Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events   (Text with EEA relevance)
Date: 2005-09-30
Institutions: European Commission
Subjects: blood transfusion, health legislation, traceability

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COMMISSION DIRECTIVE 2005/61/EC

of 30 September 2005

implementing Directive 2002/98/EC of the European Parliament and of the Council as regards
traceability requirements and notification of serious adverse reactions and events

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 2002/98/EC of
the European
Parliament and of
the Council of 27 January 2003 setting
standards of quality and safety for
testing,
storage and distribution of human blood and
processing,
blood components and amending Directive 2001/83/EC (1),
and in particular points (a) and (i) of the second paragraph of
Article 29 thereof,

the collection,

Whereas:

(1)

(2)

(3)

(4)

Directive 2002/98/EC lays down standards of quality and
safety for the collection and testing of human blood and
blood components, whatever their intended purpose, and
for
storage and distribution when
intended for transfusion so as to ensure a high level of
human health protection.

their processing,

In order to prevent the transmission of diseases by blood
and blood components and to ensure an equivalent level
of quality and safety, Directive 2002/98/EC calls for the
establishment of specific technical requirements dealing
with traceability, a Community procedure for notifying
serious adverse reactions and events and the notification
format.

Notification of suspected serious adverse reactions or
should be submitted to the
serious adverse events
competent authority as soon as known. This Directive
therefore establishes the notification format defining the
minimum data needed, without prejudice to the faculty
of Member States to maintain or introduce in their
stringent protective measures which
territory more
comply with the provisions of the Treaty as provided
under Article 4(2) of Directive 2002/98/EC.

This Directive lays down those technical requirements,
which take
account of Council Recommendation
98/463/EC of 29 June 1998 on the suitability of blood
and plasma donors and the screening of donated blood
in the European Community (2), Directive 2001/83/EC of
the European Parliament
the Council of
6 November 2001 on the Community code relating to

and of

(1) OJ L 33, 8.2.2003, p. 30.
(2) OJ L 203, 21.7.1998, p. 14.

for human use (3), Commission
medicinal products
Directive 2004/33/EC of 22 March 2004 implementing
Directive 2002/98/EC of the European Parliament and of
the Council as regards certain technical requirements for
blood and blood components (4), and certain recommen-
dations of the Council of Europe.

for

raw material

Accordingly, blood and blood components imported
from third countries,
including those used as starting
the manufacture of
material or
medicinal products derived from human blood and
distribution in the
human plasma,
Community,
Community
standards and specifications relating to traceability and
serious adverse reaction and serious adverse event noti-
fication requirements as set out in this Directive.

intended
should meet

equivalent

for

is necessary to determine common definitions for
It
technical terminology in order to ensure the consistent
implementation of Directive 2002/98/EC.

in this Directive are in
The measures provided for
accordance with the opinion of the Committee set up
by Directive 2002/98/EC,

(5)

(6)

(7)

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions

For the purposes of this Directive, the following definitions shall
apply:

(a)

‘traceability’ means the ability to trace each individual unit
of blood or blood component derived thereof
from the
donor to its final destination, whether this is a recipient, a
manufacturer of medicinal products or disposal, and vice
versa;

(b) ‘reporting establishment’ means the blood establishment, the
hospital blood bank or facilities where the transfusion takes
place that reports serious adverse reactions and/or serious
adverse events to the competent authority;

(c)

‘recipient’ means someone who has been transfused with
blood or blood components;

(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive

2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(4) OJ L 91, 30.3.2004, p. 25.

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(d) ‘issue’ means the provision of blood or blood components
by a blood establishment or a hospital blood bank for
transfusion to a recipient;

at least 30 years in an appropriate and readable storage medium
in order to ensure traceability.

(e)

‘imputability’ means the likelihood that a serious adverse
reaction in a recipient can be attributed to the blood or
blood component
that a serious adverse
reaction in a donor can be attributed to the donation
process;

transfused or

(f)

‘facilities’ means hospitals, clinics, manufacturers, and bio-
medical
research institutions to which blood or blood
components may be delivered.

Article 5

Notification of serious adverse reactions

1. Member States shall ensure that
those facilities where
transfusion occurs have procedures in place to retain the
record of
transfusions and to notify blood establishments
without delay of any serious adverse reactions observed in reci-
pients during or after transfusion which may be attributable to
the quality or safety of blood and blood components.

Article 2

Traceability

1. Member States shall ensure the traceability of blood and
blood components through accurate identification procedures,
record maintenance and an appropriate labelling system.

2. Member States shall ensure that the traceability system in
place in the blood establishment enables the tracing of blood
components to their location and processing stage.

