Workshop on the Quality Management Project (QMP) for Blood Transfusion Services in the Western Pacific Region, Singapore, 8-10 Ocotber 2001 : report

(WP)TLRlICPIHRF100 IIRB/2000 Report series number: RS/200 1IGE/31 (SIN)

English only

.,

REPORT

WORKSHOP ON THE QUALITY MANAGEMENT PROJECT (QMP) FOR BLOOD TRANSFUSION SERVICES IN THE WESTERN PACIFIC REGION

Convened by: WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC Singapore 8-10 October 2001

Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines January 2002

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NOTE

The views expressed in this report are those of the participants in the Workshop on the Quality Management Project (QMP) for Blood Transfusion Services in the Western Pacific Region and do not necessarily reflect the policy ofthe World Health Organization.

This report has been prepared by the Regional Office for the Western Pacific of the World Health Organization for governments of Member States in the Region and for the participants in the Workshop on the Quality Management Project (QMP) for Blood Transfusion Services in the Western Pacific Region held in Singapore from 8-10 October 2001.

CONTENTS Page SUMMARy .................................................................................................................................. 1 I. INTRODUCTION ................................................................................................................. 5 1.1 Objectives ..................................................................................................................... 5 1.2 Participants .................................................................................................................... 5 2. PROCEEDlNGS ................................ ,..................................... '" ....... '" ................................ 5 2.1 2.2 2.3 2.4 2.5 2.6 Opening ceremony ........................................................................................................ 5 Purpose of the meeting, procedure and outcome .......................................................... 6 Presentations ................................................................................................................. 6 Country reports ........................................................................................................... I 1 Summary of discussions and report from Working Groups ....................................... 13 Brain-storming session to develop the regional strategy on promotion of blood safety in Member States in the Western Pacific Region ............................... 17 2.7 Closing session ........................................................................................................... 20 3. CONCLUSION AND RECOMMENDATIONS ................................................................ 21 3.1 Conclusion .................................................................................................................. 21 3.2 Recommendations ....................................................................................................... 21 ANNEXES: ANNEX 1 LIST OF PARTICIPANTS, TEMPORARY ADVISERS, CONSULTANT AND SECRETARIAT ................................................... 23 WORKSHOP PROGRAMME ......................................... ··· ...................... 33 AIDE-MEMOIRE FOR NATIONAL BLOOD PROGRAMMES ........... 37 QUALITY STATUS QUESTIONNAIRE FOR lNDIVIDUAL BTSs ..... 39 WORKING GROUPS ............................................................................... 45

ANNEX 2 ANNEX 3 ANNEX 4

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ANNEX 5 -

Key words

Blood transfusion - standards / Blood safety / Quality control! Singapore

SUMMARY

A Regional Workshop on the Quality Management Project (QMP) for Blood Transfusion Services (BTSs) in the Western Pacific Region was held at the Centre for Transfusion Medicine, Health Sciences Authority, Singapore, from 8 to 10 October 200 I. This meeting was the first meeting in the Western Pacific Region to introduce a new initiative of WHO - the QMP, which was launched in 2000 as a cornerstone of WHO's goal of achieving a safe and adequate global supply of blood. The meeting was attended by 19 directors/programme managers of BTSs and responsible staff for quality of BTS, and II potential/future facilitators. The objectives of the meeting were to assess the status of quality management of BTS in the Western Pacific Region, sensitize the directors of BTSs and national blood programme officers to the importance of quality management as a part of BTSs and to the need for training in this vital area, review and adapt the curriculum for training courses on quality management for BTSs and develop a plan of action for implementation and evaluation of training courses. Summary of presentations and discussions Quality Management Project

The Quality Management Project (QMP) is one of the major activities of the Blood Transfusion Safety Team, designed to build regional and national capacity in quality management and to promote the establishment of effective quality systems in blood transfusion at all levels of the health system in Member States. Through the project, 200 participants from 75 countries (2001) have been trained in quality management, regional quality training centres have been identified and regional external quality assessment schemes have been established. Status ofBlood Transfusion Services in the Western Pacific Region

Due to the diversity in the Region, BTSs face major challenges. Less than half ofthe countries have a nationally coordinated blood programme and most still rely on family/replacement blood donors. Quality systems for most countries are not fully implemented. The need for capacity building, particularly human resource development is identified and will be assisted by the potential for good regional collaboration, particularly in the implementation of theQMP. Importance of Quality in BTSs

With the advent of HIV, the implementation of quality in blood transfusion activities is essential to ensure safe and efficacious blood and blood products. Quality cannot be assured by testing of the final product. Therefore, quality begins at the point of blood donation and ends at the conclusion of the transfusion of the patient contributing to the patients' well being. The terminology used to describe this process is 'vein to vein'.

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Human Resource Development The key to successful implementation of quality systems in the BTS is the management of human resources by ensuring that the 'right person is employed for the right job', and that they are competent in their work. Training all personnel so that they understand their overall position in the organization, through comprehensive job descriptions, is also essential. Monitoring. evaluation andfollow-up ofQMPIQMT Basic principles of monitoring and evaluation are aimed at continuous improvement as applied to quality systems. Monitoring and assessment of the project and training courses has identified indicators to indicate both the success of the project and the implementation of quality systems at the national level. Monitoring is designed to the number of participants, the proportion of countries involved in the training, and the number of training courses held. Monitoring of progress made and follow-up of participants will be done through the use of a questionnaire on quality status. Regional external quality assessment schemes (EQASs) Regional external quality assessment schemes will be established to monitor laboratory performance, evaluate quality control measures and establish inter-laboratory comparability. Benefits of EQAS include facilitation of information exchange and education through exercises, report and meetings. Under the project, regional centres will be identified to organize and coordinate the EQASs. All participants to Quality Management Training (QMT) courses will be registered for EQASs. Facilitators' toolkitfor QMT courses The QMT course curriculum is made up of IS distinct modules covered over 18 working days. The curriculum focuses on generic applications of quality management systems during the first eight modules and then trains participants to apply these principles to blood transfusion activities. The teaching method gives maximum learning opportunities through the use of interactive role-plays, group activities and self-assessment exercises. A toolkit, with presentations and activities already devised, is in final draft form. This will assist all potential facilitators to maintain a global and generic standard in quality management for blood transfusion activities. The major expected outcome of the training course is for the participants to identify their role in establishing quality systems in their own BTS and develop an action plan for implementing quality. Summary of discussions Key problems and possible solutions in BTSs The common problems identified were hospital-based BTSs and continued reliance on family/replacement blood donors. Governments (national health authorities) need to ensure centralization, where the infrastructure allows, to rationalize resources and ensure the establishment of a pool of safe voluntary, non-remunerated blood donors. Implementing nationally coordinated management ofBTSs would be assisted by the recognition of blood transfusion medicine as a specialty in its own right. Participants identified stock control as a problem for some countries. The solution would be to implement quality systems that cover all aspects of stock management. To address the problems identified in the appropriate clinical use

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of blood, participants urged the implementation of the guidelines from WHO on the clinical use of blood and training for all those involved in transfusion medicine.

Organizational structure ofBTSs Participants emphasized the need for commitment to quality supported by an appropriate management infrastructure. They highlighted the role of the directors ofBTSs who should ensure policies, strategies and plans are in place and implemented, with particular reference to quality blood donor management. Directors of BTSs also need to ensure that resources are available. Quality managers should ensure effective management and control of changes, appropriate documentation, monitoring of quality control measures and regular review of the quality system.

Planningfor implementation ofQMPlQMT The participants identified three main areas to ensure implementation of the project. These included the steps to be taken by directors of the BTSs with particular reference to open dialogue with national health authorities, identifying needs and identifying strengths (for regional collaboration). Participants felt that the identification of the appropriate participants for the QMT courses should be a collaborative effort between the directors of BTSs, national health authorities and other known interested parties in the country, e.g. the Red Cross. The participants should ideally have a medical, technical or scientific background with a broad-based knowledge of blood transfusion activities. The participants to this meeting stressed that the QMT participants should be designated a position, or have a position, of authority and responsibility to bring about change.

Brain-storming session to develop the regional strategy on promotion of blood safety in Member States in the Western Pacific Region The participants carried out a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis of the region and concluded that strategies needed to be put in place at the national level with particular reference to blood donor recruitment and implementation of quality systems through the QMP and QMT courses. Recommendations The participants endorsed the QMP and QMT courses and recommended the following: To WHO (1)

To mobilize and coordinate available resources in the region to assist Member States with implementation of the QMP.

(2) To support the Member States in the implementation ofthe QMP through advocacy to the policy makers and national health authorities. (3) To identify the regional quality training centres, external quality assessment scheme coordination centres and coordinators for the QMP in the Western Pacific Region. (4) To assist in the development ofa network for blood safety in the Western Pacific Region.

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To National Health Authorities (Ministries of Health) (I)

To identify blood safety as a priority and develop a sustainable national blood programme as an integral part of the health care system.

(2) To provide a stable infrastructure and resources (including human and financial) to BTSs to ensure attainment oflong-term objectives in blood safety. (3) To support those in charge of the BTSs in their endeavours to provide a safe and adequate blood supply through implementation of quality systems. To participants (directors) (I) To sensitize the policy makers on the need for quality in BTSs and mobilize support for the implementation of the QMP. (2) To ensure success of the QMP by selection of the appropriate trainees for the future QMT courses through consultation with national health authorities and the WHO. (3) To assist in the implementation of quality systems through support and commitment to the trainees of the QMT courses. To facilitators (I) To ensure commitment and support for providing training for quality managers.

(2) To cooperate with the coordinators of the QMT courses in the preparation, organization and follow up of the courses.

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I. INTRODUCTION

The Quality Management Project (QMP), a new initiative of WHO, was launched in 2000 as a cornerstone of WHO's goal of achieving a safe and adequate global supply of blood. With capacity building being one of the major goals of the QMP, it has proved necessary to ensure that all Member States in each region become involved in the project and in particular in the Quality Management Training (QMT) courses. A Regional Workshop on the Quality Management Project (QMP) for Blood Transfusion Services (BTSs) in the Western Pacific Region was held at the Centre for Transfusion Medicine, Health Sciences Authority, Singapore, from 8 to 10 October 200 I. The meeting was convened for directors of BTSs, and national blood programme officers, ministries of health, and responsible staff for quality of blood transfusion service (BTS) from countries in the Western Pacific Region of WHO, and also for the potential facilitators for the QMT courses in the Region. This meeting was the first meeting in the Western Pacific Region to introduce QMP and QMT to this Region. 1.1 Objectives (1) To assess the status of quality management of blood transfusion services in the Western Pacific Region. (2) To sensitize the directors of BTSs and national blood programme officers to the importance of quality management as a part ofBTSs and to the need for training in this vital area. (3) To review and adapt the curriculum for training courses on quality management for BTSs. (4) 1.2 To develop a plan of action for implementation and evaluation of training courses.

Participants

The meeting was attended by 19 directors/programme managers of BTSs and responsible stafffor qual ity of BTS, II potential/future faci Iitators, and also by short-term consu ltants, WHO-WPRO and WHO/BCT/HQ staff. A list of participants and secretariat is attached as Annex 1. 2. PROCEEDINGS

2.1

Opening ceremony

The meeting was opened by the Chairman of the Health Sciences Authority (HSA) in Singapore, Professor Hang Chang Chieh, and the WHO Representative for Brunei Darussalam, Malaysia and Singapore, Dr U.H. Susantha de Silva, who both urged all present to consider the need for introducing quality into the entire blood transfusion chain. Dr Chen Ken, Regional Adviser in Traditional Medicine, Health Research and Health Laboratories, WHO/WPRO and Dr Neelam Dhingra, Medical Officer, Blood Transfusion Safety Team, Department of Blood

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Safety and Clinical Technology, (WHO/BCT/BTS - HQ) played the role of~acilitators of the meeting, and the Rapporteur was Mrs Shan Lloyd, a short-term consultant WIth WHO/BCT/BTS - HQ). 2.2 Purpose of the meeting, procedure and outcome

Dr Chen Ken, Regional Adviser in Traditional Medicine, Health Research and Health Laboratories, WHO/wPRO and responsible officer for the meeting gave a brief introduction to the objective, process, proposed methods and expected outcome of the workshop. He indicated that the main purposes of the workshop were to familiarize participants on WHO QMP and QMT courses and to raise interest and commitment from countries to participate in the QMP initiative in the Region. The major expected outcome was a plan for implementation ofQMP/QMT in the Region, proposed by the participants of the workshop. During the workshop, presentations were given on WHO QMP and QMT courses, and the need for quality management in BTSs. Country reports were presented. Core issues were addressed by working groups and a special 'brainstorming' session was organized to discuss future collaboration on blood safety programme in the Region. (See Programme of Work Annex 2) 2.3 2.3.1 Presentations Quality Management Project

Dr Neelam Dhingra presented the problems facing the safety of blood at global level based on the data obtained from the Global Database on Blood Safety (GDBS). She highlighted the fact that 80% of the world's popUlation have access to only 20% of the safe and tested global blood supply. In response to the need, WHO has identified blood safety as one of its priorities. Dr Dhingra then highlighted the WHO strategies for safe blood transfusion and activities of the Blood Transfusion Safety Team to address these problems. The Aide-Memoire on Blood Safety (Annex 3) mentions integrated strategies for ensuring safe blood transfusion, and WHO's activities are targeted to implement these strategies. These are: • • • • • • Advocacy through the Aide-Memoire for national blood programmes and other guidelines for policy makers. Global CO.llaboration for Blood Safety (GCBS) and the Global Database on Blood Safety (GDBS) The QMP and QMT Distance learning programmes on safe blood and blood products Development of simple technologies, e.g. the Haemoglobin Colour Scale and blood cold chain devices Clinical use of blood

The QMP has been designed to build regional and national capacity in quality management and to promote the establishment of effective quality systems in blood transfusion at all levels of the health system in Member States. The project is coordinated at the global level by the Blood Transfusion Safety Team, Department of Blood Safety and Clinical Technology,

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WHO Headquarters. Regional coordination is done by WHO Regional Offices in partnership with Regional Quality Training Centres, WHO Collaborating Centres, national BTSs, international non-governmental organizations and experts in quality and transfusion medicine. The major components ofQMP are regional quality training centres, QMT, external quality assessment schemes (EQASs), regional quality networks for BTSs, post-training support and follow-up, and development of advocacy and training materials. QMT courses are designed with a generic curriculum that stresses active learning with course materials that can be adapted for regional needs. Assessment of participants and the progress made, after training, are important elements of the QMT courses. Implementation ofthe activities todate include development of the training curriculum and materials, meetings for directors ofBTSs in the WHO Regions, and meetings of facilitators at global and regional levels, and quality management training courses in SEARO (4), AFRO (3), EMRO (2), EURO (l). EQASs has been established in three Regions and a global QMP review meeting is planned for 31 October to 2 November 200 I. The major achievement of the project is that by the end of2001, 200 participants in 75 countries would have been trained in quality management in BTSs. 2.3.2 Status ofBTSs in the Western Pacific Region

Dr Chen Ken presented an overview of the status ofBTSs in the Western Pacific Region. He stated that the diversity, in geographic and population terms, was one of the challenges that faced the Region. Analysis of the organizational and management aspects of the BTSs in the Region showed that although in more than half of the countries an officially recognized BTS was in place, less than half were not nationally coordinated. Sixty-eight percent of countries had a national policy coupled with regulations or legislation that covers blood transfusion medicine. Implementation of quality management systems varied from fully implemented to no system being in place. Blood donation patterns differed vastly reflecting the global picture where countries from high Human Development Index - HDI (UNDP) have a blood donor base using VOluntary, nonremunerated blood donors while those from a medium or low HDI show donations largely from family/replacement donors. A few countries still rely on paid blood donors. Some of the countries in the Region have recorded successes in reducing reliance on family/replacement or paid blood donors (the Philippines have reduced paid blood donation from 70% in 1994 to 25% in 2000). Dr Chen reported that systematic screening for HIV and HBsAg was carried out in all countries, but that the other transfusion transmissible infection (TTl) markers were not tested uniformly, in particular, HCV (only 50% of donated blood is screened for HCV in the Region). He reported on the ongoing response from WHO to the needs for a safe blood supply in the Region, in particular assistance given to China, Cambodia, the Philippines and Viet Nam, and stressed that the needs were often related to human resource development. Furthermore, partnerships with funding agencies were crucial to the success of many projects, e.g. those supported by the World Bank and WHO. He concluded by remarking on the good potential for regional collaboration particularly in the need to strengthen quality management systems covering all aspects ofBTSs.

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2.3.3

Importance of quality in BTSs

Mrs Shan Lloyd outlined the need for quality in the BTSs. She highlighted that although many blood transfusion personnel fully understand the functioning of BTSs, they are not always fully conversant with applying quality systems to blood transfusion activities. The major need for implementing quality into a BTS is due to the fact that quality cannot be assured by only testing the final product. TTIs, in particular HIV, have challenged BTSs to regard their 'core business' in a new light. Whereas, BTSs were once considered technical organizations, and that quality was applied only to the laboratory, they are now con~idered 'service' organizations with many interested parties involved. Importantly, the service organization should fall under the academic discipline of transfusion medicine. By applying total quality management to a BTS many of the four strategies of the Aide-Memoire for National Blood Programmes can be realized. These strategies are: • • Establishment of nationally coordinated well-organized BTSs. Blood donation based on regular, voluntary, non-remunerated blood donors from an identified low risk population. All donated blood tested for TTIs and blood groups, and blood products produced under Good Manufacturing Practices (GMP). The appropriate clinical use of blood.

•

•

Society, patients/clinicians and blood donors form a strong inter-relationship in a quality system that is bound together by the staff of the BTSs. Statistical analysis of data from NBTS, Zimbabwe has demonstrated that although the general population has an HIV sero-prevalence of 25%, the sero-prevalence in the blood donor population is only 0.7%. This has been achieved by applying quality principles to the blood service with a result of increased safety and adequacy of the blood supply for the country's population. The needs to assure quality in the BTS stem mainly from the need to ensure that a patient benefits from, and is not harmed by, a blood transfusion. The quality approach for the BTS is to ensure that all blood and blood products are 'fit for their intended use'. By introducing this concept, reliable and safe blood products are available, which increases confidence in the organization that in turn leads to a highly motivated staff force who will reinforce quality into their work. She concluded the presentation by stressing that quality, therefore, needs to be applied to the entire transfusion chain from the donor to the patient ('vein to vein '). 2.3.4 Human resource development

Dr Cees Th. Smit Sibinga outlined the importance of and logistics behind staff management. Personnel in a BTS need to be given continuous and special attention to guarantee a motivated, functioning and committed work force that feel ownership for the system they work with. By defining needs for the job and for the staff member, a comprehensive job description can be in place for both the job and the staff member. All staff must be trained according to a well-documented and orderly plan. Trainers should be aware of the professional content of the

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job as well as the knowledge and skills needed. In quality systems the most important aspect of personnel management is training for competence. Competency training ensures that the personnel are trained for the job they were employed to do and according to the standard operating procedures that they will use on the job. Personnel also need to understand their overall position in the organization and be given authority and responsibility for those tasks they are trained to do. In summary, Dr Smit Sibinga stressed the need for any organization to 'get the right person for the right job' . 2.3.5 Monitoring, evaluation and follow-up ofQMP/QMT

Dr Smit Sibinga outlined the principles of quality monitoring and evaluation involving validation, audits and error management. Quality monitoring is an activity that has to be performed on an ongoing basis with appropriate indicators selected for assessing outcomes and data that is gathered analysed and acted on. He explained how quality monitoring has been applied to QMP/QMT to ensure continuous improvement. As the goal of QMP is to build national capacity in the area of quality management for BTSs, objectives and outcomes relate to that goal. Objectives focus on regional and national capacity such as training centres, regional EQAS and networking. The following will indicate the success ofQMP: • • • • • Two persons from each country trained as quality managers Regional quality training centres established Sustainable national quality systems implemented Quality desk/corner established in BTSs All donated blood tested and processed appropriately

To achieve the above outcomes, QMT monitoring is designed to the number of participants, proportion of countries involved in QMT and the number of training courses held. Monitoring and assessment of the participants and follow-up of the plan of action that they devise during training courses will also assist in progress evaluation. Establishment of base-line information and progress made will be done through the use of a quality status questionnaire (see Annex 4). Dr Smit Sibinga concluded his presentation by stressing the need to evaluate the training process itself by ensuring that materials used are suitable, participants learn through selfassessment and improve where deficiencies are identified. 2.3.6 Regional external quality assessment schemes (EQASs)

Dr Neelam Dhingra explained the overall aims of the EQASs that are being established or strengthened in each region/sub-region. She outlined that the major objectives of EQASs are to: • • Monitor laboratory performance and evaluate quality control measures Establish inter-laboratory comparability, identify common errors and provide mechanisms to remedy identified deficiencies

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• • • • •

Facilitate information exchange and education through exercises, reports and meetings. Influence reliability of future testing Ensure credibility of a laboratory and support accreditation Stimulate performance improvement Encourage use of standard reagents and methodology

Stressing the importance of establishing a centre that will organize and coordinate the EQAS in the Region, she also outlined the benefits to participating laboratories with particular reference to minimisation of errors and self-appraisal. As EQAS is an integral part of QMP, she reiterated that participants who are trained in QMT will be registered as the participants for the EQASs in TTIs and blood group serology, with the ultimate objective of establishing national quality systems and national external quality assessment schemes. 2.3.7 Review of the Facilitator's Toolkit for Quality Management Training (QMT) courses

Mrs Lloyd introduced the QMT facilitator's toolkit. The curriculum is divided into 15 distinct modules covered over an 18 working-day period. It is designed to give maximum learning opportunities to the participant with interactive role-plays and group activities, to ensure information given by the facilitators is reinforced through practice. This approach ensures improvement in knowledge and skills in applying quality principles to blood transfusion activities. The major expected outcome of the training course is for the participants to identify their role in establishing quality systems in their own BTS and develop an action plan for implementing quality. The QMT facilitators' toolkit has been developed to give guidance to facilitators on learning outcomes and the teaching focus. The training course is divided into two main parts, the first part introducing quality management systems in a generic format and the second part applying the principles learned in Part I to blood transfusion activities. ; ,

This section consists of eight modules (1-8) that introduce the concept of quality, basic elements of a quality system, organizational management, documentation, training, international quality (referential) standards such as ISO and GMP, and assessment of a quality system.

The section aims to train participants on how to apply the generic quality principles to the specific blood transfusion activities. The subsequent modules (9-15) cover quality management of a BTS including planning, infrastructure and environment, donor management and blood collection, donation testing, component preparation, and the clinical interface. Pre, mid and post course assessments, mainly in the form of self-assessment, have been devised for participants. These are based on multiple choice questions, short answer questions and case studies.

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2.4

Country reports

Representatives from countries in the Western Pacific Region presented a brief summary of the quality status in the BTSs in their country. These are summarized below. 2.4.1 Cambodia

Cambodia reported that the BTS covered more than 85% of the country through the one main blood transfusion centre and IS hospital-based provincial centres. About 21 000 units of blood were collected in 2000 for a population of II million. The national and provincial blood transfusion centres are under the Ministry of Health and a national blood policy has been developed. Although the national blood policy support coordinated BTSs, there are three private not-for-profit blood banks. Over the last two years, development of a national blood programme has resulted in an increase in voluntary, nonremunerated blood donors from 6% to 25%. Although there is a concurrent decrease in the percentage of family/replacement donation, this is still predominant with a proportion coming from 'hidden' paid donors. Quality systems are in the early stages of implementation with standard operating procedures developed but not fully implemented. A quality committee has been established for supervision of the provincial BTSs. Another independent committee has been tasked with inspection of incoming goods. There is a general lack of trained manpower in the BTSs in Cambodia and a need to initiate specialised training in blood transfusion medicine has been identified. 2.4.2 China

Due to the geographical and population size, China presented two reports (see Hong Kong). In order to standardize blood transfusion practices in China, the system is governed by laws ensuring appropriate blood donation practices, administrative regulation, basic standards and clinical use of blood. BTSs in China are certified and monitored by either the Ministry of Health or the provincial health authority. Training is coordinated by committees that oversee programmes for training in management, quality, general education, and blood donor recruitment. Government commitment and support to safe blood through the provision of resources and re-organization plans is well demonstrated. 2.4.3 Fiji

Responsibility for blood transfusion in Fiji is divided between Ministry of Health and the local Red Cross who carry out the blood donor recruitment programme. There are three blood banks that are collection and testing centres. The BTS is laboratory oriented without a fully implemented quality system that encompasses all BTS activities. Ten percent of donors are voluntary non-remunerated, and donor selection criteria have been developed (although questionnaires are not consistently used), and a limited blood donor counselling service is in operation. A quality manual has been developed and is in use in the laboratory. 2.4.4 Hong Kong

The BTS in Hong Kong is a fully ISO-certified service that demonstrates an overall quality management system. All necessary fundamentals of the system are in place as well as compliance to WHO guidelines, such as 100% of the 190000 units collected annually coming from voluntary, non-remunerated blood donors with an 80% return rate. As contract fractionation is in place, auditing by an external body to ensure GMP compliance is carried out on an annual basis.

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2.4.5

Lao People's Democratic Republic

Responsibility for the blood transfusion service has been desi~nated by the Minist'!' of Public Health to the local Red Cross Society, under a national commIttee made up of vanous interested parties. The main centre in Vientiane is closely linked to the eight peripheral blood banks to ensure that quality standards are maintained including centralised purchasing and training. Just over 4300 donations are collected annually, 80% coming from voluntary, nonremunerated blood donors. Certain elements of a quality system are in place but these largely target technical issues. 2.4.6 Malaysia

Malaysia consists of 14 states that are culturally diverse. Four hundred thousand units of blood (97% from voluntary, nonremunerated blood donors) are collected annually for a population of 22 million. BTSs are organized under the Ministry of Health and since the 1970s has worked to establishing quality standards within the service, including audits for GMP compliance to ensure contract fractionation. Most of the elements of a quality system are in place, but major work is required to consolidate available resources bearing in mind geographical problems. The National Blood Centre in Malaysia has established national EQAS for TTIs and blood group serology. Regulation and national accreditation is in the planning phase. 2.4.7 Mongolia

Mongolia has a very spread-out population (1.5 inhabitants per square kilometre) living in varying extremes of climate and geographical locations. This is a unique challenge to the overall health system. To assist with BTS activities, beside the main central blood bank, there are 23 blood stations (banks) in the provinces (aimags). Under the law implemented by the Mongolian President, all activities are regulated and controlled including relationships with other organizations such as the local Red Cross. The Ministry of Health and the national standards organization controls the overall system for the BTS. Many elements of a quality system are in place. However these are not formally incorporated into BTS activities and are targeted largely at technical issues. Collection of blood amounts to approximately 20 000 units which was reported as only 80% of estimated needs. 2.4.8 Papua New Guinea

Although an organizational structure under the department of health is in place, severe shortage of staff and trained personnel has led to many vacant positions. The national blood transfusion centre works with the local Red Cross under a memorandum of agreement. Thirteen blood banks and 26 dispensing centres are responsible for the collection of 24 000 to 26 000 units of blood per annum. This collection is to serve a population of approximately 5 million people. Quality system elements are lacking apart from standard operating procedures for certain aspects. Approximately 60% of donations are from voluntary, non-remunerated donors but the figure is not accurate due to the fragmentation in the service. 2.4.9 Philippines

The Philippines reported that the BTS comes under direct control of the Department of Health, which ensures the functioning of the national blood policy and regulation/accreditation. In partnership with the national Red Cross, the BTS collects approximately 450 000 units of blood annually. Quality systems have been implemented and quality standards manuals have been written for the laboratory, blood collection and blood stations. The national reference

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laboratory within the Department of Health using a national EQAS carries out monitoring of laboratory performance in ITIs. Standard operating procedures have been written for most blood transfusion activities. 2.4.10 Samoa

Samoa is a small country consisting of several small islands. Two of the main islands have blood banks that are part of the national health laboratory services within the Health Department. Annual collections amount to 3800 units all from voluntary, nonremunerated blood donors. Most quality system elements are targeted at the technical aspects of the blood bank although minimal donor selection procedures are in place. 2.4.11 Singapore

Singapore has a fully established BTS, the Centre for Transfusion Medicine, that operates under the Health Sciences Authority. A partnership with the local Red Cross for blood donor recruitment has proved successful with approximately 70 000 donations collected annually, all from voluntary, non-remunerated blood donors. A full and implemented quality system is in place. The quality system has ensured that the Centre has a clear mission (quality policy) and objectives, fully reflected in the blood donor programme, testing of donated blood, appropriate clinical use of blood and, in particular, a well defined staff training policy. It operates fully on the ISO recommended 'process' approach to implementing quality. Internal and external assessments of the quality system are carried out through internal and external audits, and participation in EQAS, among others. 2.4.12 Viet Nam

The BTS in Vietnam is fragmented and largely hospital-based. Coordination of all blood transfusion activities has begun. Within Ha Noi, several BTSs collect and distribute approximately 30% of the country's needs. Two hundred thirty-six thousand units of blood (250 ml) were collected in the year of which 22% came from voluntary, nonremunerated blood donors. The annual collection is to serve a popUlation of80 million people. Regulations are in place covering technical quality aspects with a few details concerning blood donors. Since the national health authority focused on blood transfusion aspects, the amount of blood collected has been steadily increasing with a parallel increase in quality awareness for blood safety. 2.5 Summary of discussions and report from Working Groups Full details of the group work are found in Annex 5. 2.5.1 Key problems and possible solutions in BTSs The objectives of the group work was to: • sensitize participants to the importance of a quality system and to allow discussions on how implementation of these systems can help to identify and solve problems; and to identify problems in the existing BTS systems and possible solutions, including constraints.

•

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Participants identified the following problems in some existing BTSs: (a) Hospital-based Blood Banks

It was agreed that the definition, often not totally clear, of hospital-based blo~d banks be used to describ e those blood banks that carry out all activities includi ng donor recrUItment, blood collection, testing, storage and distribution, as part of the hospital service . The problem s that were identified with this system were:

• •

Reliance on family/replacement and/or paid blood donors. Some particip ants felt that the system actually created a barrier to volunta ry non-remunerate d blood donation. Hospital-based blood banks were considered not cost-.effective with difficult~es !n manag ement due to inconsistent procedures and practIces, and a lack of contInUIty with the guidelines from national health authorities.

Although the above problems were identified, participants felt that hospital-based blood banks do answer a need in remote areas, are more linked to clinicia n's needs and provid e an opportunity for recipient follow-up. Participants listed many advantages to organizing a nationally coordin ated blood transfusion service as follows: • • • • A pool of regular voluntary blood donors Improv ement in quality of blood transfusion activities Improved availability Nation ally approved strategies and guidelines are more easily implem ented.

Solutions: Solutions lie with govern ment (national health authorities) to ensure centralization where the infrastructure allows bearing in mind topographical needs and availab le resources. As the hospital-based blood banking system encour ages familylreplacement blood donors, participants felt that a solution also lies in establishing a voluntary non-remunerate d donor pool from an identified low-risk population group. This could be established by introdu cing a programme of education focusing on the need for a selection process and for volunta ry, regular blood donors. Increasing the availability of donor information and adoptin g a market ing-approach with the focus ofthe donor as a 'custom er' would assist in increasing availab ility and safety of blood. Participants expres sed a need for caution to ensure that aspects of the clinical interface were not neglected when centralization was carried out. (b) BTSs functioning within a general pathology laboratory

Problems identified with this system were: • Priority given to technical aspects while neglecting donor manag ement aspects, e.g. recruitment and counselling.

- 15 -

•

Conflict between diagnostic and screening strategies that could result in inappropriate selection of test kit sensitivity/specificity for either need. Neglect of the special needs for a BTS such as traceability and confidentiality. Poor clinical interface activities.

• •

Solutions: National health authorities need to ensure that blood transfusion is recognized as a speciality in its own right. Following on such commitment, guidelines for the appropriate strategies for blood safety and clinical use of blood would be more easily implemented. (c) Lack of control over stocks of essential consumables such as test kits.

In general, this was felt to create many logistics problems. Solutions: Applying quality systems practices to stock control would allow for standardization, constant supply, incoming goods inspection through controlled procedures, and ensure high quality consumables. (d) Clinical interface

Problems identified were: • • Inappropriate requests and use of blood and blood products. Lack of training for prescribers.

Solutions: Introducing the WHO guidelines on the clinical use of blood, preventative strategies for reducing the need for blood transfusion, training of all personnel involved, e.g. doctors, nurses and technicians, and patient management protocols were considered solutions for the above problems. 2.5.2 Organizational structure ofBTSs Objectives ofthe group work were to sensitize participants to: • • • Their role in the development and implementation of a quality system. The role of directors in developing quality systems. The role of quality managers/officers in implementing quality systems

- 16 -

(a)

Commitment and support

During discussions participants emphasized the need for commitment to quality supported by an appropriate management infrastructure. The following points were raised: • Although most services in the Region have a defined organizational structure, some have a poor structure where commitment and lines of authority are either unclear or not applied. Some countries have no quality manager/officer in place. Representation on hospital transfusion committees was not consistently in place largely due to a lack of human resources.

• •

Most participants were clear on the roles of the director and quality manager, as outlined below, but felt that commitment and support from national health authorities would have to be strengthened. (b)

Role ofthe director Ensure resources are available for the overall process. Ensure policies, strategies and plans are in place. Ensure quality donor management. Advise on hospital transfusion committees - where human resources are scarce, it was suggested that instead of individual hospital transfusion committees, a regional or national committee could be formed to ensure the appropriate clinical use of blood. Role of the quality manager Oversee and monitor the overall process and quality control results. Ensure effective management and control of changes. Ensure appropriate documents, and their control, are in place. Ensure in-house training and be involved in the training where relevant. Carry out regular review. Report to the director.

•

•

• •

(c)

• • • • •

• 2.5.3

Planning for implementation ofQMP/QMT Objectives of the group work were:

•

To sensitize participants to the need for a partnership to be formed between all concerned.

- 17 -

• (a)

To create a definitive plan for implementation and ultimate success ofQMP . Steps to be taken by directors

It was emphasized that needs and plans would have to address the diversity within the region. There is a need to:

•

Have open dialogue with national (and/or regional or district) health authorities to ensure commitment to achieve the goals set. Identify provision offacilities and facilitators. Carry out a SWOT (Strengths, Weaknesses, Opportunities and Threats) or gap analysis to establish individual needs. Identify the needs and obtain assistance to fulfil the needs. Identify strengths and offer assistance to those in need. Decide on the standards to achieve. Profile of Participants to the QMT courses

• •

• • • (b)

Selection of appropriate participants should be based on the director's decision in collaboration with other stakeholders such as national health authorities, the Red Cross, if applicable, etc. The following profile was agreed on. The participants should have: • • • • A medical, technical or scientific qualification or training A broad-based knowledge of blood transfusion. Good language and communication skills. A position with authority and responsibility to bring about change. (This position may have to be designated or created). Added advantages would be managerial and training skills. Definitive action plan

• (c)

It was agreed that it was essential that plans take into account available resources such as finances, expertise, human, support and facilities. Plans also need to be realistic and ensure sufficient available resources for success.

2.6

Brain-storming session to develop the regional strategy on promotion of blood safety in Member States in the Western Pacific Region

The brain-storming session took place outside of the normal meeting hours to allow a free-flow of thoughts leading to commitment and a strategy on promoting safe blood in the Region.

- )8 -

Dr David de Leacy chaired the session and all agreed to carry out a SWOT analysis ofthe Region. A summary ofthe proceedings follows. Strengths • Expertise already exists in the Region. Some countries have well-defined programmes providing learning opportunities to others countries. Willingness to share and knowledge and experiences. A common generic approach by all countries to achieve similar goals is already in place. Commitment by many organizations such as the WHO and the Red Cross to development of strategies for ensuring a safe blood supply. High awareness in the Region for safe blood has already resulted in collaborative efforts in the region such as those between Japan and Laos, and Australia and Samoa. Successful transition programmes that can share experiences and techniques with other developing programmes. Commitment from national health authorities already having an impact on country strategies e.g. China and Viet Nam. Guidelines and tools for development of blood programmes already in existence and available. Politically stable Region, in comparison to others, enabling an environment for improvement. Diversity of countries and cultures that facilitate different strategies and approaches to solutions. (The diversity can also be viewed as a weakness).

• •

•

•

•

•

•

•

•

Weaknesses • • • • • • • • Weak infrastructures in the general health care systems in some countries. Instability or political infrastructure in some countries may not enable progress. Geographical nature ofthe Region resulting in long distances separating countries. Limited resources including inadequately trained personnel. Lack of blood transfusion education in formal education sector. Low priority compared to other health care needs. Lack of a career structure and discontinuity of staff. Health-care systems that are largely reactive and not proactive.

- 19-

• •

Lack of good management. Partial focus on the BTS by national health authorities largely aimed at technical aspects. Fragmentation of BTSs; lack of an organized blood programme; lack of a blood authority in some countries. Lack of marketing skills and a customer-focused system. Lack of public awareness regarding voluntary, non-remunerated blood donation. Globalization and population movement. Lack of standardization in information technology systems utilized by the countries.

•

• • • •

Opportunities • • Blood safety is one of the priorities ofthe WHO. Increased awareness of HIV transmission through unsafe blood transfusion facilitating resource mobilization. Mechanisms in place to ensure continuous improvement. Improved and advanced medical procedures. Access to available information through communication technology. Generally high economic performance of most countries in the Region.

• • • • Threats • • • • • • •

Unwillingness to change or move forward - conservative cultures. Pressure to use inappropriate technology. Increasing donor deferral. Emerging diseases. Political instability for some countries. Current global economic recession. The large investment required to establish a well-organized, nationally coordinated blood programme. Loss of skilled human resources to other areas and programmes.

•

- 20-

Suggestions Participants suggested the following ways in which WHO-WPRO could assist:

• •

Advocacy particularly to national health authorities for the development of sustainable blood programmes. Capacity building through training programmes. Establish a network on blood safety with a multi-faceted purpose: :::. Database of experts. :::. Web-site for facilitating the exchange of information.

•

•

Coordinate available resources in the Region and out-source, where necessary.

Priority areas identified Participants identified the following common priority areas within the Region: • Development of a national blood donor programme for the recruitment of voluntary, non-remunerated blood donors. QMP needs to be adapted to allow for the diversity of stages of development and implementation of blood programmes in the region.

•

2.7

Closing session

Dr Chen Ken summarized the three-day meeting by categorizing the countries or main areas of the Region into three main groups: Those with good resources: e.g. Australia, Brunei Darussalam, Hong Kong, Japan, Malaysia, New Zealand, Republic of Kor~a and Singapore. Those that require urgent support: e.g. China, Mongolia, Philippines, some of the larger Pacific islands particularly Papua New Guinea. Those that require support but not so urgently: due to size or the presence of development programmes. He added that priority countries would be identified through data from the WHO Global Database on Blood Safety, and through the commitment and support of the national health authorities for implementation of the QMP. He stated that training facilities were available at many sites. Finances, however, will have to be obtained through a collaborative effort. Potential facilitators for QMT, who were introduced to QMP/QMT and their role in the project, were thanked for their positive input and future involvement in the QMT courses.

- 21 -

Dr Chen emphasized the need for the participants to take ownership ofthe QMP and QMT courses to ensure their success, and the need for post-training follow-up and support which would take the form of networking, EQASs, follow-up training and country visits by WHO staff/consultants, where necessary. Dr Chen thanked all participants for their contribution to the successful, fruitful and productive meeting. He expressed his thanks to the Singapore Government, the Health Sciences Authority and Singapore Centre for Transfusion Medicine for their support. 3. CONCLUSION AND RECOMMENDATIONS

3.1

Conclusion

The workshop achieved its objectives and the participants endorsed the QMP and QMT courses.

3.2

Recommendations The participants of the workshop provided the following recommendations:

To WHO (I)

To mobilize and coordinate available resources in the region to assist Member States with implementation of the QMP.

(2) To support the Member States in the implementation ofthe QMP through advocacy to the policy makers and national health authorities.

(3) To identify the regional quality training centres, EQAS coordination centres and coordinators for the QMP in the Western Pacific Region. (4) To assist in the development of a network for blood safety in the Western Pacific Region. To National Health Authorities (Ministries of Health) (I)

To identify blood safety as a priority and develop a sustainable national blood programme as an integral part ofthe health care system.

(2) To provide a stable infrastructure and resources (including human and financial) to BTSs to ensure attainment oflong-term objectives in blood safety.

(3) To support those in charge of the BTS in their endeavours to provide a safe and adequate blood supply through implementation of quality systems.

- 22-

To participants (directors) (1 )

To sensitize the policy makers on the need for quality in BTSs and mobilize support for the implementation of the QMP.

(2) To ensure success of the QMP by selection of the appropriate trainees for the future QMT courses through consultation with national health authorities and the WHO. (3) To assist in the implementation of quality systems through support and commitment to the trainees of the QMT courses. To facilitators (I)

To ensure commitment and support for providing training for quality managers.

(2) To cooperate with the coordinators of the QMT courses in the preparation, organization and follow up ofthe courses.

- 23 ANNEX I

LIST OF PARTICIPANTS, TEMPORARY ADVISERS, CONSULTANT AND SECRETARIAT

CAMBODIA

Dr Nhem Thourk Director National Blood Transfusion Center #114 Corner Kramoun Sar and Norodom Boulevard Phnom Penh Tel. no.: (855) 16849299 FAX: (855 16849299 E-mail: nbtc@forum.org.kh Mr Vireak Voeurng Official at Laboratory Unit Hospital Department Ministry of Health No. 151-153 Kampuchea Krom Road Phnom Penh Tel. no.: (855) 12 818655 FAX: (855) 23428990

CHINA, PEOPLE'S REPUBLIC OF

DrYi Mei Director Division of Blood Management Department of Medical Administration Ministry of Health No. I Xizhimen Wai Nanli Beijing Tel. no.: (8610) 687 92212 FAX: (8610) 687 920513 E-mail: yimei@chsiz.mch.gov.cn I yimei@sina.com Dr Gao Dongying Vice-Director Beijing Red Cross Blood Center No. 37 Beisanhuan Zhonglu Beijing Tel. no.: (8610) 62370080 FAX: (86 I 0) 623 70080 E-mail: gaody@sina.com (private) brcbc@zbz.net(public)

- 24 Annex I

Dr Xl! Junping Deputy Director Wuhan Blood Center No.8 Baofeng I sl Road Wuhan 430030 Tel. no.: (8627) 83648810 FAX: (8627) 83637076 E-mail: whbloodc@public.wh.hb.cn FIJI

Dr Eka Buadromo Consultant Pathologist Pathology Department CWM Hospital Suva Tel. no.: (679) 215228 FAX: (679) 305810 E-mail ekabua@hotmail.com Dr Vimone Soukhaseum Head ofthe Service Clinical Laboratory Services Mahosot Hospital Ministry of Health Vientiane Tel. no.: (856) 212 14018 ext. 131 FAX: (856) 212 14020 Dr Manikeo Manikeo Medicine Doctor Intensive Care Unit of Adults Mahosot Hospital Vientiane Tel. no.: (856) 214018 FAX: (856)214018 E-mail: drmanikeo@hotmail.com

LAO PEOPLE'S DEMOCRATIC REPUBLIC

MALAYSIA

Mr Sin Ka Soon Science Officer Pathology Department Tengku Ampuan Rahimah Hospital Klang 41200 Selangor Tel. no.: 603-33723333 ext. 1365/1367 FAX: 603-33738139 E-mail: skasoon@yahoo.com

- 25 Annex I

MONGOLIA

Dr Davaadorj Ulaankhuu Director Blood Center of Mongolia Ulaanbaatar-48 P/Box 158 Ulaanbaatar Tel. no.: (976) II 372857 FAX: (976) II 372857 E-mail: bloodcenter@mongolnet Professor Nyamjav Jargalsaikhan Head Department Medical Service, Division Policy Coordination and Implementation Ministry of Health Olympic Street 2 Ulaanbaatar Tel. no.: (976) II 322878 FAX: (976) II 322878 E-mail: jargalsaikhan@mohsw.mng.net

PAPUA NEW GUINEA

Dr Aeno Umuli Acting Director Papua New Guinea Red Cross Blood Transfusion Service P.O. Box 1174 Boroko. N.C.D. Tel. no.: (675) 325 5750; 325 5753 FAX: (675) 3250714 Dr Linda Tamesis President, Philippine Blood Coordinating Council and Chairman Department of Pathology Far Eastern University - NRMF West Fairview Ouezon City Tel. no.: (63-2) 931 7497 FAX: (63-2) 931 7497 E-mail: butcht@skyinet.net Dr Ma. Lourdes Concepcion Medical Specialist Pediatric Blood Center Pathology Division Philippine Children's Medical Center Quezon Avenue, Quezon City Tel. no.: (63-2) 926-03-67 FAX: (63-2) 926-0367 E-mail: mlucon@yahoo.com

PHILIPPINES

- 26 Annex 1

Dr Cecilia J. Francisco Manager Philippine National Red Cross National Blood Services Bonifacio Drive Port Area Manila Tel. no.: (63-2) 5278384 to 97 FAX: (63-2) 5270861 E-mail: cjfrancisco@redcross.org.ph SAMOA Dr Faleniu Asaua Consultant Pathologist & Director of Laboratory Services National Health Laboratory Department of Health Apia, Samoa Tel. no.: (685) 21212 ext. 254 FAX: (685) 23592 NProfessor Patrick Tan Huat Chye Director Centre for Transfusion Medicine Health Sciences Authority 11 Outram Road Singapore 169078 Tel. no.: (65) 229 0600 FAX: (65) 223 8682 E-mail: pat77@pacific.net.sg Dr Tran Van Binh Blood Transfusion and Hematology Center 118 Hungvung Street 5 District Ho Chi Minh City Tel. no.: 848 855 2407 FAX: 848 855 2978 Dr Pham Quang V inh National Institute of Hematology and Blood Transfusion Bachmai Hospital HaNoi Tel. no.: 048587294 or 04-868 5582 FAX: 04 869 6250

