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General
regulations for organ transplantation in the Kingdom
Based
on the letter of the Head of the Council of Ministers No.
7/1561/M dated 19/05/1404 H addressed to the Minister of
Health, it was approved to establish the National Kidney
Foundation under the supervision of a Committee chaired by the
Minister of Health with membership of representatives from the
Presidency of the National Guard, Ministries of Defense and
Aviation, Higher Education and Health as well as King Faisal
Specialist Hospital and Research Center. The committee was
entrusted with the responsibility of determining the
objectives and activities of the National Kidney Foundation
and to assume the responsibilities and duties necessary for
its initiation and functioning. Several scientific committees
have been established in accordance with the decision of the
Deputy Minister for Executive Affairs, Ministry of Health to
carry out these responsibilities. These Committees include
Brain-Death Committee, Kidney Transplant Committee,
Hemodialysis Committee, Peritoneal Dialysis Committee and
Computer Committee.
With the increase of activities of the center and the need to
co-ordinate care of other end-stage organ diseases (heart,
lung, pancreas, liver and cornea), the Council of Ministers
Resolution No. 80 dated 20/06/1413 H was issued to rename
National Kidney Foundation as Saudi Center for Organ
Transplantation. Based on that resolution, many new committees
were established each including official representatives from
the above mentioned institutions. These committees were
Cardiac Transplant Committee, Liver Transplant Committee, Lung
Transplant Committee and Cornea Transplant Committee. After
convening intensive meetings, these committees have laid down
the regulations that follow.
The
Saudi Center for Organ Transplantation is the sole authority
responsible for coordinating and supervising all aspects
related to organ transplantation and brain death in the
Kingdom. The general regulations, which all hospitals and
organ transplant centers should follow, have been put forward,
they are:
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All
potential brain-death cases should be reported directly to
the Saudi Center for Organ Transplantation.
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Each
hospital in the Kingdom should establish local committees
which are responsible for matters pertaining to
brain-death cases and organ transplantation in the
respective hospital as follows:
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Brain-death
committee: This committee should comprise of an
internist, an administrative director or equivalent,
and a brain-death coordinator. This committee is
responsible for follow-up of all matters related to
brain-death cases and their reporting. The committee
also submits proposals for developing the
brain-death program in its region to the Saudi
Center for Organ Transplantation. The
responsibilities of the brain-death coordinator are
to report brain-death cases to the Saudi Center for
Organ Transplantation and to update follow-up
information about these cases continuously. He
should arrange for sending all necessary blood
samples to the laboratory to ensure the fitness of
brain-death organs and act as the liaison between
the Saudi Center for Organ Transplantation and the
organ transplant center to which his hospital is
attached.
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Convincing
committee: This committee is formulated by the
Hospital Director, its responsibilities being to
approach the family and relatives of the brain-death
case for the purpose of obtaining their consent for
organ donation.
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Documentation
of brain death is done in accordance with the steps laid
down in the Brain-death Documentation Form, and according
to special procedures that have been laid down by the
Brain-Death Committee in the Saudi Center for Organ
Transplantation. If the brain-dead patient is a female, it
should be ensured that she is not pregnant and if so,
organ donation is not considered at all except when there
is fetal death. Also, no member of the medical team
involved in the transplantation of organs should
participate in the diagnosis of brain death.
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Consent
for organ donation should be obtained from the heritors of
brain-death case whether they are inside or outside the
Kingdom and in accordance with the special consent form,
except if the deceased has expressed his desire to donate
organs, when alive in this will that has been attested by
the tribunal. If the brain-death case is unidentified the
consent of the official specialized organization should be
obtained before harvesting is performed.
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The
hospitals should co-ordinate with the Saudi Center for
Organ Transplantation before performing any organ
harvesting to enable beneficial distribution of the organs
in accordance with the regulations in this booklet.
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Organ
harvesting should be performed in the same hospital where
brain death is diagnosed and no case could be transferred
to another hospital except when there is an absolute
necessity. The hospital in which brain death was diagnosed
is responsible for issuing the death certificate.
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When
brain death is confirmed and consent is obtained from the
family for organ donation, distribution and
transplantation of the organs should be carried out as
laid down in the regulations concerning each organ.
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Before
performing living related transplantation the following
conditions should be fulfilled:
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Blood
relationship till the second degree should exist or
the donor should be wet mother or her children, or
spouse (except for transplantation of bone marrow).
These relationships should be attested by official
specialized organizations.
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Donor
should be in good health and it should be ensured
that organ donation would not be harmful to the
donor or recipient. Transplantation of single organs
on which life of the donor is dependent is
prohibited.
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Organ
donation should be accepted by the donor without any
social or financial pressure.
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Organ
donation should be on written consent and signed by
the donor who has the right to change his mind at
any time before surgery.
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Relevant
medical examination should be performed as laid down
in these regulations. The donor should be informed
about all possible and probable hazards resulting
from organ removal and this should be documented in
his medical file.
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An
organ transplant coordinator should be assigned in each
organ transplant center entrusted with the following
responsibilities:
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Acts
as liaison between the Saudi Center for Organ
Transplantation and the organ transplant center.
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Reporting
the names of all patients fit for transplantation to
the Saudi Center for Organ Transplantation in order
to include them in the national waiting list as well
as preparation of a local waiting list for each
organ transplant center, according to priority
regulations for each organ.
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Co-ordination
with the Saudi Center for Organ Transplantation when
there is a brain-death case in any of the hospitals
affiliated to his center and extending assistance as
needed.
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Informing
the Saudi Center for Organ Transplantation when a
suitable patient fit for transplantation is not
available in the local waiting list.
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In
every hospital, other than the organ transplant
center an organ transplant coordinator should be
assigned to send the update all information related
to patients with end-stage organ failure (kidney,
heart, liver lung etc.) who are fit for
transplantation in accordance with special forms
issued for this purpose. A second person should be
appointed to continue duties when he is absent.
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Each
hospital and organ transplant center should send a list of
the names of end-stage organ failure patients to the Saudi
Center for Organ Transplantation which is turn establishes
national and local waiting lists for each organ transplant
in accordance with priority regulations. This waiting list
is sent back to organ transplant centers to act
accordingly.
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Each
transplant center should provide reports and statistics of
organ transplant recipients, both from living related and
cadaveric donors, every three months to the Saudi Center
for Organ Transplantation in accordance with the special
forms of transplant follow-up.
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All
kidney transplant centers have to carry out their
responsibilities towards the patients in the areas which
are under their sin accordance with the established
regulations.
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Evaluation
of organ transplant centers is done every two years by
specialized scientific committees in each respective filed
and in accordance with the criteria laid down by the Saudi
Center for Organ Transplantation.
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Regulations
for transplantation in private hospitals
First:
Private hospitals could perform transplantation from living
related donors on the condition that the relationship is
proved by an official institution specialized in this field
and on the condition that the documentation of this proof is
kept in the file of each patient concerned. If any case is
discovered not fulfilling this condition the proposal for
closure of the transplant center in their hospital will be
submitted to the licensing authority for medical practice in
the Ministry of Health.
Second: Private hospitals cannot benefit from
brain-death cases from other private or government hospitals.
They have the right only to benefit from their own brain death
cases on the condition that the Saudi Center for Organ
Transplantation is informed about the brain death and its
documentation is shared by one doctor from a government
hospital through the coordination with Saudi Center for Organ
Transplantation. Private hospitals have no right to take any
monetary compensation for the organs used for transplantation.
Third: All the rules and regulations issued by the
Saudi Center for Organ Transplantation are applicable to
private hospitals as for any other government hospitals and
same penalties apply in case of non-compliance.
Fourth: Organs should be transplanted to Saudis only
according to the regulations laid down by the Saudi Center for
Organ Transplantation. If any private hospital does not have
any Saudi patient fit for transplantation it should coordinate
with Saudi Center for Organ Transplantation for
transplantation of the organ to any other Saudi patient
according to priority in the national waiting list. If this
waiting list also has no Saudi patient fit for
transplantation, another suitable patient could be
transplanted according to priority level related to each
organ. |
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