Global database on blood safety: report 2004–2005

GDBSGlobal Database on Blood Safety Report 2004–2005 WHO/EHT/08.07

GDBS Global Database on Blood Safety Report 2004–2005 Acknowledgement WHO acknowledges with thanks the contribution of ICCBBA to the preparation of this report. © World Health Organization, 2008 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). 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Contents 1 Introduction ........................................................................................................... 1 2 Methods ............................................................................................................ 1 3 Results of the Global Database on Blood Safety survey 2004–2005 .................... 3 3.1 Response rate ............................................................................................... 3 3.2 Organization and management .................................................................... 7 3.2.1 National blood policies, plans and legislative framework .................... 7 3.2.2 Data collection ................................................................................... 8 3.2.3 Costing of blood transfusion services ................................................ 8 3.2.4 Quality systems ................................................................................. 9 3.2.5 Haemovigilance .................................................................................10 3.2.6 Regulation ..........................................................................................10 3.2.7 International support ......................................................................... 13 3.3 Blood supply ................................................................................................ 13 3.4 Blood donors ............................................................................................... 15 3.5 Screening for transfusion-transmissible infections ...................................... 21 3.6 Blood grouping and compatibility testing .................................................... 24 3.7 Blood component preparation, storage and transportation ......................... 25 3.8 Clinical use of blood and blood components ............................................... 28 4 Conclusions ......................................................................................................... 32 4.1 Responses to the survey ............................................................................. 32 4.2 Organization and management ................................................................... 33 4.3 Quality systems ........................................................................................... 33 4.4 Haemovigilance ........................................................................................... 34 4.5 Regulation and inspection ........................................................................... 34 4.6 Blood donations ........................................................................................... 34 4.7 Blood donors ............................................................................................... 35 4.8 Screening for transfusion-transmitted infections ........................................ 36 4.9 Blood grouping ............................................................................................ 36 4.10 Storage and transportation .......................................................................... 37 4.11 Appropriate clinical use of blood ................................................................. 37 5 Appendix: Questionnaire 11 Introduction More than 30 years after the first World Heath Assembly resolution (WHA28.72) that addressed the issue of blood safety, blood transfusion services continue to face the dual problem of providing both a sufficient and a safe supply of blood to patients throughout the world. Although evidence-based strategies for blood safety and availability, of proven effectiveness, have been implemented in most developed countries, many countries with economies in transition and developing countries are making slow progress towards their achievement. This is the third report on the global situation of blood safety, the two previous reports having been based on data collected in 1998–1999 and 2001–2002. Much has been done to improve blood safety, in particular by better screening for transfusion-transmissible infections and a marked shift towards voluntary, non- remunerated blood donation. Even at the mid-point in the United Nations Millennium Project, however, equitable access to safe blood and blood products and rational and safe use of blood transfusion still remain major challenges throughout the world. Urgent, renewed action to ensure universal access is essential in order to achieve the health- related Millennium Development Goals to reduce child mortality, improve maternal health and combat HIV/AIDS and to provide effective support to health care in a range of clinical disciplines that depend on the availability of a safe, sufficient blood supply. 2 Methods Data for the Global Database on Blood Safety (GDBS) 2004–2005 were provided by countries as responses to a structured, closed questionnaire (see Appendix 1) based on the strategy for blood safety and availability advocated by the World Health Organization (WHO). The questionnaire was prepared in printed form in the six official languages of WHO (Arabic, Chinese, English, French, Russian and Spanish) and was distributed in 2005 to national health authorities. An electronic form of the questionnaire was tested in English only. National health authorities in all 194 WHO Member and Associate Member States (as of 2005) were asked to have the questionnaire completed by an authorized person in the ministry of health or the institution responsible for organizing transfusion services in the country. Responses were requested by November 2005; however, many countries required much more time to collect the information. The data submitted have not been independently verified, and their accuracy depends on the data collection 2systems in the Member States. The numbers of responses to the different questions varied considerably, making it difficult to build an overall picture. The report indicates the total number of responses to each question. The questionnaire contained various types of question, with responses permitted as ‘Yes/No’ or ‘Yes/Partial/No’, numerical data, percentages or selection from a list of options. Population numbers and human development indexes (HDIs) for each country were drawn from the United Nations Human development report 20061. The HDI categories are shown in Table 1. For the 19 countries with no HDI classification, a category was assigned on the basis of other indices, solely for the purposes of this analysis; this categorization does not represent any judgement concerning their human development status. Distribution of WHO Member or Associate Member States (as of 2005) by human development index (HDI) category HDI category No. of countries in HDR 2006 (data for 2004) No. for which category was assigned Total No. of responses High 62 3 65 59 Medium 82 10 92 82 Low 31 6 37 31 Total 175 19 194 172 Human development report 2006. United Nations Development Programme. The HDI of 21 countries had changed since the previous survey: 10 countries had changed from medium to high, and 8 countries from low to medium; 3 countries had changed from medium to low. Most of the global results are presented by HDI category. When trends are shown, they are based on comparisons with the results of the previous GDBS surveys, in 1998–1999 and 2001–2002. Where appropriate, numerical results have been rounded according to standard conventions. This occasionally meant that the sum of figures differed from the total by 1 in the last decimal place. 1 http://hdr.undp.org/en/media/HDR06-complete.pdf Table 1 310 70,1 19,9 7,2 68,8 19,1 0 10 20 30 40 50 60 70 80 Low Medium High P er ce n ta g e o f g lo b al p o p u la ti o n HDI 3 Results of the Global Database on Blood Safety survey 2004–2005 3.1 Response rate The questionnaire was completed by 172 of the 194 WHO Member and Associate Member States, representing a population of 6061 million, or approximately 95% of the world population (6370 million). The population covered by the responding countries was distributed across the HDI categories as shown in Figure 1. Although 95% of the global population was covered by the responses received, only 72% of the population in low-HDI regions was represented. As the aim of the Global Database is to provide the most comprehensive picture possible of the situation, any lack of information is disappointing. Most of the non- responders to the questionnaire had responded in previous years, suggesting that at least some of the information was available in those countries. Underrepresentation of populations living in low-HDI countries in particular (27.5% compared with 4.9% overall) is an ongoing problem. Responses to the survey, by HDI category Although the overall number of responding countries was similar to that in the previous survey, the composition had changed, such that some countries that reported in 2002 did not report in 2004, while some that did not report in 2002 reported in 2004 (Table 2). This change in profile, linked to their changing HDI profile, should be taken into Total population Population covered by survey Figure 1 4account in comparing the outcomes of the different surveys to determine trends, in analysing the information returned and in drawing conclusions. In the 2001–2002 survey, 14 countries did not respond (1 high-HDI, 10 medium-HDI and 3 low-HDI). In the current survey, there were 22 non-responding countries (6 high-HDI, 10 medium-HDI and 6 low-HDI; Table 2). Two countries did not respond to either survey. Non-responding countries by survey 2001–2002 (n = 14) 2004–2005 (n = 22) Bangladesh Andorra Bhutan Azerbaijan Cyprus Bahrain Ethiopia Barbados Libyan Arab Jamahiriya Belarus Malawi Djibouti Maldives Equatorial Guinea Nauru Georgia Nepal Iceland Saudi Arabia Israel Somalia Lebanon Syrian Arab Republic Liberia Tunisia Libyan Arab Jamahiriya Tuvalu Niger Nigeria Puerto Rico São Tomé and Principe Somalia Spain Turkmenistan Ukraine Yemen Table 2 5134 142 157 175 178 172 0 20 40 60 80 100 120 140 160 180 200 1988–1999 2001–2002 2004–2005 N o . o f co u n tr ie s Survey year Countries were asked to state whether they were reporting national data or, if not, the approximate percentage of the blood programme activities at country level that their response covered. In 1998–1999, 134 (78%) countries reported national data on blood transfusion services; the remainder were able to provide data only for selected centres in the main