ORGAN TRANSPLANTS (QUALITY AND SAFETY) REGULATIONS

SUBSIDIARY LEGISLATION 483.06

ORGAN TRANSPLANTS

(QUALITY AND SAFETY) REGULATIONS

12th October, 2012

LEGAL NOTICE 345 of 2012.

(1) The title of these regulations is the Organ Transplants

(Quality and Safety) Regulations.

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

Parliament and Council Directive 2010/53/EU of 7 July 2010 on

standards of quality and safety of human organs intended for

transplantation.

ORGAN AND DONOR CHARACTERISATION

PART A

Minimum data set

Minimum data - information for the characterisation of organs and donors, which

has to be collected for each donation in accordance with regulation 7(1)(b) and

without prejudice to regulation 7(2).

Minimum data set

The establishment where the procurement takes place and other general data

Type of donor

Blood group

Gender

Cause of death

Date of death

Date of birth or estimated age

Weight

Height

Past or present history of IV drug abuse

Past or present history of malignant neoplasia

Present history of other transmissible disease

HIV; HCV; HBV tests

Basic information to evaluate the function of the donated organ

PART B

Complementary data set

Complementary data - information for the characterisation of organs and donors to

be collected in addition to minimum data specified in Part A, based on the decision

of the medical team, taking into account the availability of such information and the

particular circumstances of the case, in accordance with regulation 7(1)(b).

Complementary data set

General data

Contact details of the procurement organisation/the establishment where the

procurement takes place necessary for coordination, allocation and traceability of

the organs from donors to recipients and vice versa.

Donor data

Demographic and anthropometrical data required in order to guarantee an

appropriate matching between the donor/organ and the recipient.

Donor medical history

Medical history of the donor, in particular the conditions which might affect the

sui tabi li ty of t he o rg ans fo r t ra nspl antat io n a nd im pl y t he ri s k of disease

transmission.

Physical and clinical data

ORGAN TRANSPLANTS (QUALITY AND SAFETY)

Data from clinical examination which are necessary for the evaluation of the

physiological maintenance of the potential donor as well as any finding revealing

conditions which remained undetected during the examination of the donor ’s

medical history and which might affect the suitability of organs for transplantation

or might imply the risk of disease transmission.

Laboratory parameters

Data needed for the assessment of the functional characterisation of the organs

and for the detection of potentially transmissible diseases and of possible

contraindications with respect to organ donation.

Image tests

Image explorations necessary for the assessment of the anatomical status of the

organs for transplantation.

Therapy

Treatments administered to the donor and relevant for the assessment of the

functional status of the organs and the suitability for organ donation, in particular the

use of antibiotics, inotropic support or transfusion therapy.

In these regulations unless the context otherwise requires

"authorisation" means authorisation, accreditation, designation,

licensing or registration;

"disposal" means the final placement of an organ where it is not

used for transplantation;

"donation" means donating organs for transplantation;

"donor" means a person who donates one or several organs,

whether donation occurs during lifetime or after death;

"donor characterisation" means the collection of the relevant

information on the characteristics of the donor needed to evaluate

such person’s suitability for organ donation, in order to undertake a

proper risk assessment and minimise the risks for the recipient, and

optimise organ allocation;

"European organ exchange organisation" means a non-profit

organisation, whether public or private, dedicated to national and

cross-border organ exchange, in which the majority of its member

countries are Member States;

"operating procedures" means written instructions describing the

steps in a specific process, including the materials and methods to

be used and the expected end outcome;

"organ" means a differentiated part of the human body, formed

by different tissues, that maintains its structure, vascularisation,

and capacity to develop physiological functions with a significant

level of autonomy. A part of an organ is also considered to be an

organ if its function is to be used for the same purpose as the entire

organ in the human body, maintaining the requirements of structure

and vascularisation;

"organ characterisation" means the collection of the relevant

information on the characteristics of the organ needed to evaluate

its suitability, in order to undertake a proper risk assessment and

minimise the risks for the recipient, and optimise organ allocation;

"preservation" means the use of chemical agents, alterations in

environmental conditions or other means to prevent or retard

biological or physical deterioration of organs from procurement to

transplantation;

"procurement" means a process by which the donated organs

become available;

"procurement organisation" means a healthcare establishment, a

team or a unit of a hospital, a person, or any other body which

undertakes or coordinates the procurement of organs, and is

authorised to do so by the Authority under the regulatory

framework in the Member State concerned;

"recipient" means a person who receives a transplant of an organ;

