Management of National Blood Programmes

WHO Workshop on the Management of National Blood Programmes

Workshop Report

3-7 September 2007

Singapore

Jointly Organised by the Centre for Transfusion Medicine/ Health

Sciences Authority, WHO-WPRO, WHO-SEARO, and WHO-

Geneva with support from the Singapore Government 1 Introduction

Blood transfusion is an essential part of health care. Every country shares the need to ensure the quality, safety and accessibility of blood transfusion. This is best achieved though the presence of an effective and coordinated national blood programme that is responsible for the provision and rational use of adequate supplies of safe and high quality of blood and blood components. One of the key factors towards a successful national blood programme is an efficient and well organised national blood service.

It is important that Directors and Programme Managers of national blood services are equipped with the appropriate management knowledge and skills to enable them to implement and operationalise the national blood programme. This includes the necessary skills in human resources, finance, administration and planning within the blood service that will allow them to manage their available resources and implement the national blood plans effectively.

To address these needs, a series of Training Workshops in Management of Blood Services is planned. The first series comprises three training workshops to be held on an annual basis over three years. During the course of the three years, participants will be trained in key aspects of management, with emphasis on their application in the management of the blood service. The second series comprising two workshops over two years will cover advanced training in specific priority areas that have been identified during the first series.

2 Objectives of the Workshop

The overall goal of the series of workshops is to strengthen the organization and management of national blood programmes in order to improve safety and availability of blood supply in the Region

The specific objectives of the workshops are:

1. To sensitize national directors/programme managers of national blood services with contemporary concepts on planning, organisation and management of national blood programmes 2. To promote experience sharing and networking among the Member States in the Region 3. To identify gaps and challenges in areas involving the management of blood programmes in the individual countries, and actions to address them.

The first workshop will address organisational models, strategic planning and implementation, financial management, the introduction of standards for blood safety, and the management and effective use of the communication media.

3 Expected Outcomes

1. Focus on the areas that have been identified through various WHO meetings and workshops, which include strategic planning and implementation; contingency planning and disaster preparedness; developing and implementing standards for blood safety; costing and budget management; human resource development and management; managing communication and media; and managing partnerships.

2. Provide opportunities for experience sharing and learning among the participating countries.

3. Participants will monitor progress, identify gaps, and propose necessary actions for developing and implementing the national blood programme in participating countries.

4 Proceedings of Day 1

Opening Ceremony

The Workshop was formally opened by the Senior Minister of State (Ministry of Foreign Affairs and Ministry of Information, Communications and the Arts) Dr Balaji Sadasivan.

Dr Han Tieru, WHO Representative to Malaysia, Brunei Darussalam and Singapore welcomed facilitators and participants to the workshop on behalf of the WHO and the Regional Director for the Western Pacific. Dr Han expressed sincere thanks to the Singapore government for hosting the workshop. He also expressed delight that the workshop was joined by participants from the South East Asia Region.

Dr Han highlighted that the need to maintain sufficient and equitable supplies of safe blood and blood products remains a major challenge in many developing countries. Two key areas that need to be addressed are the gap between supply and demand of a safe blood supply, and the serious safety concerns associated with inadequately screened blood. A major constraint is the lack of infrastructure and systems. To address these, WHO recommends that member states adopt and implement the following integrated strategies: the establishment of nationally coordinated blood transfusion services; collection only from voluntary non-remunerated blood donors from low-risk populations; testing of all donated blood; and minimising unnecessary transfusions through effective use of blood. Developing contries are organising their blood programmes based on these objectives, which will involve significant policy changes and structural reform. This workshop, which is intended to strengthen leadership and managerial capacity of those responsible for their blood programme therefore comes at an opportune time. The workshop also provides further opportunity to further strengthen the networks among country participants and temporary advisors. In his keynote address, Dr Balaji welcomed participants, recalling that he had previously officiated the opening of the WHO Regional Quality Management Training Course in Singapore in 2002. He commended the WHO Quality Management Project and Global Blood Safety Initiative, which had through such courses, helped to train many senior blood bank officials and health officers in the fundamentals of implementing quality management programmes. This has contributed towards establishing safe and effective blood transfusion services in the Region, and the development of an informal regional quality network.

Dr Balaji noted that organisational management is key towards achieving the pre- requisites for an effective quality system. Successful blood services must be able to provide adequate supplies of safe and high quality blood and blood components to their population, and this requires a good management system with efficient infrastructure, good corporate governance, adequate allocation of resources and financial sustainability. This workshop is intended to provide senior management teams with the practical know-how of organisation management and opportunities for them to share their experiences and network.

Dr Balaji’s keynote address was followed by the launch of a training CD on Quality in Blood Collection, developed by the CTM for the WHO Regional Office for the Western Pacific. A brief demonstration of the contents of the CD was conducted, and copies of the CD were made available to all workshop participants and also sent to national blood services in the Region. The ceremony was concluded by the launch of the Singapore Red Cross Donorweb Regional Resource Centre for Blood Donation Programmes.

Session I - Introduction of Participants and Objectives of the Workshop

Dr Yu Junping facilitated the session during which all the participants introduced themselves. There were 27 participants from 16 member states; namely Bangladesh, Bhutan, Brunei Darussalam, Cambodia, People’s Republic of China, India, Lao People’s Democratic Republic, Malaysia, Maldives, Mongolia, Myanmar, Nepal, Papua New Guinea, Philippines, Sri Lanka, and Vietnam.

Dr Yu proceeded to introduce the participants to the objectives of the workshop. He dtressed the necessity for such a workshop as blood safety programmes such as the WHO Quality Management Programmes, Blood Donor Programmes, are a priority in developing countries and also with funding partners such as the World Fund and Global Fund. Additionally, the promotion of voluntary non-remunerated blood donation is a major challenge in many Member States, as is the establishment of confidence in both blood donors and the general population.

He mentioned the 58th World Health Assembly in May 2005, during which a resolution was made (WHA 58.13), which urges Member States to support well- organised, nationally coordinated and sustainable blood programmes. Therefore this workshop is intended to sensitise participants to current concepts and practices in the management of blood programmes, and to provide a platform for sharing of experiences and best practices. Dr Yu proceeded to inform participants of the goals of the workshop, which was to enable those working in the health ministries and blood services to share and learn, and contribute their experiences. They were to develop and bring back to their countries action plans on improving the blood programmes, to recommend to WHO and CTM the action plans to be taken, and also to feedback on the improvements made.

He urged participants over the next three years to apply the learning objectives, advise the blood centres, and also to keep in touch and network through web portals, and finally to report on the progress made.

Pre-Workshop Questionnaire

Dr Peter Flanagan presented a summary of the responses obtained from the pre- workshop questionnaire circulated earlier. He mentioned that the purpose of the questionnaire was to enable the facilitators to gain a better understanding of the background of the participants, as well as to identify the current challenges they faced.

Based on the responses, the participants are on the whole very experienced (most with at least 10 years of experience) and come from a broad mixture of backgrounds. The major challenges came from the areas of donor recruitment, government support, blood collection, centralisation, and hospital issues. Some other issues included quality management, IT support, finance, and standards. The major priorities for the workshop were identified by participants in strategic planning, project planning, and training and education.

The personal self assessment by the participants on their management skills was summarised. In general, most participants felt that they were comfortable with management competence. There was mixed responses of comfortable and weak in the areas of strategic planning, project planning and financial management. Most participants felt that they felt discomfort in the areas of human resources and transfusion knowledge.

Dr Flanagan concluded the session by noting that he would redesign the questionnaire and content based on the participants’ feedback.

Session 2 – Organisation and Planning

Organisation Models for Blood Transfusion Services (BTS)

Dr Yasmin Ayob gave a presentation of the various organisation models that exist for blood services. Most blood services are either hospital based or based on centralised blood collection, processing and distribution activities. There are six types of models that currently exist for blood services :

 Hospital based  Government owned  Red Cross / Red Crescent  Red Cross / Red Crescent and Government  Private  Mixture

Hospital blood banks are generally able to meet the requirements of a BTS. The advantages are close proximity to clinical needs, vein to vein activities, and if they are in university settings greater research orientation. Disadvantages are duplication of services, inefficient use of resources, lack of donor focus with weak donor recruitment and retention, lack of national perspectives and objectives, lack of human resources and skills in some cases, reluctance to share, and presence of conflicts of interest in distribution of the blood.

Where the blood service is part of pathology departments, there is advantage in the presence of set standards and quality assurance programmes. However, donor recruitment and retention is poor and clinical aspects of transfusion are not emphasised.

