The Blood Safety and Quality Regulations 2005

1. Introductory Text

2. 1. Citation, commencement and interpretation

3. 2. Designation of the competent authority and scope of the Regulations

4. 3. Requirement for authorisation

5. 4. Authorisation of a blood establishment

6. 5. Suspension or revocation of authorisation

7. 6. The responsible person for a blood establishment

8. 7. Blood establishment requirements

9. 8. Labelling of blood and blood components and traceability

10. 9. Hospital blood bank requirements

11. 10. Requirement for hospital blood banks to provide information to the Secretary of State

12. 11. Service of notices relating to hospital blood banks

13. 12. Objections to suspensions, revocations etc

14. 13. Import of blood and blood components into the United Kingdom

15. 14. Disclosure of information by blood establishments and hospital blood banks

16. 15. Inspections, etc.

17. 16. Records to be kept by the Secretary of State

18. 17. Powers of entry, etc.

19. 18. Criminal offences

20. 19. Penalties

21. 20. Defence of due diligence

22. 21. Offences by bodies corporate and Scottish partnerships

23. 22. Fees

24. 23. Specific epidemiological situations

25. 24. Transitional provisions

26. 25. Consequential amendments

27. Signature

28. 1. SCHEDULE

       1. PART 1

          1. Definitions

       2. PART 2 INFORMATION REQUIREMENTS FOR DONORS

          1. Part A – Information to be provided to prospective donors of blood or blood components

          2. 1. Part A – Information to be provided to prospective donors of blood or blood components

          3. 2. For both allogeneic and autologous donations, the reasons for requiring...

          4. 3. For allogeneic donations, the criteria for self-deferral, and temporary and...

          5. 4. For autologous donations, the possibility of deferral and the reasons...

          6. 5. Information on the protection of personal data, including confirmation that...

          7. 6. The reasons why individuals are not to make donations which...

          8. 7. Specific information on the nature of the procedures involved either...

          9. 8. Information on the option for donors to change their mind...

          10. 9. The reasons why it is important that donors inform the...

          11. 10. Information on the responsibility of the blood establishment to inform...

          12. 11. Information as to why unused autologous blood and blood components...

          13. 12. Information that test results detecting markers for viruses, such as...

          14. 13. Information on the opportunity for donors to ask questions at...

          15. Part B – Information to be obtained from donors by blood establishments at every donation

          16. 14. Identification of the donor

          17. 15. Health and medical history of the donor

          18. 16. Signature of the donor

       3. PART 3 ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

          1. 1. Acceptance criteria for donors of whole blood and blood components

          2. 1.1. Age and body weight of donors Age 18 to 65...

          3. 1.2. Haemoglobin levels in donor’s blood Haemoglobin For females ≥ 125...

          4. 1.3. Protein levels in donor’s blood Protein ≥ 60 g/l The...

          5. 1.4. Platelet levels in donor’s blood Platelets Platelet number greater than...

          6. Deferral criteria for donors of whole blood and blood components

          7. 2.1. Deferral criteria for donors of whole blood and blood components

          8. 2.2. Temporary deferral criteria for donors of allogeneic donations

          9. 2.2.1. Infections

          10. Duration of deferral period

          11. 2.2.2. Duration of deferral period

          12. 2.2.3. Vaccination Attenuated viruses or bacteria 4 weeks Inactivated/killed viruses, bacteria...

          13. 2.2.4. Other temporary deferrals Pregnancy 6 months after delivery or termination,...

          14. 2.3. Deferral for particular epidemiological situations Particular epidemiological situations (e.g. disease...

          15. 2.4. Deferral criteria for donors of autologous donations Serious cardiac disease...

       4. PART 4 STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

          1. 1. STORAGE

          2. 1.1. Liquid storage Component Temperature of storage Maximum storage time Red...

          3. 1.2. Cryopreservation Component Storage conditions and duration Red blood cells Up...

          4. 2. TRANSPORT AND DISTRIBUTION

          5. 3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

          6. 3.1. Autologous blood and blood components must be clearly identified as...

          7. 3.2. Autologous blood and blood components must be labelled as required...

       5. PART 5 QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

          1. 1. THE BLOOD COMPONENTS 1. Red cell preparations The components listed...

          2. 2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

          3. 2.1. Blood and blood components must comply with the following technical...

          4. 2.2. Appropriate bacteriological control of the collection and manufacturing process must...

          5. 2.3. For autologous donations, the measures marked with an asterisk (*)...

29. Explanatory Note