98/463/EC: Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community
Date: 1998-06-29
Institutions: Council of the European Union
Subjects: European standard, blood transfusion, health legislation, medical research

L 203/14

‹

EN

‹

Official Journal of the European Communities

21. 7. 98

II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL RECOMMENDATION

of 29 June 1998

on the suitability of blood and plasma donors and the screening of donated
blood in the European Community

(98/463/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 129(4),
second
indent,

Having regard to the proposal from the Commission,

Having regard to the opinion of
liament (1),

the European Par-

(1) Whereas in accordance with Article 3(o) of

the
Treaty, Community activity is to include a contribu-
tion towards the attainment of a high level of health
protection;

(2) Whereas

the Commission’s Communication of
21 December 1994 on Blood Safety and Self-suffi-
ciency in the European Community identified the
need for a blood strategy in order to reinforce con-
fidence in the safety of the blood transfusion chain
and promote Community self-sufficiency;

(3) Whereas,

in response to the Commission’s Com-
munication, the Council adopted, on 2 June 1995, a
Resolution on blood safety and self-sufficiency in the
Community (2);

(4) Whereas the Council adopted, on 12 November
1996, a Resolution on a strategy towards blood safety
and self-sufficiency in the European Community (3);

(1) OJ C 138, 4. 5. 1998, p. 139.
(2) OJ C 164, 30. 6. 1995, p. 1.
(3) OJ C 374, 11. 12. 1996, p. 1.

(5) Whereas the European Parliament in its Resolutions
on blood safety and self-sufficiency in the European
Community (4) (5) (6) (7) has stressed the importance of
ensuring the highest level of safety in the selection
of donors and the testing of donations and the prin-
ciple of voluntary unpaid donations and has reit-
for the objective of
erated its continued support
Community self-sufficiency;

(6) Whereas Directive 89/381/EEC (8)

extended the
scope of pharmaceutical legislation to guarantee the
quality, safety, and efficacy of proprietary industrially
prepared medicinal products derived from human
blood or human plasma; whereas that Directive as
such does not apply to whole blood, to plasma, or to
blood cells of human origin;

(7) Whereas therapeutic use of blood and medicinal
products derived from human blood and plasma
contributes significantly to saving lives and yields
considerable benefits for those suffering from long
term blood disorders; whereas, however, in spite of
therapeutic value, blood, blood
their

significant

(4) OJ C 268, 4. 10. 1993, p. 29.
(5) OJ C 329, 6. 12. 1993, p. 268.
(6) OJ C 141, 13. 5. 1996, p. 131.
(7) OJ C 249, 25. 9. 1995, p. 231.
(8) Council Directive 89/381/EEC of 14 June 1989 extending the
scope of Directives 65/65/EEC and 75/319/EEC on the ap-
proximation of provisions laid down by law, regulation or ad-
ministrative action relation to proprietary medicinal products
and laying down special provisions for medicinal products de-
rived from human blood or human plasma (OJ L 181, 28. 6.
1989, p. 44).

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/15

components, and blood and plasma derivatives have
the potential to transmit infectious diseases;

(8) Whereas the availability of blood and plasma used
for therapeutic purposes and as starting material for
the manufacture of medicinal products is dependent
on the willingness and generosity of Community
citizens who are prepared to donate;

(9) Whereas donations should be voluntary and unpaid;

(10) Whereas in respect of blood or plasma as a starting
material for the manufacture of medicinal products,
Article 3 of Directive 89/381/EEC refers to measures
covered by the amendments to testing requirements,
referred to in Article 6 of that Directive, to be taken
by Member States to prevent the transmission of
infectious diseases, including the application of the
monographs of the European Pharmacopoeia and the
measures recommended by the Council of Europe
and the World Health Organisation (WHO) particu-
larly with reference to the selection and testing of
blood and plasma donors; to promote Community
self-sufficiency in human blood or human plasma;
and to encourage voluntary unpaid donations of
blood and plasma;

(11) Whereas it is not always possible to know at the time
of whole blood or plasma
collection which
donation may be used for further manufacture rather
than used in transfusion;

for

for

(12) Whereas all blood and plasma used for therapeutic
further
transfusion or
purposes, whether
manufacture
into industrially-prepared medicinal
products, should be obtained from individuals whose
health status is such that no detrimental effects to
their state of health will ensue as a result of the
donation and any risk of transmission of infectious
diseases is minimised; whereas each and every blood
donation should be tested in accordance with rules
which provide assurances that all necessary measures
have been taken to safeguard the health of Com-
munity citizens who are the recipients of blood and
blood products;

(13) Whereas given that the blood transfusion systems in
the Member States exist to serve their citizens, it is
necessary to secure their confidence in the safety of
these systems;

(14) Whereas there are disparities in policies and prac-
tices among the Member States regarding the selec-
tion of donors and the screening of donations within
the Community for epidemiological, historical and
cultural reasons;

(15) Whereas

to ensure sufficient

supply for clinical
purposes, cooperation among the Member States is
essential in order to overcome such disparities and
build mutual confidence in all aspects of safety of
the blood transfusion chain;

(16) Whereas the suitability of an individual to donate
in
blood and plasma is an essential component
contributing to the safety of blood and blood
products;

(17) Whereas information should be sought from poten-
tial donors on the basis of a written questionnaire,
which may vary from Member State to Member State,
whose aim should be to identify common risk beha-
viour and diseases;

(18) Whereas it is essential that all measures be taken to
those who give blood or
safeguard the health of
plasma and to minimise the hazard of transmission
of infectious diseases by blood or blood products;

(19) Whereas convergence of practice throughout
acceptance of donors,

the
Community in the
the
screening of donations and the recording of relevant
data will help to contribute to increasing confidence
in the safety of blood and plasma donations and the
transfusion process; whereas in order to bring about
such convergence of practice, measures are required
at Community level;

(20) Whereas measures at Community level should take
into account existing guidelines, recommendations
and standards in the area of blood at national level
and international
the
WHO and of the Council of Europe;

in particular those of

level,

(21) Whereas in accordance with the principle of subsid-
iarity, any new measure taken in an area which does
not
the
fall within the exclusive competence of
Community, such as donor suitability and testing of
donations, may be taken up by the Community only
if, by reason of the scale or effects of the proposed
action, the objectives of the proposed action can be
better achieved by the Community than by Member
States; whereas commonly agreed recommendations
on donor suitability and testing of donations need,
therefore, to be introduced in order to contribute to
the safety of donated blood and plasma and the
health protection of donors and to permit confidence
in the safety of the transfusion chain among citizens,
especially as they move about within the Com-
munity, and to contribute to the attainment of Com-
munity self-sufficiency as provided for
in Com-
munity legislation;

L 203/16

‹

EN

‹

Official Journal of the European Communities

21. 7. 98

(22) Whereas however, Member States remain free, while
respecting the provisions of the Treaty or measures
adopted thereunder,
to maintain or introduce re-
quirements over and above the core criteria recom-
and remain
mended in this Recommendation,
responsible for decisions about
the import and
export of donated blood and plasma;

(23) Whereas in accordance with the principle of propor-
tionality, the means to be deployed at Community
level for promoting sound practices and consistency
throughout
the Community in the suitability of
blood and plasma donors and the screening of
donated blood must be in proportion to the objective
pursued; whereas recommendations by the Council,
pursuant to Article 129 of the Treaty, are the appro-
priate means for doing so at Communhity level;
whereas such recommendations must be congruent
with Directive 89/381/EEC;

(24) Whereas recommendations on donor suitability and
form part of a strategy to
testing requirements
enhance the safety of the blood transfusion chain,
the other elements of which include the inspection
and accreditation of blood collection establishments,
the
requirements related to quality assurance of
processes involved, the optimal use of blood and
blood products, haemovigilance and public aware-
ness;