cities. The situation improved slightly to 142 (80%) countries in 2001–2002, and a similar trend was noted in 2004–2005, when 157 of the 172 countries that responded (91%) were able to report national data on blood transfusion services (Figure 2 and Table 3). Countries that provided responses covering less than 45% of the national programme were not included in the analysis. Blood collection figures for countries not reporting national data were adjusted to reflect the national picture. National data coverage in the different surveys National coverage Low HDI Medium HDI High HDI Total No. of non-responders 6 10 6 22 No. of countries reporting on 45–99% of blood programme 5 6 4 15 No. of countries reporting national data 26 76 55 157 Total 37 92 65 194 No. of countries with national coverage No. of countries responding Figure 2 Table 3 6This report is based on responses from 172 of the 194 WHO Member and Associate Member States. The 22 states that did not respond are listed in Table 2 above, and their combined population by HDI group is shown in Table 4. Populations not represented in this report HDI Countries and populations not represented in this survey WHO Member and Associate Member States and global population Population not represented (%) No. of countries Population (million) Total no. of countries Population (million) Low 6 174.5 92 634.1 27.5 Medium 10 84.4 37 4468.3 1.9 High 6 50.6 65 1267.9 4.0 Total 22 309.5 194 6370.3 4.9 The responses were well distributed across the six WHO regions (Figure 3). Responses by WHO region The numbers of countries responding to the three surveys carried out so far are summarized in Figure 4. Low HDI Medium HDI High HDI Table 4 Figure 3 26 1 1 0 1 2 13 20 10 11 10 18 2 13 4 32 0 8 0 5 10 15 20 25 30 35 African region 41/46 Americas region 34/36 Eastern Mediterranean region 15/21 European region 43/52 South-East Asia region 11/11 Western Pacific region 28/28 N o . o f co u n tr ie s 741 36 31 89 88 82 45 54 59 0 10 20 30 40 50 60 70 80 90 100 1998–1999 (n = 175) 2001–2002 (n = 178) 2004–2005 (n = 172) N o . o f co u n tr ie s Survey Responses to different surveys, by HDI Low HDI Medium HDI High HDI 3.2 Organization and management 3.2.1 National blood policies, plans and legislative framework A unit within the ministry of health with responsibility for the national blood programme existed in 110 of 153 (72%) countries. A further 11 (7%) were setting up such a unit. In 64 of 98 (65%) countries, there was a designated national blood programme manager, and a further seven countries (7%) were designating such a person. In 80 of 123 (65%) countries, there was a national blood authority, commission or equivalent, and a further nine countries (7%) indicated that such a body was to be established. These figures are similar to those reported in 2001–2002. In 97 of 161 (60%) countries, a national blood policy was in place, and 35 (22%) were in the process of drawing up a policy; the remaining 29 (18%) had no national policy. In 69 of 131 (52.7%) countries, plans were in place for implementing the policy, and a further 31 (23.7%) countries were drawing up national blood plans; 31 (23.7%) countries had no plans. National legislation covering blood transfusion existed in 82 of 155 (53%) countries; a further 31 (20%) were drawing up legislation, and 42 (27%) had none. A national advisory committee or expert panel on blood transfusion existed in 63 of 126 (50%) countries; a further 20 (16%) were setting up such a group, and 43 (34%) had no such committee or panel. 999 ( ) ( 1 ) Figure 4 811 32 37 5 11 28 12 6 0,0 0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1,0 L M H P er ce n ta g e HDI There was a specific organization responsible for blood transfusion in 87 of 128 (68%) countries, and a further 16 (12%) were setting up a service. These are similar to the proportions in 2001–2002. Information on the numbers of blood collection facilities and the numbers of blood donations collected in such facilities in countries is not available at global level, making it difficult to assess the efficiency of blood transfusion services. Attempts are being made to collect this information in future surveys. 3.2.2 Data collection Countries were asked to indicate whether they had a centralized system for data collection and analysis for the national blood transfusion service. Of the 124 countries that responded, 80 (65%) reported that such a system was in place, and a further 18 (15%) reported that a system was being set up. The distribution by HDI is shown in Figure 5. Existence of a centralized system for data collection, by HDI 3.2.3 Costing of blood transfusion services In 66 of 126 (52%) countries, there was a mechanism for calculating the cost of operating the blood transfusion service. In 81 of 155 (51%) countries, a specific national budget had been provided, and 43 of 95 (45%) countries had a cost recovery system in place. Low (n = 24) Medium (n = 55) High (n = 45) Yes Under way No Figure 5 0 90 80 70 60 50 40 30 20 10 0 9The cost of producing a unit of whole blood with red blood cells (including donor recruitment, blood collection, testing, processing, storage and distribution) was US$ 20–120 in low-HDI countries, US$ 5–180 in medium-HDI countries and US$ 23–600 in high-HDI countries (Figure 6). Cost of producing a unit of blood, by HDI One outlier, US$ 600 per unit of blood for HDI of 0.871, has been omitted from this chart 0 50 100 150 200 250 300 350 400 0.300 0.400 0.500 0.600 0.700 0.800 0.900 1.000 C o st p er u n it in U S $ HDI value 3.2.4 Quality systems Countries were asked if they had national standards for the collection, storage, processing and issue of blood and blood products. Of the 130 countries that responded, 96 (74%) indicated that they had standards, and a further 23 (18%) were developing national standards. In 61 of 128 (48%) countries there was a national quality manager for the blood transfusion service, and a further 18 (14%) countries were establishing this post. In 81 of 150 (54%) countries there was a system of audit in the national blood transfusion service, and a further 17 (11%) were setting up a system (Figure 7). The use of standard operating procedures could be analysed for only 106 countries, the response rate varying with the type of procedure (Figure 8). Three of the responding countries did not have standard operating procedures for screening for transfusion- transmissible infections, blood grouping or component preparation. Less than 100% of blood centres had standard operating procedures for screening for transfusion- transmissible infections in 19 countries, for blood grouping in 20 countries and for component preparation in 30 countries. Only 92 countries answered the question about national guidelines on waste management. Of these, 55 (60%) had such guidelines, and a further 16 (17%) were Figure 6 10 Existence of quality systems, by HDI Yes Under way No No answer Figure 7 100% < 100% 0 No answer Percentages of centres using standard operating proceduresFigure 8 47 22 36 43 25 38 6 14 7 2 3 4 6 10 7 5 5 6 4 20 13 6 19 25 1 10 14 6 14 6 27 28 12 19 2 4 0 10 20 30 40 50 60 70 80 90 National standards Quality manager System of audit National standards Quality manager System of audit National standards Quality manager System of audit H ig h H D I M ed iu m H D I Lo w H D I No. of countries 44 59 60 60 54 66 68 62 64 53 16 19 20 22 30 20 19 21 20 24 10 6 6 6 3 3 3 4 4 6 36 22 20 18 19 17 16 19 18 23 0 20 40 60 80 100 120 Administration of blood Issue of blood Compatibility testing Blood storage and transportation Blood component preparation Blood group serology Screening for transfusion-transmissible infections Blood collection and donor care Blood donor selection Blood donor recruitment No. of countries 11 1 11 30 3 14 78 23 8 0 5 10 15 20 25 30 35 L M H N o . o f co u n tr ie s HDI in the process of preparing guidelines. A system of regular staff training existed in 92 (71%) of 129 countries, and 15 (12%) were setting up a system. There was an educational programme in blood transfusion medicine and science leading to a nationally recognized university degree or diploma in 47 (49%) of 96 countries, and a further two (2%) were setting up such a programme. 3.2.5 Haemovigilance A national haemovigilance system existed in 42 (40%) of 105 countries, and 24 (23%) were preparing a system. Of the 39 (37%) countries that did not have a national haemovigilance system, 8 were high-HDI countries (Figure 9). 3.2.6 Regulation A mechanism for regulating the national blood transfusion service existed in 67 (53%) of 126 countries, and 24 (19%) were preparing regulations (Figure 10). Of the 67 countries, 64 had a national regulatory authority, 50 reported a system of regular inspection of the blood transfusion services, and 40 had inspectors with specialized training in blood transfusion. Existence of haemovigilance systems, by HDI Yes Under way No Low (n = 12) Medium (n = 48) High (n = 45) Figure 9 12 0 8 31 0 5 0 29 30 9 0 5 10 15 20 25 30 35 L M H N o . o f co u n tr ie s HDI 8 27 32 6 14 4 11 15 9 0 5 10 15 20 25 30 35 L M H N o . o f co u n tr ie s HDI Regulation of blood transfusion services, by HDI Low (n = 25) Medium (n = 56) High (n = 45) Yes Under way No A mechanism for the regulation of fractionated plasma products was present in 39 of 106 countries, and five were setting up a mechanism (Figure 11). Of the 39 countries, 24 had a national regulatory authority, 24 had a system of regular inspection of plasma fractionation facilities, and 14 had inspectors with specialized training in plasma fractionation. Regulation of fractionated plasma products, by HDI Yes Under way No Low (n = 23) Medium (n = 43) High (n = 40) Figure 10 Figure 11 13 10 33 8 2 13 35 0 5 10 15 20 25 30 35 40 45 50 L M H N o . o f co u n tr ie s HDI 3.2.7 International support In this survey, countries were asked for the first time to indicate whether they received technical or financial support from one or more international agencies, organizations or institutions. Of the 101 countries that responded to the question on technical support, 12 were low-HDI, 46 were medium-HDI and 43 were high-HDI countries. Of these, 51 (50%) indicated that they received technical support, 10 being low-HDI, 33 being medium-HDI and 8 being high-HDI countries (Figure 12). Technical support received, by HDI Yes No Low (n = 12) Medium (n = 46) High (n = 43) Of the 92 countries that responded to the question on financial support, 6 were low- HDI, 44 were medium-HDI, and 42 were high-HDI countries. Of these, 26 countries (28%) indicated that they received financial support, 4 being low-HDI and 22 being medium-HDI countries (Figure 13). 