Vox Sanguinis (2016) 110, 185–188

© 2015 International Society of Blood Transfusion

SHORT REPORT DOI: 10.1111/vox.12323

Development of standard definitions for surveillance of

complications related to blood donation
M. Goldman,1 K. Land,2 P. Robillard3 & J. Wiersum-Osselton4
1
Canadian Blood Services, Ottawa, ON, Canada
2
Blood Systems Inc., Scottsdale, AZ, USA
3
He ma-Que bec, Montre al, QC, Canada
4
Dutch National Hemovigilance Office, The Hague, The Netherlands

Standard definitions of donor reactions allow each blood establishment to moni-

Received: 21 April 2015,
revised 20 July 2015,
accepted 21 July 2015,
published online 11 September 2015
tor donor adverse events and compare with other organizations to develop best
practices. The ISBT Haemovigilance Working Party leads a multi-organizational
effort to update the 2008 ISBT standard for surveillance of complications related
to blood donation. Revised definitions have been developed and endorsed by the
ISBT, AABB, International Haemovigilance Network (IHN) and other international
organizations.
Key words: blood collection, donor health, haemovigilance.

developed by the AABB and International Haemovigi-

Introduction
Although blood donation is very safe, a small number of
donors experience adverse effects at the time of or shortly
after donation [1–3]. These include phlebotomy-related
complications, such as bruising, and systemic reactions,
such as faint or prefaint reactions, often termed vasovagal
reactions. Rarely, these reactions may result in long-term
or permanent disability or injury to the donor. Reactions
may also lead to cessation of collection and loss of the
donation, and decreased likelihood of donor return.
National and international standards exist for donor
selection, blood collection procedures and quality man-
agement. In recent years, there has been an increase in
attention to monitoring and prevention of complications
of blood donation, that is donor vigilance.
Any donor vigilance system must begin with clear defi-
nitions of donor reactions. Clear definitions are important
to each blood centre to establish baseline reaction rates,
evaluate risk factors for reactions and assess the impact
of mitigating strategies or new collection procedures.
Internationally, the use of comparable definitions would
allow comparison and benchmarking among blood sys-
tems, and data entry into haemovigilance databases
Correspondence: Mindy Goldman, Donor and Clinical Services, Canadian
Blood Services, 1800 Alta Vista Drive, Ottawa, ON, Canada K1G 4J5
E-mail: mindy.goldman@blood.ca
lance Network (IHN).
At the present time, there is considerable variability in
the definitions of adverse reactions used by blood collec-
tion agencies. A survey distributed to members of the
Alliance of Blood Operators (ABO), including America’s
Blood Centers (ABC) and European Blood Alliance (EBA)
centres, in 2013–2014, revealed that 12 respondents were
using AABB definitions, four were using ISBT definitions,
18 were using custom definitions that could be referenced
to AABB or ISBT, and five were using other local classifi-
cation systems [4].
The donor vigilance subgroup of the ISBT Haemovigi-
lance Working Party therefore aimed to revise the 2008
ISBT standard for surveillance of complications related to
blood donation. The main goal of the revision was to pro-
vide simple definitions that were easy to apply in a stan-
dard way. The classification scheme includes both
minimal requirements for international comparisons that
meet the needs of a basic surveillance programme, and
optional attributes that might be important for process
improvement or lead to research in reducing the fre-
quency or severity of donor reactions.
Methods
After discussion of basic aims, a revision subcommittee of
the ISBT working party was formed, including members

185
186 M. Goldman et al.

from Canada (M Goldman, P Robillard), the USA (K Land, P
Tomasulo) and Europe (J Wiersum-Osselton), some of
whom were also part of the AABB Donor Hemovigilance
Working Group and the IHN. Classification schemes and
definitions used in various jurisdictions were compared. A
gap analysis was performed comparing the ISBT classifica-
tion scheme and AABB Haemovigilance classification
scheme and its related software, Donor-HART (Donor Hae-
movigilance Analysis and Reporting Tool) [3, 5].
There was substantial overlap between the two sys-
tems. In the local symptoms category, the major differ-
ence was in the categorization of pain syndromes. The
2008 ISBT classification included three different cate-
gories, injury of a nerve by a haematoma, injury of a

Table 1 Definitions of donor complications, optional categories in italics

Definition

A. Local Symptoms
A1 Blood outside vessel
Haematoma (bruise) Accumulation of blood in tissues
Arterial puncture Puncture of brachial artery or brachial artery branch
Delayed bleeding Rebleeding after initial bleeding has stopped
A2 Arm pain
Nerve injury/irritation Injury or irritation of a nerve
Duration < or > 12 months
Other arm pain Pain without characteristics of nerve irritation, large haematoma, or other possibly painful complications
A3 Localized infection/inflammation of vein or soft tissue
Localized infection/inflammation Inflammation along the course of a vein, which may progress to localized infection; there may be clotting
Optional split into 2 categories:
Thrombophlebitis Redness, swelling, tenderness extend along the vein
Cellulitis Redness, swelling, tenderness not localized to the vein
A4 Other major blood vessel injury – must be medically diagnosed
Deep Venous Thrombosis Thrombosis of a deep vein in phlebotomy arm
Arteriovenous fistula Acquired connection between vein and artery
Compartment syndrome Increased intracompartment pressure leading to necrosis
Brachial artery pseudoaneurysm Collection of blood outside an artery, contained by adventitia or the surrounding tissues alone
B. Generalized symptoms – vasovagal reactions
General feeling of discomfort and weakness with anxiety, dizziness and nausea, which may progress to loss of consciousness (faint)
No loss of consciousness The donor does not faint
Loss of consciousness The donor faints for a period of time
>60 sec, and/or complications
<60 sec, without complications
With or without injury Injury caused by falls or accidents
On or off collection site Before or after donor has left donation site
C. Related to apheresis
Citrate reactions Neuromuscular hyperactivity related to reduced Ca2+
Haemolysis Damaged donor red cells, releasing haemoglobin
Air embolism Air bubble introduced into the donor’s circulation
Infiltrationa Intravenous solute (saline solution) enters tissues
D. Allergic reactions
Local Red or irritated skin at the venipuncture site
Generalized (anaphylactic) Anaphylactic reactions may begin soon after starting the procedure, progress rapidly to cardiac arrest
E. Other serious complications – must be medically diagnosed, imputability assessedb
F. Other
Major cardiovascular event MIc, cardiac arrest, other acute cardiac symptoms, TIAd, CVAe, or death within 24 hours
after donation

