(WP)LAB/ICP/GPA/012-E
ENGLISH ONLY
REPORT
~IONAL WORKSHOP ON THE ORQ'ANIZATION AND MANAGEMENT OF BLOOD TRANSFUSION SERVICES
Convened by the REGIONAL OFFICE FOR THE WESTERN PACIFIC OF THE WORLD HEALTH ORGANIZATION Manila, Philippines, 26-29 September 1989
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Not for sale Printed and distributed by the Regional Office for the Western Pacific of the World Health Organization Manila, Philippines January 1990
NOTE The views expressed in this report are those of the participants in the Regional Workshop on the Organization and Management of Blood Transfusion Services and do not necessarily reflect the policies of the 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 Regional Workshop on the Organization and Management of Blood Transfusion Services held in Manila, Philippines from 26 to 29 September 1989.
CONTENTS
1•
INTRODUCTION ..................................................................................................... 1 OBJECTIVF.S ........................................................................................................... 1 SUMMARY OF DISCUSSIONS .................... III .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ....
2.. 3..
2
4.. 5..
FIEI,D
VISIT.......................................................................................................... 8
CONCLUSIONS.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .... 8
ANNEXES: ANNEX 1 ANNEX 2 ANNEX 3 ANNEX 4 LIST OF PARTICIPANTS •••••••••••••••••••••••••••••••• 11
RECOMMENDED POLICIES ON DONOR SELECTION CRITERIA IN MALARIOUS AREAS ••••••••••••••••••••••••• 17 NATIONAL PLAN ••••••••••••••••••••••••••••••••••••••• 19
MINIMUM TARGETS FOR BLOOD TRANSFUSION SERVICES ....................................................................................... 31
ANNEX 5 - COMPARISON BETWEEN BLOOD DONATIONS AND POPULATION SIZE ••••••••••••••••••••••••••••••••••••• 37 ANNEX 6 - BLOOD DONOR SCREENING OF INFECTIOUS AGENTS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •• 39
ANNEX 7 - SEROPOSITIVITY OF INFECTIOUS AGENTS IN BLOOD DONORS ••••••••••••••••••••••••••••••••••••• 41
1.
INTRODUCTION
The Regional Workshop on the Organization and Management of Blood Transfusion Services was held at the WHO Regional Office for the Western Pacific, Menila, Philippines from 26 to 29 September 1989. Twenty-five participants from 17 countries and areas and five temporary advisers from five countries (three of which were not otherwise represented) were joined by observers and supported by staff of the WHO Regional Office and Headquarters (Annex 1). The participants were welcomed by Dr S.T. Han, Regional Director, Western Pacific Regional Office of WHO. The Workshop represented a contribution towards self-sufficient blood transfusion services within the Region, following the Workshop on Safe Blood and Blood Products held in September 1988. The group noted that several countries had acted upon the recommendations made at the 1988 workshop. Participants revised the Regional approaches to minimizing the risk of transfusion transmissible disease, and re-examined the indications for the use of blood and blood products. Central to the discussions was the question of formulating national policy and determining its content. The workshop participants developed a model national plan for blood transfusion services. Participants were able to relate this to the organization and management of blood transfusion within their own countries. Blood transfusion services in the region ranged from small, isolated services in newly developed countries to modern transfusion practices in populous areas. It was clear that while many recommendations and principles were accepted by all present, local factors influenced national implementation. 2. OBJECTIVES
The objectives of the workshop were: (1) to review the current status of the organization and management of blood transfusion systems in countries of the Western Pacific Region and identify existing problems; (2) to discuss national policy matters regarding blood transfusion;
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(3) to develop national plans for strengthening the organization and management of blood transfusion services, including: (al (bl (c) (d) voluntary donations, the supply of safe bloed and blood products, the rational use of blood, and the formation of national blood committees.
3.
SUMMARY OF DISCUSSIONS
Several background presentations brought participants up to date on the global strategy of AIDS prevention, the Global Blood Safety Initiative, the state of transfusion practices within the region, and currently operative strategies for the prevention of HIV through blood and blood products. 3.1 Country reports
Participants submitted reports on the current status of transfusion practices within their countries. Nine of these were selected for presentation on the basis of their relevance to other countries or because of changes in their transfusion practices since the last Workshop. 3.1.1 Australia was one example where the Red Cross was involved in the entire blood service and the majority of funding was from Government. Donations remained static, but platelet and Factor VIII production were increasing. The issues of user-collector relationships and their significance with respect to HIV infection were highlighted. Since the implementation of the donor declaration system, there had been no new cases of HIV due to transfusion. 3.1.2 The delegation from China presented an outline of its national organization for blood transfusion. The national policy of voluntary blood donation had been drawn up by the State Council in 1978, and the regulations regarding blood centre administration had been issued by the Ministry of Public Health in 1979. A nationwide administrative service had been formed to regulate blood donor offices through the local government. The Chinese Red Cross Society was responsible for promotion, information and international exchange. A WHO Collaborating Centre for Development and Research for blood transfusion services had been set up in Shanghai to provide technical advice.