3.3 Blood supply A total of 80.7 million donations of blood were collected in 167 countries that reported for 2004–2005; five countries did not give collection figures. There continue to be differences in the level of blood donation among low-, medium- and high-HDI countries, 55% of the global blood supply being donated in high-HDI countries and 45% in developing (medium- and low-HDI) countries, where 80% of the world’s population lives (Figures 14, 15 and 16). Figure 12 14 4 22 2 22 42 0 5 10 15 20 25 30 35 40 45 50 L M H N o . o f co u n tr ie s HDI Financial support received, by HDI Yes No Distribution of donations, by HDI Population distribution, by HDI Low (n = 6) Medium (n = 44) High (n = 42) Figure 13 Figure 14 Figure 15 Low HDI 1% 0.9 million donations High HDI 55% 44.7 million donations Medium HDI 44% 35.1 million donations Low HDI 6% Medium HDI 74% High HDI 20% 15 1 44 55 6 74 20 0 10 20 30 40 50 60 70 80 Low Medium High % HDI Survey population and blood supply Donations Population Analysis of the data by HDI category shows that the average rate of donations per 1000 population was 2.3 (range, 0.3–15.8) in low-HDI, 8.1 (range, 1.1–27.4) in medium- HDI and 36.7 (range, 8.1–69.5) in high-HDI countries (Figure 17 and Map 1). Donations per 1000 population, by HDI Figure 16 Figure 17 0 10 20 30 40 50 60 70 80 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1 N o . o f d o n at io n s p er 1 00 0 p o p u la ti o n HDI 3.4 Blood donors Information on blood donations made by different types of blood donors was provided by 154 countries, accounting for 64.8 million units. Of this total, 51.5 million (79.5%) were from voluntary non-remunerated donors, 11.0 million (17.0%) from family/replacement donors and 2.3 million (3.5%) from paid donors (Figures 18 and 19, Table 5). 16 M ap 1 : B lo od d on at io n pe r 10 00 p op ul at io n, 2 00 4 17 Only 50 countries achieved 100% voluntary non-remunerated blood donation, although these represented 92% of donations in high-HDI countries. The number of countries reporting 100% voluntary non-remunerated donation rose from 39 in 2001–2002 to 50 in 2004, and the number reporting 0–25% fell from 63 to 44 (Map 2, Figure 20). Types of blood donation, by HDI 0 5 10 15 20 25 30 Low Medium High D o n at io n s (m ill io n s) HDI Voluntary non-remunerated Family/replacement Paid Distribution of types of donation, by HDI Figure 18 Figure 19 71,3 68,1 92,1 28,2 25,5 7,5 0,5 6,4 0,4 0,0 0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9 1,0 Low Medium High P er ce n ta g e HDI Voluntary non-remunerated Family/replacement Paid 100 90 80 70 60 50 40 30 20 10 0 18 Type of whole blood donation, by number and percentage and by HDI category Type of whole blood donation Low-HDI countries (n = 27) (millions) Medium-HDI countries (n = 72) (millions) High-HDI countries (n = 55) (millions) Total (millions) Voluntary non-remunerated 0.58 71.3% 22.65 68.1% 28.29 92.1% 51.5 Family/replacement 0.23 28.2% 8.49 25.5% 2.31 7.5% 11.0 Paid 0.004 0.5% 2.14 6.4% 0.13 0.4% 2.3 Total 0.814 100% 33.28 100% 30.73 100% 64.8 Percentages of voluntary non-remunerated blood donations, by HDI, 2001–2002 and 2004–2005 Table 5 Figure 20 Low HDI Medium HDI High HDI 7 17 6 3 4 7 2 3 9 5 29 39 17 20 14 12 7 7 7 8 8 7 3 3 7 7 5 8 34 26 0 10 20 30 40 50 60 70 2004 2002 2004 2002 2004 2002 2004 2002 2004 2002 0– 25 % 26 –5 0% 51 –9 0% 91 –9 9% 10 0% No. of countries 19 M ap 2 : P er ce nt ag e of v ol un ta ry n on -r em un er at ed b lo od d on at io n, 2 00 4 20 0 10 20 30 40 50 60 70 80 1998–1999 2001–2002 2004–2005 P er ce n ta g e Survey The progress in low-HDI countries over the three surveys is notable, with a major transition from family/replacement to voluntary non-remunerated donation and a concomitant reduction in paid donors (Figure 21). Voluntary non-remunerated blood donations in low-HDI countries Paid Family/replacement Voluntary non-remunerated In medium-HDI countries, there has also been a transition from family/replacement to voluntary non-remunerated donation, but the reduction in paid donors seen between 1998–1999 and 2001–2002 has not been sustained (Figure 22). Once again, the transition of some countries between HDI categories may have influenced these figures. Voluntary non-remunerated blood donations in medium-HDI countries Paid Family/replacement Voluntary non-remunerated Figure 21 Figure 22 0 10 20 30 40 50 60 70 80 1998–1999 2001–2002 2004–2005 P er ce n ta g e Survey 21 3.5 Screening for transfusion-transmissible infections As noted above, 125 of 134 countries reported having a national strategy for screening donated blood units for transfusion-transmissible infections, and seven countries reported that a national strategy was being set up; two countries (one medium-HDI and one high-HDI) reported having no national strategy for blood screening. Nine of 114 countries reported having issued blood without screening because test kits or reagents were not available; eight of these were medium-HDI and one a high-HDI country. Information on a national external quality assessment scheme for transfusion- transmissible infections was available from 127 countries, of which 100 (79%) reported a scheme and six (5%) reported they were setting up a scheme. The remaining 21 (16%) had no such scheme. There has been a continuous increase in the number of countries in which the prevalence of transfusion-transmissible infections in the blood donor population is monitored. In this survey, 129 of 172 countries (75%) indicated that a monitoring system was in place, and a further 2 (1%) were setting up a system (Figure 23, Table 6). Countries in which the prevalence* of transfusion-transmissible infections is measured, by HDI * Although the term ‘prevalence’ is used in the questionnaire, many countries do not perform confirmatory testing and thus this figure is not strictly a prevalence rate. In 145 of 172 countries, 100% of blood donations were screened for HIV; in 13 countries, less than 100% were tested, and 14 countries did not answer the question. Of the 13 countries that tested less than 100% of donations, six tested 99% or more, and the remaining seven gave percentages of 98%, 96%, 92%, 92%, 90%, 80% and 60%. Figure 23 0 10 20 30 40 50 60 70 80 90 100 1998–1999 2000–2001 2004–2005 P er ce n ta g e Survey 22 Prevalence (%) of infection in donated blood units, all donors, by HDI HDI High Medium Low Infectious agent No. of countries Max. Min. No. of countries Max. Min. No. of countries Max. Min. HIV 43 0.72 0 65 6.0 0 21 11.00 0.04 HBV 41 5.50 0 67 23.7 0 21 16.20 1.10 HCV 43 1.00 0 62 7.5 0 19 12.00 0 Syphilis 40 2.08 0 62 10.0 0 21 8.23 0 Chagas 8 3.6 0 13 3.3 0 Malaria 7 1.5 0 11 0.2 0 HTLV 23 1.58 0 15 5.0 0 HBV: hepatitis B virus; HCV: hepatitis C virus; HTLV: human T-cell leukaemia virus For the countries reporting 100% HIV testing, a cross-analysis was done against the questions on standard operating procedures and the existence of a national external quality assessment scheme for screening for transfusion-transmissible infections. Of the 145 countries in which 100% HIV screening was conducted, 65 did not answer the question on the use of standard operating procedures, 64 fully used such procedures, 13 implemented procedures in some blood centres, and 3 had no procedures. Of the 145 countries, 37 did not answer the question on whether they had a national external quality assessment scheme for transfusion-transmissible infections; 87 responded ‘Yes’, 6 were setting up a scheme, and 15 did not have one. Only 50 countries had standard operating procedures for transfusion-transmissible infection screening in all centres and participated in a national external quality assessment scheme (Figure 24). Screening of 100% of blood donations for HBV was reported in 140 of 172 countries. One country reported no testing for HBV, 15 countries tested less than 100%, and 16 did not answer the question. Of those countries that tested less than 100%, 10 tested 90% or more, three countries reported testing 80%, and the remaining two countries gave percentages of 10% and 50%. Screening of 100% of blood donations for HCV was reported in 110 of 172 countries. In 37 countries, less than 100% were tested, and 25 countries did not answer the question. Of those countries that tested less than 100%, 15 tested 90% or more. Eight countries reported no testing for HCV, and the remaining 14 gave percentages of 7–80%. Table 6 23 Use of standard operating procedures and a national external quality assessment scheme in countries that perform 100% HIV screening 100% < 100% None No answer Screening of blood donations for syphilis was reported in 130 of 172 countries. Of these, 21 countries tested less than 100%, and 21 countries did not answer the question. Of those countries that tested less than 100%, 8 tested 90% or more. The remaining 13 gave percentages of 1–89%. These results are summarized in Figure 25. The results indicate that 77.3 million of the total of 80.7 million whole blood donations collected globally were tested for HIV. Of the remaining 3.4 million donations, 2.8 million were in countries that did not respond to the question and are therefore of unknown testing status, and 0.6 million were not tested. For HBV, 76.4 million whole blood donations were tested; of the remaining 4.2 million, 4.1 million were of unknown testing status, and 0.1 million were not tested. For HCV, 75.4 million whole blood donations were tested; of the remaining 5.3 million, 4.6 million were of unknown testing status, and 0.7 million were not tested. For syphilis, 75.1 million whole blood donations were tested; of the remaining 5.6 million, 4.8 million were of unknown testing status, and 0.8 million were not tested. On the basis that each whole blood donation should be screened for HIV, HBV, HCV and syphilis, the total number of tests that would be required for 80.7 million whole SOPs: standard operating procedures EQA: external quality assessment Figure 24 50 87 64 6 13 15 3 37 65 0 20 40 60 80 100 120 140 160 Both SOPs and EQA EQA SOPs No. of countries 24 blood donations is 322.8 million. On the basis of the number of whole blood donations and the percentages of donations screened in each country, the calculated number of tests performed was 304.3 million. Of the remaining 18.5 million, 2.2 million tests were not performed, and 16.3 million donations were of unknown testing status. Screening for HIV, HBV, HCV and syphilis 100% testing < 100% testing 0% testing No answer 3.6 Blood grouping and compatibility testing In 85 of 92 countries, there was a national strategy for testing donated units for blood groups; a further four were setting up a strategy, and three countries had no national strategy. ABO cell grouping was performed on 100% of donations in 92 of 95 countries, and the remaining three responses were 95%, 75% and 10%. The countries performing less than 100% ABO cell grouping were all medium-HDI countries. In 48 of 87 countries, ABO cell grouping was done manually (6 high-HDI, 33 medium-HDI, 9 low-HDI), in 24 by a mixture of manual, semi-automated and fully automated methods, and in 15 (13 high-HDI, 2 medium-HDI) countries by fully automated methods. ABO serum grouping was performed on 100% of donations in 72 of 84 countries. The percentages in the remaining 12 responses ranged between 90% and 0%. Of these 12, one country was a low-HDI, 10 medium-HDI and one a high-HDI country. RhD antigen testing was performed on 100% of donations in 87 of 91 countries. The percentages in the remaining four countries were 80%, 50%, 10%, 5%, all with medium HDIs. Figure 25 130 110 140 145 21 29 15 13 8 1 21 25 16 14 0 20 40 60 80 100 120 140 160 180 200 Syphilis HCV HBV HIV No. of countries 25 Red cell antibody screening was performed on 100% of donations in 38 of 70 countries; 10 countries screened less than 1% of donations. The results are shown in Figure 26. Red cell antibody screening Of the 127 countries that responded to the questions on external quality assessment of blood group serology testing, 81 (64%) had an assessment scheme, 8 (6%) were devising one, and 38 (30%) had no scheme. 