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The Blood Safety and Quality (Amendment) Regulations 2006

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Amendment of the Schedule to the principal Regulations

This section has no associated Explanatory Memorandum

15.  In the Schedule to the principal Regulations, after Part 5 (quality and safety requirements for blood and blood components) insert the following Parts—

PART 6RECORD OF DATA ON TRACEABILITY

A. 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.

B. 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.

PART 7NOTIFICATION OF SERIOUS ADVERSE REACTIONS

SECTION ARapid notification format for suspected serious adverse reactions

SECTION BSerious adverse reactions – imputability levels

SECTION CConfirmation format for serious adverse reactions

SECTION DAnnual notification format for serious adverse reactions

PART 8NOTIFICATION OF SERIOUS ADVERSE EVENTS

SECTION ARapid Notification Format for Serious Adverse Events

SECTION BConfirmation Format for Serious Adverse Events

SECTION CAnnual Notification Format for Serious Adverse Events

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