprise the national blood system  Set national standards for blood and blood products, services, processes and systems  Establish regulatory mechanisms for the registration, licensing, operation and inspection of blood transfusion services. Where blood transfusion services are fully or partially delegated to not-for-profit, nongovernmental organizations, legal agreements are required to define roles, responsibilities and accountability. The MoH should also establish a national blood commission or council, with representation of key stakeholders, that provides expert on measures for the safety and sufficiency of the national blood supply, Provision of safe blood and blood products Blood transfusion services should comply with national policies and strategies to ensure they implement standards and meet targets for the provision of safe blood and blood products. To perform their functions efficiently, BTS should have:  Adequate number of qualified, skilled and experienced personnel in human resource management, finance and administration, quality systems, transfusion medicine, blood donor programme and laboratory testing and blood processing  Suitable infrastructure and facilities in all centres in which blood collection, testing, processing and storage of blood and blood products take place. Requirements include:  Effective quality system within which all activities are performed in a quality-focused way and are continuously monitored  Sustainable donor education, motivation, voluntary NR blood donor recruitment and retention programme  Safe blood collection process, including donor selection and deferral, donor care, notification, counselling and referral, and confidentiality  Testing and processing using the most appropriate and effective methodologies and best laboratory practices  Efficient inventory management system for optimum blood stocks and minimal wastage  Effective blood cold chain for safe storage and distribution of blood and blood products  Information management system encompassing all activities from blood donors to distribution of blood and blood products to hospitals, and issue and transfusion of blood and blood products to patients  Liaison with hospitals in the implementation of transfusion guidelines and staff training  Participation in national haemovigilance system. risk management and safe clinical transfusion. The establishment of a national blood authority with executive functions may be more appropriate in countries with complex blood systems, such as those involving multiple institutions and agencies. The MoH should ensure that adequate, sustainable financing for the national blood system is integrated within the financial structure of the health system, through mechanisms such as a specific budget, cost-recovery and health insurance or a combination of these. Regulatory mechanisms should be established for the control, inspection and licensing of blood transfusion services to enforce blood product standards and monitor product safety. Clinical transfusion in patient management Hospitals and other health facilities that perform transfusion are an integral part of the national blood system. National and hospital authorities should allocate sufficient resources to optimize blood transfusion for patient health. Requirements include:  National guidelines on the clinical use of blood and blood products  Quality systems for the clinical transfusion process, including standardized procedures, blood request forms, labels and records  Training for clinicians, nurses, midwives and laboratory technical staff  Systems, processes and procedures for: – Compatibility testing and issue of blood – Rational use of blood and blood products – Safe transfusion practice at the bedside – Patient monitoring and follow-up  Process to assess current and future blood needs  Availability of critical supplies for alternatives to transfusion, compatibility testing and blood administration  Systems for correct storage and handling of blood units in hospital blood banks and clinical areas  Efficient blood stock management for the timely availability of compatible blood and reduced wastage  Patient involvement in blood management through information and consent  System for patient and product identification  Hospital transfusion committees with responsibility for implementing transfusion guidelines and monitoring transfusion practices  Indicators for assessing trends and improving transfusion practice through clinical audit  System for monitoring and investigation of adverse transfusion events to feed into the national haemovigilance system.

Blood Transfusion Safety World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety

National Haemovigilance System

AIDE-MÉMOIRE for ministries of health

Checklist Leadership and governance

The transfusion of blood and blood products is a life-saving intervention. However, there are risks of adverse events associated with the donation of blood and its components, and with the transfusion of blood and blood products to patients. Adverse events include all reactions, incidents, near misses, errors, deviations from standard operating procedures and accidents associated with blood donation and transfusion. Learning from adverse events and identifying systems problems can drive the introduction of measures to enhance the quality, safety, efficacy, and cost-effectiveness of blood and blood products as well as the donation and transfusion processes. Haemovigilance is a set of surveillance procedures covering the entire transfusion chain, from the donation and processing of blood and its components, to their provision and transfusion to patients and their followup. Haemovigilance includes the monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood, as well as the development and implementation of recommendations to prevent their occurrence or recurrence. The ultimate goal of haemovigilance is continuous quality improvement of the transfusion chain through corrective and preventive actions to improve patient safety and outcomes, enhance donor safety and reduce wastage. Haemovigilance should be fully integrated into the quality systems of all institutions involved in the donation and provision of blood and blood products, including processing, inventory management, storage and distribution, and in clinical transfusion. The organization of a haemovigilance system is largely determined by the structure of the national blood system and the health system. A system of haemovigilance is dependent on the traceability of blood and blood products from donors to recipients and vice versa, and on the monitoring, reporting, investigation and analysis of adverse events. The rigorous management of information generated through this system is key to introducing amendments in blood policies and guidelines that lead to changes in processes and practices in donation and transfusion. The establishment of a haemovigilance system involves coordination and collaboration among all stakeholders, including the ministry of health, blood transfusion services, hospitals, professional bodies, public health institutions and regulatory agencies, as well as patient and donor groups.