3.7 Blood component preparation, storage and transportation Blood components were prepared by 100% of blood centres in 47 of 96 (49%) countries. Of these 2 were low-, 16 medium- and 29 high-HDI countries. The results are shown in Figure 27. All whole blood collected was separated into blood components in 27 of 98 (26%) countries. Of these, 3 were medium- and 24 high-HDI countries. The results are shown in Figure 28. National guidelines on the storage of blood and blood components existed in 75 of 96 (78%) countries, with a further 18 (19%) planning such guidelines; three countries had no national guidelines (Figure 29). In 66 of 95 (69%) countries, there were national guidelines on the transportation of blood and blood components, with a further 25 (26%) countries in the process of drawing them up; three countries had no national guidelines (Figure 30). In 39 of 93 (42%) countries, there was a national system for blood stock management. A further 21 (23%) countries were setting up such a system, and 33 countries had no national system (Figure 31). Figure 26 0 5 10 15 20 25 30 35 40 <1 1–19 20–39 40–59 60–79 80–99 100 No. of countries P er ce n ta g e o f d o n at io n s sc re en ed 26 Percentages of blood centres preparing blood components, by HDI Low HDI Medium HDI High HDI Percentages of whole blood separated into blood components, by HDI Low HDI Medium HDI High HDI Figure 27 Figure 28 11 0 0 0 2 12 5 4 7 16 0 1 5 4 29 0 5 10 15 20 25 30 35 40 45 50 0–25 >25–50 >50–90 >90–<100 100 No. of countries B lo o d c en tr es p re p ar in g c o m p o n en ts ( % ) 4 0 0 0 0 10 5 8 24 3 2 0 2 16 24 0 5 10 15 20 25 30 35 40 45 0–25 >25–50 >50–90 >90–<100 100 No. of countries W h o le b lo o d s ep ar at ed ( % ) 27 2 30 34 7 11 7 1 3 0 5 10 15 20 25 30 35 40 45 50 L M H N o . o f co u n tr ie s HDI 3 35 37 7 7 4 2 1 0 5 10 15 20 25 30 35 40 45 50 L M H N o . o f co u n tr ie s HDI National guidelines on blood storage, by HDI Low (n = 10) Medium (n = 44) High (n = 42) Yes Under way No National guidelines on transportation of blood and blood components, by HDI Yes Under way No Low (n = 10) Medium (n = 44) High (n = 41) Figure 29 Figure 30 28 9 34 3010 14 9 5 23 14 0 10 20 30 40 50 60 70 80 L M H N o . o f co u n tr ie s HDI 2 15 22 4 12 5 4 16 13 0 5 10 15 20 25 30 35 40 45 50 L M H N o . o f co u n tr ie s HDI National system of blood stock management, by HDI Low (n = 10) Medium (n = 43) High (n = 40) Yes Under way No 3.8 Clinical use of blood and blood components National guidelines on the appropriate clinical use of blood existed in 73 of 148 countries (49%), and a further 33 (22%) were preparing them; 42 countries had no national guidelines on the appropriate use of blood (Figure 32). National guidelines on appropriate use of blood, by HDI Yes Under way No Low (n = 24) Medium (n = 51) High (n = 73) Figure 31 Figure 32 29 In 50 of 113 countries (44%), 10% or less of blood was transfused as whole blood; 32 of these countries had a high HDI, 16 a medium HDI and 2 a low HDI. In 33 (29%) countries, 80% or more of blood was transfused as whole blood, and in 15 (13%) more than 90% was transfused as whole blood. Of these 33 countries, 11 were medium-HDI and 22 low-HDI countries (Figure 33). Percentages of blood transfused as whole blood, by HDI Only 28 countries provided information on the number of patients who received a transfusion in 2004–2005. The total number was 4.39 million, in 8 countries with a high HDI (1.47 million), 15 with a medium HDI (2.86 million) and 5 with a low HDI (0.06 million). Only 12 countries provided data by sex, showing that, overall, 53% of transfusions were to male patients, with male:female ratios of 50:50 in three high-HDI countries, 61:39 in six medium-HDI countries and 31:69 in three low-HDI countries. Of the 99 countries that responded to the question about the percentage of hospitals with a functioning transfusion committee, 16 (16%) had such a committee in more than 90% of hospitals, 26 had them in 11–90% of hospitals, and 57 countries had transfusion committees in 10% or less. Figure 34 shows the percentages by HDI. More than half the countries that responded did not have transfusion committees in more than 90% of their hospitals, and widespread coverage was found mainly in high-HDI countries. In 36 of 70 (51%) countries, over 75% of hospitals had a system for monitoring post- transfusion reactions, 8 (11%) countries had monitoring in 26–75% of hospitals, and 26 (37%) countries had monitoring in 25% or less of hospitals. In 26 of 60 (43%) countries, over 75% of hospitals had a system for monitoring post-transfusion infections, 6 (10%) had monitoring in 26–75% of hospitals, and 27 (45%) had monitoring in 25% or less of hospitals. Figure 33 0 10 20 30 40 50 60 0–10 11–20 21–30 31–40 41–50 51–60 61–70 71–80 81–90 91–100 N o . o f co u n tr ie s Transfused as whole blood (%) 30 3 14 326 9 22 6 0 5 10 15 20 25 30 35 40 45 L M H N o . o f co u n tr ie s HDI 3 13 2 13 11 22 25 10 0 5 10 15 20 25 30 35 40 45 L M H N o . o f co u n tr ie s HDI Percentages of hospitals with a transfusion committee, by HDI 91–100% 11–90% 0–10% Low (n = 24) Medium (n = 41) High (n = 34) Figure 34 Yes Under way No Low (n = 12) Medium (n = 42) High (n = 38) Figure 35 A national strategy for the provision of fractionated plasma products existed in 49 of 92 countries (53%), and a further 6 were devising a strategy. The other 37 countries had no national strategy (Figure 35). National strategy for the provision of fractionated plasma products, by HDI 31 3 10 20 9 12 3 14 0 5 10 15 20 25 30 35 40 45 50 1 2 3 N o . o f co u n tr ie s HDI Fractionated plasma products can be obtained by in-country fractionation, by importing plasma and by contract. Plasma products were imported in 33 countries, fractionated in the country in 21 and fractionated by contract in 17 (Figure 36). Sources of plasma products, by HDI Imported Fractionated in country Contract fractionation Low (n = 3) Medium (n = 22) High (n = 46) Figure 36 Both excess production of plasma products and areas of acute need are found; however, in some countries excess product is discarded. A surplus of fractionated plasma products in excess of national need was reported by 14 countries: five sold the excess, five discarded it, one sold or discarded it, and three did not specify. The types of plasmapheresis donors (voluntary non-remunerated or paid) are shown in Figure 37. All plasma was obtained from voluntary non-remunerated donors in 28 countries, and another five countries had 80–99% voluntary non-remunerated donors. Four countries used 100% paid donors, two countries had 80–99% paid donors and five others had less than 60% paid plasma donors. 32 0 5 10 15 20 25 30 100 80-99 60-79 < 60 N o . o f co u n tr ie s Donors (%) Plasmapheresis donors by type 4 Conclusions 4.1 Responses to the survey This report can only reflect the information provided by the WHO Member States. While many countries worked diligently to produce comprehensive reports on their blood transfusion services, others were unable to collect the necessary information. The ability of ministries of health to respond to the questionnaire depends on both their commitment and willingness to share information and their data collection tools and systems. Consideration should be given to instituting standardized systems at national level. A number of weaknesses in the responses were identified: Non-response: The 22 countries from which no response was received cannot be represented in the report, resulting in a gap in the global picture and underrepresentation of certain populations, particularly in low-HDI countries. It is probable that, in some of these countries, the inability to collect data is an indication of an immature, fragmented transfusion service. Partial responses: Many of the countries that did respond did not answer all the questions in the survey. This made it difficult to compare responses to questions. The differences in response rates to certain closely linked questions suggest that some Figure 37 Voluntary no-remunerated Paid 33 respondents answered questions only when they could give an affirmative answer. For example, 153 countries answered the question about whether there was a unit in the ministry of health that was responsible for the blood programme, but only 123 answered the question about whether there was a national blood authority or commission or equivalent mechanism, and only 98 answered the question about whether there was a national blood programme manager. Timeliness: Responses were received from some countries almost one-and-a- half years after the survey questionnaire was sent out. This resulted in a long delay between the start of data collection and the receipt of sufficient responses to initiate analysis, and production of a final report. Despite these shortcomings, much valuable information has been collected, and the report shows some important developments and trends. Nevertheless, it is to be hoped that the concerns expressed will be acted upon by Member States to ensure that future surveys are addressed with a greater sense of importance and urgency. 4.2 Organization and management The questions selected to elucidate the effectiveness of the organization and management of national blood supplies are based on a strategy advocated in the WHO Aide Memoire for National Blood Programmes2. All governments must provide effective coordination and monitoring of their blood transfusion programmes in order to ensure universal access to a safe, sufficient blood supply. It is therefore of concern that so many countries were unable to answer the key questions about the organization and management of blood services (section 3.2). It is more difficult to collect information on blood safety when there is no single point of coordination. Overall, 62 countries appeared not to have a unit in their ministry of health that was responsible for the national blood programme (answered ‘No’ or ‘Under way’ or did not respond), and 108 countries appeared not to have a designated national blood programme manager. Having a central focus within the ministry of health is important to ensure the necessary coordination and monitoring. 