Global Advisory Panel on Corporate Governance and Risk Management of Blood Services in Red Cross and Red Crescent Societies


GAP Manual (English)
Development of Safe and SustainableNational Blood ProgrammesManualAugust 20141Inside cover:Global Advisory Panel (GAP) on Corporate Governanceand Risk Management of Blood Services in Red Crossand Red Crescent Societies, 2011GAP SecretariatL1, 69 Walters DriveOsborne Park WA 6017AustraliaCopies of all or part of this document may be made fornon-commercial use, providing the source isacknowledged. GAP would appreciate receiving detailsof its use. Requests for commercial reproduction shouldbe directed to GAP at gapsecretariat@redcrossblood.Telephone: +61 8 6213 5909Telefax: +61 8 6213 5949Email: ............................................................................................................................................. 5Acknowledgements ........................................................................................................................ 51. Introduction .............................................................................................................................. 62. Overview of National Society involvement in blood programmes........................................ 82.1 Levels of National Society engagement .............................................................................. 82.2 Promoting a safe and sustainable blood system ............................................................... 163. Fundamental Principles ......................................................................................................... 173.1 Promoting voluntary, non-remunerated blood donation (VNRBD) ..................................... 173.2 Ensuring safety for donors and recipients ......................................................................... 183.3 Promoting equity of access to blood and blood products .................................................. 183.4 Serving the community and patient interest ...................................................................... 194. Blood programme management............................................................................................ 204.1 Organizational models ...................................................................................................... 204.2 Governance ...................................................................................................................... 214.3 Corporate management .................................................................................................... 224.4 Financial management ...................................................................................................... 224.5 Risk management ............................................................................................................. 244.6 Balanced decision-making ................................................................................................ 255. Building a sustainable donor base ....................................................................................... 265.1 Voluntary, non-remunerated blood collection .................................................................... 265.2 Attracting and retaining donors ......................................................................................... 275.3 Long-term donor commitment ........................................................................................... 275.4 Donor health and counselling ............................................................................................ 286. Blood Safety ........................................................................................................................... 306.1 Strategy development ....................................................................................................... 306.2 Programme implementation .............................................................................................. 316.2.1 Minimum screening requirements.............................................................................316.2.2 Additional screening test requirements ..................................................................... 326.2.3 Testing algorithms ....................................................................................................336.2.4 Test systems ............................................................................................................336.2.5 Quality system..........................................................................................................336.2.6 Result, donor and product management................................................................... 346.2.7 Emergency provision of blood ..................................................................................347. Quality management .............................................................................................................. 357.1 The quality system ............................................................................................................ 357.2 Good manufacturing practice (GMP) ................................................................................. 367.3 Standards ......................................................................................................................... 387.4 Auditing............................................................................................................................. 388. Partnerships ........................................................................................................................... 398.1 Government ...................................................................................................................... 398.2 Community engagement ................................................................................................... 408.3 Blood sector networks....................................................................................................... 408.4 Hospitals and clinicians ..................................................................................................... 418.5 National Societies ............................................................................................................. 429. Sustainability .......................................................................................................................... 439.1 Adoption of new technologies and practices ..................................................................... 439.2 Contingency planning and disaster preparedness ............................................................. 439.3 Environmental sustainability .............................................................................................. 4510. Transition and exit strategies................................................................................................ 46Appendices ................................................................................................................................... 51Appendix 1: International Federations blood policy ..................................................................... 51Appendix 2: National Society blood risk summary........................................................................ 57Appendix 3: Framework of a Memorandum of Understanding..................................................... 58Appendix 4: ISBT Code of Ethics ................................................................................................ 61Appendix 5: Blood Safety, WHO Aide-Mmoire for National Blood Programmes ......................... 623Appendix 6: The Clinical Use of Blood, WHO Aide-Mmoire for National Health Programmes .... 64Appendix 7: Quality Systems for Blood Safety, WHO Aide-Mmoire for National BloodProgrammes ................................................................................................................................ 64Appendix 8: Safe Blood Components, WHO Aide-Mmoire for National Health Authorities ......... 664PrefaceThe safety and integrity of a nations blood supply is fundamental to a secure health system. People inall societies should have the right to expect that the blood and blood products supplied to them aregathered and provided in a safe and sustainable way. While the World Health Organization (WHO)recognizes that it is the responsibility of governments to ensure a safe and adequate supply of blood 1,the International Federation of Red Cross and Red Crescent Societies (IFRC) expects its memberNational Societies that are involved in blood programmes to meet these obligations to the community.0FThis manual supercedes the IFRC 1998 Blood Programme Development Manual and is informed by theexpertise of the Global Advisory Panel (GAP) on Corporate Governance and Risk Management of BloodServices in Red Cross and Red Crescent Societies. It identifies the features of an effective andsustainable blood programme and directs member societies to relevant resources on blood programmemanagement.By developing this manual the GAP seeks to support National Societies to manage their involvement inblood programmes in accordance with the International Federations blood policy and principles and inthe best interests of donors and recipients.This publication describes the Red Cross Red Crescent minimal requirements and international bloodservice standards that National Societies need to meet in order to maintain a blood programme. It alsoincludes generic guidelines to assist them in assessing the risks of blood service provision, and intransitioning to a lesser involvement in blood programme delivery if this is considered appropriate.Ultimately, it is the responsibility of individual societies involved in blood programmes to ensure that theyestablish sound governance and their programmes comply with the safety and quality requirements andthe necessary risk management mechanisms described in this manual and the GAP Self-assessment. Itis important that National Societies are aware of their responsibilities and exposure to risk that arise withundertaking blood service activities.AcknowledgementsThe members of the GAP (the blood services of the American Red Cross, Australian Red Cross, RedCross Society of China (Hong Kong), Ethiopian Red Cross Society, Finnish Red Cross, Honduran RedCross, Japanese Red Cross Society, Magen David Adom in Israel, Swiss Red Cross and the Thai RedCross Society) would like to thank the IFRCs Health Department for their collaboration in thedevelopment and publication of this Manual. The International Federations contribution of expertise involuntary blood donor recuitment, and their support with translations and funding assistance aregratefully acknowledged.The GAP would also like to express its thanks to both the International Society of Blood Transfusion(ISBT) and the World Health Organization (WHO) for their important work in supporting national bloodprogrammes as well as their specific contributions to this manual. ISBTs helpful feedback on the draftdocument has enabled the GAP to develop a better, more useful Manual for the use of NationalSocieties, while the GAP would like to thank WHO for allowing us to reference their excellent materials.Finally, the members would like to thank the Singapore Red Cross for their valuable assistance inbringing a blood donor recruitment perspective to appendix 3.1Aide-Mmoire: Blood Safety. Geneva, WHO, 200251.IntroductionThe International Federations mission is to improve the lives of vulnerable people by mobilizing thepower of humanity. The IFRC recognizes that health security is fundamental to global, national andindividual development and is committed to capacity building and promoting sustainability. 2 Priorities inits Global Agenda are to improve local, regional and international capacity to respond to disasters andpublic health emergencies; scale up actions with vulnerable communities in health promotion, diseaseprevention and disaster risk reduction; and to significantly increase HIV/AIDS programming andadvocacy.1FThe safety and integrity of national blood supplies are fundamental to health security. Blood and bloodproducts are vital for health care and the achievement of the United Nations Millennium DevelopmentGoals to:1. reduce child mortality (Goal 4)2. improve maternal health (Goal 5)3. combat HIV/AIDS, malaria and other diseases (Goal 6)Recognizing that voluntary, non-remunerated blood donation (VNRBD) 3 provides the foundation for safeand sustainable blood systems, the International Federation has partnered with WHO to create a globalframework for action for 100 per cent voluntary blood donation 4. Approximately 60 nations, includingresource-limited countries, have now achieved a national blood supply sourced from voluntary donors.The aim of the global framework is to eliminate paid or family replacement donation and help shift theresponsibility for the provision of blood from patients relatives (in the case of family replacementdonation) to the health care system.2F3FThe International Federation through the GAP supports the establishment of safe and sustainable bloodsystems through leadership, advocacy and guidance to National Societies and their blood programmes.This manual has been developed by the GAP with the assistance of IFRCs health department. Since itsestablishment in 2001, the GAP has provided advice to member societies on corporate governance andriskmanagement.ItFundamental Principlespromotes the adoption of(Chapter 3)best practice, knowledgeManagementSustainabilityRequirementsexchangeandthe(Chapter 9)(Chapter 4)Safe andmobilization of resourcesSustainable Bloodacross blood services. TheBlood SectorSustainable DonorPartnershipsBaseProgrammeareas highlighted in this(Chapter 8)(Chapter 5)publication, as illustrated inQuality AssuranceBlood Safetythe diagram on the right, are(Chapter 7)(Chapter 6)based on feedback fromNational Societies and their partners.2Health policy adopted at the XV Session of the IFRC General Assembly, Seoul, November 2005.Voluntary, non-remunerated blood donors are persons who give blood, plasma or other blood components of their ownfree will and receive no payment for it, either in the form of cash, or in kind which could be considered a substitute formoney. This includes time off work, other than reasonably needed for the donation and travel. Small tokens, refreshmentsand reimbursement of direct travel costs are compatible with voluntary, non-remunerated donation. Decision 34 of the VIIISession of the IFRC General Assembly, Budapest, 19914For the purposes of this manual, any reference to voluntary blood donors or voluntary blood donation assumes thedonation is non-remunerated, as per the description in the footnote above.36The International Federations blood policy (appendix one) states that National Societies must implementthe GAP Self-assessment and adhere to the requirements set out in this manual. National Societiesoperating full blood transfusion services (Level A) should find all sections of the manual relevant. Forthose societies involved only in promotion and advocacy of voluntary blood donation (Level C), Chapter3 on the fundamental principles underpinning involvement in blood activities will be of particular interest.It is worth noting here that for the purposes of this manual, any reference to voluntary blood donors orvoluntary blood donation assumes the donation is non-remunerated.National Societies that are also involved in the systematic recruitment of voluntary blood donors shouldespecially focus on the sections covering sustainability of the donor base (Chapter 5), tracking ofdonations for safety and quality assurance (Chapters 6 and 7), partnerships to support a culture ofvoluntary blood donation and to share best practice in donor recruitment (Chapter 8), and transitionstrategies (Chapter 10).The GAP and the International Federation are mindful that member societies are at different stages ofdevelopment in their blood programmes and acknowledges their efforts to date towards meeting theirobligations. This manual is intended to serve as a resource to assist members in achieving a safe andsustainable blood system, maintaining the high standing and trust that the community places in RedCross and Red Crescent societies.72.Overview of National Society involvement in bloodprogrammesThe extent of National Society engagement in blood programmes ranges from non-involvement throughto extensive responsibility for blood collection and supply. Around a quarter of member societies havesome responsibility for blood service delivery in their national blood programmes, while around 63 percent are engaged in either systematic blood donor recruitment activities or advocacy and promotion ofVNRBD. 54F2.1Levels of National Society engagementA. Full Blood Service ProvisionB. Systematic Blood Donor RecruitmentC. Advocacy for VNRBDPromotional campaignsEducation and awarenessInvolvement in WBDDDonor recruitmentPromotional campaignsEducation and awarenessInvolvement in WBDDGovernanceAdvocacy for appropriate useProduct distributionLaboratory testingComponent preparationCollection services/donor careDonor recruitmentPromotional campaignsEducation and awarenessInvolvement in WBDDThe greater the level of engagement and responsibility that National Societies have in relation to bloodprogrammes, the more extensive are their requirements, obligations and level of risk.Most National Societies are best suited to contribute towards predisposing the community to donateblood, such as through education programmes and advocacy campaigns. Feedback from manygovernments also suggests that support for their blood services from a society and its volunteers can beof most assistance in this area. The GAP regards this level of involvement as presenting the lowest riskfor any National Society.National Societies at all levels are not encouraged to expand their existing blood programme activitiesunless they have received a mandate from the appropriate government authority, and have sufficientresources, capacity and expertise to do so. Should National Societies wish to move between levels,undertake more extensive involvement in donor recruitment, or significantly increase or reduce theirinvolvement in Level A activities, it is recommended that advice be sought from the GAP at the outset.Considerations include the capacity of a National Society to undertake additional blood programmeactivities, the provision of sufficient government funding, access to suitable training and personnel, anappropriate governance structure and risk management expertise.To assist National Societies in understanding the extent of their commitment and associatedrequirements, an overview of recommendations for each level of engagement in blood programmeactivities is provided on the following pages for their consideration. A list of the minimal conditionsrecommended for undertaking a National Society blood programme can also be found in the GAP Selfassessment under key issue one. 65F5Global Mapping of Red Cross/Red Crescent involvement in blood programmes 2009/2010 (updated August 2011), GAP,2011; p. 3. For more information contact the GAP secretariat ( latest GAP Self-assessment questionnaire is available on the IFRCs internal web site https://fednet.ifrc.org8Level A: Full blood service provisionNational Societies involved in providing blood collection, storage and distribution services require stronggovernance and risk management structures. These societies can reinforce positive attitudes to blooddonation through excellent service, recognition and valuing of the donor gift. Those involved at Level Amust also meet the requirements set out for Level B and C.National Societyblood servicechecklistFundamentals Adherence to IFRC blood policy and the minimal conditions described in theGAP Self-assessment (Level A). The blood service is integrated as part of a national health policy and plan. The blood service operates under a quality assurance programme andadheres to a national regulatory framework or, if necessary, an internationalregulatory framework. For example, the AABBs Standards for Blood Banksand Transfusion Services, or the Council of Europes Guide to the preparation,use and quality assurance of blood components'. The blood service is based upon voluntary, non-remunerated blooddonation. Roles and responsibilities between the blood service, the National Society, thegovernment and other stakeholders are formally documented in a serviceagreement, and are being adhered to. Government protection/indemnity and/or appropriate insurance cover havebeen secured for blood service activities, including clinical advice. (Please referto the GAP Self-assessment for the types of insurance cover required). The blood service has a long-term and sustainable source of revenue. The blood service has sufficient facilities, supplies, equipment and trainedstaff and volunteers to meet operational and regulatory requirements. Training programmes are in place to develop and maintain operational skillsfor all staff. The donor is treated ethically and his or her privacy and confidentiality areassured.Blood programme management There is a separate