Proposal for a  Directive of the European Parliament and of the Council  setting standards of quality and safety for the collection, testing, processing, storage, and distribution of  human blood and blood components and amending Council Directive 89/381/EEC
Date: 2000-12-13
Institutions: European Commission
Subjects: blood transfusion, health control, marketing, product safety, public health, quality standard, safety standard, storage

29.5.2001

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Official Journal of the European Communities

C 154 E/141

Proposal for a Directive of the European Parliament and of the Council setting standards of quality
and safety for the collection, testing, processing, storage, and distribution of human blood and
blood components and amending Council Directive 89/381/EEC

(2001/C 154 E/14)

(Text with EEA relevance)

COM(2000) 816 final (cid:151) 2000/0323(COD)

(Submitted by the Commission on 26 January 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(a) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) The extent to which human blood is used therapeutically
demands that the quality, safety and efficacy of whole
blood and blood components be ensured in order to
prevent the transmission of diseases.

(2) The availability of blood and blood components used for
therapeutic purposes is dependent on Community citizens
who are prepared to donate; in order to safeguard public
health and to prevent
infectious
diseases by blood derivatives, all precautionary measures
during their collection, processing, distribution and use
need to be taken.

the transmission of

(3) The

and

safety,

quality,

efficacy

requirements

industrially-prepared medicinal

of
proprietary
products
derived from human blood or human plasma were
ensured through Council Directive 89/381/EEC of 14
June 1989 extending the scope of Directives 65/65/EEC
and 75/319/EEC on the approximation of provisions laid
down by Law, Regulation or Administrative Action
relating to proprietary medicinal products and laying
down special provisions for medicinal products derived
from human blood or human plasma (1);
the specific
exclusion of whole blood, plasma, and blood cells of
human origin from that Directive, however, has led to a
situation whereby their quality and safety, in so far as they

are of

comparable quality

are intended for transfusion and not processed as such,
are not subject to any binding Community legislation. It is
essential, therefore, that whatever the intended purpose,
Community provisions should ensure that blood and its
components
and safety
throughout the blood transfusion chain in all Member
States, bearing in mind the freedom of movement of
citizens within Community territory. The establishment
of high standards of quality and safety, therefore, will
help to reassure the public that human blood and blood
components that are derived from donations in another
Member State nonetheless carry the same guarantees as
those in their own country.

(4) In respect of blood or plasma as a starting material for
the manufacture of proprietary medicinal products,
Article 3 of Directive 89/381/EEC refers to measures to
be taken by Member States to prevent the transmission of
infectious diseases, comprising the application of
the
the European Pharmacopoeia and the
monographs of
recommendations of
the Council of Europe and the
World Health Organisation as regards in particular the
selection and testing of blood and plasma donors.
Furthermore, Member States should take measures to
promote Community self-sufficiency in human blood or
human plasma; and to encourage voluntary unpaid
donations of blood and plasma. Consequently,
these
provisions cover blood and blood components collected
and tested for the sole purpose of being used as starting
material for medicinal products.

(5) In order to ensure that there is an equivalent level of
safety and quality of blood components, whatever their
intended purpose, technical adaptation of both Directive
89/381/EC and this Directive should be undertaken in
accordance with the committee procedure provided for
in this Directive. Directive 89/381/EEC should be
amended accordingly.

(6) The Commission’s Communication of 21 December 1994
on Blood Safety and Self-sufficiency in the European
Community (2)
identified the need for a blood strategy
the
in order to reinforce confidence in the safety of
blood transfusion chain and promote Community self-
sufficiency.

(1) OJ L 181, 28.6.1989, p. 44.

(2) COM(94) 652 final.

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(7) The Council in its Resolution of 2 June 1995, on blood
safety and self sufficiency in the Community (1), invited
the Commission to submit appropriate proposals in the
framework of the development of a blood strategy.

both donor and recipient, benevolence of the donor, and
absence of profit on the part of
the establishments
involved in blood transfusion services.

(8) The Council in its Resolution of 12 November 1996 on a
strategy towards blood safety and self-sufficiency in the
European Community (2)
invited the Commission to
submit proposals as a matter of urgency with a view to
encouraging the development of a coordinated approach
to the safety of blood and blood products.

(14) All necessary measures need to be taken in order to
provide prospective donors of blood or plasma with
assurances regarding the confidentiality of any health-
related information provided to the authorised personnel,
the results of the tests on their donations as well as any
future traceability of their donation.

(9) The European Parliament

in its

resolutions of 14
September 1993 (3), 18 September 1993 (4), 14 July
1995 (5), and 17 April 1996 (6) on blood safety and self-
sufficiency through voluntary unpaid donations in the
European Community has stressed the importance of
level of blood safety and has
ensuring the highest
reiterated its continued support
the objective of
Community self-sufficiency.

for

(10)

In accordance with the principles of subsidiarity and
proportionality set out in Article 5 of the Treaty, the
objectives of the proposed action, namely to contribute
to general confidence both in the quality of donated blood
and plasma and in the health protection of donors, to
attain self-sufficiency at a Community level and to
enhance confidence in the safety of
the transfusion
chain among the Member States, cannot be sufficiently
achieved by the Member States and can therefore by
reason of its scale and effects be better achieved by the
Community. This Directive confines itself to the minimum
required in order to achieve those objectives and does not
go beyond what is necessary for that purpose.

(11)

In elaborating the provisions of this Directive account has
been taken of the opinion of the Scientific Committee for
Medicinal Products and Medical Devices as well as inter-
national experience in this field.

(12) Blood and plasma used for therapeutic purposes or for
use in medical devices should be obtained from indi-
viduals whose health status is such that no detrimental
effects to their state of health will ensue as a result of the
donation and that any risk of transmission of infectious
diseases is minimised; 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 Community citizens who are the
recipients of blood and blood components.

(13) Modern blood-transfusion practice has been founded on
the principles of voluntary donor services, anonymity of

(1) OJ C 164, 30.6.1995, p. 1.
(2) OJ C 374, 11.12.1996, p. 1.
(3) OJ C 268, 4.10.1993, p. 29.
(4) OJ C 329, 6.12.1993, p. 268.
(5) OJ C 249, 25.9.1995, p. 231.
(6) OJ C 141, 13.5.1996, p. 131.

(15) Directive 95/46/EC of the European Parliament and the
Council of 24 October 1995 on the protection of indi-
viduals with regard to the processing of personal data and
the free movement of such data (7) requires that data
related to the health of an individual be subject to rein-
forced protection. However, it covers only personal data
and not that rendered anonymous so that the person is
no longer identifiable. This Directive should therefore
introduce additional safeguards to prevent any unauth-
orised changes
to donation registries, or processing
records, or the unauthorised disclosure of information.

adverse

and notification of

(16) A common system of accreditation for blood estab-
and
lishments
reactions linked to the collection, processing,
testing,
storage, and distribution of blood and blood components
should be established in Member States. Accreditation
should be provided for a period not exceeding three
years and be renewable only following a satisfactory
inspection by the responsible authorities.

events

(17) Member States should organise inspection and control
measures, to be carried out by officials representing the
competent authority,
the
blood establishment with the provisions of this Directive.

to ensure the compliance of

(18) Personnel directly involved in the collection,

testing,
processing, storage and distribution of blood and blood
components need to be appropriately qualified and
provided with timely and relevant training. The provisions
laid down in this Directive as regards training should be
applicable without prejudice to existing Community legis-
lation on the recognition of professional qualifications
and on the protection of workers.

