• Mitochondria public consultation 2012
• National Donation Strategy Group
• Multiple births after IVF
• Past reviews
  • Genetic testing
  • Embryo research
  • Fees and regulation
  • Risks of treatment
  • Clinical safety
    • Safe cryopreservation of gametes and embryos
    • Witnessing the identification of samples
  • Donation

Background

The HFEA has a statutory duty under the Human Fertilisation and Embryology Act 1990 (as amended) to produce a Code of Practice which gives guidance to fertility clinics about the proper conduct of activities licensed by the HFEA.

This guidance includes procedures for witnessing to ensure that every sample of eggs, sperm or embryos can be identified at all stages of the laboratory and treatment process to minimise the risk of mismatches of gametes or embryos.

In 2006 the Authority decided to review its policy and develop new witnessing requirements which reflected best practice and ensured that clinics had measures in place to reduce the risk of misidentification and mix ups of gametes and embryos as far as possible.

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Consultation process

In developing the new witnessing standard, guidance and model protocols the HFEA sought views from the relevant professional bodies, experts and the HFEA Licensed Centres Panel.

The consultation sought views from stakeholders on three key areas:

• the traceability requirements of the EU Tissues and Cells Directive 
• the use of electronic systems for witnessing (bar coding and RFID)
• the causes of witnessing related incidents reported to the HFEA.

To specifically address the issues and concerns relating to the use of electronic systems for witnessing, the HFEA set up the Safety and New Technologies Advisory Group to feed recommendations back to the Authority. 

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Consultation outcome

At its March 2007 meeting The Authority agreed the draft standard, guidance and witnessing protocol which had been produced following consultation with experts and the wider sector.

The Authority agreed the following witnessing policy:

• that clinics complete a risk assessment, or review, of the type of system used for witnessing to determine whether they should move towards electronic witnessing 
• guidance that each stage of the witnessing trail should check the patient's/donor's full name and a unique identifier 
• guidance that centres should conduct a risk assessment before introducing any new protocols for witnessing and to decide who is the most appropriate person to witness each stage 
• guidance that once a check takes place centres should ensure that gametes or embryos from other patients or donors are not introduced into the critical working area until the procedure has been completed 
• requirement for IUI/GIFT centres to witness procedures.

Centres were asked to seriously consider using electronic systems for witnessing, to decide on the type of system they would use (whether manual or electronic) and to carry out a risk assessment for this system by the end of 2007.

The Authority agreed that the revised standard, guidance and witnessing protocol would amend the 7th Code of Practice in April/May 2007 and that centres would be given three months to implement the new requirements.

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Supporting documents

• Standard: Witnessing the identification of samples and patients/donors (43 Kb)
  Including guidance
• Model protocols for witnessing the identification of samples and patients/donors (39 Kb)
• Witnessing references (34 Kb)
• IVF witnessing and electronic systems- Report commissioned by the HFEA (97.5 Kb)

Chair's Letters:

• CH(07)02 - New witnessing guidance
• CH(04)02 - Revised Directions on Witnessing

Past reviews:

• 04-03-09

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Page last updated: 17 January 2012

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