The European Union Tissues and Cells Directive 2004/23/EC was adopted by the Council of Ministers in March 2004. All Member States were obliged to comply with its provisions by April 2006, with derogation to April 2007 in the UK. In the next few months, the regulations, which will bring the Directive and its two technical annexes in to UK law, will be formalised. The first inspections of centres subject to the new regulations will be in April 2007, only 8 months from now. For the first time, centres offering intra-uterine insemination (IUI) or gamete intra-fallopian transfer (GIFT) services alone, will also be subject to inspection against the rigours of the Directive.
An immediate task for all assisted conception centres in the UK is to establish a comprehensive Quality Management System (QMS) in line with the Tissue Directive by April 2007.
The Human Fertilisation and Embryology Authority (HFEA) - the regulator for the sector - has produced a helpful document, HFEA Standards for Assisted Conception Centres, with significant input from professional bodies including the British Fertility Society (BFS). The standards outline, in understandable language, what will be expected of centres from April 2007, in the new inspection environment.
The nature of a QMS is well set out in the HFEA Standards document, which should be studied very carefully. The move from QMS theory to practice will prove difficult for many units. Within the UK, a handful of centres have adopted ISO standards, which will meet many of the demands of QMS. However a great number of centres have not tackled QMS in a meaningful way and will be struggling to meet the deadline. Financial and manpower resource implications are considerable, and for many a fundamental restructuring of managerial responsibilities will be required.
The critical role of the Quality Manager is in many centres ill understood and inadequately supported. At a recent QMS workshop organised by the BFS with the HFEA, only 25 per cent of units in the country were represented and only a fraction of these had appointed a Quality Manager. Those few appointed were largely unaware of the demands expected of them relevant to many important elements of QMS, such as documentation control and monitoring performance, and felt unsupported in their new role.
For those centres concerned about resources, the statutory requirement to implement the Directive is a powerful tool to negotiate the necessary financial support for the establishment of QMS within their organisation. In the eyes of the regulator, QMS implementation is non-negotiable. Bound by the legislative timetable, action now on the part of assisted conception providers is mandatory.
The next BFS workshop on QMS implementation will take place at Imperial College, London on 28 and 29 September. Details can be found at http://www.fertility.org.uk & http://www.hfea.gov.uk (look under 'Public Events' in the section 'About the HFEA').
The HFEA is running workshops, primarily for currently unlicensed clinics offering IUI or GIFT services alone. These will be held on 10 October (in Bristol) and 26 October (in Manchester). A London workshop is also being organised. Again, details can be found at http://www.hfea.gov.uk (look under 'Public Events' in the section 'About the HFEA').