(19) An adequate system to ensure traceability of whole blood
and blood components should be established; traceability
should be enforced through accurate donor, patient, and
laboratory identification procedures, through record main-
tenance, and through an appropriate labelling system.

(7) OJ L 281, 23.11.1995, p. 31.

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(20) The Commission should be empowered to adopt any
necessary changes to the Annexes in order to take into
account scientific and technical progress.

This Directive applies without prejudice to Directive

2.
98/79/EC or to Directive 95/46/EC.

(21)

It is necessary that the best possible scientific advice is
available to the Community in relation to the safety of
in particular as regards
blood and blood components,
adapting the provisions of
this Directive to scientific
and technical progress.

(22) Since the measures necessary for the implementation of
this Directive are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (1),
they should be adopted by use of
the regulatory
procedure provided for in Article 5 of that Decision.

Article 3

Definitions

1.

For the purposes of this Directive:

(a) (cid:145)Blood(cid:146) shall mean whole blood collected from a donor and
processed either for transfusion or for further manufac-
turing.

(b) (cid:145)Blood component(cid:146) shall mean a therapeutic constituent of
blood (red cells, white cells, platelets, plasma) that can be
prepared by centrifugation,
filtration, and freezing using
conventional blood bank methodology.

(23) In order to increase the effective implementation of the
provisions adopted under this Directive it is appropriate
to provide for penalities to be applied by Member States.

(c) (cid:145)Blood product(cid:146) shall mean any therapeutic product derived
from human blood or plasma, and shall include both labile
blood components and stable plasma derivatives.

(24) Responsibility for the organisation of health services and
the provision of medical care should remain the respon-
sibility of each Member State,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Directive shall apply to the collection and testing of
human blood
their
storage, and
intended purpose, and to their processing,
distribution when intended for transfusion.

components, whatever

blood

and

However, when human blood and blood components are
collected and tested for the sole purpose and exclusive use as
starting materials for the manufacture of medicinal products as
defined by Directive 89/381/EEC,
that
Directive shall apply.

the provisions of

Article 2

Objectives

This Directive lays down standards of quality and safety
1.
of human blood and of blood components which are neither
medicinal products within the meaning of Council Directive
65/65/EEC (2) nor reagents within the meaning of Directive
98/79/EC of the European Parliament and of the Council (3),
in order to ensure a high level of human health protection.

(1) OJ L 184, 17.7.1999, p. 23.
(2) OJ 22, 9.2.1965, p. 369/65.
(3) OJ L 331, 7.12.1998, p. 1.

is

involved in any aspect of

(d) (cid:145)Blood establishment(cid:146) shall mean any enterprise or body
that
the collection and
testing of human blood or blood components, whatever
their intended purpose, and their processing, storage, and
distribution when intended for transfusion.

(e) (cid:145)Responsible person(cid:146) shall mean an individual with relevant
qualifications and experience for the scope of activities
carried out in a blood establishment.

(f)

shall mean formal acknowledgement of
(cid:145)Accreditation(cid:146)
compliance with accepted
for procedures,
activities, or services following an inspection by an auth-
orised institute or organisation.

standards

(g) (cid:145)Inspection(cid:146)

shall mean formal

control
according to adopted standards to identify problems and
approaches to their resolution.

and objective

(h) (cid:145)Adverse event(cid:146)

shall mean any untoward occurrence
associated with the collection, testing, processing, storage,
distribution,
blood
components.

transfusion

blood

and

and

of

(i)

(j)

(cid:145)Adverse reaction(cid:146) shall mean a harmful and unintended
response in donor or
in patient associated with the
collection or transfusion of blood or blood components.

(cid:145)Serious adverse event(cid:146) shall mean an adverse event that
might lead to death or life-threatening, disabling or inca-
pacitating conditions for patients or which results in or
prolongs hospitalisation

(k) (cid:145)Serious adverse reaction(cid:146) an adverse reaction that is fatal,
incapacitating, or which results

life-threatening, disabling,
in or prolongs hospitalisation.

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(l)

(cid:145)Deferral(cid:146) shall mean suspension of
individual
suspension being either of
deferral) or for a fixed period (temporary deferral).

the eligibility of an
to donate blood or blood components such
lifetime duration (permanent

The competent authority shall

inform the blood estab-
3.
lishment that it may only commence the activities for which
it sought accreditation upon receipt, by the responsible person,
of the competent authority’s written approval and compliance
with any conditions referred to therein.

The terminology used in Annexes II to IX shall be as set

2.
out in Annex I.

Article 4

Implementation

The competent authority empowered to grant the accredi-
submitted in the
the particulars
in this

4.
tation shall verify that
application comply with the requirements set out
Directive.

1. Member States shall establish, or designate, the competent
authority responsible for implementing the requirements of
this Directive.

5.
The competent authority shall acknowledge the date of
receipt of the information provided in paragraph 1, and within
90 days shall respond in writing to the responsible person,
indicating either:

accreditation

2. Member States shall ensure that the competent authority
implements
organises
inspections and other control measures intended to guarantee
quality and safety of human blood and blood components, in
accordance with the provisions of this Directive.

requirements

and

3.
This Directive shall not prevent a Member State from
maintaining or implementing on its territory more stringent
protective measures which comply with the provisions of the
Treaty. Those more stringent measures shall be safety measures
based on current scientific knowledge and shall not present an
obstacle to the implementation of this Directive, in particular
as regards the free circulation of labile blood products.

4.
In carrying out the activities covered by this Directive the
Commission may have recourse to technical and/or adminis-
trative assistance to the mutual benefit of the Commission and
relating to identification, preparation,
of
management, monitoring, audit and control, as well as to
support expenditure

the beneficiaries,

CHAPTER II

OBLIGATIONS ON MEMBER STATES’ AUTHORITIES

Article 5

Accreditation of blood establishments

1.
Prior to undertaking activities relating to the collection
and testing of human blood and blood components, whatever
their intended purpose, and to their preparation, storage, and
distribution when intended for transfusion, the blood estab-
lishment shall apply for accreditation from the competent
authority.

it shall deliver a notification to the competent
To this end,
authority, providing its name, address,
telephone and fax
numbers, as well as the name of the responsible person and
the information listed in Annex II, Part A.

2. Where the responsible person is replaced,
the blood
establishment shall provide immediately to the competent
authority the name of
the new responsible person and
his/her date of commencement.

(a) that the information provided complies with this Directive
and that the activities for which the blood establishment
sought accreditation may proceed, or

(b) that the activities for which the blood establishment sought
accreditation do not fulfil the conditions of this Directive
and that the accreditation is therefore rejected.

6.
For the purpose of calculating the period referred to in
paragraph 5, no account shall be taken of any period of time
during which the competent authority is:

(a) awaiting additional

information which it may have

requested from the responsible person, or

(b) carrying out

any inspection or

control measure

in

accordance with Article 4(2).

