After you apply for a treatment and storage licence - clinic inspections

Once a completed treatment and storage licence application has been received and processed by the HFEA, arrangements will be made for an inspection visit.

HFEA has a statutory duty to inspect clinics and report on their suitability to offer a range of services and treatments.  These visits are carried out by teams of people who have expertise the IVF sector or a related field.

How long will it take to become licensed?

The HFEA is committed to processing 90% of licence applications within four months of receipt of a properly completed application form.

 

Inspection of your clinic

Before undertaking an inspection, the HFEA’s compliance department will notify you in advance of the process and procedures to be followed so you are clear what will be required, have an opportunity to prepare and to minimise potential disruption to licensed activities being undertaken.

 

The purpose of a routine inspection is to: 

  • assess the extent to which centres comply with the Act; licence conditions, directions and the provisions of the Code of Practice
  • provide an independent and professional perspective on the running of the centre
  • promote good practice so that centres can improve the quality of service they provide to patients and donors
  • provide centres with a positive learning experience
  • provide centres with the opportunity to feed back on their experience of the inspection process, in order to assist the Authority to continually improve its procedures
  • give patients reliable information about a centre’s compliance with statutory and other obligations, and about the quality and safety of licensed activities undertaken at that centre.

 All inspections will be: 

  • evidence based, consistent, proportionate and open to scrutiny
  • undertaken in a professional and courteous manner
  • be focused on risk
  • aim to add value for centres and service users.

Inspection reports

After your clinic has been inspected, the inspection team will prepare a report on your centre for the HFEA Licence Committee considering the application.

 

The HFEA Compliance department will assess and report on whether your application:

  • meets the statutory requirements of the Human Fertilisation & Embryology Act 1990 (as amended) 
  • meets the requirements of the HFEA Code of Practice, Standard Conditions and the Authority's Directions. 

Clinics will receive a copy of the inspection report within 28 days of the inspection taking place.  Persons Responsible and their team will have 10 days to comment on the report, correcting any factual inaccuracies or responding to recommendations made by the inspection team.

Inspection reports are considered by a licence committee or an executive licensing panel who decide whether the licences should be granted or varied dependent upon the evidence in front of them. 

Feedback – post inspection questionnaire

The HFEA is always striving to improve systems and processes to ensure that standards within the sector are consistent and fair.  With this in mind, PRs are sent a post-inspection questionnaire to complete to provide feedback on the inspection which has just taken place. 

Next steps

Once your clinic has been inspected, an HFEA Licence Committee or Executive Licensing Panel make the final decision on the granting of a licence.

 

...Licence Committee decision

Further information

You can obtain more information about the licensing process from:

        Compliance department
        Phone: 020 7291 8200
        Email: hfeacompliance@hfea.gov.uk 

Page last updated: 27 September 2009

Application timeline

The premises timeline shows, step-by-step, each stage of the licensing process and the timeframe for processing all applications.

Download the premises timeline:

Guide to licensing - legislative framework

The HFEA is required to give guidance to licensed centres about the proper conduct of activities carried out in pursuance of a licence.

To access the complete legislative guide to licensing treatment, storage and research centres, read the HFEA’s legislative guide to licensing:

Guidance for clinics

Copyright 5AM-Images Fotolia.com

HFEA licenced clinics should be familiar with the relevant statutory information. 

The guidance is in place to make sure clinics operate to standard safety and ethical rules: