TRACEABILITY REQUIREMENTS AND NOTIFICATION OF SERIOUS ADVERSE REACTIONS AND EVENTS REGULATIONS

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

SUBSIDIARY LEGISLATION 483.03

TRACEABILITY REQUIREMENTS AND

NOTIFICATION OF SERIOUS ADVERSE

REACTIONS AND EVENTS REGULATIONS

10th November, 2006

LEGAL NOTICE 273 of 2006.

(1) The title of these regulations is the Traceability

Requirements and Notification of Serious Adverse Reactions and

Events Regulations.

(2) These regulations implement Directive 2005/61/EC

implementing Directive 2002/98/EC of the European Parliament

and of the Council of the 27th January, 2003 relating to traceability

requirements and notification of serious adverse reactions and

events.

(Regulation 5)

RECORD OF DATA ON TRACEABILITY

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.

For the purposes of these regulations, unless the context

otherwise requires

"the Authority" means the Superintendent of Public Health;

"facilities" means hospitals, clinics, manufacturers and

biomedical research institutions to which blood or blood

components may be delivered;

"imputability" means the likelihood that a serious adverse

reaction in a recipient can be attributed to the blood or blood

component transfused, or that a serious adverse reaction in a donor

can be attributed to the donation process;

"issue" means the provision of blood or blood components by a

blood establishment or a hospital blood bank for transfusion to a

recipient;

"recipient" means a person who has been transfused with blood

or blood components;

"reporting establishment" means the blood establishment, the

hospital blood bank or facilities where the transfusion takes place,

which reports serious adverse reactions and, or serious adverse

events to the Authority;

"traceability" means the ability to trace each individual unit of

blood or blood component derived therefrom, from the donor to its

final destination, whether this is a recipient, a manufacturer of

medicinal products or disposal thereof, or vice versa.

(Regulations 6 and 9)

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A

Rapid notification format for suspected serious adverse reactions.

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)

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

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)

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. When there is conclusive evidence beyond reasonable doubt for

attributing the adverse reaction to alternative causes.

Unlikely. When the evidence is clearly in favour of attributing the adverse

reaction to causes other than the blood or blood components.

Possible. 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.

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)

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

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

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 serious adverse reactions with imputability level

Number of deaths

0 to 3

after confirmation (see Part A of this Schedule)

not assessable

Level 0

Level 1

Level 2

Level 3

Immunological Haemolysis Due to ABO incompatibility. Total Deaths

Due to other allo-antibody. Total Deaths

Non-immunological haemolysis. Total Deaths

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

Transfusion-transmitted bacterial infection. Total Deaths

Anaphylaxis#hypersensitivity. Total Deaths

Transfusion related acute lung injury. Total Deaths

Transfusion-transmitted viral Infection

HBV Total Deaths

HCV Total Deaths

HIV-1/2 Total Deaths

Other (specify) Total Deaths

Transfusion-transmitted parasitical infection

Malaria Total Deaths

Other (specify) Total Deaths

Post-transfusion purpura Total Deaths

Graft versus host disease Total Deaths

Other serious reactions (specify) Total Deaths

(1) It shall be the duty of the blood establishment to have

in operation a system which ensures the traceability of blood and

blood components through accurate identification procedures,

record maintenance and an appropriate labelling system.

(2) The traceability system in place in the blood establishment

shall be of such a kind as to

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

(a) enable the tracing of blood components to their

location and processing stage; and

(b) 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.

(3)

Every blood establishment shall have

(a) a system in place to record each blood unit or blood

component received, whether it has been locally

processed or not, and the final destination of such

received unit, whether transfused, discarded or

returned to the distributing blood establishment; and

(b) a unique identifier that enables it to be precisely linked

to each unit of blood which it has collected and to each

blood component which it has prepared.

(Regulations 7 and 9)

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

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

Storage

Distribution

Materials

Others (specify)

PART B

Confirmation Format for Serious Adverse Events.

Reporting establishment

Report identification

Confirmation date (year/month/day)

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

Root cause analysis (details)

Corrective measures taken (details)

PART C

Annual Notification Format for Serious Adverse Events.

Reporting establishment

Reporting period

1 January-31 December (year)

Total number of blood and blood components processed

Serious adverse event, affecting quality and safety of blood component due to a

deviation in

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)

Any blood establishment or hospital blood bank shall,

when issuing units of blood or blood components for transfusion,

have 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.

Blood establishments, hospital blood banks or facilities

shall retain the data set out in Schedule I to these regulations for at

least thirty years in an appropriate and readable storage medium in

order to ensure traceability.

(1) It shall be the duty of all those facilities where

transfusion occurs to have procedures in place to retain the record

of transfusions and to notify blood establishments without delay of

any serious adverse reactions observed in recipients either during

or after transfusion which may be attributable to the quality or

safety of blood and blood components.

(2) It shall be the duty of reporting establishments to have

procedures in place to communicate to the Authority, as soon as

they are known, all relevant information about suspected serious

adverse reactions. The notification formats set out in Part A and

Part C of Schedule II shall be used.

(3)

Reporting establishments shall

(a) notify to the Authority all relevant information about

serious adverse reactions of imputability level 2 or

level 3, as referred to in Part B of the said Schedule II,

attributable to the quality and safety of blood and

blood components;

(b) notify the 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 transfusion or for use as plasma for

fractionation;

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS

(d) evaluate suspected serious adverse reactions according

to the imputability levels set out in Part B of the said

Schedule II;

(e) complete the serious adverse reaction notification,

upon conclusion of the investigation, using the format

set out in Part C of the said Schedule II;

(f) submit a complete report on serious adverse reactions

to the Authority on an annual basis using the format

set out in Part D of the said Schedule II.

(1) Blood establishments and hospital blood banks shall

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.

(2) Reporting establishments shall have procedures in place to

communicate to the Authority as soon as known, using the

notification format set out in Part A of Schedule III, all relevant

information about serious adverse events which may put in danger

donors or recipients other than those directly involved in the event

concerned.

(3)

Reporting establishments shall

(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 the said Schedule III;

(c) submit a complete report on serious adverse events to

the Authority on an annual basis using the format set

out in Part C of the said Schedule III.

In the case of imports of blood and blood components from

third countries blood establishments shall have

(a) a system of traceability in place equivalent to that

provided for in regulation 3;

(b) a system of notification in place equivalent to that

provided for in regulations 6 and 7.

The Authority shall submit to the Commission an annual

report, by the 30th June of the following year, on the notification of

serious adverse reactions and events received by the Authority

using the formats in Part D of Schedule II and Part C of Schedule

III.

The Authority shall communicate to other competent

authorities such information as is appropriate 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.

TRACEABILITY REQUIREMENTS AND NOTIFICATION

OF SERIOUS ADVERSE REACTIONS AND EVENTS