Reg. 8(2) substituted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 5(2)

Reg. 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)

Words 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

http://www.legislation.gov.uk/uksi/2005/50/regulation/8/2018-02-15The Blood Safety and Quality Regulations 2005texttext/xmlenStatute Law DatabaseHEALTH AND SAFETY2024-05-16Expert Participation2018-02-15These 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.Labelling of blood and blood components and traceability8.(1)

A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from outside the European Community, 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.

(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 into the European Community)—

(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.

(3)

The records referred to in sub-paragraph (a) of 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.

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Reg. 8(2) substituted (31.8.2006) by
<ref eId="c4hdem194-00017" href="http://www.legislation.gov.uk/id/uksi/2006/2013">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</ref>
,
<ref eId="c4hdem194-00018" class="subref" href="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1">regs. 1(1)</ref>
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Reg. 8(3)-(6) inserted (31.8.2006) by
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,
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Words in
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inserted (1.5.2008) by
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<p>A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from outside the European Community, shall contain the following information—</p>
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<ins class="substitution first" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">
<noteRef uk:name="commentary" href="#key-603274223b31207ee2c790c1e51f81da" class="commentary"/>
(2)
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">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 into the European Community)—</ins>
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">(a)</ins>
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">records of the information referred to in paragraph (1) above;</ins>
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">(b)</ins>
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">the records referred to in Part A of Part 6 to the Schedule; and</ins>
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<ins class="substitution" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">(c)</ins>
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<ins class="substitution last" ukl:ChangeId="key-603274223b31207ee2c790c1e51f81da-1617050676689" ukl:CommentaryRef="key-603274223b31207ee2c790c1e51f81da">such other records as are necessary to ensure full traceability of blood and blood components and identification of each single donation, unit and component.</ins>
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</level>
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<ins class="first" ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">
<noteRef uk:name="commentary" href="#key-3c16885076450f91c1ffb49f403ad1f6" class="commentary"/>
(3)
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<intro>
<p>
<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">The records referred to in sub-paragraph (a) </ins>
<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">
<ins class="first last" ukl:ChangeId="key-61aaf61399263b4d40a07850180eadd1-1619735301341" ukl:CommentaryRef="key-61aaf61399263b4d40a07850180eadd1">
<noteRef uk:name="commentary" href="#key-61aaf61399263b4d40a07850180eadd1" class="commentary"/>
of paragraph (2)
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<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6"> shall be maintained—</ins>
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<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">(a)</ins>
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<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">in an appropriate and readable storage medium, and</ins>
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<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">(b)</ins>
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<num>
<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">(4)</ins>
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</p>
</content>
</paragraph>
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<num>
<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">(5)</ins>
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<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">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.”.</ins>
</p>
</content>
</paragraph>
<paragraph eId="regulation-8-6">
<num>
<ins ukl:ChangeId="key-3c16885076450f91c1ffb49f403ad1f6-1617050645876" ukl:CommentaryRef="key-3c16885076450f91c1ffb49f403ad1f6">(6)</ins>
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