The Risk Based Assessment Tool (RBAT) captures clinical and non-clinical data from clinic returns. This data associated with key indicators assists in assessing the risk of non-performance of each centre. This is necessary to help the HFEA meet the Government’s better regulation agenda through focusing on and targeting its regulatory effort. RBAT informs the content of the inspection notebook and determines the focus of any inspection or triggers a targeted inspection. It produces a centre rating based upon a combination of Self Assessment Questionnaire (SAQ) responses (entered by a clinic), SAQ corrections (entered by an inspector) and General Performance Indicators (GPI).
For non-clinical audit purposes the RBAT produces outputs that enable a ranking of clinics based upon the rating they receive. The rating is determined by applying weightings to the raw input data placing emphasis upon activities, not all activities being equal.
The RBAT provides a what if scenario capability so that the calculations performed can be tuned to reflect changes in circumstances and centre profile capability to amplify risk based upon connections between GPIs and other elements.
The RBAT extracts a rolling 12 months’ worth of data for a specific set of General Performance Indicators (GPIs) such as pregnancy rates, from the HFEA’s Register. This usually occurs on the first day of a month and incorporates a lag of 3 months to allow for submission of outcome data. Therefore, every month the start data is 15 months before the previous month. For example, in July 2019 the Risk Model extracts data from 1 April 2018 to 31 March 2019 giving 12 months data with a 3 month lag (April to June 2019). Finance GPI data is extracted from the HFEA’s accounting system and uploaded into the RBAT system.
The Risk Model is run around the middle of each month and generates the RBAT Alert levels for GPIs ranging from red (likely to be statistically significantly below national average) to dark green (likely to be statistically significantly above national average). If there is a red alert an automated email is sent to the Person Responsible (PR) of that centre. The performance data is synchronized to the Clinic Portal and becomes available to centres on the same working day. Note that alerts are not sent out for GPIs that are just below red, at amber therefore the PR should regularly check the cumulative sum analysis (CUSUM) extracts on the clinic portal to ensure they are aware of any negative trends in the GPIs for their centre.
The result of the RBAT depends on the accuracy of the data that has been submitted to the HFEA. For example, missing early outcome information is assumed to be a negative treatment and can therefore negatively impact the GPI and alert level.
Patient feedback is captured from the website and the data synchronized back to the HFEA for analysis and reporting. Feedback over 12 months old is removed from the underlying data both on premises and in the portal on a regular basis.
Task items are synchronized on an hourly basis. However in the case of RBAT alerts relating to Register submissions these will not be cleared until the next Risk Model is run. Tasks relating to post inspection monitoring actions are cleared when the inspector deems the recommendation has been fully implemented and manually updates the HFEA regulatory system.
The HFEA’s billing system extracts any data received into the Register of Treatments for the previous month. In some cases where data corrections refer to treatments in prior months the chargeability is recalculated. If the previous state of the record meant it was not chargeable, but the correction is chargeable, an invoice will be created.
The same happens for data corrections where a previously charged record has been recalculated as not chargeable so a refund will be issued In some cases. Corrections to previous treatment cycles made at the time of data verification can result in a recalculation of chargeability and an additional invoice may be generated.
The requirement is for invoices to be paid within 30 working days of issue of the invoice. The system automatically reports this as a risk when invoices are not settled within this time.
The Clinic Portal allows permitted individuals to maintain a centre’s list of key contacts. Contacts can be added, roles changed and removed. When there are changes in key contacts it is important for the PR or other permitted individuals to update relevant email addresses to ensure alerts, billing letters etc are appropriately addressed.
Read the Clinic Portal Guidance - FAQs.