S.I. No. 547/2006 - European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006

STATUTORY INSTRUMENT

S.I. No 547 of 2006

European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006

European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions) Regulations 2006

S.I. No. 547 of 2006 .

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 2005/61/EC of the European Commission implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to traceability requirements and notification of serious adverse reactions and events hereby make the following Regulations:

1. These Regulations may be cited as the European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006.

2. These Regulations shall come into operation on 25 October, 2006.

Interpretation

3. (1) In these Regulations-

‘facilities’ means hospitals, clinics, manufacturers, and bio-medical 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 or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

‘recipient’ means someone 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 that reports serious adverse reactions and/or serious adverse events to the competent authority;

‘serious adverse event’ shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life threatening, disabling or incapacitating conditions for patients, or which results in, or prolongs hospitalization or morbidity;

‘serious adverse reaction’ means an unintended response in a donor or a patient associated with the collection or transfusion of blood or blood components that is fatal, life threatening, disabling or incapacitating, or which results in, or prolongs hospitalization or morbidity;

‘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.

(2) A word or expression that is used in these Regulations and is also used in the Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 has, unless the contrary intention appears, the same meaning in these Regulations as it has in Directive 2002/98/EC.

Traceability

4. Each blood establishment, hospital blood bank and facility shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.

5. Each blood establishment shall ensure that it has in place a traceability system such as enables the tracing of blood components to their location and processing stage.

6. Each blood establishment shall ensure that it has in place a system 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.

7. Each facility shall have a system in place to record each blood unit or blood component received, whether or not locally processed, and the final destination of that received unit, whether transfused, discarded or returned to the distributing blood establishment.

8. Each blood establishment shall have 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.

Verification procedure for issuing blood or blood components

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

Record of data on traceability

10. Each blood establishment and hospital blood bank and facility shall retain the data set out in the First Schedule hereto for at least 30 years in an appropriate and readable storage medium in order to ensure traceability.

Notification of serious adverse reactions

11. Each facility where transfusion occurs shall 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 during or after transfusion which may be attributable to the quality or safety of blood and blood components.

12. (1) Each reporting establishment shall have procedures in place to communicate to the Irish Medicines Board as soon as known all relevant information about suspected serious adverse reactions. The notification thereof shall be in the formats set out in Part A and Part C of the Second Schedule hereto.

(2) A reporting establishment shall be deemed to have complied with the requirement at paragraph (1) if it has reported all relevant information about suspected serious adverse reactions to the National Haemovigilance Office as soon as known. Such notification to the National Haemovigilance Office shall be in the formats set out in Part A and Part C of the Second Schedule hereto.

13. Each reporting establishment shall:

(a) notify to the National Haemovigilance Office all relevant information about serious adverse reactions of imputability level 2 or 3, as referred to in Part B of the Second Schedule hereto, attributable to the quality and safety of blood and blood components. The National Haemovigilance Office shall notify the Irish Medicines Board of all such notifications ;

(b) notify the National Haemovigilance Office of any case of transmission of infectious agents by blood and blood components as soon as known. The National Haemovigilance Office shall notify the Irish Medicines Board of all such notifications;

(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;

(d) evaluate suspected serious adverse reactions according to the imputability levels set out in Part B of the Second Schedule hereto;

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

(f) submit a complete report on serious adverse reactions to the National Haemovigilance Office on an annual basis using the format set out in Part D of the Second Schedule hereto. The National Haemovigilance Office shall submit all such reports on an annual basis to the Irish Medicines Board.

Notification of serious adverse events

14. Each blood establishment and hospital blood bank 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.

15.(1) Each reporting establishment shall have procedures in place to communicate to the Irish Medicines Board as soon as known, using the notification format set out in Part A of the Third Schedule hereto, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.

(2) A reporting establishment shall be deemed to have complied with the requirement of paragraph (1) if it has in place procedures to communicate to the National Haemovigilance Office as soon as is known, using the notification format set out in Part A of the Third Schedule hereto, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned. The National Haemovigilance Office shall notify the Irish Medicines Board of all such notifications;

16. Each reporting establishment 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 Third Schedule hereto;

(c) submit a complete report on serious adverse events to the National Haemovigilance Office, on an annual basis using the format set out in Part C of the Third Schedule hereto. The National Haemovigilance Office shall submit all such reports on serious adverse events on an annual basis to the Irish Medicines Board.

Requirements for imported blood components

17. Each blood establishment shall have in place a system of traceability for imports of blood and blood components from blood establishments outside the European Community equivalent to that provided for in Regulations 5 to 8 hereof.

18. Each blood establishment shall have in place a system of notification for imports of blood and blood components from outside the European Community equivalent to that provided for in Regulations 11 to 16 hereof.

Annual reports

19. The Irish Medicines Board shall submit to the European Commission an annual report by 30^th June of the following year, on the notification of serious adverse reactions and events received by it using the format set out in Part D of the Second Schedule and Part C of the Third Schedule hereto.

Communication of information between competent authorities

20. The Irish Medicines Board shall communicate to the competent authorities in the other Member States 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.

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GIVEN UNDER MY OFFICIAL SEAL

25 October, 2006

Mary Harney

_____________________________

Minister for Health and Children

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation)

These Regulations set out traceability requirements and requirements for the notification of serious adverse reactions and events in respect of human blood and blood components for the purpose of giving effect to Directive 2005/61/EC.

FIRST SCHEDULE

Record of data on traceability as provided for in Regulation 10

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.

SECOND SCHEDULE

PART A

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

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)

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)

SECOND SCHEDULE

PART B

Serious adverse reactions — imputability levels

Imputability levels to assess serious adverse reactions.

Imputability Level		Explanation
NA	Not assessable	When there is insufficient data for imputability assessment.
0	Excluded	When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.
0	Unlikely	When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.
1	Possible	When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.
2	Likely, Probable	When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.
3	Certain	When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.

SECOND SCHEDULE

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

SECOND SCHEDULE

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 0 to 3 after confirmation (see Second Schedule, Part A)
		Number of deaths
			Not assessable	Level 0	Level 1	Level 2	Level 3
Immunological Haemolysis	Due to ABO incompatibility	Total
	Due to ABO incompatibility	Deaths
	Due to other allo-antibody	Total
	Due to other allo-antibody	Deaths
Non-immunological haemolysis		Total
Non-immunological haemolysis		Deaths
Transfusion-transmitted bacterial infection		Total
Transfusion-transmitted bacterial infection		Deaths
Anaphylaxis/hypersensitivity		Total
Anaphylaxis/hypersensitivity		Deaths
Transfusion related acute lung injury		Total
Transfusion related acute lung injury		Deaths
Transfusion – transmitted viral infection	HBV	Total
	HBV	Deaths
	HCV	Total
	HCV	Deaths
	HIV - 1/2	Total
	HIV - 1/2	Deaths
	Other (specify)	Total
	Other (specify)	Deaths
Transfusion-transmitted Parasitical infection	Malaria	Deaths
	Malaria	Deaths
	Other (specify)	Total
	Other (specify)	Deaths
Post-transfusion purpura		Total
Post-transfusion purpura		Deaths
Graft versus host disease		Total
Graft versus host disease		Deaths
Other serious reactions (specify)		Total
Other serious reactions (specify)		Deaths

THIRD SCHEDULE

PART A

NOTIFICATION OF SERIOUS ADVERSE EVENTS

Rapid Notification Format for Serious Adverse Events

Reporting establishment

Report identification

Reporting date (year/month/day)

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

Specifications

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

THIRD SCHEDULE

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)

THIRD SCHEDULE

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
	Total Number	Product defect	Equipment failure	Human Error	Other (specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)