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WORLD HEALTH ORGANIZATION
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ORGANISATION MONDIALE DE LA SANTÉ EXECUTIVE BOARD
Seventy-ninth Session
Programme Committee of the Executive Board 27-30 October 1986
Provisional agenda item
4 Î 4 OCT. Ш 6
ST T
coU J
EB79/PC/WP/3 8 October 1986
BLOOD AND BLOOD PRODUCTS Report by the Director-General
This document has been prepared in response to a request made during the seventy-first session of the Executive B o a r d . It provides a progress report on subsequent events reviewing the m a i n uses of blood and blood products and quantities needed and the organization and management of blood transfusion services. Particular attention is devoted to the safety of blood and blood products in relation to AIDS causal a g e n t ( s ) . Highlights are presented of an initial analysis of a survey in a cross-section of developing countries throughout the w o r l d . Suggestions are made as to what remedial
action could be considered by both developed and developing c o u n t r i e s .
II III IV V VI
CONTENTS
Page
Introduction 2 M a i n uses of blood and blood products 2
Organization and management of blood transfusion services 4 Safety of blood and blood products in relation to cause(s) of AIDS 7
World situation 10 Concluding remarks 20
Annex 1 . Extract from Blood transfusion. A guide to formation and operation of a transfusion service
A n n e x 2 . Assessment of integrated blood transfusion services in developing countries
EB79/PC/WP/3 page 2
I . I N T R O D U C T I O N
1 . In J a n u a r y 1 9 8 3 the E x e c u t i v e B o a r d , w h e n r e v i e w i n g W H O p r o g r a m m e b u d g e t p r o p o s a l s c o n c e r n i n g p r o g r a m m e 1 2 . 3 , D r u g and v a c c i n e q u a l i t y , s a f e t y a n d e f f i c a c y , r a i s e d a n u m b e r of q u e s t i o n s c o n c e r n i n g the r a t i o n a l u s e of p l a s m a p h e r e s i s , the e t h i c s of b l o o d p u r c h a s e f r o m i n d i v i d u a l d o n o r s a n d , in m o r e g e n e r a l t e r m s , the a c t i o n w h i c h c o u l d b e t a k e n in d e v e l o p i n g c o u n t r i e s to m a k e b l o o d t r a n s f u s i o n s s a f e for the p o p u l a t i o n and to m a k e b l o o d a v a i l a b l e f r e e f o r t h o s e w h o n e e d e d i t . The E x e c u t i v e B o a r d a g r e e d t h a t , a f t e r c o n s u l t i n g the W H O r e g i o n s , a r e p o r t on t h e s e t o p i c s w o u l d be s u b m i t t e d to the P r o g r a m m e C o m m i t t e e . S u b s e q u e n t l y , the P r o g r a m m e C o m m i t t e e d e c i d e d to p r o v i d e a p p r o p r i a t e time for n a t i o n a l a n d r e g i o n a l
c o n s u l t a t i o n and to d e v e l o p a b e t t e r u n d e r s t a n d i n g of the m a g n i t u d e of the s a f e t y p r o b l e m s a s s o c i a t e d w i t h the d i s c o v e r y of a c q u i r e d i m m u n o d e f i c i e n c y s y n d r o m e ( A I D S ) . It w a s a g r e e d , t h e r e f o r e , to p l a c e the p r o b l e m of b l o o d and b l o o d p r o d u c t s on the a g e n d a of the O c t o b e r 1 9 8 6 s e s s i o n of the P r o g r a m m e C o m m i t t e e .
2 . S i n c e J a n u a r y 1984 t h e t h r e a t r e p r e s e n t e d by A I D S h a s b e e n r e c o g n i z e d by an i n c r e a s i n g n u m b e r of c o u n t r i e s , m a k i n g it i m p e r a t i v e to d e v e l o p and s y s t e m a t i c a l l y u s e s e n s i t i v e m e t h o d s f o r the d e t e c t i o n of h u m a n i m m u n o d e f i c i e n c y v i r u s ( H I V ) , its c a u s a t i v e a g e n t , a m o n g b l o o d d o n o r s , b l o o d b a t c h e s a n d b l o o d p r o d u c t s . D u r i n g this p e r i o d , the p r a c t i c a l h e a l t h
s i g n i f i c a n c e of t r a n s f u s i o n - i n d u c e d n o n — A non—В h e p a t i t i s h a s b e e n i n c r e a s i n g l y r e a l i z e d , l e a d i n g s o m e c o u n t r i e s to i m p l e m e n t a d d i t i o n a l b l o o d s c r e e n i n g p r o c e d u r e s . P r e l i m i n a r y s u r v e y s on the c h a r a c t e r i s t i c s of and p r o b l e m s f a c e d by b l o o d t r a n s f u s i o n s e r v i c e s in d e v e l o p i n g c o u n t r i e s h a v e a l s o s h o w n t h a t t e c h n o l o g i e s a v a i l a b l e for e n s u r i n g the s a f e t y of b l o o d and b l o o d p r o d u c t s a t the users‘ end w e r e n o t r o u t i n e l y u s e d for a v a r i e t y of r e a s o n s . A s a c o n s e q u e n c e , the w o r k i n g p a p e r s u b m i t t e d to the P r o g r a m m e C o m m i t t e e p r e s e n t s a b r o a d s i t u a t i o n a n a l y s i s , p l a c e s t h e m a i n i s s u e s i d e n t i f i e d b y the E x e c u t i v e B o a r d w i t h i n t h e i r p r o p e r f r a m e and m a k e s s u g g e s t i o n s for a c t i o n for c o n s i d e r a t i o n by the P r o g r a m m e C o m m i t t e e . I I . M A I N U S E S OF B L O O D A N D B L O O D P R O D U C T S
3 . B l o o d as a r e p l a c e m e n t in c a s e s of a c u t e h y p o v o l a e m i c s h o c k is a s t a n d a r d c l i n i c a l p r a c t i c e . S u c h a c u t e s h o c k s a r e u s u a l l y a s s o c i a t e d w i t h a c c i d e n t s , o b s t e t r i c e m e r g e n c i e s and s u r g i c a l i n t e r v e n t i o n s . S p e c i f i c c o n d i t i o n s f u r t h e r m o r e r e q u i r e e i t h e r the a d m i n i s t r a t i o n of w h o l e b l o o d or b l o o d p r o d u c t s . In d e v e l o p e d c o u n t r i e s the u s e of w h o l e b l o o d is b e i n g s l o w l y r e p l a c e d b y c o n c e n t r a t e d r e d - c e l l s u s p e n s i o n s w h e n the o x y g e n - c a r r y i n g c a p a c i t y of the
h a e m o g l o b i n is v i t a l� by a l b u m i n s o l u t i o n s as r e p l a c e m e n t f o r b l o o d w h e n p l a s m a d e r i v a t i v e s a r e m o r e i m p o r t a n t ; b y i m m u n o g l o b u l i n s f o r p r o t e c t i o n and t r e a t m e n t of disease； by
c r y o p r e c i p i t a t e s and f a c t o r V I I I and f a c t o r IX f o r t r e a t m e n t and m a n a g e m e n t of
h a e m o p h i l i a c s ; a n d b y l e u c o c y t e t r a n s f u s i o n s f o r i n d i v i d u a l s on i m m u n o s u p p r e s s i v e t h e r a p y ( l e u c o p h e r e s i s and t r a n s f u s i o n ) . T h i s h a s led to the g r o w t h of two s e r i e s of f a c i l i t i e s ; b l o o d t r a n s f u s i o n s e r v i c e s f o r c o l l e c t i o n , s t o r a g e , c a t e g o r i z a t i o n , d i s t r i b u t i o n and u s e of w h o l e b l o o d� and b l o o d f r a c t i o n a t i o n i n s t i t u t i o n s e x p l o i t i n g the p l a s m a a n d its m a i n
c o m p o n e n t s . N o t o n l y a r e the end p r o d u c t s d i f f e r e n t b u t a l s o l a r g e q u a n t i t i e s of p l a s m a can b e a c q u i r e d by p l a s m a p h e r e s i s i n s t e a d of w h o l e b l o o d d o n a t i o n .