In blood services where the government is the sole provider, national needs are addressed. However, the organisation may be bureaucratic and rigid, and political aspects dominant in its activities. Donors may also not donate readily to the state.

The Red Cross and Red Crescent Societies are humanitarian organisations, and this encourages donors to come forward for blood donation. These have the ability to create national organisations, have flexible set ups and also have the advantage of international support and links.

Private or commercial blood banks tend to function efficiently as they are normally profit-driven organisations. They are also able to invest in more product development and good marketing tools. However, because of the profit motive, marketing strategies tend to be aimed at creating need.

Partnership organisations within blood transfusion services are advantageous because they are able to tap the benefits of the different partner organisations, and to have combination of authority, skills, flexibility and efficiency. Examples of some models include Malaysia, where the Ministry of Education and some private organisations contribute to the blood programme run by the Ministry of Health, and Singapore where there is a partnership between the Ministry of Health and the Singapore Red Cross.

The BTS organisations in different countires were described, such as those in Malaysia, Singapore, USA, Australia, New Zealand and Japan. Dr Ayob also described the experience in Malaysia in developing a more coordinated national blood programme.

Dr Ayob concluded by recommending that whichever model is used by the BTS, it should establish proper working standards, develop guidelines, establish policies, establish regulations, and have relevant legislation in place. All BTSs should have: standardisation; coordination; clear structure in terms of authority, responsibility and accountability; clearly defined functions; and adequate resources. In developing countries, government must be responsible, committed and take the lead. She also advised that in order to obtain government support, it is important to present the case with good data, have clear objectives and knowledge, know the appropriate person to approach, continue to follow up, and be persistent and patient.

Partnership Models for Blood Transfusion Services

Dr Diana Teo gave an overview of the different partnership models involving blood services. These generally fall into the categories of outsourcing initiatives, supplier- customer partnerships, and capability strengthening initiatives. Important elements in a partnership involve choosing the right partner, having clear goals and objectives, clearly defined roles and responsibilities, set agreed performance indicators, and regular monitoring and review. Partnerships can be based on contracts, Memorandum of Understanding, Memorandum of Agreements, or Service Agreements.

The success factors in a partnership include: common goals; win-win situation; leadership commitment; clear responsibility and accountabilities; achievable and measurable performance indicators and targets; organisation buy-in and ownership; and regular dialogue. The importance of regular dialogue, regular review of performance, and setting of targets and initiatives was emphasised. She illustrated this with some partnerships involving the Centre for Transfusion Medicine (CTM). Different arrangements exist with the different partnerships; however all partnerships had the common aim of strengthening capability.

The partnership between the blood service in Singapore and the Singapore Red Cross (SRC) was initiated in 1997 with a taskforce studying how to reduce duplication of roles and activities in blood donor recruitment and collection. An MOU was signed between the two organisations in 2001. CTM has clear responsibility and accountability for the blood programme, and in ensuring the quality and safety of the blood supply. It focuses on its strength in the professional and technical aspects of collecting, processing and distributing the blood. The SRC focuses on its strength in developing and implementing appropriate national strategies to increase awareness of blood donation, donor recruitment, and training and managing volunteers. The CTM provides SC with a budget to enable it to manage the blood donor programme.

Staff from both organisations form an operations committee, which looks jointly at planning of donor recruitment and retention strategies and projects, and also ensures that both sides are kept updated of activities. Through continuous communications and joint planning, both organisations are able to achieve national goals and key performance indicators, as well as to develop annual operations plans and budget. Performance and KPIs are presented regularly at quarterly staff reviews.

The success of this partnership was due to the formal appointment of the SRC as national blood donor recruiter by the government, sufficient funding and support, strong governance, staff involvement, and common goals and objectives. The benefits from the partnership are a focus on organisational strengths of both sides, and enhanced resources such as volunteers. Another type of partnership is the outsourcing of warehousing and supplies inventory to a logistics specialist Sembcorp Logistics in 2001. The company has qualified and experienced staff able to manage the purchasing, inventory and warehousing of supplies efficiently. It also provides logistics support to mobile blood collection sites, delivering supplies and equipment from its warehouses and collecting them after the mobile. This partnership benefits the blood service, which is able to focus on its core business and devolve the supplies management functions to be better and more cost efficiently managed by specialists.

The third type of partnership involved the partnership with hospitals. This is a looser partnership based on agreed common goals of providing safe and quality blood to patients. A good partnership ensures that blood and blood products issued to hospitals are properly stored and managed. Regular meetings are conducted between staff of both sides to update on changes in policies or processes, and to address problems and issues. Within such a partnership, it is also possible to determine set performance indicators, which could include percentage of blood available to meet clinical needs, haemovigilance, wastage, or financial indicators.

Group Discussion on Appropriate Organisation Models and Partnerships

Key points arising from these include:

 While the Singapore model of partnership is a useful model to consider, it would be more difficult to centralise activities in larger countries where there would be more than one agency collecting blood.  It is important that the government is able to provide financial grants to support blood collection activities.  In some countries where the Red Cross is responsible for blood collection, it is difficult to achieve full cost recovery for these activities. These blood services then have be supported with assistance from sister national societies in more developed countries like Australia and Spain as it was difficult to obtain grant support from the government.

Developing and Implementing Strategic Plans

Mr Benjamin Pwee introduced the strategic leadership triangle which consisted of strategic thinking, strategic planning, and strategic implementation.

It is important for organisations to conduct an assessment of the external and internal environment. This would enable them to analyse their strengths, weaknesses, opportunities and threats (SWOT), and develop their strategies. One method of assessing external environment is the use of the PEST model, which focuses on four major areas : Political, Economical, Social, and Technological. He also described the 4S model which can be used to assessment the internal environment, based on Structures, Social, Strategy, and Skills. The use of the PEST and 4S models was illustrated by using examples from the Hong Kong Red Cross Blood Transfusion Service. Mr Pwee stressed that it is important for organisations to set out their mission, values and vision statements. He also described the Balanced Scorecard concept which is used in setting out and monitoring strategic action plans. The scorecard encompasses Vision and Strategy in the centre, which is interconnected on four sides with the 4 key areas of Financials, Customers, Internal Business Processes, and Learning and Growth. The application of the Balanced Scorecard in public and non-profit organisations, and in private organisations was described.

Through strategy maps and the Balanced Scorecard, the organisation can develop its targets and initiatives which should lead to the desired strategic outcomes. This approach provides a uniform and consistent way to describe its strategy, so that objectives and measures can be established and managed. Strategic maps provide the missing link between strategy formulation and strategy execution. Strategic outcome indicators should include satisfied donors and financers, delighted custmers, efficient and effective processes, and motivated and prepared staff.

In implementing one’s strategic plans, one must conduct external and internal analysis, followed by developing the mission, values and vision statements. This is then followed by setting out the Balanced Scorecard indicators, followed by setting and implementing targets and initiatives, and finally identifying and obtaining sufficient resources and approvals. It is important to conduct regular monitoring and review of the plan.

Performance Indicators and Targets

Dr Diana Teo described performance indicators as a management tool to monitor and evaluate success, as part of planning to enable efficient allocation of resources, and enable ownership and accountability for the programme or project. She stressed the importance of choosing the appropriate performance indicators and targets, which should be relevant, measurable, achievable, simple, and enable timely action. This can be summarised in the acronym SMART, which stands for Specific, Measure, Achieve, Relevant, and Timely.

Two types of measures are used. Outcome (results) measures come at the end of the process and happen after the fact. Driver measures or leading indicators are taken directly within the process and happen before the results.

Examples of performance indicators and targets that could be used in the blood services were described. These generally fall into measures of volume, quality, or efficiency. Key performance indicators for the blood service include the number of whole blood donations, number of apheresis donations, number of blood components, and daily blood stock levels. Indicators of mobile blood programme performance include the number of blood drives organised, and comparison of actual blood collection against projections. Donor satisfaction can be measured by direct indicators such as donor feedback, and indirect indicators like waiting times for medical screening, blood donation, etc. Other useful indicators mentioned included failed phlebotomies, donor haemovigilance, blood supply utilisation, blood component outdates and rejects, as well as staff satisfaction and training indicators. Performance indicators must be regularly monitored and reviewed, and this must be accompanied by timely action. Targets must be regularly evaluated and updated to be relevant. Assigned owners of the performance indicators should be appropriately empowered, and given responsibility and accountability. Platforms for monitoring and review of performance indicators include strategic planning retreats, and results communicated staff meetings and stakeholder dialogue sessions.

Practical Session on Developing Strategic Plans

The practical session involved participants working either as individuals (if there is only one country representative) or groups involving all participants from the same country. Within the session, participants were encouraged to review the organisational direction and goals of their blood service, identify the key goals to be achieved, and develop strategic plans to achieve the goals.

At the end of the session, representatives from four countries presented their work for discussion. A number of issues, constraints and challenges were identified:

 In Vietnam any changes in external environment affects the blood services as new leaders tend to change policies.  In Papua New Guinea, new minister in office has brought about new changes. The St Johns Brigade is responsible for blood collection and there is a problem with funding for the blood programme as there is lack of accountability for the government funds allocated. There is also problem with social aspects, such as the preference for directed donations amongst the public, and the increased rate of HIV and Hepatitis infections. Increase in open-heart surgeries has also led to increased need for blood transfusion, and increase in number of cars on the road to more accidents and need for blood.  In China, there has been improved organisational structure, blood collection, and donor recruitment. Quality management training has led to clearer responsibilities in quality assurance. The MOH has also rationalised blood centres in China, and established formal contact with the Red Cross and plasma fractionation organisations. There is also increased efficiency in communications, and more effective systems to measure and reward staff performance, and better career development for blood bank staff. The strategy is to achieve 100% non-remunerated blood collection, centralization of blood testing and better communication with hospitals transfusion committees. To improve skills, there is better investigation of corrective actions and preventive actions for any errors. It is also aimed to improve skills in donor recruitment and to increase optimal usage of blood by hospitals.  In India, blood collection establishments are very fragmented and many partnerships exist. As a regulator, one of the measures is to control the commercial value of the blood to ensure that it is not sold for more than 500 Rupees per bag, and also to ensure that blood is always available to the poor and needy (participant from India is a regulator).

5 Proceedings of Day 2 Managing Projects Successfully Through Effective Planning

Mr William Loh shared the experience of the National Library Board in Singapore as a project-centric organisation. He noted that 70% of work done in most organisations are project activities. A project is defined as any temporary, organised effort that creates a unique product, service, process, or plan. It is a unique venture comprising of interrelated activities with a definite beginning and end, to meet established goals within parameters of scope, schedule and resources.

A well-managed project is likely to run smoothly and produce consistent, repeatable and predictable results. It is able to combine the talents of team members and coordinate their efforts. Project management includes management of scope, time, cost, quality, human resources, communications, risk, procurement and integration in the project.

A project is initiated by: defining the problem or opportunity; identifying the project requirements, stakeholders and their needs; and developing the project strategy. Project management strategy includes: define and organise the project; plan the project; track and manage the project; and close and review.

In planning the project, it is important to give understanding of top down goals, alignmment of expectations of what has to be delivered, and clarity of roles and responsibilities. The project team (WHO), project scope )WHAT), and project tasks (HOW) must be defined. Project teams usually comprise the sponsor, project manager, core team, and extended team, and h roles of each were described in detail.

Project parameters must be defined, and this includes the project objective statement, flexibility matrix, major deliverables, completion criteria, and success criteria. Mr Loh explained the characteristics of a good project objective statement, the use of flexibility matrix, and how to select relevant deliverables and develop good criteria for completion and success.

He stressed that project tasks should be clearly defined to improve communication, minimise re-work, improve schedule predictability, and provide visualisation of the project. Defining tasks involves defining the total project scope, estimating resources/cost/time, assigning responsibility, and measuring performance and control. Each task should be described with a verb and a noun, have an owner assigned, and duration estimated. Elements of task scheduling - including logical dependance of tasks, milsetones, and logical relationships of tasks - and issue logs was described.

Finally, Mr Loh shared the importance of the first project kick off meeting. Members of the project management team should also attend project-planning workshops to familiarize themselves with the tools and processes used for planning.

Practical Session on Project Planning.

Participants broke out into four Working Groups. Each Working Group was encouraged to identify a suitable project, discuss an appropriate approach and design, and develop a comprehensive plan to implement the project. The four projects were selected for the practical session:

(a) Setting up a Donor Recruitment programme within 3 years (b) Implementing a new TTI screening test within 1 year (c) Establishment of a National Blood Programme over 20 years (d) Developing a quality system within 1 year.

Disaster Preparedness and Planning

The importance of being prepared and planning for disasters was discussed by Dr Diana Teo. Planning is essential to ensure blood supply continuity and that supplies, logistics and trained staff would be available during emergency. This is part of risk management and enhances stakeholder confidence in the blood service, as well as strengthening the case for assistance by government/funding agencies in providing resources.

In disaster preparedness planning, the impact of the disaster on critical elements of the blood programme must first be identified and then appropriate action plans developed. Coordination plans must be developed with other stakeholders and agencies involved. Standard operating procedures must be written up and staff training conducted. Supplies, facility and logistics should be organized. Readiness must be tested, gaps identified and plans reviewed regularly.

Disasters resulting in physical trauma generally result in the need for large volumes of blood, and may disrupt communications/transportation and power/water supplies. Biological disasters are usually associated with drop in donor attendance, donor deferrals, decreased blood requirements. Pandemic situations may disrupt infrastructure, result in curfews and quarantine, and lead to staff and supply shortages. Disasters involving the blood bank may result in disruption of operations, possible loss of staff and blood/blood components. Disasters will impact on public, blood donors, blood service staff, volunteers, patients, hospitals, blood bank processes, logistics and facilities. It is therefore important for blood centers to develop disaster preparedness plans to tackle such situations.

The elements of disaster plans include: command and control structure; messaging to public, donors, stakeholders; human resource management; blood inventory management; supplies and materials; facility integrity, adequacy, security; logistics (transportation and communications); and coordination with other units, agencies, countries.

In developing plans to manage disaster scenarios, the blood service must determine whether such scenarios lead to a need for more blood, and if so, whether there is sufficient blood available or how much additional is required. If additional blood is required, then these should be made available before immediate inventory runs out. Collection, processing, testing and distribution of additional blood needs must be planned for, and supply adjusted to demand. It is important that appropriate messages are provided to public and blood donors based on whether more blood is needed, and that the public are not alarmed unnecessarily as this will lead to long term disillusionment and loss of confidence in the blood programme.

BTS planning for disasters requiring large amounts of blood must consider the following when developing its preparedness plan: -  Determine policies for management of emergencies  Command and control system, roles and responsibilities  Management of blood donors  Development of communication plans  Plans for scaling up operations  Communication and distribution network with hospitals  Arrangements for additional supplies, transportation, food, water, etc  Arrangements with all organizational units  Coordination with other organizations involved

In scaling up operations, additional space needs to be identified, and crowd movement and security planned. Mobile sites can be identified so that speedy activation is enabled. Additional staff should be trained and recall systems set up. Spare capacity, supplies, additional transport and logistics that can be made available in an emergency should be identified and arrangements made for deployment when required.

It is also critical that disaster preparedness plans are appropriately disseminated, regularly reviewed and updated. There may be changes to donation criteria, computer systems, new tests and technologies, process changes, and new volunteers to be trained. Emergency exercises are also a useful way of testing and validating emergency plans.

Flu Pandemic Preparedness

Dr Lin Che Kit introduced the purpose of the disaster response plan in the Hong Kong blood service, which is to coordinate activities in the BTS, and between the BTS and hospitals or outside bodies to ensure blood supply in the event of emergency due to either a general disaster where a larger amount of blood supply is needed than normal or causing sudden influx of donors, or disruption of the service that temporarily restricts or eliminates the ability of the BTS.

He described the SARS outbreak in 2003, which severely affected several countries in the region. In addition to the human suffering, death, and negative economic impact on tourism, travel and trade, the blood supply was adversely affected. In Hong Kong, a reduction of 20% was seen in overall blood collection and 14% reduction in blood utilization during that period. Lessons were learnt from SARS and infectious disease outbreaks reveal weaknesses in public health infrastructure. An infectious disease threat in one country is a threat to all, as contagious infections do not respect national borders. These infections can be contained with high level government commitment and international collaboration.

During the SARS experience, BTS in the countries affected learnt many lessons regarding the vulnerability of the blood supply during such outbreak as donors were unable to donate due to the fear of transmission of SARS, due to deferrals imposed by concerns regarding its transmission by blood, and potential outbreak in the BTS. There was a need to strengthen donor programmes to broaden the donor base, manage donor perceptions and fears, use of media and communication tools, and staff with suitable training.