a
When return fluid consisting of red cells in plasma and citrate goes extravascular, report under A1 Haematoma.
b
Only cases with definite, probable, or possible imputability included for international reporting.
c
MI: myocardial infarction.
d
TIA: transient ischaemic attack.
e
CVA: cerebrovascular accident.

© 2015 International Society of Blood Transfusion

Vox Sanguinis (2016) 110, 185–188
 Development of standard definitions for donor reactions 187

Table 2 Recommended numerator and

denominator data, optional data shown in Numerator data about each
italics complication Denominator data about all donors

Type of donation Total donations (proceed to phlebotomy)/year

(a) Whole blood (a) Whole blood
(i) Allogeneic (i) Allogeneic
(ii) Autologous (ii) Autologous
(b) Apheresis (b) Apheresis
(i) RBC – plasma – platelets (i) RBC – plasma – platelets
(ii) Platelets – plasma (ii) Platelets – plasma
(iii) Plasma only (iii) Plasma only
Gender of donor Gender of donors in each donation category
First time vs. repeat donor First time vs. repeat donors in each category
Age group (16–18, 19–22, 23–29, Age group of donors (16–18, 19–22, 23–29, 30–69, ≥70)
30–69, ≥70)
Type of complication Total number of donors/yr by type of donation, gender,
first time vs. repeat, age group

nerve and tendon injury, as well as a category of painful
arm where no further details allowed subspecification.
The AABB classification included one category, nerve
injury/irritation. In the systemic symptoms category, the
major difference was in the categorization of vasovagal
reactions. In the 2008 ISBT classification, the differentia-
tion between mild reactions and moderate reactions was
the absence or presence of objective symptoms (changes
in pulse and/or blood pressure or loss of consciousness);
severe reactions were characterized by hospitalization or
significant incapacity. The AABB haemovigilance defini-
tions and Donor-HART capture actual symptoms to
describe what is happening in a descriptive way without
necessarily grouping symptoms into categories [3]. For
example, there is a list of 12 symptoms and signs that
can be entered related to prefaint vasovagal reactions.
The presence and duration of loss of consciousness sepa-
rated mild, moderate and severe reactions. Injury was
considered a separate attribute.
The 2008 ISBT classification scheme did not mention
what specific parameters, such as donor age and gender,
should be included both for donors experiencing a reac-
tion, and for the total donor population. This information
is necessary for understanding the incidence of reactions
in different groups, and for performing risk factor analy-
sis [2, 6, 7]. The AABB Donor-HART system permits the
entry of many denominator dimensions. For example,
donors are split into nine different age groups and 15 dif-
ferent weight categories. This granularity may be valuable
for individual blood establishments and provide data for
hypothesis generation about reaction mechanisms and
risk factors [7]. However, it is beyond what many blood
establishments capture routinely and may add a heavy
data entry burden for establishments using manual data
collection. The opposing goals of simplicity and ease of
use and granularity to permit further analysis were in
part handled by having mandatory broad categories with
optional subcategories.
A draft version of the revised standard was circulated
to members of the ISBT and AABB Donor Haemovigilance
Working Groups and other industry groups such as the
ABO medical group and the EBA. Comments were
obtained from over 10 blood establishments and resulted
in further changes or explanatory comments regarding
the proposed classification scheme and denominator data.
Results
The revised classification scheme and abbreviated defini-
tions are shown in Table 1. The recommended numerator
and denominator parameters and basic information about
donor screening and collection practices are shown in
Table 2. Optional categories are shown in italics. The
mechanisms and signs and symptoms of each reaction, as
well as a data entry form, are included on the ISBT Web-
site [5]. Adjustments were made to the AABB Haemovigi-
lance definitions to easily align with the revised
classification system. Additionally, the Donor-HART soft-
ware was modified to more easily accommodate simpler
surveillance definitions and entry of a minimal amount
of aggregate denominator data.
In December 2014, the revised definitions and recom-
mended parameters to be recorded were published online
with joint authorship and ownership of the ISBT, the
IHN and the AABB, and formal endorsement by the EBA
and the ABO. Other international organizations, includ-
ing the WHO and the Council of Europe, have also been
notified.

© 2015 International Society of Blood Transfusion

Vox Sanguinis (2016) 110, 185–188
188 M. Goldman et al.

collection, analysis and sharing between organizations and

Conclusions countries. Ultimately, we hope that the classification
The availability of a classification system with clear, scheme will be a useful tool in enabling blood establish-
standard definitions is a first step towards better data ments to monitor and improve blood donor care and safety.

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© 2015 International Society of Blood Transfusion

Vox Sanguinis (2016) 110, 185–188