"serious adverse event" means any undesired and unexpected

occurrence associated with any stage of the chain from donation to

transplantation that might lead to the transmission of a

communicable disease, 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,

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

recipient that might be associated with any stage of the chain from

donation to transplantation that is fatal, life-threatening, disabling,

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

morbidity;

"traceability" means the ability to locate and identify the organ at

each stage in the chain from donation to transplantation or disposal,

including the ability to

-

identify the donor and the procurement organisation,

-

identify any recipient at any transplantation centre,

and locate and identify all relevant non-personal information

relating to products and materials coming into contact with that

organ;

"transplantation" means a process intended to restore certain

functions of the human body by transferring an organ from a donor

to a recipient;

"transplantation centre" means a healthcare establishment, a

team or a unit of a hospital or any other body which undertakes the

transplantation of organs and i s aut hori sed t o do so by the

Authority under the regulatory framework in the Member State

concerned.

(1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of these regulations.

(2) The Licensing Authority, hereinafter referred to as "the

Authority", shall have the following functions

(a) to ensure that procurement organisations and

transplantation centres have in place a framework for

quality and safety in accordance with regulation 4;

(b) to indicate to the procurement organisations and

transplantation centres which activities they may

undertake;

(c) to establish conditions applicable to procurement

organisations and transplantation centres;

(d) to issue, renew, amend, vary, suspend or revoke any

licence that may be required by or under these

regulations;

(e) to carry out inspections of procurement organisations,

conditions of procurement and transplantation centres

and to organize control measures in such procurement

organisations and transplantation regularly and in any

case not less than once every two years;

(f)

to grant, suspend, or withdraw, as appropriate, the

authorisations of procurement organisations or

transplantation centres or prohibit procurement

organisations or transplantation centres from carrying

out their activities where control measures

demonstrate that such organisations or centres are not

complying with the requirements of these regulations;

(g) to establish guidelines concerning the conditions of

the inspections and control measures, and on the

training and qualification of the officials involved in

order to reach a consistent level of competence and

performance;

(h) to put in place a reporting system and management

procedure for serious adverse events and reactions as

provided for in regulation 11(1) and (2);

(i)

to issue appropriate guidance to healthcare

establishments, professionals and other parties

involved in all stages of the chain from donation to

transplantation or disposal, which may include

guidance for the collection of relevant post-

transplantation information to evaluate the quality and

safety of the organs transplanted;

(j)

supervise organ exchange with other Member States

and with third countries as provided for in regulation

18(1);

(k) to ensure that the fundamental right to protection of

personal data is fully and effectively protected in all

organ transplantation activities, in conformity with the

Data Protection Act and European Union legal

provisions on the protection of personal data, in

particular Directive 95/46/EC.

(3) The Licensing Authority may by rules delegate any of the

functions referred to in sub-regulation (2) to any other body it

deems competent. Such a body may also assist the Authority in

carrying out its functions.

(4) The Licensing Authority shall levy such fees as may be

prescribed for the purpose of this Act.

(1) Procurement organisations and transplantation centres

shall be bound to have in place a framework for quality and safety

covering all stages of the chain from donation to transplantation or

disposal.

(2) The framework shall provide for the adoption and

implementation of operating procedures for

(a) the verification of donor identity;

(b) the verification of the details of the donor’s or the

donor’s family’s consent, authorisation or absence of

any objection, in accordance with the national rules

that apply where donation and procurement take place;

(c) the verification of the completion of the organ and

donor characterisation in accordance with regulation 7

and the Schedule;

(d) the procurement, preservation, packaging and

labelling of organs in accordance with regulations 5, 6

and 8;

(e) the transportation of organs in accordance with

regulation 8;

(f)

ensuring traceability, in accordance with regulation

10, guaranteeing compliance with European Union and

national legal provisions on the protection of personal

data and confidentiality;

(g) the accurate, rapid and verifiable reporting of serious

adverse events and reactions in accordance with

regulation 11(1);

(h) the management of serious adverse events and

reactions in accordance with regulation 11(2).

(3) Procurement organisations and transplant centres shall

ensure that the healthcare personnel involved at all stages of the

chain from donation to transplantation or disposal are suitably

qualified or trained and competent, and shall develop specific

training programmes for such personnel.

Procurement of organs shall take place in, or be carried out

by, procurement organisations that comply with the rules laid down

in these regulations.

(1) Medical activities in procurement organisations, such

as donor selection and evaluation, shall be performed under the

advice and the guidance of a doctor of medicine as referred to in

Directive 2005/36/EC of the European Parliament and of the

Council of 7 September 2005 on the recognition of professional

qualifications.

