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Management of supply of blood and blood-derived products

Categories:
  • Organisations we regulate

This regulated activity covers the management of the supply of blood and tissue, and of matching and allocating organs.

Types of service that should be registered for this regulated activity

It is highly likely you will need to register for this regulated activity if you plan to provide a blood and transport service.

You may need to register for this regulated activity if you plan to provide acute services.

Inclusions

This regulated activity covers the management of:

  1. the supply of blood, blood components and blood-derived products for transfusion - for example, this will include the management of supply of blood by NHS Blood and Transplant; a provider managing the supply of blood to another provider; or a service from a dedicated unit, such as a central or regional facility set up for the purpose of providing this service to individual hospitals in a corporate group
  2. the supply of tissue or tissue-derived products for transplant, grafting or use in surgery - for example, this will include supply of organs or tissue by NHS Blood and Transplant or any other provider of transplant organs
  3. the matching and allocation of donor organs, stem cells or bone marrow for transplant or transfusion - for example, this will include the role of NHS Blood and Transplant or any other organisation that is involved in managing the supply of donor organs

Exclusions

This activity does not apply to the management of supply of products described in paragraphs 1) and 2) where that management does not involve direct physical contact with patients or donors from whom products are administered or derived.

In relation to blood and tissue products, this activity concerns the management of the supply. That does not include storage of, access to, and use of these products within a hospital. Having appropriate equipment and supplies, and storing them, will be part of other activities such as 'treatment of disease, disorder or injury' or 'surgical procedures', rather than an activity in its own right.

This activity does not capture a taxi service or other form of transport provision that transports blood, organs or tissue products between providers.

It does not capture autologous transplant, in which tissue is taken from an individual and stored in order to be implanted back into him/her later. For example, a dental provider removing and storing tissue or bone from a patient and re-implanting it into the same patient at a later date. It also does not include autologous blood transfusion.

It does not capture situations in which a provider’s role is only to remove an organ where the patient has chosen to be a donor. For example, removing an organ from a donor would be registerable under the regulated activity of 'surgical procedures'. In this case, a separate agency such as NHS Blood and Transplant will be responsible, and would need to be registered for the onward supply of the organ to the transplantation service provider.

In relation to donor organs, stem cells or bone marrow, the activity covers all of the supply procedures, from donation to matching and allocation. This does not include the organ demand procedures, such as managing requests or waiting lists for transplantation.

Other regulated activities you may need to register for

You should apply for other regulated activities if you are providing them, for example 'diagnostic and screening procedures'.

Last updated:
05 February 2019