(25) Whereas it is necessary that the best possible scien-
tific advice is available to the Community in relation
to the safety of blood and blood products and that
the precautionary principle prevails when scientific
evidence is not available;

(26) Whereas Directive 95/46/EC of the European Par-
liament of the Council of 24 October 1995 on the
protection of individuals with regard to the proces-
sing of personal data and the free movement of such
data (1)
the
lays down special
processing of data concerning health,

requirements

for

HEREBY RECOMMENDS THAT:

1. Definitions

2. Provision of information to prospective donors

Member States should ensure that all prospective
donors of blood or plasma are provided with:

2.1. For donor awareness

(a) accurate but generally understandable educational
materials about the essential nature of blood, the
products derived from it, and the important bene-
fits to patients of blood and plasma donations;

(b) the reasons

for

information on the risk of

requiring a medical history,
physical examination, and the testing of dona-
infectious
tions;
diseases that may be transmitted by blood and
blood products; the signs and symptoms of HIV/
AIDS and hepatitis, and the significance of
‘informed consent’, self-deferral, and temporary
and permanent deferral;

(c) the reasons why they should not donate which

may be detrimental to their own health;

(d) the reasons why they should not donate which
put recipients at risk, such as unsafe sexual beha-
viour, HIV/AIDS, hepatitis, drug addiction and
the use and abuse of drugs;

(e) the option of changing their mind about dona-
to proceeding further without any

ting prior
undue enbarrassment or discomfort;

(f)

information on the possibility of withdrawing or
self-deferring at any time during the donation
process;

(g) the opportunity to ask questions at any time;

they will be

(h) the assurance that if test results show evidence of
informed and
any pathology,
deferred from donation, as
recommended in
Annex II B and C, for their own safety as well as
that of potential recipients; prospective donors
who object
to being so informed should be
excluded from the donation process;

(i) specific information on the nature of the pro-
cedures involved in the donation process and
associated risks for those willing to participate in
whole
apheresis
programmes.

donation

blood

or

in

For the purpose of this Recommendation, Member
States should assign to the terms listed in Annex I
the meaning given to them therein.

2.2. For confidentiality

(1) OJ L 281, 23. 11. 1995, p. 31.

(a) information on the measures taken to ensure the
confidentiality of: any health-related information

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/17

provided to the health personnel, the results of
the tests on their donations, as well as any future
traceability of their donation;

(b) the assurance that all interviews with prospective

donors are carried out in confidence;

(c) the option of requesting through a confidential
self-deferral procedure the blood and plasma
collection establishment not to use their dona-
tion.

3.

Information required from prospective donors

Member States should ensure that, upon agreement
of a willingness to proceed to donate blood or
plasma, all prospective donors provide to the blood
and plasma collection establishment:

3.1. Identification

Appropriate means of identification, providing name
(first and surname), addresss, and date of birth, or
alternative means
to be
uniquely identified.

allowing each donor

4.1. Donor centre identification

Permit
every donation establishment
Member State to be uniquely identified;

in each

4.2. Donor identification and records

(a) Record information regarding the identification
of prospective donors in an automated or manual
system which allows verification each time a
donation is made;

(b) Provide for the keeping of records on donors and
prospective donors in such a way as to ensure
unique identification, protect the identity of the
donor from unauthorised access to confidential
information, but facilitate future traceabiity of any
donation;

(c) Allow for the inclusion of information related to
adverse donor reaction to the donation, reasons
for preventing an individual
from donating,
whether on a temporary or permanent basis while
ensuring confidentiality.

