The UK Human Tissue Act 2004 replaces, amongst other laws, the Human Organ Transplant (HOT) Act and regulations governing live donation and makes a number of provisions with respect to activities involving human tissue. The application of the Human Tissue Act 2004 is currently overseen by the Human Tissue Authority who license and inspect organisations that store and use human tissue for purposes such as research, patient treatment, post mortem, teaching, public display and transplantation both from deceased and live donors. That Act describes all these activities as ‘schedules purposes’ which can only be undertaken under license.
The Human Tissue Act 2004 is a key aspect of the legislative framework that underpins the quality management systems used in the H &I laboratory. Consent for donation is at the heart of the Act with specific requirements for documented informed consent for donation from live donors and from those with a qualifying relationship to deceased donors (spouse, parent, child, etc.).
The Act makes specific provision for transplantation from live as well as deceased donors. For live donors it widens the pool of potential donors by removing the requirement for proof of a ‘genetic link’ between individuals and it introduces altruistic donation and pooled and paired exchange donations. H&I laboratories which support these types of transplantation need to introduce processes into their quality management systems that will allow them to assure the quality of these processes. This includes a process of change control when introducing these types of transplant programs that include full validation of the process, documentation of the procedures, training of the staff involved, ensuring the laboratory has the right equipment and storage facilities for materials and process documents and that there are processes in place for quality management review.
The Act makes provision for ethically approved research using human tissue or material derived from human tissue provided personal identification information is removed. It clarifies which samples may be used for QC, validation and training. This is important to quality management within the H&I laboratory as such research is important for ongoing service development.
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