section

8.1
Adverse events and Distinction between serious and non-serious
Adverse events and adverse reactions range in severity from mild to moderate to

reactions during severe. The EU mandates that blood establishments notify the competent author-
ity in their country of any serious adverse events or serious adverse reactions which

blood donation may have an effect on the quality or safety of blood or blood components 1. Subsection
8.1.4 deals with levels of severity in a more detailed way. More information on notifi-
cation to competent authorities can be found in subsection 8.1.9.

8.1.1 Introduction
Donor safety is of paramount importance during blood sessions and is assured, in 8.1.3 Types and prevalence
so far as it can be, by donor selection guidelines, SOPs, adequately trained staff and This section focuses on adverse events and reactions that take place during and after
appropriate facilities. Despite these measures, various adverse events and reactions blood donation. Section 8.2 will describe adverse events and reactions in other situa-
can and do occur during and after blood donation. These complications can be a nega- tions in the donor management process.
tive experience for donors. Preventing them must be a priority.
Description and classification: Adverse events and reactions can manifest them-
Blood establishments have a duty of care to minimise the risks to donors. This is par- selves in several ways. To facilitate benchmarking, internationally accepted descrip-
ticularly so, as donating is of no proven health benefit for donors (other than for those tion and classification of adverse events and reactions was required. The Working
who have haemochromatosis). The uneven risk-to-benefit ratio for blood donors also Group on Complications Related to Blood Donation, a joint working group of the Inter-
places an ethical responsibility on health care givers, the users of blood donations, to national Society of Blood Transfusion and the European Haemovigliance Network was
avoid wastage and unnecessary use of blood transfusions. established for this purpose. In the public arena, the group uses the term ‘complica-
tion related to blood donation’ in preference to ‘adverse event or reaction’. However,
When donor complications do occur, it is essential that they are managed appropriate- the Working Group defines complications related to blood donations as ‘adverse reac-
ly. It is also essential that blood establishments analyse their complication rates and tions or incidents related in time to a blood donation (whole blood or aphaeresis)’ 2.
compare their data with those of other blood services, so as to promote best practice. They classify complications into two main categories: those with predominantly local
symptoms and those with predominantly generalized symptoms (the categorisation
This section will categorise types of complications, identify guidelines for managing is shown in Box 1). The term ‘complication related to blood donation’ will be used in
and preventing complications, describe the effect of complications on donor motiva- this entire section.
tion, and provide information on haemovigilance, notification and monitoring.
Complication statistics: Complications related to blood donation occur in about 1%
of all whole blood donation procedures 3. A higher frequency (3.5%) has been esti-
8.1.2 EU definitions mated from a donor haemovigilance programme on more than 6 million whole blood
Accidents and errors may occur at any stage in the process that starts at blood col- donations procedures in 2006 4. The differences in definitions most probably explain
lection and ends after transfusing a blood component to a patient. Serious adverse these different estimates of donor complication frequencies, but in any case donor
events and serious adverse reactions are defined by the European Union as follows 1. reactions are relatively frequent. It is well recognised that certain categories of donors
have higher reaction rates 5-8. Young age and first-time donor status have been associ-
Serious adverse event ated with higher reaction rates in many studies. Eder reported a complication rate of
Any untoward occurrence associated with the collection, testing, processing, storage and 10.7% in 16 and 17 year olds, 8.3% in 18 and 19 year olds and 2.8% in donors aged 20
distribution, of blood and blood components that might lead to death or life-threatening, years and older 5. She also found a higher incidence of donation relation injury (par-
disabling or incapacitating conditions for patients or which results in, or prolongs, hospi- ticularly physical injury from syncope-related falls) in 16 and 17 year olds compared
talisation or morbidity. with older donors5. Wiltbank, and later Kamel in an extended study from the same
group, found that compared to donors with no reactions, the strongest predictor of a
Serious adverse reaction reaction was a donor’s blood volume of less than 3,500 ml 6, 8. In addition, Kamel et al.
Any unintended response in donor or in patient associated with the collection or transfu- showed that 24% of the moderate and severe vasovagal reactions of the study were
sion of blood or blood components that is fatal, life-threatening, disabling, incapacitat- delayed, occurring more than 15 minutes after the collection. These delayed reactions
ing, or which results in, or prolongs, hospitalisation or morbidity. were significantly associated with female sex. Off-site delayed reactions (12% of the
delayed reactions) were more likely to be associated with a fall, with head trauma,
with other injury, and with the use of outside medical care 8.

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 Reporting limitations: It is also accepted that the reported rate of reactions is much
less than the true reaction rate. Newman solicited information from 1,000 randomly Box 1. Description of categories of complications related to blood
donation Source: Working Group on Complications Related to Blood Donation 2
selected donors three weeks after donation 9. He found that 36% of donors had had
one or more adverse events. The most common systemic adverse events were fatigue A: Complications mainly with local symptoms. These complications are directly
(7.8%), vasovagal symptoms (5.3%), and nausea and vomiting (1.1%). The most com- caused by the insertion of the needle.
mon arm findings were bruise (22.7%), arm soreness (10%) and haematoma (1.7%) 9. A1: Complications mainly characterized by the occurrence of blood outside the
vessels
-- haematoma
Causes: Jorgensen found that approximately one-third of complications were caused accumulation of blood in the tissues outside the vessels
by inserting the needle and two-thirds were vasovagal in nature 3. He comments that -- arterial puncture
99% of all complications collated by the EHN/ISBT common working group for 2005 puncture of the brachial artery or one of its branches
belonged to 4 common categories; vasovagal reactions (86% of all complications), -- delayed bleeding
haematomas (13%), nerve injuries (1%) and arterial punctures (0.4%). The other spontaneous recommencement of bleeding from the venepuncture site,
which occurs after the donor has left the donation site
reported complications together account for 1% of all complications. A2: Complications mainly characterized by pain
-- nerve irritation
Specific complications: Some complications are specific to aphaeresis donations, irritation of a nerve by pressure from a haematoma
e.g. citrate reactions, haemolysis, air emboli, allergic reactions to ethylene oxide -- nerve injury
used in the sterilisation of the harness, and thrombocytopenia and protein deficiency injury of a nerve by the needle at insertion or withdrawal
-- tendon injury
from excessive platelet or plasma donations respectively 10. The majority of aphaer- injury of a tendon by the needle
esis donors experience some mild citrate related side-effects e.g. metallic taste in the -- painful arm
mouth and / or tingling around the lips. This is an accepted occurrence and is consid- severe local and radiating pain in the arm arising during or within hours
ered to be a physiological effect of the anti-coagulant used in aphaeresis donations. following the donation, different from the other A2 categories
Most blood establishments will only report citrate related complications if they are A3: Other kinds of categories with local symptoms
-- thrombophlebitis
moderate or severe or if they result in the donation being discontinued. Donors who inflammation in a vein associated with a thrombus
donate granulocytes by aphaeresis may also experience allergic reactions to the -- allergy (local)
sedimenting agent that is used and may report steroid or growth factor related side- allergic skin reaction at the venepuncture site caused by allergens in
effects. solutions used for disinfection of the arm, allergens from the needle,
or from the band-aid
Potential adverse long term consequences of donation, such as iron depletion with or B: Complications mainly with generalized symptoms
without associated anaemia 11, 12 or increased bone resorption, as has been reported -- vasovagal reaction
in aphaeresis donors 13, are not currently reported as complications of donation. How- general feeling of discomfort and weakness with anxiety, dizziness and
ever, this may change, given time. nausea, which may progress to loss of consciousness (fainting)
· immediate vasovagal reaction symptoms occurred before the donor has
left the donation site
· immediate vasovagal reaction with injuryinjury caused by falls or acci-
dents in donors with a vasovagal reaction and unconsciousness before the
donor has left the donation site
· delayed vasovagal reaction
symptoms occurred after the donor has left the donation site
· delayed vasovagal reaction with injury
injury caused by falls or accidents in donors with a vasovagal reaction and
unconsciousness after the donor has left the donation site

C: Complications related to aphaeresis

-- citrate reaction
-- haemolysis
-- generalised allergic reaction
-- air embolism

D: Other complications related to blood donation

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8.1.4 Serious and non-serious; severe and non-severe
Complications range in severity from mild to moderate to severe. The European Union Box 2. Severity of complications.
uses the term ‘serious adverse events and reactions’. The EU compels blood establish- Source: Working Group on Complications Related to Blood donation 2
ments to notify serious complications that may influence the quality or safety of blood
or blood components to their competent authorities. Subsection 8.1.8 will deal fur- Level of severity Specification
ther with this notification. The term ‘serious’ used by the EU is comparable to that of
Severe Conditions which define a case as severe:
‘severe’ as defined by the Working Group on Complications Related to Blood Donation 2. complications
Non-severe complications are further classified as either ‘mild’ or ‘moderate’. Box 2 -- H ospitalization: if attributable to the com-
gives an overview of the levels of severity as described by the working group. plication
-- Intervention:
· t o preclude permanent damage or impair-
Severity: The vast majority of all complications are mild. However, some rare compli-
ment of a body function
cations are severe, such as accidents related to vasovagal reactions and nerve injuries · to prevent death (life-threatening)
with long-lasting symptoms 3. These can have serious consequences for the donor and -- Symptoms: causing significant disability or
can impact on his or her daily life. Vasovagal reactions that occur after the donor has incapacity following a complication of blood
left the donation session are of particular concern, due to the potential for the donor donation and persisted for more than a year
after the donation (long term morbidity)
to come to harm. These are called delayed reactions. It is believed that delayed vas-
-- Death if it follows a complication of blood
ovagal reactions account for 10% of all vasovagal reactions. Occasional deaths have donation and the death was possibly, prob-
occurred as a result of accidents following delayed vasovagal reactions 3. Sorensen ably or definitely related to the donation
carried out a retrospective analysis of Danish data relating to 2.5 million donations 14.
Non-severe Complications which do not satisfy any of the
He found that severe complications occurred with an incidence of 19 per 100,000
complications requirements for severe complications
procedures; two-thirds of these were due to vasovagal reactions with loss of con-
sciousness and one-third due to needle insertion. Non-severe complications may be subdivided into
mild and moderate complications, for instance for
the following
categories:

-- Haematoma
·m
 ild: local discomfort during phlebotomy only
minor pain or functional impairment
·m
 oderate: as mild but with major discomfort
during normal activities

-- Arterial puncture
· mild: no symptoms or local discomfort during
phlebotomy or haematoma
· moderate: local discomfort continuing after
the collection was terminated

-- Painful arm (subcategory specified or not)

· mild: symptoms for less than two weeks
·m oderate: symptoms for more than two
weeks but less than 1 year

-- Vasovagal reaction
· mild: subjective symptoms only
· moderate: objective symptoms

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8.1.5 Prevention strategies 8.1.6 Management
Several strategies can be used to reduce the risk of complications occurring during Adequate management of complications during blood sessions serves several goals.
and after blood donation. First, it is essential for the health and wellbeing of donors. Second, proper manage-
ment of complications helps to alleviate the negative effects complications may have
Prevention of type A complications on donor motivation and on donor return rates. Employees must be prepared and
Needle techniques: Good needle insertion techniques reduce the frequency and equipped to handle the most frequent complications. Protocols, training, first aid
severity of Type A complications. Jorgensen and Sorensen give the following advice on equipment and donor counselling are imperative.
needle insertion techniques 3.
Standard Operation Procedures
• Always move the needle forward in a slow ongoing movement. The management of complications must be clearly documented in Standard Operat-
• If the needle is not inserted in the vein at the first attempt, it is not advisable to ing Procedures (SOPs). The role of different professions e.g. medical doctors, nurses
do a second try by moving the needle a little bit backwards, change direction, and and donor attendants must be clearly outlined in these procedures. The SOPs must
then move forward again in a new direction, as this will increase the risk of injuries contain comprehensive information on the sequential steps that must be taken in the
and occurrence of haematoma, and thereby the risk of a severe complication. initial management of each complication and on the follow-up of donors after they
• Never try to insert the needle twice, using the same puncture site. Instead try the have left the donation session. The indications for referring donors for further medi-
other arm. cal assessment or treatment e.g. to an Accident and Emergency Department must
• Never ask for or give help if insertion was not a success, as this will always include be clearly defined. The standard advice that is given to donors who have had compli-
a try in a new direction. cations must be specified. Some donors who have had severe complications may be
advised not to donate again, e.g. a donor who had lost consciousness and suffered
Prevention of type B complications a head Injury. The type and severity of complication that will lead to a donor being
Type B complications, characterised predominantly as generalised symptoms such as advised not to donate again must be clearly defined.
vasovagal reactions, require different precautionary measures. Jorgenson and Soren-
son identify the following generally accepted, but not evidence-based, practices 3. Furthermore, the SOPs will give guidance on how to register the complication in the
blood bank information system. It is also advisable to develop an SOP for volunteers.
• Gentle treatment of the donor, providing refreshments before and after donation Volunteers, especially when they are assigned the task of observing donors after
to reduce the risk of vasovagal reactions. donation, must be informed of their responsibilities in case of a complication and
• Observing the donor during and after donation, treating the donor if a compli- must receive explicit instructions on the management of complications and on when
cation occurs and making sure the donor feels absolutely well before leaving the to turn to blood bank staff for assistance. Volunteers must be happy to take on these
blood session. duties and must be deemed competent to do so.
• Giving advice to the donor on secondary bleeding, driving, rest and return to work
after the donation. Asking the donor to contact the blood establishments if symp- Training
toms reoccur. Staff must be able to manage complications that occur during and after blood dona-
• Applying pressure to the venepuncture site and if necessary a pressure bandage if tion sessions. Frequent refresher instruction and training are recommended.
a haematoma is developing.
First aid equipment
The prevention techniques for type B complications listed below have been suggested Basic first aid equipment must be available at each blood session. Blood establish-
in several studies. ments vary in their practice with regard to the sophistication of the available equip-
ment. For example, some blood services routinely carry Automated Emergency Defi-
• Muscle tension: when a donor makes repeated and rhythmic contractions with brillators (AEDs) on all blood sessions, others do not.
the major muscle groups in his arms and legs, the blood flow to the brain can be
increased in order to prevent fainting.15, 16 Staff training: It is recommended that staff receive frequent refresher training and
• Distracting the donor during the bleeding procedure. Watching a movie could instruction on the use of the equipment that is available on their sessions. Providing
reduce stress in a donor 17. effective, life-saving initial care for an illness or injury that can follow blood donation
• Water or caffeine loading. Several studies have reported fewer complications requires instruction and practical training. This is especially true where it relates to
when donors drink water or coffee before their donation 18, 19. potentially life-threatening complications, such as those that require cardiopulmo-
nary resuscitation.

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 AEDs: The use of AEDs does carry a risk of injury to the donor, if used inappropriately. 8.1.7 Effect on donor motivation - next donation
Training is essential prior to use and only those who are competent in their use should A negative experience during blood donation can have a negative effect on donor
use the equipment. Training is generally provided by attending a course, typically motivation. Several studies have shown that experiencing a complication during the
leading to certification. Due to regular changes in procedures and protocols, based on bleeding procedure is an important factor that prevents donors from making a subse-
updated clinical knowledge, and to maintain skills, attendance at regular refresher quent donation 20, 21. France et al. 22 found that for light vasovagal reactions in whole
courses or re-certification is necessary. First aid training is often available through blood donors the likelihood of returning for a next donation reduced by 20% for first
community organisations such as the Red Cross or through commercial providers. time donors and by 33% for experienced donors. For moderate and severe vasovagal
This commercial training is commonly used for training of employees to perform first complications, return rates reduced by 50%. Gorlin and Petersen found that the more
aid in their workplace. severe a complication, the lower the return rate 23. Adequate handling of a complica-
tion, therefore, serves multiple goals: ensuring the donor’s health and retaining the
Managing emergencies: Each blood establishment must have clearly defined proce- donor for a subsequent donation.
dures for managing emergency situations. These will include prior arrangements with
local hospitals, medical doctors and the emergency services in order to assure the best
possible and prompt care for donors in emergency situations. 8.1.8 Haemovigilance and monitoring
Haemovigilance comprises a set of organised surveillance procedures relating to seri-
Donor counselling ous adverse or unexpected events or reactions in blood donors or recipients and the
It is an essential element of good donor care that each donor who suffers a complica- epidemiological follow-up of donors 1. It is a system of surveillance and alarm, from
tion of donation be given specific advice about the complication. This advice should blood collection to the follow-up of the recipients, gathering and analysing untoward
include information on the nature of the complication and on what the donor should effects of blood transfusion in order to correct their cause and prevent recurrence 24.
expect over the course of the complication. If, for example, the donor has a haemato- For blood donor management, haemovigilance related to complications occurring
ma he/she may expect bruising and discolouration that may be distal to the site of the during and after blood donation is particularly relevant. Haemovigilance in relation to
venepuncture. Many donors are surprised and concerned when they experience bruis- adverse patient outcomes is also important but lies outside the scope of this manual.
ing distal to the venepuncture site; thus, an adequate explanation of what to expect
can alleviate unnecessary concern. Ongoing complications monitoring: Most adverse event systems focus on severe
complications. It is highly recommended that data on non-severe complications is
Donor advice: Donors should be advised on measures they should take to prevent the also retained, in order that appropriate corrective and preventative action can be
complication from getting worse. For example, it is worthwhile to inform donors not taken. Both severe and non-severe complications can be investigated, analysed and
to use the donation arm for carrying heavy items such as bags of groceries if they have monitored so as to determine the root cause thereof. The resulting corrective and pre-
had a haematoma. They should also receive advice on how to prevent the complica- ventative actions taken will improve processes and procedures.
tion from recurring at the next donation. If necessary, the donor can be referred to a
General Practitioner or to an Accident & Emergency Department. Ideally, the verbal The use of a system to monitor adverse events in blood donors may be a useful adjunct
information given to the donor should also be available in a written format, such as a to monitoring donor deferral rates. Used in conjunction with deferral codes, the infor-
leaflet that the donor can take home. mation can be used to assess the impact of any changes to procedures or selection
criteria. A useful example would be a change in the upper or lower age limit. When
24 hour access: It is also critical that blood services provide 24 hour access to advice assessing the impact of this change, it would be useful to observe adverse event rates
for donors after donation. The 24 hour number should be readily available and all to ensure that there was no increase thereof. In addition, the availability of this data
donors should be advised of its existence after donating, as some complications of is useful to benchmark against the experiences of other organisations that apply dif-
donating only become apparent after the donor has left the blood session. ferent selection criteria. The data can help support the evidence base to change donor
selection criteria, obviously within the limits set by the EU in Commission Directive
Donor follow-up: If donors have had a complication, the blood service should make 2004/33/EU 25.
every effort to contact the donor in the days after his/her donation to enquire as to
how the donor is progressing. This is not only an essential element of good donor care,
but is basic ‘good customer relationships.’ As the complication may have a negative 8.1.9 Notification to competent authorities
effect on a donor’s motivation to make a subsequent donation (Subsection 8.1.7), the Complications during blood donation occur in different grades of severity, as described
follow-up of the donor and the provision of adequate information play an important in subsection 8.1.3. Articles 5.1 and 6.1 in EU Commission Directive 2005/61/EC 26
role in encouraging the donor to continue to donate. (Section 8.3 contains a compre- compel European member states to notify the competent authority in their country
hensive description of the donor counselling process). in cases of serious adverse events or reactions. In the DOMAINE survey on donor man-

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 agement, European blood establishments have reported that the average number
of serious adverse reactions in donors in 2007 ranged from 0 to 0.06% of all blood
section

8.2
Adverse events and
donors.
reactions: other
Blood establishments are compelled to notify only the serious adverse events and
reactions that influence the quality and safety of the blood components to their situations
national competent authority. Directive 2005/61/EC 23 provides further specifications
on the notification. All national competent authorities have to send an annual report
on the notifications to the European Commission. Additional legislation on notifica- 8.2.1 Introduction
tion of complications during blood donation may be present at national level. Some Besides complications during blood donation, as described in the previous section,
European countries require notification of all serious adverse events and reactions, several other adverse events may occur. This section concentrates on adverse events
including the cases that did not affect the quality and safety of blood products. that also have an effect on donor management: post-donation infection or other
information with consequences for blood safety and material damage.

8.1.10 Insurance
Donors who have suffered physical or material damage, related to a blood donation, 8.2.2 Post-donation infection or safety information
may file a claim with the blood establishment. Blood establishments need to have a This class of events relates to developments in relation to the donor that become
relevant insurance policy in order to cover the costs. apparent after the donation and blood screening results.

Post donation illness: Donors should be encouraged to report any illness, such as a
viral infection, that occurs shortly after donation. Depending on the circumstances, it
may be appropriate to recall blood components manufactured from the donation or
to defer the donor temporarily or permanently.

Late donor information: This is where a donor gives information relevant to blood
safety that they did not give at the interview, such as when they remembered that
they had taken medication; had contact with someone suffering from an infection;
or, for other reasons, had withheld personal information. Again, depending on the cir-
cumstances, it may be appropriate to recall blood components manufactured from
the donation or to defer the donor temporarily or permanently.

Reactive screening tests: A blood sample that reacts in a screening test will typically
be retested. A reactive laboratory test generally leads to discarding of the donated
unit. Repeated reactive laboratory tests may lead to permanent deferral of the donor,
referral for diagnostic confirmatory testing and counselling. Because of the risk of late
seroconversion, a look-back procedure may be appropriate and the recipients of com-
ponents manufactured from earlier donations identified. The look-back period will
be determined by the window period for seroconversion associated with the specific
infection.

8.2.3 Damage to donors and insurance

During a donation session accidents or serious events may happen, which may cause
damage to a donor’s possessions or loss of income. For example, spots of blood can
accidentally fall on a donor’s clothing, bag or other belongings, resulting in cleaning
bills or replacement costs, while fainting could lead to work absenteeism or direct loss

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 of income. Donors who have suffered damage may ask the blood establishment to
reimburse them for the costs involved. These costs are usually for nominal sums and
section

8.3
Establishing donor
most blood establishments are happy to do so, but may want to arrange a relevant
insurance policy. counselling services
Insurance policies: Blood establishments need to have relevant insurance policies
in place to cover the more unusual situations where larger amounts of money are 8.3.1 Introduction
involved e.g. if a donor was unfortunate enough to crash his/her car due to a delayed When significant results become evident or adverse events take place during any of
vasovagal. In this case the donor himself/herself may have been severely injured and the stages in the donor life cycle, counselling of the donor becomes important. A blood
the claim could be for a substantial amount for both personal injury, loss of earnings establishment can counsel adequately if one knows when to counsel and what out-
and damage to the donors’ property. comes to expect. Systems should be set in place to provide the ideal conditions for
successful counselling.

To ensure that a donor receives proper counselling, a Blood Collecting Team, BCT, or
blood establishment should have sufficient personnel and equipment, an adequate
infrastructure and, above all, adequate time. However, what is meant by sufficient or
adequate? This section outlines these aspects in more detail. Figure 1 shows in a flow
chart what is basically happening.
Donor

Post-
Recruitment Selection Donation donation

Significant
Results

Invite donor

Ensure:

Adequate Qualified Proper Right

time counselor atmosphere information

Counsel
donor
Suitable
Document Data Donor care

Figure 1. Counselling at a glance.

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8.3.2 Categories of conditions requiring counselling in a blood Fulfilling the criteria for SMART counselling can be achieved by making proper, prefer-
establishment setting ably written, agreements with the staff of the blood establishment.

Many conditions occur during everyday practice for which a blood establishment will
have to counsel the donor. Important conditions include the following. 8.3.4 Counselling process, additional elements
Additional requirements for counselling relate to available staff, infrastructure, infor-
• Conditions disclosed by the donor resulting in temporary or permanent deferral mation, communications and documentation.
(see Section 7.5 on donor selection and Section 7.6 on deferrals)
• Conditions identified during pre-donation health check Staff
-- Anaemia resulting in temporary or permanent deferral Sufficient and sufficiently trained personnel for counselling are of paramount impor-
-- Hypertension resulting in temporary or permanent deferral tance, particularly when information of a sensitive (and potentially life-changing)
• Conditions observed during or after donation nature is to be conveyed to unsuspecting donors. A blood establishment must take
-- Fainting/syncope: Managed according to SOP care of both these aspects.
-- Venepuncture-related problems: Managed according to SOP
• Conditions identified following blood tests • Appointed counsellors should be available in each BCT and at each blood
-- Serological findings: Irregular antibodies collecting session. Almost any member of a BCT or any member of blood
-- Transfusion Transmittable Infections, TTIs: HBV, HCV, HIV, HTLV, Syphilis, Chagas’ establishment-personnel, including blood establishment-volunteers, may face a
disease and other transmissible (infectious) diseases of regional importance donor in need of counselling. Nevertheless, it seems prudent to limit the number
• Other conditions of counsellors. Preferably, in each BCT, trained counsellors should be present: one
-- Motivation of donors with special or rare phenotypes to get enrolled in a physician and one nurse. In addition, each blood establishment should appoint
rare donor panel or aphaeresis programme administrative personnel, trained to do counselling in straightforward, non-
-- Donors who seek TTI testing and other health check-ups complex cases. However, in such a case, a trained counsellor (physician/nurse)
-- Donors who ask for post-donation self-exclusion must be available for back-up.

• Background training
8.3.3 Counselling process, basic elements -- Physician-counsellor: If a physician is part of the BCT, he/she could be the
Regarding counselling requirements, one may distinguish two levels: basic elements team counsellor. Also, when the physician is the only staff member to perform
and additional elements. Basic elements, or prerequisites for the donor counselling donor selection, he/she will be the obvious person to act as counsellor. How-
process, without which donor counselling could do more harm than good, are self-evi- ever, in other cases, a physician could act as the back-up counsellor.
dent. In fact, analogous to the description of managerial targets, counselling must be -- Nurses can also be counsellors, provided they are adequately trained. Depend-
SMART: Specific, Measurable, Accepted, Realistic, and Time-bound. ing on their background training they may treat more or less complex cases.
-- Appointed administrative members of the blood establishment may deal
• Specific: When counselling takes place, no matters should be discussed other than with straightforward donor eligibility queries, for example, when a poten-
the issue of immediate concern. Only then can successful counselling be envisaged. tial donor phones asking how long he/she has to wait before donating after
Discussing more than one topic almost unavoidably will result in confusion. returning from a tropical holiday.
• Measurable: All counselling should be both consistent and accurate, leaving no
doubt on the content of the message. The message must also be reproducible, Infrastructure
meaning that the message, when given twice, should have the same content. The only physical requirement for the infrastructure where donor counselling takes
• Accepted: The counsellor should fully accept the donor and the donor’s feelings, place is that it should ensure adequate privacy, whether in a fixed location or mobile
irrespective of their circumstances. Responses to the donor’s needs must not be setting. This should be done in a friendly atmosphere and in a separate area where the
affected by the counsellor’s feelings. counselling session is not overheard. Therefore, any part of a room, provided there is
• Realistic: Counselling should be appropriate to the cultural settings and should the possibility of avoiding direct contact with others, can be satisfactory. Preferably,
preserve confidentiality boundaries at all times (see section on Ethics and legal each blood collecting site should have at its disposal a separate room that guarantees
considerations). privacy and that has the right, clean atmosphere to maximize the possibility of get-
• Time-bound: Adequate time should be taken to counsel donors. Many times, the ting a difficult message across.
message will change the donor’s life perspective. In taking adequate time, trust
can be developed and the information is more likely to come across.

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 Information and information systems Therefore, it is very important to understand the different aspects of donor counsel-
Language and phraseology of the written information available to hand over to donors ling and to identify the key elements to make such counselling sessions successful and
after counselling must be easily understood by the target audience. This will ensure beneficial to both the donor and the transfusion service.
that the correct information is at hand when the donor returns home. The information
should include important addresses and telephone numbers, in case the donor is in
need of extra help.

Websites: Computerised information systems are an important tool in preventing

mistakes and guaranteeing that the right information is available at each stage of the
donation process. If available, internet facilities will greatly assist and speed up infor-
mation transfer. To this end a blood establishment website that includes information
on negative aspects of blood donations would be very helpful. Negative aspects, pref-
erably with relevant links to other websites include the following elements.

• Risks in the blood transfusion chain from donor to patient

• Non-compliance with selection criteria
• Deferrals for negative medical findings
• Unintended effects of blood donation
• Untoward (laboratory) test results

Communication
At times the counsellor will want to refer the counselee to health care institutions.
Moreover, some of the information is important for recipients of blood products, while
authorities may want to be informed as well. Therefore, the blood establishment staff
must have all the addresses and telephone numbers available of the following organi-
sations.

• Local/regional health care facilities

• Users/receivers of blood products
• Authorities/government

Documentation
A donor management information system (donor registry), electronic or manual, to
facilitate the counselling of the right donor at the right time must be in place. (See also
Chapter 12 on Information Technology).

8.3.5 Possible outcomes of donor counselling

The content and outcome of the counselling session varies according to the issue to be
addressed during the session. Table 1 lists the different outcomes of donor counselling
in different situations.

The counselling or discussion objectives with the donor or potential donor vary and
determine the content and the approach of such counselling. For example, counsel-
ling a donor with a rare blood group and convincing him to get enrolled in a rare donor
panel to give more donations and save more lives initiates positive emotions. A donor
receiving bad news about having tested positive for HIV will feel very differently.

174 Donor 175

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Manual 2010
 References

Medical referral depending on local practice, 3rd parties

1 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 set-
ting standards of quality and safety for the collection, testing, processing, storage and distri-
bution of human blood and blood components and amending Directive 2001/83/EC. Official

Medical referral depending on local practice

Nutritional Advice, Iron status assessment
Journal of the European Union, L33, 8/02/2003, p.30
2 Working Group on Complications related to Blood Donation, International Society of Blood

WNV, Dengue, Malaria, SARS, Flu, …?

Cultural aspects need consideration

Transfusion Working Party on Haemovigilance and European Haemovigilance Network
(2008). Standard for Surveillance of Complications Related to Blood Donation. Retrieved March

Re-entry sometimes possible

Alcohol/drugs, 3rd parties?
Alcohol/drugs, 3rd parties
18 2010 from http://www.isbt-web.org/documentation/default.asp
Other actions, remarks

3 Jorgensen J & Sorensen BS, (2008). Donor vigilance. ISBT Science Series, 3(1), 48-52
Nutritional advice

4 Eder AF et al. (2008). The American Red Cross donor hemovigilance program: complications
of blood donation reported in 2006. Transfusion, 48(9), 1809-1819

3rd parties
5 Eder AH, Hillyer CD, By BA, Notari EP & Benjamin RJ (2008). Adverse reactions to allogeneic
whole blood donation by 16- and 17-year-olds. JAMA, 299(19), 2279-2286
6 Wiltbank TB, Giordano GF, Kamel H, Tomasulo P & Custer B (2008). Faint and prefaint reac-
tions in whole-blood donors: an analysis of predonation measurements and their predictive
Life-style

Yes
Yes
Yes
Yes
Yes
Yes
Yes

No
No
No
No

No
No
No

value. Transfusion, 48(9), 1799-1808

?
?
?

issues
7 Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH & Popovsky MA (1999). A case-controlled
Psycho-
multicentre study of vasovagal reactions in blood donors: influence of sex, age, donation sta-
Yes

No

No
No
No
No
No
No

No
No
No
No
No
No

social

?
?
?
?

referral tus, weight, blood pressure, and pulse. Transfusion, 39(3),316-320

Medical 8 Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC & Custer B (2010). Delayed
Yes
Yes
Yes
Yes
Yes
Yes
Yes

No
No
No
No

No
No

?
?

?
?

referral adverse reactions to blood donation.Transfusion, 50(3), 556-565

9 Newman BH, Pichette S, Pichette D & Dzaka E (2003). Adverse effects in blood donors after
Previous donations resulted in serious complication for the
Abnormal test results interfering with the blood bank tests

get enrolled in a rare donor panel and/or aphaeresis pro-

whole-blood donation: a study of 1,000 blood donors interviewed 3 weeks after whole-

Donors who seek TTI testing and other health check-ups

Motivation of donors with special or rare phenotypes to
blood donation. Transfusion, 43(5), 598-603
Donation related reactions: syncope, venepuncture

10 Winters JL (2006). Complications of Donor Apheresis. Journal of Clinical Apheresis, 21(2), 132–

Donors who ask for post-donation self-exclusion

141
Other medical conditions requiring follow up

11 Farrugia A (2007). Iron and blood donation - an under-recognised safety issue. Developmen-
tal Biology, 127, 137-146
12 Page EA, Coppock JE & Harrison JF (2010). Study of iron stores in regular plateletpheresis
donors. Transfusion Medicine, 20 (1), 22-29
13 Dettke M, Buchta C, Bieglmayer C, Kainberger F & Macher M & Hocker P (2003). Short and
Risk factors for receiver

long term effects of citrate on bone metabolism and bone mineral density in healthy
recipient (e.g. TRALI)

plateletpheresis donors. Journal of Clinical Apheresis, 18, 87

First time donors
Chagas’ disease
Temporary or permanent deferral

14 Sorensen BS, Johnsen SP & Jorgensen J (2008). Complications related to blood donation: a
Hypertension

Recruitment
Hepatitis C
Hepatitis B

population-based study. Vox Sanguinis, 94(2), 132-137

Condition

Other TTI
Anaemia

gramme
Syphilis

15 Ditto B, France CR, Lavoie P, Roussos M & Adler PSJ (2003). Reducing reactions to blood dona-
HIV

tion with applied muscle tension: a randomized controlled trial. Transfusion, 43(9), 1269-
1275
Special Situations
Donation related
selection criteria

16 Ditto B, France CR, Albert M & Byrne N (2007). Dismantling applied tension, mechanisms of a
Failure of donor

special features
Healthy donors
screening test

treatment to reduce blood donation-related symptoms. Transfusion, 47(12), 2217-2222

Donors with
Positive TTI

Abnormal
Situation

17 Bonk VA, France CR & Taylor BK (2001). Distraction reduces self-reported physiological reac-
anxiety
results
results

tions to blood donation in novice donors with a blunting coping style. Psychosomatic Medi-
cine, 63(3), 447-452
18 Hanson SA & France CR (2004). Predonation water ingestion attenuates negative reactions
Table 1. Different outcomes of donor counselling in different situations
to blood donation. Transfusion, 44(6), 924-928
? = to be determined

176 Donor 177

Management
Manual 2010
 19 Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J & Heringhausen J (2007). The
effect of a 473 ml (16 oz) water drink on vasovagal donor reaction rates in high-school stu-
dents. Transfusion, 47(8), 1524-1533
20 France CR, France JL, Roussos M & Ditto B (2004). Mild reactions to blood donations predict a
decreased likelihood of donor return. Transfusion and Apheresis Science, 30(1), 17-22
21 Newman BH, Newman DT, Ahmad R & Roth AJ (2006). The effect of whole-blood donor
adverse events on donor return rates. Transfusion, 46(8), 1374-1379
22 France CR, Rader A & Carlson B (2005). Donors who react may not come back: analysis of
repeat donation as a function of phlebotomist ratings of vasovagal reactions. Transfusion
and Apheresis Science, 33(2), 99-106
23 Gorlin JB & Petersen J (2004). Reactions in first-time high school blood donors. Transfusion,
44(3), 463.
24 Debeir J, Noel L, Aullen JP, Frette C, Sari F, Vo Mai MP & Cosson A (1999). The French haemov-
igilance system. Vox Sanguinis, 77(2), 77-81
25 Commission Directive 2004/33/EC of 22 March 2004 implementing directive 2002/98/EC of
the European Parliament and of the Council as regards certain technical requirements for
blood and blood components. Official Journal of the European Union, L91, 30/03/2004, p.25
26 Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/
EC of the European Parliament and of the Council as regards traceability requirements and
notification of serious adverse reactions and events. Official Journal of the European Union,
L256, 1/10/2005, p.32

CHAPTER

178 Donor
Management
Manual 2010
Authors:
Matheos Demetriades 09
179
section

9.1
Multiple-transfused •
•
Thalassaemia major and intermedia
Sickle cell disease

patients •
•
Diseases of the newborn
Stem cell transplantation - heterologous or autologous - for malignant or non-
malignant disorders
• Leukaemias and myelodysplastic syndromes
9.1.1 Introduction • Immune deficiencies
This section describes patients who constitute the multiple-transfused or special • Coagulation disorders, such as haemophilia
patient groups. In addition, it covers issues dealing with the procedures that blood
establishments have implemented in order to cover needs in blood and blood prod- Each of these groups requires different quantities and types of blood product, and
ucts of the various groups of multiple-transfused patients identified in the DOMAINE puts a particular strain on the blood transfusion chain.
survey. The focus is on blood collection and processing. All other processes dealing
with screening for infectious diseases are beyond its scope. Epidemiology of haemoglobin disorders
Globally, it is estimated that more than 500,000 children with haemoglobin disor-
One of the aspects of this section is the identification of ‘Good Donor Management’ ders are born every year, 30% of whom are in middle- and high resourced countries 1.
practices that blood establishments have devised in order to manage donors and cov- Of these children, 40% are born with thalassaemia and 60% with sickle cell anaemia.
er the needs for multiple-transfused patients, especially relating to rare blood types. About 50-80% of children with sickle cell anaemia and about 20-40% of children
with thalassaemia major die every year. In the last 10 years, haemoglobin disorders
First, a brief description is given of some groups of the multiple-transfused patients, are slowly emerging as a serious public health priority, whose prevalence has signifi-
highlighting patients with haemoglobin disorders, who are now presenting a chal- cantly increased for two reasons: the influx of migrant populations from highly affect-
lenge to blood establishments across Europe. A short summary follows on the special ed developing countries, and the development of improved diagnostic technologies
processes implemented by blood establishments in donor management, identified by and care of patients.
the survey, in order to cater for special groups of patients.
It is estimated that, in order to keep alive 500,000 new affected transfusion-depend-
ent patients worldwide, many more additional units of blood will be required. This
9.1.2 Multiple-transfused patients number of units cannot be specified with accuracy, since the new cases will have dif-
Several patient groups form a special category of individuals who have long-term and ferent requirements in red blood cells (RBCs) depending on the severity of their con-
special transfusions needs: multiple-transfused patients. To cover their needs, many dition to the already existing requirements are needed. It is estimated that about
blood establishments across Europe have developed various methods to recruit new 20,000 living transfusion-dependent patients reside in Europe, and an additional
and retain regular donors, especially donors with rare blood types. This practice has 1,500-2000 babies with these disorders are born each year. The latter is, in part, due
become of critical importance since the progress of medical science has introduced to the circumstance that in many European countries, no comprehensive control
new therapies, allowing longer survival in chronic disorders, extending such patients’ programme or national prevention strategies yet exist 2. As a result, the blood supply
lives. needs to increase each year, to cover the needs of these patients.

A significant number of such patients depend on blood-transfusions. In addition, the Thalassaemia

influx of migrant populations across Europe, from countries that are highly affected Thalassemia is particularly demanding in terms of quantity of blood, especially for
with haemoglobin diseases, not indigenous in Northern European populations, accen- patients with thalassaemia major. These patients have a hereditary disorder: their
tuates the need for good donor management of rare blood phenotypes. Examples of need for RBC transfusions starts from early infancy and continues throughout life.
such diseases are thalassaemia and sickle sell disease. Their therapy requires life-long With comprehensive medical care, their life-span is now over 50 years in developed
safe and adequate blood supply. countries.

Each of the major medical conditions that require long-term blood transfusion is RBC transfusions are required to increase the haemoglobin level, but also to suppress
briefly described below, highlighting only the haemoglobin disorders which are rap- non-effective red blood cell formation and non-effective red cell producing tissue in
idly becoming a challenge to European blood establishments. bones. In this way, vitality, normal growth and avoidance of deformity are achieved 3.
Apart from all the potential dangers of blood transfusion, these multiple-transfused
patients are especially vulnerable to antibody formation, reactions to blood compo-

180 Donor 181

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 nents, transmission of infectious agents and iron overload. For these reasons, they Stem cell transplantation
require both a constant supply of adequate and safe blood to maintain their haemo- Patients in need of stem cell transplantation are a group of individuals with severe-
globin levels (above 9g/dl)3 and special attention needs to be paid to the following issues. ly, medically-induced immuno-suppression. Their endogenous haematopoiesis has
been destroyed and replaced with donor stem cells. For prolonged periods of time, the
• Exact compatibility with the patient, which requires extensive phenotyping patient may need to be supported by the following blood products.
• Appropriate processing, storage and transport
• Quality laboratory screening and other procedures for reducing the risk of • Red cell concentrates to maintain the haemoglobin level
transmission of pathogens • Platelet concentrates to prevent bleeding from thrombocytopenia, derived from
All these safety measures require meticulous quality control of blood establishments several donors
and donation policies based on regular voluntary, non-remunerated collection of blood. • White cell concentrates administered usually in acute infections
• Immunoglobulins (IgG)
Sickle cell disease
Most sickle cell patients maintain an acceptable haemoglobin level and do not require Infections, whose treatment requires blood products derived from pooled donor
life-long blood transfusions. However, during vaso-occlusive crises and infections, blood, render these patients particularly vulnerable to complications and infectious
periodic transfusions may be needed. In some circumstances, more regular transfu- agent contamination.
sions are needed to relieve anaemia and improve blood flow, and prevent new compli-
cations. Such circumstances include the following. Leukaemias and myelodysplastic syndromes
Leukaemia patients face serious haematological disorders. They often have their endog-
• Haemolytic episodes and severe anaemia enous haematopoiesis suppressed by chemotherapeutic agents and irradiation. They
• Prevention and treatment of stroke require comparable blood product to the previously described group of transplant patients.
• Prolonged priapism In fact, these patients may also be candidates for stem cell transplantation. Patients with
• Lung infarction or pneumonia myelodysplastic syndromes may need regular blood transfusions for several years.
• Frequent and severe outbreaks of pain
Immune deficiencies
These may be treated by simple transfusions or by regular exchange transfusion which Patients with congenital immune deficiencies need protection with immunoglobulin
may better increase blood flow. The risks to these patients then become the same as preparations throughout their lives in order to be free from life-threatening infec-
those faced by regularly transfused thalassaemia patients. This includes iron overload tions. IgG preparations are derived from pooled plasma. This pooling process harbours
and, when overt, iron chelation should be considered. risks of contamination from infected donors, especially with HIV and HCV.

Diseases of the newborn Coagulation disorders

Neonates in intensive care may require blood products to support them. Examples of Patients with coagulation disorders have a deficiency in one of the blood clotting fac-
dispositions and disorders, requiring transfusions include the following. tors, mainly Factors VIII and IX. Replacement therapy is required regularly in most
patients with severe deficiency: milder cases can be dealt with through periodic
• Anaemia, premature babies are particularly susceptible and may require several replacement to prevent bleeding. Blood clotting factors can be derived from human
‘top-up’ transfusions. The blood product required in this situation is pure RBC. blood serum or from recombinant industrially manufactured ones. In the past, HIV
• Babies with haemolytic disease, such as caused by Rhesus (Rh) incompatibility, infection was transmitted by clotting factors derived from pooled plasma. Strict donor
may require exchange blood transfusions, not only to increase the foetal selection is necessary to avoid such tragic consequences.
haemoglobin, but also to reduce the bilirubin levels which may cause brain
damage. In specialised centres, these transfusions may also be performed intra-
uterinely in the yet unborn child. 9.1.3 Dealing with multiple-transfused patients with special
• Serious neonatal infections may require the support of another blood product transfusion requirements
(usually immunoglobulin IgG). This product may also be used in another condition Even though data is missing from non-responders, especially from private blood
which affects premature and low-birth weight babies, such as necrotising establishments, the general trend that the DOMAINE survey has revealed on donor
enterocolitis. management for multiple-transfused patients is that blood establishments across
Europe, although not uniform, have procedures in place to deal with these blood
requirements, to recruit and maintain a pool of relevant blood donors.

182 Donor 183

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Manual 2010
 No standard strategy for donor management
It is noted that no standard strategy for donor management in Europe exists. More
section

9.2
Multiple-transfused
than 52% of the countries involved in the survey have a special strategy for donor
management specifically directed to provide blood products for these groups of patients and donor
patients. However, the nature of the strategy implemented and the type of ‘spe-
cial donors’ registry established in each country, largely reflects the type of chronic mobility
patients a blood establishment deals with in its region and country, as is the case in
countries with large ethnic minorities, large numbers of thalassaemia patients, or 9.2.1 Introduction
many patients undergoing cancer or organ transplantation treatment. A decade ago, neither patient nor blood donor mobility at European level was given
much thought. The Treaty of Amsterdam 4, 5 made it clear that health systems, which
Within the general population, awareness of the need to recruit prospective donors include the blood establishments, were a matter for national governments. This sec-
for these groups of patients is largely absent. Steps needed to enlarge the donor base tion gives a brief overview on the new situation that is created with the increased
with special blood types are dealt with in more detail in Chapter 5. migration of populations across Europe, and the opportunities for improvement
that may arise with regard to donor management for chronic patients. Finally, a brief
Strategies used throughout Europe description is provided of the costs that may be implicated in implementing these
The patients described above, form a miscellaneous group which are often immuno proposed improvements for better donor management.
suppressed and in need of multiple transfusions or lifelong transfusions. Most of the
blood establishments involved in the DOMAINE survey provide blood products for the
needs of these groups of patients. Most blood establishments also regularly inform 9.2.2 Migration and demography
their (regular) donors about special blood requirements, using various means of com- Population migration in an expanded Europe is slowly increasing: not just migration
munication tools such as telephone, email or text messaging (SMS). Regular donors of patients, but also of prospective donors. Collaboration between health systems
may be recalled for donation when the need arises, including when recruiting for neo- across borders could now become of major benefit.
natal patients. Special collections may be organised for ethnic minorities to cater for
their needs. In fact, patient mobility is considered a positive step towards opening new opportuni-
ties not only for the patient, giving greater choice for quality health care in another
Donor panels country that in his/her country is lacking, but also in that it helps to clarify Europe-
Furthermore, in order to meet the demand for ‘special or rare blood phenotypes’, a an standards of quality of care. This allows improved cross border collaboration and
special donor panel policy is advocated for registering donors with these special phe- access to high quality of information. For example, some minor disorders can be man-
notypes. These donors may be excluded from making regular donations to keep them aged in a single episode of care. However, many patients may present an aggrava-
available for the donor panel. tion of a pre-existing condition, where either visiting or migrating to another country
requires communication with the patient’s usual health care provider. This means
that medical records preferably are accessible and understandable by different health
providers; for example, between various blood establishments where procedures for
follow-up assessments and rehabilitation should be available and shared.

Opportunities for improvement

Most of the blood requirement problems arising from chronic patients’ mobility stem
from the restricted collaboration and the limited sharing of patient and donor data
between European blood establishments. Patient and donor mobility now present
unique opportunities for improvement that may help to avoid duplication of proce-
dures and unwarranted draining of resources, both human and financial, within blood
establishments. Concurrently, a solid blood donor base for chronic patients could be
sustained including the following possibilities.

• E-Health: EU wide blood establishment donor information systems, within

the framework of their countries systems, may lead to better coordination of

184 Donor 185

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Manual 2010
 information technology through regional and European networks. Collaboration References
between blood establishments may help to avoid duplication, for example, of 1 World Health Organization (2006). Management of birth defects and haemoglobin disorders:
screening or confirmatory procedures. This means more efficient use of existing report of a joint WHO-March of Dimes meeting, Geneva, Switzerland, 17-19 May 2006. Geneva:
capacities across borders, which, in turn, will increase mutual learning through World health Organization
exchange of knowledge and experience on ‘best practices’. 2 World Health Organization (2008). Management of haemoglobin disorders: report of joint WHO-
• Sharing patient and donor records between blood establishments for improved TIF meeting, Nicosia, Cyprus, 16-18 November 2007. Nicosia: World Health Organization
and faster provision of services to chronic patients. 3 Cappellini MD, Cohen A, Eleftheniou A, Piga A, Porter J & Taher A (2008). Guidelines for the
clinical management of thalassaemia, 2nd revised edition. Nicosia: Thalassaemia International
Federation
9.2.3 Implicated costs 4 European Union (1997). Treaty of Amsterdam. Luxembourg: Office for Official Publications of
Each of these opportunities requires one or more of the following cost items. The the European Communities
projected expenses for the above-stated recommendations can be shared not only 5 Brusse R, Drews M & Wismar, M. (2002). Consumer choice of healthcare services across bor-
between collaborating blood establishments, but also with other stakeholders and ders. In: Brusse R, Wismar M & Berman P (Eds.), The European Union and health services: The
institutions. impact of the single European market on member states (231-248) Brussels: IOS Press

• A
 dministrative Personnel Personnel directly involved in administration and
processing of information, including information. It does not include personnel
costs of IT, transport and overheads.
• Services Purchase of services between collaborating blood establishments for
specialised laboratory testing or blood processing.
• IT-system
-- IT-personnel for support and maintaining the information network between
blood establishments, and between blood establishments and hospitals
-- Hardware: Computer and printing equipment
-- Software: IT-software systems that will alert blood establishments and hos-
pitals for any increased demand for ‘special blood group’ phenotypes
-- ID-card for chronic patient, enabling the patient to notifying the nearest hos-
pital and blood establishments in his/her vicinity of new residence
-- ID-card for ‘special donors’ for automatic recall
• Transport/logistics:
-- Drivers: personnel costs
-- Transport vehicles: purchasing costs, maintenance and fuel costs
• Overheads Donor costs that are not specified elsewhere

Conclusions
Multiple-transfused patient mobility presents a challenge to blood establishments
and other involved stakeholders such as hospitals. Even though the introduction of a
European information network for sharing donor and transfusion-dependent patient
information may present a financial obstacle at the beginning, nonetheless, in the
long-term, it will save both human and financial resources for blood establishments
and will assist them to anticipate the potential fluctuations in terms of their client
and donor base. More importantly, it will present a unique opportunity for chronic
multiple-transfused patients to receive a good quality and timely service.

186 Donor 187

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 CHAPTER

188 Donor
Management
Manual 2010
Authors:
Dragoslav Domanovic
Matheos Demetriades
Riin Kullaste
Wim de Kort 10
189
 Donor management in
section

10.1
this situation requires immediate replacement or resupply of the region’s blood
inventory from another region

disaster situations1 • A sudden influx of donors, requiring accelerated drawing of blood to meet an
emergent need elsewhere 1

1
This section is largely a re-edited version of the American Association of Blood Banks’
issue on disaster management (Disaster operations handbook 1) 10.1.3 Experience from previous disaster situations
All disasters are unique; however, lessons from the past can be very helpful for improv-
ing one’s knowledge about disasters and providing better response programmes.
10.1.1 Introduction Analyses of former disaster situations have shown that there has not yet been any
Blood transfusion is a significant factor in reducing the number of deaths in disasters. situation where the immediate need for blood or blood components has been beyond
Strong community response to disaster is triggered by socially embedded, disaster the capabilities of the blood community 6. The requirements for blood in large disaster
related altruism and sympathy in the general population. For instance, the publicity situations has mainly been determined by the number of injured who survived long
given to blood donation and transfusion during World War Two helped create a strong enough to be presented for care and the rate of blood used in providing that care 2. The
link in the public mind between the individual act of donating blood and the care of single greatest risk of disasters is not lack of supply but disruption of the blood distri-
victims of war and disaster 2. Blood donations are thereby increased in both the disas- bution system 1. More lessons learned are stated in Box 1.
ter-affected and unaffected regions.

However, blood is rarely needed in excessive quantities at the moment a disaster Box 1. Lessons of the past: recommendations
occurs, and the outpouring of blood donations, especially at the site of a disaster,
• E nsure that facilities maintain inventories to be prepared for disasters at all
often proves counterproductive 3. To avoid such events, and in order to be prepared to
times in all locations. Keep a seven-day supply of the combined inventory of
respond to a disaster effectively, many of the activities that normally are involved in both blood collectors and hospitals
the blood supply chain should be planned and adjusted to take account of the precise • Control collections made in response to a disaster that are in excess of actual
nature of the disaster and the resulting needs. need
• Send a clear and consistent message to the community, donors, and the public
regarding the status of the blood supply (both locally and nationally) during a
This section reviews topics covering blood supply and blood donor management
disaster
in disaster situations that will help blood establishments, hospital blood banks and • Organise continuous disaster planning, including participation in disaster drills
blood transfusion services to prepare for and respond to disasters affecting the blood and close coordination with local, state, and federal response agencies
supply. • Entail overall inventory management within the country, including a unified
approach to communication among blood facilities and transportation of blood
and blood components during a disaster 1

10.1.2 Definition
The word disaster stems from the Old Italian word disastro, which means in the astro-
logical sense a calamity blamed on an unfavourable position of a planet 4. There are 10.1.4 Disaster management
various definitions and classifications of disaster in the literature derived from the Each blood establishment should plan, prepare and remain prepared for a disaster
complexity of such events. However, a disaster is a natural or man-made event that situation. The process of emergency management involves four phases: mitigation,
negatively affects life, property, livelihood or industry often resulting in permanent preparedness, response, and recovery 7. In all four phases, key issues (see Box 2) must
changes to human societies, ecosystems and environment 5. In the context of blood be dealt with adequately. At the end of this section some special aspects of disaster
supply, the word ‘disaster’ refers to the following characteristic events giving rise to management (managing people and working with the media) are addressed.
these needs.
I. Mitigation is the most cost-efficient method for reducing the impact of hazards;
• Suddenly requiring a much larger amount of blood than usual however it is not always suitable. Mitigation efforts attempt to prevent hazards from
• Temporarily restricting or eliminating a blood collector’s ability to collect, test, developing into disasters altogether, or to reduce the effects of disasters when they
process, and distribute blood occur. They focus on long-term measures for reducing or eliminating risk. In the con-
• Temporarily restricting or preventing the local population from donating blood, text of blood supply the mitigation strategy can be the building of frozen RBC stock
or restricting or preventing the use of the available inventory of blood products: especially 0 RhD negative.

190 Donor 191

Management
Manual 2010
 ter, each employee should be made aware of, and trained in factors required to imple-
Box 2. Key issues in disaster blood management ment key elements of the national and internal disaster plan. The exercises should be
followed by a written knowledge assessment to ensure competency and to evaluate the
• Leadership (including command, control and management structure)
• Prioritisation of activities course. The organisation should schedule annual refresher training for all staff, along
• Communication with quarterly or semi-annual disaster drills that include resource-sharing groups.
• Maximising and managing the available supply (including shortage
management) The response plan should be centred at the blood establishment in the affected area
• Recipient safety and donor deferral
that acts as a main conduit for information and communication 1. The activation of
• Donor safety and availability
• Staff safety and availability the response plan is a step-by-step process. The affected blood establishment’s role is
• Consumables and supply chain resilience to assess the local medical need for blood and to communicate this need to the blood
• Equipment and infrastructure supply coordination authority. This authority will then consider the magnitude of
• Finance needed response and recommend an action strategy including, but not limited to, the
shipment of blood to the affected blood collector, and the coordination and dissemi-
nation of a message to the national blood community and donors.
II. Preparedness encompasses a response plan that is constructed and adapted
in accordance with national and local public health guidance and, where possible, The blood supply coordination authority facilitates coordination among national
should also be devised to be generic and flexible enough to respond to almost every blood organisations, blood competent authority, regional, state, and local government
disaster outbreak. bodies. This is necessary to determine the medical need for blood, facilitate transpor-
tation of blood from one facility to another, and to communicate a common message
III. Planning and response require contact, collaboration and consultation with to the national blood community and the public about the status of the blood supply
major stakeholders, such as the blood establishment management board, regulatory in the disaster-affected area and the nation. General assumptions are that all disas-
bodies, donor organisations, hospitals and users of blood services, staff and contrac- ters are inherently local. Immediate shipment of required blood products will be from
tors, health and public health departments, neighbouring blood organisations, and blood establishments with access to the most rapid means of transportation to the
neighbouring countries. Disaster plan preparation strategies should be centred on the affected blood establishment. The blood supply coordination authority will reassess
major response action areas for blood establishments. All this is needed to set up a tai- the needs 24 hours after the event (and daily as necessary) and may alter the strategy
lor made Disaster Blood Collection Plan that should address the items mentioned in for meeting blood needs, depending on the circumstances 1.
Box 3. Planning and response to disaster are exhaustively elaborated in the American
Association on Blood Bank’s Disaster operations handbook 1. The following blood products are the most likely to be needed in each of the following
phase of a disaster.

Box 3. Essential elements of a Disaster Blood Collection Plan • First 24 hours: type O red blood cells (RBCs), Rh negative
• One to ten days: RBCs (all ABO/Rh types) and platelets (PLTs)
• Assess the medical need for blood • Eleven to thirty days: RBCs, PLTs, and (for radiologic incidents) stem cells and
• Assess the maximum collection limits (consider staffing, collection, testing,
bone marrow 1.
storage, etc.)
• Prioritise the type of blood products to collect
• Decide what to do with extra donors (e.g., draw samples from new donors, IV. Recovery phase. After the disaster event, the response plan should be deactivat-
schedule future appointments) ed and the recovery phase should begin. The aim of the recovery phase is to restore
• Decide what to do with eventual donor shortages the affected area to its previous state. Recovery efforts are primarily concerned with
• Decide what to do with scheduled blood drives and mobile operations that are
actions that involve rebuilding destroyed property; re-employment; the repair of oth-
under way
• Tell donors how they can help immediately and in the future er essential infrastructure; re-scheduling blood donation sessions.
• Update contact information for donors displaced by the event
Managing donors, volunteers, and crowds
Once a disaster has occurred, blood establishments should activate strategies to man-
Continuous education and training of the blood establishment staff on the disaster age donors and volunteers. The messages to the blood donors and local community
plan, as well as active drills are necessary to ensure that planned response will run through local media should be coordinated and assessed by the blood supply coordi-
smoothly and will be managed properly. Upon hiring, and, at least, annually thereaf- nation authority.

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 10.1.5 Specific disaster events
Box 4. Crowd control Specific disaster events can have various potential impacts on the blood supply. It is
necessary, therefore, to create specific disaster operation plans for every particular
• D uring a mobile blood collection session, blood establishments should be
prepared to control a donor crowd by the following means hazard present in the relevant area. The Canadian Disaster Database (CDD) 8 catego-
• Maintaining frequent communication with waiting donors rised disasters in five different types as follows.
• Enforcing limits on the number of donors staff can handle
• Shutting down, where appropriate, mobile collection sites to focus on certain • Biological disasters
large or fixed sites
• Geological disasters
• Relocating the primary collection site if it is not sufficient or operational (locate
facilities for mass collections) • Meteorological disasters
• Setting up triage tables where donors can be screened for ABO group, medical • Human conflict disasters
questions can be answered, and pledges can be obtained • Technological disasters
• Allowing plenty of parking
• Setting and communicating clear working time (especially a time to shut down
because the lines may be endless)
10.1.6 Biological disasters
The following paragraph on pandemic influenza was based on the document Pandem-
ic influenza, planning for blood establishments by the European Blood Alliance 9.
Blood establishments, with appropriate and carefully prepared messages, should dis-
courage donors from appearing en masse until the medical need has been assessed. Pandemic influenza
However, they should be prepared to control significant crowds of blood donors as The impact of a severe human influenza pandemic on the blood supply is likely to be
well as to react if blood donor shortage appears (see Box 4). Special concerns with staff very significant and specific for blood organisations. The risk of transmission of influ-
and volunteers are shown in Box 5. enza through transfusion of blood components itself or associated activities is low
since major symptoms and viremia tend to closely coincide.

Box 5. Staff and volunteers: Special concerns However, measures should be taken to minimize any risk of additional transmissions
via blood transfusion. Donors should be screened for absence of influenza symptoms
• Take steps to prevent staff and volunteer burnout and asked about recent close contact with ill persons. They should also be asked to
• Ensure that sufficient water, food, HVAC (heating, ventilation, air conditioning), report any personal illness emerging soon after donation.
and restroom facilities are available
• Issue temporary security identification to volunteers
Reduced demand: Due to an expected (probably temporary) reduction in elective health-
• Assign predetermined, non-regulated tasks to volunteers
• Identify the assigned contact person for volunteers care only a modest (10-25%) reduction in demand for red cells and no reduction in
• Train volunteers on their exact responsibilities demand for other blood components is assumed. The demand for specialised diagnostic
• Track volunteers by getting their names, phone numbers, and training status services provided by blood services is likely to be reduced too. The demand for fractionated
• Maintain records of each volunteer’s responsibilities. blood products is assumed not to be significantly changed by a pandemic influenza.

Affected donors: Blood donors will be affected by pandemic influenza to the same
extent as the general public. Therefore, they will generally be much less likely to
Working with the media donate blood and will not be eligible to donate until several weeks after making a full
When a disaster has occurred, it is imperative to inform the general public about blood recovery from influenza, or for some time after they have been in close contact with
supply needs. To communicate these needs to its current donor base and potential new an infected person.
donors, blood establishments should contact print and broadcast reporters (if reporters
are not already calling the blood establishment) to provide them with an accurate, con- Staff shortages: Staff of blood establishments and the suppliers and contractors
cise message. However, before talking to the media, blood establishments should speak on whom it depends will be severely impacted by the pandemic. Staff absence rates
to and cooperate with the blood supply coordination authority to ensure that a consist- could peak between 25% and 40% with small teams potentially being hit even harder
ent message is being delivered. Blood establishments should have updated local media (up to 100% absence) for short periods of 2-3 weeks. There is a small but real risk that
lists (TV, newspapers, radio stations, wire services), delegate the spokesperson(s) and entire departments or sites could be forced to close for short periods due to lack of key
prepare drafts of press releases. (See also Section 10.2 Media). staff. Where possible, put in place backup arrangements for such staff.

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 Key consumables: The supply of key consumables to blood organisations as well as 10.1.7 Geographical disasters
their own infrastructure, IT systems, vehicles and equipment could be impacted due Geological disasters generally do not create an immediate need for blood. Floods and
to insufficient staff or as a result of equipment breakdown and abnormal difficulty in earthquakes immobilize a community’s transportation and medical care infrastruc-
sourcing timely repairs. As a result of the pandemic, there will be a significant impact ture, including the blood supply with subsequent failure to fulfil the demand.
on the economy as a whole with lost capacity and income.
Earthquake
Advance planning: The response to pandemic influenza should be planned and the The blood supply could be directly affected by the severity of the earthquake. Blood
disaster plan activated in accordance with the current situation in a particular affect- usage may not be initially significant, but the event could significantly hamper collec-
ed country. The overall response objective for the blood organisation is that of main- tion activities if a large area is deemed uninhabitable. Hospitals may temporarily sus-
taining the supply of critical blood products and services at the level demanded by the pend elective surgeries, followed by a spike in such surgeries once operations are back
healthcare community throughout the pandemic, the recovery period and, if applica- to normal. Blood establishments should make special preparations to ensure that
ble, subsequent pandemic wave(s). The importance of ensuring that widely accepted operations can be quickly resumed following an earthquake (facilities, power supply,
shortage management plans are prepared and published in advance of a pandemic staff, transportation).
cannot be over-emphasised.
Post-earthquake communication: Communication channels damaged through
Response management: Managing the response should be a top priority. To maxim- earthquake should be reactivated with hospital customers (i.e., to contact each other
ise the chances of maintaining services for the entire duration of the pandemic, the as soon as the event is over). The blood establishment should also notify staff, donors,
response should be carefully paced. The major objective will be to make every effort and vendors of the facility’s status. In addition, a process should be established to rou-
to ensure a continued supply of safe, high quality, life-saving products and services. tinely update these groups until full operational status is restored. Hospital customers
Standards, operating procedures and related duties and requirements should only be should also be contacted after the earthquake to assess their operational status and
varied to the minimum extent necessary to respond to the disaster. Every effort should blood product needs 10.
be made to maintain normal high standards of service to, and care for, donors and to
create an environment in which donors are encouraged to donate and will feel safe to Alternative suppliers and premises: The use of alternative suppliers may be needed.
do so without being at increased risk of influenza infection. If the blood centre’s main facility is to be evacuated, activate emergency relocation
procedures.
Staff and contractors: The blood establishments will need to support staff and con-
tractors so as to optimise their ability to help provide critical, life-saving blood com- Floods
ponents and services. Additionally, it will need to address the physical, emotional and In an area where flooding has happened, the impact may be small, but can also be dev-
psychological safety and well-being of staff and others to whom it has health and astating. The blood supply may suffer little or no impact unless the blood establish-
safety obligations before, during and after the pandemic. ment or its hospitals themselves are flooded. Hospitals may suspend elective surger-
ies until the event has passed, followed by a spike in such surgeries when operations
Internal communications policy: It will be important to provide regular, up-to-date and are back to normal. Citizens may decide to donate blood to help the victims, which
accurate information to employees, their staff side organisations and other key stakehold- may result in a donor surge. If the blood establishment is flooded, emergency evacua-
ers regarding the pandemic and the blood service’s operational response. This is essential tion should be executed to ensure the safety of staff. Blood donors, hospital customers
for ensuring understanding of, and agreement and mutual commitment to overcoming and other staff should be notified.
the pandemic and to maintaining the supply of essential products and services.

Proportionality: The response should be flexible so as to remain as proportionate as

possible to the evolution of the actual pandemic in real time, consistent with govern-
ment and public health advice. Actions that would facilitate the spread of the pan-
demic should be avoided.

Cooperation, national and international: Blood establishments should exchange

information with, seek help from, and provide help to other international blood serv-
ices where this is feasible and necessary. They should work especially with other blood
services with whom there are operational or national inter-dependencies.

