Blood Transfusion Services in South-East Asia Region. A 5-year review

Blood Transfusion Services in South-East Asia Region. A 5-year review ISBN: 978-92-9022-651-2 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). 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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Foreword Access for all people everywhere to a sufficient and secure supply of blood and blood products – as well as safe transfusion services – is an essential part of any strong health system. It is also a critical component of the WHO South-East Asia Region’s (and the world’s) drive towards universal health coverage. In recent years the risk of transmission of serious infections – including HIV and hepatitis – through unsafe blood and chronic blood shortages has drawn significant global attention. WHO has been at the forefront of aims to combat that risk. The World Health Assembly, for example, has adopted several resolutions on the matter, noting that special efforts need to be made in low- and middle-income countries to ensure universal access to blood and blood products. This is particularly important to support key interventions for the health of mothers and children, for HIV/AIDS prevention, as well as for patient safety, especially in peripheral health facilities. As the following pages outline, and as WHO’s global strategy on blood safety emphasizes, several tools and strategies can be harnessed to help countries in the Region build on their substantial achievements and strengthen blood and blood product systems. These include establishing nationally coordinated blood transfusion services; ensuring 100% of all blood donated is from non-remunerated, voluntary blood donors from low- risk areas; and ensuring all blood is tested for transfusion-transmitted infections (as well as for compatibility). They also include enhancing the rational use of blood and augmenting haemovigilance – the set of surveillance procedures covering the entire blood transfusion chain. In highlighting the importance of these interventions, this document draws on five years’ data (2011–2015) from WHO’s Global Database on Blood Safety (GDBS) and provides an analytical review of blood transfusion services in each of the WHO South-East Asia Region’s Member States. As such, it provides crucial information for countries to act on as and where appropriate. In keeping with the Region’s Flagship Priorities, WHO South-East Asia is committed to providing Member States full technical assistance in their efforts to ensure all people everywhere can access a sufficient and secure supply of blood and blood products – as well as transfusion services – and to thereby accelerate progress towards universal health coverage. Dr Poonam Khetrapal Singh Regional Director Acknowledgements The Health Laboratory Services, Department of Communicable Diseases of the WHO Regional Office for South-East Asia (SEARO) wishes to express its gratitude to Professor Neelam Marwaha, Professor Ratti Ram Sharma Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research , Chandigarh, India and Professor Ravneet Kaur, Department of Transfusion Medicine, Government Medical College, Chandigarh, India and the team of experts who have contributed to the development of this report. This report has been reviewed by Dr Shobini Rajan, Assistant Director General, Blood Transfusion Services and Director, NBTC–NACO, Ministry of Health and Family Welfare, India; Dr Geeta Shakya, former Director, National Public Health Laboratory, Kathmandu, Nepal; Dr Mahrukh Getshen, transfusion specialist, Thimpu, Bhutan; and Dr Joy Mammen, Professor and Head, Department of Transfusion Medicine, Christian Medical College, Vellore, India. Dr Aparna Singh Shah, Regional Advisor, Health Laboratory Services and Blood Safety, WHO SEARO, Dr Bharat Rewari, Scientist-HIV, Hepatitis, STI, WHO-SEARO, and Mr Yu Junping, Technical Officer, Blood Transfusion Safety, WHO HQ helped in the development and review of this report. WHO would also like to extend special thanks to the Ministries of Health and National Blood Transfusion Services for providing data to the WHO Global Database on Blood Safety (GDBS). This report is based on GDBS data from 2011 through 2015. Contents S.No. Topic Page Number 1 INTroduCTIoN 1-2 2 orgANIzATIoN ANd mANAgemeNT oF blood TrANSFuSIoN ServICeS 3-7 2.1 National governance 3 2.2 Blood centres 5 2.3 Quality management 6 3 blood ColleCTIoN 8-13 3.1 Blood donor programme 8 3.2 Blood donations 8 3.3 Types of blood donation 9 3.4 Whole blood donations 10 3.5 Blood donor profile 11 3.6 Donor deferral 12 3.7 Predeposit autologous blood donation 12 3.8 Donor notification 13 3.9 Apheresis donations 13 4 SCreeNINg doNATed blood For mArkerS oF TrANSFuSIoN-TrANSmISSIble INFeCTIoNS 14-25 4.1 Blood safety from transfusion-transmissible infections 14 4.1.1 HIV 14 4.1.2 Hepatitis B virus 15 4.1.3 Hepatitis C virus (HCV) 16 4.1.4 Syphilis 17 4.1.5 Chagas disease 17 4.1.6 Malaria 17 4.1.7 Human T-lymphotropic virus 18 4.2 Policy of performing confirmatory testing on reactive unit 18 4.3 Coverage of laboratories screening for blood donations 19 4.4 Quality of laboratories performing screening for blood donations 19 4.4.1 Screening of whole blood and apheresis donations in a quality-assured manner 20 4.5 Prevalence of markers of infection in blood donations 21 4.6 Policy for screening of blood donations using rapid tests 25 5 ProCeSSINg oF whole blood doNATIoNS INTo ComPoNeNTS 26-32 5.1 Packed red cell preparation 27 5.2 Platelet component preparation 28 5.3 Plasma component preparation 30 5.4 Cryoprecipitate preparation 31 5.5 Blood component harvesting by apheresis technology 32 6 ClINICAl uSe oF blood 33-41 6.1 Red cell transfusions 33 6.2 Platelet transfusions 34 6.3 Plasma component transfusions 35 6.4 Mechanisms to improve and monitor safe and appropriate blood transfusion 37 6.5 Patient age and blood transfusions 38 6.6 Haemovigilance 39 6.7 Discard of blood 40 6.8 Plasma fractionation 41 7 dISCuSSIoNS ANd reCommeNdATIoNS 42-45 8 CoNCluSIoN 46 ANNexeS 47-63 Annex 1a Details of funding from various sources for blood transfusion services 47-48 Annex 1b Details of government funding for blood transfusion services 49-50 Annex 2 International organizations which provided financial assistance to the blood transfusion services of the SEAR countries 51-52 Annex 3 Information on regulatory systems for blood transfusion services in the countries 53-54 Annex 4 National quality assurance schemes and external technical support 55-57 Annex 5 Percentage coverage of screening of blood donation for transfusion-transmissible infections 58-59 Annex 6 Percentage of blood donation screened for transfusion-transmissible infections in a quality-assured manner 60-61 Annex 7 Prevalence of infections in blood donations 62-63 AbbrevIATIoNS ANd ACroNymS 64

1Introduction Blood transfusion is a vital component of every country’s health-care delivery system. The provision of an adequate supply of safe blood and blood products, and their safe and rational use are the responsibility of the government and should be an integral part of each country’s national health-care policy and health-care infrastructure. There is a marked difference in the level of access to blood between low- and high-income countries. The whole blood donation rate is an indicator of the general availability of blood in a country. The median blood donation rate in high- income countries is 32.1 donations per 1000 people. The corresponding figures for upper-middle-income countries, lower-middle-income countries and low-income countries are 14.9, 7.8 and 4.6 donations per 1000 people, respectively. There are great variations between countries in terms of the age distribution of transfused patients. For example, in the high-income countries, the most frequently transfused group of patients are over 65 years of age, accounting for up to 76% of all transfusions. In low-income countries, up to 65% of transfusions are for children under the age of 5 years. In high-income countries, transfusion is most commonly used for supportive care in cardiovascular surgery, transplant surgery, massive trauma, and therapy for haematological malignancies and other cancers. In low- and middle-income countries, it is used more often to manage pregnancy-related complications and severe childhood anaemia. The blood transfusion programme should define the measures taken to meet the transfusion requirements of the patient population, equitably and when required, at the minimum cost, with the minimum wastage and the optimum safety and efficacy. An efficient blood transfusion programme is dependent on reliable data for policy-making and the development of programmes. All countries make efforts to gather data and subject them to analytical processes for decision-making. To assist countries in this endeavour, WHO has been collecting and analysing data from all over the world. The WHO Global Database on Blood Safety (GDBS) was established with the objective of collecting and analysing data on blood and blood product safety from all Member States across the globe and, based on the gaps, helping them to improve their national blood transfusion services. 1 2This document attempts to collate and analyse data pertaining to the Member States in the South-East Asia (SEA) Region that was officially submitted to the GDBS (2011–2015). The data have been extensively analysed. The focus of the analysis is to provide the countries with information on the current status of blood transfusion services to enable them to assess their needs in the area of improving blood safety, to formulate strategic recommendations for them, and to plan and implement activities and evaluate progress. A few discrepancies or gaps in sequential data may be seen in this document. This is primarily because of incomplete information submitted by few Member States to the GDBS. This, however does not take away the essentials of situation of blood transfusion services in the Region. Available data can provide strong advocacy as well as action points for the Member States to improve their respective blood transfusion services for the benefit of their people. The report is divided into various sections to help understand the entire blood system, right from governance, the blood supply chain, laboratory testing, component preparation and quality management to clinical use of blood and blood products. The analysis and review are limited due to the incomplete submission of data by a few countries in some of the reporting years (2011–2015). However, an overall picture can be extrapolated from the given data. I N T R O D U C T I O N 3organization and management of blood transfusion services 2.1 NATIoNAl goverNANCe Government commitment is essential to ensure the safety and adequate availability of blood and blood products to patients in need of transfusions. The essential elements and structure of a good national blood system include a national blood policy and strategic plan, a budget, legislation, a regulatory framework and haemovigilance. Each country should have a nationally coordinated blood transfusion service with an appropriate national blood policy and the infrastructure to support the objectives of the policy. For presence of national blood policy 10 countries submitted reports in year 2011, all 11 in 2012 and 2013, nine reports in 2014 and eigh\t reports in 2015.In 2011, eight of the 10 countries had a national blood policy and in 2012, two more reported having policies. Thus, for the years when all the 11 countries gave this information national blood policy had been formulated in 10 (90.9%) out of 11 countries. Only one country did not have a national blood policy for all the five reporting years. Since 2011, eight countries (72.7%) have had a unit within the Ministry of Health (or other government department) that is responsible for governing all activities related to the provision of blood and blood products. They were joined by one more country in 2012. Specific legislation covering the safety and quality of blood for transfusion was reported in seven (63.6%) countries in 2012 and six (54.5%) in 2011. Four countries have not reported any specific legislation during 2011–2015. Three out of 11 countries (27.2%) reported a multi-year national strategic plan for blood safety in 2011. The number increased to six (54.5%) in 2012 and 2013. Six countries (54.5%) reported that they had constituted a national blood committee to assist the Ministry of Health in formulating policy and plans, setting standards and offering advice on key issues. Ten countries (90.9%) have a national blood transfusion service. (Fig. 1). 