Witnessing the identification of samples and patients/donors

The Authority has been reviewing the policy on witnessing to take into account:

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

In developing the new witnessing standard, guidance and model protocols the Authority consulted with relevant professional bodies, experts and our Licensed Centres Panel.

What are the new requirements?

The new requirements 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.

The guidance advises on the best way to decide on the type of system centres should use for witnessing, the risks and benefits they should be aware of when making this decision and the extent to which electronic witnessing can replace manual witnessing.

The main changes made to requirements/guidance (compared with Direction 2004/4) are:

• clarification of the current requirements and exactly what witnessing involves;
• clarification that witnessing should  take place at the time the procedure takes place and it is the labelling which should be witnessed not the laboratory or clinical procedure;

introduction of:

• 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 the most appropriate person to witness each stage is
• guidance that once a check takes place centres should ensure that gametes or embryos from other patients or donors are not introduced into the criticial working area until the procedure has been completed
• requirement for IUI/GIFT centres to witness procedures

Standard: Witnessing the identification of samples and patients/donors (43 Kb)
Including guidance

When will these new requirements be introduced?

The new witnessing standard, guidance and model protocols will be become part of the 7th edition of the HFEA Code of Practice, which will be launched shortly. Centres will then have until 7th June 2007 to implement the new requirements, along with the rest of the standards and guidance in the new Code.

Model protocols for witnessing the identification of samples and patients/donors (39 Kb)
 

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

Witnessing references (34 Kb)

IVF Witnessing and Electronic systems
IVF witnessing and electronic systems- Report commissioned by the HFEA (97.5 Kb)

Page updated: 20 December 2007