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31 January 2001

Dear Colleague,

Relationships with Hospital Management

The importance of good communications between fertility centres and senior hospital management has been highlighted by recent events. Hospital chief executives and other senior managers may be unaware of the budgetary, staffing and accommodation concerns of individual centres unless communications are adequate. While these management issues are not fundamental aspects of the regulatory scheme, good administrative and management practices are essential to ensure the quality controlled environment needed to secure safety and compliance in licensed clinics.

Hospital management should be encouraged to have some degree of involvement in the governance of centres and should make sure that the Chief Executive or a designated senior manager is aware of any issues concerning centres. One way communications between centres and hospital management could be improved is through the position of Nominal Licensee.

Under the HFE Act 1990, an application must name 'the person under whose supervision the activities to be authorised by the licence are to be carried on', this person is the Person Responsible. The responsibilities of the Person Responsible are laid out in paragraph 1.4 of the Code of Practice.

The Nominal Licensee is the holder of the licence; it is currently the case in many centres that the individual who holds the position of Nominal Licensee is also the Person Responsible. Either the Person Responsible or the Nominal Licensee may apply for a licence or for its variation or revocation. However, it should be noted that only the Nominal Licensee may apply to a Licence Committee to vary a licence in order to designate another individual to be the person responsible.

If no separate person is designated as nominal licensee and, for example, an accident befalls the person responsible, the only course of action available is the revocation of that centre's licence. A new licence can then be applied for naming an alternative person responsible.

Clinics operating within a hospital or other healthcare organisation may find it advantageous therefore for a senior hospital management representative to be considered to hold the post of nominal licensee on an HFEA licence.

Licence Committees will be asked to consider this issue as licences are reviewed or renewed during the course of the coming year, and centres are invited to consider whether in view of the issues outlined above, current arrangements for their Person Responsible and Nominal Licensee are appropriate.

Yours sincerely,

 

Ruth Deech
Chairman

Page last updated: 14 April 2009

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