271 tal-2006 - Regolamenti tal-2006 dwar il-Kwalità u s-Sigurezza tat-Tessut u ċ-Ċelloli

L.N. 271 of 2006

HUMAN BLOOD AND TRANSPLANTS ACT, 2006

(ACT NO. IV OF 2006)

Tissues and Cells (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 Tissues and Cells

(Quality and Safety) Regulations, 2006.

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

2004#23#EC of the European Parliament and of the Council of 31 March

2004 on setting standards of quality and safety for the donation,

procurement, testing, processing, preservation, storage and distribution

of human tissues and cells, and Directive 2006#17#EC of the European

Parliament and of the Council of the 8th February 2006 as regards certain

technical requirements for the donation, procurement and testing of

human tissues and cells.

In these regulations unless the context otherwise requires>

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

“allogeneic use” means cells or tissues removed from one

person and applied to another<

“autologous use” means cells or tissues removed from and

applied in the same person<

“cells” means individual human cells or a collection of human

cells when not bound by any form of connective tissue<

“Directive 2004#23#EC” means the Dirctive of the European

Parliament and of the Council of 31 March 2004 on setting

standards of quality and safety for the donation, procurement,

testing, processing, preservation, storage and distribution of human

tissues and cells<

“Directive 2006#17#EC” means the Directive of the European

Parliament and of the Council of the 8th February 2006 as regards

certain technical requirements for the donation, procurement and

testing of human tissues and cells<

“direct use” means any procedure where cells are donated

and used without any banking<

“distribution” means transportation and delivery of tissues or

cells intended for human applications<

“donation” means donating human tissues or cells intended

for human applications<

“donor” means every human source, whether living or

deceased, of human cells or tissues<

“human application” means the use of tissues or cells on or in

a human recipient and extracorporal applications<

“organ” means a differentiated and vital part of the human

body, formed by different tissues, that maintains its structure,

vascularisation and capacity to develop physiological functions

with an important level of autonomy<

“partner donation” means the donation of reproductive cells

between a man and a woman who declare that they have an intimate

physical relationship<

“preservation” means the use of chemical agents, alterations

in environmental conditions or other means during processing to

prevent or retard biological or physical deterioration of cells or

tissues<

“processing” means all operations involved in the preparation,

manipulation, preservation and packaging of tissues or cells

intended for human applications<

“procurement” means a process by which tissue or cells are

made available<

“procurement organisation” means a health care

establishment or a unit of a hospital or another body that undertakes

the procurement of human tissues and cells and that may not be

accredited, designated, authorised or licensed as a tissue

establishment<

“quality system” means the organisational structure, defined

responsibilities, procedures, processes, and resources for

implementing quality management and includes all activities which

contribute to quality, directly or indirectly<

“quarantine” means the status of retrieved tissue or cells, or

tissue isolated physically or by other effective means, whilst

awaiting a decision on their acceptance or rejection<

“reproductive cells” means all tissues and cells intended to

be used for the purpose of assisted reproduction<

“serious adverse event” means any untoward occurrence

associated with the procurement, testing, processing, storage and

distribution of tissues and cells that might lead to the transmission

of a communicable disease, to death or life-threatening, disabling

or incapacitating conditions for patients or which might result in,

or prolong, hospitalisation or morbidity<

“serious adverse reaction” means an unintended response,

including a communicable disease, in the donor or in the recipient

associated with the procurement or human application of tissues

and cells that is fatal, life-threatening, disabling, incapacitating or

which results in, or prolongs, hospitalisation or morbidity<

“standard operating procedures” (SOPs) means written

instructions describing the steps in a specific process, including

the materials and methods to be used and the expected end product<

“storage” means maintaining the product under appropriate

controlled conditions until distribution<

“tissue” means all constituent parts of the human body formed

by cells<

“tissue establishment” means a tissue bank or a unit of a

hospital or another body where activities of processing,

preservation, storage or distribution of human tissues and cells are

undertaken. It may also be responsible for procurement or testing

of tissues and cells<

“traceability” means the ability to locate and identify the tissue

or cell during any step from procurement, through processing,

testing and storage, to distribution to the recipient or disposal, which

also implies the ability to identify the donor and the tissue

establishment or the manufacturing facility receiving, processing

or storing the tissue or cells, and the ability to identify any recipient

at the medical facility or facilities applying the tissue or cells to

any recipient< traceability also covers the ability to locate and

identify all relevant data relating to products and materials coming

into contact with those tissues or cells<

“validation” (or “qualification” in the case of equipment or

environments) means establishing documented evidence that

provides a high degree of assurance that a specific process, SOP,

piece of equipment or environment will consistently produce a

product meeting its predetermined specifications and quality

attributes< a process is validated to evaluate the performance of a

system with regard to its effectiveness based on intended use.

