Public Health (Blood Safety And Quality) Act 2007 (Gibraltar)

Public Health (Blood Safety And Quality) Act 2007

Published: 2008-01-31

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Public Health (Blood Safety and Quality)

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

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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

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2007-06

Public Health (Blood Safety and Quality)

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;

(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;

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;

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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;

(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

(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;

(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

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

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

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;

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

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;

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

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;

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;

(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

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;

(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

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

(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;

(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

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;

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

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

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;

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

(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

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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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

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

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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

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;

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

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

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;

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

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

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;

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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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;

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

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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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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

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

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

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

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

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

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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2007-06

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

Public Health (Blood Safety and Quality)

2007-06

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

(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

(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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2007-06

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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2007-06

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

(d) Death

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2007-06

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

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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2007-06

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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2007-06

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)

Public Health (Blood Safety and Quality)

2007-06

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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2007-06

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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2007-06

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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2007-06

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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2007-06

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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2007-06

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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2007-06

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.