272 tal-2006 - Regolamenti tal-2006 dwar il-Kwalità u s-Sigurezza tad-Demm

L.N. 272 of 2006

HUMAN BLOOD AND TRANSPLANTS ACT, 2006

(ACT NO. IV OF 2006)

Blood (Quality and Safety) Regulations, 2006

BY virtue of article 16 of the Human Blood and Transplants Act,

2006, the Minister for Health, the Elderly and Community Care, after

consultation with the Licensing Authority, has made the following

regulations>-

(1) The title of these regulations is the Blood (Quality and Title and scope.

Safety) Regulations, 2006.

(2) The scope of these regulations is to transpose the

European Parliament and Council Directives 2002#98#EC of the of 27th

January, 2003 setting standards of quality and safety for the collection,

testing, processing, storage and distribution of human blood and blood

components and 2004#33#EC of the 22nd 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 2005#62#EC implementing Directive 2002#98#EC of

European Parliament and of the Council as regards Community

Standards and specifications relating to a quality system for blood

establishments.

In these regulations unless the context otherwise requires >

Interpretation.

“the Act” means the Human Blood and Transplants Act, 2006<

“autologous transfusion” means transfusion in which the

donor and the recipient are the same person and in which pre-

deposited blood and blood components are used<

“blood” means whole blood collected from a donor and

processed either for transfusion or for further manufacturing<

“blood component” means a therapeutic constituent of blood

(red cells, white cells, platelets, 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 any structure or body that is

responsible for any aspect of the collection and testing of human

blood or blood components, whatever their intended purpose, and

their processing, storage, and distribution when intended for

transfusion. This does not include hospital blood banks<

“blood product” means any therapeutic product derived from

human blood or plasma<

“deferral” means suspension of the eligibility of an individual

to donate blood or blood components, such suspension being either

permanent or temporary<

“distribution” means the act of delivery of blood and blood

components to other blood establishments, hospital blood banks

and manufacturers of blood and plasma derived products. It does

not include the issuing of blood or blood components for

transfusions<

“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 blood bank” means a hospital unit 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<

“inspection” means formal and objective control to identify

problems in accordance with standards adopted to assess

compliance with these regulations<

“qualified health professional” includes a doctor and a nurse<

“serious adverse event” means any untoward occurrence

associated with the collection, testing, processing, storage, and

distribution, of blood and blood components that might lead to

death or life-threatening, disabling or incapacitating conditions for

patients or which results in, or prolongs, hospitalisation or

morbidity<

“serious adverse reaction” means an unintended response in

donor or in patient associated with the collection or transfusion of

blood and blood components that is fatal, life-threatening, disabling,

incapacitating, or which results in, or prolongs, hospitalisation or

morbidity.

An application for a licence to operate a blood establishment Information on

application.

shall include all the information referred to under Annex I to Directive

2002#98#EC and any amendments thereto.

(1) A blood establishment shall designate a person who is Responsible person.

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 these regulations<

(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 these regulations<

(c) providing information to the Authority relating to the

licence of the blood establishment for the purposes of regulation 3

of these regulations< and

(d) the implementation in the blood establishment of the

requirements of articles 10,11, 12, 13, 14 and 15 of the Act.

(2) A blood establishment shall not designate a person as a

responsible person 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

Authority < and

(b) practical post-graduate experience in areas of work

relevant to the responsibilities of the responsible person under these

regulations for at least two years, in one or more establishments

licenced in any Member State to undertake activities related to the

collection and, or testing of blood and blood components, or to

their preparation, storage and distribution.

(3) The responsible person may delegate any of the tasks

specified in sub-regulation (1) to other persons who shall be qualified

by training and experience to perform them.

(4) Blood establishments shall notify the Authority of the

name of any persons to whom tasks have been delegated by the

responsible person under sub-regulation (4), and the specific tasks which

have been delegated to such persons.

(5) Where the responsible person or a person to whom tasks

have been delegated under sub-regulation (4) is permanently or

temporarily replaced, the blood establishment shall immediately provide

the Authority with the name of the replacement, details of his

qualifications and the date on which the replacement began his duties.

(6) If the Authority considers that the responsible person

does not meet the requirements of sub-regulation (2), he may serve a

notice to that effect on the blood establishment.

(7) If, within 14 days of receiving a notice in accordance

with sub-regulation (7), a blood establishment is not able to

demonstrate to the reasonable satisfaction of the Authority that the

responsible person does meet the requirements of sub-regulation (2),

it shall, without delay -

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

of the establishment<

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

(c) notify the Authority that it has appointed a new

responsible person and provide details of the name and

qualifications of the person appointed.

