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THE HUMAN TISSUE TRANSPLANT LAW, 2013 (LAW 15 OF 2013) THE HUMAN TISSUE DONATION AND TRANSPLANT REGULATIONS, 2018 The Human Tissue Donation and Transplant Regulations, 2018 THE HUMAN TISSUE DONATION AND TRANSPLANT REGULATIONS, 2018 ARRANGEMENT OF REGULATIONS PART 1 - PRELIMINARY\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_1\", \"num\": \"1.\", \"text\": \"Citation\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_2\", \"num\": \"2.\", \"text\": \"Definitions\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_3\", \"num\": \"3.\", \"text\": \"Non-application of Regulations PART 2 - HUMAN TISSUE DONATION REGISTER\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_4\", \"num\": \"4.\", \"text\": \"Human Tissue Donation Register\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_5\", \"num\": \"5.\", \"text\": \"Eligibility for registration\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_6\", \"num\": \"6.\", \"text\": \"Registration as a donor\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_7\", \"num\": \"7.\", \"text\": \"Role of the Council\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_8\", \"num\": \"8.\", \"text\": \"De-registration PART 3 - CERTIFICATES OF CONSENT\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_9\", \"num\": \"9.\", \"text\": \"Prescribed certificates PART 4 - TISSUE BANKS AND TRANSPLANT CENTRES\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_10\", \"num\": \"10.\", \"text\": \"Authorization of health care facility to operate tissue bank or transplant centre\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_11\", \"num\": \"11.\", \"text\": \"Suspension of authorization\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_12\", \"num\": \"12.\", \"text\": \"Revocation of authorization\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_13\", \"num\": \"13.\", \"text\": \"Guidelines for assessment of live tissue donors\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_14\", \"num\": \"14.\", \"text\": \"Record-keeping requirements\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_15\", \"num\": \"15.\", \"text\": \"Trafficking in human tissue PART 5 - IMPORT AND EXPORT OF HUMAN TISSUE\", \"element\": \"section\", \"heading\": null}, {\"eId\": \"sec_16\", \"num\": \"16.\", \"text\": \"Import or export of human tissue prohibited unless certain requirements are met Schedule 1 - Donor Registration Form Schedule 2 - Consent of parent to the removal of regenerative tissue or organ from the body of a living child Schedule 3 - Consent by adult to the removal of regenerative tissue or organ from the adult\u2019s body Schedule 4 - Consent by adult to the removal of non-regenerative tissue or organ(s) from the adult\u2019s body Schedule 5 - Certificate of registered medical practitioner authorizing removal of tissue or organ(s) from a person\u2019s body after death The Human Tissue Donation and Transplant Regulations, 2018 THE HUMAN TISSUE TRANSPLANT LAW, 2013 (LAW 15 OF 2013) THE HUMAN TISSUE DONATION AND TRANSPLANT REGULATIONS, 2018 In exercise of the powers conferred by section 27 of the Human Tissue Transplant Law, 2013 the Cabinet makes the following Regulations - PART 1 - PRELIMINARY 1. These Regulations may be cited as the Human Tissue Donation and Transplant Regulations, 2018. 2. (1) In these Regulations - \u201cauthorized health care facility\u201d means a health care facility authorized by Cabinet by Notice published in the Gazette, to operate a tissue bank or a transplant centre, or both; \u201cdonation\u201d means the act of giving human tissue for a permitted purpose; \u201cdonor\u201d means a person who registers to donate or donates one or more tissues, whether the donation occurs during the person\u2019s lifetime or after death; \u201chealth care facility\u201d means a health care facility as defined in section 2 of the Health Practice Law (2017 Revision); \u201cparent\u201d, in relation to a child, means - (a) the child\u2019s natural mother or father; (b) the legal guardian of the child; (c) a person who has adopted the child pursuant to an adoption order; and (d) the spouse of the natural mother or father of the child who has been cohabiting with that person for not less than one year; \u201corgan\u201d means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop Citation Definitions (2017 Revision) The Human Tissue Donation and Transplant Regulations, 2018 physiological functions with a significant level of autonomy and includes a part of an organ if - (a) its function is to be used for the same purpose as the entire organ in the human body; and (b) that part maintains its structure, vascularisation and capacity to develop physiological functions with a significant level of autonomy; \u201cRegister\u201d means the Cayman Islands Human Tissue Donation Register established by regulation 4; \u201ctissue bank\u201d means a place operated by an authorized health care facility where a transplant coordinator or transplant team or unit undertakes the procurement, storage and supply of human tissues for permitted purposes; \u201ctransplant centre\u201d means an authorized health care facility where the transplantation of human tissues or organs is carried out; and \u201ctransplant co-ordinator\u201d means a registered and licensed medical practitioner employed by an authorized health care facility to coordinate the activities of a tissue bank or transplant centre. (2) Where these Regulations confer a duty or a liability on a tissue bank or transplant centre, the duty is imposed on, or the liability is incurred by, the health care facility authorized to operate the tissue bank or transplant centre. 3. These Regulations do not apply to blood or blood products or their storage or removal from the body of a person, whether living or deceased. PART 2 - HUMAN TISSUE DONATION REGISTER 4. (1) The Council shall maintain, in physical or electronic form, a Cayman Islands Human Tissue Donation Register. (2) The Council shall record the following information in the Register - (a) details of persons residing in the Islands who wish to become donors; (b) any particular tissue that a donor chooses to donate; and (c) any particular tissue that a donor chooses not to donate. (3) The Register shall be the only human tissue Register having legal validity for purposes of a donation in the Islands. Non-application of Regulations Human Tissue Donation Register The Human Tissue Donation and Transplant Regulations, 2018 5. (1) An adult may register to donate tissues from the adult\u2019s body by signing and submitting to the Council the registration form contained in Schedule 1. (2) The Council shall record all donations in the Register. 6. (1) The Council shall only register a person as a donor if it is satisfied that the person - (a) is an adult; (b) is not suffering from a mental disorder that renders the person incapable of understanding the nature and consequences of the donation; (c) is making the donation voluntarily, of the person\u2019s own free will; and (d) is adequately informed about and understands the nature and consequences of the donation. (2) Before registering a person as a donor, the Council may require the person to submit a certificate from a registered medical practitioner confirming that the person meets the criteria in paragraph (1)(b) or (d). 