(2) Procurement shall take place in operating theatres, which

are designed, constructed, maintained and operated in accordance

with adequate standards and best medical practices so as to ensure

the quality and safety of the organs procured.

(3) Procurement materials and equipment shall be managed

with due regard to relevant national and international regulations,

standards and guidelines covering the sterilisation of medicines and

medical devices. Qualified, sterile instruments and procurement

devices shall be used for organ procurement.

7.(1) (a) All procured organs and donors thereof shall be

characterised before transplantation through the

collection of the information set out in the Schedule.

(b) The information specified in Part A of the Schedule

contains a set of minimum data which has to be

collected for each donation. Information specified in

Part B of the Schedule contains a set of

complementary data to be collected in addition, based

on the decision of the medical team, taking into

account the availability of such information and the

particular circumstances of the case.

(2) Notwithstanding the provisions of sub-regulation (1), if

according to a risk-benefit analysis in a particular case, including

in life-threatening emergencies, the expected benefits for the

recipient outweigh the risks posed by incomplete data, an organ

may be considered for transplantation even where not all of the

minimum data specified in Part A of the Schedule are available.

(3) In order to meet the quality and safety requirements laid

down in these regulations, the medical team shall endeavour to

obtain all necessary information from living donors and for that

purpose shall provide them with the information they need in order

to understand the consequences of donation. In the case of

deceased donation, where possible and appropriate, the medical

team shall endeavour to obtain such information from relatives of

the deceased donor or other persons. The medical team shall also

endeavour to make all parties from whom information is requested

aware of the importance of the swift transmission of that

information.

(4) The tests required for organ and donor characterisation

shall be carried out by laboratories with suitably qualified or

trained and competent personnel and adequate facilities and

equipment.

(5) Organisations, bodies and laboratories involved in organ

and donor characterisation shall have appropriate operating

procedures in place to ensure that the information on organ and

donor characterisation reaches the transplantation centre in due

time.

(6) Where organs are exchanged between Member States, the

information on organ and donor characterisation, as specified in the

Schedule, shall be transmitted to the other Member State with

which the organ is exchanged.

(1) The following requirements shall be met during the

transportation of organs

(a) the organisations, bodies or companies involved in the

transportation of organs shall have appropriate

operating procedures in place to ensure the integrity of

ORGAN TRANSPLANTS (QUALITY AND SAFETY)

the organs during transport and a suitable transport

time;

(b) the shipping containers used for transporting organs

shall be labelled with the following information

(i)

identification of the procurement organisation

and the establishment where the procurement

took place, including their addresses and

telephone numbers;

(ii) identification of the transplantation centre of

destination, including its address and telephone

number;

(iii) a statement that the package contains an organ,

specifying the type of organ and, where

applicable, its left or right location and marked

"HANDLE WITH CARE";

(iv) recommended transport conditions, including

instructions for keeping the container at an

appropriate temperature and position;

(c) the organs transported shall be accompanied by a

report on the organ and donor characterisation.

(2) The requirements laid down in sub-regulation (1)(b) need

not be met where the transportation is carried out within the same

establishment.

(1) Transplantation shall take place in, or shall be carried

out by, transplantation centres that are duly authorised.

(2) The Licensing Authority shall indicate in the authorisation

which activities the transplantation centre concerned may

undertake.

(3) The transplantation centre shall verify before proceeding to

transplantation that

(a) the organ and donor characterisation are completed

and recorded in accordance with regulation 6 and the

Schedule;

(b) the conditions of preservation and transport of shipped

organs have been maintained.

(4) The Licensing Authority shall, upon the request of the

E u r o p e a n C o m m i s s i o n o r a n o t h e r M e m b e r St a t e , p r o v i d e

information on the national requirements for the authorisation of

transplantation centres.

(1) Procurement organisations and transplantation centres

shall ensure that

(a) all organs procured, allocated and transplanted on their

territory can be traced from the donor to the recipient

and vice versa in order to safeguard the health of

donors and recipients;

(b) they have a donor and recipient identification system

that can identify each donation and each of the organs

and recipients associated with it.

(2) With regard to such a system, it shall be ensured that

confidentiality and data security measures are in place in

compliance with the provisions of the Data Protection Act.

(3)

(a) The bodies involved in the chain from donation to

transplantation or disposal shall keep the data needed

to ensure traceability at all stages of the chain from

donation to transplantation or disposal and the

information on organ and donor characterisation as

specified in the Schedule, in accordance with the

framework for quality and safety.