2 4Only three (27.2%) countries published an annual report on the activities of national blood transfusion services in 2011, while seven (63.6%) did so in 2012. In 2015, only two countries did not have a published annual report; information was not received from three countries. Fig. 1. National governance for blood transfusion services in the 11 SeAr countries According to seven of the eight country reports received in 2011, the government budget included a specific line item for the blood transfusion services within the Ministry of Health, while in 2012 and 2013, eight of the 10 country reports gave a positive response. In 2014 and 2015, reports were received from eight countries and six mentioned budgetary allocation. Five countries (45.4%) had a cost recovery system for blood transfusion services through the reporting years, four (36.3%) had none and in two, cost recovery systems existed only in some years. Nine of the 11 countries (81.8%) reported receiving financial assistance from international organizations or other national agencies. Two received no external financial assistance and managed through a specific government S E C T I O N 2 5budget and a cost recovery system. Information on the total national government funding for blood transfusion services and funding from cost recovery schemes was provided by eight (72.7%) countries and six countries also reported the data on external funding. There was a marked intercountry variation in the cost of producing a unit of whole blood and/ or red blood cells. It ranged from US$ 7–58 per whole blood unit in 2011, US$ 6–100 per whole blood unit in 2012, US$ 7–100 in 2013, US$ 0–110 in 2014 and US$ 7–120 in 2015. Annexure 1a and 1b provide the details of funding from various sources as estimated in US dollars and from national governments respectively. Annexure 2 lists the international organizations which provided financial assistance to the blood transfusion services of the SEA Region countries. 2.2 blood CeNTreS The total number of blood centres in the region in 2014 was 4074. This was the year that the maximum number was reported. Overall, 20–25% were stand-alone blood centres, the rest being hospital-based. There was marked intercountry variation. All blood centres in Bhutan were hospital-based, while over 90% were hospital-based in DPR Korea, the Maldives, Myanmar, Sri Lanka, Thailand and Timor-Leste. In Indonesia and Nepal, 50–60% blood centres were stand-alone facilities. Data on whether blood centres were stand-alone facilities or hospital-based were not available from India. In Bangladesh, the number of stand-alone blood centres increased from 2013 to 2015. Table 1. distribution of blood centres in the region as reported from 2011 to 2015 by some countries year Stand-alone hospital-based Total Country data 2011 507 (25.8%) 1455 (74.15%) 1962 9 excluding India and Timor-Leste 2012 322 (20.8%) 1224 (79.1%) 1546 9 excluding India and Maldives 2013 380 (23.4%) 1238 (76.5%) 1618 10 excluding India 2014 201 (15.2%) 1113 (84.7%) 1314 +2760 (India)= 4074 9 excluding DPR Korea and Timor-Leste 2015 373 (25.0%) 1119 (75.0%) 1492 8 excluding DPR Korea, India and Timor-Leste O R G A N I z A T I O N A N D M A N A G E M E N T O f B L O O D T R A N S f u S I O N S E R v I C E S 6Fig. 2. distribution of standalone and hospital-based blood centres in countries 2.3 QuAlITy mANAgemeNT Eight of the nine reporting countries had national standards for the collection, testing, processing, storage and distribution of blood and blood components in 2011. In 2012, all 11 countries responded and eight gave an affirmative response (72.7%). In 2013, nine out of 10 S E C T I O N 2 7reporting countries had national standards, while the corresponding figures for 2014 were seven out of eight and for 2015, eight out of eight. Four (36.3%) had a system of regular inspection and licensing of the blood transfusion services by national regulatory agencies. One country had no system for regulatory inspections. Information from the other six countries is variable during the reporting years. Four countries had national guidelines on the appropriate clinical use of blood and blood products in 2011. This figure rose to seven in 2012– 2015. Three countries (27.2%) had accreditation programmes – India, Sri Lanka and Thailand, but the proportion of blood centres accredited was around 2.5% in India, 1.1% in Sri Lanka and 8.2% in Thailand. Four countries also had computerized information management systems in blood transfusion services in 2014 and 2015. In Indonesia, such a system was present in 14.5% of blood centres, in Myanmar 11.0%, in Sri Lanka 3.0% and in Thailand, all blood centres (100%). Ten countries had received technical support for their blood transfusion services from international organizations. Annexure 3 provides detailed information on the regulatory systems for blood transfusion services in the countries. In 2011, seven countries reported the existence of an external quality assessment scheme (EQAS) for laboratory screening for transfusion- transmissible infections (TTIs). The number of countries giving a positive response increased to 10 (90.9%) in 2012 and 2013. No such data were available from three countries in 2014 and 2015, but only one country had no EQAS; hence, it may be presumed that 10 countries continued to have EQAS for TTIs. The WHO Regional Office for South-East Asia is supporting Member States in the matter of EQAS for screening of TTIs with the help of the National Reference Laboratory (NRL) Victoria, Australia (WHO Collaborating Centre- diagnostics and laboratory quality)). Some countries have developed their own national EQAS to support blood banks within the country. Only three countries (27.2%) consistently had an EQAS for blood group serology and compatibility testing for all five years. Three countries had not initiated such a scheme at all. One country had no scheme in place in 2011, but started one from 2012 onwards. In the remaining four countries, EQAS was in place for blood group serology during only one or two reporting years. Five countries (45.4%) had initiated the establishment of a national haemovigilance system, which would include capturing data on both donor- and recipient-related adverse events. Ten countries (90.9%) had a programme of continuing education for personnel involved in blood transfusion services. Six (54.5%) also had educational programmes that offered a nationally-recognized university degree or diploma in blood transfusion services. Annexure 4 provides the details of national quality assurance schemes and external technical support. O R G A N I z A T I O N A N D M A N A G E M E N T O f B L O O D T R A N S f u S I O N S E R v I C E S 8blood Collection 3.1 blood doNor ProgrAmme An organized blood donor programme is essential to maintain a safe and sufficient supply of blood. Table 1a shows salient features of the national blood donor programmes in SEA Region. All 11 (100%) countries in the region have national donor selection criteria for assessing suitability for blood donation so that only healthy individuals are recruited as blood donors. All countries are aware of World Blood Donor Day, which is celebrated. A database of blood donors is maintained at the level of blood centres, whether stand-alone or hospital-based, in six countries. Two countries maintain a national database of blood donors. Four have reported the existence of local databases and/or a national database in different reporting years. Eight countries (72.7%) have a specific budgetary allocation for a national blood donor programme. Two countries had no such budget during 2011–2015, while one country made a budgetary allocation in 2015. Table 1a: Salient features of national blood donor programmes in SeA region No of countries with national blood donor criteria 11 No of countries maintaining database on blood donors at blood centre level 6 No of countries maintaining database on blood donors at national level 2 No of countries with specific budgetary allocation for national blood donor programme 8 3.2 blood doNATIoNS The norm for blood requirement is taken as approximately 1% of the population, or a whole blood donation rate of 10 per 1000 population. Blood donations were estimated per 1000 population for each country per year, for the years 2011–2015. In 2011, data were available from eight countries, of which seven had a blood donation rate of less than 10 per 1000 population. In 2012, data were available from all 11 countries, of 3 9which eight had a blood donation rate of less than 10 per 1000 population. In 2013, the number of countries with a donation rate of less than 10 per 1000 population decreased to seven. In 2014 and 2015, reports were available from only nine and eight countries, respectively. The countries which reported more than 10 donations per 1000 population for one or more years were Bhutan, Indonesia, Maldives and Sri Lanka. The SEA region houses 26% of the global population, but accounts for only 13% of the global blood collection. Fig. 3. blood donations per 1000 population in SeAr countries from 2011 to 2015* * Data from countries is not complete, e.g. reported collections in Thailand accounted for only 30% of the national collection. 