The organ transplant, which saves life or improves the health of tens of thousands of patients annually, presents a number of distinctive features of any other treatment, so it requires principles, regulation and a specific organisation. As an example of these attributes, the shortage of organs, whose availability is based on solidarity and a rigorous systematization of the process of obtaining, the deterioration or the death of patients on a waiting list, the reduced the likelihood of receiving an organ under certain circumstances, the urgent decision-making in critical situations, the geographical distance to be saved to bring the organ from the donor to the most appropriate recipient, or the inherent risks to the same, since from the theoretical point of view, the simple transmission of biological material from an individual to another carries some risk.

Law 30/1979 of 27 October on the extraction and transplantation of organs established the requirements for the disposal, extraction, conservation, exchange and transplantation of human organs for therapeutic purposes, and was developed by Royal Decree 426/1980 of 22 February, for the development of Law 30/1979 of 27 October on the extraction and transplantation of organs, which regulated the conditions of staff and health centres and the ethical principles to be followed in the donation in brain death and organ transplantation. Scientific and technical progress led to a repeal of the development by Royal Decree 2070/1999 of 30 December on the activities of the collection and clinical use of human organs and coordination. In the area of organ and tissue donation and transplantation, which incorporated new features such as donation after death by cardiorespiratory arrest, with implications for the preservation, technological advances in the diagnosis of the brain death or the functioning of the state and regional organizations dedicated to the coordination, rapid exchange of information and monitoring and evaluation of activities, taking into account the growing organisational complexity.

Directive 2010 /53/EU of the European Parliament and of the Council of 7 July 2010 on quality and safety standards for human organs intended for transplantation provides for minimum requirements to be applied to the donation, assessment, characterization, procurement, preservation, transport and transplantation of human organs for transplantation, in order to ensure high levels of quality and safety of such organs. These include the designation of competent authorities, the establishment of national criteria for the approval of centres, the development of a quality and safety framework that includes the necessary protocols for development. the process, the qualifications of the professionals involved and the implementation of specific training programmes. The Directive also imposes traceability requirements and the development of a system for the notification and management of serious adverse events and events, provides the minimum data to be collected for the assessment of donors and (a) the establishment of information systems and the provision of periodic reports of activity. Among its ethical foundations are those related to voluntariness and gratuitousness, consent, protection of the living donor and the protection of personal data.

Law 14/1986, of 25 April, General of Health, in its Article 40, paragraph 8, assigns to the General Administration of the State powers for the regulation on accreditation, approval, authorization and registration of centers or services, in accordance with the provisions of the legislation on organ transplantation, and in paragraph 13 of the same Article, powers for the establishment of health information systems and the performance of statistics of general interest suprachomunit.

Law 41/2002, of 14 November, basic regulation of the autonomy of the patient and of rights and obligations in the field of information and clinical documentation, reinforces and completes the provisions of Law 14/1986, of 25 April, in the rights of patients, being of particular importance as regards their will and consent and confidentiality, in line with the regime established by the Organic Law 15/1999, of 13 December, of Data Protection Personal character, which qualifies as specially protected health data. Law 16/2003, of 28 May, of cohesion and quality of the National Health System, establishes coordination and cooperation actions between public health administrations, based on the principles of equity and quality, combining the incorporation of innovations with security, effectiveness and citizen participation. In addition, given the impact of training and qualification of the professionals involved in the system, it is necessary to cite Law 44/2003 of 21 November of the management of health professions, which is a framework for the high (a) specialization necessary for the execution of the tasks of the coordination of transplants and the obtaining and transplantation of the organs. Moreover, it is appropriate to cite Law 26/2011 of 1 August, adapting regulations to the International Convention on the Rights of Persons with Disabilities, which introduced requirements in relation to the appropriate formats in the information the patient is provided with assistance and support in the provision of consent for persons with disabilities.

The scientific and technical progress of recent years, the improvement of the diagnostic capacity and the publication of new international guidelines on the criteria that apply to the diagnosis of death, should be taken into account in this royal decree. Among the advances is the one of the vascularized allotracers of composite tissues, whose scarcity and impossibility of storage assimilates their process of obtaining and transplantation to the organs. For this reason, the provisions herein are considered to be applicable to the vascularized allotracers of composite tissues. The recent expansion in our country of transplantation of organs of living donor, with the implementation of programs of donation and transplantation among non-affective or genetically related persons demands a concrete legal treatment that is reinforced by the provisions of Directive 2010 /53/EU in relation to the protection of the living donor. The expansion of the donation of deceased persons after death by cardiorespiratory arrest should not be omitted, according to the terminology of Royal Decree 2070/1999 of 30 December, which established the basis for the development of this type of donation. in Spain, taking as a reference the Spanish consensus document on organ donation in asystole elaborated in 1995. In the last two years, an update has been carried out on this consensus document, which deals with ethical, terminological, procedural and technical aspects. The Spanish Consensus Paper on Donation in Asistolia 2012 supports the updates that are included in this royal decree.

Directive 2010 /53/EU of 7 July 2010 explicitly recognises the work of the transplant coordinator in the effective development of the procurement process and in ensuring the quality and safety of the organs intended for transplantation. A fundamental pillar of our model, this royal decree recognizes the care unit for the coordination of transplants and explicitly awards the activities of this professional group in the process of obtaining and clinical use of organs. The royal decree also provides for the provision of safe and quality organs, highlighting the obligation to develop a framework programme of quality and safety that acts as an integral element of the activities carried out. in all the procurement and transplantation centers of the State, and a set of systems that organizes the flow and storage of the information that the activity generates and that must be constituted in element of cohesion and improvement. It should also be noted that, for the first time in our country, following the recognition of their need over the last few years, an express and graduated relationship of activities and practices that are punishable in the process that is the subject of this rule is established.

In the drafting of this royal decree, which incorporates into Spanish law the Directive 2010 /53/EU of 7 July 2010, the Charter of Fundamental Rights of the European Union and the Convention of the Council of Europe for the protection of human rights and the dignity of the human being in respect of the applications of biology and medicine, signed in Oviedo on 4 April 1997, and which entered into force in Spain on 1 January 2000, as the International Convention on the Rights of Persons with Disabilities, of enforced in our country since 3 May 2008. With respect to the internal legal order, the provisions of Law 30/1979 of 27 October, Law 14/1986 of 25 April, Law 15/1999 of 13 December, Law 41/2002 of 14 November, Law 16/2003 of 28 May, are respected. and Title VI of Law 33/2011, of 4 October, General of Public Health. Finally, from an organisational point of view, the provisions of Royal Decree 1277/2003 of 10 October 2003 laying down the general bases for the authorisation of health centres, services and establishments have been taken into account. Royal Decree 1825/2009 of 27 November, approving the Statute of the National Transplantation Organization, and Royal Decree 1301/2006 of 10 November, laying down quality and safety standards for the donation, the obtaining, evaluating, processing, preserving, storing and distributing human tissues and cells and the standards of coordination and operation for their use in humans, as amended by Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of their performance.

The royal decree is ordered in thirty-four articles structured in nine chapters, four additional provisions, a transitional provision, a derogation provision, four final provisions and three annexes. Chapter I deals with the general provisions, Chapter II, respect for and protection of the donor and the recipient, Chapter III, the procurement of organs, Chapter IV, their allocation, transport and exchange, Chapter V of the organ transplantation, Chapter VI of its quality and safety, Chapter VII of the authorities and the coordination of activities related to the procurement and transplantation of organs, Chapter VIII of the information systems, and the Chapter IX, of the inspection, supervision and precautionary measures and of the infringements and penalties. The additional provisions deal, successively, with the transport of potentially dangerous material, the evaluation and accreditation of centres and services, the application of the royal decree to the cities of Ceuta and Melilla, and of the military health network. The transitional provision refers to the survival of health authorizations for organ procurement and transplantation centers. The derogatory provision repeals Royal Decree 2070/1999 of 30 December on the activities of the collection and clinical use of human organs and the territorial coordination in the field of organ donation and transplantation. tissues. The final provisions regulate the jurisdiction and the basic character of the rule, the incorporation of the European Union law, the enabling for the normative development and the entry into force of the royal decree. Finally, the three annexes, respectively, comprise technical requirements related to the diagnosis and certification of death in order to obtain organs from deceased donors, the authorization of organ transplant centers and the characterization of donors and human organs.

In accordance with the provisions of Article 149.1.16 of the Constitution, this royal decree is dictated in accordance with the competence of the State to regulate the bases and general coordination of health and health outside.

In the process of elaboration of this standard, the autonomous communities and cities of Ceuta and Melilla, and public and private bodies in the process of information and hearing, including associations of patients and professional and scientific societies. It has also submitted to the plenary session of the Interterritorial Council of the National Health System and its Advisory Committee, and has issued a mandatory report by the General Council of the Judicial Branch and the Spanish Data Protection Agency.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers, at their meeting on 28 December 2012,

DISPONGO:

CHAPTER I

General Provisions

Article 1. Object.

This royal decree aims to regulate the activities related to the obtaining and clinical use of human organs and to establish requirements related to the quality and safety of human organs, in order to to ensure a high level of protection of human health and to reduce as much as possible the loss of the available organs.

Article 2. Scope.

1. This royal decree applies to the donation, evaluation, characterization, extraction, preparation, allocation, transport and transplantation and monitoring, as well as the exchange of human organs with other countries.

2. It shall apply where the organs are to be used for therapeutic purposes, that is to say, in order to promote the health or the conditions of life of the recipient, without prejudice to any research which may be carried out additionally.

