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The Blood Safety and Quality Regulations 2005
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- UK Statutory Instruments
- 2005 No. 50
- Regulation 8
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Labelling of blood and blood components and traceabilityU.K.
This section has no associated Explanatory Memorandum
8.—(1) A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it [F1 from a third country], shall contain the following information—
(a)the official name of the component;
(b)the volume or weight or number of cells in the component, as appropriate;
(c)a unique numeric or alphanumeric donation indication;
(d)the name of the producing blood establishment;
(e)the ABO Group, except in the case of plasma intended only for fractionation;
(f)the Rh D Group, either Rh D positive or Rh D negative, except in the case of plasma intended only for fractionation;
(g)the date or time of expiry, as appropriate;
(h)the temperature of storage;
(i)the name, composition and volume of any anticoagulant and any additive solution.
[F2(2) A blood establishment shall maintain, in relation to all blood and blood components collected or prepared by it (including blood and blood components which are imported by it [F3from a third country])—
(a)records of the information referred to in paragraph (1) above;
(b)the records referred to in Part A of Part 6 to the Schedule; and
(c)such other records as are necessary to ensure full traceability of blood and blood components and identification of each single donation, unit and component.]
[F4(3) The records referred to in sub-paragraph (a) [F5of paragraph (2)] shall be maintained—
(a)in an appropriate and readable storage medium, and
(b)for a period of not less than 30 years.
(4) A blood establishment shall ensure that the traceability system in place in the blood establishment enables the tracing of blood and blood components to their location and processing stage.
(5) A blood establishment shall have 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 unit of blood or blood component has been delivered.”.
(6) A blood establishment shall ensure, when it issues a unit of blood or blood components for transfusion, that the facility to which the unit of blood is issued has in place a procedure to verify that each unit of blood issued has been transfused to the intended recipient or, if not transfused, to verify its subsequent disposition.]
Textual Amendments
F1Words in reg. 8(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 8(2) substituted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 5(2)
F3Words in reg. 8(2) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Reg. 8(3)-(6) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 5(3)
F5Words in reg. 8(3) inserted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 7
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