4.3 Quality systems The indicators used to elucidate the status of quality systems in Member States were: national standards for collection, testing, processing, storage and issue; a national quality manager; and a system of audit and participation in external quality assessment 2 Aide-mémoire for national blood programmes: Blood safety. WHO/BCT/02.03. Geneva, World Health Organization, 2002. 34 schemes. Some countries at all HDI levels did not have these important elements in place. The responses about the use of standard operating procedures were also disappointing, as only about half the countries that responded to the survey answered these questions. In a number of countries, standard operating procedures were not used in all blood centres, even in critical areas such as screening for transfusion- transmissible infections, blood grouping and component processing. 4.4 Haemovigilance National haemovigilance systems can be set up only when effective mechanisms for information collection in hospitals and coordination at national level exist. Such systems are a sign of a well-developed transfusion infrastructure; in such environments, a national haemovigilance system is essential. For less well-developed transfusion services, the first objective is to ensure that effective hospital transfusion committees are in place and are monitoring clinical transfusion practice at local level. 4.5 Regulation and inspection A mechanism for regulating the blood service existed in 67 (53%) of the countries that responded. Thus, 59 countries had no regulations, and a further 46 did not answer this question. Of the 67 that had a mechanism, only 50 had a system of regular inspection, and only 40 had inspectors with specialized knowledge in blood transfusion. Regular review of performance, by internal audit and external inspection, is essential to ensure that high standards are maintained. It is troubling that some countries in each category of HDI did not have such mechanisms in place. 4.6 Blood donations The number of donations per 1000 population had decreased in countries at every level of HDI since the last report, and there continued to be large differences in collection rates. The average rate of donations per 1000 population was 15 times higher in high- HDI than in low-HDI countries, and the overall range was 0.3–69.5 donations per 1000 population. These figures should be interpreted, however, in the context of the clinical requirements for blood transfusion, which depend on the level of development of the health-care system and the burden of disease. Thus, the appropriate level of blood collection will vary from country to country. Whatever the transfusion requirements of its patient population, every country must ensure the universal availability of adequate supplies of safe blood and blood products to all patients requiring transfusion. 35 Both medium- and low-HDI countries showed a reduction in the number of donations per 1000 population when compared with the previous survey. While the transition of some countries from low to medium HDI might have affected these figures, a real reduction in blood supplies in low- and medium-HDI countries, many of which already have insufficient blood supplies, would be a cause for concern. Further investigation of the situation in these countries is warranted. Donations per 1000 population were also lower in high-HDI countries, perhaps due to more restrictive donor selection criteria and population ageing. Other factors also contribute to a reduction in demand, including more appropriate use of blood, improved surgical procedures and cell salvage and better blood inventory management. These positive developments are to be welcomed. Some blood services are finding it increasingly difficult to maintain adequate levels of donation, and some are collecting double donations of red cells or collecting single donations at increased frequency. This development raises concern about donor health, particularly with regard to iron reserves. Pre-donation estimation of haemoglobin avoids blood collection from anaemic persons but does not provide information on the long-term effects of the blood donation regime. More investigation is required to determine safe limits on donation in different economic, population and nutritional settings. Apart from collecting information on donations per 1000 population, the survey did not focus on questions of sufficiency and accessibility. National blood strategies must take into account the geographical distribution of the population and the state of transport routes, to ensure that the location of blood and blood component stocks will ensure universal access to safe blood in a timely manner. Information collection systems should be in place to record incidents in which lack of a timely blood transfusion results in mortality or morbidity. 4.7 Blood donors Voluntary non-remunerated blood donation is a key component of the WHO Blood Safety strategy, as the safety of the blood collected from family/replacement or paid donors continues to be a concern. The significant progress that has been made in voluntary blood collection is encouraging. Building a panel of voluntary donors nevertheless takes time and effort, and the transition between voluntary and paid donors must be handled carefully to ensure continuation of a sufficient blood supply. Although 79% of blood in 2004–2005 was collected from voluntary non-remunerated donors, at least 11 million family/replacement donations and 2.2 million paid donations were collected. In many countries, patients or their families are responsible for providing blood, encouraging paid and family/replacement donation. In all countries, it 36 is the responsibility of the national health-care system to ensure a sufficient, readily available blood supply. As noted above, the term ‘family/replacement’ covers a wide range of donor types, from genuine family and friends to donors who present themselves as family members or friends but have received payment. Information is not available on the distribution of family/replacement donors across this spectrum, but it is likely that a significant percentage of the 11 million family/replacement donations were in fact paid donations. 4.8 Screening for transfusion-transmissible infections Obtaining a comprehensive global picture of the screening of donated blood for infectious diseases is an important aspect of the GDBS surveys. The responses provided indicate that more centres tested for markers of the four main infections, HIV, HBV, HCV and syphilis, since the previous report; however, no information was available on 16.3 million tests, which is 5% of the total test requirement for 80.7 million donations, and this number is far higher than in the previous survey. Of particular concern are the responses of countries that reported 100% testing for some markers but did not respond concerning other markers, which suggests that no testing was done for the latter. It therefore seems likely that a significant percentage of the tests of unknown status were in fact not performed. It is extremely important that a full global picture be obtained of screening activity, and the importance of full, accurate reporting is emphasized. It is also essential to ensure that the quantity and quality of testing go hand in hand. Several countries that reported 100% HIV screening did not fully use standard operating procedures for screening for transfusion-transmissible infections or did not participate in a national external quality assessment scheme. This suggests that the screening figures do not reflect the overall safety of blood at global level. 4.9 Blood grouping In some countries basic ABO and RhD grouping and antibody screening were not performed in accordance with recognized good practice. This is a serious cause for concern. Some countries do not routinely type donations for RhD because the prevalence of this antigen in the population is very high. With increasing population mobility and tourism, however, it is important that RhD typing be performed on a sufficient number of blood donations to ensure the availability of RhD-negative blood when required, particularly for women of reproductive age. ABO and RhD testing are fundamental requirements of safe transfusion practice, and the poor response levels to these questions are a concern. 37 4.10 Storage and transportation National guidelines on the storage and transportation of blood and blood components are an important basis for audit to ensure the integrity of the blood cold chain. Guidelines themselves do not, however, ensure that the storage and transportation infrastructure is adequate to ensure access to safe blood for the entire population, and this should be considered in the blood accessibility strategy referred to above. 