- 3The concept of non-remunerated blood donation was gaining steady acceptance by the population. China had been able to produce more blood components, and 20% of the total blood collection had been processed. There was a Quality Assurance System at national, provincial and blood centre levels. 3.1.4 In French Polynesia the Blood Transfusion Service was based on the French model. Hepatitis B sero-epidemiology showed that 20%-25% of its population were carriers of anti HBc antibody. Their problem was that if they followed the French recommendations of not allowing anti-HBc carriers to be blood donors, they would not be able to meet their blood requirements. The positivity rate of alanine amino transferase (ALT) in their donor population was 1.7% and if these donors were excluded it would be even more difficult to meet the blood requirements. 3.1.5 For Japan a historical perspective of the change from a paid donor system to a 100% voluntary system was presented. The Japan Blood Transfusion Service was the result of collaboration between the Red Cross Society and the Government. Their current activities were outlined. They had a problem meeting plasma requirements because of HIV infection from imported plasma products; they planned to be self-sufficient in plasma production in two years time. They were studying the use of hepatitis C virus (HCV) testing to detect non-A non-B hepatitis (NANB) hepatitis; 75% of NANB hepatitis could be detected by this method. 3.1.6 The participant from Papua New Guinea described its blood services which were of 2 types: (1) blood bank, (2) dispensing centre. In the blood bank, a full range of screening tests was carrried out, including HIV. In the dispensing centres, screening tests could not be done because the centres were too far apart. Funding was by Government to the Red Cross. Blood products were processed by the Commonwealth Serum Laboratories in Australia. Papua New Guinea had a donor problem because of high carrier rates of hepatitis B surface antigen, which ranged from 25%-50%. It was the practice to give HBsAg positive blood to positive patients, but not to pregnant mothers or non-immune patients. 3.1.7 The Philippines had a mixed blood transfusion service system, consisting of hospital-based blood banks, free standing blood banks, and the Red Cross. It had drawn up its basic policy on blood, which was to provide an adequate and equitable supply of safe blood and efficient utilization of blood an~ its components. Its projects included public education, professional education, blood donations in communities and blood replacement in hospitals. There was still a problem dispensing with paid donors; only 30% were volunteer donors. Five per cent of the total blood collection was processed and transfused as components.
- 4Future objectives included increasing voluntary donations and improving facilities to process blood. The Department of Health, the Philippine National Red Cross, and the Philippine Blood Coordinating Council had formulated the National Blood Services Program with clearly outlined objectives and strategies. 3.1.8 The representative from Singapore outlined the government involvement and contribution to the development of the National Blood Transfusion Service, which was directly under the Ministry of Health and totally funded by the Government. Government involvement in the Blood Transfusion Service had been in the following areas: (1) (2) (3) acceptance of the policy of voluntary blood donations; donor recognition through a system of awards and souvenirs; a scheme of medical benefits for regular blood donors including the nomination of one immediate family member to enjoy certain medical benefits for one year; (4) the promotion of blood donations in uniformed organizations such as the armed forces and the police force; (5) the promotion of donor and public education; and (6) the construction of a new blood center.
3.1.9 Tonga had a voluntary blood donation system whereby patients' relatives replaced donated blood. Pre-donation testing was practised, leading to the problem of persons wanting to be tested but not wanting to donate. Donor recruitment was difficult because of the two factors below: (1) in extended families, people did not want to donate blood to people outside the family; (2) religion. Health education was needed for both the public and the professionals. 3.1.10 The blood transfusion services in Vanuatu was financed by the Ministry of Health. Because islands were far apart, radio was used as the medium for donor motivation and recruitment. Improvements had been instituted after the September 1988 WHO Workshop on Safe Blood and Blood Products and the visit of the WHO Consultant to help improve laboratory services and blood programmes in the Region. In 1989, hepatitis B positive blood was no longer transfused to patients and all screening tests were now done as recommended, vis HBsAg, VORL, HIV and malaria. The need for the judicious use of blood was stressed because 20% of the donated blood had to be discarded.
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3.2 Transfusion transmitted infections 3.2.1 Participants acknowledged the three-fold proposal that a reduction in the risk of transfusion transmitted infections (TTl) required safer donors, safer products (or the safest available) and safe transfusion practices. The risk of withholding blood or blood products should outweigh the risk associated with their administration.
3.2.2 It was further acknowledged that three options were available to minimize the risk of TTl, namely: (a) identifying donors at risk; (b) protecting recipients; and (c) treating the product to make it non-infectious. In most instances, the first option was the most practical one available. 3.2.3 In general, a national policy concerning any TTl must take into account the following: (a) the seropositivity rates for the infection concerned;
(b) the epidemiology of the infection in the area of interest; and (c) the health priorities of the authority supporting the blood transfusion services. Preventive strategies Several changes were noted in the positions of WPR countries regarding TTls in 1988. The current situation is reflected below: 3.2.4.1 HIY It was agreed that HIY screening in blood transfusion services was essential, although this policy might need to be modified specifically in emergency situations when there was not enough time for testing; screening might also have to be waived in remote areas, where previously screened negative donors could be used. The pooling of specimens was discussed at length, and several reasons for not pooling, such as nonspecific reactivity, were offered. The consensus was that pooling was appropriate in places where the procedure had been evaluated, and where it was justifiable on scientific and economic grounds. 3.2.4.2 Hepatitis B Policy was likely to be influenced by the availability of antigen (and antibody) testing and by knowledge of local prevalence. Where practicabl~, ~rticipants agreed that HBsAg positive donors should be excluded from the doftor panel.
