Blood Safety Indicators 2010

Global Database on Blood Safety

Example of Completed Blood Safety Indicators Form

The WHO Blood Transfusion Safety team appreciates your kind cooperation in completing the attached Blood Safety
Indicators Form for 2010. To assist you in providing the information requested, an example of a completed form is provided.
This is designed to provide:
n Examples of indicators
n Explanatory notes on the indicators
n Formulae for making calculations.

The entries on this example form represent a country with a national blood transfusion service which is responsible for
the majority of blood collected in the country, but where a number of smaller centres operate in certain regions. Sample
entries are given in red.

Please read the example form and explanatory notes before completing the Blood Safety Indicators form and returning
it to WHO.

When the electronic version of the form provided by WHO is used, data in the shaded cells will be automatically created
based on calculation.

example of completed blood safety indicators form, 2010 1 of 9

 Blood Safety Indicators 2010
Global Database on Blood Safety

ADMINISTRATIVE INFORMATION
Date of report
Country
Name
Title
Position
Organization
Address
Telephone number
Fax number
E-mail
Period covered by report 1 January 2010 to 31 December 2010
Total population (give year and source) 8 500 000 (National Census, 2008)

A FACILITIES FOR BLOOD COLLECTION AND SUPPLY

1 Number of blood centres in the country
1.1 Stand-alone blood centres 1
1.2 Hospital-based blood centres 9
1.3 Total 10
2 Number of blood centres covered in the report
2.1 Stand-alone blood centres 1
2.2 Hospital-based blood centres 7
2.3 Total 8

Blood centre: A facility which carries out all or part of the activities for donor recruitment, blood collection (whole blood
and, in some cases, apheresis), testing for transfusion-transmissible infections and blood groups, processing into blood
components, storage, distribution to hospital blood banks within a defined region, and liaison with clinical services.
Blood centres may be stand alone or hospital-based. The following should NOT be categorized as blood centres:
n Mobile or fixed blood collection sites/rooms which are operated as part of a blood centre
n Hospital blood banks which only store, check compatibility and issue screened blood.

B BLOOD DONORS AND BLOOD COLLECTION

3 Number of blood donors who donated blood during the reporting period (excluding autologous donors)
Through apheresis
Whole blood (a) Total (c)
procedure (b)
3.1 Total number of donors who donated 73 000 2 510 75 510
3.2 Number of voluntary non-remunerated
51 000 1 650 52 650
donors who donated

For indicator 3, the number of individual donors who donated blood during the reporting period is required. Donors who
donated on more than one occasion in the reporting period should be counted only once. For example, if one blood donor
donated three times during the reporting period, the number of donors counted should be 1 rather than 3. Registered
donors who did not donate blood during the reporting period should not be counted.

example of completed blood safety indicators form, 2010 2 of 9

 In this example, during the reporting period, 73 000 donors, including 51 000 voluntary unpaid donors, donated
whole blood at least once; 2510 donors, including 1650 voluntary unpaid donors, donated blood through aphaeresis
procedures at least once. In total, 75 510 donors, including 52 650 voluntary unpaid donors, donated whole blood
or blood through aphaeresis procedures at least once. In this example, c = a + b. If some donors donated both whole
blood and through aphaeresis, c will be less than a + b.
This Indicator should not be confused with indicator 4, which requires a count of donations.
The number of autologous blood donors should not be included for this indicator.

4 Number and % of donations collected during the reporting period (excluding autologous donations), by type of
donation
Whole blood (a) Apheresis (b) Total (c) Percent
4.1 Voluntary non-remunerated donations 91 000 4 000 95 000 79.2%
4.2 Family / replacement donations 24 000 1 000 25 000 20.8%
4.3 Paid donations 0 0 0 0%
4.4 Others (please specify _____________) 0 0 0 0%
4.5 Total donations 115 000 5 000 120 000 100.0%

Voluntary non-remunerated donation: donation given by an altruistic donor who gives blood freely and voluntarily without
receiving money or any other form of payment.
Family/replacement donation: donation given by an individual 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 donation: “Donation” by an individual in return for money or other form of payment.
For indicator 4, the donations of all types (excluding autologous donations) carried out in the reporting period should
be accounted for. Donations of different types should add up to the same sum of the values given in the corresponding
cells in row 4.5 and column “total (c)”. The total percentage in indicator 4.5 should equal to 100%.
In this example:
91 000 + 24 000 +0 +0 = 115 000 (total whole blood donations)
4 000 +1 000 +0 + 0 = 5 000 (total apheresis donations)
91 000 + 4 000 = 95 000 (total voluntary non-remunerated donations)
24 000 + 1 000 = 25 000 (total family/replacement donations)
When multiple blood components (such as platelet and plasma) are collected through one apheresis procedure, the
number of donations (procedure) should be only counted as "1".