SINGAPORE

VIETNAM

- 27 Annex I

2. TEMPORARY ADVISERS Dr Yasmin Ayob Director National Blood Centre lalan Tun Razak 50400 Kuala Lumpur Malaysia Tel. no.: (603) 2695 5555 FAX: (603) 2692 5826 Ms Susan Best Senior Scientist National Serology Reference Laboratory 4th Floor Healy Building 41 Victoria Parade Fitzroy 3065 Victoria Australia Tel. no.: 61 39418 IIII FAX: 61394181155 E-mail: sue@nrl.gov.au Mr Stephen Cheng Quality Manager Hong Kong Red Cross, Blood Transfusion Service National Blood Service IS King's Park Rise Kowloon Hong Kong Tel. no.: 85227\0\399 FAX: 85227804246 E-mail: chengck@ha.org.hk Dr Faraizah Abdul Karim Consultant Pathologist National Blood Centre lalan Tun Razak 50400 Kuala Lumpur Malaysia Tel. no.: (603) 2693 3888 FAX: (603) 2698 0362 E-mail: faraizah@hotmail.com

- 28 Annex 1

Dr Lai Hock Choong Associate Consultant Centre for Transfusion Medicine Health Sciences Authority 11 Outram Road Singapore 169078 Tel. no.: 652290602 FAX: 652290749 E-mail: LAI_HOCK_Choong@hsa.gov.sg Dr Lin Che Kit Hospital Chief Executive Hong Kong Red Cross Blood Transfusion Service 15 King's Park Rise Kowloon Hong Kong Tel. no.: (852) 2710 1301 FAX: (852) 27801862 E-mail: cklin@ha.org.hk Mr Patrick Prakash Senior Laboratory Officer Centre for Transfusion Medicine Health Sciences Authority I I Outram Road Singapore 169078 Tel. no.: 65 229 0602 FAX: 652238682 E-mail: prakash]AOMANABHAN@hsa.gov.sg Or Cees Th. Smit Sibinga Director Sanquin Consulting Services Blood Bank Noord Nederland Postbus 1191 9701 BO Groningen The Netherlands Tel. no.: +31 503695555 FAX: +31503695556 E-mail: csmitsibinga@sanquinbbnn.nl Sibinga@wolmail.nl

- 29 Annex 1

Ms Helen Starr Quality Assurance Consultant Unit 1003 Eventide 36 Refinery Drive Pyrmont, NSW 2009 Australia Tel. no.: 6129571 5582 FAX: 6129571 5583 E-mail: qastarr@hotmail.com Dr Diana Teo Consultant/Deputy Director Centre for Transfusion Medicine Health Sciences Authority II Outram Road Singapore 169078 Tel. no.: 652290605 FAX: 65 223 8682 E-mail: diana_TEO@hsa.gov.sg Dr Kaicheng Qian Vice President Quality Affairs Shanghai Blood Center 1191 Hongqiao Road Shanghai 200052 People's Republic of China Tel. no.: (8621) 662089896 FAX: (8621) 62958414 E-mail: kcqian53@shI63b.sta.net.cn

3. CONSULTANT Mrs Shan Lloyd Quality Manager National Blood Transfusion Service P.O. Box A101 Avondale Harare Zimbabwe Tel. no.: +2634707801 FAX: +2634707820 E-mail: slloyd@zimnbts.co.zw

- 30 Annex 1

4. SECRETARIAT Dr Chen Ken (Responsible Officer) Regional Adviser in Traditional Medicine, Laboratories and Research WHO Western Pacific Regional Office United Nations Avenue, Ermita, Manila Philippines Tel. no.: (632) 528-9844 FAX: (632) 521-1036 E-mail: chenk@wpro.who.int Dr U.H.S. de Silva WHO Representative in Brunei Darussalam, Malaysia and Singapore World Health Organization 1st Floor, Wisma UN, Block C, Komplek Pejabat Damansara, lalan Dungun, Damansara Heights 50490 Kuala Lumpur Malaysia Tel. no.: (603) 253 9908 FAX: (603) 2537446 E-mail: desilvas@maa.wpro.who.int Dr Oscar Barreneche Medical Officer Blood Safety World Health Organization P.O. Box 1217 120, Streets 51 & 228 Sangkat Chaktomuk Khan Daun Penh Phnom Penh Cambodia Tel. no.: (855-23) 216610 & 212228 FAX: (855) 16914610 Mobile: (855) 12914610 E-mail: barrenecheo@cam.wpro.who.int Dr David William De Leacy Medical Officer Blood Safety World Health Organization 63 Tran Hung Dao Street Hoan Kiem District Ha Noi. Viet Nam Tel. no.: (844) 9433734 FAX: (844) 9433740 E-mail: de1eacyd@vtn.wpro.who.int Davidwde1eacy@hotmai1.com

- 31 Annex I

Dr Neelam Dhingra-Kumar Medical Officer Blood Transfusion Safety Blood Safety and Clinical Technology World Health Organization Ave Appia20 CH-1211 Geneva 27 Switzerland Direct Tel: + 41 22791 4660 Direct Fax: + 41227914836 E-mail: dhingran@who.ch

- 33 ANNEX 2

Programme for tbe Workshop on the Quality Management Project for Blood Transfusion Services in the Western Pacific Region Centre for Transfusion Medicine Singapore, 8-10 October 2001

DaylDate/ Time Monday 8 October 0830-0900 0900-1000 1000-1030 Registration Inauguration Tea/coffee

Sessions

Principal speaker

Session I - WHO Quality Management Project 1030-1115 Item 1 Quality Management Project (QMP) for blood transfusion services: WHO initiative • Introduction • Review of Global activities under QMP during 2000-2001 Session II - Overview of Status of Quality in blood transfusion services 1115-1200 Item 2 Status of blood transfusion services in WP region Item 3 The importance of quality in the blood transfusion service and Basic concepts of quality systems in a BTS Item 4 Country reports on quality in BTS in order to identify needs to strengthen quality system Lunch Dr Chen Ken Dr Neelam Dhingra

1200-1230

Ms Shan Lloyd

1230-1300

Directors of BTSs

1300-1400 1400-1530

Item 4 (contd.) Country reports on quality in BTS in order to identify needs to strengthen quality system (contd) Tea/coffee

Directors of BTSs

1530-1600

- 34 Annex 2

DaylDateJ Time 1600-1630

Sessions Item 5 Overview of Quality Management System in Centre for Transfusion Medicine, Singapore Summary of Day 2 Visit to Centre for Transfusion Medicine, Singapore Satellite meeting Brain storming session to develop the Regional Strategy on Promotion of Blood Safety in Member States in WPRO region

Principal speaker Dr. Diana Teo

1630-1645 1645-1745 1900-2030

Chair Dr Diana Teo Optional

Tuesday 9 October 0830-0845 0845-1015 Summary of day I Item 6 Group work 1 (in 3 groups) Identifying key problems and possible solutions to improve the quality in BTSs Presentation of group work Tea/coffee Presentation of group work and discussion (contd.) Item 7 Group work 2 • Discuss organogram and the role of directors of BTSs in developing the quality systems • Role of the quality manager in implementation of a quality system in the BTS Lunch Presentation of group work and discussion Session III - WHO Materials on Quality Management Project ModeratorDr Cees Th. Smit Sibinga Chair Moderator- Dr Neelam Dhingra

1015-1030 1030-1100 1100-1145 1145-1300

1300-1400 1400-1445

- 35 Annex 2

DaylDatel Time 1445-1530

Sessions Item 8 Introduction to the Quality management training facilitators' toolkit & Discussion on Curriculum and material: Modules 1-5 ofQMT course Tea/coffee Item 9 Human resource development -selection and training of personnel in quality management in BTSs Summary of Day 2

Principal speaker Ms Shan Lloyd

1530-1600 1600-1700

Dr Cees Th. Smit Sibinga Chair

1700-1715 Wednesday 10 October 0830-0845 0845-1030

Review of day 2 Item 10 Discussion on the Curriculum and material: Modules 615 of QMT course Tea/Coffee Item 11 Monitoring, evaluation and follow up of training courses • Indicators • Targets Item 12 Regional external quality assessment scheme • Organization • Outcomes Session IV - Action Plan and Recommendations

Chair Ms Shan Lloyd

1030-1100 1100-1125

Dr Cees Th. Smit Sibinga

1125-1145

Dr Neelam Dhingra

1145-1300

Item 13 Group work 3 • Identification of steps the directors of BTSs can take to make QMP/QMT a success • Discuss and agree on the profile of the participants forQMT • Development of definitive action plan for countries for implementation of QMP

Moderator- Dr Cees Th. Smit Sibinga

- 36 Annex 2

Day/Date/ Time 1300-1400 1400-1530 Lunch

Sessions

Principal speaker

Presentation of model country plan of action for implementation ofQMP Tea/coffee Item 14 Proposed mechanism of organization of QMT courses in WPRO in 2002 • Priority countries • Training facilities • Availability and role of regional facilitators • Requirements of international facilitators • Identification and development of local facilitators • Post training follow up and support • Monitoring and evaluation Discussion, Conclusions & Next Steps Valedictory and closure

Directors of BTSs

1530-1600 1600-1630

Moderator- Dr Chen Ken

1630-1700 1700-1730

Moderator - Dr Neelam Dhingra Dr Chen Ken & Dr Neelam Dhingra, Singapore CTM

- 37 ANNEX 3

l~

~

~\;~ ~ WORLD HEALTH ORGANIZATION ,

It'M' ~WI ,.,

~

AIDE·MEMOIRE fOl' National Blood Programmes A well-organized blood transfusion service (BTS) is a prerequisite for the safe and effective use of blood and blood products. The HN / AIDS pandemic has focused particular attention on the importance of preventing transfusion-transmitted infections (TrIs). Between 5% and 10% of HIV infections worldwide are transmitted through the transfusion of contaminated blood and blood products, Many more recipients of blood products are infected by hepatitis Band C viruses, syphilis and other infectious agents, such as Chagas disease. Transfusion-transmitted infections can be eliminated or substantially reduced through an integrated strategy for blood safety which includes: • • • Establishment of a blood transfusion service Collection of blood only from voluntary non-remunerated blood donors from low-risk populations Screening of all donated blood for transfusion-transmissible infections, including HIV; hepatitis viruses, syphilis and other infectious agents Reduction in unnecessary transfusions through the effective clinical use of blood, including the use of simple alternatives to transfusion (crystalloids and colloids), wherever possible.

