VISTO Law No. 24,193 on Human ANNUAL ORGANS AND MATERIAL TRASPLANTS, and
That the MINISTERY OF HEALTH and SOCIAL ACTION, through the Technical Agencies of its SECRETARIAT OF HEALTH and with the participation of the representative entities of the transplant activity, has projected the corresponding regulation.
That the present measure is determined in accordance with the powers conferred by Article 99, paragraph 2 and the Transitional Provision DUODECIMA of the NATIONAL CONSTITUTION.
THE PRESIDENT OF THE ARGENTINA NATION
RIGHT:Article. 1. . Approve the body of provisions that constitute the Regulation of Law 24.193 that as Annex I is an integral part of this Decree. Art. 2°. . Please refer to the HEALTH SECRETARIAT of the MINISTERY OF HEALTH and SOCIAL ACTION, to dictate the complementary and clarification of the regulations adopted. Art. 3. . Communicate, publish, give to the National Directorate of the Official Register and archvese. . MENEM. . Alberto J. MAZZA
ARTICLE 1. El The power of the Sanitary Police regarding the ablation of organs and anatomical materials for the implantation of the same human corpses to humans and among human beings will be effective by the judicial health authorities without prejudice to the competences agreed to in the NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACIÓN e IMPLANTE by article 44 of Law 24.193. The exception of Article 1, 2nd paragraph, does not correspond to the bone marrow.
ARTICLE 2°. s The following medical-surgical practices will be considered as standard technique:
1) Ablation and implantation of the heart, vessels and valve structures.
2) Ablation and implantation of the lung.
3) Ablation and implantation of the liver.
4) Ablation and implantation of pancreas.
5) Bowl ablation and implantation.
(6) Ablation and implantation of kidney and ureter.
7) Ablation and implantation of elements of the osteoarticular system.
8) Skin ablation and implantation.
9) Eyeball ablation for the implantation of corneas and sclera.
10) Ablation and implantation of constitutive tissues of the middle and outer ear.
11) Ablation and implantation of duramother.
(12) Abolishment and implantation of erupted and non-erupted dentories.
13) Ablation and implantation of elements of the peripheral nervous system.
14) Ablation and implantation of bone marrow.
In order to initiate a new experimental practice in our country, prior authorization must be requested from the national health authority by providing the following elements, in accordance with the other precautions required by the Law:
(a) Objective of the procedure.
(b) Medical-surgical technique.
(c) Expected results.
(d) Idoneity and training of medical-surgical equipment.
(e) Clinical history and current status of the patient.
(f) Authorization of the patient to submit to the proposed technique.
In order for a new experimental practice of the above-mentioned practices to be incorporated as a standard technique for the purposes of Article 2°, the medical professional or head of intervening equipment shall submit to the National Health Authority the following documentation:
I) Results obtained.
II) Evolution, sequelae and complications observed in patients under the above-mentioned experimental practice.
III) Updated statistics showing the positivity of results in patients treated with the proposed procedure.
IV) Statistical information on the work accomplished.
The National Sanitary Authority may propose the incorporation of medical-surgical practices of ablation and implantation when its viability in humans is strongly proven.
ARTICLE 3°. . Training and expertise in the specialty will be credited through the corresponding specialist and curriculum title.
Medical professionals of a team may be members of other teams, in all cases having to apply to the Jurisdictional Health Authority for the integration of each team.
Professionals who perform the medical acts referred to in transplants under Act No. 24.193, individually or as heads of a medical team, shall have the specialization which in each case is indicated below:
1. . For ablation and implantation of heart, vessels and valve structures: Cardiovascular surgeons or cardiologists.
2. . For lung ablation and implantation: Medical chest surgeons or doctors cardiovascular surgeons or pneumologists.
3. . For ablation and implantation of the liver, pancreas and intestine: Doctors surgeons or gastroenterologists.
4. . For kidney and ureter ablation and implant: Nephretic doctors or surgeons.
