In this Act, unless the context otherwise requires
"adult"
means a person who is eighteen years of age or above;
"adverse reaction"
means any biological dysfunction, communicable or other infectious disease that is possibly, reasonably likely or definite to have been transmitted by transplantation of donor organ, tissue or cells;
"allograft"
means tissue that is transplanted from one person to another;
"audit"
means a documented review of procedures, records, personnel functions, equipment, materials, facilities or vendors to evaluate adherence to this Act, any other applicable law, written standards of operation and other relevant standards;
"authorised officer"
means an officer or other person acting under the authority of the Minister or the Council under this Act;
"autograft"
means tissue which is transplanted within the same person;
"autologous use"
means the implantation, transplantation, infusion or transfer of human organ, tissue or cells back into the individual from whom the organ, tissue or cells were recovered;
"bank"
means an entity within a designated transplant centre that provides or engages in one or more services involving the storage of organs, tissues or cells from living or deceased individuals for transplantation and assessing donor suitability, including screening, recovery, processing, evaluation, testing, quarantine, labeling, storage, distribution, tracking, disposition and recall of organs, tissues or cells;
"bone marrow"
means the soft, spongy, gelatinous tissue that fills the medullary cavities or the centers of the bones, which is responsible for the production of red blood cells, white blood cells and platelets;
"brain dead"
means a condition where a person is on an artificial life support machine, with irreversible cessation of all functions of the entire brain, including the brainstem, confirmed by an electroencephalogram and independent team, and the person has no chance of revival;
"cells"
means individual cells or collections of cells when not bound by any form of connective tissue;
"child"
means a person under the age of eighteen years;
"close relation"
means a spouse, son, daughter, father, mother, brother or sister;
"Council"
means the Uganda Human Organ Donation and Transplant Council appointed under section
6
;
"competency"
means the ability of an employee to acceptably perform tasks related with his or her educational level for which he or she has been trained;
"competency assessment"
means the evaluation of the ability of an employee to acceptably perform tasks that are expected of the employee for the duties and responsibilities assigned to him or her;
"complaint"
means any written or oral communication concerning dissatisfaction with the identity, quality, packaging, durability, reliability, safety, effectiveness or performance of a human organ, tissue or cell transplanted in accordance with this Act;
"consent"
means the process by which approval for donation is obtained from the donor or the donor's close relation or any other legal representative;
"consignee"
means any bank, banking intermediary, designated transplant centre or transplanting surgeon whether an individual, bank or designated transplant centre, institution or organisation, that receives a human organ, tissue or cell, and assumes responsibility for any step in the processing, storage, distribution or use of such organ, tissue or cell;
"container"
means a receptacle used to contain human organs, tissues or cells and which is in direct contact with the organ, tissue or cell;
"cornea"
means the transparent anterior part of the outer fibrous coat of the eye bounded by an outer stratified epithelium and an inner monolayer of endothelial cells which is the major refractive component of the eye;
"cryopreserved"
means preservation by freezing or vitrification in the presence of a cryoprotectant and using a method validated to maintain cellular viability or preserve tissue matrix structure;
"currency point"
has the value assigned to it in Schedule 1 to this Act;
"deceased donor"
means an individual from whom at least one organ, tissue or cell is recovered for the purpose of transplantation after determination and declaration of death in accordance with this Act;
"departure from procedure or accident"
means a planned excursion from Standard Operating Procedure and where the Standard Operating Procedure is relevant to preventing risks of communicable disease transmission, a responsible person must determine that the departure does not increase the risks of communicable disease transmission and must document the decision;
"disposition"
means the final destination of an organ, tissue or cell, including use for transplantation or discarded;
"distributing bank"
means an entity that is reimbursed for or billed for providing an organ, tissue or cell to the end user; and which shall be responsible for tracking recipient or consignee information, post operation follow-up and reporting any adverse reaction to the source bank or the designated transplant centre;
"distribution"
means the process of allocation of tissues, cells or organs for transplant and includes receipt of request, selection, inspection and release of the tissue, cell or organ to a consignee which is responsible for maintaining the principles of tracking, traceability and adverse reaction reporting throughout the process of distribution;
"donated material"