3. Excluded from the scope of this royal decree:

(a) the organs, when their extraction is exclusively intended to carry out clinical studies or analyses, or other diagnostic or therapeutic purposes;

b) the blood and its derivatives;

(c) tissues and cells and their derivatives, with the exception of vascularized composite tissues;

d) the gametes;

e) human embryos and fetuses;

f) hair, nails, placenta and other human waste products;

g) the conduct of clinical autopsies, as established in Law 29/1980, of June 21, of clinical autopsies, and in Royal Decree 2230/1982, of June 18, on clinical autopsies;

h) the donation of the body itself for use in studies, teaching or research;

i) xenotransplantation.

Article 3. Definitions.

For the purposes of this royal decree, it is understood by:

1. Competent authority: each of the health administrations responsible for the implementation of the provisions of this royal decree.

2. Health authorisation: administrative resolution which, according to the requirements laid down, empowers a health centre for the procurement or transplantation of organs.

3. Donor characterization: process of collecting the information necessary to assess the suitability of the donor, in order to perform an appropriate risk-benefit analysis, minimize the risks to the donor and to the recipient and optimize the organ allocation.

4. Organ characterization: process of collecting the necessary information to assess the suitability of the organ, in order to allow an appropriate risk-benefit analysis, to minimize the risks to the donor and to the recipient and to optimize the organ allocation.

5. Centre for obtaining deceased donor organs: a health centre which, in compliance with the requirements laid down, has the appropriate authorisation for the development of the activity of obtaining deceased donor organs.

6. Centre for the procurement of living donor organs: a health centre which, in compliance with the requirements laid down, has the corresponding authorisation for the development of the activity of obtaining organs from living donors.

7. Organ transplant center: health center that, in compliance with the established requirements, has the corresponding authorization for the development of organ transplant activity.

8. Death certificate: medical act by virtue of which a written record of the diagnosis of the death of an individual is recorded, either by neurological criteria (brain death) or by circulatory and respiratory criteria. This written record does not replace the subsequent and mandatory completion of the medical certificate of death, established in Law 20/2011, of July 21, of the Civil Registry.

9. Hospital coordination of transplants: a care unit that aims to organize and optimize the collection and clinical use of human organs. The staff of the coordination team may belong to the staff of any hospital health service, and shall have the appropriate qualification or training and competence for the performance of the coordination tasks, which shall always be will be performed by a physician or by nursing staff under their supervision.

10. Dismissal: definitive status of the organ which, once obtained, is not used for transplantation, either because it is removed or because it is intended for different uses.

11. Diagnosis of death: a process that confirms the irreversible cessation of circulatory and respiratory functions or brain functions, in accordance with the criteria established in this royal decree.

12. Donation: cession of organs for subsequent human transplantation.

13. Deceased donor: deceased person from whom it is intended to obtain organs for further transplantation and which, in accordance with the requirements laid down in this royal decree, would not have left express evidence of his opposition.

14. Living donor: a living person from whom, in accordance with the conditions laid down here, it is intended to obtain those organs, or part thereof, whose production is compatible with life and whose function can be compensated by the donor's body appropriate and sufficiently secure form.

15. Assessment: A process of analysis and decision-making that determines the suitability of a donor and his organs for transplantation.

16. Serious adverse event: any unwanted or unforeseen incidence linked to any stage of the process from donation to transplantation, the consequence of which may be the transmission or prolongation of a disease, hospitalization or prolongation, disability or disability, or death.

17. Procurement: A process by which the donated organs are available for transplantation into one or more receptors, and which extends from donation to surgical removal of organs and their preparation.

18. European organisation for the exchange of organs: a supranational non-profit organisation dedicated to the national and cross-border exchange of organs, in which the majority of its members are member states of the European Union.

19. Organ: the differentiated part of the human body made up of various tissues that maintains its structure, vascularization and capacity to develop physiological functions with an important degree of autonomy and sufficiency. In this sense, they are organs: the kidneys, the heart, the lungs, the liver, the pancreas, the intestine, and how many others with similar criteria can be obtained and transplanted according to scientific and technical advances. It is also considered an organ, the part of it whose function is to be used in the human body for the same purpose as the whole organ, maintaining the requirements of structure and vascularization. For the purposes of this royal decree, organs are also considered to be the vascularized composite tissues.

20. Preparation: A set of procedures to which an organ is subjected to reach the recipient in order to transplant it.

21. Preservation: use of chemical, physical or other agents or procedures in order to stop or delay the deterioration of organs, from death to transplantation in the case of donation after death diagnosed by circulatory and respiratory criteria, or from their extraction to their transplantation, in the case of donation after death diagnosed by neurological criteria or living donation.

22. Protocol: Written instructions describing the steps of a specific process, including the materials and methods to be used and the final result to be obtained.

23. Serious adverse reaction: unintended response in the living donor or recipient, including a communicable disease, that may be associated with any stage from donation to transplantation, and cause or prolong a disease or a disease hospitalization, generate disability or disability, be life-threatening, or cause death.

24. Recipient: a person who receives the transplant from one or more organs for therapeutic purposes.

25. Transplantation: a process aimed at restoring certain functions of the human body by replacing a diseased organ, or its function, from a living donor or a deceased donor.

26. Traceability: ability to locate and identify the organ at any stage from donation to transplantation or its dismissal including the ability to:

a) Identify the donor and the procurement center.

b) Identify recipients in transplant centers.

c) Locate and identify all non-personal information regarding products and materials that have come into contact with the organ and which may affect the quality and safety of the organ.

CHAPTER II

Respect and protection for the donor and the recipient

Article 4. Fundamental principles governing the procurement and clinical use of human organs.

1. In obtaining and using human organs, the fundamental rights of the person and the ethical postulates that apply to clinical practice and biomedical research must be respected.

2. The principles of voluntarism, altruism, confidentiality, non-profit and gratuitousness will be respected, so that it is not possible to obtain economic compensation or any other kind of donation from any part of the human body.

3. Selection and access to the transplant of potential recipients will be governed by the principle of equity.

4. Safety and quality measures will be taken to reduce organ losses, minimize potential risks, seek to ensure maximum chances of transplant success, and improve the efficiency of the procurement and transplantation process. of organs.

Article 5. Confidentiality and protection of personal data.

1. No information shall be disclosed to permit the identification of the donor and the recipient of human organs. From this principle, the exception of cases where an individual, in a public, free and voluntary manner, is identified as a donor or as a recipient. Even if such an extreme occurs, the provisions of the following paragraph must be respected.

2. Neither the donors nor their relatives will be able to know the identity of the recipient or their relatives and vice versa. Any dissemination of information that may directly relate to the obtaining and subsequent transplantation shall be avoided.

This limitation is not applicable to those directly interested in the transplantation of live donor organs among people who are genetically related, by parentage or by intimate friendship.

3. The information concerning donors and recipients of human organs shall be collected, treated and protected in the strictest confidentiality, in accordance with the provisions of article 10.3 of Law 14/1986 of 25 April, General of Health, the Organic Law 15/1999, of 13 December, of Protection of personal data, and Law 41/2002, of 14 November, basic regulation of the autonomy of the patient and of rights and obligations in matters of information and clinical documentation.

4. The duty of confidentiality shall not prevent the adoption of preventive measures where the existence of risks to individual or collective health is suspected in the terms provided for in Articles 26 and 28 of Law 14/1986 of 25 April, or in its In accordance with the provisions of the Organic Law 3/1986 of 14 April of Special Measures on Public Health and Article 16 of Law 41/2002 of 14 November.

Article 6. Education, promotion and advertising.

1. The competent authorities shall promote the information and education of the population in respect of donation and transplantation, of the benefits they provide to the persons in need, as well as of the conditions, requirements and guarantees which assume.

2. The promotion of human organ donation will always be carried out in a general way and by pointing out its voluntary, altruistic and selfless character.

3. The promotion and publicity of the centres and activities referred to in this royal decree shall be subject to inspection and control by the competent authorities as provided for in Article 30.1 of Law 14/1986 of 25 April.

4. The advertising of organ donation is prohibited for the benefit of individual persons, health centres, or institutions, foundations or particular companies. It is also expressly prohibited from misleading advertising which leads to errors in the procurement and clinical use of human organs, in accordance with the available knowledge.

Article 7. Gratuity of donations.

1. No gratification may be received for the donation of human organs by the donor, nor for any other natural or legal person. No pecuniary or other benefits may be offered or delivered in relation to the assignment of one or more organs for transplantation, as well as to request or accept them.

2. The completion of medical procedures related to the procurement shall in no case be burdensome for the living donor or for the family of the deceased. The principle of gratuitousness will not prevent living donors from the compensation of expenses and the loss of income directly related to the donation. Where such a refund is appropriate, it shall necessarily be carried out by means of the mechanisms which may be provided for by the competent authorities for that purpose.

3. It is prohibited to make any publicity about the need for an organ or about its availability, offering or seeking some kind of gratification or remuneration.

4. The recipient shall not be required to pay any price for the transplanted organ.

CHAPTER III

From obtaining the organs

Article 8. Requirements for obtaining living donor organs.

1. Obtaining organs from living donors for further transplantation may be performed if the following requirements are met:

a) The donor must be older, enjoy full mental faculties, and a proper state of health.

(b) It must be an organ, or part thereof, whose production is compatible with life and whose function can be compensated by the donor body in an appropriate and sufficiently safe manner.

c) The donor must be informed in advance of the consequences of his decision, of the risks, to himself or to the recipient, as well as of the possible contraindications, and of the way to proceed provided by the center before the contingency that once the organ had been removed, its transplant could not be possible on the recipient to which it was intended. The donor must give his consent in an express, free, conscious and disinterested manner. Information and consent shall be made in appropriate formats, in accordance with the rules set out in the design principle for all, in such a way as to make people with disabilities accessible and comprehensible.

d) The donor must not suffer from or have any mental deficiencies, mental illness or any other condition for which he or she cannot give his consent in the manner indicated. The obtaining of organs of minors, even with the consent of the parents or guardians, cannot be performed.

e) The destination of the organ obtained will be your transplant to a given person for the purpose of substantially improving your life prognosis or living conditions.