5. . For the ablation and implantation of elements of the osteoarticular system: Doctors surgeons specialists in orthopedics and traumatology.
6. . For skin ablation and implantation: Doctors surgeons specializing in plastic surgery.
7. . For the ablation and implantation of cornea and other constitutive tissues of the eye: Ophthalmologists.
8. . For ablation and implantation of constitutive tissues of the middle and outer ear: Doctors surgeons otorhinolaryngologists.
9. . For the ablation and implant of duramother: Doctors corresponding to the specialty in which the duramother will be used.
10. . For the ablation and implantation of erupted and non-eruptioned dental organs: Dentologists or physicians maxillo-facial surgeons.
11. . For the ablation and implantation of peripheral nervous system elements: Neurosurgeons or doctors specialized in orthopedics and traumatology or doctors specializing in plastic surgery.
12. . For bone marrow ablation and implantation: Hematologist.
ARTICLE 4°. de Will be obligations of the team leader:
(a) To comply in time and form with the provisions relating to medical records and statistics ordered in this regulation.
(b) Coordinate the actions of the members of the team in charge, for the purpose of strict compliance with this Law.
(c) Immediately inform the National Sanitary Authority of any modification to introduce in the constitution of your team.
(d) To comply with and enforce all administrative rules and provisions emanating from the Director of the medical-surgical establishment in which they perform medical-surgical practices
(e) To comply with and enforce all regulations and provisions relating to the specific provisions of Act No. 24.193.
(f) Propose the modifications of your equipment at the time you consider it appropriate.
The obligations under subparagraphs (a), (d) and (e) of this article shall be observed by practitioners who perform medical-surgical practices that do not require the intervention of a team.
ARTICLE 5°. . WITHOUT REGLAMENT.
ARTICLE 6°. El NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACIÓN E IMPLANTE will keep an updated record of medical equipment and professionals authorized by the jurisdictional health authorities.
ARTICLE 7°. El NATIONAL INSTITUTO CENTRAL UNICO COORDINADOR DE ABLACIÓN E IMPLANTE will keep an updated record of the payroll of hemodialized patients, their conditions and characteristics, having to ensure the treating professional that patients receive by a doctor or transplant team enabled for the purposes of Law N.24.193 qualified, objective and early information about the feasibility of a transplant.
Social Security entities of any character that provides care coverage to patients undergoing treatments that replace the renal function should require as a condition for such coverage the record of having made the professional treating the complaint prescribed in this article.
ARTICLE 8°. La The information referred to in Article 8 of Law No.24.193 must be made within the time limit of TREINTA (30) days of diagnosis of the disease. For the purposes of this article, the disease that is likely to be treated by an implant must be interpreted as the one that for its evolutionary moment allows the incorporation of the patient in a waiting list, which must be done within the time of TREINTA (30) days since his or her diagnosis.
ARTICLE 9°. s For the purposes of registration of establishments authorized for the conduct of medical acts related to transplants under Law 24.193, the minimum physical and instrumental infrastructure indicated in each case shall be required:
(a) For ablation and implantation of the heart, vessels and valve structures, lung, liver, pancreas, intestine and kidney:
I) DOS (2) simultaneous and contiguous operating theatres.
II) Appropriate and sufficient surgical instrumentation and simultaneous implantation.
III) Count within the service or establishment with:
Permanent laboratory service of routine analysis and speciality, radiology; imaging; hemotherapy with blood bank; intensive therapy with possibility of individual isolation and radiology within the scope of the same intensive therapy service; active and permanent medical guard.
IV) Contain with the operating room provided with: Monitoring equipment, cardioversion and electro-cardy stimulation and vascular perfusion.
(b) For the ablation and implantation of the heart, vessels and valve and lung structures, in addition to the infrastructure and equipment noted above must be counted with:
I) Specialized regular and continuous operation surgery service, with extracorporeal circulation equipment and hemodynamic service, all within the scope of the establishment.
II) Pressure-ciclad respiratory assistance and similar equipment cycled to volume (exclusively for lung).