means the body of a brain dead person or relevant material which has come from a human body, which is, or has been, the subject of donation;
"donor"
means a living or deceased person who provides the source of an organ, tissue or cell for transplantation;
"donor eligibility determination"
means the evaluation of all available information about a potential donor to assess whether the donor meets the qualifications specified in the Standard Operating Procedures and any other standards and includes, medical, social and sexual histories, laboratory test results, physical assessment or physical examination and autopsy findings, if performed;
"evaluation"
means the assessment of an entity, organ, tissue, cell, equipment, personnel and performance in relation to predetermined expectations or standards;
"expiration date"
means the date after which instruments, supplies, organs, tissues and cells are deemed to be no longer suitable for use;
"harvest"
means obtaining an organ that is still receiving perfusion;
"human organ"
means any part of the human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body;
"human organ, tissue or cell acquisition"
means the process by which the donated organs, tissues or cells are removed from a donor for transplantation, research or education;
"living donor recipient"
means a transplant recipient that receives a living donor organ, tissue or cell;
"medical record"
means a chronological account of a patient's examination and treatment that includes the patient's medical history and complaints, the physician's physical findings, the results of diagnostic tests and procedures, and medications and therapeutic procedures;
"Minister"
means the Minister responsible for health;
"national waiting list"
means the list created under section
51
;
"non-domino therapeutic donor"
means an individual who has a tissue, cell or organ removed as a component of medical treatment and whose organ is transplanted into another person, but the donor does not receive a replacement organ;
"organ"
means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy;
"organ transplant"
means the procedure for transplantation of organs including solid organ transplants and islet infusions, which begins at the start of organ anastomosis or the start of an islet infusion; and an organ transplant procedure is complete when any of the following occurs-
(a)
the chest or abdominal cavity is closed and the final skin stitch or staple is applied;
(b)
the transplant recipient leaves the operating room, even if the chest or abdominal cavity cannot be closed; or
(c)
the islet infusion is complete;
"parental responsibilities"
has the meaning assigned to it in the Children Act;
"parental rights"
has the meaning assigned to it in the Children Act;
"payment"
means payment in money or money's worth but does not include any payment for defraying or reimbursing-
(a)
the cost of removing, transporting or preserving the human organ to be supplied; or
(b)
any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his or her supplying any human organ from his or her body;
"post-mortem examination"
means the examination of the body of a dead person; involving its dissection and the removal of organs, tissue sample or any material derived from any body fluid which is carried out for any or all of the following purposes-
(a)
providing information about or confirming the cause of death;
(b)
investigating the effect and efficacy of any medical or surgical intervention carried out on the dead person;
(c)
obtaining information which may be relevant to the health of any other person; or
(d)
determining suitability for donation and transplant;
"procurement"
means the process of acquisition of human organs, tissues and cells but excludes trade in human organs, tissues or cells;
"quality assurance programme"
means a programme that-
(a)
defines the policies and environment required to meet standards of quality and safety prescribed under this Act, regulations made under this Act, any other applicable law and standards issued by the Minister; and
(b)
provides confidence that the processes and tissue, cell or organ consistently conform to requirements for quality, and the dimensions of quality assurance may include quality control, auditing and process control, standards for personnel, facilities, procedures, equipment, testing and record keeping activities;
"quality control"
means specific tests defined by the quality programme of a bank, hospital or designated transplant centre to be performed to monitor retrieval, processing, preservation and storage of organ,
tissue or cell quality and test accuracy, including performance evaluations, inspection, testing and controls used to determine the accuracy and reliability of the equipment and operational procedures and the monitoring of supplies, reagents, equipment, and facilities;
"qualifying purpose"
means-
(a)
a purpose specified in Schedule 2 to this Act;
(b)
the purpose of medical diagnosis or treatment;
(c)
the purpose of proper disposal; and
(d)
a purpose specified in regulations made by the Minister;
"quarantine"
means the identification of a tissue, cell or organ as not currently eligible for transplantation, including ocular tissue, other organs, tissues or cells that have not yet been characterised as being eligible for transplantation and includes the storage of that tissue, cell or organ in an area clearly identified for such use or other procedures, such as automated designation, to prevent the premature release of the tissue, cell or organ for transplantation;