4.11 Appropriate clinical use of blood Ensuring the safe and effective clinical use of blood components is an essential element of blood safety, and the establishment and effective functioning of a hospital transfusion committee are seen as key factors in achieving this aim. Many countries have transfusion committees in less than 10% of their hospitals. Transfusion should be coordinated at hospital level to ensure that: staff are appropriately trained; local or national transfusion guidelines are adhered to; inappropriate use of blood is avoided; standard procedures are in place and are followed; mechanisms exist to detect, report and learn from adverse events; and data on the use of blood and occasions on which the blood supply could not meet the demand are recorded. The hospital transfusion committee should submit regular reports to the appropriate health authorities demonstrating effective monitoring of transfusion activities. These reports should include statistical information, such as the number of patients transfused, the number of blood components transfused and the number and type of adverse events. Guidelines on the appropriate clinical use of blood are essential. When these do not exist at national level, local guidelines should be prepared by the hospital transfusion committee and communicated to all prescribing clinicians. National guidelines on the appropriate clinical use of blood were in place in 73 (49%) of the countries that responded, whereas 75 countries did not have such guidelines and a further 24 did not answer the question. Only 28 countries could provide information on the number of patients transfused. The gender distribution in countries at different HDI levels is interesting, with more males receiving transfusions in medium-HDI countries, and more females in low- HDI countries. Further information and analysis are required to conclude whether this difference is justified by clinical requirements or is due to inequality in access to adequate blood supplies. The percentage of blood transfused as whole blood varied considerably and was linked to HDI status, with considerably more whole blood transfused in lower-HDI than in high-HDI countries. The appropriate level of whole blood transfusion in a country depends on a number of factors, including the degree of development of both the blood service and the wider health-care system, the clinical need for blood 38 components and the supporting infrastructure and funding. These factors should be assessed to determine the need for and the feasibility of moving from whole blood to component production before this activity is begun or expanded. The global information on fractionated plasma products shows a mixed picture. Of particular note are the lack of a national strategy on the provision of fractionated plasma products in many low- and medium-HDI countries and the waste of excess production, despite severe shortages, in many parts of the world. This suggests that advocacy at local level is needed to encourage national strategies, and a global initiative is needed to ensure that excess production is not wasted but is used to treat patients. GDBSGlobal Database on Blood Safety Data collection questionnaire for January–December 2004 WHO Global Database on Blood Safety (GDBS) 2004 2 Blood Safety Global Database on Blood Safety (GDBS) 2004 Data collection for the period January 2004–December 2004 The World Health Organization (WHO) programme on Blood Transfusion Safety would appreciate your kind cooperation in completing this questionnaire which has been designed to obtain information for the WHO Global Database on Blood Safety (GDBS). The GDBS was established by WHO to address global concerns about the safety and availability of blood for transfusion. It covers the four major components of the integrated strategy for blood safety advocated by WHO: „ The establishment of well-organized, nationally-coordinated blood transfusion services with quality systems in all areas „ The collection of blood only from voluntary non-remunerated blood donors from low-risk populations „ The screening of all donated blood for transfusion-transmissible infections, including HIV, hepatitis B and C, syphilis and other infectious agents, blood grouping and compatibility testing „ A reduction in unnecessary transfusions through the effective clinical use of blood. The objective of the GDBS is to collect and analyse data from all 192 Member States of WHO in order to enable the Organization to: „ Obtain the best available information on blood transfusion services in each Member State „ Assess the global situation on blood safety „ Monitor trends and progress „ Identify priority countries for support „ Identify problems and needs in order to provide appropriate technical assistance „ Plan research and develop appropriate strategies to address specific needs. The information provided to the GDBS for 2004 will be published on the WHO website in order to enable each country to assess its own situation and monitor its progress in relation to other countries and to regional and global trends. This GDBS questionnaire is designed to collect data for the year 2004. The GDBS was initiated in 1998 and the first two collections of data for the GDBS covered the periods 1998–1999 and 2001–2002. GDBS reports for these two periods are available on the WHO website (http://www.who.int/bloodsafety) and from WHO Headquarters and Regional Offices (see Annex 1 for addresses). Please contact WHO for further information and assistance on completing the 2004 GDBS questionnaire. The 2004 GDBS questionnaire The GDBS questionnaire should be completed by an authorized person in the Ministry of Health or an organization, such as the National Blood Transfusion Service, which has statutory responsibility for the operation of blood transfusion services in your country. Please provide details of the person who completes the questionnaire so that WHO can make contact, if necessary, for clarification and further information. The GDBS questionnaire should be completed with data for the period January to December 2004. If data for this period are not available, please provide data for the period January 2003 to December 2003. Please give information relating to your country as a whole, if possible. Where national data are not available, please indicate the level covered by the data. The questionnaire contains both qualitative and quantitative questions. Three options are offered for responses to qualitative questions: ‘Yes’, ‘In process’ and ‘No’. Please use the option ‘In process’ to indicate partial development or partial implementation: for example, if a unit is being created within the Ministry of Health for the national blood programme, but is not yet operational (Question 2.1), or a national blood policy is being developed, but has not yet been finalized (Question 2.4). WHO Global Database on Blood Safety (GDBS) 2004 3 Some questions request data in the form of numbers and/or percentages. Where accurate data are not available, please give estimates. Glossary Annex 1 contains an explanation of terms in italics which are marked with a superscript number (1). The printed version of the 2004 GDBS questionnaire is available in all six official languages used by WHO: Arabic, Chinese, English, French, Russian and Spanish. Electronic data collection tool An electronic version of the 2004 questionnaire, based on MS Word, is being piloted in English only. Following evaluation and further refinement, subsequent GDBS questionnaires will be available in both printed and electronic formats in all six WHO languages. You are requested to complete the electronic version of the questionnaire, if possible. If a copy has not been provided, please contact bloodsafety@who.int. Please note that this electronic data collection tool is a unique file which contains embedded codes that are specific to each country. Only the file provided by WHO should be used. The advantage of using the electronic questionnaire is that you can keep a permanent electronic record of the responses for 2004 for use in monitoring your country’s progress in the future. In addition, the special software application used for the questionnaire enables the data provided by countries to be collated, analysed and accessed electronically. Returning the 2004 GDBS questionnaire When you have completed this questionnaire, please return it to the World Health Representative in your country. Please also send a copy to: „ WHO Regional Office „ WHO Headquarters. The contact details of all World Health Representatives are available on the WHO website (http:// www.who.int/countries). If there is no WHO Country Office in your country, please send the completed questionnaire directly to the appropriate WHO Regional Office, with a copy to WHO Headquarters at the addresses given in Annex 2. © World Health Organization, 2005 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization 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 express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed by FM Services SA, Geneva, Switzerland. WHO Global Database on Blood Safety (GDBS) 2004 4 Global Database on Blood Safety (GDBS) 2004 1 Administrative information Information provided by: 1.1 Name 1.2 Title 1.3 Position 1.4 Organization 1.5 Address 1.6 Country 1.7 Tel. no. 1.9 E-mail 1.10 Date 1.11 Please provide data for the period January 2004 to December 2004. If data for this period are not available, please provide data for the period January 2003 to December 2003. Attach additional sheets, if necessary. Data provided for the year (please tick appropriate box): ‰ 2003 ‰ 2004 1.12 The information given applies to blood programmes at the following level: ‰ National level ‰ State/regional/provincial level ‰ Other (please specify): 1.12.1 If not national, what percentage of your country’s blood programme does this report % cover? 1.13 Total number of whole blood units collected in the reporting year: 2 Organization and management Yes In process No 2.1 Is there a unit within the Ministry of Health (or other government department) with ‰ ‰ ‰ responsibility for the national blood programme1? 2.2 Is there a designated national blood programme manager? ‰ ‰ ‰ 2.3 Is there a national blood authority/commission2 (or equivalent)? ‰ ‰ ‰ 2.4 Is there a national blood policy3? ‰ ‰ ‰ 2.4.1 If yes, year of adoption: 2.5 Is there a national blood plan for the implementation of the blood policy? ‰ ‰ ‰ 2.5.1 If yes, has it been implemented? ‰ ‰ ‰ 2.6 Is there national legislation covering blood transfusion? ‰ ‰ ‰ 2.7 Is there a national advisory committee/expert panel on blood transfusion? ‰ ‰ ‰ 2.8 Is there a national blood transfusion service4 (NBTS)? ‰ ‰ ‰ 2.8.1 If yes: „ In which year was the NBTS established? „ Is there a national director/chief executive officer for the NBTS? ‰ ‰ ‰ „ Is there an NBTS management committee? ‰ ‰ ‰ 1.8 Fax no. Blood Safety WHO Global Database on Blood Safety (GDBS) 2004 5 Yes In process No 2.9 Has the government delegated any responsibility for the NBTS/blood transfusion services5 ‰ ‰ ‰ to a nongovernmental organization? 2.9.1 If yes: Name of the organization(s): Role of the organization(s): 2.10 How is the responsibility for the operation of the NBTS/blood transfusion services5 distributed? For each category, please indicate the number of different types of blood centre. Blood centres Hospital-based blood Hospital blood banks that collect, screen, centres that collect, that store, check Management process and screen, process and compatibility and responsibility distribute blood issue blood issue blood only Others Government (total) „ Ministry of Health „ Other government department(s) „ University/ teaching hospitals Nongovernmental/nonprofit organizations (total) „ Red Cross/Red Crescent Society „ Other nongovernmental organizations „ University/ teaching hospitals Please specify the role of any nongovernmental/nonprofit organizations: Commercial (for profit) organizations (total) „ Commercial blood centres „ Private hospitals „ Others (please specify their role): Yes In process No 2.11 Does any international agency/organization/institution provide technical support to NBTS/ ‰ ‰ ‰ blood transfusion services? 2.11.1 If yes, please specify name of agency: 2.12 Does any international agency/organization/institution provide financial support to NBTS/ ‰ ‰ ‰ blood transfusion services? 