(b) Data required for full traceability shall be kept for a

minimum of thirty years after donation. Such data may

be stored in electronic form.

(4) Where organs are exchanged between Member States, the

procurement organisations and transplant centres shall transmit the

necessary information to ensure the traceability of organs, in

conformity with the procedures established by the European

Commission pursuant to Article 29 of Directive 2010/53/EU.

(1) Procurement organisations and transplant centres shall

establish and maintain a system to report, investigate, register and

transmit relevant and necessary information concerning serious

adverse events that may influence the quality and safety of organs

and that may b e attributed to the testing, characterisation,

procurement, preservation and transport of organs, as well as any

serious adverse reaction observed during or after transplantation

which may be connected to those activities.

(2) Procurement organisations and transplant centres shall have

an operating procedure in place for the management of serious

adverse events and reactions.

(3) In particular, and with regard to sub-regulations (1) and (2),

procurement organisations and transplant centres shall ensure that

operating procedures are in place for the notification, in due time,

of

(a) any serious adverse event and reaction to the

Licensing Authority and to the concerned procurement

organisation or transplantation centre;

(b) the management measures with regard to serious

adverse events and reactions to the Authority.

(4) Where organs are exchanged between Member States, the

procurement organisations and transplant centres shall ensure that

serious adverse events and reactions are reported in conformity

with the procedures established by the European Commission

pursuant to Article 29 of Directive 2010/53/EU.

(5) Procurement organisations shall, where relevant, ensure the

interconnection between the reporting system referred to in sub-

regulation (1) and the notification system established in accordance

with regulation 8 of the Tissues and Cells (Quality and Safety)

Regulations.

(1) Healthcare personnel directly involved in the chain

from donation to the transplantation or disposal of organs shall be

suitably qualified or trained and competent to perform their tasks

and are provided with the relevant training, as referred to in

regulation 4(3).

(2) Procurement of organs shall be carried out by persons who

have successfully completed a training programme specified by a

clinical team specialising in the organs to be procured, or in a

centre authorised for procurement.

(1) Donations of organs from deceased and living donors

shall be voluntary and unpaid.

(2) The principle of non-payment shall not prevent living

donors from receiving compensation, provided it is strictly limited

to making good the expenses and loss of income related to the

donation. The Authority shall define the conditions under which

such compensation may be granted, while avoiding there being any

financial incentives or benefit for a potential donor.

(3) It shall be illegal to advertise the need for, or availability

of, organs where such advertising is with a view to offering or

seeking financial gain or comparable advantage.

(4) A person who engages in an activity to which sub-

regulation (3) applies does not commit an offence under that sub-

regulation if he is designated by the Licensing Authority as a

person who may lawfully engage in the activity.

(5) The procurement of organs shall be carried out on a non-

profit basis.

(1) The Authority shall lay down the standards expected

in relation to the obtaining of consent.

(2) The procurement of organs shall be carried out only after

all requirements relating to consent, authorisation or absence of

any objection have been met.

(3)

The procurement of organs shall be carried out only when

(a) all prospective organ donors, their relatives or any

other person granting consent on behalf of donors,

have been given information in accordance with

guidelines and authorisation requirements as

established by the Authority;

(b) information in accordance with guidelines and

authorization requirements established by the

Authority has been obtained from all persons who are

willing to donate organs, their relatives or any other

person granting consent on behalf of donors.

(1) Procurement organisations and transplant centres shall

take all n ece ssary m e asures to en sure t h e hi gh es t p ossi b le

protection of living donors in order to fully guarantee the quality

and safety of organs for transplantation.

(2)

Procurement organisations and transplant centres shall

ensure that living donors are selected on the basis of their health

and medical history, by suitably qualified or trained and competent

professionals. Such assessments may provide for the exclusion of

persons whose donation could present unacceptable health risks.

(3) Procurement organisations and transplant centres shall keep

and maintain a register or record of the living donors.

(4) Living donors shall be followed up and procurement

organisations, transplant centres and institutions responsible for the

follow up of living donors shall have a system in order to identify,

report and manage any event potentially relating to the quality and

safety of the donated organ, and hence of the safety of the

recipient, as well as any serious adverse reaction in the living donor

that may result from the donation. Such adverse events and

reactions shall be reported to the Authority.

(1) Procurement organisations and transplant centres shall

ensure that the fundamental right to protection of personal data is

fully and effectively protected in all organ donation and

transplantation activities, in conformity with the provisions on the

protection of personal data laid down in the Data Protection Act.

