LLB MA Solicitor Advocate
Specialist Regulation Lawyer and Partner
Veale Wasbrough Vizards
Yvonne has been advising private and public providers of health, social care and education services on regulatory law for more than 10 years. Much of this work includes preparing care homes and independent schools for inspection to ensure they not only comply with national minimum standards, but are able to demonstrate best practice in order to excel in their inspection ratings. Yvonne has a masters degree in human rights law and, as a higher court advocate, has appeared before the High Court and Court of Appeal in cases dealing with regulatory challenges
Consultant Solicitor and Chartered Arbitrator
Veale Wasbrough Lawyers
Derek has a particular interest in the primary healthcare sector, acting for over 250 GP and dental practices throughout the south and western regions of England and Wales over a period of 20 years
The background to the new regulatory framework began with Sir Liam Donaldson’s post-Shipman report Good doctors, safer patients.(1) Sir Liam made no less than 44 recommendations, many of which are being introduced at the same time the Care Quality Commission (CQC) is extending the range of its regulatory powers to cover GP/dental practices from April 2012.
It is salutary to note that, even as late as 2001, the General Medical Council (GMC) was saying that it was “unthinkable” that there should ever be “any alternative to professionally led regulation”.(2) As in the case of other professions (eg, solicitors), however, the argument that professions should regulate themselves has, as a result of public pressure, reached the point when it is no longer sustainable.
The precursor to regulation by the CQC is the Commissioners and Investments Asset Management Strategy (CIAMS) process. We call CIAMS the “Domesday Book”, as it is intended to constitute a comprehensive record of all premises (together with a variety of information about the suitability, condition, quality, etc).
To us, this looks suspiciously like preparation for the CQC’s work, in that the CQC will be able to search the CIAMS register to get a first view on how existing surgery premises comply with their requirements!
CIAMS is intended to provide a factual base for strategic evaluation of the primary care sector real estate, and it seems this is something practice-based commissioning (PBC) “clusters” should surely involve themselves with. A further “use” is that practices considering expansion of their surgery premises will have access to considerable detail about the number, sustainability and functionality of neighbouring surgery premises.
Alongside what may be termed “organisational” regulation, all GPs should have taken a Licence to Practise with effect from 16 November 2009. This is expressed to be the “first practical step towards introduction of revalidation”.(3)
As far as revalidation is concerned, fresh consultation on the subject is going to take place in early 2010. At the same time, the Department of Health is issuing papers on “Clinical Governance”, and the processes for complaints handling were formalised in regulations issued last year.(4)
Ten tips for good preparation
It is beyond the scope of this article to go into the detail of any of these regulations. In any event, much of the detail is yet to be finalised. From the general standpoint of dealing with “the regulators”, we offer the following 10 top tips:
- 1. As is clearly laid out in the guidance on revalidation, it is essential that there is “unequivocal commitment from the highest levels of the responsible organisation.”5 This means all partners must buy into the process and give leadership to it – however much many of them will hate what they regard as bureaucratic “interference” into the way that they carry on their professional activities.
- 2. Someone, preferably a partner committed to the process, must take on the specific leadership role as “Compliance Officer” to lead the process through.
- 3. Early planning is essential, with all aspects of regulation being covered and prepared for. It is a good idea, perhaps assisted by outside consultancy advice, to do “dummy runs” to make sure that the organisation is compliant.
- 4. Other professional organisations have found that, more often than not, most of them are doing everything right. The change, with outside regulators looking on, is that compliance must be demonstrable, and there has to be comprehensive compliance. It is not good enough to be 80% “excellent” and 20% “no good”. You have to be 100% “excellent”.
- 5. Central to revalidation is the appraisal process. Appraisals have to be comprehensive and cover everyone in the organisation; 360-degree appraisals are a good idea, and even partners can sometimes find things out about themselves of which they were previously unaware. The “key” to successful appraisals, in our view, is to make them positive, proactive and a part of the general business planning process. To treat them merely as “box-ticking” exercises is demoralising and unhelpful to the appraisee. If individuals feel that appraisals are a part of their own personal development, they can cease to be viewed in a negative way.
- 6. Like it or not, the “paper trail” in every aspect of regulation is essential. Make sure that proper written policies are in place and that these are regularly updated and adhered to in particular situations. This will be particularly galling to many GPs, who may believe that the constant process of recording written information does not really add to substantive care of patients in any way, shape or form. Nevertheless, it is essential that everyone does accept the need for this.
- 7. An effective complaints procedure is essential. While there is a requirement to notify the primary care trust (PCT) of complaints as it is, it is nevertheless desirable that each practice does adopt a comprehensive complaints procedure and follows it in practice. This is something that regulators, in other professions, have been particularly keen on; GP practices should be particularly aware that regulators have powers to make “unannounced” visits, and it will often be a “tip off” from a disgruntled patient, whose complaint has not been adequately addressed, which will have triggered such a visit.
- 8. While, in many respects, compliance with external requirements of regulators can only be described as “a bit of a drag”, we would urge practices to regard it as something that is not going to go away and also something that may provide opportunities. Many practices will not, at least initially, be compliant with the CQC’s anticipated regulatory requirements – opportunities for expanding existing, efficient and well-regulated practices will arise. It also has to be said that if compliance requires, say, expenditure on buildings alterations, then practices will look in vain towards the PCT for financial “bail out” – they are cash-strapped as it is, and they will say it is up to individual practices to make sure they comply.
- 9. Having a “clean bill of health” in regulatory terms will, in any event, be essential if a practice wishes to expand in any way at all by, for instance, developing a new surgery, expanding an existing one or tendering for services being commissioned by the PCT.
- 10. Once you have been through the initial regulatory inspection process, do not give up there. Keep the pressure up on the organisation. There will be regular visits, subsequently, from the regulator. In any event, other professions have found that once one gets used to compliance it does (dare we say it!) get easier all the time.
1. Department of Health. Good doctors, safer patients: proposals to strengthen the system to assure and improve the performance of doctors and to protect the safety of patients. London: DH; 2006. Available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati…
2. See http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1120633/
3. Department of Health. Medical revalidation. Available from: http://www.dh.gov.uk/en/Managingyourorganisation/Workforce/Professionals…
4. For more information on the new complaints handling procedures in general practice, see: http://www.managementinpractice.com/
5. NHS Revalidation Support Team. Assuring the Quality of Medical Appraisal for Revalidation. May 2009. Available from: http://www.rcpsg.ac.uk/Education/Revalidation_CPD/Documents/Revalidation…
Care Quality Commission