(c) For the ablation and implantation of the liver, pancreas and intestine, in addition to the infrastructure and equipment identified in subsection I (a), it shall have:
I) General surgery service for regular and continuous use.
II) Radiographic or radioscopic equipment with intensifier of images for intraoperative use.
(d) For kidney ablation and implantation in addition to the infrastructure and equipment referred to in subparagraph I (a) should include:
I) Continuous regular surgery service.
II) Peritoneal and extracorporeal dialysis equipment.
(e) For the ablation and implantation of elements of the osteoarticular system, skin, external and medium ear, cornea and other constituent elements of the eye and elements of the peripheral nervous system:
II) Instrumental sufficient and appropriate to speciality.
(f) For the ablation and implantation of elements of the osteoarticular, cornea and other constitutive tissues of the eye, external and medium ear and of the peripheral nervous system, in addition to the infrastructure and equipment specified in subparagraph (e), the following should be:
I) Radiographic or radioscopic equipment with intraoperative imaging intensifier (exclusively for the osteoarticular system).
II) Binocular microscope for intraoperative use exclusively for the implantation of corneas, constitutive elements of the ear and peripheral nervous system. In addition to performing in cornea, constitutive tissues of the eye, pre-surgical feasibility tests.
(g) For the ablation and implant of duramother:
I) Ablation: necessary and appropriate instruments for its realization.
II) Printer: equipment necessary to the specialty in which the duram will be used.
(h) For the ablation and implantation of erupted and non-erupted dental organs:
I) A dental office.
II) Instrumental necessary to perform dentomaxilar surgery
Without prejudice to the above, implantations of anatomical organs and/or materials may be carried out by medical equipment or medical professionals authorized in unauthorized care establishments where reasons of distance, transfers or other circumstances do not allow the transfer of the receiver or the giver to an authorized service or establishment, and the establishment must have the minimum equipment and infrastructure that for each medical-surgical practice is indicated in the preceding paragraphs. To this end, medical opinion will be necessary to document impediments or circumstances that prevent the transfer of the receiver or giver.
The Jurisdictional Sanitary Authority for the purposes of authorization and when it deems necessary, may require other requirements to the minimum equipment or infrastructure for the purpose of its resolution. The request and any documentation accompanying shall be submitted in accordance with the form established by the Jurisdictional Health Authority, which is signed by the Director of the establishment or service.
Established establishments that do not meet the requirements set out in the first paragraph of this article shall adapt their infrastructure, equipment and personnel to the requirements of assistance complexity established within the period of THREAT SESENTA (360) days from the validity of this regulation.
ARTICLE 10. . WITHOUT REGLAMENT.
(a) Public or private care services or establishments, authorized for the purposes of Act No. 24.193, shall carry the following foliated and rugged records by the Jurisdictional Health Authority:
I) Recording of living daggers without mediating prior internment and after death.
II) Registration of dadores, receptors and transplants.
III) Register of dadores with prior placement.
(b) Public or private care services or establishments, not authorized for the purposes of Act No. 24,193, shall carry with the following searches:
I) Recording of living daggers without mediating prior internment and after death.
II) Register of dadores with prior placement.
The seats in the registers will be made chronologically and will be signed by the Director of the service or establishment or by the person who replaces it at the time, it is forbidden to alter the order of the same, leave blank spaces, unusable, annular or boot folios, obliging the amendments, scraps or corrections that occur to be saved or explained in a row.
ARTICLE 12. . The assistance, official or private services must inform the jurisdictional authority of any modification that reduces the conditions of empowerment, noting the grounds that motivated it.
The Jurisdictional Sanitary Authority shall, upon verification, provide if the agreed authorization is maintained or not, with the authority to determine the time limits for the re-establishment of the enabling conditions.
During the procedure mentioned above, the medical-surgical practices for which they were authorized may not be performed.
From such decisions, the Jurisdictional Sanitary Authority will report to the NATIONAL INSTITUTE UNICO COORDINADOR DE ABLACIÓN and IMPLANTE for the purposes of the corresponding registrations.