2. No living donor organs will be obtained or used if sufficient chances of transplant success are not expected, if there are suspicions that the donor's free consent is altered to this article, or when Any circumstances may be considered to be an economic, social, psychological or any other type of conditioning.

In any case, a report of the Ethics Committee will be required to proceed with the procurement.

3. Living donors will be selected on the basis of their health and their clinical background. The physical and mental health of the donor must be accredited by a qualified doctor other than those who are to carry out the extraction and transplantation, which shall inform the risks inherent in the intervention, the consequences predictable or psychological, the effects that may be expected in your personal, family or professional life, as well as the benefits expected from the transplant and the potential risks to the recipient. In this regard, the importance of the transmission of personal records should be transferred to the living donor. In the light of the outcome of this examination, any person may be excluded where the procurement may pose an unacceptable risk to his or her health, or the organ transplant obtained for that of the recipient.

The above shall be accredited by a medical certificate which shall necessarily refer to the health status, the information provided and the response and motivations freely expressed by the donor and, in his/her case, any indication of pressure external to it. The certificate shall include the nominal relationship of other professionals who may have collaborated in such tasks with the doctor who certifies.

4. In order to obtain organs from a living donor, the presentation shall be required before the Court of First Instance of the locality in which the removal or transplantation is to be carried out, at the choice of the sponsor, of a request from the donor or communication from the Director of the health centre at which it is to be carried out, or the person to whom it delegates, in which the personal and family circumstances of the donor, the subject of the donation, the health centre to be carried out shall be expressed; the removal, the identity of the doctor responsible for the transplant and accompanying the medical certificate on the mental and physical health of the donor.

The donor must give his or her express consent to the Judge during the hearing to be held in the case of the Voluntary Jurisdiction that is being processed, following the explanations of the physician to carry out the extraction and in the presence of the doctor referred to in paragraph 3 of this Article, the doctor responsible for the transplant and the person to whom it is appropriate to give the agreement for the intervention, in accordance with the authorisation document for the removal of organs granted.

5. The document of assignment of the organ where the donor's conformity is manifested will be extended by the Judge and signed by the donor, the physician who has to execute the extraction and the other assistants. If any of the above doubt that the consent for the obtention has been granted expressly, freely, consciously and disinterested, it will be able to effectively oppose the donation. Copies of the transfer document shall be made available to the donor. In no case may organ procurement be performed without the prior signature of this document.

6. Between the signature of the transfer document of the organ and the removal of the organ must elapse at least twenty-four hours, the donor being able to revoke his consent at any time prior to the intervention without any formality. Such revocation may not give rise to any kind of compensation.

7. The procurement of organs from living donors may only be carried out in the health centres expressly authorised to do so, and shall inform the competent authority responsible prior to its completion of the procedure.

8. By way of derogation from Article 7, the living donor shall be provided with health care for his/her re-establishment and shall be provided with clinical monitoring in relation to the procurement of the organ.

Article 9. Requirements for obtaining deceased donor organs.

1. The procurement of organs from deceased donors for therapeutic purposes may be performed if the following requirements are met:

(a) That the deceased person from whom it is intended to obtain organs, has not expressly expressed his opposition to the fact that after his death the obtaining of organs is carried out. Such opposition, as well as their conformity if they wish to express, may refer to all types of organs or only to one of them and shall be respected.

In the case of minors or incapacitated persons, the opposition may be put on record by those who have been in the life of those who represent them, in accordance with the provisions of the legislation. civil.

(b) Whenever it is intended to obtain organs from deceased donors in an approved centre, the person responsible for the hospital coordination of transplants, or the person to whom he delegates, shall carry out the following: relevant checks on the will of the deceased:

1. Investigate if the donor made a patent of his or her will to any of his relatives, or to the professionals who have cared for him in the health center, through the annotations that they have been able to make in the history clinical, or in the means provided for in the legislation in force.

2. Examine the documentation and personal belongings that the deceased carried with him.

Whenever circumstances do not prevent this, family members present in the health center should be provided with information about the need, nature, and circumstances of obtaining, restoring, preserving, or of mortuary healing.

2. The obtaining of deceased organs may be made only after diagnosis and certification of death carried out in accordance with this royal decree, and in particular in Annex I, the ethical requirements, the scientific advances in the subject matter and generally accepted medical practice.

Professionals who diagnose and certify death must be qualified for this purpose, other than those who have to intervene in the extraction or transplantation and will not be subject to the instructions of the latter.

The death of the individual may be certified after confirmation of the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of brain functions. It will be recorded as the time of death of the patient when the diagnosis of death was completed.

3. The irreversible cessation of circulatory and respiratory functions shall be recognised by appropriate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, observation periods, as well as confirmatory tests as required under the medical conditions, shall be in accordance with the protocols listed in Annex I.

In the case referred to in the preceding paragraph, and for the purposes of the certification of death and the obtaining of organs, the existence of a certificate of death extended by a doctor other than that which intervenes shall be required. in the removal or transplant.

4. The irreversible cessation of brain functions, i.e. the observation of a known structural etiology and irreversible character, shall be recognised by appropriate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, observation periods, as well as confirmatory tests as required under the medical conditions, shall be in accordance with the protocols listed in Annex I.

In the case referred to in the preceding paragraph, and for the purposes of the certification of death and the obtaining of organs, the existence of a death certificate signed by three doctors, including a certificate of death, shall be required. neurologist or neurosurgeon and the Head of Service of the medical unit where you are admitted, or your replacement. In no case shall such facultative be part of the extractor or transplantation of the organs.

5. In cases of accidental death, as well as when a judicial investigation is carried out, prior to the obtaining of organs, the consent of the appropriate judge must be sought, which, after the medical examiner's report, must be granted provided that the result of the instruction in criminal proceedings is not impeded.

In cases of death diagnosed by circulatory and respiratory criteria that require judicial authorization, to proceed with the exercise of maintenance of the organs and with the exercise of preservation, act in accordance with the provisions set out in Annex I.

The application for obtaining organs must be accompanied by the death certificate referred to in paragraphs 3 or 4 of this article, in accordance with a medical report explaining the personal and admission to the hospital, and an accreditative sheet, signed by the person responsible for the hospital coordination of transplants or the person to whom the person is delegated, that the doctor or doctors who sign the death certificate are different from the one who will perform the organ removal and/or transplantation.

6. For the person responsible for the hospital coordination of transplants or for the person to whom the delegation is delegated, as determined in the authorisation of the centre, a document shall be issued stating that:

a) That checks have been made on the will of the deceased, or on persons who have their legal representation.

b) That the necessary information about the procurement process has been provided to the family members, provided that the objective circumstances have not prevented them, indicating the latter situation if it were to occur.

c) That death certificate has been checked and certified and the certificate of death is attached to the authorization document.

(d) In the case of death referred to in paragraph 5, which is granted the authorisation of the appropriate judge.

e) That the hospital center where the procurement is to be performed is authorized for this and that authorization is in effect.

f) The organs for which the procurement is not authorized, taking into account the constraints that the donor may have established.

g) The name, surnames and professional qualifications of doctors who have certified death, and none of these physicians are part of the extractor or transplant team.

7. Deceased donors shall be appropriately characterised in accordance with the provisions of Article 21.

8. Once the restoration of the deceased donor's body has been carried out after obtaining, the access or visitation of his or her family members and close associates shall be permitted, if so requested.

Article 10. Centers for obtaining live donor organs: general requirements and procedures for their health authorization.

1. The procurement of organs from living donors for further transplantation may only be carried out in health centres expressly authorised by the competent authority of the autonomous community concerned.

2. In order to be authorised, the centres where these activities are carried out shall, at least, meet the following requirements:

(a) Be authorised as a centre for obtaining organs from deceased donors and as a transplant centre for the organ for which the authorisation to obtain a living donor is sought.

b) Dispose of sufficient medical and nursing staff with qualifications and proven experience for the correct assessment and selection of the donor and the achievement of the achievement.

c) Dispose of the necessary facilities and materials for the correct realization of the obtentions, in accordance with the standards accepted in this field and with the best medical practices.

d) Dispose of health services, including laboratories and imaging techniques, necessary to ensure the appropriate preoperative study of the donor and the correct treatment of any complications that may arise. emerge in the same. These health services will have qualified staff and appropriate facilities and equipment.

e) To provide protocols to ensure the proper evaluation and selection of the donor, the transmission of information regarding the donor and the recipient when obtaining and transplantation are not carried out in the same center, the process of the immediate and long-term procurement and follow-up as well as other protocols referred to in Article 25.

f) Dispose of a restricted and confidential access register, with their corresponding alphanumeric keys, where the necessary data will be collected to ensure traceability.

g) Ensure the recording of the information relating to living donors and their clinical follow-up, in accordance with Article 31, without prejudice to the provisions on the protection of personal and secret data statistic.

h) Meet the requirements for confidentiality and protection of personal data, promotion and advertising, and free donations.

3. Without prejudice to the specific rules of each autonomous community, the procedure for granting, renewing and extinguishing the approval of the centres for the attainment of the living donor shall be adjusted to the requirements of the Article 11 on the authorisation of institutions to obtain organs from deceased donors.

The authorization will determine the person to whom, in addition to the person responsible for the medical unit in which the transplant is to be performed, it is appropriate to give the agreement for each intervention.

