SEA -HLM-334 Distribution: General
Quality Management Training in Blood Transfusion Services in South-East Asia Report of a Regional Workshop Bangkok, Thailand, 26 March – 13 April 2001
WHO Project : ICP BCT 001
Regional Office for South-East Asia New Delhi June 2001
World Health Organization
© World Health Organization 2001 This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors.
Contents Page 1. 2. 3. 4. INTRODUCTION........................................................................................... 1 OBJECTIVES................................................................................................... 1 INAUGURAL SESSION................................................................................... 2 WORKSHOP.................................................................................................. 3 4.1 Pre-course Assessment of the Participants................................................ 3 4.2 Status Report on Quality in BTS ............................................................... 3 4.3 Mechanics of Training............................................................................. 3 4.4 Summary of Subjects Covered ................................................................. 4 4.5 Post-course Assessment of the Participants .............................................. 5 4.6 Hand outs Provided to the Participants.................................................... 6 4.7 Evaluation of Course by the Facilitators ................................................... 6 4.8 Evaluation of Course by the Coordinator................................................. 6 4.9 Valedictory Session.................................................................................. 7 RECOMMENDATIONS.................................................................................. 7 5.1 To WHO................................................................................................. 7 5.2 To Member Countries ............................................................................. 7 5.3 To Participants ........................................................................................ 8 Annexes 1. 2. 3. List of Participants........................................................................................... 9 Programme of Work..................................................................................... 13 Status of BTS Activities in Different Institutions in the Countries of South-East Asia ......................................................................... 21
5.
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1.
INTRODUCTION The first Regional Workshop on Quality Management Training (QMT) in Blood Transfusion Services (BTS) was organized at Bangkok, Thailand, from 26 March to 13 April 2001. Twenty two participants representing all the ten Member countries of the South-east Asia Region (SEAR) of WHO attended this workshop. Staff from WHO Headquarters as well as from the Regional Office along with experts from South Africa, the United Kingdom, India and Thailand facilitated the workshop. The List of Participants is at Annex 1 and the Programme of Work at Annex 2. WHO has identified blood safety as one of its seven priority areas. Safety of blood was also identified as the theme of World Health Day 2000. Quality management of BTS has been identified by WHO as one of the significant components to achieve safety, adequacy and quality of blood in all the Member countries. Accordingly, a quality management project (QMP) for BTS was initiated in 2000 and will be implemented in all Member countries. Under QMP, capacity building through quality management training courses is an important activity. The Regional Office of WHO organized the first Regional Workshop on QMT to create a core group of quality managers for BTS in all Member countries who will also act as trainers in their respective countries.
2.
OBJECTIVES The following were the objectives of the workshop: (1) (2) To ascertain the status of quality management in blood transfusion services in the Member countries of SEAR; To sensitize trainees towards quality management project in blood transfusion services and the need for quality management training to promote blood safety;
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(3) (4)
To impart training in theoretical and practical aspects of quality management in every aspect of blood transfusion services; To upgrade the skills of participants in the planning, management and implementation of quality systems, including preparation of SOPs and assuring quality implementation, and To develop a plan of action and follow-up on quality management, including training needs at the country level and staff development.
(5)
3.
INAUGURAL SESSION The workshop was inaugurated by Dr Mongkol Chetthakul, Senior Officer, Ministry of Public Health, Government of Thailand. He emphasized the need for safe blood and the role of voluntary non-remunerated blood donors in achieving this objective. WHO's support to promote safety, adequacy and quality of blood was reflected in the address of the Regional Director, that was read out at this function by Dr Sudarshan Kumari, Regional Adviser, BCT, South-East Asia Region, WHO. The adoption of the theme of safe blood for World Health Day 2000 with the slogan 'Safe blood starts with me: blood saves lives' also demonstrated the priority accorded by WHO to this subject. Dr Neelam Dhingra-Kumar, Blood Safety Team, WHO, headquarters presented the objectives and mechanics of the course. Earlier the participants were welcomed by Mr Phan Wannamethee, Secretary-General, Thai Red Cross Society. Dr Srivilai, Tanprasert Director, National Blood Centre, Thai Red Cross Society and local organizer for the workshop proposed a vote of thanks. Dr Neelam Dhingra-Kumar outlined the quality management project that WHO has initiated recently. She described the various components of QMP and the importance of quality management training (QMT) in improving overall quality in blood transfusion services. She also detailed various activities that were undertaken during the past one year by WHO to develop a curriculum and learning material for the QMT courses. Dr Dhingra emphasized that all efforts needed to be directed to sustain the programme so that quality was integrated into all the activities of BTS.