3.2. Health history

5. Donor eligibility

(a) Information on their health and medical history,
including any relevant behavioural characteristics,
that may assist in identifying and screening out
persons whose donation could present a health
risk to themselves or a risk of
transmitting
diseases to others, by way of a written question-
naire addressing the criteria recommended in
Annex II and a personal interview with a trained
health care staff member.

and

that

been presented,

(b) Their signature alongside that of the health care
staff member conducting the interviews on the
donor questionnaire or their signature on a sep-
arate attestation to acknowledge that the educa-
tional materials provided have been read and
understood, that the opportunity to ask questions
satisfactory
has
responses have been received; to give their agree-
ment that their blood or plasma donation could
be used for patients needing transfusion or blood
products in the country where the donation is
made or in another country, to which it would be
transferred in accordance with the provisions of
the legislation of the country where the donation
is made, particularly with regard to the destina-
the donation; and to indicate their
tion of
informed consent that they wish to proceed with
the donation process.

4. Registration of donor

Member States, in order to ensure the eligibility of
individuals to be accepted as donors of blood and
plasma, should ensure that:

5.1. Eligibility criteria for the acceptance of donors of

whole blood and donors of components by apheresis

(a) the general criteria for the acceptance of blood
and plasma donors are publicised in every dona-
tion establishment and that clear messages are
presented to donors as to the importance of their
willingness to donate but also the importance of
the acceptance criteria;

(b) the responses given to the issues raised in the
written questionnaire and/or the personal inter-
view provide the necessary confidence that the
donation will not adversely affect the health of a
future recipient of the products derived from that
donation;

(c) the prospective donor meets the physical require-
ments criteria recommended in Annex II A in
order that
there are no detrimental effects to
his/her own health as a result of the donation;

(d) the prospective donor’s eligibility is determined

at each donation session;

Member States should ensure the establishment of a
donor identification/registration system to:

(e) the practice of using ‘replacement donors’

is

phased out;

L 203/18

‹

EN

‹

Official Journal of the European Communities

21. 7. 98

(f) a responsible physician gives his/her written
authorisation of
the acceptance of prospective
donors, when their eligibility may be question-
able;

5.2. Deferral criteria for donors of whole blood and

donors of components by apheresis

Those who may show evidence of any of the condi-
tions and characteristics listed in Annex II B and C
should be declared either permanently or tempor-
arily ineligible to donate blood and plasma;

5.3. Deferral records

for

(a) ensure that a sample of all donations of blood or
plasma whether intended for transfusion purposes
or
further manufacturing into industrially
prepared medicinal products is tested for diseases
transmissible by blood or plasma using approved
screening tests to eliminate units that are repeat
reactive;

(b) ensure that all blood and plasma donations be
found non-reactive for the transmissible disease
markers listed in Annex IV prior to use;

(c) require re-testing of the blood samples found to
taking
be reactive in an initial screening test
account of the indicative algorithm set out in
Annex V.

Donation establishments should maintain a record of
any prospective donor deferral, whether permanent
or temporary, including the reasons why.

9. Additional measures

Member States should:

6. Data protection

Member States should, in accordance with Directive
sensitive
95/46/EC, ensure the confidentiality of
medical information about prospective donors, and
in particular:

(a) ensure that data security measures are in place as
well as safeguards against unauthorised data addi-
tions, deletions or modifications to donor files or
deferral registers, and transfer of information;

(b) ensure that procedures are in place to resolve data

discrepancies;

(c) prevent the unauthorised disclosure of such in-
formation, while ensuring the traceability of
donations.

7. Volumes and time intervals

To protect the health of the donor, Member States
should ensure that:

(a) volumes of blood and plasma collected are no
greater than those recommended in Annex III;

(b) time intervals between donations are no less than

those recommended in Annex III;

(c) medical attention is available to the donor in the
event of an adverse event related to the donation.

