Ann Smith

Clinical Scientist and Head of Stem Cell Laboratory, Royal Marsden NHS Foundation Trust, Surrey

I am responsible for the laboratory elements of the haematopoietic stem cell transplant programme at the Royal Marsden NHS Foundation Trust, and I am the DI for the human application licence. We treat adults and children with several different types of cancer of the blood and bone marrow, such as leukaemia, as well as some solid tumours.

The HTA regulates all aspects of our work, including stem cell collection, processing, storage and distribution; as well as consent and governance. Part of my job is to make sure that the unit is ready for inspection, but I think of this as an ongoing process - it is important to focus on quality every day. The European legislation is very complicated in this area and the HTA tries to make sense of it and pull out the salient elements for us to implement.

Regulation has driven up standards in this area. We have always tried to achieve high standards, but having them specified and achieving them gives the team confidence. Before regulation there was disparity in the way different groups interpreted guidelines, whereas now there is much more consensus in the sector. Being licensed gives the team reassurance that we are performing well.

We were the first stem cell transplant establishment to be inspected by the HTA. Since that first inspection two years ago, the HTA has taken advice from experts in the field and their understanding has grown a great deal. We had our second inspection recently and the HTA staff were familiar with the work, making for a balanced and thorough inspection with good communication on both sides. Although inspections are always stressful, having a licence from the HTA makes it worthwhile.