4 . E c o n o m i c d e v e l o p m e n t and p u b l i c i n f o r m a t i o n a r e g i v i n g p e o p l e i n c r e a s i n g a c c e s s to h e a l t h f a c i l i t i e s , w h i c h in t u r n is r a i s i n g the d e m a n d for m o r e a n d b e t t e r b l o o d and b l o o d p r o d u c t s t h r o u g h o u t the w o r l d , w h i l e the s t e a d i l y i n c r e a s i n g r e a l i z a t i o n of the p u b l i c h e a l t h i m p l i c a t i o n s of b l o o d - t r a n s m i t t e d d i s e a s e s r e s u l t s in a d d i t i o n a l q u a l i t y c o n t r o l
r e q u i r e m e n t s . T h e s e are n o t o n l y c o m p l e x and c o s t l y , b u t s e v e r e l y l i m i t the p r o p o r t i o n of
" s a f e d o n o r s " and the a v a i l a b i l i t y of c h e a p a n d s a f e b l o o d and b l o o d p r o d u c t s .
5 . F o r h i s t o r i c a l and s o c i o e c o n o m i c r e a s o n s no t w o c o u n t r i e s a r e a l i k e in the d e v e l o p m e n t of their b l o o d t r a n s f u s i o n s e r v i c e s and p l a s m a f r a c t i o n a t i o n f a c i l i t i e s . T h e l e a s t d e v e l o p e d of t h e d e v e l o p i n g c o u n t r i e s u s u a l l y s t i l l r e l y h e a v i l y on the use of w h o l e b l o o d , w h i l e at the o t h e r e n d of the s c a l e d e v e l o p e d i n d u s t r i a l i z e d c o u n t r i e s a r e i n c r e a s i n g l y u s i n g b l o o d p r o d u c t s f o r s p e c i f i c a p p l i c a t i o n s . H o w e v e r , w h a t e v e r a p p r o a c h is a d o p t e d , the h i g h r i s k of t r a n s m i s s i o n of b l o o d - b o r n e d i s e a s e s c a l l s f o r s t r i c t s t a n d a r d s in b l o o d c o l l e c t i o n , s t o r a g e d i s t r i b u t i o n and r e c o r d - k e e p i n g .
6 . T h e s t r i c t q u a l i t y c o n t r o l r e q u i r e m e n t s a d o p t e d in the p a s t for b l o o d - g r o u p i n g and p r e v e n t i o n of c e r t a i n p a r a s i t i c and b a c t e r i a l d i s e a s e s ( e . g . , m a l a r i a , C h a g a s1 d i s e a s e , s y p h i l i s , y a w s ) had to be r e i n f o r c e d to p r e v e n t the t r a n s m i s s i o n of h e p a t i t i s B , and
a d d i t i o n a l c o n t r o l s a r e n o w r e q u i r e d to c o p e w i t h H I V and n o n - A n o n - B h e p a t i t i s . T h e r e is no
EB79/PC/WP/3 Corr.3 page 17 evidence that m o r e controls w i l l not be added in the future due to the discovery of still
undetected blood-borne d i s e a s e s . It is e s s e n t i a l , t h e r e f o r e , that the public health community look at transfusion of blood and the administration of blood products more critically in order to better identify the n e e d s , indications and c o n t r a i n d i c a t i o n s , to prevent the spread of blood-borne d i s e a s e s , and to optimize the exploitation of blood resources which dwindle whenever additional control procedures are i n t r o d u c e d .
7 . Every transfusion of blood has an element of risk and hence the indications m u s t be p r e c i s e . W h o l e blood t r a n s f u s i o n , always w i t h an anticoagulant added (usually a citrate) is indicated：
(a) w h e n hypovolaemic shock of an acute nature threatens the integrity and capacity of the circulatory system to combat i t , resulting in an irreversible process；
(b) to increase the oxygen-carrying capacity of the blood when there is severe h y p o x i a . 8 . Blood should be given to a recipient only w h e n the ABO and R h ( D ) group of the patient and the donor are congruous and cross-matching has established the total compatibility of the blood g i v e n . This is imperative for all clinical use of blood and means that blood-grouping r e a g e n t s , equipment and expertise are needed both at the time and place of blood collection and when the blood is u s e d .
9 . Storage of blood beyond 21 days even at 4°C results in decrease in erythrocytes to less than 8 0 % , loss of coagulation f a c t o r s , a drop in pH from 7 to 6.5 and a fourfold increase in extracellular potassium from 4 m e q / l i t r e to 15-20 m e q / l i t r e , resulting in hyperkalaemia after transfusion. Besides h y p e r k a l a e m i a , excessive citrate accumulation w h e n large quantities of blood have been used can lead to hypocalcaemia due to chelation of calcium by the c i t r a t e . Undetected hypocalcaemia can lead to cardiac a r r e s t . Excessive transfusion of blood also has the effect of decreasing the platelet c o m p o n e n t , and thrombocytopenia can o c c u r , resulting in haemorrhagic patches and a drop in prothrombin l e v e l s .
1 0 . M a n y other applications of whole blood transfusion could be mentioned h e r e , such as those used for treating the haemolytic disease of the n e w b o r n , or alleviating the periodic haemolytic crisis of the carriers of the thalassaemia g e n e , but such a detailed presentation is not the purpose of the present r e p o r t . It should be n o t e d , h o w e v e r , that each of these applications requires specific s k i l l s , e q u i p m e n t , biological and/or chemical laboratory r e a g e n t s , and a proper f o l l o w - u p . In the absence of such facilities the transfusions cannot be safely carried out o r , at b e s t , have little chance of being c o s t - e f f e c t i v e . These requirements apply also to the administration of specific blood f r a c t i o n s , a few examples of w h i c h are listed b e l o w .
1 1 . Red cell concentrate therapy is based on the administration of cells separated from the b l o o d , one unit of red cell concentrate corresponding to the amount of cells found in 540 m l of b l o o d , the usual blood transfusion u n i t . The cells must be prepared and used within 12 h o u r s . The suspension of red cells in Ringer lactate solution is of particular value in elective surgery in patients with cardiac d e c o m p e n s a t i o n . In paediatric practice washed red cells may be necessary in certain cases such as those of haemolytic a n a e m i a , paroxysmal
haemoglobinuria and "ABO" haemolytic d i s e a s e . Additional uses are also coming to l i g h t . For e x a m p l e , it has been suggested recently that the selective use of red cell concentrate or even washed red cells instead of w h o l e blood might improve the chances of survival of patients who h a v e undergone surgery for certain cancers.1
1 2 . Platelet concentrates are used primarily in t h r o m b o c y t o p e n i a , purpura and haemorrhagic d i a t h e s i s , secondary to platelet suppression as a result of immunosuppressive t h e r a p y , or on patients who are on antineoplasic d r u g s . S i m i l a r l y , leucocyte concentrates obtained by selective leucopheresis are of use in patients who have leucocyte or bone marrow suppression as a result of cancer c h e m o t h e r a p y , r a d i o t h e r a p y , radionucleide a d m i n i s t r a t i o n , or for
treatment of malignant lymphomas.