The accreditation shall be given for a maximum period of
7.
three years. The accreditation shall be renewable, in accordance
with the provisions of Article 7.

Article 6

Provisions for existing establishments

Member States may decide to maintain national provisions for
nine months after the date laid down in Article 30 so as to
enable blood establishments operating under their legislation to
comply with its requirements.

Article 7

Renewal of accreditation

For the purposes of

the renewal of accreditation,

1.
the
responsible person shall submit to the competent authority
to which the original application was transmitted, not
less
than nine months before the expiry of the accreditation, a
notification that contains in particular the information listed
in Annex II, Part B and any relevant information listed in
Annex II, Part A if modified since the first notification.

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The blood establishment may only proceed with the activities
for which it is accredited upon receipt of the written accredi-
tation, and compliance by the responsible person with any
conditions referred to therein, from the competent authority.

The competent authority shall organise inspection and
(4)
other control measures as appropriate in the event of any
serious adverse reaction or event notified in accordance with
Article 14.

2.
The competent authority shall respond in writing to the
responsible person, within 60 days following receipt of the
notification in accordance with the first
subparagraph of
paragraph 1, indicating either:

(a) that the information is in compliance with this Directive
and that the activities for which it was granted an author-
isation may continue; or

CHAPTER III

PROVISIONS FOR BLOOD ESTABLISHMENTS

Article 9

Responsible person

The responsible person shall fulfil the following minimum

1.
conditions of qualification:

(b) that its activities for which it was granted accreditation do
the

this Directive and that

not
accreditation is therefore suspended.

the conditions of

fulfil

3.
For the purpose of calculating the period referred to in
paragraph 2, no account shall be taken of any periods of time
during which the competent authority is:

(a) awaiting further information which it may have requested

from the responsible person, or

(b) carrying out

any inspection or

control measure

in

accordance with Article 4(2).

The accreditation shall be renewed for a maximum period

4.
of three years.

Article 8

Inspection and control measures

1.
The competent authority shall organise inspections and
other appropriate control measures in blood establishments to
ensure that the requirements of this Directive are complied
with.

2.
Inspection and control measures shall be organised by the
competent authority on a regular basis. The interval between
two inspections and control measures shall not exceed one
year.

3.
Such inspection and control measures shall be carried out
by officials representing the competent authority who must be
empowered to:

(a) he/she shall possess a diploma, certificate or other evidence
formal qualifications awarded on completion of a
of
university course of
study, or a course recognised as
equivalent by the Member State concerned, extending
over a period of at
theoretical and
practical study in one of the following scientific disciplines:
pharmacy, medicine, veterinary medicine, chemistry, phar-
maceutical chemistry and technology, biology;

four years of

least

(b) he/she shall have practical experience for at least two years,
in one or more establishments which are authorised to
undertake activities related to collection and testing of
human blood and blood components, or to their prep-
aration, storage, and distribution.

2.
The responsible person shall be responsible for ensuring
that each batch of blood or blood components has been
intended purpose, and
collected and tested, whatever
processed, stored, and distributed, when intended for trans-
fusion, in compliance with the laws in force in the Member
State.

its

Article 10

Personnel

directly

Personnel

testing,
involved
1.
processing, storage, and distribution of human blood and
blood components shall be provided with timely and relevant
training.

collection,

in

(a) inspect blood establishments as well as facilities of any third
parties entrusted by the holder of the accreditation referred
to in Article 5 with the task of carrying out evaluation and
testing procedures pursuant to Article 18;

The training of

the personnel shall be provided on
2.
recruitment, and then at regular intervals of at
least once
every year. It shall be repeated in the event of a transfer or a
change of job, as well as following the introduction of any new
technology.

(b) take samples;

subject

(c) examine any documents relating to the object of

the
inspection,
in force in the
to the provisions
Member States at the time of notification of this Directive
and which place restrictions on these powers with regard to
the descriptions of the method of preparation.

It shall be assessed periodically and at least every two years
(proficiency testing).

Training guidelines addressing the issues listed in Annex

3.
III shall be provided for personnel.

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CHAPTER IV

Article 14

QUALITY MANAGEMENT

Notification of adverse reactions and events

Article 11

Quality system for blood establishments

1.
The competent authority shall take all necessary measures
to ensure that each blood establishment establishes and
maintains a quality system for blood establishments ((cid:145)QSBE(cid:146)).

1. Member States shall ensure that there is a system in place
information about adverse
to collect, collate, and transmit
reactions
testing,
collection,
and events
processing,
storage and distribution of blood and blood
components to the competent authority.

related to the

The QSBE shall

2.
involve all activities of blood estab-
lishments that determine the quality policy, objectives, and
them by such means as
responsibilities and implement
quality planning, quality control, quality assurance,
and
quality improvement within the quality system.

3.
The Commission shall establish in accordance with the
procedure referred to in Article 26(2) detailed Community
standards and specifications relating to the activities set out
in paragraph 2 of this Article, to be carried out by a blood
establishment.

Article 12

Documentation

1. Member States shall take all necessary measures in order
to ensure that blood establishments maintain documentation
on operational procedures, guidelines, training and reference
manuals, and reporting forms.

2. Member States shall take all necessary measures in order
to ensure that access is provided to these documents for
officials
entrusted with inspection and control measures
referred to in Article 8.

The

2.
competent
responsible person shall notify the
authority of any serious adverse reaction or event linked to
the collection of blood and blood components.

3.
The Community procedure for notifying these adverse
reactions and events, referred to in paragraphs 1 and 2 of
this Article, and the notification format shall be established
by the Commission in accordance with the procedure
referred to in Article 26(2).

Article 15

Record keeping

1. Member States shall take all necessary measures to ensure
that blood establishments maintain records of the information
required in Annexes V, VI, and VII, as well as the prevalence of
viral markers in blood and plasma donors, and confirmed
positive seroconversions.

2.
The competent authority shall keep records of the data
received from the blood establishments according to the
provisions of Articles 5, 6, 7, and 14.

3.

The records shall be kept for a minimum of 30 years.

Article 13

Traceability

CHAPTER V

PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD
AND BLOOD COMPONENTS

1. Member States shall take all necessary measures in order
to ensure that blood and blood components collected, tested,
processed, stored or distributed on their territory can be traced
from donor to patient and vice versa.

Article 16

Provision of information to donors

Member States shall ensure that all donors of blood or plasma
are provided with information as outlined in Annex V, Part A.

To this end, Member States shall ensure that blood estab-
lishments under the responsibility of the responsible person
implement
identification system and assign a
number to each donation and its products.

a donor

2. Member States shall take all necessary measures in order
to ensure that blood and blood components collected, tested,
processed, stored and distributed on their territory comply with
the labelling requirements listed in Annex IV.

Article 17

Information required from donors

Member States shall take all necessary measures to ensure that,
upon agreement of a willingness to commence the donation of
blood or
the
information listed in Annex V, Part B to the blood estab-
lishment.

donors provide

components,

blood

all

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Article 18

Eligibility of donors

1.
Blood establishments shall ensure that in order to protect
there are
the health of both the donor and the recipient,
evaluation procedures in place for all donors of blood and
blood components and that the criteria for donation set out
in Annex VI are met.