 Haemovigilance as an element of the national blood policy and plan, and legislative and regulatory framework  Haemovigilance advisory committee(s)  Adequate human and financial resources  Standards and definitions  Confidential and non-punitive system  Traceability of blood and blood products from donors to patients and vice versa  Quality system throughout the transfusion chain  Corrective and preventive action.

Organization and coordination organizations and institutions haemovigilance system

 Identification of stakeholders and responsible  Organizational arrangements for the  Coordinated links with organizations and  Defined roles and responsibilities of all  Haemovigilance education and training for all  Monitoring, reporting, investigation health-care staff and analysis of adverse events, with recommendations for safety and quality improvements. stakeholders institutions involved in the system

Haemovigilance in the donation and provision of blood and blood products

 Donor haemovigilance: recognition, clinical

Words of advice  Provide effective leadership, governance and adequate resources for    

management, monitoring, reporting, investigation and analysis of adverse events associated with donation  Policies, guidelines, protocols and standard operating procedures for all processes  Reporting of errors and deviations associated with these processes  Post-donation information and look-back  Liaison between blood transfusion services and hospital blood banks, transfusion committees and clinical services.

Haemovigilance in clinical transfusion



establishing and maintaining an effective haemovigilance system Incorporate haemovigilance into national blood and health policies and systems Adopt a stepwise approach in establishing a haemovigilance system Engage all stakeholders in the blood transfusion chain Set up efficient organizational arrangements for the haemovigilance system and ensure integration with institutional quality management systems Develop a confidential and non-punitive system

 Patient haemovigilance: recognition,

clinical management, monitoring, reporting, investigation and analysis of adverse events associated with transfusion  Clinical guidelines, hospital protocols, standard operating procedures, patient identification and sample labelling  Hospital transfusion committees  Response to recall and look-back notification  Coordination between hospital departments and services, and liaison with blood transfusion services.

© World Health Organization 2015. All rights reserved. WHO/HIS/SDS/2015.10

Key elements Leadership and governance The ministry of health (MoH) holds ultimate responsibility for its national blood system and for the quality, safety and sufficiency of the supply of blood and blood products. A haemovigilance system contributes to the safety of donation, blood products and transfusion. It improves risk management, increases trust and should be confidential and non-punitive in nature. The MoH should provide effective leadership and governance for a national haemovigilance system, including:  systematic and comprehensive surveillance of the entire transfusion chain as an element of the national blood policy and plan, and legislative and regulatory framework;  haemovigilance advisory committee(s) with medical, scientific and quality expertise;  adequate human and financial resources for the establishment, development and sustainability of the haemovigilance system Organization and coordination of a haemovigilance system A haemovigilance system requires coordination and collaboration between multiple stakeholders involved in the donation, provision, transfusion, surveillance and regulation of blood and blood products. Haemovigilance may operate at local and institutional levels, but national coordination and management are vital for effective surveillance. The MoH should:  Establish organizational arrangements and mechanisms to engage and coordinate all key stakeholders;  Define the roles, responsibilities and accountabilities of all stakeholders;  Facilitate international cooperation with existing haemovigilance networks. Core haemovigilance coordination and management functions include:  Establishment of links and communication with participating organizations and institutions;  Education and training of all personnel on haemovigilance;  Collection, management and review of data on adverse events from all organizations involved in the blood transfusion chain;  Identification of underlying systems and process failures, weaknesses, gaps and deficiencies that have led to adverse events;  Recommendations for the improved safety of donors, blood products and patients through changes in policies, strategies, standards, guidelines and procedures;  Production and dissemination of reports and recommendations;  Development of a rapid alert and early warning platform to communicate and share information;  Periodic review, monitoring and evaluation of the haemovigilance system.  standards and definitions in line with

international recommendations. The MoH should define the scope and elements of the haemovigilance system for a stepwise development of the system. This should include:  Reporting characteristics: whether it is mandatory, voluntary or mixed;  Coverage: whether it concerns donors, processes, clinical practices or patients;  Blood products: whether it covers only blood components for transfusion or also plasma-derived medicinal products;  Types of events to be reported: whether it covers all types of adverse events or selected reactions, near misses and errors;  Severity of adverse events to be reported: fatal, serious or all levels of severity;  Imputability: the probability of attribution (definite, probable and possible, or also Haemovigilance in the donation and provision of blood and blood products In a national haemovigilance system, blood centres and transfusion services have the following roles and responsibilities:  Donor haemovigilance, including recognition and clinical management of adverse events associated with donation, and their monitoring, reporting, investigation and analysis;  Implementation of policies, guidelines, protocols and standard operating procedures for all processes in the donation and provision of blood and blood products;  Epidemiological surveillance of donors, post-donation information and look-back;  Identification, recording and reporting of: — Near misses, errors and deviations associated with these processes; — Abnormalities in intermediate and finished blood products.  Traceability of each donation from the donor to blood processing, the blood product, its issue to a health-care facility and transfusion to the patient, and vice versa;  Response to notification of a patient adverse event, by retrieval of all blood components associated with the index blood component(s);  Implementation of haemovigilance as part of the quality system, and mechanisms for taking corrective and preventive actions and monitoring their outcomes;  Training and assessment of staff involved in all steps of the donation and provision of blood and blood products;  Liaison with hospitals: administration, blood banks, transfusion committees and clinical services.