7. (1) The Council shall amend the Register whenever it is necessary or appropriate to do so in order to give effect to these Regulations, to bring the Register up to date or to correct any erroneous or incomplete information entered into it. (2) The Council shall not allow access to the information contained in the Register except to - (a) a donor or the donor\u2019s next of kin, in respect of a donation made by the donor or registered in the donor\u2019s name; and (b) a tissue bank or transplant centre, for the purpose of determining whether a person is a registered donor. 8. (1) A person registered as a donor under this Part may, at any time, apply in writing to the Council to retract the offer to donate a particular tissue. (2) The Council shall forthwith cancel a person\u2019s registration as a donor or amend the Register to reflect any changes respecting the person\u2019s proposed donation on receipt of - (a) an application under paragraph (1); or (b) a notice in writing from a registered medical practitioner who is attending the donor in a professional capacity indicating that the person has revoked the the person\u2019s consent under section 15(2) Eligibility for registration Schedule 1 Registration as a donor Role of the Council De-registration The Human Tissue Donation and Transplant Regulations, 2018 of the Law or is no longer in agreement with proposed donation as described in section 16(1) of the Law. PART 3 - CERTIFICATES OF CONSENT 9. The following certificates are prescribed for the purposes of the Law - (a) consent of a parent under section 13(1) of the Law to the removal of regenerative tissue from the body of a child for the purpose of transplantation to the body of another living person as set out in Schedule 2; (b) consent by an adult under section 6 of the Law to the removal of regenerative tissue from the adult\u2019s body for a permitted purpose as set out in Schedule 3; (c) consent by an adult to the removal of non-regenerative tissue from the adult\u2019s body for the purpose of transplantation to the body of another person as set out in Schedule 4; and (d) a registered medical practitioner\u2019s certificate under section 18 of the Law authorizing removal of tissue from a person\u2019s body after death as set out in Schedule 5. PART 4 - TISSUE BANKS AND TRANSPLANT CENTRES 10. (1) A health care facility may apply under this regulation to Cabinet to be authorized to operate a tissue bank or transplant centre or both. (2) An application under this regulation shall be in writing and in a manner and form determined by Cabinet. (3) An applicant health care facility shall provide the Cabinet with such further information that the Cabinet requires in a particular case. (4) The Cabinet may grant an approval under this regulation unconditionally or subject to conditions. (5) An authorized health care facility may apply to the Council for a permit to import or export human tissue for the purposes of its business for a period of up to twelve months from the day that the permit is granted. 11. (1) The Council may suspend a health care facility\u2019s authorization to operate a tissue bank or transplant centre if the facility - Prescribed certificates Schedule 2 Schedule 3 Schedule 4 Schedule 5 Application for authorization to operate tissue bank or transplant centre Suspension of authorization The Human Tissue Donation and Transplant Regulations, 2018 (a) is charged with an an offence under the Law; or (b) has failed to comply with the requirements of the Law. (2) Prior to suspending a health care facility\u2019s authorization under paragraph (1), the Council shall serve a notice on the health care facility stating that it intends to suspend its authorization, with effect from the date specified in the notice, and identifying - (a) the requirements of the Law that the health care facility is contravening; (b) the action which the health care facility is required to take to bring itself into compliance with the Law; and (c) the time within which the the action identified in subparagraph (b) shall be taken. (3) If aa authorized health care facility fails to comply with the requirements set out in a notice served under paragraph (2) within the specified time, the Council shall suspend the health care facility\u2019s authorization to operate the tissue bank or transplant centre. (4) A suspension under this regulation - (a) shall be for such period as the Council considers necessary, having regard to the reasons for the suspension; (b) may be total or limited to - (i) a particular activity or activities carried out at the tissue bank or transplant centre; or (ii) the procurement, storage or supply of particular tissues; and (c) shall be vacated if, in the case of suspension of an authorized health care facility charged with an offence under the Law, the health care facility is acquitted, or the charge is dropped. 12. (1) The Cabinet may, on the recommendation of the Council - (a) revoke a health care facility\u2019s authorization to operate a tissue bank or transplant centre; or (b) issue an order limiting a health care facility\u2019s authorization to - (i) a particular activity or activities carried out at a tissue bank or transplant centre; or (ii) the procurement, storage or supply of particular tissues. (2) Prior to recommending revocation or limitation of a health care facility\u2019s authorization under paragraph (1), the Council shall serve a notice on the health care facility stating its intention to make the recommendation, with effect from the date specified in the notice, and identifying - (a) the requirements that the health care facility is contravening; Revocation of authorization The Human Tissue Donation and Transplant Regulations, 2018 (b) the action which the health care facility is required to take to bring itself into compliance with the Law; and (c) the time within which such action shall be taken. (3) If the health care facility fails to comply with the requirements set out in the notice within the specified time, the Council shall recommend to Cabinet revocation or limitation of the health care facility\u2019s authorization, as the case may be. 13. (1) An authorized health care facility shall maintain guidelines approved by the Council to assess all potential live tissue donors in order to decide whether to supply human tissue for transplant, based on the following criteria - (a) in the case of donation between blood relatives and family members who are not blood relatives, the tissue shall be donated to an identified recipient; (b) in other non-related donations a pre-existent close emotional link shall be present between the donor and the recipient for such a donation to be acceptable; and (c) in the case of a non-directed altruistic tissue donation, the principle of distributive justice shall be adopted, by which the donated tissue shall be allocated to a recipient according to the recipient\u2019s medical needs. (2) Every authorized health care facility shall maintain updated and peerreviewed guidelines approved by the Council respecting the diagnosis of irreversible cessation of brain stem function. 14. (1) An authorized health care facility shall maintain written records - (a) of the activities of the tissue bank or transplant centre in procuring, testing, processing, testing, preserving, storing and distributing human tissue intended for transplant; (b) of the names of donors; (c) of the names of registered medical practitioners performing transplants; (d) of the names of recipients of transplanted tissue; and (e) containing details of - (i) every donation of tissue (whether regenerative or nonregenerative) by a living person; (ii) every removal of tissue from a deceased person; (iii) any arrangement negotiated or initiated by the health care facility involving the giving of benefits for the supply of, or for an offer to supply, tissue; (iv) every import or export of tissue by or on behalf of the health care facility; Guidelines for assessment of live tissue donors Record-keeping requirements The Human Tissue Donation and Transplant Regulations, 2018 (v) the costs incurred in the operation of the tissue bank or transplant centre associated with - (A) importing and exporting of tissue; (B) the transportation, removal, evaluation, storage and processing of tissue; and (C) the distribution and transplantation of tissue removed in accordance with the Law. (2) An authorized health care facility shall, on request by the Council, produce any record maintained under this regulation and permit the Council to - (a) inspect and take copies of, or extracts from, any book, document, computer data or record, in whatever form it is held at the premises of the tissue bank or transplant centre; (b) take possession of any human tissue samples for examination and analysis; and (c) question any person found on the premises of the tissue bank or transplant centre whom the Council has reasonable cause to believe is able to give information that is relevant to the functions of the Council or to a record required to be provided by the health care facility. 15. (1) An authorized health care facility that knowingly does or participates in any of the following activities - (a) makes use of illicitly removed human tissue for a permitted purpose; (b) supplies human tissue from a donor for transplantation to the body of another person, knowing that the transplantation will be carried out in contravention of the Law; (c) prepares, preserves or stores an illicitly removed human tissue; or (d) transports, transfers, receives, imports or exports an illicitly removed human tissue, commits an offence and is liable on summary conviction to a fine of ten thousand dollars. (2) Any person employed by an authorized health care facility, or who is a member of a transplant team or unit operating in conjunction with a tissue bank or transplant centre, who knowingly commits or participates in an offence committed by an authorized health care facility under paragraph (1) commits an offence and is liable to the same penalty as the health care facility. (3) In this regulation, illicitly removed human tissue is tissue that is removed from a living or deceased donor in any of the following circumstances - (a) where the removal is performed - Trafficking in human tissue The Human Tissue Donation and Transplant Regulations, 2018 (i) without the free, informed and specific consent of the living donor; or (ii) in the case of a deceased donor,  in contravention of the requirements of section 18(4)(b) of the Law, or without being consented to as required by the Law; or; (b) where, in exchange for the removal of the tissue, the donor or a third party has been offered or has received a financial gain or comparable advantage. PART 5 - IMPORT AND EXPORT OF HUMAN TISSUE 16. (1) A person or authorized health care facility shall not import human tissue into the Islands for the purpose of transplant unless - (a) the importation is made by or on behalf of a tissue bank or transplant centre; (b) the tissue - (i) meets standards of quality and safety approved by the Council; and (ii) can be traced from the donor to the recipient and vice versa in accordance with procedures established by the Council; and (c) the authorized health care facility has made an application for a permit for the importation under regulation 10(2) and the application has been approved by the Council. (2) A person or authorized health care facility shall not export human tissue from the Islands unless - (a) the export is made by or on behalf of a tissue bank or transplant centre; and (b) the authorized health care facility has made an application for a permit for the export under regulation 10(2) and the application has been approved by the Council. (3) An authorized health care facility or person that contravenes paragraph (1) or (2) commits an offence and is liable on summary conviction to a fine of ten thousand dollars. Import or export of human tissue prohibited unless certain requirements are met The Human Tissue Donation and Transplant Regulations, 2018 SCHEDULE 1 (Regulation 5(1)) DONOR REGISTRATION FORM 1. Name of donor: _________________ ________________  _________________________ First Middle Last 2. Contact information: Permanent Address: _________________________________________________________________ _________________________________________________________________ Present Address: _________________________________________________________________ _________________________________________________________________ Telephone number:___________________ Email address: ___________________________ 3. Personal information: Date of birth:________________________________________ Gender (Check one ) :                                    Male                Female 4. Tissues donated: I wish to become a donor under the Human Tissue Transplant Law, 2013 for the purpose of (Check one ) Transplant only; OR Transplant \/ organ and tissue research I wish to donate (Check one ) Any needed tissue or organ(s); The Human Tissue Donation and Transplant Regulations, 2018 The following tissue or organ(s) only: \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026. \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026. \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026. \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.   OR Any needed tissue or organs except for those indicated below: (Check only tissue and organ(s) that you do not want to donate) Kidneys    Heart Eyes Bone Liver Lungs Skin Pancreas Bone Marrow Other I do not wish my donated tissues or organs to be used as a cadaver for medical or scientific purposes. 5. Declaration: I declare that I am donating the tissue and organ(s) listed above voluntarily and of my own free will and that I am adequately informed about, and understand the nature and consequences of, the donation. By signing below, I am consenting to be a tissue or organ donor after my death. _____________________________ ________________________ (Signature of Donor) Date ______________________________ _________________________ (Signature of Witness) Date The Human Tissue Donation and Transplant Regulations, 2018 SCHEDULE 2 (Regulation 9(a)) CONSENT OF PARENT TO THE REMOVAL OF REGENERATIVE TISSUE OR ORGAN FROM THE BODY OF A LIVING CHILD PART 1 - Consent of Parent to Removal of regenerative tissue or organ I, .., parent of (Name of donor) a child under the age of 18 years, HEREBY CONSENT to the removal of the following regenerative tissue from the child\u2019s body for the purpose of transplant to the body of another living person (Tissue or organ to be removed for transplant) I CERTIFY THAT: (a) I have obtained advice from a medical practitioner (other than the practitioner who will be transplanting the tissue or organ) regarding the nature and effect of the removal of the tissue or organ and the nature of the transplantation; (Name of donor) understand the nature and effect of the removal and the nature of the transplantation; and of (Name of donor) the regenerative tissue or organ for the purpose of its transplantation to the body of another living person. The Human Tissue Donation and Transplant Regulations, 2018 (Signature  of parent) PART 2 - Certification by medical practitioner THAT (Name of registered medical practitioner) (Name of parent of donor) under (Name of donor) the age of 18 years, has consented to the removal of the following regenerative tissue or organ from the body of the child for the purpose of transplantation to the body of (Name of recipient) (Tissue or organ to be removed for transplant) I FURTHER CERTIFY THAT: (a) I am satisfied that, at the time consent was given, the child was capable of understanding the nature and effect of the removal of the tissue or organ and the nature of the transplantation; (b) I explained those matters to the child, who understood them; (c) the child was in agreement with the proposed removal and transplantation of the tissue or organ; and *(d) I am satisfied that the brother\/ sister\/ parent is likely to die unless the tissue or organ is transplanted to the body of that brother, sister or parent. (Paragraph (d) applies only where the consent relates to the removal of any specified regenerative tissue or organ The Human Tissue Donation and Transplant Regulations, 2018 for the purpose of transplantation to the body of a brother, sister or parent of the child.) (Signature of registered medical practitioner) * Strike through as necessary SCHEDULE 3 (Regulation 9(b)) CONSENT BY ADULT  TO THE REMOVAL OF REGENERATIVE TISSUE OR ORGAN FROM THE ADULT\u2019S BODY PART 1 - Consent to Removal of regenerative tissue or organ I, (Name of donor) HEREBY CONSENT to the removal from my body, while I am alive, of the following regenerative tissue or organ for the purpose of: (Check one) transplantation to the body of another living person; or other therapeutic purposes or for medical or scientific purposes (Tissue or organ to be removed) PART 2 - Certification by medical practitioner (Name of registered medical practitioner) (Name of donor) gave the above written consent in my presence. I FURTHER CERTIFY THAT I have explained to_ The Human Tissue Donation and Transplant Regulations, 2018 (Name of donor) of the regenerative tissue or organ from  his\/her  body and I am of the opinion that  he\/she  understood the implications of the removal. (Signature of registered medical practitioner) SCHEDULE 4 (Regulation 9(c)) CONSENT BY ADULT TO THE REMOVAL OF NONREGENERATIVE TISSUE OR ORGAN(S) FROM THE ADULT\u2019S BODY PART 1 - Consent to Removal of non-regenerative tissue or organ(s) (Name of donor) HEREBY CONSENT to the removal from my body, while I am alive, of the following non-regenerative tissue or organ(s): (Tissue or organ(s) to be removed) for the purpose of transplant to the body of another living person. (Signature of donor) PART 2 - Certification by medical practitioner (Name of registered medical practitioner) (Name of donor) gave the above written consent in my presence. The Human Tissue Donation and Transplant Regulations, 2018 I FURTHER CERTIFY THAT I have explained to (Name of donor) of the non-regenerative tissue or organ(s) from  his\/her  body and I am of the opinion that  he\/she  understood the implications of the removal and freely consents to it. (Signature of registered medical practitioner) SCHEDULE 5 (Regulation 9(d)) CERTIFICATE OF REGISTERED MEDICAL PRACTITIONER AUTHORIZING REMOVAL OF TISSUE OR ORGAN(S) FROM A PERSON\u2019S BODY AFTER DEATH (Name Of Registered Medical Practitioner) the removal of the following tissue: (Tissue or organ(s) to be removed) (Name of donor) for the purpose of: (Check one) transplantation to the body of another living person; or other therapeutic purposes or for medical or scientific purposes. I CERTIFY THAT *(a) another registered medical practitioner has carried out a clinical examination of the deceased and has certified in writing that, in his\/ her opinion, the person has died;  OR The Human Tissue Donation and Transplant Regulations, 2018 *(b) two other registered medical practitioners (each of whom has been registered as a medical practitioner for a period of not less than five years) have carried out a clinical examination of the deceased while the respiration or the circulation of the blood of that person was being maintained by artificial means; and have certified in writing that, in his\/her opinion, at the time of examination, irreversible cessation of all function of the brain stem of the person had already occurred. I FURTHER CERTIFY THAT I have made such enquiries as are reasonable in the circumstances and that (a) I am satisfied that the deceased during his\/her lifetime - *(i) expressed the wish for, or consented to, the removal of the tissue or organ(s) from his\/her body after death for any purpose or use referred to above and that the deceased had not withdrawn the wish or revoked the consent; OR *(ii) never expressed any objection to the removal of the tissue or organ(s) from his\/her body after death for any purpose or use referred to above and I am satisfied that the next of kin of the deceased consents to the removal of the tissue or organ(s) from the body of the deceased for any such purpose or use; AND (b) I have no reason to believe that the deceased, at the time that his\/her consent was given, lacked capacity to consent. (Signature of registered medical practitioner) * Strike through as necessary Made in Cabinet the 18th day of December, 2018. 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Authorization of health care facility to operate tissue bank or transplant\ncentre\n11. Suspension of authorization\n12. Revocation of authorization\n13. Guidelines for assessment of live tissue donors\n14. Record-keeping requirements\n15. Trafficking in human tissue\nPART 5 - IMPORT AND EXPORT OF HUMAN TISSUE\n16. Import or export of human tissue prohibited unless certain requirements\n\nare met\n\nSchedule 1 - Donor Registration Form\nSchedule 2 - Consent of parent to the removal of regenerative tissue or organ\n\n    from the body of a living child\nSchedule 3 - Consent by adult to the removal of regenerative tissue or organ from\n    the adult\u2019s body\nSchedule 4 - Consent by adult to the removal of non-regenerative tissue or\n    organ(s) from the adult\u2019s body\nSchedule 5 - Certificate of registered medical practitioner authorizing removal of\n    tissue or organ(s) from a person\u2019s body after death\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n3\nCAYMAN ISLANDS\n\nTHE HUMAN TISSUE TRANSPLANT LAW, 2013\n(LAW 15 OF 2013)\n\nTHE HUMAN TISSUE DONATION AND TRANSPLANT\nREGULATIONS, 2018\nIn exercise of the powers conferred by section 27 of the Human Tissue\nTransplant Law, 2013 the Cabinet makes the following Regulations -\nPART 1 - PRELIMINARY\n1.\nThese Regulations may be cited as the Human Tissue Donation and\nTransplant Regulations, 2018.\n2.