corporate governance structure for the blood service,including a professional blood service board with the appropriate skills andknowledge to manage corporate governance effectively. There is a well-defined system of delegation that provides clarity on authorityand accountability between the: National Society council and blood service board blood service board and blood service management A policy is in place to ensure there are no conflicts of interest for boardmembers, senior staff and major suppliers. The blood service is under the direction of an appropriately qualifiedprofessional who has authority over the necessary resources. A separate corporate structure for the administration of the blood service hasbeen established. There is a nationwide organizational model for the blood service.9 The blood service has a clear vision and mission, and a strategic plan thatmeets the needs of donors, recipients and clinicians. Performance goals and key performance indicators have been establishedto monitor progress against the strategic plan. Training programmes are in place to develop and maintain management andleadership skills.Financial management The blood service has an independent budget with a service level agreementfor the transfer of funds between the National Society and the blood service.Risk management There is a risk management framework in place to identify, prioritize andmanage risks relevant to the local environment. The framework should includeregular completion of the GAP Self-assessment. Systems are in place to identify emerging threats to the safety of the bloodsupply relevant to the local environment. Mechanisms are in place for supporting recipients of infected blood,including record-keeping policies for potential future claims. If undertaking fractionation, the appropriate risk management measuresdescribed in the GAP Self-assessment are in place.Donor care and counselling The health and well-being of the donor and recipient are paramount. The blood service maintains donor records and a donor register. National donor selection and deferral criteria are defined and a deferralsystem relevant to the local environment has been implemented. A counselling system for donors, especially those that have been deferred, isin place.Blood Safety A national screening strategy is developed and implemented by the bloodservice that: reflects international good practice and takes into account localvariables and national regulations; describes minimal requirements for pre-donation screening (includingdonor eligibility), laboratory testing and product management; ensures 100% of blood donations are tested and only those foundnegative for specified transfusion transmitted infections (TTIs) arereleased; and includes a system to manage the disposal of at risk product inaccordance with national regulations for bio-hazardous wasteQuality assurance The blood service adheres to a national regulatory framework, or there isnational acknowledgement that an international regulatory framework (suchas AABB, Council of Europe) should be applied. The blood service adheres to quality assurance standards and goodmanufacturing practice (GMP) to ensure the quality and safety of blood andblood components in accordance with WHO and international or local regulatoryrequirements.10 Systems of quality assurance, monitoring, evaluation and accountabilityare in place for all aspects of blood service provision, including collection,preparation, testing, storage and distribution. Staff are continually trained in all aspects of quality assurance.Stakeholder partnerships The blood service participates with government in the development of nationalregulatory standards. A system is in place for performing a cost-benefit analysis, with government,on all safety-enhancement proposals. The government is educated on the importance of adequately funding bloodsafety. A national system is established to report Haemovigilance/serious adverseevents to the National Society blood programme where a donor might beimplicated. If there is no national system, hospital-based reporting should beencouraged. There are systems in place to educate the public on the safety of the bloodsupply and the risks of blood transfusion. Clinicians are educated on the appropriate use of blood and bloodcomponents, the risks of blood transfusion and relevant aspects of PatientBlood Management Hospitals are encouraged to develop a system that monitors and works towardsreducing wastage and advocates appropriate blood product use. The blood service has formal agreements with end users (e.g., hospitals) oninventory holdings, ordering and supply systems. Hospitals are encouraged to set up multidisciplinary transfusioncommittees. The blood service has developed a supply plan with stakeholders (includingend users) to ensure that recruitment and collection activities produce sufficientblood and blood components to meet the needs of the health system.Sustainability A clear disaster preparedness and contingency plan is in place. The blood service has an appropriate environmental and hazardous wastemanagement policy.Level of RiskHigh (refer to Chapter 4, Appendix 2, and the GAP Self-assessment Level A).Key Resources forLevelAblood7programmes Promoting Safe and Sustainable Blood Systems Policy (draft). Geneva, IFRC,2011 (see Appendix 1).6F GAP Self-assessment Level A. GAP, current version. WHA 63.12, Availability, safety and quality of blood products. Sixty-Third WorldHealth Assembly, Geneva, 21 May 2010, Geneva, WHO 2010 (also WHA 28.72and WHA 63.12). Aide-Mmoire: Blood Safety. Geneva, WHO, 2002 (attached as Appendix 5)7GAP recommends that National Societies and their blood services keep a copy of all key resources with the GAP manualfor easy reference11 Aide-Mmoire: The Clinical Use of Blood. Geneva, WHO, 2003 (attached asAppendix 6) Aide-Mmoire: Developing a National Blood System, Geneva, WHO, 2011 Aide-Mmoire: Good Policy Process for Blood Safety and Availability. Geneva,WHO, 2008 Aide-Mmoire: Quality Systems for Blood Safety. Geneva, WHO, 2002(attached as Appendix 7) Aide-Mmoire, Safe Blood Components. Geneva, WHO, 2005 (attached asAppendix 8) Aide-Mmoire: Safe health-care waste management. Geneva, WHO, September2000 Blood Cold Chain: Selection and Procurement of Equipment and Accessories.Geneva, WHO, 2002. Costing Blood Transfusion Services. Geneva, WHO, 1998. Manual on the Management, Maintenance and Use of Blood Cold ChainEquipment. Geneva, WHO, 2005 Screening Donated Blood for Transfusion-Transmissible Infections. Geneva,WHO, 2009 Safe management of wastes from healthcare activities. Geneva, WHO, 1999 Code of Ethics for Blood Donation and Transfusion. International Society ofBlood Transfusion (ISBT), General Assembly, 12 July 2000; amended by theISBT General Assembly, 5 September 2006 (attached as Appendix 4). Australian Code of Good Manufacturing Practice for Human Blood and Tissues.Canberra, Therapeutic Goods Administration, 2000 Guide to the Preparation, Use and Quality Assurance of Blood Components.European Directorate for the Quality of Medicine (EDQM), Council of Europe,current edition. Standards for Blood Banks and Transfusion Services. AABB, current edition Making a difference...Recruiting voluntary, non-remunerated blood donors.Toolkit, Geneva, IFRC, 2008 Towards 100 per cent voluntary blood donation: A global framework for action.Geneva, WHO/IFRC, 2010Please note: References relevant to the content in each manual chapter arelisted under the Resources heading found at the end of most sections.12Level B: Systematic recruitment of voluntary blood donorsSome National Societies support their domestic blood programme and blood services by recruitingblood donors and providing access to blood donation centres. These societies act in partnership with ablood service, actively promote non-remunerated donation, and motivate donors through information andrecruitment campaigns. National Societies at Level B need to enter into a dialogue with the bloodservices to which they recruit donors to ensure that the blood service has the appropriate standards indonor care and quality assurance.National SocietyVNRBDRecruitmentprogrammechecklistFundamentals Adherence to the IFRCs blood policy and the minimal conditions described inthe GAP Self-assessment (Level B). Ensuring that the blood service the National Society recruits blood donors tomeets local regulatory requirements and/or WHO and international standardsrecommended for national blood programmes (see Level A information on pages8-11). The blood donor recruitment programme is based on VNRBD. Roles and responsibilities between the National Society and government havebeen clarified and there is a documented service agreement for VNRBDrecruitment activities. A long-term and sustainable source of revenue for the donor recruitmentprogramme has been secured. The donor recruitment programme is evaluated regularly to assess whether a) itis meeting demands or b) it is grossly exceeding requirements. The donor is treated ethically and his or her privacy and confidentiality areassured. The IFRC toolkit Making a differenceRecruiting VNRBD is used.Blood donor recruitment programme management There is a clear vision, mission and strategic plan for the donor recruitmentprogramme. Performance goals and key performance indicators have been established tomonitor progress against the strategic plan. The programme is under the direction of a professional director with authorityover the necessary resources, who is part of the National Societys seniormanagement team. The director organizes, manages, trains, monitors and evaluates the staff,volunteers and procedures involved in blood donor recruitment and retention. Staff are continually trained in all aspects of blood donor recruitment andretention.Donor care and counselling A donor register and records are maintained. The National Societys donor recruitment and deferral practices reflect nationaldonor selection and deferral criteria. Counselling for donors, especially those that have been deferred, is provided by13the National Society or blood service, as appropriate. Good customer service and donor care is the responsibility of all staff members. Staff performance is subject to monitoring and evaluation.Promotion A community education programme develops positive attitudes to VNRBD. Donor populations at low risk of transfusion-transmitted infections (TTIs) aretargeted. The worth of blood donations and blood donors is recognized. The National Society works with clinicians (through education, awareness, etc.)to promote VNRBD.Sustainability There is a risk management framework in place to identify, prioritize andmanage risks relevant to the local environment. A clear disaster preparedness and contingency plan is in place.Level of RiskMedium (refer to Chapter 4, Appendix 2, and the GAP Self-assessment Level B).Key Resources Promoting Safe and Sustainable Blood Systems Policy (draft). Geneva, IFRC,2011 (see Appendix 1). GAP Self-assessment Level B. GAP, current version. Towards 100 per cent voluntary blood donation: A global framework for action.Geneva, WHO and IFRC, 2010. Making a differenceRecruiting voluntary, non-remunerated blood donors.Toolkit, Geneva, IFRC, 2008. Developing a Voluntary Blood Donor Programme for Blood Safety (DONOR).Geneva, WHO and IFRC. Aide-Mmoire: Blood Safety. Geneva, WHO, 2002. Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005. New blood for the world, DVD and leaflet. Geneva, IFRC, 2009. Proceedings of the international colloquia on the recruitment of VNRBD.Making the most of World Blood Donor Day. WHO/IFRC/FIODS/ISBT, note: References relevant to the content in each manual chapter are listedunder the Resources heading found at the end of most sections.14Level C: Motivation and advocacy for voluntary, non-remuneratedblood donationMany National Societies report they play a significant role in promoting VNRBD for blood programmes intheir countries and in generating positive attitudes to blood donation through volunteer networks,education programmes and advocacy campaigns. These activities predispose a population to donateblood. All National Societies are encouraged to be involved at this level, if practicable and appropriate.National SocietyExpectationsBring to public attention the role of voluntary blood donors in meeting the needs ofthe most vulnerable.Undertake occasional, broad-based community education and awarenessprogrammes.Participate in World Blood Donor Day events (14 June).Level of RiskLow.Basic ChecklistNational Societies involved in the occasional promotion and advocacy of blooddonation should: have a general agreement with national and local government authorities touse World Blood Donor Day, 14 June, as an opportunity to pay tribute tovoluntary blood donors remind its own membership about the need for securing a safe blood supplythrough voluntary and unpaid blood donation have clarified its roles and responsibilities and those of other stakeholders insetting up viable Club 25 Programmes, whereby youth assist by giving blood ona regular basis and also help with peer education in health promotion explore with the government ways to phase out family replacement donationand move towards 100 per cent voluntary blood donationKey Resources Promoting Safe and Sustainable Blood Systems Policy. Geneva, IFRC, draft.(see Appendix 1). GAP Self-assessment Level C. GAP, current version. Making a differenceRecruiting voluntary, non-remunerated blood donors.Toolkit, Geneva, IFRC, 2008. Towards 100 per cent voluntary blood donation: A global framework for action.Geneva, WHO and IFRC, 2010. Developing a Voluntary Blood Donor Programme for Blood Safety (DONOR).Geneva, WHO and IFRC, 2010. New blood for the world, DVD and leaflet. Geneva, IFRC, 2009.Making the most of World Blood Donor Day. WHO/IFRC/FIODS/ISBT, note: References relevant to the content in each manual chapter are listedunder the Resources heading found at the end of most sections.152.2Promoting a safe and sustainable blood systemAll National Societies, irrespective of whether they are directly or indirectly involved in the administrationof their national blood programmes, can contribute towards the development of a safe and sustainablenational blood system. Advocacy and promotion of VNRBD builds the foundations of global blood safety,which ultimately saves lives.National Societies with no formal involvement in blood programmes (Level C) can support the process ofchanging attitudes and beliefs towards blood donation in their countries through advocacy, educationcampaigns and participating in blood donor recognition events, notably World Blood Donor Day on 14June each year. Also, community health programmes supported by the International Federation and itsmember societies, such as strategies to prevent AIDS or hepatitis and to control diseases such asmeasles or cholera, promote healthy lifestyles in local communities and provide the basis for a low-riskblood donor population.Societies involved in blood donor recruitment activities (Level B) can further build participation involuntary blood donation through campaigns and providing access to donation centres. Thoseextensively involved in blood services (Level A) can promote a culture of donation by valuing andrecognizing the commitment of donors, and can encourage regular donation by providing effective,accessible services to donors.Level AFULL BLOOD SERVICE(INCLUDING BLOOD COLLECTION)Reinforcing a culture of donationLevel BSYSTEMATIC RECRUITMENTEnabling voluntary blood donationLevel CMOTIVATION AND ADVOCACYPredisposing the population to voluntary blood donation163.Fundamental PrinciplesThe International Federation expects that National Societies engaging in blood programmes adhere toand promote the Fundamental Principles of humanity, impartiality, neutrality, independence, voluntaryservice, unity and universality. National Societies are also expected to demonstrate and uphold IFRCcore values when engaging with blood service partners and the community. These are:the protection of life, health and human dignityrespect for the human beingnon-discrimination on the basis of nationality, race, gender, religious beliefs, class or politicalopinionsmutual understanding, friendship, cooperation and lasting peace among peopleservice by volunteersThese principles and values are reflected in the following commitments that underpin safe, equitable andsustainable national blood programmes. National Societies should also comply with the InternationalSociety of Blood Transfusion (ISBT) Code of Ethics for Blood Donation and Transfusion (2006), whichhas been adopted by WHO and is included in this manual as appendix four. The Code is available indifferent languages on the ISBT web site ( voluntary, non-remunerated blood donation (VNRBD)VNRBD has been viewed as critical to the international health effort since the 1975 World HealthAssembly (WHA) resolution 8 called for member states to promote the development of national bloodservices based on voluntary, non-remunerated donation of blood, a principle reasserted by the WHA in2005. 9 Voluntary, non-remunerated blood donors, particularly those who donate blood regularly, providethe foundation for a safe, sustainable blood supply that can meet the needs of all patients requiring bloodtransfusion. The International Red Cross and Red Crescent Movement has been a strong advocate forVNRBD and continues to work towards this objective internationally.7F8FA number of studies have shown that blood derived from altruistic, voluntary donors is safer than thatsourced from paid donors or family replacement donors, with the lowest rates of transfusiontransmissible infection among regular donors. 10 The recognition of donor contribution to the well-being ofothers, rather than payment, supports the integrity of the blood system and maintains human dignity.Sourcing blood from voluntary blood donation will help eliminate paid and family replacement donationand support universal and equitable access to safer blood transfusion.9FA safe and sustainable blood supply is underpinned by programmes aimed at recruiting and retainingvoluntary blood donors from low-risk populations. Many countries have achieved the transition from paidand family replacement donation to VNRBD and, as illustrated overleaf, many others have madesignificant progress towards this objective.8 WHA 28.72, Utilization and supply of human blood and blood products. Twenty-Eighth World Health Assembly, 13-30May 1975. Geneva , WHO, 19759 WHA 58.13, Blood safety: proposal to establish World Blood Donor Day. Fifty-Eighth World Health Assembly, Geneva,WHO, 200510 Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, p. 18.17Developing (Low HDI) Countries Progression towards VNRBD2003Paid donation, 8%2008VNRBD, 31%Paid donation, 2%Family replacement, 30%VNRBD, 69%Family replacement, 61%Source: World Health Organization Global Data Base, 20093.2Ensuring safety for donors and recipientsThose National Societies involved in blood donor recruitment, collection or service delivery are entrustedby their community and government to act as good stewards of the blood supply and to safeguard itsintegrity. This requires mechanisms for oversight of blood management and processes that ensure highstandards of safety and quality, as will be outlined in subsequent chapters.National Societies have a responsibility to maintain the well-being of both donors and the recipients ofblood products. To meet this obligation, recruitment should focus on attracting low-risk donors, witheffective donor screening and deferral processes. Donor welfare should be supported througharrangements for donor health and counselling. The quality and safety of blood and blood componentsis further ensured by laboratory testing of donated blood, systems to trace and recall potentiallycontaminated blood components; standards for inventory storage, handling and distribution; andguidelines and training for appropriate clinical use.3.3Promoting equity of access to blood and blood productsBlood transfusion is a life-saving function that should be available in a first-referral level of a health carefacility providing comprehensive emergency obstetric and newborn care. 11 Access to safe blood for allpatients reduces morbidity and mortality, supporting the International Federations global agenda goalsand the Millennium Development Goals. The timely availability of safe blood and blood products isessential for blood transfusion in emergency situations, such as from road accidents or haemorrhageduring childbirth. Haemorrhage accounts for over 25 per cent of the 530,000 maternal deaths each year.Almost all of these are in the developing world. Access to safe blood could help prevent up to a quarterof maternal deaths. 12 A large proportion of traffic accident victims need blood transfusion during the first24 hours of treatment. Road accidents are projected to become the third largest contributor to the globalburden of disease. 13 Children under the age of five suffering from life-threatening anaemia, often as aresult of malaria or malnutrition, also require transfusion support. 