unlikely and excluded) in the context of blood donation, processing and clinical transfusion;  Collection and use of denominators to calculate rates of adverse events. An efficient haemovigilance system requires:  Traceability of the blood product from donor to patient, and vice versa;  Effective structure and clear channels for adverse events reporting, investigation, feedback and communication of findings, as well as monitoring and evaluation;  Methods and mechanisms for data collection, validation and analysis;  Guidelines, procedures and formats for notification and modalities of reports;  A quality system throughout the transfusion chain, and implementation of corrective or preventive actions to quickly rectify weaknesses and deficiencies. Haemovigilance in clinical transfusion In a national haemovigilance system, hospitals and other health-care facilities have the following roles and responsibilities:  Patient haemovigilance, through recognition and clinical management of adverse events associated with transfusion, and their monitoring, reporting, investigation and analysis;  Correct identification of patients, samples and blood products, and appropriate labelling;  Implementation of hospital standards, clinical guidelines and protocols for safe blood transfusion, investigation of adverse events and reporting by clinical services;  Traceability and documentation of transfused blood products in patient records;  Response to product recall and look-back notification;  Active participation in a hospital transfusion committee;  Integration of haemovigilance in the hospital quality system, and mechanisms for taking corrective and preventive actions and monitoring outcomes;  Training and assessment of staff involved in all steps of clinical transfusion, including clinical decision-making, pre-transfusion sampling, laboratory practice, handling of blood units in the clinical area, bedside administration of transfusion and patient monitoring;  Regular audit of clinical transfusion practices;  Mechanisms for coordination between hospital departments and clinical services, and liaison with blood transfusion services.

Aide-mémoire produced by the Service Organization and Clinical Interventions unit, Department of Service Delivery and Safety, World Health Organization, Geneva, Switzerland. E-mail: bloodsafety@who.int www.who.int/bloodsafety

WORLD HEALTH ORGANIZATION

Quality Systems for Blood Safety

AIDE-MEMOIRE for National Blood Programmes Blood transfusion is a key part of modern health care. It is the responsibility of the national blood programme to provide an adequate supply of blood for all patients requiring transfusion and to ensure the quality of blood and blood products for clinical use. All products must be safe, clinically effective and of appropriate and consistent quality. The strategies for achieving this are: A well-organized, nationally-coordinated blood transfusion service (BTS) Blood collected from regular, voluntary non-remunerated blood donors from low-risk populations Testing of all donated blood, including screening for transfusiontransmissible infections, blood grouping and compatibility testing Appropriate clinical use of blood. Every blood transfusion service should develop an effective quality system to ensure the implementation of these strategies. The quality system should cover all aspects of its activities and ensure traceability, from the recruitment and selection of blood donors to the transfusion of blood and blood products to patients. It should also reflect the structure, needs and capabilities of the BTS, as well as the needs of the hospitals and patients that it serves. Key elements of quality systems include: Organizational management Standards Documentation Training Assessment. Management commitment and support are essential for the development, implementation and monitoring of a national quality system in order to ensure continuous quality improvement. All staff should understand the importance of quality and the consequences of failure in the quality system.

Checklist Prerequisites Nationally-coordinated BTS Management commitment and support Integration of quality in the national blood policy National quality policy and plan National quality manager Adequate resources Organizational management Clearly defined organizational structure Quality manager in each blood centre and hospital blood bank Quality section in each blood centre and hospital blood bank Culture of quality Commitment and support of all staff Identification of processes and procedures and their critical control points Standards for quality systems Regulatory or legislative framework Appropriate national or international standards Standards relevant to BTSs Documentation Appropriate, comprehensive documents, including a quality manual and standard operating procedures (SOPs) Complete, accurate records System for controlling documents Training Training policy and plan Training of all BTS staff in quality and quality systems Training of other health care professionals involved in blood transfusion Evaluation of training and its impact Assessment Validation Ongoing data collection and analysis Haemovigilance Regular review of all activities Internal and external audits Error management, corrective and preventive action External quality assessment schemes

Words of advice Secure the commitment and support of management at all levels Identify the need for quality in the national blood policy Develop a national quality policy and plan Secure adequate resources Designate a national quality manager with overall responsibility for the implementation of quality systems in BTSs at all levels Develop a quality section, with appropriate staffing and expertise, in each blood centre and hospital blood bank Provide training in quality for all BTS staff and other health care professionals involved in blood transfusion Assess the effectiveness of the quality system continually

© World Health Organization 2002. All rights reserved. WHO/BCT/02.02. Printed July 2002