1 British M e d i c a l J o u r n a l , 1986, 293, 5 3 0 .
EB79/PC/WP/3 Corr.4
page 17 1 3 . Reconstituted pooled plasma is primarily reserved for burns and crush injuries where
protein loss in the burned area results in a haemoconcentration as exhibited by a high
haematocrit value. Its use is governed by the availability of a product of assured quality.
This plasma is deficient in coagulation factors. Fresh frozen plasma may be used in haemophilia and factor V deficiency, particularly when factor VIII is not available.
1 4 . Cryoprecipitated factor VIII is the most important single protein fraction of plasma in the treatment of haemophilia. Its production and use are not routinely taking place in many developing countries. Factor IX for the treatment of Christmas disease (a haemorrhagic diathesis due to factor IX deficiency) is obtained by a process of cryoprecipitation.
1 5 . Fibrinogen administration is sometimes essential. Depletion of fibrinogen occurs in severe postpartum haemorrhage and in accidental haemorrhage in the third trimester of
p r e g n a n c y . It has been known to occur following total prostatectomy and in patients who have been exposed to severe trauma and crush injury. Incompatible blood transfusion can give rise to a severe drop in fibrinogen levels. Falls of levels from 300 mgm/100 m l to less than 90 m g m have been reported in afibrinogenaemia. Severe bleeding episodes occur in patients w i t h afibrinogenaemia. Fibrinogen, if a v a i l a b l e , is reconstituted and given intravenously owing to its major role in clotting.
1 6 . Albumin is one of the most useful plasma proteins and is extensively used in many developed countries as a pre-operative, operative and post-operative substitute for blood transfusion. Because of its high molecular weight it maintains an osmotic balance in the blood v e s s e l s , and loss of albumin due to nephrotic syndrome or in cirrhosis can be reversed w i t h adequate intravenous administration of albumin. Albumin fractions can be subject to heat treatment and hence do not transmit hepatitis viruses B , non-A and rion-B. It has become so important in the management of shock following severe blood loss due to trauma, and in post-operative m a n a g e m e n t , that its use is now widespread in many resuscitation u n i t s . 1 7 . Quantification of theoretical needs varies a great deal from country to country but should be based on epidemiological surveys of the disease patterns in the country and evolution of medical practice regarding indications for transfusion. Actual needs are
invariably dependent on the characteristics of the national health system. Many countries do not have the fiscal resources to satisfy their needs or have not adequately developed their services to provide blood and blood products. It has been estimated that a well-functioning health system would require approximately 10 units of blood per hospital bed per y e a r . Unpublished information provided by Leikola and Towle of the League of Red Cross and Red Crescent Societies covers the situation in industrial market c o u n t r i e s , middle-income c o u n t r i e s , low-income c o u n t r i e s , China, India, USSR and U S A . The highest reported
requirement is nine units per hospital bed per year (USA), and the world average is
approximately 4.7 units per hospital bed per y e a r . These figures do not include the products available from plasmapheresis. A more accurate quantification should also take into account the bed occupancy rate of the countries concerned,
1 8 . The quality of collected b l o o d , and quality control at all stages of processing, storage and use of blood and blood products, are crucial to ensure that greater benefits may be expected from the administration of these substances than the associated risks. The routine quality control procedures begin with the medical examination and selection of candidate donors and include in particular the sterile techniques of collection, the characterization of each blood batch collected； the preparation of s e t s , eventually the fractionation, the storage and transport, the matching of the blood and blood products with the specific requirements of the p a t i e n t , the sterile techniques of transfusion a n d , last but not l e a s t , end with the post-transfusion care of the patient to cope with transfusion reactions, if a n y , as w e l l as with diseases which may have inadvertently been transmitted by transfusion.
I I I . ORGANIZATION AND MANAGEMENT OF BLOOD TRANSFUSION SERVICES
19. A l l the above factors have to be taken into account when organizing and managing blood transfusion services. In a d d i t i o n , account has to be taken of such matters as the
establishment of registers of d o n o r s , including their blood group and other relevant information, the logistics of supply and d e m a n d , appropriate blood storage facilities,
adequate laboratories, related equipment and supplies, accessible information on the location of all blood centres in the country in order to rationalize the use of services, to gain access to special blood groups such as 0 , Rh n e g a t i v e , and to ensure suitable staff and staff
EB79/PC/WP/3 Corr.5 page 17 training and supervision for the blood transfusion service. W H O , in close association with
the other main organizations concerned, has produced a number of reports and publications providing technical guidance to institutions and Member States for the organization and management of blood transfusion services, with special emphasis on quality control requirements and procedures. The following have been issued during the past 16 y e a r s . 20. Blood transfusion. A guide to formation and operation of a transfusion service.
(a) The introductory chapter describes the organization of a national blood bank transfusion service and the establishment of regional transfusion centres and a national reference
c e n t r e , and includes an assessment of the transfusion needs of a country.
(b) The succeeding chapters deal with:
- r e c r u i t m e n t and selection of blood donors and maintenance of donor records, including medical examination; attention is particularly drawn to the sections of the document that list the diseases that have to be excluded through a proper history and medical examination, supported by laboratory examination when required (see Annex 1 for an extract from this chapter of the guide)；
- c e n t r a l organization of a blood b a n k , including staffing and accommodation, preparation of containers, c l o s u r e s , and anticoagulants, preparation of taking and giving sets；
- b l o o d collection and storage, conduct of a donor session, storage and transport of blood；
- o r g a n i z a t i o n and management of a blood b a n k , grouping techniques (ABO and R h ) , compatibility tests, preservation of red cells for grouping, cleaning of laboratory g l a s s w a r e , preparation of blood grouping sera, laboratory documentation, laboratory staff and equipment；
- i n v e s t i g a t i o n and record of transfusion reactions；
- b a s i c techniques.
An addendum to the guide issued in 1978 introduced sections on voluntary blood d o n a t i o n , enumerating the problem of hepatitis В and n o n - A , n o n - B , and providing suggestions for the management of blood-borne diseases. It includes a short introductory chapter on blood b a g s , component therapy, plasmapheresis and haemolytic disease of the n e w b o r n .
2 1 . Report of a WHO Scientific Group on Prevention of Rh S e n s i t i z a t i o n .2 This report gives details of the production of Rh immunoglobulin, the acceptable antibody levels in plasmapheresis d o n o r s , anti-Rh and other red cell antibodies, volume of plasma removed and frequency of plasmapheresis, as recommended by the Council of Europe Sub-Committee of Specialists on Blood Problems.
22. Twenty-eighth Report of a WHO Expert Committee on Biological Standardization.3 Annex 1 to that report is mostly concerned with the standardization of blood grouping reagents as well as human blood components and derivatives used for clinical purposes.
Specifications for a number of standards and reference preparations are proposed.
23. Report of a Meeting on the Utilization and Supply of Human Blood and Blood Products.^
The participants underlined that a non-profit-based national transfusion service can collect enough blood to satisfy the national need for erythrocytes, arid can also provide sufficient plasma for the preparation of a l b u m i n , coagulation factors and immunoglobulin. H o w e v e r , many
1 Published by the World Health Organization, the International Society of Blood Transfusion and the League of Red Cross Societies, 1971.