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It was agreed that HBsAg testing was not appropriate technology for most countries in the Region, and that anti HBc testing was inappropriate as a surrogate test where HB prevalence was high. There were technical issues that required clarification relating to hepatitis B testing and possible strategies to reduce the risk of transmission of this virus by blood transfusion, particularly in countries with high seroprevalence. WHO should seek to resolve these issues and to provide definitive guidelines. 3.2.4.3 NANB Hepatitis (Hepatitis C) At this stage in the development of a test for non-A, non-B (NANB) hepatitis (hepatitis C) it was not appropriate for participants to define policy on this matter, except to note that local practice should be determined according to local prevalence. A pilot study producing definitive data was a minimum prerequisite for blood transfusion services. Malaria Policy on the prevention of malaria transmitted by blood transfusions reflected prevalence in the local community. Practice ranged from excluding people from donating red cells on the basis of their case history to the other extreme of offering malaria treatment to non-immune blood recipients. In areas where malaria was endemic, a safe supply of blood should be sought through donor selection criteria (see Annex 2). If testing was performed, the method should be validated. Post-transfusion prophylaxis for blood recipients should be practised if there is any doubt about the risk of malaria. Syphilis The continued need for syphilis screening was recognized even though it called for case finding rather than prevention of TTl. Participants noted that the risk of transfusion-transmitted syphilis, although very low, had increased in the light of recent reports of longer survival of T. pallidum in stored blood. Another reason for this increase was that there was more demand for blood and blood products, notably platelet concentrates, which were kept for less than two to five days. 3.3 National Policy A further topic for discussion was the role and content of national policy, as well as the composition, role and function of a National Committee. This served as a preliminary discussion, the substance of which is reflected in the section on the National Plan (Annex 3).
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3.4 Blood and blood products 3.4.1 In discussing the use of blood and blood products, the safety of the patient remained paramount. It was essential to educate professionals about the correct use of blood and blood products for the benefit of the patient, and to ensure that the best use was made of a limited human resource.
3.4.2 Minimum component production included the availability of packed cells, cryoprecipitate, fresh frozen plasma and cryoprecipitatedepleted frozen plasma (cryosupernatant). 3.4.3 It is considered an important part of controlling blood product use to ensure that haematinics are used for patients with chronic anaemia and that synthetic plasma volume expanders are used in preference to products of human origin. 3.4.4 Dialogue between providers and clinical users should be actively promoted sO that users made the best use of the blood and blood products. 3.4.5 In small centres where there was no blood bank medical officer, a hospital transfusion officer should be appOinted. 3.5 National Plan The members of the Workshop spent a great deal of time discussing the content of a prototype National Plan. Topics were dealt with under several headings including objectives, targets, policies and strategies. The Plan is in Annex 3.
3.6 Rh(D) Testing The Workshop agreed that a panel of Rh(D) negative donors should be available in all centres but it might not be appropriate to test all donations for Rh(D) status in regions where Rh(D) frequency is very high and resources are limited. Recipients should normally be tested for Rhesus (D) status before transfusion.
3.7 Regional data base Reports and information provided by participants during the Workshop allowed the regional data base, established in 1988, to be updated (see Annexes 5 to 7).
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4.
FIELD VISIT
Participants, temporary advisers and WHO staff members visited the National Blood Center of the Philippine National Red Cross Society, where their visit was hosted by the Director, Dr Celso Samson. The visitors saw the numerous aspects of the operation of the service and three participants made a blood donation during the visit.
5.
CONCLUSIONS
The workshop reached the following conclusions: (1)
Voluntary, non-remunerated blood donation was an important principle for both self-sufficiency and transfusion safety. It should be actively pursued in countries which did not have an all volunteer blood programme. Continued efforts were required to ensure the best use of the blood and blood products available in each country. Substantial and sustained educational efforts were required to accomplish this aim, directed towards several key target groups (see Targets, Para. 2.3 of Annex 3). development of appropriate screening tests to minimize transfusion transmitted infection. The appropriateness of the tests depended on the prevalence and resources in each country. Workshop participants were advised to examine their current practices in the light of changes noted in the body of this Report (Para 3.2.4).