Key elements Requirements for quality systems in blood transfusion It is the responsibility of governments to ensure that the blood and blood products provided for clinical use by the national blood programme are safe, adequate to meet demand, effective and produced consistently to the appropriate standards. To achieve this, the blood transfusion service must develop an effective quality system. This should provide a framework within which BTS activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. The establishment of a quality system will ensure the collection of adequate supplies of blood from regular, voluntary non-remunerated donors, the testing of all blood before use and the appropriate clinical use of blood. Prerequisites for developing a quality system within the national blood programme include: Nationally-coordinated blood transfusion service Commitment and support of management at all levels Recognition of the importance of quality in the national blood policy National quality policy and quality plan detailing the strategy, mechanism and resources for their implementation Designation of a national quality manager with the necessary responsibility and authority for the development, implementation and monitoring of the quality system Provision of appropriate, adequate and sustainable resources to support the development and maintenance of the quality system.

Organizational management Central to an effective quality system is commitment and support from management at all levels, including: Clearly defined organizational structure that defines accountability, authority and responsibility Designation of a quality manager, with the necessary skills and expertise, in each blood centre and hospital blood bank Formation of a quality section or identified work area in each blood centre and hospital blood bank from which quality activities can be coordinated Development of a culture of quality through a management focus on building quality into all activities Motivation of staff to ensure their commitment and support for the quality system Identification of specific processes and procedures and their critical control points.

The standards adopted must be relevant to the BTS and its activities.

Documentation An effective and accurate documentation system that ensures traceability of all BTS activities is the foundation of good quality management. Important activities include: Development of a quality manual: a document describing the quality system, including the organization’s quality policy, standards and procedures Production and use of appropriate, comprehensive documents for all activities, including standard operating procedures, forms, labels and any other documents required Generation and maintenance of complete and accurate records Development of a system to manage the issue, use and retrieval of documents.

Training programmes for other health care professionals involved in blood transfusion Clear understanding of the role of the individual in the quality system and the consequences of quality failures Ongoing monitoring and evaluation of training and its impact.

Assessment Ensuring quality is a continual process. Ongoing assessment of the effectiveness of the quality system is essential through: Validation of all processes, procedures, equipment and reagents Ongoing collection and analysis of data generated from key activities and their use in quality improvement Establishment of haemovigilance through a system of monitoring, reporting and investigation of adverse incidents related to all blood transfusion activities Regular review of all activities to assess the overall effectiveness of the quality system and ensure continuous improvement Programme of regular internal and external audits of the quality system Reporting and analysis of errors with effective corrective and preventive action Active participation in appropriate external quality assessment schemes to improve laboratory performance.

Standards for quality systems Relevant and appropriate standards are required to provide the framework for the development of the quality system: The existence of any relevant national legislation or regulations must be acknowledged and incorporated into the framework for quality Standards may be national or international: e.g. International Organization for Standardization (ISO) and Good Manufacturing Practice (GMP)

Training Comprehensive, appropriate and effective training is required for all BTS staff and other health care professionals involved in blood transfusion. Important activities include: Training policy and plan Training for all BTS staff in general principles of quality, the quality system, documentation and the use of quality monitoring tools

Department of Blood Safety and Clinical Technology World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bct

Blood Safety Aide-Memoire for National Health Programmes A well-organized blood transfusion service (BTS), with quality systems in all areas, is a prerequisite for safe and effective use of blood and blood products. The HIV/AIDS pandemic has focused particular attention on the importance of preventing transfusion-transmitted infections (TTIs). Up to 3% of HIV infections worldwide are transmitted through the transfusion of contaminated blood and blood products. Many more recipients of blood products are infected by hepatitis B and C viruses, syphilis and other infectious agents, such as Chagas disease. The global burden of disease due to unsafe blood transfusion can be eliminated or substantially reduced through an integrated strategy for blood safety which includes:  Establishment of a nationally-coordinated blood transfusion service  Collection of blood only from voluntary non-remunerated blood donors from low-risk populations  Testing of all donated blood, including screening for transfusion-transmissible infections, blood grouping and compatibility testing  Reduction in unnecessary transfusions through the effective clinical use of blood, including the use of simple alternatives to transfusion (crystalloids and colloids), wherever possible.

