Journal of Pediatric Surgery 49 (2014) 241–243
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
James J. Mason Brown Memorial Lecture
Competence assurance — Who cares?☆ George G. Youngson ⁎ Royal Aberdeen Children's Hospital, Foresterhill, Aberdeen, AB25 2ZG, Scotland, United Kingdom
a r t i c l e
i n f o
Article history: Received 29 October 2013 Accepted 9 November 2013 Key words: Revalidation General Medical Council United Kingdom Paediatric surgery Medical regulation
a b s t r a c t The provision of clinical care in the United Kingdom now requires the acquisition of a licence to practise from the regulatory authority. A review process-revalidation has been put in place to ensure that standards of care are maintained by the medical workforce, and that all doctors remain up-to-date and fit for purpose so that this licence can be retained. This article outlines how this new statutory requirement pertains to paediatric surgery and highlights those areas where adjudication of competence remains imprecise and where progress in this process of revalidation needs to be made. © 2014 Elsevier Inc. All rights reserved.
As the history of the British Association of Paediatric Surgeons (BAPS) is recounted and celebrated in this 60th year Congress, it is timely to look back at the history of some of the formative influences for BAPS and before that, at some of the events responsible for establishing the regulatory standards of the practice of paediatric surgery in the United Kingdom. James Johnson Mason Brown's contributions to British paediatric surgery in its early years as an independent surgical specialty have been well described recently by previous presenters of this eponymous lecture [1,2] as has his influence on the surgical care of children whilst concurrently President of the Royal College of Surgeons of Edinburgh and the British Association of Paediatric Surgeons [3]; but a review of the regulation of paediatric surgery as part of the whole of medicine within the United Kingdom, requires an earlier start. Indeed, the introduction of revalidation in 2013, the year of this lecture, constitutes an important historic landmark in determining the standards of the practice of medicine. It represents the single most major regulatory event since the inception, in 1858, of the General Medical Council (GMC) — a body whose primary purpose is to serve and protect the well-being of patients through regulation of the medical profession. The GMC developed a list of doctors (the medical register) who were permitted to treat patients (and other medical duties) and that listing process continues to date. It is through the process of revalidation introduced in December 2012, that the profession now aspires to establish a competence assurance mechanism designed to endorse and ratify the principles that every doctor in the United Kingdom remains up-to-date on their practice and fit for purpose [4], and in the case of our specialty, meeting the standards of
☆ James J. Mason Brown Memorial Lecture. ⁎ Tel.: +44 1224861305. E-mail address: [email protected]. 0022-3468/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpedsurg.2013.11.030
care required of every neonate, infant, child and young person with a surgical illness. 1. Medical regulation Self-regulation of the medical profession and the role of the GMC have been challenged in UK in the last two decades by a series of highprofile adverse events of either individual doctors or institutions that have prompted a requirement for more rigorous review and regulation of individual practice. Placement on the medical register and then the specialist register (vide infra), with no further obligatory formal assessment during a lifetime of clinical practice is no longer considered acceptable. The serial public enquiries of surgery in Kennedy [5] and Dame Janet Smith [6] concerning poor results from paediatric cardiac surgery and undetected homicidal actions of Dr Harold Shipman respectively and recently the enquiry report from Mr Robert Francis QC reviewing excess mortality and poor standards of care at Mid-Staffordshire Hospital Trust [7], have placed emphasis on the need for greater accountability of all doctors to the GMC for their standards of clinical practice and, in turn, a statutory duty has been put in place for the GMC to account through legislation to the British Parliament [8,9]. The privilege and duty of treating patients and carrying out a wide range of associated professional duties must now satisfy a range of regulatory requirements. First amongst these, is registration with the GMC and acquisition of a licence to practise (LtP). This permits clinical (and nonclinical) activity within the UK alone (LtP is not required for overseas activities). Certification of completion of surgical training permits placement on the specialist register of the GMC as a paediatric surgeon. Retention of the licence (and hence the privileges of clinical activity) now will require renewal on a five yearly cycle and that process is termed revalidation. Revalidation pertains to all doctors in the UK (235,000) irrespective of their employment characteristics
242
G.G. Youngson / Journal of Pediatric Surgery 49 (2014) 241–243