3. Member States shall ensure that every blood establishment
has a system in place to uniquely identify each donor, each
blood unit collected and each blood component prepared,
whatever its intended purpose, and the facilities to which a
given blood component has been delivered.

4. Member States shall ensure that all facilities have a system
in place to record each blood unit or blood component
received, whether or not locally processed, and the final desti-
nation of that received unit, whether transfused, discarded or
returned to the distributing blood establishment.

5. Member States shall ensure that every blood establishment
has a unique identifier that enables it to be precisely linked to
each unit of blood that it has collected and to each blood
component that it has prepared.

2. Member States shall ensure that reporting establishments
have procedures in place to communicate to the competent
information about
authority as soon as known all relevant
suspected serious adverse reactions. The notification formats
set out in Part A and Part C of Annex II shall be used.

3. Member States shall ensure that reporting establishments:

(a) notify to the competent authority all relevant information
about serious adverse reactions of imputability level 2 or 3,
as referred to in Part B of Annex II, attributable to the
quality and safety of blood and blood components;

(b) notify the competent authority of any case of transmission
of infectious agents by blood and blood components as
soon as known;

(c) describe the actions taken with respect to other implicated
blood components that have been distributed for trans-
fusion or for use as plasma for fractionation;

(d) evaluate suspected serious adverse reactions according to the

imputability levels set out in Part B of Annex II;

Article 3

(e) complete the serious adverse reaction notification, upon
conclusion of the investigation, using the format set out
in Part C of Annex II;

Verification procedure for issuing blood or blood
components

Member States shall ensure that the blood establishment, when
it issues units of blood or blood components for transfusion, or
the hospital blood bank has in place a procedure to verify that
each unit issued has been transfused to the intended recipient or
if not transfused to verify its subsequent disposition.

(f)

submit a complete report on serious adverse reactions to
the competent authority on an annual basis using the
format set out in Part D of Annex II.

Article 6

Article 4

Notification of serious adverse events

Record of data on traceability

Member States shall ensure that blood establishments, hospital
blood banks, or facilities retain the data set out in Annex I for

1. Member States shall ensure that blood establishments and
hospital blood banks have procedures in place to retain the
record of any serious adverse events which may affect
the
quality or safety of blood and blood components.

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2. Member States shall ensure that reporting establishments
have procedures in place to communicate to the competent
authority as soon as known, using the notification format set
out
information about
serious adverse events which may put in danger donors or
recipients other
than those directly involved in the event
concerned.

in Part A of Annex III, all relevant

3. Member States shall ensure that reporting establishments:

(a) evaluate serious adverse events

to identify preventable

causes within the process;

(b) complete the serious adverse event notification, upon
conclusion of the investigation, using the format set out
in Part B of Annex III;

(c) submit a complete report on serious adverse events to the
competent authority on an annual basis using the format set
out in Part C of Annex III.

Article 7

Requirements for imported blood and blood components

1. Member States shall ensure that for imports of blood and
blood components from third countries blood establishments
have a system of traceability in place equivalent to that provided
for in Article 2(2) to (5).

2. Member States shall ensure that for imports of blood and
blood components from third countries blood establishments
to that
have a system of notification in place equivalent
provided for in Articles 5 and 6.

Article 8

Annual reports

Member States shall submit
to the Commission an annual
report, by 30 June of the following year, on the notification
received by the
of
competent authority using the formats in Part D of Annex II
and Part C of Annex III.

serious adverse reactions and events

with regard to serious adverse reactions and events in order to
guarantee that blood or blood components known or suspected
to be defective are withdrawn from use and discarded.

Article 10

Transposition

1. Without prejudice to Article 7 of Directive 2002/98/EC,
Member States shall bring into force the laws, regulations and
to comply with this
administrative provisions necessary
Directive by 31 August 2006 at
the latest. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
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
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 11

Entry into force

This Directive shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

Article 12

Addressees

This Directive is addressed to the Member States.

Article 9

Done at Brussels, 30 September 2005.