1410F11F12F13F11Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, p. 9.Ibid13 Ibid14 Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, p. 9.1218It is important that all patients have access to life-saving blood on the basis of their clinical need. Insystems supported by an established voluntary donor base, patients generally have improved access tosafe blood transfusion in both routine and emergency situations. Hospitals, patients and patient familiesshould not be placed under pressure to find blood donors. Family replacement donors do not provide forthe communitys blood supply needs and hospitals dependent on such donors usually have insufficientinventory to administer transfusions when needed.It is more appropriate that the community takes ownership for the blood system through voluntary, nondirected donations. With altruistic blood donation, patients experience a sense of being cared for byothers in the community, which can generate a reciprocal spirit of generosity and engagement. AVNRBD system supports equity of access by providing a regular, reliable supply of safe blood.3.4Serving the community and patient interestA strong commitment to humanity is the basis of National Society involvement in blood programmeactivities. Engagement in blood services and promotion of safe blood donation provides tangible andoccasionally life-saving benefits to members of the community.Humanitarian values also motivate individuals to generously and unconditionally donate their blood. Thishumanitarian spirit is core to the International Federations work and is reflected by the many volunteerswho give freely of their time. Societies have an obligation to respect this commitment by recognizing andvaluing the gift of blood donation. For those societies directly involved in blood programme delivery,serving the patient and community interest also requires maintaining the integrity of donated blood byensuring its quality and safety, and striving to make best use of scarce blood to achieve the bestoutcomes for patients.Chapter resourcesA Code of Ethics for Blood Donation and Transfusion. International Society of Blood Transfusion (ISBT),2000, amended 2006.194.Blood programme management4.1Organizational modelsBlood programmes can be national, regional or hospital-based. National Societies can range from beingthe sole provider of the national blood programme to undertaking large or small-scale blood collection ata regional or district level, or providing support to the national blood service through the recruitment ofdonors or the promotion of VNRBD. Regardless of the structure of blood service delivery arrangements,the IFRC and GAP support WHO recommendations that blood service provision be guided by nationalregulations and a national blood policy to promote consistency in practice, accessibility and equity ofaccess. 1514FWHO recommends that a national blood system should be organized and coordinated to ensure themost efficient and cost effective use of all resources 16. A centralized structure supports a safe andsustainable blood supply by improving safety and quality, ensuring a consistent, regular blood supplywhich is less dependent on local contingencies, and providing flexibility when responding to emergencysituations. Centralization of blood processing and testing provides for increased cost-efficiency anduniformity of standards.15FBlood transfusion services should be coordinated at national regional and provincial levels, with criticalactivities such as blood screening and processing consolidated in strategic locations 17. The GAPrecommends that, where possible, National Society blood programmes should function under anationwide operational model 18 in which district and regional services form part of a central blood servicemanaged by a national blood service director. The director should be responsible for ensuring the bloodservice adheres to national standards in quality assurance and good manufacturing practice (GMP) andfor setting internal organizational policies and procedures in line with national regulations.16F17FWhatever model is used, it is important that the blood service has a clear organizational structure, andthat the roles and responsibilities at national, regional and district level (if applicable) are clear, andaccountabilities between the different levels, if any, are clearly defined. Individual Blood TransfusionServices (BTS) should be structured, staffed and managed in accordance with national regulations withsuitable medical, technical and quality processes for the provision of safe blood and blood componentsto patients. BTSs should be accessible and sustainable with:suitable premises that comply with GMPsufficient numbers of appropriately trained staffspecialized equipment for blood collection, processing, testing, storage and transportation and apreventative maintenance systema reliable supply of blood collection bags and reagents 1918FThe GAP can facilitate collaboration with partners such as WHO and government health agencies andprovide guidance to National Societies on which organizational structure may be most appropriate. Thiswould be informed by a situation analysis that looked at the local context, availability of resources, andso on.15Aide-Mmoire: Safe Blood Components. Geneva, WHO, 200516Aide-Mmoire: Developing a National Blood System. Geneva, WHO, 201117Ibid18Key Issue two: GAP Self-assessment Level A. GAP, current version.19 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 200520Resources Aide-Mmoire: Safe Blood Components, Geneva, WHO, 2005 Aide-Mmoire: Developing a National Blood System, Geneva, WHO, 2011 GAP Self-assessment Level A. GAP, current version4.2GovernanceNational Societies are expected to apply principles of good corporate governance in respect of their bloodprogrammes. Blood programme management is complex and requires specialist medical, technical, andfinancial expertise. The GAP recommends that National Societies delivering blood programmes establish aseparate, professional board that comprises members with blood sector, clinical and businessmanagement experience. The separate board should have delegated responsibility to govern the bloodprogramme, including the appointment of the director of the blood programme and authority over dedicatedblood programme resources. There should be clearly defined roles and accountability between the bloodservice director and the blood service board.The chairman of the blood service board and the majority of its members should be independent of theblood service management team. The boards role includes to:ensure the blood service has an effective system of corporate governance and that the board alsooperates in accord with corporate governance standardsestablish the strategic direction and ensure sufficient resources are available for the blood serviceto achieve its strategic objectivesmonitor performance and approve budgets, new business proposals and major items of capitalexpenditureoversee operations and ensure effective managementensure major policies are established with appropriate support systemsensure procedures for risk management, internal control and compliance are adhered toappoint and monitor the performance of the director of the blood programme and developsuccession planningensure that the blood service has appropriate interaction with external stakeholders 2019FThe functions of a blood service board can be supported by the establishment of more specializedoversight committees, such as finance, audit and risk, and clinical governance committees. Eachcommittee should comprise the relevant managers responsible for that function of the blood service andboard members with appropriate experience and technical expertise. 2120FWhile a separate board can provide National Societies with additional expertise with which to manageblood service risks, National Societies may still be exposed to financial and reputational risks. It isimportant that there are clearly defined lines of authority and accountability between the NationalSocietys blood service board and the societys governing council. A National Society might alsoconsider establishing an advisory committee to provide independent advice to the blood service boardon medical, scientific and research matters and to provide assurance to the governing council that highstandards are being maintained.ResourcesGAP Self-assessment Level A. GAP, current version.2021Informed by the official description for an Australian Red Cross blood service board member, November 2008Informed by the Australian Red Cross blood services terms of reference for their advisory committees, 2008-2009.214.3Corporate managementThe GAP recommends that a National Society blood service has a separate corporate structure for theadministration of the blood programme, with an independent budget. The roles and responsibilities ofthe National Society and the blood service should be discussed and clarified, and then documented andrespected. A service level agreement should be in place for the transfer of funds between the NationalSociety and blood service, and measures established so the National Society does not have access tofinancial contributions (unless prior approval from donors has been given) and personal information fromblood donors.A blood service director should be appointed who is well qualified to manage the blood service andaccountable to the National Society, the board and the wider community. The blood service director shouldbe accountable nationally for ensuring that all blood service operations are carried out properly andcompetently, as required by the relevant health acts, regulations and standards. He or she could besupported by a management committee comprising the managers of the various departments includingclinical, donor recruitment, quality, finance, risk and audit, etc.Staff roles and responsibilities should be clearly defined in job descriptions and there should be sufficientstaff to meet regulatory requirements and support the organization and its activities. Blood service staffshould have the appropriate experience and training for their positions. 2221FA clear vision and mission should be in place for the blood service or blood donor recruitmentprogramme and stakeholders should be consulted in the development of a strategic plan. Performancegoals and key performance indicators need to be established to measure progress against the strategicplan, which should be reviewed regularly to ensure that it remains relevant.Resources:GAP Self-assessment Levels A and B. GAP, current versions.4.4Financial managementNational Societies involved in blood programmes at any level should develop and implement a financialmanagement system. It should be appropriately costed, effectively managed, supported by governmentand ensure the ongoing financial sustainability of their blood programme. WHO in its Aide-Mmoire onBlood Safety notes that the responsibility for adequately funding the blood service to ensure a safe andadequate supply of blood rests with the government. 23 It is critical that there should be transparentfinancial arrangements, including a service level agreement for the transfer of funds, between theNational Society and blood service so the government or other funding body is assured that the fundsare being used for relevant blood programme activities.22FThe WHO and IFRC Global Framework 24 provides National Societies operating Level B or C bloodprogrammes (recruitment and motivation only) with information and action points to secure sustainablefinancing for their blood programmes. National Societies operating at Level A may also use this resourceto help in budgeting for their donor recruitment activities.23FOne of the key challenges for National Society blood services is advocacy to funders around the cost of22Aide-Mmoire: Blood Safety. Geneva, WHO, 200223Ibid.Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, pp. 40-41.2422blood. The time and resources that inform the final cost of blood are often not known or misunderstoodby funders, and therefore they can be unwilling to support fully the seemingly high cost of blood.Therefore, it is very important that National Societies actively engage and advocate with funders on theissue of sustainable blood service funding.National Societies may seek sustainable financing for their blood services either through cost recovery orannual budget allocation. Whatever the method of financing, in order to be sustainable the level offunding must cover capital and recurrent costs 25 and the financial model must allow for potential futureincreases in the cost of blood service delivery (for example, the introduction of new tests, staff increases,building renovations, inflation, devaluation, etc.). The WHO Blood Costing Model is an example of a toolthat can be used by National Societies with full blood programmes for costing their blood services. 2624F25FNational Societies should seek to develop and implement a funding agreement with their government (orother funder) which outlines the financing arrangements for their blood service, including reportingrequirements, and which allows for regular renegotiation of future funding levels should the blood servicecost increase.It is recommended that there should be a dedicated resource person (chief financial officer) for bloodservice financial management who is accountable to the blood programme director. Blood services mayalso wish to establish a finance and audit committee, which may comprise the chief financial officer andsuitably qualified members of the blood service board and also provides for oversight of financialpractice. National Societies should aim to conduct regular audits (either annually or in line withgovernment requirements) to demonstrate transparency to funders and as an opportunity to reviewfinancial practices to identify areas for improvement.Minimum checklist for financial management of blood services: Advocate to potential funders (e.g., government) on the resources required for blood transfusionservices, and the associated costs. Develop a realistic costing of blood service activities the WHO model is recommended. Negotiate an agreement with government for the ongoing provision of blood service financing (costrecovery or budget allocation). Establish a service level agreement for the transfer of funds between the National Society and theblood service, including overhead costs if applicable. Implement an appropriate financial management model, with a focus on transparency andsustainability, in line with any government requirements. Implement regular (at least annually, or as required by government) financial reporting to the funderand other appropriate authorities (e.g., the National Society and the blood service board). Appoint a dedicated financial manager, responsible to the blood service director. Undertake annual budgeting, including a review of blood service costs capital and recurrent. Undertake an annual audit of the financial management systems, including expenditure.ResourcesCosting Blood Transfusion Services. Geneva, WHO, 199825Capital costs are those incurred during start-up, expansion or improvement phases of a blood programme, such as forbuildings, vehicles, equipment, furniture, and also training costs. Recurrent costs include staff remuneration, heating andlighting, insurance, travel, consumables and administration.26 Costing Blood Transfusion Services. Geneva, WHO, 1998234.5Risk managementThere are inherent risks in collecting and supplying blood and blood components. Blood services need toensure the health of donors, to manage the risk of transfusion-transmitted infection and other transfusionrelated complications, to ensure blood and blood components are stored and handled appropriately, andthat they are delivered in time and to order. Communities also expect National Societies to operate withprofessional integrity and to maintain high ethical standards. Appropriately managing risks involved in thedelivery of blood programmes results in improved consequences for donors or recipients, and has apositive impact on the reputation and financial stability of a National Society.A brief list of the main risks facing National Societies involved in blood services (Level A) and VNRBDrecruitment (Level B) can be found in Appendix 2, while a more exhaustive checklist can be found in theGAP Self-assessments. It should be recognized, however, that while compliance with the standardsdescribed in the GAP Self-assessment and this manual will significantly reduce National Societiesexposure to risk, securing government indemnity and/or adequate insurance cover is essential in theeventuality of compensation or other legal claims arising from blood service delivery.GAP recommends that National Societies consult with local legal experts to clarify the risk managementbenefits of securing government assurance for its blood programme activities, particularly against bloodborne disease liabilities, or acquiring appropriate insurance cover as a last resort. Any recommendationsmade as a result of those consultations should be implemented by the National Society as a matter ofpriority.It is important that National Societies establish systems for the identification, prioritization andmanagement of risks that are relevant to the local context. ISO 31000 provides generic principles andguidelines for risk management. These recommend a risk management framework that integrates riskmanagement into the culture of the organization, including governance, planning, decision-making andreporting. A risk management framework promotes understanding of the context in which theorganization operates, sets out a risk management policy and processes to address and manage risk,and assign responsibilities and accountability. There should be consultation with management, staff andexternal stakeholders when identifying actual and potential risks. These risks can then be assessed andplans developed to manage them. Risk management processes and decisions should be welldocumented. As with other quality assurance processes, a National Societys approach to riskmanagement needs to be monitored and reviewed for continuous improvement.To illustrate, a risk framework might begin with workshops attended by board members and seniormanagement to determine the blood services risk tolerance and its key strategic risks. 27 A risk matrixcan then be developed to categorize risks, and criteria agreed for which type of risk would need to beescalated for the attention of senior management and the board. Strategic risks are passed on to theappropriate operational areas, which are responsible for ensuring actions are in place to manage eachrisk. The risks are then prioritized and recorded on an organizational risk register, which is monitoredaccording to agreed risk and control indicators. High-risk actions would be included in business planningprocesses and progress against actions regularly monitored.26FThe GAP provides information and advice to National Societies on appropriate risk managementstructures and processes. The GAP Self-assessment questionnaire includes a checklist to guideNational Societies in understanding their exposure to potential risks and to signal areas requiringattention. It enables National Societies to ascertain:27This example is informed by the Australian Red Cross Blood Services risk management framework.24their own performance against international benchmarkswhere they are performing well and where improvements can be madewhether it is appropriate they continue their involvement in blood service activities (see Chapter10)National Societies engagement should in general be aimed for long-term provision and support. Anyconsiderations to reduce the National Societies level of involvement in blood activities should clearlyfollow the recommendations detailed in Chapter 10 (transition and exit strategies). GAP Selfassessments are available for National Societies involved at all levels of blood programme activity.Participating Level A blood services receive an individual feedback report from the GAP that analysestheir Self-assessment results and provides them with specific risk management recommendations.Depending upon the number of Self-assessments received by the GAP, blood services may receive anadditional report comparing their Self-assessment results with those of other Level A blood services intheir region. Level B National Societies may complete the Self-assessment and receive a feedbackreport upon request, according to the GAPs capacity.It should be noted that only the National Society that completed the Self-assessment is identified in itsindividual report - the anonymity of other participating National Societies is maintained to encourageaccurate self-reporting.The GAP endeavours to respond to the many requests for corporate governance and risk managementassistance received from National Society blood services. However, specific technical support can onlybe offered to two or three societies a year. Those seeking assistance should first contact the GAPsecretariat to discuss what assistance is required before submitting a written request from their secretarygeneral to the GAP chair.Resources GAP Self-assessment, Level A, B and C. GAP, current version International Standard ISO 31000 Risk Management Principles and Guidelines. InternationalOrganization for Standardisation (ISO), 2009. Available from the ISO web site, Aide-Mmoire: Good Policy Process for Blood Safety and Availability. Geneva, WHO, 20084.6Balanced decision-makingThere is a public expectation that blood services not only respond to established risks to blood safety butalso anticipate potential or emerging risks and act accordingly. Under the precautionary principle, wherethere is reason to believe that a potential threat to public health may occur, preventative action should beundertaken and not delayed until definitive evidence is available.Balanced decision-making encompasses both evidence-based and precautionary approaches to guideinvestment and safety decisions. This is supported by engagement with blood sector decision-makers,regulators and the community to ascertain blood-related risks and inform decisions on investmenttowards safety, taking into account all relevant scientific, financial and social considerations and ensuringthat a balance is maintained between safety and cost. Increased blood safety should be weighed upagainst any potential costs, for example a decrease in the availability of blood or blood products.Resources GAP Self-assessments Level A, B and C. GAP, current versions Aide-Mmoire: Good Policy Process for Blood Safety and Availability. Geneva, WHO, 2008255.Building a sustainable donor baseThe capacity of a blood programme to provide sufficient blood and blood products is ultimatelydetermined by the availability and commitment of healthy, regular VNRBD donors and the appropriateuse of blood and blood products by the clinical community. In building a sustainable donor base, bloodservices need to establish a positive, long-term relationship with donors that recognizes theircommitment, promotes good donor health, fosters repeat donation and encourages referrals ofcolleagues, family and friends.5.1Voluntary, non-remunerated blood collectionVoluntary, non-remunerated donors who regularly give blood are the foundation of a safe and adequateblood supply. Blood collection with well-selected voluntary donors from low-risk populations provides thefirst line of defense in minimizing the risk of transfusion-transmitted infection. 