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10.1.8 Meteorological disasters Whole blood consumption markedly increases during the war while the use of compo-
Storms (hurricane, tornado, thunderstorm or winter storm) may have a negative effect on nents drops. Deviations from standards and prescribed procedures are common and
blood collections in the days before (local efforts to prepare for the storm) and right after should be carefully approved and monitored.
the storm (reparation activities). In addition to the potential loss of blood collections, there
may be a slight decrease in elective surgeries shortly before and after the storm, followed Wars cause infrastructure damage, staff shortages, and transportation problems, thus
by a spike in such surgeries once hospitals in the region resume full operations. increasing the inefficiencies in a blood supply system at the same time as the need
Occasionally the storms can cause significant, even catastrophic damage. Tornadoes for blood supply increases. War creates additional injury victims in need of blood and
and severe windstorms pose a direct risk to blood facilities and to other medical struc- removes individuals from the donor population: these combined factors can produce
tures in their path. Blood may be needed to treat casualties, which may number from shortages in blood supply.
a few to scores. Blood collection schedules may be disrupted, depending on the sever-
ity of the tornado and the size of the destruction path. New medical technologies: The recent development of haemorrhage control band-
ages based on fibrinogen plus thrombin and chitosan, as well as drugs such as recom-
Blood establishments should make special preparations to ensure that operations binant FVIIa, provides more rapid haemorrhage control and reduces the need for
can be quickly resumed following a storm and that disrupted communication chan- blood replacement.
nels are repaired so that they can contact hospital customers as soon as the storm has
passed. Walking donor transfusion is the collection and transfusion of previously typed and
screened whole blood from a healthy donor (soldier) to a patient in need of a lifesav-
Wildfires: A wildfire with devastating effects displaces people from their homes and ing transfusion. As a rule, military personnel are typed and screened during initial
businesses. Blood usage has historically not been significant during wildfires. If the processing to the military.
facility is affected by a wildfire, the blood supply will be quarantined until its safety,
purity, and potency can be determined. A common response of the public after a disas- Biological event
ter is to donate blood, so it is important to prepare for a donor surge. The deliberate release of viruses, bacteria, or other germs (agents) poses the greatest
threat to the collection of blood products. Depending on the type of agent involved in
Heat waves: A heat wave hinders blood donations and causes blood shortages. In high the event, staff, volunteers, and donors may be infected; facilities and vehicles may be
temperatures, blood donor turnout and response to appeals are low and deferrals for contaminated; donors may have to be deferred.
low haemoglobin are more frequent 11. Blood drives in the non air-conditioned facili-
ties and mobile units are often cancelled because the heat makes the mobile centre Depending on the biological agent, local authorities may direct the blood establish-
uncomfortable. However, the need for blood and blood usage is not correspondingly ment to implement its shelter-in-place plan or evacuate. Because of the various incu-
changed; therefore, such heat waves could lead to blood shortages. bation periods of different agents, the blood establishment may be required to con-
duct an aggressive call-back of donors who develop symptoms after a blood donation.
In the summer season, more frequent blood drives should be planned. Blood estab-
lishments should communicate their concerns about blood shortages to the general Quarantine: Mandated quarantine measures or self-initiated actions by the popula-
community, to existing blood donors, as well as to the hospitals. Additionally, they tion could result in loss of blood donations. Such measures or travel restrictions may
should assure air-conditioned blood donation areas, and adequate refreshment with also prevent or hinder blood establishment employees’ ability to travel to work and
drinking water for the donors before and after donation. collection sites, and may affect access to the supply chain for critical supplies, equip-
ment, and fuel.

10.1.9 Human conflict Nuclear explosion

Human conflicts, such as wars, biological events, nuclear explosions and explosive A nuclear explosion combines large-scale blast damage with dispersal of radioac-
events can have major consequences for the blood supply. tive material. Unlike conventional mass-casualty events, large numbers of trauma
patients over a wide area could consume available blood components to the maxi-
War mum capacity of functioning hospitals. In the aftermath, patients with severe radia-
The supply and use of blood during war are specific for every particular country and tion toxicity would have compromised hematopoiesis and would need bone marrow
require efficient cooperation between national and regional civilian authorities and transplantation (see paragraph 10.1.10, radiological incidents).
blood banks, as well as the military chain of command and medical units. Response
plans of both sides should be harmonised at national level.

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 National coordination of supply and demand for blood components and hematopoi- Radiological incidents
etic progenitor cell units would be required as part of the overall emergency response. An accidental or terrorist dispersal of radioactive material can have a different spec-
If the event occurs elsewhere in the world, demand for matched stem cell donations trum of biological effects, depending on its type, amount, half-life (environmental and
would be generated. internal persistence), and particles emitted (penetrating distance). In blood banks,
cesium-137 (Cs-137) in blood irradiators could become problematic in the event of
Explosive event a catastrophic barrier breach or acquisition by terrorists. Radiation toxicity includes
A large blast from an accidental industrial, military, or flammable-material source, or suppression of hematopoiesis, and victims may need RBC (red blood cell), platelet, and
from an intentional terrorist or criminal bomb, can cause high immediate mortality. granulocyte transfusions: hematopoietic stem cell transplantation may be considered.
Survivors would require resuscitation and surgery with associated transfusion sup-
port. Local inventories of blood components would need assessment for adequacy Where radiation is widely dispersed, blood collections would be curtailed if the public
and augmentation. Surges of blood donors have occurred after such events, and coor- (staff and donors) were advised to shelter in place for a period of time during assess-
dinated public announcements about the blood supply are helpful to strike the appro- ment and early radioisotope decay. Blood donors may need extra screening or labo-
priate balance between supply and demand. ratory testing (blood lymphocyte count) for whether they have taken antiradiation
medication or have evidence of radiation exposure by symptoms (e.g., vomiting).

10.1.10 Technological disasters Wide-area power outage

Technological disasters are subdivided into industrial accidents, chemical incidents, Wide-area power outages jeopardise the storage of blood. Backup generators oper-
radiological incidents and wide-area power outage. ate only until available fuel supplies are exhausted. Fuel resupply may be jeopard-
ised because power is needed to pump fuel and a wide-area outage will create higher
Industrial accidents demand for fuel. Blood collection will also be interrupted, which can have an impact
Industrial accidents such as fire, collapse of buildings, roads, or bridges, or explosions, five to seven days later when existing supplies of platelets are exhausted and replace-
can result in large-scale destruction and anywhere from a few to numerous human ments have not been collected.
injuries. If the industrial accident involves the blood establishment (such as a fire), the
blood supply should be quarantined until its safety, purity, and potency can be deter-
mined. Accidents that do not directly involve the blood establishment may or may not 10.1.11 Conclusion
require blood support, depending on the nature and number of injuries. The public Adequate and sufficient supply of blood components is an important part of emergen-
often responds by donating blood out of a desire to help. cy preparedness for disaster situations. It requires a robust and well developed blood
supply system, trained workers and well-equipped staging facilities, combined with
Chemical incidents thoughtful, flexible, evidence-based, emergency planning and efficient cooperation
Most chemical events (industrial, terrorist or household) do not increase the imme- between blood establishments and civilian/military authorities. Managing donors,
diate demand for blood products, although ’blood agents’ or nitrogen mustard com- volunteers and crowds as well as working with the media are vital parts of the blood
pounds may have complications requiring later blood product support. Depending on supply chain that should be especially carefully planned and enacted during disaster
the type of chemical, the projected path, and the wind speed, the blood centre may situations.
have little time to react. Blood establishment occupants may be directed by local
authorities to shelter in place until the chemical cloud/plume dissipates. Blood col-
lections may be lost, and transport of blood collected at local blood drives may be
adversely affected. Some militarised and industrial chemicals may require specific
decontamination of buildings and vehicles and the administration of antidotes to
people in the affected areas.

Blood collectors should be prepared to minimise the negative impact of a chemical

incident, ensure the reestablishment of operations, and protect staff, donors, and vol-
unteers.

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 Media
section

10.2
Using media is not as simple as it seems: many aspects must be considered. Whose
attention is one trying to get? What are their favourite media channels? Is the inten-
tion to build up, provoke, or call up and image? Thankfully, the abundance of choices is
used extensively by the people responsible for donor recruitment.
10.2.1 Introduction
Dealing with the media is a topic that deserves special attention. This section The DOMAINE survey on donor management in Europe (see chapter 2) clearly reflects
describes the media landscape that is applicable to blood establishments. It stresses the wide usage and importance of media. Donor management deals with two clearly
the importance of choosing the right medium and identifying important media for distinctive aspects of media use. First, the way blood establishments themselves use
different target groups. For communication purposes, it provides rules of thumb for and apply media in their donor management strategy and everyday practice. Second,
dealing with the media. the way media (RTV and newspapers) report on blood establishments in their work
and for their purposes.

10.2.2 Media, definitions

The term media is not easy to define. It is all around us, in its old meaning of ‘environ- 10.2.3 Use of media by blood establishments in donor management
ment’, but nowadays media has evolved.
Importance of media among the other recruitment methods
The Oxford Dictionary defines ‘media’ as ‘the means of mass communication, espe- Every single blood establishment uses many recruitment and retention methods.
cially television, radio, and newspapers collectively’. The term also relates to the Chapters 5 and 6 address these two donor management steps in more detail. The
world of information technology, communication and entertainment addressed to a DOMAINE survey shows that various media tools are used for both donor recruitment
huge audience. Over the past several years the ever developing kinds of communica- and retention.
tion technology have had a tremendous impact on everyday life and are impossible to
avoid. Media gadgets are attractive to everyone who has a message to communicate. • Commercials on national and local television and radio
• Advertising in national and local newspapers and magazines
From early oral forms, we now have a vast range of electronic media systems, col- • Advertising on websites
ouring every form of communication. There have been tremendous developments in
writing, printing, telegraphic, journalistic and audiovisual communication styles. Altogether 80% of blood establishments use websites, local radio and local newspa-
pers. More than half of the blood establishments use national media channels and
Marshall McLuhan, a famous media theorist said almost fifty years ago: ’The medium 40% use advertisements in magazines. The low priority of magazines in this list is
is the message’ 12. Therefore, choosing the right tool for communication may be more explainable by their lower frequency of appearing in print and relatively long prepara-
important than the actual message content. McLuhan’s words have been analysed tion time. These are two relatively new methods.
by many media theoreticians over the years. A good interpretation is given by Lance
Strate in 2008 13: • Cooperation with mobile phone companies for advertising
• Phoning people who have indicated their interest in donation by filling in a
’The words we think to ourselves seem different when we utter them out loud. The relevant internet survey
words we write down take on a permanence, distance, and impersonal quality in com-
parison to speech. Along the same lines, information does not exist in a vacuum. It can Media and their suitability for different groups of donors
be found riding radio waves or the electric current running through wires, or stored in In choosing the correct medium, the above mentioned ’medium is the message’ prin-
magnetic or optical form. Or information can be found in the sequences of chemicals ciple remains here in full force. The right media tool choice comes first and only there-
that make up strands of DNA and RNA. The code and the mode of information that is after the contents of the message itself. Not surprisingly, therefore, the DOMAINE
used will determine who has access to the data and who controls its dissemination, survey shows that 88% of the European blood establishments differentiate between
how much information will be distributed, how fast it will be transmitted, how far it media tools suitable for younger and older generations.
will travel, how long the information will be available, and the form in which it will
be displayed. As these variables change, so does the message that is being communi- Many blood establishments apply recruitment targeted towards young people – high
cated’. school pupils and students. New media technologies, internet, web based materials,
SMS text messages and e-mails are likely to be more effective for young people. Con-
ventional media such as TV, radio and newspapers work better for potential donors of

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 an older age. Younger generations adopt new technologies more often and more eas- Commercial considerations: Media outlets pursue their own goals: they sell rather
ily. It is important, therefore, not to be behind such technological novelties, as the line than give information. News value comes first in choosing issues. High value news
between conventional and unconventional media is moving all the time. sells easier than low value news. For example, the news value of one patient dying
from an erroneous transfusion can be a multiple of the ‘routine’ fact that one thou-
Effective use of media sand lives have been saved last year. Subsequently, their goal can be directly opposite
In general, blood establishments do not monitor cost-effectiveness of their recruit- to the goal of the blood establishment.
ment policy or strategy. For the most part campaigns’ successes are measured sim-
ply by the number of newly registered donors. It follows that the number of recruited Contacting the media
donors seems to be the only indicator of success, regardless of the costs. Attracting attention: Blood establishments may actively seek the help of the media,
by attracting attention in order to publish news or novelties relating to blood dona-
National television: According to the DOMAINE survey results, effectiveness of com- tion or their organisation. It may be a good and relatively cheap way to attract their
mercials on national television shares the first place with donor-recruits-donor meth- attention – via donor related news or novelties. Good examples of issues with news
ods in donor recruitment, but these two methods differ widely in costs since commer- value are celebrities visiting to the blood centre, opening a new facility, implementing
cials can be very costly. some progressive method in blood collecting or introducing an e-donor project.

Local radio and television: Other media tools in the top ten most effective recruit- New scientific developments: Many other news matters exist which deserve the
ment methods are commercials on local radio and local television, and advertising in attention of the public and the media; for example, new developments in the world
local and national newspapers. of blood transfusion will attract media attention and possibly generate new interest
among potential donors.
Donor-recruits-donor methods are cheap and straightforward, if performed wisely.
Public appeals: Practical information and general invitations to donate are effec-
Websites: Surprisingly, websites are generally not considered as effective recruitment tively brought to public through the media. Information and public appeals may be
methods. It brings up the question whether blood establishments underestimate the dispersed in a number of ways. Most commonly they take the following forms.
influence of internet. At the same time most blood establishments are convinced that
web media is the choice of younger people. If both conventional and unconventional • Publications – articles in the newspapers, magazines, or on the internet
media are used simultaneously, it is conceivable that applying conventional media is • News – TV, newspapers, internet portals
more efficient. Considering that ageing of the population presents a problem in most • Advertisements
European countries, recruitment of young and middle aged people will become the
key issue very soon. Finding the right approach must have high priority. Apart from publications issued through the blood establishment’s editorial office or
website, media organisations are the primary way of bringing information to the public.
Chapter 5 and 6 contain several examples of effective media use.
Press releases or interviews: Important ways of contacting the media are through
either press releases or interviews. Press releases are issued actively by the blood
10.2.4 Dealing with the media. Some practical advices establishment. Clear, factful and updated press releases represent a very important
tool that helps guaranteeing the quality of the information which will be issued. But,
Media and their goals of course, the initiative for interviews rests with the media.
Using the media is very important for image building and it is often a good idea to be
‘in the picture’. However, while dealing with the media several pitfalls exist. It is crucial Simple points of interest in dealing with the media are listed in Box 6 and Box 7.
to be aware of the way media operates when trying to convey messages through these
channels. The character of messages to be conveyed to donors or the public all together could be
divided into three categories.
Journalistic independence: One should realise that journalists and the media act
beyond control of the blood establishment. Freedom of press entails that one cannot
assume or ensure that media will duplicate your message exactly. They may give their
own interpretation to the information given by the blood establishment, which can
either be positive or negative.

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 3. Highly media sensitive and political issues
Box 6. Rules of thumb in press releases • Urgent or ‘red alert’ calls for blood
• The number of messages in a press release must be limited. Preferably just one
• Serious events, such as death in donors or patients, pandemics, large scale
• Be consistent accidents and disasters
• Be the first to bring out bad news. This is not synonymous with bringing out
the bad news fast. Careful phrasing and exact documentation of facts are Dealing with communication technology and the media is an important aspect of
paramount modern donor management. Handled prudently, it can greatly facilitate donor man-
• Gather all necessary information
• Be prepared for interviews
agement. To conclude, some remarks on the role of the media are important.
• Appoint a spokesperson. This person is to be the only person to address the
media • Regularly update your repertoire of media tools, as your imagination of possibilities
is limited. Remember that besides conventional media, unconventional media
exist. Gossip is inevitable.
• Bad media attention is not better than no media attention. On the contrary,
Box 7. Rules of thumb in interview contacts donors and especially potential donors are very sensitive to emotionally charged
appeals. Very often negative attention has a strong negative effect and could bring
• Be well prepared about great losses of donors.
• Answer the interviewer, but address the public in doing so • It is dangerous to overdo desperate appeals to the public. They gradually become
• Have all answers documented
ineffective.
• Do not give undocumented information. ‘I do not know’ can be a perfect answer
• Always stress the positive side of the matter, without denying the negative side
• Stick to your message
• Be consistent
• Transparency and sincerity pay. Hiding issues and distorting facts necessitates
a thorough book keeping of all the hidden and distorted facts. This is doomed
to fail
• Unexpected questions always arise. Use them to bring up your issue
• Do not fill in silent gaps with new messages. Say nothing or, if inappropriate, use
them to rephrase your message

1. Straightforward informative messages

• E
ducational items, popular scientific articles or written interviews in newspapers
and magazines, and talk shows on radio or TV
• News about novelties or events
• Use of celebrities or otherwise acknowledged positive media personalities
• Peaceful messages

2. Emotional or sensitive issues

• Provoking messages, such as
-- Patient stories
-- Stories on perceived declining intention or motivation to donate
• Small scale serious events, such as serious adverse reactions in patients or donors

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 References
1 American Association of Blood Banks (2003). Disaster operations handbook. Coordinating the
nation’s blood supply during disasters and biological events. Bethesda, Maryland: American
Association of Blood Banks
2 Hess JR & Thomas MJG (2003). Blood use in war and disaster: lessons from the past century.
Transfusion, 43 (11), 1622-1633
3 Klein G (2005). Transfusion during disaster. Vox Sanguinis, 89(s1), 204
4 Online Etymology Dictionary. Retrieved March 19 from http://www.etymonline.com /index.
php?search=disaster&searchmode=none
5 Quarantelli EL (1998). What is a disaster? London: Routledge.
6 Schmidt PJ (2002). Blood and disaster-supply and demand. New England Journal of Medicine,
346(8), 617-20
7 Haddon GD & Bullock JA (2004). Introduction to Emergency Management. Amsterdam: But-
terworth-Heinemann
8 Public Safety Canada. Canadian Disaster database. Retrieved march 19 2010 from http://
www.publicsafety.gc.ca/prg/em/cdd/srch-eng.aspx
9 European Blood Alliance Emergency Planning Action Group (EBA EPAG) (2009). Pandemic
Influenza-Planning for Blood Organisations. EBA
10 Sönmezoglu M, Kocak N, Öncul O, Özbayburtlu S, Hepgul Z, Kosan E, Aksu Y & Bayik M (2005).
Effects of a major earthquake on blood donor types and infectious diseases marker rates.
Transfusion Medicine, 15(2), 93-97
11 Hoekstra T, Veldhuizen I, Van Noord PA & De Kort WLAM (2007). Seasonal influences on
hemoglobin levels and deferral rates in whole-blood and plasma donors. Transfusion, 47(5),
895-900
12 McLuhan M & Quentin F, (1967). The Medium is the Message: An Inventory of Effects. New
York: Random House
13 Strate L, (2008). Studying media as media: McLuhan and the media ecology approach. Media
Tropes eJournal, 1, 127–142

CHAPTER

208 Donor
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Authors:
Matheos Demetriades
Dragoslav Domanovic
Satu Pastila
Elze Wagenmans 11
209
 Required
section

11.1
Data from the DOMAINE survey on donor management in Europe show that the larg-
est part of the total number of full time equivalents (fte) in donor management is

qualifications reserved for nurses, followed by donor attendants not qualified for venepuncture.

EU Commission Directives do not provide detailed guidance on required qualifications

for personnel: only general regulations are given. All staff involved in blood transfu-
11.1.1 Introduction sion activities should be competent and qualified to perform their tasks and should be
Among the various factors that impact blood supply efficiency and safety, having good provided with timely, relevant and regularly updated training 2, 3. No details are given
staff for blood establishments is of key importance to the whole system. New staff for required education, preparatory training and skills. More detailed qualification
must learn relevant aspects of blood donor management, which are not taught at requirements may be included in national legislation or in blood establishments’ own
school. Clear job descriptions, transparent hierarchical lines and strong commitment guidelines, such as medical degrees, nursing qualifications or other education and
are the mainstay of well functioning human resources management. The diversity of training in health care.
jobs and ways in which blood establishments are organised among European coun-
tries precludes describing the jobs and hierarchical lines in the context of this manual. In order to have the right person in the right position, both adequate employee recruit-
Here, focus is on competences, skills, attitudes and training. ment and staff training are important. When hiring new employees with no specific
background or education for their new position, specific job training can be offered,
This section aims to specify the personnel categories and qualifications, describe and e.g. for donor attendants (Section 11.2 contains more information on training).
discuss the role of volunteers, and to discuss performance indicators.

11.1.4 General competences: knowledge, skills and attitudes

11.1.2 The importance of good personnel Blood donor management requires general and professional competences that
Maintaining a safe and sufficient blood supply is the primary goal of blood establish- encompass a combination of knowledge, skills and attitudes. Areas of professional
ments: employees, both individually and collectively, contribute to achieving this competences include those listed in Box 1.
objective. Applying the principles of good human resources management to employ-
ees serves several purposes 1. It allows for optimal use and development of employee
knowledge and skills and it encourages efficient methods of working, high productivi-
ty, employee commitment and satisfaction. All of these result in low levels of sick leave Box 1. Professional competences in donor management
and low staff turnover.
Basic
• Knowledge of blood and blood banking practice
• Understanding the country, its people and its culture, including that of
11.1.3 Positions and required qualifications in donor management minorities
Several positions are involved in the donor management process. Although exact job Medical
titles may vary from country to country, in general, the following positions exist. • Basic nursing competences
• Venepuncture techniques
• Blood donation procedures
• Medical doctors responsible for donors • Donor health and safety management
• Medical doctors responsible for clinical or patient consultation • Management of adverse events and reactions, including first aid
• Nurses Behavioural
• Donor attendants, qualified for venepuncture • Motivation, ability to understand the psychology of (non-)donors
• Liaising with donors, donor organisation and blood banks
• Donor attendants, not qualified for venepuncture • Planning information, education and communication (IEC) materials
• Communication, marketing and public relations staff • Evaluating launched programmes
• Donor administration staff, including call centre staff • Counselling
• Support staff, such as finance and control, and facility management Management
• Quality assurance • Organising blood donation sessions
• Assisting in relieving emergencies and blood shortages
• Transport • Administration, including record keeping
• Volunteers on several jobs, such as donor catering and administrative positions • Working with computers
• Other, country-specific positions

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 Knowledge and background training Crucial attitudes
Blood donor management requires information and knowledge from different dis- The attitudes described in Box 4 are considered as general qualities of staff involved in
ciplines, such as medical science, sociology, psychology, biomedical sciences, com- blood donor management.
munication sciences and organisation sciences. People with background training in
bioscience, social science, management science, transfusion medicine, blood banking,
haematology, pathology, medicine, surgery, education, psychology, communication, Box 4. General attitudes
public relations, ethics or literature may be prepared for work in donor management
• Compassion and empathy
through special training programmes prepared by experts in the field. Their basic spe-
• Understanding
cialist knowledge generally requires upgrading and additional training on specific • Patience
knowledge in the donor management field. • Politeness
• Imagination and innovation
Skills • Enthusiasm and stamina
• Strong motivation, conviction and dedication
Box 2 shows skills for which all staff in blood donor management will be held account-
able - both in their daily performance and in their performance reviews. These com-
petencies are equally important to all professional skill requirements of blood donor
management. Desirable attitudes
Additional attitudes desirable for management staff are shown in Box 5.

Box 2. General skills

Box 5. Additional attitudes for management staff
• Task-related skills, such as venepuncture
• Ability to work in a team and to solve problems • Loyalty
• Skills in oral and written communication • Recognition that blood is a valuable product that should be treated with great
• Change control care
• Incident reporting • Commitment to providing excellent blood donor service by treating others with
• Quality management a positive and proactive attitude that demonstrates interest in helping the
• Safety and security blood donors, and going the extra mile when necessary
• Following through on commitments in a timely and efficient manner and
keeping blood donors appropriately appraised when delays occur
Additional specific skills • Actively and patiently listening to donors to ensure that their needs and
expectations are well understood before providing service
Besides these general skills, specific skills are required for management staff, stated • Recognizing that each blood donor is a unique individual and important to the
in Box 3. blood supply chain

Box 3. Additional skills for management staff

11.1.5 Tasks and responsibilities
The donor management process comprises a variety of tasks. These tasks are divided
• P lanning skills: ability to conduct planning in blood donor management for among several staff positions. For every position and for every employee an up-to-
geographic areas. Understanding of transportation and infrastructure planning date job description should be available, clearly describing their tasks and responsi-
• Computer skills: skilled in word processing, able to use descriptive statistical bilities 3. Furthermore, an organisational chart showing the hierarchical structure of
packages, knowledgeable about blood donor management information systems
• Organisational skills: ability to organise blood donation sessions
the organisation and the delineation of lines of responsibilities is recommended 4.
• Communications skills: effective in public relations, presentations of the blood
donation data, technical report writing
• Language skills: fluent in one or more languages in addition to the native 11.1.6 Multiskilling
language Particularly in blood collection, tasks are traditionally done by teams composed of
• Analytical skills: understanding of demographic analysis; knowledgeable about
basic statistical analysis
employees who have well-delineated, separate tasks. Over the years, more teams
have changed to a ‘multi-skilling’ approach. Multi-skilled staff can perform a range
of different tasks within the team; for example, employees who register attending

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 donors may select donors during a blood session and also perform the venepuncture. as catering activities, administrative tasks and providing post-donation care. The
Evidently, combining tasks can only be done within the specifications of the prevailing DOMAINE survey shows that the majority of the responding blood establishments
quality system. Multi-skilling within teams demands a clear description of tasks and (76%) work with volunteers. Fifty-seven percent of these use the help of volunteers
responsibilities. to promote blood sessions, while 52% are assisted by volunteers in donor recruitment
activities, such as reminding donors of a scheduled blood session (under the guidance
Multi-skilling within teams also entails several advantages, as described in Box 6 5. of a qualified blood establishment blood donation coordinator). In addition, 38% use
volunteers during the donation process, such as providing post-donation care.

Box 6. Advantages of multi-skilling Volunteer skills: The EU Directive 2002/98/EC 2 does not mention or specify whether
any volunteers facilitating the efforts of blood establishments need to have any spe-
• Teams are flexible cial qualifications. In fact, no special skills are required. For example, volunteers work-
• Employees are more aware of the workflow ing for the Red Cross have different social and economic backgrounds, talents and skill
• Employees are better prepared to anticipate problems or requirements of other
levels. It seems that all blood establishments welcome such invaluable contributions
tasks
• Employees can assume other tasks when there is absenteeism in facilitating their work, especially in terms of auxiliary assistance.
• Employees can be moved to other positions at peak times of the operation
• Jobs remain interesting and challenging Blood establishments often have no policy with regard to which individual constitutes
a suitable volunteer. There is always room for more volunteers, whose contribution to
the chain of securing a continuous blood supply is invaluable. Training programmes
specifically aimed at volunteers are recommended, in order to gear staff and volun-
11.1.7 Performance indicators for human resources management teer activities.
Section 3.3 describes several performance indicators (PIs) that allow for benchmark-
ing within and between blood establishments. In order to evaluate human resources, Volunteers and donors: Donors seem to relate well to volunteers, and are often
the following PIs can be used, in accordance with generally accepted HRM perform- encouraged by them to donate blood, especially when the volunteers are donors
ance indices. themselves. In addition, involving volunteers from ethnic minorities may be advanta-
geous especially when efforts are made to recruit blood donors within these groups in
• Number of employees (full timers, part timers, free lance workers) order to cater for patients of ethnic minorities. Potential donors from ethnic minori-
• Turnover ties do not feel alienated through language barriers, and seem to relate well to their
• Absenteeism compatriots.

In addition, the following PIs are relevant. The use of a volunteer contract, which describes tasks and mutual expectations, and
special insurance provided by the blood establishment is highly recommended.
• Training level of all workers
• Number of volunteers in donor management
• Number of volunteer hours spent in donor management
• Ratio of productive workings hours of the donor team to the total of paid hours
of the donor teams. Productive, direct hours are those hours within which donors
can visit the donor session, i.e. opening hours. Non-productive, but paid hours,
may include the travelling time of the donor team, and the time needed for
setting up and breaking down the mobile collection site

11.1.8 Volunteers
In several European countries, volunteers are involved in the donor management
process. Blood establishments receive help from either individual volunteers or from
volunteer organisations, such as the Red Cross. Typically, volunteers are involved in
recruiting and retaining blood donors and in activities during blood sessions, such

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 section

11.2 Training
11.2.1 Introduction 1. Identify Training Needs
Ensuring the competence of blood establishment staff is a crucial element in sustain-
ing a safe blood supply. Good donor management requires specific skills, competenc-
es and attitudes, and training of all staff is a legal requirement and responsibility of
the blood establishment. Such training should be carefully planned and its quality
assessed on a regular basis.

The purpose of this section is to assist blood establishments in EU countries to meet 5. Evaluate training results 2. Set Training Goals
the training needs of blood donor management, in order to improve their capacity to
collect sufficient quantities of safe blood and blood components, and cover patient
transfusion needs.

This section aims to discuss staff continuous training, and evaluate the criteria for
training effectiveness.

11.2.2 The importance of training

Training helps to increase knowledge and to optimise employee skills, which benefits 4. Perform Training 3. Select Training Methods

the blood establishment’s strategic goals. Skills and knowledge can be increased at
each level, which contributes both to the individual development of employees and to
team goals. Training can increase understanding for organisational goals and, at the
same time, increase performance and productivity.

The EU Commission Directives require that all staff involved in blood transfusion activi-
Figure 1. Training cycle. See text for further explanation.
ties should be competent to perform their tasks and receive timely and relevant train-
ing2. Blood establishments are obliged to have initial and continued training available
for all staff, appropriate to their specific tasks. Training records should be maintained3. 1. Identify training needs
Additionally, the Council of Europe requires that this initial and continued training Training needs should be assessed by determining the knowledge and skill require-
should cover the relevant principles and practices of transfusion medicine 4. ments for each specific task, and the person responsible for training. The number of
staff requiring training should be established together with the training currently
available. A baseline assessment of knowledge and practice should take place to
11.2.3 The education and training cycle identify areas which need improvement and to target training and education. This
There are five fundamental, cyclical steps to consider when implementing a continu- assessment will also ensure better use of resources and increased efficiency that
ous education and training programme in blood establishments. can improve working relationships, communication, and liaison between staff and
management. Two methods often used to gather information about the existing
knowledge and practice are questionnaires and observation in practice.

2. Set training goals

Training goals should be determined by and communicated with staff and man-
agement.

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 3. Select training methods DOMAINE training programme on donor management
Teaching methods, based on the training needs of the identified staff groups and The quality of donor management relies on the competence and appropriate and
available resources, should be selected. An effective training programme requires timely training of staff. Up until now, no public training programs with set syllabi have
leadership and full commitment from the senior management of the blood estab- been in place for blood donor management. However, in 2011 the DOMAINE project
lishment. Several forms of training are available: classroom learning, teaching on- will provide a donor management programme for blood establishments. The training
the-job, self-teaching e-learning, and train-the trainer methods. programme will be based on this DOMAINE Donor Management Manual.

In-company training allows programmes to be tailored to a blood establishment’s

specific needs and provides concise guidance on all the key practical aspects of 11.2.4 Evaluating training effectiveness
developing a training programme. In this way, in-company training is easily adapt- Training staff is a continuous process. New staff receive initial training and employees
able to comply with the legal requirements for staff to have demonstrable evidence already employed at the blood establishment receive continual training in order to
of training, and knowledge and competence in the tasks that they perform. Curricu- keep up with current knowledge and required skills.
la for the training programmes have to be designed to meet all these needs.
Staff assessment: EU Commission Directive 2005/62/EC 2 states that the compe-
4. Perform training tence of personnel should be evaluated regularly. The Council of Europe adds that all
Choosing the right training facilities and training schedule are important organisa- personnel should have a competency evaluation appropriate to their specific tasks
tional steps. Trainers should be acceptable to the trainees to achieve the right out- and that this should at least include good practice and relevant knowledge in micro-
come. One should not hesitate to switch the trainer, if the ‘click‘ between trainer and biology and hygiene.
trainees is lacking or insufficient.
The assessment of theoretical knowledge and practical competency is necessary
5. Evaluate training results to evaluate or measure learning achievements and competence as well as to pro-
Training needs should be evaluated regularly, as knowledge and skills can get out of vide information for more effective teaching. A record management system should
date. The required knowledge and competence for each position should be evalu- be developed for the training. The evaluation of a teaching programme against pre-
ated periodically, as emerging new techniques and knowledge can change training determined goals can help determine the overall effectiveness of several components
needs. including participant learning, trainer effectiveness, learning environment, use of
resources and organisational impact. Commitment and maintaining momentum will
Training programme content assure higher levels of awareness and motivation of the staff for training that will
In line with the competences mentioned in Subsection 11.1.4, the contents of training bring the continuity in training.
programmes could include the following topics. Choice of topics and level of training
depend on the tasks and jobs involved. Training Evaluation: EU Commission Directive 2005/62/EC 2 also requires periodic
assessment of training programmes. Such training programmes must be periodically
• Initial training covering the general blood banking process reviewed and the effectiveness of training courses periodically assessed 3. Training
• Initial training covering specific position-related knowledge and skills and competency should be documented and a training record maintained for each
• Position-specific training, such as venepuncture and donor care employee.
• Haematology or transfusion medicine
• Quality Management, with special reference to Good Manufacturing Practice
(GMP) and Standard Operating Procedures (SOPs)
• First aid training
• Management programmes for managerial positions
• Communication skills
• Customer service
• ICT training
• Complaint handling
• Training for volunteers

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 References
1 Nieuwenhuis M (2009). The art of management. Retrieved 19 March 2010 from http://
www.123management.nl/index.html
2 Commission Directive 2002/98/EC of the European Parliament and of the Council of 27
January 2003 setting standards of quality and safety for the collection, testing, processing,
storage and distribution of human blood and blood components and amending Directive
2001/83/EC. Official Journal of the European Union, L33, 8/02/2003, p.30
3 Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/
EC of the European Parliament and of the Council as regards Community standards and
specifications relating to a quality system for blood establishments (Text with EEA relevance)
4 European Directorate for the Quality of Medicines & HealthCare (EDQM), European Commit-
tee (Partial Agreement) on Blood Transfusion (CD-P-TS), (Ed. Council of Europe). Guide to the
preparation, use and quality assurance of blood components. 14th Edition, 2008
5 National Food Service Institute, University of Mississippi. Jobs and multiskilling in the
food system [PowerPoint slides]. Retrieved March 19 2010 from www.olemiss.edu
/depts/nfsmi/Information/HR_modules/achieving/multiskilling.ppt

CHAPTER

220 Donor
Management
Manual 2010
Authors:
Gilles Folléa
Wim de Kort 12
221
 section

12.1
Basic issues
12.1.1 Introduction 100% 100% 50% 47% 32%
Most blood establishments use information technology (IT) and computerised sys- Date of birth Sex Country of birth Profession Level of
education
tems, not only for blood donor and collection management, but also for the whole
transfusion chain process from donors to patients. The first objective of using such
technology and equipment is to ensure complete and reliable traceability of actions
and (intermediary) products in the entire process. Beyond this primary objective,
there are some additional ones.
97% 87% 96% 85% 100%
First, IT-systems improve the safety of donors and recipients. Second, they simplify the Number of donations Number of deferrals Deferral reasons Length of deferral Address
donation process and help the staff involved to systematically comply with the regu-
latory/mandatory requirements. Last but not least, they greatly facilitate managing
the entire donation process by facilitating information retrieval.