4. The approval of the centres to obtain human organs may be revoked or suspended as a result of the inspection and inspection by the competent authorities in accordance with Article 31 of Law 14/86, April 25.

Article 11. Centres for obtaining deceased donor organs: requirements and procedure for their health authorisation.

1. The procurement of organs from deceased donors may only be carried out in health centres which have been expressly authorised by the competent authority of the relevant Autonomous Community.

2. In order to be authorised, the procurement centres of deceased donor bodies shall at least meet the following requirements:

a) Dispose of an organization and a functioning regime that allows to ensure successful completion.

b) Dispose of a hospital coordination unit for transplants, staffed and adequate means, that will be responsible for coordinating the procurement process, including donation as well as monitoring and validation the selection and evaluation of donors.

(c) Ensure the availability of qualified medical personnel and the technical means to verify death in accordance with Article 9 and Annex I.

d) Ensure the availability of properly qualified medical and nursing staff, as well as adequate health services and technical means for the correct selection, assessment, characterization and maintenance of the donor.

e) Ensuring the availability of adequate health services, including laboratories and imaging techniques, for the performance of those determinations that are considered at any time necessary and that permit a adequate clinical evaluation of the donor. These services will have qualified staff and appropriate facilities and equipment.

f) Ensure the availability of the facilities and materials necessary for the correct realization of the obtentions, in accordance with the standards accepted in this field and with the best medical practices.

g) Dispose of the protocols referred to in Article 25, in order to ensure the quality and safety of the entire process.

h) Dispose of a restricted and confidential access register, with its corresponding alphanumeric keys, where the necessary data will be collected to guarantee traceability, as well as to link the traceability of the tissues and cells obtained from the donors referred to in this Article.

i) Dispose of a donor's sera file for a minimum period of ten years, in order to make, if necessary, biological controls.

j) Ensure the availability of the appropriate personnel, facilities and services for the restoration of the deceased person's body, once the procurement has been performed.

k) Meet the requirements for confidentiality and protection of personal data, promotion and advertising, and free donations.

3. Without prejudice to the specific rules of each Autonomous Community, the application for authorisation shall contain at least:

a) The name of the or those responsible for the procurement process, which will include the person responsible for the hospital coordination of transplants.

b) A memory with the detailed description of the human and material means and the protocols that the center has at its disposal, in accordance with the requirements of paragraph 2 of this article.

4. Without prejudice to the specific rules of each autonomous community, the authorisation shall contain at least:

a) The activity for which the center is authorized.

b) The name of the or those responsible for the procurement process.

c) Its duration, depending on the period of validity to be determined by the competent authority.

5. At the end of the period of validity of the authorization, it may be renewed on the basis of a finding that the conditions which gave rise to the authorisation remain. In no case shall it be automatically extended.

6. Any substantial modification which takes place under the conditions, structure, responsibility or operation of the centre shall be notified to the competent authority and may give rise to the review of the health authorisation, including their extinction, even if the period of validity has not expired.

7. The Autonomous Communities shall notify the Ministry of Health, Social Services and Equality of the decisions they take in relation to the approval of the centres for the collection of deceased donor organs which is governed by this provision. and which are to be included in the General Register of Health Centres, Services and Facilities and in the register referred to in Article 30.

8. The procurement centres shall provide the competent authority of the autonomous community with all the information requested to them in respect of the authorised activity, in accordance with the provisions of the European Union and national on the protection of personal data and statistical confidentiality.

9. The approval of the centres to obtain human organs may be revoked or suspended as a result of the inspection and inspection by the competent authorities in accordance with Article 31 of Law 14/86, April 25.

10. Exceptionally, in situations where it is feasible and necessary to obtain organs from a deceased donor in a health centre which is not authorised for such an activity, a specific and extraordinary authorisation may be granted. to proceed with such procurement when the following circumstances are present:

(a) The person responsible for the unauthorised health centre, or in whom this delegate is responsible, agrees to carry out such a procedure.

(b) An approved centre for the procurement of deceased donor organs assumes, with the knowledge and approval of the person responsible for such a centre, or in whom it delegates, the protection for the execution of the process of obtaining organs in the unauthorised centre where the potential donor is located.

c) Such a guardianship is exercised through the hospital coordination of transplants of the authorized center.

(d) Each and every one of the requirements set out in this Article for the approval of centres for obtaining deceased donor organs is fulfilled and in case the unauthorised centre does not comply with any of the requirements set out in this Article. These requirements, their compliance is guaranteed by the center whose hospital coordination of transplants exercises the guardianship.

e) The favourable will of the potential donor with respect to organ donation or, in its absence, no objection to it is known.

(f) Compliance with all the requirements laid down in this Royal Decree, and in particular those relating to the process of obtaining deceased donor organs, is ensured in accordance with the provisions of the Article 9.

g) There is a clear requirement for the autonomic transplant coordinator, who has to verify compliance with all of the above and, after obtaining, will bring to the attention of the competent authority of the autonomous community performing such a procurement in accordance with the requirements herein laid down and the result thereof.

Article 12. Preparation of human organs.

1. The staff of the procurement centre shall use the appropriate techniques and means to ensure that each organ reaches its recipient in the best possible conditions, in accordance with the protocols relating to the preservation, packaging and labelling of refers to Article 25.

2. Where the organ is to be transferred to a transplant centre other than the procurement centre, it shall be accompanied by the following documentation:

(a) An external label, which shall have a common format at least when the transport of the organ is carried out between autonomous communities or from Spain to other countries, and in which, in all cases, the following shall be shown:

1. An indication that a human organ is transferred, specifying the type of organ, and if appropriate, its right or left anatomical location, with the warning " HUMAN ORGAN FOR TRANSPLANTATION. MANIPULATE WITH CARE. "

2. The origin and destination of the organ: the procurement center and transplant center involved, with the name of the responsible for the shipment and the reception, and the addresses and telephone numbers of the centers mentioned.

3. Day and Time of Getting Out of the Get Center.

4. Transportation Recommendations, with instructions for keeping the container at an appropriate temperature and in an appropriate position.

b) A report on the characteristics of the donor and organ, its extraction and the preservation solutions used.

c) Studies performed and their results.

3. Without prejudice to the provisions of the previous paragraph, where the body is sent to another country of the European Union, the documentation relating to the characteristics of the donor and the organ shall comply with the procedures laid down by the European Commission. set to the effect.

CHAPTER IV

From the allocation, transport and exchange of organs

Article 13. Assignment of human organs.

1. The allocation of the organs will be carried out by clinical criteria, equity, quality, safety and efficiency. The allocation criteria shall cover situations where there is immediate vital risk.

2. The allocation criteria shall be updated where it is considered appropriate to obtain an improvement in clinical outcomes, equity, quality, safety, or efficiency.

3. Without prejudice to the above, it will be ensured by all means to optimize each donation, to encourage the clinical use of the organs and to reduce the losses of the organs.

Article 14. Transport of human organs.

1. The transport of the organs from the procurement centre to the transplantation centre shall be carried out under appropriate conditions, in accordance with the characteristics of each organ and the provisions of Article 12.

2. Organisations, bodies or undertakings involved in the transport of organs shall have appropriate protocols in place to ensure the integrity of the body during transport, as well as their performance at an appropriate time.

3. Without prejudice to the specific clinical or urgent criteria of each case, the transport shall be organised in accordance with criteria of quality, safety and efficiency.

Article 15. Exchange of human organs with other countries.

1. In Spain, the entry or exit of human organs for transplantation will be the subject of prior authorisation by the Ministry of Health, Social Services and Equality through the National Transplant Organisation.

2. The National Transplant Organisation may authorise the entry into Spain of human organs for transplantation from other countries, if the following conditions are met:

(a) The exit of the organ is carried out under the supervision of the competent authority of the country from which the organ originates, or from whom it receives the delegation of the organ, including a European organ exchange organisation.

b) Appropriate receiver exists in Spain.

(c) Where the body comes from a Member State of the European Union, the exit is carried out in compliance with the Community procedures laid down for the characterisation of donors and organs, traceability and notification and management of serious adverse events and reactions.

d) When the organ comes from third countries, ethical and quality and safety requirements equivalent to those set out in this royal decree, including the traceability of organs, are met.

3. The National Transplant Organisation may authorise the departure from Spain of human organs for transplantation to other countries, if the following conditions are met:

a) The appropriate receiver exists in the target country.

(b) The entry of the body is carried out under the supervision of the competent authority of the country of destination, or of whom it receives the delegation of the body, including a European organ exchange organisation.

(c) Where the organ is intended for a Member State of the European Union, the entry is made in compliance with Community procedures to be established for the characterisation of the donor and the organ, the traceability and the notification and management of serious adverse events and reactions.

d) When the organ is intended for third countries, ethical and quality and safety requirements equivalent to those set out in this royal decree, including the traceability of organs, are met.

4. The exchange of human organs for transplantation with other countries may be carried out in the framework of collaboration agreements between Spain and those countries.

Article 16. Powers of authorisation and supervision of the international exchange of human organs.

The powers of the State in this matter may, where appropriate, be the subject of a discharge in accordance with the terms laid down in Article 15 of Law No 30/1992, the Legal Regime of Public Administrations and the Rules of Procedure. Common Administrative.

CHAPTER V

Organ Transplant

Article 17. Requirements for human organ transplantation.

1. The transplantation of human organs may only be carried out in approved centres, with the prior written consent of the recipient or his legal representatives, as provided for in Article 9 of Law 41/2002 of 14 November, prior to information of the risks and benefits involved in the intervention, as well as of the studies that are technically appropriate for the type of transplant in question in each case.

2. The document setting out the informed consent of the recipient shall include: the name of the transplant centre and the name of the recipient and, where appropriate, the name of the representatives authorising the transplant. The document will have to be signed by the doctor who informed the recipient and by himself or his representatives.