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4. 4.1
WORKSHOP Pre-course Assessment of the Participants A questionnaire with 45 multiple-choice questions was used to assess the precourse knowledge of the participants. Twenty-three of the questions related to pure quality issues and the remaining pertained to quality as applied to BTS. Participants were given 30 minutes to provide answers to these questions. An analysis of the result showed that only 7 (35%) of the trainees could give more than 50% correct answers to all the questions.
4.2
Status Report on Quality in BTS The participants were sent a questionnaire before they left their respective countries. They were advised to fill up these in consultation with their colleagues and superiors. A wide variation in quality was seen between the various countries. Many countries reported some form of quality control within the laboratories but few had a fully or even partially implemented formal quality system that covered all major aspects of a BTS. A summary of salient features of quality in their BTS is given at Annex 3.
4.3
Mechanics of Training The main aim of the workshop was to provide the participants with the tools of quality management and demonstrate how to use them in BTS. The training was largely in the format of short presentations followed by group activities and extensive interaction with the participants to reinforce the teaching aims and learning objectives. The group activities involved carrying out an assigned task in groups and then reporting back for discussion with all the participants and facilitators. Some activities involved the whole class using scenarios and role plays (see Annex 2). The participants visited the National Blood Centre, Bangkok, to see the quality management system in operation in BTS. They also visited a mobile blood donation session organized by the National Blood Centre. Both these visits were followed by extensive discussions on quality aspects of visits.
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Handouts of all the presentations were provided to the trainees as part of their work book. In addition, they were given a list of references on quality. They were also requested to indicate their requirements of WHO publications on BTS which will be sent to them in due course of time by WHO.
4.4
Summary of Subjects Covered First week The participants briefly presented their expectations from the course which included improvement in their skills to institute quality systems in their respective BTS to generate quality products and results. They also opined that after being trained in this workshop they will be able to impart training to their colleagues and other personnel in BTS in their respective countries. The participants also believed that after three weeks’ training they will be in a better position to advocate the need for quality in BTS, handle organizational constraints and optimally utilize the resources that are made available to them. The major objective of the activities in the first week was to provide the basics of quality and create firm foundations for implementing quality systems following the ISO model. The terminology used internationally in quality was extensively discussed. Other important topics that were covered included: quality systems; quality policy; a quality officer's job description; documentation, with emphasis on standard operating procedures (SOPs); organizational structure; and process flow charts and validation. All activities and examples used were based on everyday activities or objects but, where appropriate, examples pertaining to the blood transfusion service were used. Second week Participants were introduced to the concepts of good manufacturing practice (GMP) and started to apply the quality principles learnt in week one to blood transfusion activities. Job descriptions and delegation as specifically applied to a blood transfusion service were emphasised. Flow charts and SOPs were applied to selected BTS activities. Monitoring and evaluation activities in the form of error reporting, corrective and preventive action and quality audits were introduced. Validation of processes and equipment was also covered.
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The role and value of training in the quality system were highlighted. Procurement, maintenance and calibration of equipment; monitoring of assay performance and the documentation of testing and processing were also discussed in detail. The costing of activities in a BTS was discussed using the WHO Module (Costing blood transfusion services WHO/BLS/98.8) as the basis. The week also concentrated on quality aspects of blood donors, including donor education, motivation, recruitment and retention. Donor selection, screening and handling of donated blood and donor records were discussed. Safety in BTS, including environmental factors were discussed. A mid-course evaluation of participants through a 20 open-ended questions was also undertaken. Third week The week concentrated on applying quality to th e main BTS activities. All aspects of the testing for transfusion transmissible infections (TTIs) were covered, including quality elements in laboratories and selection of test kits. An introduction to the concepts of external quality assessment schemes (EQAS) was given. Applying quality concepts to immuno-haematology and component preparation, documentation of activities, process flow and related critical points, and monitoring and evaluation in the immuno-haematology laboratory were discussed. The clinical interface learning included a general presentation and work on the role of the BTS in the clinical use of blood. Participants also began a draft plan for implementing quality into their own particular BTS which was finalized in consultation with the facilitators. Advice was given with a template on generating a plan of action. Where quality systems already existed, some problems were encountered on exactly what the participants should plan for but the participants were advised to concentrate on critical areas of their immediate concern and to ensure that they communicated with the appropriate management personnel to ensure that a collaborative effort was put into the proposed plan.