3.3 TyPeS oF blood doNATIoN Blood can be collected as whole blood or as a specific blood component through apheresis technology. Donors may be either voluntary non- remunerated, or family/replacement donors and paid donors in some countries. A voluntary non-remunerated blood donor (VNRD) is a person who gives blood, plasma or cellular components out of his/her own free will and receives no payment for it, either in the form of cash or in kind that could be considered a substitute for money. Family/replacement donors are also non-remunerated; however, their donation is triggered by the staff of hospitals or blood centres and is intended to replace the blood given to a hospitalized family member or friend in the context of a blood shortage. WHO recommends the collection of blood from voluntary non-remunerated donors from low-risk populations. There was an increase in total whole blood donations in the region from 14.25 million units to 14.85 million units from 2012 to 2013, when reports from all 11 countries were available. B L O O D C O L L E C T I O N 10 3.4 whole blood doNATIoNS Three countries in the SEA Region had more than 90% VNRD during 2011–2015. Three others achieved 90% VNRD in 2014 and 2015. In three countries, the majority of blood collections were through family/ replacement donors. Overall, the countries’ average VNRD for five years ranged from 28.3% to 100%. Five countries reported serial data on VNRD from first-time donors and repeat donors. In four of these five countries, there was a rising trend in repeat voluntary non-remunerated donations. From 2011 to 2015, the increase In Bhutan was from 9.6% to 32.4%, in Myanmar from 46.9% to 54.1%, in Sri Lanka from 30.0% to 78.4%, and in Thailand from 82.0% to 85.2%. Fig. 4. Percentage of voluntary non-remunerated blood donations from first-time and repeat blood donors Data from some countries showed only total numbers of VNRDs and information on first-time and repeat donors was not provided. Table 2. Change in voluntary non-remunerated donations reported in member States Country Number of voluntary non-remunerated donations % change of voluntary donation numbers Initial year Number of donations/total Subsequent year Number of donations/total Bangladesh 2011 95412/415372 2015 200906/679681 110.5% Bhutan 2011 4628/8175 2015 6797/8794 46.8% DPR Korea 2011 97228/97228 2013 99200/99200 2.02% India 2012 7379897/9807953 2014 8427714/10838383 14.19% Indonesia 2011 1954600/2310721 2015 3034904/3370935 55.2% Maldives* 2012 1489/7747 2015 1209/2200 35.7% Myanmar* 2011 145310/197482 2015 61037/62923 23.5% Nepal* 2011 177195/177195 2015 98000/115000 14.8% Sri Lanka 2011 318885/330200 2015 395500/395500 24.0% Thailand 2011 591192/591192 2015 650107/650107 9.9% Timor-Leste 2012 1000/1937 2013 739/2007 14.8% S E C T I O N 3 11 Myanmar*, Nepal* and Maldives* showed a decrease in the total collection as well as collection from voluntary blood donors in 2015. Timor-Leste showed a marginal increase in total blood donations but a decrease of 14.8% in voluntary blood donation. 3.5 blood doNor ProFIle Nine countries gave data on the gender of blood donors and/or the age stratification. The gender distribution of blood donors amongst the countries was highly variable. Male donors outnumbered females in seven countries (male: female ratio varying from 1.6:1 to 75.6:1). The proportion of male and female donors was almost equal in one country, and in another, the number of female donors was greater (threefold to six- fold) than male donors. Donor data as stratified by age could be analyzed from eight countries. Most of the donors (71.07–97.6%) were in the age range of 18 to 44 years. In six countries, there were no donors under 18 years of age. This may be as per the national donor selection criteria. Donations decreased in the age range of 45–64 years and were scant among individuals of the age of 65 years or older. In three countries, there were no donations by those who were of the age of 65 years or older. Thus, some countries seem to have specified age limits for blood donation. Three countries did not give any data on age stratification of blood donors. Table 3. Proportion of donors as stratified by age Country (number of reports) under 18 years 18 to 24 years 25 to 44 years 45 to 64 years 65 years or older Bhutan (5) 1.5% (1.13–2.0) 51.58% (46.3–60.7) 46.02% (33.8–49.8) 3.32% (2.1–4.3) 0.01 (0–0.02) Indonesia (4) 3.25% (0.26–13.2) 32.95% (24.0–42.9) 38.12% (29.7–55.7) 23.0% (5.58–40.5) 2.25% (1.14 .3) Maldives (4) 0 22.82% (9.1–30.6) 72.47% (65.4–82.6) 4.27% (2.3–8.1) 0.02% (0.01–0.03) Myanmar (5) 1 year only 41.1% (32.1–46.3) 48.06% (45.6–50.8) 9.1% (8.01–10.5) 0.0004 (0–0.002) Nepal (4) 0 26.0% (20–29.9) 48.6% 25.1% (17.7–30) 0 Sri Lanka (2) 0 31.7% 58.1% 10.09% 0 Thailand (5) 1.71% (1.0–4.7) 17.7 (15.6–20.3) 61.6% (59.8–64.8) 18.54% (14.8–22.2) 0.02% (0.02–0.04) Timor-Leste (2) 12.65% (12.4–12.9) 35.45% (34.8–36.1) 44.0% (42.3–45.7) 7.73% (5.16–10.3) 0 Values represent the average and range within the listed countries. Bangladesh, DPR Korea and India are not included as their data was not available. B L O O D C O L L E C T I O N 12 3.6 doNor deFerrAl Data on donor deferral could be analysed from ten countries. Overall, temporary donor deferrals outweighed permanent deferrals. Low donor haemoglobin accounted for the most common reason for donor deferral. Donor deferral on account of low haemoglobin ranged from 13.3% to 60.7% in different countries, with a mean value of 35.84%±12.79% SD. Fig. 5. Causes of donor deferral in countries of SeAr 3.7 PredePoSIT AuTologouS blood doNATIoN Predeposit autologous blood donation is defined as blood drawn from a patient for re-transfusion into himself/herself. Only two countries reported predeposit autologous blood donation. Bhutan had two autologous blood donations, one each in 2014 and 2015, which constituted only 0.02% of total whole blood donations. Thailand reported two such donations in 2011, and these accounted for 0.0004% of donations. S E C T I O N 3 13 3.8 doNor NoTIFICATIoN All 11 countries (100%) had a donor notification system for those donors whose test results were reactive for HIV, hepatitis B, hepatitis C and syphilis. Three countries (India, Indonesia and Sri Lanka) also notified donors who tested positive for malaria. All countries had a system of post- donation counselling and referral to care and treatment for blood donors who tested positive for transfusion-transmissible infections. 3.9 APhereSIS doNATIoNS Eight countries had apheresis donations during all/some of the reporting years. Three did not report any apheresis donations. In four countries, apheresis donations were collected from VNRDs, while in two, replacement donors outnumbered VNRDs. Two countries did not submit information on the types of apheresis donors or the number of apheresis donations collected. Table 4. whole blood and apheresis donations Country/ year Number of whole blood donations (in thousands) Number of apheresis donations (in thousands) Bangladesh 2013 593.7 0.3 Indonesia 2013 2722.7 0.301 Myanmar 2011 197.4 0.053 2012 208.0 0.011 2013 266.5 0.033 2014 50.9 0.044 2015 62.92 0.035 Nepal 2012 75.72 0.012 2013 201.11 0.02 2015 115.0 0.100 Sri Lanka 2011 330.2 0.81 2012 351.60 1.107 2013 380.8 1.636 2014 380.3 1.318 2015 395.5 1.534 Thailand 2011 591.192 15.612 2012 616.673 15.628 2013 618.675 15.871 2014 639.919 15.865 2015 650.107 17.773 Two countries only mentioned that apheresis donations were being done but no numbers of apheresis donation were recorded. B L O O D C O L L E C T I O N 14 Screening donated blood for markers of TTIs 4.1 blood SAFeTy From TTIS Safety from TTIs is of paramount importance for blood safety and is still a concern, especially in the SEA Region countries, where the prevalence of TTIs among blood donors is high but the quality and coverage of blood screening may be inadequate. Each country needs to have a national policy on screening whole blood and apheresis blood donations for TTIs. This section gives the analyzed data on the number of SEA Region countries that had a minimum laboratory screening policy for various TTIs from 2011 to 2015. The analysis of the data obtained demonstrates that all 11 countries screen for a minimum of 4 TTIs, namely, HIV, HBV, HCV and syphilis, with one or more markers, although all the countries did not submit data for all the five years. Screening data for HIV, HCV and HBV were obtained from: • 10 countries in 2011 • 11 countries in 2012 and 2013 • 9 countries in 2014 • 8 countries in 2015. 4.1.1 hIv All 11 countries (100%) reported that testing for HIV 1 & 2 antibody (Ab) was required for all blood donations. Six countries reported having a policy of testing all/selective blood donations for HIV antigen (Ag) 1&2. Three reported having no policy for testing blood donations for HIV 1 & 2 Ag, while two did not respond to the question regarding such a policy. One country (Thailand) reported having a policy for testing all blood donations for HIV RNA using nucleic acid amplification technology (NAT). Three countries reported having a policy for screening selective blood donations for HIV RNA. Figure 6 shows the countries’ policy-related responses. 4 15 Fig 6. Policy for laboratory screening of blood donations for hIv Note – The values in the figure represent the number of countries. In 2011, data were available from 10 countries. In 2012 and 2013, data were available from 11 countries. In 2014, data were available from nine countries. In 2015, data were available from eight countries. 4.1.2 hePATITIS b vIruS (hbv) All 11 countries (100%) reported that testing for hepatitis B surface antigen (HBsAg) was required for all blood units. Six (54.5%) countries had a policy of screening all or selective blood donations for anti-hepatitis B core antibody (anti-HBcAb). One country (Thailand) reported having a policy of testing all blood donations for HBV using NAT. Three (Indonesia, Myanmar and Sri Lanka) reported having a policy of screening selective blood donations for HBV using NAT. Figure 7 shows the countries’ policy-related responses. S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 16 Fig. 7. Policy for laboratory screening of blood donations for hbv Note – The values in the figure represent the number of countries. In 2011, data were available from 10 countries. In 2012 and 2013, data were available from 11 countries. In 2014, data were available from nine countries. In 2015, data were available from eight countries. 4.1.3 hePATITIS C vIruS (hCv) All 11 countries (100%) reported that testing for anti-HCV was required for all blood donations during one or more years as per the submitted country data. For the years 2011, 2012, 2014 and 2015, the countries which submitted report had a policy of testing for anti-HCV. Only in the year 2013, ten out of eleven countries reported the same. One country (Thailand) reported having a policy of testing all blood donations for HCV, using NAT. Three countries (Indonesia, Myanmar and Sri Lanka) reported having a policy of screening selective blood donations for HCV, using NAT. S E C T I O N 4 17 Fig. 8. Policy for laboratory screening of blood donations for hCv Note – The values in the figure represent the number of countries. In 2011, data were available from 10 countries. In 2012 and 2013, data were available from 11 countries. In 2014, data were available from nine countries. In 2015, data were available from eight countries. 4.1.4 SyPhIlIS All countries (100%) reported having a policy of performing syphilis (Ab) testing in the case of all blood donations. This was a screening and not a specific test. 4.1.5 ChAgAS dISeASe Ten countries (90.91%) reported either having no policy of screening blood donations for Chagas disease or did not reply to the question regarding this. Chagas disease is not prevalent in most parts of the Region. 