29 March 2007
Dear Colleagues,
The new edition of the Code of Practice, which is due to be issued this spring, will contain a revised policy on witnessing. This policy was reviewed to take into account traceability requirements of the EU Tissues and Cells Directive, use of electronic systems for witnessing (bar coding and radio frequency identification) and causes of witnessing related incidents reported to the HFEA.
Direction 2004/4 on records of witnessing clinical and laboratory procedures will be revoked when the 7th Edition of the Code of Practice comes into force on 7th June 2007.This will be replaced by a new standard and guidance to come into force at the same time.
The new standard and guidance are available on our website. These reflect best practice and aim to ensure that clinics have measures in place which reduce the risk of misidentification and mix ups of gametes and embryos as far as possible.
Model protocols for witnessing are also available on our website. These protocols provide a basis for centres to create their own witnessing protocols which take into account the specific environment and workings of the centre.
In addition to following the new standard and guidance, the Authority expects all centres to assess which type of witnessing system, manual or electronic, they consider to be most suitable for their local environment and, in doing so, to give serious consideration to the use of electronic systems (bar coding and RFID systems). Centres are expected to make their decision, outline their reasoning and conclusions and carry out a risk assessment of their chosen system within six months of the implementation of the new Code. This report and risk assessment should be made available when the centre is next inspected.
The new witnessing guidance includes advice on the best way to decide on the type of system centres should use for witnessing, the risks and benefits to be aware of when making this decision and the extent to which electronic witnessing can replace manual witnessing.
The Authority has also considered the advantages and disadvantages of electronic systems in general terms, and has noted that:
- The use of bar coding systems in other settings (blood transfusion and medication administration) has been shown to reduce error rates in patient identification, ensuring correct labelling of samples and avoiding mismatches. There is clearly the potential for the same benefits in IVF clinics. However, there is currently not enough evidence to demonstrate this as yet.
- Electronic witnessing can replace manual witnessing at a number of steps, reducing the number staff which need to be present for certain procedures. This is set out in more detail in the model protocols.
- A manual system may be more effective in some cases, e.g. in small IVF and IUI centres. Electronic systems may be too complicated and costly for smaller centres which may not have the resources to operate and maintain them properly.
- The use of electronic systems can introduce new types of errors and risks (e.g. some systems may be easy to circumvent; there is a risk of software and printer errors; and there is potential risk of harm to gametes and embryos from light/radiation used in scanners/readers) – see new witnessing guidance.
If you have any enquiries on the issues raised in this letter please contact:
Hannah Darby, Policy Officer
020 7291 8237 or
hannah.darby@hfea.gov.uk or
Charles Lister, Head of Policy
020 7291 8230 or
email charles.lister@hfea.gov.uk.
Yours sincerely,
Shirley Harrison
Chair
Page last updated: 23 August 2012