ARTICLE 13. . The information provided as well as the consent of the giver and receiver must be recorded in a record that must be subscribed by the latter and by the informant doctor. These records must be settled by chronological order in a book previously folied and signed by the Jurisdictional Sanitary Authority.
ARTICLE 14. Los The anatomical organs and/or materials that can be ablation of living people will be the following:
(a) Kidney, ureter.
(c) Elements of the osteoarticular system.
(d) Disrupted and non-erupted dental organs.
(e) Cornea: in case of tumor enucleation and another cause, the cornea being able to be grafted to another person.
(f) Bone medulla.
(g) Pancreas: partial resection is allowed, according to the techniques prevailing at the time of the intervention, and only if the receiver suffers from severe juvenile diabetes, with possible short-term terminal evolution. The non-predisposition in the donor of such a disease should also be fedibly diagnosed. This intervention will be reserved for centers with experience in cadaveric pancreatic transplants, whose results are compatible with international statistics
(h) Liver: Segmentary resection is allowed, according to the clinical techniques and conditions of the receiver prevailing at the time of the intervention. This intervention will be reserved for establishments with experience in cadaveric liver transplants, whose results are consistent with international statistics.
ARTICLE 15. Las The completed records as provided for in article 15, paragraph 3, of the Act shall be subscribed by the Chief of the Team.
Together with the record, the establishment shall archive the items issued by the Registry of Civil Status and Capacity of Persons, record of judicial authorization, if any, or other legally appropriate documentation to justify the link between the giver and the receiver.
The copy of such a record referred to the authority of the Comptroller shall be filed by chronological order for the period specified in the Law.
ARTICLE 16. . It is understood that the release of expenses associated with surgical intervention includes only those related directly or indirectly to the medical act of ablation, implantation and postoperative both of the receiver and the live giver. The SECRETARY OF HEALTH OF THE MINISTERY OF HEALTH AND SOCIAL ACTION, following a report of the NATIONAL COORDINARY INSTITUTE OF ABLATION AND IMPLANTE, will set the tariff value of the procurement of organs and tissues. For the determination of such value, the corresponding tariffs shall be taken into account:
(a) Diagnosis of death of the donor potential.
(b) Biological maintenance of the donor to ablation of anatomical organs and/or materials.
(c) Histocompatibility and laboratory studies required.
(d) Expenditures of surgical procedures for ablation of anatomical organs and/or materials.
(e) Perfusion and maintenance costs of anatomical organs and/or materials.
(f) Expenses originated in the operational distribution of anatomical organs and/or materials.
(g) Post-ablation expenses directly linked to it, as stated in the respective clinical history of the living donor.
The NATIONAL ADMINISTRATION OF THE HEALTH FOLLOWER or the Agency that replaces it should automatically recognize the tariff value of the procurement of organs and tissues for the purposes that the respective Social Works of the recipients will give effect to it. In all cases, the NATIONAL ADMINISTRATION OF HEALTH FOLLOW-UP and the like, should ensure the patient ' s free choice with respect to the Transplant Centre to be assisted.
ARTICLE 17. . WITHOUT REGLAMENT.
ARTICLE 18. Los The specific assumptions referred to in paragraph 1, the last part of Article 18 of the Law are:
ARTICLE 19. . WITHOUT REGLAMENT.
ARTICLE 20. . Officials of the CIVIL STATE REGISTRATION AND CAPACITY OF PERSONS shall agree in the National Document of Identity in force or replace it, both for nationals and for foreigners, the manifestation of will of the elderly capable persons of DIECIOCHO (18) years, positive or negative regarding the granting of authorization for the ablation of organs or anatomical materials of their own body, in order to carry out their own procedures.
The FEDERAL ARGENTINA POLICY, the NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACION E IMPLANTE, the judicial health authorities and the REGISTER OF THE CIVIL STATE AND CAPACITY OF PERSONS, will arbitrate within the Ninth (90) days of the publication of the present Regulatory Decree, a system of dissemination and joint information intended to give faithful expression of the
ARTICLE 21. . WITHOUT REGLAMENT.
