UK Statutory Instrument SI 2005 United Kingdom

Blood Safety and Quality Regulations 2005

These Regulations impose safety and quality requirements on human blood collection and storage. The requirements apply to blood transfusion services in England, Scotland, Wales and Northern Ireland. Many of the provisions of the Regulations also apply to hospital blood banks.

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
MHRA
Status
Amended (in force with amendments)
Penalty ceiling
Imprisonment 4 of 21 obligations carry up to 2 years imprisonment. 17 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person17 Director or Officer1

Plus 3 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2684 other Acts
Director or Officer — also bound by 482 other Acts
Companies Act 2006 126 duties

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.001 Modification of provisions of the Annex to Commission Directive 2005/62/EC Regulated
  • Maintain quality and safety standards for blood and blood componentsAny Person
s.004 Authorisation of a blood establishment (opens in a new tab) Regulated
  • Obtain MHRA authorisation before operating a blood establishmentAny Person
s.006 The responsible person for a blood establishment (opens in a new tab) Regulated
  • Designate a qualified Responsible Person for your blood establishmentAny Person
s.007 Blood establishment requirements (opens in a new tab) Regulated
  • Maintain quality, safety, and donor standards for blood establishmentsAny Person
s.008 Labelling of blood and blood components and traceability (opens in a new tab) Regulated
  • Label blood units and maintain full traceability recordsAny Person
s.009 Hospital blood bank requirements (opens in a new tab) Regulated
  • Maintain safety and quality standards for hospital blood banksAny Person
s.010 Requirement for hospital blood banks to provide information to the Secretary of State (opens in a new tab) Regulated
  • Submit annual compliance reports for hospital blood banksAny Person
s.012 Requirement that facilities retain certain data Regulated
  • Establish blood unit tracking and retain records for 30 yearsAny Person
s.012 Requirement to report serious adverse reactions and events Regulated
  • Report and record serious adverse blood transfusion reactions and eventsAny Person
s.013 Import of blood and blood components into Northern Ireland Regulated
  • Ensure safety standards when importing blood into Northern IrelandAny Person
s.013 Import of blood and blood components into Great Britain (opens in a new tab) Imprisonment
  • Ensure imported blood meets UK safety and quality standardsAny Person
s.014 Disclosure of information by blood establishments and hospital blood banks (opens in a new tab) Regulated
  • Securely manage and protect blood donation and donor dataAny Person
s.015 Inspections, etc. (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • MHRA must inspect blood establishments at least every two yearsCrown / Minister / Government department
s.016 Requirement that the Secretary of State communicate certain information in respect of Northern Ireland to other competent authorities Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must share safety info regarding Northern Ireland bloodCrown / Minister / Government department
s.016 Records to be kept by the Secretary of State (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must maintain records on blood establishments and banksCrown / Minister / Government department
s.018 Criminal offences (opens in a new tab) Imprisonment
  • Breach of core blood safety regulations (regs 3,7,9,13,23(2),12A,12B)Any Person
s.019 Penalties (opens in a new tab) Imprisonment
  • Breach of blood safety and quality standardsAny Person
s.021 Offences by bodies corporate and Scottish partnerships (opens in a new tab) Imprisonment
  • Personal liability for directors and officers for blood safety breachesDirector or Officer
s.022 Fees (opens in a new tab) Regulated
  • Pay required fees for blood establishment and hospital blood bank operationsAny Person
s.023 Specific epidemiological situations in relation to Northern Ireland Regulated
  • Adopt and comply with emergency blood donation deferral and testing criteriaAny Person
s.023 Specific epidemiological situations in relation to Great Britain (opens in a new tab) Regulated
  • Adopt and comply with emergency blood donation safety criteriaAny Person
42 other provisions — procedural and definitional
sch. Acceptance criteria for donors of whole blood and blood components
sch. para. 1 sch. para. 1
sch. para. 10 sch. para. 10
sch. para. 15 sch. para. 15
sch. para. 16 sch. para. 16
sch. para. 2 TRANSPORT AND DISTRIBUTION
sch. para. 2n14 sch. para. 2n14
sch. para. 6 sch. para. 6
sch. para. 9 sch. para. 9
s.001 Citation, commencement and interpretation (opens in a new tab)
s.001 Age and body weight of donors Age 18 to 65...
s.001 Haemoglobin levels in donor's blood Haemoglobin For females ≥ 125...
s.001 Protein levels in donor's blood Protein ≥ 60 g/l The...
s.001 Platelet levels in donor's blood Platelets Platelet number greater than...
s.002 Designation of the competent authority for Northern Ireland and scope of the Regulations (opens in a new tab)
s.002 Deferral criteria for donors of whole blood and blood components
s.002 Temporary deferral criteria for donors of allogeneic donations
s.002 Infections
s.002 Exposure to risk of acquiring a transfusion-transmissible infection — Endoscopic...
s.002 Vaccination Attenuated viruses or bacteria 4 weeks Inactivated/killed viruses, bacteria...
s.002 Other temporary deferrals Pregnancy 6 months after delivery or termination,...
s.002 Deferral for particular epidemiological situations Particular epidemiological situations (e.g. disease...
s.002 Deferral criteria for donors of autologous donations Serious cardiac disease...
s.003 Requirement for authorisation (opens in a new tab)
s.003 Autologous blood and blood components must be clearly identified as...
s.003 Autologous blood and blood components must be labelled as required...
s.005 Suspension or revocation of authorisation (opens in a new tab)
s.011 Service of notices relating to hospital blood banks (opens in a new tab)
s.012 Objections to suspensions, revocations etc (opens in a new tab)
s.017 Powers of entry, etc. (opens in a new tab)
s.020 Defence of due diligence (opens in a new tab)
s.024 Transitional provisions (opens in a new tab)
s.025 Consequential amendments (opens in a new tab)
s.026 “Granulocytes, apheresis” means a concentrated suspension of granulocytes obtained by... (opens in a new tab)
s.027 “Statistical process control” means a method of quality control of... (opens in a new tab)
s.definitions Definitions
s.references to the requirements set out in the anne References to the requirements set out in the Annex to Commission Directive 2005/62/EC
s.regulations relating to the quality and safety of Regulations relating to the quality and safety of blood and blood components
s.scope and nature of powers Scope and nature of powers
s.scrutiny of regulations made by the scottish minis Scrutiny of regulations made by the Scottish Ministers
s.scrutiny of regulations made by the secretary of s Scrutiny of regulations made by the Secretary of State
s.scrutiny of regulations made by the welsh minister Scrutiny of regulations made by the Welsh Ministers
Schedules

Schedules

0 of 5 shown
5 other schedules
s.schedule/part/1/paragraph/wrapper1n2 Definitions
s.schedule/part/2/paragraph/wrapper2n2 Part A – Information to be provided to prospective donors of blood or blood components
s.schedule/part/2/paragraph/wrapper3n2 Part B – Information to be obtained from donors by blood establishments at every donation
s.schedule/part/3/paragraph/wrapper4n2 Duration of deferral period
s.schedule/part/3/paragraph/wrapper5n2 However, the following deferral periods shall apply for the infections...

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.