t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Matter for debate
Medical error and disclosure e A view from the U.K. George G. Youngson Royal Aberdeen Children’s Hospital, Foresterhill, Aberdeen AB25 2ZG, Scotland, United Kingdom
article info
abstract
Article history:
Whilst the steps for reacting to and communicating following a surgical error should be
Received 9 September 2013
clear to all, actual practice is punctuated by a range of failures which lead to the harm done
Received in revised form
by the error being compounded by inadequacies in the disclosure and subsequent pro-
26 October 2013
cesses. This article outlines best practice at the current time within the United Kingdom
Accepted 28 October 2013
when responding to a surgical error and it also reports the type of behaviours which result
Available online 7 December 2013
in poor levels of satisfaction from the patients’ perspective e often resulting in litigation being invoked.
Keywords: Surgical error
ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Disclosure Apology Liability Litigation
“Sorry seems to be the hardest word”: Bernie Taupin/Elton John. 1976
Introduction It is self-evident that a medical error committed during an episode of surgical care should prompt recognition of the impact of that error for all concerned (primarily the patient), as well as issuing an apology and making every attempt to remedy any consequences of that error. In practice, however, that simplicity becomes necessarily more complex and in many circumstances, a range of other steps may be needed e each one having its own realm of importance. These include: 1. Detection, notification and documentation of the error which should be carried out in a timely fashion and should include an acknowledgement of the error.
2. Immediate and appropriate treatment to mitigate against the error and prevent further harm. 3. Assessment of the circumstances surrounding the event and, if appropriate, establish an investigation team 4. Provision of a verbal and written apology with an accurate account of the facts known to date 5. An offer made of any practical or emotional help required and a communication plan established for any further information provision 6. There should be a timely and appropriately authorised response to queries 7. Any analysis of the event should detail practical examples of changes to practice and how they might be implemented These steps need to be contextualised. They may need modification in the event of the patient being a child, if the patient dies, if the patient has compromised cognitive ability,
E-mail address: [email protected]. 1479-666X/$ e see front matter ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.surge.2013.10.011
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
(e.g. a patient with learning disability), in the face of cultural requirements or linguistic needs, or if there is contest with any aspect of the accounts given. The gravity of the error/ incident will likely affect the magnitude of the response and the introduction of scale or gradation of error is where complexity begins to affect the requisite response. That error e recognition e intervention e apology sequence, however, is influenced by a number of factors and these may modify the type of response required as is seen in the following examples. It is important to note however that an expression of contrition does not necessarily equate with acceptance of liability and an apology made out of empathy (with a careful choice of words) is considered an essential ingredient in all responses to a medical error.
Error-no harm-disclosure If no harm accrues to the patient as a consequence of the error, then disclosure of that error to the patient at least, may not be an obligation. The decision on whether or not the patient should be informed, depends upon a range of considerations including the magnitude of the error, the potential impact of the error, and how close to harm the patient came. A nondisclosure approach if no harm occurs runs the risk of non-reporting, no learning at individual, team nor institutional level, and little or no documentation of the events.1 A potential for recurrence may therefore seem more likely and the recording at least of “near miss incidents” appears to be the minimum action to be taken, e particularly if the incident could have affected the patient’s well-being. Intentional omission of disclosure also runs the risk of the patient subsequently discovering the event through informal means or communications and reacting to both the event and its concealment. If the safety event was of a magnitude deserving of documentation and reporting in spite of no harm, then informing the patient and explaining the circumstances is a consideration. Judgement of what constitutes such a magnitude is discretionary with a culture of openness and eagerness to effect learning as a consequence of adverse events progressively lowering the reporting/disclosure threshold. The scale of the problem of adverse events in the UK and how to report them, has been known for many years and first identified by Sir Liam Donaldson in his seminal report “An Organisation with a Memory”.2 It is of note however that very recently, the National Advisory Group on the Safety of Patients in England, set up under the chairmanship of Don Berwick in response to the Francis Enquiry, suggests that, e “where an incident qualifying as a serious incident occurs, CQC regulation should require that the patient or carers affected by the incident be notified and supported. We do not subscribe to an automatic “duty of candour” where patients are told about every error or near miss, as this will lead to defensive documentation and large bureaucratic overhead that distracts from patient care. However patients should be given all the information they ask for”.3 This is a position for further consideration and one for which there is no acknowledged evidence base. Little is known on the potential impact of disclosure of near misses upon patients and available literature reports wide variation in public opinion on whether or not being
69
informed of the near miss constitutes good practice or merely a source of unnecessary concern.4
Error-harm-no disclosure Whilst failure to report harm occurring as a consequence of error is a culpable act in terms of professional duties and responsibilities (and maybe answerable to the General Medical Council e GMC) so is the failure to report others who have caused an adverse event through their actions but have subsequently failed to disclose them. The term “whistleblowing” does little for the status of this process, e likening it to the responsibilities of a referee at a sporting event witnessing foul play and momentarily suspending the game; but the importance of relaying concern over the actions of a fellow surgeon particularly if that surgeon shows no intention of moderating or altering future actions, is now given significant weight by the GMC and others. Failure to report on the actions of others, is now considered to be of such significance as to constitute an unprofessional act, carrying with it liability if not culpability, with the GMC indicating “all doctors have a duty to act when they belief patients’ safety is at risk, or that patients’ care or dignity is being compromised”. The advice states that if a patient is not receiving care to meet their needs you must tell someone who is in a position to act “straight away”. Good Medical Practice goes on to state “if you are still concerned you must report this in line with our guidance and your workplace policy and make a record of the steps you have taken”.5e8
Error-harm-disclosure-to whom? Many clinical tasks and decisions are selected and chosen by senior doctors only to be performed by middle-grade and other junior surgical staff. Such delegation is commonplace. If the complexity of the tasks exceeds the capability of the recipient and the patient is harmed as a consequence, then the reporting of that episode will need considerable sensitivity and consideration before the obligate reporting to the patient. Was the complexity of the task such that the delegation was inappropriate e or was the clinical ability of the junior doctor inadequate and falling short of expectation? In either event, the clinical responsibility for informing the patient resides with the senior staff member/consultant and it should be that individual who is informed about the event in the first instance and who in turn, informs the patient of the cause of the medical accident and the sequence of events leading to it.
