HFEA Risk Tool

What is the Risk Tool?

The HFEA has developed a tool, known as the Risk Based Assessment Tool, which helps us assess the information provided to us by centres.

The Risk Tool:

  • uses the same methodology for all centres, ensuring consistency and fairness 
  • has been designed to assess whether a centre has complied with all of the statutory requirements that contribute to the effective mitigation of six key risks
  • has been developed to assess the quality of the service provided by a centre.

Quality and risk are the key elements of the tool. The Risk Tool is one part of a broad assessment that culminates in inspection.

 

How will it help the HFEA improve performance?

The Risk Tool will be used to inform the focus of inspections so that our inspections add as much value as possible and prioritise the things that matter most.  Where the outputs from the Risk Tool prompt contact with centres in between inspections, it will help us provide reassurance that standards of quality are maintained in the time between inspections.

 

Why does the HFEA need a risk tool?

The Better Regulation agenda recommends that all regulation is risk based and we also believe that it is essential for us to be able to demonstrate that:

  • our regulatory activities are fair and consistent
  • our focus is targeted to where it can add most value
  • consideration is given to quality as well as compliance
  • we continue to be alert to regulatory issues in between inspections.

We started testing the Risk Tool In April 2011. We use outputs from the Risk Tool to inform inspection activity and increasingly we will be using the outputs to prompt contact with centres if concerns about performance arise.

If your centre has any feedback on the Risk Tool outputs, contact the Head of Inspection at debra.bloor@hfea.gov.uk

How it works

The six key risks

The Risk Tool focuses on six key risks:

  • Incorrect identification of gametes or embryos
  • Consent failures
  • Damage or loss of gametes or embryos
  • Cross infection of gametes, embryos or patients
  • Multiple pregnancy
  • Incorrect or incomplete information on donors.

How are the key risks assessed?

The assessment of a centre’s key risk status is based on the premise that compliance with the requirements of the Human Fertilisation and Embryology Act, the HFEA Code of Practice and Directions helps centres to mitigate against the likelihood of key risks.

The statutory requirements have been ranked 1-4, with those requirements thought to have a direct impact on risk ranked 4 and those with an indirect impact 3, 2 or 1 (with 1 being most indirect). 

The Risk Tool acknowledges that actually “doing things” to prevent risks happening is critical. While effective documentation is important, having a good standard operating procedure (SOP) is only effective in helping prevent risks when the SOP is followed. Therefore, an audit of practice ensuring that SOPs are being followed contributes more to the mitigation of risk than simply having an SOP or a quality indicator.

This is demonstrated in the diagram (right) which shows some of the requirements linked to the risk of incorrect identification of gametes and/or embryos.

Compliance with the requirements shown in red are considered likely to have a direct impact on the mitigation of the key risk; those in amber and yellow have a progressively more indirect impact on mitigating the key risk.

The tool analyses the information that a centre submits in their SAQ to help us form a view as to whether the centre is effective in mitigating key risk or to identify areas of practice where there is an opportunity for improvement.

 

 

How the quality of service is assessed

The Risk Tool analyses information provided to the HFEA through Register submissions and to the HFEA finance directorate to assess quality of service in terms of:

  • outcomes (in the form of  real time analysis of clinical pregnancy rates)
  • multiple clinical pregnancy rates
  • submission of critical donor information
  • payment of fees
  • incident reporting.

By applying a consistent methodology to the analysis of this data we will ensure consistency and fairness. Where the analysis shows that a centre’s outputs are outside the sector norms we will share this information with the centre and support them in identifying whether there is an opportunity for improvement. The same will apply where clinical multiple birth rates indicate that a centre is not likely to meet HFEA targets; where critical Register submissions are not submitted or where fees are not paid.

See how your centre is performing

You will be able to see the outputs for your centre through an application in the Clinic Portal.  These outputs are refreshed on a monthly basis.

Interpretation of RBAT outputs

The HFEA has chosen to use cumulative sum (CUSUM) analysis to assess on-going performance. Further information on the interpretation of CUSUM plots can be downloaded below:

 

 

Page last updated: 07 February 2013