4.5
Post-course Assessment of the Participants A comprehensive evaluation of the training course was completed on the last day. The results revealed a significant improvement in the knowledge of the participants. The pre-course questionnaire was used for post-course assessment as well. The number of participants who answered more than 50% Page 5
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questions correctly increased to 95% from 35% as was observed in precourseassessment.
4.6
Hand outs Provided to the Participants All the participants were provided with handouts for the presentation. Additional notes were also circulated by some of the facilitators. A list of BTS publications of WHO was circulated to participants who desired that they be sent all the documents that have been published by WHO and are available gratis. A few participants requested supply of selected priced publications of WHO.
4.7
Evaluation of Course by the Facilitators The facilitators also reviewed the course. They expressed their satisfaction with the duration of the course, curriculum, quality of the teaching material provided by WHO and the response and involvement of participants in various activities undertaken during the workshop. However, some additional information was provided by most of the facilitators to fill in the gaps. They also volunteered their technical services for assisting in the implementation of QMP.
4.8
Evaluation of Course by the Coordinator The contents and duration of the course were adequate. The teaching material was usually appropriate and the programme of work logical. Field visits to mobile and static units were educative. A seco nd field visit to the blood centre may be incorporated so that a functional quality system can be seen by the participants. The implementation of the quality system requires sustained efforts by participants, country programme managers and WHO. A mechanism with indicators should be developed for monitoring and evaluation of QMP in Member countries.
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4.9
Valedictory Session The valedictory session was chaired by Dr Sudarshan Kumari, Regional Adviser for Blood safety and Clinical Technology wherein participants expressed their gratitude to WHO and the National Blood Centre, Bangkok, for arranging this workshop. They appreciated the QMP initiative of WHO and enumerated the benefits that had accrued to them by attending this workshop. Dr Kumari requested them to commit themselves, and their respective organizations, to the cause of quality in BTS to ensure safety, adequacy and quality of blood and blood products. She also assured them of all possible technical support from WHO in achieving their goals.
5. 5.1
RECOMMENDATIONS To WHO (1) WHO should assist in the implementation of quality systems at country and regional levels through advocacy, support organization of QMT courses and provide technical support to Member countries in implementing QMP. Periodic review s of all activities of BTS under QMP should also be performed. WHO should provide technical support in identified areas in improving technical skills of personnel working in BTS. WHO should provide technical support to organize regional EQAS in blood group serology and anti-HIV antibody detection for participants of this Regional QMT course. WHO should identify and support a Regional Quality Training Centre which should follow-up the progress made by the participants as well as act as a resource center for providing technical assistance to the participants of this, and other similar courses.
(2) (3)
(4)
5.2
To Member Countries (1) The Ministry of Health should provide the support and infrastructure to implement quality systems in Blood Transfusion Services as per the plan of action. Adequate budget should be earmarked for blood safety.
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(2) (3)
QMT courses should be organized at country levels with trained personnel as trainers. The participants of this course should be permitted to participate in the WHO supported regional EQAS on blood group serology and anti-HIV antibody detection.
5.3
To Participants (1) A plan of action in keeping with the priority needs of the participants’ centres may be developed and discussed with the Programme Director. They should make an all-out effort to ad vocate the need to implement the plan of action to improve blood safety. The participants should provide monthly feedback to the Regional Quality Centre and also seek their technical support to overcome the problems being encountered in establishing quality management.