2.
Blood and blood components shall be collected from
donors who meet the criteria for donation set out in Annex VI.

Any deviation in the age of donors, blood pressure, pulse,
shall not go beyond the

3.
haemoglobin or haematocrit
requirements listed in Annex VI.

CHAPTER VI

DATA PROTECTION

Article 22

Data protection

shall,

1. Member States
95/46/EC, ensure the confidentiality of
information about donors,
according to Article 17.

in accordance with Directive
sensitive medical
including information obtained

the protection of

2. Member States shall ensure that donors are informed
including the
about
guarantee of no unauthorised disclosure of the name of the
donor, of information concerning his health, or of the results
of the tests performed.

their personal data,

4.
The time interval between two donations for whole blood
or for apheresis plasma and the volume given during each
donation by the donors shall comply with the requirements
of Annex VI.

3. Member States shall take all necessary measures to ensure
that all data collated within the scope of this Directive have
been rendered anonymous so that
the donor is no longer
identifiable.

5.
If any of the diseases or symptoms listed in Annex VI are
identified during the donation process, donors shall be deferred
permanently.

The

results of

6.
evaluation and testing
procedures shall be documented and any abnormal findings
shall be reported to the donor.

the donor

Article 19

Testing of donations

Blood establishments shall ensure that each donation of blood
and
in conformity with
requirements listed in Annex VII.

components

tested

blood

is

Article 20

Storage and freezing conditions

Blood establishments

1.
storage
shall
conditions of blood and blood components comply with the
provisions listed in Annex VIII, Part A.

ensure

that

the

Blood establishments shall ensure that requirements as
2.
regards time of
freezing of blood and blood components
after collection are clearly identified according to Annex VIII,
Part B.

Article 21

Quality requirements for blood components

Blood establishments shall ensure that quality requirements for
blood components meet high standards in compliance with the
provisions listed in Annex IX.

For that purpose, they shall ensure:

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

(b) that procedures are in place to resolve data discrepancies;

(c) that no unauthorised disclosure of such information occurs,

whilst guaranteeing the traceability of donations.

CHAPTER VII

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 23

Information exchange

In order to facilitate the exchange of information associated
with the collection, testing, processing, storage and distribution
including information on
of blood and blood components,
the Commission shall meet
adverse events or
regularly with the competent authorities designated by the
Member States to exchange information on the experience
acquired with regard to the implementation of measures for
the protection of human health.

reactions,

Article 24

Reports

send

shall

States

1. Member
the Commission,
commencing on 31 December 2003 and thereafter annually,
a report on the activities undertaken in relation to the
provisions of
the
national measures taken in relation to inspection and control.

including an account of

this Directive,

to

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The Commission shall

European
2.
Parliament, the Council, the Economic and Social Committee
and the Committee of the Regions, the reports submitted by
the Member States on the experience gained in implementing
this Directive.

transmit

to the

The Commission shall

3.
European
Parliament, the Council, the Economic and Social Committee
and the Committee of the Regions, every three years, a report
on the functioning of requirements in the Directive, and in
particular those relating to inspection and control.

transmit

to the

Article 25

Penalties

Member States shall lay down the rules on penalties applicable
to infringements of the national provisions adopted pursuant to
this Directive and shall take all measures necessary to ensure
that they are implemented. The penalties provided for must be
effective, proportionate, and dissuasive. Member States shall
to the Commission by the date
notify those provisions
specified in Article 30 at
the latest and shall notify it
without delay of any subsequent amendments affecting them.

CHAPTER VIII

COMMITTEES

Article 26

Committee procedure

The Commission shall be assisted by a committee
the Member States and

1.
composed of
representatives of
chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

Article 27

Adaptation to technical progress

Annexes I to IX shall be adapted to scientific and technical
progress in accordance with the procedure referred to in
Article 26(2).

Article 28

Consultation of scientific committee(s)

the

scientific
consult
The Commission may
committee(s) when adapting the Annexes of this Directive to
scientific and technical progress, in particular with a view to
ensuring a comparable level of quality and safety of blood and
plasma used for transfusion and blood and plasma used as a
starting material for the manufacture of medicinal products.

relevant

CHAPTER IX

FINAL PROVISIONS

Article 29

Amendment of Directive 89/381/EEC

The following Article is inserted into Directive 89/381/EEC:

(cid:145)Article 6a

for

In respect of the use of human blood or human plasma as
a starting material
the manufacture of medicinal
products as referred to in Article 3, the amendments to
the Annex to Directive 75/318/EEC as provided for in
Article 6 shall be adapted to technical progress
in
accordance with the procedure referred to in Articles 26
and 28 of Directive . . . /. . . /EC of the European Parliament
(setting standards of quality and
and of
safety for the collection, testing, processing, storage, and
distribution of human blood and blood components and
amending Council Directive 89/381/EEC).

the Council (1)

___________
(1) OJ L . . .(cid:146)

Article 30

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not
than 31 December 2002. They shall
forthwith inform the Commission thereof.

later

When Member States adopt those provisions they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
texts of the provisions of national law that they have already
adopted or which they adopt in the field governed by this
Directive.

Article 31

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 32

Addressees

This Directive is addressed to the Member States.

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ANNEX I

TERMINOLOGY USED IN ANNEXES

1. Apheresis: process by which one or more blood components is selectively obtained from a donor by withdrawing
whole blood, separating it by centrifugation or filtration into its components, and returning those not required to
the donor;

2. Buffy coat: a blood component prepared by centrifugation of a unit of whole blood that contains most of its

leukocytes and, depending on the centrifugation, its platelets;

3. Cell-derivative: a therapeutic product derived from a blood component (as derived from leukocytes (cid:151) interferon,

cytokines (cid:151) or from outdated erythrocytes (cid:151) haemoglobin solution);

4. Cryoprecipitate: a blood component obtained from a unit of fresh frozen plasma and containing the major portion

of factor VIII, von Willebrand factor, fibrinogen, factor XIII and fibronectin;

5. Cytapheresis: an apheresis procedure intended for the collection of a cellular component of blood, such as red cells,

leukocytes or platelets;

6. Donor: a person in normal health with a good medical history who voluntarily gives blood or plasma for

therapeutic use;

7. Expiry date: the last day on which the blood or blood component is safe to use for transfusion;

8. Granulocytes: a kind of leukocyte; also used as name for a blood component, obtained either by the separation of
whole blood or by apheresis, and in which granulocytes are represented several times more than in whole blood;

9. Granulocytes, apheresis: a granulocyte concentrate prepared by cytapheresis;

10. Leukocytes: white blood cells also used as a name for a blood component obtained either by the separation of
whole blood or by apheresis and in which leukocytes are represented several times more than in whole blood;

11. Plasma derivative: highly purified human plasma protein prepared from pooled plasma under licensed phar-

maceutical manufacturing conditions;

12. Plasma: the liquid portion of anticoagulated blood remaining after separation from the cellular components;

13. Plasma, cryoprecipitate depleted: the supernatant plasma removed during the preparation of cryoprecipitate. The
content of albumin and immunoglobulins is comparable with fresh frozen plasma, factor VIII, von Willebrand
factor, fibrinogen, factor XIII and fibronectin are reduced;