(2)
(3) It was clear that changes were occurring constantly in the
(4) A national plan for each country's transfusion services was considered essential. Those countries in the Region which lacked a national plan should be encouraged to prepare one during the next six months according to the model (Annex 3) developed during the Workshop. Those who already had such a plan were invited to evaluate it alongside the prototype plan. Those countries which developed plans along the lines of the model, or which already had plans were encouraged to share this information with the Regional Office in order to increase the scope and value of the Regional data base. (5) A National Blood Transfusion Committee should be established in every country. It should include representatives of government and
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any involved voluntary agencies, together with scientific and clinical nominees capable of bringing wide administrative and professional skills and experience to bear on the operation of the transfusion service. It should propose poliCies, review objectives and sonitor the achievement of targets at the national level. (6) All hospitals making regular use of blood and blood products should have a Hospital Transfusion Conmittee. Membership should comprise a representative of the medical ~dministration, representatives of key user groups (surgeons, anaesthetists, haematologists) as well as representatives of nursing staff, the hospital blood bank director or the technologist in charge, and a nominee of the provider transfusion service. The role of this Committee would be to monitor the usage of blood and components by ward user group, to conduct regular and unscheduled transfusion audits, to establish and maintain effective liaison between the provider and the user and to resolve any disputes arising from perceived excessive demands or inadequate supplies. (7) There was an urgent need to ensure that sufficient appropriately trained staff were available to ensure that each country implemented a national transfusion plan successfully. Training was required for medical, technical, nursing and ancillary staff, and should be made available at local, regional and international levels through international organizations such as WHO.
- 11. ANNEX 1
LIST OF PARTICIPANTS, OBSERVERS, TD4PORARY ADVISERS AND SECRETARIAT
1.
PARTICIPANTS
CHINA
Dr Fang Su Zhen Division Cbiet ot PRe Department ot Medical Administration Ministry ot Public Healtb Beijing Dr Zbang Qin Hui
Senior Technician Shanghai Blood Centre Shanghai Dr Xie Min
Physician-in-Charge '. Sbanghai Hygiene and Antiepidemic:Centre Sbanghai FIJI Mr Farhad Kban Technical Officer c/o Blood Bank Lautoka Hospital Lautoka Mr Uraia Rabuatoka c/o Department of Pathology C'fIM Rospital §!!!!
Dr Alain Leguellec Responsibls Ofticer Blood Transtusion Centre Direction de la Sante publique Papeete IAO PEOPlE'S JID.lXmTIC RmJIlLIC
Dr Te Thammavong Chef du Centre de transfusion sanguine Ministere de la sante publique et des affaires sociales Vientiane Dr Traykhouane Chef-adjoint de laboratoire Institut national d1hygiene et d1epidemiologie Ministere de la sante publique et des affaires sociales Vientiane
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Annex 1
MALAYSIA
Dr (Hrl) G. Duraisamy Acting Director Blood Transfusion Services General Hospital Kuala Lumpur Hr M. Stanley
MICRONESIA, FEDERATED STATES OF
Acting Laboratory Supervisor Truk State Hospital Truk State Mrl Marlene Meunier Chief Nurse Blood Transfusion Services B.P. J5 Noumea CEDEX Dr J. Faed Regional Transfusion Director and Immunohaematologist Otago Area Health Board Private Bag Dunedin Dr Diro Babona Director Blood Transfusion Services Department of Health . Boroko Hr Ua Rage
NEW CALEDONIA
NEW ZEALAND
Technologist-in-Charge Blood Transfusion Services Department of Health Boroko
PHILIPPINES
Dr Carmen T. Narciso President Philippine Blood Coordinating Council Department of Health Manila Dr Criselda O. Abesamis Medical Specialist Bureau of Research & Laboratories Department of Health Manila
- 13 Annex 1
REPUBLIC OF KOREA
Dr Sang In Kill Department of Clinical Pathology College of Medicine Seoul National Univer8ity ~
SAMOA
Dr Filipaina Anesone National Health Laboratory Services Western Samoa National Hospital Apia
SINGAPORE
Dr Diana Teo Regbtrar Blood Transfusion Service c/o Ministry of Health Singapore Mdm Sim Soon Boey Laboratory Technician Blood Transfusion Service c/o Ministry of Health Singapore
SOLOMON ISLANDS
Mr
F. Fatale Senior Medical Technologist Medical Laboratory Central Hospital Ministry of Health and Medical Services Honiara Dr S. Moala Medical Officer Special Grade In Charge Central Public Health Laboratory Ministry of Health Nuku'alofa Mr D. Kalorib Principal Laboratory Officer Central Hospital Vila
. TONGA
VANUATU
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Annex 1
SOCIALIST REPUBLIC OF VIET NAH
Professor Bach Quae Tuyen National Institute of Haematology and Blood Transfusion Bach Mai Hospital
l!!!!21 Mr Nguyen DiM Blood Transfusion-Hae.atology Center Ho Chi Minh City 2.
OBSERVERS
DEPARTMENT OF HEALTH
Dr Rodrigo Rodrigo Medical Specialist I Department of Laboratory Services Rizal Medical Center Fasig. Metro Manila
PHILIPPINE NATIONAL RED CROSS
Dr Celso Samson Director National Blood Center Philippine National Red Cross Bon1t'acio Drive Port Area Manila J.
TEMPORARY ADVISERS Dr R.W. Beal Director Rad Cross Blood Transfusion Services Adelaide. Australia Dr S. Leong Director Blood Transfusion Services Hong Kong Red Cross Hong Kong
I I
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Annex 1
Dr TOllas P. Haruba, Jr. Undersecretary of Health tor Standards and Regulation Officer-in-Charge Department ot Health Manila
Dr K. Nishioka Vice Director The Japanese Red CrosB Central Blood Centre Tokyo Japan Dr Ong Yong Wan Director, Haematology Department and Chairman, National AIDS Committee Ministry of Health Singapore
4.
