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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.
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)
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.
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.
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".
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)
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.
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 _____________) – –
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
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.
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
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%
% 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%
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.
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.
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 %
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 %
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)
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.
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.