(1) A tissue and cell establishment, hereinafter referred to Responsible person.

as “establishment”, shall designate a person who shall be responsible

for the following tasks>

(a) ensuring that human tissues and cells intended for human

applications in the establishment for which that person is

responsible are procured, tested, processed, stored and distributed

in accordance with these regulations and with the laws in force in

Malta<

(b) providing information to the competent authority or

authorities as required in regulation 6 of these regulations<

(c) implementing the requirements of Articles 7, 10, 11, 15,

16 and 18 to 24 of the Directive 2004#23#EC within the tissue

establishment< and

(d) ensure that the Authority is notified of any serious

adverse events and reactions and is provided with a report analysing

the cause and the ensuing outcome.

(2) An establishment shall only designate a person as a

responsible person if such person is in possession of>

(a) a diploma, certificate or other evidence of formal

qualifications in the field of medical or biological sciences awarded

on completion of a university course of study or a course recognised

as equivalent by the Authority< and

(b) at least two yearsí practical experience in the relevant

fields.

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

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

qualified by training and experience to perform them.

(4) The establishments shall notify the Licensing Authority,

hereinafter referred to as “the Authority” of the name of any persons to

whom tasks have been delegated by the responsible person 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 is permanently or temporarily replaced, the

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), it may serve a

notice to that effect on the establishment.

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

with sub-regulation (6), a 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), the establishment 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) An establishment shall -

(a) ensure that the personnel directly involved in the

procurement, processing, preservation, storage and distribution of

tissues and cells are qualified to perform such tasks and are provided

with timely, relevant and regularly updated training<

(b) ensure that all donations of human tissues and cells are

subjected to tests in accordance with the requirements referred to

in Directive 2004#23 and any annexes thereto and that the selection

and acceptance of tissues and cells comply with the requirements

referred to in Directive 2004#23#EC, and Directive 2006#17#EC

and any annexes thereto<

(c) ensure that human tissue and cells and associated

documentation comply with the requirements referred to in

Directive 2004#23#EC, and Directive 2006#17#EC and any annexes

thereto<

(d) verify and record the fact that the packaging of human

tissue and cells received complies with the requirements referred

to in Directive 2004#23#EC and Directive 2006#17#EC and any

annexes thereto<

(e) discard all tissues and cells that do not comply with those

requirements<

(f) document the acceptance or rejection of received tissues

or cells<

(g) ensure that human tissues and cells are correctly

identified at all times by assigning an identifying code to each

delivery or batch of tissues or cells in accordance with Regulation

6 of these regulations.

(h) hold tissue and cells in quarantine until such time as the

requirements relating to donor testing and information have been

met in accordance with article 15 of the Act<

(i) maintain documentation on operational procedures,

guidelines, training and reference manuals and reporting forms so

that they are readily available for inspection<

(j) include in their standard operating procedures all

processes that affect quality and safety and shall ensure that they

are carried out under controlled conditions<

(k) ensure that the equipment used, the working environment

and process design, validation and control conditions are in

compliance with the requirements referred to Directive 2004#23#EC

and any annexes thereto<

(l) ensure that any modifications to the processes used in

the preparation of tissues and cells shall also meet the criteria laid

down in the preceeding paragraph<

(m) include in their standard operating procedures special

provisions for the handling of tissues and cells to be discarded, in

order to prevent the contamination of other tissues or cells, the

processing environment or personnel<

(n) ensure that all procedures associated with the storage of

tissues and cells are documented in the standard operating

procedures and that the storage conditions comply with the

requirements referred to in Directive 2004#23#EC and any annexes

thereto<

(o) ensure that all storage processes are carried out under

controlled conditions<

(p) establish and apply procedures for the control of

packaging and storage areas, in order to prevent any situation

arising that might adversely affect the functioning or integrity of

tissues and cells<

(q) not to distribute processed tissues and cells until all the

requirements laid down in Directive 2004#23#EC and Directive

2006#17#EC have been met<

(r) have agreements and procedures in place to ensure that,

in the event of termination of activities for whatever reason, stored

tissues and cells shall be transferred to other tissue establishment

or establishments licensed by the Authority<

(s) ensure that labelling and documentation and packaging

conform to the requirements set by Directive 2004#23#EC and any

annexes thereto< and

(t) ensure the quality of tissues and cells during distribution

and that the distribution conditions comply with the requirements

set by Directive 2004#23#EC and Directive 2006#17#EC and any

annexes thereto<

(1) Tissue establishments shall>

(a) establish written agreements with a third party each time

an external activity takes place which influences the quality and

safety of tissues and cells processed in cooperation with a third

party, and in particular in the following circumstances>

(i) where a tissue establishment entrusts one of the

stages of tissue or cell processing to a third party<

(ii) where a third party provides goods and services

that affect tissue or cell quality and safety assurance, including

their distribution<

(iii) where a tissue establishment provides services to

a tissue establishment which is not accredited<

(iv) where a tissue establishment distributes tissue or

cells processed by third parties<

(b) evaluate and select third parties on the basis of their

ability to meet the standards laid down in Directive 2004#23#EC,

and Directive 2006#17#EC and any other annexes.