\n(1) In these Regulations -\n\u201cauthorized health care facility\u201d means a health care facility authorized by\nCabinet by Notice published in the Gazette, to operate a tissue bank or a\ntransplant centre, or both;\n\u201cdonation\u201d means the act of giving human tissue for a permitted purpose;\n\u201cdonor\u201d means a person who registers to donate or donates one or more tissues,\nwhether the donation occurs during the person\u2019s lifetime or after death;\n\u201chealth care facility\u201d means a health care facility as defined in section 2 of the\nHealth Practice Law (2017 Revision);\n\u201cparent\u201d, in relation to a child, means -\n(a)\nthe child\u2019s natural mother or father;\n(b) the legal guardian of the child;\n(c)\na person who has adopted the child pursuant to an adoption\norder; and\n(d) the spouse of the natural mother or father of the child who has\nbeen cohabiting with that person for not less than one year;\n\u201corgan\u201d means a differentiated part of the human body, formed by different\ntissues, that maintains its structure, vascularisation and capacity to develop\nCitation\nDefinitions\n\n(2017 Revision)\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n4\nphysiological functions with a significant level of autonomy and includes a part\nof an organ if -\n(a)\nits function is to be used for the same purpose as the entire organ\nin the human body; and\n(b) that part maintains its structure, vascularisation and capacity to\ndevelop physiological functions with a significant level of\nautonomy;\n\u201cRegister\u201d means the Cayman Islands Human Tissue Donation Register\nestablished by regulation 4;\n\u201ctissue bank\u201d means a place operated by an authorized health care facility where\na transplant coordinator or transplant team or unit undertakes the procurement,\nstorage and supply of human tissues for permitted purposes;\n\u201ctransplant centre\u201d means an authorized health care facility where the\ntransplantation of human tissues or organs is carried out; and\n\u201ctransplant co-ordinator\u201d means a registered and licensed medical practitioner\nemployed by an authorized health care facility to coordinate the activities of a\ntissue bank or transplant centre.\n(2) Where these Regulations confer a duty or a liability on a tissue bank or\ntransplant centre, the duty is imposed on, or the liability is incurred by, the health\ncare facility authorized to operate the tissue bank or transplant centre.\n3.\nThese Regulations do not apply to blood or blood products or their storage\nor removal from the body of a person, whether living or deceased.\nPART 2 - HUMAN TISSUE DONATION REGISTER\n4.\n(1) The Council shall maintain, in physical or electronic form, a Cayman\nIslands Human Tissue Donation Register.\n(2) The Council shall record the following information in the Register -\n(a)\ndetails of persons residing in the Islands who wish to become\ndonors;\n(b) any particular tissue that a donor chooses to donate; and\n(c)\nany particular tissue that a donor chooses not to donate.\n(3) The Register shall be the only human tissue Register having legal\nvalidity for purposes of a donation in the Islands.\n\nNon-application of\nRegulations\nHuman Tissue Donation\nRegister\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n5\n5.\n(1) An adult may register to donate tissues from the adult\u2019s body by\nsigning and submitting to the Council the registration form contained in Schedule\n1.\n(2) The Council shall record all donations in the Register.\n6.\n(1) The Council shall only register a person as a donor if it is satisfied that\nthe person -\n(a)\nis an adult;\n(b) is not suffering from a mental disorder that renders the person\nincapable of understanding the nature and consequences of the\ndonation;\n(c)\nis making the donation voluntarily, of the person\u2019s own free will;\nand\n(d) is adequately informed about and understands the nature and\nconsequences of the donation.\n(2) Before registering a person as a donor, the Council may require the\nperson to submit a certificate from a registered medical practitioner confirming\nthat the person meets the criteria in paragraph (1)(b) or (d).\n7.\n(1) The Council shall amend the Register whenever it is necessary or\nappropriate to do so in order to give effect to these Regulations, to bring the\nRegister up to date or to correct any erroneous or incomplete information entered\ninto it.\n(2) The Council shall not allow access to the information contained in the\nRegister except to -\n(a)\na donor or the donor\u2019s next of kin, in respect of a donation made\nby the donor or registered in the donor\u2019s name; and\n(b) a tissue bank or transplant centre, for the purpose of determining\nwhether a person is a registered donor.\n8.\n(1) A person registered as a donor under this Part may, at any time, apply\nin writing to the Council to retract the offer to donate a particular tissue.\n(2) The Council shall forthwith cancel a person\u2019s registration as a donor or\namend the Register to reflect any changes respecting the person\u2019s proposed\ndonation on receipt of -\n(a)\nan application under paragraph (1); or\n(b) a notice in writing from a registered medical practitioner who is\nattending the donor in a professional capacity indicating that the\nperson has revoked the the person\u2019s consent under section 15(2)\nEligibility for\nregistration\nSchedule 1\nRegistration as a donor\nRole of the Council\nDe-registration\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n6\nof the Law or is no longer in agreement with proposed donation\nas described in section 16(1) of the Law.\n\nPART 3 - CERTIFICATES OF CONSENT\n\n9.\nThe following certificates are prescribed for the purposes of the Law -\n(a)\nconsent of a parent under section 13(1) of the Law to the removal\nof regenerative tissue from the body of a child for the purpose of\ntransplantation to the body of another living person as set out in\nSchedule 2;\n(b) consent by an adult under section 6 of the Law to the removal of\nregenerative tissue from the adult\u2019s body for a permitted purpose\nas set out in Schedule 3;\n(c)\nconsent by an adult to the removal of non-regenerative tissue\nfrom the adult\u2019s body for the purpose of transplantation to the\nbody of another person as set out in Schedule 4; and\n(d) a registered medical practitioner\u2019s certificate under section 18 of\nthe Law authorizing removal of tissue from a person\u2019s body after\ndeath as set out in Schedule 5.\n\nPART 4 - TISSUE BANKS AND TRANSPLANT CENTRES\n\n10. (1) A health care facility may apply under this regulation to Cabinet to be\nauthorized to operate a tissue bank or transplant centre or both.\n(2) An application under this regulation shall be in writing and in a manner\nand form determined by Cabinet.\n(3) An applicant health care facility shall provide the Cabinet with such\nfurther information that the Cabinet requires in a particular case.\n(4) The Cabinet may grant an approval under this regulation unconditionally\nor subject to conditions.\n(5) An authorized health care facility may apply to the Council for a\npermit to import or export human tissue for the purposes of its business for a\nperiod of up to twelve months from the day that the permit is granted.\n\n11. (1) The Council may suspend a health care facility\u2019s authorization to\noperate a tissue bank or transplant centre if the facility -\nPrescribed certificates\n\nSchedule 2\n\nSchedule 3\n\nSchedule 4\n\nSchedule 5\nApplication for\nauthorization to operate\ntissue bank or transplant\ncentre\nSuspension of\nauthorization\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n7\n(a)\nis charged with an an offence under the Law; or\n(b) has failed to comply with the requirements of the Law.\n(2) Prior to suspending a health care facility\u2019s authorization under\nparagraph (1), the Council shall serve a notice on the health care facility stating\nthat it intends to suspend its authorization, with effect from the date specified in\nthe notice, and identifying -\n(a)\nthe requirements of the Law that the health care facility is\ncontravening;\n(b) the action which the health care facility is required to take to\nbring itself into compliance with the Law; and\n(c)\nthe time within which the the action identified in subparagraph\n(b) shall be taken.