ARTICLE 22. El The report to be submitted by the doctor who has performed the ablation of organs or anatomical material should describe the outside aspect of the body, visible external lesions, external aspect of the ablation body and technique of ablation used.
The report signed by the intervening professional must be elevated to the judge of the case within the VEINTICUATRO (24) hours of the ablation.
In the event of no prior police intervention, the corresponding complaint shall be made to the police authority with jurisdiction in the place of detention of the shooter or directly before the judge in office.
The Police shall give evidence of the filing of the complaint by the authority on duty immediately.
ARTICLE 23. . WITHOUT REGLAMENT.
ARTICLE 24. . For the purposes of Article 24 of the Law, it will be time of death that of the moment when all the signs established in Article 23 were verified, for the first time.
ARTICLE 25. . WITHOUT REGLAMENT.
ARTICLE 26. . For the purposes of this Article, it shall be understood that with the verification of the signs established in the THREE (3) first Article 23 of Law No. 24.193, the conditions are given for the obligatory denunciation of the fact to the Director or person in charge of the establishment.
(a) No way.
(b) No way.
(c) No way.
(d) No way.
(e) No way.
(f) No way.
(g) No way.
(h) The NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACION E IMPLANTE will be the competent authority to authorize advertisements and/or publicity of the activities contemplated in this Law, keeping in reserve the identity of donors and recipients of anatomical organs and materials unless there is a legitimate interest at the discretion of that Agency.
They are covered by this article and are therefore subject to the requirement of prior authorization, advertisements and advertising that may be made by non-profit associations and entities, regardless of their object and any title.
ARTICLE 28. . WITHOUT REGLAMENT.
ARTICLE 29. . WITHOUT REGLAMENT.
ARTICLE 30. . WITHOUT REGLAMENT.
ARTICLE 31. . WITHOUT REGLAMENT.
ARTICLE 32. . WITHOUT REGLAMENT.
ARTICLE 33. . WITHOUT REGLAMENT.
ARTICLE 34. . WITHOUT REGLAMENT.
ARTICLE 35. . WITHOUT REGLAMENT.
ARTICLE 36. . WITHOUT REGLAMENT.
ARTICLE 37. . WITHOUT REGLAMENT.
ARTICLE 38. . WITHOUT REGLAMENT.
ARTICLE 39. . WITHOUT REGLAMENT.
ARTICLE 40. . WITHOUT REGLAMENT.
ARTICLE 41. . WITHOUT REGLAMENT.
ARTICLE 42. . WITHOUT REGLAMENT.
ARTICLE 43. . WITHOUT REGLAMENT.
(a) No way.
(b) It is understood by Banco de Organos y/o Materiales Anatomy the Public Agency, or private non-profit, which aims at the collection and preservation of anatomical organs and/or materials specified for subsequent use for therapeutic or research purposes in accordance with the rules of organization and operation established by the NATIONAL INSTITUTO CENTRAL UNICO COORDINADOR DE ABLACION E IMPLANTE.
(c) No way.
(d) No way.
(e) The suspension and/or revocation reaches the establishments or equipment when, following an audit of the NATIONAL INSTITUTE UNICO COORDINADOR DE ABLACION E IMPLANTE, its results are less than the minimum updated on a regular basis as established by its Directory, with the intervention of the TECHNICAL ASESOR COUNCIL, all according to the indicative mean of the national reality.
(f) No way.
(g) No way.
(h) The tariffs are to be fixed by the board of the NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACIÓN y IMPLANTE.
(i) No way.
(j) No way.
(k) No way.
(l) No way.
(m) No way.
(n) The registration of a patient in the Organ Expectation List shall be formalized by the treating physician with the intervention of a team or professional authorized under this Law, in accordance with the technical requirements or "criteria of inclusion" which, for that purpose, determines the NATIONAL INSTITUTE UNICO COORDINADOR DE ABLACIÓN E IMPLANTE according to an anatomical body or material.
