The HFEA (Human Fertilisation and Embryology Authority) is 'not fit for purpose' - so says Professor Toft who investigated the Authority closely following a previous laboratory error. The HFEA should not be surprised if, having established itself as the protector of patients and laboratory standards, it is challenged when an error occurs. Realistically though, zero risk is unachievable. The response to an error is to change practice to prevent recurrence. It is the responsibility of the clinic/professionals to make appropriate changes. The role of the HFEA should be to ensure that changes have been made, not to determine the changes needed. Recent political events illustrate again that moral duty lies within one's own conscience not with the regulator's rules.
The HFEA's statutory duties include the maintenance of a Code of Practice (COP) that provides centres with guidance on how they should carry out their licensed activities. The current COP is a hybrid document. Based on generic quality management principles (e.g. ISO), it rightly provides an overview of the standards required, for example that facilities must be 'appropriate for use' without giving proscriptive design details. The guidance section provides detailed advice but is not evidence-based as would be expected in professional guidelines. In reality the COP has minimal relevance to daily practice.
The HFE Act expects licensed Centres to follow the standards set out in the COP and effectively requires a Licence Committee to take into account compliance with the COP when making licence decisions. Inevitably then, questions asked by clinics such as 'what does that Standard mean?' can actually be translated as 'what do I have to do to pass the inspection?' What it does not mean is 'what is good practice?' We are driven by the need to obtain an HFEA licence, not by the need to have the highest standards of laboratory practice.
The recently reported errors illustrate the problem. The HFEA requires double witnessing to protect against misidentification errors. Compliance noted at inspections is taken to be a measure of approval, assumed to be 'best' practice. But the Toft Report reminded us of the limited benefit and potential risks of this procedure. Common sense tells us that if embryos and gametes from different couples are handled in the same space, misidentification is still a significant risk. The embryo pathway within each clinic must be risk-assessed individually. For this reason the HFEA must leave clinics to determine appropriate local procedures. Responsibility for good practice lies with the professionals who are directly accountable to patients. Repeated errors reflect a systematic problem in a clinic. If such problems are not addressed, the HFEA Licence Committee must then act appropriately.
In 1990, clinical embryology was a totally new area of clinical science with no existing professional body. Within this vacuum, legislation required the HFEA to provide a COP. The Association of Clinical Embryologists (ACE) was established in 1993 and should now determine best practice procedures. Many of the recommendations in Toft's Report in 2004 begin with the phrase 'The Authority should, in consultation with the relevant professional Bodies...' Yet despite nominal consultation, the HFEA retains 'ownership' of the COP. It fails to encourage good practice; favouring an inflexible 'tick list' culture. The production of documents has limited value as an accreditation tool. Misidentification is not prevented by a signature required by a regulator. The risk of misidentification is reduced if everyone in the clinic is aware of the risk at every stage of treatment and tailors their practice accordingly. Professional bodies must been given ownership of laboratory guidelines, accept that changes are needed and take a lead on making improvements.
Clinical scientists must be registered with the Health Professions Council (HPC), www.hpc-UK.org which was established in 2002 following the Health Professions Order 2001. This regulator keeps a register of health professionals who meet standards for their training, professional skills, behaviour and health. The HFEA requires scientists to be registered with the HPC. The rigorous registration procedures are given in their 'Standards of Proficiency' which includes the statement '... registrants meet our standards and are able to practise lawfully, safely and effectively. However, we don't dictate how you should meet our standards.'
In a changed world, the role of the HFEA and the professional bodies needs to be revised. Duplication of HPC regulation is not needed. The professional bodies must take direct responsibility for the recommendations for good practice and clinical scientists must look to fellow professionals not the regulators for support, advice and accountability. If the HFEA both sets detailed guidance for good practice and approves clinics that work to these guidelines, it is not surprising that it is then considered to be 'not fit for purpose' if repeated errors occur.