2827FThe International Federation shares the belief of WHO that it is morally unacceptable for health care tobe based on the purchase of body parts, including blood. Blood services have an obligation to safeguardthe health of donors and no coercion should be brought to bear upon an individual to donate. 29 Peoplewho give blood for monetary reward or in response to pressure from others may conceal information thatwould otherwise cause them to be deferred, either temporarily or permanently. For people in thesecircumstances, donation may not only be potentially harmful to a recipient, it may also have negativehealth consequences for the donors themselves.28FA system of voluntary, non-remunerated blood donation can reduce the risk of patient exposure tocontaminated blood and blood products. Non-paid blood donors invariably have a lower prevalence oftransfusion-transmissible infection than paid donors because they have no reason to withhold anyinformation about their health status that may make them unacceptable as donors.The International Federation is working in partnership with WHO to promote a global framework foraction in achieving VNRBD blood programmes internationally. 30 The global framework outlinesstrategies for progressing towards this goal in each of the areas illustrated in the figure below.29FGoal AGoal BCreate an enablingenvironment for100% VNRBDFoster a culture ofvoluntary donationGoal CGoal DBuild and maintain asafe, sustainablevoluntary donor baseProvide quality donorservice and care28Screening Donated Blood for Transfusion-Transmissible Infections. Geneva. WHO, 2009, p. 6.29Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, p. 14.30Ibid.265.2Attracting and retaining donorsTo provide for even the most basic blood supply requirements a country needs at least 1 per cent of thepopulation to donate, with requirements in most countries far exceeding this. 31 WHO asserts that regulardonation by suitable donors requires effective donor recruitment, call-up and retention strategies. This issupported by national donor selection and deferral criteria that factor in the maintenance of donor health,and blood collection targets informed by clinical demand. 3230F31FBlood services are encouraged to appoint an officer responsible for the national blood donor programmeto lead a group trained in relevant aspects of donor education, motivation, recruitment and retention. Aregister of VNBRD donors should be established and efforts made to identify and attract donorpopulations with low risk of transfusion-transmitted infection. It is also appropriate to monitor transfusiontransmitted infection in the donor population. 3332FThe IFRC toolkit Making a differenceRecruiting voluntary, non-remunerated blood donors presentspractical international examples to inform all aspects of blood donor recruitment. The toolkit coversplanning and implementation of education and social marketing programmes, recruiting and retainingtarget groups, engaging young people, approaches to quality service provision, and national and globalpartnerships in support of donor recruitment.Resources Making a differenceRecruiting voluntary, non-remunerated blood donors. Toolkit, Geneva, IFRC,2008 Towards 100 per cent voluntary blood donation: A global framework for action. Geneva,WHO/IFRC, 2010 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005 Aide-Mmoire: Blood Safety. Geneva, WHO, 20025.3Long-term donor commitmentRepeat donors are generally safer than new donors because they are better informed about theimportance of low-risk behaviour and understand the need for self-deferral should their donationpotentially be harmful to a recipient. Testing for transfusion transmissible infections like HIV, HCV andHBV of repeat donors at each donation additionally decreases the risk for recipients of bloodcomponents. It is also more cost-effective to retain existing or former donors than to recruit first-timedonors. The retention of existing donors is therefore crucial to achieving an adequate, safe andsustainable blood supply.Quality management starts with blood donor recruitment and donor care. This includes valuing andcaring for donors and considering how their needs can better be met. Opening times and locations ofdonor centres and mobile sites should be convenient for donors while ensuring that adequate staffing isavailable. Surveys of donors can provide feedback on convenience and customer service. Bloodservices should also have a mechanism to receive and address customer complaints.A customer service ethos should be reflected in: the mission statement of the blood service job descriptions of every employee31Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010, p. 10.32Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005Aide-Mmoire: Blood Safety. Geneva, WHO, 20023327an effective quality system, including standard operating procedures for each processstanding agenda items for staff meetingssystematic monitoring and evaluationsacknowledgement and rewards for staff that provide the best customer servicecommunication with the publicThe higher the quality of interaction between a blood service and its donors, the more likely it is tosucceed. Expectations of customer service need to be clearly communicated to staff and volunteers.Staff motivation is a primary factor in the provision of excellent service to donors. A good workingenvironment, job security, opportunities for promotion, regular training and appropriate remuneration allcontribute to job satisfaction, which will support positive attitudes towards customer service.5.4Donor health and counsellingBlood services should have in place a counselling and support system for their donors. Counselling ofdonors includes the provision of information before an individual registers to donate, a donor interviewbefore donation, making available blood collection and testing information during blood donation, andproviding post-donation information, counselling and referral when appropriate. 3433FCounselling is particularly important when a donor is found to be ineligible to donate because of atemporary deferral, as this can affect a donors morale and potentially discourage future donation.Particular care must be taken in post-donation counselling of donors whose screening tests areconfirmed positive for a transfusion-transmitted infection or where they have been implicated in atransfusion reaction. Temporary and permanently deferred donors require professional and sympatheticattention from an appropriately trained staff member. The health needs of a deferred donor should beaddressed through referral to a medical practitioner or a counselling service.Integral to the trust relationship between blood services and donors is an understanding that the resultsof blood tests and any information they divulge will be regarded as strictly confidential. Donor interviewsshould be conducted in an environment in which the conversation cannot be overheard. Donor recordsneed to be kept secure. This confidentiality is critical so that donors are truthful about their health statusor recent behaviours that might contribute to an increased risk to blood safety, and so deferred donorsare not subjected to victimization from their community.Minimum checklist for blood donor counselling: 3534F Provide counselling to individuals who are temporarily or permanently deferred from blood donationunder national donor selection criteria. Provide oral or simple written pre-donation information that educates donors about donor selection,testing, deferral/referral and self-deferral. Give as a first step with the medical questionnaire.o Give donors that have medical conditions information on healthy lifestyles and/or encouragethem to see their doctors.o Ensure donors are given a forward appointment at the end of the deferral period to motivate theirreturn. Provide pre-donation counselling just before blood donation. Blood service staff should conduct aconfidential interview with the donor to ensure they have and understand the pre-donationinformation, go over the medical questionnaire, allow the donor to ask questions and secure theirinformed consent to donate. Measure blood donors blood pressure and haemoglobin.3435Implementation Guidelines on Donor Counselling. Geneva, WHO-CDC-IFRC, 2012Ibid.28o Advise donors deferred for low haemoglobin how to improve their haemoglobin levels.o Refer donors deferred for anaemia for medical treatment and review their donation frequency.o Encourage donors that have been permanently deferred to advocate VNRBD to others. Provide the donor with information on the type of screening tests conducted during the blooddonation and the fate of components should any of the tests show abnormal results. Offer post-donation counselling to all donors that return positive results. Counselling should:o be handled tactfully, with understanding and empathyo be conducted as soon as results are availableo be conducted one-on-one by a trained and knowledgeable staff membero be held in privacy and the donor assured that his or her information will be kept confidentialo discuss the test results and the implications for the donors healtho be conducted at a reasonable and understandable pace and offer the donor the opportunity toask questions and clarify doubts and concernso explore risk behaviour and reinforce cessation/prevention of unsafe behaviour refer the donor toan appropriate medical specialist for further management, care and treatmento advise the donor to inform contacts that might be at risk of infection so they can be tested andtreatedo be used to identify any weaknesses in the pre-donation screening process i.e. the donorquestionnaire and interviewResources Implementation Guidelines on Donor Counselling. Geneva, WHO-CDC-IFRC, 2012 Screening Donated Blood for Transfusion-Transmissible Infections. Geneva, WHO, 2009 (Section6.3)296.Blood SafetyThis section discusses the principles and requirements for screening of donated blood to ensure thesafety of the blood supply. Transfusion of an incompatible blood product or a blood product carryingtransfusion-transmissible infections (TTIs) has the potential for significant harm to the recipient, and alsoprovides significant reputational and financial risk to the National Society providing the blood service.National Societies should implement rigorous donor and donation screening strategies into bloodprogrammes to minimize these risks.A primary aim of blood safety screening is to safeguard recipients of blood and blood components fromthe risk of TTI. Effective blood safety screening strategies target the identification and exclusion of riskfrom the blood supply through screening of both the donor and the donation. Blood safety screeningbegins with the recruitment of voluntary, non-remunerated blood donors from low risk populations, andcontinues with the pre-donation assessment of prospective donors against established selection criteria.Provision for the voluntary and confidential self exclusion of blood donors either at the time ofassessment or post donation is an important safeguard to exclude donations with a previously undisclosed risk factor. Finally donated blood is laboratory tested for markers of transfusion-transmissibleinfections prior to release.Blood Safety strategies should also target the processes and tests that safeguard recipients from the riskof transfusion with incompatible blood. Appropriate strategies include testing of all blood donations forspecified blood groups and screening for the presence of antibodies, prior to their release. Furtherlaboratory testing with the intended recipient is conducted pre-transfusion to confirm the appropriatenessof the selected donor unit for transfusion, and exclude incompatibility between the intended recipient anddonor blood.6.1Strategy developmentTo ensure the provision of safe blood to the community, an overall blood safety screening strategy tomanage blood safety and specifically reduce the risk of TTIs must be developed and implemented. Thestrategy should: Be nationally consistent and described in national policy and regulations Reflect international good practice (WHO, Council of Europe, AABB etc) and take into accountlocal variables Ensure the ethical assessment and management of blood donors including appropriate donorcounseling (in accordance with WHO recommendations) Identify the mandatory screening requirements for blood donations and any additional or selectivescreening requirements. Prescribe the universal screening of all donations for TTIs. Be based on appropriate risk assessment and analysis. The risk assessment must consider thegeographic epidemiology, incidence and prevalence of blood borne infection in the country and theresidual risk estimates for the local donor population. Be reviewed periodically. Changes in the epidemiology of current TTIs and the potential foremergence of new TTIs may require the strategy to be updated to ensure its ongoing effectivenessand appropriateness. Clearly define the responsibilities for pre-transfusion compatibility testing (hospital or bloodservice).30Resources Screening Donated Blood for Transfusion-Transmissible Infections. Geneva WHO, 2009 Aide-Mmoire: Blood Safety. Geneva, WHO, 2002 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 20056.2Programme implementationThe effectiveness of the screening strategy depends upon the consistent implementation of all aspectsof the strategy into blood programmes at the local level. During the implementation process NationalSocieties must ensure that:All prospective donors, including repeat donors, complete a pre-donation assessment100% of blood donations are screened and only those found negative for TTIs are releasedblood screening programmes are operated within the context of a well supported and wellmanaged quality systemthe screening programme incorporates all blood screening requirements specified in countryspecific regulations/standards (where these exist) or other internationally recognized regulations/standards, and must also address the minimum screening requirements outlined in 6.2.1.where pre-transfusion compatibility testing occurs outside of the National Society, actively promotethe use of relevant testing standards to ensure the blood safety pre-transfusion testing isconducted appropriately.ResourcesThe resources listed below apply to all the remaining sections of this chapter (6.2.1-6.2.7). Additionalresources are listed at the end of each section, where applicable. Screening Donated Blood for Transfusion-Transmissible Infections. Geneva, WHO, 2009 Guide to the Preparation, Use and Quality Assurance of Blood Components. European Directoratefor the Quality of Medicine (EDQM), Council of Europe, current edition. Standards for Blood Banks and Transfusion Services. AABB, current edition Australian Code of Good Manufacturing Practice for Human Blood and Tissues. Canberra,Therapeutic Goods Administration, 2000 Aide-Mmoire: Blood Safety. Geneva, WHO, 2002 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005 Aide-Mmoire: Quality Systems for Blood Safety. Geneva, WHO, 20026.2.1 Minimum screening requirementsa.) Pre-donation screening Donor AssessmentAll prospective blood donors must undergo a pre-donation assessment including completion of a donorquestionnaire, confidential interview and medical assessment against established donor selectioncriteria. If not already in place, national standardised selection and deferral criteria should be developedthat reflect international best practice (e.g. Council of Europe, AABB guidelines) as well as national andlocal epidemiological data on infectious diseases, prevalent risk behaviours and other local variables 36.35FThe donor questionnaire must be designed to obtain the donors medical and travel history, and anybehaviours that may result in increased risk to blood safety. The donor selection criteria must bedesigned specifically to identify and manage donors with risk factors that could indicate infection with atransfusion transmissible agent. Donors unable to fulfill the donor selection criteria must be excludedfrom blood donation via permanent or temporary deferral and appropriately counselled.36Towards 100 per cent voluntary blood donation: A global framework for action. Geneva, WHO/IFRC, 2010; P10231b.) Laboratory screening of blood donationsTesting for markers of transfusion-transmissible infections:The blood screening programme must ensure that 100% of blood donations are screened by appropriatelaboratory screening test systems for at least one marker for each of the following TTIs: HIVHIV-1 and HIV-2 Antibody or combination antigen-antibody assay (test) HCVHCV antibody or combination HCV Antigen-antibody assay HBVHepatitis B surface antigen (HBsAg) Syphilis Screening for specific antibodies to tremonema pallidumTesting for blood group and antibody screeningEvery blood donation must be typed for ABO and Rh(D) blood groups.All first time donors must be tested for clinically significant irregular red cell antibodies.The ABO and Rh(D) typing result on each donation must be verified with the historicallydetermined blood type for repeat donors. For first time donors, the ABO and Rh(D) typing must bebased on two independent ABO and Rh(D) tests.Pre-transfusion compatibility testing with intended recipient (this testing may occur outside theblood service in hospital transfusion laboratories)ABO and Rh(D) typing of both the donation and recipient red cells.Recipient serum or plasma tested for irregular antibodies.Compatibility testing of donation red cells and recipient plasma for all cases with irregular red cellantibodies.6.2.2 Additional screening test requirementsAll National Society blood services should adhere to the minimum screening requirements listed insection 6.2.1 however additional screening tests may also be applied depending on local risk profilesand blood safety management strategies (or donor selection guidelines). Consideration should be givento extending the screening programme beyond the minimum requirements for TTIs based on the localincidence and prevalence of blood borne disease in the country and the associated risk of theseinfections to the blood supply.In some countries, additional screening for Trypanosoma cruzii [Chagas disease], West Nile virus,HTLVI/II and malaria may be considered. For example, in malaria endemic areas, it would beappropriate to consider the implementation of malaria-specific donor selection and deferral guidelinesaimed at identifying donors at least risk of malaria infection, in addition to the implementation oflaboratory screening of donations for parasitaemia.The practice of additional pre-donation testing of prospective blood donors for TTIs should be consideredcarefully as pre-donation testing is generally not cost-effective (except in some countries where theprevalence of TTIs is extremely high), and the associated inconvenience to the donor and increased riskof stigmatization may undermine the development of a base of regular VNRBD donors, all of which canadversely affect the sustainability of the blood programme 37. Post