(in) No way.
(o) No way.
(p) The jurisdictions, establishments and authorized teams will provide annual statistical data on topics related to the transplant activity required by the NATIONAL INSTITUTE UNICO COORDINADOR DE ABLACIÓN E IMPLANTE (INCUCAI).
(q) No way.
(r) No way.
(s) No way.
(t) No way.
(u) No way.
(v) No way.
(w) No way.
(x) No way.
ARTICLE 45. . The full-time dedication required to the members of the Board implies incompatibility with the professional exercise, under any of the modalities provided for in this regulation, for the realization of the medical-surgical practices subject to the Law or the title and/or leadership of a Bank of Anatomical Organs and/or Materials during the end of its mandate, as well as the performance of any public office, except the exercise of any public office.
ARTICLE 46. . WITHOUT REGLAMENT.
ARTICLE 47. . WITHOUT REGLAMENT.
(a) PATIENT ASSATOR COUNCIL: It will be composed of a representative and one alternate for each organization with national legal status. It shall develop its work as a collegiate body and shall set its rules of procedure by appointing a Registrar from among its members.
It will understand the Board's requirement on the social aspects that make the population aware in favor of the donation of organs; in the psychological support activities of the pre- and post-transplant patients and their family environment and in the control activities of the NATIONAL INSTITUTO CENTRAL UNICO COORDINADOR DE ABLACION E IMPLANTE including the distribution of organs.
Its recommendations will not be binding on the Directory of the NATIONAL INSTITUTE UNICO COORDINADOR DE ABLACION E IMPLANTE and the incorporation of its members will be formalized by Resolution of the MINISTERY OF HEALTH and SOCIAL ACTION on the proposal of the Directory of the NATIONAL INSTITUT CENTRAL UNICO COORDINADOR DE ABLATION EMPdesignLANTE, lasting in its identical periods (4)
(b) ASESOR COUNCIL: You will understand at the request of the board of the NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR OF ABLATION and IMPLANTE on technical and scientific topics related to the transplant activity and their opinions will not be binding acting as a collegiate body setting its own internal rules and choosing from among its members, a Secretary.
Scientific societies and associations that develop transplantological activities represented in this Advisory Body should have legal status in the national order. It will also be composed by the President of the SOCIEDAD ARGENTINA DE TRASPLANTES who will be a permanent member. A representative shall be invited to be appointed to each of the Universities with a Faculty of Medicine. They will be able to integrate it, also, professionals of recognized trajectory on the proposal of the Board of Directors of the NATIONAL INSTITUTE CENTRAL UNICO COORDINADOR DE ABLACIÓN y IMPLANTE.
Its members shall be appointed by Resolution of the MINISTERY OF HEALTH and SOCIAL ACTION on the proposal of the Board of the National CENTRAL INSTITUTE UNICO COORDINADOR OF ABLATION AND IMPLANTE, lasting in their functions CUATRO (4) years except revoke of designation; representatives may be re-designed for identical periods in an uninterrupted manner.
ARTICLE 49. . WITHOUT REGLAMENT.
ARTICLE 50. . WITHOUT REGLAMENT.
ARTICLE 51. . WITHOUT REGLAMENT.
ARTICLE 52. . WITHOUT REGLAMENT.
ARTICLE 53. . WITHOUT REGLAMENT.
ARTICLE 54. . WITHOUT REGLAMENT.
ARTICLE 55. . WITHOUT REGLAMENT.
ARTICLE 56. . WITHOUT REGLAMENT.
ARTICLE 57. . WITHOUT REGLAMENT.
ARTICLE 58. . WITHOUT REGLAMENT.
ARTICLE 59. . WITHOUT REGLAMENT.
ARTICLE 60. . WITHOUT REGLAMENT.
ARTICLE 61. . WITHOUT REGLAMENT.
ARTICLE 62. . WITHOUT REGLAMENT.