Public Health (Blood Safety And Quality) Act 2007

Link to law: http://www.gibraltarlaws.gov.gi/articles/2007-06o.pdf
Published: 2008-01-31

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I ASSENT Public Health (Blood Safety and Quality)
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
2007-06


PUBLIC HEALTH (BLOOD SAFETY AND QUALITY)
ACT 2007

Principal Act

Act. No. 2007-06 Commencement (LN. 2008/003) 31.1.2008
Assent 13.4.2007




Amending
enactments
Relevant current
provisions
Commencement
date

LN. 2011/157 Sch. 4 22.9.2011
2015/221 Sch. 2 31.12.2015


English sources:
None cited

EU Legislation/International Agreements involved:
Directive 2001/83/EC
Directive 2002/98/EC
Directive 2004/33/EC
Directive 2005/61/EC
Directive 2005/62/EC
Directive 2011/38/EU

Public Health (Blood Safety and Quality)
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
2007-06
ARRANGEMENT OF SECTIONS

Section

1. Title and commencement.
2. Interpretation.
3. Designation of the competent authority and application of the Act.
4. Requirement for authorisation.
5. Authorisation of a blood establishment.
6. Suspension or revocation of authorisation.
7. The responsible person for a blood establishment.
8. Blood establishment requirements.
9. Labelling of blood and blood components.
10. Traceability.
11. Verification procedure for issuing blood or blood components.
12. Hospital blood bank requirements.
13. Requirement for hospital blood banks to provide information to the
competent authority.
14. Service of notices relating to hospital blood banks.
15. Quality system standards and specifications.
16. Objections to suspensions, revocations etc.
17. Requirement that facilities retain certain data.
18. Requirement to report serious adverse reactions and events.
19. Import of blood and blood components into Gibraltar.
20. Disclosure of information by blood establishments and hospital
blood banks.
21. Inspection, etc.
22. Authorised persons.
23. Records to be kept by the competent authority.
24. Requirement that the competent authority communicate certain
information to other competent authorities.
25. Offences and penalties.
26. Specific epidemiological situations.
27. Regulations.

SCHEDULE 1
INFORMATION REQUIREMENTS FOR DONORS

SCHEDULE 2
ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND
BLOOD COMPONENTS

SCHEDULE 3
STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR
BLOOD AND BLOOD COMPONENTS

SCHEDULE 4
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QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND
BLOOD COMPONENTS

SCHEDULE 5
NOTIFICATION OF SERIOUS ADVERSE REACTIONS

SCHEDULE 6
NOTIFICATION OF SERIOUS ADVERSE EVENTS

SCHEDULE 7
QUALITY SYSTEM STANDARDS AND SPECIFICATIONS
Public Health (Blood Safety and Quality)
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2007-06
Public Health (Blood Safety and Quality)
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
2007-06
AN ACT TO TRANSPOSE INTO THE LAW OF GIBRALTAR
DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL OF 27 JANUARY 2003 SETTING OUT THE
STANDARDS OF QUALITY AND SAFETY FOR THE COLLECTION,
TESTING, PROCESSING, STORAGE AND DISTRIBUTION OF
HUMAN BLOOD AND BLOOD COMPONENTS AND COMMISSION
DIRECTIVE 2004/33/EC OF 22 MARCH 2004 IMPLEMENTING
DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL AS REGARDS CERTAIN TECHNICAL
REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, AND
COMMISSION DIRECTIVE 2005/61/EC OF 30 SEPTEMBER 2005
IMPLEMENTING DIRECTIVE 2002/98/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL AS REGARDS
TRACEABILITY REQUIREMENTS AND NOTIFICATION OF
SERIOUS ADVERSE REACTIONS AND EVENTS, AND COMMISSION
DIRECTIVE 2005/62/EC OF 30 SEPTEMBER 2005 IMPLEMENTING
DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL AS REGARDS COMMUNITY STANDARDS AND
SPECIFICATIONS RELATING TO A QUALITY SYSTEM FOR BLOOD
ESTABLISHMENTS; AND FOR CONNECTED PURPOSES.


Title and commencement.

1. This Act may be cited as the Public Health (Blood Safety and Quality)
Act 2007 and comes into operation on the day appointed by the Minister for
Health by notice in the Gazette and different days may be appointed for
different purposes.

Interpretation.

2.(1) In this Act, unless the context otherwise requires–

“additive solution” means a solution specifically formulated to maintain
beneficial properties of cellular components during storage;

“allogeneic donation” means blood and blood components collected from
an individual and intended for transfusion to another individual, for
use in medical devices or as starting material or raw material for
manufacturing into medicinal products;

“apheresis” means a method of obtaining one or more blood components
by machine processing of whole blood in which the residual
components of the blood are returned to the donor during or at the
end of the process;

“authorised person” means a person appointed under section 22(1);
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“autologous donation” means blood and blood components collected
from an individual and intended solely for subsequent autologous
transfusion or other human application to that same individual;

“autologous transfusion” means a transfusion in which the donor and the
recipient are the same person and in which pre-deposited blood or
blood components are used;

“biomedical research institution” means any body which carries out
biomedical research;

“blood” means whole human blood collected from a donor and processed
either for transfusion or for further manufacturing;

“blood component” means a therapeutic constituent of human blood (red
cells, white cells, platelets and plasma) that can be prepared by
various methods;

“blood component release” means a process which enables a blood
component to be released from a quarantine status by the use of
systems and procedures to ensure that the finished product meets its
release specification;

“blood establishment” means a person who carries out any of the
activities specified in section 4(2) which requires an authorisation
under section 5;

“blood product” means any therapeutic product derived from human
blood or plasma;

“buffy coat” means a blood component prepared by centrifugation of a
unit of whole blood, and which contains a considerable proportion
of the leucocytes and platelets;

“clinic” means an establishment or a facility that is devoted to the
diagnosis and care of patients and in which services are provided
by qualified health professionals;

“Commission” means the European Commission;

“competent authority” means the competent authority designated under
section 3(1);

“computerised system” means a system including the input of data,
electronic processing and the output of information to be used
either for reporting, automatic control or documentation.
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“Cryopreservation” means prolongation of the storage life of blood
components by freezing;

“Cryoprecipitate” means a plasma component prepared from plasma,
fresh-frozen, by freeze-thaw precipitation of proteins and
subsequent concentration and re-suspension of the precipitated
proteins in a small volume of the plasma;

“deferral” means suspension of the eligibility of an individual to donate
blood or blood components, such suspension being either
permanent or temporary;

“dentist” means a person who is registered as a dentist under the Medical
and Health Act 1997;

“the principal Directive” means Directive 2002/98/EC of the European
Parliament and of the Council of 27 January 2003 setting out the
standards of quality and safety for the collection, testing,
processing, storage and distribution of human blood and blood
components;

“distribution” means the act of delivery of blood and blood components
to other blood establishments, hospital blood banks and
manufacturers of blood products, other than the issuing of blood or
blood components for transfusion;

“doctor” means a person who is a registered medical practitioner within
the meaning of the Medical and Health Act 1997;

“donor carer” means a nurse who by virtue of training and experience in
the care of donors is awarded a certificate of competence by the
Gibraltar Health Authority;

“facilities” means–

(a) a hospital,

(b) any other facility or service owned or managed by the Gibraltar
Health Authority;

(c) a clinic;

(d) a manufacturer; or

(e) a biomedical research institution;

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“Gibraltar Health Authority” means the Authority established by section
3 of the Medical (Gibraltar Health Authority) Act, 1987;

“good practice” means all elements in established practice that
collectively will lead to final blood or blood components that
consistently meet predefined specifications and compliance with
defined regulations;

“granulocytes, apheresis” means a concentrated suspension of
granulocytes obtained by apheresis;

“haemovigilance” means a set of organised surveillance procedures
relating to serious adverse or unexpected events or reactions in
donors or recipients, and the epidemiological follow-up of donors;

“hospital” means any hospital run by the Gibraltar Health Authority or
any other hospital in Gibraltar;

“hospital blood bank” means a unit within a hospital which stores and
distributes, and may perform compatibility tests on, blood and
blood components exclusively for use within hospital facilities,
including hospital based transfusion activities;

“implementing Directives” means Commission Directive 2004/33/EC of
22 March 2004 implementing Directive 2002/98/EC of the
European Parliament and of the Council as regards certain technical
requirements for blood and blood components, and Commission
Directive 2005/61/EC of 30 September 2005 implementing
Directive 2002/98/EC of the European Parliament and of the
Council as regards traceability requirements and notification of
serious adverse reactions and events, and Commission Directive
2005/62/EC of 30 September 2005 implementing Directive
2002/98/EC of the European Parliament and of the Council as
regards Community standards and specifications relating to a
quality system for blood establishments;

“imputability” means the likelihood that a serious adverse reaction in a
recipient can be attributed to the blood or blood component
transfused or that a serious adverse reaction in a donor can be
attributed to the donation process;

“inspection” means formal and objective control to identify problems in
accordance with standards adopted to assess compliance with this
Act;

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“issue” means the provision of blood or blood components by a blood
establishment or a hospital blood bank for transfusion to a
recipient;

“manufacturer” means a person or an entity that manufactures medicinal
products or medical devices;

“medical device” means medical device as defined in Article 1(2)(a) of
Council Directive 1993/42/EEC of 14 June 1993 concerning
medical devices;

“medicinal product” means medicinal products as defined in Directive
2001/83/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to medicinal
products for human use;

“midwife” means a person who is registered as a midwife under the
Medical and Health Act 1997;
“Minister” means the Minister with responsibility for Health;

“mobile site” means a temporary or movable place used for the collection
of blood and blood components which is in a location outside of
but under the control of the blood establishment;

“nurse” means a person who is registered as a nurse under the Medical
and Health Act 1997;

“person responsible for management of a hospital blood bank” means a
person designated by the Gibraltar Health Authority for
management of a hospital blood bank and in the case of a private
clinic or hospital, the owner;

“person responsible for the management of a facility” means–

(a) in the case of a hospital, facility or service which is owned or
managed by the Gibraltar Health Authority, the Gibraltar
Health Authority ;

(b) in the case of a clinic, the owner or manager of the clinic;

(c) in the case of a manufacturer or a biomedical research
institution, the manufacturer or biomedical research institution;

“person responsible for the management of a reporting establishment”
means a blood establishment, the person responsible for the
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management of a facility or the person responsible for the
management of a hospital blood bank;

“Plasma” means the liquid portion of the blood in which the cells are
suspended. Plasma may be separated from the cellular portion of a
whole blood collection for therapeutic use as fresh-frozen plasma
or further processed to cryoprecipitate and cryoprecipitate-depleted
plasma for transfusion. It may be used for the manufacture of
medicinal products derived from human blood and human plasma
or used in the preparation of pooled platelets, or pooled, leucocyte-
depleted platelets. It may also be used for re-suspension of red cell
preparations for exchange transfusion or perinatal transfusion;

“plasma, fresh-frozen” means the supernatant plasma separated from a
whole blood donation or plasma collected by apheresis, frozen and
stored;

“plasma, cryoprecipitate-depleted for transfusion” means a plasma
component prepared from a unit of plasma, fresh-frozen. It
comprises the residual portion after the cryoprecipitate has been
removed;

“platelets, apheresis” means a concentrated suspension of blood platelets
obtained by apheresis;

“platelets, apheresis, leucocyte-depleted” means a concentrated
suspension of blood platelets, obtained by apheresis, and from
which leucocytes are removed;

“platelets, recovered, pooled” means a concentrated suspension of blood
platelets, obtained by processing of whole blood units and pooling
the platelets from the units during or after separation;

