Key takeaways
Clinics should ensure that a ‘souvenir scan service’ does not entail what may be interpreted as clinical advice
A service is likely deemed to have provided clinical advice where, for example, reassurance or commentary is offered regarding fetal health or ‘well-being’.
Increased claims exposure
A duty of care is likely to arise where the expectant parent may reasonably rely on the clinical information provided by the clinic to make health-related decisions.
Clear boundaries are essential to managing risk
It is important for pregnancy scan clinics to ensure that robust procedures are in place to distinguish between “diagnostic” vs “non-diagnostic” services.
Background
Private high-street baby scan clinics have become increasingly popular with expectant parents. This is unsurprising, facilitating prompt service compared to the NHS and a profusion of keep sake images, through “bonding”, “gender reveal” and other souvenir-style scans (such as 4D).
Whilst many private pregnancy-scan clinics operate to high standards, the Society of Radiographers (“SOR”) have raised concerns about unregulated operators lacking adequate clinical skills or pertinent training.
Media coverage has highlighted an increasing number of concerns such as misdiagnosis following some scans. Problems arise where reassurance (or what could be interpreted as clinical advice) is provided and/or where scans are being performed by either under-qualified or un-qualified staff. This raises important questions about liability exposure.
Regulatory and litigation considerations
Presently individuals without formal sonography or radiological qualification can conduct scans provided it is in a private setting.
As the SOR have noted, “anyone with an ultrasound machine can call themselves a sonographer” and they are calling for the term ‘sonographer’ to become a protected title .
The Care Quality Commission (“CQC”) emphasise the clear distinction between ‘diagnostic’ and ‘souvenir’ scans, highlighting that the latter "are not for diagnosing problems with you or the baby" .
This distinction is important and can help to determine whether a duty of care and subsequent clinical negligence risk may arise in circumstances where complications have sadly arisen. However, there is seemingly an ever increasing “blurring” of this demarcation to the extent that it is often far from clear-cut.
A duty of care is likely to arise when reassurance or commentary is offered regarding fetal health or ‘well-being’. This may include for example comments about whether the heartbeat or development appears normal, or ‘everything looks OK’. Under such circumstances, the commentary would likely be considered clinical advice, even if it had intended to be a non-diagnostic service and simply provide ‘keep sake’ images.
Disclaimers
Disclaimers which emphasise the service is non-diagnostic or non-clinical may help to avoid the risk of criticism or a claim should it subsequently be established that the information provided was incorrect, but there must be no lack of clarity about the service being offered.
In the context of a scan which many would consider a clinical matter, even a brief comment about fetal health can alter the dynamic and may be construed as clinical advice. The parent may reasonably rely on the information to make health-related decisions; for example, determining that they need not attend NHS follow up.
In addition, in accordance with the Consumer Rights Act 2015, disclaimers cannot exclude liability for death or personal injury if it has been caused by negligence.
Implications for insurers
Insurers will no doubt be alive to the importance of ensuring policies distinguish between “diagnostic” vs “non-diagnostic” services.
To ensure policies are robust, we suggest:
Attention is paid to the scope of cover for non-diagnostic ultrasound work;
Services that risk blurring the lines between providing a souvenir-style scan and clinical advice are clearly identified, so that adequate risk management can be put in place. Clinics that market ‘reassurance’, ‘well-being’ or ‘bonding scans’ to ‘check progress’ may fall under this category;
Staff qualifications are carefully monitored and adequate training is provided to raise staff awareness.
Conclusion
Despite the number of private pregnancy-scan clinics that operate to a high standard, there are increasing and legitimate concerns that some scans performed by unregulated operators are unsafe and could lead to harm.
We will keep under close review whether further regulation of the Sonographer title is likely to be implemented as recommended by the SOR, as well as any further indication that there may be a general tightening up of the regulation in this area.
Hill Dickinson LLP as a full-service Health specialist firm can assist with all legal matters that may arise relating to these issues.