5 Number of deferrals, by reason for deferral

5.1 Low weight 350
5.2 Low haemoglobin 2 100
5.3 Other medical conditions 1 640
5.4 High-risk behaviour 2 700
5.5 Travel 1 350
5.6 Other reasons (please specify _____________) 0
5.7 Total number of deferrals 8 140
5.8 % of total deferrals 6.35%

Indicator 5.7 should be the sum of the values given in 5.1 to 5.6.
For indicator 5.8, use the following formula:
Total deferrals (indicator 5.7)
% of total deferrals =
Total donations (indicator 4.5c) + Total deferrals (indicator 5.7)

example of completed blood safety indicators form, 2010 3 of 9

 6 Whole blood donation rate
6.1 Whole blood donations per 1000 population 13.5
6.2 If this report does not cover all blood donations that were actually collected
in your country, please estimate the percentage of the donations or of the 80%
population that is covered by this report
6.3 Adjusted whole blood donations per 1000 population 16.9

Use the following formula to calculate the unadjusted whole blood donations rate:
Whole blood donations (Indicator 4.5a)
Whole blood donations per 1000 population =
Total population (in 1000)

In this example:
115 000 ÷ (8 500 ) = 13.5 donations per 1000 population
Indicator 6.2 provides the percentage of blood donations (or of the population) in the country that is covered by the
report. If all blood donations (or population) are accounted for, the figure is 100 %.
In this example, it was estimated that the donations covered in the report represent 80% of the total donations in the
country in 2010. An adjusted donation rate can be calculated using the following formula:
Whole blood donations (Indicator 4.5a)
Adjusted whole blood donation rate =
Total population (in 1000) x % donations (Indicator 6.2)

In this example:
115 000 ÷ (8 500 x 80%) = 16.9 donations per 1000 population

7 Donation : donor ratio (average frequency of donations per donor) for voluntary non-
1.78
remunerated whole blood donors

Use the following formula to calculate Donation: donor ratio for voluntary non-remunerated whole blood donation:
Voluntary non-remunerated whole blood donations (Indicator 4.1a)

Voluntary non-remunerated whole blood donors (Indicator 3.2a)
In this example:
91 000 ÷ 51 000 = 1.78
Since there are variations in the definition of “regular” voluntary blood donation, the Donation: Donor Ratio is used to
provide a surrogate indication of regular voluntary blood donations and donor retention.

C SCREENING FOR TRANSFUSION-TRANSMISSIBLE INFECTIONS

Number Percent
8 Number and % of blood centres that perform laboratory screening of blood
5 62.5%
donations for transfusion-transmissible infections

Provided numbers of blood centres that perform laboratory screening of blood donations for transfusion-transmissible
infections. To calculate the percentage, the number of blood centres covered by this report (indicator 2.3) is used as
denominator. Here the percentage is: (5 ÷ 8) x 100 =62.5%

9 Number and % of donations (whole blood and apheresis) screened for transfusion-transmissible infections (TTIs)
TTI markers Number Percent
9.1 HIV 120 000 100%
9.2 HBV 120 000 100%
9.3 HCV 96 000 80%
9.4 Syphilis 96 000 80%
9.5 Chagas disease – –
9.6 Malaria – –
9.7 HTLV I/II – –
9.8 Other (please specify _____________) – –

example of completed blood safety indicators form, 2010 4 of 9

 Provide the number of donations (whole blood and apheresis) that were screened for each TTI marker. Then express
this as a percentage of total donations (indicator 4.5c) using the formula below:
No. donations screened for the marker
% donations screened for a specified TTI marker = x 100
Total donations (Indicator 4.5 c)

In this example, for HCV:

(96 000 ÷ 120 000) x 100 = 80%
The denominator used for automatic calculation of the percentage in the electronic version of the tool is the total
number of donation who donated whole blood or donated through apheresis procedure (4.5c). If particular denominator
should be used for accurate calculation, please give this in the ‘comments’ box.
If screening for any of these markers is not mandatory and therefore not routinely performed, please leave the
relevant cells blank. Use the figure zero only to indicate that no donations were screened for a specified TTI marker
which is required according to national policy/standard.