Checklist Blood transfusion service

 Government commitment and support  National blood policy and plan  Legislation/regulation  Organization with responsibility and  BTS management committee  BTS medical director  BTS quality manager  Specialist BTS advisory groups  Trained BTS administrative and technical  Adequate budget  National quality system Blood donors staff authority for the BTS

 National blood donor programme officer  Blood donor unit  Blood donor recruitment officer  Standard operating procedures  Training of staff in blood donor unit  Low-risk donor populations  Educational materials  Register of voluntary non-remunerated  Donor selection, deferral, care and  Donor notification and referral  Monitoring of TTIs Testing of donated blood confidentiality blood donors

Words of advice  Secure government commitment and support for the

national blood programme  Establish a blood transfusion service as a separate unit

 

  

with responsibility and authority, an adequate budget, a management team and trained staff Educate, motivate, recruit and retain voluntary nonremunerated blood donors from low-risk populations Ensure good laboratory practice in screening for transfusion-transmissible infections, blood grouping, compatibility testing, blood component production and the storage and transportation of blood products Reduce unnecessary transfusions through the effective clinical use of blood, including alternatives to transfusion Establish a quality system for the BTS Train all BTS and clinical staff to ensure the provision of safe blood and its effective clinical use

 Technical officer  Screening strategies and protocols  Training of laboratory technical staff  Screening of all donated blood for TTIs  Blood grouping and compatibility testing  Good laboratory practice, including  Continuity in testing  Effective blood cold chain Clinical use of blood clinical use of blood standard operating procedures (SOPs)

 National policy and guidelines on the  Training of clinicians and BTS staff  Prevention, early diagnosis and treatment  Alternatives to transfusion (crystalloids  Effective clinical use of blood  Monitoring and evaluation and colloids)

© World Health Organization, 2002. All rights reserved. WHO/BCT/02.03. Reprinted May 2009.

Key elements Establish a blood transfusion service It is the responsibility of governments to ensure a safe and adequate supply of blood. This responsibility may be delegated to a non-profit nongovernmental organization, but the BTS should be developed within the framework of the country’s health care infrastructure. The BTS requires government commitment and support and recognition as a separate unit with an adequate budget, management team and trained staff. Important activities in establishing a blood transfusion service include: Educate, motivate, recruit and retain low-risk blood donors High priority should be given to the elimination of family/replacement and paid blood donor systems, which are associated with a significantly higher prevalence of TTIs. Voluntary non-remunerated blood donors from low-risk populations who give blood regularly are the foundation of a safe and adequate blood supply. Important activities include:  Appointment of an officer responsible for the national blood donor programme  Establishment of a BTS unit responsible for donor education, motivation, recruitment and retention  Appointment of a designated blood donor recruitment officer  Preparation of SOPs in accordance with BTS guidelines  Training of staff in the blood donor unit  Identification of donor populations at low risk for TTIs  Development of educational materials  Establishment of a register of voluntary non-remunerated blood donors  Assurance of safe blood collection procedures, including donor selection and deferral, donor care and confidentiality  Formalization of government

commitment and support policy and plan

 Appointment, when necessary, of

specialist BTS advisory groups

 Development of a national blood  Development of necessary

 Appointment and training of staff

experienced in each key aspect of the BTS

legislation/regulation for the BTS responsibility and authority for the BTS committee

 Development and implementation

 Formation of an organization with

 Formation of a BTS management  Appointment of a medical director  Appointment of a quality manager  Donor notification and referral for

of a budgeting and finance system to ensure a sustainable blood programme through cost recovery and/or annual budget allocation

 Establishment of national quality

system, including guidelines, standard operating procedures, accurate records, monitoring and evaluation.

counselling  Monitoring of TTIs in the donor population. Test all donated blood

Reduce unnecessary transfusions by effective clinical use of blood Blood transfusion has the potential for acute or delayed complications and the transmission of infection. The risks associated with transfusion can be reduced by minimizing unnecessary transfusions through the effective clinical use of blood and blood products and the appropriate use of simple alternatives to transfusion which are safer and more cost-effective. Important activities include:  Development of a national policy and guidelines on the clinical use of blood  Training in the clinical use of blood for all clinicians involved in the transfusion process and for BTS staff  Commitment to the prevention, early diagnosis and treatment of conditions that could result in the need for transfusion (obstetrical complications, trauma and other causes of anaemia)  Availability of intravenous replacement fluids (crystalloids and colloids) for the correction of hypovolaemia  Availability of pharmaceuticals and devices to minimize the need for blood  Effective clinical use of blood and blood products in accordance with national guidelines  Monitoring and evaluation of the clinical use of blood.

The BTS should develop and maintain a national strategy for the testing of all donated blood and blood products, using the most appropriate and effective tests, and for good laboratory practice. Important activities include:  Appointment of a designated technical officer  Development of protocols for the testing, selection and evaluation of appropriate screening assays to be used at each site  Training of BTS laboratory technical staff  Screening of all donated blood for TTIs, including HIV, hepatitis viruses, syphilis and other infectious agents, such as Chagas disease  Blood grouping and compatibility testing  Good laboratory practice, with effective documentation, including standard operating procedures  Procurement, supply, central storage and distribution of reagents and materials to ensure continuity in testing at all sites  Maintenance of an effective blood cold chain for the storage and transportation of blood and blood products.