14. Plasma, fresh frozen: plasma that has been separated from a unit of whole blood within a few hours of donation or
selectively collected by an apheresis procedure, has been rapidly frozen, and stored at a temperature below (cid:150) 20 (cid:176)C
(and preferably below (cid:150) 30 (cid:176)C);

15. Plasma, recovered: plasma prepared from individual donations of whole blood;

16. Plasma, thawed: plasma that has been thawed for clinical use after having been fresh frozen;

17. Platelets (single unit): a platelet concentrate prepared by processing a unit of whole blood;

18. Platelets pool (buffy coat): a platelet concentrate prepared by processing a pool of buffy coats obtained from

different units of whole blood;

19. Platelets, apheresis: a platelet concentrate prepared by apheresis;

20. Platelets, cryopreserved: apheresis: a blood component prepared by the freezing of platelets within 24 hours of

collection by apheresis, using a cryoprotectant and storing them at (cid:150) 80 (cid:176)C or below;

21. Platelets: a blood component obtained either by separation of whole blood or by apheresis and suspended in a small

volume of plasma from the same donation;

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22. Red cells in additive solution, buffy coat removed: a blood component prepared by centrifugation of whole blood,
removal of the buffy coat and most of the plasma, with subsequent addition to the red cells of an appropriate
nutrient solution;

23. Red cells in additive solution: a blood component obtained by centrifugation of whole blood and removal of most

of the plasma, with subsequent addition to the red cells of an appropriate nutrient solution;

24. Red cells, buffy coat removed: a blood component prepared by centrifugation of whole blood and removal of the

buffy coat and most of the plasma;

25. Red cells, cryopreserved: a blood component derived from whole blood in which red cells are frozen, preferably

within 7 days of collection, using a cryoprotectant, and stored at (cid:150) 80 (cid:176)C or below;

26. Red cells, deglycerolized: red cells that have been thawed and from which glycerol has been removed by washing;

27. Red cells, frozen in 20 % glycerol: red cells that have been stored continuously at (cid:150) 65 (cid:176)C or below, and to which

20 % glycerol has been added before freezing;

28. Red cells, frozen in 40 % glycerol: red cells that have been stored continuously at (cid:150) 65 (cid:176)C or below, and to which

40 % glycerol has been added before freezing;

29. Red cells, frozen in glycerol: red cells that have been stored continuously at (cid:150) 65 (cid:176)C or below, and to which glycerol

has been added before freezing;

30. Red cells, frozen: red cells that have been stored continuously at (cid:150) 65 (cid:176) or below, and to which a cryoprotectant

agent such as glycerol has been added before freezing;

31. Red cells, leukocyte-reduced: a blood component prepared by centrifugation of whole blood, removal of most of the

plasma and reduction of leukocytes through filtration;

32. Red cells, washed: a blood component prepared by washing centrifuged red cells with a volume of compatible

solution in order to remove leukocytes, platelets and almost all of the plasma;

33. Red cells: a blood component prepared by centrifugation of whole blood and removal of most of the plasma.

ANNEX II

INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY

PART A

(cid:151) Identification of blood collection establishment (address, telephone & fax numbers, emergency numbers)

(cid:151) Identification of responsible person, qualified personnel

(cid:151) Number and qualifications of personnel; their responsibilities; written job descriptions

(cid:151) Hygiene requirements (e.g. protective garments, hygiene in work area)

(cid:151) Identification of products prepared

(cid:151) Compliance of premises and equipment with regulatory requirements

(cid:151) Disposal of infectious waste

(cid:151) Standard Operating Procedures (SOPs) for donor suitability, testing, preparation, processing, distribution

(cid:151) Storage requirements (time, temperature)

(cid:151) Labelling provisions to be applied

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PART B

(cid:151) Total number of donors per year

(cid:151) Total number of donations per year

(cid:151) Number of donors/donations rejected

(cid:151) Incidence of diseases in the donations

(cid:151) Donor identification numbers

(cid:151) Donation identification numbers

(cid:151) Number of donations separated into components.

ANNEX III

GUIDELINES FOR TRAINING

To Be Provided For Personnel Directly Involved in the Collection, Testing, Processing, Storage and
Distribution of Whole Blood and blood components

Training guidelines for all personnel

Supplementary training
guidelines for tech-
nicians

Supplementary training guidelines for
nurses

Supplementary
training guidelines
for scientists
(biology, chemistry)

Suppl. training
guidelines for
physicians

Suppl. training
guidelines for
physicians managers

Technical training
in preparation of
blood
components;
Training in
testing of blood
donations and
pre-transfusion
testing.

General overview about blood
and blood transfusion;
Basic steps in the blood
collection and transfusion
process;
Importance of adhering to
procedures whose scope is to
ensure both quality and safety of
final product;
Importance of respecting and
complying with confidentiality
regulations;
Elements of quality
management.

Technical training in blood
collection and processing
(cid:151) theory related to collection

Training in
transfusion
medicine

procedures;

(cid:151) practice

in whole

blood

collection and apheresis
procedures;

Training in interviewing/assessing
potential donors;
Training in storage, quality
control requirements for blood
and blood components;
Training in identifying contra-
indications to donation/
collection;
Training in completing and
maintaining manual/
computerised records (donor,
donation, patients)

Management
training

Training in
epidemiology
/haemo-
vigilance
procedures;
Emergency
procedures

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ANNEX IV

LABELLING REQUIREMENTS

Component

The label on specimen receptacles and containers should contain at least the following
information

GENERAL LABELLING REQUIREMENTS

Specify
(cid:151) Nature of whole blood or component (or intended component)
(cid:151) Volume of component
(cid:151) Unique numeric or alphanumeric donation identification
(cid:151) Producer’s name and address (clear text or code)
(cid:151) ABO group
(cid:151) Rh (D) group, specifying (cid:145)Rh (D)-positive(cid:146) if D positive or (cid:145)Rh (D) negative(cid:146)

if D negative

(cid:151) Date of collection and expiry date
(cid:151) Temperature of storage
(cid:151) Name of anticoagulant (not required for frozen, deglycerolized, rejuvenated,

or washed red blood cells)

(cid:151) Approximate volume of blood collected from the donor
(cid:151) That the blood or component must not be used for transfusion if abnormal

haemolysis or other deterioration is evident

(cid:151) That blood or component must be administered through a 170-200 (cid:236)m

filter

SUPPLEMENTARY SPECIFIC LABELLING REQUIREMENTS

Plasma, fresh frozen

Platelets: apheresis

Specify
(cid:151) Whether component is from whole blood or apheresis donation;
(cid:151) Volume and composition of anticoagulant used;
(cid:151) Whether quarantined or virus inactivated

(cid:151) Volume of content and average number of platelets; if unit does not meet

recommended standard, actual number of platelets to be specified;

(cid:151) Whether leukocyte depletion has been carried out

Platelets, recovered

(cid:151) Donation number (if platelets are pooled,

labelling system must allow

Red cells

Red cells, cryopreserved

identification of original donations);
(cid:151) Whether or not leukocyte depleted;
(cid:151) Composition of anticoagulant solution

(cid:151) Name and volume of component;
(cid:151) Composition of anticoagulant or additive solution

