1-2 Donation During Life:

• 1-1-2 Conditions of Donation:

  • 1-1-1-2 The donation must be made with free will and consent.

  • 2-1-1-2 The donor must be in complete physical and mental health.

  • 3-1-1-2 The donor must be medically fit according to the evidence.

  • 4-1-1-2 There must be proof of identity for the donor.

  • 5-1-1-2 The donor must pass the immunological and compatibility tests between the donor and the patient according to the scientific rules followed and stated in the evidence.

  • 6-1-1-2 The donor must be either:

    • 1-6-1-1-2 (Related) to the recipient up to the fourth degree of kinship or by marriage or by breastfeeding (provided that the breastfeeding relationship is proven by official authorities).

    • 2-6-1-1-2 (Unrelated) to the recipient within the specific regulations outlined in the evidence.

• 2-1-2 Through a family exchange program according to the specific regulations outlined in the evidence, provided that a commitment and acknowledgment is written between the two families or households and that there are no claims from the parties for compensation in the event of failure of the transplanted member after the transplantation procedure.

2-2 Will for Donation After Death:

• 1-2-2 The person's will must be written and documented within the officially recognized channels in the Kingdom of Saudi Arabia.

• 2-2-2 The center has the right to inquire about the wills of donors through the official inquiry service detailed in the evidence.

• 3-2-2 The center must enforce the written and officially documented will in accordance with the procedures detailed in the evidence.

1-3 Procedures for obtaining approval for organ donation cannot commence until the death is documented in accordance with the approved form provided in the evidence.

2-3 Approval for organ donation must be obtained from the closest heir, whether they are within the country or outside it, according to the approved admission form provided in the evidence.
 

1-4 The decision to Depart From:

• 1-1-4 Donation during life must be available in writing and documented within the approved form provided in the Evidence.

• 2-1-4 The Will must be available in writing and documented within the official channels approved in the Kingdom of Saudi Arabia (Saudi Center for Organ Transplantation website / Ministry of Justice platform / Tawakkalna).

• 3-1-4 Donation from heirs must be available in writing and documented within the approved form provided in the Evidence.

2-4 The organ transplant team is not permitted to perform the organ removal procedure if they are aware of the decision to Depart From the donation.
 

6-1 The healthcare facility is obligated to fill out the Member Transfer Form immediately upon the completion of the transfer and notify the center according to the procedures outlined in the Evidence within a maximum period of 24 hours from the date of the transfer operation.

6-2 The healthcare facility is obligated to fill out the Patient Follow-up Form after the organ transplantation in accordance with the approved forms provided in the Evidence within a maximum period of one month from the date of the transfer operation.
 

7-1 The doctor at the center is responsible for reviewing the suitability and appropriateness of the human organ donated by deceased individuals intended for transplantation into the recipient's body, based on the medical and technical standards specific to each organ, as approved by the various national committees for organ transplantation and outlined in the evidence.

7-2 The doctor at the center may request consultation from members of the technical committees specialized in infection control or various organ transplantation, whether from within the Kingdom or from abroad, based on the agreements established between the Saudi Center for Organ Transplantation and global national institutions, if available.
 

1-9 The medical team has the right to conduct an examination on the human organ intended for donation for the purpose of verifying epidemic diseases or for scientific purposes related to learning and teaching, to ensure the successful transplantation of the organ into the recipient's body. This is based on the fatwa of the Council of Senior Scholars No. 47 dated 20/8/1396 AH, "Conducting medical surgical operations on a deceased Muslim for the purposes of medical service interests," which permitted this in the interest of the public. Additionally, in accordance with Article (twenty) of the Ethics of Research on Living Creatures Regulation, issued by Royal Decree No. (M/59), it states: "It is permissible, when excising an organ for purely medical purposes, to benefit from it in scientific research, after obtaining informed consent."
 

11 -1 Verification of death for the purpose of organ donation shall be as follows:

• 1-1-11 Completion of the approved form for diagnosing death based on brain criteria as stated in the Evidence.

• 2-1-11 Completion of the approved form for diagnosing death after cardiac and circulatory arrest as stated in the Evidence.

• 3-1-11 Issuance of a death certificate in cases of tissue donation only.

2-11 No member of the organ transplant team shall participate in the process of documenting death.

3-11 The donating hospital must inform the relatives of the deceased and the center of the death immediately upon verification and document this according to the mechanism stated in the Evidence.

11-4 The official death certificate shall be issued after the removal of the ventilators and the permanent cessation of the heartbeat from the hospital where the organ removal operation took place, and it shall be signed by the attending physician / on-call physician or the intensive care physician or the supervising anesthesiologist of the removal operation.
 

1-13 The Agricultural Center - in the event of the inability to transplant the member - is obligated to fill out the form for the inability to transplant the member as stated in the evidence and notify the center of this before taking action.

13-2 The licensed healthcare facility designated as a donor hospital is obligated to:

• 13-2-1 Follow the critical pathway for potential death cases related to organ donation after death as stated in the evidence.

• 13-2-2 Notify the center of potential death cases within a maximum of 24 hours from the time of the incident that may lead to death according to the mechanism outlined in the evidence.

• 13-2-3 Notify the center of death cases for tissue donation immediately upon occurrence within a maximum of 6 hours from the time of death and according to the mechanism outlined in the evidence.

• 13-2-4 Send a monthly report on death cases in the various departments of the facilities according to the specific form provided in the evidence.

13-3 The center shall review and audit the monthly report sent by the healthcare facility and evaluate performance according to the key performance indicators outlined in the evidence.

13-4 The center shall issue a warning to the healthcare facility in the event of a breach of the provisions in item (1) and grant it a one-month period from the date of the warning for corrective action, and if the period is exceeded, the provisions of Article Twenty-One, item one, paragraph (c) shall be applied to the healthcare facility.
 

15-1 No healthcare facility has the right to perform organ transplants or donation operations without a valid license from the center.

2-15 The center issues a separate license for the transplantation of each organ based on the facility's request and the fulfillment of the standards and requirements for the appropriation of that organ as stated in the evidence.

3-15 Healthcare facilities must adhere to the limits of the license regarding the types of transplant/donation operations and the organs permitted under the facility's license.

15-4 Healthcare facilities wishing to obtain the license must comply with the fees specified in the evidence.

15-5 The license for the healthcare facility as a donor hospital is as follows:

• 1-5-15 The center issues a decision to form an evaluative committee for healthcare facilities as donor hospitals.

• 2-5-15 The committee prepares a list of healthcare facilities as donor hospitals according to the standards outlined in the evidence.

• 3-5-15 The general director issues the licensing decision for healthcare facilities as donor hospitals annually and whenever necessary.

6-15 The license for the healthcare facility as a transplantation center is as follows:

• 1-6-15 The healthcare facility submits a request for a license to perform human organ removal or transplantation, specifying the type of license required.

• 15-6-2 The center forms an evaluative committee to study the licensing request based on the mechanism outlined in the evidence, consisting of at least four members with expertise in the required licensing area (the member's rank must not be less than that of a consultant physician), in addition to a representative(s) from the center or any accredited healthcare facility nominated by the general director.

• 3-6-15 The committee is responsible for studying the request and evaluating the healthcare facility according to the standards outlined in the evidence.

• 4-6-15 Committee members are treated financially based on the regulations for specialized experts that the center consults.

• 5-6-15 The committee submits the results of the study of the request and proposes recommendations to the general director within a maximum period of 3 months from the date of the request.

• 6-6-15 The general director issues a decision to grant or refuse the license to the healthcare facility.

7-15 The healthcare facility must comply with the conditions and regulations for the continued validity of the license as stated in the evidence.

8-15 The healthcare facility – if it wishes to renew the license – must submit the renewal request within 3 months before the expiration date of the license according to the mechanism outlined in the evidence.

9-15 The license expires if the specified period in the previous clause elapses, and the facility will be notified of this by the center. The healthcare facility must submit a new request for the license if it wishes to continue performing human organ removal or transplantation operations.
 

1-17 The licensed healthcare facility is obligated to fill out the live donor follow-up form according to the model and mechanism provided in the evidence.

2-17 The center assigns the healthcare facility to follow up with the live donor for life according to the available financial resources.

3-17 The healthcare facility is obligated to accept the live donor - provided that they reside in the Kingdom - in the event of any complications resulting from the donation process.

4-17 The center has the right to refer the live donor to any healthcare facility for the purpose of monitoring their medical condition.

5-17 The licensed healthcare facility is obligated to fill out the follow-up forms for the donor's recipient (transplant patient) according to the models and mechanism provided in the evidence.

17 -6 The center is responsible for studying the results of the transplant operations conducted at the healthcare facility where they are being followed up, with the aim of evaluating the adequacy of the service provided to the donors regarding transplant operations and the necessary medical care for them.