“platelets, recovered, pooled, leucocyte-depleted” means a concentrated
suspension of blood platelets, obtained by processing of whole
blood units and pooling the platelets from the units during or after
separation, and from which leucocytes are removed;

“platelets, recovered, single unit” means a concentrated suspension of
blood platelets, obtained by processing of a single unit of whole
blood;

“platelets, recovered, single unit, leucocyte-depleted” means a
concentrated suspension of blood platelets, obtained by processing
of a single whole blood unit from which leucocytes are removed;

Public Health (Blood Safety and Quality)
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“processing” means any step in the preparation of a blood component that
is carried out between the collection of blood and the issuing of a
blood component;

“qualification”, as part of validation, means the action of verifying that
any personnel, premises, equipment or material works correctly and
delivers the expected results;

“qualified health professional” means–

(a) a doctor;

(b) a dentist;

(c) a midwife;

(d) a nurse; or

(e) a donor carer;

“quality assurance” means all the activities from blood collection to
distribution made with the object of ensuring that blood and blood
components are of the quality required for their intended use;

“quality control” means part of a quality system focussed on fulfilling
quality requirements;

“quality management” means the co-ordinated activities to direct and
control an organisation with regard to quality at all levels within the
blood establishment;

“quality system” means the organisational structure, responsibilities,
procedures, processes, and resources for implementing quality
management;

“quarantine” means the physical isolation of blood components or
incoming materials or reagents or both over a variable period of
time while awaiting acceptance, issuance or rejection of the blood
components or incoming materials or reagents or both;

“recipient” means a person who has been transfused with blood or blood
components;

“red cells” means the red cells from a single whole blood donation, with
a large proportion of the plasma from the donation removed;

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“red cells, buffy coat removed” means the red cells from a single whole
blood donation, with a large proportion of the plasma from the
donation removed. The buffy coat, containing a large proportion of
the platelets and leucocytes in the donated unit, is removed;

“red cells, leucocyte-depleted” means the red cells from a single whole
blood donation, with a large proportion of the plasma from the
donation removed, and from which leucocytes are removed;

“red cells in additive solution” means the red cells from a single whole
blood donation, with a large proportion of the plasma from the
donation removed. A nutrient or preservative solution is added;

“red cells, buffy coat removed, in additive solution” means the red cells
from a single whole blood donation, with a large proportion of the
plasma from the donation removed. The buffy coat, containing a
large proportion of the platelets and leucocytes in the donated unit,
is removed. A nutrient or preservative solution is added;

“red cells, leucocyte-depleted, in additive solution” means the red cells
from a single whole blood donation, with a large proportion of the
plasma from the donation removed, and from which leucocytes are
removed. A nutrient or preservative solution is added;

“red cells, apheresis” means the red cells from an apheresis red cell
donation;

“relevant thing” means–

(a) any blood, blood component or blood product; or

(b) any article or substance used in the manufacture, processing or
storage of any blood, blood component or blood product;

“reporting establishment” means the blood establishment, the hospital
blood bank or the facility where the transfusion takes place;

“reporting year” means a period of twelve months ending on 31st March
of any year;

“responsible person" in relation to a blood establishment means the
person who has been designated under section 7 as the responsible
person for that blood establishment;

“serious adverse event” means any untoward occurrence associated with
the collection, testing, processing, storage and distribution of blood
or blood components that might lead to death or life-threatening,
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disabling or incapacitating conditions for patients or which results
in, or prolongs, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response in a donor or in
a patient associated with the collection or transfusion of blood or
blood components that is fatal, life-threatening, disabling or
incapacitating, or which results in or prolongs hospitalisation or
morbidity;

“site”, in relation to a blood establishment, means any premises at which
the blood establishment carries out any of the activities listed in
section 4(2) or any mobile blood collection unit, but shall not
include any premises not owned or managed by the blood
establishment at which blood is collected;

“specification” means a description of the criteria that must be fulfilled in
order to achieve the required quality standard;

“statistical process control” means a method of quality control of a
product or a process that relies on a system of analysis of an
adequate sample size without the need to measure every product of
the process;

“standard” means the requirements that serve as the basis for comparison;

“third country” means a country or territory outside the European
Community;

“traceability” means the ability to trace each individual unit of blood or
blood component derived thereof from the donor to its final
destination, whether this is a recipient, a manufacturer of medicinal
products or disposal, and vice versa;

“trace-back” means the process of investigating a report of a suspected
transfusion-associated adverse reaction in a recipient in order to
identify a potentially implicated donor;

“validation” means the establishment of documented and objective
evidence that the particular or pre-defined requirements for a
specific procedure or process or specific intended use can be
consistently fulfilled;

“washed” means a process of removing plasma or storage medium from
cellular products by centrifugation, decanting of the supernatant
liquid from the cells and addition of an isotonic suspension fluid,
which in turn is generally removed and replaced following further
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centrifugation of the suspension. The centrifugation, decanting,
replacing process may be repeated several times;

“whole blood” means a single blood donation;

“written procedures” means controlled documents that describe how
specified operations are to be carried out.

(2) Any term used in this Act, but not defined, shall be construed in
accordance with the provisions of the principal Directive and the
implementing Directives.

Designation of the competent authority and application of the Act.

3.(1) The Minister is designated the competent authority for the purposes of
this Act.

(2) The competent authority may enter into a contractual arrangement with
a person for the purposes of the person assisting the competent authority to
perform his functions under this Act.

(3) Subject to subsection (4), the requirements of this Act apply to the
collection and testing of blood and blood components, whatever their
intended purpose, and to their processing, storage, and distribution when
they are intended to be used for transfusion.

(4) This Act does not apply to blood stem cells.

Requirement for authorisation.

4.(1) Subject to subsection (3), no person shall carry on any of the activities
listed in subsection (2) otherwise than in accordance with an authorisation
granted under section 5.

(2) The activities referred to in subsection (1) are–

(a) the collection and testing of blood or blood components,
whatever their intended purpose;

(b) the processing, storage and distribution of blood and blood
components when they are intended to be used for transfusion;
and

(c) the import of blood or blood components from a third country.

(3) The restriction in subsection (1) shall not apply to–

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(a) the storage and distribution of, and the performance of
compatibility tests on, blood and blood components exclusively
for use within hospital facilities, including transfusion activities
where such activities are performed by a hospital blood bank;
or

(b) any person carrying out any of the activities referred to in
subsection (2), where that person carries out that activity on
behalf of, or pursuant to a contractual arrangement with–

(i) a blood establishment which is authorised under this Act
to carry out the activity in question, or

(ii) a person responsible for management of a hospital blood
bank; and

(c) the import of blood and blood components from a third country
when undertaken by–

(i) a manufacturer, or

(ii) a person acting on behalf of and pursuant to a contractual
arrangement with a manufacturer,

for the purposes of manufacturing a medicinal product or medical devices.

Authorisation of a blood establishment.

5.(1) The competent authority may grant an authorisation to a blood
establishment to carry out any of the activities referred to in section 4(2).

(2) An application for authorisation under subsection (1) shall be made to
the competent authority.

(3) An application shall–

(a) include the information set out in subsection (4); and

(b) be accompanied by a fee of the amount prescribed by
Regulations.

(4) The information referred to in subsection (3) is–

(a) the name and address of the blood establishment and general
information about its activities which shall include–

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(i) details of each site at which it wishes to carry out any of
the activities referred to in section 4(2),

(ii) a description of the activities which it wishes to carry out
at each site,

(iii) where it has or intends to enter into a contractual
arrangement with any person to carry out any of the
services in respect of which it is seeking authorisation,
the name and address of that person and of the services
which he will carry out,

(iv) the name, qualifications and contact details of the
responsible person for the establishment,

(v) the list of hospital blood banks which it supplies; and

(b) a description of the quality system in place at each site for each
activity in respect of which the application for authorisation is
made, which shall include the following information–

(i) documentation, such as an organisation chart, setting out
the responsibilities of responsible persons and reporting
relationships,

(ii) documentation, such as a site master file or quality
manual, describing the quality system and explaining
how it meets the requirements of Schedule 4,

(iii) details of the number and qualifications of personnel,

(iv) details of hygiene provisions,

(v) details of premises and equipment, and

(vi) a list of standard operating procedures for–

(aa) recruitment, retention and assessment of
donors,

(bb) processing, testing, distribution and recall of
blood and blood components, and

(cc) the reporting and recording of serious adverse
reactions and events.

(5) The competent authority may–
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(a) grant or refuse any application for authorisation made under
subsection (2); and

(b) grant such application–

(i) in respect of particular sites or activities only, and

(ii) subject to conditions.

(6) Where the competent authority grants an application for authorisation,
he shall give notice in writing to the blood establishment specifying–

(a) the activities which the blood establishment may undertake
under this Act at each site in respect of which authorisation is
granted; and

(b) the conditions which apply to the undertaking of those
activities.

(7) Subject to the requirements of subsection (8), the competent authority
may at any time remove or vary any of the conditions referred to in
subsection (5)(b)(ii), or may impose additional conditions.

(8) Where the competent authority removes or varies any condition or
imposes any additional condition under subsection (7), the competent
authority shall serve a notice on the blood establishment in question that
shall–

(a) give details of the conditions which he proposes to remove, or
of the variation which he proposes to make to any existing
conditions, or of any additional condition which he proposes to
impose;

(b) give the reasons for his decision; and

(c) specify the date, which shall be not less than 14 days from the
date on which the notice is served, from which the removal or
variation of any condition, or the imposition of any additional
condition shall apply.

(9) A blood establishment shall not make any substantial change in the
activities that it undertakes without the prior written approval of the
competent authority.

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(10) Any application for approval to make a substantial change in its
activities shall be made in writing to the competent authority, and shall be
accompanied by a fee of the amount prescribed by Regulations.

(11) For the purposes of this section, a substantial change in a blood
establishment's activities is any change–

(a) to the sites from which the blood establishment operates or to
the activities to be carried out at each site;

(b) that would result in breach of this Act or of any condition
specified by the competent authority under this section; or

(c) to the quality system which is likely to have a substantial
impact on the conduct of, or might compromise the safety of,
any of the activities which the blood establishment has been
authorised to undertake under this section.

Suspension or revocation of authorisation.

6.(1) The competent authority may suspend or revoke the authorisation of a
blood establishment on one or more of the following grounds–

(a) that the blood establishment has failed, in any material respect,
to comply with the requirements of this Act;

(b) that the collection, testing, processing, storage or distribution of
blood or blood components by the establishment cannot be
carried out safely;

(c) that any blood or blood components cannot be supplied to
hospital blood banks in such a state that they could be safely
administered for transfusion; or

(d) that the information given by the blood establishment under
section 5(3) was false or incomplete in any material respect.

(2) Subject to subsection (3), before suspending or revoking the
authorisation of a blood establishment, the competent authority shall serve a
notice on the blood establishment stating that he intends to suspend or
revoke its authorisation with effect from the date specified in the notice,
which date shall be not less than 7 days from the date on which the notice is
served.

(3) Where the competent authority considers that it is necessary in the
interests of safety, he may, by a notice served on a blood establishment,
suspend or revoke its authorisation with immediate effect.
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(4) Where–

(a) the blood establishment has failed, in any material respect, to
comply with the requirements of this Act; or

(b) the information given by the blood establishment under section
5(3) was false or incomplete in any material respect,

and the competent authority considers that the failure in question is not
sufficiently serious to warrant suspension or revocation of the authorisation
of the blood establishment in the first instance, he may serve a notice on the
responsible person of the blood establishment in accordance with subsection
(5).