(2)
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Annex 1 LIST OF PARTICIPANTS BANGLADESH Dr Muhammad Shahidul Islam Assistant Professor of Blood Transfusion Dinajpur Medical College Dinajpur Tel: 0531-64787 Dr Syed Golam Kibria Assistant Professor Department of Blood Transfusion Rajshahi Medical College Rajshahi Tel:0721-775599 Res: 0721-760108 BHUTAN Dr Krishna Prasad Sharma Deputy Chief Pathologist Central Laboratory JDW National Referral Hospital Thimphu, Tel: 00975-2-323812 Fax: 00975-2-326841 Res: 00975-2-323812 e-mail: drkpsharma@yahoo.com Mr Dorji Phuntsho Laboratory Technican Central Laboratory JDW National Referral Hospital Thimphu Tel: 00975-2-323812 DPR KOREA Dr Ri Chol Jun Official (Focal Point for Safe Blood) Ministry of Public Heal th Pyongyang Dr Kim Yong Chun Interpreter Ministry of Public Health Pyongyang INDIA Dr Poonam Shrivastava In-charge Blood Bank ESI Hospital, Basai Darapur New Delhi 110 015 Tel: 91-11-5100963 Res: 91-11-5694402 Professor K Selvarajan Head Department of Transfusion Medicine Government Royapetta Hospital Chennai, 600014 Tel: 8522611, Res: 5960226 Dr Nabajyoti Choudhury Associate Professor Transfusion Medicine Department Sanjay Gandhi Post Graduate Institute of Medical Sciences Rae Bareli Road, Lucknow-226 014 Tel: 440700, 440800 e-mail: nabajyoti_2000@yahoo.com
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Quality Management Training in Blood Transfusion Servic es in South-East Asia INDONESIA Dr Sutji Muljati In-charge, Donor Recruitment Jakarta Blood Transfusion Services Kramat raya No 47, Jakarta-Pusat Tel: 62-21-3906666 Fax: 62-21-3101107 e-mail: utddki@link.net.id Dr Lilianawati Head of Laboratory Division Jakarta Blood Transfusion Services Kramat raya No 47, Centre Jakarta 10450 Tel: 62-21-3906666 Fax: 62-21-3101107 e-mail: utddki@link.net.id MALDIVES Dr Farzana Khatoon Registrar in Medicine National Thalssaemia Centre Male Tel: 321085 Fax: 321863 Ms Shareefa Manike Laboratory Supervisor Indira Gandhi Memorial Hospital Male Tel: 316636-127 MYANMAR Dr Tun Myint Pathologist In-charge of Blood Bank National Blood Bank, Yangon General Hospital, Yangon Tel: 95-01-280204 Res : 95-01-571403 Dr (Ms) Mi Mi Sein Pathologist In-charge of Blood Bank Insein General Hospital Yangon Tel: 95-01-640132 Res : 95-01-250534 NEPAL Dr Manita Rajkarnikar Senior Deputy Medical Officer Blood Transfusion Centre Nepal Red Cross Society Kathmandu Tel: 977-1-225344/229344 Res: 977-1-530941 fax: 977-1-271915 e-mail: nrcs@nhqs.wlink.com.np Mr Bhup Raj Rai Medical Technologist National Public Health Laboratory Teku, Kathmandu Tel: 977-1-261141 Fax: 977-1-252375 Res: 977-1-480852 e-mail: bhupraj@usa.net SRI LANKA Dr K.K.S. Kuruppu Central Blood Bank National Blood transfusion Services National Hospital, Colombo Tel 941-692317 Res: 941-868658 Dr (Mrs) S.D. Tillakawardena Central Blood Bank National Blood transfusion Services National Hospital, Colombo, Tel 941-692317 Res: 941-539905 THAILAND Dr Dhanoo Lawbundis Chief, Department of Pathology Lerdsin General Hospital Department of Medical Services Ministry of Public Health Bangkok, 10500 Tel: 2360562 Fax: 2356909 e-mail: dhanoo@health.moph.go.th