BTS also need to establish systems to ensure donor and blood traceability, which should include effective product recall systems, patient notification and look-back studies and patient registries. Contingency plans also need to be developed to address operational issues, such as setting up blood collection sites at location perceived to be of lower risks and to have alternative plans in event of disease outbreak amongst staff. The impact of development of diagnostic tests, and implementation of screening tests also needs to be considered.

The potential impact of an influenza pandemic on the blood supply includes: impact on blood safety through collection of blood from infected individuals; blood shortage due to donor deferral and drop in donor attendance; reduced blood demand from cancellation of elective surgery; spread of infection among blood donors and staff; and disruption in blood bank operations due to staff illness.

For consistency of reporting and contingency planning purposes, it is useful to adopt the WHO system of staging Alert Levels from 1 to 6 ( 1, low - 6,pandemic). Dr Lin described the different measures that can be developed to address the impact of disease outbreaks at each stage of an influenza pandemic. One of the measures is the formation of regional and international collaborative networks, such as the Asia Pacific Blood Network and WHO.

Contingency Planning, Principles and Practice

Dr Peter Flanagan explained that contingency planning manages the “What if”. It is a form of risk management, and provides the opportunity to plan without pressure. Contingency planning aims to identify potential problems in advance, and decide how to avoid it occurring or how to manage its occurrence.

Contingency planning should form part of the business planning process. The involvement of cross-functional teams and high level support are essential. The response developed must be proportionate to the risk and its impact. The steps to be taken in planning for contingencies involve: starting point; impact assessment; developing plan; testing plan; personnel training; and monitoring plan.

Impact assessment involves the development of a list of serious incidents that might occur and have impact on normal business. For each incident, the likelihood and potential should be assessed, and a matrix should be developed of the likelihood of the event (low, moderate, high) versus the impact severity (low, moderate, high). Factors that affect the impact of the incident include the site where it occurs, duration of the event , and intensity of the event.

Contingency plans must be developed for each identified risk. These include the following aspects. What organisational functions are critical and must be supported. For each function, the level of contingency support required. Identify the specific roles and people for each task. Dr Flanagan illustrated the development of contingency plans using the example of the risk of loss of electrical supply.

The effectiveness of the plan should be tested where feasible, and the level of support revised if needed. Personnel training requires documentation of procedures, training of staff in the activation of emergency plans, and listening to feedback. Maintaining the plan involves regular review. It should be resilient to staff turnover, modified as organisational capacity changes, and tested on a regular basis.

Common contingency planning scenarios were discussed in detail – earthquake/flood, recall of HIV test kits/blood packs, industrial action – and the experience and plans developed by the New Zealand Blood Service shared with the participants.

Emergency Support Regional Networks

Dr Yasmin Ayob stressed the importance of regional networks during emergencies. Such networks allow information sharing, provide professional and technical support, increase awareness of blood supply safety, encourage joint actvities, enable rapid alert, and effective disaster management.

She described the regional networks currently in place in the region – World Health Organisation (WHO), Asia Pacific Blood Network (APBN), and the International Federation of Red Cross and Red Crescent Societies (IFRC). WHO works through its Western Pacific (WPRO) and South East Asia (SEARO) Regional Offices and the IFRC through its regional offices and the Global Advisory Panel (GAP). These regional networks are able to maintain knowledge exchange, close communication and also good transport systems of blood movement to needed areas. Disasters such as Tsunami, earthquake, flood and outbreak of an infection are emergency situations, which require blood banks to be on high alert.

The WHO is looking at future regional collaboration for update of knowledge, sharing of information, training of staff such as staff secondment to advanced BTS centers, and also by developing shared regional position, by auditing and also by participating in research trials. In addition to WHO, the Red Cross has the TRAG and GAP to provide support to the participating countries. The objective is to advise, share knowledge, have clear policy, the availability of disaster management and also checking current facilities and improvement to better facilities.

Some of the regional alliances support shared testing, such as NAT and malaria testing. These have the advantages of enabling review of test before committing to its use, better cost effectiveness for small volumes, and as interim measures while awaiting new technology.

Another area involves knowledge exchange in areas such as emergency planning and disaster preparedness, blood donor management, and risk management issues (management approaches, strategy plans, testing algorithms). Regional workshops are a good platform for development and strengthening of regional networks, e.g. the Inter-Regional Workshop in Kuala Lumpur in March 2007. Future regional collaborations could include: expansion of the APBN; staff secondment between blood services for development and training; shared regional position for suppliers; auditing; research trials; coordinated humanitarian assistance, and regional workshops. Emergency assistance between countries could take the form of resources (people, equipment, reagents, facilities, transport) or blood supply.

Practical Session on Disaster Preparedness Planning

The practical session involved participants working either as individuals (if there is only one country representative) or groups involving all participants from the same country. Within the session, participants were encouraged to identify the challenges and constraints that will be faced in their country in the event of a flu pandemic, identify strategies the will be effective in overcoming these challenges, and develop a framework for action plans to secure the blood supply in the event of flu pandemic.

At the end of the session, representatives from four countries presented their work for discussion. Some key points included:

 Public would be educated through media on use of protective clothing and measures to be taken during a flu pandemic, as well limit travel to affected areas  In the event of a blood shortage, the media should be used to inform public. In some countries, blood donors would be encouraged to donate blood through a liaison with recruitment organization. There could also be recall of healthy donors from uninfected areas.  Blood donors could be recruited during the early stage of the pandemic to increase the blood stock. Where available, frozen blood stocks could be used.  Information pamphlets could be developed for public and donors.  The address, home telephone and hand phone number of staff and volunteers could be kept, so that they could be contacted when and where necessary.  If there is insufficient staff, they could be deployed from other departments, and trained in blood donor screening and other critical tasks. If there is heavy donor response to blood shortage call, additional manpower may be deployed from outside the organisation, e.g. army and police was suggested.  Staff and volunteers should take and record their temperatures regularly. PPE should be provided, and frequency of cleaning of the facilities should be increased.  Vaccination for all health care workers should be carried out.  If there is no space for the blood donation, alternate sites such as stadiums or concert halls could be considered.  Processes may have to be simplified and shortened in some cases. Staff may also need to be trained on the use of alternative techniques.  In the case of logistics, options for managing supplies include maintaining adequate back-up supplies, listing down the supplier’s hotline number so that they could be contacted, and sourcing for alternative suppliers.  Hospitals would be informed to reduce elective operations and only handle emergency situations. Clinicians may also need to be educated on stringent usage of blood.

Session 3 – Ensuring Financial Sustainability

Principles of Financial Planning

Ms Grace Chan introduced the participants to the basic principles and practices of financial planning in an organisation. She defined accounting as the process of identifying, measuring, recording and communicating economic transactions; this measurement is normally made in monetary terms. Such accounting processes produce records in the form of financial statements such as Profit and Loss Accounts and Balance Sheets. Accounting can be subdivided into (i) financial accounting - reporting to external parties and compliance with external accounting standards such as audits and taxation; and (ii) management accounting for providing information for management.

She then went on to describe three key accounting reports in detail with examples and illustrations: Profit and Loss Account, Balance Sheet, and the Cash Flow Statement. The Profit and Loss Account is a statement of income, and forms a record in monetary terms of activities of a business during a stated period of time, usually one year. The Balance Sheet is a snapshot view produced at the end of this accounting period and forms a statement of assets and liabilities and ownership of a business at the close of business on a stated date. The Cash Flow Statement is a statement of sources and uses of case, and reflects the cash position of a business.

The Balance Sheet Statement provides a summary of the financial position and business net worth at a specific time period, and is represented by the equation “Assets = Liabilities + Equity”. Assets include current assets (cash in bank, inventory, etc) and fixed assets (building, land, equipment, furniture, etc). Liabilities include current liabilities (accounts payable to creditors, accrued expenses, short term loans, etc) and long term liabilities (long term loans, lease). Equities include shareholders equity and retained earnings.

Cash flow is critical to an organisation’s survival, but does not equal profit. It is determined by 3 components by which cash enters and leaves the organization – core operations, investing, financing. Examples of cash flow statements were discussed.

All stakeholders need to be able to appreciate how the company is performing and this can be measured through ratio analysis. These are usually calculated by comparing 2 values in accounts, and must be compared over time or against other ratios to be meaningful. Different types of ratio analyses include performance ratios, liquidity ratios, gearing ratios, and shareholder ratios; these were described with illustrations.