(5) A notice served under this subsection shall–

(a) identify the requirements of the sections of which the blood
establishment is in breach or, in the case of false and
incomplete information, the further information which is
required;

(b) identify the action which the blood establishment is required to
take; and

(c) give the timescale within which the blood establishment shall
take the action identified in paragraph (b).

(6) If the blood establishment fails to comply with the requirements set out
in the notice within the specified time scale, the competent authority may,
by a notice served on the blood establishment, suspend or revoke the
authorisation of the blood establishment.

(7) A suspension or revocation under subsection (6) shall take effect–

(a) in a case where the competent authority considers that it is
necessary in the interests of safety, immediately; or

(b) in all other cases, from a date specified in the notice.

(8) Any suspension under subsections (1) or (6) shall be for such period as
the competent authority shall consider necessary having regard to the
reasons for the suspension.

(9) The suspension or revocation of an authorisation under subsection (1)
or subsection (6) may be total, or may be limited to a particular activity or to
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one or more activities carried out at a particular site or sites, or to a
particular blood component.

The responsible person for a blood establishment.

7.(1) A blood establishment shall designate a person who is responsible for
the following tasks–

(a) ensuring that every unit of blood or blood component that has
been collected or tested for any purpose has been collected and
tested in accordance with the requirements of this Act;

(b) ensuring that every unit of blood or blood components intended
for transfusion has been processed, stored and distributed in
accordance with the requirements of this Act;

(c) providing information to the competent authority relating to the
authorisation of the blood establishment for the purposes of
section 5; and

(d) the implementation in the blood establishment of the
requirements of sections 8, 9 and 15.

(2) A blood establishment shall not designate a person under subsection
(1) unless that person has–

(a) a diploma, certificate or other evidence of formal qualification
in the field of medical or biological sciences awarded on
completion of–

(i) a university course of study, or

(ii) a course recognised as an equivalent course by the
competent authority; and

(b) practical post-graduate experience in areas of work relevant to
the responsibilities of the responsible person under this Act for
at least 2 years, in an establishment (or more than one
establishment) authorised in any Member State to undertake
activities related to the collection or testing (or both) of blood
and blood components, or to their preparation, storage and
distribution.

(3) The competent authority shall from time to time publish details of
courses recognised by him for the purposes of subsection (2)(a)(ii).

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(4) The responsible person may delegate any of the tasks specified in
subsection (1) to other persons who shall be qualified by training and
experience as prescribed by this section to perform them.

(5) Blood establishments shall notify the competent authority of the name
of any persons to whom tasks have been delegated by the responsible person
under subsection (4), and the specific tasks which have been delegated to
such persons.

(6) Where the responsible person or a person to whom tasks have been
delegated under subsection (4) is permanently or temporarily replaced, the
blood establishment shall without delay provide the competent authority
with the name of the replacement, details of his qualifications and the date
on which the replacement began his duties.

(7) If the competent authority considers that the responsible person does
not meet the requirements of subsection (2) or that he is failing to carry out
the tasks specified in subsection (1) adequately or at all, he may serve a
notice to that effect on the blood establishment.

(8) If, within 14 days of receiving a notice in accordance with subsection
(7), a blood establishment is not able to demonstrate to the reasonable
satisfaction of the competent authority that the responsible person does meet
the requirements of subsection (2) or that he is carrying out the tasks
specified in subsection (1) adequately, it shall, without delay–

(a) relieve him of the duties of responsible person in respect of the
establishment;

(b) appoint a new responsible person in his place; and

(c) notify the competent authority that it has appointed a new
responsible person and provide details of the name and
qualifications of the person appointed.

Blood establishment requirements.

8.(1) A blood establishment shall–

(a) ensure that the personnel directly involved in the collection,
testing, processing, storage and distribution of human blood
and blood components for the blood establishment are qualified
to perform those tasks and are provided with timely, relevant
and regularly updated training;

(b) establish and maintain a quality system for blood
establishments based on the principles of good practice, which
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complies with the Community standards and requirements set
out in Schedule 7;

(c) ensure that all testing and processes of the blood establishment
which are referred to in Schedules 1 to 4 are validated;

(d) maintain documentation on operational procedures, guidelines,
training and reference manuals and reporting forms so that they
are readily available for inspection under section 21;

(e) establish and maintain a procedure, which is accurate, efficient
and verifiable, for the withdrawal from distribution of blood or
blood components associated with any notification referred to
in section 18;

(f) ensure that autologous donations comply with the requirements
of this Act; and

(g) retain, for a period of at least 15 years, a record of any serious
adverse events which may affect the quality or safety of blood
and blood components.

(2) A blood establishment shall, in relation to the donation of blood–

(a) give all prospective donors of blood or blood components
information in accordance with Part A of Schedule 1;

(b) obtain from all persons who are willing to provide blood or
blood components, information in accordance with Part B of
Schedule 1;

(c) put and keep in place procedures for the evaluation of donors;

(d) apply eligibility criteria for all donors of blood and blood
components in accordance with Schedule 2;

(e) maintain records of the results of donor evaluations and report
to donors any relevant abnormal findings from the evaluations;

(f) ensure that–

(i) an examination of the donor, including an interview, is
carried out before any donation of blood or blood
components,

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(ii) a qualified health professional is responsible for giving
to and gathering from donors the information which is
necessary to assess their eligibility to donate, and

(iii) on the basis of that information, a qualified health
professional assesses the eligibility of all donors to
donate; and

(g) encourage voluntary and unpaid blood donations with a view to
ensuring that blood and blood components are, in so far as
possible, provided from such donations, in particular, by–

(i) disseminating information about blood donation, and

(ii) advertising for blood donors.

(3) A blood establishment shall ensure that, in relation to the blood and
blood components which it collects, processes, stores or distributes–

(a) each donation of blood and blood components (including blood
and blood components which are imported into the European
Community) is tested in conformity with–

(i) the basic testing requirements for whole blood and
apheresis donations, specified in subsection (7); and

(ii) any additional tests which may be necessary for specific
components, types of donors or epidemiological
situations;

(b) the storage, transport and distribution conditions of blood and
blood components comply with the requirements of Schedule
3; and

(c) quality and safety requirements for blood and blood
components meet the standards specified in Schedule 4.

(4) A blood establishment shall, in relation to the activities specified in
section 4(2) for which it is responsible, maintain records, for a minimum
period of 15 years, of–

(a) the information specified in subsections (5) and (6);

(b) the conduct of the tests referred to in subsection (3)(a).

(5) The information specified in this subsection is–

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(a) the total number of donors who give blood and blood
components;

(b) the total number of donations;

(c) an updated list of the hospital blood banks which it supplies;

(d) the total number of whole donations not used;

(e) the number of each component produced and distributed;

(f) the incidence and prevalence of transfusion transmissible
infectious markers in donors of blood and blood components;

(g) the number of product recalls; and

(h) the number of serious adverse events and serious reactions
reported.

(6) The information specified in this subsection is–

(a) information provided to donors by the blood establishment in
accordance with subsection (2)(a);

(b) information obtained from donors by the blood establishment
in accordance with subsection (2)(b); and

(c) information relating to the suitability of blood and plasma
donors in accordance with the eligibility criteria specified in
Schedule 2.

(7) The basic testing requirements with which blood establishments shall
ensure compliance under subsection (3)(a)(i) are testing–

(a) to establish ABO Group, except in respect of plasma intended
only for fractionation;

(b) to establish Rh D Group, except in respect of plasma intended
only for fractionation; and

(c) for the following infections of donors–

(i) Hepatitis B (HBs-Ag);

(ii) Hepatitis C (Anti-HCV);

(iii) HIV 1 and 2 (Anti-HIV 1 and 2).
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(8) The competent authority may issue guidance as to the additional tests
referred to in subsection (3)(a)(ii) which are necessary in relation to specific
components, types of donor or epidemiological situations and blood
establishments shall have regard to such guidance.

(9) As soon as practicable after the end of the reporting year, each blood
establishment shall provide to the competent authority a report specifying–

(a) the information referred to in subsection (3) for that year; and

(b) details of the steps it has taken during that year to comply with
subsection (2)(g).

Labelling of blood and blood components.

9.(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 subregulation (1);
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(b) the records referred to in section 10(3)(a); 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 subsection (2)(a) shall be maintained–

(a) in an appropriate and readable storage medium; and

(b) for a period of not less than 30 years.

Traceability.

10.(1) A blood establishment shall ensure that–

(a) the labelling system established under this Act is adequate or
appropriate for the purpose of traceability of blood and blood
components;

(b) the traceability system in place enables the tracing of blood
components to their location and processing stage.

(2) Every blood establishment shall ensure that it has–

(a) a system in place 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 blood
component has been delivered; and

(b) a unique identifier that enables it to be precisely linked to each
unit of blood that it has collected and to each blood component
that it has prepared.

(3) Every facility shall ensure that it has a system in place to record each
blood unit or blood component received, whether or not locally processed,
and the final destination of that received unit, whether transfused, discarded
or returned to the distributing blood establishment.

(4) Every blood establishment, hospital blood bank and facility shall retain
the data set out in subsection (5) for at least 30 years in an appropriate and
readable storage medium in order to ensure traceability.

(5) The record of data on traceability required to be retained as referred to
in subsection (4) are as follows–
(a) by blood establishments–
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(i) blood establishment identification,

(ii) blood donor identification,

(iii) blood unit identification,

(iv) individual blood component identification,

(v) date of collection (year/month/day), and

(vi) facilities to which blood units or blood components are
distributed, or subsequent disposition;
(b) by facilities–
(i) blood component supplier identification,

(ii) issued blood component identification,

(iii) transfused recipient identification,

(iv) for blood units not transfused, confirmation of
subsequent disposition,

(v) date of transfusion or disposition (year/month/day), and

(vi) lot number of the component, if relevant.

(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.

Verification procedure for issuing blood or blood components.

11. No blood establishment or hospital blood bank shall issue any units of
blood or blood components for transfusion, unless it has in place a
procedure to verify that each unit issued has been transfused to the intended
recipient or if not transfused to verify its subsequent disposition.

Hospital blood bank requirements.

12.(1) The person responsible for the management of a hospital blood bank
shall–

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(a) ensure that personnel directly involved in the testing, storage
and distribution of human blood and blood components for the
hospital blood bank are qualified to perform those tasks and are
provided with timely, relevant and regularly updated training;

(b) establish and maintain a quality system for the hospital blood
bank which is based on the principles of good practice that
complies with the Community standards and requirements set
out in Schedule 7 insofar as they are applicable to the activities
carried out by the hospital blood bank;

(c) ensure that all processes referred to in Schedule 4 which are
applicable to activities carried out by the hospital blood bank,
are validated;

(d) maintain documentation on operational procedures, guidelines,
training and reference manuals and reporting forms so that they
are readily available for inspection under section 21;

(e) maintain in an appropriate and readable storage medium and
for a period of not less than 30 years–

(i) the data set out in section 10(5) (insofar as those data are
applicable to the activities carried out by the hospital
blood bank), and

(ii) such other data as are needed to ensure full traceability of
blood and blood components and the unique
identification of each unit of blood and each blood
component from the point of receipt of the blood or
blood components by the hospital blood bank;

(f) retain, for a period of not less than 30 years, a record of any
serious events which may affect the quality or safety of blood
or blood components;

(g) establish and maintain a procedure, which is accurate, efficient
and verifiable, for the withdrawal from distribution of blood or
blood components associated with any notification referred to
in section 18;

(h) ensure that the storage, transport and distribution conditions of
blood and blood components by the hospital blood bank
comply with the requirements of Schedule 3; and

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(i) ensure that the traceability system in place in the hospital blood
bank enables the tracing of blood components to their final
destination; and

(j) where it delivers blood or blood components for transfusion at
another facility, have in place a system to uniquely identify the
facility to which a given unit of blood or blood component has
been delivered.