4.1.6 mAlArIA Four countries (36.6%) – Bangladesh, India, Maldives (for the year 2015 only) Sri Lanka and Timor-Leste (for the year 2013 only) – reported having a policy of mandatory screening of all blood donations for malaria, whereas Bhutan reported testing of all units for malaria in endemic districts and testing of selective blood donations in non-endemic areas, in cases in which there was a positive history of travel to endemic regions or a past history of malaria. Timor-Leste reported on having a policy but no data was available on the numbers of donations tested. Testing for malaria was performed by smear microscopy. Two countries (Democratic People’s Republic of Korea and Indonesia) reported having a policy of performing smear microscopy on selective blood donations. One country S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 18 (Maldives) reported screening of donations for malaria only since 2015. Three countries had no policy for screening for malaria (Fig. 9). Five countries (45.4%) reported screening of all or partial blood donations for malaria using antigen-based assay. Fig. 9. Percentage of whole blood and apheresis donations screened for malaria Data are shown from countries which perform screening for malaria. 4.1.7 humAN T-lymPhoTroPIC vIruS No country reported having a policy of screening blood donations for human T-lymphotropic virus I/II (HTLV I/II). 4.2 PolICy oF PerFormINg CoNFIrmATory TeSTINg oN reACTIve uNIT hIv Eight countries (72.7%) reported having a policy of performing confirmatory tests on all units reactive for HIV in one or more reporting years. Two countries reported not performing any such test in the blood centres and one country reported having a policy of performing confirmatory tests on some proportion of units reactive for HIV. hbv Seven countries (63.6%) had a policy of performing confirmatory tests on all/partial units reactive for HBV. One country reported having introduced the policy of performing confirmatory tests on all units reactive for HBV in 2015. Three countries reported not performing any confirmatory test. hCv Seven countries (63.6%) had a policy of performing confirmatory tests on all/partial units reactive for HCV. Four reported not performing any confirmatory tests. S E C T I O N 4 19 SyPhIlIS Eight (72.7%) countries reported having a policy of performing confirmatory tests on all or some units reactive for syphilis. Three reported not performing any confirmatory test. 4.3 CoverAge oF lAborATorIeS SCreeNINg For blood doNATIoNS Ten countries reported screening of 100% of whole blood and apheresis donations for key TTIs (HIV, HBV, HCV, syphilis). One country reported being able to screen 99.9% of whole blood and apheresis donations for HIV, HBV, HCV and syphilis in the year 2011, but was able to achieve 100% screening in the subsequent years. Annexure 5 gives detailed data on the percentage of units screened, country- and year-wise. Three countries reported screening 100% of whole blood and apheresis donations for malaria. No country performed screening of whole blood and apheresis donation for HTLV I/II. 4.4 QuAlITy oF lAborATorIeS PerFormINg SCreeNINg For blood doNATIoNS Quality-assured screening of all donated whole blood or apheresis units is a prerequisite to blood safety. To assess whether blood screening was conducted in a quality-assured manner, data were collected on two aspects: (i) if the laboratories performing screening participated in TTIs EQAS, and (ii) whether standard operating procedures were used. Only one country reported that all blood centres performing laboratory screening had participated in EQAS from 2011 to 2015. However, this number went up to four by 2015 In one country, all blood centres performing laboratory screening reported participating in EQAS for HIV only in 2015. Figure 10 shows the total number of blood centres and the number of blood centres participating in EQAS as reported by the 11 countries. Fig. 10. Participation of blood centres performing laboratory screening of TTIs in external quality assessment scheme (eQAS) S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 20 4.4.1 SCreeNINg oF whole blood ANd APhereSIS doNATIoNS IN A QuAlITy-ASSured mANNer Five of the 11 countries provided data on the number and percentage of blood donations screened for key infections (HIV, HBV, HCV and syphilis) in a quality-assured manner. Four provided partial data for the same. There was no response from two countries. Three countries reported that 100% of donations were screened for HIV in a quality-assured manner during all five years. Two more countries reported that 100% of donations were screened for HIV in a quality-assured manner in 2015. It is important to note that not all the centres involved in blood collection, component separation and other activities related to blood transfusion services (BTS) in the Member States are reporting to the GDBS, so the data should be interpreted with caution. Figures 11 to 13 show the percentage of whole blood and apheresis donations screened in a quality-assured manner for HIV, HBV, HCV and syphilis. Annexure 6 shows the details of whole blood and apheresis donations screened in a quality-assured manner for HIV, HBV, HCV and syphilis. Fig. 11. Percentage of whole blood and apheresis donations screened in a quality-assured manner for hIv S E C T I O N 4 21 Fig. 12. Percentage of whole blood and apheresis donations screened in a quality-assured manner for hbv and hCv Fig. 13. Percentage of whole blood and apheresis donations screened in a quality-assured manner for syphilis 4.5 PrevAleNCe oF mArkerS oF INFeCTIoN IN blood doNATIoNS hIv, hbv, hCv Figures 14 to 16 show the prevalence of the markers of HIV, HBV and HCV infection as reported by 11 countries. The prevalence is largely based on the results of screening tests. In two countries, the seroprevalence of HIV S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 22 was less than 0.01%. In six, there was a decreasing trend towards 2014– 2015. Figure 14 shows the prevalence of HIV infection in blood donations. The seroprevalence of HBV was less than 1% in nine countries. In two countries, it ranged from 1.5 to 2.5%. Figure 15 depicts the prevalence of HBV infection in blood donations. The seroprevalence of HCV was less than 0.5% in nine countries. Figure 16 depicts the prevalence of HCV infection in blood donations. Annexure 7 gives detailed information on various infections country- and year-wise. Fig. 14. Prevalence of hIv infection in blood donations The prevalence of HIV infection in voluntary, first-time and repeat donors was reported partially by five countries only and is shown in Table 5. S E C T I O N 4 23 Table 5. Prevalence of HIV infection in voluntary, first-time and repeat blood donors 2011 2012 2013 2014 2015 hIv in vNrd (%) hIv in first- time donors (%) hIv in repeat donors (%) hIv in vNrd (%) hIv in first- time donors (%) hIv in repeat donors (%) hIv in vNrd (%) hIv in first- time donors (%) hIv in repeat donors (%) hIv in vNrd (%) hIv in first- time donors (%) hIv in repeat donors (%) hIv in vNrd (%) hIv in first- time donors (%) hIv in repeat donors (%) Bangladesh - - - - - - - - - - - - - - - Bhutan - - - 0.06 0.08 - 0.1 0.2 - - - - 0.041 0.041 0 Democratic People’s Republic of Korea - - - - - - - - - - - - - - - India - - - - - - - - - - - - - - - Indonesia - - - - - - - - - - - - - - - Maldives - - - - - - - - - - - - - - - Myanmar 0.24 0.46 0.12 0.1 0.1 0.07 - - - 0.16 0.3 0.06 Nepal - - - - - - - - - - - - - - - Sri Lanka - - - - - - - - - 0.007 - - - - - Thailand 0.68 0.029 0.039 - - - - - - 0.11 0.21 0.22 0.21 0.06 Timor- Leste - - - 0.06 0.06 - 0 0.001 0 - - 0 - - - Fig. 15. Prevalence of hbv infection in blood donations S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 24 Fig. 16. Prevalence of hCv infection in blood donations SyPhIlIS ANd mAlArIA Figures 17 and 18 show the prevalence of the markers of syphilis and malaria, as reported by the 11 countries. The seroprevalence of syphilis ranged from 0.01% to 1.5% and was less than 1% in 10 of the countries. The prevalence of malaria was around 1% in two countries and less than 0.01% in the other two countries. Fig. 17. Prevalence of syphilis infection in blood donations S E C T I O N 4 25 Fig. 18. Prevalence of malaria infection in blood donations 4.6 PolICy For SCreeNINg oF blood doNATIoNS uSINg rAPId TeSTS Five countries reported screening blood donations using rapid tests. For four countries, the percentage ranged from 50% to 100%. One country reported screening only 0.2% (HIV), 2.2% (HBV) and 1% (HCV) of blood donations using rapid tests. Five countries (Bangladesh, Bhutan, Myanmar, Nepal and Sri Lanka) replied partially to the question regarding the policy for screening of blood donations using rapid tests. Bangladesh reported testing 100% of donations using rapid tests in 2014. Myanmar reported screening 94.3% and 83.4% of blood donations using rapid tests in 2013 and 2014, respectively. Nepal reported screening 50% of blood donations using rapid tests in 2015. Sri Lanka reported screening only 0.2% (HIV), 2.2 % (HBV) and 1 % (HCV) of blood donations using rapid tests. S C R E E N I N G D O N A T E D B L O O D f O R M A R K E R S O f T T I S 26 Processing of whole blood donations into components Blood in an anti-coagulant preservative solution is called whole blood and when blood is transfused as such to the patient, it is called whole blood transfusion. However, whole blood can be used more judiciously by separating it into its components (red cell concentrates, fresh frozen plasma, cryoprecipitate and platelet concentrates) so that it can meet the requirements of more than one patient. Facilities for the preparation of components were available in all 11 countries. The percentage of whole blood subjected to component preparation was 20–30% in two countries, 30–60% in another two, 60–90% in four and more than 90% in three. The data have been summarized in Table 6 and Fig. 19. Table 6. Proportion of whole blood donations processed into components in SeA region countries % Separation of components <30% 30–60% 60–90% >90% Countries Bangladesh, Nepal Bhutan, India Democratic People’s Republic of Korea, Indonesia, Myanmar, Timor-Leste Maldives, Sri Lanka, Thailand Four of the 11 countries showed a rising trend in the separation of blood components during the observation period. This was 28–64% (2011–2015) in Bhutan, 25 –100% (2011–2015) in Myanmar, 20–28% (2011–2015) in Nepal and 60–70% (2011–2013) in the Democratic People’s Republic of Korea. In three countries, it was already more than 90% and in the remaining countries, there was a variable trend in component preparation during 2011–2015. 5 27 Fig. 19. whole blood donation processed into components in SeA region countries From India data was available only on percentage of whole blood donation processed into components but actual numbers of donations were not given. Fig. 20. SeA region countries with rising trend in component preparation (2011–2015) Using components produced per whole blood collection as an indicator of the productivity of blood transfusion services, the data were analysed and it was observed that there are country-level variations in the degree of processing of whole blood into different blood components. The most commonly produced blood components were packed red cells, platelets and fresh frozen plasma. 