2 WHO Technical Report Series N o . 4 6 8 , 1971.
3 WHO Technical Report Series N o . 6 1 0 , 1977.
4 Unpublished document LAB/76.2, 1976.
EB79/PC/WP/3 Corr.6
page 17 conditions must be fulfilled before this purpose can be served. Participants also stressed
that the worldf s needs for plasma and its products cannot be satisfied by this approach a l o n e , making the participation of private enterprises e s s e n t i a l . After analysing published data they concluded that donors repeatedly involved in plasmapheresis had significantly depressed plasma protein concentrations and recommended that no more than 13 to 15 litres of plasma per year be given by any healthy d o n o r , and that an interval of one to two weeks be allowed between two consecutive plasmaphereses (removing each time some 500 m l of p l a s m a ) . The participants noted, however, that the United States Food and Drug Administration
considers it safe in that country to take up to 50-60 litres of plasma per donor per y e a r . They recognized that lowering the ceiling to 15 litres per donor per year would make it much m o r e difficult to practise commercial plasmapheresis and to satisfy world demand for plasma p r o d u c t s . The participants recommended that criteria for blood d o n a t i o n , including
collection of plasma by plasmapheresis, should take into account the specific medical and ethical problems relevant to the area and donor group c o n c e r n e d , and should primarily aim at protecting the health of donors and recipients.
2 4 . Twenty-ninth Report of a WHO Expert Committee on Biological Standardization.
Requirements for the C o l l e c t i o n , Processing and Quality Control of Human Blood and Blood P r o d u c t s . 1 ~ T h e very extensive Annex 1 to that report provides in some 70 pages a detailed guidance on requirements for the collection of source materials; for single donor and small-pool products; for the manufacture of human blood products； and for the control of plasma fractions. It also makes concrete suggestions concerning national quality control requirements.
2 5 . The collection, fractionation, quality control and use of blood and blood products.2 This gives specific advice on plasmapheresis and immunization of donors and indications and contraindications for the use of albumin solutions, coagulation factor concentrates, and normal and specific immunoglobulins. In the chapter dealing with plasmapheresis, the group of experts have classified plasmapheresis into three levels of intensity according to the volume of plasma and the frequency of sessions: f i r s t , donors participating in a
plasmapheresis programme once or twice a year; secondly, w h e n the quantity of plasma and the frequency of sessions are planned in such a way as to allow both the serum levels and the synthesis rates of the serum proteins to return to normal before any subsequent collection (conditions in force mostly in European countries)； thirdly, when 1000-1200 ml of plasma are removed per week (up to 50-60 litres per y e a r ) from each d o n o r , as is sometimes done in the U S A . Studies in donors subjected to this plasmapheresis schedule have revealed that although plasma protein levels change from initial values and may not have returned to normal before any subsequent collection, they usually remain within accepted normal ranges. Studies on small groups of h e a l t h y , well-nourished donors undergoing this programme have shown no overt clinical d i s e a s e s , but the experts emphasized that these findings may not apply to other donor populations with a different health s t a t u s , and that epidemiological studies, as w e l l as studies of serum constituents (lipoproteins and antithrombin I I I ) , are needed to
characterize further the safety of this third level of intensity in plasmapheresis.
26• Report of a consultation on the development of blood transfusion services on a country-wide basis. The report was prepared by a group of experts in accordance with resolution W H A 2 8 . 7 2 , which requested that increased assistance should be given to Member States in the development of national blood services based on voluntary d o n a t i o n , in collaboration with the League of Red Cross Societies. This paper deals with the basic aspects of whole blood transfusion, and is not concerned with the development of component therapy or the preparation of plasma derivatives.
27• Joint WHO/League of Red Cross Societies Consultation on Development of Blood Transfusion Services at Peripheral Level.^ This document provides directors of national blood~
transfusion services w i t h guidelines for planning and introducing peripheral blood
transfusion facilities, with special emphasis on the requirements of patients affected by haemorrhage and/or severe anaemia.
1 WHO Technical Report Series N o . 6 2 6 , 1978.
2
Published by the World Health Organization, G e n e v a , 1981.
3 Unpublished document L A B / 7 7 . 1 , 1 9 7 7 .
4 Unpublished document LAB/80.1, 1980.
EB79/PC/WP/3 Corr.7 page 17 2 8 . The production of ABO and D ( R hQ) grouping r e a g e n t s .1 This d o c u m e n t , prepared at
the request of directors of national blood transfusion services of various countries, describes the procedures for the production of ABO and D blood grouping reagents for human plasma or serum, and also for those from other sources.
2 9 . Use of plasma volume substitutes and plasma in developing countries.^ This document provides information for developing countries on plasma volume substitutes, together with guidelines for their u s e , and basic indications and information on limitations and side effects of simple electrolyte solutions and artificial c o l l o i d s , as well as on p l a s m a , albumin and protein fractions. It also includes practical guidelines for proper management of patients suffering from blood loss, plasma loss, or overall extracellular fluid and electrolyte loss.
3 0 . The aforementioned publications and d o c u m e n t s , although providing excellent guidance on essential issues, w e r e for the most part written before the transfusion problems due to
hepatitis В were fully r e a l i z e d , and when the problems associated with hepatitis n o n - A , non-B were even less u n d e r s t o o d . Furthermore, they were all produced before the discovery of the threat caused by H I V . During the past few years it became o b v i o u s , therefore, that several problems needed further elucidation and that additional guidance should be disseminated to limit the transfusional spread of hepatitis and HIV v i r u s e s .
I V . SAFETY OF BLOOD AND BLOOD PRODUCTS IN RELATION TO C A U S E ( S ) OF AIDS
31. In 1983， as the significance of AIDS as an international health problem began to be appreciated, WHO convened the first of a series of meetings to discuss various aspects of the disease and especially strategies for prevention. The safety of blood and blood products was already at i s s u e , and though a virus had not yet been established as the cause of A I D S , certain recommendations were made on the basis of the accumulated experience. Following the discoveries of H I V , WHO held a second consultation in April 1985 at which blood and blood products were again d i s c u s s e d . The meeting recommended that where feasible, potential donors of blood and plasma be screened for the presence of antibody to HIV and that potential donors be informed in advance about this screening procedure.^ Blood from seropositive donors should not be used for transfusion or for the manufacture of products where there is a risk of transmitting infectious a g e n t s . In a d d i t i o n , heat treatment or another proven method of inactivation of HIV was recommended to reduce the risk of HIV transmission through
concentrates of factors VIII and IX.
3 2 . As more cases of AIDS began to appear in countries other than USA and the risk of transmitting the disease through blood transfusion became o b v i o u s , an increasing level of concern developed about the safety not only of national blood supplies but also of blood and blood products which were moving in international c o m m e r c e , in particular plasma p r o d u c t s , and especially immune globulins and coagulation factors. The problems connected with screening people for antibodies to the AIDS virus also caused some concern. Taking all of these factors into consideration, WHO decided to organize a meeting on the safety of blood and blood products and antibody screening issues in relation to A I D S . This meeting took place in Geneva from 14 to 16 April 1986.
3 3 . A n informal survey of Member States that had been carried out just before April 1986 showed that 55 countries had begun routine screening of blood donors for antibodies to the AIDS v i r u s , and almost two-thirds of those were notifying donors about the screening in advance (Table 1 ) . The large differences in the size of the populations tested and in the test kits which w e r e used in the various programmes make any meaningful comparison of testing results almost impossible. It is important to n o t e , h o w e v e r , that at least 0.15% to 2.2% of donors had positive screening test r e s u l t s , calling for confirmatory testing and follow-up of d o n o r s , an important consideration to keep in mind w h e n a testing programme is to be b e g u n . The survey also showed that in some parts of the world there was little or no routine screening of donor blood for H I V .
丄 Unpublished document LAB/81.1, 1981.
2
Unpublished document LAB/81.5, 1981.