\n(3) If aa authorized health care facility fails to comply with the\nrequirements set out in a notice served under paragraph (2) within the specified\ntime, the Council shall suspend the health care facility\u2019s authorization to operate\nthe tissue bank or transplant centre.\n(4) A suspension under this regulation -\n(a)\nshall be for such period as the Council considers necessary,\nhaving regard to the reasons for the suspension;\n(b) may be total or limited to -\n(i)\na particular activity or activities carried out at the tissue\nbank or transplant centre; or\n(ii) the procurement, storage or supply of particular tissues; and\n(c)\nshall be vacated if, in the case of suspension of an authorized\nhealth care facility charged with an offence under the Law, the\nhealth care facility is acquitted, or the charge is dropped.\n12. (1) The Cabinet may, on the recommendation of the Council -\n(a)\nrevoke a health care facility\u2019s authorization to operate a tissue\nbank or transplant centre; or\n(b) issue an order limiting a health care facility\u2019s authorization to -\n(i)\na particular activity or activities carried out at a tissue bank\nor transplant centre; or\n(ii) the procurement, storage or supply of particular tissues.\n(2) Prior to recommending revocation or limitation of a health care\nfacility\u2019s authorization under paragraph (1), the Council shall serve a notice on\nthe health care facility stating its intention to make the recommendation, with\neffect from the date specified in the notice, and identifying -\n(a)\nthe requirements that the health care facility is contravening;\nRevocation of\nauthorization\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n8\n(b) the action which the health care facility is required to take to\nbring itself into compliance with the Law; and\n(c)\nthe time within which such action shall be taken.\n(3) If the health care facility fails to comply with the requirements set out\nin the notice within the specified time, the Council shall recommend to Cabinet\nrevocation or limitation of the health care facility\u2019s authorization, as the case may\nbe.\n13. (1) An authorized health care facility shall maintain guidelines approved\nby the Council to assess all potential live tissue donors in order to decide whether\nto supply human tissue for transplant, based on the following criteria -\n(a)\nin the case of donation between blood relatives and family\nmembers who are not blood relatives, the tissue shall be donated\nto an identified recipient;\n(b) in other non-related donations a pre-existent close emotional link\nshall be present between the donor and the recipient for such a\ndonation to be acceptable; and\n(c)\nin the case of a non-directed altruistic tissue donation, the\nprinciple of distributive justice shall be adopted, by which the\ndonated tissue shall be allocated to a recipient according to the\nrecipient\u2019s medical needs.\n(2) Every authorized health care facility shall maintain updated and peerreviewed guidelines approved by the Council respecting the diagnosis of\nirreversible cessation of brain stem function.\n14. (1) An authorized health care facility shall maintain written records -\n(a)\nof the activities of the tissue bank or transplant centre in\nprocuring, testing, processing, testing, preserving, storing and\ndistributing human tissue intended for transplant;\n(b) of the names of donors;\n(c)\nof the names of registered medical practitioners performing\ntransplants;\n(d) of the names of recipients of transplanted tissue; and\n(e)\ncontaining details of -\n(i)\nevery donation of tissue (whether regenerative or nonregenerative) by a living person;\n(ii) every removal of tissue from a deceased person;\n(iii) any arrangement negotiated or initiated by the health care\nfacility involving the giving of benefits for the supply of, or\nfor an offer to supply, tissue;\n(iv) every import or export of tissue by or on behalf of the\nhealth care facility;\nGuidelines for\nassessment of live tissue\ndonors\nRecord-keeping\nrequirements\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n9\n(v) the costs incurred in the operation of the tissue bank or\ntransplant centre associated with -\n(A) importing and exporting of tissue;\n(B) the transportation, removal, evaluation, storage and\nprocessing of tissue; and\n(C) the distribution and transplantation of tissue removed\nin accordance with the Law.\n(2) An authorized health care facility shall, on request by the Council,\nproduce any record maintained under this regulation and permit the Council to -\n(a)\ninspect and take copies of, or extracts from, any book, document,\ncomputer data or record, in whatever form it is held at the\npremises of the tissue bank or transplant centre;\n(b) take possession of any human tissue samples for examination and\nanalysis; and\n(c)\nquestion any person found on the premises of the tissue bank or\ntransplant centre whom the Council has reasonable cause to\nbelieve is able to give information that is relevant to the functions\nof the Council or to a record required to be provided by the\nhealth care facility.\n15. (1) An authorized health care facility that knowingly does or participates\nin any of the following activities -\n(a)\nmakes use of illicitly removed human tissue for a permitted\npurpose;\n(b) supplies human tissue from a donor for transplantation to the\nbody of another person, knowing that the transplantation will be\ncarried out in contravention of the Law;\n(c)\nprepares, preserves or stores an illicitly removed human tissue; or\n(d) transports, transfers, receives, imports or exports an illicitly\nremoved human tissue,\ncommits an offence and is liable on summary conviction to a fine of ten thousand\ndollars.\n(2) Any person employed by an authorized health care facility, or who is a\nmember of a transplant team or unit operating in conjunction with a tissue bank\nor transplant centre, who knowingly commits or participates in an offence\ncommitted by an authorized health care facility under paragraph (1) commits an\noffence and is liable to the same penalty as the health care facility.\n(3) In this regulation, illicitly removed human tissue is tissue that is\nremoved from a living or deceased donor in any of the following circumstances -\n(a)\nwhere the removal is performed -\nTrafficking in human\ntissue\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n10\n(i)\nwithout the free, informed and specific consent of the living\ndonor; or\n(ii) in the case of a deceased donor,  in contravention of the\nrequirements of section 18(4)(b) of the Law, or without\nbeing consented to as required by the Law; or;\n(b) where, in exchange for the removal of the tissue, the donor or a\nthird party has been offered or has received a financial gain or\ncomparable advantage.\nPART 5 - IMPORT AND EXPORT OF HUMAN TISSUE\n16. (1) A person or authorized health care facility shall not import human\ntissue into the Islands for the purpose of transplant unless -\n(a)\nthe importation is made by or on behalf of a tissue bank or\ntransplant centre;\n(b) the tissue -\n(i)\nmeets standards of quality and safety approved by the\nCouncil; and\n(ii) can be traced from the donor to the recipient and vice versa\nin accordance with procedures established by the Council;\nand\n(c)\nthe authorized health care facility has made an application for a\npermit for the importation under regulation 10(2) and the\napplication has been approved by the Council.\n(2) A person or authorized health care facility shall not export human\ntissue from the Islands unless -\n(a)\nthe export is made by or on behalf of a tissue bank or transplant\ncentre; and\n(b) the authorized health care facility has made an application for a\npermit for the export under regulation 10(2) and the application\nhas been approved by the Council.\n(3) An authorized health care facility or person that contravenes paragraph\n(1) or (2) commits an offence and is liable on summary conviction to a fine of ten\nthousand dollars.\nImport or export of\nhuman tissue prohibited\nunless certain\nrequirements are met\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n11\nSCHEDULE 1\n(Regulation 5(1))\nDONOR REGISTRATION FORM\n\n1.\nName of donor:\n\n _________________\n  ________________  _________________________\n                     First\n\n              Middle\n\nLast\n\n2.\nContact information:\nPermanent Address:\n_________________________________________________________________\n_________________________________________________________________\nPresent Address:\n_________________________________________________________________\n_________________________________________________________________\n\nTelephone number:___________________\n\nEmail address: ___________________________\n\n3.\nPersonal information:\n\nDate of birth:________________________________________\nGender (Check one ) :                                    Male                Female\n\n4.\nTissues donated:\n\nI wish to become a donor under the Human Tissue Transplant Law, 2013 for the\npurpose of\n(Check one )\n\nTransplant only; OR\n\nTransplant \/ organ and tissue research\n\nI wish to donate\n (Check one )\n\nAny needed tissue or organ(s);\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n12\n\nThe following tissue or organ(s) only:\n\n\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\n\n\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\n\n\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\n\n\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.   OR\n\nAny needed tissue or organs except for those indicated below:\n\n(Check only tissue and organ(s) that you do not want to donate)\n\nKidneys    Heart\n    Eyes\nBone\n\nLiver\nLungs\n    Skin\nPancreas\n\nBone Marrow\n\nOther\n\nI do not wish my donated tissues or organs to be used as a cadaver for\nmedical or scientific purposes.\n5.\nDeclaration:\nI declare that I am donating the tissue and organ(s) listed above voluntarily and of\nmy own free will and that I am adequately informed about, and understand the\nnature and consequences of, the donation.\n\nBy signing below, I am consenting to be a tissue or organ donor after my death.\n\n_____________________________\n________________________\n(Signature of Donor)\n\nDate\n\n______________________________\n_________________________\n(Signature of Witness)\n\nDate\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n13\n\nSCHEDULE 2\n(Regulation 9(a))\nCONSENT OF PARENT TO THE REMOVAL OF REGENERATIVE TISSUE\nOR ORGAN FROM THE BODY OF A LIVING CHILD\n\nPART 1 - Consent of Parent to Removal of regenerative tissue or organ\nI,\n..................................................................................................................\n..,\nparent of\n..........................................................................................................,\n(Name of donor)\n\na child under the age of 18 years, HEREBY\nCONSENT to the removal of the following regenerative\ntissue from the child\u2019s body for the purpose of\ntransplant to the body of another living person\n\n............................................................................................................\n(Tissue or organ to be removed for transplant)\n\nI CERTIFY THAT:\n\n(a) I have obtained advice from a medical practitioner (other\nthan the practitioner who will be transplanting the tissue or\norgan) regarding the nature and effect of the removal of the\ntissue or organ and the nature of the transplantation;\n\n(b) ................................................... has the mental capacity to\n(Name of donor)\n\nunderstand the nature and effect of the removal and the\nnature of the transplantation; and\n\n(c) ................................................... has agreed to the removal\nof\n(Name of donor)\n\nthe regenerative tissue or organ for the purpose of its\ntransplantation to the body of another living person.\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n14\n\nDate ......................  ..............................................................................\n(Signature  of parent)\n\nPART 2 - Certification by medical practitioner\n\nI, ............................................................................................. ,  CERTIFY\nTHAT\n(Name of registered medical practitioner)\n................................................................................... ..................,  a parent of\n(Name of parent of donor)\n..................................................................................................,   a child\nunder\n(Name of donor)\nthe age of 18 years, has consented to the removal of the\nfollowing regenerative tissue or organ from the body of the\nchild for the purpose of transplantation to the body of\n\n............................................................................................................\n(Name of recipient)\n\n............................................................................................................\n(Tissue or organ to be removed for transplant)\n\nI FURTHER CERTIFY THAT:\n\n(a) I am satisfied that, at the time consent was given, the child\nwas capable of understanding the nature and effect of the\nremoval of the tissue or organ and the nature of the\ntransplantation;\n(b) I explained those matters to the child, who understood\nthem;\n(c) the child was in agreement with the proposed removal and\ntransplantation of the tissue or organ; and\n*(d) I am satisfied that the brother\/ sister\/ parent is likely to die\nunless the tissue or organ is transplanted to the body of that\nbrother, sister or parent.\n\n(Paragraph (d) applies only where the consent relates to\nthe removal of any specified regenerative tissue or organ\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n15\nfor the purpose of transplantation to the body of a brother,\nsister or parent of the child.)\n\nDate ...........................  ..............................................................................\n(Signature of registered medical practitioner)\n* Strike through as necessary\n\nSCHEDULE 3\n(Regulation 9(b))\nCONSENT BY ADULT  TO THE REMOVAL OF REGENERATIVE\nTISSUE OR ORGAN FROM THE ADULT\u2019S BODY\nPART 1 - Consent to Removal of regenerative tissue or organ\nI,\n.......................................................................................................................,\n(Name of donor)\nHEREBY CONSENT to the removal from my body, while I\nam alive, of the following regenerative tissue or organ for the\npurpose of:\n\n(Check one)\n\ntransplantation to the body of another living person; or\n\nother therapeutic purposes or for medical or scientific purposes\n\n............................................................................................................