Checklist Blood transfusion service o Government commitment and support o National blood policy/plan o Legislation/regulation o Organization with responsibility and authority for the BTS ::I BTS management committee o BTS medical director o BTS quality manager o Specialist BTS advisory groups o Trained BTS administrative and technical staff o Adequate budget CJ National quality system Blood donors ::J National blood donor programme officer :J Blood donor unit :.J Blood donor recruitment officer ::J Standard operating procedures :.J Training of staff in blood donor unit ::J Low-risk donor populations o Educational materials ::J Register of voluntary non-remunerated blood donors :.J Donor selection, deferral, care and confidentiality CJ Donor notification and referral :J Monitoring of TTls Blood screening

•

:J Technical officer :J Screening strategies and protocols :J Training of laboratory technical staff ::I Screening of all donated blood for nis

:J Good laboratory practice, including

o

standard operating procedures Continuity in screening CJ Effective blood cold chain

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

- 38 -

Annex 3

Key elements Establish a blood transfusion service It is the responsibility of governments to ensure a safe and adequate supply of blood. lhis responsibility may be delegated to a non-profit non-governmental organization, but the BTS should be developed within the framework of the country's health care infrastructure.

• • • • • • •

The BTS requires government commitment and support and recognition as a separate unit with an adequate budget, management team and trained staff. Important activities in establishing a blood transfusion service include:

Formalization of government commitment and support Development of a national blood policy and plan Development of necessary legislation/ regulation for the BTS Formation of an organization with responsibility and authority for the BTS Formation of a BTS management committee Appointment of a medical director Appointment of a quality manager

• •

•

Appointment, when necessary, of specialist BTS advisory groups Appointment and training of staff experienced in each key aspect of the BTS Development and implementation of a budgeting and finance system to ensure a sustainable blood programme through cost recovery and/ or annual budget allocation Establishment of national quality system, including guidelines, standard operating procedures (SOPs), accurate records, monitoring and evaluation.

•

Educate, motivate, recruit and retain low-risk blood donors High priority should be given to the elimination of family / replacement and paid blood donor systems, which are associated with a Significantly higher prevalence of TTIs. Voluntary non-remunerated blood donors from low-risk popUlations who give blood regularly are the foundation of a safe and adequate blood supply. Important activities include: • Appointment of an officer responsible for the national blood donor programme • Establishment of a BTS unit responsible for donor education, motivation, recruitment and retention • AppOintment of a designated blood donor recruitment officer • Preparation of SOPs in accordance with BTS guidelines • Training of staff in the blood donor unit • Identification of donor populations at low risk for TTls • Development of educational materials • Establishment of a register of voluntary non-remunerated blood donors • Assurance of safe blood collection procedures, including donor selection and deferral, donor care and confidentiality • Donor notification and referral for counselling • MOnitoring of TTIs in the donor population.

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

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

•

•

•

•

•

•

•

Blood Safe~ Unit, World Health Organization 20 Avenue Appla, CH-1211 Geneva 27, Swltzertand. Fax: +4122 7914836

- 39 ANNEX 4

Quality Status Questionnaire for Individual BTSs Background Information 1. 2. Name of centre Address of centre

3. 4.

Approximate number of units collected annually Component preparation Component Packed cells Fresh frozen plasma Cryoprecipitate Platelet concentrates Prepared (Yes/No) %prepared by single whole by apheresis blood donation

5.

What percentage of donations come from voluntary, non-remunerated blood donors?

Quality Systems 1. 2. 3. Is the organizational structure defined and documented? Is the document authorized (signed) by the head of the centre? Is there a chart (organogram) that shows the organizational structure with authority, responsibility and accountability? (If yes, please attach a copy) Do all staff have a job description that specifies tasks, responsibilities and accountability? State which authority, all departments?

Yes

No

4

If no, in some departments?

CJCJ CJCJ

5. 6 7.

When are job descriptions reviewed?

Regularly?

I

When tasks change?

I

Rarely?

I

Is there a specific person appointed as the quality managerl officer? If yes, give the name of the person What proportion of time does the person devote to this function? 100% 50-100% <50%

DD

B. 9.

Does the centre have a documented quality policy? Is there a quality manual available? If yes, is this a current edition?

10. Are there written procedures (SOPs)?

all departments? If no, in some departments?

DD DD DD DD DD DD DD

State which 11. Is there a plan for regular review of documents? If yes, when was the last review and how many documents were reviewed? 12. Are quality system documents controlled?

- 40 Annex 4 Training Yes No

13. 14. 15.

Is there a training policy or strategy? Is there a system for assessing training needs for all staff? Staff training (please tick the appropriate box if applicable)

DD DD

~eofstaff

Training Curriculum Training Technical Management On-going programmes developed material training training education

Medical personnel Blood donor motivators Blood donor counsellors Donor clinic staff Lab technicians Prescribers of blood Others (specify) 16. 17.

Is there a system for assessing the outcomes of the training programmes? Are staff trained to SOPs to ensure competency? When were staff last trained to ensure competency? Type of staff Medical personnel Blood donor motivators Blood donor counsellors Donor clinic staff Lab technicians Prescribers of blood Others (specify) Last trained

DD DD

18.

19.

Are records maintained of all training in the centre?

DD Yes No

Stock Control 20.

(Consumables)

21. 22. 23.

DD DD Has a minimum stock level been determined for each critical item? DD Are there documented procedures for the inspection of all critical supplies which are received? DD If yes, give a fewexamples _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ Does the centre have direct control over ordering? Is there a system of stock control? Is stock maintained under the correct conditions? E.g. fridges Are those conditions monitored? E.g. temperature monitoring On approximately how many occasions in the last 12 months has your BTS run out of a critical item? Are there procedures in place for such occasions? Approximately how many kits or reagents were discarded in the last 12 months due to expiry?

24.

25.

DD DD I I

26.

27.

28.

DD DD DD DD DD DD

Quality Audits 29.

Is there a general policy on quality audits? Is there a documented audit schedule?

30.

31. Does the centre have trained auditors? 32.

Does the centre have authorized auditors?

33. Last quality audits done /Internal External 34.

I

Date of last audit IBYWhOm

Non-conformances identified during the last audit No. identified No. not closed ~ due date

- 41 Annex 4 Equipment 35.

Yes

No

Has all critical equipment been identified and documented? If yes, please provide a copy of the list Is there a documented policy for validating new critical equipment? "I

36.

37. Is therE'

documented policy for calibration of a/l critical equipment? All equipment If no, some equipment

38. Are the methods for calibration documented?

DO DO DO DO DD DO DO DO DD DO DO

!

I

State which

39. Do the methods include the frequency of calibration? 40.

Is there a maintenance schedule for all critical equipment?

All equipment If no, some equipment

State which 41.

Are records kept of calibrations? Do these include when the calibration was done? Who did the calibration?

What the result was? 42. 43.

Are records kept of maintenance and repair? Is there a system to ensure that equipment is calibrated and maintained within the specified time period?

BB DO I

44. 45.

How many pieces of equipment are currently not in use due to breakdown? Are fridges and freezers: Alarmed? Connected to an emergency generator? Monitored?

I

46.

How often are the temperatures of fridges and freezers checked?

I

DO DO DO

I

47. How is the information from the check recorded? Safety

48. Is there a documented policy on safety procedures at your centre? 49. Is there a person responsible for ensuring safe work practices?

50. Are there standard procedures (SOPs) covering the following safety issues: Work related injuries? Waste disposal? 51. Is there a specific area in training that ensures staff are aware of their responsibility regarding cleanliness and tidiness?

DO DD DO DO DD DD DD DO DO

Errors 52. 53.

Is there a documented policy or strategy for error reporting and handling? Does the policy include how to: report errors? investigate errors? resolve errors?

54.

In the last 12 months:

I

>20

20

10

<10

unknown

Errors reported Errors solved

I I I I

I

I

- 42 -

Annex 4 Blood Donor Clinic 55. Is there an identified separate department responsible for blood donor management? Yes

No

DO

56. Are the following documents available for: SOPs

Information material

yes donor education? donor motivation? donor recruitment? donor retention?

no

yes

no

donor counselling? 57. 58. 59. 60. 61. 62. Is there a questionnaire used for donor selection? Is epidemiological data used to target low-risk groups for blood donation? Is there a blood donor register? Does the register clearly differentiate between active and deferred blood donors? Is data from donor selection activities monitored, analyzed and acted on? Is data received from the laboratory regarding positive results monitored, analyzed and used?