5.1 PACked red Cell PrePArATIoN Packed red cell concentrates were prepared by centrifugation of whole blood units in all 11 countries. However, a few units were prepared by sedimentation in one country. The fraction of whole blood separated into packed red cell concentrate ranged from 8% to 97.5%. The variation in the percentage of packed red cell concentrate prepared from whole blood collections in the countries is shown in Fig. 21. P R O C E S S I N G O f W H O L E B L O O D D O N A T I O N S I N T O C O M P O N E N T S 28 Fig. 21. Average percentage variation of packed red cell concentrate prepared from whole blood in SeA region countries Timor-Leste – Data for 2012 and 2013 only DPR Korea – Data for 2011, 2012 and 2013 only Maldives – Data for 2012, 2013, 2014 and 2015 only There was a rising trend in red cell concentrate preparation in 8 (72.7%) countries. Fig. 22. Trends in preparation of packed red cell concentrate from whole blood in SeAr countries (2011–2015) 5.2 PlATeleT ComPoNeNT PrePArATIoN All 11 countries reported data on the preparation of platelet components. The percentage of platelet component preparation ranged from 3.95% to 57%. The mean percentage variation of platelet components prepared from whole blood donation is depicted in Fig. 23 (mean %) and trends in platelet component preparation for each country are shown in Figure 24. S E C T I O N 5 29 Fig. 23. Average percentage variation in preparation of platelet components from whole blood donation in SeAr countries (2011–2015) Fig. 24. Trends in platelet component preparation in SeAr countries (2011–2015) There was a rising trend in the preparation of platelet components derived from whole blood in Bhutan, DPRK, Indonesia, Nepal, Maldives, Sri Lanka and Myanmar. The average number of platelet components produced from one unit of collected whole blood ranged from 0.05 to 0.57. It was below 0.1 in three countries, between 0.1 and 0.2 in four, and between 0.2 and 0.4 in two. It was 0.57 in one country, as shown in Fig. 25. P R O C E S S I N G O f W H O L E B L O O D D O N A T I O N S I N T O C O M P O N E N T S 30 Fig. 25. Average number of platelet components produced per unit of collected whole blood in SeAr countries (2011–2015) There were no data available from India. In addition, not all the centres involved in blood collection and component separation in the Member States are reporting to the GDBS. 5.3 PlASmA ComPoNeNT PrePArATIoN In six countries, the predominant form of plasma component preparation was fresh frozen plasma, a plasma separated from whole blood within six hours of collection and stored at ≤-30oC. In three countries, other plasma types not qualifying for fresh frozen plasma constituted the major fraction of the plasma component prepared. The proportion of the two plasma components prepared is shown in Fig. 26. Fig. 26. mean percentage variation of FFP and other plasma types prepared in SeA region countries (2011–2015) S E C T I O N 5 31 Fig. 27. Average number of plasma components (FFP and plasma) produced per whole blood collection The preparation of fresh frozen plasma component per one unit of collected whole blood varied between 0.03 and 0.89 (Fig. 27). It was less than 0.1 in three countries, between 0.1 and 0.2 in two countries, between 0.2 and 0.5 in three and more than 0.5 in two. The trends in fresh frozen plasma and other plasma preparations are depicted in Fig. 28. Fig. 28. Trends in plasma component preparation in SeAr countries (2011–2015) 5.4 CryoPreCIPITATe PrePArATIoN Seven of the 11 countries also reported having prepared cryoprecipitates in variable proportions of the total collected blood. The figure ranged from 0.1% to 35.18%. P R O C E S S I N G O f W H O L E B L O O D D O N A T I O N S I N T O C O M P O N E N T S 32 Fig. 29. mean percentage variation of cryoprecipitate prepared in SeA region countries (2011–2015) 5.5 blood ComPoNeNT hArveSTINg by APhereSIS TeChNology Six out of 11 countries have provided information regarding harvesting of blood components through apheresis. The majority (Bangladesh, Indonesia, Myanmar, Nepal and Sri Lanka) harvested only platelet components, whereas in Thailand, red cells, platelets and plasma were also harvested by apheresis, as shown in Fig. 30. Fig. 30. blood component harvesting by apheresis technology S E C T I O N 5 33 Clinical use of blood As facilities for separation of blood components were available in all 11 countries, various blood components were issued and transfused to meet patients’ clinical needs. The proportion of whole blood to component transfusion varied in these countries, depending on the clinical practices and mechanisms to improve and monitor safe and appropriate blood transfusions. In low- and middle-income countries, blood transfusions are more often used to treat pregnancy-related complications and severe childhood anaemia. A measure of variation in the proportion of whole blood transfused to specific blood components can help target specific deficiencies. GDBS data reveal great variations in the use of whole blood for transfusion among countries with different incomes. In high-income countries, whole blood is rarely used for transfusion. As health systems develop and become able to offer a wider range of diagnostic and treatment options, component therapy becomes increasingly important for clinical use. 6.1 red Cell TrANSFuSIoNS To achieve the desired increment in haemoglobin levels, both whole blood as well as packed red cells were transfused in varying proportions in eight of the 11 countries, depending on the prevalent clinical practices. Since Sri Lanka and Thailand have achieved 100% component separation, only packed red cells were issued for transfusion. Information on the clinical use of blood components was not reported from India, hence not included in the analysis. The whole blood to packed red cell transfusion ratio ranged from 9:1 to 1:14.6. The variation in whole blood and packed red cell usage in different countries is depicted in Fig. 31. The mean rate of red cell (whole blood and packed red cells) transfusions per 1000 population between countries ranged from 0.71 to 16.53 during the observation period of 2011 to 2015. The country-wise variation is depicted in Fig. 31. 6 34 Fig. 31. Percentage comparison of wb: PrbC transfusions in SeA region countries Fig. 32. mean number of red cell units (wbC + rbC) transfused per thousand population during 2011–2015 6.2 PlATeleT TrANSFuSIoNS Platelets were transfused predominantly as whole blood-derived random donor platelets in all 11 countries. The proportion of platelet transfusions varied from 3.2% to 27.64% of the total transfusions in these countries and is depicted in Fig. 33. Fig. 33. Comparison of whole blood-derived and apheresis platelet transfusions in SeA region countries S E C T I O N 6 35 Six of the 11 countries also transfused apheresis platelet components and their proportion to the total blood component transfusions ranged from 0.02% to 1.54%, as shown in Fig. 33. The mean rate of platelet transfusions (whole blood-derived and apheresis- derived) per 1000 population among the countries ranged from 0.11 to 7.21 during 2011–2015. The country-wise variation in the mean rate of platelet transfusion per 1000 population is depicted in Fig. 34. Fig. 34. units of platelets transfused per 1000 population in SeAr countries 6.3 PlASmA ComPoNeNT TrANSFuSIoNS Fresh frozen plasma and plasma components were issued for transfusion in all 11 countries. The fraction of plasma component transfusions was based on their availability and the prevalent clinical practice, and ranged from 4.35% to 37% of total blood component transfusions. The variation in plasma component usage in different countries is shown in Fig. 35. Fig. 35. mean percentage variation in plasma component usage C L I N I C A L u S E O f B L O O D 36 The predominant fraction of plasma component issued/transfused was fresh frozen plasma and its usage ranged from 34.5% to 99.6%. The proportion of fresh frozen plasma to other plasma types is shown in Figure 36. Fig. 36. mean percentage variation in FFP and other plasma component usage in various SeAr countries The overall rate of plasma component transfusion (including FFP and other plasma types) per 1000 population also showed a marked variation between countries and ranged from 0.1 to 9.54, as shown in Fig. 37. Fig. 37. units of plasma component transfused (FFP and other plasma types) per 1000 population in SeA region countries Five of the 11 countries also issued/transfused cryoprecipitate to their patients. Cryoprecipitate transfusion ranged from 1% to 12.69% of the total blood component transfusions. The variations in cryoprecipitate usage is shown in Fig. 38. S E C T I O N 6 37 Fig. 38. mean percentage variation in cryoprecipitate usage in various SeAr countries (2011–2015) 6.4 meChANISmS To ImProve ANd moNITor SAFe ANd APProPrIATe blood TrANSFuSIoN For overall improvement in clinical transfusion practice, hospital transfusion committees were present in six of the 11 countries. However, the presence of such committees varied from 3.5% to 100% of the hospitals performing blood component transfusions in these countries. Table 7. Number of hospitals performing transfusions and existing hospital transfusion committees No. of hospitals performing transfusion No. of hospital transfusion committees Bangladesh 244 150 Bhutan 29 1 DPRK 1884 1884 Myanmar 333 2 Nepal 200 10 Sri Lanka 96 68 C L I N I C A L u S E O f B L O O D 38 Fig. 39. Number of hospitals performing transfusions and existing hospital transfusion committees Clinical audits and systems for reporting adverse events were present in all hospitals performing transfusions in one country, whereas only 3.5% to 4.3% hospitals performed clinical audits in two other countries. Two countries had a system for reporting of adverse events. The other five countries did not report any of the above clinical practice monitoring mechanisms. 