Blood Transfusion Safety Department of Essential Health Technologies World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety

THANK YOU FOR SAVING MY LIFE

THANK YOU FOR SAVING MY LIFE

Frequently Asked Questions on Blood Donation

SEA-HLM-418

Frequently Asked Questions (FAQs) on Blood Donation

FAQs Q 1: Q 2: Q 3: Q 4: Q 5: Q 6: Q 7: Q 8: Q 9: Q 10: Q 11: Q 12: Q 13: Q 14: Q 15: Q 16: Q 17: Q 18: Q 19: Q 20: Q 21: What is blood? How much blood does a human body contain? What is the composition of blood? How is blood formed? What is the natural life of blood cells? What is haemoglobin? What are blood groups? What is the importance of knowing the blood groups? Why is an A group person not given B group blood? 2 2 3 3 4 4 5 5

Why are Rh negative and Rh positive incompatible? 6 What is a unit of blood? For how long can blood be stored? Can blood be separated into its components? In which situations do patients need blood transfusion? Is all the collected blood tested? In which situations do people generally donate blood? Who is a healthy donor? 6 7 7 8 9 9 10

Does a donor need to do anything special before donating blood? 10 How long does it take to donate blood? Can blood of animals be transfused to human beings? Does the person suffer from any harmful effects after donating blood? Is any special diet required for a donor after giving blood? 10 11 11 11

Frequently Asked Questions (FAQs) on Blood Donation5 | iii

Q 22: Q 23: Q 24: Q 25: Q 26:

How long will it take for the body to replenish the donated blood? How frequently can one donate blood? Can a donor work after donating blood? Are there any other benefits of blood donation?

12 12 12 13

Does any disease debar a person from donating blood? 12

iv | Frequently Asked Questions (FAQs) on Blood Donation

FA Q

s

“Every two seconds someone in the South-East Asia Region needs blood transfusion”.

Q 1:

What is blood? How much blood does a human body contain? human body’s circulatory system. On an average, a human being has about 5-6 litres of blood flowing in the body. About 7% of the body weight of a healthy individual is accounted for by blood.

Ans: Blood is the red coloured fluid flowing continuously in the

Q 2:

What is the composition of blood? types of cells - Red Blood Cells or RBC’s, White Blood Cells or WBC’s and platelets. Plasma acts as a vehicle to carry nutrition including protein, glucose, enzymes, and hormones etc; Red blood cells carry oxygen from the lungs to various body tissues; White blood cells help the immune system of the body and platelets facilitate the process of clotting and coagulation of blood.

Ans: Blood mainly contains a fluid called plasma which has three

2 | Frequently Asked Questions (FAQs) on Blood Donation

Q 3:

How is blood formed? mainly by bone marrow. The lymphocytes and monocytes are formed in the lymphoid and reticulo-endothelial tissues. The orderly proliferation of the cells in the bone marrow and their release into the circulatory system is carefully regulated according to the needs of the body. Every day, new blood cells are produced in the bone marrow and every day old cells die and are removed from the body.

Ans: The RBC, grannulocytes of WBC and platelets are produced

“More than 38,000 blood donations are needed every day in SouthEast Asia Region.”

Q 4:

What is the natural life of blood cells? live for a few days and platelets for a few hours. The addition of new cells and removal of old cells is a continuous process.

Ans: Red blood cells have a life of about 120 days, white blood cells

Frequently Asked Questions (FAQs) on Blood Donation3 | 3

“One out of every 10 people admitted to hospital needs blood.”

Q 5:

What is haemoglobin? It helps in carrying oxygen and carbon dioxide to different parts of the body. On an average, the haemoglobin level for a healthy male should be between 14 - 16 gm % and for a female between 12 - 14 gm %.

Ans: Haemoglobin is a substance present in the red blood cells.

Q 6:

What are blood groups? The first is called the ABO - group and the second type is called the Rh - group. In the ABO - group there are four categories namely: A Group, B Group, O Group and AB Group. In the Rh - group either the individual is Rh-positive, or Rh-negative. Rh denotes the Rhesus factor, named for Rhesus monkeys.

Ans: Every individual belongs to two major types of blood groups.

Thus every human being belongs to one of the following groups. A positive or A negative B positive or B negative O positive or O negative AB positive or AB negative The positive or negative aspect is based on the Rh factor.

4 | Frequently Asked Questions (FAQs) on Blood Donation

Q 7:

What is the importance of knowing the blood groups? the patient the same group of blood which he/she belongs to. Under no circumstances can an O group person get any other blood except O. Similarly, an A group patient cannot be given B group blood and vice versa. It is only in a dire emergency that we take O group as a universal donor and AB groups as universal recipient.

Ans: For all practical and routine purposes, it is ideal to transfuse to

Q 8:

Why is an A group person not given B group blood? antibodies. In those with B group blood, there are anti – A group antibodies. If we give A group blood to a B group patient, it is bound to be incompatible and will result in serious consequences.

“The total number of blood units collected annually in the South-East Asia Region is around 15.5 million.”