SECRETARIAT
Dr Sima Hullan (Operational Officer) Regional Adviser Health Laboratory SBrvices WHO Regional Office tor the Western Pacific Manila Mr M. Lynch Laboratory Scientist Regional Programme on AIDS WHO Regional Office for the Western Pacific Manila
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Annex 1
Dr T. Akiba
Technical Officer Oftice of the WHO Country Liaison Officer Nuku1alofa Tonga Dr W.N.T. Gibbs Chief Health Laboratory Technology WHO Headquarters Geneva Dr D. Harris Coordinator Global Blood Safety Initiative WHO Headquarters Geneva
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ANNEX 2
RECOMMENDED POLICIES ON DONOR SELECTION CRITERIA IN MALARIOUS AREAS
The plasmodia whioh oause malaria in man (P. vivax, ~
~
2!!1!, In non-
malariae and
~
faloiparum) infeot red blood oells, and thus
transfusion of oellular oomponents may transmit the disease.
endemio areas there has been growing oonoern for this hazard beoause of the inoreasing numbers of people who travel to endemic areas, but the number of reported cases do not substantiate this fear. Nevertheless, in non-endemio areas, it is important to exclude donors who have returned from endemic areas. A prospeotive donor
who has lived in an endemio area, and who has been receiving ohemoprophylaxis, is deferred leaving the endemio area. until at least three years after
Donors who have had malaria are deferred
for at least three years following the successful treatment of the disease. People who have visited an endmic area are deferred for at Antibody screening tests are sometimes helpful,
least six months.
but are not universally applioable beoause they depend upon the availability of the appropriate antigens. antibody oonjugates are most widely used. In countries where malaria is endemic it is not practioable to reject donors who have had a previous history of malaria infeotion or to screen the blood for malaria. Recipients are given Tests based on fluorescent
ohloroquine or, in areas where the parasite is resistant to chloroquine, sulphodoxine/pyrimethanine or mefloquine.
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NATIONAL PLAN
Prime Objective To provide safe, affordable, adequ4te supplies of blo.od and blood products, accessible to all who need them.
Specific Objectives 1. To develop an integrated national blood transfusion service, coordinated with the health services.
2.
To formulate a national blood policy.
3.
To establish and maintain a safe, adequate and reliable source of blood based on voluntary non-remunerated donations.
4.
To ensure the appropriate supply and use of blood and blood products.
5.
To provide a system of quality assurance for all procedures and products.
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Annex 3 A. PRIME OBJECTIVE ~o
provide safe, affordable, adequate supplies of blood and blood
products, accessible to all who need them.
B.
SPECIFIC OBJECTIVES AND PRINCIPLES (The relevant strategies are lilted under the correspondingly numbered headings)
1.
To develop an integrated national blood transfusion service, coordinated with the health services Princ iples: a. Ultimate responsibility for BTS must rest with Government but in some situations, operational responsibility may be delegated to a non-profit organization. b. c. There will be variations in organizational structure. There should be integration of BTS in all aspects, including the collection, processing and usage of blood. d. There should be integration of the services nationally, at all levels. e. There should be coordination and collaboration with other departments in the health services.
2.
To fODmulate a national blood polic~ Principles: a. Establish appropriate national regulations to ensure donor welfare, and safety for the recipient and health care worker; control import and export of blood and blood products I I
i
I I !
- 21 Annex
3
b.
Define financial responsibility:
appropriate funding
arrangements should be made to ensure the satisfactory support of the transfusion services, provided that collection and supply are on a non-profit basis.
3.
To establish and maintain a safe, adequate and reliable source of blood based on voluntary non-remunerated donations Principles: a. b. Donations must be voluntary, non-remunerated* An organized and sustained public education programme is required to encourage recruitment and retention of donors c. Self-sufficiency in blood and blood components should be aimed at d. Wherever feasible, the possibility of using the patient's blood will be pursued (e.g. autologous blood collection; peri-operative blood salvage).
4.
To ensure the appropriate supply and use of blood and blood products Principles: a. Blood supply and component production appropriate to the needs and state of development. b. Blood and blood products should be used only when they are clearly indicated. c. Alternatives to the be promoted. use of blood and blood products should
*within the Region, it is recognized than this policy is as yet not attainable; nevertheless, it remains the goal for all services.
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Annex 3 alternative health strategies use of haematinics in some anaemias use of plasma substitutes where appropriate d. Education of health care workers, particularly medical practitioners, including programmes during their training.
5.
To provide a system of quality assurance for all procedures and products Principles: a. Good manufacturing practice - including provision of necessary space, reagents, equipment and appropriately trained staff. b. Standard methods should be established for all transfusion services. c. Appropriate internal quality control for all procedures and products, including performance specifications. d. Appropriate external proficiency testing programmes should be utilised. e. f. Selection of appropriate technology. l~e
quality of the service should be maintained.