6.5 PATIeNT’S Age ANd blood TrANSFuSIoNS Two of the 11 countries reported the age group-wise break-up of patients who received transfusions. Maldives reported this for the years 2012, 2014 and 2015, and Timor-Leste for 2012 and 2013. The mean number of patients under the different age groups are shown in Fig. 40. Table 8. mean number of patients who received transfusions, age-wise Age Maldives Timor-Leste <5 213 382 5–14 182 330 15–44 978 590 45–59 303 1071 >=60 490 252 S E C T I O N 6 39 Fig. 40. mean number of patients receiving transfusions, age-wise - Maldives reported data for 2012, 2014 and 2015 - Timor-Leste reported data for only 2012 and 2013 6.6 hAemovIgIlANCe Haemovigilance is an important part of the blood safety system and entails the adoption of a systematic approach to monitoring and evaluating adverse events associated with the blood supply and transfusion service, and to using the findings to improve blood safety and transfusion outcomes. Five of the 11 countries reported transfusion-related adverse events during the observation period of 2011–2015. These adverse events were broadly classified as Immunological and non-immunological. The country-wise details of these adverse events are given in Table 9. Table 9. Transfusion-related adverse events (2011–2015) bhutan democratic People’s republic of korea myanmar Sri lanka Timor- leste Causes Immunological Total Percentage Haemolysis due to ABO incompatibility 11 (61.1%) 2 (9.5%) 0 114 (3.3%) 2 (11.8%) 129 3.50 Other alloimmune haemolysis 7 (38.9%) 7 (33.3%) 109 (96.5%) 22 (0.6%) 0 145 3.90 Post-transfusion purpura 0 2 (9.5%) 0 0 0 2 0.05 Anaphylaxis 0 - 0 2897 (82.5%) 0 2897 78.70 Tr a n s f u s i o n - r e l a te d acute lung injury (TRALI) 0 - 0 75 (2.1%) 0 75 2.10 Graft-vs-host disease 0 - 0 0 0 0 0 C L I N I C A L u S E O f B L O O D 40 bhutan democratic People’s republic of korea myanmar Sri lanka Timor- leste Non-immunological Non-immune Haemolysis 0 - 4(3.5%) 0 0 4 0.10 Transfusion-associated viral infections 0 - 0 0 0 0 0 (HIV/ HBV/ HCV/ others) Sepsis due to bacterial contamination 0 - 0 - 15 (88.2%) 15 0.40 Parasitic infections 0 - 0 0 0 0 0 Transfusion-associated circulatory overload (TACO) 140 (4%) 0 140 3.80 Others - 10(47.7%) - 264 (7.5%) - 0 7.40 Total 18 21 113 3512 17 3681 6.7 dISCArd oF blood Information on discarded blood units was provided by 10 of the 11 countries. The mean discard ranges from 1% to 13% of the total blood collected, as analyzed from the data from the countries during 2011–- 2015. Reactivity for markers of TTIs, outdated stock and incomplete collection were among the main reasons for discard. Fig. 41. Percentage of blood discarded due to various reasons in SeAr countries Discard due to reactivity for infectious markers was a major reason and the proportion of total discard varied in different countries. It was 100% in Bangladesh and Indonesia; 81.15% in Myanmar; 61.86% in the Democratic People’s Republic of Korea; 52% in Thailand and 75.58% in Timor-Leste. It was 20–25% in Bhutan (22.9%) and Nepal (21.9%) and less than 20% in The Maldives (15.5%) and Sri Lanka (9.6%). The other major reason for discard was blood components being outdated. S E C T I O N 6 41 Discarding due to this reason ranged from 1.74% in Myanmar to 75.80% in Maldives of the total discarded units. Fig. 42. The variation in discard due to various reasons 6.8 PlASmA FrACTIoNATIoN Three of the 11 countries (Democratic People’s Republic of Korea, India and Thailand) reported fractionation of plasma both by non-profit (Democratic People’s Republic of Korea and Thailand) and for-profit (India) organizations. India and Thailand also reported sending plasma outside the country for contract fractionation. During the observation period, albumin, intravenous immunoglobulin (IVIG), factor VIII and factor IX concentrates were enlisted in plasma- derived medicinal products in the essential medicines list in Bangladesh (2012), India (except IVIG), Indonesia, Thailand, Democratic People’s Republic of Korea (only albumin) and Timor-Leste (only factor VIII). Indonesia also included human tetanus immunoglobulins in its plasma- derived medicinal product list. Thailand reported the use both of recovered and apheresis plasma obtained from voluntary donors for fractionation. No such information was provided by the other SEAR countries. India, Thailand and the Democratic People’s Republic of Korea reported indigenous manufacture of albumin, IVIG and factor VIII (only Thailand), whereas the other eight countries import these plasma-derived medicinal products. C L I N I C A L u S E O f B L O O D 42 discussions and recommendations 1. bACkgrouNd A well-organized, nationally coordinated blood transfusion service, with quality systems along the entire transfusion chain, is essential for safe and effective clinical use of blood and blood products. Voluntary non- remunerated regular repeat donors form the cornerstone of a safe blood supply. Testing of all blood donations for TTIs of global and regional concern minimizes the risk of transmission. The separation of whole blood into various components helps in the appropriate use of a precious human resource and ensures the availability of plasma for fractionation into plasma-derived medicinal products. Monitoring mechanisms for donor safety, product safety and recipient safety are of immense value for continuous improvement. Trained staff is required at all levels, be it central/national governance, the implementation mechanisms, the blood centres or community-based donor organizers. The assessment of the status of blood availability and safety of any region or country depends on the completeness of the data on national governance, blood collections, screening for TTIs, separation of components, clinical use of blood and haemovigilance. During the years 2011–2015, there was marked variability in the submission of data from the SEAR countries. Three of the countries had not submitted reports for one to two of the five years and also, the parameters of information were not complete in some cases. Only three countries provided information on all blood collections. The national reporting systems need to be strengthened through adequately managed information management systems. A computerized information management system can be considered, depending on the availability of resources. The completeness of data on blood availability and safety will help the countries in setting priorities in the utilization of resources and will also facilitate international data exchange. 2. orgANIzATIoN ANd mANAgemeNT oF blood TrANSFuSIoN ServICeS Government commitment is necessary for the provision of safe, adequate and accessible blood and blood components to patients in need of transfusion. Most countries in the region have a unit within their Ministry of Health responsible for the overall governance of blood transfusion services. A national blood policy has also been formulated in nine of the 11 countries, thus showing the governments’ commitment to blood transfusion services. The policies, however, are not supported 43 by legislation in some countries. WHO recommends specific legislation to support the national blood policy to ensure effective implementation. Some of the countries have a multi-year strategic plan for blood safety and have constituted a national blood committee of experts to assist the Ministry of Health in formulating plans, setting standards and to give advice on key issues. Less than 50% of the countries had a system of regular inspections by the regulatory authorities. Effective organization of blood transfusion services also requires adequate funding. Although most countries in the region reported that the government made budget allocations for the blood transfusion services, the proportion of the government budget was insufficient to meet the total cost of operating the services. Nine of the 11 countries received financial assistance from WHO and other international/national agencies. Government spending on health in most of the SEAR countries is low which, in turn, reflects on the budget allocation for the blood transfusion services. The countries in the region would require external financial assistance till such time as the budgetary allocations for health infrastructure and consequently, blood transfusion services increase. Mechanisms of self-sustenance through cost recovery and health insurance may well work in developed countries and also in some of the developing countries. It would be useful for the Member States to decide on this as part of their national health policy and existing resources. In some countries, regulated new avenues for the generation of revenue, such as the routing of surplus plasma component to plasma fractionation centres, have emerged. The countries have made efforts to initiate national quality management programmes. The majority have reported that national standards have been formulated for the collection, testing, processing, storage and distribution of blood and blood components. These countries continue to have technical support for quality practices from WHO and other international agencies/organizations. A system for the accreditation of blood centres was present in about a quarter of the countries. A national quality management system for the blood transfusion services, with designated staff, should be established at the level of the central/ ministerial unit managing the services. There is a need to define and follow through directions for quality practices and monitoring and feedback mechanisms at different levels of organization and implementation. 3. blood ColleCTIoNS Seven countries continued to have less than 10 donations per 1000 population during 2011–2015. There is a need to increase the total blood collection in the region. From 2012–2013, the total blood collection increased from14.25 to 14.85 million units, with the population in the region being 1861.7 million in 2012 and 1883.6 million in 2013. There was a shortfall of 4.4 million in 2012 and 4.0 million in 2013. Voluntary non-remunerated blood donations in the countries varied from 28.3% to 100%. They formed more than 90% of the total collections D I S C U S S I O N S A N D R E C O M M E N D A T I O N S 44 only in six countries. The rest of the countries were largely dependent on replacement/family donations. It is necessary to augment the national blood donor programme and ensure effective networking and communication strategies to motivate, recruit and retain donors. Budget allocation for the national donor programme had been made in eight countries. It is essential to identify factors restricting voluntary blood donation and to devise strategies to overcome these factors, which may be region/country-specific. It was heartening to observe that there was a significant proportion of repeat voluntary non-remunerated donors and a rising trend in the number of such donors in five countries. The celebration of World Blood Donor Day should be followed by activities to encourage healthy adults to donate blood regularly. Male donors outnumbered female donors in most countries. Low haemoglobin seems to be a contributory factor. Iron deficiency anaemia is prevalent in this region, especially among women in the reproductive age group. This contrasts with the male: female donor ratio, which is almost one, in developed countries because the nutritional status of women is better. In developing countries, a significant proportion of the donor base is thus not available, often due to easily preventable causes. 