HUMAN TISSUE PART 1 PRELIMINARY Citation, interpretation and commencement 1 1 These Regulations may be cited as the Human Tissue (Scotland) Act 2006 (Maintenance of Records and Supply of Information Regarding the Removal and Use of Body Parts) Regulations 2006. 2 In these Regulations– “ the Act ” means the Human Tissue (Scotland) Act 2006; “the 1978 Act ” means the National Health Service (Scotland) Act 1978 ; “body part” means any part of a body of a living or deceased person other than tissue; “donor” means a deceased or living person from whose body it is proposed to remove a body part for transplantation into another person who is alive; “Health Board” means a board constituted by order under section 2(1)(a) of the 1978 Act ; “health service hospital” has the meaning given by section 108(1) of the 1978 Act ; “ NHSBT ” means NHS Blood and Transplant (Gwaed a Thrawsblaniadau'r GIG) established by NHS Blood and Transplant (Gwaed a Thrawsblaniadau'r GIG) (Establishment and Constitution) Order 2005 ; “recipient” means a living person into whom it is proposed to transplant a body part from another deceased or living person; “relevant section 3(1) purpose” means any purpose referred to in section 3(1) of the Act other than transplantation; and “Special Health Board” means a Special Health Board constituted by order under section 2(1)(b) of the 1978 Act. 3 These Regulations shall come into force on 1st September 2006. PART 2 MAINTENANCE OF RECORDS Records to be maintained by registered medical practitioner who removes body parts for transplantation 2 1 A registered medical practitioner who has removed a body part for transplantation shall compile and maintain records in accordance with this regulation. 2 Records shall be compiled in a permanent form in accordance with this regulation in relation to each body part which is removed for transplantation. 3 Where the donor was living at the time of the removal of the donor’s body part, the records compiled in accordance with paragraph (2) shall be maintained for a period of– a six years beginning with the date on which the body part is removed for transplantation; or b three years beginning with the date on which the donor died (even although the donor dies after the expiry of that six year period), whichever is the later date. 4 Where the donor was deceased at the time of the removal of the donor’s body part, the records compiled in accordance with paragraph (2) shall be maintained for a period of six years beginning with the date on which the body part is removed for transplantation. Records to be maintained by persons who use or retain body parts for a relevant section 3(1) purpose 3 1 Any person specified in paragraph (2) who has received a body part which is to be used or retained for a relevant section 3(1) purpose shall compile and maintain records in accordance with this regulation. 2 The persons specified for the purposes of paragraph (1) are– a where the body part is received in a hospital managed by a Special Health Board, that Special Health Board; b where the body part is received in a hospital which is not managed by a Special Health Board, the Health Board for the area in which the body part is received; and c where the body part is received in any other establishment that is not a hospital, the manager of that establishment. 3 Records shall be compiled in a permanent form in accordance with this regulation in relation to each body part which is received which is to be used or retained for a relevant section 3(1) purpose. 4 Where the donor was living at the time of the removal of the donor’s body part, the records compiled in accordance with paragraph (3) shall be maintained for a period of– a six years beginning with the date on which the body part is received; or b three years beginning with the date on which the donor died even (although the donor dies after the expiry of that six year period), whichever is the later date. 5 Where the donor was deceased at the time of the removal of the donor’s body part, the records compiled in accordance with paragraph (3) shall be maintained for a period of six years beginning with the date on which the body part is received. PART 3 SUPPLY OF INFORMATION Information to be supplied by registered medical practitioner who removes body parts for transplantation 4 A registered medical practitioner who has removed a body part for transplantation shall supply the information specified in Schedule 1 to these Regulations to the following authorities– a NHSBT in all cases; and b i where the removal was carried out in a hospital managed by a Special Health Board, to that Special Health Board; or ii where the removal was carried out in a hospital other than one managed by a Special Health Board or in any other establishment which is not a hospital, to the Health Board for the area in which the removal of the body part was carried out. Information to be supplied by registered medical practitioner who uses or retains body parts for transplantation 5 A registered medical practitioner who has received a body part which is to be used or retained for transplantation shall supply the information specified in Parts 1 to 3 of Schedule 2 to these Regulations to the following authorities– a NHSBT in all cases; and b i where the removal was carried out in a hospital managed by a Special Health Board, to that Special Health Board; or ii where the removal was carried out in a hospital other than one managed by a Special Health Board or in any other establishment which is not a hospital, to the Health Board for the area in which the removal of the body part was carried out. Information to be supplied by persons who use or retain body parts for a relevant section 3(1) purpose 6 1 Any person specified in paragraph (3) who has received a body part which is to be used or retained for a relevant section 3(1) purpose shall supply the information specified in Parts 1, 2 and 4 of Schedule 2 to these Regulations to NHSBT. 2 Any person specified in paragraph (3)(c) who has received a body part which is to be used or retained for a relevant section 3(1) purpose shall, in addition to supplying the specified information to NHSBT under paragraph (1), supply the information specified in Parts 1, 2 and 4 of Schedule 2 to these Regulations to the Health Board for the area in which the removal of the body part was carried out. 3 The persons specified for the purposes of paragraphs (1) and (2) are– a where the body part is received in a hospital managed by a Special Health Board, that Special Health Board; b where the body part is received in a hospital which is not managed by a Special Health Board, the Health Board for the area in which the body part is received; and c where the body part is received in any other establishment that is not a hospital, the manager of that establishment. LEWIS MACDONALD Authorised to sign by the Scottish Ministers St Andrew’s House, Edinburgh 8th June 2006