(2) A person responsible for management of a hospital blood bank shall
ensure that when a hospital blood bank issues a unit of blood for
transfusion, that it 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.

Requirement for hospital blood banks to provide information to the
competent authority.

13.(1) On or before the date specified in subsection (2), the person
responsible for management of a hospital blood bank shall submit a report to
the competent authority, which shall–

(a) include a declaration that the hospital blood bank has in place
appropriate systems to ensure compliance with the
requirements of this Act; and

(b) provide details of the systems which it has in place to ensure
such compliance.

(2) The date referred to in subsection (1) is–

(a) in relation to the reporting year ending on 31 st March 2007, 31
st
December 2006;

(b) in relation to each subsequent reporting year, 30 th
April
following the end of that year.

(3) The person responsible for management of a hospital blood bank shall
without delay notify the competent authority of any changes to the matters in
respect of which evidence has been supplied under subsection (1) which
might affect compliance with the requirements of this Act.

Service of notices relating to hospital blood banks.

14.(1) If the competent authority is of the opinion that–

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(a) the person responsible for management of a hospital blood
bank has failed, in any material respect, to comply with the
requirements of this Act; or

(b) the testing, storage or distribution of blood or blood
components by the hospital blood bank is such that any blood
or blood components cannot be safely administered for
transfusion; or

(c) the information given by the person responsible for
management of a hospital blood bank under section 13 was
false or incomplete in any material respect,

he may serve a notice on the person responsible for management of the
hospital blood bank requiring that the hospital blood bank ceases to conduct
any of the activities specified in the notice, or refrains from administering to
patients any blood or blood components specified in the notice, until the
requirements of subsection (4) are met.

(2) Subject to subsection (3), any notice served by the competent authority
under subsection (1) shall specify the date from which the prohibition
specified in the notice shall take effect, which shall be not less than 7 days
from the date on which the notice is served.

(3) Where the competent authority considers that it is necessary in the
interests of safety, he may specify in the notice that the prohibition takes
immediate effect.

(4) The requirements of this subsection are, as may be applicable in each
case, that–

(a) the person responsible for management of the hospital blood
bank is no longer in breach of the requirements of this Act;

(b) the hospital blood bank is able to show that the activity or
product referred to in the notice given under subsection (1)(b)
may be safely carried out or, as the case may be, administered;
or

(c) all necessary information has been supplied to the competent
authority.

Quality system standards and specifications.

15. Every blood establishment shall ensure that the quality system in place
in it complies with the Community standards and specifications set out in
Schedule 7.
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Objections to suspensions, revocations etc.

16.(1) A blood establishment or a person responsible for the management
of a hospital blood bank who–

(a) objects to any suspension or revocation of authorisation, or to
any notice served under section 5(8), 6 or 14; or

(b) objects to the refusal of authorisation or the imposition of any
condition under section 5(5),

may notify the competent authority of its desire to make written
representations to, or to appear before and be heard by, a person appointed
by the competent authority for that purpose.

(2) Any notification of an objection under subsection (1) shall be made
within 14 days of service on the blood establishment or the person
responsible for the management of the hospital blood bank of the notice to
which the notification under subsection (1) relates.

(3) Where the competent authority receives a notification under subsection
(1), he shall appoint a person to consider the matter.

(4) The person appointed under subsection (3) shall–

(a) determine the procedure to be followed with respect to the
consideration of any objection;

(b) consider any written or oral objections made by the blood
establishment or the person responsible for management of the
hospital blood bank in support of its objection; and

(c) make a recommendation to the competent authority.

(5) A recommendation made under subsection (4)(c) shall be made in
writing to the competent authority, and a copy of it shall be sent to the blood
establishment or the person responsible for the management of the hospital
blood bank concerned, or to its nominated representative.

(6) The competent authority shall take into account any recommendation
made under subsection (4).

(7) Within 14 days of receipt of any recommendation made under
subsection (5), the competent authority shall inform the blood establishment
or the person responsible for the management of the hospital blood bank
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whether he accepts the recommendation and, if he does not accept it, of the
reasons for his decision.

(8) Subject to subjection (10), where the competent authority is notified of
an objection under subsection (1)(a) before the date upon which the
suspension or revocation or the notice is due to take effect, the suspension or
revocation or notice in respect of which the objection is made shall not take
effect until–

(a) the person appointed under subsection (3) has considered the
matter in accordance with the provisions of this section and
made a recommendation; and

(b) the competent authority has informed the blood establishment
or the person responsible for the management of the hospital
blood bank concerned of his decision with regard to the
recommendation under subsection (7).

(9) Subject to subsection (10), where the competent authority is notified of
an objection under subsection (1)(a), within the period specified in
subsection (2), to a suspension, revocation or other notice which has already
taken effect on the date the notification was made, the suspension,
revocation or notice in respect of which the objection is made shall cease to
have effect until–

(a) the person appointed under subsection (3) has considered the
matter in accordance with the provisions of this section and
made a recommendation; and

(b) the competent authority has informed the blood establishment
or the person responsible for the management of the hospital
blood bank concerned of his decision with regard to the
recommendation under subsection (7).

(10) Subsections (8) and (9) shall not apply–

(a) in relation to a suspension or revocation, or a notice served
under section 14, which takes immediate effect in accordance
with section 6(3) or 14(3); or

(b) in any other case, where the competent authority determines
that it is necessary in the interests of public safety for the
suspension, revocation or notice to take effect on the date
originally specified, and serves a notice in writing to that effect
on the blood establishment or person responsible for
management of the hospital blood bank concerned.

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Requirement that facilities retain certain data.

17. A person responsible for management of a facility shall ensure that the
facility–

(a) retains the data set out in section 10(3)(b), in an appropriate
and readable storage medium, for a period of at least 30 years;
and

(b) has in place a system in place to record each unit of blood or
blood component received, whether or not locally used, and the
final destination of that received unit whether transfused, used
in the manufacture of medicinal products, discarded or returned
to the blood establishment or hospital blood bank.

Requirement to report serious adverse reactions and events.

18.(1) A person responsible for management of a reporting establishment
shall ensure that the reporting establishment–

(a) has in place procedures to retain the record of transfusions for a
period of at least 30 years;

(b) notifies blood establishments without delay of any serious
adverse reactions observed in recipients during or after
transfusion which may be attributable to the quality or safety of
blood or blood components; and

(c) notifies the competent authority as soon as is known all
relevant information about suspected serious adverse reactions
using the notification formats set out in Part A and Part B of
the Schedule 6.

(2) A person responsible for management of a reporting establishment
shall ensure that the reporting establishment–

(a) notifies the competent authority of all relevant information
about serious adverse reactions of imputability level 2 and 3 as
referred to in Part B of the Schedule 5, which may be
attributable to the quality and safety of blood or blood
components;

(b) notifies the competent authority, as soon as is known, of any
case of transmission of infectious agents by blood or blood
components;

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(c) as part of the notification referred to in paragraph (a), describes
the actions taken with respect to other implicated blood or
blood components that have been distributed for transfusion or
for plasma fractionation;

(d) as soon as is reasonably practicable after each suspected serious
adverse reaction, evaluates that reaction according to the
imputability levels set out in Part B of Schedule 5;

(e) completes the serious adverse reaction notification, upon
conclusion of the investigation, using the format set out in Part
C of Schedule 5; and

(f) submits a complete report to the competent authority on serious
adverse reactions in any calendar year by no later than 1st April
in the following calendar year, using the format set out in Part
D of Schedule 5.

(3) A person responsible for management of a reporting establishment
shall ensure that the reporting establishment notifies the competent authority
as soon as is known, using the notification formats set out in Part A of
Schedule 6, of all relevant information about serious adverse events which
may put in danger donors or recipients other than those directly involved in
the event concerned.

(4) A person responsible for management of a reporting establishment
shall ensure that the reporting establishment–

(a) as soon as is reasonably practicable after each serious adverse
event, evaluates that serious adverse event to identify
preventable causes within the process;

(b) upon completion of the investigation, completes the serious
adverse event notification, using the format set out in Part B of
Schedule 6; and

(c) submits a complete report to the competent authority on
serious adverse reactions in any calendar year by no later than
1st April in the following calendar year, using the format set
out in Part C of Schedule 6.

(5) A facility may make arrangements with a hospital blood bank for the
hospital blood bank to submit to the competent authority or the blood
establishment the reports required by subsection (1)(b) and (c), (2)(a),(b),(e)
and (f) and (3)(b) and(c) on the facility’s behalf, only if either the condition
set out in subsection (6)(a), or the conditions set out in subsection (6)(b) and
(c) are satisfied.
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(6) The conditions referred to in subsection (5) are that–

(a) the person responsible for management of the hospital blood
bank is the same person as the person responsible for
management of the facility with which the arrangement is
made; or

(b) the arrangements referred to in subsection (5) must be–

(i) evidenced by a written agreement, and

(ii) made with the person responsible for management of the
hospital blood bank who supplied the blood or blood
components to the facility for transfusion; and

(c) the facility must supply the information necessary to enable the
hospital blood bank to make the reports within the timescale
specified by this regulation in relation to that report.

Import of blood and blood components into Gibraltar.

19. Any person who imports blood or blood components into Gibraltar
from a third country shall ensure that each unit of blood and each blood
components which he imports

(a) has been prepared in accordance with standards equivalent to
the Community standards and requirements set out in Schedule
7; and

(b) meets standards of quality and safety equivalent to those laid
down in Schedule 4.

Disclosure of information by blood establishments and hospital blood
banks.

20.(1) A blood establishment and the person responsible for management of
a hospital blood bank shall ensure that all information which is collected for
the purposes of this Act is held securely so that it is–

(a) available for the purpose of tracing donations;

(b) not disclosed except–

(i) in accordance with one or more of the requirements of
subsection (2), or

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(ii) where they have been rendered anonymous so that
donors are no longer identifiable;

(c) subject to safeguards against unauthorised additions, deletions
or modifications.

(2) The requirements of this subsection are–

(a) the disclosure is made in accordance with an order of a court or
is otherwise required by law;

(b) the disclosure is to an authorised person appointed by the
competent authority in accordance with section 22(1); or

(c) the disclosure is for the purpose of tracing a donation from
donor to recipient or recipient to donor.

(3) Where a disclosure is made to an authorised person under subsection
(2)(b), the authorised person shall not further disclose the information
received unless–

(a) the disclosure is made in accordance with an order of a court or
is otherwise required by law;

(b) the disclosure is to another officer of the competent authority
where this is necessary for the proper performance of the
authorised person’s or officer's duties; or

(c) the information has been rendered anonymous so that that
donors are no longer identifiable.

(4) Where a disclosure is made by an authorised person to another officer
of the competent authority under subsection (3), that person shall not further
disclose the information he receives other than in accordance with the
requirements of that subsection.

(5) The responsible person of the blood establishment and the person
responsible for management of the hospital blood bank shall ensure that they
put in place a procedure to ensure that any discrepancies relating to data that
are brought to their attention are resolved without delay.

Inspections, etc.

21.(1) The competent authority shall conduct a regular inspection of each
site of a blood establishment, not less than once every two years, for the
purpose of ensuring that–

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(a) blood establishments comply with the requirements of this Act;
and

(b) problems relating to compliance with those requirements are
identified.

