• Directions
• Chair's letters
• Chief Executive's letters
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2005-2008
  • 2001-2004
  • 1997-2000
  • 1993-1996
• Multiple Births Minimisation Strategy: achievements and compliance
• Frequently used guidance
• Do I need to be registered by either the CQC or licensed by the HTA?
• Retrieval of storage of gametes where patients are unable to consent
• Surrogacy and legal parenthood – changes from 1 October 2013

11 April 2000

To: Persons Responsible, Storage Centres

Dear Colleague,

REVISED APPLICATION FORMS, NEW INTERIM INSPECTION REPORT FORMS AND INSPECTION PROTOCOLS

On 14th June 1999 the HFEA's Chairman, Ruth Deech, wrote to all Persons Responsible about forthcoming modifications to the licensing system, particularly plans to phase in three year licences.

In her letter Mrs Deech explained that, whatever the length of a licence, annual inspections would continue to take place. However, because under the redesigned system centres would usually not be applying to renew their licences prior to an inspection, there was a need to ensure that the inspection team and subsequent Licence Committee had information on the centre's current activities. To meet this need the HFEA has decided to introduce a new interim inspection report form for storage centres.

This form is modelled on the shortened application form that many of you submitted in previous years. As you can see, the format has changed slightly and there are some additional questions, most notably the request for a report on the steps taken to address any additional conditions or recommendations set by the last Licence Committee. One significant introduction, which I hope will be of benefit to centres, is that, where there is a particular focus to the interim inspection, this will be clearly stated on the report form's cover.

The need to provide a new form has also given us the opportunity to revise the initial and renewal application forms that were last reviewed in 1996. Although similar to the existing forms, we have updated the questions, particularly with regard to the list of licensable activities. The additional questions contained in the interim inspection report form are also included in the revised renewal application form. Copies of the new forms mentioned above are enclosed.

Mrs Deech's letter also informed centres that, in order to achieve greater consistency between inspections, a series of checklists, or protocols, was to be developed. These protocols have now been finalised and are also enclosed with this letter. The protocols cover the overall inspection process and the examination of specific activities. They are based on the 1990 Act, the Code of Practice (4th edition) and guidelines issued by professional bodies. Inspection protocols have been developed for the following areas: the overall inspection process; clinical service; IVF laboratory service; andrology laboratory service; counselling service; patient assessment and Welfare of the Child; patient information; oncology/storage centres; and the examination of patient records. All protocols relevant to a centre's activities will be used at full inspections, and at focussed inspections, protocols relevant to the focus will be used. Copies of protocols designed to be used when inspecting storage centres' activities are enclosed. If you wish to have a copy of any protocol not included with this letter, please contact your Inspector Co-ordinator.

Centres should note that the protocols are intended to highlight areas for consideration, but will not preclude discussion on other subjects. Centres should also be advised that, while they should strive for best practice in their service, and the protocols are designed to stimulate discussion as to how this can be achieved, not fulfilling all the criteria examined by the protocols will not necessarily result in an adverse report. As at present, a narrative report of the inspection will be presented to a Licence Committee along with centre's application for licence renewal.

It is anticipated that the protocols and the interim inspection report form will come into use in May following the HFEA Inspectors' meetings. If you have any queries about the contents of this letter, please contact your Inspector Co-ordinator.

Yours faithfully

Suzanne McCarthy
Chief Executive

Enc:
Initial Application for a Licence to Store Gametes, Embryos and Tissue
Application for Renewal of a Licence to Store Gametes, Embryos and Tissue
Interim Inspection Report
HFEA Inspection Visit Protocol
Oncology/Storage Centre Protocol
Patient Information Inspection Protocol
Protocol for the Examination of Patient Files

Page last updated: 24 August 2012

• Send to a friend