This chapter is not meant for IT managers. It is written for donor managers, including
employees involved in donor related activities to highlight the most relevant IT-princi-
100% 63% 63% 25% 85%
ples and to mark points of interest when acquiring (new) ICT systems. Telephone number Email address Call-up preference Direct marketing Stop reasons
materials

• Functions: What could be expected from computerised systems for blood donor
Registration by blood establishments (%)
and collection management?
• Processes: Which donor management steps benefit from ICT?
Figure 1. Percentage of blood establishments that register the data mentioned

12.1.2 Donor information management

The DOMAINE survey on donor management in Europe showed that a large majority
of blood establishments in Europe use computerised systems to register data. How-
ever, a few blood establishments still use handwritten registries. All blood establish- Box 1. Basic donor entry information
ments register the donor’s name, date of birth, gender, home address and telephone
• Name
number. A majority also record a donor’s email address. Less often, they record the • Gender
country of birth, profession and level of education. • Birth date, birthplace and, when authorised, ethnicity
• Contact details
The majority of blood establishments keep a registry of the number of donations; the -- home address
number of deferrals and their reasons; the length of the deferral period; and reasons -- working address
-- (mobile) telephone number
for stopping. Finally, many blood establishments register the donor’s preference in -- e-mail address
invitation method, and even keep track of which direct marketing materials are sent • Preferred contact medium
to their donors (see Figure 1). • Preferred address of donating opportunity when appropriate
• Response(s) to invitation(s)
The foremost requirement for an effective computerised system for blood collection • Special donor category or ‘club’ status
• Donor relationship communications record
organisations is a robust (personal) data record system which meets current confi- • Donor call up status
dentiality demands. All parts of the system should comply with data confidentiality • Donor awards/recognition record, marketing materials sent
legislation and preferably should facilitate on-line access for direct data update or
change of contact details or donation status. Boxes 1, 2, and 3 display recommended All of the above should be available for direct on line update, accessed after sub-
items to be stored in a (computerised) registry. Storing that many items is not feasible mission of agreed personal password.
without the use of a computer.

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 12.1.4 Pre-donation interviews
Box 2. Health screening history data As was recently reported, a computer-assisted touch screen for donor self-interview-
• Health questionnaire results
ing could replace the classical face to face interviews 1. The authors’ experience has
• Health screening data and comments shown that the automated donor interviewing system was enthusiastically accepted
• Medication by the blood donors and collections staff. This system proved to be more effective than
• Biometry face to face interviews in eliciting a higher frequency of truthful answers to sexual and
• (pre-donation) Hemoglobin and or hematocrit level socially sensitive questions, and in reducing the frequency of staff errors and omis-
• Any other health check results
• Deferrals
sions during the interviewing process. It was also shown to be more efficient, with an
-- reasons average staff time reduction of five minutes per interview. It is highly probable that
-- length of the deferral period, in case of definite deferral: infinite such a computer-assisted interviewing system will be developed in blood establish-
• Laboratory results ments in the near future.
-- blood group: ABO, Rhesus type, any other
-- infectious disease markers
• Post-donation donor information baring consequences for collected products
12.1.5 Donation process information management
Concerning the donation process itself, it is currently recommended that bar codes
and handheld scanners be used (see also Section 12.2 Technical Aspects). In doing so,
one can actually register in ‘real-time’ the different equipment and disposables suc-
Box 3.
cessively used in each collection process, and identify the employees involved at each
a. Donation History step of the process. Thus, at the end of the collection line, the up-to-the-minute story
• Dates and types of donations of each collected whole blood unit or blood component will be available.
• Volumes collected
• Total number of each type of donation
• Adverse events
12.1.6 Archiving historic data
b. Donor Status Storage time of data contained in the donor/donation database regularly exceeds the
From the donation history the donor status can be derived time limit fixed in the regulatory requirements (minimum of 15 years in the Direc-
(see Section 4.1 for further explanation and definitions) tive 2002/98/EC) or in the blood establishment’s country regulations (which could
indicate longer time limits). It also happens that the current computerised system
• Newly registered donor
• First time donor is replaced by a new one, with consequences for data storage. The data not required
• Regular donor for immediate access, may or may not be archived, depending on national rules and
• Returning donor regulations (among other considerations). Archiving must be done in such a way that
• Lapsing donor, including reason if available data can be retrieved and read (unless the data is migrated to a validated replacement
• Inactive donor, including reason if available
system). An archive report should be generated describing the appropriate archive
• Stopped donor, including reason if available
approach and listing the electronic records archived, again fully in compliance with
current rules and regulations.

12.1.3 Donor invitation

The computerised system can be used to develop and facilitate invitations to donors
to donate at a given collection venue, date and time. It allows developing different
modalities of invitations: post letter, SMS, e-mail. A website connected to the blood
establishment’s computerised system may also allow donors to make reservations for
a next donation and, in some cases, to register their interest in becoming a donor. A
range of dedicated software for this purpose is commercially available.

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 Technical aspects
section

12.2
12.2.3 Programmes, software, donor relationship software
The DOMAINE survey showed that in 2007 a large majority of participating blood
establishments used data processing software. They either used commercial software
only, in-house software only, or a combination of both. Only three blood establish-
12.2.1 Introduction ments (7%) indicated no use of an electronic data processing system and two of them
Working with ICT is not feasible without proper hardware, software and specially reported that their data registration was handwritten.
trained personnel. Moreover, if a blood establishment works with ICT-systems, all
members of the staff will be confronted with different parts of the system. Donor Internal and Europe wide IT compatibility: Countries differ with respect to requir-
management is not an exception. This section describes some practical aspects. ing uniformity within a country for those data processing systems used by different
blood establishments. Somewhat less than half of the blood establishments indicated
The first and most important practical requirement is that the systems used in the dif- with-in country uniformity, i.e. that their system is used in their country by all other
ferent parts of the blood transfusion chain are compatible with the training level of blood establishments. Most blood establishments reported non-uniformity or com-
the employees and compatible with each other. New and renewed technologies are patibility, i.e. that the data processing systems in their country, used by other blood
continuously made available and some of them are very promising for the manage- establishments, were different. Given the growing effect of increased migration, it
ment of the complex processes present in the blood establishment. However, incom- is recommended that, at least on a national scale, but preferably Europe wide, some
patibility may turn a good purchase into a ‘nightmare’. exchange of data could be facilitated. Therefore, uniformity and compatibility, at least
within countries, should be considered.
Validation and safety issues are discussed also in this section. Easiness of managing
the donor data base and extracting management information are also important Donor management software: Besides their regular data processing system, some
requirements when selecting (new) ICT systems. blood establishments use special donor relationship management software (or Cli-
ent Relation Management, CRM, software), defined as software used specifically to
• Precautions: What general precautions have to be taken regarding IT system manage communications with donors, co-ordinate campaigns and assist with donor
infrastructure, programs and software, interfaces with identification means and recruitment.
interfaces with other software: technical aspects?
• Validation: What are the main principles of computerised system validation? User Requirement Specifications: In all cases, writing the User Requirement Specifi-
• Confidentiality: What are the main confidentiality and safety aspects to take into cation (URS) for these functional requirements of the computerised system is essen-
account? tial. The approval of the URS should be documented in accordance with the prevailing
• Performance indicators: How can the computerised system be used to produce Quality Management System and should integrate compliance with the current regu-
performance indicators and help managing both donors and collections? latory requirements as stated by the blood establishment or the national government.

12.2.2 IT-system hardware and infrastructure 12.2.4 Interfaces with means of personal identification
IT-system infrastructure can be divided into several parts as follows. An increasing number of automated technologies exist for identifying persons, and
identifying and labelling products. Apart from the old passport (or other form of per-
• Servers and hosts including operating systems and database hardware sonal identification, such as driver’s licence), the applicability of systems such as fin-
• Internal network infrastructure, which can be defined as the transportation ger print readers or iris scans to identify persons is expanding. At present, bar code
and communications systems, including switches, routers, cabling and network identification (labels and readers) is applied by most blood establishments in some
monitoring tools within the blood establishment organisation way. Labelling and subsequent identification using newer technologies is also on the
• User interfaces: workstations, laptops, web access tools rise. The technology of Radio Frequency Identification Device, RFID, which is more or
• External interfaces, networks and security components less in a developmental stage in the blood transfusion world, seems very promising.

For each component of the IT infrastructure, great attention should be paid to writing Barcode
the User Requirement Specification (URS). This key document should describe what the For many years, a bar-code donor (and patient) identification system has been found
process owner (the blood establishment or, more precisely, the donor managers) want to simplify and make safer the transfusion process 2. A great deal of important infor-
or expect from the system. It is required for any new automated system or significant mation is carried by the bar-coded blood product labels. Since blood collected and
change to an existing system. processed in one blood establishment may be used in another blood establishment or

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 even in another country, it is important to use globally unique blood product coding Identification of the donor by means of a chip card
and labelling systems. Chip cards (or smart cards) can be used for donor identification. These are pocket-
sized cards that contain embedded integrated computer circuits. Donor data can be
The international system for coding and labelling blood products, called ISBT 128, has stored on these chip cards. Every time a donor presents himself at a donor session, his
been implemented in many blood establishments in Europe and all over the world. identity should be checked. Chip cards can facilitate this process.
These implementations have always been successful 3. It is highly recommended that
the ISBT 128 coding and labelling system be implemented in every blood establishment. There are two types of card readers for chip cards. The most common is the contact
‘contact chip card reader’, which is a communications medium between the smart
Whilst most existing bar coding systems in blood transfusion are based on the linear card and the donor database. A second type is the ‘contactless chip card reader’, in
bar code (Code 128), two dimensional (2D) barcodes are also available. 2D codes are which the chip communicates with the card reader through RFID-technology.
able to store much more information in a small amount of space making them a suita-
ble alternative for labelling small items. ISBT 128 recommends use of the Data Matrix Chip cards can be used for authentication of identity. The most secure way is to use
2D symbology and provides a means of placing several ISBT 128 data structures into a PKI (Public key Infrastructure) and digital certificates. The owner has to use a PIN-
single Datamatrix code. code that will be validated by a central organisation. The need for specific infrastruc-
ture makes that this identification technique is mostly used in applications supported
RFID by the internet. The central and local infrastructure is costly and not easy to imple-
Radio Frequency Identification Devices (RFID) are currently being actively evaluated ment in a mobile environment. The easiest way of identification is when the card has
as information carriers for use in the transfusion chain. The recently published ISBT a photograph of the owner. In that case there is a visual check that the card belongs to
Guidelines on RFID (4) recognise the importance on ensuring consistency between the right person.
information held in bar codes and RFID and recommend the use of ISBT 128 data
structures in RFID. Such an approach will minimise the impact of this new technology In some countries such as Belgium, the entire population has a chip card, eID, issued
on data processing software. by the Belgian government. Every citizen is obliged to have the card with him. The eID
is used to identify the donor and to manage the donor registration process for each
RFIDs enables more information to be stored on the RFID tag, it allows for automated donation. If the data on the card deviates from the data in the donor database, e.g.
identification and data capture, it can include sensors for condition monitoring such when the donor’s address has changed, the donor database can be updated in an easy,
as time and temperature, and in certain conditions it permits simultaneous read of electronical way.
multiple tags. The potential advantages of passive RFID technology (where the tag
is activated by the energy from the reader’s RF field) and its potential benefits for
improving safety, quality and efficiency have been explored by several teams 5-7.

Among others, RFID technology offers the following possibilities.

• Inserting much if not all relevant donor data in the donor card
• Inserting all relevant data in the tag of any collected product
• Inserting any additional information in the tag of any (intermediary) blood
Figure 2. Bar code, 2d bar code, RFID and chip
product all along the transfusion chain process
• Helping to manage blood products in (secondary) blood processing and issuing
units at a distance from the central blood establishment facility
• Ultimately, improving recipient safety in allowing an electronic cross-match at 12.2.5 Interfaces with other software
the bedside of the patient, also tagged and identified through RFID technology Two important, but different software linkage or interface issues arise: the first is
directly linked to the blood collection process; the second concerns the blood chain
For all these reasons, it is expected that this technology will be developed for applica- and related processes. A way to overcome compatibility difficulties between software
tion to the transfusion chain in the near future. Nevertheless, an important statement systems is to construct a data warehouse.
from the conclusion of the RFID guideline is that ‘RFID adds another layer of safety
to the safeguards of current labelling systems. The tag will not substitute, replace, or Directly linked to the collection process
interfere with any required barcode or labelling information, and RFID software will It is possible to use different software for different parts of the donor or collection
augment existing blood bank and transfusion systems and not replace them’ 4. management process. For example, some blood establishments are using both com-

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 mercial software for blood banking activities and specific, different software for donor 12.2.6 Validation
relationship management (see above). Also, it is conceivable that specific software The guidelines published in early 2010 by the Working Party on Information Technol-
could be developed for managing donor marketing activities. In all these cases, ensur- ogy Validation Task Force of the International Society of Blood Transfusion updated the
ing compatibility between different software simultaneously used for different parts ISBT guidelines for validation of automated systems in blood establishments 8. They
of the process is essential to prevent frustration and the loss of time. provide guidance on the validation of automated systems in blood establishments
and this covers the organisations involved in donor management and blood collec-
Not directly linked to the collection process tions.
The same applies to the human resources software, as they are used at least for work
time planning, working time managing for collections staff, and also for calculating In all cases, the validation process consists of evaluating the automated system
indicators as collection efficiency ratios (see Chapter 7 Collection). Current experienc- against established User Requirement Specifications and against regulation and stand-
es reported by many blood establishments show that ensuring compatibility between ards as applicable in the concerned blood establishment or country. The validation
commercial blood banking software and commercial human resources software process also includes evaluating the needs of system and environment configuration,
seems to be difficult everywhere. evaluating the requirements for installation, and evaluating the training require-
ments. In all cases, installation qualification, operational qualification and perform-
Other examples of similar compatibility difficulties can be given in relation to tem- ance qualification will be performed for each component of the computerised system
perature monitoring software (monitoring the temperature of collected products), infrastructure and for the functional aspects.
maintenance recording software and finance software (particularly for cost account-
ing). In all these cases, special effort should be made to ensure compatibility between
the different software systems to optimise the benefit that could be drawn from the 12.2.7 Confidentiality and safety issues
simultaneous use of different software for donor/collection management. Security policies should be developed to define the rules and provide guidance regard-
ing the use of and access to critical information. This could be performed through the
Data warehousing Guidelines on Information Security from ISBT 9. User access policies should be devel-
The reason compatibility difficulties arise between software systems relates to the oped requiring unique identification codes for each user, periodic password change,
differences between programming languages, data and file architecture. The princi- and prohibition of password sharing. Appropriate measures should be taken against
ples to construct a data warehouse, to help overcoming these problems, are briefly unauthorised input, deletion, or modification of critical data. System access policies
described thereafter. should be developed in order to protect the system from unauthorised access (see also
Chapter 13 on ethical considerations for a discussion on related issues).
Data from incompatible software systems is extracted and transformed into a com-
mon format as it is loaded into the warehouse. This allows reports using data from Risk assessment: Risk assessment is required when a new automated system is to be
different computer software to be analysed and reports written in a common format. implemented, changed or upgraded. It is also required when it has never been per-
This can provide the basis for the establishment of an overarching management infor- formed previously for an existing automated system. It must be performed to identify
mation system (M.I.S.) critical control points and to define risk mitigation or elimination plans. This requires
Such data warehouses allow the integration of electronic information from many consideration of the impact, probability and detectability of a potential hazard or
sources and the provision of useful management reports. Data can be taken from sys- harm to the computerised system.
tems such as the following.
Business plan: A business continuity plan is required and consists of a number of ele-
• Blood Banking Software ments designed to minimise disruption to the business in case of system failure/una-
• Customer Relationship Management Software including donor appointments vailability. An approach based on such risk assessments is recommended.
• Human Resources software
• Resource Planning and Scheduling software
• Accounting System software 12.2.8 Donor database management
• Automated collection equipment such as that used for the collection of double red Maintaining a data base and validly extracting data from it is a specialty of its own.
cell donations, aphaeresis platelets and plasma donations Although the (donor) managers should be in the lead when defining data extractions,
• External data sources – census information, geographical/mapping data, post often called ‘data base queries’, this is doomed to fail without the specialised help of
code databases IT-personnel, such as programmers.

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 Database maintenance References
One important function of any IT system is to record data and to establish relevant 1 Katz LM, Cumming PD, Wallace EL & Abrams PS (2005). Audiovisual touch-screen computer-
and useful indicators from the recorded data. For donor and collection managers, this assisted self-interviewing for donor health histories: results from two years experience with
relates to donor database management and it is of paramount importance to regu- the system. Transfusion, 45(2), 171-180
larly improve the donor database quality. As an example, this concerns the donor clas- 2 Turner CL, Casbard AC & Murphy MF (2003). Barcode technology: its role in increasing the
sification into segments for donor marketing activities and updating donor data. safety of blood transfusion. Transfusion, 43(9), 1200-1209
3 Aandahl GS, Knutsen TR & Nafstad K (2007). Implementation of ISBT 128, a quality system,
This work should allow for the clear delineation or elimination of stopped donors from a standardized bar code labeling of blood products worldwide, electronic transfusion path-
the active donor data base, as far as possible. The ratios of the different population way: four years of experience in Norway. Transfusion, 47(9), 1674-1678
segments are important to consider regularly in order to deduce the appropriate cor- 4 Knels R et al. (2010). Guidelines for the Use of RFID Technology in Transfusion Medicine. Vox
rective measures. (See also Chapter 4 Donor Base for a more thorough discussion). Sanguinis, 98(s2), 1-24
5 Sandler SG, Langeberg A, DeBandi L, Gibble J, Wilson C & Feldman CL (2007). Radiofrequency
Donor identification: Another example concerns the quality of donor identification. identification technology can standardize and document blood collections and transfusions.
Some blood establishments developed daily alerts enabling recognition of evident Transfusion, 47(5), 763-770
abnormalities of donor identification, according to predefined rules. This kind of tool 6 Van der Togt R, Van Lieshout EJ, Hensbroek R, Beinat E, Binnekade JM & Bakker PJM (2008).
could significantly contribute to improving the safety of the whole transfusion proc- Electromagnetic Interference From Radio Frequency Identification Inducing Potentially
ess in regularly correcting donor identification errors, thus improving donor identifi- Hazardous Incidents in Critical Care Medical Equipment. JAMA, 299(24), 2884-2890
cation quality. 7 Davis R, Geiger B, Gutierrez A, Heaser J & Veeramani D (2009). Tracking blood products in
blood centres using radio frequency identification: a comprehensive assessment. Vox San-
Performance Indicators guinis, 97(1), 50-60
Structuring and maintaining the Donor Data Base and related data bases are, amongst 8 International Society of Blood Transfusion Working Party on Information Technology Valida-
others, processes set up to produce relevant and useful performance indicators, and tionTask Force (2010). ISBT Guidelines for Validation of Automated Systems in Blood Estab-
to help donor managers to manage these processes. This potentially concerns all the lishments. Vox Sanguinis, 98(s1), 1-19
performance indicators shown in this manual. 9 Information Security Task Force of the International Society of Blood Transfusion, Working
Party on Automation and Data Processing (2006). ISBT Guidelines for Information Security in
Making performance indicators easily available could give managers additional time Transfusion Medicine. Vox Sanguinis, 91(s1), S1-S23
to analyse the results and to find and implement appropriate solutions to continuous-
ly improve the donor and collection management process. The kind and definitions of
these Performance Indicators, PIs, are discussed throughout this manual. General or
Key Performance Indicators, KPIs, are discussed in Section 3.3 Performance Indicators.

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 CHAPTER

234 Donor
Management
Manual 2010
Authors:
Wim de Kort 13
235
 Ethical issues in blood
section

13.1
entitled to receive them, if appropriate for improving health. From that point of view,
this unique human act precludes any trade or commercialisation 3 - 6

donation Blood as commodity? In contrast, some people argue that blood is a commodity
or good like many other health care products, albeit that it has special and partially
unique properties.
13.1.1 Introduction Every individual produces blood in the same way: only ‘production conditions’ vary
For good reasons, participating in the blood product chain, from donation to trans- and so do some of the product specifications, such as blood type. Commercialisation
fusion, entails a series of ethical 1 issues. Blood is of human origin and this precious from that point of view is a logical result.
resource has a limited shelf life. Donor management carries a two-sided moral
responsibility towards both donors and blood product recipients. This often entails Selling blood? Some argue that ‘People sell their talent, experience, skills, services,
negotiating between different interests and ethical decision making. creations, et cetera, and their value is determined by the laws of the market. So, why
should persons not be able to sell their blood? There is hardly any risk involved in
Policy and donor management decisions are founded on four principles of ethics. donating blood, is there?’

• Respect for individuals and their autonomy Economics

• Protecting individuals’ rights and well being Notably, among all the actors in the blood transfusion chain, recipients, volunteers
• Avoiding exploitation, part of the more general principle of distributive justice 2 and donors are the ones who do not make money.
• The Hippocratic principle of primum non nocere or ‘first, do no harm’
Recipients: Recipients of blood products (patients, or ‘clients’) can, in fact, be expect-
In donor management, some special ethical issues arise and can be divided into two ed to pay for blood products, either themselves or through their insurance, or in what-
groups. ever way, depending on a country’s health care financing system. The patient’s gain
for this payment is extra life expectancy and quality of life.
Commercial considerations: There is a lengthy and heated debate on the permissi-
bility of trading one’s own blood. Given that blood products derive from non-remuner- Volunteers: By definition, volunteers deny payment. We all accept their choice, and
ated donations, how can one avoid exploitation and ensure distributive justice if such take proper advantage of it.
products then enter a commercial chain?
Donors: This leaves the blood donor as the only person breaking the common rules of
Mistreatment of donors and prospective donors: Blood is a sensitive matter, and economics in the entire transfusion chain. This works out well, as long as no shortages
perceived or true mistreatment of donors can have a strong impact on public and arise 7. All the others in the blood transfusion chain do make money, not uncommonly,
political discussions. even for a living. They include the following groups of persons.

This section touches upon some of the ethical issues. For additional information and • Management and employees of a blood establishment
discussion, further references are mentioned below. • Suppliers of equipment, disposables, housing and all other materials necessary to
run a blood establishment
• Health care workers, such as prescribing doctors, those involved in
13.1.2 Remuneration or not? administering blood products and supporting activities such as laboratory testing
All over the world, donating blood, tissues or even organs represents for many, their and distribution
giving the priceless, special ‘gift of life’. Preferably, this is done out of true altruism and
is simply meant to help others in need of blood products, without which they soon There is probably nothing wrong with that, as long as market principles are considered
would die or lose quality of life. a socially acceptable elaboration in accordance with distributive justice. Subsequent-
ly, these ‘paid actors’ in the transfusion chain must guarantee individual rights and
Dangers of exploitation: Selling one’s bodily parts, such as blood, traditionally is ‘not well being. Paid staff must show respect for a different set of opinions. They should, for
done’. Even though hardly any risk is involved in the act of blood donation, exploitation example, not refuse transfusing blood products to people merely on the grounds that
may easily emerge when bodily parts become subject to the market system. Impor- they are not (or have not been) blood donors themselves.
tantly, the blood products donated become ‘joint property’, meaning that everybody is

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 Blood as tradable good? All of this may imply that blood is some kind of tradable
commodity or good. However, from a legal point of view, the question arises as to Box 1a. ISBT code of ethics for blood donation and transfusion 11
whether blood or blood products can actually be considered a good.
A CODE OF ETHICS FOR BLOOD DONATION AND TRANSFUSION
In the European Union goods have been defined as: ‘products which can be valued in The objective of this code is to define the ethical principles and
rules to be observed in the field of Transfusion Medicine.
money and which are capable, as such, of forming the subject of commercial transac-
tions’ 8. In their reasoning the European Commission did not exclude the possibility Blood Centers: donors and donation
that blood may be considered a ‘good’, for the following reasons. 1. Blood donation including haematopoietic tissues for transplantation shall, in
all circumstances, be voluntary and non-remunerated; no coercion should be
1. Although international treaties prohibit financial gain of blood, these treaties are brought to bear upon the donor. A donation is considered voluntary and non-
remunerated if the person gives blood, plasma or cellular components of his/
not binding.
her own free will and receives no payment for it, either in the form of cash, or
2. In the European Community, blood is subject to normal customs tariff. in kind which could be considered a substitute for money. This would include
time off work other than that reasonable needed for the donation and travel.
The question as to whether or not blood is a ‘good’ has not yet been decided and could Small tokens, refreshments and reimbursements of direct travel costs are
become a matter before the European Court of Justice. The door to commercialisation compatible with voluntary, non-remunerated donation. The donor should
provide informed consent to the donation of blood or blood components and
has not been closed.
to the subsequent (legitimate) use of the blood by the transfusion service.

Recipient safety: Another important reason remains for not wanting blood to be 2. A profit motive should not be the basis for the establishment and running of
commercialised: the safety of the recipient. It is a proven fact that donors paid in cash a blood service.
show a much higher risk of having a transfusion transmittable infectious disease 9.
3. The donor should be advised of the risks connected with the procedure; the
But also other types of payment, including vouchers or free tickets and time off work,
donor’s health and safety must be protected. Any procedures relating to the
could imply an increased risk 10. A plausible reason behind that increased risk is that administration to a donor of any substance for increasing the concentration
the prospective donor involved might be inclined to ‘forget’ recent risky behaviour or of specific blood components should be in compliance with internationally
health impairment that could interfere with their being eligible for blood donations. accepted standards.

4. Anonymity between donor and recipient must be ensured except in special

situations and the confidentiality of donor information assured.
13.1.3 Voluntary donation
Possible coercion? As is laid down, for example, in the ISBT Code of Ethics, ‘blood dona- 5. The donor should understand the risks to others of donating infected blood
tion including haematopoietic tissues for transplantation shall, in all circumstances, and his or her ethical responsibility to the recipient.
be voluntary and non-remunerated; no coercion should be brought to bear upon the
6. Blood donation must be based on regularly reviewed medical selection crite-
donor’ (see Box 1). Although many people and organisations, including the WHO,
ria and not entail discrimination of any kind, including gender, race, nation-
agree with the above principles, in many places some kind of coercion is present, as is ality or religion. Neither donor nor potential recipient has the right to require
the case when so-called replacement donations occur. that any such discrimination be practiced.

Donor motivation: When donors are asked why they donate, five primary motives 7. Blood must be collected under the overall responsibility of a suitably quali-
fied, registered medical practitioner.
emerge.
• Altruism: out of unselfish concern for others, or, for the benefit of someone else, 8. All matters related to whole blood donation and haemaphaeresis should
not impossibly at one’s own expense be in compliance with appropriately defined and internationally accepted
• Solidarity: for the unity resulting from common interests, feelings, or sympathies standards.
• Social Capital: some people donate blood, others donate money or goods and so,
9. Donors and recipients should be informed if they have been harmed.
everybody takes their share of duties
• Reciprocity: exchanging blood donations with others for mutual benefit. ‘I 10. Blood is a public resource and access should not be restricted.
donate blood now, because I want to get it when I need it’
• Incentives (‘quid pro quo’): better self-esteem, items of small or limited value, 11. Wastage should be avoided in order to safeguard the interests of all potential
payment, compensation, health check, or anything else that represents value to recipients and the donor.
the donor

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 Criteria for exclusion: On the other hand, justified distinctions may still be made for
Box 1b. Hospitals: patients deferring certain groups of prospective donors, when clear health risks for the recipi-
12. Patients should be informed of the known risks and benefits of blood transfu-
ent exist 14. The primary reason for excluding candidate male donors on the ground
sion and/or alternative therapies and have the right to accept or refuse the of MSM is not that being homosexual made them non-eligible, but that their sexual
procedure. Any valid advance directive should be respected. behaviour carries a greater risk of transmitting HIV-infected blood. The deferral crite-
ria are not a judgement on behaviour or (sexual) preference or (ethnic) descent, but a
13. In the event that the patient is unable to give prior informed consent, the judgement on the (general, anticipated) risk related to behaviour. Having travelled in
basis for treatment by transfusion must be in the best interests of the patient.
the jungle does not make someone a bad person, but does entail that person carrying
14. Transfusion therapy must be given under the overall responsibility of a regis- a greater risk of transmitting malaria.
tered medical practitioner.
Age concerns: Inclusion of certain groups may also cause concern and debate, as the
15. Genuine clinical need should be the only basis for transfusion therapy. example of minors show. Most countries do not allow persons under 18 to donate. But
16. There should be no financial incentive to prescribe a blood transfusion.
the threat of blood shortages forces many countries to lower, or consider lowering the
age standard down to 17 or 16. Here, not the safety of the recipient, but the safety of
17. As far as possible the patient should receive only those particular compo- the donor is at issue. Younger donors show a higher risk of adverse reactions to donat-
nents (cells, plasma, or plasma derivatives) that are clinically appropriate and ing blood 15, 16.
afford optimal safety.

18. Blood transfusion practices established by national or international health

Other potential limitations: There seems to be a general consensus that being hand-
bodies and other agencies competent and authorised to do so should be in icapped or disabled should not prevent people from donating blood. On the contrary,
compliance with this code of ethics. it is generally felt that all should be done to increase accessibility of collection centres,
so as to facilitate donating blood by people who may experience some kind of limita-
The Code has been elaborated with the technical support and adopted by the WHO tion. Many limitations can be neutralised by personal help, environmental accommo-
Adopted by General Assembly of ISBT, July 12, 2000
Amended by the General Assembly of ISBT, September 5, 2006
dations, or special equipment.

13.1.5 DOMAINE survey findings

13.1.4 Right to donate? Remuneration of donors: The principle of voluntary and unpaid donations does not
From the outset, the question regularly arises: are all people eligible to donate blood? exclude compensation for donors, if it is limited to reimbursing the expenses and
This is definitely not the case. Of course, all free persons have the right to present inconveniences related to the donation. These expense allowances can be given in
themselves for blood donation. But this does not mean that they have the right to different ways. In some blood establishments such compensation is limited to trav-
donate blood. What is the justification for refusing some people, or even groups of elling costs reimbursement, or a food voucher. In six of the 35 countries involved in
people from donation? the DOMAINE survey, donors might be given an expense allowance in cash, based on
the incurred expenditure and the particular type of donation. Not all six countries are
Safety: The safety of both donor and recipient is the main reason for deferring pro- EU member states. Expense allowance mainly relates to plasma or platelet aphaeresis
spective donors, thus ensuring the second principle: protection of the individual. A donations, and in only one country all donors are offered an amount of money. The
person is only entitled to donate blood, when he or she fulfils the eligibility criteria. sum, given to donors, ranges from €12 to €25 per donation.
Eligibility criteria must not be in conflict with other, fundamental rights. Eligibil-
ity criteria must not entail discrimination – i.e. unjustified distinction, meaning that Other incentives: Other establishments may offer a free physical check-up, or a free
eligibility criteria must be built on solid ground. The burden of proof for criteria to be vaccination for influenza in winter. To some extent, these two means may be consid-
acceptable rests with the person or organisation formulating them. ered as useful for the blood establishment to maintain a safe donor population.