(2) The competent authority may conduct such additional inspections of
blood establishments sites as he considers necessary for the purpose of
ensuring compliance with the requirements of this Act.

(3) The competent authority may also serve a notice on a blood
establishment requiring that it furnish him with such information concerning
its compliance with this Act as shall be specified in the notice within such
period as shall be specified in the notice.

(4) Any blood establishment that receives a request or information in
accordance with subsection (3) shall provide the information requested
within the period specified in the notice.

(5) The competent authority may inspect hospital blood banks and
facilities with a view to ensuring that–

(a) hospital blood banks and facilities, and persons responsible for
the management of such blood banks and facilities comply with
the requirements of this Act; and

(b) problems relating to compliance with those requirements are
identified.

(6) The competent authority may also serve a notice on the person
responsible for managing a hospital blood bank or a facility requiring that he
furnish him with such information concerning the compliance of the blood
bank or a facility with this Act as shall be specified in the notice within such
period shall be specified in the notice.

(7) Any person responsible for management of a hospital blood bank or a
facility who receives a request for information in accordance with
subsection (6) shall provide the information requested within the period
specified in the notice.

(8) In the event of any serious adverse event or any serious adverse
reaction or suspicion thereof, the competent authority shall request such
information or conduct such inspections in accordance with this section as
he shall consider appropriate.

(9) Any reference to an inspection of a site which the competent authority
is required or empowered to conduct by virtue of this section, shall be
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construed so as to include an inspection of premises within Gibraltar at
which any of the activities listed in section 4(2) are carried out by any
person on behalf of, and under a contractual arrangement with, a blood
establishment or, as the case may be, a person responsible for management
of a hospital blood bank.

Authorised persons.

22.(1) The Minister may–

(a) appoint such and so many persons as authorised persons as he
thinks necessary for the proper discharge by them of his
functions set out in this Act; and

(b) in appointing such persons, determine such terms and
conditions (including conditions as to remuneration, benefits,
allowances and reimbursement for expenses) as he thinks fit.

(2) For the purposes of enforcing compliance with this Act or conducting
inspections under section 21, the competent authority, or in the case of an
authorised person appointed under subsection (1) upon production of
evidence that such person is so authorised, shall have the right–

(a) at any reasonable hour to enter any premises, other than
premises used only as a private dwelling house, which he has
reason to believe it is necessary for him to visit, including–

(i) any premises owned or managed by a blood
establishment or person responsible for management of a
hospital blood bank, or at which the blood establishment
or person responsible for management of a hospital
blood bank carries out any of the activities referred to in
section 4,

(ii) any premises of any person who carries out any of the
activities referred to in section 4(2) on behalf of, or
pursuant to a contractual arrangement with, a blood
establishment or a person responsible for management of
a hospital blood bank,

(iii) where any facilities for donor evaluation and testing are
in the premises of any person other than a blood
establishment or hospital blood bank, those facilities in
that person's premises; and

(iv) any premises where transfusion of blood or blood
components takes place, or which are owned or managed
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by a person responsible for management of a facility to
which blood or blood components have been delivered;

(b) to carry out at those premises during that visit or inspections,
examinations, tests and analyses as he considers necessary;

(c) to require the production of, and inspect any article or
substance at, the premises;

(d) to require the production of, inspect and take copies of, or
extracts from, any book, document, data or record (in whatever
form it is held) at, or (in the case of computer data or records)
accessible at the premises;

(e) to take possession of any samples for examination and analysis
and any other article, substance, book, document, data, record
(in whatever form they are held) at, or (in the case of computer
data or records) accessible at, the premises;

(f) to question any person whom he finds at the premises and
whom he has reasonable cause to believe is able to give him
relevant information;

(g) to require any person to afford him such assistance as he
considers necessary with respect to any matter within that
person’s control, or in relation to which that person has
responsibilities;

(h) to require, as he considers necessary, any person to afford him
such facilities as he may reasonably require that person to
afford him,

but nothing in this subsection shall be taken to compel the production by any
person of a document of which he would on grounds of legal professional
privilege be entitled to withhold production on an order for disclosure in an
action in the Supreme Court or on an order for production of documents in
an action in the Magistrates’ court.

(3) Where the Stipendiary Magistrate or a justice of the peace is satisfied
by any written information on oath that there are reasonable grounds for
entry into any premises, other than premises used only as a private dwelling
house, for any purpose mentioned in subsection (2), and–

(a) admission to the premises has been refused or is likely to be
refused and notice of intention to apply for a warrant under this
subsection has been given to the occupier;

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(b) an application for admission, or the giving of such notice,
would defeat the object of the entry; or

(c) the premises are unoccupied or the occupier is temporarily
absent and it might defeat the object of the entry to await his
return,

the Stipendiary Magistrate or the justice of the peace may, by warrant signed
by him, which shall continue in force for a period of one month, permit the
authorised person to enter the premises, if need be by force.

(4) An authorised person entering premises by virtue of subsection (2) or
of a warrant under subsection (3) may take with him when he enters those
premises such equipment as may appear to him necessary and any other
person who is also authorised by the competent authority to accompany him
on that visit.

(5) On leaving any premises which an authorised person is permitted to
enter by a warrant under subsection (3), he shall, if the premises are
unoccupied, or the occupier is temporarily absent, leave the premises as
effectively secured against trespassers as he found them.

(6) Where, under subsection (2)(e), an authorised person takes–

(a) possession of any article, substance, book, document, data or
record, he shall leave at the premises with a responsible person,
or if there is no such person present on the premises, leave in
the premises in a prominent position, a statement giving
particulars of the article, substance, book, document, data or
record sufficient to identify it and stating that he has taken
possession of it; and

(b) a sample for analysis, the competent authority may, subject to
the requirements of subsection (7), make such arrangements for
analysis of that sample as he considers appropriate.

(7) The requirements of this subsection are–

(a) that the competent authority shall inform the responsible
person of the blood establishment or person responsible for the
management of the hospital blood bank from which the sample
of relevant thing was taken that he intends to make
arrangements for analysis of the sample, and of the tests which
he intends should be made; and

(b) that if the responsible person or person responsible for the
management of the hospital blood bank so requests, the
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competent authority shall divide the sample of relevant thing of
which an analysis is to be made into three equal parts and deal
with those parts in accordance with the requirements of
subsections (8), (9) and (10).

(8) Subject to subsection (10), where an authorised person takes a sample
of a relevant thing, he shall–

(a) divide the sample into 3 approximately equal parts;

(b) place each part into separate containers; and

(c) forthwith seal and mark each such container in such a manner
as to identify it as part of the sample taken by that authorised
person.

(9) Where an authorised person has complied with subsection (1), he
shall–

(a) offer one of the sealed containers to the owner or person for the
time being in charge or possession of the relevant thing from
which the sample concerned was taken;

(b) retain one of the sealed containers;

(c) forward or caused to be forwarded, one of the sealed containers
for test, examination or analysis.

(10) Where a relevant thing is contained in a container and its division into
parts under subsection (8) is, for whatever reason, not practicable, an
authorised person, who wishes to take samples of such relevant things for
the purposes of any test, examination or analysis, shall take possession of 3
such containers belonging to the same batch, and each such container shall
be deemed to be part of a sample for the purposes of subsection (8), and
subsections (8) and (9) shall apply to it accordingly.

Records to be kept by the competent authority.

23.(1) The competent authority shall keep such records of information
which he receives from, or relating to, blood establishments as he considers
appropriate and shall, in particular, keep records relating to–

(a) authorisations under section 5;

(b) the designation of responsible persons under section 7;

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(c) notification of serious adverse events and serious adverse
reactions by such establishments under section 8(1)(e);

(d) inspections or requests for information under section 21.

(2) The competent authority shall keep such records of information which
he receives from persons responsible for management of hospital blood
banks and facilities, or otherwise relating to hospital blood banks or
facilities, as he considers appropriate and shall, in particular keep records
relating to–

(a) notification of serious adverse events and serious adverse
reactions under section 18;

(b) the information supplied by hospital blood banks under section
13;

(c) inspections or requests for information under section 21.

Requirement that the competent authority communicate certain
information to other competent authorities.

24. The competent authority shall communicate to the competent
authorities of Member States such information as is appropriate with regard
to serious adverse reactions and events in order to guarantee that blood or
blood components known or suspected to be defective are withdrawn from
use and discarded.

Offences and penalties.

25.(1) Any person who contravenes section 4(1), section 8, section 11,
section 12, section 15, section 17, section 18, section 19 or section 26(2)
shall be guilty of an offence.

(2) Any person who contravenes section 5(9), section 7 (other than section
7(3)), section 9, section 13 or section 21(4) or (7) shall be guilty of an
offence

(3) Any person who fails to comply with a notice of suspension or
revocation of his authorisation served under section 6, save where the
operation of that notice has been suspended under section 16, or has been
withdrawn or revoked by the competent authority, shall be guilty of an
offence.

(4) Any person who knowingly sells or supplies blood or any blood
component which is not labelled in accordance with the requirements of
section 9, shall be guilty of an offence.
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(5) Any person who contravenes the requirements of any notice served by
the competent authority under section 14(1), shall be guilty of an offence.

(6) Any person who contravenes section 20 or who discloses any
information referred to in section 20(1) to which they have access by virtue
of this Act, otherwise than in accordance one or more of the requirements
specified in section 20(2) and (3), shall be guilty of an offence.

(7) Subject to subsection (5)–

(a) a person who–

(i) intentionally obstructs an authorised person; or

(ii) without reasonable cause fails to comply with any
requirements made of him by an authorised person, in
circumstances where that authorised person is acting in
pursuance of any of his functions under this Act; or

(b) any person who, in purported compliance with any such
requirement as is mentioned in paragraph (a), intentionally or
recklessly furnishes information which is false or misleading in
a material respect,

shall be guilty of an offence.

(8) Nothing in subsection (7)(a)(ii) shall be construed as requiring any
person to answer any question or give any information if to do so might
incriminate him or, in the case of a person who is married, his spouse.

(9) A person guilty of an offence under subsection (1), (3), (5) or (7) shall
be liable–

(a) on summary conviction to a fine not exceeding level 5 on the
standard scale or to imprisonment for a term not exceeding 3
months, or to both; or

(b) on conviction on indictment, to a fine, or to imprisonment for a
term not exceeding 2 years, or to both.

(10) A person guilty of an offence under subsection (2), (4) or (6) shall be
liable on summary conviction to a fine not exceeding level 4 on the standard
scale, or to imprisonment for a term not exceeding 3 months, or to both.

(11) Where an offence under subsection (1) or (2) is committed by a
person who is employed by the Gibraltar Health Authority or by the Crown,
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the provisions of subsections (9) and (10) shall not apply, and that person
shall be liable to such disciplinary action as the Minister may deem
appropriate.

Specific epidemiological situations.

26.(1) Where the competent authority is aware of a specific epidemiological
situation, such as an outbreak of a disease, which may affect the safety of
blood donations, and as a result of which he considers that specific deferral
criteria for the collection of blood donations should be adopted, he shall–

(a) notify blood establishments that those criteria must be adopted;
and

(b) notify the European Commission of–

(i) the epidemiological situation; and

(ii) the additional deferral criteria which the blood
establishments are required to adopt in relation to it
under paragraph(a).

(2) A blood establishment shall adopt and comply with any criteria for
additional tests notified to them by the competent authority under subsection
(1).

Regulations.

27. The Minister may make Regulations–

(a) prescribing fees to be paid under this Act;

(b) giving effect to or implementing any International Convention,
Protocol or Agreement or any European Union Directive or
Regulations that relate to the subject-matter of this Act; or

(c) providing for generally carrying out the purposes of this Act.
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SCHEDULE 1
Section 8(2)

INFORMATION REQUIREMENTS FOR DONORS

PART A

Information to be provided to prospective donors of blood or blood
components.