(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 laid down in the Annexes to Directive 2005#62#EC

implementing Directive 2002#98#EC of the European Parliament

and the Council as regards Community Standards and specifications

relating to a quality system for Blood Establishments<

(c) ensure that all testing and processes of the blood

establishment which are referred to in Annexes II and V to Directive

2004#33#EC are validated<

(d) maintain documentation on operational procedures,

guidelines, training and reference manuals and reporting forms so

that they are readily available for inspection<

(e)

notify the Authority of -

(i) any serious adverse events related to the collection,

testing, processing, storage and distribution of blood and blood

components by the blood establishment which may have an

influence on their quality and safety, and

(ii) any serious adverse reactions observed during or

after transfusion which may be attributable to the quality or

safety of blood or blood components collected, tested,

processed, stored or distributed by the blood establishment<

and

(f) 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 paragraph (e) hereof.

(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 Annex II to Directive

2004#33#EC and any amendments thereto<

(b) obtain from all persons who are willing to provide blood

or blood components, information in accordance with Part B of

Annex II to Directive 2004#33#EC and any amendments thereto<

(c)

put and keep in place procedures for the evaluation of

donors<

(d) apply eligibility criteria for all donors of blood and blood

components in accordance with Annex III to Directive 2004#33#EC

and any amendments thereto<

(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,

(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.

(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 the requirements listed

in Annex IV to Directive 2002#98#EC and any amendments thereto<

(b) the storage, transport and distribution conditions of blood

and blood components comply with the requirements of Annex

IV to Directive 2004#33#EC and any amendments thereto< and

(c) quality and safety requirements for blood and blood

components meet the standards specified in Annex V to Directive

2004#33#EC and any amendments thereto.

(4) A blood establishment shall, in relation to the

information required by Annexes II and IV to Directive 2002#98#EC

and Annexes II Part A and Part B and Annex III to Directive 2004#33#EC,

maintain records, for a minimum period of 15 years.

(5) As soon as practicable after the end of the reporting year,

each blood establishment shall provide to the Authority a report

specifying>-

(a) the information referred to in sub-regulation (3) for that

year< and

(b) details of the steps it has taken during that year to comply

with the provisions of paragraph (g) of sub-regulation (2) hereof.

(1) A blood establishment shall ensure that the label on each Labelling and

traceability of blood

unit of blood or blood component supplied by it, or imported by it from and blood

outside the European Community, shall contain all the information components.

referred to under Annex III to Directive 2002#98#EC and any

amendments thereto.

(2) A blood establishment shall, for a period of not less than

30 years, keep such records of the information referred to in sub-

regulation (1) hereof and such additional records as are necessary -

(a) for the identification of each single blood donation and

each single blood unit and its components, including blood and

blood components which are imported into the European

Community< and

(b) to ensure full traceability to the point of delivery to a

hospital.

(1) The person responsible for the management of a hospital Hospital Blood

Banks.

blood bank shall -

(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<

(c) ensure that all processes referred to in Annex IV to

Directive 2004#33#EC and any amendments thereto, which are

applicable to activities carried out by the hospital blood bank, are

validated<

(d) maintain documentation on operational procedures,

guidelines, training and reference manuals and reporting forms so

that they are readily available for inspection<

(e) maintain, for not less than 30 years, the data needed to

ensure full traceability of blood and blood components, from the

point of receipt of the blood or blood component by the hospital

blood bank<

(f) notify the Authority and the blood establishment from

whom the blood and blood components were procured of -

(i) any serious adverse events related to the testing,

storage and distribution of blood and blood components by

the hospital blood bank which may have an influence on their

quality and safety, and

(ii) any serious adverse reactions observed during or

after transfusion which may be attributable to the quality or

safety of blood or blood components issued for transfusion

by the hospital blood bank<

(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 paragraph (f) hereof< and

(h) ensure that the storage, transport and distribution

conditions of blood and blood components by the hospital blood

bank comply with the requirements of Annex IV to Directive

2004#33#EC and any amendments thereto.

(1) As soon as practicable after the end of the reporting year,

the person responsible for management of a hospital blood bank shall

submit an annual report to the Authority, which shall -

(a) include a declaration that the hospital blood bank has in

place appropriate systems to ensure compliance with the

requirements of these regulations< and

(b) provide details of the systems which it has in place to

ensure such compliance.

(2) The person responsible for management of a hospital

blood bank shall without delay notify the Authority of any changes to

the matters in respect of which evidence has been supplied pursuant to

sub-regulation (1) which might affect compliance with the requirements

of these regulations.

(1) A blood establishment and the person responsible for Data protection and

confidentiality.

management of a hospital blood bank shall ensure that all information

which is collected for the purposes of these regulations 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 sub-regulation (2) hereof, or

(ii) where they have been rendered anonymous, so that

donors are no longer identifiable<

(c) subject to safeguards against unauthorised additions,

deletions or modifications.

(2) The requirements referred to under sub-paragraph(i) of

paragraph (b) of sub-regulation (1) hereof are that>

(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 inspector appointed by the

Authority< or

(c) the disclosure is for the purpose of tracing a donation

from donor to recipient or recipient to donor.

(3) 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 which are brought to their attention are resolved without

delay.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press