(a) ensure that appropriate provisions are in place in
for counselling, as
to prospective donors who are

the donation establishment
appropriate,
deferred;

(b) encourage the collection, analysis and evaluation
of epidemiological data concerning donors and
donations, with a view to improving the safety of
blood transfusion;

(c) take the necessary steps for the dissemination of
this recommendation to all parties concerned,
and in particular to blood collecting establish-
ments in their territory;

(d) take all necessary measures to encourage the
voluntary and unpaid donation of blood and
plasma, and entirely support the efforts of the
Council of Europe in this area; take account of
the Council of Europe definition of voluntary and
non-remunerated donation as follows:

‘A donation is considered voluntary and non-re-
munerated if the person gives blood, plasma or
cellular components of his/her own free will and
receives no payment for it, either in the form of
cash or in kind which could be considered a
substitute for money. This would include time off
work other than that reasonably needed for the
donation and travel. Small tokens, refreshments
and reimbursements of direct
travel costs are
compatible with voluntary, non-remunerated
donations.’

8. Testing samples of donated blood

INVITES THE COMMISSION

Member States, in order to ensure the safety of all
blood and plasma donations, should:

— to report on the application of these recommenda-
tions and keep the matters covered therein under
review in order to make the necessary proposals for

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/19

revision and updating;
to involve national experts
from all the Member States in the preparation of such
proposals;

— to promote as a priority,

in the light of scientific
studies, work on the potential health effects of depart-
ing from the maximum volume limits and minimum
time intervals between donations set out in Annex III,
in order in particular to determine whether or not
adverse health effects may result from collecting, by
apheresis, annual plasma volumes higher than those
recommended in existing international guidelines; and
to undertake work on common volume and frequency
limits for other types of apheresis;

— to propose where appropriate common terminology
for the purpose of further developing the Community
strategy on blood safety and self-sufficiency;

— to examine as soon as possible, in close cooperation
with the Member States, all the aspects related to the
use of genome amplification technology (GAT), in-
cluding polymerase chain reaction (PCR)-screening, in
order to prevent the transmission of communicable
diseases by blood transfusion.

Done at Luxembourg, 29 June 1998.

For the Council

The President

R. COOK

L 203/20

‹

EN

‹

Official Journal of the European Communities

21. 7. 98

ANNEX I

COMMON TERMINOLOGY

Blood

Whole blood collected from a single donor and processed either
for transfusion or further manufacturing

Blood product

Any therapeutic product derived from human blood or plasma

Blood component

Therapeutic components of blood (red cells, white cells, platelets,
plasma) that can be prepared by centrifugation, filtration, and
freezing using conventional blood bank methodology

Medicinal product derived from
blood or plasma

Same meaning as that given in Directive 89/381/EEC

Donor

Prospective donor

A person in normal health with a good medical history who
voluntarily gives blood or plasma for therapeutic use

Someone who presents himself/herself at a blood or plasma
collection establishment and states his/her wish to give blood or
plasma

First time donor

Someone who has never donated either blood or plasma

Repeat donor

Regular donor

Someone who has donated before but not within the last two
years in the same donation centre

Someone who routinely donates their blood or plasma (i.e. within
the last two years), in accordance with minimum time intervals,
in the same donation centre

Replacement donor

Donors recruited by patients to enable them to undergo therapy
which requires blood transfusion

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/21

ANNEX II

CORE CRITERIA FOR ACCEPTANCE OR DEFERRAL OF BLOOD AND PLASMA DONORS

A: Physical requirements criteria for acceptance of blood and plasma donors for their own

protection

Age

Blood and plasma donors should be 18-65 years of age. Acceptance of first time donors age 60-65 is at
the discretion of the responsible physician. Repeat donors may continue to donate after the age of 65
with the permission of the responsible physician given annually.

For whole blood, donors aged 17, and not legally classified as minors, may be accepted; otherwise written
consent should be required according to applicable law.

Body weight

Donors weighing no less than 50 kg may donate whole blood or plasma.

Blood pressure

The systolic blood pressure should not exceed 180 mm of mercury and the diastolic pressure should not
exceed 100 mm of mercury.