1. Accurate educational materials, which are written in terms which can be
understood by members of the general public, about the essential nature of
blood, the blood donation procedure, the components derived from whole
blood and apheresis donations, and the important benefits to patients.

2. For both allogeneic and autologous donations, the reasons for requiring
an examination and health and medical history, and the testing of donations,
and the significance of “informed consent”.

3. For allogeneic donations, the criteria for self-deferral, and temporary and
permanent deferral, and the reasons why individuals are not to donate blood
or blood components if there could be a risk for the recipient.

4. For autologous donations, the possibility of deferral and the reasons why
the donation procedure would not take place in the presence of a health risk
to the individual whether as donor or recipient of the autologous blood or
blood components.

5. Information on the protection of personal data, including confirmation
that there will be no disclosure of the identity of the donor, of information
concerning the donor's health, and of the results of the tests performed, other
than in accordance with the requirements of this Act.

6. The reasons why individuals are not to make donations which may be
detrimental to their health.

7. Specific information on the nature of the procedures involved either in
the allogeneic or autologous donation process and their respective associated
risks. For autologous donations, the possibility that the autologous blood
and blood components may not suffice for the intended transfusion
requirements.


8. Information on the option for donors to change their mind about donating
prior to proceeding further, or the possibility of withdrawing or self-
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deferring at any time during the donation process, without any undue
embarrassment or discomfort.

9. The reasons why it is important that donors inform the blood
establishment of any subsequent event that may render any prior donation
unsuitable for transfusion.

10. Information on the responsibility of the blood establishment to inform
the donor, through an appropriate mechanism, if test results show any
abnormality of significance to the donor’s health.

11. Information as to why unused autologous blood and blood components
will be discarded and not transfused to other patients.

12. Information that test results detecting markers for viruses, such as HIV,
HBV, HCV or other relevant blood transmissible microbiologic agents, will
result in donor deferral and destruction of the collected unit.

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

PART B

Information to be obtained from donors by blood establishments at
every donation

Identification of the donor

14. Personal data uniquely, and without any risk of mistaken identity,
distinguishing the donor, as well as contact details.

Health and medical history of the donor

15. Health and medical history, provided on a questionnaire and through a
personal interview performed by a qualified health professional, that
includes relevant factors that may assist in identifying and screening out
persons whose donation could present a health risk to others, such as the
possibility of transmitting diseases, or health risks to themselves.

Signature of the donor

16. Signature of the donor, on the donor questionnaire, countersigned by the
qualified health professional responsible for obtaining the health history
confirming that the donor has–

(a) read and understood the educational materials provided;

(b) had an opportunity to ask questions;
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(c) been provided with satisfactory responses to any questions
asked;

(d) given informed consent to proceed with the donation process;

(e) been informed, in the case of autologous donations, that the
donated blood and blood components may not be sufficient for
the intended transfusion requirements; and

(f) acknowledged that all the information provided by the donor is
true to the best of his knowledge.
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SCHEDULE 2
Section 8(2)(d), (6)(c)

ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND
BLOOD COMPONENTS

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

Under exceptional circumstances, individual donations from donors who do
not comply with following criteria may be authorised by a qualified
healthcare professional in the blood establishment. All such cases must be
clearly documented and subject to the quality management provisions of
regulations 8 and 21 and Schedule 7 of these Regulations.

The criteria in this subsection do not apply to autologous donations.

1.1 Age and body weight of donors:


Age 18 to 65 years
17 years and over Where, in the opinion of a
qualified health professional,
the donor has sufficient
knowledge and understanding
of what is involved in the
process of blood donation to
give their informed consent, or
otherwise with the written
consent of a person with
parental responsibility.
First time donors
over 60 years
-at the discretion of the doctor
in the blood establishment
Over 65 years -with permission of the doctor
in the blood establishment,
given annually
Body weight ≥ 50 kg for donors either of whole blood or
apheresis blood components

1.2 Haemoglobin levels in donor’s blood

Haemoglobin For females ≥
125 g/1
For males
≥ 135 g/1
Applicable to
allogeneic
donors of whole
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blood and
cellular
components

1.3 Protein levels in donor’s blood

Protein ≥ 60 g/1 The protein analysis for apheresis
plasma donations must be
performed at least annually

1.4 Platelet levels in donor’s blood

Platelets Platelet number greater
than or equal to 150 x
10 9 /1
Level required for
apheresis platelet
donors

DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND
BLOOD COMPONENTS

The tests and deferral periods indicated by an asterisk (*) are not required
when the donation is used exclusively for plasma for fractionation.

2.1 Permanent deferral criteria for donors of allogeneic donations

Cardiovascular disease Prospective donors with active or past
serious cardiovascular disease, except
congenital abnormalities with complete
cure
Central nervous system
disease
A history of serious CNS disease
Abnormal bleeding
tendency
Prospective donors who give a history of
a coagulopathy
Repeated episodes of
syncope, or a history of
convulsions
Other than childhood convulsions or
where at least three years have elapsed
since the date the donor last took
anticonvulsant medication without any
recurrence of convulsions
Gastrointestinal,
Genitourinary,
haematological,
immunological,
Prospective donors with serious active,
chronic, or relapsing disease
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metabolic, renal, or
respiratory system
diseases
Diabetes If being treated with insulin
Infectious diseases Hepatitis B, except for HBsAg-negative
persons who are demonstrated to be
immune
Hepatitis C
HIV - 1 and 2
HTLV I/II
Babesiosis (*)
Kala Azar (visceral leishmaniasis) (*)
Trypanosomiasis cruzi (Chagas' disease)
(*)
Malignant diseases Except in situ cancer with complete
recovery
Transmissible
spongiform
encephalopathies (TSEs)
(e.g. Creutzfeldt Jakob
Disease, variant
Creutzfeldt Jakob
Disease)
Persons who have a family history which
places them at risk of developing a TSE,
or persons who have received a corneal
or dura mater graft, or who have been
treated in the past with medicines made
from human pituitary glands. For variant
Creutzfeldt Jacob disease, further
precautionary measures may be
recommended.
Intravenous (IV) or
intramuscular (IM) drug
use
Any history of non-prescribed IV or IM
drug use, including body-building
steroids or hormones
Xenotransplant recipients
Sexual behaviour Persons whose sexual behaviour puts
them at high risk of acquiring severe
infectious diseases that can be
transmitted by blood

2.2 Temporary deferral criteria for donors of allogeneic donations

2.2.1 Infections

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Duration of deferral period

After an infectious illness, prospective donors shall be deferred for at least
two weeks following the date of full clinical recovery.

However, the following deferral periods shall apply for the infections listed
in the table:

Brucellosis (*) 2 years following the date of full recovery
Osteomyelitis 2 years after confirmed cured
Q fever (*) 2 years following the date of confirmed cure
Syphilis (*) 1 year following the date of confirmed cure
Toxoplasmosis (*) 6 months following the date of clinical
recovery
Tuberculosis 2 years following the date of confirmed cure
Rheumatic fever 2 years following the date of cessation of
symptoms, unless evidence of chronic heart
disease
Fever >38°C 2 weeks following the date of cessation of
symptoms
Flu-like illness 2 weeks after cessation of symptoms
Malaria (*)
- individuals who
have lived in a
malarial area within
the first five years
of life
3 years following return from last visit to any
endemic area, provided person remains
symptom free; may be reduced to 4 months if
an immunologic or molecular genomic test is
negative at each donation.
- individuals with a
history of malaria
3 years following cessation of treatment and
absence of symptoms.
Donations may be accepted thereafter only if
an immunologic or molecular genomic test is
negative
- asymptomic
visitors to endemic
areas
6 months after leaving the endemic area unless
an immunologic or molecular genomic test is
negative
- individuals with a
history of
undiagnosed febrile
3 years following resolution of symptoms;
may be reduced to 4 months if an
immunologic or molecular test is negative
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illness during or
within six months
of a visit to an
endemic area
West Nile Virus
(WNV) (*)
28 days after leaving a risk area of locally
acquired West Nile Virus unless an individual
Nucleic Acid Test (NAT) is negative

2.2.2 Exposure to risk of acquiring a transfusion-transmissible infection

- Endoscopic examination using flexible
instruments,
- mocusal splash with blood or needlestick
injury,
- transfusion of blood components,
- tissue or cell transplant of human origin,
- major surgery,
- tattoo or body piercing,
- acupuncture unless performed by a qualified
practitioner and with sterile single-use
needles,
- persons at risk due to close household
contact with persons with hepatitis B.
Defer 6 months, or
4 months provided
a NAT test for
hepatitis C is
negative
Persons whose behaviour or activity places
them at risk of acquiring infectious diseases
that may be transmitted by blood.
Defer after
cessation of risk
behaviour for a
period determined
by the disease in
question, and by
the availability of
appropriate tests.


2.2.3 Vaccination

Attenuated viruses or bacteria 4 weeks
Inactivated/killed viruses, bacteria
or rickettsiae
No deferral if well
Toxoids No deferral if well
Hepatitis A or hepatitis B
vaccines
No deferral if well and if no
exposure
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Rabies No deferral if well and if no
exposure.
If vaccination is given
following exposure defer for
one year
Tick-borne encephalitis vaccines No deferral if well and if no
exposure

2.2.4 Other temporary deferrals

Pregnancy 6 months after delivery or
termination, except in
exceptional circumstances and
at the discretion of a physician
Minor surgery 1 week
Dental treatment Minor treatment by dentist or
dental hygienist - defer until
next day (NB: Tooth
extraction, root-filling and
similar treatment is considered
as minor surgery)
Medication Based on the nature of the
prescribed medicine, its mode
of action and the disease being
treated

2.3 Deferral for particular epidemiological situations

Particular epidemiological
situations (e.g. disease outbreaks)
Deferral consistent with the
epidemiological situation

2.4 Deferral criteria for donors of autologous donations

Serious cardiac disease Depending on the clinical
setting of the blood collection
Active bacterial infection

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SCHEDULE 3
Sections 8(3)(b), 12(1)(h)

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR
BLOOD AND BLOOD COMPONENTS

1. STORAGE

1.1 Liquid storage

Component Temperature of
storage
Maximum storage time
Red cell preparations
and whole blood (if
used for transfusion as
whole blood)
+2 to +6°C 28 to 49 days according
to the processes used
for collection,
processing and storage
Platelet preparations +20 to +24°C 5 days, may be stored
for 7 days in
conjunction with
detection or reduction
of bacterial
contamination
Granulocytes +20 to +24°C 24 hours

1.2 Cryopreservation

Component Storage conditions and duration
Red blood cells Up to 30 years according to processes
used for collection, processing and
storage
Platelets Up to 24 months according to processes
used for collection, processing and
storage
Plasma and
cryoprecipitate
Up to 36 months according to processes
used for collection, processing and
storage
Cryopreserved red blood cells and platelets must be formulated in
a suitable medium after thawing. The allowable storage period
after thawing to depend on the method used.

2. TRANSPORT AND DISTRIBUTION
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Transport and distribution of blood and blood components at all stages of
the transfusion chain must be under conditions that maintain the integrity of
the product.

3 ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

3.1 Autologous blood and blood components must be clearly identified as
such and stored, transported and distributed separately from allogeneic
blood and blood components.