(cid:151) Date and time of preparation and expiry;
(cid:151) Composition and volume of suspending solution;
(cid:151) Extra caution should be applied in identification of frozen bag units

Red cells, buffy coat removed

(cid:151) Composition of anticoagulant solution

Red cells, in additive solution

(cid:151) Composition and volume of additive solution

Red cells in additive solution, buffy
coat removed

(cid:151) Composition and volume of additive solution

Red cells, leucocyte-depleted

(cid:151) Composition of anticoagulant solution

Red cells, washed

Whole blood

(cid:151) Time of preparation and expiry;
(cid:151) Composition and volume of the suspending solution

(cid:151) Volume of preparation;
(cid:151) Composition and volume of anticoagulant solution

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ANNEX V

INFORMATION REQUIREMENTS

A. INFORMATION TO BE PROVIDED TO DONORS ACCORDING TO ARTICLE 16

1. Accurate but generally understandable educational materials about the essential nature of blood, the products

derived from it, and the important benefits to patients of blood and plasma donations;

2. The reasons for requiring a medical history, physical examination, and the testing of donations; information on
the risk of infectious diseases that may be transmitted by blood and blood products; the signs and symptoms of
AIDS, and the significance of (cid:145)informed consent(cid:146), self-deferral, and temporary and permanent deferral;

3. Information about protection of personal data: No unauthorised disclosure of the name of the donor, of

information concerning his health, and of the results of the tests performed;

4. The reasons why they should not donate which may be detrimental to their own health;

5. The reasons why they should not donate which put recipients at risk, such as unsafe sexual behaviour, HIV/

AIDS, hepatitis, drug addiction and the use and abuse of drugs;

6. The option of changing their mind about donating prior to proceeding further without any undue embar-

rassment or discomfort;

7.

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

8. The opportunity to ask questions at any time;

9. The undertaking that if test results shows evidence of any pathology, they will be contacted by the blood

collection centre;

10. Specific information on the nature of the procedures involved in the donation process and associated risks for

those willing to participate in apheresis programmes, whether for plasma or cellular components.

B.

INFORMATION TO BE OBTAINED FROM DONORS ACCORDING TO ARTICLE 17

1. Identification

Appropriate means of identification, providing

(cid:151) name (first and surname),

(cid:151) address,

(cid:151) date of birth,

or alternative means allowing the donor to be uniquely identified.

2. Health history

Health and medical history

(cid:151) any relevant factors 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 questionnaire
addressing the criteria listed in Annex VI and a personal interview with a trained health care staff member;

3. Signature

(cid:151) Signature, on the donor questionnaire, countersigned by the health care staff member conducting the
interview under the responsibility of the responsible person, or subject to the approval of this responsible
person

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(cid:151) Signature on a separate attestation,

(cid:151) to acknowledge

(cid:151) that educational materials provided have been read and understood,

(cid:151) that opportunity to ask questions has been presented, and

(cid:151) that satisfactory responses have been received.

(cid:151) to agree that his/her 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 destination of the donation; and

(cid:151) to indicate his/her informed consent of the wish to proceed with the donation process.

REQUIREMENTS CONCERNING THE SUITABILITY OF BLOOD AND PLASMA DONORS AND THE
SCREENING OF DONATED BLOOD

ANNEX VI

1. Requirements for the protection of blood and plasma donors

(a) Physical acceptance criteria

Age

18-65 years

Body weight

Blood pressure

Pulse

‡ 50 kg for either
whole blood or
plasma

Systolic
£ 180 mm of
mercury

50-110 beats per
minute and regular

60-65 years
(first-time donor)
at discretion of
responsible
physician

17 years and not legally
classified as a minor;
otherwise written
consent according to
law

+ 65 years
with permission of
responsible
physician given
annually

Diastolic
£ 100 mm of
mercury

< 50 beats per
minute
Accepted if
undergoes
intensive sport
training

Haemoglobin
(or haematocrit)

for females
‡ 12.5 g/100 ml

for males
‡ 13.5 g/100 ml

Haematocrit

Protein

for females
‡ 38 %

for males
‡ 40 %

For plasmapheresis
60 g/litre

For apheresis plasma:
males and females
‡ 12.5 g/100 ml

For apheresis plasma
‡ 38 %

(b) Donation criteria

Time interval

For whole blood
> 8 weeks

For apheresis
plasma
> 72 hours

Volume

Per whole blood
donation
£ 500 ml

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2. Permanent Deferral Criteria

(a) For protection of donor

(cid:151) Auto-immune diseases

(cid:151) Cardiovascular diseases

(cid:151) Central nervous system diseases

(cid:151) Malignant diseases

(cid:151) Abnormal bleeding tendency

(cid:151) Fainting spells (syncope) or convulsions

(cid:151) Severe or chronic gastrointestinal, haematological, metabolic, respiratory, or renal disease not included in

preceding categories

b) For protection of recipient

Prospective donors who have, or have a history of, any of the following:

(cid:151) Auto-immune diseases

(cid:151) Infectious diseases (cid:151) persons suffering or having suffered from

(cid:151) Babesiosis

(cid:151) Hepatitis B (HBsAg confirmed positive)

(cid:151) Hepatitis C,

(cid:151) Hepatitis, infectious (of unexplained aetiology)

(cid:151) HIV/AIDS

(cid:151) HTLV I/II

(cid:151) Leprosy

(cid:151) Kala Azar (leishmaniasis)

(cid:151) Q fever

(cid:151) Syphilis

(cid:151) Trypanosoma cruzi (Chagas’ disease)

(cid:151) Malignant diseases

(cid:151) TSEs (or history thereof in genetic family)

(cid:151) Alcoholism, chronic

(cid:151) Cornea/dura mater transplantation recipient

(cid:151) Diabetes, if treated with insulin

(cid:151) Intravenous (IV) drug use

(cid:151) Pituitary hormone of human origin (e.g. growth hormone) recipient

(cid:151) Sexual behaviour that places them at high risk of transmitting infectious diseases, including persons who have

had sex in return for money or drugs

3. Temporary Deferral Criteria

Whether for protection of the donor or recipient: should take fully into account Recommendation 98/463/EC.