Ms Chan discussed some issues in investment analysis and decision making. When acquiring capital assets such as equipment, options of lease versus purchase may be available. It is important to consider the pros and cons of each in terms of financial and business aspects. Issues that should be considered include: length of lease commitment versus business needs; impact on cash flow/available finance; cost of finance; whether leasing can be terminated part way through; what happens to the asset at the end of the lease; security requirement and what happens if there is default on payment; and type of lease including maintenance and breakdown.

When embarking on key investment projects, 3 questions must be asked. Does the proposed investment fits the overall business strategy, and if not why consider the investment? Has the financial implications of the proposed investment and the associated sensitivities and risks been taken into account? Are there operational capabilities to manage the investment project and then successfully employ the investment within the business?

Ms Chan discussed methods of evaluating capital investments such as Discounted Cash Flow, Net Present Value, Internal Rate of Return and Discounted Payback. She concluded by describing cost of capital, cost of equity, cost of debt and economic value, illustrating these with examples.

Budgeting and Budget Management for Blood Programmes

Dr Yasmin Ayob discussed budget management in blood programmes. She noted in starting that total costs of the blood transfusion service should include all resources – including those with and without invoices, and those with no market price like volunteers, facility and electricity. Having a dedicated budget to the BTS provides more flexibility.

One practical way to allocate costs is by activity, e.g. blood donor recruitment, blood collection, blood processing, blood storage and distribution. Total costs would therefore be the sum of the cost of all these activities. Costs are divided into capital and recurrent costs. Capital costs include infrastructure like building, vehicles, equipment, furniture and training. Recurrent costs include personnel, utilities, insurance, transport, supplies, and administration. Costs are also divided into direct and indirect costs. Direct costs are charges that have a direct relationship to the service, while indirect costs are computed costs based on a percentage of direct costs.

Dr Ayob defined cost as the estimated expenses from task items developed in the work break-down structure. Managing cost requires a disciplined approach with proper estimation and control of expenditure. A budget lists all the planned activities, and the expenditure of these activities. Any budget developed must be consistent with cost. Variance between the budget and actual cost will affect any activities planned. Insufficiency in productivity and new activity introduced will increase cost. Tracking of expenditure minimises such variations, and awareness of any changes in the budget is essential. In conclusion, managing the budget depends on the accuracy of the estimated and resulting budget. The development and execution of the budget must be a disciplined process, and it is also important to be aware of any changes.

Principles of Costing in Blood Services

Dr Diana Teo explained the rationale for costing in the blood bank setting. It can be used as a tool for planning and mobilizing resources needed to sustain blood supply; it provides information on the cost of the different activities involved in providing products and services; improves budgeting and budget allocation; enables monitoring of costs; enables realistic planning for future initiatives or expansion; evaluates cost effectiveness of the products/services; provide stakeholders with information on the budget required to produce the product or service; and helps to determine blood processing fees. 4 In the blood bank setting, classification by activity defines a framework that allows estimation of costs and outputs of specific activities. Allocation of costs to various cost centres enables good capture of data without duplication. Each cost centre can be designed to cover clearly defined areas involved in specific activities, e.g. blood donor recruitment, blood collection, blood processing, etc.

When costing blood products/services, the purpose of costing has to be defined, the organizational structure of the blood service determined, and the time frame and sample size identified for data collection. Sources of data include financial records, payroll records, output data, and time and motion studies. The costs are then calculated from the data collected.

Cost categories can be based on time frames or based on involvement in activity. Time frame based costs are divided into capital and recurrent costs. Costs based on involvement in activity are divided into direct (stand-alone) costs and indirect (shared) costs. These were explained in detail with examples of capital and recurrent costs, direct and indirect costs, and annualisation of capital costs. The total annual cost of an activity is the sum of the average annualised capital cost (direct + indirect) and the recurrent cost (direct + indirect). The unit cost of activity is therefore the total annual cost divided by the total activity output.

The process of costing blood involves the following steps: determine all items contributing to the activity; determine which are direct and indirect, and compute the allocation of indirect cost to the activity; determine which are capital and recurrent, and determine the annualising factor based on the useable shelf life for capital items; determine output indicators; and calculate the total cost of the activity divided by the relevant output indicator. This was illustrated using the example for whole blood.

The allocation of source costs in blood components was discussed. The cost of the blood component must include the portion of cost of the source whole blood unit. The formula used to determine allocation ratios differs among blood services depending on the practice and policy; it is often based on distribution of components, disposition of components, or blood service/MOH costing policy. This was illustrated using the example for platelets.

Dr Teo went on to discuss product pricing and blood processing fees. She noted that pricing is not equivalent to costing. Where full cost recovery is expected, product pricing must include wastage and outdate rates which are often not taken into account during costing. She concluded by highlighting important considerations in costing blood products; that whole blood is divided into many components; each component is processed differently; different equipment are used with varying usage period to process components; some equipment may be used for different components, each using it for different time periods.

Financial Models

Dr Lin Che Kit reminded participants that the budget lists all the planned activities of the blood service, and the expenditure of these activities.

There are many different models by which blood services are funded. These include: government funding, which is either direct or indirect (through national blood authorities or through blood supply); parent organisations, e.g. Red Cross or other agency; and recovery from the blood supply.

He showed examples of the different models that exist in the Region. For example, Malaysia obtains 100% direct funding from the government, while New Zealand, Australia and Hong Kong receive 100% funding indirectly from the government through the national blood authority/blood supply. In Singapore, direct government funding accounts for about 42% with the remaining recovered from the blood supply as processing fees. In Thailand and Indonesia, there is partial funding from all the various sources, while in China mode of funding varies from province to province.

There are also different models of the budgeting process. One model is based on incremental budgeting process, where the budget for each year takes as its starting position the budget from previous year, and adds/subtracts from that base. This is practised in Hong Kong and Malaysia. The other model is based on the rational budgeting process, which is less concerned with budget base, but more concerned with using resources to meet currently established objectives. This is practised in Singapore and Australia. Some blood services may use a mixture of both models.

Dr Lin went on to describe in detail the financial frameworks and models used in Singapore and Hong Kong as illustration. He concluded that financial and budgeting models for blood services are variable. However, most involve setting of annual objectives and targets, usually based on previous years actual figures. The more competitive economic environment is shifting attention away from levels of service to income and ratios of cost recovery. Knowledge of costs is therefore important in order to tender correctly and budget efficiently.

Practical session on Budget Planning and Costing The practical session involved participants working either as individuals (if there is only one country representative) or groups involving all participants from the same country. Within the session, participants were encouraged to identify the key budget components and a revenue source in their organizational budget, identify challenges and constraints in managing the budgets, and develop a financial strategy and plan to ensure sustainability. Participants were also encouraged to review the principles and methods of costing blood and blood components.

At the end of the session, representatives from four countries presented their work for discussion. Some key points included:

 Most of the participants identified the following components as key budget components: blood donor program; purchase of equipment; purchase of consumables; utilities; maintenance; training; salaries.  In India, there are 2,300 blood banks, with majority in government hospital blood banks. There are also private hospital blood banks and some stand-alone blood banks. Funds are given to the hospital by the government and then divided to the blood bank. Blood is free to the patient and there is small cost recovery charge in public hospitals, while recovery fee is high in private hospitals.  In China, the financial models for blood banks differ amongst provinces. In one participant’s blood bank, the Government is the main source of funding. Cost recovery is through the cost of one unit of whole blood, which is same all over the country. The blood centre recovers the cost from each hospital. Health insurance cover is established for public. Recurrent budget is generally high and needs to approved by the health bureau every year.  In Nepal, the main source of funding is through the Nepal Red Cross. Blood is provided to patient on a cost recovery basis. However, the cost of a blood unit was determined many years ago and has not been updated since. It is therefore necessary to perform a costing of blood units so that the MOH can determine the pricing for blood and its components, and help to fund any deficit.  In Brunei, the government funds the blood service. Budget requirements should be informed to MOH every year, and additional funding obtained if necessary. Blood is totally free to patients and there is no cost recovery.  In Bangladesh, the government is the main source of funding and there is no cost recovery from patients.  In Vietnam, the source of funding varies from province to province. It may be directly from the government, through authority from the government or from other organisations.

Session 4 - Effective Communication with Stakeholders

Principles of Communication - 7 Sins and 7 Virtues Mr Peter Lim started the session by stating that principles should be kept simple. In communications, it is important to keep the message short and simple. Using the context of 7 sins and 7 virtues, he described the basic principles of communication.

