Duty of Candour in the Independent Sector - are you ready for April 2015?
From 1st April 2015, all health and social care providers registered with the Care Quality Commission (CQC) are required to comply with a new Statutory Duty of Candour (DOC).
Published 12 June 2015
The General Medical Council ('GMC') has launched a public consultation on new draft Guidance which sets out the standards they expect doctors offering 'cosmetic interventions' to meet.
The Guidance will build on and incorporate principles from the GMC existing guidance for doctors, good medical practice and is expected to be published in early 2016.
The draft Guidance defines cosmetic interventions as 'any intervention, procedure (both surgical and non-surgical) or treatment carried out at the request of a patient (which also includes any person with legal authority to make a request on a patient's behalf) that has the primary objective of improving a patient's appearance'. For example surgical procedures such as face-lifts, tummy tucks and breast implants and non-surgical procedures such as dermal fillers, Botox®, use of laser or intense pulsed light (IPL) are all 'cosmetic interventions'.
The supply of cosmetic interventions in the UK generated approximately £2.3 billion in 2010, which is estimated to rise to £3.6 billion by the end of 2015. It is a rapidly expanding area and for those who practise in it the level of individual professional risk can be high, for example when working with vulnerable patients who may wish to undergo unnecessary treatments due to mental health conditions such as body dysmorphia and with young people where complex patient consent issues can arise.
In April 2013, Professor Sir Bruce Keogh KBE conducted a review of the regulations applicable to cosmetic interventions, in the wake of the Poly Implant Prothese (PIP) breast implant safety concerns which affected over 50,000 women in the UK.
The Keogh review identified the existing regulatory framework for cosmetic interventions had not kept pace with the changes in the market, and failed to provide sufficient protection against many of the potential risks arising from cosmetic intervention such as unintended muscle weakness, bleeding, scarring, burns and infection. The review called for an ethical framework to be established to support professionals supplying cosmetic interventions, to ensure high quality care is provided with the use of safe products, by skilled practitioners and responsible providers.
The GMC draft Guidance addresses the Keogh review's safety concerns and in some cases sets higher standards than in the current good medical practice guidance. The key Guidance recommendations for healthcare organisations and individuals to consider at this draft stage include:
The Guidance recommendations reflect the wider changes which are occurring in the health and social care sector with the drive for greater openness, transparency and prioritisation of the patient following the recommendations made by Robert Francis QC in the Mid-Staffordshire Inquiry.
There is a need for organisations and individuals to understand the practical and cultural changes that the new Guidance will bring for those undertaking cosmetic interventions. Any serious or persistent failure to follow any GMC guidance (which will include the Guidance on cosmetic interventions once published) will put a doctor's registration at risk.
We anticipate the finalised Guidance will become pivotal for those providing cosmetic interventions, making familiarisation with the draft Guidance and responding to the consultation a priority. The consultation is open until 1st September 2015 and can be viewed on the GMC's website. We would encourage individuals and organisations to respond to the consultation.
In particular we anticipate there will be discussion regarding the draft recommendation that there will be no specified time period for a patients "cooling off" reflection time, as such a provision could create uncertainty and ambiguity both in the Guidance itself and in its implementation. This, in turn, may give risk to additional claims risk, linked to variation in practice regarding effective consent and cooling off periods.
Clinicians, organisations they are either directly employed by, or with whom they enjoy practising privileges, or those who indemnify either, will need to understand the new professional obligations when performing cosmetic interventions and associated risks.
Our experience of healthcare organisations, the regulatory landscape and professional disciplinary proceedings enables us to support individuals, organisations and insurers by: