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07 June 2004

 To: All Persons Responsible

Dear Collegue,

Revised Directions on Witnessing

The HFEA has been informed of two incidents in the past 9 months where the wrong embryos were selected and thawed. Both of these incidents were caused by avoidable administrative and procedural errors. Although a pregnancy did not result, these were nonetheless very serious incidents that happened despite clinics believing that their procedures were safe.   

The occurrence of two such incidents in a relatively short space of time is extremely concerning. We are therefore issuing with this letter revised Directions on Witnessing of Clinical and Laboratory Procedures to replace the existing Directions D2002/1 which were issued with the Chair's letter CH(02)01 on 29 August 2002. These Directions also supersede the requirements in Chapter 15 of the 6th edition of the Code of Practice. The revised Directions strengthen the existing procedures by requiring the use of Unique Patient Identifiers for all patients, including donors and recipients.  In particular, your attention is brought to point 7 ‘Gamete/Embryo Freezing' where all ampoules/straws must be clearly labelled with the patient's full name, and two unique patient identifiers (e.g. hospital/unit number, date of birth, freeze record  number, date of freezing).

All licensed Centres are reminded of the requirement to have procedures in place to double-check the identification of:

• the individuals undergoing treatment,
• the sperm and eggs at the time of insemination;
• the embryos and the patient at the time of embryo transfer;
• the gametes and embryos at the time of cryopreservation and thawing.

Centres are also asked to review key administrative procedures so that primary data (e.g. Patient Records) should be available for verification against patient name, date of birth and one Unique Patient Identifier.

Centres should introduce as a matter of urgency, if they have not already done so, the following procedures in their witnessing protocols:

(i) Each stage of the witnessing paper trail should be checking the same two methods of identification.

(ii) A system of active identification of patients should be introduced, for example to avoid confusion where two patients on a clinic's' register have the same name and date of birth.    This should include the use of a further piece of information to ensure that the patient being treated is the same as the patient in the notes.

(iii) A training programme for new staff, and refresher training, should be in place to ensure that the principles of witnessing procedures are fully understood and that the centre specific protocols are followed.

(iv) Protocol compliance should be checked regularly, including at the time of the centre's internal annual audit.

Centre's compliance with these Directions will be followed up at inspections. Centres are reminded that under S18(1)(c) of the Human Fertilisation & Embryology Act 1990, a licence committee may revoke a centre's licence if the person responsible has failed to comply with Directions issued under the Act.    

If you have any queries with regard to this new policy please contact Mr Charles Lister, Head of Policy on 020 7291 8230, e-mail charles.lister@hfea.gov.uk or Dr Christina Panton, Policy Manager on 020 7291 8232, email christina.panton@hfea.gov.uk.

Yours faithfully,

Suzi Leather
Chair

Page last updated: 17 August 2012

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