donation screening (as per theminimum screening requirements) is essential to allow release labeling of the final product.36F37Screening donated blood for transfusion transmissible infections. Geneva, WHO, 2009, section 5.8326.2.3 Testing algorithmsNational testing algorithms should be developed to describe the specific process of testing and resultmanagement for each individual TTI. These algorithms ensure consistency in blood screening and resultinterpretation by describing:the precise sequence of testing (i.e. initial screening, repeat testing, and any additionalsupplemental or confirmatory testing) the resulting component fate depending on the test result outcomeThey should also describe actions to be undertaken regarding donor management (i.e. donor deferral,notification, counseling and, where applicable re-instatement testing), again to ensure consistency ofapplication.6.2.4 Test systemsThere are a number of considerations that should be taken into account when selecting a test system forblood screening including effectiveness, cost, availability and ease of use. Assays selected must bedesigned specifically for blood donor screening, and must have both high sensitivity and specificity.Screening assays must be adequately validated prior to use to ensure that the test system consistentlyperforms as intended in the local environment where it will be used, and systems must be used inaccordance with the manufacturers instructions.The use of rapid/simple assays is not recommended for large scale blood screening as they aredesigned for the immediate and rapid testing of small numbers of samples, mainly for diagnosticpurposes, and in general have inferior sensitivity compared to assays optimised for blood screening.Apart from the technical assay specifications (including rates of biological false positives and period ofdetection), other factors such as availability of ongoing supply of associated test kits/reagents, as well ascomplexity and the level of operator expertise required to use the system should also be considered.Regardless of the type of screening test system selected, having an adequate number of suitably trainedoperators with the appropriate level of technical expertise to perform the required testing and resultinterpretation in accordance with the national testing algorithms and procedural instructions is essential.6.2.5 Quality systemThe blood screening programme must be supported by, and operated within a well managed qualitysystem. Quality system oversight of the screening programme provides assurance that the bloodscreening processes are implemented as intended and are regularly monitored for their effectiveness.Quality assurance in blood screening processes should include:the implementation of good laboratory practice,the appropriate use of internal quality control processes in addition to the use of external orreference controls for the purpose of monitoring testing performance (eg from national referencelaboratories),the participation in independent quality assurance panels.Quality systems are discussed in further detail in section 6.336.2.6 Result, donor and product managementOnly blood donations that have been screened and found negative for TTIs are suitable for release forsupply and ultimately transfusion. The blood service must implement systems of quarantine andsegregation to ensure that components/donations cannot be released until the full complement ofscreening tests have confirmed that the unit is negative for known TTIs and the required testing for bloodgrouping and antibody screening is complete.Blood donations found to be reactive or indeterminate as a result of the screening test should beconsidered to be infectious and immediately quarantined, to prevent accidental release. Quarantinedblood donations must be easily identifiable, be physically segregated from the blood inventory, andshould wherever possible be safely discarded without delay. Disposal of quarantined units must be inaccordance with national regulations for bio-hazardous waste and should reflect the WHOrecommendations on healthcare waste management 38.37FStaff should be safeguarded from risk from handling potentially infectious blood through theestablishment of appropriate training in universal/standard precautions and the implementation of GoodLaboratory Practices.Screening test results must remain confidential and the blood service should have systems in place toensure that access to this information is highly restricted. Only nominated individuals within the bloodservice should be permitted access to the donor screening records.Processes for ethical donor management should be established including donor confirmatory testing andcounseling and, where appropriate, processes for undertaking lookback (i.e. tracing/testing recipients ofblood components from donors with TTI positive results).Additional resources Safe management of wastes from healthcare activities. Geneva, WHO, 1999 Aide-Memoire: Safe health-care waste management. Geneva, WHO, 20006.2.7 Emergency provision of bloodThe blood screening strategy should include provision for the emergency release of blood under reducedscreening arrangements in response to specific defined emergency conditions. The types of emergencyconditions should be agreed in consultation with relevant regulatory authorities, governments andstakeholders, and be based on appropriate risk assessment where failure to provide blood would resultin greater adverse health outcomes than the risk of issuing partially, or in extreme circumstances, whollyunscreened blood. In such circumstances, the use of rapid test systems and individual labelingspecifying the limitations of testing may be appropriate. Blood samples of any units issued under theemergency provisions must be tested as soon as possible by appropriate blood screening tests, and theresults communicated to the recipients treating physician.38Safe management of wastes from healthcare activities. Geneva, WHO, 1999347.Quality managementNational Societies engaged in the provision of blood services should have a quality managementframework in place which ensures that the blood and blood components produced are fit and safe forclinical use.An effective quality management framework ensures that a blood service produces blood and bloodcomponents that are safe and clinically effective in a way that does not cause harm to patients, donorsor staff. The framework should meet regulatory and legal requirements and allow opportunities forimprovement in quality and safety to be identified.There are three essential aspects that must be considered by a blood service when implementing aquality management framework:the quality systemgood manufacturing practicestandards7.1The quality systemWHO recommends that a quality system should cover all aspects of blood service activities and ensuretraceability, from donor recruitment through to the transfusion of blood and blood components topatients, and should take into account the structure, needs and capabilities of the blood service. 39 Itshould be guided by a quality policy (preferably national) and operate under the direction of a nationalmanager.38FAn effective system should ensure that policies and procedures are in place to define and control allactivities that have the potential to affect the quality of blood components and the safety of donors, staffand patients. For each activity, procedures should be in place covering:establishment of specificationsmanagement of resourcesmonitoring and analysis of activities against specifications to confirm quality and identifyimprovementsidentifying and resolving situations where the required standards are not metmanagement responsibility for reviewing the effectiveness of the quality system and drivingcontinuous improvementThe quality policy and procedures should form the basis of a manual which sets out the system structureand clear accountability. The manual should be read and understood by all staff.There are a number of resources that are available to guide National Societies in the implementation of aquality system, including the International Organization for Standardizations ISO 9001 Standard which isgeneric to all industries. The AABB, the Council of Europe, and the Australian Therapeutic GoodsAdministration (TGA) have regulatory frameworks for blood services. It is important that a NationalSociety, if it does not have local regulatory requirements in place or they are not up to internationalstandards, selects and adopts one of these international standards for its blood service.39Aide-Mmoire: Quality Systems for Blood Safety. Geneva, WHO, 200235Resources Aide-Mmoire: Quality Systems for Blood Safety., Geneva, WHO, July 2002 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005 ISO 9001 Quality Management Systems Requirements. ISO, 2008. Available from the ISO website, Guide to the Preparation, Use and Quality Assurance of Blood Components. European Directoratefor the Quality of Medicine (EDQM), Council of Europe, current edition. Standards for Blood Banks and Transfusion Services. AABB, current edition Australian Code of Good Manufacturing Practice for Human Blood and Tissues. Canberra,Therapeutic Goods Administration, 20007.2Good manufacturing practice (GMP)The blood service quality system should be based on good manufacturing practice (GMP). Thisincorporates all activities performed by the blood service that ensure a finished component or deliveredservice consistently meets the required specifications.GMP requirements are usually set out in Codes ofGMP that are developed by blood services in conjunction with regulatory or government authorities orare adopted from any existing documents. With respect to blood service-related activities, Codes ofGMP include a very strong emphasis on checking and controlling all steps of manufacturing and controlto show that the component or service is suitable for its intended use i.e., fit for purpose and that thiscan be repeated. Principles of GMP should apply to the whole manufacturing process, from donorselection to release of blood components for use. Key requirements include: Implementation (or introduction) of a quality system: Quality system structures and proceduresshould be in place and a quality manager who is independent of the manufacturing process shouldbe appointed. Monitoring the effectiveness of the quality system: An internal audit programme should be inplace to review existing activities regularly and a system be set up to identify, report, monitor andanalyse incidents when errors occur or the final component or service is not fit for use (i.e., acontinuous improvement system to monitor non-conforming components and services). Management review: The staff within the senior management level should regularly review theresults of activity monitoring such as internal audits, corrective actions, non-conformances andcustomer complaints or adverse event reports to identify improvement opportunities. Staff training and performance: Staff should be trained in and be able to follow the quality systemrequirements and GMP principles applicable to their role, and their work performance evaluatedregularly. This should be documented and the records should be made available to staff and foraudit or monitoring purposes. Lines of accountability should be clearly documented and understoodby all staff, including senior management. Suitable premises: Buildings should be suitable for the activities performed by the blood service.All areas, especially those used for production and manufacturing, should be constructed andorganized in a way that reduces errors and allows for easy cleaning. The working environment (e.g.,air temperature, humidity, etc.) should be appropriate for the activities and, where critical, should bemonitored and alarmed. Equipment suitable for intended use: Equipment important (or critical) to any blood serviceactivity, from recruitment through to distribution, should be fit for its purpose and validated (i.e.,tested to make sure it performs as expected) before use. A regular maintenance programme shouldbe in place, including testing of equipment performance against known standards (calibration),especially for refrigeration and bar code equipment. Document control: There should be a system for controlling the content of documents (a documentcontrol system) to ensure that instructional documents, such as standard operating procedures, arealways current. The system should make sure there is a regular review and update of the36documents and that obsolete documents are removed from use. A copy should be kept for archivingpurposes.Record management: The blood service should establish specifications for the storage, retention,archiving and disposal or destruction of any records holding information on the blood servicesmanufacturing activities, including determining which records to keep. The retention period shouldbe based on regulatory or legislative requirements.Control of materials: Materials used in the manufacturing chain should be purchased from reliablesuppliers wherever possible and assessed against specifications for their performance and qualityprior to release for use. Critical materials should be traceable to components in the event of a recalldue to defective material. Suppliers of critical materials should be audited regularly to ensurecompliance with quality requirements.Donor recruitment, selection, collection and testing: Donors should be assessed for suitabilityaccording to defined donor selection criteria that are appropriate for the local environment andensure the safety of the donor, the staff and the patient or recipient. Records should exist todemonstrate full traceability of the steps taken from donor to component, and each donation shouldbe screened for infectious agents. The donor selection criteria and testing/screening requirementsare stipulated in the standards adopted by the blood service.Quality control monitoring and process control: Procedures should be established to ensurethat all activities, processes, materials, equipment, etc. are tested or validated before beingimplemented for use. Blood components should be regularly monitored by a quality control testingprogramme and the results checked against the agreed specifications of the quality system. Anychanges to established systems should be managed via a change control process that includesany re-validation or re-testing that needs to occur before the change is implemented. The status ofmaterials, equipment and blood components should be clearly demonstrated by status labelling orphysical location where status could mean fit for use, in quarantine, not tested, failed test results,under-validation, etc. Where possible, physical segregation is best and any non-conformingmaterial or blood components that have not been assessed as fit for use should be securelysegregated. There should be documented procedures for the release of blood components by anauthorized person where the component has been assessed as fit for use and rapid recall ofreleased components if required.Storage and Transport: Materials and blood components should be stored and transported inequipment or facilities that maintain the required storage conditions (temperature, etc.). Thereshould be clear differentiation between in process/unfinished/quarantined/non-conformingcomponents and finished fit for use components. Transport containers should be validated for thecomponent type, the temperature at which they are to be transported, and the distance or time oftransport. Where possible, the transport should also be monitored, using a data logger.Computer systems: Computer systems, where used in the blood service operations, should bevalidated to demonstrate that they perform as required. Strict data control should be applied tocomputer records.Contracted suppliers: Where services are sub-contracted, there is a responsibility to ensure thatthe sub-contractor follows all the relevant standards that apply to the blood service and providesservices as detailed in a contract.The World Health Organization has established GMP guidelines and provides training workshops andseminars on the assessment of compliance with GMP at manufacturing sites, details of which can beprovided by local or regional WHO offices.37Resources: As per Section 7.1, plus: WHO Guide to Good Manufacturing Practice (GMP) Requirements. Geneva, WHO, 1997 Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials,Volume 2, Good Manufacturing Practices and Inspection. Geneva, WHO, 2007 Blood Cold Chain: Selection and Procurement of Equipment and Accessories. Geneva, WHO,2002 Manual on the Management, Maintenance and Use of Blood Cold Chain Equipment. Geneva,WHO, 2005 Safe Blood and Blood Products Distance Learning Material. Geneva, WHO, 2002 Principles of Good Manufacturing Practice in Respect of Medicinal Products for Human Use andInvestigational Medicinal Products for Human Use. European Commission Directive 2003/94/EC7.3StandardsWhile the adoption of GMP can provide confidence that a blood services blood components will meetspecifications, Codes of GMP generally do not set out the required specifications for those components.These are contained in Standards.Standards detail the minimum acceptable specifications or criteria for the most important (or critical)steps in the blood services activities, and for the services and finished blood components provided bythe blood service. Standards can either be used as guidelines for practice, or set as minimum regulatoryrequirements that must be met depending on the regulatory and legislative requirements of the country.Standards are often seen as the minimum requirement and a blood service may chose to exceed themin practice.Appropriate Standards for blood and blood components should be selected by the National Society, theregulator or government authority, or both in consultation, and may include the selection of an existingIndustry Standard such as the AABB Standards for Blood Banks and Transfusion Services or Council ofEurope Guide to the preparation, use and quality assurance of blood components, or the development ofa set of locally specific Standards.Resources: As per Section 6.2, plus:Screening Donated Blood for Transfusion-Transmissible Infections. Geneva, WHO, 20097.4AuditingAn internal audit programme should be established to review periodically the operation and effectivenessof the quality system. The audit programme should ensure that all activities and manufacturing steps arecovered, and that the level of compliance with internal and regulatory requirements is assessed. Internalaudits also provide opportunities to identify areas that need improvement. External audits may also beconducted by a regulatory agency or a third party.There should be a procedure that describes the frequency and the requirements for conducting internalaudits, including time frames for reporting and responding to audits. The scope of each audit should beclearly defined and the audit conducted by a trained auditor who is independent of the activity beingaudited. Corrective action taken in response to audit outcomes should be reviewed and verified beforeclosing out the audit.Audit outcomes should be regularly reviewed as part of management review.Resources: ISO 19011: Guidelines for quality and/or environmental management systems auditing. ISO, 2002.Available from the ISO web site, www.iso.org388.PartnershipsFostering global partnerships and collaboration is a United Nations Millennium Development Goal.There are limits to the capacity of individual organizations to generate a culture of voluntary donation andbuild sustainable blood systems. Achieving a safe and sustainable blood system requires thecooperation and assistance of government, as well as communication and engagement with other bloodservices and National Societies.8.1GovernmentAs blood transfusion services are an essential part of modern health care provision, governments have astrong interest in maintaining a healthy, sustainable, self-sufficient national blood programme. WHOrecognizes that it is ultimately the responsibility of the Ministries of Health to ensure a safe and sufficientsupply of blood and blood products and their safe and rational use. Even if this responsibility has beendelegated to a nongovernmental blood service organization, governments should provide effectiveleadership and governance and sufficient resources to establish and maintain a sustainable nationalblood system 40. This should include:39F providing adequate financial resources with which to develop and maintain a viable bloodprogramme formalising government support and commitment to the blood programme enabling the blood transfusion service to operate with a discrete budget, separate managementand appropriately trained staff establishing appropriate support systems and structures for the national blood system, including anational blood policy and strategic plan which emphasizes the principle of VNRBD 4140F developing a legislative and regulatory framework based upon international standards toencourage and enforce appropriate blood service standards and behaviour (if not in place) supporting national clinical guidelines for blood transfusion creating a broadly