2.12.1 If yes, please specify name of agency: 2.13 Is there a system of centralized data collection and analysis for the NBTS/blood ‰ ‰ ‰ transfusion services? 2.14 Is there a mechanism for calculating the costs of the operation of the NBTS/blood ‰ ‰ ‰ transfusion services? 2.15 What is the approximate cost (in US dollars) of producing a unit of whole blood/red blood cells US$ (including donor recruitment, blood collection, testing, processing, storage and distribution)? 2.16 Is a specific national budget provided for the NBTS/blood transfusion services? ‰ ‰ ‰ 2.17 Is there a national cost recovery system for the NBTS/blood transfusion services? ‰ ‰ ‰ 2.18 Are there national standards for the collection, storage, processing and issue of blood and blood ‰ ‰ ‰ products? 2.19 Is there a designated national quality manager6 for blood transfusion services? ‰ ‰ ‰ 2.20 What percentage of blood centres use standard operating procedures7 (SOPs) or local written instructions for relevant functions? „ Blood donor recruitment % „ Blood donor selection % „ Blood collection and donor care % „ Screening for transfusion-transmissible infections % „ Blood group serology % WHO Global Database on Blood Safety (GDBS) 2004 6 „ Blood component preparation % „ Blood storage and transportation/distribution % „ Compatibility testing (cross-matching) % „ Issue of blood and blood components % „ Administration of blood and blood components % 2.21 What percentage of blood centres maintain records of the following: Manual system Electronic system „ Blood donor recruitment % % „ Blood donor selection % % „ Blood collection and donor care % % „ Screening for transfusion-transmissible infections % % „ Blood group serology % % „ Blood component preparation % % „ Blood storage and transportation/distribution % % „ Compatibility testing (cross-matching) % % „ Issue of blood % % „ Patients receiving blood transfusions % % „ Patients with transfusion reactions % % Yes In process No 2.22 Is there a system of audit8 in the NBTS/blood transfusion services? ‰ ‰ ‰ 2.23 Is there a national external quality assessment scheme9 for blood group serology? ‰ ‰ ‰ 2.24 Is there a national external quality assessment scheme9 for transfusion-transmissible infections? ‰ ‰ ‰ 2.25 Is there a mechanism for the bulk procurement of consumables for the NBTS/blood ‰ ‰ ‰ transfusion services? 2.25.1 If yes, which of the following consumables are procured in bulk at various levels? National State/provincial/ Individual blood Type of consumable level regional level centre/hospital „ Blood bags ‰ ‰ ‰ „ Test kits ‰ ‰ ‰ „ Reagents ‰ ‰ ‰ „ Others (please specify): ‰ ‰ ‰ Yes In process No 2.26 Did stocks of any of the following consumables run out in 2004? ‰ ‰ „ Blood bags ‰ ‰ „ Test kits ‰ ‰ „ Reagents ‰ ‰ „ Others (please specify): ‰ ‰ 2.27 Are there national guidelines for waste management in blood transfusion services? ‰ ‰ ‰ 2.28 Is there an educational programme in blood transfusion medicine/science leading to a ‰ ‰ ‰ nationally-recognized university degree/diploma? 2.29 Is there a system of regular training of staff? ‰ ‰ ‰ 2.30 Please indicate the types of training available for the following categories of staff. In-service Short courses/ Formal courses Formal courses Staff category training workshops (in country) (outside country) „ Medical officers ‰ ‰ ‰ ‰ „ Administrative staff ‰ ‰ ‰ ‰ „ Quality officers ‰ ‰ ‰ ‰ „ Blood donor education/recruitment staff ‰ ‰ ‰ ‰ „ Blood collection/donor care staff ‰ ‰ ‰ ‰ „ Blood donor counsellors ‰ ‰ ‰ ‰ WHO Global Database on Blood Safety (GDBS) 2004 7 In-service Short courses/ Formal courses Formal courses Staff category training workshops (in country) (outside country) „ Blood component preparation staff ‰ ‰ ‰ ‰ „ Laboratory technical staff ‰ ‰ ‰ ‰ „ Clinicians who prescribe blood ‰ ‰ ‰ ‰ „ Nurses who administer blood ‰ ‰ ‰ ‰ Yes In process No 2.31 Is there a national haemovigilance10 system? ‰ ‰ ‰ 2.32 Is there a mechanism for the regulation of the NBTS/blood transfusion services? ‰ ‰ ‰ 2.32.1 If yes, is there a system of regular inspection of the NBTS/blood transfusion services? ‰ ‰ ‰ „ Do the inspectors have specialized training in blood transfusion? ‰ ‰ ‰ „ Is there a national regulatory authority? ‰ ‰ ‰ „ If yes, please specify name of regulatory authority: 2.33 Is there a mechanism for the regulation of fractionated plasma products? ‰ ‰ ‰ 2.33.1 If yes, is there a system of regular inspection of plasma fractionation facilities? ‰ ‰ ‰ „ Do the inspectors have specialized training in plasma fractionation? ‰ ‰ ‰ „ Is there a national regulatory authority? ‰ ‰ ‰ „ If yes, please specify name of regulatory authority: 2.34 What percentage of blood centres have direct access to: „ Personal computers % „ Internet? % Yes No 2.35 Would the NBTS/blood transfusion services benefit from external training or technical support? ‰ ‰ 2.35.1 If yes, please specify areas: 2.36 Could the NBTS/blood transfusion services in your country provide training or technical support to ‰ ‰ other countries? 2.36.1 If yes, please specify areas: 3 Blood donors and blood collection Yes In process No 3.1 Is there a unit designated for the national blood donor recruitment programme? ‰ ‰ ‰ 3.2 Is there a designated national blood donor recruitment officer? ‰ ‰ ‰ 3.3 Is a specific national budget provided for the blood donor recruitment programme? ‰ ‰ ‰ 3.4 Was World Blood Donor Day 2004 celebrated in your country? ‰ ‰ 3.5 Are information and education materials available for blood donors? ‰ ‰ ‰ 3.6 What percentage of blood centres have trained donor recruitment staff? % 3.7 What percentage of blood centres have trained blood collection/donor care staff? % 3.8 Are there national criteria for assessing the suitability of donors for blood donation? ‰ ‰ ‰ 3.8.1 If yes, what percentage of blood centres have a system for assessing the suitability of % donors based on the national criteria? 3.8.2 What percentage of blood centres have a system of pre-donation counselling for % blood donors? 3.9 What percentage of blood donors have a haemoglobin/haematocrit estimation done before % blood donation? WHO Global Database on Blood Safety (GDBS) 2004 8 3.10 In 2004, what percentage of donors were deferred after being assessed as unsuitable % to donate blood? Yes In process No 3.11 Is there a register/database of blood donors? ‰ ‰ ‰ 3.11.1 If yes, at what level is the register/database of blood donors maintained? „ National ‰ ‰ ‰ „ State/provincial/regional ‰ ‰ ‰ „ Individual blood centre or hospital ‰ ‰ ‰ 3.12 In 2004, how many units of whole blood were collected from the following types of blood donors11? Number Percentage „ Voluntary non-remunerated donors % „ Family/replacement donors % „ Paid donors % „ Autologous donors % 3.12.1 How many units of whole blood were collected from the following types of voluntary non-remunerated blood donors11? „ New voluntary donors % „ Lapsed voluntary donors % „ Regular voluntary donors % 3.12.2 What was the approximate percentage of all donations from: „ Male donors % „ Female donors % 3.13 What percentage of blood centres collect whole blood units in sterile, disposable, plastic blood % collection bags? 3.14 What is the average volume of a whole blood unit? ml 3.15 What percentage of blood centres have a system of recording adverse blood donor reactions? % Yes No 3.16 Is the prevalence of transfusion-transmissible infections monitored in the blood donor population? ‰ ‰ 3.17 What percentage of blood centres have a system of post-donation counselling of blood donors % who test positive for transfusion-transmissible infections? 3.18 What percentage of blood centres have a system to maintain the confidentiality of blood donors? % 3.19 What percentage of blood centres have a system to obtain feedback and complaints from % donors? 4 Screening for transfusion-transmissible infections Yes In process No 4.1 Is there a national strategy for screening donated blood units for transfusion-transmissible ‰ ‰ ‰ infections? 4.2 In 2004, what percentage of donations were screened for transfusion-transmissible infections? Which assay systems were used? Marker(s) Yes % donations EIA Simple/rapid Molecular Infection tested tested test (e.g. NAT, TMA) HIV I/II „ Ab ‰ % ‰ ‰ ‰ „ Ag ‰ % ‰ ‰ ‰ „ Combined Ag + Ab ‰ % ‰ ‰ ‰ „ DNA/RNA ‰ % ‰ ‰ ‰ HBV „ HBsAg ‰ % ‰ ‰ ‰ „ Anti-HBc ‰ % ‰ ‰ ‰ „ Others ‰ % ‰ ‰ ‰ HCV „ Ab ‰ % ‰ ‰ ‰ „ Combined Ag + Ab ‰ % ‰ ‰ ‰ „ DNA/RNA ‰ % ‰ ‰ ‰ WHO Global Database on Blood Safety (GDBS) 2004 9 Marker(s) Yes % donations EIA Simple/rapid Molecular Infection tested tested test (e.g. NAT, TMA) Syphilis „ Ab ‰ % ‰ ‰ ‰ „ Others ‰ % ‰ ‰ ‰ Chagas’ disease „ Ab ‰ % ‰ ‰ ‰ „ Others ‰ % ‰ ‰ ‰ Malaria „ Ab ‰ % ‰ ‰ ‰ „ Ag ‰ % ‰ ‰ ‰ „ DNA/RNA ‰ % ‰ ‰ ‰ „ Others ‰ % ‰ ‰ ‰ HTLVI/II „ Ab ‰ % ‰ ‰ ‰ „ Others ‰ % ‰ ‰ ‰ Other (please specify) ‰ % ‰ ‰ ‰ Other (please specify) ‰ % ‰ ‰ ‰ Yes No 4.3 In 2004, was blood ever issued without screening due to the non-availability of test kits/reagents? ‰ ‰ 4.4 In 2004, what was the prevalence (in percentage) of infection in donated blood units from different types of blood donor? Total New Lapsed Regular Family/ All voluntary voluntary voluntary voluntary replacement Paid Infection donors donors donors donors donors donors donors „ HIV % % % % % % % „ HBV % % % % % % % „ HCV % % % % % % % „ Syphilis % % % % % % % „ Chagas disease % % % % % % % „ Malaria % % % % % % % „ HTLV % % % % % % % „ Other % % % % % % % Please specify: „ Other % % % % % % % Please specify: 4.5 From which tests are prevalence data obtained? Yes No „ Screening tests ‰ ‰ „ Confirmatory tests ‰ ‰ 4.6 What percentage of blood centres store frozen samples of donor plasma for look-back testing? % 4.7 In 2004, what was the total percentage of blood discarded after screening for transfusion- % transmissible infections? 