S.L. 483.6 Art. 20Penalties. Special procedure. Cap. 9. PART A Minimum Minimum has to be without Minimum The Type of Blood group Gender Cause of Date of Date of birth Weight Height Past or Past or Present HIV; HCV; Basic PART B be collected of the medical particular General data Contact procurement the organs Donor d

(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. SCHEDULE

ORGAN AND DONOR CHARACTERISATION

data set data - information for the characterisation of organs and donors, which collected for each donation in accordance with regulation 7(1)(b) and prejudice to regulation 7(2). data set establishment where the procurement takes place and other general data donor death death or estimated age present history of IV drug abuse present history of malignant neoplasia history of other transmissible disease

HBV tests information to evaluate the function of the donated organ

Complementary data set Complementary data - information for the characterisation of organs and donors to in addition to minimum data specified in Part A, based on the decision team, taking into account the availability of such information and the circumstances of the case, in accordance with regulation 7(1)(b). Complementary data set details of the procurement organisation/the establishment where the takes place necessary for coordination, allocation and traceability of from donors to recipients and vice versa.

Demographic and anthropometrical data required in order to guarantee an matching between the donor/organ and the recipient. medical history history of the donor, in particular the conditions which might affect the the organs for transplantation and imply the risk of disease clinical data Data from clinical examination which are necessary for the evaluation physiological maintenance of the potential donor as well as any finding conditions which remained undetected during the examination medical history and which might affect the suitability of organs for or might imply the risk of disease transmission. Laboratory parameters

Data needed for the assessment of the functional characterisation and for the detection of potentially transmissible diseases and contraindications with respect to organ donation. Image tests

Image explorations necessary for the assessment of the anatomical organs for transplantation.

Therapy Treatments administered to the donor and relevant for the assessment functional status of the organs and the suitability for organ donation, in use of antibiotics, inotropic support or transfusion therapy.