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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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