The 7 sins were described as:

 Lust: We want, but we don’t connect  Gluttony: We get what we want, but it’s never enough  Greed: We have got our goals but no values  Sloth: We show & tell, but we don’t know enough  Wrath: We don’t like, so we anyhow hit out  Envy: We see, we sigh, but we don’t really see what people are about. No empathy,  Pride: We know our stuff, but we don’t know how to connect

The 7 virtues were described as :

 Faith: Connect with our cause/mission  Hope: Get across our wish to connect  Charity: get it across that we care  Fortitude: Get across our integrity. Takes guts to tell the truth  Justice: Commit to balance and fairness  Temperance: That means self-restraint! So stat relevant, maintain perspective  Prudence: That means good sense, which means good taste. That’s how we connect.

In all communications, it is important to understand the other person’s needs, desires, fears and aspirations. Using blood as an example, he added that just as the components of blood are critical, so content is also important in communications. Good communications should have Relevance, Accuracy and Clarity. The use of fun in communication content can sometimes be effective too; however this should only be used where appropriate and in the correct context.

Managing your communication

Ms Carol Teo discussed how to manage communications through the media, through outreach programmes, and during crisis. Media is a way of communicating to the masses using various forms of mediums such as print media (magazines, newspaper), broadcast media (TV and radio), and digital media/new media (website, blogs, on-line forums). Relating to the media provides opportunity to raise awareness, mobilize the public around events or causes, or improve the organisation’s image. It can be used to present or challenge a particular point of view, or the way the organisation’s issues are covered. It can also help efforts to recruit more people or volunteers, or to raise funds, donations and services.

Media relations is a two-way relationship, and the media can be friend or foe. Because the media has commitment and accountability to the public, media content usually relates to what the public would like to hear. This can be in the form of hard news (events happening now, serious information) or soft news (follows hard news, how the hard news has affected people).

It is important to work with the media based on the relationship of trust and confidence and also through the support of one’s own communication department as they are then able to state the facts from a reliable source. Participants were advised against the following: using terms such as “No comment” and “Off the record”, and jargon and acronyms; repeat negative questions and phrases; lie and confuse the media; make demands; and play the blame game. Messages provided to the media must be more than a “spin”, and must reflect genuine action, practices, commitment and ethics of the organisation. The CEO or director is primarily responsible for maintaining corporate reputation, integrity, and professionalism.

The tools of communication include press releases, media advisories, interviews, “op- ed pieces”, news or press conferences, briefings, seminars, news feature, etc. Organisations must be prepared to handle queries through the use of holding statements and FAQs (Frequently Asked Questions). Press releases should have catchy and concise titles, and the lead paragraph should contain important information and the objective of the release. The body usually includes one or two paragraphs to explain the issue, and it should close with the organisation’s position on the issue.

In managing print interviews, the questions and angle of the story must be developed in advance. It is useful to adopt the practice of using no more than three key messages. Objectives must be stated at the beginning, and if unrelated questions are asked, the answers should bridge back to the key messages. Most of the time, the interview are not live, and therefore it gives one time to summaries one’s thoughts. In TV and radio interviews, it is important to know the audience and the interviewer, initiate conversation rather than give a speech, and keep to the point. It is important to adapt and control behaviours such as fidgeting during a TV interview. In radio interviews, appearance is not an issue and the voice must be able to deliver the message. Varying the tone of voice is useful.

Press conferences are difficult and it is important to consider the relevance of a press conference. The communications during the conference should include the objectives of the conference, the current situation, facts and figures as support, any repercussions of the situation, where do we want to be, and call for action if any. If there should be a call for donors, the target audience and eligibility criteria should be stated.

Ms Teo then discussed the management of media during a crisis. It is important to be prepared and to have a disaster management plan. During a disaster, assess the situation and gather the facts. Information should be provided through one central information centre. A proactive approach should be adopted, and holding statements used until more information is received to enable specific statements. Events should be recorded as the crisis evolves, and communication plans updated and implemented.

She concluded by using a recent case study in Singapore to illustrate the management of media communications during a crisis. Panel Discussion on Managing Your Communication

 How does one manage the media when somebody dies due to lack of blood ? It is important that proper systems for blood delivery are in place and that there is no deviation from standards, as there will always be close scrutiny of the blood bank processes including blood delivery to the patient in such cases.  In the case of a case involving blood supply deficiency, is it appropriate for the blood bank director to apologise to the media. Lawyers in several countries would usually discourage this practice. However, if the blood bank is at fault, then apologising through the media could be positively perceived by the public as being supportive.  A new dilemna for blood banks nowadays is how to manage the issue of donors who may have tested negative for infectious diseases in the past, but now test positive when new technology with higher sensitivity is used. When new such tests are introduced, it may result in the need to recall a great number of donors, and also potentially affect hundreds of patients. The infectious risk to the general population would need to be studied, and if there is potential that the public might over-react, then it might be better to share the information with the media in a diplomatic manner. Such decisions could be decided through the ethics committee; however, whatever decisions are made should be made responsibly and with accountability.  In countries with many languages, communications can be a major problem even with media.  Sometimes the media report the wrong facts, e.g. reporting expiry of blood at 365 days instead of 35 days. In such instances, it is important to approach the media to make the correction the following day.  It is good practice to periodically provide information and updates to the media about blood and blood transfusion. This helps to educate them so that they are more knowledgeable and accurate in their reporting.  Sometimes there are news reporters who may distort information to the public. It is useful in these cases to ask for corrections and clarifications, or if they refuse, then to report in another newspaper or use other channels. In countries with many media, the blood service should ideally approach only media with good and sound reputation.

Methods of Communication

Dr Peter Flanagan conducted a interactive session involving the use of mind-mapping technique to discuss the different methods of communication and the influence of the reason for communication and target audience in selecting the right method.

Participants were able to identify a comprehensive list of communication methods that included: press release; television; radio; website; newspaper; newsletter; music; party; teleconference; lectures; seminars; press conference; text messaging; e-mail; sms; fax; bulletin; road show.

The use of different types of communication was discussed: formal versus informal, individual versus group, internal versus external, and lateral versus vertical methods. Some examples of tools used to communicate with stakeholders were also discussed. In communicating with donors, one-to-one approaches such as writing to them or sending sms text to them were effective methods. Invitation letters to them 2 weeks before they were due for their next donation was one example, as well as asking them to make appointments to donate. Use of websites to provide information was another good method of communication, including reaching out to the public. Communications with stakeholders such as hospitals could involve methods such as the use of electronic links or fax that enabled them to provide updates on their blood inventory levels.

Social Marketing and Developing Effective Communication Strategies

Dr Lin Che Kit explained the need for effective social marketing strategies for blood programmes. Social marketing is the application of generic marketing with objective to change social behaviour primarily to benefit the target audience and general society. The goal of social marketing is not to market products and services but to influence social behaviour, e.g. anti-smoking, blood donation.

Different types of social behaviour change programmes exist with increasing difficulties – one time behaviour vs continuing behaviour, individual decision vs group decision, low involvement vs high involvement. In blood donation behaviour, it is common to begin with one time behaviour with continuous behaviour as the goal. High involvement continuing behaviour change is the most difficult.

There are differences between social and generic marketing. Social marketing is often under intense public scrutiny, must meet extravagant expectations, influence non- existing demand, or influence negative demand. It is often required to target the less literate audience, and requires understanding of highly sensitive issues. It can focus on many benefits – intangible invisible benefit, benefit to third parties (blood donation being one), self-reward. Long-term changes are central to planning, and limited resources are a reality that must be taken into consideration.

Good social marketing begins with philosophy that is deeply rooted in the target audience. Good social marketing involves many factors. Exchange is central, and marketing management involves influencing exchange. Consumers make decisions as choices among alternative behaviours that vary in benefits and costs provided. There must be willingness by the marketeer to change the product being offered, i.e behaviour being promoted. Customers may not always agree (e.g because blood donation is painful), and different strategies (e.g. how to make it less painful) may have to be considered.

Market research is important to determine customer needs and wants, and should be conducted at the start of strategy development and constantly assessed. Alternative strategies may have to be experimented with to determine the most effective. There is usually diversity in target audience needs/wants/lifestyle/perceptions/preferences and strategies should be fine-tuned to needs and wants of each subpopulation.

Bottom line orientation is important and marketeers need to be mindful of limited resources. This requires them to keep evaluating the cost effectiveness of the marketing plan, with constant attention to efficiency and effectiveness of everything that they do. There must be commitment to planning and to think systematically through major steps to be undertaken. There must also be willingness to take “reasoned risks”, which incorporates formal calculation of inherent risk into decision- making processes.