\n(Tissue or organ to be removed)\n\nPART 2 - Certification by medical practitioner\n\nI, .......................................................................................,  CERTIFY THAT\n(Name of registered medical practitioner)\n\n........................................................................, being an adult of sound mind,\n\n(Name of donor)\n\ngave the above written consent in my presence.\n\nI\nFURTHER\nCERTIFY\nTHAT\nI\nhave\nexplained\nto_\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n16\n_............................................................... the implications of the removal\n(Name of donor)\nof the regenerative tissue or organ from  his\/her  body and I am of the\nopinion that  he\/she  understood the implications of the removal.\n\nDate ...........................  ..............................................................................\n(Signature of registered medical practitioner)\n\nSCHEDULE 4\n(Regulation 9(c))\nCONSENT BY ADULT TO THE REMOVAL OF NONREGENERATIVE TISSUE OR ORGAN(S) FROM THE\nADULT\u2019S BODY\nPART 1 - Consent to Removal of non-regenerative tissue or organ(s)\nI, .......................................................................................................................,\n(Name of donor)\nHEREBY CONSENT to the removal from my body, while I am alive, of the\nfollowing non-regenerative tissue or organ(s):\n\n...................................................................................................................\n(Tissue or organ(s) to be removed)\n\nfor the purpose of transplant to the body of another living person.\n\nTime of consent:  ...... o\u2019clock AM \/ PM\n\nDate:  ...........................\n\n..............................................................................\n\n(Signature of donor)\n\nPART 2 - Certification by medical practitioner\n\nI, ....................................................................................,  CERTIFY THAT\n(Name of registered medical practitioner)\n\n........................................................................, being an adult of sound mind,\n\n(Name of donor)\n\ngave the above written consent in my presence.\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n17\n\nI FURTHER CERTIFY THAT I have explained to\n\n....................................................................... the implications of the removal\n(Name of donor)\nof the non-regenerative tissue or organ(s) from  his\/her  body and I am of the\nopinion that  he\/she  understood the implications of the removal and freely\nconsents to it.\n\nDate ...........................  ..............................................................................\n(Signature of registered medical practitioner)\n\nSCHEDULE 5\n(Regulation 9(d))\nCERTIFICATE OF REGISTERED MEDICAL PRACTITIONER\nAUTHORIZING REMOVAL OF TISSUE OR ORGAN(S)\nFROM A PERSON\u2019S BODY AFTER DEATH\n\nI, ..............................................................................................,  AUTHORIZE\n(Name Of Registered Medical Practitioner)\nthe removal of the following tissue:\n................................................................................................................................\n(Tissue or organ(s) to be removed)\n\nfrom the body of......................................................................................, deceased\n(Name of donor)\n\nfor the purpose of: (Check one)\n\ntransplantation to the body of another living person; or\n\nother therapeutic purposes or for medical or scientific purposes.\n\nI CERTIFY THAT\n*(a) another registered medical practitioner has carried out a clinical\nexamination of the deceased and has certified in writing that, in his\/\nher opinion, the person has died;  OR\n\nThe Human Tissue Donation and Transplant Regulations, 2018\n\n18\n*(b) two other registered medical practitioners (each of whom has been\nregistered as a medical practitioner for a period of not less than five\nyears) have carried out a clinical examination of the deceased while\nthe respiration or the circulation of the blood of that person was being\nmaintained by artificial means; and have certified in writing that, in\nhis\/her opinion, at the time of examination, irreversible cessation of all\nfunction of the brain stem of the person had already occurred.\n\nI FURTHER CERTIFY THAT I have made such enquiries as are reasonable in\nthe circumstances and that\n\n(a)\nI am satisfied that the deceased during his\/her lifetime -\n\n*(i) expressed the wish for, or consented to, the removal of the tissue\nor organ(s) from his\/her body after death for any purpose or use\nreferred to above and that the deceased had not withdrawn the\nwish or revoked the consent; OR\n\n*(ii) never expressed any objection to the removal of the tissue or\norgan(s) from his\/her body after death for any purpose or use\nreferred to above and I am satisfied that the next of kin of the\ndeceased consents to the removal of the tissue or organ(s) from\nthe body of the deceased for any such purpose or use; AND\n\n(b) I have no reason to believe that the deceased, at the time that his\/her\nconsent was given, lacked capacity to consent.\n\nDate ...........................  ..............................................................................\n(Signature of registered medical practitioner)\n* Strike through as necessary\n\nMade in Cabinet the 18th day of December, 2018.\n\nKim Bullings\n\nClerk of the Cabinet.","akn_extracted_at":"2026-06-22 15:38:38.322965+00","cms_id":"2018-0040","law_type":"subordinate","year":"2018","number":"40","title":"Human Tissue Donation and Transplant Regulations","status":"in_force"},"provenance":{"files":[{"file_id":"5970","expr_id":"732","kind":"akn_xml","filename":"2018-0040_SL 40 of 2018.akn.xml","source_url":null,"storage_path":"\/Users\/q\/kyleg-data\/working\/SUBORDINATE\/2018\/2018-0040\/2018-0040_SL 40 of 2018.akn.xml","content_md5":"776047413bdf9900e43e3d08a2ea0162","byte_size":"31093","http_last_modified":null,"fetched_at":"2026-06-22 15:38:38.572877+00"},{"file_id":"1463","expr_id":"732","kind":"pristine_pdf","filename":"2018-0040_SL 40 of 2018.pdf","source_url":"\/cms\/images\/LEGISLATION\/SUBORDINATE\/2018\/2018-0040\/2018-0040_SL 40 of 2018.pdf","storage_path":"\/Users\/q\/kyleg-data\/pristine\/SUBORDINATE\/2018\/2018-0040\/2018-0040_SL 40 of 2018.pdf","content_md5":"a22e2cc3682b354753d44f0bf33443b2","byte_size":"170455","http_last_modified":null,"fetched_at":"2026-06-21 23:09:35.44377+00"},{"file_id":"1464","expr_id":"732","kind":"working_pdf","filename":"2018-0040_SL 40 of 2018.pdf","source_url":"\/cms\/images\/LEGISLATION\/SUBORDINATE\/2018\/2018-0040\/2018-0040_SL 40 of 2018.pdf","storage_path":"\/Users\/q\/kyleg-data\/working\/SUBORDINATE\/2018\/2018-0040\/2018-0040_SL 40 of 2018.pdf","content_md5":"a22e2cc3682b354753d44f0bf33443b2","byte_size":"170455","http_last_modified":null,"fetched_at":"2026-06-21 23:09:35.44377+00"}],"paragraph_count":8,"latest_history":null},"quality":{"expr_id":"732","doc_id":"732","quality_state":"needs_review","quality_score":"76","needs_human_review":"t","deterministic_categories":"{duplicate_text,page_header_footer_noise}","llm_categories":"{truncated_text,other}","repair_actions":"{collapse_duplicate_text,manual_review,reextract_full_text,strip_page_furniture}","finding_severity_counts":"{\"low\": 1, \"medium\": 1}","finding_summary":"Extraction likely incomplete at the end; 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