3 Weekly Epidemiological R e c o r d , N o . 1 8 , 1986, pp. 138-140.
TABLE 1. PRELIMINARY RESULTS OF AIDS ANTIBODY SCREENING IN WHO REGIONS (SHOWING POSITIVE RESULTS AS A PROPORTION OF DONORS)
Africa
Americas (excluding U S A , Canada)
U S A , Canada South-East
Asia Europe Eastern Mediterranean
Western
Pacific Totals
Countries responding 19/45
Routine screening of donor blood
Advance notification of donor screening ELISA test results (positive/donors) Confirmation test results
(positive/donors)
2/19
1/2
487/22 482 2.2%
21/32
10/21
8/10
26/18 678 0.41%
17/10 661 0.16%
2/2
2/2
2/2
13 112/5 396 180 0.24%
398/1 157 699 0.034%
11/11 29/34
0/11 29/29
19/29
3 308/2 138 082 0.15%
460/2 112 034 0.02%
7/22
6/7
1/6
15/7 016 0.21%
2/5 000 0.04%
9/20
6/9
5/6
2 832/677 642 0.42%
28/654 081 0.004%
98/166 59%
55/98 56%
34/55 62%
EB79/I>C/WP/3
pP JO
Qe 8
EB79/PC/WP/3 Corr.9 page 17 3 4 . Originally the AIDS epidemic resulted largely from the spread of the virus through
intimate sexual relationships or the use of contaminated injection needles； transmission by blood transfusion and blood products played a relatively m i n o r r o l e . E v e n r e c e n t l y , only 2%
to 3% of AIDS cases detected in W e s t e r n Europe and North America have been caused by blood t r a n s m i s s i o n . The situation in other areas of the world is less c l e a r , but wherever AIDS is identified as a significant p r o b l e m , transfusion-associated cases can be expected in the absence of preventive m e a s u r e s . Effective measures to reduce m a r k e d l y the risk of
transmitting HIV during the course of administration of blood and blood products fall into two m a i n c a t e g o r i e s : pre-donation selection of donors and post-donation inactivation or separation of the v i r u s .
3 5 . Specific screening and control m e a s u r e s w h i c h have been found useful in some countries should be assessed by other countries in the context of their o v e r a l l h e a l t h programmes and the availability of human and m a t e r i a l r e s o u r c e s . The composition of risk groups is not the same in all geographical a r e a s , and in some populations specific risk factors may not be readily d e f i n e d . Donor selection can be p a s s i v e , w h e n effective education leads donors voluntarily to s e l f - e x c l u s i o n , or a c t i v e , through attention to m e d i c a l history and physical examination; reliance on s e l f - e x c l u s i o n , w h e n persons with risk factors for AIDS refrain from giving b l o o d , is most effective w h e n epidemiological studies h a v e identified risk
factors for a given population or a r e a . C o n t i n u a l education of donors is essential to ensure the reliability of that method and it is likely to be most effective w i t h unpaid d o n o r s . Exclusion based oil attention to current history of possible exposure to known risk factors as w e l l as symptoms such as severe chronic d i a r r h o e a , night s w e a t s , fever and weight loss c a n help to reduce the number of infected d o n o r s . Physical examination of the d o n o r , although not feasible in a l l blood collection s e t t i n g s , should be encouraged because it can identify unusual m u c o s a l or skin l e s i o n s , l y m p h a d e n o p a t h y , and w a s t i n g , depending on the expression of the d i s e a s e . Physical examination and m e d i c a l history are especially important in areas w h e r e laboratory screening is not a v a i l a b l e .
3 6 . Post-donation processing includes i n i t i a l screening of donations for antibodies to H I V , as w e l l as partitioning or inactivating steps for blood products derived from large pools of blood which are m o r e likely to contain infected u n i t s . Testing donated blood and plasma for antibodies to HIV should be considered w h e n the risk of transmitting the virus through blood and blood products is s i g n i f i c a n t , and the benefits of such testing outweigh other important factors in providing an adequate and safe supply of donor b l o o d . Whenever products are m a d e from p l a c e n t a s , placenta donor screening should also be considered in this same c o n t e x t . 3 7 . It is important to realize that false-positive results occur w i t h essentially a l l of the currently available tests and therefore repeated testing is n e c e s s a r y . Further, due to the lack of absolute confidence and consistency of current screening t e s t s , confirmatory tests are essential for adequate interpretation of positive results; donor n o t i f i c a t i o n ,
c o u n s e l l i n g , and m e d i c a l follow-up are particularly important in this c o n n e c t i o n .
3 8 . There is considerable evidence that immunoglobulin p r e p a r a t i o n s , when manufactured by methods based on the conventional Cohn-Oncley cold e t h a n o l precipitation m e t h o d , do not
transmit HIV whether or not they contain antibodies to the v i r u s .
3 9 . Because A I D s has occurred in haemophiliacs without any other known risk f a c t o r , manufacturers have incorporated treatments w i t h h e a t , chemicals and radiation in their production processes for factor V I I I and factor IX c o n c e n t r a t e s . Such v i r a l inactivation steps are currently widely used and others are under i n v e s t i g a t i o n . The risk of transmitting HIV by factor V I I I and factor IX concentrates treated w i t h proven m e t h o d s of inactivation can therefore be considerably reduced or e l i m i n a t e d . Additional strategies for risk reduction m a y include single-donor and small-pool preparations.
4 0 . Albumin preparations derived from human plasma that meet WHO requirements have been shown not to transmit H I V .
4 1 . Well-accepted general principles concerning the use of blood and blood products need to be emphasized since they can contribute to the control of A I D S . The most important
principles are the following:
(1) strategies of health care services that reduce the demand for b l o o d , such as improved antenatal c a r e , should be encouraged；
EB79/PC/WP/3 page 10
(2) w h e n appropriate and safer components and derivatives are available they are preferable to w h o l e blood or plasma；
(3) whole blood or plasma should be transfused only when their administration is absolutely essential to the care of the p a t i e n t .
4 2 . S e v e r a l scientific problems relating to the detection of the AIDS v i r u s , such as those of standardizing the assay procedures and increasing the sensitivity of the a s s a y s , still need to be solved in order to further increase the quality control of viral inactivation procedures and provide for adequate follow-up counselling of initially seropositive i n d i v i d u a l s .
4 3 . Every quality control procedure on the one hand adds to the cost of blood and blood products and on the other hand decreases the number of acceptable donors and the amount of blood and serum w h i c h can be safely processed for transfusion p u r p o s e s . There is a n e e d , t h e r e f o r e , to keep a realistic balance between the operational implications of each quality c o n t r o l component and the public health implications of disregarding or weakening that
q u a l i t y control e l e m e n t . No two countries are a l i k e , and it is essential that the variety of situations encountered throughout the world be c o n s i d e r e d .
4 4 . The cost of ELISA kits ranges w i d e l y throughout the w o r l d . H o w e v e r , at present the m i n i m u m cost per test is approximately one United States d o l l a r , which does not include the cost of ancillary s u p p l i e s , capital costs for equipment such as ELISA dilutors and r e a d e r s , storage costs for the heat-labile ELISA kit m a t e r i a l s , or personnel c o s t s . Standard blood screening practice currently requires repeat ELISA testing of initially positive s p e c i m e n s , followed by confirmatory testing using either immunoblot or immunofluorescent testing. The costs for immunoblot testing exceed US$ 10 per test for materials a l o n e . In the absence of a s i m p l e , i n e x p e n s i v e , h e a t - s t a b l e , r e l i a b l e , h i g h l y sensitive yet specific testing procedure w i t h a long s h e l f - l i f e , the task of safeguarding the blood supply through screening of blood donors w i l l continue to be relatively e x p e n s i v e .