3.2 Autologous blood and blood components must be labelled as required
by section 9, and, in addition, the label must include the identification of the
donor and the warning “FOR AUTOLOGOUS TRANSFUSION ONLY”.
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SCHEDULE 4

Sections 5(4)(b), 8(3)(c) and 19

QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND
BLOOD COMPONENTS

1. THE BLOOD COMPONENTS

1. Red cell preparations The components listed in points 1.1
to 1.8 may be further processed
within blood establishments and
must be labelled accordingly
1.1 Red cells
1.2 Red cells, buffy coat removed
1.3 Red cells, leucocyte-depleted
1.4 Red cells, in additive solution
1.5 Red cells, buffy coat removed, in
additive solution
1.6 Red cells, leucocyte-depleted, in
additive solution
1.7 Red cells, apheresis
1.8 Whole blood
2. Platelet preparations The components listed in points 2.1
to 2.6 may be further processed
within blood establishments and
must be labelled accordingly
2.1 Platelets, apheresis
2.2 Platelets, apheresis, leucocyte-
depleted
2.3 Platelets, recovered, pooled
2.4 Platelets, recovered, pooled,
leucocyte-depleted
2.5 Platelets, recovered, single unit
2.6 Platelets, recovered, single unit,
leucocyte-depleted
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3. Plasma preparations The components listed in 3.1 to 3.3
may be further processed within
blood establishments and must be
labelled accordingly
3.1 Fresh-frozen plasma
3.2 Fresh-frozen plasma,
cryoprecipitate-depleted
3.3 Cryoprecipitate
4. Granulocytes, apheresis

2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND
BLOOD COMPONENTS

2.1 Blood and blood components must comply with the following technical
quality measurements and meet the acceptable results.

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

2.3 For autologous donations, the measures marked with an asterisk (*) are
recommendations only.


Component Quality measures
required
The required frequency of
sampling for all
measurements shall be
determined using
statistical process control
Acceptable results
for quality
measures
Red cells Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 45g
per unit
Haemolysis Less than 0.8% of
red cell mass at
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end of the shelf
life
Red cells, buffy
coat removed
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 43 g
per unit
Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Red cells,
leucocyte-
depleted
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 40g
per unit
Leucocyte content Less than 1 x 10 6
per unit
Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Red cells, in
additive solution
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 45g
per unit
Haemolysis Less than 0.8% of
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red cell mass at
end of the shelf
life
Red cells, buffy
coat removed, in
additive solution
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 43g
per unit
Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Red cells,
leucocyte-
depleted, in
additive solution
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 40g
per unit
Leucocyte content Less than 1 x 10 6
per unit
Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Red cells,
apheresis
Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis
Haemoglobin (*) Not less than 40g
per unit
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Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Whole blood Volume Valid for storage
characteristics to
maintain product
within
specifications for
haemoglobin and
haemolysis 450ml
+/- 50ml

For paediatric
autologous whole
blood collections -
not to exceed
10.5ml per kg
body weight
Haemoglobin (*) Not less than 45g
per unit
Haemolysis Less than 0.8% of
red cell mass at the
end of the shelf
life
Platelets,
apheresis
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
single donation are
permitted within
the limits that
comply with
validated
preparation and
preservation
conditions
pH Minimum 6.4
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corrected for 22°C,
at the end of the
shelf life
Platelets,
apheresis,
leucocyte-
depleted
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
single donation are
permitted within
the limits that
comply with
validated
preparation and
preservation
conditions
Leucocyte content Less than 1 x 10 6
per unit
pH Minimum 6.4
corrected for 22°C,
at the end of the
shelf life
Platelets,
recovered, pooled
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
pool are permitted
within limits that
comply with
validated
preparation and
preservation
conditions
Leucocyte content Less than 0.2 x 10 9
per single unit
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(platelet-rich
plasma method)

Less than 0.05 x
10 9 per single unit
(buffy coat
method)
pH Minimum 6.4
corrected for 22°C,
at the end of the
shelf life
Platelets,
recovered,
pooled,
leucocyte-
depleted
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
pool are permitted
within limits that
comply with
validated
preparation and
preservation
conditions
Leucocyte content Less than 1 x 10 6
per pool
pH Minimum 6.4
corrected for 22°C,
at the end of the
shelf life
Platelets,
recovered, single
unit
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
single unit are
permitted within
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limits that comply
with validated
preparation and
preservation
conditions
Leucocyte content Less than 0.2 x 10 9
per single unit
(platelet-rich
plasma method)

Less than 0.05 x
10 9 per single unit
(buffy coat
method)
pH Minimum 6.4
corrected for 22°C,
at the end of the
shelf life
Platelets,
recovered, single
unit, leucocyte-
depleted
Volume Valid for storage
characteristics to
maintain product
within
specifications for
pH
Platelet content Variations in
platelet content per
single unit are
permitted within
limits that comply
with validated
preparation and
preservation
conditions
Leucocyte content Less than 1 x 10 6
per unit
pH Minimum 6.4
corrected for 22°C,
at the end of the
shelf life
Plasma, fresh-
frozen
Volume Stated volume +/-
10%
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Factor VIIIc(*) Average (after
freezing and
thawing): 70% or
more of the value
of the freshly
collected plasma
unit
Total protein Not less than 50g/l
Residual cellular
content(*)
Red cells: less than
6.0 x 10 9 /l

Leucocytes: less
than 0.1 x 10 9 /l

Platelets: less than
50 x 10 9 /l
Plasma, fresh-
frozen,
cryoprecipitate-
depleted
Volume Stated volume +/-
10%
Residual cellular
content(*)
Red cells: less than
6.0 x 10 9 /l

Leucocytes: less
than 0.1 x 10 9 /l

Platelets: less than
50 x 10 9 /l
Cryoprecipitate Fribrinogen content(*) Greater than or
equal to 140mg
per unit
Fractor VIIIc content (*) Greater than or
equal to 70
international units
per unit
Granulocytes,
apheresis
Volume Less than 500ml
Granulocyte content Greater than 1 x
10 10
granulocytes
per unit

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SCHEDULE 5
Section 18
NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A
Rapid notification format for suspected serious adverse reactions

Reporting establishment

Report identification

Reporting date (year/month/day)

Date of transfusion (year/month/day)

Age and sex of recipient

Date of serious adverse reaction (year/month/day)

Serious adverse reaction is related to-

(a) Whole blood

(b) Red blood cells

(c) Platelets

(d) Plasma

(e)Other (specify).
Type of serious adverse reaction(s)-

(a) Immunological haemolysis due to ABO incompatibility

(b) Immunological haemolysis due to other allo-antibody

(c) Non-immunological haemolysis

(d) Transfusion-transmitted bacterial infection

(e) Anaphylaxis/hypersensitivity

(f) Transfusion related acute lung injury

(g)Transfusion-transmitted viral infection (HBV)

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(h) Transfusion-transmitted viral infection (HCV)

(i)Transfusion-transmitted viral infection (HIV-1/2)

(j) Transfusion-transmitted viral infection, Other (specify)

(k) Transfusion-transmitted parasitical infection (Malaria)

(l) Transfusion-transmitted parasitical infection, Other (specify)

(m) Post-transfusion purpura

(n) Graft versus host disease

(o)Other serious reaction(s) (specify)


Imputability level (NA, 0-3)


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PART B
Serious adverse reactions — imputability levels

Imputability levels to assess serious adverse reactions.

Imputability
level
Explanation
NA Not
assessable
When there is insufficient data for imputability
assessment.

0 Unlikely When there is conclusive evidence beyond
reasonable doubt for attributing the adverse
reaction to alternative causes.

Unlikely When the evidence is clearly in favour of
attributing the adverse reaction to causes other
than the blood or blood components.

1 Possible When the evidence is indeterminate for
attributing adverse reaction either to the blood
or blood component or to alternative causes.

2 Likely,
Probable
When the evidence is clearly in favour of
attributing the adverse reaction to the blood or
blood component.

3 Certain When there is conclusive evidence beyond
reasonable doubt for attributing the adverse
reaction to the blood or blood component.


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PART C
Confirmation format for serious adverse reactions

Reporting establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Confirmation of serious adverse reaction (Yes/No)

Imputability level (NA, 0-3)

Change of type of serious adverse reaction (Yes/No)

If Yes, specify

Clinical outcome (if known)-

(a) Complete recovery

(b) Minor sequelae

(c) Serious sequelae

(d) Death


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PART D

Annual notification format for serious adverse reactions
________________________________________________________
Reporting establishment
________________________________________________________
Reporting period
This Table refers to

[] Whole blood
[] Red blood cells
[] Platelets
[] Plasma
[] Other

(use separate table for
each component)
Number of units issued (total number of units issued with a given
number of blood components)
Number of recipients transfused (total number of recipients
transfused with a given number of blood components) (if
available)
Number of units transfused (the total number of blood
components (units) transfused over the reporting period) (if
available)
Total
number
reported

Number of serious adverse reactions with
imputability level 0 to 3 after confirmation (see
Part A of this Schedule) Number
of deaths
not
assessable
Level
0
Level
1
Level
2
Level
3
Immunological
Haemolysis
Due to ABO
incompatability
Total
Deaths
Due to other
allo-antibody
Total
Deaths
Non-immunological haemolysis Total
Deaths
Transfusion-transmitted bacterial
infection
Total
Deaths
Anaphylaxis/hypersensitivity Total
Deaths
Transfusion related acute lung injury Total
Deaths
Transfusion-transmitted
viral infection
HBV Total
Deaths
HCV Total
Deaths
HIV-1/2 Total
Deaths
Other
(specify)
Total
Deaths
Transfusion-transmitted
parasitical infection
Malaria Total
Deaths
Other
(specify)
Total
Deaths
Post-transfusion purpura Total
Deaths
Graft versus host disease Total
Deaths
Other serious reactions (specify) Total
Deaths


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SCHEDULE 6
Section 18
NOTIFICATION OF SERIOUS ADVERSE EVENTS
PART A
Rapid notification Format for Serious Adverse Events

________________________________________________________
Reporting establishment
________________________________________________________
Reporting identification
________________________________________________________
Reporting date (year/month/day)
________________________________________________________
Date of serious adverse event (year/month/day)
Serious adverse
event, which may
affect quality and
safety of blood
component due to a
deviation in:
Specification Product
defect
Equipment
failure
Human
error
Other
(specify)
Whole blood
collection

Aspheresis
collection

Testing of
donations

Processing
Storage
Distribution
Materials
Others (specify)

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PART B

Confirmation Format for Serious Adverse Events
________________________________________________________
Reporting establishment
________________________________________________________
Reporting identification
________________________________________________________
Confirmation date (year/month/day)
________________________________________________________
Date of serious adverse event (year/month/day)
________________________________________________________
Root cause analysis (details)
________________________________________________________
Corrective measures taken (details)
________________________________________________________
PART C

Annual Notification Format for Serious Adverse Events

Reporting establishment
Reporting period 1 January – 31 December (year)
Total number of blood components processed:
Serious adverse
event, which may
affect quality and
safety of blood
component due to a
deviation in:
Total
number
Specification Product
defect
Equipment
failure
Human
error
Other (specify)
Whole blood
collection

Apheresis
collection

Testing of
donations

Processing
Storage
Distribution
Materials
Others (specify)


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SCHEDULE 7
Sections 12(1)(b) and 15
QUALITY SYSTEM STANDARDS AND SPECIFICATIONS
1. INTRODUCTION AND GENERAL PRINCIPLES
1.1. Quality system
1. Quality shall be recognised as being the responsibility of all
persons involved in the processes of the blood establishment
with management ensuring a systematic approach towards
quality and the implementation and maintenance of a quality
system.