Precautionary principle: On several occasions the precautionary principle 12 is Free time off work: The DOMAINE survey (see Chapter 2) shows that donors are
applied. In health care and transfusion contexts this principle is applied by letting the allowed free time off work in 14 countries. In most of these countries, this time is
safety of the recipient prevail. This becomes tricky when sensitive issues arise, such as capped to the time needed for the entire donation process or to a limited amount of
the exclusion of men having had sex with other men (MSM)13. Clearly, discrimination time (e.g. two or four hours). However, some blood establishments continue to allow
must be avoided. donors to get a full day off work and this obviously is closer to real remuneration. Most

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 countries have discontinued such practices. It is important to underline that this dis-
continuation never resulted in a shortage of donors.
section

13.2
Ethico-legal issues in
Commercial establishments: Blood establishments in seven countries reported the treating donors
existence of commercial establishments. In four countries the commercial establish-
ments only collect plasma for fractionation, but in three countries they also collect
whole blood. This introduces competition for both donor recruitment and blood prod- 13.2.1 Introduction
uct selling, which, in recent experience, strongly impacts on donor retention, donor The following subsections deal with issues that historically relate to legal rather than
safety and patient safety (see also Section 3.5 on competition). to ethical aspects of treating donors. In particular, some fundamental rights of the
individual are discussed: the integrity of the body and protection of donor privacy. In
In conclusion, voluntary, non-remunerated blood donation forms the ethical corner- general, these items have become accepted as ethical issues.
stone for donor management worldwide and is reflected in written literature and
ethical deliberations. However, discussions are ongoing and the DOMAINE survey
indicated that the margin between compensation and remuneration in practice is not 13.2.2 Informed consent
always clear. No donation can be collected without the informed consent of the (prospective) donor
and several rules and regulations have been set up to that end 17, 18. But not all blood
establishments seem always to adhere to them 19. To obtain informed consent, the
information given to the donor must include the following items (see also Section
5.4.5).

• The purpose of donating blood

• The risks and potential consequences of donating blood
• A description of any benefits of donating
• Information on insurance coverage for donors
• A statement describing the extent of confidentiality of records
• Explanation of whom to contact for answers to pertinent questions
• Statement that participation is voluntary
• Statement that refusal to participate will involve no penalty or loss of benefits/
statement that the subject may discontinue participation at any time without
penalty
• The ability to withdraw and not continue with the donation process

Information should be available in writing, but that does not preclude the necessity of
personal communication.

13.2.3 Treating the donor respectfully

Staff must observe general etiquette. There is no difference of opinion on that,
although cultural diversity may lead to differences on what is considered appropriate.
The special situation in the collection centre, however, puts some extra demands on
how donors should be treated.

• Donating blood is voluntary at all time. Care must be taken to prevent any kind of
real or perceived coercion or pressure. Some blood supply systems still rely on the
phenomenon of replacement donors. Whenever possible, this should be avoided
• A donor has the right to stop a donation procedure or being a donor at any time

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 for any reason whatsoever References
• The donor has the right to ask questions. Staff must therefore be receptive and 1 Ethics (Oxford English Dictionary): the moral principles governing or influencing conduct
amenable to any question that may arise 2 Distributive Justice. Principles of distributive justice are normative principles
• The privacy of the donor must be guaranteed at every stage of the donation designed to guide the allocation of the benefits and burdens of economic activity.
process The first relatively simple principle of distributive justice examined [for further explana-
• Premises must be accessible for people with physical restraints tion, see the website page, Eds] is strict egalitarianism, which advocates the allocation
of equal material goods to all members of society. John Rawls’ alternative distributive
principle, which he calls the Difference Principle, is then examined. The Difference Prin-
13.2.4 Privacy, confidentiality ciple allows allocation that does not conform to strict equality so long as the inequal-
Blood establishments gather much personal data on the donor that is usually put into ity has the effect that the least advantaged in society are materially better off than they
computerised systems. These systems are governed by current laws. would be under strict equality. However, some have thought that Rawls’ Difference
Principle is not sensitive to the responsibility people have for their economic choices.
• Confidentiality of the data must be secured Resource-based distributive principles, and principles based on what people deserve
• Access to personal data must be limited to authorized staff because of their work, endeavor to incorporate this idea of economic responsibility.
• The donor has the right to inspect his records Advocates of Welfare-based principles do not believe that the primary distributive concern
• The donor has the right of correction and removal of his personal data within the should be material goods and services. They argue that material goods and services have no
boundaries of the current laws intrinsic value and are valuable only in so far as they increase welfare. Hence, they argue, the
distributive principles should be designed and assessed according to how they affect wel-
fare. Advocates of Libertarian principles, on the other hand, generally criticize any patterned
13.2.5 Specific issues regarding the donation distributive ideal, whether it is welfare or material goods that are the subjects of the pattern.
In keeping with the principle of distributive justice, implying universal access to blood They generally argue that such distributive principles conflict with more important moral
products, the donor has no say in determining the destination of the blood prod- demands such as those of liberty or respecting self-ownership. Finally, feminist critiques of
ucts derived from the donation. It is up to the doctor in attendance to decide how to existing distributive principles note that they tend to ignore the particular circumstances of
administer the blood products. There are two exceptions to this rule. women, especially the fact that women often have primary responsibility for child-rearing.
Some feminists therefore are developing and/or modifying distributive principles to make
• Personal use: Donors can make an autologous donation, i.e. a donation for them sensitive to the circumstances of women and to the fact that, on average, women
therapeutical use in themselves. Then, the blood products can only be used for spend less of their lifetimes in the market economy than men. Stanford Encyclopedia of Phy-
that purpose losophy. Retrieved March 19 2010 from http:// plato.stanford.edu/entries/justice-distribu-
• Research: With direct informed consent, a donation can be used for non- tive
therapeutic purposes, e.g. research. The donor has the right to grant permission 3 Titmuss RM (1971). The gift relationship: from human blood to social policy. London: Allen &
for this purpose, not to change or modify its use Unwin
4 Hagen PJ (1982). Blood: gift or merchandise. New York, Alan R. Liss Inc.
5 Macpherson CR, Domen RE & Perlin T (2001). Ethical Issues in Transfusion Medicine. Bethesda,
13.2.6 Notification of important (adverse) information Maryland, AABB Press
The blood establishment must notify a donor of any important result or findings that 6 Robinson EA (1999). Altruism: is it alive and well? Proceedings of the international seminar,
arise during or after the visit to the blood establishment. Royal College of Pathologists, November 13th, 1998. Transfusion Medicine, 9(4), 351-382
7 Del Pozo PR (1994). Paying donors and the ethics of blood supply. Journal of Medical Ethics,
• Positive screening tests for infectious diseases 20(3), 31-35
• Abnormal results from the biometrics or medical examination 8 Case law European Court of Justice, Commission vs. Italy, 1968.
• Hereditary predispositions-/diseases 20 9 Eastlund T (1998). Monetary donation incentives and the risk of transfusion-transmitted
• Any other accidental finding that can be considered to be important to the donor infection. Transfusion 38(9), 874-882
or his/her family or acquaintances 10 Oswalt RM & Napoliello M (1974). Motivations of blood donors and non-donors. Journal of
Applied Psychology 59(1), 122-124
Bringing important information to donors requires special skills, also known as coun- 11 International Society of Blood Transfusion. A code of ethics for blood donation and transfusion.
selling skills. In Section 8.3 counselling is treated in more detail. Retrieved 19 March 2010 from http://www.isbt-web.org/files /documentation/code_of_eth-
The reverse also holds. A donor must notify the blood establishment of any informa- ics.pdf
tion that can reasonably be considered of importance to the safety of the donor or the
recipient of the blood products.

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 12 The definition of the precautionary principle most widely used relates to environmental
issues and stems from the Rio Declaration of the UN, 1992: ‘In order to protect the envi-
ronment, the precautionary approach shall be widely applied by States according to their
capabilities. Where there are threats of serious or irreversible damage, lack of full scientific
certainty shall not be used as a reason for postponing cost-effective measures to prevent
environmental degradation.’ There is no law or European Directive on the precautionary
principle. However, the EU Commission stated that the principle might be invoked where
‘preliminary objective scientific evaluation, indicates that there are reasonable grounds for
concern that the potentially dangerous effects on the environment, human, animal or plant
health may be inconsistent with the high level of protection chosen for the Community’.
Commission of the European Communities (2000) Communication from the Commission on
the Precautionary Principle. Brussels: Commission of the European Communities
13 Franklin IM (2007). Is there a right to donate blood? Patient rights; donor responsibilities.
Transfusion Medicine, 17(3), 161-168
14 “Commissie Gelijke Behandeling, CGB”, (Netherlands Equal Treatment Commission, NETC,
2005). CBG opinion about whether the Red Cross Blood Bank Central Netherlands, based in
Utrecht, had discriminated against MrXX within the meaning of the Equal Treatment Act. In:
CGB (Equal Treatment Commission), Utrecht, the Netherlands, 1–22.
15 Eder AH, Hillyer CD, By BA, Notari EP & Benjamin RJ (2008). Adverse reactions to allogeneic
whole blood donation by 16- and 17-year-olds. JAMA, 299(19), 2279-2286
16 Jones RL (2009). Young donors: opportunity, responsibility, vulnerability—report on YDAR
task force. Transfusion 2009, 49(10), 2019-2020
17 Alaishuski LA, Grim RD & Domen RE (2008). The informed consent process in whole blood
donation. Archives of Pathology & Laboratory Medicine, 132(6), 947-51
18 Food and Drug Administration, FDA. Guidance for institutional review boards and
clinical investigators 1998 update. A guide to informed consent. Rockville (MD):
Food and Drug Administration. Retrieved March 19 2010 from http://www.fda.gov
/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/
ucm073433.htm
19 Shaz BH, Demmons DG & Hillyer CD (2009). Critical evaluation of informed consent forms for
adult and minor aged whole blood donation used by United States blood centers. Transfu-
sion, 49(6), 1136-45
20 Kamel H & Tomasulo P (2009). A healthy donor or unsuspecting patient. Transfusion, 49(5),
818-820

246 Donor 247

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Manual 2010
 Appendix I Appendix II
Websites of relevant organisations Websites of DOMAINE partners

Council of Europe World Health Organization Blutspendedienst Sweizerisches Rotes Kreuz NHS Blood and Transplant
www.coe.int www.who.int (Blood Transfusion Service of the Swiss England
Red Cross) www.nhsbt.nhs.uk
European Union Executive Agency for Health and Consumers Switzerland
http://europa.eu http://ec.europa.eu/eahc www.transfusion.ch
Northern Ireland Blood Transfusion Service
European Blood Alliance International Federation of Blood Donor Deutsches Rotes Kreuz Blutspendedienst Northern Ireland
www.europeanbloodalliance.eu Organizations Baden-Württemberg - Hessen gGmbH www.nibts.org
www.fiods.org (German Red Cross Blood Donation Service)
Germany Põhja-Eesti Regionaalhaigla
www.blutspende.de (North Estonian Regional Hospital)
Websites of related EU-projects Estonia
Établissement Français du Sang www.regionaalhaigla.ee
EU Optimal Blood Use Project European Blood Inspection Project (EuBIS) (French Blood Establishment)
www.optimalblooduse.eu www.eubis-europe.eu France Országos Vérellátó Szolgálat
www.dondusang.net (Hungarian National Blood Transfusion
EU-Q-Blood-SOP Project Service)
ww.eu-q-blood-sop.de Κέντρο Αίματοs Κύπρου Hungary
(Cyprus Blood Establishment) www.ovsz.hu
Cyprus
Website is not available yet Österreichisches Rotes Kreuz
(Austrian Red Cross) Austria
Het Belgische Rode Kruis Dienst voor het www.roteskreuz.at / www.blut.at
Bloed (Belgian Red Cross Blood Service)
Belgium Rdeči križ Slovenije
www.bloedgevendoetleven.be (Slovenian Red Cross) Slovenia
www.rks.si
Instituto Português do Sangue, IP
(Portugese Blood Institute) Regionale Blutspendedienst
Portugal Schweizerisches Rotes Kreuz Bern AG
www.ipsangue.org (Regional Blood Transfusion Service of the
Swiss Red Cross Bern)
Irish Blood Transfusion Service Switzerland
Ireland www.bsd-be.ch
www.giveblood.ie
Scottish National Blood Transfusion Service
National Blood Transfusion Service Malta Scotland
Malta www.scotblood.co.uk
www.health.gov.mt/nbts

248 Donor 249

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Manual 2010
 South-eastern Europe Health Network
Blood Safety Programme
Thalassaemia International Federation
www.thalassaemia.org.cy Appendix III
www.euro.who.int/stabilitypact/net- Directive 2002/98/EC
© European Union, http://eur-lex.europa.eu
work/20040611_1 The Welsh Blood Service
Wales
Stichting Sanquin Bloedvoorziening www.welsh-blood.org.uk
(Sanquin Blood Supply Foundation)
The Netherlands Zavod Republike Slovenije za transfuzijsko
www.sanquin.nl medicino (Blood Transfusion Centre of
Slovenia)
Suomen Punainen Risti Veripalvelu Slovenia
(Finnish Red Cross Blood Service) www.ztm.si
Finland
www.veripalvelu.fi

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L 33/30 EN Official Journal of the European Union 8.2.2003 8.2.2003 EN Official Journal of the European Union L 33/31

(8) In its Resolution of 12 November 1996 on a strategy (16) Blood establishments should establish and maintain
DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL towards blood safety and self-sufficiency in the European quality systems involving all activities that determine the
Community (1), the Council invited the Commission to quality policy objectives and responsibilities and imple-
of 27 January 2003 ment them by such means as quality planning, quality
submit proposals as a matter of urgency with a view to
setting standards of quality and safety for the collection, testing, processing, storage and distribu- encouraging the development of a coordinated approach control, quality assurance, and quality improvement
tion of human blood and blood components and amending Directive 2001/83/EC to the safety of blood and blood products. within the quality system, taking into account the princi-
ples of good manufacturing practice as well as the EC
conformity assessment system.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE should ensure that blood and its components are of
EUROPEAN UNION, comparable quality and safety throughout the blood (9) In its Resolutions of 14 September 1993 (2), 18
transfusion chain in all Member States, bearing in mind November 1993 (3), 14 July 1995 (4), and 17 April
Having regard to the Treaty establishing the European Commu- the freedom of movement of citizens within Community 1996 (5) on blood safety and self-sufficiency through
nity, and in particular Article 152(4)(a) thereof, territory. The establishment of high standards of quality voluntary unpaid donations in the European Commu- (17) An adequate system to ensure traceability of whole
and safety, therefore, will help to reassure the public that nity, the European Parliament stressed the importance of blood and blood components should be established.
human blood and blood components which are derived ensuring the highest level of blood safety and has reiter- Traceability should be enforced through accurate donor,
Having regard to the proposal from the Commission ( ), 1
ated its continued support for the objective of Commu-
from donations in another Member State nonetheless patient, and laboratory identification procedures,
meet the same requirements as those in their own nity self-sufficiency. through record maintenance, and through an appro-
Having regard to the opinion of the Economic and Social
country. priate identification and labelling system. It is desirable
Committee (2),
that a system is developed in order to enable the unique
(10) In elaborating the provisions of this Directive account and unmistakable identification of donations of blood
Having regard to the opinion of the Committee of the has been taken of the opinion of the Scientific and blood components in the Community. In the case of
Regions (3), Committee for Medicinal Products and Medical Devices blood and blood components imported from third coun-
(4) In respect of blood or blood components as a starting as well as international experience in this field. tries, it is important that an equivalent level of trace-
Acting in accordance with the procedure laid down in Article material for the manufacture of proprietary medicinal ability be ensured by the blood establishments in the
251 of the Treaty (4), in the light of the joint text approved by products, Directive 2001/83/EC refers to measures to be stages preceding importation into the Community. The
the Conciliation Committee on 4 November 2002, taken by Member States to prevent the transmission of (11) The nature of autologous transfusion necessitates a same requirements of traceability which apply to blood
infectious diseases, comprising the application of the specific consideration in respect of how and when to and blood components collected in the Community
Whereas: monographs of the European Pharmacopoeia and the apply the different provisions of this Directive. should be ensured in the stages following importation.
recommendations of the Council of Europe and the
(1) The extent to which human blood is used therapeutically World Health Organisation (WHO) as regards in parti-
demands that the quality and safety of whole blood and cular the selection and testing of blood and plasma (12) Hospital blood banks are hospital units which perform a
blood components be ensured in order to prevent in donors. Furthermore, Member States should take
limited number of activities, storage, distribution, and (18) It is important to introduce a set of organised surveil-
particular the transmission of diseases. measures to promote Community self-sufficiency in
compatibility tests. In order to ensure that the quality lance procedures to collect and evaluate information on
human blood or blood components and to encourage
and safety of blood and blood components are preserved the adverse or unexpected events or reactions resulting
voluntary unpaid donations of blood and blood compo-
(2) The availability of blood and blood components used for during the whole transfusion chain, while taking account from the collection of blood or blood components in
nents.
therapeutic purposes is dependent largely on Commu- of the specific nature and functions of hospital blood order to prevent similar or equivalent events or reactions
nity citizens who are prepared to donate. In order to banks, only provisions relevant to these activities should from occurring thereby improving the security of trans-
safeguard public health and to prevent the transmission apply to hospital blood banks. fusion by adequate measures. To this end a common
of infectious diseases, all precautionary measures during system of notification of serious adverse events and reac-
their collection, processing, distribution and use need to tions linked to the collection, processing, testing, storage,
be taken making appropriate use of scientific progress in (5) In order to ensure that there is an equivalent level of and distribution of blood and blood components should
(13) Member States should ensure that an appropriate
the detection and inactivation and elimination of transfu- safety and quality of blood components, whatever their be established in Member States.
mechanism for designating, authorising, accrediting or
sion transmissible pathogenic agents. intended purpose, technical requirements for the collec-
licensing exists to ensure that the activities of blood
tion and testing of all blood and blood components
establishments are performed in accordance with the
including starting materials for medicinal products
(3) The quality, safety, and efficacy requirements of proprie- requirements of this Directive.
should be established by this Directive. Directive 2001/
tary industrially-prepared medicinal products derived
83/EC should be amended accordingly. (19) It is important that when abnormal findings are reported
from human blood or plasma were ensured through
Directive 2001/83/EC of the European Parliament and of to the donor, relevant counselling is also provided.
(14) Member States should organise inspection and control
the Council of 6 November 2001 on the Community measures, to be carried out by officials representing the
code relating to medicinal products for human use (5). competent authority, to ensure the compliance of the
The specific exclusion of whole blood, plasma and blood blood establishment with the provisions of this Direc-
cells of human origin from that Directive, however, has (6) The Commission's Communication of 21 December
1994 on Blood Safety and Self-sufficiency in the tive. (20) Modern blood-transfusion practice has been founded on
led to a situation whereby their quality and safety, in so the principles of voluntary donor services, anonymity of
far as they are intended for transfusion and not European Community identified the need for a blood
strategy in order to reinforce confidence in the safety of both donor and recipient, benevolence of the donor, and
processed as such, are not subject to any binding absence of profit on the part of the establishments
Community legislation. It is essential, therefore, that the blood transfusion chain and promote Community (15) Personnel directly involved in the collection, testing,
self-sufficiency. processing, storage and distribution of blood and blood involved in blood transfusion services.
whatever the intended purpose, Community provisions
components need to be appropriately qualified and
(1) OJ C 154 E, 29.5.2001, p. 141 and provided with timely and relevant training, without
OJ C 75 E, 26.3.2002, p. 104. prejudice to existing Community legislation on the
(2) OJ C 221, 7.8.2001, p. 106. recognition of professional qualifications and on the (21) All necessary measures need to be taken in order to
(3) OJ C 19, 22.1.2002, p. 6. protection of workers.
(4) Opinion of the European Parliament of 6 September 2001 (OJ C 72 (7) In its Resolution of 2 June 1995, on blood safety and provide prospective donors of blood or blood compo-
E, 21.3.2002, p. 289), Council Common Position of 14 February self-sufficiency in the Community (6), the Council invited nents with assurances regarding the confidentiality of
2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the European the Commission to submit appropriate proposals in the (1) OJ C 374, 11.12.1996, p. 1. any health-related information provided to the
Parliament of 12 June 2002 (not yet published in the Official framework of the development of a blood strategy. (2) OJ C 268, 4.10.1993, p. 29.
Journal). Decision of the European Parliament of 18 December (3) OJ C 329, 6.12.1993, p. 268. authorised personnel, the results of the tests on their
2002 and Decision of the Council of 16 December 2002. (4) OJ C 249, 25.9.1995, p. 231. donations as well as any future traceability of their dona-
(5) OJ L 311, 28.11.2001, p. 67. (6) OJ C 164, 30.6.1995, p. 1. (5) OJ C 141, 13.5.1996, p. 131. tion.
L 33/32 EN Official Journal of the European Union 8.2.2003 8.2.2003 EN Official Journal of the European Union L 33/33

(22) According to Article 152(5) of the Treaty, the provisions (28) It is necessary that the best possible scientific advice is Article 2 (h) ‘serious adverse reaction’ shall mean an unintended
of this Directive cannot affect national provisions on the available to the Community in relation to the safety of response in donor or in patient associated with the collec-
donations of blood. Article 152(4)(a) of the Treaty states blood and blood components, in particular as regards Scope tion or transfusion of blood or blood components that is
that Member States cannot be prevented from main- adapting the provisions of this Directive to scientific and fatal, life-threatening, disabling, incapacitating, or which
taining or introducing more stringent protective technical progress. 1. This Directive shall apply to the collection and testing of results in, or prolongs, hospitalisation or morbidity;
measures as regards standards of quality and safety of human blood and blood components, whatever their intended
blood and blood components. (29) Tests should be carried out in conformity with the latest purpose, and to their processing, storage, and distribution (i) ‘blood component release’ shall mean a process which
scientific and technical procedures that reflect current when intended for transfusion. enables a blood component to be released from a quaran-
best practice as defined by, and regularly reviewed and tine status by the use of systems and procedures to ensure
updated through, an appropriate expert consultation 2. Where blood and blood components are collected and that the finished product meets its release specification;
(23) Voluntary and unpaid blood donations are a factor tested for the sole purpose and exclusive use in autologous
process. This review process should also take due
which can contribute to high safety standards for blood transfusion and are clearly identified as such, the requirements
account of scientific advances in the detection, inactiva-
and blood components and therefore to the protection (j) ‘deferral’ shall mean suspension of the eligibility of an indi-
tion and elimination of pathogens which can be trans- to be complied with in respect thereof shall be in accordance
of human health. The efforts of the Council of Europe in vidual to donate blood or blood components such suspen-
mitted via transfusion. with those referred to in Article 29(g).
this area should be supported and all necessary measures sion being either permanent or temporary;
should be taken to encourage voluntary and unpaid
(30) The measures necessary for the implementation of this 3. This Directive shall apply without prejudice to Directives
donations through appropriate measures and initiatives (k) ‘distribution’ shall mean the act of delivery of blood and
Directive should be adopted in accordance with Council 93/42/EEC (1), 95/46/EC or 98/79/EC (2).
and through ensuring that donors gain greater public blood components to other blood establishments, hospital
recognition, thereby also increasing self-sufficiency. The Decision 1999/468/EC of 28 June 1999 laying down
4. This Directive does not apply to blood stem cells. blood banks and manufacturers of blood and plasma
definition of voluntary and unpaid donation of the the procedures for the exercise of implementing powers
derived products. It does not include the issuing of blood
Council of Europe should be taken into account. conferred on the Commission (3).
or blood components for transfusion.

(31) In order to increase the effective implementation of the Article 3

provisions adopted under this Directive it is appropriate (l) ‘haemovigilance’ shall mean a set of organised surveillance
(24) Blood and blood components used for therapeutic to provide for penalties to be applied by Member States. Definitions procedures relating to serious adverse or unexpected
purposes or for use in medical devices should be events or reactions in donors or recipients, and the epide-
obtained from individuals whose health status is such For the purposes of this Directive: miological follow-up of donors;
that no detrimental effects will ensue as a result of the (32) Since the objectives of this Directive, namely to contri-
donation and that any risk of transmission of infectious bute to general confidence both in the quality of donated (a) ‘blood’ shall mean whole blood collected from a donor and
blood and blood components and in the health protec- (m) ‘inspection’ shall mean formal and objective control
diseases is minimised; each and every blood donation processed either for transfusion or for further manufac- according to adopted standards to assess compliance with
should be tested in accordance with rules which provide tion of donors, to attain self-sufficiency at a Community turing;
level and to enhance confidence in the safety of the this Directive and other relevant legislation and to identify
assurances that all necessary measures have been taken problems.
to safeguard the health of individuals who are the recipi- transfusion chain among the Member States, cannot be (b) ‘blood component’ shall mean a therapeutic constituent of
ents of blood and blood components. sufficiently achieved by the Member States and can blood (red cells, white cells, platelets, plasma) that can be
therefore by reason of its scale and effects be better prepared by various methods;
achieved at Community level, the Community may
adopt measures, in accordance with the principle of (c) ‘blood product’ shall mean any therapeutic product derived
(25) Directive 95/46/EC of the European Parliament and the subsidiarity as set out in Article 5 of the Treaty. In from human blood or plasma; Article 4
Council of 24 October 1995 on the protection of indivi- accordance with the principle of proportionality, as set
(d) ‘autologous transfusion’ shall mean transfusion in which
duals with regard to the processing of personal data and out in that Article, this Directive does not go beyond
the donor and the recipient are the same person and in
the free movement of such data (1) requires that data what is necessary in order to achieve those objectives. Implementation
which pre-deposited blood and blood components are
related to the health of an individual be subject to rein- used;
forced protection. However, it covers only personal data (33) Responsibility for the organisation of health services and
and not that rendered anonymous. This Directive should the provision of medical care should remain the respon- (e) ‘blood establishment’ shall mean any structure or body that 1. Member States shall designate the competent authority or
therefore introduce additional safeguards to prevent any sibility of each Member State, is responsible for any aspect of the collection and testing authorities responsible for implementing the requirements of
unauthorised changes to donation registries, or proces- of human blood or blood components, whatever their this Directive.
sing records, or the unauthorised disclosure of informa- intended purpose, and their processing, storage, and distri-
tion. bution when intended for transfusion. This does not
include hospital blood banks; 2. This Directive shall not prevent a Member State from
HAVE ADOPTED THIS DIRECTIVE: maintaining or introducing in its territory more stringent
(f) ‘hospital blood bank’ shall mean a hospital unit which protective measures which comply with the provisions of the
(26) The Commission should be empowered to establish stores and distributes and may perform compatibility tests Treaty.
technical requirements and adopt any necessary changes on blood and blood components exclusively for use within
thereto and to the Annexes in order to take into account CHAPTER I hospital facilities, including hospital based transfusion
scientific and technical progress. activities;
In particular, a Member State may introduce requirements for
GENERAL PROVISIONS voluntary and unpaid donations, which include the prohibition
(g) ‘serious adverse event’ shall mean any untoward occur-
rence associated with the collection, testing, processing, or restriction of imports of blood and blood components, to
(27) Setting of technical requirements and adaptation to storage and distribution, of blood and blood components ensure a high level of health protection and to achieve the
progress should take into account the Council recom- Article 1 that might lead to death or life-threatening, disabling or objective set out in Article 20(1), provided that the conditions
mendation of 29 June 1998 on the suitability of blood incapacitating conditions for patients or which results in, of the Treaty are met.
and plasma donors and the screening of donated blood or prolongs, hospitalisation or morbidity;
Objectives
in the EC (2), relevant recommendations of the Council
of Europe and the WHO as well as indications of rele- (1) Council Directive 93/42/EEC of 14 June 1993 concerning medical 3. In carrying out the activities covered by this Directive the
vant European institutions and organisations such as the This Directive lays down standards of quality and safety of devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Commission may have recourse to technical and/or administra-
monographs of the European Pharmacopoeia. human blood and of blood components, in order to ensure a Directive 2001/104/EC of the European Parliament and of the tive assistance to the mutual benefit of the Commission and of
high level of human health protection. Council (OJ L 6, 10.1.2002, p. 50).
(2) Directive 98/79/EC of the European Parliament and of the Council the beneficiaries, relating to identification, preparation, manage-
(1) OJ L 281, 23.11.1995, p. 31. of 27 October 1998 on in vitro diagnostic medical devices (OJ L ment, monitoring, audit and control, as well as to support
(2) OJ L 203, 21.7.1998, p. 14. (3) OJ L 184, 17.7.1999, p. 23. 331, 7.12.1998, p. 1). expenditure.
L 33/34 EN Official Journal of the European Union 8.2.2003 8.2.2003 EN Official Journal of the European Union L 33/35

CHAPTER II 2. Inspection and control measures shall be organised by the (b) he/she shall have practical post-graduate experience in rele- Article 13
competent authority on a regular basis. The interval between vant areas for at least two years, in one or more establish-
OBLIGATIONS ON MEMBER STATES AUTHORITIES two inspections and control measures shall not exceed two ments which are authorised to undertake activities related Record keeping
years. to collection and/or testing of human blood and blood
components, or to their preparation, storage, and distribu- 1. Member States shall take all necessary measures to ensure
Article 5 tion. that blood establishments maintain records of the information
3. Such inspection and control measures shall be carried out
by officials representing the competent authority who must be required in Annexes II and IV and under Article 29(b), (c) and
3. The tasks specified in paragraph 1 may be delegated to (d). The records shall be kept for a minimum of 15 years.
Designation, authorisation, accreditation or licensing of empowered to:
other persons who shall be qualified by training and experience
blood establishments to perform such tasks.
(a) inspect blood establishments as well as facilities of any third 2. The competent authority shall keep records of the data
parties on its own territory entrusted by the holder of the received from the blood establishments according to Articles 5,
1. Member States shall ensure that activities relating to the 4. Blood establishments shall notify the competent authority 7, 8, 9 and 15.
collection and testing of human blood and blood components, designation, authorisation, accreditation or licence referred
of the name of the responsible person referred to in paragraph
whatever their intended purpose, and to their preparation, to in Article 5 with the task of carrying out evaluation and
1 and other persons referred to in paragraph 3 together with
storage, and distribution when intended for transfusion, are testing procedures pursuant to Article 18;
information on the specific tasks for which they are respon- CHAPTER V
undertaken only by the blood establishments which have been sible.
designated, authorised, accredited or licensed by the competent (b) take samples for examination and analysis;
HAEMOVIGILANCE
authority for that purpose. 5. Where the responsible person or such other persons
(c) examine any documents relating to the object of the inspec- referred to in paragraph 3 are permanently or temporarily
2. For the purpose of paragraph 1, the blood establishment tion, subject to the provisions in force in the Member States replaced, the blood establishment shall provide immediately the
at the time of the entry into force of this Directive and Article 14
shall submit the information listed in Annex I to the competent name of the new responsible person and his or her date of
authority. which place restrictions on these powers with regard to the commencement to the competent authority.
descriptions of the method of preparation. Traceability
3. The competent authority, having verified whether the
1. Member States shall take all necessary measures in order
blood establishment complies with the requirements set out in 4. The competent authority shall organise inspection and Article 10 to ensure that blood and blood components collected, tested,
this Directive, shall indicate to the blood establishment which other control measures as appropriate in the event of any processed, stored, released and/or distributed on their territory
activities it may undertake and which conditions apply. serious adverse event or reaction or suspicion thereof in accor- Personnel can be traced from donor to recipient and vice versa.
dance with Article 15.
4. No substantial change in activities shall be undertaken by Personnel directly involved in collection, testing, processing, To this end, Member States shall ensure that blood establish-
the blood establishment without prior written approval by the storage, and distribution of human blood and blood compo- ments implement a system for identification of each single
competent authority. nents shall be qualified to perform those tasks and be provided blood donation and each single blood unit and components
CHAPTER III with timely, relevant and regularly updated training. thereof enabling full traceability to the donor as well as to the
5. The competent authority may suspend or revoke the transfusion and the recipient thereof. The system must unmis-
designation, authorisation, accreditation or licence of a blood PROVISIONS FOR BLOOD ESTABLISHMENTS takably identify each unique donation and type of blood
establishment if inspection or control measures demonstrate CHAPTER IV component. This system shall be established in accordance with
that the blood establishment does not comply with the require- the requirements referred to in Article 29(a).
ments of this Directive. QUALITY MANAGEMENT

