Compliance cycle
With the introduction of the new Act, we’ve looked at how we can improve what we do as part of the Government’s Better Regulation initiatives. This, and discussions we’ve had with you, have prompted us to look at how we inspect the fertility sector.
Following this feedback, we have developed a new compliance and inspection cycle which we think meets the demands for better regulation. This will be supported by a range of online tools.
What are the changes?
We have been reviewing policies and practices to ensure that our inspections and reports:
- are open, evidence based, and consistent
- use risk assessment to help determine the focus
- place the responsibility on centres to demonstrate compliance
- highlight and share good practice
- provide patients with clear information on the compliance of the centre
- are carried out in a professional and courteous manner providing the centre with a positive learning experience, and
- meet Hampton ‘better regulation’ requirements.
A new self assessment questionnaire will replace the current pre-inspection questionnaire. Inspection will now take place over a four year cycle. Licences will granted for four years in the majority of cases.
Benefits to centres
- A more transparent, risk-based inspection process
- There will be fewer routine inspections
- Shorter, more focussed interim inspections
- More focus by inspectors on highlighting good practice
- More active follow-up of issues to be addressed post inspection
- Integration of audit with inspection
- Faster publication of inspection reports
Get ready
From April 2010, centres can expect:
- more focused and risk based inspections
- great clarity about the focus of their inspection
- shorter interim inspections
- less duplication of information requested
- greater recognition of good practice, and
- more active follow up on licence decisions
Risk Tool
Our risk tool is designed to help you assess your own risk prior to inspection.
The tool has two parts:
The generic performance indicators (GPI’s)
The GPI’s are composed of information previously submitted to the HFEA, such as prompt payment of invoices and timely submission of registry dates.
The self assessment questionnaire (SAQ)
Centres complete the SAQ and the information they submit is combined with the GPI information. The results will provide an overview of the centres’ activities.
The risk tool:
- will use an industry standard model provided by risk experts
- will focus on clinical risk
- will use data from the self assessment questionnaire and information held by the HFEA
- will help determine the focus of all inspections and highlight ‘areas of concern’ to be raised on interims, and
- may lead to targeted inspections or reviews of centres before the next interim is due.
The Self Assessment Questionnaire (SAQ)
The centre self assessment questionnaire is currently being piloted with a reference group. It is planned that attendees at the annual conference on 1 October will have an opportunity to see and use the new SAQ. All centres will be asked to complete the SAQ between December 2009 – January 2010 via the clinic portal on the website.
The questionnaire will:
- be comprehensive, reflecting the guidance notes in the Code of Practice
- be modular – allowing centres to complete only those elements relevant to them
- enable more focussed inspections
- feed into the risk tool, and
- replace the pre–inspection questionnaire.
New Inspection format
|
Type |
Length |
Focus |
Report |
| Initial | 1-2 days | Core requirments | Full report |
| Renewal | 1-2 days | Core requirments - Areas of concern - Themes |
Full report |
| Interim (2 year cycle) |
1/2 day |
- Areas of concern |
Short targeted report |
| Targeted (announced) |
1/2 - 1 day | -Areas of concern | Short targeted report |
| Incident | 1 day | - Areas of concern | Root cause analysis |
| Random (unannounced) |
1/2 - 1 day | - Themes | Short tarted report |
| Closure | 1/2 - 1 day | - Targeted | Short targeted report |
Page last updated: 21 August 2009