Ans: The blood of an A group person contains anti - B group

Frequently Asked Questions (FAQs) on Blood Donation5 | 5

One roadside accident victim can require as many as 100 units of blood.

q 9: Ans:

Why are rh negative and rh positive incompatible? A patient with Rh-negative blood cannot be given Rh-positive blood as the antigen-antibody reaction will result in severe consequences. In cases where a woman is Rh negative and her husband is Rh positive, the first child with Rh positive may be normal. But, subsequently, the woman may not conceive or may have repeated abortions. There may be intra-uterine fetal death. If the child born is alive, it will suffer from a fatal disease called “Erythroblastosis Foetalis”. Now, mothers can be given an injection of anti-D within 24 hours of the delivery of a Rh-positive child and thus protect the next baby from this catastrophe.

q 10: What is a unit of blood? Ans: Blood is collected in plastic bags that contain in liquid chemical which prevents blood from coagulating. On an average, about 450 mL of blood is collected from a person. This blood, plus the amount of anticoagulant present in bottle or bag, is known as one unit of blood.

6 | FrEquEntLy ASkEd quEStionS (FAqS) on BLood donAtion

Q 11: For how long can blood be stored? Ans: Whole blood can be stored for up to 35 days, when kept in CPDA anti- coagulant solution and refrigerated at 2 - 4oC.

Q 12: Can blood be separated into its components? Ans: Several components from blood can be separated and used to treat specific conditions. This helps in utilization of one unit of blood for several patients. These components are : Packed RBCs, Fresh Frozen Plasma, Platelet Rich Plasma, Platelet Concentrate, Cryoprecipitate, Factor VIII and IX, Albumin, Globulin and many others. Now, with the advent of cell-separater machines a particular component from the donor can be collected while blood circulates through the machine and rest of the blood constituents go back to the donor.

“Blood cannot be manufactured – it can only be donated by humans.”

Frequently Asked Questions (FAQs) on Blood Donation7 | 7

“Blood donation is a safe and simple four-step process that takes around 30 minutes.”

Q 13: In which situations do patients need blood transfusion? Ans: There are many situations in which patients need blood to stay alive: • A patient needs blood after a major accident or surgery in which there is loss of blood. • On an average, for every open heart surgery, about six units of blood is required. • After a miscarriage or childbirth, the patient may need a large amount of blood to be transfused for saving her life and also the child’s. • For patients with blood diseases like severe anaemias, leukaemias (blood cancer), haemophilia (bleeding disorder), thalassemia etc. repeated blood transfusions are the only solution. • In many other situations like poisoning, drug reactions, shock and burns, blood transfusion is the only way to save precious human life.

8 | Frequently Asked Questions (FAQs) on Blood Donation

Q 14: Is all the collected blood tested? Ans: Yes. All blood units are tested for HIV, hepatitis B, hepatitis C, syphilis, etc. Only those units of blood are transfused which are free from these infectious markers.

Q 15: In which situations do people generally donate blood? Ans: There are three types of blood donors: 1. Professional blood donors - They sell their blood, which is of very poor quality and can transmit very dangerous diseases to the recipient. 2. Replacement blood donors - Healthy relatives and friends of the patient give their blood, of any group, to the blood bank. In exchange, the required number of units of the required blood group is given to the patient. 3. Voluntary blood donors - Here, a person donates blood voluntarily. The blood can be used for any patient without divulging the identity of the donor. This is the best type of blood donation where a motivated human being gives blood in an act of selfless service.

The most common reason for people to donate blood is because they “want to help others”.

Frequently Asked Questions (FAQs) on Blood Donation9 | 9

The most common reason cited by people who do not give blood is: “never thought about it”.

Q 16: Who is a healthy donor? Ans: Usually, any person within the age group of 18 - 60 years with a minimum body weight of 45 kgs, and having a minimum haemoglobin content of12 gm% is eligible to donate. However, all countries have criteria for blood donation in their respective countries.

Q 17: Does a donor need to do anything special before donating blood? Ans: Nothing special. The donor should eat at regular meal times and drink plenty of fluids.

Q 18: How long does it take to donate blood? Ans: The procedure is done by skilled, specially trained technicians and takes three to eight minutes. However, from start to finish (filling form, post-donation rest etc.) the entire process should take around 30 minutes.

10 | Frequently Asked Questions (FAQs) on Blood Donation

Q 19: Can blood of animals be transfused to human beings? Ans: No. Only the blood of a human being can be transfused to a human.

Q 20: Does the person suffer from any harmful effects after donating blood? Ans: Absolutely not. Rather a donor after having given blood voluntarily gets a feeling of pleasure and peace. Within a period of 24 - 48 hours, the volume of blood donated is again formed in the body.

The donation of one unit of blood (450 ml) can potentially save at least three lives.

Q 21: Is any special diet required for a donor after giving blood? Ans: Not really. After resting for a while, the donor is given something to drink. It may be a cup of coffee or milk or fruit juice alongwith a few biscuits or fruit. The donor needs no other special diet. A routine, balanced diet is adequate.

Frequently Asked Questions (FAQs) on Blood Donation11 | 11

If you begin donating blood at age 18, donate every 90 days until age 60, you will donate 75 litres of blood and may save over 500 lives!