(2) Procurement organisations and transplant centres shall take

all necessary measures to ensure that

(a) the data processed are kept confidential and secure in

accordance with the provisions of Data Protection Act;

(b) donors and recipients whose data are processed within

the scope of these regulations are not identifiable,

except as permitted by the provisions of the Data

Protection Act;

(c) the principles relating to data quality, as set out in the

provisions of the Data Protection Act, are met.

(3) Procurement organisations and transplant centres 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;

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

these regulations is held securely to ensure that -

(i)

the information is available for the purpose of

tracing donations;

(ii) the information is only disclosed in accordance

with an order by the courts, upon request by the

Licensing Authority or as permitted by law.

(4) The medical director responsible for the procurement

organisation or the transplantation centre shall ensure that the

r e s u l t s o f t h e d o n o r e v a l u a t i o n a n d t e s t i n g p r o ce d u r e s a r e

documented and any major anomalies are reported to the Licensing

Authority.

(5) Any unauthorised accessing of data or systems that makes

identification of donor or recipients possible shall be punishable in

accordance with regulation 20.

(6) Any use of systems or data that makes the identification of

donors or recipients possible with a view to tracing donors or

recipients other than for the purposes permitted by the Data

Protection Act, or as provided in these regulations, shall be

punishable in accordance with regulation 20 of these regulations.

(1) The Licensing Authority shall

(a) keep a record of the activities of procurement

organisations and transplantation centres, including

aggregated numbers of living and deceased donors,

and the types and quantities of organs procured and

transplanted, or otherwise disposed of in accordance

with European Union and national legal provisions on

the protection of personal data and statistical

confidentiality;

(b) draw up and make publicly accessible an annual report

on activities referred to in paragraph (a);

(c) establish and maintain an updated record of

procurement organisations and transplantation centres.

(2) The Licensing Authority shall, upon the request of the

E u r o p e a n C o m m i s s i o n o r a n o t h e r M e m b e r St a t e , p r o v i d e

information on the record of procurement organisations and

transplantation centres.

(1) The Licensing Authority shall authorise and supervise

o rgan e xc h a ng e wi th t hi r d c o un tr ie s . F or th is pu r po s e , t he

Licensing Authority may authorise procurement organisations and

transplant centres to conclude agreements with counterparts in

third countries.

(2) The supervision of organ exchange with third countries

may be delegated by the Licensing Authority to European organ

exchange organisations.

(3) European organ exchange organisations may conclude

agreements with counterparts in third countries.

(4) Organ exchange, as referred to in sub-regulation (1), shall

be allowed only where the organs

(a) can be traced from the donor to the recipient and vice

versa;

(b) meet quality and safety requirements equivalent to

those laid down in these regulations.

The Licensing Authority may authorise procurement

organisations and transplant centres to conclude agreements with

European organ exchange organisations, provided that such

organisations ensure compliance with the requirements laid down

in these regulations, delegating to those organisations, inter alia

(a) the performance of activities provided for under the

framework for quality and safety;

(b) specific tasks in relation to the exchanges of organs to

and from Member States and third countries.

(1) Any person who fails to comply with any of the

provisions of these regulations or rules made thereunder, shall be

guilty of an offence and shall, on conviction, be liable a fine

(multa) not exceeding eleven thousand six hundred and forty-six

euro (€11,646).

(2)

(a) Notwithstanding any other law providing for the trial

of offences, where the Authority believes that a person

has committed an offence against these regulations, the

Licensing Authority shall give notice in writing to

such person describing the offence of which the person

is accused, indicating the steps to be taken to remedy

the offence and the penalty he is required to pay in

respect of that offence.

(b) The Minister may further prescribe the penalties that

may be demanded by the Licensing Authority in

relation to any specified offence provided that such

penalty shall not exceed the amount of eleven

thousand six hundred and forty-six euro (€11,646).

(3) Where a notice under this article has been given, the person

named in the notice may, within twenty-one days of the service of

the notice, accept responsibility for the offence specified in the

notice and within the same period pay the penalty indicated in the

notice, and comply with the relative provision of these regulations

or rules made thereunder and no further proceedings may be taken

under these regulations in respect of such offence.

(4) Where the person to whom notice is given under sub-

regulation (1) has not paid the penalty within the twenty-one day

period referred to in sub-regulation (3) and has not, within the time

specified, complied with the requirements of these regulations,

criminal proceedings may be taken against him in accordance with

the provisions of the Criminal Code, of these regulations and of any

other law applicable to the offence.

ORGAN TRANSPLANTS (QUALITY AND SAFETY)