10 Details of blood centres/laboratories where testing for TTIs is performed: number of donations tested, use of
standard operating procedures (SOPs) and participation in External Quality Assessment (EQA)
Blood Transfusion-transmissible infections
centre/ Total
No. of donations screened for TTIs SOPs Participate in EQA
laboratory donations
ID HIV HBV HCV Syphilis used HIV HBV HCV Syphilis
1. Centre A 30 000 30 000 30 000 30 000 30 000 Yes Yes Yes Yes Yes
2. Centre B 25 000 25 000 25 000 20 800 20 800 Yes Yes Yes Yes Yes
3. Lab. C 10 000 10 000 10 000 8 000 8 000 Yes No No No No
4. Lab. D 10 000 10 000 10 000 4 000 4 000 No Yes No No No
5. Centre E 12 000 12 000 12 000 8 000 8 000 Yes No No No No
6. Lab. F 20 000 20 000 20 000 15 000 15 000 Yes Yes Yes No No
7. Centre G 10 000 10 000 10 000 8 000 8 000 No No No No No
8. Lab. H 3 000 3 000 3 000 2 200 2 200 No No No No No
9.
10.
Total 120 000 120 000 120 000 96 000 96 000

Add more rows in the table, if required, to include each blood centre and laboratory covered in the report.
For each blood centre or laboratory, provide:
n Total number of donations handled
n Number of donations screened for each TTI marker
n Use of standard operating procedures (SOPs) for TTI screening
n Participation in an External Quality Assessment scheme (EQA) for TTI screening

11 Number and % of donations screened for TTIs in a quality-assured manner

Total number of donations screened/tested in % of donations screened/ tested in a quality-
a quality-assured manner assured manner
11.1 HIV 75 000 62.5%
11.2 HBV 75,000 62.5%
11.3 HCV 50 800 42.3%
11.4 Syphilis 50 800 42.3%

Donated blood units are considered to be tested in a quality-assured manner if they are tested in centre/laboratories
which uses standard operating procedures (SOPs) and participates in an External Quality Assessment scheme (EQA).
Information provided in indicator 10 will be used for the calculation.

example of completed blood safety indicators form, 2010 5 of 9

 The number of donated blood units screened for TTIs in a quality-assured manner is the sum of the number of donations
tested in centres/laboratories that use SOPs and participate in EQA. In this example, only those donations tested in
Blood Centre A, Blood Centre B and Laboratory F are included in the calculation. Express this as a percentage of the
total number of donations (indicator 4.5c).
In this example:
HIV [(30 000 + 25 000 + 20 000) ÷ 120 000] x 100 = 62.5%
HBV [(30 000 + 25 000 + 20 000) ÷ 120 000] x 100 = 62.5%
HCV [(30 000 + 20 800) ÷ 120 000] x 100 = 42.3%
Syphilis [(30 000 + 20 800) ÷ 120 000] x 100 = 42.3%

12 Number and % of donations that were reactive in the screening test and/or positive in the confirmatory test
Screening test reactive (a) Confirmatory test positive (b)
TTI markers
Number Percentage Number Percentage
12.1 HIV 2 400 2.00% 1,980 1.65%
12.2 HBV 3 600 3.00% 3,000 2.50%
12.3 HCV 2 880 3.00% 2,688 2.80%
12.4 Syphilis 1 440 1.50% 864 0.90%
12.5 Chagas disease – – – –
12.6 Malaria – – – –
12.7 HTLV I/II – – – –
12.8 Other (please specify _________) – – – –

For each TTI marker, provide the number of donations that were reactive in the screening test. Express this as a
percentage of donations screened (indicator 9), using the formula below:

No. of donations reactive in screening test
% donations screen test reactive = x 100
No. of donations screened (Indicator 9)