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TESTING REQUIREMENTS AS REGARDS WHOLE BLOOD AND PLASMA DONATIONS

ANNEX VII

Components

Testing requirements

Required outcome

Whole blood/Plasma

Serological tests

ABO typing (*)

Rh D typing (*)

Rh C and E typing

HLA typing

Antibodies to red cell
antigens

Determined using approved blood grouping
reagents

Determined using approved anti-D blood
grouping reagents

Determined using approved blood grouping
reagents

Surface antigen of Hepatitis B

HbsAg

Negative using an approved ELISA or RIA test

Antibodies
immunodeficiency virus 1

to the human

Anti-HIV 1

Non-reactive for antibodies to HIV-1 using
approved screening tests

Antibodies
immunodeficiency virus 2

to the human

Anti-HIV 2

Non-reactive for antibodies to HIV-2 using
approved screening tests

Antibodies to the Hepatitis C
virus

Anti-HCV

Non-reactive for antibodies to HCV using
approved screening tests

Treponema pallidum
(syphilis)

ALT (when required)

not elevated (as specified by national auth-
orities)

HBc-Ab (when required)

Negative by approved screening test

Syphilis (when required)

Negative by screening test

CMV-Ab (when required)

Negative by screening test

HTLV-Abs (when required)

Negative by screening test

Malaria
for
endemic areas

travellers

to

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

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A. STORAGE

ANNEX VIII

STORAGE AND FREEZING

Blood product

Storage temperature

Length of storage

Transportation temperature

Transportation time

Cryoprecipitate

(cid:150) 18 (cid:176)C (cid:151) (cid:150) 25 (cid:176)C

(cid:150) 25 (cid:176)C (cid:151) (cid:150) 30 (cid:176)C

£ 30 (cid:176)C

Granulocytes

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

Plasma, cryoprecipitate-
depleted

(cid:150) 18 (cid:176)C (cid:151) (cid:150) 25 (cid:176)C

(cid:150) 25 (cid:176)C (cid:151) (cid:150) 30 (cid:176)C

£ 30 (cid:176)C

Plasma, fresh frozen

18 (cid:176)C (cid:151) (cid:150) 25 (cid:176)C

(cid:150) 25 (cid:176)C (cid:151) (cid:150) 30 (cid:176)C

£ 30 (cid:176)C

Thawed between
+ 30 (cid:176)C (cid:151) + 37 (cid:176)C

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

Plasma, thawed

Platelets

Platelets (single unit)

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

Platelets, apheresis

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

3 months

6 months

12 months

Administered ASAP and
within 12 hours of
collection.

3 months

6 months

£ 12 months

3 months

6 months

£ 12 months

Similar to storage
temperature

Similar to storage
temperature

Similar to storage
temperature

Transfused as soon as
possible

24 hours (cid:151) 5 days (with
continuous gentle
agitation)
< 6 hours (after open
system manipulation)

Similar to storage
temperature
(with continuous gentle
agitation)

According to container
bag

Similar to storage
temperature

According to container
bag

Similar to storage
temperature

Platelet
recovered

Platelets,
apheresis

concentrate,

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

24 hours (cid:151) 5 days (with
continuous gentle
agitation)

cryopreserved:

Frozen platelets: maintained at:
(cid:150) 80 (cid:176)C (in electrical freezer)
(cid:150) 150 (cid:176)C (in vapour phase
liquid nitrogen).
Thawed platelets
To be stored at + 20 (cid:176)C to
+ 24 (cid:176)C with adequate
agitation, if short term storage
required

+ 12 months
To be used immediately
after thawing

Similar to storage
temperature

Platelets pool (buffy coat)

+ 20 (cid:176)C (cid:151) + 24 (cid:176)C

According to container
bag

Similar to storage
temperature

Red cells

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

cells

Red
solution

in

additive

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

£ 35 days (in adenine
supplemented anti-
coagulant)

£ 35 days according to
anticoagulant and additive
solution

+ 1 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

+ 1 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

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Blood product

Storage temperature

Length of storage

Transportation temperature

Transportation time

+ 1 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

+ 1 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

in

Red
cells
solution, buffy coat
removed

additive

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

Red cells, leukocyte-
reduced

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

Red cells, frozen in glycerol

(cid:150) 80 (cid:176)C

Red cells,
glycerol

Red cells,
glycerol

frozen in 20 %

< (cid:150) 120 (cid:176)C

frozen in 40 %

< (cid:150) 65 (cid:176)C

£ 35 days according to
anticoagulant and additive
solution

£ 35 days with adenine
supplemented anti-
coagulant.
< 12 hours if prepared in
open system

10 years from
phlebotomy

10 years from
phlebotomy

10 years from
phlebotomy

Red cells, washed

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

< 12 hours

+ 2 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

Whole blood (for
fusion as whole blood)

trans-

+ 2 (cid:176)C (cid:151) + 6 (cid:176)C

< 35 days with adenine
supplemented anti-
coagulant

+ 1 (cid:176)C (cid:151) + 10 (cid:176)C

£ 12 hours

Whole blood (for
component preparation)

+ 1 (cid:176)C (cid:151) + 6 (cid:176)C
(within 8 hours of collection)

B.

FREEZING

Plasma A

Plasma B

Plasma C

Platelets

Red cells

Blood product

Time of freezing

Frozen within 6 hours of phlebotomy

Frozen within 24 hours of phlebotomy

Frozen after 24 hours of phlebotomy

Frozen within 24 hours

Frozen within 7 days

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ANNEX IX

QUALITY REQUIREMENTS FOR BLOOD COMPONENTS

Component

Properties

Cryoprecipitate

Contains a major portion of
Factor VIII, von Willebrand
factor, fibrinogen, Factor XIII and
fibronectin present in freshly
drawn and separated plasma

Parameter to be checked on all units
(unless otherwise indicated)

Blood donation testing
requirements listed in Annex VII
plus

Quality requirements

Volume

Factor VIIIc

10-25 ml

> 70 I.U./unit

Sampling (cid:151) 1 % of all units

Every two months:

(a) pool of 6 units of mixed
blood groups during first
month of storage;

(b) pool of 6 units of mixed
blood groups during last
month of storage

Fibrinogen

> 140 mg/unit

Sampling (cid:151) 1 % of all units;

Blood donation testing
requirements listed in Annex VII
plus

Volume

Granulocytes

< 500 ml

> 10 (cid:215) 109/unit
‡ 1010 in 75 % of all units

Granulocytes, apheresis

Principal function is phagocytosis
of bacteria

Plasma, cryoprecipitate-depleted

Content of albumin, immuno-
globulins and coagulation factors
comparable to fresh frozen
plasma. Reduced levels of Factors
V, VIII, XIII, von Willebrand
factor, fibrinogen, & fibronectin

Blood donation testing
requirements listed in Annex VII
plus
(unless plasma itself is the source)

Plasma, fresh frozen

Contains normal plasma levels of
stable coagulation factors,
albumin & immunoglobulins; at
least 70 % of original Factor
VIIIc, other labile coagulation
factors, & naturally occurring
inhibitors

European Community legislation
applies if source material for
fractionated products

Stated volume – 10 %

Volume

Sampling (cid:151) all units

Blood donation testing
requirements listed in Annex VII
plus
(unless plasma itself is the source)

Volume

Sampling: 3 units/day

Appearance

Sampling: all units

Red Cells

Sampling: all units

(recovered) 150-300 ml with anti-
coagulant solution

(apheresis) 500-600 ml with anti-
coagulant solution

Clear

< 6 (cid:215) 109

C 154 E/160

EN

Official Journal of the European Communities

29.5.2001

Component

Properties

Parameter to be checked on all units
(unless otherwise indicated)

Quality requirements

HBc-Abs (*)

(when required)

Negative by approved screening
test

Platelets, apheresis

Platelet content per procedure
variable depending on method of
preparation and machine used.
Same applies to leukocyte and
red cell contamination of
product. Standard unit = 5-6
single units by PRP

Blood donation testing
requirements listed in Annex VII
plus

Volume

Platelet content

Sampling (cid:151) all units.