representative national blood commission 42 or national blood authority withexecutive functions 4341F42FNational Society blood services and voluntary blood donor recruitment activities should, therefore, befully integrated into the governments health plans. Any roles and responsibilities delegated to a NationalSociety by a government should be defined in a legal agreement 44 such as a service agreement orMemorandum of Understanding that also defines the source of financial support and the cost-recoverysystem. An example framework for a Memorandum of Understanding is included as Appendix 3. Anyagreement for blood service provision should also include government indemnity or protection for theNational Societys blood service activities acknowledging that there are risks associated with undertakinga blood programme.43FNational Societies and their blood services have a responsibility to practice humanitarian diplomacy 45 toensure that the government appreciates the role that safe blood and a sufficient supply of such bloodand blood products play in national health security, and the benefits to public health that will come from44F40Aide-Mmoire: Developing a National Blood System. Geneva, WHO, 2011Processes for effective blood policy and policy considerations are outlined in Aide-Mmoire: Good Policy Process forBlood Safety and Availability. Geneva, WHO, 200842Aide-Mmoire: Blood Safety. Geneva, WHO, 200243Aide-Mmoire: Developing a National Blood System. Geneva, WHO, 201144Ibid45IFRC Humanitarian Diplomacy Policy, adopted by the 19th session of the IFRC Governing Board in Paris, May 2009.4139appropriately funding and supporting the national blood programme. National Society communicationsand interactions with government should stress the need for a national policy of VNRBD, action tominimize risk in blood services and the importance of adequately funding blood safety measures, theneed for balancing blood safety and accessibility, and the importance of donor care and donor andrecipient safety. Governments should also be reminded of their responsibilities in maintaining a nationalblood system that is fully integrated into the health care system (as described by WHO in Aide-Mmoirefor Ministries of Health, Developing a National Blood System 46).45 FBecause of their strong ties to the community and their extensive volunteer networks, some NationalSocieties may find that the government would like them to increase their engagement in bloodprogramme activities, particularly blood donor recruitment. Any increase in blood activities comes with anincrease in risk to the National Society, so it is recommended that any society considering a change toits level of engagement in its national blood programme first contacts the GAP and/or the InternationalFederation for advice.Resources Aide-Mmoire: Developing a National Blood System. Geneva, WHO, 2011 Aide-Mmoire: Good Policy Process for Blood Safety and Availability. Geneva, WHO, 2008 Aide-Mmoire: Blood Safety. Geneva, WHO, 2002 Blood Transfusion Safety, Information Sheet for National Health Authorities. Geneva, WHO,current version8.2Community engagementBlood services are encouraged to engage with government health, education and community agencies,the media, other voluntary and educational organizations and the business community in promotingVNRBD and community support for the national blood programme. These networks and channels ofcommunication can improve public understanding of the role of blood in health care, influence attitudesto blood donation, and convey the importance of blood safety. Government and business employers canalso support blood services by providing opportunities for their employees to donate blood and byforming corporate donor groups.Resources Towards 100 per cent voluntary blood donation: A global framework for action. Geneva,WHO/IFRC, 20108.3Blood sector networksInternational collaboration supports resilience in blood systems and the capacity of blood services toadapt in response to uncertainty and change. Collaboration assists national blood services in emergencypreparedness and pandemic planning. Sharing of best practice examples, emerging technologies andinvestments in safety supports blood services in pursuing continuous improvement. It can also informdiscussions with government on investment in new technology and appropriate safety measures.National and regional blood services recognize that there are significant benefits in engaging in bloodsector networks such as the international Alliance of Blood Operators (ABO), the European BloodAlliance (EBA), Asia-Pacific Blood Network (APBN), AABB, ISBT, the International Plasma FractionationAssociation (IPFA), the International Haemovigilance Network (IHN), the International Society ofThrombosis and Haemostasis (ISTH), and the International Federation of Blood Donor Organizations46Aide-Mmoire: Developing a National Blood System. Geneva, WHO, 201140(FIODS). Blood sector networks support performance improvement and operational efficiency throughbenchmarking, the exchange of knowledge, and the development of consistent policies, standards andprocesses across countries and regions.Benchmarking operational performance against other comparable blood services provides identificationof best practice, quality assurance and continuous improvement. Blood services affiliated with ABOparticipate in an annual Balanced Scorecard that allows for comparison of performance and practice inthe areas of donor attraction and retention, blood component demand and issue rates, clinic efficiency,collection and processing efficiency, and workforce turnover. The scorecard gives participating bloodservices a clear indication of where they are positioned relative to other (non-identified) countries in eachaspect of blood service delivery. Data from the benchmarking informs discussions among networkmembers on best practice and collaborative approaches such as sharing information.Information from the ABO and APBN Balanced Scorecards is shared among participating blood services.National Societies interested in learning more about benchmarking using a scorecard are advised tocontact the ABO or the APBN secretariats.The Global Blood Safety Network (GBSN) forum, convened by WHO, involves internationalorganizations, agencies and experts from developing and developed countries in sharing expertise insupport of global blood safety. The forum promotes information exchange, consensus on appropriateblood safety standards and practices, and fosters cooperative arrangements between institutions tosupport the safety of blood donors and recipients in all countries. Further information on the aims andoutcomes of the GBSN is available on the WHO web site.8.4Hospitals and cliniciansThe implementation of appropriate patient blood management (PBM) systems during blood storage,handling, use and administration by hospitals is important in ensuring that the quality and safety of bloodand blood components is maintained and that scarce blood resources are used to best effect withrespect to patient outcome. While National Society blood services may not have any direct involvementin the treatment of patients by blood transfusion, they do have a responsibility to patients to ensure thatblood is collected while maintaining both the quality and safety of the units, and to their blood donors toensure that donated blood is not wasted and that it is used appropriately.Blood services should have in place formal agreements for the supply of blood to hospitals that includeprovisions such as: a commitment from the hospital that it adheres to WHO recommendations on the clinicaltransfusion process and patient safety 47 and PBM 48 the appropriate levels of stock systems for ordering and supply monitoring and reporting of appropriate use and wastage and expiry monitoring and reporting of patient adverse events46F47FIt is recommended that blood services engage with transfusion medicine experts, hospital administrators,and government stakeholders (e.g., military representatives and national contingency or disastermanagement teams) to establish a national or local inventory management and supply plan. This shouldbe aimed at ensuring sufficient supplies to meet routine demands and respond to surges if additionalblood is required, for example in emergency situations (see Section 9.2), while minimizing wastage from47Aide-Mmoire: Clinical Transfusion Process and Patient Safety. Geneva, WHO, 201048Aide-Mmoire: The Clinical Use of Blood. Geneva, WHO, 200341expiry and inappropriate use. It is recommended that blood services and hospitals also establisharrangements for priority supply and transportation.Blood services should encourage hospitals to establish multidisciplinary transfusion committeesresponsible for implementing the national policy and guidelines in a local context and monitoring howblood components are being used, as described by WHO in its Clinical Use of Blood, Aide-Mmoire forNational Health Programmes (2003). Blood services should work with hospital transfusion committees indetermining current and anticipated blood supply needs, and in promoting leading transfusion practice.National Society blood services should work to educate clinicians as well as medical and nursingstudents on aspects of blood transfusion safety, the risks of blood transfusion, alternatives andprevention strategies, the importance of appropriate product use, and the benefits of voluntarily donatedblood. Level B and C National Societies could also focus on hospitals and clinicians in their advocacyefforts to change family replacement donation to 100 per cent VNRBD.Resources Aide-Mmoire: Clinical Transfusion Process and Patient Safety. Geneva, WHO, 2010 Aide-Mmoire: The Clinical Use of Blood. Geneva, WHO, 2003 Aide-Mmoire: Safe Blood Components. Geneva, WHO, 2005 WHA 63.12, Availability, safety and quality of blood products. Sixty-Third World Health Assembly,Geneva, 21 May 2010, Geneva, WHO 20108.5National SocietiesThe GAP supports cooperation between National Societies involved in blood programme deliverythrough regional meetings and the establishment of twinning or buddying relationships between bloodservices.GAP regional meetings allow National Society blood services to discuss issues arising from the GAPSelf-assessment and provide societies from similar environments the opportunity to share corporategovernance and risk management experiences, challenges and successful approaches. The GAPszonal coordinators can also hold in-depth discussions with societies seeking priority assistance with theorganization of their blood programme.Upon request the GAP and/or the International Federation can help National Societies establish twinningor buddying relationships with other National Societies that have expertise and experience in areas ofneed, and can also provide them with direct advice as to the appropriate level of engagement in theirnational blood programme (see Chapter 10).The International Federation encourages National Societies involved in donor recruitment to share theirexperiences and some zones and regions hold regular meetings for societies involved in bloodprogramme activities, including VNRBD recruitment. National Societies should contact their Federationzone office for more information.429.Sustainability9.1Adoption of new technologies and practicesBlood services benefit from shared learning with other blood services on best practice in bloodmanagement, testing, manufacturing and distribution. This includes evaluations of new technologies andequipment, and comparisons of operational approaches and performance. Information exchange canoccur through blood sector networks, visits to other blood services, attending conferences or engaging inpartnering arrangements.Equipment needs to be appropriate to the defined task and meet specified standards. In determining thesuitability of new equipment, blood services should consider factors such as performance in localconditions, operating requirements (e.g., power, water), staff training and maintenance. Coordinatingequipment purchases across a blood service can assist in standardization, provide for economies ofscale, and simplify processes for training, maintenance and support.When considering receipt of donated equipment it is important to assess how the equipment willintegrate with the existing system, whether trained operators are available, and if replacement parts andmaintenance services are obtainable.The transition to new technologies or systems should be planned to minimize disruption, with a processof monitoring, evaluation and review. Time should be allowed to ensure appropriate training of staff usingthe equipment. Blood services should also consider whether outmoded equipment that still operates tospecified standards might be of use to other National Society blood services. Equipment shouldotherwise be appropriately disposed of.9.2Contingency planning and disaster preparednessDisruption of blood services as a result of a natural disaster, pandemics, war or terrorism can potentiallyimpact upon the lives of patients in need of blood transfusion. After a disaster, demand for blood maysuddenly escalate at the same time as blood collection sites become unusable and the publics responseand willingness to donate increase. A significant issue will be managing the influx of donors. Power cutsmay cause stored blood and blood products to become unsafe as they fall outside of prescribed storagetemperatures. A crisis situation may also be caused by publicity concerning contaminated bloodproducts. Delivery of blood services entails responsibility to ensure an adequate and timely supply ofblood and blood components. A lack of preparation and contingency for adverse events could result in aloss of confidence and reputational damage to a National Society. A disaster plan is therefore essentialto manage a response, so that blood service staff and other partners are clear on what should be done,by whom, and in what order.A comprehensive plan for disaster management includes actions for mitigation, preparedness, responseand recovery. Mitigation actions might include relocating facilities to alternate sites or designing facilitiesto reduce the impact of recurring natural disasters. Preparedness addresses the risks that cannot besufficiently reduced by mitigation strategies and involves a risk analysis of potential disasters and thoseareas of operation most likely to be adversely affected. Preparatory actions should be routinely reviewedto ensure that they address these risks and, where possible, a test run or exercise included to monitorpreparedness and the accuracy of key information such as contact numbers.43Response during a disaster includes critical actions initiated by staff to protect life and property but thesafety of staff must be the primary consideration. These actions include establishing internal andexternal communication, conducting emergency evacuations, and re-establishing operations at analternate site (if required). This requires clearly defined, understood and practised processes,emergency operating procedures, and a leadership succession plan. Recovery operations focus on therestoration of critical infrastructure to re-establish important functions, such as communications, power,water, sewage and transportation. Identifying areas that may require additional mitigation actions in theevent of future disasters is also an aspect of recovery.Contingency and disaster planning involves identifying recurring natural disasters and events that areendemic to the region e.g., earthquakes and seasonal disease patterns. Information regarding manmade threats can also be provided by government agencies responsible for health, defence and utilities,or from the private sector. A National Societys blood service disaster plan should be integrated with anynational disaster plan and should detail: membership of the crisis management team with their roles and responsibilities names, roles and contact information of key contact persons plus back-up personnel internal communication management for staff and volunteers external communication management, including names and roles of official spokespersons andresponsibilities for communication with donors, the media, and other stakeholders (e.g., hospitals) information on alternative collection sites information on alternative finished product storage sites (e.g., have established agreements withhospitals to increase on-site stock should blood service storage equipment fail) information on alternative supplies of equipment and consumables information and procedures for recruitment, collection, processing, testing, storage and distributionactivity continuation in the event of a disaster names, addresses and contact details for all staff responsibilities of individual staff in relation to contingency and disaster planning arrangements for back-up storage of all donor and sponsor records arrangements for computer back-up systems, where in useThe disaster plan needs to be well practiced, so that staff know exactly what to do and can actimmediately in assuming their designated role. Disaster management responses should be rehearsed ona regular basis as part of staff training.Resources Maintaining a Safe and Adequate Blood Supply during Pandemic Influenza: Guidelines for BloodTransfusion Services. WHO, July 2011. Pandemic Influenza Planning for Blood Organizations. European Blood Alliance EmergencyPlanning Action Group, 2009 Disaster Operations Handbook: Coordinating the Nations Blood Supply during Disasters andBiological Events. AABB, 2008. Available from the AABBs web site, The John Hopkins and Red Cross Red Crescent Public health guide in emergencies. John HopkinsBloomberg School of Public Health and IFRC, 2008, second edition.449.3Environmental sustainabilitySound environmental management helps to minimize the impact of blood service operations upon theenvironment and public health. It not only supports compliance with regulatory standards but alsodemonstrates to the public and employees that their National Society is acting in an environmentallyresponsible way. Good environmental management practices can also deliver savings through lowerenergy usage, less consumption of materials, and reduced waste management and distribution costs. 