Similarly, for each TTI marker, provide the number of donations that were positive in the confirmatory test. Express this
as a percentage of donations screened (indicator 7) using the formula below.
No. of confirmed positive donations
% donations confirmed positive = x 100
No. of donations screened (Indicator 9)

In this example:
HIV: 2,400 donations were reactive in the screening test. Out of these, 1,980 were positive in the confirmatory test:
(2 400 ÷ 120 000) x 100 = 2.00% screening test reactive
(1 980 ÷ 120 000) x 100 = 1.65% confirmatory test positive
HCV: 2 880 donations were reactive in the screening test. Out of these, 2 688 were positive in the confirmatory test:
(2 880 ÷ 96 000) x 100 = 3.00% screening test reactive
(2 688 ÷ 96 000) x 100 = 2.80% confirmatory test positive

D BLOOD COMPONENT PREPARATION, STORAGE AND TRANSPORTATION

Number Percentage
13 Number and % of blood centres that prepare blood components 6 75%
14 Number and % of blood centres that prepare small paediatric blood units 3 37.5%

For indicator 13, provide the number of centres covered in the report that prepares blood components. Use the following
formula to calculate the percentage of centres that prepare blood components.
No. of blood centres that prepare blood components
% blood centres that prepare components = x 100
No. of blood centres covered in the report (indicator 2.3)

In this example:
(6 ÷ 8) x 100 = 75%

example of completed blood safety indicators form, 2010 6 of 9

 For Indicator 14, provide the number of centers covered in the report that prepare pediatric blood units. Using the
formulae below to calculate the percentage of centres that prepare paediatric blood units:

% blood centres that prepare No. of blood centres that prepare small paediatric blood units
small paediatric components = No. of blood centres covered in the report(indicator 2.3)
x 100

In this example:
(3 ÷ 8) x 100 = 37.5%

15 Number and % of whole blood donations separated into components 92 500 80.4%

Provide the number of whole blood donations that were separated into components. Express this as a percentage of
total whole blood donations (indicator 4.5a), using the formula below.

% whole blood donations No. of whole blood donations separated into components
x 100
separated into components = No. of whole blood donations (Indicator 4.5a)

In this example:
(92 500 ÷ 115 000) x 100 = 80.4%

16 Number of units of blood components prepared from whole blood

16.1 Red cell preparations 92 000
16.2 Platelet concentrates 6 597
16.3 Fresh Frozen Plasma 50 324
16.4 Plasma 41 112
16.5 Cryoprecipitate 10 223

The number of units of blood components prepared from whole blood is required.
1 unit of blood component is defined as the preparation from whole blood donations of 450 ml. If units of whole
blood used for component preparation are not 450 ml, please indicate the volume that is used in your country in the
‘Comments box’.
If platelet concentrates are pooled, the total number of the original platelet concentrates that were pooled should be
counted. For example, if 6 units of platelet concentrates were pooled into one bag, this should be counted as 6 platelet
concentrates rather than 1.

17 Number of units of blood components prepared through apheresis procedures

17.1 Apheresis red cells 0
17.2 Apheresis platelets 4 707
17.3 Apheresis plasma 3 677

For indicator 17, the numbers of blood units prepared through apheresis procedures are required.
When a single apheresis procedure produces more than one type of component (e.g. plasma and platelets), all units
of components should be counted.
One unit of apheresis platelets usually contains 200–450 x 109 platelets.

18 Number and % of whole blood donations/red cell components discarded, by cause

Number Percentage
18.1 Incomplete collection 278 0.24%
18.2 TTIs 9 951 8.65%
18.3 Date expiry 1 320 1.15%
18.4 Storage problems 150 0.13%
18.5 Transportation problems 210 0.18%
18.6 Processing problems 425 0.37%
18.7 Total 12 334 10.73%

example of completed blood safety indicators form, 2010 7 of 9

 Provide the number of discarded donations, by cause. Only donations with whole blood or red cell discarded should be
counted. For each category, use the following formula to calculate the percentage of donations that were discarded.
No. of donations discarded, by cause
% donations discarded, by cause = x 100
Total whole blood donations (Indicator 4.5a)