Sustainability and institutionalisation is an important consideration as many social marketing programmes may be temporary in nature, and may be subsidised by “outside” organisations. Steps must always be taken to train local staff in critical marketing skills.

Influencing behaviour is primarily a matter of communication. Communication involves informing target audiences about alternatives for action, positive consequences of choosing a particular one, and motivations for acting in a particular way. Everything about an organisation – products/ employees/ facilities/ actions – communicates something. Organisations must therefore examine their communications styles, needs and opportunities, and develop a communications plan that is influential and cost effective. Communications plans should take into consideration parties other than the target audience; this includes external parties (e.g. press, government agencies) and internal parties (e.g. board members, middle management, employees, volunteers).

Dr Lin concluded by discussing how to develop effective communication, firstly by setting communication objectives and generating possible messages. Messages could be rational, emotional or moral in nature. He also emphasised the need to overcome selective attention and perceptual distortion in the target audience. This requires careful message evaluation and selection, and advised participants to select one that is most desirable, exclusive and believable. Finally, message execution is important, e.g. the difference between “Give blood, save life”, “Be a lifesaver, give blood”, and “Give blood, give life”.

Developing Communications Plans

Dr Yasmin Ayob described the process of communications. The main elements include the source (communicator), message (set of symbols), medium (channel), receiver (target audience), and response.

The message developed must have clear content, and channels could include the mass media, pamphlets, posters, newspapers. Other means of facilitating communication could be the use of effective promotion programmers, advertising, and leveraging on networks. Depending on the need, one could use mass (able to reach large number of people) versus interpersonal (persuasive, stronger impact) communications. In developing a message, it is important to know the target audience and the environment ,e.g. the characteristics of the people in the community and cultural factors. The objective of the message, e.g. to get more regular blood donors, should also be kept in mind. Messages could be connotative (essentially feeling and relationship) or denotative (primarily literal and factual) in form, or rational versus emotional. In planning delivery of the message, the promotional component (what to promote) and specific activity (how to promote) must be determined.

Dr Ayob went on to discuss the issues surrounding the communication of blood donation, such as the health and social issues, building of relationships, the image of the BTS as receiver and giver, donor management. Usually blood campaigns are short-term in nature, and public relations management is important to complement the other activities.

Developing communications plans involve first analysing the situation and environment, and then setting the promotional objective and defining the target audience. The message must be defined, appropriate channels selected, budget prepared, and the promotional mix chosen. Following implementation of the plan, results should always be evaluated for effectiveness.

Communications involving blood programmes usually involve the following target audiences:

 Public e.g. to encourage blood donation  Govt e.g. to establish a nationally blood program  Media e.g. tainted blood, transmission of disease thru transfusion  Blood donor e.g. reactive for TTI screening  Patient e.g. transfusion of possible tainted blood

When dealing with the public and community, correct facts and information must be provided and appropriately delivered, in both language and form. The appeal to the target audience could be based on rational or emotional appeal, e.g. we need blood to replenish our stock versus a bleeding patient needs blood. The response achieved and effectiveness of the plan should be monitored.

When communicating with blood donors, Dr Ayob advised participants to tell the truth, give the facts, gauge response, evaluate understanding of the facts given, encourage questions, and not to adopt judgemental attitude. In the case of the media, inform them that certain things cannot be compromised (e.g. safe blood donors, public trust), be conscious of public sensitivities and clear of role and responsibility. It is useful to engage the media as partners and to bring them to your side. Finally, when communicating with the government, have a clear objective, present clear facts with local data, and provide the assessment of the situation if the proposed intervention is not carried out.

Group Discussion on Communications Planning

Key points arising from these include:  In some countries such as Hong Kong, television advertisements are free. Similarly in China, some advertisements are provided free for certain programmes and blood donation is included in these.

Practical Session on Communications Strategies and Plans

Participants broke out into four Working Groups. Each Working Group was provided a scenario and encouraged to discuss appropriate strategies to manage the scenario, and to develop effective communication plans to handle the situation favorably. Scenarios were developed based on true experiences.

The four scenarios discussed were:

 Based on studies that show that many female donors in your country are iron deficient at your current Haemoglobin criteria of 12.0 g/dL, you have decided to raise the criteria for female donors to 12.5 g/dL. Develop your communications plans to manage this without causing significant donor loss.  There is a major disaster involving a plane crash overseas. Five casualties from your country are flown back for treatment for severe burns. The public, wishing to help, rush in to the blood bank to donate blood. However, the patients need few transfusions initially, but will need more blood support over the next few months. The blood bank is flooded with donors beyond the normal capacity. Develop your communications strategy to manage this event.  Patients are charged blood processing fees to recover the costs of processing and testing the blood. However, blood is donated voluntarily and freely and there is no charge for blood. Nevertheless the rumour is circulated around that the blood bank sells blood, and many donors call in angrily in response. Develop your communications strategy to manage this event.  A survey has shown that many donors do not donate because some fear that they will catch a disease during donation, some feel that they are too weak, and some believe that they will get fat. Develop your communications strategy to manage these misconceptions.

Session 5: Achieving Quality Through Standards and Regulation

Standards: Why do we need standards, Who should develop standards and How do we develop and enforce standards

Dr Peter Flanagan introduced the transfusion paradigm, with the medical model of clinical service provision that is focused on patients and their needs, or the pharmaceutical manufacturing model that is focused on products and their “fitness for purpose”. The regulatory paradigm, with its focus on products, involves quality (conformance to specifications or standards), safety (risk reduction and avoidance of harm), and efficacy (achieves intended purpose). He went on to define quality-related terms. Quality is defined as conformance to specifications. Quality control is the measurement of parameters to demonstrate that the system is performing correctly. Quality assurance is the development of a systematic approach that will ensure that products and services meet stated requirements.

Standards are important as they provide a common goal, enable communication of the organisation’s requirements to staff and stakeholders. Standards are also a first step in ensuring production of consistent, safe and effective components. There are internal standards and external standards. The primary responsibility for internal standards lies with the blood service. Internal regulation means that a system exists within the blood service to ensure that the standards are met. This improves management confidence that the system is working is intended. A local quality system might achieve this.

External standards may be are set either by a competent authority (regulator or government), puchaser (plasma fractionator or hospitals), or the blood service. External regulation is the enforcement of standards by an approved body and designed to improve overall performance and assure quality control. Compliance to the standards are determined by external inspectors and controls.

Two complementary types of standards exist. The first are technical standards which identify what needs to be achieved - these include the AABB Standards, the Council of Europe Guide, and the UKBTS Red Book. The second are quality standards which identify systems that must be in place to achieve stated goals. Standards must be: clear and easily understood; measurable; realistic and achievable; appropriate to the local environment; defensible; and may incremental in nature. HIV antibody testing was used as an example of incremental standards.

Dr Flanagan went on to describe the quality improvement cycle. Key questions that must be asked are “What do I want to achieve”, “What do I need to do to achieve it”, and “How will I know if I have achieved it”.

In the blood service, standards generally include the following categories :  Donor Acceptance Standards  Blood Donation Standards  Blood Processing Standards  Blood Donation Testing standards  Blood Component Standards  Service Standards – donors / hospitals.

He used the New Zealand Blood Service (NZBS) Standards as an example. The NZBS Standards uses the Council of Europe Guide as the primary reference standard, as this utilises the benefit of a larger and more experienced group (greater status) and provides useful justification for practice when challenged (defensible). The NZBS Standards were then produced based on the Council of Europe Guide; however, changes must be approved by the regulator (MedSafe) and deviations from the Guide must be justified. Reference standards that can be used by blood services include the Council of Europe Guides, WHO guidelines, AABB Standards, FDA Code of Federal Regulations, and UKBTS Guidelines (Red Book). It is useful to refer to more than one reference when defining internal standards as it provides for high level of commonality and clarifies critical requirements.

Donor selection standards are critical in assuring the safety of blood donor and recipient, and should ensure careful balance between safety and sufficiency. Standards must be relevant to the local situation as it is not always appropriate to take another country’s standards and apply it locally. It is therefore useful to learn from sharing and understand reasons for differences. Common causes for differences include donor age, donor haemoglobin, volume of blood collected, and frequency of donation. The key requirement is to set justifiable limits appropriate to the local situation.

Component specifications defines the product intended for manufacture. Critical manufacturing requirements usually include volume and content. Specifications should take into account the intrinsic biological variation in the primary donation. It should also identify quality monitoring requirements. Dr Flanagan illustrated this with examples of component specifications used in the NZBS.

