Surgical procedures
Following agreement with the Care Quality Commission, from 1 October 2013, the HFEA will extend its remit to include the inspection of surgical procedures carried out in connection with HFEA licensed activities. The below questions have been put together to provide clarity to clinics on how this will be implemented. You should read the below FAQs as well as our surgical procedures page.
Background:
- What do you mean by surgical procedure?
- Who will this affect?
- You say that CQC will join you on your inspection; does this mean we will have a joint inspection?
- When will you inspect against the guidance?
- How will you inspect the guidance?
The requirements:
- My Trust/hospital has policies on some areas mentioned in the guidance; will you expect us to now tailor these to the fertility clinic?
- My Trust/hospital audits (or requires me to audit) our compliance with infection control. Will we be required to do separate audits?
- My centre uses an operating theatre that also carries out non-HFEA licensable activities and is subject to CQC oversight, will you still inspect this theatre?
- I am licensed by the HFEA for IUI treatment only, but also act as a transport centre doing egg collections for a licensed treatment and storage centre – will I be inspected for surgical procedures?
- What is the impact of not adhering to the guidance?
Others:
- How do I know whether I should apply to vary my registration with CQC?
- Will you change your guidance or inspection process?
Background
What do you mean by surgical procedure?
Any operation or procedure carried out under anaesthetic or any procedure where the skin is breached (as it is during egg collection).
Who will this affect?
Initially, this will only affect clinics in England who carry out surgical procedures such as egg collection or testicular biopsy.
However, some of the new guidance is relevant to all clinics, for example best practice on effective infection control. We plan to inspect against some of this best practice for all clinics from next year, even if surgical procedures are not carried out at the centre, for example IUI and storage only centres. We also plan to work with the devolved nations to see whether this change can/should be applied in Wales, Scotland and Northern Ireland from next year.
We will keep you up to date on how things progress.
You say that CQC will join you on your inspection; does this mean we will have a joint inspection?
No. We plan to include a CQC inspector on some inspections: this should ensure that HFEA inspections are consistent with those that were carried out by CQC and ensure that our inspection methodology is robust and effective.
When will you inspect against the guidance?
Initially we will only inspect against the guidance during a renewal inspection, when inspecting a new clinic that has applied for a licence for the first time or inspecting a clinic that is moving premises. We will consider how this approach has worked when we review the first set of inspections in spring 2014.
How will you inspect the guidance?
We intend to observe practice (eg, infection control practices), and speak to staff (to, for example, gauge understanding of the safeguarding procedures). We will also review patient notes to, for example, review evidence of how pre-operative assessment has been conducted and recorded and we may ask you to show us some key policies (eg, policies for safeguarding and infection control).
Where members of staff are carrying out activities that are outside their usual professional remit (eg, where members of the nursing team are performing egg collection) we will expect to see evidence of their training and competence to carry out these roles. Where general anaesthetics are being administered we will expect you to be able to provide us with reassurance and evidence that these activities are being carried out by appropriately qualified individuals.
We will also expect you to be able to show us evidence that your premises remain safe and suitable (eg, evidence of on-going fire and electrical safety). Your HFEA inspector will give you further information nearer to your inspection.
The requirements
My Trust/hospital has policies on some areas mentioned in the guidance; will you expect us to now tailor these to the fertility clinic?
Not necessarily. For example, we would not expect a centre to create a new policy on infection control just for the fertility clinic. However, for safeguarding, we would want to see evidence that rules around the confidentiality provisions of the Act are understood in the context of any general safeguarding policy.
My Trust/hospital audits (or requires me to audit) our compliance with infection control. Will we be required to do separate audits?
No. We are aware that NHS centres are required to submit evidence to their Trust, or their Trust will have audited certain aspects of their service (for example, infection control). Where this is the case, we suggest centres consider showing these audits to the HFEA inspector.
My centre uses an operating theatre that also carries out non-HFEA licensable activities and is subject to CQC oversight, will you still inspect this theatre?
If centres can show that such theatres are subject to regulatory oversight, we will not inspect these facilities. We may wish to observe activities carried out in the theatre, such as witnessing practices, and you should be able to show your inspector evidence that the theatre environment has been assessed as suitable (by showing them a copy of the CQC registration and/or inspection report for example).
I am licensed by the HFEA for IUI treatment only, but also act as a transport centre doing egg collections for a licensed treatment and storage centre – will I be inspected for surgical procedures?
Initially, we will not inspect these centres against the new guidance and they should remain registered with CQC. However, this may be subject to review in the future once the transfer of responsibilities is clearly embedded and established.
What is the impact of not adhering to the guidance?
Where there is only minor deviation from the guidance then this will most likely be cited as an “other” area of practice that requires improvement in an HFEA inspection report. Where significant deviation from the guidance is observed then this will be cited as non-compliance with standard licence conditions T2 and/or T17 (suitable practices and premises).
Other
How do I know whether I should apply to vary my registration with CQC?
View information on the registration with the CQC and HTA which will help you to make this decision. The CQC will write to providers to give them further information on applying to vary their registration, and will have some information on their website shortly.
Will you change your guidance or inspection process?
As we roll this out between October 2013 and April 2014, we will make any changes that we think are necessary. We will learn from each set of inspections, and refine our guidance and inspection methodology. The October 2014 update to the Code of Practice will include finalised guidance having taken on board the earlier learning.
Page last updated: 29 August 2013