Pulse

The pulse should be regular and between 50 to 110 beats per minute. Those prospective donors who
undergo intensive sport training and have a pulse rate lower than 50 beats per minute may be accepted.

Either:

Haemoglobin

The haemoglobin concentration should be determined at the time of the donation and should be no less
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

2. Temporary deferral

Ineligible for nine months

— Pregnancy (after delivery)
— Abortion

Ineligible (time frame variable)

— Participation in hazardous sports
— Employment which might cause problems shortly after blood donation
— Other reasons.

C: Deferral criteria for blood and plasma donors for the protection of recipients

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 potential recipients:

1. Permanent deferral

— Auto-immune diseases
— Infectious diseases — persons suffering or having suffered from:

— Babesiosis
— Hepatitis B (HBsAg confirmed positive)
— Hepatitis C
— Hepatitis, infectious (of unexplained aetiology)
— HIV/AIDS
— HTLV I/II
— Leprosy
— Kala Azar (leishmaniasis)
— Q fever
— Syphilis
— Trypanosoma cruzi (Chagas’ disease)

— 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)

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/23

2.3 Ineligible for six months

— Infectious mononucleosis (after recovery)

2.4 Ineligible for four weeks

— Following administration of live attenuated viral vaccines

2.5 Ineligible for two weeks

— Minor infectious diseases

2.6 Ineligible for one week

— Minor surgery

2.7 Ineligible for 72 hours

— Following administration of vaccines (desensitising)

2.8 Ineligible for 48 hours

— Treatment by dentist or dental hygienist
— Following administration of killed/inactivated viral/bacterial and rickettsial vaccines
— Rabies vaccine (prophylactic administration)

2.9 Ineligible (time frame variable)

— Hepatitis A
— Medicines
— Malaria (does not apply to plasmapheresis donors)
— Tropical diseases (other)

Additional reasons may exist for the temporary deferral of a donor for the protection of the recipient.
A decision as to length of time is as the discretion of a qualified physician in the blood collection
establishment.

L 203/24

‹

EN

‹

Official Journal of the European Communities

21. 7. 98

ANNEX III

WHOLE BLOOD AND PLASMA DONATIONS

recommended maximum volumes and minimum time intervals between donations

Whole blood

Maximum volume

per donation

500 ml

per consecutive 12 month period

three litres

Minimum time interval between dona-
tions

Automated plasmapheresis

Maximum volume
(excluding anticoagulant)

per donation

Minimum time interval between dona-
tions

eight weeks

650 ml

least

two days

At
should elapse
between donations. No more than
two donations should be permitted
within a seven-day period

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.

21. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 203/25

ANNEX IV

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

Antibodies to the hepatitis C virus

Antibodies to the human immunodeficiency virus 1

Antibodies to the human immunodeficiency virus 2

Surface antigen of hepatitis B

Anti-HCV

Anti-HIV 1

Anti-HIV 2

HBsAg

ABO-group (A) (B)
Rh-type (A) (B)

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)

Treponema pallidum (syphilis) (B)

(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
of the blood component by using a validated automated information technology system, it is not neces-
sary to repeat the determination of ABO- and Rh-groups at the time of every blood donation. In such a
case the blood group of the blood donor should be periodically verified.

(B) Not required for apheresis plasma intended only for fractionation.

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
1 x screening test

screening test result
reactive/indeterminate

result negative donor and donation cleared

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
cleared

eliminate unit

all results
negative

possible additional
tests/donor cleared

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

positive
result

indeterminate
result

establishments which have 
received blood components 
from previous donation to be 
informed as soon as possible, 
and in any case within 7 days: 
look back

plasma processing 
establishment to be informed 
about previous donations
as soon as possible, and in 
any case within 7 days:
look back

2nd blood sample

screening and
confirmation tests

all results negative

positive result

indeterminate result

donor cleared

permanently
defer/inform donor

tracing back procedure
and look back

temporarily
defer/inform donor

further clarification