Communication of information between competent
authorities

Member States shall ensure that
their competent authorities
communicate to each other such information as is appropriate

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Record of data on traceability as provided for in Article 4

BY BLOOD ESTABLISHMENTS

1. Blood establishment identification

2. Blood donor identification

3. Blood unit identification

4. Individual blood component identification

5. Date of collection (year/month/day)

6. Facilities to which blood units or blood components are distributed, or subsequent disposition.

BY FACILITIES

1. Blood component supplier identification

2. Issued blood component identification

3. Transfused recipient identification

4. For blood units not transfused, confirmation of subsequent disposition

5. Date of transfusion or disposition (year/month/day)

6. Lot number of the component, if relevant.

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ANNEX II

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

Rapid notification format for suspected serious adverse reactions

PART A

Reporting establishment

Report identification

Reporting date (year/month/day)

Date of transfusion (year/month/day)

Age and sex of recipient

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

Serious adverse reaction is related to
— Whole blood
— Red blood cells
— Platelets
— Plasma
— Other (specify)

Type of serious adverse reaction(s)
— Immunological haemolysis due to ABO incompatibility
— Immunological haemolysis due to other allo-antibody
— Non-immunological haemolysis
— Transfusion-transmitted bacterial infection
— Anaphylaxis/hypersensitivity
— Transfusion related acute lung injury
— Transfusion-transmitted viral infection (HBV)
— Transfusion-transmitted viral infection (HCV)
— Transfusion-transmitted viral infection (HIV-1/2)
— Transfusion-transmitted viral infection, Other (specify)
— Transfusion-transmitted parasitical infection (Malaria)
— Transfusion-transmitted parasitical infection, Other (specify)
— Post-transfusion purpura
— Graft versus host disease
— Other serious reaction(s) (specify)

Imputability level (NA, 0-3)

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PART B
Serious adverse reactions — imputability levels

Imputability levels to assess serious adverse reactions.

Imputability level

Explanation

Not assessable When there is insufficient data for imputability assessment.

Excluded

Unlikely

Possible

When there is conclusive evidence beyond reasonable doubt for attributing the adverse
reaction to alternative causes.

When the evidence is clearly in favour of attributing the adverse reaction to causes other
than the blood or blood components.

When the evidence is indeterminate for attributing adverse reaction either to the blood or
blood component or to alternative causes.

Likely, Probable When the evidence is clearly in favour of attributing the adverse reaction to the blood or

blood component.

Certain

When there is conclusive evidence beyond reasonable doubt for attributing the adverse
reaction to the blood or blood component.

NA

0

1

2

3

PART C

Confirmation format for serious adverse reactions

Reporting establishment

Report identification

Confirmation date (year/month/day)

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

Confirmation of serious adverse reaction (Yes/No)

Imputability level (NA, 0-3)

Change of type of serious adverse reaction (Yes/No)

If Yes, specify

Clinical outcome (if known)
— Complete recovery
— Minor sequelae
— Serious sequelae
— Death

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PART D

Annual notification format for serious adverse reactions

Reporting establishment

Reporting period

This Table refers to
[ ] Whole blood
[ ] Red blood cells
[ ] Platelets
[ ] Plasma
[ ] Other
(use separate table for each component)

Number of units issued (total number of units issued with a given number of
blood components)

Number of recipients transfused (total number of recipients transfused with a given
number of blood components) (if available)

Number of units transfused (the total number of blood components (units)
transfused over the reporting period) (if available)

Total number
reported

Number of
deaths

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

not
assessable

Level
0

Level
1

Level
2

Level
3

Immunological Haemolysis

Due to ABO incompatibility

Total

Due to other allo-antibody

Total

Deaths

Non-immunological haemolysis

Transfusion-transmitted bacterial infection

Anaphylaxis/hypersensitivity

Transfusion related acute lung injury

Transfusion-transmitted
Infection

viral

HBV

HCV

HIV-1/2

Other (specify)

Transfusion-transmitted para-
sitical infection

Malaria

Other (specify)

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

Total

Deaths

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Post-transfusion purpura

Graft versus host disease

Other serious reactions (specify)

Total

Deaths

Total

Deaths

Total

Deaths

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ANNEX III

NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A

Rapid Notification Format for Serious Adverse Events

Reporting establishment

Report identification

Reporting date (year/month/day)

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

Serious adverse event, which may
affect quality and safety of blood
component due to a deviation in:

Specification

Product defect

Equipment
failure

Human error

Other
(specify)

Whole blood collection

Apheresis collection

Testing of donations

Processing

Storage

Distribution

Materials
Others (specify)

PART B

Confirmation Format for Serious Adverse Events

Reporting establishment

Report identification

Confirmation date (year/month/day)

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

Root cause analysis (details)

Corrective measures taken (details)

PART C

Annual Notification Format for Serious Adverse Events

Reporting establishment

Reporting period

Total number of blood and blood components processed:

1 January-31 December (year)

Serious adverse event, affecting
quality
blood
component due to a deviation in:

safety

and

of

Total
number

Specification

Product
defect

Equipment
failure

Human
error

Other
(specify)

Whole blood collection

Apheresis collection

Testing of donations

Processing

Storage

Distribution

Materials
Others (specify)