GDBS Global Database on Blood Safety

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GDBS

Global Database on Blood Safety

Report 2004–2005

WHO/EHT/08.07

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Global Database on Blood Safety GDBS

Report 2004–2005

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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: [email protected]). 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:

[email protected]).

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All reasonable precautions have been taken by the World Health Organization 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 the World Health

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1 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

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systems 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.

Table 1

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10

70,1

19,9 7,2

68,8

19,1

0 10 20 30 40 50 60 70 80

Low Medium High

Percentage of global population

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

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account 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

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134 142

157

175 178 172

0 20 40 60 80 100 120 140 160 180 200

1988–1999 2001–2002 2004–2005

No. of countries

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

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This 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

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41 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)

Survey

Responses to different surveys, by 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.

1998–1999 (n = 175) 2001–2002 (n = 178) 2004–2005 (n = 172)

Figure 4

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11 32

37 5

11

8 12 26

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

Percentage

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

100 90 80 70 60 50 40 30 20 10 0

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The 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

Cost per unit in US$

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

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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 procedures Figure 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

High HDIMedium HDILow HDI

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

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1

11

30

3

14

8 7

23

8

0 5 10 15 20 25 30 35

L M H

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

Figure 9

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0

8

31

0

5

0

29 30

9

0 5 10 15 20 25 30 35

L M H

HDI 8

27

32

6

14

4 11

15

9

0 5 10 15 20 25 30 35

L M H

HDI

Regulation of blood transfusion services, by HDI

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

Figure 10

Figure 11

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10

33

8 2

13

35

0 5 10 15 20 25 30 35 40 45 50

L M H

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

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

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4

22 2

22

42

0 5 10 15 20 25 30 35 40 45 50

L M H

HDI

Financial support received, by HDI

Yes No

Distribution of donations, by HDI

Population distribution, by HDI

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%

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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

No. of donations per 1000 population

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).

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000 population, 2004

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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

Donations (millions)

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

0,5 6,4 7,50,4

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

Percentage

Voluntary non-remunerated HDI Family/replacement Paid

100 90 80 70 60 50 40 30 20 10 0

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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%26–50%51–90%91–99%100%

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Map 2: Percentage of voluntary non-remunerated blood donation, 2004

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0 10 20 30 40 50 60 70 80

1998–1999 2001–2002 2004–2005

Percentage

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

Family/replacement Voluntary non-remunerated

Figure 21

Figure 22

0 10 20 30 40 50 60 70 80

1998–1999 2001–2002 2004–2005

Percentage

Survey

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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

Percentage

Survey

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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.

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

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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

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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

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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

Percentage of donations screened

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Percentages of blood centres preparing blood components, by HDI

Percentages of whole blood separated into blood components, by 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

Blood centres preparing components (%)

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

Whole blood separated (%)

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2

30 34

7

11 7

1

3

0 5 10 15 20 25 30 35 40 45 50

L M H

HDI 3

35 37

7

7 4

2 1

0 5 10 15 20 25 30 35 40 45 50

L M H

HDI

National guidelines on blood storage, by HDI

Yes Under way No

National guidelines on transportation of blood and blood components, by HDI

Yes Under way No

Figure 29

Figure 30

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9

34 30

10

14

9 5

23

14

0 10 20 30 40 50 60 70 80

L M H

HDI 2

15

22 4

12

5

4

16 13

0 5 10 15 20 25 30 35 40 45 50

L M H

HDI

National system of blood stock management, by HDI

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

Figure 31

Figure 32

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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

Transfused as whole blood (%)

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3

14 6 32

9

22

6

0 5 10 15 20 25 30 35 40 45

L M H

HDI 3

13 2

13

11 22

25 10

0 5 10 15 20 25 30 35 40 45

L M H

HDI

Percentages of hospitals with a transfusion committee, by HDI

91–100%

11–90%

0–10%

Figure 34

Yes Under way No

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

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3

10

20 9

12 3

14

0 5 10 15 20 25 30 35 40 45 50

1 2 3

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

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.

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0 5 10 15 20 25 30

100 80-99 60-79 < 60

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

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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.

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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.

GDBS Global Database on Blood Safety

GDBS

Global Database on Blood Safety

Report 2004–2005

Global Database on Blood Safety GDBS

Report 2004–2005

Contents

1 Introduction

2 Methods

3 Results of the Global Database on Blood Safety survey 2004–2005

3.1 Response rate

3.2 Organization and management

3.2.1 National blood policies, plans and legislative framework

3.2.2 Data collection

3.2.3 Costing of blood transfusion services

3.2.4 Quality systems

3.2.5 Haemovigilance

3.2.6 Regulation

3.2.7 International support

3.3 Blood supply

3.4 Blood donors

3.5 Screening for transfusion-transmissible infections

3.6 Blood grouping and compatibility testing

3.7 Blood component preparation, storage and transportation

3.8 Clinical use of blood and blood components

4 Conclusions

4.1 Responses to the survey

4.2 Organization and management

4.3 Quality systems

4.4 Haemovigilance

4.5 Regulation and inspection

4.6 Blood donations