The document will be archived in the patient's medical history and will be made available to the patient.

3. Prior to the transplantation of an organ, it shall be verified that:

a) The characterization of the organ and the donor has been completed and recorded.

b) The requirements for organ preparation and transport have been respected.

4. The person responsible for the medical unit in which the transplant is to be carried out may only give its conformity if, after assessing the information relating to the characterisation of the donor and the organ in accordance with Annex III and the situation of the recipient, there are reasonable prospects for substantially improving the vital prognosis or the living conditions of the recipient and whether studies have been conducted between donors and recipients that are technically appropriate for the type of transplant that is in each case treat. In the event that all the minimum data set out in Annex III (A) are not available and, if on the basis of the risk-benefit analysis of each particular case, including vital emergencies, the expected benefits for the The recipient is superior to the risks involved in the incomplete data, the transplant of the organ in question may be considered.

5. In order to maintain traceability, the data necessary for the identification of the donor, the organ and the hospital establishment from which the transplanted organ is derived shall be collected in the clinical history of the recipient. corresponding alphanumeric keys that ensure data protection and confidentiality.

Article 18. Human organ transplant centers: general requirements for your health authorization.

1. Human organ transplantation may only be performed in health centres with specific authorisation from the competent authority of the relevant Autonomous Community.

2. In order to be authorised, human organ transplant centres shall meet at least the following general requirements:

(a) Be authorised as a centre for obtaining deceased donor organs and demonstrate sufficient activity to ensure the viability and quality of the transplant programme.

b) Dispose of a health organization and an appropriate operating system to perform the requested intervention.

c) Dispose of the appropriate medical and surgical unit with sufficient healthcare personnel and with proven experience in the type of transplant concerned.

d) Ensure the availability of specialists with proven expertise in the diagnosis and treatment of transplant complications to develop.

e) Dispose of a hospital coordination unit for transplants.

f) Dispose of the facilities and materials necessary for the proper performance of the transplantation process, both in the preoperative period, as well as in the intervention and in the postoperative period, in accordance with the standards accepted in This is a matter of best medical practice.

g) Dispose of the health services, including laboratories and imaging techniques, necessary to ensure the completion of the transplant, the appropriate clinical follow-up of the recipient and the correct treatment of the possible complications that the practice of this transplant requires. These health services will have qualified staff and appropriate facilities and equipment.

h) Dispose of a pathological anatomy service with the technical and human means necessary for the study of complications associated with transplantation and to be able to carry out the possible post-mortem studies.

i) Dispose of a microbiology laboratory where the controls of infectious complications presented by patients can be carried out.

(j) Ensure the availability of an immunology laboratory and a histocompatibility unit with the necessary technical and human resources to ensure the correct performance of the immunological studies necessary for the pre and post-transplant monitoring.

k) Dispose of a Transplant Commission and of those protocols that ensure adequate selection of the recipients, the process of transplantation and the immediate and long-term post-operative follow-up, and that guarantee the quality and the safety of the entire therapeutic procedure, as well as of the other protocols referred to in Article 25.

l) Dispose of a record, restricted and confidential access, with their corresponding alphanumeric keys, where they will consist of the transplants performed with the precise data to guarantee the traceability.

m) Ensure the recording of information to enable the assessment of the activity of the transplants performed at the centre, as well as the results obtained, in accordance with Article 31 and without prejudice to the provisions on the protection of personal data and statistical confidentiality.

n) Adecuate at all times the performance and means of the medical units involved in the different types of transplantation to scientific progress, following updated diagnostic and therapeutic protocols.

or) Meet the requirements for confidentiality and protection of personal data, promotion and advertising, and free donations.

Article 19. Human organ transplant centres: specific requirements for their health authorisation.

In addition to the general requirements laid down in the previous Article, the human organ transplantation centres shall meet the minimum specific requirements set out in Annex II for the procedures laid down in Annex II. details.

Article 20. Procedure for the granting, renewal and extinction of health authorization to human organ transplant centers.

1. Human organ transplantation shall be carried out in health centres which have been specifically authorised for each of its modalities by the competent authority of the relevant autonomous community.

2. Without prejudice to the specific rules laid down in each autonomous community, the application for authorisation shall contain at least:

a) The type of transplant to perform.

b) The relationship of physicians responsible for the transplant team, as well as the documentation supporting their qualification.

c) A memory with the detailed description of the human and material means and protocols available to the center, in accordance with the requirements required to perform the corresponding activity.

3. Without prejudice to the specific rules of each autonomous community, the authorisation shall contain at least:

a) The type of transplant for which the center is authorized.

b) The name of the or those responsible for the transplant team.

c) Its duration, depending on the period of validity to be determined by the competent authority.

4. At the end of the period of validity of the authorisation, it may be renewed on the basis of a finding that the conditions which gave rise to the authorisation remain. In no case shall it be automatically extended.

5. Any substantial modification which takes place under the conditions, structure, responsibility or operation of the centre shall be notified to the competent authority and may give rise to the review of the health authorisation, including their extinction, even if the period of validity has not expired.

6. The competent authority of the autonomous community, in the light of the results obtained in the transplants carried out by the centre, may revoke the authorisations granted.

7. The Autonomous Communities shall notify the Ministry of Health, Social Services and Equality of the decisions which they adopt in relation to the transplanters of human organs which are governed by this provision and which must appear on the General Register of Centres, Services and Health Facilities and in the register referred to in Article 30.

8. Human organ transplantation centres shall provide the competent authority of the autonomous community with all the information requested for them in relation to the activity for which they have been authorised.

9. The different organ transplantation modalities that exist or may appear as a result of scientific-technical development may be contemplated in the following three situations:

(a) Modes expressly regulated by the Ministry of Health, Social Services and Equality, as laid down in Article 19 and Annex II, in which the technical requirements and minimum conditions which have been applied are developed; to comply with the centres and services to be carried out: the competent authority of the autonomous community concerned, after having verified compliance with those conditions and requirements, may, in accordance with its own discretion, grant the authorization.

(b) Modes for which there is no express regulation by the Ministry of Health and Social Services and Equality and National Regulations of the Autonomous Community concerned: the competent authority of the Autonomous Community it may be authorized for a given center and service for the development of each individual procedure, prior to the report of the Transplant Commission of the Interterritorial Council of the National Health System.

(c) Modes for which there is an express regulation by the Ministry of Health, Social Services and Equality which prohibits their initiation or suspends their development: such prohibition or suspension shall be given by the Ministry of Health, Social Services and Equality, heard or on a proposal from the entities or societies of a scientific nature that are relevant in each case, and in consideration of special circumstances of risk to patients.

The competent authorities of the Autonomous Communities shall not grant or withdraw the authorisations which they may have granted to the centres and services in those forms expressly prohibited or suspended.

10. The approval of the centres to obtain human organs may be revoked or suspended as a result of the inspection and inspection by the competent authorities in accordance with Article 31 of Law 14/86, April 25.

CHAPTER VI

Of the quality and safety of the organs

Article 21. Characterization of donors and human organs.

1. All organs obtained and their donors must be adequately characterized before transplantation.

For each donation the minimum set of data specified in Annex III (A) must be collected. Furthermore, a decision of the responsible medical team, taking into account the availability of the data and the particular circumstances of each case, should also be collected for the additional data specified in paragraph B of that Annex.

2. Without prejudice to the provisions of paragraph 1 of this Article, if, according to the risk-benefit analysis of each particular case, including vital emergencies, the expected benefits for the recipient are higher than the risks involved. incomplete data, an organ may be considered for transplantation even if all the minimum data set out in paragraph A of the Annex are not available.

3. In order to meet the quality and safety requirements laid out in this royal decree, the responsible medical team:

a) Seek to obtain all necessary information from living donors, and to this end, provide the information they need to understand the consequences of the donation.

(b) In the case of a deceased donor, he shall endeavour to obtain the necessary information, whenever possible and appropriate, from family members or other persons.

(c) In any event, it shall endeavour to ensure that all parties to whom information is requested are aware of the importance of early transmission of the information.

4. The analyses necessary for the characterisation of the organ and the donor shall be carried out by laboratories equipped with qualified personnel and appropriate facilities and equipment.

5. The procurement and transplantation centers, including laboratories and other departments that can participate in the characterization of the organs and donors, will have adequate protocols to ensure the timely transmission of the information relating to the characterization.

6. Without prejudice to the provisions of this Article, where the body is sent to another country of the European Union, the information contained in Annex III to this royal decree shall be sent at least and shall be acted upon in accordance with the procedures laid down in this Article. European Commission set the effect. In addition, where the body is received from another European Union country, the receipt of such information shall be verified in accordance with the same procedures.

Article 22. Traceability of human organs.

1. In order to protect the health of living and receiving donors, the traceability of all organs obtained, assigned, transplanted or dismissed in Spain shall be ensured.

2. A donor and recipient identification system will be implemented to identify each donation and each of the organs and receptors associated with it. Such a system shall comply with the requirements relating to the confidentiality and security of data established by the existing rules on the protection of personal data.

3. Without prejudice to the powers of the autonomous communities in this field, the procurement centres and transplant centres, together with the National Transplant Organisation, will retain the necessary data to ensure traceability and information on the characterization of organs and donors.

4. The data required for complete traceability shall be kept at least 30 years after the donation, and may be stored in electronic form.

5. Without prejudice to the provisions of the previous Article, where there is an exchange of organs between Spain and another Member State, the information necessary to ensure traceability shall be transmitted in accordance with the procedures which, Effect, establish the European Commission.

Article 23. System for reporting and managing serious adverse events and reactions.