Q 22: How long will it take for the body to replenish the donated blood? Ans: The body replaces blood volume or plasma within 24 hours. Red blood cells need about four to eight weeks for complete replacement.

Q 23: How frequently can one donate blood? Ans: A three-month gap between donations is a very safe interval. Q 24: Can a donor work after donating blood? Ans: Of course! Routine work is absolutely fine after the initial rest. Rigorous physical work should be avoided for a few hours.

Q 25: Does any disease debar a person from donating blood? Ans: Yes, if the donor has suffered from any of the under-mentioned diseases: Fever: The donor should not have suffered from fever for the past 15 days.

12 | Frequently Asked Questions (FAQs) on Blood Donation



Jaundice: A donor should not have tested positive for hepatitis and suffered from jaundice. Blood transmitted diseases: Syphilis, malaria, filaria etc. debar a donor from donating blood until treatment is over and the donor is disease-free. Drugs: If a person is taking drugs like aspirin, antihypertensives, anti-diabetics, hormones, corticosteroids etc., he/she is unfit to donate blood. No HIV-positive person can be allowed to donate blood.

Q 26: Are there any other benefits of blood donation? Ans: Yes, blood donation is a noble, selfless service! It gives the donor a feeling of joy and contentment. Also it is an expression of love for mankind, as blood knows no caste, colour, creed, religion or race.

Globally, more than 287 000 women die each year during pregnancy, childbirth or in the postpartum period – 99% of them in developing countries; availability of safe blood can save many of them.

Frequently Asked Questions (FAQs) on Blood Donation13 | 13

Every year on 14 June we celebrate World Blood Donor Day to raise awareness of the need for safe blood and blood products, and to thank blood donors for their life-saving gifts of blood. The FAQs aim to dispel some of the myths surrounding blood donation, and to provide information on the topic. Become someone’s hero – donate blood today!

World Health Organization Regional Office for South-East Asia World Health House, Mahatma Gandhi Marg New Delhi - 110002, India Website: www.searo.who.int/blt 18 | Frequently Asked Questions (FAQs) on Blood Donation

Mahatma Gandhi Marg, Indraptrastha Estate, New Delhi-110002, Tel: 91-11-23370804, Fax: 91-11-23370197, Website: www.searo.who.int

Message from Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia Region, on the occasion of World Blood Donor Day, 14 June 2015 Blood is vital for life. The uninterrupted flow of blood in the human body is the ultimate indication of the persistence of life. Blood is equally critical to ensure recovery from many acute and chronic ailments. The success of many contemporary, complex surgeries, especially transplantation, depends on maintaining requisite blood volumes in patients. With advancements in medical sciences, there is greater demand for safe blood. The basic blood needs of any health system can be met if only 1% of the population donated blood at least once a year. In settings where advanced medical care and complex surgeries are undertaken, this requirement would go up to 3% of the population donating at least once annually. Blood donation by communities is essential and necessary since blood can neither be synthesized artificially nor can it be obtained from non-human sources. For the forseeable future, human beings are and shall continue to be the only source of this life- giving fluid. To advocate with the communities to come forward and regularly donate blood, and to express gratitude to blood donors, in 2005, the World Health Assembly decided to celebrate 14 June every year as the World Blood Donor Day in collaboration with the International Federation of Red Cross and Red Crescent Societies, the International Society of Blood Transfusion, and the International Federation of Blood Donor Organizations. The day is celebrated globally and plays an important role in enhancing visibility of this altruistic action by people. Advocacy for regular blood donation by healthy people leads to the availability of safe blood. Safety of blood from various infectious markers, especially HIV, hepatitis B and hepatitis C is assured by a quality screening of blood for these infectious agents. Rapid strides have been made by all Member States in the WHO South-East Asia Region in improving quantity and quality of blood for transfusion with continuous technical assistance from WHO.

Thank you for saving my life

Presently, of an annual estimated requirement of 18 million units of blood in the SouthEast Asia Region, around 15.5 million units are collected every year. Of these, around 82% of donated blood is obtained from voluntary donors. We need to accelerate our advocacy with healthy communities and urge them to voluntarily donate blood. The ultimate goal is for every country to achieve 100% voluntary and unpaid blood donation. The South-East Asia Region has been consistently doing well to ensure 100% screening of donated blood for HIV and for hepatitis B and C. We need to increase our efforts to ensure quality of screening and safety of all donated blood. The theme of this year’s World Blood Donor Day campaign is “Thank you for saving my life.” It focuses on thanking blood donors who save lives every day by donating their blood, and strongly encourages more people all over the world to donate blood voluntarily and regularly with the slogan “Give freely, give often. Blood donation matters.” On World Blood Donor Day 2015, I express my gratitude to voluntary, nonremunerated donors for their noble lifesaving contribution. I also urge Member States to involve, educate and empower communities to regularly and voluntarily donate blood to meet the national demand for safe blood.

Dr Poonam Khetrapal Singh Regional Director

THANK YOU FOR SAVING MY LIFE