(National Health Service, independent practice, part-time, full-time, local, in training, or any combination thereof) and its wholesale implementation across the entire healthcare system of the UK is the first in the world of this type of comprehensive and obligate recertification mechanism. 2. Appraisal The cornerstone of revalidation is appraisal which is an interview taking place on an annual basis. To undergo appraisal, every doctor has an identified contact (prescribed connection) with a senior doctor (termed the Responsible Officer) appointed in the main, by employing authorities (for the purposes of revalidation these agencies are termed Designated Bodies). The Responsible Officer (RO) appoints a trained appraiser who usually comes from the same or allied discipline, to undertake that appraisal. There are established process and content to this activity and the appraisee (the paediatric surgeon) is required to develop a portfolio of supporting information which informs the appraisal process which is intended in the first instance to be a formative event. However the summation of the five appraisals over the cycle constitutes the basis for the revalidation assessment and is the basis for recommendations made by the RO to the GMC in respect of revalidation of that doctor. The RO has three recommendation options: 1. The doctor is suitable to revalidate and hence for retention of LtP. 2. The doctor has been unable to satisfy requirements sufficient to revalidate at the appointed time and requires an early (within nine months) reassessment. 3. The doctor has not engaged in the revalidation process (and the licence to practice is hence at risk). The omission of a fourth recommendation – "the doctor is not suitable for a revalidation" – is at first sight perhaps an omission, but the GMC has taken the view that any event or assessment which identifies suboptimal performance and places patients at risk, should be reported immediately to their Fitness to Practise Department and not await a five yearly cycle to trigger an intervention. 3. Standards, outcomes and continuing professional development (CPD) Implicit in the assessment process, is the notion that some context is available which constitutes a comparator for the requisite level proficiency or sufficiency when adjudicating on the quality of care provided by any individual paediatric surgeon. BAPS, along with the surgical royal colleges and other specialty associations, has established guidance which provides the denominator against which the assessment/appraisal process can be made; the benchmarking process includes clinical standards against which practice should be compared [10]. This includes activity data, the scope and extent of practice across all professional domains (including teaching, management, research etc.) the reporting of adverse events (if any) and peer-based feedback as well as patient/parent-based feedback from questionnaires. Recommendations have been made in both the types of continuous professional development (CPD) (internal, external, personal), as well as the quantity which has 50 hours per year (i.e. 250 per 5 years) identified as a suitable minimum. Perhaps more importantly however, reflection on how this time spent has changed practice for the betterment of patients is viewed as being important, as well as contributing to the maturation of professional development, and that process of reflection has been deemed a more significant contribution than the simplicity of measuring the number of hours spent at conference attendance/examinations/involvement in literature reviews/etc. Outcome analysis has been a particular challenge for many specialties, including our own, particularly those where mortality is an unsuitable endpoint for analysis and quality of life measures are
but one proxy of quality to be used in pursuit of a marker which denotes the standard of individual surgical practice. The criteria to be met in identifying suitable outcome indicators for use in revalidation include the reliability of the data collected, the direct attribution of that outcome to the individual surgeon (as opposed to the effect of the team or institution) and these two features alone pose a particular challenges for a specialty such as ours that is defined by an age range as opposed to a body system. The need for the measurement to be suitably powered to ensure reliable confidence intervals which can be used to justify the identification of outliers is an elusive product in paediatric surgery and understanding the significance of, and the reasons for an outlying position, is similarly complex; an alternative view, however, is that the ultimate position in a performance table or a funnel plot is less important than is the opportunity to discuss results, suitably contextualised according to available resource, geography and support, with a suitably experienced and informed appraiser. That review process may be ultimately of greater benefit to the individual surgeon, than an arbitrary position in national tables. BAPS has identified a basket of procedures that might be considered suitable for this comparative analysis in general paediatric surgery and also in paediatric surgical specialties but these are likely to be developed further with usage [11]. 4. Implications of implementation Chief amongst concerns of many surgeons, is the issue of whether or not the process of revalidation is designed, on the one hand, with sufficient sensitivity to accommodate the complexity of modern day surgical practice and identification of those practitioners who failed to meet the requisite standards, and on the other hand with the ability to avoid an administrative burden which might constitute a diversion away from patient care. The need for proportionality in time and financial costs and the sensitivity of the process to identify those who are underperforming, provides a tension that will only become better defined and hence resolved with both time and usage. But the aspiration to improve patient care at the same time supporting the needs of clinicians, particularly the needs of those requiring support to reach the required standards of clinical ability, is one that should not be contestable. Remediation of those in need of support by virtue of underperformance revealed through revalidation, may be a new phenomenon in that the existing mechanisms for remediation are triggered by a response to a significantly untoward event(s) rather than a preemptive recognition of borderline clinical/professional performance. This new "grey zone" of borderline performance, particularly if the concern surrounds a pattern of repeated underperformance, will be an area for expert intervention as might be provided through BAPS where peer group assistance may be made available and put in place. 5. Contention, consistency and cost The need for consistency in standard-setting across a spectrum of geography and across the 67 different registered specialties of British medicine is self-evident as is the need for the quality assurance of both the process and adjudication tasks assumed by the responsible officer. A high level of consistency in adjudication and the recommendations given by the responsible officer is required at the appraisal stage and appraiser training is key to obtaining that objective. Training programmes have been put in place across the UK which have identified organisational readiness for implementation factoring an assumption that one appraiser will be able to deal with approximately 10 appraisees per year. The scale of training of appraisers is therefore significant. Whilst the legislation surrounding the process of revalidation has been defined by UK Parliament and therefore considered a reserved matter, implementation of the process is delegated to the devolved
G.G. Youngson / Journal of Pediatric Surgery 49 (2014) 241–243
administrations (Scotland, Northern Ireland and Wales), and remediation is an example of that delegated responsibility, as is the revalidation of trainees. Geographic differences in process have accordingly emerged with Scotland using a single electronic process for revalidation of all its doctors (SOAR; Scottish Online Appraisal Resource). No such imperative currently exists in any of the other nations where implementation methods have been delegated at local level. Similarly in Scotland, single multisource feedback tool has been made available for all Scottish doctors with a preference for a range of feedback tools being acceptable elsewhere within UK. Whilst that raises the potential for differentials of process and standards throughout the UK, the dominant principles of equity consistency and proportionality have been set out by the GMC and the quality assurance process is to be set in place by the health departments of UK to ensure that consistency. There have been a range of cost estimates to support implementation across an entire healthcare system, but more importantly, revalidation offers an opportunity for British paediatric surgery to identify the metric and standards against which acceptable performance can be judged. It provides an opportunity to review and restate the professional standards that will support safe practice but also provide reassurance to public and patients alike that the aspiration to
243
provide the highest quality of care to children treated within the UK healthcare system is one jointly shared by parents, patients, politicians and, crucially, our profession. References [1] Young DG. The Mason Brown Lecture; Scots and paediatric surgery. J R Coll Surg Edinb 1999;44:211–5. [2] Orr JD. James J Mason Brown Memorial Lecture; surgical training then and now. J Pediatr Surg 2008;43:261–6. [3] McIntyre I, McLaren I. Surgeons lives. Royal College of Surgeons of Edinburgh09503620-9-3; 2005 248–9. [4] Youngson GG, Knight P, Hamilton L, et al. The UK proposals for revalidation of doctors: implications for the recertification of surgeons. Arch Surg 2010;145:93–6. [5] The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary. The Stationery Office; 2001 1984–95. [6] Shipman Inquiry. The final report; 2005 (http://www.official-documents.gov.uk/ document/cm58/5854//5854.pdf.). [7] Francis Robert. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry: executive summary; 2013 (http://www.midstaffspublicinquiry.com/report). [8] The General Medical Council. (Licence to practice and revalidation) Regulations order of Council. http://www.legislation.gov.uk/uksi/2012/2685/contents/made; 2012. [9] General Medical Council. Revalidation. http://www.gmc-uk.org/doctors/ revalidation.asp. [10] http://www.rcsed.ac.uk/media/237085/revalidation_guide_2012_ed_v2.pdf. [11] http://www.rcsed.ac.uk/media/173320/paed%20surgery%202011.pdf.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
James J. Mason Brown Memorial Lecture
Competence assurance — Who cares?☆ George G. Youngson ⁎ Royal Aberdeen Children's Hospital, Foresterhill, Aberdeen, AB25 2ZG, Scotland, United Kingdom
a r t i c l e
i n f o
Article history: Received 29 October 2013 Accepted 9 November 2013 Key words: Revalidation General Medical Council United Kingdom Paediatric surgery Medical regulation
a b s t r a c t The provision of clinical care in the United Kingdom now requires the acquisition of a licence to practise from the regulatory authority. A review process-revalidation has been put in place to ensure that standards of care are maintained by the medical workforce, and that all doctors remain up-to-date and fit for purpose so that this licence can be retained. This article outlines how this new statutory requirement pertains to paediatric surgery and highlights those areas where adjudication of competence remains imprecise and where progress in this process of revalidation needs to be made. © 2014 Elsevier Inc. All rights reserved.
As the history of the British Association of Paediatric Surgeons (BAPS) is recounted and celebrated in this 60th year Congress, it is timely to look back at the history of some of the formative influences for BAPS and before that, at some of the events responsible for establishing the regulatory standards of the practice of paediatric surgery in the United Kingdom. James Johnson Mason Brown's contributions to British paediatric surgery in its early years as an independent surgical specialty have been well described recently by previous presenters of this eponymous lecture [1,2] as has his influence on the surgical care of children whilst concurrently President of the Royal College of Surgeons of Edinburgh and the British Association of Paediatric Surgeons [3]; but a review of the regulation of paediatric surgery as part of the whole of medicine within the United Kingdom, requires an earlier start. Indeed, the introduction of revalidation in 2013, the year of this lecture, constitutes an important historic landmark in determining the standards of the practice of medicine. It represents the single most major regulatory event since the inception, in 1858, of the General Medical Council (GMC) — a body whose primary purpose is to serve and protect the well-being of patients through regulation of the medical profession. The GMC developed a list of doctors (the medical register) who were permitted to treat patients (and other medical duties) and that listing process continues to date. It is through the process of revalidation introduced in December 2012, that the profession now aspires to establish a competence assurance mechanism designed to endorse and ratify the principles that every doctor in the United Kingdom remains up-to-date on their practice and fit for purpose [4], and in the case of our specialty, meeting the standards of
☆ James J. Mason Brown Memorial Lecture. ⁎ Tel.: +44 1224861305. E-mail address: [email protected]. 0022-3468/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpedsurg.2013.11.030
care required of every neonate, infant, child and young person with a surgical illness. 1. Medical regulation Self-regulation of the medical profession and the role of the GMC have been challenged in UK in the last two decades by a series of highprofile adverse events of either individual doctors or institutions that have prompted a requirement for more rigorous review and regulation of individual practice. Placement on the medical register and then the specialist register (vide infra), with no further obligatory formal assessment during a lifetime of clinical practice is no longer considered acceptable. The serial public enquiries of surgery in Kennedy [5] and Dame Janet Smith [6] concerning poor results from paediatric cardiac surgery and undetected homicidal actions of Dr Harold Shipman respectively and recently the enquiry report from Mr Robert Francis QC reviewing excess mortality and poor standards of care at Mid-Staffordshire Hospital Trust [7], have placed emphasis on the need for greater accountability of all doctors to the GMC for their standards of clinical practice and, in turn, a statutory duty has been put in place for the GMC to account through legislation to the British Parliament [8,9]. The privilege and duty of treating patients and carrying out a wide range of associated professional duties must now satisfy a range of regulatory requirements. First amongst these, is registration with the GMC and acquisition of a licence to practise (LtP). This permits clinical (and nonclinical) activity within the UK alone (LtP is not required for overseas activities). Certification of completion of surgical training permits placement on the specialist register of the GMC as a paediatric surgeon. Retention of the licence (and hence the privileges of clinical activity) now will require renewal on a five yearly cycle and that process is termed revalidation. Revalidation pertains to all doctors in the UK (235,000) irrespective of their employment characteristics
242
G.G. Youngson / Journal of Pediatric Surgery 49 (2014) 241–243
(National Health Service, independent practice, part-time, full-time, local, in training, or any combination thereof) and its wholesale implementation across the entire healthcare system of the UK is the first in the world of this type of comprehensive and obligate recertification mechanism. 2. Appraisal The cornerstone of revalidation is appraisal which is an interview taking place on an annual basis. To undergo appraisal, every doctor has an identified contact (prescribed connection) with a senior doctor (termed the Responsible Officer) appointed in the main, by employing authorities (for the purposes of revalidation these agencies are termed Designated Bodies). The Responsible Officer (RO) appoints a trained appraiser who usually comes from the same or allied discipline, to undertake that appraisal. There are established process and content to this activity and the appraisee (the paediatric surgeon) is required to develop a portfolio of supporting information which informs the appraisal process which is intended in the first instance to be a formative event. However the summation of the five appraisals over the cycle constitutes the basis for the revalidation assessment and is the basis for recommendations made by the RO to the GMC in respect of revalidation of that doctor. The RO has three recommendation options: 1. The doctor is suitable to revalidate and hence for retention of LtP. 2. The doctor has been unable to satisfy requirements sufficient to revalidate at the appointed time and requires an early (within nine months) reassessment. 3. The doctor has not engaged in the revalidation process (and the licence to practice is hence at risk). The omission of a fourth recommendation – "the doctor is not suitable for a revalidation" – is at first sight perhaps an omission, but the GMC has taken the view that any event or assessment which identifies suboptimal performance and places patients at risk, should be reported immediately to their Fitness to Practise Department and not await a five yearly cycle to trigger an intervention. 3. Standards, outcomes and continuing professional development (CPD) Implicit in the assessment process, is the notion that some context is available which constitutes a comparator for the requisite level proficiency or sufficiency when adjudicating on the quality of care provided by any individual paediatric surgeon. BAPS, along with the surgical royal colleges and other specialty associations, has established guidance which provides the denominator against which the assessment/appraisal process can be made; the benchmarking process includes clinical standards against which practice should be compared [10]. This includes activity data, the scope and extent of practice across all professional domains (including teaching, management, research etc.) the reporting of adverse events (if any) and peer-based feedback as well as patient/parent-based feedback from questionnaires. Recommendations have been made in both the types of continuous professional development (CPD) (internal, external, personal), as well as the quantity which has 50 hours per year (i.e. 250 per 5 years) identified as a suitable minimum. Perhaps more importantly however, reflection on how this time spent has changed practice for the betterment of patients is viewed as being important, as well as contributing to the maturation of professional development, and that process of reflection has been deemed a more significant contribution than the simplicity of measuring the number of hours spent at conference attendance/examinations/involvement in literature reviews/etc. Outcome analysis has been a particular challenge for many specialties, including our own, particularly those where mortality is an unsuitable endpoint for analysis and quality of life measures are
but one proxy of quality to be used in pursuit of a marker which denotes the standard of individual surgical practice. The criteria to be met in identifying suitable outcome indicators for use in revalidation include the reliability of the data collected, the direct attribution of that outcome to the individual surgeon (as opposed to the effect of the team or institution) and these two features alone pose a particular challenges for a specialty such as ours that is defined by an age range as opposed to a body system. The need for the measurement to be suitably powered to ensure reliable confidence intervals which can be used to justify the identification of outliers is an elusive product in paediatric surgery and understanding the significance of, and the reasons for an outlying position, is similarly complex; an alternative view, however, is that the ultimate position in a performance table or a funnel plot is less important than is the opportunity to discuss results, suitably contextualised according to available resource, geography and support, with a suitably experienced and informed appraiser. That review process may be ultimately of greater benefit to the individual surgeon, than an arbitrary position in national tables. BAPS has identified a basket of procedures that might be considered suitable for this comparative analysis in general paediatric surgery and also in paediatric surgical specialties but these are likely to be developed further with usage [11]. 4. Implications of implementation Chief amongst concerns of many surgeons, is the issue of whether or not the process of revalidation is designed, on the one hand, with sufficient sensitivity to accommodate the complexity of modern day surgical practice and identification of those practitioners who failed to meet the requisite standards, and on the other hand with the ability to avoid an administrative burden which might constitute a diversion away from patient care. The need for proportionality in time and financial costs and the sensitivity of the process to identify those who are underperforming, provides a tension that will only become better defined and hence resolved with both time and usage. But the aspiration to improve patient care at the same time supporting the needs of clinicians, particularly the needs of those requiring support to reach the required standards of clinical ability, is one that should not be contestable. Remediation of those in need of support by virtue of underperformance revealed through revalidation, may be a new phenomenon in that the existing mechanisms for remediation are triggered by a response to a significantly untoward event(s) rather than a preemptive recognition of borderline clinical/professional performance. This new "grey zone" of borderline performance, particularly if the concern surrounds a pattern of repeated underperformance, will be an area for expert intervention as might be provided through BAPS where peer group assistance may be made available and put in place. 5. Contention, consistency and cost The need for consistency in standard-setting across a spectrum of geography and across the 67 different registered specialties of British medicine is self-evident as is the need for the quality assurance of both the process and adjudication tasks assumed by the responsible officer. A high level of consistency in adjudication and the recommendations given by the responsible officer is required at the appraisal stage and appraiser training is key to obtaining that objective. Training programmes have been put in place across the UK which have identified organisational readiness for implementation factoring an assumption that one appraiser will be able to deal with approximately 10 appraisees per year. The scale of training of appraisers is therefore significant. Whilst the legislation surrounding the process of revalidation has been defined by UK Parliament and therefore considered a reserved matter, implementation of the process is delegated to the devolved
G.G. Youngson / Journal of Pediatric Surgery 49 (2014) 241–243
administrations (Scotland, Northern Ireland and Wales), and remediation is an example of that delegated responsibility, as is the revalidation of trainees. Geographic differences in process have accordingly emerged with Scotland using a single electronic process for revalidation of all its doctors (SOAR; Scottish Online Appraisal Resource). No such imperative currently exists in any of the other nations where implementation methods have been delegated at local level. Similarly in Scotland, single multisource feedback tool has been made available for all Scottish doctors with a preference for a range of feedback tools being acceptable elsewhere within UK. Whilst that raises the potential for differentials of process and standards throughout the UK, the dominant principles of equity consistency and proportionality have been set out by the GMC and the quality assurance process is to be set in place by the health departments of UK to ensure that consistency. There have been a range of cost estimates to support implementation across an entire healthcare system, but more importantly, revalidation offers an opportunity for British paediatric surgery to identify the metric and standards against which acceptable performance can be judged. It provides an opportunity to review and restate the professional standards that will support safe practice but also provide reassurance to public and patients alike that the aspiration to
243
provide the highest quality of care to children treated within the UK healthcare system is one jointly shared by parents, patients, politicians and, crucially, our profession. References [1] Young DG. The Mason Brown Lecture; Scots and paediatric surgery. J R Coll Surg Edinb 1999;44:211–5. [2] Orr JD. James J Mason Brown Memorial Lecture; surgical training then and now. J Pediatr Surg 2008;43:261–6. [3] McIntyre I, McLaren I. Surgeons lives. Royal College of Surgeons of Edinburgh09503620-9-3; 2005 248–9. [4] Youngson GG, Knight P, Hamilton L, et al. The UK proposals for revalidation of doctors: implications for the recertification of surgeons. Arch Surg 2010;145:93–6. [5] The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary. The Stationery Office; 2001 1984–95. [6] Shipman Inquiry. The final report; 2005 (http://www.official-documents.gov.uk/ document/cm58/5854//5854.pdf.). [7] Francis Robert. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry: executive summary; 2013 (http://www.midstaffspublicinquiry.com/report). [8] The General Medical Council. (Licence to practice and revalidation) Regulations order of Council. http://www.legislation.gov.uk/uksi/2012/2685/contents/made; 2012. [9] General Medical Council. Revalidation. http://www.gmc-uk.org/doctors/ revalidation.asp. [10] http://www.rcsed.ac.uk/media/237085/revalidation_guide_2012_ed_v2.pdf. [11] http://www.rcsed.ac.uk/media/173320/paed%20surgery%202011.pdf.