4. SCreeNINg oF doNATed blood For TrANSFuSIoN- TrANSmISSIble INFeCTIoNS All the countries in the region were screening 100% of whole blood donations for TTIs of global concern: HIV, HBV, HCV and syphilis. As screening tests, immunoassays were being performed for HIV and HCV antibody detection, and HBsAg testing for HBV. In some countries, a combination of antigen and antibody testing has been introduced for HIV and HCV. Confirmatory tests have been implemented in seven countries and one country also had NAT screening for HIV, HBV and HCV for all donations. Three countries where malaria is endemic reported that all donations were being screened for malaria. Although the reports indicate screening of all donations, the data capture information on 60–100% of total blood collections in various countries, and one must be cautious about assuming 100% screening in cases in which total donations are not covered in the report. Quality-assured screening for TTIs was reported consistently for five years by three countries, and by 2014/2015 by another four countries. There seems to be a steady improvement in quality practices for screening for infectious markers. Since the prevention of TTIs is critical for safe blood transfusion, it is necessary for the remaining countries to strengthen quality assurance in laboratory testing. This assumes further significance in view of the seroprevalence data for these infections in some of the countries in the region and also, the fact that seroreactivity was the most significant factor for the discard rate of blood. Rapid tests were still in use in five countries. S E C T I O N 7 45 5. ProCeSSINg oF whole blood doNATIoNS INTo ComPoNeNTS All 11 countries (100%) had facilities for the separation of components, though the percentage of whole blood separated into components varied from 18.1 to 100 in different countries. Of the eight countries which separated less than 90% of whole blood donations, four showed a rising trend in the preparation of components. This is an encouraging trend as it will not only pave the way for the judicious use of blood, but will also gradually help make it possible to make available plasma for plasma fractionation into plasma-derived medicinal products, which are in scarce supply in most of the SEA Region countries. There was no survey on the quality of blood components, but in subsequent years, it would be beneficial to assess the proportion of blood components that meet the requisite quality control criteria in the interest of clinical efficacy. 6. ClINICAl uSe oF blood The proportion of whole blood to packed red cell use varied widely, ranging from 9:1 to 1:14.6. Appropriate clinical use is an important component of blood safety. Separation of blood components is an important tool, but guidelines on clinical usage and continuing education programmes for clinical personnel are equally important. All countries had educational opportunities for the personnel of blood centres, but awareness needs to be generated among clinicians and the prescribers of blood and blood products as well. Further, they will benefit from educational programmes on evidence-based guidelines for clinical transfusion practices and early recognition of adverse events and their management. The developed countries are establishing patient blood management programmes. Hospital transfusion committees could be effective in improving clinical transfusion practices, but only 6 (54.5%) of the 11 countries reported having hospital transfusion committees. That too, the number was variable among the countries – scant (3.5% of hospitals) to 100% (all hospitals). The constitution of hospital transfusion committees needs to be strengthened. D I S C U S S I O N S A N D R E C O M M E N D A T I O N S 46 Conclusion Blood transfusion is an integral constituent of health care delivery, hence an adequate, accessible, safe and quality blood supply is necessary to support a good health care system. Blood transfusion services consist of a complex chain with vital links from the blood donor to the recipient of the transfusion. There are multiple stakeholders involved in effective blood transfusion services, as also many processes for the operationalization of effective services. The complexity of the service necessitates government commitment, in the form of a nationally coordinated blood transfusion service, a national blood policy and legislation to support the policy. The extent of government commitment in the 11 countries is definitely encouraging, but resource allocation needs to be augmented. Till then, they will have to rely on WHO and other international agencies. There has been a steady increase in total collections and also in voluntary non-remunerated blood donations in most of the countries. Not only has the recruitment of non-remunerated blood donors been showing a rising trend, but the retention of blood donors as regular repeat voluntary donors is also evident. Hence, a safe donor base is being built up, though the proportion varies across the countries. The coverage of screening of all donated units for TTIs has increased to 100%, but the reports do not necessarily capture information on all donations in the country. National reporting systems need to be strengthened and there is still scope for improvement in quality-assured screening for the infectious markers. There has been a rising trend in the separation and use of components in the region. Most countries have national guidelines on clinical use of blood and blood components, but the monitoring mechanisms, including haemovigilance, are not adequate. There are opportunities for educational programmes and capacity-building for blood centre personnel, but continuing education programmes are required for the clinical staff to update them on evidence- based transfusion guidelines. The region reflects the traditional practice of developing blood centres as blood banks, linked to the point of demand – the hospital. Most developed nations have moved from this model to one in which collection and production under Good Manufacturing Program (GMP) conditions have improved substantially because of delinking from the hospital; this system also allows one to address distribution efficiencies, thus ensuring access to quality-assured blood. In conclusion, this five-year WHO survey of the 11 SEAR countries has shown that there has been an improvement in several areas of blood safety and availability, though there is considerable variation between the countries. Government support, technical support and judicious blood use need to be strengthened further to address the continuing challenges. 47 Annexes Annex 1a. details of funding from various sources for blood transfusion services Country estimated total funding (in uS$) for operating blood centres estimated total direct funding (in uS$) to bTS from the national government estimated total funding [from fees and cost recovery] (in uS$) estimated total funding from external donors (in uS$) Bangladesh 2011 N/A N/A N/A N/A 2012 N/A N/A N/A N/A 2013 N/A N/A N/A N/A 2014 N/A N/A N/A N/A 2015 N/A N/A N/A N/A Bhutan 2011 N/A N/A N/A N/A 2012 N/A N/A N/A N/A 2013 N/A N/A N/A N/A 2014 N/A N/A N/A N/A 2015 N/A N/A N/A N/A Democratic People’s Republic of Korea 2011 N/A N/A N/A N/A 2012 N/A N/A N/A N/A 2013 N/A N/A N/A N/A 2014 2015 India 2011 2012 140 000 000 25 000 000 2013 8 458 000 000 25 000 000 2014 11 340 000 000 25000000 0 0 2015 Indonesia 2011 15 524 700 2012 12 462 000 2013 135 300 000 12 300 000 123 000 000 2014 2015 48 Country estimated total funding (in uS$) for operating blood centres estimated total direct funding (in uS$) to bTS from the national government estimated total funding [from fees and cost recovery] (in uS$) estimated total funding from external donors (in uS$) Maldives 2011 130 000 2012 1 000 000 1 000 000 6 ,000 2013 2014 1 100 000 1 100 000 10 000 2015 1 111 000 1 111 000 0 1 111 000 Myanmar 2011 1 417 570 35 200 843,128 539 242 2012 2 065 200 465 200 1 150 000 450 000 2013 2 065 200 465 200 1 150 000 450 000 2014 2 065 200 465 200 1 150 000 450 000 2015 615 000 615 000 0 0 Nepal 2011 2012 800 000 0 700 000 100 000 2013 2 000 000 2 000 000 100 000 2014 2 200 000 0 2 000 000 200 000 2015 2 000 000 0 1 900 000 100 000 Sri Lanka 2011 2012 13 853 2013 2014 3761 2015 8 663 539 0 1951 Thailand 2011 50 468 426 13 855 183 36 613 243 2012 60 226 676 13 077 380 47 149 296 2013 2014 24 351 265 14 650 027 25 374 046 18 655 631 2015 318 000 000 4 657 143 16 457 143 10 685 714 Timor-Leste 2011 2012 2013 100 100 100 100 2014 2015 Data is either not available or only partially submitted. A N N E x 1 A 49 Annex 1b details of government funding for blood transfusion services [Country does the government budget include a specific line item for the NbTS/ blood transfusion services within the ministry of health or another government entity Is there a system of cost- recovery for NbTS/ blood transfusion services- (e.g. via health insurance schemes, direct payments, such as user fees, etc.) Bangladesh 2011 Yes Yes 2012 Yes Yes 2013 Yes Yes 2014 Yes Yes 2015 Yes Yes Bhutan 2011 Yes No 2012 No No 2013 Yes No 2014 No No 2015 No No Democratic People’s Republic of Korea 2011 Yes N/A 2012 Yes No 2013 Yes No 2014 2015 India 2011 Yes Yes 2012 Yes Yes 2013 Yes Yes 2014 Yes Yes 2015 Indonesia 2011 Yes Yes 2012 Yes Yes 2013 Yes Yes 2014 Yes Yes 2015 Yes Yes Maldives 2011 N/A N/A 2012 Yes Yes 2013 Yes No 50 2014 N/A N/A 2015 Yes Yes Myanmar 2011 No Yes 2012 Yes Yes 2013 Yes Yes 2014 Yes No 2015 Yes No Nepal 2011 N/A Yes 2012 N/A Yes 2013 No Yes 2014 No Yes 2015 No Yes Sri Lanka 2011 Yes No 2012 Yes No 2013 Yes No 2014 Yes No 2015 Yes No Thailand 2011 Yes Yes 2012 Yes Yes 2013 N/A Yes 2014 Yes Yes 2015 Yes Yes Timor-Leste 2011 2012 Yes No 2013 Yes No 2014 N/A N/A 2015 N/A N/A data is either not available or only partially submitted. A N N E x 1 B 51 Annex 2 International organizations which provided financial assistance to the blood transfusion services of the SeAr countries Country International organizations Bangladesh 2011 2012 World Bank, WHO, OFID, CIDA 2013 World Bank, DFID 2014 WHO, World Bank, DFID 2015 WHO, World Bank, DFID Bhutan 2011 OFID and WHO 2012 WHO and OFID 2013 WHO and OFID 2014 WHO/OFID 2015 WHO/OFID Democratic People’s Republic of Korea 2011 WHO 2012 WHO 2013 2014 2015 India 2011 2012 2013 2014 2015 Indonesia 2011 Australian Red Cross 2012 2013 2014 2015 Maldives 2011 2012 WHO 2013 WHO 2014 WHO 2015 WHO Myanmar 2011 JICA, Thai Red Cross 2012 National AIDS Project , Thai Red Cross 52 Country International organizations 2013 National AIDS Project , Thai Red Cross 2014 2015 Nepal 2011 WHO/OFID, Japanese Red Cross, Red Cross National Societies 2012 Luxembourg Red Cross, Global Fund , OFID, WHO 2013 International Red Cross societies, Global Fund, UNDP, Global Advisory Panel, DFID , WHO, KOICA, etc., for short-term projects 2014 IFRC, Red Cross national societies, Global Fund, GAP Australia, Haukeland University Hospital, Norway , Nepal government as activities-based project on and off, American Embassy, Nepal 2015 Short-term projects, WHO Sri Lanka 2011 2012 WHO 2013 WHO 2014 WHO 2015 WHO Thailand 2011 2012 2013 2014 2015 Timor-Leste 2011 2012 WHO and Division of Global Fund 2013 WHO Regional Timor-Leste, Division of Global Fund 2014 2015 data is either not available or only partially submitted. A N N E x 2 53 Annex 3 Information on regulatory systems for blood transfusion services in the countries Country National standards for the collection, testing, processing, storage and distribution of blood and blood components System of regular inspection(s) of the NbTS/blood transfusion service(s) by the national regulatory agency or another entity System of licensing of the NbTS/ blood transfusion service(s) by the national regulatory agency or another entity Accredition of NbTS/ blood transfusion service(s) Bangladesh 2011 Yes Yes Yes 2012 Yes Yes Yes No 2013 Yes Yes Yes No 2014 N/A Yes Yes No 2015 Yes Yes Yes No Bhutan 2011 Yes No No 2012 Yes No No No 2013 Yes Yes Yes