4948FThe requirements and guidelines for an environmental management system are set out in the ISO 14000Standards, which complement the ISO Standards for quality management (ISO 9000). ISO 14000provides a holistic framework with which blood services can develop an environmental policy and plans.An effective management system will enable the blood service to manage hazardous waste, identify andcontrol environmental impacts, set environmental objectives and targets, plan actions to achieve these,and continually improve environmental performance.A blood services environmental approach should be conveyed in an environmental policy madeavailable to the government, suppliers, contractors and the community. This will:comply fully with all applicable environmental and hazardous waste management laws andregulations, and reflect international good practice, including WHO recommendations on healthcare waste managementseek to minimize or control (to the extent possible) environmental impacts from operationsset objectives and targets for continuous improvement in environmental performancepromote staff awareness of environmental objectives and responsibilities, and their activeinvolvementcommunicate the environmental policy and environmental requirements to contractors andsuppliers and seek to influence, as far as possible, their environmental practices 5049FResources ISO 14000, Environmental Management. ISO, 2007. Available from the ISO web site, Safe management of wastes from healthcare activities. Geneva, WHO, 1999 Aide-Memoire: Safe health-care waste management. Geneva, WHO, September 20004950See ISO web site, areas are informed by the environmental policy of the Hong Kong Red Cross blood transfusion service.4510. Transition and exit strategiesAs previously highlighted, involvement in blood service delivery (Level A) entails a high degree ofresponsibility and compliance to manage National Society exposure to blood-related risks. These riskscan be reduced through adherence to the standards outlined in this document (refer to the tables inSection 2.1). If a National Society involved in blood programmes determines that it has insufficientcapacity to manage the associated risks or if the government is prepared to take over the bloodprogramme, it could consider reducing its level of involvement in blood activities, as in the diagrambelow.A. Full Blood Service ProvisionB. Systematic, Voluntary BloodDonor RecruitmentHigher RiskC. Advocacyfor VNRBDLower RiskNational Societies that are considering either building their capacity and ability to operate their bloodservices in a safe and sustainable manner or withdrawing to a lesser involvement in blood activities areencouraged to contact the GAP or the International Federation for advice. Decisions to reduceinvolvement in blood programmes are not made lightly, and it is important to consider and mitigate theconsequences to the community of a National Societys withdrawal from blood service provision.It is important that the National Society engages key stakeholders (the government, the InternationalFederation, WHO, the GAP and others) before it initiates action to exit from its blood service. The resultof the negotiations might be that an alternative provider is identified, making it easier for the NationalSociety to withdraw strategically from its blood service activities. However, in some cases thegovernment might decide to increase resources to the National Society and, with technical support frominternational agencies such as the GAP or WHO, the blood service can improve its operations to meetthe required standards and remain the national blood programme provider.The following pages present generic guidelines for blood service National Societies contemplating atransition from Level A to a lesser degree of involvement. The guidelines are broad, so they can beadapted to local circumstances and conditions.The guidelines may also serve as a tool for engagement with government regarding the requirements foran effective and sustainable national blood programme. Blood services cannot function effectivelywithout adequate financing and appropriate infrastructure. The GAP can provide guidance to NationalSocieties when engaging with government and other stakeholders regarding the extent of theirinvolvement in blood programme activities.46Exit Strategy FrameworkThis framework and its guidelines are designed to assist National Societies that have decided that theirbest course of action is to exit from their blood service activities. It includes strategies to ensureappropriate consultation and processes are undertaken during the transition phase, when the bloodservice transfers from the National Society to another entity (as determined by the appropriategovernment body). The following phased change plan is recommended:Introductory phase:Engaging all stakeholdersFeasibility phase:Assessment and development of the exit strategyProgramme phase:Implementing the exit strategyMonitoring and evaluation phase:Follow up with reporting to all stakeholders on progressThe following guidelines are intended to assist National Societies designing an effective exit or transitionplan. It includes objectives, considerations and potential activities.Phase 1: Introductory phaseObjective: To facilitate the gradual implementation of an exit strategy by consulting key stakeholdersand identifying requirements for effective transition.Activities:Hold discussions between a) the National Society blood service and the ministry of health, b) theNational Society blood service, the ministry of health and the appropriate GAP zonal coordinator(focal point), if necessary.Share information arising from the GAP Self-assessment report.Clarify the new role of the National Society (Level B or C).Discuss options and a time frame for the exit strategy/change plan (recommended minimum oftwo years).Appoint a project team involving all stakeholders and establish its terms of reference, taking intoconsideration any additional fund-raising that might be needed to manage the implementation ofthe exit strategy.Phase 2: Feasibility phaseObjective: To develop a project/exit plan for the handover of blood service activities that ensures: Asmooth transition to the new authority, security for the blood service and its stakeholders, and themaintenance of optimal blood safety and levels of donor care.47ActivitiesPerform a detailed risk analysis of the impacts of the National Societys exit from blood servicesin the local situation (see Section 4.5).The project team (including government authorities) should develop a project/exit plan thatensures:oa clear governance regime for the handover, and for each area of blood service operationsthe following are identified: what is required to properly effect a handover who is responsible how those tasks will be done by the responsible party when those tasks will be done by the responsible partyothe following are incorporated as areas for attention (as applicable): the operational transition of products and services. May include: transfer of assets,equipment, hardware and software, personnel, knowledge exchange/training, transfer ofdatabases, provision of statement of third party contracts, and insurance information blood service functions. May include: donor management and recruitment, collections,testing, processing, inventory management and distribution, operations support,transfusion medicine, research and development, corporate support and planningothe safety of blood donors and blood recipients through the application of the fundamentalprinciples of VNRBD and equity in access to blood and blood products (see Section 3)othe integration of international standards in quality assurance and good manufacturingpractice (GMP) (see Section 6) into national regulations as recommended by WHOoblood donors are aware of and confident in the transition process, so they continue todonate bloodoa costing analysis is completed to ensure that the future blood programme operation isfinancially sustainable (see Section 4.2)oappropriate compensation is given to the National Society for the transfer of any assetsorisks are identified and managed throughout the process of transition and beyond (seeSection 4.5)osufficient resources are put towards communicating with government, key stakeholders (e.g.,media, regulators, suppliers, hospital staff and clinicians), donors and the general publicoa contingency plan is in place to manage either: lack of preparedness to exit according to the initial time frame a local disaster which may result in the necessity to re-establish the National Society bloodservice temporarily to deal with the crisisAgree on a Memorandum of Understanding that clarifies each partys role and responsibilitiessubsequent to the handover (see Appendix 3).A GAP review 51 of the project/exit plan proposal with recommendations to ensure that anypossible risk management issues for IFRC have been considered (e.g., reputational risk).5150FSubject to the availability of resources48Phase 3: Programme phaseObjective: To implement the project/exit plan within the agreed time frame while maintaining a servicethat meets all the needs of both the donor and patient populations.Activities:Implementation of the project/exit plan and Memorandum of Understanding with scaling down ofNational Society involvement during the transition, ensuring:othe systematic transfer of blood service functions and operational products and servicesothe establishment of national regulations for the blood programme based upon internationalstandards, if they are not in place alreadyoblood safety is maintained through the application of quality assurance and GMP systems(as per WHO recommendations)oprogress is being made towards 100 per cent VNRBDoongoing collaboration with partners, patient organizations, professional societies and otherstakeholders to ensure supply plans are set up to meet the nations need for bloodo the supply of blood and blood products is on a non-for-profit basisochanges and updates are communicated to stakeholders through key spokespersonsoa system and process is established to manage the ongoing requirement for donor lookbackand counselling once the exit is completeIf withdrawing to Level B or C, in parallel, the National Society should consider:oappointing a team with a focus on donor recruitment or community education and settingup training programmes based on: the IFRC toolkit Making a differenceRecruiting voluntary, non-remunerated blood donors the workshop materials compiled jointly by WHO and IFRC, entitled DONOR Towards 100 per cent voluntary blood donation: A global framework for action the requirements basic checklists found in this manual in Section 2.1 (pages 12-14)oestablishing a sub-committee to address legal responsibilities to blood donors and bloodrecipients in order to comply with World Health Assembly recommendation 28.72, which callsfor member states to enact effective legislation governing the operations of blood services andto take any other necessary action to protect and promote the health of blood donors andrecipients 5251Foproviding ongoing capacity building and mentoring to the new blood service operatorLiaise with WHO to ensure requirements are being met in all areas of blood service operations andto secure access to the full Basic Operational Framework for Blood Transfusion Safety.52Subsequent WHA resolutions (WHA58.13, 2005 and WHA60.18, 2007) have called upon all member states to establishor strengthen systems for the recruitment of voluntary, non-remunerated donors and the implementation of stringentcriteria for donor selection.49Phase 4: Monitoring and Evaluation phaseObjective: To report on a regular basis on all matters of accountability to the new services donors,the funding agencies, users of blood and blood products, and the community at large.Potential activities:Report on agreed targets (e.g., blood donation, blood component production).Review the new systems impact, if any, on wider health and care priorities (maternal health,child mortality).Benchmark progress with key partners (see Section 7.3). Access to safe blood and bloodcomponents cannot be achieved without cost but an unsafe or inadequate blood supply is evenmore costly in both human and economic terms. Benchmarking with key partners can assist inquality improvements at all levels of service delivery and is a useful tool for monitoring progress ina cost-efficient way.Report back to the GAP with full case study details for the benefit of other National Societies andministries of health.Conduct a Learning Review to identify what:owas done well and would be done againowas not done well and would be improved on next timeThe review could report back to the GAP for the benefit of other National Societies and ministriesof health.50AppendicesAppendix 1: International Federations blood policyPOLICYPromoting Safe and Sustainable National Blood SystemsIntroduction:Blood safety is a critical underpinning for safe blood transfusion and health systems. People in allcountries have a right to expect that the blood and blood products supplied to them are gathered,produced and provided in a safe and sustainable way that supports their communities and their healthsystems.The International Federation recognises that health security is a fundamental and indispensableprerequisite to global, national and individual development 53 and it supports the advancement of globalhealth security by promoting voluntary non-remunerated blood donation (VNRBD), and advocating forthe safe provision of blood and products 54.While the World Health Organisation (WHO) recognises that it is the responsibility of governments toensure a safe and adequate supply of blood 55, Red Cross/Red Crescent Societies in many countries, asauxiliaries to their governments, play an important role in promoting safe and sustainable bloodprogrammes. National Society activities range from the provision of the national blood service, tosystematic recruitment of voluntary blood donors, to promotion of blood donation and advocacy forVNRBD, for example annual participation in World Blood Donor Day.52F53F54FScope of policyThis policy sets out the International Federation and member National Societies position on advancinghealth security through safe and sustainable blood systems.Importance of blood servicesSustainable and quality blood services play a critical role in the health of any society, and in terms ofdisaster preparedness the existence of a quality blood service is critical. While the availability of bloodcould be a major concern in the event of a disaster, the safety is also always of paramount concern toany emergency/disaster response. Blood is used for a multitude of life saving purposes including:assisting patients undergoing surgery; treating diseases including anaemia and malaria; caring forpatients on chemotherapy; supporting women with complications during childbirth (postpartumhaemorrhage) and patients on Antiretroviral (ARV) treatments. The unavailability of safe blood can leadto serious health consequences such as death from haemorrhage or the transmission of life threateninginfections HIV/AIDS, hepatitis B and C, syphilis and other infections.There should be preparedness plans to provide rapid response to emergency situations and for postdisaster reconstruction of blood transfusion services.The availability of safe blood contributes directly to three of the United Nations MillenniumDevelopment Goals:4. the reduction of child mortality;5. the improvement of maternal health; and6. combating HIV/AIDS, malaria and other diseases.53Health Policy adopted at the 15 session of the General Assembly of the IFRC, Seoul, November 2005.Strategy 2020, p 15, IFRC55Blood Safety, Aide-Memoire for National Blood programme, WHO, 20025451It is recognised that a sufficient supply of safe blood and blood components based on voluntarynonremunerated blood donation (VNRBD), and the security of that supply, are important national goalsto prevent blood shortages and meet the transfusion needs of the patient population 56.VNRBD is a critical component in ensuring a safe and sustainable blood supply that meets the needs ofall recipients. VNRBD was enshrined as a fundamental principle of blood service when the 1975 WorldHealth Assembly (WHA) resolution called for member states to promote the development of nationalblood services based upon voluntary non-remunerated donation of blood 57.Patients must have equitable access to safe transfusion on the basis of their clinical needs, and thesafety of the donor and patient must be considered paramount. The International Federation and itsmember National Societies promote equity, access, quality and safety of blood and blood componentsso that citizens can have confidence in the security and integrity of their blood system.While the benefits of blood transfusion are widely acknowledged, there are also some risks inherent inthe blood transfusion process, including accidental exposure to transfusion transmitted infections suchas HIV. To secure the safety of the blood supply, blood services must ensure that appropriate donorscreening and quality management processes are in place, and that they remain vigilant against newthreats to the blood supply.55F56FCharacteristics of well-functioning RC/RC blood programmesWhile it is the responsibility of a countrys government to ensure an adequate and safe blood supply,many National Societies play an important role in supporting their government to achieve that objective.National Societies may be involved in blood-related activities at three levels:A: Full blood services (collecting, testing, processing, distribution)B: Systematic recruitment of blood donors to a blood serviceC: Promotion and advocacy of blood donationThese levels are reflected in the figure below.Figure 1: Red Cross/Red Crescent role in blood activitiesEach level of National Society involvement in blood services is characterised by different requirementsregarding capacity and risk management. While Level A requires the most resources and has thehighest level of risk, a well run National Society blood service can contribute enormously to the healthand well-being of the community in which it is based. However, all National Societies can contribute5657WHA resolution 63.12.WHA resolution 28.72 This principle was reasserted again by the WHA in 2005 (WHA58.13) and 2010 (WHA28.72)52towards the development of a safe and sustainable blood system through the advocacy and promotion ofVNRBD.For a full description of the characteristics of each level, please refer to the Global Advisory Panel onCorporate Governance and Risk Management of Blood Services in Red Cross and Red CrescentSocieties (GAP) blood manual Development of Safe and Sustainable Blood Programmes. A summaryof the main characteristics of a well-functioning level A or B blood programme is provided below.For both Levels A and B: Systems are in place to ensure that the health and well-being of the donor and recipient areprotected There is national blood policy in place which reflects WHO recommendations, including VNRBD, andit is supported by a legislative framework The blood programme is integrated as part of a national health policy and plan The allocation of roles and responsibilities between the Government , the blood programme, and theNational Society reflect the overall responsibility of the Government to ensure an adequate and safeblood supply and are formally documented in a service agreement Long-term and sustainable funding allows the blood programme to:o meet operational and regulatory requirements with regards to facilities, supplies, equipmentand trained staff and volunteers; ando implement appropriate donor care and risk management systems leading to high quality, safeand effective blood products. The blood programme is nationally coordinated to ensure uniformity of standards and cost efficiency Donor selection criteria are in place to identify low risk donors and counselling is provided in cases ofdeferral There is a risk management framework in place, to identify, prioritise and manage risksAt Level A: The National Society has secured government protection/indemnity and/or insurance cover for itsblood service activities, including clinical advice. The National Society should assure that adequate external assessments are conducted regularly toensure that the Blood services operate under the necessary quality assurance programme andadheres to a national regulatory framework based upon internationally recognised standards. The blood service is involved in collaborations and partnerships to ensure a safe and adequate bloodsupply and appropriate product use.At Level B: The blood service to which the National Society recruits donors operates under a quality assuranceprogramme and adheres to a national regulatory framework based upon internationally recognisedstandards. There are agreements in place whereby the roles and responsibilities of the National Societies andthe Blood Service are clearly defined.It is therefore important that National Societies consider carefully the level of blood activity which is mostappropriate for their engagement. The global burden of disease due to unsafe blood can be eliminated orsubstantially reduced through an integrated approach to blood safety, requiring, The establishment of a nationally coordinated blood service Formalization of government commitment and support. Contribute where appropriate to the Development of National blood policy and plans. Advocacy of necessary legislation/regulation for the Blood Transfusion Service . Establishment of nationwide quality systems, including guidelines, standard operating procedures,accurate records, monitoring and evaluation aligning to Government policy. Collection of blood only from vnrbd from low risk populations53Haemovigilance system for monitoring, reporting and investigating adverse events.Trained staff and continuing professional development and upgrading for latest technology as aprerequisite.Ensure efficient and good laboratory practices in screening for transfusion transmissible infections,blood grouping, compatibility testing, blood component production, storage and transportationReduction of unnecessary transfusions through effective clinical use of bloodBut a National Society needs to consider carefully all aspects of a sustainable and qualityprogramme, and if it is contemplating a commitment to undertake activities at Level A the NationalSociety:1. Should have a clear mandate from their government to do so;2. Should have the capacity to adhere to regulatory requirements and implement appropriateblood safety measures;3. is able to manage any legal liabilities, possibly by considering whether a separate legal entityis required to separate the assets of the National Society from the blood business.Independence with its own director, board of management and budget may also lead toincreased public trust and confidence, crucial to a successful national blood programme.Framework of support to RC/RC blood programmesTogether with WHO the IFRC is committed to the achievement of 100 per cent voluntary blooddonation, in keeping with our Fundamental Principles, and we have a long history of collaboration inthe area of blood safety and availability. The strength of the partnership lies in its complimentary andsynergistic approach at national as well as global level. Three key milestones have marked ourstrategic collaboration, each providing a global framework of support:(1) the designation of Blood Safety as the theme of WHOs World Health Day 7 April 2000,supported by IFRC(2) the foundation and establishment of World Blood Donor Day in 2004-5 which is nowcelebrated each year on 14 June to raise awareness of the importance of blood donationand recognize the contribution of voluntary non-remunerated blood donors in saving livesand improving health.