(c) keep a complete list of the agreements referred to in

sub- regulation (1) of this regulation which they have established

with third parties< and

(d) provide copies of agreements with third parties at the

request of the competent authority or authorities.

(2) Agreements between tissue establishments and third

parties shall specify the responsibilities of the third parties and detailed

procedures.

An establishment shall ensure that>

Traceability.

(a) all tissues and cells procured, processed, stored or

distributed on their territory can be traced from the donor to the

recipient and vice versa. This traceability shall also apply to all

relevant data relating to products and materials coming into contact

with these tissues and cells<

(b) by means of a donor identification system a unique code

is assigned to each donation and to each of the products associated

with it<

(c) all tissues and cells are identified with a label that

contains the information or references allowing a link to the

information referred to in the annexes to Directive 2004#23#EC<

and Directive 2006#17#EC< and

(d) the data necessary to ensure traceability at all stages is

kept for a minimum of 30 years after clinical use. Data storage

may also be in electronic form.

(1) Tissue establishments shall keep a record of their

activities, including the types and quantities of tissues and, or cells

procured, tested, preserved, processed, stored and distributed, or

otherwise disposed of, and on the origin and destination of the tissues

and cells intended for human applications, in accordance with the

requirements referred to in Directive 2004#23#EC and Directive

2006#17#EC and any annexes thereto.

(2) Such establishments shall submit to the Authority an

annual report on these activities which shall be publicly accessible.

An establishment shall>

(a) establish and maintain a system to report, investigate,

register and transmit information about serious adverse events and

reactions which may influence the quality and safety of tissues

and cells and which may be attributed to the procurement, testing,

processing, storage and distribution of tissues and cells, as well as

any serious adverse reaction observed during or after clinical

application which may be linked to the quality and safety of tissues

and cells<

(b) report any relevant information to establishments

engaged in the donation, procurement, testing, processing, storage

and distribution of human tissues and cells in order to facilitate

traceability and ensure quality and safety control< and

(c) ensure that an accurate, rapid and verifiable procedure

is in place which will enable such establishment to recall from

distribution any product which may be related to an adverse event

or reaction.

(1) An establishment shall, in relation to the procurement of

human tissues or cells>

(a) give all prospective donors of tissues or cells, their

relatives or any other person granting consent on behalf of donors,

information in accordance with guidelines and authorization

requirements as established by the Authority<

(b) obtain from all persons who are willing to donate tissues

or cells, their relatives or any other person granting consent on

behalf of donors, information in accordance with guidelines and

authorization requirements established by the Authority<

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

donors in accordance with the requirements set by Directive

2004#23#EC and Directive 2006#17#EC and any annexes thereto<

(d) apply eligibility criteria for all donors of tissues and cells<

(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 tissues or cells,

(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<

(g) encourage voluntary and unpaid tissue and cell donations

with a view to ensuring that tissues and cells are, in so far as

possible, provided from such donations< and

(h) the tissues and cells are procured, packaged and transported

in accordance with the requirements set by Directive 2004#23#EC

and Directive 2006#17#EC and any annexes thereto.

(1) An establishment shall ensure that all data, including Data protection and

confidentiality.

genetic information, collated within the scope of the Act and any

regulations made thereunder and to which third parties have access,

have been rendered anonymous so that neither donors nor recipients

remain identifiable.

(2) For that purpose, the establishment shall ensure that>

(a) data security measures are in place, as well as safeguards

against any unauthorised data additions, deletions or modifications

to donor files or deferral records, and transfer of information<

(b) procedures are in place to resolve data discrepancies<

(c) no unauthorised disclosure of information occurs, whilst

guaranteeing the traceability of donations<

(d) the identity of any recipient is not disclosed to the donor

or his family and vice versa, without prejudice to any legislation

in force on the conditions for disclosure, notably in the case of

gametes donation<

(e) the information which is collected for the purposes of

these regulations is held securely so that it is-

(i) available for the purpose of, tracing donations<

(ii) not disclosed except in accordance with one or

more of the requirements of sub-regulation (3).

(3) The requirements referred to under sub-paragraph (ii)

of paragraph (e) of sub-regulation (2) are that the disclosure>

(a) shall be in accordance with an order of a court, or as

may otherwise be required by law<

(b) is made to an inspector appointed by the Authority.