1. Without prejudice to the powers of the Autonomous Communities, and in cooperation with them, the National Transplant Organization shall implement a state system to notify, investigate, register and transmit relevant information and necessary on serious adverse events and serious adverse reactions.

2. Through the Quality and Safety Framework Programme, protocols will be established for the timely notification and management of serious adverse events or reactions.

3. The procurement and transplantation centres shall have protocols for the timely notification of any serious adverse reaction or event to the competent authorities involved and, through them, to the procurement centre or the transplantation centre. corresponding. Those protocols shall also specify the procedures for the notification, to the competent authorities involved, of the management measures related to serious adverse reactions or events.

4. Where there is an exchange of organs between Spain and another Member State, the notification of serious adverse reactions and events shall be carried out in accordance with the procedures established by the European Commission.

5. The quality and safety framework programme and the protocols referred to in paragraph 3 of this Article shall specify the procedures for ensuring the interconnection between the notification and management system set out in this Article and the provisions of Article 34 of Royal Decree 1301/2006 of 10 November laying down quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human tissues and cells and the rules for coordination and operation are approved for use in humans.

Article 24. Training of health personnel.

All healthcare personnel directly involved in any stage from donation to transplantation or the dismissal of organs will have the appropriate qualification to perform their tasks and receive training. appropriate.

Article 25. Quality and safety framework programme.

1. The National Transplant Organisation, in cooperation with the Autonomous Communities, shall establish a framework programme of quality and safety comprising all stages from the donation to the transplantation of the organs or their dismissal, and which Consider, at least, the adoption and application of protocols for:

a) Verification of the identity of the donor.

b) Verification of compliance with the consent requirements for obtaining organs.

c) The verification that the organ and donor characterization has been completed, as well as the transmission of such information.

(d) Obtaining the organs, including their preparation, as defined in Article 3, as well as the verification of the requirements for the preparation of the organs.

e) The transport of organs, as well as the verification of their requirements.

f) Ensure traceability.

g) Accurate, rapid and verifiable notification and management of serious adverse events and reactions.

The protocols referred to in points (f) and (g) shall specify the responsibilities of the procurement centres, the transplant centres and the competent authorities, and where applicable, those assigned to them. European organ exchange organisations.

2. The content of the protocols to be provided by the procurement and transplantation centres for authorisation, as specified in Articles 10, 11 and 18, shall be in line with the protocols to be developed in the Programme. the quality and safety framework referred to in paragraph 1 of this Article.

3. The quality and safety framework programme will ensure that the health workforce directly involved in any stage, from donation to transplantation or dismissal, has the qualification or training and skills required. appropriate. This programme shall include the design of specific training programmes for such staff, as referred to in Article 24.

CHAPTER VII

From the authorities and the coordination of activities related to obtaining and transplantation of organs

Article 26. Competent authorities.

For the purposes of this royal decree, the competent authorities are the Ministry of Health, Social Services and Equality and the Autonomous Communities, each in the field of their respective competences.

Article 27. National Transplant Organization.

The competencies of the Ministry of Health, Social Services and Equality in obtaining and transplantation correspond to the National Transplant Organization, which will exercise the functions assigned to it in its Statute, Royal Decree 1825/2009, dated 27 November, approving the Statute of the National Transplant Organization. These functions, among others, include coordination of procurement, national distribution, and international exchange of organs, tissues, and cells for transplantation.

Article 28. Regional, sectoral and hospital coordination units for transplant coordination.

1. The Autonomous Communities shall establish units for the autonomic coordination of transplants, headed by an autonomic coordinator, appointed by the competent authority in each case. These units will collaborate in the fulfilment of the general objectives set by the Permanent Transplant Commission of the Interterritorial Council of the National Health System.

It is up to the autonomous communities to provide the infrastructure and means to the autonomous units for the proper development of their functions.

2. In those communities deemed necessary, sectoral coordination units may be established.

3. Hospital coordination units, staffed with qualified personnel and the necessary infrastructure and means, shall be established in all approved centres for organ procurement and transplantation.

Article 29. Permanent Transplant Commission of the Interterritorial Council of the National Health System.

The Transplant Commission of the Interterritorial Council of the National Health System, which is governed in accordance with the provisions of the first provision of Royal Decree 1825/2009 of 27 November, is the organ of the responsible for interterritorial coordination and the advice of the National Health System on organ, tissue and cell donation and transplantation.

CHAPTER VIII

Of the information systems

Article 30. Registration of procurement centers and transplant centers.

1. The National Transplant Organisation, without prejudice to the registration powers of the Autonomous Communities, shall develop and maintain a register of procurement and transplantation centres where it shall specify, for each of them, the specific activities for which it is authorised. The list of approved centres shall be accessible to the public.

2. In the field of their competencies, the autonomic coordination of transplants must communicate in real time to the National Transplantation Organization the information regarding the health authorization of the centers of production and transplantation. Such information shall include at least the name of the centre, its postal address, the name of the persons responsible for the procurement process and those responsible for the transplantation equipment, and its contact details, as well as the activities for which it has been carried out. granted the authorisation. Any substantial modification of the authorization must also be communicated.

3. The National Transplant Organisation shall provide information on the registration of procurement and transplantation centres or national requirements for the approval of such centres, at the request of the European Commission or another Member State of the European Union.

Article 31. Information systems.

1. Without prejudice to conventions which may be established with the relevant professional and scientific associations or systems which may be implemented by the Autonomous Communities for such purposes, and in cooperation with them, it shall be a function of the National Transplant Organisation to develop and maintain the state information systems in which the data relating to:

are recorded and maintained;

a) Donors and organs and their characterization.

b) The traceability of organs from donation to transplantation or dismissal and vice versa.

c) The characteristics and movements of patients included in a waiting list for transplantation.

d) The characteristics and follow-up data of transplant patients.

e) The characteristics and monitoring data of living donors.

f) The notification and management measures of serious adverse events and events.

2. For each of the preceding paragraphs, the National Transplant Organization shall define, in cooperation with the autonomous communities, the minimum data to be provided to the state system for any donor, organ, patient on the list of wait or receiver.

3. These state information systems will receive data from the procurement centres or transplant centres, as appropriate, either directly or through the available autonomic systems. The National Transplant Organisation shall define, in cooperation with the autonomous communities, the procedures for the state integration of the information.

4. The state information systems mentioned will allow for regular statistical analysis.

5. With the data included in the systems, and without prejudice to other reports that may be carried out, the National Transplant Organization will produce annual reports of the activity developed by the centers for obtaining and transplantation of all the national territory, including aggregated data from living and deceased donors and the number and type of organs obtained and transplanted or dismissed. These reports, which will in no case contain personal data from donors or recipients, will be disseminated to the transplant coordination network and the transplant teams and will be accessible to the public.

6. State information systems may be used as autonomic or hospital information systems as far as their own data is concerned, where the autonomous community or the hospital concerned so requires.

7. Access to any of the data contained in the information systems shall be restricted to persons authorised in the centres, in the autonomous coordination units or in the National Transplant Organisation.

All information systems, at the hospital, regional or state level, will comply with the provisions of the current regulations on the protection of personal data, confidentiality and statistical confidentiality.

CHAPTER IX

Of inspection, supervision and precautionary measures and of violations and sanctions

Article 32. Inspection, supervision of activities and precautionary measures.

1. The inspection or supervision at regular intervals of the transplant coordination units, the procurement centers and the transplant centers will be the function of each autonomous community. To this end, the units and centres shall provide all the information in the form and manner in which it is requested in relation to the activity for which they have been authorised.

2. If a performance or irregular situation is detected which may compromise the health and/or safety of patients, the preventive and precautionary measures referred to in Articles 5.4, 10.4, 11.9 and 20.10 of this Article shall be adopted. decree, and to notify it immediately to the relevant autonomous coordination unit and the National Transplant Organisation, in order to take appropriate action.

Article 33. Violations.

1. They shall have the consideration of infringements in accordance with the provisions of this royal decree, those provided for in Chapter VI of Title I of Law 14/1986 of 25 April, and Title VII of Organic Law 15/1999 of 13 December, and Title VI of Law 33/2011 of 4 October, General Public Health, and the specific actions or omissions defined in this Article, which may be very serious, serious and minor.

a) Very serious infractions:

1. The realization of any regulated activity in this royal decree without respecting the principle of confidentiality, provided that it is enforceable.

2. The realization of any regulated activity in this royal decree without respecting the principles of voluntarism, altruism, absence of profit or gratuitousness.

3. º Advertising about the need or availability of an organ, offering or requesting some kind of gratification or remuneration.

4. The obtaining of living donor organs in the absence of compliance with any of the prerequisites established in this royal decree, in particular those relating to the majority of age, mental faculties, state of health and consent.

5. The obtaining of deceased donor organs in the absence of any of the prerequisites established in this royal decree, in particular those concerning the investigation into the will of the deceased with respect to the organ donation and the diagnosis and certification of death.

6. º The obtaining or transplantation of organs in a center that does not have the required authorization of the competent authority.

7. º Non-compliance with traceability requirements.

8. º The entry or exit of organs in Spain without the mandatory authorization, in accordance with the provisions of article 15 of this royal decree.

9. The obstruction or impediment of the inspector's work.

b) Serious infractions:

1. Advertising on the need for organs for the benefit of specific persons, health centres or institutions, foundations or certain undertakings, as well as misleading advertising which leads to errors in obtaining and the clinical use of human organs.

2. The failure to comply with the obligation to have qualified personnel, facilities and equipment appropriate for the performance of the activities regulated by this royal decree.

3. The failure to comply with the notification duty referred to in Article 23 of this royal decree when there is a risk to the health of the other recipients.