Article 9 With regard to blood and blood components imported from

third countries, Member States shall ensure that the donor iden-
Article 6 Article 11 tification system to be implemented by blood establishments
Responsible person permits an equivalent level of traceability.
Quality system for blood establishments
Hospital blood banks
1. Blood establishments shall designate a person (responsible 2. Member States shall take all necessary measures in order
1. Member States shall take all necessary measures to ensure to ensure that the system used for the labelling of blood and
Articles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to person), responsible for: that each blood establishment establishes and maintains a blood components collected, tested, processed, stored, released
hospital blood banks. quality system for blood establishments based on the principles
— ensuring that every unit of blood or blood components has and/or distributed on their territory complies with the identifi-
of good practice. cation system referred to in paragraph 1 and the labelling
been collected and tested, whatever its intended purpose,
and processed, stored, and distributed, when intended for requirements listed in Annex III.
Article 7 2. The Commission shall establish the Community standards
transfusion, in compliance with the laws in force in the
and specifications referred to in Article 29(h) for the activities 3. Data needed for full traceability in accordance with this
Member State,
Provisions for existing establishments relating to a quality system to be carried out by a blood estab- Article shall be kept for at least 30 years.
lishment.
— providing information to the competent authority in the
Member States may decide to maintain national provisions for designation, authorisation, accreditation or licensing proce-
nine months after the date laid down in Article 32 so as to dures as required in Article 5, Article 15
enable blood establishments operating under their legislation to Article 12
comply with the requirements of this Directive. — the implementation of the requirements of Articles 10, 11, Notification of serious adverse events and reactions
12, 13, 14 and 15 in the blood establishment. Documentation
1. Member States shall ensure that:
1. Member States shall take all necessary measures in order
Article 8 2. The responsible person shall fulfil the following minimum to ensure that blood establishments maintain documentation — any serious adverse events (accidents and errors) related to
conditions of qualification: on operational procedures, guidelines, training and reference the collection, testing, processing, storage and distribution
Inspection and control measures manuals, and reporting forms. of blood and blood components which may have an influ-
(a) he/she shall possess a diploma, certificate or other evidence ence on their quality and safety, as well as any serious
1. Member States shall ensure that the competent authority of formal qualifications in the field of medical or biological 2. Member States shall take all necessary measures in order adverse reactions observed during or after transfusion
organise inspections and appropriate control measures in blood sciences awarded on completion of a university course of to ensure that access is provided to these documents for offi- which may be attributed to the quality and the safety of
establishments to ensure that the requirements of this Directive study or a course recognised as equivalent by the Member cials entrusted with inspection and control measures referred to blood and blood components are notified to the competent
are complied with. State concerned; in Article 8. authority,
L 33/36 EN Official Journal of the European Union 8.2.2003 8.2.2003 EN Official Journal of the European Union L 33/37

— blood establishments have in place a procedure accurately, 2. Member States shall submit reports to the Commission CHAPTER VIII 2. Where reference is made to this paragraph, Articles 5 and
efficiently and verifiably to withdraw from distribution on these measures two years after the entry into force of this 7 of Decision 1999/468/EC shall apply, having regard to the
blood or blood components associated with the notification Directive, and thereafter every three years. On the basis of these EXCHANGE OF INFORMATION, REPORTS AND PENALTIES provisions of Article 8 thereof.
referred to above. reports the Commission shall inform the European Parliament
and the Council of any necessary further measure it intends to The period referred to in Article 5(6) of Decision 1999/468/EC
2. These serious adverse events and reactions shall be noti- take at Community level. shall be set at three months.
Article 25
fied in accordance with the procedure and notification format
referred to in Article 29(i).
Information exchange 3. The Committee shall adopt its rules of procedure.
Article 21
CHAPTER VI The Commission shall hold regular meetings with the compe-
Testing of donations
tent authorities designated by the Member States, delegations of
PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD experts from blood establishments and other relevant parties to Article 29
AND BLOOD COMPONENTS Blood establishments shall ensure that each donation of blood exchange information on the experience acquired with regard
and blood components is tested in conformity with require- to the implementation of this Directive. Technical requirements and their adaptation to technical
ments listed in Annex IV. and scientific progress
Article 16
Member States shall ensure that blood and blood components
Provision of information to prospective donors imported into the Community are tested in conformity with Article 26 The adaptation of the technical requirements set out in
requirements listed in Annex IV. Annexes I to IV to technical and scientific progress shall be
Member States shall ensure that all prospective donors of blood Reports decided in accordance with the procedure referred to in Article
or blood components in the Community are provided with 28(2).
information referred to in Article 29(b).
Article 22 1. Member States shall send to the Commission, commen-
cing on 31 December 2003 and every three years thereafter, a The following technical requirements and their adaptation to
Storage, transport and distribution conditions report on the activities undertaken in relation to the provisions technical and scientific progress shall be decided in accordance
Article 17
of this Directive, including an account of the measures taken in with the procedure referred to in Article 28(2):
Information required from donors Blood establishments shall ensure that the storage, transport relation to inspection and control.
(a) traceability requirements;
and distribution conditions of blood and blood components
Member States shall take all necessary measures to ensure that, comply with the requirements referred to in Article 29(e). 2. The Commission shall transmit to the European Parlia-
(b) information to be provided to donors;
upon agreement of a willingness to commence the donation of ment, the Council, the Economic and Social Committee and the
blood or blood components, all donors in the Community Committee of the Regions, the reports submitted by the (c) information to be obtained from donors including the iden-
provide the information referred to in Article 29(c) to the Article 23 Member States on the experience gained in implementing this tification, health history, and the signature of the donor;
blood establishment. Directive.
Quality and safety requirements for blood and blood (d) requirements concerning the suitability of blood and
components 3. The Commission shall transmit to the European Parlia- plasma donors and the screening of donated blood
Article 18 ment, the Council, the Economic and Social Committee and the including
Blood establishments shall ensure that quality and safety Committee of the Regions, commencing on 1 July 2004 and
Eligibility of donors every three years thereafter, a report on the implementation of — permanent deferral criteria and possible exemption
requirements for blood and blood components meet the high thereto
standards in compliance with the requirements referred to in the requirements in this Directive, and in particular those
1. Blood establishments shall ensure that there are evalua- relating to inspection and control. — temporary deferral criteria;
tion procedures in place for all donors of blood and blood Article 29(f).
components and that the criteria for donation referred to in (e) storage, transport and distribution requirements;
Article 29(d) are met.
CHAPTER VII Article 27
(f) quality and safety requirements for blood and blood
2. The results of the donor evaluation and testing proce- components;
dures shall be documented and any relevant abnormal findings DATA PROTECTION Penalties
shall be reported to the donor. (g) requirements applicable to autologous transfusions;
Member States shall lay down the rules on penalties applicable
Article 24 to infringements of the national provisions adopted pursuant (h) Community standards and specifications relating to a
Article 19 to this Directive and shall take all measures necessary to ensure quality system for blood establishments;
Data protection and confidentiality that they are implemented. The penalties provided for must be
Examination of donors effective, proportionate, and dissuasive. Member States shall (i) Community procedure for notifying serious adverse reac-
Member States shall take all necessary measures to ensure that notify those provisions to the Commission by the date specified tions and events and notification format.
An examination of the donor, including an interview, shall be all data, including genetic information, collated within the in Article 32 at the latest and shall notify it without delay of
carried out before any donation of blood or blood components. scope of this Directive to which third parties have access have any subsequent amendments affecting them.
A qualified health professional shall be responsible, in parti- been rendered anonymous so that the donor is no longer iden-
cular, for giving to and gathering from donors the information Article 30
tifiable.
which is necessary to assess their eligibility to donate and shall,
on the basis thereof, assess the eligibility of donors. CHAPTER IX
For that purpose, they shall ensure: Consultation of scientific committee(s)
COMMITTEES
(a) that data security measures are in place as well as safe- The Commission may consult the relevant scientific commit-
Article 20 guards against unauthorised data additions, deletions or tee(s) when establishing the technical requirements referred to
modifications to donor files or deferral records, and transfer in Article 29 and when adapting the technical requirements set
Voluntary and unpaid blood donation Article 28
of information; out in Annexes I to IV to scientific and technical progress, in
1. Member States shall take the necessary measures to (b) that procedures are in place to resolve data discrepancies; particular with a view to ensuring an equivalent level of quality
encourage voluntary and unpaid blood donations with a view Regulatory procedure and safety of blood and blood components used for transfusion
to ensuring that blood and blood components are in so far as (c) that no unauthorised disclosure of such information occurs, and blood and blood components used as a starting material
possible provided from such donations. whilst guaranteeing the traceability of donations. 1. The Commission shall be assisted by a Committee. for the manufacture of medicinal products.
L 33/38 EN Official Journal of the European Union 8.2.2003 8.2.2003 EN Official Journal of the European Union L 33/39

CHAPTER X When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such ANNEX I
FINAL PROVISIONS reference on the occasion of their official publication. Member
States shall determine how such reference is to be made. INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR
Article 31 THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCOR-
2. Member States shall communicate to the Commission the DANCE WITH ARTICLE 5(2)
texts of the provisions of national law that they have already
Amendment of Directive 2001/83/EC
adopted or which they adopt in the field governed by this
Pa r t A : General information:
Article 109 of Directive 2001/83/EC shall be replaced by the Directive.
following: — identification of the blood establishment
Article 33 — name, qualification and contact details of responsible persons
‘Article 109
Entry into force — a list of hospital blood banks which it supplies.
For the collection and testing of human blood and human
plasma, Directive 2002/98/EC of the European Parliament This Directive shall enter into force on the day of its publica- Pa r t B : A description of the quality system, to include:
and of the Council of 27 January 2003 setting standards of tion in the Official Journal of the European Union.
quality and safety for the collection, testing, processing, — documentation, such as an organisation chart, including responsibilities of responsible persons and
reporting relationships
storage and distribution of human blood and blood compo- Article 34
nents and amending Directive 2001/83/EC (*) shall apply. — documentation such as site master file or quality manual describing the quality system in accordance
Addressees with Article 11(1)
(*) OJ L 33, 8.2.2003, p. 30.’ This Directive is addressed to the Member States. — number and qualifications of personnel
— hygiene provisions
Article 32 — premises and equipment
Done at Brussels, 27 January 2003. — list of standard operating procedures for recruitment, retention and assessment of donors, for proces-
Transposition sing and testing, distribution and recall of blood and blood components and for the reporting and
recording of serious adverse reactions and events.
1. Member States shall bring into force the laws, regulations For the European Parliament For the Council
and administrative provisions necessary to comply with this
Directive not later than 8 February 2005. They shall forthwith The President The President
inform the Commission thereof. P. COX G. DRYS

ANNEX II

REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY

This annual report will include:

— total number of donors who give blood and blood components
— total number of donations
— an updated list of the hospital blood banks which it supplies
— total number of whole donations not used
— number of each component produced and distributed
— incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components
— number of product recalls
— number of serious adverse events and reactions reported.
L 33/40 EN Official Journal of the European Union 8.2.2003
Appendix IV
Commission Directive 2004/33/EC
© European Union, http://eur-lex.europa.eu
ANNEX III

LABELLING REQUIREMENTS

The label on the component must contain the following information:

— the official name of the component
— the volume or weight or number of cells in the component (as appropriate)
— the unique numeric or alphanumeric donation identification
— the name of producing blood establishment
— the ABO Group (not required for plasma intended only for fractionation)
— the Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation)
— the date or time of expiry (as appropriate)
— the temperature of storage
— the name, composition and volume of anticoagulant and/or additive solution (if any).

ANNEX IV

BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS

The following tests must be performed for whole blood and apheresis donations, including autologous predeposit dona-
tions:
— ABO Group (not required for plasma intended only for fractionation)
— Rh D Group (not required for plasma intended only for fractionation)
— testing for the following infections in the donors:
— Hepatitis B (HBs-Ag)
— Hepatitis C (Anti-HCV)
— HIV 1/2 (Anti-HIV 1/2)
Additional tests may be required for specific components or donors or epidemiological situations.

263
30.3.2004 EN Official Journal of the European Union L 91/25 L 91/26 EN Official Journal of the European Union 30.3.2004

Article 6 communicate to the Commission the text of those provisions

COMMISSION DIRECTIVE 2004/33/EC and a correlation table between those provisions and this Direc-
Quality and safety requirements for blood and blood tive.
of 22 March 2004 components
implementing Directive 2002/98/EC of the European Parliament and of the Council as regards When Member States adopt those provisions, they shall contain
Blood establishments shall ensure that the quality and safety a reference to this Directive or be accompanied by such a refer-
certain technical requirements for blood and blood components requirements for blood and blood components comply with ence on the occasion of their official publication. Member
(Text with EEA relevance) the requirements set out in Annex V. States shall determine how such reference is to be made.

Article 7 2. Member States shall communicate to the Commission the

THE COMMISSION OF THE EUROPEAN COMMUNITIES, (6) It is necessary to determine common definitions for text of the main provisions of national law which they adopt in
technical terminology in order to ensure the consistent Autologous donations the field covered by this Directive.
Having regard to the Treaty establishing the European implementation of Directive 2002/98/EC. 1. Blood establishments shall ensure that autologous dona-
Community, tions comply with the requirements set out in Directive 2002/ Article 10
(7) The measures provided for in this Directive are in 98/EC and the specific requirements set out in this Directive.
accordance with the opinion of the Committee set up by Entry into force
Having regard to Directive 2002/98/EC of the European Parlia-
ment and of the Council of 27 January 2003 setting standards Directive 2002/98/EC, 2. Autologous donations shall be clearly identified as such This Directive shall enter into force on the 20th day following
of quality and safety for the collection, testing, processing, and shall be kept separate from allogeneic donations. that of its publication in the Official Journal of the European
storage and distribution of human blood and blood compo- Union.
nents and amending Directive 2001/83/EC (1), and in particular Article 8
points (b) to (g) of the second paragraph of Article 29 thereof, HAS ADOPTED THIS DIRECTIVE: Article 11
Validation
Member States shall ensure that all testing and processes Addressees
Whereas:
Article 1 referred to in Annexes II to V are validated. This Directive is addressed to the Member States.
(1) Directive 2002/98/EC lays down standards of quality
and safety for the collection and testing of human blood Definitions Article 9
and blood components, whatever their intended Done at Brussels, 22 March 2004.
purpose, and for their processing, storage and distribu- For the purposes of this Directive, the definitions set out in Transposition
tion when intended for transfusion so as to ensure a Annex I shall apply.
1. Without prejudice to Article 7 of Directive 2002/98/EC, For the Commission
high level of human health protection. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc- David BYRNE
(2) In order to prevent the transmission of diseases by blood Article 2 tive by 8 February 2005 at the latest. They shall forthwith Member of the Commission
and blood components and to ensure an equivalent level
of quality and safety, Directive 2002/98/EC calls for the Provision of information to prospective donors
establishment of specific technical requirements.
Member States shall ensure that blood establishments provide
prospective donors of blood or blood components with the
(3) This Directive lays down those technical requirements,
information set out in Part A of Annex II.
which take account of Council Recommendation 98/
463/EC of 29 June 1998 on the suitability of blood and
plasma donors and the screening of donated blood in
the European Community (2), certain recommendations Article 3
of the Council of Europe, the opinion of the Scientific
Committee for Medicinal Products and Medical Devices, Information required from donors
the monographs of the European Pharmacopoeia, parti-
cularly in respect of blood or blood components as a Member States shall ensure that upon agreement of willingness
starting material for the manufacture of proprietary to commence the donation of blood or blood components,
medicinal products and recommendations of the World donors provide the information set out in Part B of Annex II to
Health Organisation (WHO), as well as international the blood establishment.
experience in this field.

(4) Blood and blood components imported from third coun- Article 4
tries, including those used as starting material/raw mate-
rial for the manufacture of medicinal products derived Eligibility of donors
from human blood and human plasma, should meet the
quality and safety requirements set out in this Directive. Blood establishments shall ensure that donors of whole blood
and blood components comply with the eligibility criteria set
(5) With regard to blood and blood components collected out in Annex III.
for the sole purpose of, and exclusive use in, autologous
transfusion (autologous donation), specific technical
requirements should be laid down, as required by Article Article 5
2(2) of Directive 2002/98/EC. Such donations should be
clearly identified and kept separate from other donations Storage, transport and distribution conditions for blood
to ensure that they are not used for transfusion to other and blood components
patients.
Blood establishments shall ensure that the storage, transport
(1) OJ L 33, 8.2.2003, p. 30. and distribution conditions for blood and blood components
(2) OJ L 203, 21.7.1998, p. 14. comply with the requirements set out in Annex IV.
30.3.2004 EN Official Journal of the European Union L 91/27 L 91/28 EN Official Journal of the European Union 30.3.2004

21. ‘Platelets, recovered, pooled’ means a concentrated suspension of blood platelets, obtained by processing of whole
ANNEX I blood units and pooling the platelets from the units during or after separation.
22. ‘Platelets, recovered, pooled, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by
DEFINITIONS processing of whole blood units and pooling the platelets from the units during or after separation, and from which
leucocytes are removed.
(as referred to in Article 1)
23. ‘Platelets, recovered, single unit’ means a concentrated suspension of blood platelets, obtained by processing of a
1. ‘Autologous donation’ means blood and blood components collected from an individual and intended solely for single unit of whole blood.
subsequent autologous transfusion or other human application to that same individual. 24. ‘Platelets, recovered, single unit, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by
processing of a single whole blood unit from which leucocytes are removed.
2. ‘Allogeneic donation’ means blood and blood components collected from an individual and intended for transfusion
to another individual, for use in medical devices or as starting material/raw material for manufacturing into medic- 25. ‘Plasma, fresh-frozen’ means the supernatant plasma separated from a whole blood donation or plasma collected by
inal products. apheresis, frozen and stored.
26. ‘Plasma, cryoprecipitate-depleted for transfusion’ means a plasma component prepared from a unit of plasma, fresh-
3. ‘Validation’ means the establishment of documented and objective evidence that the particular requirements for a frozen. It comprises the residual portion after the cryoprecipitate has been removed.
specific intended use can be consistently fulfilled.
27. ‘Granulocytes, apheresis’ means a concentrated suspension of granulocytes obtained by apheresis.
4. ‘Whole blood’ means a single blood donation.
28. ‘Statistical process control’ means a method of quality control of a product or a process that relies on a system of
analysis of an adequate sample size without the need to measure every product of the process.
5. ‘Cryopreservation’ means prolongation of the storage life of blood components by freezing.

6. ‘Plasma’ means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the
cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryo-
precipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal
products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled,
leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion
or perinatal transfusion.

7. ‘Cryoprecipitate’ means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of
proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the
plasma.

8. ‘Washed’ means a process of removing plasma or storage medium from cellular products by centrifugation,
decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is
generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting,
replacing process may be repeated several times.

9. ‘Red cells’ means the red cells from a single whole blood donation, with a large proportion of the plasma from the
donation removed.

10. ‘Red cells, buffy coat removed’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes
in the donated unit, is removed.

11. ‘Red cells, leucocyte-depleted’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed, and from which leucocytes are removed.

12. ‘Red cells in additive solution’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed. A nutrient/preservative solution is added.

13. ‘Additive solution’ means a solution specifically formulated to maintain beneficial properties of cellular components
during storage.

14. ‘Red cells, buffy coat removed, in additive solution’ means the red cells from a single whole blood donation, with a
large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the
platelets and leucocytes in the donated unit, is removed. A nutrient/preservative solution is added.

15. ‘Buffy coat’ means a blood component prepared by centrifugation of a unit of whole blood, and which contains a
considerable proportion of the leucocytes and platelets.

16. ‘Red cells, leucocyte-depleted, in additive solution’ means the red cells from a single whole blood donation, with a
large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient/
preservative solution is added.

17. ‘Red cells, apheresis’ means the red cells from an apheresis red cell donation.

18. ‘Apheresis’ means a method of obtaining one or more blood components by machine processing of whole blood in
which the residual components of the blood are returned to the donor during or at the end of the process.

19. ‘Platelets, apheresis’ means a concentrated suspension of blood platelets obtained by apheresis.

20. ‘Platelets, apheresis, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by apheresis,
and from which leucocytes are removed.
30.3.2004 EN Official Journal of the European Union L 91/29 L 91/30 EN Official Journal of the European Union 30.3.2004

3. Signature of the donor

ANNEX II Signature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for
obtaining the health history confirming that the donor has:
INFORMATION REQUIREMENTS (a) read and understood the educational materials provided;
(as referred to in Articles 2 and 3) (b) had an opportunity to ask questions;
(c) been provided with satisfactory responses to any questions asked;
PART A
(d) given informed consent to proceed with the donation process;
Information to be provided to prospective donors of blood or blood components
(e) been informed, in the case of autologous donations, that the donated blood and blood components may not be
sufficient for the intended transfusion requirements; and
1. Accurate educational materials, which are understandable for members of the general public, about the essential
nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, (f) acknowledged that all the information provided by the donor is true to the best of his/her knowledge.
and the important benefits to patients.

2. For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history,
and the testing of donations and the significance of ‘informed consent’.

For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are
not to donate blood or blood components if there could be a risk for the recipient.

For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take
place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or
blood components.

3. Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of informa-
tion concerning the donor's health, and of the results of the tests performed.

4. The reasons why individuals are not to make donations which may be detrimental to their health.

5. Specific information on the nature of the procedures involved either in the allogeneic or autologous donation
process and their respective associated risks. For autologous donations, the possibility that the autologous blood and
blood components may not suffice for the intended transfusion requirements.

6. Information on the option for donors to change their mind about donating prior to proceeding further, or the
possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrass-
ment or discomfort.

7. The reasons why it is important that donors inform the blood establishment of any subsequent event that may
render any prior donation unsuitable for transfusion.

8. Information on the responsibility of the blood establishment to inform the donor, through an appropriate
mechanism, if test results show any abnormality of significance to the donor's health.

9. Information why unused autologous blood and blood components will be discarded and not transfused to other
patients.

10. Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmis-
sible microbiologic agents, will result in donor deferral and destruction of the collected unit.

11. Information on the opportunity for donors to ask questions at any time.

PART B
Information to be obtained from donors by blood establishments at every donation

1. Identification of the donor

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

2. Health and medical history of the donor

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified
healthcare professional, that includes relevant factors that may assist in identifying and screening out persons whose
donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to them-
selves.
30.3.2004 EN Official Journal of the European Union L 91/31 L 91/32 EN Official Journal of the European Union 30.3.2004

Repeated episodes of syncope, or a history Other than childhood convulsions or where at least three years
ANNEX III
of convulsions have elapsed since the date the donor last took anticonvulsant
medication without any recurrence of convulsions
ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS
(as referred to in Article 4) Gastrointestinal, genitourinary, haemato- Prospective donors with serious active, chronic, or relapsing
logical, immunological, metabolic, renal, disease
or respiratory system diseases
1. ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

Under exceptional circumstances, individual donations from donors who do not comply with the following Diabetes If being treated with insulin
criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases
must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Infectious diseases Hepatitis B, except for HBsAg-negative persons who are demon-
Directive 2002/98/EC. strated to be immune

The following criteria do not apply to autologous donations. Hepatitis C

1.1. Age and body weight of donors HIV-1/2

HTLV I/II
Age 18 to 65 years
Babesiosis (*)
17 to 18 years — unless classified as a minor by law, or
with written consent of parent or legal
guardian in accordance with law Kala Azar (visceral leishmaniasis) (*)

Trypanosomiasis cruzi (Chagas' disease) (*)

First time donors over 60 years — at the discretion of the physician in the
blood establishment
Malignant diseases Except in situ cancer with complete recovery
Over 65 years — with permission of the physician in the
blood establishment, given annually Transmissible spongiform encephalopa- Persons who have a family history which places them at risk of
thies (TSEs), (e.g. Creutzfeldt Jakob developing a TSE, or persons who have received a corneal or dura
Disease, variant Creutzfeldt Jakob mater graft, or who have been treated in the past with medicines
Body weight ≥ 50 kg for donors either of whole blood or apheresis blood components Disease) made from human pituitary glands. For variant Creutzfeldt Jacob
disease, further precautionary measures may be recommended.
1.2. Haemoglobin levels in donor's blood
Intravenous (IV) or intramuscular (IM) Any history of non-prescribed IV or IM drug use, including body-
drug use building steroids or hormones
Haemoglobin for females for males Applicable to allogeneic donors of
≥ 125 g/l ≥ 135 g/l whole blood and cellular components Xenotransplant recipients

Sexual behaviour Persons whose sexual behaviour puts them at high risk of
1.3. Protein levels in donor's blood acquiring severe infectious diseases that can be transmitted by
blood

Protein ≥ 60 g/l The protein analysis for apheresis plasma donations must be performed at
least annually 2.2. Temporary deferral criteria for donors of allogeneic donations

2.2.1. Infections
1.4. Platelet levels in donor's blood
Du r a ti on of de fe r r a l p e r i o d
Platelets Platelet number greater than or equal to Level required for apheresis platelet donors
150 × 109/l After an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full
clinical recovery.

2. DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS However, the following deferral periods shall apply for the infections listed in the table:

The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclu-
Brucellosis (*) 2 years following the date of full recovery
sively for plasma for fractionation.

Osteomyelitis 2 years after confirmed cured

2.1. Permanent deferral criteria for donors of allogeneic donations

Q fever (*) 2 years following the date of confirmed cured

Cardiovascular disease Prospective donors with active or past serious cardiovascular
disease, except congenital abnormalities with complete cure Syphilis (*) 1 year following the date of confirmed cured

Central nervous system disease A history of serious CNS disease Toxoplasmosis (*) 6 months following the date of clinical recovery

Abnormal bleeding tendency Prospective donors who give a history of a coagulopathy Tuberculosis 2 years following the date of confirmed cured
30.3.2004 EN Official Journal of the European Union L 91/33 L 91/34 EN Official Journal of the European Union 30.3.2004

2.2.3. Vaccination
Rheumatic fever 2 years following the date of cessation of symptoms, unless
evidence of chronic heart disease Attenuated viruses or bacteria 4 weeks

Inactivated/killed viruses, bacteria or rickettsiae No deferral if well

Fever > °C 2 weeks following the date of cessation of symptoms Toxoids No deferral if well

Hepatitis A or hepatitis B vaccines No deferral if well and if no exposure

Flu-like illness 2 weeks after cessation of symptoms Rabies No deferral if well and if no exposure
If vaccination is given following exposure defer for one
year
Malaria (*) Tick-borne encephalitis vaccines No deferral if well and if no exposure

2.2.4. Other temporary deferrals

— individuals who have lived in a malarial 3 years following return from last visit to any endemic area,
area within the first five years of life provided person remains symptom free;
Pregnancy 6 months after delivery or termination, except in exceptional circum-
may be reduced to 4 months if an immunologic or molecular
stances and at the discretion of a physician
genomic test is negative at each donation
Minor surgery 1 week

Dental treatment Minor treatment by dentist or dental hygienist — defer until next day
— individuals with a history of malaria 3 years following cessation of treatment and absence of symptoms.
(NB: Tooth extraction, root-filling and similar treatment is considered as
Accept thereafter only if an immunologic or molecular genomic
minor surgery)
test is negative
Medication Based on the nature of the prescribed medicine, its mode of action and the
disease being treated
— asymptomatic visitors to endemic areas 6 months after leaving the endemic area unless an immunologic or
molecular genomic test is negative 2.3. Deferral for particular epidemiological situations

Particular epidemiological situations (e.g. disease Deferral consistent with the epidemiological situation
— individuals with a history of undiag- 3 years following resolution of symptoms; outbreaks) (These deferrals should be notified by the competent
nosed febrile illness during or within six may be reduced to 4 months if an immunologic or molecular test authority to the European Commission with a view to
months of a visit to an endemic area is negative Community action)

2.4. Deferral criteria for donors of autologous donations

West Nile Virus (WNV) (*) 28 days after leaving an area with ongoing transmission of WNV
to humans Serious cardiac disease Depending on the clinical setting of the blood collec-
tion

Persons with or with a history of Member States may, however, establish specific provi-
— hepatitis B, except for HBsAg-negative persons who sions for autologous donations by such persons
are demonstrated to be immune
— hepatitis C
2.2.2. Exposure to risk of acquiring a transfusion-transmissible infection — HIV-1/2
— HTLV I/II

Active bacterial infection

— Endoscopic examination using flexible instruments, Defer for 6 months, or for 4 months provided a NAT
— mucosal splash with blood or needlestick injury, test for hepatitis C is negative
— transfusion of blood components,
— tissue or cell transplant of human origin,
— major surgery,
— tattoo or body piercing,
— acupuncture unless performed by a qualified practi-
tioner and with sterile single-use needles,
— persons at risk due to close household contact with
persons with hepatitis B.

Persons whose behaviour or activity places them at risk Defer after cessation of risk behaviour for a period
of acquiring infectious diseases that may be transmitted determined by the disease in question, and by the avail-
by blood. ability of appropriate tests
30.3.2004 EN Official Journal of the European Union L 91/35 L 91/36 EN Official Journal of the European Union 30.3.2004

ANNEX IV ANNEX V

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
(as referred to in Article 5) (as referred to in Article 6)

1. STORAGE 1. THE BLOOD COMPONENTS

1.1. Liquid storage
1. Red cell preparations The components listed in points 1.1 to 1.8 may be further processed within blood
establishments and must be labelled accordingly
Component Temperature of storage Maximum storage time
1.1 Red cells
Red cell preparations and whole + 2 to + 6 °C 28 to 49 days according to the processes
blood (if used for transfusion as used for collection, processing and storage 1.2 Red cells, buffy coat removed
whole blood)
1.3 Red cells, leucocyte-depleted
Platelet preparations + 20 to + 24 °C 5 days; may be stored for 7 days in
conjunction with detection or reduction of 1.4 Red cells, in additive solution
bacterial contamination
1.5 Red cells, buffy coat removed, in additive solution
Granulocytes + 20 to + 24 °C 24 hours
1.6 Red cells, leucocyte-depleted, in additive solution

1.2. Cryopreservation 1.7 Red cells, apheresis

Component Storage conditions and duration 1.8 Whole blood

Red blood cells Up to 30 years according to processes used for collection, processing and storage 2. Platelet preparations The components listed in points 2.1 to 2.6 may be further processed within blood
establishments and must be labelled accordingly
Platelets Up to 24 months according to processes used for collection, processing and storage
2.1 Platelets, apheresis
Plasma and cryoprecipitate Up to 36 months according to processes used for collection, processing and storage
2.2 Platelets, apheresis, leucocyte-depleted
Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allow-
able storage period after thawing to depend on the method used. 2.3 Platelets, recovered, pooled

2.4 Platelets, recovered, pooled, leucocyte-depleted

2. TRANSPORT AND DISTRIBUTION
2.5 Platelets, recovered, single unit
Transport and distribution of blood and blood components at all stages of the transfusion chain must be under
conditions that maintain the integrity of the product. 2.6 Platelets, recovered, single unit, leucocyte-depleted

3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS 3. Plasma preparations The components listed in 3.1 to 3.3 may be further processed within blood estab-
lishments and must be labelled accordingly.
3.1. Autologous blood and blood components must be clearly identified as such and stored, transported and distributed
separately from allogeneic blood and blood components. 3.1 Fresh-frozen plasma
3.2. Autologous blood and blood components must be labelled as required by Directive 2002/98/EC and in addition 3.2 Fresh-frozen plasma, cryoprecipitate-depleted
the label must include the identification of the donor and the warning ‘FOR AUTOLOGOUS TRANSFUSION
ONLY’. 3.3 Cryoprecipitate

4. Granulocytes, apheresis

5. New components Quality and safety requirements for new blood components must be regulated by
the competent national authority. Such new components must be notified to the
European Commission with a view to Community action

2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

2.1. Blood and blood components must comply with the following technical quality measurements and meet the accep-
table results.