(3) the 2009-10 release of the WHO/IFRC Global Framework for action-towards 100 per centvoluntary blood donationThe International Federations main toolkit, designed to assist key stakeholders in best practice, indonor recruitment and advocacy for 100 per cent vnrbd is the package Making aDifferencerecruiting voluntary, non-remunerated blood donors. This is a self-help manualempowering personnel in the field to motivate, recruit and retain vnrbd and to phase-out anydependence on family/replacement donors.National Societies and the International Federation have created an experts group (GAP) togenerally assist and advise National Societies on the governance and risk management issuesrelevant to blood services, as resources allow. GAPs main tool in working with National Societies isthe Self-assessment, a questionnaire that: enables National Societies to identify potential problem areas where their blood programmeactivities may be exposing them to risk; and offers strategies for improving corporate governance and risk management.54Meanwhile, as ongoing support to sister societies and in accordance with the spirit of theInternational Federation, the sharing of best practice between National Societies is encouraged inorder to maintain and expand on the competitive advantage which the International Federation andits member National Societies have in this specialized field of health care.It is clearly acknowledged and understood that each National Society is fully responsible for its ownblood activities. The support provided by either the International Federation, GAP or assistingNational Societies does not in any way dilute or transmit this responsibility.Specific Responsibilities arising out of this policy:The International Federation, GAP and National Societies engage to:support and advocate the principle of voluntary, non-remunerated blood donation (VNRBD)advocate a balanced decision-making approach to blood safety that addresses both evidence-basedconsiderations and the precautionary principle promote and uphold high ethical standards, integrity and accountability consistent with the Code ofEthics for Blood Donation and Transfusion of the International Society of Blood Transfusion, asadopted by the International Conference of Red Cross and Red Crescent Societies, 1981, andsupported by the World Health OrganizationNational Societies have a responsibility to:work to ensure their Governments accept their responsibility to ensure a safe and adequate bloodsupply within their jurisdictionsidentify their role in the overall strategy of blood service delivery in their country in accordance withtheir capacity, technical know-how, available resources, local priorities and in liaison with governmentpromote safe, sustainable and equitable practices in the development and administration of bloodprogrammesensure their blood programme has an adequate governance structure with a well-defined system fordelegation of authority and the aspiration of national self-sufficiency, including ensuring adequate blood and bloodproducts to meet domestic health needsundertake Humanitarian Diplomacy as necessary to seek government action to minimise risk in bloodservices and to help ensure that Government alerts the public to any reasonably preventableinadequacy in blood service delivery which places them at riskimplement the GAP Self-assessment and adhere to the Development of Safe and Sustainable NationalBlood Programmes Manual, which may necessitate a more detailed analysis, assessment anddevelopment of an exit strategyrespect the confidentiality and privacy of all information relating to blood donors and blood donationadminister any blood programmes in compliance with this position; inform all staff, volunteers andblood sector partners participating in blood programmes of this positionwhere practical, provide support to other National Societies and blood services in achieving a safe andsustainable blood system in ways that enable self-empowerment and long-term sustainabilitytake steps in consultation with GAP and other partners to ensure that appropriate risk managementmeasures are implemented; this includes ensuring that its senior management and governing leadersare alerted to any material risks and that appropriate action is subsequently takenensure that all blood programmes comply with this policyThe International Federation has a responsibility to:focus on the promotion of voluntary blood donor recruitment and to liaise and work in closecollaboration with GAP, WHO and other partners in implementating the WHO/IFRC Global Frameworkfor action-towards 100 per cent voluntary blood donationshare knowledge and exchange information with GAP at a strategic, regional and country level.55ensure this policy is reviewed after five yearswork with the GAP membership to help ensure necessary GAP resourcingkeep through the International Federation Secretary General International Federation Governanceappropriately informed of major material risks for the International Federation it becomes aware ofThe GAP has a responsibility to:share knowledge and provide advice to National Societies on governance and management of riskassociated with blood programmes, as resources allowensure any lessons learned from the implementation of the GAP manual Development of Safe andSustainable National Blood Programmes are incorporated into an update of the manual at same timeas the policy reviewinform both the International Federation Secretariat and the concerned National Societies of majormaterial risks for the International Federation discovered through the GAP National Society selfassessment program in blood service delivery and any other GAP workReview and Reference:This policy was drawn up in 2010 and it is designed to replace the previously established policy onQuality Provision in Blood Services. IFRC will ensure this policy is reviewed after five years, withany proposed amendments to be submitted to the Federation for approval. The review is to beinitiated no later than 30 Dec 2014.This policy is submitted to Governing Board Dec 2010 for its approval and submission to the GeneralAssembly in Nov 2011.Further Reference Texts:Decision 34, 8th session of the General Assembly, Budapest, 25-28 Nov 1991.Voluntary nonremuneratedblood donors are persons who give blood, plasma or other blood components of theirown free will and receive no payment for it, either in the form of cash, or in kind which could beconsidered a substitute for money. This includes time off work, other than reasonably needed for thedonation and travel. Small tokens, refreshments and reimbursement of direct travel costs arecompatible with voluntary, non-remunerated donationCode of Ethics for Blood Donation and Transfusion. International Society of Blood Transfusion,General Assembly, Montreal, 1980 and XXIVth International Conference of the Red Cross, Manila,1981.Code of Ethics for Blood Donation and Transfusion. International Society of Blood Transfusion,General Assembly, 12 July 2000; amended by the ISBT General Assembly, 5 September 2006.Decision 36, Blood Quality Programme. Seville, Spain: 11th Session of the General Assembly,November 1997.Melbourne Declaration 2009, arising from WHO/IFRC global consultation on 100 per cent vnrbdwhereby participants (more than 65 experts in transfusion medicine, policy makers, government andnon-government representatives from 38 countries across WHO/IFRC regions) agreed, inter alia, towork in collaboration in international efforts to promote safe and sustainable vnrbd programmes thatfoster community engagement and benefit the recipients of blood and blood products.Decision, World Health Assembly, 2010, Availability, safety and quality of blood products(WHA63:12)56Appendix 2: National Society blood risk summaryThere are a number of risk issues facing Level A and Level B National Societies. For a full list of riskmanagement recommendations, see the GAP Self-assessment.Main risks for National Society blood services (Level A)Below is a list of the main risk issues the GAP has identified for National Society blood services (Level A)in order of priority:Risk issueConsequenceLack of government protection and/orappropriate insurance cover for bloodborne disease transmissionExposes the National Society to financial risks beyond itscapacity to resolve should an incident occurThe inability to meet either regulatory ornational standardsShould be minimum requirements of any blood service blame for a lack of achievement can be clearly laid at thefeet of the National SocietyLack of funding and resourcesFundamental risk management and donor and productsafety systems/processes are prejudicedThe lack of systematic identification,analysis, evaluation and prioritization ofrisks and their managementLack of appreciation of risks and therefore identification ofthose which are the most imperative to reduceIneffective governanceSignificant risks in lack of assurance and leadershipLack of systems of monitoring emergingthreats to the blood supplyLack of risk management measures in place to dealwithblood-borne diseasesFailure to provide meaningful, practicalsupport for victims of blood-bornedisease transmissionRisks the very reputation of Red Cross Red Crescent as ahumanitarian organizationMain risks for National Societies involved in blood donor recruitment (Level B)Without clear Memoranda of Understanding with either the ministry of health or blood service, theNational Society may recruit to a blood service without appropriate standards to ensure bloodsafety and blood donor care and safety.Without adequate knowledge of the criteria for blood donor selection, there is a risk of mobilizinggroups of people, some of whom may not be eligible to donate blood, which could result in theNational Society being criticized as unprofessional.With pressure from government, some societies may participate in recruiting donors to potentiallyunsafe blood services and expose themselves to potential risks including a) victims of bloodborne diseases seeking meaningful and practical support from the societies due to theirinvolvement in the recruitment of the donor and b) a donor seeking compensation from thesocieties for injuries related to blood donation at the blood service.57Appendix 3: Framework of a Memorandum of UnderstandingWhen a National Society agrees to undertake the provision of part (Level B) or all (Level A) of a nationalblood programme on behalf of the government or health authority, GAP recommends that this issupported by a Memorandum of Understanding (MoU) or service agreement between the two parties. AMoU provides clarity on respective roles and responsibilities and facilitates a cooperative workingrelationship based on expectations that have been agreed to by both parties. It can also be used todocument and reaffirm the governments responsibility to assist the National Society in managing itsblood programme risks both financially and with regards to assurance.MoUs are established for a clearly specified period (such as 1-3 years) however they should bereviewed annually. It is in the interest of both parties that a formal contract be negotiated each year(perhaps as an addendum to the MoU) that specifies the volume/number of products to be provided andthe funding that will be provided by, or funding arrangements that are supported by, the government.MoU formats may vary but generally they will include the following:A title which describes clearly the parties and the purpose of the MoU, for example: Memorandum ofUnderstanding (MoU) between [the Country government or health authority] and [the NationalSociety/blood service] for the [Specific programme of work e.g. implementation of the national bloodprogramme/provision of the blood donor recruitment programme]I.Mission/ObjectiveA preamble which includes a brief description of the missions of both the National Society/bloodservice and the government, and the area which the partnership will promote e.g. the adequatesupply of safe blood and blood products to patients, through a national blood programme based onvoluntary blood donation.II.Purpose and ScopeA description of the intended results that both parties hope to achieve in forming the partnership,and the area(s) that the specific activities listed later will cover.Delegations could be covered in this section. If a National Society is delegated as the nationalblood service, the National Society should seek an assurance that it will have autonomy andindependence in the technical management of the programme. Funding arrangements and theprovision of assurance could also be covered here.III. ResponsibilitiesA list of the specific responsibilities and/or tasks of each party, and any joint obligations, that havebeen agreed as part of the negotiation process including annual operations and budget plans withagreed Key Performance Indicators. Below is a list of government and National Societyresponsibilities that could be considered for inclusion in a MoU for a Level A blood programme.Government obligations: The implementation of a clear blood policywhich spells out the agreed roles and functionsof all parties, including the National Society, andestablishes VNRBD as the basis for the nationalblood programmeGovernment obligations (cont.):58National Society/blood service obligations: Comply strictly with all laws, regulations andguidelines issued by government Provide the population with access to the safestpossible blood and blood products, equitablyand appropriatelyNational Society/blood service obligations (cont.): The provision of an appropriate legislativeframework for the blood programme andregulatory oversight The provision of sufficient resources to enablethe National Society to undertake the task at therequired level of quality and competencewithout compromising standards or diminishingits own resources The provision of an adequate level ofprotection/assurance to the National Society forundertaking the blood programme on its behalf,particularly regarding incidents of no faulttransfusion transmitted infection. Recruit VNRB donors, provide appropriatedonor care, and collect, test, process anddistribute blood and blood components Retaincompetentstaff,includinganappropriatelyskilleddirectorwiththeresponsibility and authority for planning,coordinatingandmanagingthebloodprogramme Provide a technical, financial and administrativestructuretoensuretheappropriatemanagement of the blood programme Maintain an appropriate quality managementsystem for its activities and productionprocesses Submit agreed financial and quality reports tothe government in a timely mannerA number of the examples above could also apply for Level B National Societys entering intopartnership with a blood centre. Additional suggestions are included below:Government/Blood Centre obligations: The implementation of appropriate donor caresystems and of quality standards in thecollection, testing and processing anddistribution of blood and blood components toensure the population has access to the safestpossible blood and blood products, equitablyand appropriately The provision of professional expertise for thedevelopment ofthepublic awarenessprogramme, in liaison with those responsible fordonor recruitment programme (includingRC/RC) Assistance in the orientation and training ofRC/RC volunteers Management of a dedicated budget for theblood service allocating appropriate resourcesto those responsible for donor recruitment(including RC/RC)59NationalSociety/blooddonorrecruitmentprogramme obligations: Work in partnership with Blood Centre to ensurean adequate supply of safe blood Recruit and build a team to implement the blooddonorrecruitmentandmanagementprogramme, implementing wherever possiblethe IFRCs standard toolkit Making a Differencerecruiting voluntary , non-remunerated blooddonors Develop and implement a continuous nationalawareness programme to heighten theimportance of blood donation Develop and manage education, publicity andpromotion activities to promote, recruit andretain blood donors to the level as agreed withthe blood service. Develop recognition programmes for regularblood donors, in partnership with the bloodservice, including World Blood Donor Day on 14June. Motivate and enlist the support of thecommunity to organize and host blood mobilesessions and to coordinate the activities for theblood mobile drives with the blood service. Recruit, train and manage a pool of volunteersto maximize the impact of the donor recruitmentprogrammeIV. Terms of UnderstandingDescribes the terms of length for the MoU and the effective date from which the agreement will start(usually when it is signed). A review period, usually annually, should be included to ensure that theMoU is meeting its purpose and that any necessary revisions can be made. The option to extendthe MoU upon mutual agreement could also be written into this section.The process for termination of the MoU and for resolving disputes should be clarified. Aconfidentiality clause could also be incorporated to ensure that information and documents receivedor acquired are treated as strictly confidential.The MoU should end with the signatures of the duly authorised representatives of both the governmentand National Society and the date upon which the document was signed. The signatures of at least twowitnesses, one from each party, should also be included.GAP may be able to assist in providing example MoUs for National Societies to consider. Pleasecontact the GAP Secretariat or the IFRC, if further information is required.60Appendix 4: ISBT Code of EthicsA CODE OF ETHICS FOR BLOOD DONATION AND TRANSFUSIONThe objective of this code is to define the ethical principles andrules to be observed in the field of Transfusion Medicine.Blood Centers: donors and donation1. Blood donation including haematopoietic tissues fortransplantation shall, in all circumstances, be voluntaryand non-remunerated; no coercion should be brought tobear upon the donor.A donation is considered voluntary and nonremunerated if the person gives blood, plasma orcellular components of his/her own free will andreceives no payment for it, either in the form of cash,or in kind which could be considered a substitute formoney. This would include time off work other thanthat reasonable needed for the donation and travel.Small tokens, refreshments and reimbursements ofdirect travel costs are compatible with voluntary, nonremunerated donation.The donor should provide informed consent to thedonation of blood or blood components and to thesubsequent (legitimate) use of the blood by thetransfusion service.2. A profit motive should not be the basis for theestablishment and running of a blood service.3. The donor should be advised of the risks connectedwith the procedure; the donors health and safety mustbe protected. Any procedures relating to theadministration to a donor of any substance forincreasing the concentration of specific bloodcomponents should be in compliance withinternationally accepted standards.4. Anonymity between donor and recipient must beensured except in special situations and theconfidentiality of donor information assured.5. The donor should understand the risks to others ofdonating infected blood and his or her ethicalresponsibility to the recipient.6. Blood donation must be based on regularly reviewedmedical selection criteria and not entail discriminationof any kind, including gender, race, nationality orreligion. Neither donor nor potential recipient has theright to require that any such discrimination bepracticed.7.Blood must be collected under the overall responsibilityof a suitably qualified, registered medical practitioner.8. All matters related to whole blood donation andhaemapheresis should be in compliance withappropriately defined and internationally acceptedstandards.9. Donors and recipients should be informed if they havebeen harmed.10. Blood is a public resource and access should not berestricted.11. Wastage should be avoided in order to safeguard theinterests of all potential recipients and the donor.Hospitals: patients12. Patients should be informed of the known risks andbenefits of blood transfusion and/or alternative therapiesand have the right to accept or refuse the procedure. Anyvalid advance directive should be respected.13. In the event that the patient is unable to give priorinformedconsent, the basis for treatment bytransfusion must be in the best interests of the patient.14. Transfusion therapy must be given under the overallresponsibility of a registered medical practitioner.15. Genuine clinical need should be the only basis fortransfusion therapy.16. There should be no financial incentive to prescribe ablood transfusion.17. As far as possible the patient should receive only thoseparticular components (cells, plasma, or plasmaderivatives) that are clinically appropriate and affordoptimal safety.18. Blood transfusion practices established by national orinternational health bodies and other agencies competentand authorised to do so should be in compliance with thiscode of ethics.The Code has been elaborated with the technical support and adopted by the WHO.Adopted by General Assembly of ISBT, July 12, 2000Amended by the General Assembly of ISBT, September 5, 200661Appendix 5: Blood Safety, WHO Aide-Mmoire for National BloodProgrammes6263Appendix 6: The Clinical Use of Blood, WHO Aide-Mmoire for NationalHealth Programmes6465Appendix 7: Quality Systems for Blood Safety, WHO Aide-Mmoire forNational Blood Programmes6667Appendix 8: Safe Blood Components, WHO Aide-Mmoire for NationalHealth Authorities6869
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