4. The resistance to providing data to the competent authority in relation to the requirements for their health authorisation.

c) Mild infractions:

1. Non-compliance with the requirements for the labelling and transport of human organs.

2. The non-compliance with the requirements for information systems.

3. Non-compliance with the requirements, obligations or prohibitions established in this royal decree or in the provisions that develop it, when they do not constitute a serious or very serious fault.

2. Very serious infringements will be prescribed at the age of five, the serious ones at three years and the mild ones within one year. The limitation period shall begin to be counted after the infringement has been committed.

3. The prescription shall be interrupted from the date of notification of the initiation agreement of the disciplinary procedure. The limitation period returns to run if the procedure remains paralyzed for six months for reasons not attributable to the person subject to the sanctioning file.

Article 34. Penalties.

1. Actions or omissions constituting an infringement, in accordance with Article 33, may be the subject of the administrative penalty provided for in paragraph 3 of this Article, subject to the instruction of the appropriate procedure. sanctioning, without prejudice to any criminal, civil or other liability that may be involved.

In cases where the offences could be a criminal offence, the competent jurisdiction will be given both the fault of the fault and the prosecution will refrain from following the sanction procedure as long as the judicial authority does not dictate firm resolution to end the procedure.

If the existence of a crime has not been estimated, the sanctioning file will be continued based on the facts that the Courts have considered to be proven.

2. The sanctioning procedure shall be that provided for in Article 60 of Title VI of Law 33/2011 of 4 October. The opening, processing and resolution of the sanctioning files shall be the responsibility of the competent authority for the territory and the matter.

3. The offences referred to in Article 33 shall be punishable by fine in accordance with the graduation laid down in Article 58 of Law 33/2011 of 4 October, Article 45 of Organic Law 15/1999 of 13 December and Article 36 of Law 14/1986 of 25 April.

4. The penalties shall be independent of those which may be imposed by other competent, state or regional authorities, on grounds other than those for infringements of the health rules.

Additional disposition first. Transport of potentially hazardous material.

In the transport of potentially infectious organs or in need of dangerous substances for conservation, the provisions contained in national and international regulations on the transport of dangerous goods.

Additional provision second. Assessment and accreditation of centres and services.

In the exercise of the powers laid down in Article 70.2.d) of Law 14/1986, of 25 April, the National Transplant Organization (prior agreement of the Permanent Transplant Commission of the Interterritorial Council) At the request of the different competent authorities of the Autonomous Communities and health services, it may act as a technical entity for the assessment and accreditation of approved centres and services.

Additional provision third. Cities of Ceuta and Melilla.

The references that in this royal decree are made to the autonomous communities, will be understood made to the cities of Ceuta and Melilla.

Additional provision fourth. Military health network.

With regard to healthcare facilities belonging to the military health network, the competencies provided for in this royal decree will be exercised by the General Inspection of Defense Health.

Without prejudice to the foregoing and in relation to the provisions of this royal decree, it may be possible to act in accordance with the agreements that may be concluded between the Ministry of Defense and the Ministry of Health, Social Services and Equality or the autonomous communities where the hospitals of the military health network are located.

Single transient arrangement. Survival of the health authorization for the centers for human organ procurement and transplantation.

The centers that have granted the authorization for the currently existing modalities of obtaining and transplantation of human organs will not need new authorization, according to the norms contained in the present royal decree, until to end the lifetime of your current authorization.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they are opposed to what is foreseen in this royal decree, and in particular, Royal Decree 2070/1999 of 30 December, which regulates the activities of obtaining and clinical use of human organs and territorial coordination in organ and tissue donation and transplantation.

Final disposition first. Basic character.

Without prejudice to its possible impact on the scope of the rights of the personality, this royal decree is dictated under the protection of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in (a) the basic rule of law, except Article 15, which is issued under the exclusive competence of the State in the field of external health, is of a basic standard.

Final disposition second. Incorporation of EU law.

By this royal decree, Directive 2010 /53/EU of the European Parliament and of the Council of 7 July 2010 on quality and safety standards for human organs intended for human consumption is incorporated into the Spanish legal order. transplant.

Final disposition third. Regulatory development and updates to the annexes.

The Minister of Health, Social Services and Equality is empowered to make the necessary provisions for the implementation and development of this royal decree, as well as for the amendment of its annexes, in order to adapt them the advancement of scientific and technical knowledge or to adapt them to European Union legislation.

Final disposition fourth. Entry into force.

This royal decree will enter into force on the twentieth day of its publication in the "Official Gazette of the State".

Given in Madrid, on December 28, 2012.

JOHN CARLOS R.

The Minister of Health, Social Services and Equality,

ANA MATO ADROVER

ANNEX I

Diagnostic and death certification protocols for obtaining organs from deceased donors

1. Diagnosis and certification of death

The diagnosis and certification of the death of a person will be based on confirmation of the irreversible cessation of circulatory and respiratory functions or brain functions (brain death), as established by the Article 9 of this royal decree.

2. Diagnostic of death by neurological criteria (brain death)

1. Diagnostic conditions.

Coma of known and irreversible etiology. There should be clinical evidence or neuroimaging of destructive injury to the central nervous system compatible with the brain death situation.

2. Neurological clinical examination.

a) The diagnosis of brain death always demands the realization of a neurological exploration that must be systematic, complete and extremely rigorous.

b) Immediately before starting the neurological clinical examination, it is necessary to check whether the patient presents:

1. º hemodynamic stability.

2. Appropriate Oxigation and ventilation.

3. ° Body temperature above 32ºC, and in children up to 24 months of age, above 35ºC. However, in order to maintain clinical stability during the scan, a body temperature of more than 35ºC is recommended in all cases.

4. No Absence of metabolic and endocrinological alterations, which may cause coma.

5. º Absence of central nervous system depressant substances or drugs, which may cause coma.

6. º Absence of neuromuscular blockers.

c) The fundamental findings in neurological exploration are as follows:

1. º Coma arreactive, without any motor or vegetative response to the algesic stimulus produced in the territory of the cranial nerves; there must be no posturing or decortication postures.

2. º Absence of troncoencephalic reflexes (photomotor, corneal, oculocephalic, oculovestibular, nausea, and tusigene).

3. Atropin Test Absence from Atropin Test. After intravenous administration of 0.04 mg/Kg atropine sulfate there should be no more than 10% increase in baseline heart rate.

4. Apnea, demonstrated by the "apnea test", by checking that there are no chest or abdominal respiratory movements when the PCO₂ in arterial blood is greater than 60 mm Hg.

d) The presence of motor activity of spontaneous or induced spinal origin does not invalidate the diagnosis of brain death.

e) Conditions that hinder the clinical diagnosis of brain death. Certain clinical situations may hinder or complicate the clinical diagnosis of brain death by preventing the neurological exploration from being performed in a complete or necessary safety. Such conditions are:

1. º Patients with severe craniofacial massif damage or any other circumstance that prevents the exploration of troncoencephalic reflexes.

2. Intolerance to the apnea test.

3. Hypothermia (body temperature less than or equal to 32 °C).

4. º intoxication or prior treatment with high doses of drugs or central nervous system depressants.

3. Period of observation.

The observation period should be assessed individually, taking into account the type and severity of the causative injury, as well as the instrumental tests performed.

Whenever the diagnosis is exclusively clinical, it is recommended to repeat the neurological scan according to the following periods:

a) At six hours in cases of known destructive injury.

b) At twenty-four hours in cases of anoxic encephalopathy.

c) If the use of drugs or central nervous system depressants is suspected or used, the observation period should be prolonged, at the medical discretion, according to the average life of the drugs or substances present and to the general clinical and biological conditions of the patient.

The observed observation periods may be shortened or even omitted at the medical criteria, in accordance with the diagnostic support instrumental tests performed (see paragraph 4).

4. Diagnostic support instrumental tests.

a) From a scientific point of view, they are not mandatory, excluding the following situations:

1. º The referred to in section 2.e.

2. º Absence of demonstrable brain-destructive injury by clinical evidence or by neuroimaging.

3. When the causal injury is primarily infratentorial.

However, in order to complement the diagnosis and shorten the observation period, it would be advisable to perform some instrumental test.

In the particular case that the etiology causing the coma is of an infratentorial location, the instrumental test to be performed must demonstrate the existence of irreversible lesion of the cerebral hemispheres (electroencephalogram or blood flow test).

b) The number and type of instrumental diagnostic tests to be used must be assessed individually, taking into account the particular characteristics of each case and the diagnostic contributions of the techniques used. Diagnostic instrumental tests are of two types:

1. º Tests that evaluate the neural function:

a) Electroencephalography.

b) Evoked potential.

2. º Tests that evaluate cerebral blood flow:

a) Brain arteriography of the 4 vessels.

b) Brain angiography by digital subtraction (arterial or venous).

c) Brain Angiography by Multicutting Computerized Tomography, with or without a cerebral perfusion study.

d) Brain Angiography by Nuclear Magnetic Resonance.

e) Brain Angiogammagrafia with radiopharmaceuticals able to traverse the intact blood-brain barrier.

f) Transcranial doppler sonography.

For the diagnosis of brain death, and if scientific and technical advances so permit, any other instrumental test not included in the prior relationship may be used, provided that it is absolute proof. diagnostic guarantee.

5. Diagnosis of uncomplicated brain death.

Before a known cause coma, and once excluded the existence of situations that might make it difficult to diagnose (para. 2.e), a patient presenting a clinical scan for brain death and a test A conclusive diagnostic support instrument may be diagnosed with brain death, without having to wait for the observation period referred to in paragraph 3.