(4) The responsible person of the establishment shall ensure

that the results of the donor evaluation and testing procedures are

documented and any major anomalies are reported to the Authority in

accordance with the requirements referred to in the Annex to Directive

2004#23#EC and any amendments thereto.

(1) Each tissue establishment shall put in place and update

a quality system based on the principles of good practice.

(2) Such quality system shall include at least the following

documentation>

(a)

standard operating procedures,

(b) guidelines,

(c)

training and reference manuals,

(d) reporting forms,

(e)

donor records,

(f)

information on the final destination of tissues or cells.

(3) The documentation referred to in sub-regualtion (2)

hereof shall be available for inspection by an authorised officer.

(4) Tissue establishments shall keep the data necessary to

ensure traceability in accordance with regulation 4 of these regulations.

(1) Procurement of human tissues and cells shall be carried Requirements for

the procurement of

out by persons who have successfully completed a training programme human tissues and

specified by a clinical team specialising in the tissues and cells to be cells.

procured or a tissue establishment authorised for procurement.

(2) The establishment or procurement organisation shall

have written agreements with the staff or clinical teams responsible for

donor selection, unless they are employed by the same organisation or

establishment, specifying the procedures to be followed to assure

compliance with the selection criteria for donors set out in Annex I of

Directive 2006#17#EC.

(3) The establishment or procurement organisation shall

have written agreements with the staff or clinical teams responsible for

tissue or cell procurement, unless they are employed by the same

establishment or organisation, specifying any type of tissues and, or

cells and, or test samples to be procured and the protocols to be followed.

(4) (a) There shall be standard operating procedures

(SOPs) for the verification of>

(i) donor identity<

(ii) the details of donor or donor family consent or

authorisation<

(iii) the assessment of the selection criteria for donors as

detailed in regulation 13<

(iv) the assessment of the laboratory tests required for donors

as detailed in regulation 14.

(b) There shall also be SOPs describing the procedures

for procurement, packaging, labelling and transportation of the tissues

and cells to the point of arrival at the tissue establishment or, in the case

of direct distribution of tissues and cells, to the clinical team responsible

for their application or, in the case of tissue or cell samples, to the

laboratory for testing, in accordance with regulation 15.

(5) Procurement shall take place in appropriate facilities,

following procedures that minimise bacterial or other contamination of

procured tissues and cells, in accordance with regulation 15.

(6) Procurement materials and equipment shall be managed

in accordance with the standards and specifications laid down in Annex

IV, section 1.3 of Directive 2006#17#EC, and with due regard to relevant

national and international regulation, standards and guidelines covering

the sterilisation of medicines and medical devices. Qualified, sterile

instruments and procurement devices shall be used for tissue and cell

procurement.

(7) Procurement of tissues and cells from living donors shall

take place in an environment that ensures their health, safety and privacy.

(8) Where appropriate, the staff and equipment necessary

for body reconstruction of deceased donors shall be provided. Such

reconstruction shall be completed effectively.

(9) The procedures for the procurement of tissues and cells

shall be carried out in accordance with the requirements specified in

regulation 15.

(10) A unique identifying code shall be allocated to the

donor and to the donated tissues and cells, during procurement or at the

tissue establishment, to ensure proper identification of the donor and

the traceability of all donated material. The coded data shall be entered

in a register maintained for the purpose.

(11) Donor documentation shall be maintained in

accordance with section 1.4 of Annex IV of Directive 2006#17#EC

Selection criteria for

Tissue and cells establishments shall in respect of donors

adopt the selection criteria set out in Directive 2004#17#EC namely>

(a) Annex I for donors of tissues and cells, except donors

of reproductive cells<

(b) Annex III for donors of reproductive cells.

(1) It shall be the duty of the establishment to ensure that>

(a) donors of tissues and cells, except donors of reproductive

cells, undergo the biological tests set out in point 1 of Annex II of

Directive 2006#17#EC<

(b) such tests are carried out in compliance with the general

requirements set out in point 2 of Annex II of Directive 2006#17#EC<

(c) donors of reproductive cells undergo the biological tests

set out in points 1, 2 and 3 of Annex III of Directive 2006#17#EC<

(d) such tests are carried out in compliance with the general

requirements set out in point 4 of Annex III of Directive

2006#17#EC.

The establishment shall ensure that the tissue and, or cell Tissue and, or cell

donation and

donation and procurement procedures and the reception of tissues and, procurement

or cells at the tissue establishment comply with the requirements set procedures and

reception at the

out in Annex IV of Directive 2006#17#EC.

tissue

establishment.

The Authority may authorise the direct distribution of specific Requirements for

direct distribution to

tissues and cells from where the procurement is carried out to a health the recipient of

care establishment for immediate transplantation.

specific tissues and

cells.

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