- 23 Annex 3 C. TARGETS Background Information 1. The minimum targets for blood transfusion services established by the Global Blood Safety Initiative Consultation in March 1989 are relevant to every service in every country and should be read in conjunction with each national plan (See Annex 4). 2. It is recognized that each national plan will reflect the national health service priorities and the perceived role of blood transfusion in the overall health services plan. Transfusion services need to emphasize the critical supporting role which they play for most medical specialties, particularly surgery and obstetrics, and patients, with cong,enital bleeding disorders. 1. General Targets should be prepared following retrospective review of current operations, and will take in,to account current activities; projections will be based on the perceived forward developments and demands. 2. Outputs (Specific quantifiable targets should be set as a five-year plan) 2.1 Collection and Utilization Each transfusion service should have data available On donations collected source of donations (voluntary, replacement, paid) components produced plasma sent for fractionation percentage used
- 24 Annex
3 This information should be supplied by both the collecting/
processing .ervice and user institutions and be made available regularly (e.g. quarterly) to the National Blood Committee. 2.2 Staff Data Details of the numbers of staff listed by category should be supplied regularly, e.g. quarterly. Review of this data should
ensure that staff resources are matched to the amount and type of work undertaken. Where relevant, comparative workload statistical
analysis may be applied. 2.3 Status of Facilities Annual reports describing the facilities used at central/regional/ district levels and their ad~quacy
are required to assess the overall
standard of the service's plant and physical resources in relation to other relevant sectors of the Health Care Services. 2. 4 Training of" Peraonn" 1 (The numbers of staff and type of training should be indicated for each group) 2.4.1 Medical personnel should be exposed to relevant transfusion medical information, both at the undergraduate and postgraduate level. 2.4.2 Technical staff require training at levels sufficient to allow them to perform their task effectively and safely. 2.4.3 Nursing staff require instruction on the safe storage, handling and administration of blood and blood products
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(While recognizing the central role of nursing staff in administering and maintaining intravenous infusion, the responsibility for initiating blood orders rests with the designated medical practitioner). 2.5 Development Projects Target-oriented projects which will evaluate defined problems in local/national transfusion activities, and are intended to improve performance should be identified, together with their expected timetable. 3• Inputs (Quantitative targets should be recorded) 3.1 Public Education Appropriate, up-to-date, professionally. produced materials are required for public education in different fields, including schools, and new and existing donors. Appropriate and active use should be made of all relevant media outlets to promote the activity of blood donation. 3.2 Health Care Worker Education Hands-on participation at many different levels will improve the quality of transfusion practice. Such programmes may be run at
the institutional level, or at regional or central levels for appropriate staff. The role of regular WHO seminars and workshops
in stimulating the acquisition of knowledge and raising of standards is acknowledged.
·. .. D.
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Annex 3 STRATEGIES (The five sections are to be read in conjunction with the correspondingly numbered principle) 1. General 1.1 A National Blood Transfusion Committee should be formed and have representacion from Government, transfusion experts and other appropriate interested parties. will have an advisory/management. role in: determining national transfusion policy reviewing effectiveness of the Transfusion Service, and where appropriate, reviewing and determining funding of the Service. 1.2 Operation of the service should be integrated to ensure optimal use of blood collected. Specific details of integration should be identified, e.g.: coordination of preparation of publicity resource materials transport of blood for testing and preparation of blood components at central transfusion services regional coordination of appropriate routine and emergency supplies to hospitals, etc. rotation of stock between centres to minimize outdating establishment of referral centres for investigation of serological problems The Committee
• Alterna.tives depending on Government strategy for managing Health Care Services
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Annex 3
1.3
Diagnostic services and/or blood banks capable of meeting expected service demands will be located in appropriate hospitals and health care facilities.
2.
Regulation 2.1 2.2 Legislative support should be sought for the National Plan. Regulations which set minimum standards for Blood Transfusion Services and Blood Banks should be prepared by appropriate experts. 2.3 Each Blood Transfusion Service and Blood Bank must prepare its own Standard Operating Procedures and these must be readily available to all staff. 2.4 Blood Transfusion Services and Blood Banks must be prepared to be inspected by a licensing authority or technical expert in some cases as part of an accreditation process and review of quality control tests. Where appropriate standards are
not met, prompt corrective action must be taken. 3. The Blood Supply 3.1 The blood supply will be maintained by the following means: a. A sustained public education programme targeted at responsive groups and especially at the schools will be mounted. b. A programme which ensures effective donor retention will be established. c. Blood collection will be undertaken at accessible and
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Annex 3 convenient venues in blood donor centres, hospitals and mobile collection units. d. Collection facilities will be of good physical standard and have efficient staff who are trained in public relations. e. Voluntary non-remunerated donors will be used whenever possible (as not all countries can accept this practice, it is noted that replacement donations from relatives may be considered appropriate - use of material inducements for donors should be only regarded as an interim solution to meet demands). f. Donor registries with relevant blood group, serological and donor health information should be maintained. g. The national standard for selecting donors will follow accepted international standards. 3.2 Autologous blood collection for elective surgery and peri-operative blood collection will be supported. 3.3 Access to a fractionation plan for supply of appropriate blood products fDom nationally derived plasma should be established where appropriate. 4. Procedures 4.1 Blood donations should be collected in sterile, disposable
closed systems which permit aseptic preparation of blood components whenever possible.