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Report of a Regional Workshop Dr Roongrasamee Soisangwan Technical Manager of PT Section Bureau of Laboratory Quality Standards Department of Medical Sciences Ministry of Public Health 88/7 Tiwanon Rd, Nonthaburi 11000 Tel: 66-2-9510000 Ext 9263 Fax: 9510669 e-mail: roongrasamee@dmse.moph.go.th Ms Pintira Tanthien Pharmacist Quality Control Section National Blood Centre Thai Red Cross Society, Bangkok e-mail: nbcptt@redcross.or.th TEMPORARY ADVISERS Dr Srivilai Tanprasert Director, National Blood Centre Thai Red Cross Society Henri Dunant Road, Bangkok 10330 Tel 662-2513111 e-mail: srivilai@redcross.or.th Dr Pimol Chiewslip Consultant, National Blood Centre Thai Red Cross Society Henri Dunant Road, Bangkok 10330 Tel: 662-2513111 Dr V. Ravi Additional Professor and Head Department of Neurovirology National Institute of Mental Health and Neuro Sciences, Bangalore-560 029 Tel: 91-80-6995128 Fax: 91-80-6564830 e-mail: vravi@nimhans.kar.nic.in Dr V.L. Ray Head, Department of Transfusion Medicine Sanjay Gandhi Post Graduate Institute of Medical Sciences Rae Bareli Road, Lucknow-226 014 Tel: 91-522-440700/2500 e-mail: vl ray@sgpgi.ac.in Tel 662-2513111 e-mail: pimol@redcross.or.th Dr R.N. Makroo Senior Consultant and Head Department of Transfusion Medicine Indraprastha Apollo Hospital Sarita Vihar, Mathura Road New Delhi-110 044 Tel: 6825707 Fax 6823629 e-mail: raj_makroo@hotmail.com Er Raghbir Singh Khandpur Director-General Centre for Electronics Design and Technology of India (CEDTI), A-34, Industrial Area Phase VIII, Mohali, Panjab Tel: 91-172-254050 Fax: 91-172-254051 e-mail: rskhandpur@rediffmail.com Mr Mike Clark IT Systems Assurance Coordinator National Blood Service Leeds Centre, Bridle Path Leeds LS15 7TW U.K. Tel: 0113-2148605 Mobile: 0411-447006 Fax: 0113-2148629 e-mail: mike.clark@nbs.nhs.uk Mr Neil Rosin Quality Manager South African Blood Transfusion Service Private Bag X14 Weltevreden Park 1715, South Africa Tel: 27117619217 Fax: 27117619259 e-mail: nrosin@sabts.org.za WHO SECRETARIAT HQ Dr Neelam Dhingra Blood Safety Team, BCT WHO, Geneva (Switzerland) e-mail: dhingran@who.ch
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Quality Management Training in Blood Transfusion Servic es in South-East Asia SEARO Dr Sudarshan Kumari Regional Adviser, BCT Tel: 00-91-11-3370804/26504 e-mail: kumaris@whosea.org Dr Rajesh Bhatia STP-BCT Tel: 00-91-11-3370804/26193 e-mail: bhatiaRaj@whosea.org
Dr Z.S. Bharucha National Consultant Project Coordinator National AIDS Control Organization 9th Floor, Chandralok Building 36 Janpath, New Delhi 110001 Tel: 00-91-11-3731774/Ext 17 e-mail: zsbharucha@rediffmail.com
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Annex 2 PROGRAMME OF WORK Week/Day/time Week 1/ Day 1 26 March 2001 0830-0930 0930-1000 1030-1100 1100-1130 Registration Inauguration Pre-course evaluation Introduction to Quality Management Project (QMP) Objectives of Quality Management Training (QMT) 1130-1230 1230-1300 Need for Quality: Quality terminology Group work 1 Fitness for purpose 1400-1530 1545-1730 Week 1/ Day 2 27 March 2001 0830-0900 0900-1000 1000-1045 1100-1230 Review and discussion Presentation of expectations from course by the participants: 5 minutes each country Quality system Group work 2 Development of quality policy 1230-1300 Organizational structure and organizational chart/ organogram Participants Chairperson: Dr S. Kumari Mr Neil Rosin Participants+ Mr Neil Rosin Mr M Clark Drs Kumari, Dhingra, Bhatia Mr Mike Clark Quality terminology (contd.) Quality terminology (discussion contd) Mr Neil Rosin Mr Neil Rosin+Mike Clark Drs Kumari, Dhingra, Bhatia Mr Neil Rosin Participants + Mr Mike Clark Drs Kumari, Dhingra, Bhatia Dr Neelam Dhingra-Kumar Activity Principal speaker
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Week/Day/time 1400-1530 Group work 3
Activity
Principal speaker Participants + Mr Mike Clark Mr Rosin Drs Kumari, Dhingra, Bhatia Mr Mike Clark Participants + Mr Neil Rosin Mr Mike Clark Drs Kumari, Dhingra,Bhatia
Development of organograms 1545-1615 1615-1730 Job description Group work 4 Write job de scription of quality officer in a biscuit factory Week 1/ Day 3 28 March 2001 0830-0900 0900-1000 1000-1100 1115-1300 Review and discussion Elements of quality system Flow chart as a tool for mapping processes and identifying critical control points (CCP) Group work 5 Development of a flow chart 1400-1430 1430-1600 Quality planning Group work 6 Preparation of quality plan 1600-1730 Week 1/ Day 4 29 March 2001 0830-0900 0900-0930 0930-1030 1045-1300 Review and discussion Documentation : Types, necessity and importance How to write SOP/work instructions Group work 7 writing a SOP on making a cup of Nescafe 1400-1430 1430-1515 Validation of SOP Group work 8 Validation of SOP 1515-1545 Document control Visit to BTC to have an overview of a working quality system
Mr Neil Rosin Mr Neil Rosin Participants + Mr Neil Rosin Mr M Clark Drs Kumari, Dhingra, Bhatia Mr Mike Clark Participants + Mr Rosin + Mr Clark + Drs Kumari, Dhingra, Bhatia Dr Pimol
Mr Neil Rosin Mr Neil Rosin Participants + Mr Neil Rosin Mr M Clark Drs Kumari, Dhingra,Bhatia Mr Neil Rosin Participants + Mr Neil Rosin Mr M Clark Drs Kumari, Dhingra, Bhatia Mr Neil Rosin
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Week/Day/time 1545-1700 Group Work 9: SOP Revision Week 1/ Day 5 30 March 2001 0830-0900 0900-0930 0930-1100 Review and discussion
Activity
Principal speaker Participants+Mr Neil Rosin Mr Clark Drs Kumari, Dhingra,Bhatia
Error management: Reporting, analysing and corrective / preventive action Group work 10 Error management: Reporting, analysing and corrective / preventive action
Mr Mike Clark Participants + Mr Mike Clark Mr N Rosin Drs Kumari, Dhingra, Bhatia Mr Mike Clark Participants
1115-1145 1145-1300
Quality policy for BTS, organogram and job description Group work 11 Quality policy for BTS, organogram and job description
1400-1445 1445-1530
Introduction to quality audits Group work 12 Role play on process of Audit
Mr Mike Clark Participants + Mr Mike Clark Mr N Rosin Drs Kumari, Dhingra,Bhatia Participants + Mr Mike Clark Mr Rosin Drs Kumari, Dhingra,Bhatia
1545-1730
Group work 13 Identifying non-conformities in audit scenario Documentation of audit
Week 2/ Day 1 0830-0900 0900-1015 Review and discussion GMP as essential component of BTS and consequences of failure of good manufacturing practices (GMP) in BTS Group work 14 GMP Role Play 1115-1300 1400-1430 Identification of critical control points Principles of validation Mr Mike Clark
1015-1130
Mr Neil Rosin Mr Clark & Dr Bhatia Mr Neil Rosin Mr Mike Clark
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Week/Day/time 1430-1600
Activity Group work 15 (in two groups) Prepare validation plan for an equipment (Group1) and reagent (Group 2)
Principal speaker Participants
1615-1700
Group work 16 Prepare validation plan for a process pr software
Participants + Mr Mike Clark Mr Rosin, Dr Bhatia
Week 2/ Day 2: 3 April 2001 0830-0900 0900-1115 Review and discussion Role of training in quality system Training: needs and plans Documentation of training Monitoring and evaluation of training Group work 17 Development of an effective training plan in BTS 1400-1515 Biosafety in BTC – I Hygiene, prevention of infection and contamination of environment 1530-1630 Biosafety in BTC - II Disposal of waste 1630-1730 Group work 18 Identify safety issues and risk management Week 2/ Day 3: 4 April 2001 0830-0915 0915-1030 Inventory management of perishable and nonperishable items in a blood centre Group work 19 Inventory/stock preparation 1030-1100 1100-1200 1200-1300 Quality monitoring tools Monitoring and performance of assays, blood donations, blood products Mid-term review Mr Neil Rosin Participants+Mr Neil Rosin Mr Clark, Dr Bhatia Mr Mike Clark Mr Mike Clark Mr Neil Rosin et al Participants + Mr Neil Rosin Mr Clark, Dr Bhatia Mr Neil Rosin Mr Mike Clark