(75 % of units sampled should fall
within specified values)

> 40 ml/60 (cid:215) 109
platelets

> 240 (cid:215) 109
platelets/donation

Residual leukocytes

(cid:151) before leukocyte depletion

(cid:151) after leukocyte depletion

< 1.0 (cid:215) 109/standard unit
< 1.0 (cid:215) 106/standard unit

Sampling (cid:151) all units.

(90 % of units sampled should
fall within specified values.)

Swirling

Sampling (cid:151) all units

+ 1 (score)

HLA or HPA (when & as
required)

ph measured

Sampling (cid:151) all swirling negative
units

Typing

6.5-7.4

Platelets, cryopreserved: apheresis

Reconstituted unit of cryopre-
served platelets is practically free
of red cells and granulocytes

Blood donation testing
requirements listed in Annex VII
plus

Volume

50-200 ml

Platelet content

> 40 % of original pre-frozen
platelet content

Residual leukocytes

< 0.2 (cid:215) 106 (cid:215) 1011
platelets

Platelets, recovered from single unit
by PRP

Amount of platelets in adult
(cid:145)standard dose(cid:146) equivalent to that
obtained from 4-6 units of whole
blood

Blood donation testing
requirements listed in Annex VII
plus

HLA or HPA

(when & as required)

Typing

29.5.2001

EN

Official Journal of the European Communities

C 154 E/161

Component

Properties

Parameter to be checked on all units
(unless otherwise indicated)

Quality requirements

Platelet pool from buffy coat

Volume

Sampling (cid:151) all units

40-60 ml of

plasma/donation

‡ 55 (cid:215) 109
platelets/single unit equivalent

Platelet content

Sampling (cid:151) 1 % of all units:

‡ 10 units/month

(75 % of units sampled should fall
within values specified).

Residual leukocyte content

(cid:151) before leukocyte depletion

< 0.2 (cid:215) 109/single unit equivalent

(cid:151) after leukocyte depletion

< 0.2 (cid:215) 106/single unit equivalent

Sampling (cid:151) 1 % of all units;

‡ 10 units/month

(75 % of units sampled should fall
within values specified)

pH (at end of recommended shelf
life)

6.4-7.4

Sampling (cid:151) 1 % of all units

Blood donation testing
requirements listed in Annex VII
plus

HLA or HPA

(when & as required)

Volume

Platelet content

Sampling

Residual leukocyte content

n. s.

2.5 (cid:215) 1011

(cid:151) before leukocyte depletion

< 0.05 (cid:215) 109/single unit equivalent

(cid:151) after leukocyte depletion

< 0.2 (cid:215) 106/single unit equivalent

Sampling (cid:151) 1 % of all units;

‡ 10 units/month

(75 % of units sampled should fall
within values specified)

pH

6.5(cid:151)7.4

Red cells

Contains all red cells from
donated unit after centrifugation.
No procedures taken to remove
leukocytes or platelets

Blood donation testing
requirements listed in Annex VII
plus

Volume

280 – 50 ml

Sampling (cid:151) 3 units/day

Haematocrit (Hct)

55-75 %

Sampling (cid:151) 3 units/day

Haemoglobin

‡ 45 g

Sampling (cid:151) 3 units/day

Red cells, buffy coat removed

All red cells from donated unit,
except 10-30 ml, remain after
centrifugation

Blood donation testing
requirements listed in Annex VII
plus

C 154 E/162

EN

Official Journal of the European Communities

29.5.2001

Component

Properties

Parameter to be checked on all units
(unless otherwise indicated)

Quality requirements

Volume

280 – 60 ml

Sampling (cid:151) 3 units/day

Haematocrit (Hct)

50-75 %

Sampling (cid:151) 3 units/day

Haemoglobin

> 43 g/unit

Sampling (cid:151) 3 units/day

Leukocyte content

Sampling (cid:151) 3 units/day

< 1.2 (cid:215) 109
cells/unit

(75 % of units sampled should fall
within specified values)

Platelet content

Sampling

< 10 (cid:215) 109
cells/unit

Red cells in additive solution

All red cells from donated unit
remain after centrifugation. No
procedures taken to remove
leukocytes or platelets

Blood donation testing
requirements listed in Annex VII
plus

Volume

280-420 ml

Sampling (cid:151) 1 % of all units

(75 % of units sampled should fall
within specified values)

Haematocrit (Hct)

50-70 %

Sampling (cid:151) 75 % of units
sampled should fall within
specified values

(depending on additive solution,
method of centrifugation, &
quantity of remaining plasma)

Haemoglobin.

Sampling

‡ 45 g/unit

Red cells in additive solution, buffy
coat removed

All red cells from donated unit,
except 10-30 ml, remain after
centrifugation.

Blood donation testing
requirements listed in Annex VII
plus

Volume

280 – 60 ml

Sampling (cid:151) 3 units/day

Haematocrit (Hct)

50-70 %

Sampling (cid:151) 3 units/day

(depending on nature of additive
solution, method of centrifugation,
& amount of remaining plasma)

Haemoglobin.

43 g/unit

Sampling (cid:151) 3 units/day

Leukocyte content

Platelet content

Sampling (cid:151) 3 units/day

< 1.2 (cid:215) 109
cells/unit

(in 75 % of units sampled)
< 20 (cid:215) 109
cells/unit

Red cells, cryopreserved

Blood donation testing
requirements listed in Annex VII
plus

29.5.2001

EN

Official Journal of the European Communities

C 154 E/163

Component

Properties

Parameter to be checked on all units
(unless otherwise indicated)

Quality requirements

Volume

Hb (supernatant) (Final
suspending solution)

Haematocrit (Hct)

H(cid:228)moglobin

Osmolarity.

> 185 ml

< 0.2 g/unit

0-0.75

‡ 36 g/unit

< 340 mOsm/L

Sampling (cid:151) 1 % of all units:

Leucocytes

< 0.1 (cid:215) 109

Sampling (cid:151) 1 % of all units:

(75 % of units sampled fall within
values specified)

Sterility.

Sterile

Sampling (cid:151) 1 % of all units:

Blood donation testing
requirements listed in Annex VII
plus

Volume

280 – 60 ml

Residual leukocyte content

< 5 (cid:215) 106 cells/unit

Sampling: validation with 100
filtrations for each kind of filter

Haematocrit (Hct)

Haemoglobin.

50(cid:151)75 %

‡ 40 g/unit

Sampling (cid:151) validation with 100
filtrations for each kind of filter

Blood donation testing
requirements listed in Annex VII
plus

Volume

Haematocrit (Hct)

Haemoglobin

Sampling (cid:151) 3 units/day

280 – 60 ml

65(cid:151)75 %

‡ 40 g/unit

Residual protein of final super-
natant

< 0.5 g/unit (To ensure IgA
content

< 0.2 mg/unit)

Blood donation testing
requirements listed in Annex VII
plus

Volume

Sampling (cid:151) all units:

Haematocrit (Hct)

H(cid:228)moglobin

Sampling

400(cid:151)500 ml excluding anti-
coagulant

35-45 %

‡ 45 g/unit

Haemolysis at end of storage

< 0.8 % of red cell mass

Sampling

Red cells, leukocyte-reduced

Red cells, washed

Amount of residual plasma
depends upon washing protocol

Whole blood

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