• - 29 Annex 3 4.2 Except in extreme emergencies, blood and blood components should only be transfused after appropriate
tests for blood groups, antibody screening and infection serology (as set out in the national policy) have been performed. 4.3 Pretransfusion compatibility testing which will detect potential serological transfusion reactions will be performed except in extreme emergency. 4.4 Access should exist to a referral centre for serological problems. 4.5 Appropriate temperature-controlled facilities should be used for storage and transport of blood and blood products. 4.6 Equipment should be technologically appropriate to the country's level of development and maintenance should be sustainable. Arrangements and training for ongoing
maintenance must be an important consideration for selection of equipment. 5. Evaluation, Review, Training and Education 5.1 An internal Quality Control programme should exist to ensure that test results are valid have the expected content. and blood components
Specific procedures must be
listed and records maintained of the results. 5.2 Blood Transfusion Services should participate in an external Proficiency Testing Programme.
- 30 -
Annex 3
5.3
The future needs for technical staff in numbers and level of experience should be identified regularly and appropriate trainees recruited. Access to appropriate training
courses which lead to a certified qualification must be established. 5.4 The basic training for technical staff should include the knowledge and skills required of the minimum standards for diagnostic testing in blood transfusion service. Access to
advanced training programmes for career technologists must be established. Senior staff should have training in
management procedures. 5.5 The training of medical and other health care pDofessionals should be undertaken in cooperation with professional training programmes. 5.6 Appropriate continuing education programmes for transfusion service staff and other health workers must be established.
- 31 ANNEX 4
MINIMUM TARGETS FOR SLOOD TRANSFUSION SERVICES Geneva 20-22 March 1989
- 32 Annex 4 The Global Blood Safety Initiative (GBSI) is a cooperative endeavour to support the development of safe and effective blood transfusion services in all countries. Core participants are the World Health Organization Global Programme on AIDS (GPA) and unit of Health Laboratory Technology (LAB), the League of Red Cross and Red Crescent Societies (LRCS), United Nations Development Programme (UNDP) and International Society of Blood Transfusion (ISBT). The Initiative is also supported by The World Federation of Haemophilia and other bilateral and multilateral development agencies and nongovernmental organizations, is coordinated by the Global Programme on AIDS, and managed by a Secretariat which comprises representatives of GPA, LAB and LRCS.
This document was reviewed and endorsed by the GBSI Consultation on Developing and Strengthening Blood Transfusion Services held in Geneva, 20-22 March 1989. A total of 23 specialists in blood transfusion medicine and haematology from 17 countries participated.
- 33 Annex
4
MINIMUM TARGETS FOR BLOOD TRANSFUSION SERVICES
Blood transfusion services are multifaceted and may be established or developed at different levels of sophistication. This outline of minimum targets is to be regarded as the basic requirements to ensure a sate blood supply. It is hoped that many countries will be able to surpass these targets immediately or after a period of development at the basic level. 1. Organization/Administrative 1.1 1.2 1.3 National (or regional) blood transfusion advisory committee(s) should be formed. A national blood policy should be formulated. The post(s) of Director(s) of the transfusion services should be established and appointments made. These may be national or regional depending on the size of the country and organization of the transfusion services. SUpporting professional, administrative and ancillary staff must be adequate and a career structure for professional staff should be defined. Responsibility for operation of the services should be clearly defined (e.g., government itself or delegated). Armed Forces transfusion services should collaborate closely or be integrated with national transfusion services in order to pool resources and to respond better to national emergencies. Thera should be assurance of capital costs and recurrent funding.
1.4
1.S 1.6
1.7 2.
Blood Donations 2.1 2.2 The principle of voluntary nonremunerated donations should be accepted and practised. Donor recruitment should be on a scheduled basis for at least part of the blood supply, with plans for expansion, and there should be a system to encourage repeat donations. If family or "replacement" donors are used their donations should be to the transfusion service and not "directed" to named recipients. Care must be taken to ensure that this is not a hidden professional system. 2.3 There should be a consistent and reliable system for donor selection and deferral.
- 34 Annex
4 Procedures should be clearly set out for caring for the donor before, during and after donations and for referrals where necessary.
2.4
2.S Records should be kept which will allow tracing of donors without breaching confidentiality. At the basic level the.e will be operated lIIBIIually. 3. Blood Collection Centre 3.1 The basic equipment should include a refrigerator for storing red cell., with a reliable monitoring system for ensuring that the temperature is maintained between 2" and 6"C. (NB: a lis,t of basic equipment and consumables is provided in the GBSI document -Basential Consumables and Equipment".) ABO grouping should include cell and serum typing of all units with appropriate internal controls. Rh(O) typing should include appropriate internal controls. Screening for human immunodeficiency virus, hepatitis viruses, syphilis and other infectious agents transmissible by blood should be performed as indicated by the national blood policy based on sound epidemiological stUdies. Verifiable records should be kept. There should be a labelling system indicating that testing has been done on all blood units and that those units issued meet the agreed criteria. An
3.2 3.3 3.4
3.5
3.6
inventory system for blood collected, in storage and issued. should be installed. If blood is returned, there must be documentation of the storage conditions, including storage temperature and the integrity of each unit.