In this example:
% discards due to TTIs: (9 951 ÷ 115 000) x 100 = 8.65%

19 Number and % of blood centres that store blood and blood components in
7 87.5%
temperature-monitored equipment

Provide the number of centres covered in the report in which blood and blood components are stored in temperature-
monitored equipment. Use the following formula to calculate the percentage.
No. of centres that store blood/components in temperature-monitored equipment
% of blood centres = x 100
No. of blood centres covered in this report (Indicator 2.3)

In this example:
(7 ÷ 8) x 100 = 87.5 %

20 Number and % of blood centres that transport blood and blood

2 25%
components in temperature-monitored equipment

Provide the number of centres covered in the report in which blood and blood components are transported in
temperature monitored equipment. Use the following formula to calculate the percentage.
No. of centres that transport blood/components in temperature-monitored equipment
% of blood centres = x 100
No. of blood centres covered in this report (Indicator 2.3)

In this example:
(2 ÷ 8) x 100 = 25 %

E CLINICAL USE OF BLOOD AND BLOOD COMPONENTS

21 Number of hospitals in the country that perform blood transfusion 30
22 Number and % of hospitals performing blood transfusion that have or participate in:
Number Percent
22.1 Hospital transfusion committee 24 80%
22.2 Clinical audits 18 60%
22.3 Mechanism for reporting adverse transfusion incidents and reactions 21 70%

For indicator 21, provide the number of hospitals in the country where blood transfusion were performed. Please provide
national data if it is available. If partial data is provided, please give coverage information in the ‘Comments’ box.
Indicator 21 is also used as denominator to calculate indicator 22.
For each part of indicator 22, provide the number of hospitals which perform blood transfusion and that have or
participate in hospital transfusion committee, clinical audit, mechanism for reporting of adverse transfusion incidentss
and reactions. Express this as a percentage of the total number of hospitals in which transfusion is performed.

% hospitals with No. of hospitals with transfusion committee
= x 100
transfusion committee Total number of hospitals performing blood transfusion (indicator 21)

Example for 22.1:

(24 ÷ 30) x 100 = 80%
Clinical Audit: A quality improvement process that seeks to improve patient care and outcomes through systematic
review of the use of transfused blood components against transfusion guidelines and the implementation of change.
The aim of this process is to create a culture of delivering a quality service to patients and improve medical care on a
continuous basis.

example of completed blood safety indicators form, 2010 8 of 9

 23 Number of units of each of the following blood and blood components transfused/issued (excluding autologous
blood units) in the country
23.1 Whole blood 21 120
23.2 Red cells 81 030
23.3 Platelet, whole blood-derived 5 495
23.4 Platelet, apheresis 4 692
23.5 Fresh frozen plasma 33 250
23.6 Plasma 0
23.7 Cryoprecipitate 8 240

Provide the number of units of components listed that were transfused. If the number of units transfused is not
available, provide number of units that were issued/distributed to the hospitals. Please provide national data if it is
available. If partial data is provided, please give coverage information in the ‘Comments’ box.
Autologous blood units should not be included for this indicator.

24 Number of patients transfused in the country 73 220

For indicator 24, the number of individual patients who received blood transfusion is required. Patients who were
transfused on more than one occasion/episode in the reporting period should only be counted once. Please provide
national data if it is available. If partial data is provided, please give coverage information in the ‘Comments’ box. In
the example, 73 220 patients were transfused in the country during the reporting period.

25 Number of serious adverse transfusion incidents and reactions reported in the country
25.1 Serious adverse transfusion incidents 6
25.2 Serious adverse transfusion reactions 4
25.3 Total ( incidents and reactions) 10

Serious adverse incident: A case where the patient is transfused with a blood component that did not meet all the
requirements for a suitable transfusion for that patient, or was intended for another patient and that might lead to death
or a life-threatening, disabling or incapacitating condition or which results in, or prolongs, hospitalization or morbidity.
A serious adverse incident may be due to transfusion errors or to deviations from standard operating procedures or
hospital policies that have led to mistransfusion. It may or may not lead to a serious adverse reaction.
Serious adverse reaction: An undesirable response or effect in a patient associated with the administration of
blood or blood components that is fatal, life-threatening, disabling or incapacitating or which results in, or prolongs,
hospitalization or morbidity.
Please provide national data if it is available. If partial data is provided, please give coverage information in the
‘Comments’ box.

example of completed blood safety indicators form, 2010 9 of 9