No 2014 Yes No No No 2015 Yes No No No Democratic People’s Republic of Korea 2011 Yes Yes Yes 2012 Yes Yes Yes Yes 2013 Yes Yes Yes No 2014 2015 India 2011 N/A Yes Yes 2012 Yes Yes Yes Yes 2013 Yes Yes Yes Yes 2014 Yes N/A Yes Yes 2015 Indonesia 2011 Yes No No 2012 No No No No 2013 No No No No 2014 Yes No Yes No 2015 Yes No Yes No 54 Country National standards for the collection, testing, processing, storage and distribution of blood and blood components System of regular inspection(s) of the NbTS/blood transfusion service(s) by the national regulatory agency or another entity System of licensing of the NbTS/ blood transfusion service(s) by the national regulatory agency or another entity Accredition of NbTS/ blood transfusion service(s) Maldives 2011 No No No 2012 No No No N/A 2013 Yes No No No 2014 N/A N/A N/A N/A 2015 Yes No No No Myanmar 2011 Yes No No 2012 Yes Yes No No 2013 Yes Yes No No 2014 Yes N/A Yes No 2015 Yes No No No Nepal 2011 Yes Yes Yes 2012 No No No No 2013 Yes Yes Yes No 2014 Yes Yes Yes No 2015 Yes Yes Yes No Sri Lanka 2011 Yes No No 2012 Yes No No Yes 2013 Yes No No Yes 2014 Yes No No Yes 2015 Yes No No Yes Thailand 2011 Yes N/A N/A 2012 Yes Yes No Yes 2013 Yes Yes No Yes 2014 Yes Yes No Yes 2015 Yes Yes No Yes Timor-Leste 2011 2012 Yes Yes Yes No 2013 N/A Yes Yes Yes 2014 N/A N/A N/A N/A 2015 N/A N/A N/A N/A data is either not available or only partially submitted. A N N E x 3 55 Annex 4 National quality assurance schemes and external technical support Country Provision of technical support to the blood transfusion services by international agency/ organization/ institution Name of the international agency/organization National external quality assessment scheme for laboratory screening for transfusion- transmissible infections National external quality assessment scheme for blood group serology and compatibility testing Bangladesh 2011 Yes WHO Yes No 2012 Yes WHO Yes 2013 Yes WHO Yes Yes 2014 Yes WHO No No 2015 N/A No No Bhutan 2011 Yes WHO Yes Yes 2012 Yes WHO Yes Yes 2013 N/A Yes Yes 2014 No Yes Yes 2015 No Yes Yes Democratic People’s Republic of Korea 2011 Yes WHO, IFRC No No 2012 Yes WHO No No 2013 Yes WHO No No 2014 2015 India 2011 No No No 2012 No Yes Yes 2013 Yes Christian Medical Association of India with the support of CDC, US, WHO Country Office Yes Yes 2014 Yes Christian Medical Association of India with the support of CDC, US, WHO Country Office Yes Yes 2015 Indonesia 2011 Yes Australian Red Cross; WHO Yes Yes 2012 Yes WHO Yes No 2013 Yes Australian Red Cross; WHO Yes No 56 Country Provision of technical support to the blood transfusion services by international agency/ organization/ institution Name of the international agency/organization National external quality assessment scheme for laboratory screening for transfusion- transmissible infections National external quality assessment scheme for blood group serology and compatibility testing 2014 No Yes Yes 2015 No Yes Yes Maldives 2011 No No No 2012 No Yes No 2013 Yes WHO Yes No 2014 Yes WHO 2015 Yes WHO Yes No Myanmar 2011 Yes NRL (Australia); SIF Singapore; JICA Yes Yes 2012 Yes JICA,NRL (Australia), SIF (Singapore) Yes No 2013 Yes JICA , NRL (Australia), SIF (Singapore) Yes No 2014 Yes NRL Australia, THAI Red Cross Society, Singapore International Foundation, JICA, NHS UK Yes No 2015 Yes NRL (Australia), NCGM Japan, NHS UK Yes No Nepal 2011 Yes WHO/OFID, Japanese Red Cross, NRL (Australia), Red Cross national societies Yes No 2012 Yes WHO, Japanese Red Cross, Luxembourg Red Cross, Nepal Government Yes No 2013 Yes WHO, Global Advisory Panel, Japanese Red Cross, Australian Red Cross, Luxembourg Red Cross, etc. Yes No 2014 Yes WHO, Japanese Red Cross, GAP Australia, Haukeland University Hospital, Norway Yes No 2015 Yes WHO, GAP, Japanese Red Cross, Thai Red Cross, HUH Norway , Australian Red Cross, etc. Yes Not answered Sri Lanka 2011 Yes WHO Yes Yes 2012 Yes WHO, SAATM, ISBT Yes Yes A N N E x 4 57 Country Provision of technical support to the blood transfusion services by international agency/ organization/ institution Name of the international agency/organization National external quality assessment scheme for laboratory screening for transfusion- transmissible infections National external quality assessment scheme for blood group serology and compatibility testing 2013 Yes WHO, SAATM,ISBT Yes Yes 2014 Yes WHO, AATM, ISBT Yes Yes 2015 Yes WHO, AATM, ISBT Yes Yes Thailand 2011 Not answered Yes Yes 2012 No Yes Yes 2013 Not answered Yes Yes 2014 No Yes Yes 2015 No Yes Yes Timor-Leste 2011 2012 Yes WHO and Division of Global Fund Yes Yes 2013 Yes Timor-Leste Red Cross (CVTL) for mobilization of community for blood donation Yes Yes 2014 No response 2015 No response data is either not available or only partially submitted. A N N E x 4 58 Annex 5 Percentage coverage of screening of blood donation for transfusion-transmissible infections Country Number of donations (whole blood and apheresis) screened for transfusion- transmissible infections Percentage (%) of donations (whole blood and apheresis) screened for hIv 1+2 Percentage (%) of donations (whole blood and apheresis) screened for hepatitis b Percentage (%) of donations (whole blood and apheresis) screened for hepatitis C Percentage (%) of donations (whole blood and apheresis) screened for syphilis Percentage (%) of donations (whole blood and apheresis) screened for malaria Bangladesh 2011 415 372 100 100 100 100 2012 593 774 100 100 100 100 100 2013 100 100 100 100 100 2014 651 718 100 100 100 100 100 2015 46 100 100 100 100 100 Bhutan 2011 8175 100 100 100 100 6 2012 6615 100 100 100 100 15 2013 8854 100 100 100 100 23.02 2014 9375 100 100 100 100 23 2015 8794 100 100 100 100 23 Democratic People’s Republic of Korea 2011 98 080 100 100 100 100 24 2012 101 357 100 100 100 100 16.5 2013 99 200 100 100 100 100 2014 2015 India 2011 2012 9 807 953 100 100 100 100 100 2013 9 807 953 100 100 100 100 100 2014 10 838 383 100 100 100 100 100 2015 Indonesia 2011 2 310 561 99.9930758 99.98169403 99.91673595 99.950535 2012 2 538 314 100 100 100 100 3.78877 2013 2 722 758 100 100 100 100 3.658 2014 3 043 194 100 100 100 100 100 2015 2 860 082 100 100 100 100 100 Maldives 2011 12 910 100 100 99.98 99.96 59 Country Number of donations (whole blood and apheresis) screened for transfusion- transmissible infections Percentage (%) of donations (whole blood and apheresis) screened for hIv 1+2 Percentage (%) of donations (whole blood and apheresis) screened for hepatitis b Percentage (%) of donations (whole blood and apheresis) screened for hepatitis C Percentage (%) of donations (whole blood and apheresis) screened for syphilis Percentage (%) of donations (whole blood and apheresis) screened for malaria 2012 7747 100 100 100 100 2013 5826 100 100 100 100 2014 10 651 100 100 100 100 2015 9761 100 100 100 100 Myanmar 2011 197 482 100 100 100 100 2012 208 008 100 100 100 100 0 2013 266 540 100 100 100 100 2014 313 662 100 100 100 100 0 2015 379 088 100 100 100 100 0 Nepal 2011 177 195 100 100 100 100 0 2012 189 321 100 100 100 100 2013 201 122 100 100 100 100 2014 217 160 100 100 100 100 2015 231 000 100 100 100 100 Sri Lanka 2011 330 200 100 100 100 100 100 2012 351 605 100 100 100 100 100 2013 380 808 100 100 100 100 100 2014 381 685 100 100 100 100 100 2015 397 034 100 100 100 100 100 Thailand 2011 591 192 100 100 100 100 2012 616 527 100 100 100 100 2013 100 100 100 100 2014 638 117 100 100 100 100 2015 665 920 100 100 100 100 Timor-Leste 2011 2012 1937 100 100 100 100 0 2013 16 100 100 100 100 0 2014 2015 data is either not available or only partially submitted. A N N E x 5 60 Annex 6 Percentage of blood donations screened for transfusion- transmissible infections in a quality-assured manner Country hIv 1+2 (%) hbv (%) hCv (%) Syphilis (%) Bangladesh 2011 2012 24.04 24.04 24.04 24.04 2013 2014 2015 100 100 100 100 Bhutan 2011 49 49 49 49 2012 62.3 62.3 62.3 62.3 2013 100 100 100 100 2014 100 100 100 100 2015 100 100 100 100 Democratic People’s Republic of Korea 2011 2012 2013 2014 2015 India 2011 2012 2013 2014 2015 Indonesia 2011 2012 2013 100 100 100 100 2014 2015 Maldives 2011 25 25 25 25 2012 100 100 100 100 2013 100 100 100 100 2014 100 100 100 100 2015 Myanmar 61 2011 100 17.9 17.9 64.6 2012 100 19 19 19 2013 100 28.9 28.9 100 2014 100 100 100 100 2015 100 16.5 16.5 100 Nepal 2011 100 100 100 100 2012 42 42 42 42 2013 94.47002 94.47002 94.47002 94.47002 2014 87 87 87 87 2015 100 100 100 100 Sri Lanka 2011 100 100 100 100 2012 100 100 100 100 2013 100 100 100 100 2014 100 100 100 100 2015 100 100 100 100 Thailand 2011 100 100 100 100 2012 100 100 100 100 2013 100 100 100 100 2014 100 100 100 100 2015 100 100 100 100 Timor-Leste 2011 2012 100 100 100 100 2013 0.6 0.6 0.6 0.6 2014 2015 data is either not available or only partially submitted. A N N E x 6 62 Annex 7 Prevalence of infections in blood donations Country Prevalence ( %) of hIv 1+2 Prevalence ( %) of hepatitis b Prevalence ( %) of hepatitis C Prevalence ( %) of syphilis Prevalence ( %) of malaria Bangladesh 2011 0.005 1.048 0.065 0.043 0.009 2012 2013 0.01 0.87 0.1 0.1 0.02 2014 0.01 0.84 0.07 0.11 0.007 2015 0.01 0.8 0.11 0.09 0.01 Bhutan 2011 0.02 0.62 0.04 1.27 2012 0.04 0.88 0.03 0.77 2013 0.07 0.94 0.16 0.6 0 2014 0.07 0.75 0.29 1.25 0 2015 0.034 0.75 0.08 1.57 0 Democratic People’s Republic of Korea 2011 0.73 0.1 0.02 2012 0.735 0.115 0.021 2013 0.79 0.129 2014 2015 India 2011 2012 0.2 1.1 0.4 0.2 0.1 2013 0.2 1 0.4 0.2 0.1 2014 0.14 0.85 0.33 0.19 0.8 2015 Indonesia 2011 0.0290 1.649 0.494 0.700 2012 0.0700 1.640 0.400 0.840 0.669 2013 0.224 1.632 0.407 0.830 0.970 2014 0.263 1.519 0.398 0.863 0.646 2015 0.265 1.402 0.400 0.832 0.267 Maldives 2011 2012 0.087 0.413 0.180 0.141 2013 0.02 0.39 0.51 0.2 2014 0.056 0.413 0.563 0.281 2015 63 Country Prevalence ( %) of hIv 1+2 Prevalence ( %) of hepatitis b Prevalence ( %) of hepatitis C Prevalence ( %) of syphilis Prevalence ( %) of malaria Myanmar 2011 0.3 2.67 0.59 0.59 2012 0.28 2.25 0.47 0.63 2013 0.29 2.42 0.5 0.8 2014 0.18 2.39 0.5 0.79 2015 0.2 2.3 0.5 0.9 Nepal 2011 0.15 0.47 0.39 0.37 2012 0.07 0.29 0.3 0.42 2013 0.050 0.293 0.231 0.365 2014 0.03 0.31 0.21 0.38 2015 0.03 0.3 0.22 0.42 Sri Lanka 2011 0.002 0.124 0.312 0.04 0 2012 0.004 0.12 0.3 0.05 0 2013 0.004 0.07 0.25 0.047 0 2014 0.0068 0.1 0.17 0.04 0 2015 0.005 0.1 0.2 0.04 0 Thailand 2011 0.07 0.34 0.09 0.13 2012 0.080 0.350 0.086 0.125 2013 2014 0.09 0.28 0.16 0.1 2015 0.100 0.257 0.157 0.083 Timor-Leste 2011 2012 0.06 0.6 0.02 0.31 0 2013 0.01 0.06 0.001 0.01 0 2014 2015 data is either not available or only partially submitted to gdbS. A N N E x 7 64 Abbreviations and Acronyms Ab Antibody Ag Antigen Anti-HBcAb anti-hepatitis B core antibody EQAS External quality assessment scheme GDBS Global Database on Blood Safety HBsAg hepatitis B surface antigen HBV hepatitis B virus HCV hepatitis C virus HIV human immunodeficiency virus HTLv I/II human T-lymphotropic virus I/II IvIg intravenous immunoglobulin NAT nucleic acid amplification technology NBTS national blood transfusion service NRL national reference laboratory RNA ribonucleic acid SEA South-East Asia TTIs transfusion-transmitted infections VNRD voluntary non-remunerated blood donations WHA World Health Assembly WHO World Health Organization