V , W O R L D SITUATION
4 5 . In order better to appraise the problems faced by Member States in the organization and m a n a g e m e n t of blood transfusion s e r v i c e s , a survey was carried out w h e r e the problems are the m o s t o b v i o u s , in the developing c o u n t r i e s . In 1984 W H O issued a questionnaire prepared by a group of experts entitled "Assessment of integrated blood transfusion services in developing c o u n t r i e s " . It dealt with organization and m a n a g e m e n t , training and career d e v e l o p m e n t , blood p r o c u r e m e n t , equipment and c o n s u m a b l e s , blood u s a g e , blood centre laboratory
a c t i v i t i e s , quality a s s u r a n c e , and plasma p r o c e s s i n g . For each subject the questions were arranged in order of increasing c o m p l e x i t y . E v e n the least developed countries could thus respond to some of the earlier q u e s t i o n s , w h e r e a s only the more technologically advanced w o u l d be in a position to reply to the final q u e s t i o n . Replies to the questionnaire were received from 60 of the 130 developing countries to which it was s e n t .
4 6 . It may be regretted that only 45% of the solicited countries found it possible to provide information on the status of their blood transfusion services; these countries may not c o n s t i t u t e a perfect sample of the target g r o u p . The m a t e r i a l received nevertheless constitutes a useful basis for d e t e r m i n i n g , for the first t i m e , the m a i n characteristics and problems of blood transfusion services in developing c o u n t r i e s . E s s e n t i a l findings have been summarized on a regional basis in Tables 2 to 6 , and some essential comparisons of regional prevailing trends are presented in Tables 7 to 9 . Table 1 may also be referred to for a summary of the overall situation in terms of AIDS-related quality c o n t r o l . Three regional committees have reviewed regional presentations summarizing the country r e p o r t s . The R e g i o n a l Committee for the Americas had already reviewed the matter in 1 9 8 3 . When the R e g i o n a l Committee for Europe reviewed the problem of AIDS in 1986 it included a review of the safety of blood and blood products in relation to A I D S . (The relevant documentation is being m a d e available to members of the Programme Committee of the Executive Board.)
1 Document LAB/84.9 (see A n n e x 2).
TABLE 2: DATA RELEVANT TO BLOOD DONOR RECRUITMENT AND ON (VOLUNTARY/REPLACEMENT/PAID) DONORS PER THOUSAND POPULATION AND DONATIONS PER HOSPITAL BED
AFRICAN REGION
Country Population Number of (in blood thousands) donations
per year
Sites fixed mobile
Proportion of donors (1) (2) (3) voluntary/replacement/paid
Proportion Number of Donations Donations of donations hospital per 1000 per used as beds population hospital
components bed
Benin Botswana Burkina Faso Burundi Cameroon Congo Ethiopia Gambia Kenya Lesotho
Malawi Mali Mauritius Mozambique Nigeria Seychelles Sierra Leonel.
Sudan Swaziland Togo
United Republic of Tanzania Zambia Zimbabwe
005 079 933 631 714 740 454 673 20 600
1 520 36
14 95
21
22 6 8
016 053 050 085 198 69 602 550 64 9 923
499 666 767
7 14 5 4 6 11 8 2 113 6
10 6
9 65
60 5 4
13 8 47
000
426
000
736
000
292
000
272 448
000
000
895 847
000
600 365
000
712 705
846 585 336
90 10%
500 504 268
21 975
500
500 385
0
20%
10%
949 756
о 5 3 1
90 95
50 40 20
50
65 70 85 +
10
80
50 60 80
50
0
4%
very small components not demanded
0
very smal
0
0-20%
Nil
very small 10%
85-95%
5 21 6 11
26
13 61
17 3
36 20 21
067 141 024 231 271 876 147 699 900 564
125 215 032 180 628 362 930 738 328 63A
357 639 418
13
0
74 36 72 02 617 48 ,22 375 ,507 95
24 89 699 682 2 93 78 8 61
61 29 39
38 73 65 90 282 64 717 25 22 34
37 27 7A 05 42 86 526 32 29
381 42 210 一 Replacement donors a be paid.
EB7VO/PC/WP/3
IJ
aw
e
1
1
TABLE 3： DATA RELEVANT TO BLOOD DONOR RECRUITMENT AND ON (VOLUNTARY/REPLACEMENT/PAID) DONORS PER THOUSAND POPULATION AND DONATIONS PER HOSPITAL BED
REGION OF THE AMERICAS
Country Population (in thousands)
Number of blood donations per year
Sites fixed mobile
Proportion of donors (1) (2) (3) voluntary/replacement/paid
Proportion Number of Donations Donations of donations hospital per 1000 per used as beds population hospital
components bed
Barbados 255 Belize 156 British Virgin
Islands
Canada 25 183 Chile 11 880 Costa Rica 2 435 Cuba 9 782
Dominica 72 Dominican
R e p u b l i c ^ 6 102 El Salvador 5 386 Ecuador 8 451 Guatemala 8 167
Guyana 802 H a i t l A 5 401
Honduras 4 234 Jamaica 2 289 Uruguay 2 990
821 198
40 472
1
12
17 24 85
88.1%
88.5%
111 All 1 117 712 30%
000
263 100
80.8%
70%
19 237 4 096 50 000
40%
80%
100 300 780
000
97.6%
95.4%
9.3%
11-97%
11.5%
0
70%
19.8%
10%
60%
20%
2.4%
• 6%
All All
All All
？
All All 495
000
All All
7%
4 600 7 800 All 3.5%
10%
55%
84.47%
1 500 Nil some
4 500 5 800" a
20% 2 151
0 395
96.5%
0
95%
35%
43%
0
？
0
40-60%
？
?
20%
2-3%
25%
70% (city) 162
33 34 522 877 7 570
61 000
230
7 7 16
3 3 4
1
5 15
700 375 764 964 611
400 723 553 335
14.42 13.91
0.895 44.3
16.42 48.27 15.27
3.15 0.76 5.9
1.78 5.56
3.26 6.87
5.28 7.74 4.78
2.49 0.56 2.98
2.24 4.08 10.82 28.42
10% (peripheral) 2.75 10.04 4.46 5.54
EB7VO/PC/WP/3
pa
ge
1
2
— M i x e d system - Red C r o s s , paid donors, social security and hospitals.
TABLE 4; DATA RELEVANT TO BLOOD DONOR RECRUITMENT AND ON (VOLUNTARY/REPLACEMENT/PAID) DONORS PER THOUSAND POPULATION AND DONATIONS PER HOSPITAL BED
SOUTH-EAST ASIA REGION
Country Population (in thousands)
Number of blood donations per year
Sites Proportion of donors (1) (2) (3) fixed mobile voluntary replacement paid
Proportion Number of Donations Donations of donations hospital per 1000 per used as beds population hospital
components bed
Bangladesh Bhutan India Indonesia Nepal Sri Lanka Thailand
101
1
761 164 16
9 51
147 417 175 887 482 241 571
36
557 385 4 65 689
489 500 163£
000£
087 687b 572£
All 30%
2 711 6 725
60-65%
1 376 18 491
470
33.8%
80.0%
2 564 28%
87%
15 488
43.6%
20.0%
1 623 72%
13%
20 531 500 22.6%
nil nil nil nil
nil nil 0-5%
20%
8%
10%
25 057
1 066 98
2
44 71
164 543 669 029 718
0.34 0.35 0.732 2.335 0.248 7.108 13.37
1.37
0.522 3.9 1.53 1.49 9.62
ICMR (Indian Council of Medical Research) report.