In assuring quality, two general approaches are used: control of product (component monitoring) and control of process (process control). Component monitoring measures output of manufacturing process and identifies whether components meet specifications. Process control extends the quality system to include control of processes with the aim of ensuring that blood components will be manufactured to specifications. Control of process generally provides greater control of the final product and leads to a relatively standardised product.

Dr Flanagan concluded that standards are an essential part of any blood programme. At a minimum, each blood service must define its own internal standard and then put systems in place to ensure that they are met. Where possible, linkage to acknowledged international standards should be considered. Regulation and external standards would need to be undertaken in blood services operating within the pharmaceutical paradigm.

Group Discussion on Standards

 If existing standards were developed many years ago, they need to be updated. This can be done by approaching an experienced person to document the standards and then compare them with standards from other countries and update accordingly.  It is not always necessary to fully comply with international standards or standards from other countries, e.g. AABB standards, if there are differences as a result of local cultural difference for example. In such cases, there should be good justification for the difference. For example, AABB accreditation allows variance from its standards if there are good reasons given.  In New Zealand, the components standards are developed by clinical advisory groups using the UKBTS, Council of Europe, and Australian standards as a guide.  Internal quality control (e.g. temperature monitoring of fridge) is similar to IQA but not exactly the same. IQC checks only various points, whereas IQA involves independant people auditing. While external audit might not be compulsory, IQA is essential.  WHO is currently developing a set of minimum standards for blood services, which will be available to all countries.

Regulatory Philosophy and the Role of Regulation in Protecting Public Health

Dr John Lim described the regulatory challenges now facing regulators. The role of regulator is changing, from that of controller and regulator, to that of nurturer and facilitator, to that of convener and aggregator. Finding the correct regulatory balance is a constant balance of role, policy and resources. This is because no health product is 100% safe, and “safe” does not equal a risk free product. This is complicated by changing and unstable external environment, such as infectious disease threats and natural disasters. Operational challenges include service delivery turn-around time, product safety monitoring, and cost efficiency (maximising resources and minimising cost of regulation and operations).

He then went on to describe the conceptual frameworks of risk management in regulation. The old framework involving a zero failure regime with a one size fits all approach is not possible or desirable. The alternative is smart regulation with a risk- based approach. This requires collaboration and partnerships, and a consultative approach to determine the acceptable risk management position.

The regulatory toolkit includes: surveillance (market intelligence, environment scanning, benchmarking), intervention (legislative controls, system and process redesign, inspection, education, communication), enforcement (warning to legal actions), and strategic partnerships. Using the right tools is a science and an art.

Dr Lim shared the experience of the Singapore HSA. Strategic partnerships are important to effective regulation. In Singapore, this is facilitated by a coordinated biomedical landscape, and the HSA is able to work with many partners. He described the HSA’s regulatory aims, the risk management partnership in Singapore involving the regulator, business and consumer, and its role in managing medicinal product risks to consumers. The risk challenge is to determine acceptable levels of risk in the societal context, and this involves risk assesssment, risk intervention, and risk communications. Effective risk management involves facilitating access of the appropriate product at appropriate dose/level to the appropriate patient in appropriate manner, considering the requirements and expectations of healthcare community.

He then described the restructuring taking place in HSA, which is necessary to deal with change, improve public health protection while ensuring timely access to medicines, enhance regulatory efficiency by minimising duplication and using resources appropriate to risk, and reduce regulatory costs. Legislative restructuring to modernise the regulatory framework resulted in introduction of the Health Products Act in 2007. The Act is intended to consolidate medicines control laws, and is based on a modular approach, which is more responsive and flexible to deal with products with different degrees of risk.

Organisation restructuring aims for more efficiency through better integration. The approach includes: focus on outcomes and risk management; matrix model; whole-of- government approach; and leverage on regulatory partnerships locally and overseas. Systems and process restructuring is also required. Regulatory cooperation involves inter-agency cooperation which can cover a range of possible activities: harmonisation of regulatory technical requirements; exchange of information; mutual recognition; and joint inspection.

Dr Lim summarised the key actions taken. Firstly to study the regulatory restructuring options, and apply the risk management approach. Wisely select and use regulatory tools appropriate to context, and implement matrix structure and coordination. Review and re-engineer systems and processes, and increase regulatory partnerships to leverage on other systems.

Group Discussion on Regulatory Philosophy

 As HSA is a regulator as well as the national blood service, how does it ensure that there is regulatory independance and no conflict of interest ? In this case, there must be transparency, external audit, and well-defined roles and responsibilities. The regulators (CDA) and the blood service (CTM) are very independant, and the regulatory professionals do not involve the CEO or the Senior Directors in their professional deliberations or decisions. Where necessary, external evaluators are used. The MOH also licenses the blood bank; only plasma derivatives are licensed by the CDA.  In New Zealand, all drugs require evaluation, even though the drug is a subsidised drug and registered elsewhere. In Singapore, drugs coming in for registration are assessed for quality, clinical efficacy, registration with other relevant bodies, manufacturer, and relevance to the population. The subsidy is not a factor.  Cord blood regulation in Singapore falls under the purview of the MOH. HSA only deals with the clinical trials and drug developments in this area.  Regulators are now under immense pressure to standardise practices. Amongst participants countries, it is best to have coordination, sharing and collaboration than starting from scratch.

Country sharing and discussion – Pitfalls and limitations, roadblocks and how to overcome them Dr Peter Flanagan conducted a group discussion on the challenges and limitations they faced in managing their blood programmes. Participants were encouraged to identify roadblocks and also potential solutions.

A number of constraints and roadblocks were identified:

 Buy in from another country  Lack of government support  National policy  Weak organisational structures  Lack of financial sustainability, weak financial framework  Planning capability (resources for planning)  Duplication  Lack of co-ordination/communication  Lack of oversight  Lack of trained staff - “brain drain”  Staff resistance  Limited facilities  Public awareness of blood donation  Patient expectation of free blood products  Lack of data  Clinical education  Research

Some key issues were discussed and possible approaches to overcome limitations are roadblocks discussed:

 Assistance in costing tools and finance. WHO has developed basic costing tools for blood banks, but these are not comprehensive. One suggestion is to collate the various data and information from other countries and make it available.  Training and supervision of staff – training department to conduct training for staff, including medical staff, hospital staff, donor management staff. Also useful to train government staff, auditors to create better awareness.  External support could be in form of technical consultants  Must be ownership of action plans and development of the blood service from the local staff. External consultants able to provide advice and guidance, but local blood bank staff often already have good knowledge already present and are capable of making very significant difference.  Management skills are important and must be developed among blood bank staff through training  It is also important to have clinical competence within the blood bank, so that blood bank staff feel comfortable providing clinical advice to clinicians and nursing staff in hospitals.  WHO Aide-Memoires are available on many areas and topics. These are useful references and can be obtained from WHO Office.  Staff motivations and attitudes are important. The FISH philosophy from Seattle Fish Market is one approach where a positive attitude, innovation and excellence is celebrated in spite of a difficult work environment. Participants were encouraged to adopt this philosophy.  There are different types of staff and the manager must be able to differentiate between them and manage each accordingly. Sometimes lack of contribution and value add from a staff may be due to inadequate opportunity.

Session 6: National Action Plans

Group Discussion on the Development of Action Plans

Dr Yu Junping introduced the session relating to the development of action plans by participants following the workshop. Participants broke up into country groups to develop action plans. Action plans were presented from the Maldives, Papua New Guinea, Nepal, and Lao PDR were presented for discussion.

Participants shared their national action plans with WHO. It was envisaged that updates on the progress of these action plans would be presented at the Second Workshop slated for 2008.

Workshop Recommenations

Participants

1. Progress the implementation of the draft action plans developed at this workshop. 2. Prepare a progress report presentation for the 2008 workshop. 3. Seek possible management development opportunities within one’s own country. 4. The CTM would work with the Singapore Red Cross to develop a regional internet-based forum to facilitate regional networking and training initiatives.

World Health Organisaton

1. Improve financial capability of national blood services by development of tools to support financial management 2. Provide support to enhance training and education systems of national blood services 3. Assist in provision of external support

Closing Ceremony Dr Diana Teo thanked the participants and facilitators for their active participation in making the Workshop a success, and wished them a safe journey back to their countries. On behalf of WHO, Dr Yu Junping thanked the Singapore Government and Ministry of Foreign Affairs, the CTM staff, and all the participants. Mr Chua Teck Hock, representing the Singapore Ministry of Foreign Affairs concluded the ceremony by presenting participants with their Certificate of Participation.