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03 August 2004

To: All Persons Responsible & All HFEA Inspectors

Dear Colleague,

The Authority has revised its policy on the licensing of individuals carrying out intracytoplasmic sperm injection (ICSI) and polar body / blastomere biopsies and on the information to be reported regarding treatment cycles involving preimplantation testing.

Changes in the process for the recognition of ICSI and Polar Body / Blastomere Biopsy Practitioners

I am happy to inform you that at the June 2004 meeting of the Authority, the Members agreed that it would no longer be necessary for new ICSI practitioners to be inspected and approved by the HFEA. This will significantly reduce the administrative burden on centres and ICSI inspectors. In addition, it was agreed that it would no longer be necessary for centres to apply to a Licence Committee of the Authority for the recognition of new polar body / blastomere biopsy practitioners, though these practitioners will still be required to be inspected by a HFEA inspector prior to carrying out clinical biopsies. Guidance on the new process for recognising ICSI and polar body / blastomere biopsy practitioners is attached at Annex A to this letter.

The decision was set against a review of our Licensing system and a desire to make our processes more efficient and respond to comments made by centres, inspectors and ACE in the past.

The HFEA will continue to require centres to record and report information on individual ICSI and polar body / blastomere practitioners. Directions instructing centres on the information required to be submitted to the HFEA are enclosed with this letter (attached at Annexes B and C)

Preimplantation Testing

In June 2003 the Authority issued guidance on preimplantation testing [see Chair's Letter CH(03)04]. This guidance was accompanied by Directions (D/2003/1) that required centres to record and report information in relation to practitioners carrying out polar body / blastomere biopsies. In addition these Directions instructed all centres to record information on each treatment cycle involving preimplantation testing. 

In order to support effective regulation and monitoring of the use of preimplantation testing, the HFEA is issuing revised Directions requiring Centres to submit this information to the HFEA on a monthly basis. Directions instructing centres to this effect are enclosed with this letter (attached at Annex C).

You will also notice changes to the standard conditions associated with ICSI and PGD/PGS on your centre licence the next time it is issued. These will reflect this change of policy.

If you have any queries about this letter please contact the Senior Regulatory Manager for your centre.

Yours faithfully,

Suzi Leather
Chair

Encl:

Annex A:  Guidance on the process for recognising ICSI and polar body / blastomere biopsy practitioners (attached below)

Annex B: Directions D. 2004/5 (opens PDF)

Annex C: Directions D. 2004/6 (opens PDF)

Annex A
Guidance on the process for recognising ICSI and polar body / blastomere biopsy practitioners 

Page last updated: 17 August 2012

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