2. The quality system encompasses quality management, quality
assurance, continuous quality improvement, personnel,
premises and equipment, documentation, collection, testing and
processing, storage, distribution, quality control, blood
component recall, and external and internal auditing, contract
management, nonconformance and self-inspection.

3. The quality system shall ensure that all critical processes are
specified in appropriate instructions and are carried out in
accordance with the standards and specifications set out in this
Schedule. Management shall review the system at regular
intervals to verify its effectiveness and introduce corrective
measures if deemed necessary.

1.2. Quality assurance
1. All blood establishments and hospital blood banks shall be
supported by a quality assurance function, whether internal or
related, in fulfilling quality assurance. That function shall be
involved in all quality-related matters and review and approve
all appropriate quality related documents.

2. All procedures, premises, and equipment that have an influence
on the quality and safety of blood and blood components shall
be validated prior to introduction and be re-validated at regular
intervals determined as a result of these activities.

2. PERSONNEL AND ORGANISATION
1. Personnel in blood establishments shall be available in
sufficient numbers to carry out the activities related to the
collection, testing, processing, storage and distribution of blood
and blood components and be trained and assessed to be
competent to perform their tasks.

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2. All personnel in blood establishments shall have up to date job
descriptions which clearly set out their tasks and
responsibilities. Blood establishments shall assign the
responsibility for processing management and quality
assurance to different individuals and who function
independently.

3. All personnel in blood establishments shall receive initial and
continued training appropriate to their specific tasks. Training
records shall be maintained. Training programmes shall be in
place and shall include good practice.

4. The contents of training programmes shall be periodically
assessed and the competence of personnel evaluated regularly.

5. There shall be written safety and hygiene instructions in place
adapted to the activities to be carried out and are in compliance
with section 6 of the Factories Act and the Management of
Health and Safety at Work Regulations 1996 and the Factories
(Protection of Workers from Risks Related to Exposure to
Biological Agents at Work) Regulations 2006.

3. PREMISES
3.1. General
Premises including mobile sites shall be adapted and maintained to suit the
activities to be carried out. They shall enable the work to proceed in a
logical sequence so as to minimise the risk of errors, and shall allow for
effective cleaning and maintenance in order to minimise the risk of
contamination.

3.2. Blood donor area
There shall be an area for confidential personal interviews with and
assessment of individuals to assess their eligibility to donate. This area shall
be separated from all processing areas.
3.3. Blood collection area
Blood collection shall be carried out in an area intended for the safe
withdrawal of blood from donors, appropriately equipped for the initial
treatment of donors experiencing adverse reactions or injuries from events
associated with blood donation, and organised in such a way as to ensure the
safety of both donors and personnel as well as to avoid errors in the
collection procedure.

3.4. Blood testing and processing areas
There shall be a dedicated laboratory area for testing that is separate from
the blood donor and blood component processing area with access restricted
to authorised personnel.
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3.5. Storage area
1. Storage areas shall provide for properly secure and segregated
storage of different categories of blood and blood components
and materials including quarantine and released materials and
units of blood or blood components collected under special
criteria (e.g. autologous donation).

2. Provisions shall be in place in the event of equipment or power
failure in the main storage facility.

3.6. Waste disposal area
An area shall be designated for the safe disposal of waste, disposable items
used during the collection, testing, and processing and for rejected blood or
blood components.

4. EQUIPMENT AND MATERIALS
1. All equipment shall be validated, calibrated and maintained to
suit its intended purpose. Operating instructions shall be
available and appropriate records kept.

2. Equipment shall be selected to minimise any hazard to donors,
personnel, or blood components.

3. Only reagents and materials from approved suppliers that meet
the documented requirements and specifications shall be used.
Critical materials shall be released by a person qualified to
perform this task. Where relevant, materials, reagents and
equipment.

4. Inventory records shall be retained for a period acceptable to
and agreed with the competent authority.

5. When computerised systems are used, software, hardware and
back-up procedures must be checked regularly to ensure
reliability, be validated before use, and be maintained in a
validated state. Hardware and software shall be protected
against unauthorised use or unauthorised changes. The back-up
procedure shall prevent loss of or damage to data at expected
and unexpected down times or function failures.

5. DOCUMENTATION
1. Documents setting out specifications, procedures and records
covering each activity performed by the blood establishment
shall be in place and kept up to date.

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2. Records shall be legible and may be handwritten, transferred to
another medium such as microfilm or documented in a
computerised system.

3. All significant changes to documents shall be acted upon
promptly and shall be reviewed, dated and signed by a person
authorised to perform this task.

6. BLOOD COLLECTION, TESTING AND PROCESSING
6.1. Donor eligibility
1. Procedures for safe donor identification, suitability interview
and eligibility assessment shall be implemented and
maintained. They shall take place before each donation and
comply with the requirements set out in Part B of Schedule 1
and Schedule 2 of this Act.

2. The donor interview shall be conducted in such a way as to
ensure confidentiality.

3. The donor suitability records and final assessment shall be
signed by a qualified health professional.

6.2. Collection of blood and blood components
1. The blood collection procedure shall be designed to ensure that
the identity of the donor is verified and securely recorded and
that the link between the donor and the blood, blood
components and blood samples is clearly established.

2. The sterile blood bag systems used for the collection of blood
and blood components and their processing shall be CE-
marked or comply with equivalent standards if the blood and
blood components are collected in third countries. The batch
number of the blood bag shall be traceable for each blood
component.

3. Blood collection procedures shall minimise the risk of
microbial contamination.

4. Laboratory samples shall be taken at the time of donation and
appropriately stored prior to testing.

5. The procedure used for the labelling of records, blood bags and
laboratory samples with donation numbers shall be designed to
avoid any risk of identification error and mix-up.

6. After blood collection, the blood bags shall be handled in a way
that maintains the quality of the blood and at a storage and
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transport temperature appropriate to further processing
requirements.

7. There shall be a system in place to ensure that each donation
can be linked to the collection and processing system into
which it was collected and/or processed.

6.3. Laboratory testing
1. All laboratory testing procedures shall be validated before use.

2. Each donation shall be tested in conformity with the
requirements specified in section 8(7) of this Act.

3. There shall be clearly defined procedures to resolve discrepant
results and ensure that blood and blood components that have a
repeatedly reactive result in a serological screening test for
infection with the viruses mentioned in section 8(7) of this Act
shall be excluded from therapeutic use and be stored separately
in a dedicated environment. Appropriate confirmatory testing
shall take place. In case of confirmed positive results,
appropriate donor management shall take place including the
provision of information to the donor and follow-up
procedures.

4. There shall be data confirming the suitability of any laboratory
reagents used in the testing of donor samples and blood
component samples.

5. The quality of the laboratory testing shall be regularly assessed
by the participation in a formal system of proficiency testing,
such as an external quality assurance programme.

6. Blood group serology testing shall include procedures for
testing specific groups of donors (e.g. first time donors, donors
with a history of transfusion).

6.4. Processing and validation
1. All equipment and technical devices shall be used in
accordance with validated procedures.

2. The processing of blood components shall be carried out using
appropriate and validated procedures including measures to
avoid the risk of contamination and microbial growth in the
prepared blood components.

6.5. Labelling
1. At all stages, all containers shall be labelled with relevant
information of their identity. In the absence of a validated
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computerised system for status control, the labelling shall
clearly distinguish released from non-released units of blood
and blood components.

2. The labelling system for the collected blood, intermediate and
finished blood components and samples must unmistakably
identify the type of content, and comply with the labelling and
traceability requirements referred to in sections 9 and 10 of this
Act. The label for a final blood component shall comply with
the requirements of section 9(1) of this Act.
3. For autologous blood and blood components, the label also
shall comply with section 8(1)(g) and Schedule 1 of this Act
and the additional requirements for autologous donations
specified in Schedule 3 of this Act.

6.6. Release of blood and blood components
1. There shall be a safe and secure system to prevent each single
blood and blood component from being released until all
mandatory requirements set out in this Act have been fulfilled.
Each blood establishment shall be able to demonstrate that
each blood or blood component has been formally released by
an authorised person. Records shall demonstrate that before a
blood component is released, all current declaration forms,
relevant medical records and test results meet all acceptance
criteria.

2. Before release, blood and blood components shall be kept
administratively and physically segregated from released blood
and blood components. In the absence of a validated
computerised system for status control the label of a unit of
blood or blood component shall identify the release status in
accordance with paragraph 6.5.1 of this Schedule.

3. In the event that the final component fails release due to a
confirmed positive infection test result, in conformity with the
requirements set out in paragraphs 6.3.2 and 6.3.3 of this
Schedule, a check shall be made to ensure that other
components from the same donation and components prepared
from previous donations given by the donor are identified.
There shall be an immediate update of the donor record.

7. STORAGE AND DISTRIBUTION
1. The quality system of the blood establishment shall ensure that,
for blood and blood components intended for the manufacture
of medicinal products, the storage and distribution
requirements shall comply with Directive 2003/94/EC.

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2. Procedures for storage and distribution shall be validated to
ensure blood and blood component quality during the entire
storage period and to exclude mix-ups of blood components.
All transportation and storage actions, including receipt and
distribution, shall be defined by written procedures and
specifications.

3. Autologous blood and blood components as well as blood
components collected and prepared for specific purposes shall
be stored separately.

4. Appropriate records of inventory and distribution shall be kept.

5. Packaging shall maintain the integrity and storage temperature
of blood or blood components during distribution and
transportation.

6. Return of blood and blood components into inventory for
subsequent reissue shall only be accepted when all quality
requirements and procedures laid down by the blood
establishment to ensure blood component integrity are fulfilled.

8. CONTRACT MANAGEMENT
Tasks that are performed externally shall be defined in a specific written
contract.

9. NON-CONFORMANCE
9.1. Deviations
Blood components deviating from required standards set out in Schedule 4
shall be released for transfusion only in exceptional circumstances and with
the recorded agreement of the prescribing physician and the blood
establishment physician.

9.2. Complaints
All complaints and other information, including serious adverse reactions
and serious adverse events, which may suggest that defective blood
components have been issued, shall be documented, carefully investigated
for causative factors of the defect and, where necessary, followed by recall
and the implementation of corrective actions to prevent recurrence.
Procedures shall be in place to ensure that the competent authorities are
notified as appropriate of serious adverse reactions or serious adverse events
in accordance with regulatory requirements.

9.3. Recall
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1. There shall be personnel authorised within the blood
establishment to assess the need for blood and blood
component recall and to initiate and coordinate the necessary
actions.

2. An effective recall procedure shall be in place, including a
description of the responsibilities and actions to be taken. This
shall include notification to the competent authority.

3. Actions shall be taken within pre-defined periods of time and
shall include tracing all relevant blood components and, where
applicable, shall include trace-back. The purpose of the
investigation is to identify any donor who might have
contributed to causing the transfusion reaction and to retrieve
available blood components from that donor, as well as to
notify consignees and recipients of components collected from
the same donor in the event that they might have been put at
risk.

9.4. Corrective and preventive actions
1. A system to ensure corrective and preventive actions on blood
component non-conformity and quality problems shall be in
place.

2. Data shall be routinely analysed to identify quality problems
that may require corrective action or to identify unfavourable
trends that may require preventive action.

3. All errors and accidents shall be documented and investigated
in order to identify system problems for correction.

10. SELF-INSPECTION, AUDITS AND IMPROVEMENTS
1. Self-inspection or audit systems shall be in place for all parts of
the operations to verify compliance with the standards set out
in this Schedule. They shall be carried out regularly by trained
and competent persons in an independent way according to
approved procedures.

2. All results shall be documented and appropriate corrective and
preventive actions shall be taken in a timely and effective
manner.