40 471 in peripheral centres.
Using 250-300 cc bags.
TABLE 5： DATA RELEVANT TO BLOOD DONOR RECRUITMENT AND ON ( V O L U N T A R Y / R E P L A C E _ T / P A I D ) DONORS PER THOUSAND POPULATION AND DONATIONS PER HOSPITAL BED
EASTERN MEDITERRANEAN REGION
Country Population Number of Sites (in blood
thousands) donations fixed mobile per year
Proportion of donors (1) (2) (3) voluntary/replacement/paid
Proportion Number of Donations Donations of donations hospital per 1000 per used as beds population hospital
components bed
Egypt Iran Jordan Somalia Yemen
46 800 45 108
509 552 124
250 424 35 4
000
299
000
216
10 000
(no infor- mation Oil other centres)
83 23 2 5
328
000
796
000
85 824Í.
3 000£
670£
0a
80%
10%
10%
20%
90%
40%
45%
87 67 3 5 2
600
724 272 163 963
34 414 974 759
• 708
2.91 6.26
10.6 0.816 3.375
— C o l l e c t i o n at peripheral centres not included.
TABLE 6. DATA RELEVANT TO BLOOD DONOR RECRUITMENT AND ON
(VOLUNTARY/REPLACEMENT/PAID) DONORS PER THOUSAND POPULATION AND DONATIONS PER HOSPITAL BED WESTERN PACIFIC REGION
Country Population (in thousands)
Number of blood donations per year
Sites fixed mobile
Proportion of donors (1) (2) (3) voluntary/replacement/paid
Proportion Number of Donations Donations of donations hospital per 1000 per used as beds population hospital
components bed
Cook Is. 18 Fiji 684 Hong Kong 5 608
Malaysia 15 551 Philippines 54 709 (1) Hospitals
(2) Commercial
Solomon Islands 252
Tonga 98 Vanuatu 124 Vietnam 59 451
135 100
？
?
1 1 1
312
000
000
000£
526
000
700
500
45£-70%
14 366 a_
10
16 000
donations/
(250cc) donations/
40 000 litres
All
30-55£%
68 333
90
very little
%
10 10 100 70 80 10
80 10 70
% 90 90
30 20 90
20 90 30
0
20
20-70%
10%
0 0 0
30%
1 774
22 935 74 167
688
307 448 131 200
8 576 1.46
8.68 1.82
6.05 10.2 5.64 1.34
0.583
5.86 1.35
2.22
3.25 1.56 0.609
— A t central level.
EB79/PC/WP/3
pa
ge 15
TABLE 7 . FUNCTION A N D QUALITY OF SERVICE IN FIVE W H O REGIONS
Countries w i t h Countries with
Proportion Countries witV training national quality
of countries Countries with codes of Countries w i t h certification/ control responding legislation practice Countries w i t h statutory accreditation proficiency R e g i o n to question on transfusion available inspectorate basis of staff testing
A f r i c a n 23/45 1 2 2 4 lb
(51%)
A m e r i c a s 16/34 3 9 3 3 6 5
(33.4%)
South-East 7/11 0 l 4 £ 3 3 5 2
Asia (63.6%)
E a s t e r n 5 / 2 2 ( 2 2 . 7 % ) 3 5 3 2 5 2
M e d i t e r r a n e a n (22.7%)
W e s t e r n 9/ 2 4 4 5 7 2 £
Pacific (47%)
— C a m e r o o n (in two other countries it is under study and two have pharmaceutical l e g i s l a t i o n ) .
~ B e n i n .
— I n most instances manuals are not a v a i l a b l e .
— T h e s e countries have pharmaceutical l e g i s l a t i o n .
一 Both involved in the External Quality Assessment S c h e m e . Q
EB79/PC/WP/3 page 17
T A B L E 8 . MAINTENANCE OF EQUIPMENT IN FIVE W H O REGIONS
Countries with
P r o p o r t i o n Countries w i t h records of
of countries standardized Countries w i t h equipment responding equipment Countries w i t h standardized m a i n t e n a n c e / Region to q u e s t i o n policy spare parts e q u i p m e n t list repair
A f r i c a n 12/23 7/12 7/12 9/12 7/12
Americas 16/16 8/16 4/16 11/16 4/16
South-East 7 2/7 3/7 3/7 4/7
A s i a
E a s t e r n 5/5 4/5 2/5 5/5 2/5
M e d i t e r r a n e a n
W e s t e r n 9/9 3/9 4/9 5/9 3/9
Pacific
TABLE 9 . FRACTIONATION FACILITIES IN DEVELOPING COUNTRIES IN FIVE WHO REGIONS X) и OQ ^J P w
Region
Number of countries
Fractionation
inside outside Preparation of country country blood fraction
00 о
Fraction
capacity Fraction produced §
ы
African 23
Americas 16£ 2 Cuba
1 Belize 1 Uruguay 1 Ecuador
1 in planning in Costa Rica
15 000 litres/yr 5 000 litres/yr
50 000 litres ordinary plasma
?
10 000 l i t r e s £ 20 litres specific plasma
Eastern Mediterranean
1 Egypt
1 Iran 38.19%
14 774 litres specific A / B £
1 320 litres other plasma 12 266 litres
10 000 litres/yr 20 000 litres/yr
South-East Asia
1 (Indonesia)
1 Thailand
1.5%
500 litres
(outdated plasma)
300 litres/yr
W e s t e r n Pacific
Vietnam 2 (Fiji,竺
Hong K o n g )
South Pacific Pharmaceutical Service
？L Uncertain in El Salvador, Guatemala, Honduras and Dominican R e p u b l i c . Costa Rica collects plasma (outdated,
70 litres/month every 2 to 3 years) and then exchanges the plasma with commercial firms for e q u i p m e n t . Canada imports 46.6%
anti-haemophilia factor and immunoglobulins.
~ Commonwealth Serum L a b o r a t o r y , M e l b o u r n e , A u s t r a l i a , с
一 Fresh frozen p l a s m a .
EB79/PC/WP/3 Corr.19 page 17 4 7 . T h e f o l l o w i n g a r e h i g h l i g h t s of the i n i t i a l a n a l y s i s of r e p l i e s to the q u e s t i o n n a i r e .
In m a n y c o u n t r i e s the o r g a n i z a t i o n and m a n a g e m e n t of t r a n s f u s i o n f a c i l i t i e s a r e g e n e r a l l y h o s p i t a l - b a s e d , o f t e n d e v e l o p e d a r o u n d h o s p i t a l l a b o r a t o r y d e p a r t m e n t s . T h e o c c u r r e n c e of d i s t i n c t b l o o d t r a n s f u s i o n s e r v i c e s , o p e r a t i n g in c l o s e l i a i s o n w i t h p u b l i c h e a l t h
a u t h o r i t i e s in c o n s o n a n c e w i t h a g r e e d h e a l t h care p o l i c i e s and s t r a t e g i e s , s u p p o r t e d by p r o p e r b l o o d f r a c t i o n a t i o n f a c i l i t i e s and a p p r o p r i a t e q u a l i t y c o n t r o l p r a c t i c e s , a r e the e x c e p t i o n r a t h e r t h a n the r u l e .
4 8 . T h e g e n e r a l p i c t u r e g a i n e d f r o m the c o u n t r y r e p o r t s is o n e of g r o s s i n a d e q u a c y of t r a i n e d personnel， t r a i n i n g p r o g r a m m e s , and l a c k of f a c i l i t i e s for e s s e n t i a l c o n t i n u i n g s e l f - e d u c a t i o n .