5 Blood group serology and compatibility testing Yes In process No 5.1 Is there a national strategy for testing donated blood units for blood groups? ‰ ‰ ‰ 5.2 What percentage of donations are tested for blood group and by which methodology? Percentage Manual Semi- Fully Test performed tested method automated automated „ ABO cell grouping % ‰ ‰ ‰ „ ABO serum grouping % ‰ ‰ ‰ „ RhD antigen testing % ‰ ‰ ‰ „ Antibody screening % ‰ ‰ ‰ „ Other blood groups % ‰ ‰ ‰ 5.3 Are there national guidelines on compatibility testing? ‰ ‰ ‰ 5.4 What percentage of blood units are issued annually without compatibility testing? % 5.5 What percentage of hospital blood banks use electronic cross-matching? % WHO Global Database on Blood Safety (GDBS) 2004 10 6 Blood component preparation, storage and transportation 6.1 What percentage of blood centres prepare blood components? % 6.2 What percentage of blood centres have the following equipment? „ Blood bank refrigerator with temperature monitoring system and alarm % „ Plasma freezer % „ Platelet agitator/incubator % „ Refrigerated centrifuge % „ Standby generator % „ Blood transport boxes % 6.3 In 2004, what percentage of whole blood units were separated into components? % 6.4 Which blood components are prepared? Component Prepared from whole blood Prepared by apheresis „ Red cell preparations ‰ ‰ „ Platelet concentrates ‰ ‰ „ Plasma ‰ ‰ „ Fresh frozen plasma ‰ ‰ „ Cryoprecipitate ‰ ‰ „ Inactivated plasma ‰ ‰ „ Small paediatric units ‰ ‰ „ Leucocyte-reduced units ‰ ‰ „ Peripheral blood stem cells ‰ ‰ „ Others (please specify) ‰ ‰ 6.5 What percentage of blood centres prepare blood components by apheresis? % Yes In process No 6.6 Is there a surplus of plasma in excess of national needs? ‰ ‰ ‰ 6.6.1 If yes, how is surplus plasma utilized? „ Donated to another country/organization ‰ ‰ ‰ „ Sold to another country/organization ‰ ‰ ‰ „ Discarded ‰ ‰ ‰ „ Other (please specify) ‰ ‰ ‰ 6.7 Are there national guidelines on the storage of blood and blood components? ‰ ‰ ‰ 6.8 Are there national guidelines on the transportation of blood and blood components? ‰ ‰ ‰ 6.9 What percentage of blood centres store blood and blood components in temperature-monitored % equipment with an appropriate alarm? 6.10 What percentage of blood centres use domestic refrigerators for blood storage? % 6.11 What percentage of blood centres transport blood and blood components in temperature- % monitored equipment? 6.12 What percentage of blood centres store reagents in temperature-monitored equipment? % 6.13 What percentage of blood centres have a system of separate blood storage areas for quarantine13 % and the issue of blood components? Yes In process No 6.14 Is there a national system of blood stock management? ‰ ‰ ‰ 6.15 In 2004, what were the number and percentage of blood units discarded due to the following causes? Number Percentage „ Faulty blood collection % „ Positive for transfusion-transmissible infection % „ Date expiry % „ Processing failure % „ Storage and transportation problems % „ Other causes (please specify) % Total % WHO Global Database on Blood Safety (GDBS) 2004 11 7 The clinical use of blood and blood components Yes In process No 7.1 Are there national guidelines on the appropriate clinical use of blood? ‰ ‰ ‰ 7.2 In 2004, what percentage of blood was transfused as whole blood? % 7.3 In 2004, approximately how many patients received a transfusion of blood or blood components? „ Total patients transfused „ Male patients transfused „ Female patients transfused 7.4 What percentage of hospitals have a functioning hospital transfusion committee? % 7.5 What percentage of hospitals follow a maximum surgical blood ordering schedule (MSBOS)14 % for routine surgery? 7.6 What percentage of hospitals have a system for monitoring clinical transfusion practice? % 7.7 What percentage of hospitals have a system for monitoring post-transfusion reactions? % 7.8 What percentage of hospitals have a system for monitoring post-transfusion infections? % 8 Fractionated plasma products Yes In process No 8.1 Is there a national strategy for the provision of fractionated plasma products15? ‰ ‰ ‰ 8.1.1 If yes: „ Imported from abroad ‰ ‰ ‰ „ Fractionated within the country ‰ ‰ ‰ – Public/not-for-profit sector ‰ ‰ ‰ If yes, please specify the name of the organization: – Private/for-profit sector ‰ ‰ ‰ „ Contract fractionation: ‰ ‰ ‰ If yes, please specify: „ Name of the organization: „ Country: 8.2 What is the total volume of plasma designated nationally for fractionation in a year? „ Recovered plasma litres „ Apheresis plasma litres „ Not applicable ‰ 8.3 Which products are manufactured by fractionation within the country? „ Albumin ‰ ‰ ‰ „ Immunoglobulin ‰ ‰ ‰ „ Factor VIII ‰ ‰ ‰ „ Factor IX ‰ ‰ ‰ „ Others (please specify): ‰ ‰ ‰ 8.4 Is there a surplus of fractionated plasma products in excess of national needs? ‰ ‰ 8.4.1 If yes, how are these products utilized? „ Donated to another country/organization ‰ ‰ ‰ „ Sold to another country/organization ‰ ‰ ‰ „ Discarded ‰ ‰ ‰ „ Other (please specify): ‰ ‰ ‰ 8.5 What is the percentage of different types of plasmapheresis donors? „ Voluntary non-remunerated plasma donors % „ Paid plasma donors % „ Other plasma donors (please specify): % WHO Global Database on Blood Safety (GDBS) 2004 12 Comments Please use the space below and attach additional pages, if necessary, to provide any further relevant information or comments on the GDBS questionnaire. WHO Global Database on Blood Safety (GDBS) 2004 13 Annex 1 GLOSSARY 1 National blood programme: The government programme with overall responsibility for planning, implementation and monitoring of all activities related to blood transfusion throughout the country. Responsibility for the implementation of the blood programme may be fully or partially delegated to a governmental or nongovernmental organization designated as the national blood transfusion service. 2 National blood authority/commission: The highest policy formulation and decision-making body under the national health authority for issues pertaining to blood transfusion services in the country. All major stakeholders in the blood transfusion process are usually represented in this authority. 3 National blood policy: A statement of intent by the national health authority that defines the organizational, financial and legal measures that will be taken to ensure the quality, safety, availability and accessibility of blood transfusion within the country. 4 National blood transfusion service (NBTS): The organization with statutory national responsibility for the provision of blood for transfusion and liaison with clinical services for the appropriate use of blood for patient care. The NBTS coordinates all activities concerned with blood donor recruitment and the collection, testing, processing, storage and distribution of blood and blood products, the clinical use of blood and surveillance of adverse transfusion events. Activities are carried out within a network of national/regional/provincial blood centres and hospital blood banks. 5 Blood transfusion services: Hospitals and other facilities involved in the provision of blood in countries where there is no National Blood Transfusion Service. 6 Quality manager: The appointed, responsible and authorized individual within an organization with responsibility for developing and managing the quality system. 7 Standard operating procedure: Local written instructions for the performance of a specific procedure. 8 Audit: Systematic, independent and documented examination to determine whether activities comply with a planned and agreed quality system. 9 External quality assessment (EQA): The external assessment of a laboratory’s performance using samples of known, but undisclosed, content and comparison with the performance of other laboratories. An external quality assessment scheme is a recognized scheme for organizing EQA. This can be a local scheme or may be organized at national, regional or international level. 1 0 Haemovigilance: The monitoring, reporting and investigation of adverse incidents/near-misses related to all blood transfusion activities. 1 1 Blood donors „ Voluntary non-remunerated blood donor: An altruistic donor who gives blood freely and voluntarily without receiving money or any other form of payment. New voluntary donor: A voluntary non-remunerated blood donor who has never donated blood before. Lapsed voluntary donor: A voluntary non-remunerated blood donor who has given blood in the past but does not fulfil the criteria for a regular donor. Regular voluntary donor: A voluntary non-remunerated blood donor who has given blood at least three times and who continues to donate blood at least once a year. „ Family/replacement blood donor: A donor who gives blood when it is required by a member of the patient’s family or community. This may involve a hidden paid donation system in which the donor is paid by the patient’s family. „ Paid donor: A donor who gives blood for money or other form of payment. „ Autologous donor: A patient who donates his/her blood to be stored and reinfused, if needed, during surgery. 1 2 NAT: Nucleic acid testing. 1 3 Quarantine: Non-authorization to proceed to next stage of a process until specified standards or conditions are met. 1 4 Maximum surgical blood ordering schedule (MSBOS): A guide to expected normal blood usage for elective surgical procedures which lists the number of units of blood to be routinely cross-matched or grouped, screened and held for each procedure preoperatively. 1 5 Fractionated plasma products: Human plasma protein products prepared under pharmaceutical manufacturing conditions. Plasma products include albumin, immunoglobulin and coagulation factors VIII and IX. WHO Global Database on Blood Safety (GDBS) 2004 14 WHO Regional Office for Europe Dr Valentina Hafner Technical Officer, Quality of Health Systems Division of Country Support WHO Regional Office for Europe 8 ScherfigsvejDK-2100 Copenhagen 0, Denmark Fax: +45 39 171 875 E-mail: vha@euro.who.int http://www.euro.who.int WHO Regional Office for South-East Asia Dr Rajesh Bhatia Regional Adviser, Blood Safety and Clinical Technology WHO Regional Office for South-East Asia World Health House Indraprastha Estate, Mahatma Gandhi Marg New Delhi 110 002, India Fax: +91 11 2337 0197 E-mail: bhatiaraj@whosea.org http://www.whosea.org WHO Regional Office for the Western Pacific Dr Yu Junping Blood Safety Specialist WHO Regional Office for the Western Pacific P. O. Box 2932, 1000, Manila, Philippines Fax: +63 2 522 2036 E-mail: yuj@wpro.who.int http://www.wpro.who.int Annex 2 CONTACT INFORMATION WHO Headquarters Dr Neelam Dhingra Coordinator, Blood Transfusion Safety Department of Essential Health Technologies World Health Organization 20 Avenue Appia, CH-1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int http://www.who.int/bloodsafety WHO Regional Office for Africa Dr Jean-Baptiste Tapko Regional Adviser, Blood Safety and Laboratory Services WHO Regional Office for Africa Boîte postale 6, Brazzaville, Congo Fax: +47 241 39511 E-mail: tapkoj@afro.who.int http://www.afro.who.int WHO Regional Office for the Americas/ Pan American Health Organization Dr José Ramiro Cruz-Lopez Regional Adviser, Blood and Laboratory Services Pan American Health Organization 525, 23rd Street, N.W.Washington, DC 20037, USA Fax: +1 202 974 3610 E-mail: cruzjose@paho.org http://www.paho.org WHO Regional Office for the Eastern Mediterranean Dr Nabila Metwalli Regional Adviser, Blood Safety, Laboratory & Imaging WHO Regional Office for the Eastern Mediterranean Abdul Razzak Al Sanhouri Street P.O. Box 7608, Nasr City, Cairo 11371,Egypt Fax: +20 2 276 5416 E-mail: metwallin@emro.who.int http://www.emro.who.int Blood Transfusion Safety Department of Essential Health Technologies World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety