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Revalidation - Transforming Medical Regulation in the UK Print E-mail
The Quarterly 2011

 

The drive to reform the way in which the medical profession is regulated in the UK came from a series of catastrophic failures of care. The Bristol paediatric cardiac surgeons, in the early 1990s continued to perform an operation that was killing babies and small children. Carrying on in the hope that their technique would improve resulted in the unnecessary deaths of 90 children. This was followed by other, less high profile but nevertheless devastating cases. One included a gynaecologist who caused immense harm to many of his patients and two psychiatrists who sexually abused their particularly vulnerable patients for many years.

Whilst a number of measures had been taken to improve the safety of patients, including the introduction of medical appraisal and clinical governance, the final impetus came from the emergence of the horrific activities of Harold Shipman. Shipman was a much loved and well renowned General Practitioner who was found to have caused the deaths of some 250 of his patients, perhaps more. On analysis of all these cases, it became very clear that whilst many people knew that 'something was not quite right' no one put the various disparate pieces of information together to give the whole picture until it was far too late.

In the UK, up until this reform, a doctor's licence to practise was granted on the basis of their passing their initial qualification and then undertaking a year's probation. The date a doctor passed the qualifying examinations and completed the year's probation is recorded by the General Medical Council (GMC). If a doctor chooses to specialise they take the appropriate training and gain registration on the specialist register. The entire basis of the regulator's decision to deem an individual practitioner fit to practise was the historical record of examination success.

The reform, described as the introduction of a system of revalidation for doctors, was first discussed as long ago as 1995. There have been many reasons for the delay in implementation, not least of which was the reluctance of parts of the profession for whom revalidation presents an invasion of what they believed was an unassailable right - their 'clinical freedom'. Other factors included the information systems and manpower cost to make revalidation work, and the fear that revalidation of doctors would set the stage for other clinical practitioners, even non-medical managers, to require revalidation.

Dame Janet Smith's inquiry into the case of Dr Harold Shipman resulted in the Chief Medical Officer's review of medical regulation, which resulted in 2007 with a White Paper, 'Trust, Assurance and Safety'. This outlined the proposals for assuring the public in the UK that licensed doctors are up to date and fit to practise.

At the heart of these proposals lie the process of medical revalidation, the introduction of a new medical management role, the Responsible Officer and a major shift in the information recorded about each medical practitioner holding a licence to practise in the UK.

Following the White Paper in 2007, regulation was developed and passed through Parliament. From January 1st 2011 it became mandatory by law in the UK, that each Designated Body (hospital trust or primary care unit) appoint a Responsible Officer. The key principle of medical revalidation is to bring together the intelligence on an individual practitioner from local internal clinical governance systems with that held by the regulator (the GMC) in such a way as to identify the failing doctor early, taking proactive preventative steps before the doctor has harmed patients.

The Responsible Officer is generally a senior doctor and in most cases the Medical Director. They are appointed to make a recommendation to the GMC on the fitness to practise or otherwise on each of the doctors for whom he or she is responsible. The mechanism for allocation of every doctor to a Responsible Officer is a clearly articulated set of 'prescribed connections' based on the doctor's main employer.

Each doctor must undergo a regular and in most cases yearly, appraisal. Once in every five -year cycle each doctor must provide evidence of having collected and responded appropriately to colleague feedback and they must also provide evidence that they have collected and responded to patient feedback, if they provide direct care to patients. The appraisal information is triangulated with other patterns of information generated by the organisation's clinical governance systems and once every five years the Responsible Officer makes a recommendation as to whether the doctor is fit to practise in the role they currently hold.

The GMC makes the decision, based on the Responsible Officer's recommendation, as to whether the doctor should be granted a licence to practise for a further five years. The GMC is changing the nature of the information it will record and retain on its register. To date, all that has been recorded has been successful achievement of qualifications. Now it will record what the doctor currently does and that they are fit to practise in this role. Doctors changing role between revalidation cycles will need to demonstrate to their appraiser and Responsible Officer that they have undergone suitable training to take on the new role and have an appropriate plan for CPD that matches their responsibilities.

If there are no concerns, the Responsible Officer makes a positive recommendation to the GMC. If there are serious concerns about a doctor's practice steps are taken immediately to remove the doctor from patient care and they are referred to the GMC's Fitness to Practise Committee. If the degree of concern is less certain the recommendation is deferred until further information has been gathered or other action or investigation has been instigated.

The Responsible Officer must also oversee the clinical governance and appraisal systems of the organisation and put processes in place to ensure that any failure of these systems is picked up early. Revalidation and the Responsible Officer's decision-making are of course dependent upon robust information systems at the local level and on the consistency and rigour of appraisal.

The systems at the local level throughout the UK are variable in terms of accuracy and sophistication. Furthermore most of the systems that generate the information that will be used to derive a pattern of the doctor's practice were not designed to capture information specific to individual practitioners. With the NHS not in a financial position to replace all of its systems, the regulations place a burden of responsibility on the employing organisations to resource the systems needed for revalidation to the appropriate level.

Appraisers in the UK similarly vary, with some taking the process very seriously and others less so. There is still a great deal of work to be done before the first recommendations are due to be made in March 2013. The process will be evolutionary, with those organisations that are ready and have the systems in place going first. The Responsible Officers are in place and a single training process to an agreed curriculum is underway. An agreed uniform approach to appraisal is being drafted and audits of the readiness of the necessary systems and processes are taking place on a regular basis.

Medical Revalidation is finally coming into being in the UK, after some 15 years of deliberation. The intention is to strengthen the processes to ensure patient safety - and to put in place robust mechanisms for identifying doctors in difficulty sooner rather than later and supporting them through their issues rather than waiting until patients are harmed. It transforms the role of senior medical managers in the UK. Previously they had to rely on their ability to convince their colleagues of the need to improve their practice. Now they are in a position of power, giving them the 'teeth' to insist on proper systems of appraisal and monitoring of performance. This is a role transformation that has been long overdue.

Professor Jenny Simpson OBE
European Alliance of Medical Managers
Revalidation Support Team, Department of Health


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