Annual conference breakout session: New Compliance Cycle

About the session

The session covered the new compliance cycle, including the risk tool and the self assessment questionnaire.

The session included:

  • A presentation on the outline of the new compliance cycle. The cycle will consist of a renewal inspection after four years with an interim inspection after two. 
  • A presentation on the risk tool. This calculates the current risk of the centre based on the data the HFEA holds. The speaker explained that currently all the information is held in different places, for example, Finance and QA.

Examples of questions asked at the session

Witnessing

  • Does your centre carry out procedures involving the manipulation of gametes or embryos for use in treatment? 
  • If so, is the identification of samples and the patients or donors to whom they relate witnessed by two members of staff at all critical points of the clinical and laboratory process?

Equipment and materials

  • Does your centre process gametes and/or embryos intended for treatment purposes or for the creation of stem cell lines for human application or provide storage for treatment purposes or donation? 
  • If so, is it possible to track all the equipment and materials (those used in the procurement and processing of gametes and/or embryos intended for human application or in the derivation of stem cells for human application)?

Results of the session

Level of compliance

Delegates from both groups were asked to state their level of compliance by placing a sticky label on a large bar chart.

Those who were fully compliant were then asked what evidence they would provide at inspection to demonstrate compliance. 

A slide was shown giving of examples of audit tools. Delegates were then asked if they would like to change their compliance level (see graph 1 and 2). 

Most felt they were fully compliant (1) with the witnessing question although there was a slight shift to almost compliant (2) and partially compliant (3) after discussing the level of evidence which would be required at inspection.

There was almost an equal split between those thinking they were fully (1) and almost compliant (2) to the traceability question, again with a slight shift towards almost compliant (2) after the type of evidence required was discussed.

Graph showing levels of compliance before and after asking for evidence

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Centres taking responsibility

The facilitator raised the issue about the need to move away from prescriptive inspections to centres taking responsibility for themselves.

It was also raised that centres should not be too worried if they did not receive a score of 1 (fully compliant). It was more important that they put measures in place to improve.

Likewise if an incident was reported, centres should be looking at how they can improve and prevent the same incident occurring again.
 
Weightings of general performance indicators for risk tool

Delegates were then asked to give weightings to the general performance indicators which feed into the risk tool.

Most decided that finance (payment of accounts) should be weighted low risk whereas incidents, success rates and complaints should be classified as high risk. The accuracy of HFEA returns was seen as medium risk (graph 3).

Graph showing weightings of GPI's for Risk Tool

Questions and comments raised:

  • It would be beneficial to have clear guidelines on the website such as:
    • OHSS incident reporting: If a patient is admitted through an A&E to a gynaecology ward which is not linked to an IVF unit, how is the OHSS reported as staff on that ward will not be aware of the HFEA regulations? Is it the patient’s responsibility to inform the staff that they are required to notify the IVF unit? Non-IVF staff can not be expected to report to the HFEA.
    • If a centre which is a transport centre has an incident is this reported directly from the transport centre or to the PR of the centre who is the licensed treatment centre. 
  • Can the inspection report format be reviewed by a user group?
  •  Prior to the inspection can a clinic be clearly informed on how long the inspection will take, what staff need to be available and which procedures are going to be observed?
  • Could the compliance cycle / risk tool slides be posted on the website?
  • What are the minimum requirements to be fully compliant? Could the HFEA develop some guidelines / templates for quality indicators / audit tools to help clinics and stop individual clinics keep ‘reinventing the wheel’?  This includes producing patient information leaflets on such issues such as opening the register to researchers.
  • Why doesn’t the HFEA provide a standardised Audit tool for all centres to use to avoid ambiguity?
  • Will the information on the SAQ end up being disclosed as part of an FOI request?
  • A delegate explained how in a similar working environment they were able to log their own risks and look at their own risk assessments and the date they were logged, and the dates the incidents occurred and what was done to improve. 

Page last updated: 30 October 2009