1130-1300
Participants + Mr Mike Clark Mr Rosin, Dr Bhatia Mr Neil Rosin
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Week/Day/time 1400-1445 Group work 20
Activity
Principal speaker Mr Mike Clark + Participants Mr Rosin, Dr Bhatia Mr RS Khandpur Mr RS Khandpur Participants Mr Khandpur Dr Bhatia
Analysis of data from BTS/lab and identify the trends 1445-1530 1530-1615 1615-1730 Procurement of equipment Maintenance and calibration of equipment Group work 21 Identify key maintenance and calibration needs of equipment and prepare an appropriate schedule Week 2/ Day 4 5 April 2001 0830-0900 0900-0945 0945-1030 1045-1215 Review and discussion Costing of activities in BTS - Principles and benefits, WHO model Cost of Quality and Additional costs of poor quality Group work 22 (in two groups) Calculation of testing cost (group 1) Calculation of cost of donor recruitment (group 2) 1215-1300 1400-1445 1445-1530 1545-1615 1615-1645 1645-1730 Review of Group work 22 Quality in donor recruitment and selection Collection of blood and care of donors Donor satisfaction and feedback Quality records in donor clinics Group work 23 Preparation of a check list of CCP for field visit Week 2/ Day 5 6 April 2001 0900-1500 Visit to mobile blood session and blood centre
Dr Zarin Bharucha Dr RN Makroo Participants + Drs Bharucha, Bhatia and Makroo Participants + Drs Bharucha Bhatia and Makroo Dr RN Makroo Dr RN Makroo Dr Zarin Bharucha Dr RN Makroo Participants+ Dr RN Makroo Drs Bharucha and Bhatia
Dr Pimol Dr Zarin Bharucha Dr RN Makroo Participants Dr Zarin Bharucha Dr RN Makroo, Dr Bhatia
1515-1700
Group work 24 Discussion on post visit donor issues
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Week/Day/time Week 3/ Day 1 9 April 2001 0830-0900 0900-0945 0945-1015 1015-1045 1100-1200 Review and discussion
Activity
Principal speaker
Quality in BTS laboratories and essential quality elements in Immunohaematology Quality in BTS laboratories and essential quality elements in Transfusion Transmitted Infections (TTI) Run validation Group work 25 Essential quality elements in immunohaematology (Group 1) and TTI (Group 2)
Dr Zarin Bharucha Dr V Ravi Dr V Ravi Participants Dr Bharucha Dr Ravi, Dr Bhatia Dr Bharucha Participants Dr Bharucha Dr Ravi, Dr Bhatia Dr Z Bharucha Dr R Bhatia and Dr R Soisangwan
1200-1300 1400-1500
Selection of test kits/reagents, blood bags and other disposables Group work 26 Choice of test kits and reagents
1500-1530 1600-1700
Documentation in laboratories External quality assessment schemes Importance, organization, participation
Week 3/ Day 2 10 April 2001 0830-0900 0900-1000 Review and discussion Quality in blood component production GMP Processes and procedures Documentation Maintenance and calibration Labelling Group work 27 Flowchart of blood component production process 1115-1145 1145-1230 1230-1300 Documentation in blood component production Monitoring and evaluation of blood component production Quarantine and release Dr VL Ray
1000-1100
Participants Dr VL Ray Dr Bharucha, Dr Bhatia Dr VL Ray Dr Zarin Bharucha Dr VL Ray
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Week/Day/time 1400-1500 Group work 28
Activity
Principal speaker Participants Dr Zarin Bharucha Dr VL Ray, Dr Bhatia Dr VL Ray Dr VL Ray Participants + Dr Zarin Bharucha Dr VL Ray, Dr Bhatia
