HFEA inspections

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The HFEA’s continuous monitoring cycle of licensed UK fertility centres involves a four year inspection cycle during which the majority of centres will receive a four year licence and be inspected once every two years.

More frequent inspections may be made when we have concerns about a centre’s compliance - particularly if we consider the safety of patients, embryos and gametes are at risk. In these circumstances, shorter licences may be issued by the Executive Licensing Panel / Licence Committee.

 

What is the purpose of inspection visits?

The purpose of an inspection is to:

  • assess the extent to which centres comply with the Human Fertilisation and Embryology 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 us to continually improve our 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.

Before the inspection

Before undertaking a routine inspection, we will notify the centre, in advance, of the process and procedures to be followed, so that the centre is clear what will be required of it, has an opportunity to prepare and to minimise potential disruption to licensed activities being undertaken.

The core assumption will be that centres wish to demonstrate compliance with the Act; licence conditions; directions and the Code of Practice. The onus is on centres to demonstrate compliance, not on inspectors to find fault.

 

What happens during an inspection?

During all inspection visits our focus will be on quality, practice and evaluation, with the protection of the embryo and patient experience foremost in our thinking.  Most time will be spent on direct observation of practice and sampling of documentation and records. 

The inspection team usually consists of two to four inspectors, depending on the size and services offered by the centre.

These inspectors are employed by the HFEA though we also have a panel of external advisors who occasionally form part of the inspection team.

These external advisors include:

  • doctors
  • nurses
  • embryologists
  • counsellors who work in licensed centres.

 A list of our external advisors can be found in our annual report.

 

Initial and renewal inspection visits

During the inspection of new centres or centres applying to renew their licence, the inspection team evaluates:

  • the premises and facilities 
  • laboratory processes 
  • the ability of the clinic to provide the services it offers 
  • the suitability of the person responsible and the staff providing the services.

Interim inspection visits

An interim inspection takes place mid way through the four year inspection cycle. During the interim inspection the inspection team evaluates:

  • the action(s) taken by the centre in relation to areas of non-compliance identified either at the last inspection visit or through the continuous monitoring cycle
  • compliance against the inspection themes (the Authority has decided that a number of areas of practice should be looked at all inspections. These are referred to as 'themes'. The themes are changed every two years.) Please see March 2012 Authority meeting and the associated papers.

Standard interim inspection agenda 2012 – 2014

Further to the article in May 2012’s Clinic Focus, unannounced inspection visits will be phased in, in 2012.

  • Treatment and storage clinics due to have an interim inspection before the end of July 2012 will be provided with a date of inspection.
  • Treatment and storage clinics due to have an inspection between August and October 2012 will receive five days’ notice of an inspection visit.
  • Treatment and storage clinics due an inspection visit between November 2012 and March 2013, will not receive any notice.

To minimise the risk that clinics could be closed on the day chosen for inspection, clinics with low levels of activity, and those that provide basic partner treatments or only store gametes and/or embryos, will receive five days’ notice of an HFEA inspection visit.

It will not be possible to set a specific agenda for each inspection as was the case previously. This plan replaces the standard agenda for an interim inspection.

The purpose of interim inspections

Licensed clinics usually receive a licence to operate for up to four years and must, by law, be inspected every two years. The full inspection, prior to a licence being granted or renewed, assesses a clinic’s compliance with the law and the HFEA’s Code of Practice.

Interim inspections are carried out at the licence mid-term. At interim inspections undertaken in 2012-14, inspectors will aim to gather information without spending time talking to clinic staff or reviewing documentation. Instead, we will observe practice, speak with patients and carry out a records audit.

This style of inspection will allow us to evaluate:

  • patient experience
  • the effectiveness of witnessing
  • staffing levels
  • the effectiveness of measures designed to maintain patient confidentiality
  • whether patient consent is being complied with – particularly consent to disclosure of information to researchers and consent to storage.

The inspection report will also comment on information from on-going monitoring of clinics’ performance and on information in self assessment questionnaires.

Length of inspection

A focused interim inspection may take only three or four hours. It is likely that the inspection will need to start early to allow scientific inspectors an opportunity to observe activities such as egg collection.

Preparing for an unannounced inspection

It may be useful if your clinic makes plans for how to respond to an unannounced inspection so that staff are not taken by surprise by the arrival of an HFEA inspection team.

Would your staff know who to contact and what to do? Beyond this there will be no need to prepare for an inspection other than by maintaining efforts to be compliant with HFEA requirements.

Feedback after a short notice or unannounced inspection

We recognise that the PR and other staff members may find it difficult to set aside time to discuss the inspection findings when an inspection has taken place at short notice or is unannounced.

When the inspection team is ready to provide feedback, they will notify the PR or the person in charge of the unit on the day of the inspection. The team will be happy to negotiate a convenient time or way to ensure that feedback is given: we would not want to interrupt patient care or laboratory activities.  If there isn’t a good time for staff or the inspection team to meet to discuss feedback then the lead inspector will liaise with the PR to identify a mutually convenient time to discuss the feedback by telephone in the days after the inspection.

 

What happens after the inspection visit?

During the course of an inspection of a licensed centre, the inspection team may identify areas of practice which require improvements to be made.

The inspection team will explain to the centre’s Person Responsible why any improvement needs to be made and the legal basis for requiring it. 

Following an inspection a report is written. This report highlights areas of good practice and those areas of practice which require improvement.

Areas of practice that require improvement will be divided into:

  • A critical area of non compliance – a critical area of non compliance is an area of practice which poses a significant risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services
  • A major area of non compliance – a major area of non compliance is an area of practice which:
    •  poses an indirect risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services
    • indicates a major shortcoming from the statutory requirements
    • indicates a failure of the Person Responsible to carry out his/her legal duties
    • is a combination of several “other” areas of non compliance, none of which on their own may be major but which together may represent a major area of non compliance
  • Another area of non compliance – a departure from non major statutory requirements or good practice

For areas requiring improvement, the report references the legal basis for requiring it and makes recommendations on the actions needed in order for the centre to be compliant with the Human Fertilisation and Embryology Act, directions, licence conditions or Code of Practice.

In making these recommendations the inspection team takes account of the challenges a centre might face in meeting a requirement but is always mindful of the health, safety and well-being of people who use the service, and the protection of the embryo.

See also:

Page last updated: 31 October 2012

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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: