1. CLINICAL GOVERNANCE
2. ADDITIONAL QUESTIONS
“To work, revalidation must be built on effective and robust clinical governance systems, which, as we know, are essential prerequisites for high quality care… Revalidation is no silver bullet, but it should act as a catalyst for the most far reaching and concerted push to improve clinical governance and, through that, can help improve the quality of care provided.”
Niall Dickson, Chief Executive of the GMC
The Faculty does not manage any of the doctors with whom it has a prescribed connection and there is currently no way for the Responsible Officer (RO) to ensure that there is effective clinical governance in place for the doctors about whom he is responsible for making a revalidation recommendation.
We are aware that some doctors have stated that they have colleagues who are General Practitioners or who have a prescribed connection to another designated body and that their requirements are ‘lower’ or not as stringent with regard to clinical governance and have described the current approach as ‘making the bar higher’ for those revalidating through the Faculty. However, this is just a reflection of the different governance issues that arise between very different types of designated bodies. Designated bodies such as NHS Trusts have direct ‘line of sight’ over those revalidating through their Responsible Officer and have clearly publicised clinical governance standards. This is not the case for the Faculty which is a designated body which does not have any management oversight or indeed influence over the clinical governance of any of its revalidating members.
In order for the Responsible Officer to meet his responsibilities and for the Faculty to meet theirs as a designated body, both have certain obligations under the legislation and expectations from the regulator that extend to ensuring that effective clinical governance is in place.
The Medical Profession (Responsible Officers) Regulations 2010 gives Responsible Officers in England a range of duties embracing wider responsibilities relating to clinical governance. These are further clarified in the Department of Health document, Closing the Gap in Medical Regulation – Responsible Officer Guidance which, in Section 3.9, specifically states that “the Responsible Officer will be accountable for ensuring that the systems for appraisal, clinical governance and for gathering and retaining other local relevant supporting information are in place and are effective”. Sections 4.14 – 4.22 further clarify those additional responsibilities.
In relation to trainees, RO’s “…need to consider clinical governance information that assures you about their fitness to practise in order to make a recommendation to the GMC. This includes information from all organisations in which they have undertaken clinical placement.”
In turn, revalidation is cited as being a key driver in clinical governance. Section A.2 (The purpose and effect of revalidation), of Ready for Revalidation, Making revalidation recommendations: the GMC Responsible Officer protocol states that “The purpose of revalidation is to provide assurance for patients and the public, employers and other healthcare professionals that licensed doctors are up to date and fit to practise. Revalidation should contribute to the provision of high quality healthcare in the UK by…cting as a driver for improving clinical governance at the local level and, ultimately, improving standards of patient care.”
Doctors are also asked to ensure that clinical governance is addressed in their continuing professional development. The GMC document Supporting information for appraisal and revalidation states that “You should make sure that your CPD is influenced by your participation in clinical governance processes, individual, organisational and national audit, workplace-based assessments, and other mechanisms that shed light on your professional and work practices”.
It is therefore clear that clinical governance is a key issue which it is the responsibility and duty of both the RO and individual doctors to address. Due to the fact that the Faculty RO is responsible for over 300 doctors, many in individual practice, spread across the UK, the only practicable way to ascertain the clinical governance in place is by a specific questionnaire and the best time to address this is during annual appraisal.
All of the additional questions have been mapped against Good Medical Practice 2013. These are therefore questions concerning clinical governance where doctors should already be compliant and if they are not then the appraisal is the best area to address them.
A formal recording of clinical governance issues is required to provide an audit trail in order to maintain the integrity of the revalidation process in its duty to patient safety. It is possible that the Faculty, the Responsible Office and the appraiser will at some point be subjected to close legal and / or media scrutiny regarding a doctor who, having had a successful appraisal and received a positive revalidation recommendation, is found engaging in practices which raise serious concerns, particularly if they relate to patient safety. The appraiser and Faculty RO need to be able to demonstrate that they have taken all steps necessary to undertake a robust and complete appraisal and revalidation process and the additional questions ensure that clinical governance is adequately covered.
This audit trail also ensures that the appraisee can demonstrate that questions regarding their clinical governance were addressed in their annual appraisal should this be an issue for them at a later date.
Where a doctor may be operating with weak clinical governance, the additional questions ensure that this is identified, can be acted upon and development monitored. It should help to improve standards across the profession and the specialty and will identify issues relating to clinical governance before they become a fitness to practise issue.
The Responsible Officer has a legislative and regulatory responsibility for the revalidation recommendations he makes and requires sufficient information to be able to do so. If clinical governance was omitted then the RO could not make a clear recommendation to the GMC.
If a doctor does not engage with the process then, of course, there will have to be consequences to such actions. As Dr Flower said in the e-mail accompanying the questions “…I will be unable to make revalidation recommendations to the GMC without this information. All appraisees will therefore need to undertake this.”
Further to this, the Individual Agreement which is signed by every doctor revalidating through the Faculty states;
4.3In particular (but not exclusively) the doctor must:
4.3.6 supply any further information that may be required by the Faculty RO and in the format as required by the Faculty RO in a timely manner (including the doctor’s scope of practice)
4.3.12 comply with Good Medical Practice
Therefore these additional questions fall under 4.3.6 as well as 4.3.12.
Appraisers and appraisees should both have copies of the questions and they should be addressed during the appraisal. As with other areas of the appraisal process, these questions can be discussed, information can be shared and documentation provided before the meeting.
The appraisee should upload the document, or a scanned version, to their Supporting Information area on PReP with an appropriate filename.
A detailed review is explicitly not being requested with the Additional Questions and where there are concerns or shortcomings these can often be best addressed as an area of development in the Personal Development Plan (PDP). If the discussion around clinical governance takes a significant amount of time this may point to issues that need to be addressed. However, in the first year of revalidation it is reasonable to expect that some aspects of appraisal will take longer than expected as they are being addressed for the first time under the new system.
Neither are appraisers being asked to perform an evidence based review of their appraisees’ probity in relation to the questions. These questions help to identify areas where clinical governance may be weak and can be improved via the PDP. If serious concerns are revealed then these can be raised as a matter of urgency and resolved before a risk to patient safety occurs.
The appraiser is not being asked to sign off on the statements but to confirm that they have asked the questions and recorded the appraisee’s responses. This ensures that clinical governance is an explicit part of appraisal and creates a firm audit trail should such activity be necessary at a later date.
There are various areas of appraisal where the appraiser has to take on faith that the appraisee is being completely honest during the process and not omitting anything, despite the obligations they have. Failure to do so is covered by the standard requirements of GMC probity and if a doctor chooses to lie or omit in relation to these questions and this is discovered, this would clearly be a serious matter just as it would be for other areas of appraisal and revalidation.
In the first year of revalidation it is reasonable to expect that some aspects of the appraisal will take longer than expected as they are being addressed for the first time under the new system. As revalidation becomes a part of each doctor’s normal practice, I would expect the workload associated with it to lessen, not that requirements will be dropped, rather that the mechanics of it will be part of routine behaviour. For example, once the recently circulated additional questions on clinical governance have been answered the first time, it should be quicker to complete them the following year, quicker the year after that and so on.
In addition, once clinical governance issues have been identified in the first appraisal then these can be addressed as part of the appraisee’s Personal Development Plan and progress assessed at the next appraisal.
I would expect the extra questions to take no more than 15 – 20 minutes and usually be achieved by discussion rather than detailed review of supporting information. However, we will monitor the amount of time it takes for the questionnaires to be completed and look to our members to provide us with such feedback. After the questions have been answered once, we would expect the time taken to complete them the second and third, etc, time to reduce as clinical governance questions become a regular part of appraisal.
Most other specialties appraisals are conducted within a known governance framework – such as a hospital – and so a Responsible Officer does not need to make specific enquiries in regards to clinical governance. This is not the case with the Faculty.
In recognition that individual circumstances differ between practitioners, not all questions will apply to all doctors.
The context of appraisal has changed with revalidation and the document Making Revalidation Recommendations: the GMC Responsible Officer protocol (Guide for Responsible Officers) states that an RO has a duty to “…ensure that your designated body or bodies carries out robust and regular appraisals…” and that “…To recommend a doctor for revalidation, your judgement must be that the doctor’s annual appraisals do reflect the requirements of the GMP Framework”. To satisfy these duties it was therefore necessary for the RO to issue the additional questions as they are directly related to GMP 2013.
The additional questions are concerned with the clinical governance of the doctor’s own practice. If they work for an Occupational Health provider then clinical governance issues for that portion of their work will be covered by that organisation. As a guide, if the appraise works:
The additional questions are concerned with the clinical governance of the doctor’s own practice. If they work for an Occupational Health provider then clinical governance issues for that portion of their work will be covered by that organisation. However, if they work at a number of different sites as part of their own independent practice then it may be necessary to address a number of the additional questions separately for each of the sites.
For instance, each site must be considered with regard to facilities and equipment (Question 5f) or there may be different systems for the maintenance of health records (Questions 5b, 5c and 5d) in place at different sites.
Self-assessment and signed statements regarding aspects of practice can and do have an important part in appraisal. Indeed, it was considered in relation to clinical governance, but as this is such a vital element of a doctor’s practice it needs to be formally addressed.
These are areas of core clinical governance that all doctors should already be compliant with. The questionnaire allows the appraiser to formally record the appraisee’s compliance with a basic framework of clinical governance. Delaying their introduction until 2018 would be unacceptable and the Faculty does not have the power to delay aspects of revalidation.
The importance of identification is specifically mentioned in The Medical Profession (Responsible Officers) Regulations 2013 16.2.(c) which states that Responsible Officers must “…take any steps necessary to verify the identity of medical practitioners”. The appraisee must be positively identified, either through photographic identification or based on previous acquaintance. Many appraisers will appraise doctors they have not met before which is why identification is important.
This requirement has been established by legislation. The Medical Profession (Responsible Officers) (Amendment) Regulations 2013 4.2.(a) (aa) states that Responsible Officers must “…ensure that medical practitioners have sufficient knowledge of the English language necessary for the work to be performed in a safe and competent manner”.
The questions were mapped to SEQOHS as an accepted and respected standard of occupational health governance. However, they were also mapped to Good Medical Practice 2013 which all doctors must be compliant with.
The reason for GMP 2013 and the SEQOHS standards being mapped as references for the questions was to provide context as to what was being asked and how it fitted into both a specialist and the wider GMC framework. The Additional Questions Appraisal Guide was also developed to provide a plain English guide to what is being asked and how the question might be answered. As Dr Flower said, “I have used the GMC’s Good Medical Practice 2013 and the SEQOHS (Safe Effective Quality Occupational Health Service) Standards for Accreditation to highlight and map key areas of enquiry and to develop a limited number of additional questions related to clinical governance for appraisals”.
No. At no time has the Faculty said that individual practitioners must be SEQOHS accredited to revalidate through the Faculty.
No. SEQOHS is entirely a voluntary standard, there is no requirement for individual practitioners to be SEQOHS accredited and the Faculty has not stated that this is the case. The SEQOHS standards are not being used to assess clinical governance for individual doctors. Instead, they are being used as a reference – along with GMP 2013 – to give context to the questions and serve as a guide to what is being asked and why.
No. The Faculty has not benefitted and does not seek to benefit financially by adding these extra questions to appraisal. On the contrary, as for appraisers, it entails additional work for no additional income.