4 9 . M o s t blood is o b t a i n e d e i t h e r on a v o l u n t a r y b a s i s or t h r o u g h r e p l a c e m e n t d o n o r s , some of t h e m r e m u n e r a t e d . T h e b l o o d o b t a i n e d f r o m the p o p u l a t i o n is f a r f r o m a d e q u a t e to m e e t the e s s e n t i a l t r a n s f u s i o n n e e d s . In m o s t c o u n t r i e s the b l o o d p r o c u r e m e n t p e r h o s p i t a l b e d , or p e r p a t i e n t a d m i s s i o n , r e p r e s e n t s o n l y 40% to 75% of w h a t is u s u a l l y c o n s i d e r e d a s a d e q u a t e , w h i c h , t a k i n g into a c c o u n t the f a c t that a c c e s s to h o s p i t a l f a c i l i t i e s is u s u a l l y r e s t r i c t e d to s e r i o u s c a s e s , r e p r e s e n t s in a c t u a l t e r m s a m u c h l o w e r d e g r e e of s a t i s f a c t i o n of e s s e n t i a l t r a n s f u s i o n n e e d s . B l o o d s u b s t i t u t e s f o r s u r g i c a l p r o c e d u r e s , s u c h as s e r u m a l b u m i n , a r e r a r e l y p r o d u c e d w i t h i n c o u n t r i e s o w i n g to the a b s e n c e of p l a s m a p h e r e s i s and f r a c t i o n a t i o n f a c i l i t i e s in m o r e than 80% of the s u r v e y e d c o u n t r i e s ; w h e n a v a i l a b l e such b l o o d s u b s t i t u t e s a r e g e n e r a l l y i m p o r t e d . T h e s i t u a t i o n s e e m s to be e v e n l e s s s a t i s f a c t o r y w i t h r e g a r d to red c e l l c o n c e n t r a t e s , p l a t e l e t c o n c e n t r a t e s , l y m p h o c y t e s , i m m u n o g l o b u l i n s , f a c t o r V I I I and o t h e r b l o o d d e r i v a t i v e s .
5 0 . A s a l r e a d y i n d i c a t e d , p l a s m a p h e r e s i s , c y t o p h e r e s i s ( c o n c e n t r a t i o n of c e l l s like l y m p h o c y t e s and p l a t e l e t s ) and f r a c t i o n a t i o n f a c i l i t i e s a r e p o o r l y d e v e l o p e d , or e n t i r e l y a b s e n t , in m o s t r e p o r t i n g c o u n t r i e s . F u r t h e r m o r e , c o u n t r y r e p o r t s v e r y o f t e n m e n t i o n e d m a j o r p r o b l e m s in the e s s e n t i a l f i e l d s of q u a l i t y and m a i n t e n a n c e of r o u t i n e t r a n s f u s i o n e q u i p m e n t , as w e l l as in t e r m s of a v a i l a b i l i t y a n d q u a l i t y of e s s e n t i a l s u p p l i e s , s u c h as q u a l i t y
c o n t r o l r e a g e n t s . T h e m o s t f r e q u e n t p i c t u r e is of i n a d e q u a t e e q u i p m e n t and s u p p l i e s p r e v e n t i n g the c o n t i n u o u s p r o v i s i o n of a s e r v i c e .
5 1 . R e l a t i v e l y l i t t l e i n f o r m a t i o n w a s g a t h e r e d on a c t u a l u s e of b l o o d , the b l o o d c e n t r e l a b o r a t o r y a c t i v i t i e s and q u a l i t y a s s u r a n c e . O n l y e i g h t out of 60 r e p o r t i n g c o u n t r i e s h a d a n y l e g i s l a t i o n f o r t r a n s f u s i o n s e r v i c e s . T h e c o u n t r y r e p o r t s g a v e the o v e r a l l i m p r e s s i o n t h a t the a v a i l a b i l i t y of i n s p e c t i o n and n a t i o n a l q u a l i t y c o n t r o l f a c i l i t i e s w a s a b y s m a l l y p o o r .
5 2 . I n f o r m a t i o n c o l l e c t e d f r o m o t h e r s o u r c e s c o n c e r n i n g the less d r a m a t i c s i t u a t i o n in d e v e l o p e d i n d u s t r i a l c o u n t r i e s n e v e r t h e l e s s h i g h l i g h t s p r o b l e m s t h a t g i v e r i s e to c o n c e r n . In o n e the e x t e n t of o v e r u s e of blood p r o d u c t s is e s t i m a t e d to be of the o r d e r of 20% to 25%
for red c e l l s , and as m u c h a s 90% for a l b u m i n and 95% for f r e s h f r o z e n p l a s m a ; i r o n d e f i c i e n c y a n a e m i a c o n t i n u e s to be a m o n g the l e a d i n g r e a s o n s for t r a n s f u s i o n e v e n t h o u g h it r a r e l y w a r r a n t s it； the g r o w i n g u s e of p l a t e l e t s h a s a l s o b e e n q u e s t i o n e d and o f t e n f o u n d to be w i t h o u t any s c i e n t i f i c b a s i s .
5 3 . D e v e l o p e d c o u n t r i e s a r e c o n s i d e r a b l y t i g h t e n i n g t h e i r q u a l i t y c o n t r o l p r o c e d u r e s in a n a t t e m p t to r e d u c e d r a s t i c a l l y the i n c i d e n c e of b l o o d - t r a n s m i t t e d d i s e a s e s , b u t the c o s t is so h i g h that m o s t d e v e l o p i n g c o u n t r i e s c o u l d n o t a f f o r d i t . In one of the d e v e l o p e d c o u n t r i e s b l o o d b a n k s p e r f o r m a t o t a l of t h r e e E L I S A t e s t s for H I V p o s i t i v i t y oil a b l o o d s a m p l e b e f o r e r e j e c t i n g it as " r e p e a t e d l y reactive"； t h e n they use the m o r e s p e c i f i c W e s t e r n b l o t test to c o n f i r m E L I S A - p o s i t i v e reactions； to d e c r e a s e the risk of t r a n s m i s s i o n of n o n - A , n o n - B h e p a t i t i s , p o t e n t i a l d o n o r s a r e c h e c k e d f o r a l a n i n e a m i n o t r a n s f e r a s e l e v e l s (an i n d i c a t o r of l i v e r d y s f u n c t i o n ) and for the p r e s e n c e of a n t i b o d i e s to h e p a t i t i s - B c o r e a n t i g e n (the
p r e s e n c e of w h i c h is o f t e n c o r r e l a t e d w i t h the p r e s e n c e of n o n - A , n o n - B h e p a t i t i s agent)； this p r o c e s s , w h i c h is e x p e c t e d to r e d u c e b y n e a r l y half the r i s k of t r a n s m i s s i o n of n o n - A , n o n - B h e p a t i t i s , w i l l a l s o i n c r e a s e the c o s t of the unit of b l o o d by s e v e r a l U n i t e d S t a t e s d o l l a r s . T h e same c o u n t r y is a l s o r o u t i n e l y c h e c k i n g the b l o o d s a m p l e s for h e p a t i t i s B . It is h o p e d that t h e s e r o u t i n e q u a l i t y c o n t r o l p r o c e d u r e s w i l l e x c l u d e o n l y a s m a l l p r o p o r t i o n , p o s s i b l y 1 0 % , of t h e a p p a r e n t l y h e a l t h y d o n o r s t h e r e ; the i m p a c t on the d o n o r p o o l m i g h t be m u c h g r e a t e r in t h o s e c o u n t r i e s w h e r e h e p a t i t i s В has a h i g h p r e v a l e n c e .