"recall"
means an action taken to locate and retrieve organ, tissue or cell from distribution and dispensary inventories or the removal or correction of a marketed or distributed tissue, cell or organ that designated transplant centre considers to be in violation of this Act and any other applicable law and recalls may be conducted at the designated transplant centre's own initiative or at the request or directive of the Council;
"recipient"
means an individual who receives a donated human organ, tissue or cell;
"recover"
means the removal, acquisition, recovery or collection of donor organ, tissue or cell;
"recovery establishment"
means an entity that recovers organ, tissue or cell from a donor;
"registered medical practitioner"
means a medical practitioner who is registered under the Medical and Dental Practitioners Act, duly qualified and certified by the Council to undertake organ, tissue and cell donation and transplantation activities;
"relevant communicable disease"
means any communicable disease relevant to transplantation of organ, tissue or cell in humans as determined by the Minister;
"retrieval team"
means an intensive care team that is capable of handling a patient on life support;
"reward"
means any description of financial or other material advantage, but does not include any payment in money or money's worth for defraying or reimbursing-
(a)
the cost of removing, transporting, preparing, preserving or storing the organ, tissue or cell;
(b)
any liability incurred in respect of expenses incurred by a third party in, or in connection with, any of the activities referred to in paragraph (a); or
(c)
any expenses or loss of earnings incurred by the person from whose body the organ, tissue or cell is harvested, so far as reasonably and directly attributable to the donation;
"safety"
means a level of quality of organ, tissue or cell that indicates handling according to acceptable standards and assures substantial freedom from the potential for harmful effects to recipients, and includes the condition of being protected from risk or injury associated with occupational exposure;
"sedation"
means the reduction of irritability or agitation by administration of sedative drugs, generally to facilitate a medical procedure or diagnostic procedure;
"stem cells"
means undifferentiated cells originating from adult or embryonic tissue that can turn into specific cells, as the body needs them;
"stem cell transplant"
means a medical procedure performed to replace bone marrow that has been damaged or destroyed by disease, infection, or chemotherapy;
"therapeutic purposes"
means systematic treatment of any disease or the measures to improve health according to any particular method or modality;
"tissue"
means all constituent parts of a human organ formed by cells, including skin, cornea and bone marrow;
"tissue evaluation"
means the analysis of tissue for viability, abnormality, contaminants, compatibility and microorganisms to determine its fitness for purpose;
"tolerance limits"
means the limits that define a range of acceptable values established for each testing procedure that, when exceeded, require the implementation of corrective action designed to produce results within the acceptable range in future tests;
"traceability"
means the act or ability to locate an organ, tissue or cell during any step of its recovery, processing, evaluation, testing, quarantine, labeling, storage, distribution, disposition or recall, and includes the capacity to identify the surgeon, consignee, or designated transplant centre receiving the tissue, and the ability of the surgeon, consignee or designated transplant centre to identify the storage, recipient or final disposition of the organ, tissue or cell;
"tracking"
means the act or ability to locate individual organs, tissues or cells during any step of its recovery, processing, evaluation, testing, quarantine, labeling, storage, distribution, disposition and recalling; and includes the capacity of the distributing bank or designated transplant centre to identify the consignee and the consignee to identify the recipient;
"transplant"
means the process of reconstituting a function by transferring equivalent organs, tissues or cells from a donor to a recipient, and transplantation may be from one person to another (allogenic) or from a person to himself or herself (autologous);
"transplant centre"
means a hospital designated by the Minister under section
27
;
"transplant operation"
means an operation performed on a living person by a registered medical practitioner-
(a)
which is designed to safeguard or promote the physical health of the person by transplanting an organ, tissue or cell into the person; and
(b)
by so doing, necessitates the removal of an organ or part of an organ, tissue or cell from the person, which in turn is intended to be used for transplantation in respect of another living person;
"transplant programme"
means an organisation of medical personnel and allied health care professionals, operating in one or more designated transplant centres, with the responsibility for the transplantation of one or more types of organs, tissues or cells;
"withdrawal"
means the removal or collection of a distributed organ, tissue or cell by a bank that involves a minor violation or that involves no violation and does not involve a communicable disease.
