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You will need the third party agreements with anyone who:carries on a licensed activity (other than import or storage), on behalf of the licensed establishment or supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.
Those establishments who intend to conduct the activities specified above. The applicant for the Licence Holder could be the Designated Individual (DI) who has responsibilities under the Human Tissue to ensure good practice is followed and licence conditions are complied with.
The HTA will appoint individuals to perform site visits. Our aim is to work collaboratively with other regulators and we may seek to delegate the inspection function or work together with another inspectorate.
If a serious adverse event or reaction has implications for other tissue establishments - for example, because of a shared donor - the tissue establishment should also notify those other tissue establishments as appropriate without delay.
The specialist laboratory should be made aware if the family has requested that relevant material be returned to them, in order that it can be sent back to the licensed establishment for the family’s wishes to be acted upon.
The HTA has a statutory responsibility to make decisions on all cases of bone marrow and PBSC donation where the donor is a child who lacks competence to consent or the donor is an adult lacking capacity to consent.
According to the stillbirth and neonatal death charity Sands, around 15 babies a day die before, during, or soon after birth (ref - Baby death: current picture (2016)).
In around 20% of adult post-mortem examinations and in most paediatric post-mortem examinations, the cause of death is not immediately obvious. A diagnosis can only be made by retaining small tissue samples of relevant organs for more detailed examination.
By studying human tissue, scientists improve their understanding of how diseases start and progress, and what keeps us healthy. They may find different ways of diagnosing disease, or develop new treatments.
In Sands consultations, parents said they did not like the phrase 'baby/child'. It made the form seem bureaucratic, insensitive and uncaring, and added to their distress.