3.7
A system of quality assurance should be installed. The minimum requirement is a manual of standard operating procedures and internal quality controls for all tests.
4.
Hospital Transfusion Service 4.1 4.2 The basic equipment should include a refrigerator as indicated in 3.1. The targets for ABO grouping and Rh(O) typing are as has been already indicated above in 3.2 and 3.3. All reCipient and donor samples must be grouped.
- 35/36 Annex 4
4.3
Compatibility testing should be performed in tubes at room temperature to detect ABO incompatibility, and at 37'C in a system which will reliably detect coating (IgG) antibodies, such as the anti-human globulin method. Compatibility testing should be carried out on all blood transfused even if, in a life-threatening emergency, this is after it has been issued.
4.4 4.5 4.6
Blood should be screened for infectious agents as indicated in 3.4 if this has not been done previously. There must be a clinical record of all transfusions and a system for recording and investigating post transfusion reactions. Guidelines for transfusion of blood and blood derivatives should be defined and propagated to all health-care professionals in clinical charge of patients. crystalloids and synthetic colloids must be available for the emergency treatment of acute blood loss. The blood transfusion service should assist in developing red cell salvage and autologous transfusion procedures.
4.7 4.8 5.
Training and Education There must be educational programmes (including continuing education) for all health-care professionals involved in blood transfusion.
- 37/38 ANNEX 5
Comparison Between Blood Donations and Population Size
Country Australia China Fiji
Population lin thousandsl 16018 1,053,970 750 180 5,613 121,672 70 3,585 16,749 185 3,367 3,419 58,000 41,865 160 2,650 286 97 145 64,863
Ho. 01' blood donations per year !unitj 931,808 2,500,000 7,000 7,000 155,079 8,217,340 700 4,800 186,000 7,226 186,209 30,000 400,000 999,444 2,768 57,991 1,681 970 1,216 80,000
Ho. 01' blood donations per population lin thousandsl 58 2.3 9 25 28 68 10 1.3 11 39 57 8.8 6.9 24 17 21 5.9 10 8 1.2
Ho. 01' Hospital Beds"_ 94,931 2,342,000 1,774 56912 24,000 1,184,899 209 10,587
Unit bed 9.8 1.0 3.9
French Polynesia Hong Kong Japan Kiribati ,lao l".D.R.
6.4 6.9 2.6 0.45,
Malaysia New Caledonia New Zealand Papua New Quinea Philippines ,Republic of Korea S!mra
1,540 23,109 13,034 85,888
4.7 8.0 2.3 4.6
680 6,516 1,351 335 437 221,244
4.0 8.8 1.2 2.9 2.7 0.36
Singapore Solomon Islands Tonga Vanuatu Viet Nam
"Reference:
WHO Country Profile from 1981-1984.
- 39/40 ANNEX 6
Blood Donor Screening of Infectious Agents Countrl AUlltral1a China Fiji French Polynesia Hong Kong Japan Kiribati . Lao }I.D.I\ ... Malaysia New Caledonia New Zealand Papua New Guinea Philippines il:epubl1c of Korea Samoa Singapore Solomon Islands Tonga Vanuatu Viet Nam Yo
SlEhil1B x x (part) x x x x x ..x x x x
HBBAg x x x(part) x x x x x(part) x x x x(part) x(part) x x x x(part) x x(part) x(part)
HIV x x(few) x(part) x x x x· x(part) x x x x(part) x(part) x x(part) x x(part) x x(part) x(part)
HTLV-I
Malaria
CMV
x~t)
x (part) x (part) x
x (part)
x(part)
x
(par~
x
x x x x x x (part) x
x(part)
x
·stopped since July 1988.
- 41 ANNEX 7
SeroEositivitl of Infectious Agents in Blood Donors Countrl Australia China Fiji French Polynesia Hong Kong Japan Kiribati 2% 0.)% 0.0)% 0.)% 0
SYJ)bilis 0.001%
HBsAg 0.1% 6 - 7% 11% 1.7% 9.7% 1.)% 20+% 6.)% 14% ).5% ).)% 0.)%
HIV 0.0001%
HTLV-I
Malaria
0.014% 0.0005% 0.0014% 0.0001% 0 2.2%
Republic of Korea 0.15% Laos Malaysia New Caledonia New Zealand Papua New Guinea Philippines 0.2% 6.)% (yaws) 0.1% 11.7% (yaws) 1% 1.2% 0.05% 0 0.4% 2.29% (yaws) 0.01%
0 0.001% 0.045% 0.0016% 2.5% <1% 1.65%
17-22.5% 0 12-15% 9.8-10% 0 1.6% 2).4% 11% 15% 12-15% 0 0.009% 0 0
.s... Singapore Solomon Islands Tonga Vanuatu Viet Nam
0.5% 0.01%