6. Diagnosis of brain death in special situations.

In those clinical conditions where there are circumstances that hinder or complicate clinical diagnosis (paragraph 2.e), when there is no demonstrable destructive brain injury due to clinical evidence or neuroimaging and where there is a causal injury that is primarily infratentorial, in addition to the neurological examination, at least one confirmatory diagnostic support test must be performed.

7. Newborns, infants and children.

a) The clinical diagnosis of brain death in newborns, infants and children is based on the same criteria as in adults, although with some peculiarities.

Neurological exploration in neonates and small infants should include the suction and search reflexes. In neonates, especially the preterm, the clinical examination must be repeated several times, as some reflexes of the trunk may not have developed or be of incipient appearance, which makes these reflexes very vulnerable. In turn, in children up to 24 months of age, the clinical examination for the diagnosis of brain death shall be performed after verification that the body temperature requirement specified in paragraph 2.b is met.

(b) When using instrumental diagnostic support tests in children, the technical characteristics of the children shall be taken into account. Therefore, the tests must be adjusted to the age, clinical conditions and international standards and recommendations of the different scientific societies.

c) The recommended observation period varies with age and with instrumental tests performed:

1. Neonates preterm: although there are no internationally accepted guidelines, a period of observation of 48 hours is recommended. This observation period may be shortened to medical criteria, in accordance with the diagnostic support tests performed, and may be omitted if a diagnostic test is performed which shows, in an unequivocal manner, no flow cerebral blood.

2. Neonates (from 37 weeks of gestation to 30 days of age): 24 hours. This observation period may be shortened to medical criteria, in accordance with the diagnostic support tests performed and may be omitted if a diagnostic test is performed which shows, unequivocally, no blood flow. brain.

3. Children over 30 days up to 24 months of age: 12 hours. This observation period may be shortened to medical criteria, in accordance with the diagnostic support tests performed and may be omitted if a diagnostic test is performed which shows, unequivocally, no blood flow. brain.

3. Diagnosis of death by circulatory and respiratory criteria

1. Diagnosis:

(a) The diagnosis of death by circulatory and respiratory criteria shall be based on the unequivocal observation of the absence of circulation and the absence of spontaneous respiration, both for a period of not less than five minutes.

(b) As a prerequisite for the diagnosis and certification of death by circulatory and respiratory criteria, one of the following conditions must be verified:

1. The advanced cardiopulmonary resuscitation maneuvers, which have been unsuccessful, have been applied for an adequate period of time. This period, as well as the maneuvers to be applied, will be adjusted depending on the age and circumstances that caused the circulatory and respiratory arrest. At all times, what is specified in the protocols for advanced cardiopulmonary resuscitation that the competent scientific societies periodically publish should be followed. In cases of body temperature less than or equal to 32ºC, the body must be reheated before the irreversibility of the cessation of circulatory and respiratory functions can be established and therefore the diagnosis of death.

2. The performance of cardiopulmonary resuscitation maneuvers is not considered to be indicated on the basis of medical and ethically justifiable reasons, in accordance with the recommendations published by the competent scientific societies.

c) The absence of circulation shall be demonstrated by the presence of at least one of the following findings:

1. º Asistolia on a continuous electrocardiographic plot.

2. º Absence of blood flow in invasive blood pressure monitoring.

3. No aortic flow absence on an echocardiogram.

If scientific and technical progress so permits, any other instrumental test that accredits absolute diagnostic assurance may be used.

2. Feasibility and preservation maintenance maneuvers:

(a) To initiate the preservation procedure it will be necessary for the medical team responsible for the patient to have left the written record of death, specifying the time of death.

(b) In cases where judicial authorization is required as specified in Article 9.5 of this royal decree, the following shall proceed as follows:

1. In the cases referred to in the first subparagraph of paragraph 1 (b), the blood flow maintenance exercises may be resumed to the organs and the appropriate communication shall be made to the court of instruction on the existence of a potential donor.

After the favorable response of the court or after fifteen minutes without any notification of limitation for its practice, the preservation maneuvers may be initiated. Prior to the start of these manoeuvres, the removal of a 20 cc blood sample and if possible 20 cc of urine and 20 cc of gastric juices (according to the accompanying protocol of chain of custody) will be made available to the The court of inquiry, as well as any other evidence or evidence required by the latter. The preservation maneuvers will be initiated later.

2. In the cases referred to in the second subparagraph of paragraph 2 (b) and before the commencement of the proceedings, the court of instruction shall be informed of the existence of a potential donor, informing him of the circumstances of the case and act individually, in accordance with the guidelines established by the Court.

3. In the previous two cases, it may be possible to obtain organs, once obtained the corresponding judicial authorization, as established in article 9.5 of this royal decree.

Custody Chain:

Donor's Clinical History Name and Number

Judged number ...................... City

Judicial case number

Identification of transplant equipment:

Transplant coordinator don/dona

Doctor Doctor/a don/dona

Doctor Doctor/a don/dona

DUE don/dona

DUE don/dona

Sampling performed:

Blood: Place of extraction ....................................... Volume

Urine: Yes/No .............................. Volume

Reason for the absence of extraction

Gastric content: Yes/No ............................................ Volume

Reason for the absence of extraction

Custody Chain:

Sample Take: Day .................... Time ....................

Samples packaged and tagged by ..........................................

(Transplant Coordinator/a).

Type, seal, and seal number:

Number of clinical history ..........................................................

(Lacre/ink).

Storage Conditions: .................................................

(Refrigeration/freeze).

Receiving in Court:

Day ................... Time ......................

Transportation by gift/dona ................................................................................

(Person named by Coordinator/a)

Receiver at the courthouse by don/dona ....................................................................

Coordinator Signature

Signature Trial Signature delegated by Coordinator/

ANNEX II

Specific requirements for the authorization of organ transplant centers

1. The specific requirements for the authorisation of the deceased donor organ transplant centres shall be as follows:

a) For the performance of renal transplants: having a nephrology unit, and urology and/or general and digestive surgery and/or vascular surgery with sufficient, qualified and experienced staff for ensure the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

b) To perform cardiac transplants: to have a cardiology and cardiac surgery unit with sufficient, qualified staff and with demonstrated experience in cardiac surgery that requires extracorporeal circulation and the the availability of a hemodynamic unit with the necessary experience in invasive cardiology techniques to ensure the correct performance of these transplants and the proper follow-up and treatment of the possible complications of these patients.

c) For the performance of lung transplants: having a unit of pneumology and thoracic surgery with sufficient staff, qualified and with demonstrated experience in lung surgery and the availability of Respiratory function tests necessary to ensure the correct performance of these transplants and the proper diagnosis and treatment of any complications of these patients.

d) For the performance of heart-lung transplants: the centers must meet the specified requirements for the completion of cardiac and pulmonary transplants.

e) For the performance of liver transplants: have a gastroenterology-hepatology unit and general and digestive surgery with sufficient, qualified staff and with proven experience in hepatobiliary surgery to ensure the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

f) For the performance of pancreatic transplants: have a unit of endocrinology and general and digestive surgery or urology with sufficient staff, qualified and with proven experience in surgery hepatobiliary-pancreatic to ensure the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

g) For the completion of intestinal transplants: having a gastroenterology and general surgery and digestive unit with sufficient, qualified staff and with proven experience in intestinal surgery to guarantee the correct performance of these transplants and the proper monitoring, diagnosis and treatment of any complications of these patients.

2. For the performance of any transplant of live donor organs, it is essential that the centre is approved for the transplantation of the deceased donor organ and demonstrate proven experience in its performance.

3. In order to perform any other multiple organ transplant, it is essential to be authorized as a transplant center for each organ to transplant.

4. In the case of child transplants, it will be necessary to have a specific authorisation from the centre, which will take into account, in addition to the specific requirements for the transplantation of each type of organ, the availability of adequate means and staff with sufficient experience to do so.

ANNEX III

Characterization of donors and human organs

Minimum Data Set Section

Minimum data: Information for the characterization of the organs and donors to be collected for each donation in accordance with the second subparagraph of Article 21 (1), and without prejudice to Article 21 (2) 2.

Minimum data set

Get Center and other general data.

Donor type.

Type of organ.

Blood group.

Date of birth or estimated age.

Sex.

Cause of death.

Date and time of death.

Date and time of the clamage.

Weight.

Height.

History of intravenous drug abuse.

History of malignancy.

History of other communicable diseases.

HBV, HCV, HIV tests.

Basic information to evaluate the function of the donated organ.

Paragraph B. Complementary data set

Supplementary data: Information that, at the decision of the responsible medical team and taking into account the availability of the data and the particular circumstances of each case, should be collected in addition to the minimum data are listed in paragraph A in accordance with paragraph 2 of Article 21 (1).

Complementary data set

General data:

Getting Center Contact Information, required for coordination, assignment, and traceability of donor organs to recipients and vice versa.

Donor data:

Demographic data, including donor provenance, and anthropometric data needed to ensure adequate compatibility between the donor/organ and the recipient.

Donor background:

Any antecedents that may affect the suitability of organs for transplantation or risk of disease transmission.

Physical and clinical data:

Data from clinical exploration regarding the maintenance of the potential donor, as well as any finding that reveals conditions that would not have been detected in the donor's medical history and could affect the donor. the suitability of the organs for transplantation or to involve a risk of disease transmission.

Lab parameters:

Data needed for functional assessment of organs and for the detection of potentially communicable diseases and other possible contraindications for organ donation.

Image tests:

Imaging scans required for the evaluation of the anatomical or functional status of organs for transplantation.

Treatment:

Donor-administered treatments that may influence the functional state of the organs and their suitability for donation, in particular, the use of antibiotics, inotropic support, or transfusion therapy.

Other:

Anatomical information relevant, prior to or after obtaining.

Body macroscopic description and histopathology, in case of biopsy.