DO DO DO DO DO DO DO DO DO DO DO DO DO DO 00 00 DO DO DO 00

Laboratory testing 63. Is there a documented policy or strategy for tests done on donated blood?

64. Are there standard procedures (SOPs) for: HIV testing? HBsAg testing? HCV testing? Syphilis screening? ABO grouping? Rh grouping? Antibody screening? 65. Control used on testing for transfusion-transmissible infections: Internal quality controls (IQC)? Controls graphed? Validation of test runs based on kit controls? Validation of test runs based on IQC? 66. Are records maintained of invalid test runs? 67. Is there a documented system for ensuring the accuracy of data entryltranscription?

68. What control are used in blood group serology? 69. How frequently are the blood group serology controls used?

70. Which of the following are recorded about tests done: date ottest? person performing test? name, batch no., and expiry date of reagents/kit used? results of calculations? whether the test run was valid? any other? 71. Are there any circumstances under which you would accept results from invalid runs? Briefly describe the circumstances and how you would control this?

DD DD

DO DO DO DO

- 43 Annex 4 Laboratory testing contd. Yes No

72. Are there any circumstances under which you would use expired reagents or test kits? Briefly describe the circumstances and how you would control this?

DO DO DO DO DO DO DO DO DO

73.

Does the testing laboratory participate in an external quality assessment scheme (EQAS) for: TTl testing? Blood group serology? Please state the names of the schemes and the tests covered:

Processing of blood products

74. Are there documented specifications for each product made? 75. Are there standard procedures (SOPs) for the production of each product? 76. Are there records of quality monitoring of production? 77. Is the data from quality monitoring analyzed on a continuing basis?

78. Are there formal written quarantine/release procedures?

79. Is there a system of blood stock control? 80. Percentage of expired products:

Clinical Interface 81. Are there standard procedures (SOPs) for: Cross matching? Issue of blood and blood products? Managing adverse transfusion reactions? Investigating post transfusion infections? 82. 83. 84. 85. Is there a system for monitoring turn-around time? Are there guidelines for the clinical use of blood? Is there a system for auditing the guidelines? Is there a standard blood request form? If yes, please provide a copy. How many of the hospitals to whom you provide blood have hospital transfusion committees? Is there a documented blood order schedule for surgical cases?

Yes

No

DD DD DD DD DO DO DD DD I I

86. 87.

88. Are there established criteria for monitoring the activities of the cross match laboratory? 89. 90. What is the cross matched to transfused ratio? Has the laboratory ever had to carry out a formal look-back? If yes, how successful were you in tracing all the applicable records? Are alternatives to human blood available? Please give the products used

DD DD DD DO

91

- 45 ANNEX 5

Working groups

Group Work 1 Identifying key problems and possible solutions to improve the quality in BTSs

Rationale During many consultations and from global reports, it has become apparent that although quality control in the laboratory can be well executed, overall quality management and application of quality systems to the BTSs are often neglected or even thought to be inapplicable. Allowing directors and the scientists in the BTSs to discuss common problems is one way of ensuring open dialogue and identification of quality issues. This session, through interactive discussions serves to sensitize directors of BTSs and the blood transfusion scientists on how introducing a quality system can assist in identifying and solving problems.

Objectives • To sensitize participants to the importance of a quality system and to allow discussion on how implementation of these systems can help to identify and solve problems. • To identify problems in your blood transfusion system and solutions, including constraints

Issues that need to be highlighted during the discussions Organization and Management

I. The use of hospital-based blood banks: • Does the practice of using hospital-based blood banks ensure a constant supply of quality blood products? • How could the introduction of nationally coordinated blood banks improve the availability and quality of blood? 2. Blood banks being part of the general pathology laboratory: • What detrimental effects can be experienced from this scenario? • What special quality needs does a BTS have over and above those of a general laboratory?

Blood Donors

I. Reliance on family/replacement donation: • Is this predominant practice desirable? • How can introducing a quality system positively influence donation patterns? • Is the concept of donor selection emphasized sufficiently in all BTSs? • How can the introduction of customer satisfaction influence attitudes to blood donors?

- 46 Annex 5

2. Donor education, recruitment, motivation and retention: • What quality aspects can be introduced into donor education? . . . • By applying quality monitoring and evaluation exercises, what problems can be Identified III donor recruitment?

Testing of Donated Units of Blood I. Is the control of ordering and stock oftest reagents essential for maintaining quality in screening of donated blood? 2. What problems are encountered when screening donated blood for TIIs? 3. How would the introduction of a quality system resolve these problems?

Clinical Interface How many identified problems related to blood transfusion are due to lack of training of clinical users? 2. How would quality systems benefit the recipients of a blood transfusion? I.

Group Work 2 • • Discussion related to organogram and the role of directors ofBTSs in developing the quality system Role of the quality manager in implementation of a quality system in a BTS

Rationale It is essential that management of a BTS understand that full commitment from the top is the driving force behind the success of a quality system. Management also should provide the appropriate organizational infrastructure through clear leadership, lines of responsibility and authority, and accountability. Management also needs to fully understand and carry out its role, and ensure that a responsible person carries out the essential co-ordination to ensure implementation. This session, through interactive discussions serves to sensitize leaders in the various BTSs on their role in developing and implementing a quality system.

Objective To sensitize participants to their role in development and implementation of a quality system, to the role of the directors in developing and the role of the quality officer/manager in the implementation.

Issues that need to be highlighted during the discussions 1. Commitment: • • • • Is there a quality policy? Is there a quality plan? Is there an organogram that clearly shows the lines of authority and answerability, and positions of responsibility Is there a specific person, responsible for implementing quality, which is directly answerable to the director/CEO?

- 47 Annex 5

2. Role of the director: • • Does the director's role include ensuring an organizational infrastructure including a quality team? Does the director's role include ensuring that the following are in place: • A training policy? • Implementation of strategies for a safe blood supply e.g. testing TTIs, donor management and hospital transfusion committees?

3. Role ofthe quality manager? • • • • Does this include writing SOPs for all departments? If not, who should write SOPs? Is the quality manager expected to carry out the monitoring exercises in the ITI testing laboratory? Should the quality manager report on all monitoring and evaluation outcomes to the top management (director)? Should the quality manager be involved in in-house training?

Group Work 3 • • • Identification of steps the directors of BTSs can take to make QMP/QMT a success Discuss and agree on the profile of the participants for QMT Development of a definitive action plan for countries for implementation of QMP

Rationale The WHO needs proactive BTSs if the QMP is to succeed in making a quality difference to the global blood supply. QMP can only succeed if all BTSs are active partners in the project either as facilitators, participants and advisors. If a global plan can be devised, needs of different regions and . the member states can be fully identified and action taken. All concerned need to discuss their individual country needs and those of the region as a whole. Objective To sensitize participants to the need for a partnership to be formed between all concerned and for a definitive plan to be devised and followed to ensure success ofthe QMP.

Issues that need to be highlighted during discussions Steps to be taken by the Directors I. Is open dialogue with local health authorities essential for success of the QMP? 2. Is the provision of facilitators, facilities and expertise from those who have them necessary to ensure success of the QMT? 3. Would a 'gap' analysis assist the WHO in identifying needs? 4. Who are the most relevant people to make the decision on who attends the QMT courses?

- 48 Annex 5

Profile of the participants to the QMT courses I. Is the profile identical for each region or member state? 2. Is a technical background essential for the learning outcomes of the participant?

Definitive action plan I. Will the needs of each country be identical? 2. For each activity in the plan, what resources will be required? 3. Who will be responsible for monitoring the action plans?

Format for Group Discussions: All participants will be divided into 3 working groups (A, B & C). Each group will have a moderator and a rapporteur.

Notes and key points to be given to the moderators to ensure that the salient objectives are achieved and the important issues are discussed in the group meetings. After each group work, the entire group will meet for a presentation of a summary and recommendations from each group.

Group A Members: I. 2. 3. 4. 5. 6. 7. 8. 9. 10. J J. J 2. Dr Nhem Thourk Dr Gao Dongying Dr Vimone Soukhaseum Dr Davaadorj Ulaankhuu Dr Linda Tamesis Dr Faleniu Asaua Dr Pham Quang Vinh Mr Stephen Cheng Dr Lai Hock Choong Dr Cees Th. Smit Sibinga Dr Chen Ken Dr Oscar Barreneche

- 49 Annex 5

Group B Members: 1. Mr Vireak Voeumg 2. 3. 4. 5. 6. 7. 8. 9. 10. II. 12. Dr Yu Junping Dr Manikeo Manikeo Dr Nyamiav Jargalsaikhan Dr Ma. Lourdes Concepcion A/Professor Patrick Tan Huat Chye Dr Yasmin Ayob Dr Kaicheng Qian Dr Lin Che Kit Ms Helen Starr Dr David William De Leacy Dr Neelam Dhingra

Group C Members: I. 2. DrYi Mei Dr Eka Buadromo Mr Sin Ka Soon Dr Aeno Umuli Dr Cecilia J. Francisco Dr Tran Van Binh Ms Susan Best Dr Faraizah Abdul Karim Mr Patrick Prakash Dr Diana Teo Mrs Shan Lloyd Dr U.H.S. de Silva

3. 4. 5.

6. 7.

8. 9. 10. 11. 12.