Case study two – a centre has not submitted information required by the HFEA within the set timescale
During the on-going monitoring of a Treatment and Storage centre the risk tool identified that the centre was not submitting information required to be held on the HFEA register within the timescale required by General Direction 0005. This was classified as an ‘other’ area of non-compliance.
The inspector contacted the Person Responsible to discuss the issue and asked that the Person Responsible investigate the issue to identify any area of practice which may be contributing to the late submission of information to the HFEA. The Person Responsible is asked to provide this explanation within 4 weeks.
Scenario 1:
The Person Responsible contacts the inspector within 4 weeks and provides an explanation. The Inspector accepts the explanation and continues to monitor the centre through the normal mechanisms. The on-going monitoring provides evidence that the centre is now submitting information within the required timescales. No further action is taken and the inspector continues to monitor the centre through the normal mechanisms.
Scenario 2:
The Person Responsible contacts the inspector within 4 weeks and provides an explanation. The Inspector accepts the explanation and continues to monitor the centre through the normal mechanisms.
The on-going monitoring provides evidence that the centre is still not submitting information within the required timescales.
The inspector invites the Person Responsible and any relevant members of the centre’s staff to attend a management review: at this meeting the Person Responsible agreed to implement systems to ensure that information would be submitted to the HFEA within the required timescales.
The on-going monitoring provides evidence that the centre is now submitting information within the required timescales. No further action is taken and the inspector continues to monitor the centre through the normal mechanisms.
Page last updated: 28 September 2011
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