2.2. Appropriate bacteriological control of the collection and manufacturing process must be performed.

2.3. Member States must take all necessary measures to ensure that all imports of blood and blood components from
third countries, including those used as starting material/raw material for the manufacture of medicinal products
derived from human blood or human plasma, shall meet equivalent standards of quality and safety to the ones laid
down in this Directive.
30.3.2004 EN Official Journal of the European Union L 91/37 L 91/38 EN Official Journal of the European Union 30.3.2004

2.4. For autologous donations, the measures marked with an asterisk (*) are recommendations only.
Quality measurements
required
The required frequency of
Quality measurements Component Acceptable results for quality measurements
sampling for all measurements
required shall be determined using statis-
The required frequency of tical process control
Component Acceptable results for quality measurements
sampling for all measurements
shall be determined using statis-
tical process control Red cells, apheresis Volume Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis
Red cells Volume Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis
Haemoglobin (*) Not less than 40 g per unit

Haemoglobin (*) Not less than 45 g per unit

Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life
Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life
Whole blood Volume Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis
Red cells, buffy coat Volume Valid for storage characteristics to maintain product 450 ml +/- 50ml
removed within specifications for haemoglobin and haemolysis For paediatric autologous whole blood collections — not
to exceed 10,5 ml per kg body weight
Haemoglobin (*) Not less than 43 g per unit
Haemoglobin (*) Not less than 45 g per unit
Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life
Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life
Red cells, leucocyte- Volume Valid for storage characteristics to maintain product
depleted within specifications for haemoglobin and haemolysis
Platelets, apheresis Volume Valid for storage characteristics to maintain product
within specifications for pH
Haemoglobin (*) Not less than 40 g per unit

Leucocyte content Less than 1 × 106 per unit Platelet content Variations in platelet content per single donation are
permitted within limits that comply with validated
preparation and preservation conditions
Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life
pH 6,4 – 7,4 corrected for 22 °C, at the end of the shelf life
Red cells, in additive Volume Valid for storage characteristics to maintain product
solution within specifications for haemoglobin and haemolysis Platelets, apheresis, Volume Valid for storage characteristics to maintain product
leucocyte-depleted within specifications for pH
Haemoglobin (*) Not less than 45 g per unit
Platelet content Variations in platelet content per single donation are
Haemolysis Less than 0,8 % of red cell mass at the end of the shelf permitted within limits that comply with validated
life preparation and preservation conditions

Red cells, buffy coat Volume Valid for storage characteristics to maintain product Leucocyte content Less than 1 × 106 per unit
removed, in additive within specifications for haemoglobin and haemolysis
solution
pH 6,4 – 7,4 corrected for 22 °C, at the end of the shelf life
Haemoglobin (*) Not less than 43 g per unit

Haemolysis Less than 0,8 % of red cell mass at the end of the shelf Platelets, recovered, Volume Valid for storage characteristics to maintain product
life pooled within specifications for pH

Red cells, leucocyte- Volume Valid for storage characteristics to maintain product Platelet content Variations in platelet content per pool are permitted
depleted, in additive within specifications for haemoglobin and haemolysis within limits that comply with validated preparation and
solution preservation conditions
Haemoglobin (*) Not less than 40 g per unit
Leucocyte content Less than 0,2 × 109 per single unit (platelet-rich plasma
Leucocyte content Less than 1 × 106 per unit method)
Less than 0,05 × 109 per single unit (buffy coat method)

Haemolysis Less than 0,8 % of red cell mass at the end of the shelf
life pH 6,4 – 7,4 corrected for 22 °C, at the end of the shelf life
30.3.2004 EN Official Journal of the European Union L 91/39
Appendix V
Commission Directive 2005/61/EC
Quality measurements © European Union, http://eur-lex.europa.eu
required
The required frequency of
Component Acceptable results for quality measurements
sampling for all measurements
shall be determined using statis-
tical process control

Platelets, recovered, Volume Valid for storage characteristics to maintain product

pooled, leucocyte- within specifications for pH
depleted
Platelet content Variations in platelet content per pool are permitted
within limits that comply with validated preparation and
preservation conditions

Leucocyte content Less than 1 × 106 per pool

pH 6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets, recovered, Volume Valid for storage characteristics to maintain product

single unit within specifications for pH

Platelet content Variations in platelet content per single unit are permitted
within limits that comply with validated preparation and
preservation conditions

Leucocyte content Less than 0,2 × 109 per single unit (platelet-rich plasma
method)
Less than 0,05 × 109 per single unit (buffy coat method)

pH 6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets, recovered, Volume Valid for storage characteristics to maintain product

single unit, leucocyte- within specifications for pH
depleted
Platelet content Variations in platelet content per single unit are permitted
within limits that comply with validated preparation and
preservation conditions

Leukocyte content Less than 1 × 106 per unit

pH 6, 4 — 7,4 corrected for 22 °C, at the end of the shelf life

Plasma, fresh-frozen Volume Stated volume +/- 10 %

Factor VIIIc (*) Average (after freezing and thawing): 70 % or more of

the value of the freshly collected plasma unit

Total protein (*) Not less than 50 g/l

Residual cellular content (*) Red cells: less than 6,0 × 109/l
Leucocytes: less than 0, 1 × 109/l
Platelets: less than 50 × 109/l

Plasma, fresh-frozen, Volume Stated volume: +/- 10 %

cryoprecipitate-depleted
Residual cellular content (*) Red cells: less than 6,0 × 109/l
Leucocytes: less than 0,1 × 109/l
Platelets: less than 50 × 109/l

Cryoprecipitate Fibrinogen content (*) Greater than or equal to 140 mg per unit

Factor VIIIc content (*) Greater than or equal to 70 international units per unit

Granulocytes, apheresis Volume Less than 500 ml

Granulocyte content Greater than 1 × 1010 granulocytes per unit

279
L 256/32 EN Official Journal of the European Union 1.10.2005 1.10.2005 EN Official Journal of the European Union L 256/33

COMMISSION DIRECTIVE 2005/61/EC (d) ‘issue’ means the provision of blood or blood components at least 30 years in an appropriate and readable storage medium
by a blood establishment or a hospital blood bank for in order to ensure traceability.
of 30 September 2005 transfusion to a recipient;
implementing Directive 2002/98/EC of the European Parliament and of the Council as regards
traceability requirements and notification of serious adverse reactions and events Article 5
(e) ‘imputability’ means the likelihood that a serious adverse
(Text with EEA relevance) reaction in a recipient can be attributed to the blood or Notification of serious adverse reactions
blood component transfused or that a serious adverse
reaction in a donor can be attributed to the donation 1. Member States shall ensure that those facilities where
THE COMMISSION OF THE EUROPEAN COMMUNITIES, medicinal products for human use (3), Commission process; transfusion occurs have procedures in place to retain the
Directive 2004/33/EC of 22 March 2004 implementing record of transfusions and to notify blood establishments
Directive 2002/98/EC of the European Parliament and of without delay of any serious adverse reactions observed in reci-
Having regard to the Treaty establishing the European the Council as regards certain technical requirements for (f) ‘facilities’ means hospitals, clinics, manufacturers, and bio- pients during or after transfusion which may be attributable to
Community, blood and blood components (4), and certain recommen- medical research institutions to which blood or blood the quality or safety of blood and blood components.
dations of the Council of Europe. components may be delivered.

Having regard to Directive 2002/98/EC of the European 2. Member States shall ensure that reporting establishments
Parliament and of the Council of 27 January 2003 setting (5) Accordingly, blood and blood components imported Article 2
from third countries, including those used as starting have procedures in place to communicate to the competent
standards of quality and safety for the collection, testing, authority as soon as known all relevant information about
material or raw material for the manufacture of Traceability
processing, storage and distribution of human blood and suspected serious adverse reactions. The notification formats
blood components and amending Directive 2001/83/EC (1), medicinal products derived from human blood and
human plasma, intended for distribution in the 1. Member States shall ensure the traceability of blood and set out in Part A and Part C of Annex II shall be used.
and in particular points (a) and (i) of the second paragraph of blood components through accurate identification procedures,
Article 29 thereof, Community, should meet equivalent Community
standards and specifications relating to traceability and record maintenance and an appropriate labelling system.
serious adverse reaction and serious adverse event noti- 3. Member States shall ensure that reporting establishments:
Whereas: fication requirements as set out in this Directive.
2. Member States shall ensure that the traceability system in
place in the blood establishment enables the tracing of blood
components to their location and processing stage. (a) notify to the competent authority all relevant information
(6) It is necessary to determine common definitions for
(1) Directive 2002/98/EC lays down standards of quality and about serious adverse reactions of imputability level 2 or 3,
technical terminology in order to ensure the consistent as referred to in Part B of Annex II, attributable to the
safety for the collection and testing of human blood and implementation of Directive 2002/98/EC.
blood components, whatever their intended purpose, and 3. Member States shall ensure that every blood establishment quality and safety of blood and blood components;
for their processing, storage and distribution when has a system in place to uniquely identify each donor, each
intended for transfusion so as to ensure a high level of blood unit collected and each blood component prepared,
(7) The measures provided for in this Directive are in
human health protection. whatever its intended purpose, and the facilities to which a (b) notify the competent authority of any case of transmission
accordance with the opinion of the Committee set up
given blood component has been delivered. of infectious agents by blood and blood components as
by Directive 2002/98/EC,
soon as known;
(2) In order to prevent the transmission of diseases by blood
4. Member States shall ensure that all facilities have a system
and blood components and to ensure an equivalent level HAS ADOPTED THIS DIRECTIVE: in place to record each blood unit or blood component
of quality and safety, Directive 2002/98/EC calls for the (c) describe the actions taken with respect to other implicated
received, whether or not locally processed, and the final desti-
establishment of specific technical requirements dealing blood components that have been distributed for trans-
nation of that received unit, whether transfused, discarded or
with traceability, a Community procedure for notifying Article 1 fusion or for use as plasma for fractionation;
returned to the distributing blood establishment.
serious adverse reactions and events and the notification
format. Definitions
For the purposes of this Directive, the following definitions shall 5. Member States shall ensure that every blood establishment (d) evaluate suspected serious adverse reactions according to the
apply: has a unique identifier that enables it to be precisely linked to imputability levels set out in Part B of Annex II;
(3) Notification of suspected serious adverse reactions or each unit of blood that it has collected and to each blood
serious adverse events should be submitted to the component that it has prepared.
competent authority as soon as known. This Directive (a) ‘traceability’ means the ability to trace each individual unit
therefore establishes the notification format defining the (e) complete the serious adverse reaction notification, upon
of blood or blood component derived thereof from the
minimum data needed, without prejudice to the faculty Article 3 conclusion of the investigation, using the format set out
donor to its final destination, whether this is a recipient, a
of Member States to maintain or introduce in their in Part C of Annex II;
manufacturer of medicinal products or disposal, and vice Verification procedure for issuing blood or blood
territory more stringent protective measures which versa;
comply with the provisions of the Treaty as provided components
under Article 4(2) of Directive 2002/98/EC. (f) submit a complete report on serious adverse reactions to
Member States shall ensure that the blood establishment, when
(b) ‘reporting establishment’ means the blood establishment, the the competent authority on an annual basis using the
it issues units of blood or blood components for transfusion, or
hospital blood bank or facilities where the transfusion takes format set out in Part D of Annex II.
the hospital blood bank has in place a procedure to verify that
(4) This Directive lays down those technical requirements, place that reports serious adverse reactions and/or serious each unit issued has been transfused to the intended recipient or
which take account of Council Recommendation adverse events to the competent authority; if not transfused to verify its subsequent disposition.
98/463/EC of 29 June 1998 on the suitability of blood Article 6
and plasma donors and the screening of donated blood
in the European Community (2), Directive 2001/83/EC of (c) ‘recipient’ means someone who has been transfused with Article 4 Notification of serious adverse events
the European Parliament and of the Council of blood or blood components;
6 November 2001 on the Community code relating to Record of data on traceability 1. Member States shall ensure that blood establishments and
(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive hospital blood banks have procedures in place to retain the
(1) OJ L 33, 8.2.2003, p. 30. 2004/27/EC (OJ L 136, 30.4.2004, p. 34). Member States shall ensure that blood establishments, hospital record of any serious adverse events which may affect the
(2) OJ L 203, 21.7.1998, p. 14. (4) OJ L 91, 30.3.2004, p. 25. blood banks, or facilities retain the data set out in Annex I for quality or safety of blood and blood components.
L 256/34 EN Official Journal of the European Union 1.10.2005 1.10.2005 EN Official Journal of the European Union L 256/35

2. Member States shall ensure that reporting establishments with regard to serious adverse reactions and events in order to ANNEX I
have procedures in place to communicate to the competent guarantee that blood or blood components known or suspected
authority as soon as known, using the notification format set to be defective are withdrawn from use and discarded.
out in Part A of Annex III, all relevant information about Record of data on traceability as provided for in Article 4
serious adverse events which may put in danger donors or
recipients other than those directly involved in the event Article 10 BY BLOOD ESTABLISHMENTS
concerned.
Transposition 1. Blood establishment identification
3. Member States shall ensure that reporting establishments:
1. Without prejudice to Article 7 of Directive 2002/98/EC,
Member States shall bring into force the laws, regulations and 2. Blood donor identification
(a) evaluate serious adverse events to identify preventable
administrative provisions necessary to comply with this
causes within the process; 3. Blood unit identification
Directive by 31 August 2006 at the latest. They shall
forthwith communicate to the Commission the text of those
(b) complete the serious adverse event notification, upon provisions and a correlation table between those provisions and 4. Individual blood component identification
conclusion of the investigation, using the format set out this Directive.
in Part B of Annex III; 5. Date of collection (year/month/day)

(c) submit a complete report on serious adverse events to the When Member States adopt those provisions, they shall contain 6. Facilities to which blood units or blood components are distributed, or subsequent disposition.
competent authority on an annual basis using the format set a reference to this Directive or be accompanied by such a
out in Part C of Annex III. reference on the occasion of their official publication. Member
States shall determine how such reference is to be made. BY FACILITIES
Article 7
1. Blood component supplier identification
Requirements for imported blood and blood components
2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in 2. Issued blood component identification
1. Member States shall ensure that for imports of blood and
blood components from third countries blood establishments the field covered by this Directive.
have a system of traceability in place equivalent to that provided 3. Transfused recipient identification
for in Article 2(2) to (5).
Article 11 4. For blood units not transfused, confirmation of subsequent disposition
2. Member States shall ensure that for imports of blood and
blood components from third countries blood establishments Entry into force 5. Date of transfusion or disposition (year/month/day)
have a system of notification in place equivalent to that
This Directive shall enter into force on the 20th day following 6. Lot number of the component, if relevant.
provided for in Articles 5 and 6.
that of its publication in the Official Journal of the European
Union.
Article 8

Annual reports
Article 12
Member States shall submit to the Commission an annual
report, by 30 June of the following year, on the notification Addressees
of serious adverse reactions and events received by the
This Directive is addressed to the Member States.
competent authority using the formats in Part D of Annex II
and Part C of Annex III.

Article 9 Done at Brussels, 30 September 2005.

Communication of information between competent
authorities For the Commission
Member States shall ensure that their competent authorities Markos KYPRIANOU
communicate to each other such information as is appropriate Member of the Commission
L 256/36 EN Official Journal of the European Union 1.10.2005 1.10.2005 EN Official Journal of the European Union L 256/37

ANNEX II PART B
NOTIFICATION OF SERIOUS ADVERSE REACTIONS Serious adverse reactions — imputability levels

PART A Imputability levels to assess serious adverse reactions.

Rapid notification format for suspected serious adverse reactions
Imputability level Explanation

Reporting establishment NA Not assessable When there is insufficient data for imputability assessment.

Report identification 0 Excluded When there is conclusive evidence beyond reasonable doubt for attributing the adverse
reaction to alternative causes.
Reporting date (year/month/day)
Unlikely When the evidence is clearly in favour of attributing the adverse reaction to causes other
Date of transfusion (year/month/day) than the blood or blood components.

Age and sex of recipient 1 Possible When the evidence is indeterminate for attributing adverse reaction either to the blood or
blood component or to alternative causes.
Date of serious adverse reaction (year/month/day) 2 Likely, Probable When the evidence is clearly in favour of attributing the adverse reaction to the blood or
blood component.
Serious adverse reaction is related to
— Whole blood 3 Certain When there is conclusive evidence beyond reasonable doubt for attributing the adverse
reaction to the blood or blood component.
— Red blood cells
— Platelets
— Plasma
PART C
— Other (specify)
Confirmation format for serious adverse reactions
Type of serious adverse reaction(s)
— Immunological haemolysis due to ABO incompatibility Reporting establishment
— Immunological haemolysis due to other allo-antibody
Report identification
— Non-immunological haemolysis
— Transfusion-transmitted bacterial infection Confirmation date (year/month/day)

— Anaphylaxis/hypersensitivity Date of serious adverse reaction (year/month/day)

— Transfusion related acute lung injury
Confirmation of serious adverse reaction (Yes/No)
— Transfusion-transmitted viral infection (HBV)
— Transfusion-transmitted viral infection (HCV) Imputability level (NA, 0-3)
— Transfusion-transmitted viral infection (HIV-1/2)
Change of type of serious adverse reaction (Yes/No)
— Transfusion-transmitted viral infection, Other (specify)
If Yes, specify
— Transfusion-transmitted parasitical infection (Malaria)
— Transfusion-transmitted parasitical infection, Other (specify) Clinical outcome (if known)
— Post-transfusion purpura — Complete recovery
— Graft versus host disease — Minor sequelae
— Other serious reaction(s) (specify) — Serious sequelae
— Death
Imputability level (NA, 0-3)
L 256/38 EN Official Journal of the European Union 1.10.2005 1.10.2005 EN Official Journal of the European Union L 256/39

PART D Post-transfusion purpura Total

Annual notification format for serious adverse reactions
Deaths

Graft versus host disease Total

Reporting establishment
Deaths
Reporting period Other serious reactions (specify) Total
This Table refers to Number of units issued (total number of units issued with a given number of Deaths
[ ] Whole blood blood components)
[ ] Red blood cells
[ ] Platelets Number of recipients transfused (total number of recipients transfused with a given
[ ] Plasma number of blood components) (if available)
[ ] Other
(use separate table for each component) Number of units transfused (the total number of blood components (units)
transfused over the reporting period) (if available)

Total number
reported
Number of serious adverse reactions with imputability level
0 to 3 after confirmation (see Annex IIA)
Number of
deaths

not Level Level Level Level

assessable 0 1 2 3

Immunological Haemolysis Due to ABO incompatibility Total

Deaths

Due to other allo-antibody Total

Deaths

Non-immunological haemolysis Total

Deaths

Transfusion-transmitted bacterial infection Total

Deaths

Anaphylaxis/hypersensitivity Total

Deaths

Transfusion related acute lung injury Total

Deaths

Transfusion-transmitted viral HBV Total

Infection
Deaths

HCV Total

Deaths

HIV-1/2 Total

Deaths

Other (specify) Total

Deaths

Transfusion-transmitted para- Malaria Total

sitical infection
Deaths

Other (specify) Total

Deaths
L 256/40 EN Official Journal of the European Union 1.10.2005
Appendix VI
Commission Directive 2005/62/EC
© European Union, http://eur-lex.europa.eu
ANNEX III

NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A
Rapid Notification Format for Serious Adverse Events

Reporting establishment

Report identification

Reporting date (year/month/day)

Date of serious adverse event (year/month/day)

Serious adverse event, which may Specification

affect quality and safety of blood Equipment Other
component due to a deviation in: Product defect failure Human error (specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)

PART B
Confirmation Format for Serious Adverse Events

Reporting establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse event (year/month/day)

Root cause analysis (details)

Corrective measures taken (details)

PART C
Annual Notification Format for Serious Adverse Events

Reporting establishment
Reporting period 1 January-31 December (year)
Total number of blood and blood components processed:

Serious adverse event, affecting Specification

quality and safety of blood Total
number Product Equipment Human Other
component due to a deviation in: defect failure error (specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)

289
1.10.2005 EN Official Journal of the European Union L 256/41 L 256/42 EN Official Journal of the European Union 1.10.2005

COMMISSION DIRECTIVE 2005/62/EC (8) It is necessary to determine common definitions for (j) ‘processing’ means any step in the preparation of a blood
technical terminology in order to ensure the consistent component that is carried out between the collection of
of 30 September 2005 implementation of Directive 2002/98/EC. blood and the issuing of a blood component;
implementing Directive 2002/98/EC of the European Parliament and of the Council as regards
Community standards and specifications relating to a quality system for blood establishments
(9) The measures provided for in this Directive are in
(Text with EEA relevance) (k) ‘good practice’ means all elements in established practice
accordance with the opinion of the Committee set up
by Directive 2002/98/EC, that collectively will lead to final blood or blood
components that consistently meet predefined specifi-
THE COMMISSION OF THE EUROPEAN COMMUNITIES, November 2001 on the Community code relating to cations and compliance with defined regulations;
medicinal products for human use (3), Commission
Directive 2003/94/EC of 8 October 2003 laying down HAS ADOPTED THIS DIRECTIVE:
the principles and guidelines of good manufacturing
Having regard to the Treaty establishing the European
practice in respect of medicinal products for human (l) ‘quarantine’ means the physical isolation of blood
Community,
use and investigational medicinal products for human Article 1 components or incoming materials/reagents over a
use (4), Commission Directive 2004/33/EC of 22 March variable period of time while awaiting acceptance,
2004 implementing Directive 2002/98/EC of the Definitions issuance or rejection of the blood components or
Having regard to Directive 2002/98/EC of the European European Parliament and of the Council as regards incoming materials/reagents;
Parliament and of the Council of 27 January 2003 setting certain technical requirements for blood and blood For the purposes of this Directive, the following definitions shall
standards of quality and safety for the collection, testing, components (5), certain recommendations of the apply:
processing, storage and distribution of human blood and Council of Europe, the monographs of the European
blood components and amending Directive 2001/83/EC (1), Pharmacopoeia, particularly in respect of blood or (m) ‘validation’ means the establishment of documented and
and in particular point (h) of the second paragraph of Article blood components as a starting material for the manu- (a) ‘standard’ means the requirements that serve as the basis objective evidence that the pre-defined requirements for a
29 thereof, facture of proprietary medicinal products, recommen- for comparison; specific procedure or process can be consistently fulfilled;
dations of the World Health Organisation, as well as
international experience in this field.
Whereas: (b) ‘specification’ means a description of the criteria that must
be fulfilled in order to achieve the required quality (n) ‘qualification’, as part of validation, means the action of
standard; verifying that any personnel, premises, equipment or
material works correctly and delivers the expected results;
(1) Directive 2002/98/EC lays down standards of quality and (5) In order to ensure the highest quality and safety for
safety for the collection and testing of human blood and blood and blood components, guidance on good
blood components, whatever their intended purpose, and practice should be developed to support the quality (c) ‘quality system’ means the organisational structure, respon-
for their processing, storage and distribution when system requirements for blood establishments taking sibilities, procedures, processes, and resources for imple- (o) ‘computerised system’ means a system including the input
intended for transfusion so as to ensure a high level of fully into account the detailed guidelines referred to in menting quality management; of data, electronic processing and the output of infor-
human health protection. Article 47 of Directive 2001/83/EC so as to ensure that mation to be used either for reporting, automatic control
the standards required for medicinal products are main- or documentation.
tained. (d) ‘quality management’ means the co-ordinated activities to
direct and control an organisation with regard to quality at
(2) In order to prevent the transmission of diseases by blood all levels within the blood establishment;
and blood components and to ensure an equivalent level
Article 2
of quality and safety, Directive 2002/98/EC calls for the
establishment of specific technical requirements including (6) Blood and blood components imported from third Quality system standards and specifications
Community standards and specifications with regard to a (e) ‘quality control’ means part of a quality system focussed on
countries, including those used as starting material or fulfilling quality requirements;
quality system for blood establishments. raw material for the manufacture of medicinal products 1. Member States shall ensure that the quality system in
derived from human blood and human plasma intended place in all blood establishments complies with the
for distribution in the Community, should meet Community standards and specifications set out in the Annex
equivalent Community standards and specifications (f) ‘quality assurance’ means all the activities from blood to this Directive.
(3) A quality system for blood establishments should
relating to a quality system for blood establishments as collection to distribution made with the object of
embrace the principles of quality management, quality
set out in this Directive. ensuring that blood and blood components are of the
assurance, and continuous quality improvement, and
quality required for their intended use;
should include personnel, premises and equipment, docu-
2. Good practice guidelines shall be developed by the
mentation, collection, testing and processing, storage and
Commission, in accordance with Article 28 of Directive
distribution, contract management, non-conformance
(g) ‘trace-back’ means the process of investigating a report of a 2002/98/EC, for the interpretation of the Community
and self-inspection, quality control, blood component
(7) It is necessary to specify that a quality system is to be suspected transfusion-associated adverse reaction in a standards and specifications referred to in paragraph 1. When
recall, and external and internal auditing.
applied for any blood and blood components circulating recipient in order to identify a potentially implicated donor; developing these guidelines, the Commission shall take fully
in the Community and that Member States therefore into account the detailed principles and guidelines of good
should ensure that for blood and blood components manufacturing practice, as referred to in Article 47 of
(4) This Directive lays down those technical requirements, coming from third countries there is a quality system Directive 2001/83/EC.
which take account of Council Recommendation (h) ‘written procedures’ means controlled documents that
in place for blood establishments in the stages describe how specified operations are to be carried out;
98/463/EC of 29 June 1998 on the suitability of blood preceding importation equivalent to the quality system
and plasma donors and the screening of donated blood provided under this Directive.
in the European Community (2), Directive 2001/83/EC of 3. Member States shall ensure that for blood and blood
the European Parliament and of the Council of 6 (i) ‘mobile site’ means a temporary or movable place used for components imported from third countries and intended for
(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive
2004/27/EC (OJ L 136, 30.4.2004, p. 34). the collection of blood and blood components which is in use or distribution in the Community, there is a quality
(1) OJ L 33, 8.2.2003, p. 30. (4) OJ L 262, 14.10.2003, p. 22. a location outside of but under the control of the blood system for blood establishments in the stages preceding impor-
(2) OJ L 203, 21.7.1998, p. 14. (5) OJ L 91, 30.3.2004, p. 25. establishment; tation equivalent to the quality system provided for in Article 2.
1.10.2005 EN Official Journal of the European Union L 256/43 L 256/44 EN Official Journal of the European Union 1.10.2005

Article 3 Article 4 ANNEX

Transposition Entry into force Quality system standards and specifications

1. Without prejudice to Article 7 of Directive 2002/98/EC, This Directive shall enter into force on the 20th day following
Member States shall bring into force the laws, regulations and its publication in the Official Journal of the European Union. 1. INTRODUCTION AND GENERAL PRINCIPLES
administrative provisions necessary to comply with this
Directive by 31 August 2006 at the latest. They shall 1.1. Quality system
Article 5
forthwith communicate to the Commission the text of those 1. Quality shall be recognised as being the responsibility of all persons involved in the processes of the blood
provisions and a correlation table between those provisions and Addressees establishment with management ensuring a systematic approach towards quality and the implementation and
this Directive. maintenance of a quality system.
This Directive is addressed to the Member States.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a 2. The quality system encompasses quality management, quality assurance, continuous quality improvement,
Done at Brussels, 30 September 2005. personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution,
reference on the occasion of their official publication. Member quality control, blood component recall, and external and internal auditing, contract management, non-
States shall determine how such reference is to be made. conformance and self-inspection.
For the Commission
2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in Markos KYPRIANOU 3. The quality system shall ensure that all critical processes are specified in appropriate instructions and are carried
the field covered by this Directive. Member of the Commission out in accordance with the standards and specifications set out in this Annex. Management shall review the
system at regular intervals to verify its effectiveness and introduce corrective measures if deemed necessary.

1.2. Quality assurance

1. All blood establishments and hospital blood banks shall be supported by a quality assurance function, whether
internal or related, in fulfilling quality assurance. That function shall be involved in all quality-related matters and
review and approve all appropriate quality related documents.

2. All procedures, premises, and equipment that have an influence on the quality and safety of blood and blood
components shall be validated prior to introduction and be re-validated at regular intervals determined as a result
of these activities.

2. PERSONNEL AND ORGANISATION

1. Personnel in blood establishments shall be available in sufficient numbers to carry out the activities related to the
collection, testing, processing, storage and distribution of blood and blood components and be trained and
assessed to be competent to perform their tasks.

2. All personnel in blood establishments shall have up to date job descriptions which clearly set out their tasks and
responsibilities. Blood establishments shall assign the responsibility for processing management and quality
assurance to different individuals and who function independently.

3. All personnel in blood establishments shall receive initial and continued training appropriate to their specific
tasks. Training records shall be maintained. Training programmes shall be in place and shall include good
practice.

4. The contents of training programmes shall be periodically assessed and the competence of personnel evaluated
regularly.

5. There shall be written safety and hygiene instructions in place adapted to the activities to be carried out and are
in compliance with Council Directive 89/391/EEC (1) and Directive 2000/54/EC of the European Parliament and
of the Council (2).

3. PREMISES
3.1. General
Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out. They shall
enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective
cleaning and maintenance in order to minimise the risk of contamination.

(1) OJ L 183, 29.6.1989, p. 1.

(2) OJ L 262, 17.10.2000, p. 21.
1.10.2005 EN Official Journal of the European Union L 256/45 L 256/46 EN Official Journal of the European Union 1.10.2005

3.2. Blood donor area 3. All significant changes to documents shall be acted upon promptly and shall be reviewed, dated and signed by a
person authorised to perform this task.
There shall be an area for confidential personal interviews with and assessment of individuals to assess their
eligibility to donate. This area shall be separated from all processing areas.
6. BLOOD COLLECTION, TESTING AND PROCESSING

3.3. Blood collection area 6.1. Donor eligibility

Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately 1. Procedures for safe donor identification, suitability interview and eligibility assessment shall be implemented and
equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with maintained. They shall take place before each donation and comply with the requirements set out in Annex II and
blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to Annex III to Directive 2004/33/EC.
avoid errors in the collection procedure.
2. The donor interview shall be conducted in such a way as to ensure confidentiality.
3.4. Blood testing and processing areas
There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood component 3. The donor suitability records and final assessment shall be signed by a qualified health professional.
processing area with access restricted to authorised personnel.
6.2. Collection of blood and blood components
3.5. Storage area 1. The blood collection procedure shall be designed to ensure that the identity of the donor is verified and securely
recorded and that the link between the donor and the blood, blood components and blood samples is clearly
1. Storage areas shall provide for properly secure and segregated storage of different categories of blood and blood established.
components and materials including quarantine and released materials and units of blood or blood components
collected under special criteria (e.g. autologous donation).
2. The sterile blood bag systems used for the collection of blood and blood components and their processing shall
be CE-marked or comply with equivalent standards if the blood and blood components are collected in third
2. Provisions shall be in place in the event of equipment or power failure in the main storage facility. countries. The batch number of the blood bag shall be traceable for each blood component.

3.6. Waste disposal area 3. Blood collection procedures shall minimise the risk of microbial contamination.

An area shall be designated for the safe disposal of waste, disposable items used during the collection, testing, and
processing and for rejected blood or blood components. 4. Laboratory samples shall be taken at the time of donation and appropriately stored prior to testing.

4. EQUIPMENT AND MATERIALS 5. The procedure used for the labelling of records, blood bags and laboratory samples with donation numbers shall
be designed to avoid any risk of identification error and mix-up.
1. All equipment shall be validated, calibrated and maintained to suit its intended purpose. Operating instructions
shall be available and appropriate records kept.
6. After blood collection, the blood bags shall be handled in a way that maintains the quality of the blood and at a
storage and transport temperature appropriate to further processing requirements.
2. Equipment shall be selected to minimise any hazard to donors, personnel, or blood components.
7. There shall be a system in place to ensure that each donation can be linked to the collection and processing
system into which it was collected and/or processed.
3. Only reagents and materials from approved suppliers that meet the documented requirements and specifications
shall be used. Critical materials shall be released by a person qualified to perform this task. Where relevant,
materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC (1) for medical 6.3. Laboratory testing
devices and Directive 98/79/EC of the European Parliament and of the Council (2) for in vitro diagnostic medical
devices or comply with equivalent standards in the case of collection in third countries. 1. All laboratory testing procedures shall be validated before use.

4. Inventory records shall be retained for a period acceptable to and agreed with the competent authority. 2. Each donation shall be tested in conformity with the requirements laid down in Annex IV to Directive
2002/98/EC.

5. When computerised systems are used, software, hardware and back-up procedures must be checked regularly to 3. There shall be clearly defined procedures to resolve discrepant results and ensure that blood and blood
ensure reliability, be validated before use, and be maintained in a validated state. Hardware and software shall be components that have a repeatedly reactive result in a serological screening test for infection with the viruses
protected against unauthorised use or unauthorised changes. The back-up procedure shall prevent loss of or mentioned in Annex IV to Directive 2002/98/EC shall be excluded from therapeutic use and be stored separately
damage to data at expected and unexpected down times or function failures. in a dedicated environment. Appropriate confirmatory testing shall take place. In case of confirmed positive
results, appropriate donor management shall take place including the provision of information to the donor and
follow-up procedures.
5. DOCUMENTATION
1. Documents setting out specifications, procedures and records covering each activity performed by the blood 4. There shall be data confirming the suitability of any laboratory reagents used in the testing of donor samples and
establishment shall be in place and kept up to date. blood component samples.

2. Records shall be legible and may be handwritten, transferred to another medium such as microfilm or docu- 5. The quality of the laboratory testing shall be regularly assessed by the participation in a formal system of
mented in a computerised system. proficiency testing, such as an external quality assurance programme.

(1) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1). 6. Blood group serology testing shall include procedures for testing specific groups of donors (e.g. first time donors,
(2) OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003. donors with a history of transfusion).
1.10.2005 EN Official Journal of the European Union L 256/47 L 256/48 EN Official Journal of the European Union 1.10.2005

6.4. Processing and validation 8. CONTRACT MANAGEMENT

1. All equipment and technical devices shall be used in accordance with validated procedures. Tasks that are performed externally shall be defined in a specific written contract.

9. NON-CONFORMANCE
2. The processing of blood components shall be carried out using appropriate and validated procedures including
measures to avoid the risk of contamination and microbial growth in the prepared blood components. 9.1. Deviations
Blood components deviating from required standards set out in Annex V to Directive 2004/33/EC shall be released
for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and
6.5. Labelling
the blood establishment physician.
1. At all stages, all containers shall be labelled with relevant information of their identity. In the absence of a
validated computerised system for status control, the labelling shall clearly distinguish released from non-released 9.2. Complaints
units of blood and blood components.
All complaints and other information, including serious adverse reactions and serious adverse events, which may
suggest that defective blood components have been issued, shall be documented, carefully investigated for causative
2. The labelling system for the collected blood, intermediate and finished blood components and samples must factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent
unmistakably identify the type of content, and comply with the labelling and traceability requirements referred to recurrence. Procedures shall be in place to ensure that the competent authorities are notified as appropriate of
in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC (1). The label for a final blood serious adverse reactions or serious adverse events in accordance with regulatory requirements.
component shall comply with the requirements of Annex III to Directive 2002/98/EC.
9.3. Recall

3. For autologous blood and blood components, the label also shall comply with Article 7 of Directive 2004/33/EC 1. There shall be personnel authorised within the blood establishment to assess the need for blood and blood
and the additional requirements for autologous donations specified in Annex IV to that Directive. component recall and to initiate and coordinate the necessary actions.

2. An effective recall procedure shall be in place, including a description of the responsibilities and actions to be
6.6. Release of blood and blood components taken. This shall include notification to the competent authority.
1. There shall be a safe and secure system to prevent each single blood and blood component from being released
until all mandatory requirements set out in this Directive have been fulfilled. Each blood establishment shall be 3. Actions shall be taken within pre-defined periods of time and shall include tracing all relevant blood components
able to demonstrate that each blood or blood component has been formally released by an authorised person. and, where applicable, shall include trace-back. The purpose of the investigation is to identify any donor who
Records shall demonstrate that before a blood component is released, all current declaration forms, relevant might have contributed to causing the transfusion reaction and to retrieve available blood components from that
medical records and test results meet all acceptance criteria. donor, as well as to notify consignees and recipients of components collected from the same donor in the event
that they might have been put at risk.

2. Before release, blood and blood components shall be kept administratively and physically segregated from 9.4. Corrective and preventive actions
released blood and blood components. In the absence of a validated computerised system for status control
the label of a unit of blood or blood component shall identify the release status in accordance with 6.5.1. 1. A system to ensure corrective and preventive actions on blood component non-conformity and quality problems
shall be in place.

3. In the event that the final component fails release due to a confirmed positive infection test result, in conformity 2. Data shall be routinely analysed to identify quality problems that may require corrective action or to identify
with the requirements set out in Section 6.3.2 and 6.3.3, a check shall be made to ensure that other components unfavourable trends that may require preventive action.
from the same donation and components prepared from previous donations given by the donor are identified.
There shall be an immediate update of the donor record. 3. All errors and accidents shall be documented and investigated in order to identify system problems for correction.

10. SELF-INSPECTION, AUDITS AND IMPROVEMENTS

7. STORAGE AND DISTRIBUTION
1. Self-inspection or audit systems shall be in place for all parts of the operations to verify compliance with the
1. The quality system of the blood establishment shall ensure that, for blood and blood components intended for
standards set out in this Annex. They shall be carried out regularly by trained and competent persons in an
the manufacture of medicinal products, the storage and distribution requirements shall comply with Directive
independent way according to approved procedures.
2003/94/EC.

2. All results shall be documented and appropriate corrective and preventive actions shall be taken in a timely and
2. Procedures for storage and distribution shall be validated to ensure blood and blood component quality during effective manner.
the entire storage period and to exclude mix-ups of blood components. All transportation and storage actions,
including receipt and distribution, shall be defined by written procedures and specifications.

3. Autologous blood and blood components as well as blood components collected and prepared for specific
purposes shall be stored separately.

4. Appropriate records of inventory and distribution shall be kept.

5. Packaging shall maintain the integrity and storage temperature of blood or blood components during distribution
and transportation.

6. Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all
quality requirements and procedures laid down by the blood establishment to ensure blood component integrity
are fulfilled.

(1) See page 32 of this Official Journal.

 Appendix VII
Council Recommendation 98/463/EC
© European Union, http://eur-lex.europa.eu

298 Donor 299

Management
Manual 2010
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components, and blood and plasma derivatives have (15) Whereas to ensure sufficient supply for clinical
the potential to transmit infectious diseases; purposes, cooperation among the Member States is
essential in order to overcome such disparities and
II build mutual confidence in all aspects of safety of
(8) Whereas the availability of blood and plasma used the blood transfusion chain;
(Acts whose publication is not obligatory) for therapeutic purposes and as starting material for
the manufacture of medicinal products is dependent
on the willingness and generosity of Community (16) Whereas the suitability of an individual to donate
citizens who are prepared to donate; blood and plasma is an essential component in
contributing to the safety of blood and blood
products;
COUNCIL (9) Whereas donations should be voluntary and unpaid;

(17) Whereas information should be sought from poten-

(10) Whereas in respect of blood or plasma as a starting
tial donors on the basis of a written questionnaire,
material for the manufacture of medicinal products,
which may vary from Member State to Member State,
Article 3 of Directive 89/381/EEC refers to measures
COUNCIL RECOMMENDATION whose aim should be to identify common risk beha-
covered by the amendments to testing requirements,
of 29 June 1998 viour and diseases;
referred to in Article 6 of that Directive, to be taken
on the suitability of blood and plasma donors and the screening of donated by Member States to prevent the transmission of
blood in the European Community infectious diseases, including the application of the
monographs of the European Pharmacopoeia and the (18) Whereas it is essential that all measures be taken to
measures recommended by the Council of Europe safeguard the health of those who give blood or
(98/463/EC)
and the World Health Organisation (WHO) particu- plasma and to minimise the hazard of transmission
larly with reference to the selection and testing of of infectious diseases by blood or blood products;
THE COUNCIL OF THE EUROPEAN UNION, (5) Whereas the European Parliament in its Resolutions blood and plasma donors; to promote Community
on blood safety and self-sufficiency in the European self-sufficiency in human blood or human plasma;
Community (4) (5) (6) (7) has stressed the importance of and to encourage voluntary unpaid donations of
Having regard to the Treaty establishing the European blood and plasma; (19) Whereas convergence of practice throughout the
Community, and in particular Article 129(4), second ensuring the highest level of safety in the selection Community in the acceptance of donors, the
indent, of donors and the testing of donations and the prin- screening of donations and the recording of relevant
ciple of voluntary unpaid donations and has reit- data will help to contribute to increasing confidence
erated its continued support for the objective of (11) Whereas it is not always possible to know at the time
in the safety of blood and plasma donations and the
Having regard to the proposal from the Commission, Community self-sufficiency; of whole blood or plasma collection which
transfusion process; whereas in order to bring about
donation may be used for further manufacture rather
such convergence of practice, measures are required
than used in transfusion;
Having regard to the opinion of the European Par- at Community level;
liament (1),
(6) Whereas Directive 89/381/EEC (8) extended the
(12) Whereas all blood and plasma used for therapeutic
(1) Whereas in accordance with Article 3(o) of the scope of pharmaceutical legislation to guarantee the (20) Whereas measures at Community level should take
purposes, whether for transfusion or for further
Treaty, Community activity is to include a contribu- quality, safety, and efficacy of proprietary industrially into account existing guidelines, recommendations
manufacture into industrially-prepared medicinal
tion towards the attainment of a high level of health prepared medicinal products derived from human and standards in the area of blood at national level
products, should be obtained from individuals whose
protection; blood or human plasma; whereas that Directive as and international level, in particular those of the
health status is such that no detrimental effects to
such does not apply to whole blood, to plasma, or to WHO and of the Council of Europe;
their state of health will ensue as a result of the
blood cells of human origin;
donation and any risk of transmission of infectious
(2) Whereas the Commission’s Communication of
diseases is minimised; whereas each and every blood
21 December 1994 on Blood Safety and Self-suffi-
donation should be tested in accordance with rules (21) Whereas in accordance with the principle of subsid-
ciency in the European Community identified the
which provide assurances that all necessary measures iarity, any new measure taken in an area which does
need for a blood strategy in order to reinforce con-
(7) Whereas therapeutic use of blood and medicinal have been taken to safeguard the health of Com- not fall within the exclusive competence of the
fidence in the safety of the blood transfusion chain
products derived from human blood and plasma munity citizens who are the recipients of blood and Community, such as donor suitability and testing of
and promote Community self-sufficiency;
contributes significantly to saving lives and yields blood products; donations, may be taken up by the Community only
considerable benefits for those suffering from long if, by reason of the scale or effects of the proposed
(3) Whereas, in response to the Commission’s Com- term blood disorders; whereas, however, in spite of action, the objectives of the proposed action can be
munication, the Council adopted, on 2 June 1995, a their significant therapeutic value, blood, blood (13) Whereas given that the blood transfusion systems in better achieved by the Community than by Member
Resolution on blood safety and self-sufficiency in the the Member States exist to serve their citizens, it is States; whereas commonly agreed recommendations
Community (2); necessary to secure their confidence in the safety of on donor suitability and testing of donations need,
(4) OJ C 268, 4. 10. 1993, p. 29.
(5) OJ C 329, 6. 12. 1993, p. 268. these systems; therefore, to be introduced in order to contribute to
(6) OJ C 141, 13. 5. 1996, p. 131. the safety of donated blood and plasma and the
(4) Whereas the Council adopted, on 12 November (7) OJ C 249, 25. 9. 1995, p. 231.
1996, a Resolution on a strategy towards blood safety (8) Council Directive 89/381/EEC of 14 June 1989 extending the health protection of donors and to permit confidence
and self-sufficiency in the European Community (3); scope of Directives 65/65/EEC and 75/319/EEC on the ap- (14) Whereas there are disparities in policies and prac- in the safety of the transfusion chain among citizens,
proximation of provisions laid down by law, regulation or ad- tices among the Member States regarding the selec- especially as they move about within the Com-
ministrative action relation to proprietary medicinal products tion of donors and the screening of donations within munity, and to contribute to the attainment of Com-
(1) OJ C 138, 4. 5. 1998, p. 139. and laying down special provisions for medicinal products de-
(2) OJ C 164, 30. 6. 1995, p. 1. rived from human blood or human plasma (OJ L 181, 28. 6. the Community for epidemiological, historical and munity self-sufficiency as provided for in Com-
(3) OJ C 374, 11. 12. 1996, p. 1. 1989, p. 44). cultural reasons; munity legislation;
L 203/16  EN  Official Journal of the European Communities 21. 7. 98 21. 7. 98  EN  Official Journal of the European Communities L 203/17

(22) Whereas however, Member States remain free, while 2. Provision of information to prospective donors provided to the health personnel, the results of 4.1. Donor centre identification
respecting the provisions of the Treaty or measures the tests on their donations, as well as any future
adopted thereunder, to maintain or introduce re- traceability of their donation; Permit every donation establishment in each
quirements over and above the core criteria recom- Member States should ensure that all prospective
donors of blood or plasma are provided with: (b) the assurance that all interviews with prospective Member State to be uniquely identified;
mended in this Recommendation, and remain
responsible for decisions about the import and donors are carried out in confidence;
export of donated blood and plasma; (c) the option of requesting through a confidential
self-deferral procedure the blood and plasma 4.2. Donor identification and records
2.1. For donor awareness collection establishment not to use their dona-
(23) Whereas in accordance with the principle of propor- tion.
tionality, the means to be deployed at Community (a) Record information regarding the identification
level for promoting sound practices and consistency (a) accurate but generally understandable educational of prospective donors in an automated or manual
throughout the Community in the suitability of materials about the essential nature of blood, the system which allows verification each time a
products derived from it, and the important bene- 3. Information required from prospective donors donation is made;
blood and plasma donors and the screening of
donated blood must be in proportion to the objective fits to patients of blood and plasma donations;
Member States should ensure that, upon agreement (b) Provide for the keeping of records on donors and
pursued; whereas recommendations by the Council,
(b) the reasons for requiring a medical history, of a willingness to proceed to donate blood or prospective donors in such a way as to ensure
pursuant to Article 129 of the Treaty, are the appro-
physical examination, and the testing of dona- plasma, all prospective donors provide to the blood unique identification, protect the identity of the
priate means for doing so at Communhity level;
tions; information on the risk of infectious and plasma collection establishment: donor from unauthorised access to confidential
whereas such recommendations must be congruent
with Directive 89/381/EEC; diseases that may be transmitted by blood and information, but facilitate future traceabiity of any
blood products; the signs and symptoms of HIV/ donation;
AIDS and hepatitis, and the significance of 3.1. Identification
(24) Whereas recommendations on donor suitability and ‘informed consent’, self-deferral, and temporary (c) Allow for the inclusion of information related to
testing requirements form part of a strategy to and permanent deferral; Appropriate means of identification, providing name adverse donor reaction to the donation, reasons
enhance the safety of the blood transfusion chain, (first and surname), addresss, and date of birth, or for preventing an individual from donating,
the other elements of which include the inspection (c) the reasons why they should not donate which alternative means allowing each donor to be whether on a temporary or permanent basis while
and accreditation of blood collection establishments, may be detrimental to their own health; uniquely identified. ensuring confidentiality.
requirements related to quality assurance of the
processes involved, the optimal use of blood and (d) the reasons why they should not donate which
blood products, haemovigilance and public aware- put recipients at risk, such as unsafe sexual beha- 3.2. Health history
ness; 5. Donor eligibility
viour, HIV/AIDS, hepatitis, drug addiction and
the use and abuse of drugs; (a) Information on their health and medical history,
including any relevant behavioural characteristics, Member States, in order to ensure the eligibility of
(25) Whereas it is necessary that the best possible scien- (e) the option of changing their mind about dona- that may assist in identifying and screening out individuals to be accepted as donors of blood and
tific advice is available to the Community in relation ting prior to proceeding further without any persons whose donation could present a health plasma, should ensure that:
to the safety of blood and blood products and that undue enbarrassment or discomfort; risk to themselves or a risk of transmitting
the precautionary principle prevails when scientific diseases to others, by way of a written question-
evidence is not available; naire addressing the criteria recommended in
(f) information on the possibility of withdrawing or
Annex II and a personal interview with a trained 5.1. Eligibility criteria for the acceptance of donors of
self-deferring at any time during the donation
health care staff member. whole blood and donors of components by apheresis
process;
(26) Whereas Directive 95/46/EC of the European Par-
liament of the Council of 24 October 1995 on the (b) Their signature alongside that of the health care (a) the general criteria for the acceptance of blood
protection of individuals with regard to the proces- (g) the opportunity to ask questions at any time; staff member conducting the interviews on the and plasma donors are publicised in every dona-
sing of personal data and the free movement of such donor questionnaire or their signature on a sep- tion establishment and that clear messages are
data (1) lays down special requirements for the (h) the assurance that if test results show evidence of arate attestation to acknowledge that the educa- presented to donors as to the importance of their
processing of data concerning health, any pathology, they will be informed and tional materials provided have been read and willingness to donate but also the importance of
deferred from donation, as recommended in understood, that the opportunity to ask questions the acceptance criteria;
Annex II B and C, for their own safety as well as has been presented, and that satisfactory
that of potential recipients; prospective donors responses have been received; to give their agree- (b) the responses given to the issues raised in the
who object to being so informed should be ment that their blood or plasma donation could written questionnaire and/or the personal inter-
excluded from the donation process; be used for patients needing transfusion or blood view provide the necessary confidence that the
products in the country where the donation is donation will not adversely affect the health of a
HEREBY RECOMMENDS THAT: (i) specific information on the nature of the pro- made or in another country, to which it would be future recipient of the products derived from that
cedures involved in the donation process and transferred in accordance with the provisions of donation;
associated risks for those willing to participate in the legislation of the country where the donation
whole blood donation or in apheresis is made, particularly with regard to the destina- (c) the prospective donor meets the physical require-
programmes. tion of the donation; and to indicate their ments criteria recommended in Annex II A in
1. Definitions informed consent that they wish to proceed with order that there are no detrimental effects to
the donation process. his/her own health as a result of the donation;
For the purpose of this Recommendation, Member (d) the prospective donor’s eligibility is determined
States should assign to the terms listed in Annex I 2.2. For confidentiality
4. Registration of donor at each donation session;
the meaning given to them therein.
(a) information on the measures taken to ensure the Member States should ensure the establishment of a (e) the practice of using ‘replacement donors’ is
(1) OJ L 281, 23. 11. 1995, p. 31. confidentiality of: any health-related information donor identification/registration system to: phased out;
L 203/18  EN  Official Journal of the European Communities 21. 7. 98 21. 7. 98  EN  Official Journal of the European Communities L 203/19

(f) a responsible physician gives his/her written (a) ensure that a sample of all donations of blood or revision and updating; to involve national experts — to examine as soon as possible, in close cooperation
authorisation of the acceptance of prospective plasma whether intended for transfusion purposes from all the Member States in the preparation of such with the Member States, all the aspects related to the
donors, when their eligibility may be question- or for further manufacturing into industrially proposals; use of genome amplification technology (GAT), in-
able; prepared medicinal products is tested for diseases — to promote as a priority, in the light of scientific cluding polymerase chain reaction (PCR)-screening, in
transmissible by blood or plasma using approved studies, work on the potential health effects of depart- order to prevent the transmission of communicable
screening tests to eliminate units that are repeat ing from the maximum volume limits and minimum diseases by blood transfusion.
reactive; time intervals between donations set out in Annex III,
5.2. Deferral criteria for donors of whole blood and
donors of components by apheresis in order in particular to determine whether or not
(b) ensure that all blood and plasma donations be adverse health effects may result from collecting, by
found non-reactive for the transmissible disease
apheresis, annual plasma volumes higher than those Done at Luxembourg, 29 June 1998.
Those who may show evidence of any of the condi- markers listed in Annex IV prior to use;
recommended in existing international guidelines; and
tions and characteristics listed in Annex II B and C
to undertake work on common volume and frequency
should be declared either permanently or tempor- (c) require re-testing of the blood samples found to
limits for other types of apheresis;
arily ineligible to donate blood and plasma; be reactive in an initial screening test taking For the Council
account of the indicative algorithm set out in — to propose where appropriate common terminology
for the purpose of further developing the Community The President
Annex V.
strategy on blood safety and self-sufficiency; R. COOK
5.3. Deferral records

Donation establishments should maintain a record of 9. Additional measures

any prospective donor deferral, whether permanent
or temporary, including the reasons why.
Member States should:

(a) ensure that appropriate provisions are in place in

6. Data protection the donation establishment for counselling, as
appropriate, to prospective donors who are
Member States should, in accordance with Directive deferred;
95/46/EC, ensure the confidentiality of sensitive
medical information about prospective donors, and (b) encourage the collection, analysis and evaluation
in particular: of epidemiological data concerning donors and
donations, with a view to improving the safety of
(a) ensure that data security measures are in place as blood transfusion;
well as safeguards against unauthorised data addi-
tions, deletions or modifications to donor files or (c) take the necessary steps for the dissemination of
deferral registers, and transfer of information; this recommendation to all parties concerned,
and in particular to blood collecting establish-
(b) ensure that procedures are in place to resolve data ments in their territory;
discrepancies;
(d) take all necessary measures to encourage the
(c) prevent the unauthorised disclosure of such in- voluntary and unpaid donation of blood and
formation, while ensuring the traceability of plasma, and entirely support the efforts of the
donations. Council of Europe in this area; take account of
the Council of Europe definition of voluntary and
non-remunerated donation as follows:
7. Volumes and time intervals
‘A donation is considered voluntary and non-re-
munerated if the person gives blood, plasma or
To protect the health of the donor, Member States cellular components of his/her own free will and
should ensure that: receives no payment for it, either in the form of
cash or in kind which could be considered a
(a) volumes of blood and plasma collected are no substitute for money. This would include time off
greater than those recommended in Annex III; work other than that reasonably needed for the
donation and travel. Small tokens, refreshments
(b) time intervals between donations are no less than and reimbursements of direct travel costs are
those recommended in Annex III; compatible with voluntary, non-remunerated
(c) medical attention is available to the donor in the donations.’
event of an adverse event related to the donation.

INVITES THE COMMISSION

8. Testing samples of donated blood
— to report on the application of these recommenda-
Member States, in order to ensure the safety of all tions and keep the matters covered therein under
blood and plasma donations, should: review in order to make the necessary proposals for
L 203/20  EN  Official Journal of the European Communities 21. 7. 98 21. 7. 98  EN  Official Journal of the European Communities L 203/21

ANNEX I ANNEX II

COMMON TERMINOLOGY CORE CRITERIA FOR ACCEPTANCE OR DEFERRAL OF BLOOD AND PLASMA DONORS

Blood Whole blood collected from a single donor and processed either
for transfusion or further manufacturing A: Physical requirements criteria for acceptance of blood and plasma donors for their own
protection
Blood product Any therapeutic product derived from human blood or plasma
Age
Blood component Therapeutic components of blood (red cells, white cells, platelets, Blood and plasma donors should be 18-65 years of age. Acceptance of first time donors age 60-65 is at
plasma) that can be prepared by centrifugation, filtration, and the discretion of the responsible physician. Repeat donors may continue to donate after the age of 65
freezing using conventional blood bank methodology with the permission of the responsible physician given annually.

Medicinal product derived from For whole blood, donors aged 17, and not legally classified as minors, may be accepted; otherwise written
blood or plasma Same meaning as that given in Directive 89/381/EEC consent should be required according to applicable law.

Donor A person in normal health with a good medical history who Body weight
voluntarily gives blood or plasma for therapeutic use Donors weighing no less than 50 kg may donate whole blood or plasma.

Prospective donor Someone who presents himself/herself at a blood or plasma Blood pressure
collection establishment and states his/her wish to give blood or
plasma The systolic blood pressure should not exceed 180 mm of mercury and the diastolic pressure should not
exceed 100 mm of mercury.
First time donor Someone who has never donated either blood or plasma
Pulse
Repeat donor Someone who has donated before but not within the last two The pulse should be regular and between 50 to 110 beats per minute. Those prospective donors who
years in the same donation centre undergo intensive sport training and have a pulse rate lower than 50 beats per minute may be accepted.

Regular donor Someone who routinely donates their blood or plasma (i.e. within
Either:
the last two years), in accordance with minimum time intervals,
in the same donation centre
Haemoglobin
Replacement donor Donors recruited by patients to enable them to undergo therapy The haemoglobin concentration should be determined at the time of the donation and should be no less
which requires blood transfusion than 12,5 g/100 ml for females and 13,5 g/100 ml for males (or equivalent values expressed in mmol/I).

or

Haematocrit
The packed cell volume (haematocrit) should be determined at the time of the donation and should be
no less than 38 % for females and 40 % for males. For apheresis plasma donors, the minimum should
be 38 %.

For plasmapheresis only

Protein should measure a minimum of 60 g per litre.

B: Deferral criteria blood and plasma donors for their own protection
If prospective donors have, or have a history of, any of the following, a qualified physician in the blood
collection establishment should consider declaring them permanently or temporarily ineligible to donate
blood or plasma for the protection of their own health:

1. Permanent deferral
— Auto-immune diseases
— Cardiovascular diseases
— Central nervous system diseases
— Malignant diseases
— Abnormal bleeding tendency
— Fainting spells (syncope) or convulsions
— Severe or chronic gastrointestinal, haematological, metabolic, respiratory or renal disease, not
included in the preceding categories
L 203/22  EN  Official Journal of the European Communities 21. 7. 98 21. 7. 98  EN  Official Journal of the European Communities L 203/23

2. Temporary deferral 2.3 Ineligible for six months

Ineligible for nine months — Infectious mononucleosis (after recovery)
— Pregnancy (after delivery)
— Abortion 2.4 Ineligible for four weeks
— Following administration of live attenuated viral vaccines
Ineligible (time frame variable)
— Participation in hazardous sports 2.5 Ineligible for two weeks
— Employment which might cause problems shortly after blood donation
— Other reasons. — Minor infectious diseases

2.6 Ineligible for one week

C: Deferral criteria for blood and plasma donors for the protection of recipients
— Minor surgery
If prospective donors have, or have a history of, any of the following, a qualified physician in the blood
collection establishment should consider declaring them permanently or temporarily ineligible to donate 2.7 Ineligible for 72 hours
blood or plasma for the protection of potential recipients:
— Following administration of vaccines (desensitising)
1. Permanent deferral
2.8 Ineligible for 48 hours
— Auto-immune diseases
— Infectious diseases — persons suffering or having suffered from: — Treatment by dentist or dental hygienist
— Babesiosis — Following administration of killed/inactivated viral/bacterial and rickettsial vaccines
— Hepatitis B (HBsAg confirmed positive) — Rabies vaccine (prophylactic administration)
— Hepatitis C
2.9 Ineligible (time frame variable)
— Hepatitis, infectious (of unexplained aetiology)
— HIV/AIDS — Hepatitis A
— HTLV I/II — Medicines
— Leprosy — Malaria (does not apply to plasmapheresis donors)
— Kala Azar (leishmaniasis) — Tropical diseases (other)
— Q fever Additional reasons may exist for the temporary deferral of a donor for the protection of the recipient.
— Syphilis A decision as to length of time is as the discretion of a qualified physician in the blood collection
— Trypanosoma cruzi (Chagas’ disease) establishment.
— Malignant diseases
— TSEs (or history thereof in the genetic family)
— Alcoholism, chronic
— Cornea/dura mater transplantation recipient
— Diabetes, if treated with insulin
— Intravenous (IV) drug use
— Pituitary hormone of human origin (e.g. human growth hormone) recipient
— Sexual behaviour which places them at a high risk of transmitting infectious diseases, including
persons who have had sex in return for money or drugs

2. Temporary deferral
2.1 Ineligible for two years
— Tuberculosis (after declared cured)
— Toxoplasmosis (after recovery and absence of IgM antibodies)
— Brucellosis (after full recovery)

2.2 Ineligible for one year

— Accidental exposure to blood or blood contaminated instruments
— Acupuncture (if not performed by a qualified practitioner)
— Endoscopic examination
— Treatment involving use of catheters
— Blood transfusion or major surgery
— Tissue or cell transplant
— Body piercing
— Drug allergy, in particular allergy to penicillin (after last exposure)
— Tattoo
— Close contact with a case of hepatitis B or C
— Rabies vaccine (if post exposure)
L 203/24  EN  Official Journal of the European Communities 21. 7. 98 21. 7. 98  EN  Official Journal of the European Communities L 203/25

ANNEX III ANNEX IV

WHOLE BLOOD AND PLASMA DONATIONS CORE SCREENING TESTS FOR ALL BLOOD SAMPLES WHETHER FROM A WHOLE
BLOOD OR PLASMA DONATION

recommended maximum volumes and minimum time intervals between donations

Antibodies to the hepatitis C virus Anti-HCV
Antibodies to the human immunodeficiency virus 1 Anti-HIV 1
Whole blood Antibodies to the human immunodeficiency virus 2 Anti-HIV 2
Maximum volume per donation 500 ml Surface antigen of hepatitis B HBsAg

per consecutive 12 month period three litres

ABO-group (A) (B)
Rh-type (A) (B)
Minimum time interval between dona-
tions eight weeks
Malaria (B) for travellers to endemic areas (unless risk of malaria transmission is otherwise dealt with by a
deferral period of three years for such travellers)
Automated plasmapheresis
Treponema pallidum (syphilis) (B)
Maximum volume per donation 650 ml
(excluding anticoagulant) (A)
If it can be proven that the blood group of an already known blood donor, whose blood group has been
previously determined and verified from two separate donations, can be reliably transferred into the label
Minimum time interval between dona- of the blood component by using a validated automated information technology system, it is not neces-
tions At least two days should elapse sary to repeat the determination of ABO- and Rh-groups at the time of every blood donation. In such a
between donations. No more than case the blood group of the blood donor should be periodically verified.
two donations should be permitted
within a seven-day period (B)
Not required for apheresis plasma intended only for fractionation.

Existing guidelines at international level in the area of blood recommend 15 litres as the maximum annual
volume of plasma to be collected via automated plasmapheresis; there is no scientific evidence of whether or
not adverse health effects may result from higher volume collection; this area should be a priority area for
scientific study.

In assessing individually appropriate donation volumes, account should also be taken of physical character-
istics such as gender and body weight.
L 203/26  EN  Official Journal of the European Communities 21. 7. 98

ANNEX V

Indicative Algorithm for Interpretation of reactive results in screening tests in relation to clinical
use of donation and Reactive results in supplementary/confirmation tests in relation to donor
deferral

blood sample
result negative donor and donation cleared
1 x screening test

screening test result

reactive/indeterminate

2 repeats of the same test kit using the same blood sample

screening test result screening test result screening test result screening test result
– – ++ +? +/?–

unit/donor
eliminate unit
cleared

supplementary tests based on a different principle using the same blood sample,
including tests to confirm the screening result

positive indeterminate
result result

all results
establishments which have plasma processing
negative
received blood components establishment to be informed
from previous donation to be about previous donations
informed as soon as possible, as soon as possible, and in
and in any case within 7 days: any case within 7 days:
look back look back

possible additional
tests/donor cleared

2nd blood sample

screening and
confirmation tests

all results negative positive result indeterminate result

permanently temporarily
donor cleared
defer/inform donor defer/inform donor

tracing back procedure further clarification

and look back

313
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Apheresis Method of obtaining one or more blood components by machine Donor attrition of those donors that did give blood in the year before, the percent-
processing of whole blood in which the residual components of the age of donors who did not give blood in the year of concern.
blood are returned to the donor during or at the end of the process.
Donor panel A group of donors whose blood is only used for a specific patient
Autologous donation The donation of a donor, collected for therapeutic use in the same group.
donor
Donor recruitment All activities directed at recruiting new donors.
Blood Whole blood collected from a single donor and processed either for
transfusion or further manufacturing. Donor relationship Software used specifically to manage communications withdonors,
management software co-ordinate campaigns and assist with donor recruitment.
Blood component Therapeutic components of blood (red cells, white cells, platelets,
plasma) that can be prepared by centrifugation, filtration and freez- First time donor Someone who has made his first and to date only donation within
ing using conventional blood bank methodology. the last 12 months.

Blood establishment Any structure or body that is responsible for any aspect of the col- First time donation The lifetime first non-autologous donation of a donor
lection and testing of human blood or blood components, whatever
their intended purpose, and their processing, storage and distribu- Fixed site A location where blood session materials are permanently present.
tion when intended for transfusion. This does not include hospital
blood banks. Hospital blood bank A hospital unit which stores and distributes and may perform com-
patibility tests on blood and blood components exclusively for use
Blood session Session during which blood is collected, which can take place in a within hospital facilities, including hospital based transfusion activ-
fixed site, a mobile site or a mobile vehicle site. ities. Please compare ‘hospital-based blood establishment ’.

Deferral Suspension of the eligibility of an individual to donate blood or blood Hospital-based blood A hospital unit which is responsible for the collection of homologous
components, such suspension being either permanent or tempo- establishment blood, testing for transfusion-transmissible infections and blood
rary. group, processing into blood components and storage. Please com-
pare ‘hospital blood bank’.
Deferral rate Total number of temporary and permanent deferrals in the report-
ing period, excluding self-deferral, divided by the total number of Inactive donor Someone who has made at least one donation. This donor has made
donors attending a blood session. the last donation NOT within the last 24 months, but is still regis-
tered in the donor data base.
Donation The result of collecting whole blood or blood components from an
individual in a single procedure; a donation is counted from the Lapsing donor Someone who has made at least one donation within the last 24
point of skin puncture onwards months, but NOT within the last 12 months.

Donation not-for-transfusion The donation of a donor collected for other purposes than transfu- Mobile site A location where blood session materials are not permanently
sion to patients present; materials have to be transported to and from the location.

Donor Someone who voluntarily gives blood or blood components. Mobile vehicle site A location visited by a mobile vehicle. The donor donates inside this
vehicle. The mobile vehicle is a truck/trailer with all blood session
Donor association Association established by donors in order to unite donor interests. materials inside.
Some donor associations are involved in donor recruitment.
Newly registered donor A donor who has been registered as a donor but who has not donat-
Donor attendant An employee without nursing qualification, who has received some ed yet.
medical and/or procedural training relating to blood donation.
Nurse An employee with a nursing qualification.

316 Donor 317

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Patients with special Patients who need special (e.g. multiple, long-term, specified antigen Stopped donor Someone who was registered as a donor and may or may not have
transfusion needs  typing) transfusions, such as thalassaemic patients, patients with made one or more donations, but has subsequently been deregis-
leukaemia or sickle cell anaemia. tered as a donor from the donor data base for any reason.

Prospective donor Someone who states his/her wish to give blood or plasma but is not Successful donation A donation where the puncture of the donor skin did result into
registered as a donor yet. whole blood or blood components suitable for processing

Registered donor Someone who is registered in the donor data base (newly registered Unsuccessful donation A donation where the puncture of the donor skin did not result into
donors, first time donors, regular donors, returning donors, lapsing whole blood or blood components suitable for processing
donors and inactive donors).

Regular donor Someone who made at least two donations within the last 24
months. The last donation has been made within the last 12 months. Abbreviations

Response rate Number of invited donors attending a blood session divided by the CoE Council of Europe
total number of invited donors.
EU European Union
Repeat donation Any non-autologous donation other than first time donations
Fte Full time equivalent
Replacement donor A donor recruited by a patient to enable the patient to undergo ther-
apy which requires blood transfusion. ISBT International Society of Blood Transfusion

Returning donor Someone who has made at least two donations. This donor has SOP Standard Operating Procedure
made only one donation within the last 12 months AND the inter-
val between the last and the before last donation is more than 24 PI Performance Indicator
months.

Self-deferral The donor himself decides before donation that he is not eligible to
donate. Please compare: self-exclusion.

Self-exclusion The donor himself decides after donation that his donation should not
be used for transfusion. Please compare: self-deferral.

Serious adverse event Any untoward occurrence associated with the collection, testing,
processing, storage and distribution, of blood and blood compo-
nents that might lead to death or life-threatening, disabling or inca-
pacitating conditions for patients or which results in, or prolongs,
hospitalisation or morbidity.

Serious adverse reaction An unintended response in donor associated with the collection or
transfusion of blood or blood components that is fatal, life-threat-
ening, disabling, incapacitating, or which results in, or prolongs,
hospitalisation or morbidity.

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