Develop a plan for monitoring and evaluation of blood components 1500-1530 1545-1615 1615-1715 Storage, transportation and distribution of blood and blood components Blood stock management Group work 29 Blood stock management Week3/ Day 3 11 April 2001 0830-0900 0900-0945 0945-1015 1015-1045 1100-1215 Review and discussion Applying quality principles to clinical interface Essential information required on a blood request form Quality at bedside Group work 30 Development of an appropriate and effective blood request form 1215-1300 1400-1500 National policy and guidelines for clinical use of blood Group work 31 Monitoring and evaluation of the use of blood 1515-1600 1600-1630 1630-1730 Documentation and transfusion records Haemovigilance Group work 32 Quality issues in post transfusion monitoring Week3/ Day 4 12 April 2001 0830-0915 Development of action plan
Dr Zarin Bharucha Dr VL Ray Dr Zarin Bharucha Participants + Dr Zarin Bharucha Dr VL Ray Dr Kumari, Dr Bhatia Dr Zarin Bharucha Participants Dr Zarin Bharucha Dr VL Ray Dr Kumari, Dr Bhatia Dr VL Ray Dr Zarin Bharucha Participants Dr Zarin Bharucha Dr VL Ray, Dr Kumari, Dr Bhatia
Dr S Kumari
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Week/Day/time 0900-1000 1115-1300
Activity Contingency plan in BTS Group work 34 Development of action plan for respective BTS
Principal speaker Dr VL Ray Participants Chairperson: Dr S Kumari Participants Chairperson: Dr S Kumari
1400-1700
Group work 35 Presentation of individual blood centre plans
Week 3/ Day 5 13 April 2001 0900-1000 1015-1115 1115-1300 1400-1500 1500-1600 Round Table Discussion Discussion on respective plans Post-course assessment Course evaluation by participants Open discussions Closing and valedictory session Dr S Kumari Participants Dr S Kumari Dr S Kumari, Dr Rajesh Bhatia Dr S Kumari, Dr Rajesh Bhatia
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Annex 3 STATUS OF BTS ACTIVITIES IN DIFFERENT INSTITUTIONS IN THE COUNTRIES OF SOUTH-EAST ASIA Feature Units in thousands collected/year Components prepared % VNRD Quality manager Organogram Job description Documented quality policy Quality manual SOPs Training policy/strategy SOP for training System of stock control Policy on audit Trained auditors Critical equipment listed BAN 1 6 3 + v + + + + 2 10 10 + v + + + + BHU 4 + 65 V V + V + + + + + IND 1 7 + 100 v + + v + + + + + 2 15 + 10 + + + + + + + + + + 3 2.6 18 + V V + + INO 210 + 85 + + + + + + MAV 1 2.8 98 + + + 2 2.3 + 98 + + + V + + + MMR NEP 24 + 60 + + 60 + 40 + + + V + + + + SRL 50 + 83 + v + v + + V V THA 1 380 + 100 + + + + + + + + + + + + 2 7.2 100 + + + + + + + + + + + +
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Quality Management Training in Blood Transfusion Services in South-East Asia
Feature Equipment calibrated Equip maintained Policy on safety procedures SOP for safety Policy on error management Separate donor management deptt Donor questionnaire Data for screening analyzed Policy on screening for TTI SOP for TTI SOP for IH Test run validation EQAS participate Specifications of products made SOP for production Record of quality monitoring Guidelines for clinical use Haemovigilance v: variable-
BAN 1 v v + + v 2 v v + + v -
BHU V V V V + + + + + + + v -
IND 1 + + + + + + + + + + + + + 2 + + + + + + + + + + + + + + + 3 V + V + + + + + + + V v -
INO v + + + + + + + + + + + + + -
MAV 1 + + + + + + + + + + 2 + V + V V + V + V v + -
MMR NEP + + + + + + + + + + + + + + + + + + + + + + -
SRL V V V V V + + + + + + V + V + + v
THA 1 + + + + + + + + + + + + + + + + + + 2 + + + + + + + + + + V + + -
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