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Tripartite agreement to guarantee quality, safety and ongoing improvement for procedures

Spanish National Transplant Organisation, European Society for Blood and Marrow Transplantation and Foundation for Quality in Blood Transfusion, Cellular Therapy and Tissue Therapy sign partnership agreement

Monday 12 December 2016

More specifically, the goal of this agreement is to develop a voluntary centre accreditation system in Spain - supported by the Spanish National Transplant Organisation and the regional governments - capable of ensuring that the centres where haematopoietic progenitor cells are obtained, processed and implanted offer the highest levels of treatment care and meet all the requirements demanded by the certification bodies of the highest international prestige.

To do so, a certification programme will be put in place that is intended to act as a framework for quality. The criteria and standards for obtaining the certification are guaranteed by the ONT, as the competent authority in this regard. The agreement includes efforts to ensure the certification process is not undertaken for profit-making purposes.

Those responsible for this agreement believe that certifying the quality of these centres is of strategic interest for the Spanish National Health System because the added prestige associated with certified centres will incentivise best practices and improve results. It also represents a valuable tool for healthcare authorities for the fostering of and ongoing quality improvement in biological safety, and is also a guarantee for professionals, healthcare authorities and the general public.

Under the agreement, the signatories undertake the following, among other things:

  • To promote this certification programme among Spanish healthcare authorities
  • To communicate the international recognition of the certificates awarded to Spanish centres under this programme
  • To support and collaborate on audit and assessor training courses in Spain
  • To encourage widespread communication of the certification programme among centres authorised for the extraction, processing and transplantation of haematopoietic progenitors in Spain.

The agreement will remain in effect for an initial period of four years.

The agreement also provides for the creation of an Oversight Committee. This committee will be made up by the ONT, EBMT and FCAT on an equal basis, as well as one representative from the Spanish Haematopoietic Transplantation Group, to ensure compliance with the targets set in the partnership agreement.

Haematopoietic progenitor transplantation

Haematopoietic progenitor transplantation (HPT) began 50 years ago, but was referred to as bone marrow transplantation at the time. Nowadays, it is an established therapy for a wide range of diseases that affect bone marrow, some of which are tumorous (such as leukaemia) and others are congenital (such as bone marrow aplasia or immunodeficiencies).

HPT encompasses all those blood cell precursor transplants stemming from bone marrow, peripheral blood stem cells or umbilical cord blood cells that are administered for the purpose of regenerating diseased bone marrow.

About the signatory institutions

The goals of the Spanish National Transplant Organisation include coordinating organ and tissue donation, extraction, preservation, distribution, exchange and transplantation throughout the Spanish healthcare system, and it may also act as a technical entity for the assessment and accreditation of centres and services authorised to engage in these activities.

The European Society for Blood and Marrow Transplantation (EBMT) and the Foundation for Quality in Blood Transfusion, Cellular Therapy and Tissue Therapy (FCAT) are quality certification bodies in the field of haematopoietic transplantation. The EBMT and the International Society for Cellular Therapy have developed JACIE, a non-profit organisation set up to promote medical practice quality at centres and laboratories involved in the extraction, processing and haematopoietic stem cell transplantation (haematopoietic progenitors) by developing a European voluntary accreditation programme.

In turn, the FCAT is made up by the Spanish Blood Transfusion Society and the Spanish Association of Haematology and Haemotherapy.

The ONT and FCAT previously signed a partnership agreement four years ago in the field of certification and auditing umbilical cord blood banks and centres for obtaining, processing and administering cellular therapy products.