Error-harm-disclosure-by whom and when? The relationship in time between diagnostic and procedural errors may be quite different with most procedural errors in surgery being conspicuous by virtue of their immediate or proximal effect. By contradistinction, diagnostic errors may be delayed in their presentation/realisation or distant in time from any initial episode of care and therefore present to another subsequent doctor/surgeon who is unrelated to the initial care episode. Exchange of complete information
70
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
between both initial and current surgeon/doctor is important so that an accurate assessment can be made. As an example, e whilst unduly radical surgery for a lesion thought originally to be malignant but subsequently proving to be histologically/ biologically benign may be unsatisfactory, a poor outcome or even death magnifies the magnitude of such an error. By the same token, unduly conservative management of a lesion originally thought to be benign but subsequently proving to be malignant is similarly unsatisfactory and in both instances, an account of the original decision-making is best given by the individual responsible for the initial episode of treatment rather than the doctor who “discovered” the anomaly. In the event of circumstances making some form of disclosure by the current/attending doctor obligate, such information needs to be finite, give an account of facts and be relatively devoid of opinion or subjective comment with the provision that a subsequent consultation with the responsible/initial surgeon is assured. Most healthcare provision is now carried out by multidisciplinary teams and errors may constitute the end of a sequence of events which may involve many “contributors”. Whilst root cause analysis and significant event analysis seek to identify the origins of an error, the reality is that many factors, as opposed to a single event, may accumulate to produce an untoward incident as recognised by James Reason’s “Swiss Cheese” model of mistakes and errors. Nonetheless clinical responsibility is often a solitary duty and usually resides with the lead clinician/consultant who must bear the burden of the disclosure process (recognising that the clinical governance process involves more than clinicians and extends to institutional responsibility with the Chief Executive of the hospital having ultimate accountability).
Current trends The Parliamentary and Health Service Ombudsman (NHS England and Wales) is the agent responsible for dealing with unresolved complaints about the National Health Service and in the current year of reporting, (2011e12), she notes a 8% rise in complaints from the public about the NHS compared to the previous year.5 The ombudsman resolved 16,333 complaints in that year and examined 4399 closely. 2400 had no case to answer. In 950 complaints the NHS had put right. In 649 cases the ombudsman intervened with satisfactory outcome leaving 400 complaints, 60% of which were fully upheld and 19% partly upheld. The work of the ombudsman led to 474 apologies, 358 wider remedies and 333 compensation payments. Of the issues raised, the following were the basis of the 4739 complaints:
failure to act in accordance with law and relevant guidance e 6% In the same year in Scotland, the Scottish Public Services Ombudsman (SPSO), received 1002 complaints about Health Boards and resolved 937. This was approximately 12% more than the previous year. The highest portion of complaints related to clinical care, treatment and diagnoses (43%). Failure of the process of disclosure, therefore, appears to contribute substantially to the lack of resolution of the impact of a medical error or adverse effects of care.
Claims and litigation In England, the Clinical Negligence Scheme for Trusts (CNST) came into effect on 1 April 1995 to provide indemnity to clinicians in respect of clinical negligence claims. It is administered by the NHS Litigation Authority (NHSLA) in England and now has an extensive database of legal claims. Separate indemnity schemes for private practice are provided to clinicians by their own medical defence organisations. In Scotland members of NHS Scotland are covered by the Clinical Negligence and Other Risks Scheme (CNORIS). Surgery leads all specialties in the total number of clinical negligence claims since the inception of the CNST9 (Fig. 1). In cost terms, however, because of the high costs associated with birth-related neurological injury, Obstetrics is the most “expensive” specialty to be associated with adverse events (see Fig. 2). Approximately one third of all such claims are abandoned by claimants, one half (46%) are settled out of court, and 2.65% are settled by court action. The Document e “A Very Brief Guide for Clinicians”10 indicates for patients pursuing a litigation claim, that there is an obligation to prove: that the treatment fell below an accepted standard of competence; and that he/she had suffered an injury; and that it is more likely than not, that the injury would have been avoided or less severe with proper treatment. The time limit for making a claim in all countries of the UK is three years from the date of injury or longer if the patient is a child, when the three-year period begins on his/her 18th birthday; or the patient has a mental disorder thus considered to be incapable of managing his/her own affairs when the three-year period is suspended; and there is an interval before the patient realised/could have reasonably found out that he/ she suffered a significant injury related to his/her treatment.
Best practice
Poor explanation e 33% no acknowledgement of mistakes e 32% inadequate financial remedy e 14% response incomplete e 12% inadequate other personal remedy e 12% factual errors in response to complaints e 10% unnecessary delay e 10% inadequate apology e 9%
The ombudsman indicates that a good action plan for responding to an adverse event should include the following explanations: what went wrong and the causes identified explain what action will be taken to stop it happening again give timescales from when the action took place
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
71
Fig. 1 e Total number of reported CNST claims by specialty as at 31/03/12. provide evidence of those actions explain how the organisation will check that the actions have been taken and are working The sooner that staff are asked about what happened, e the easier it is for them to describe and offer an apology
which must be accompanied by an explanation of what went wrong. If the patient has requested financial redress any decision not to pay compensation should be well reasoned and explained. This is, of course, in addition to a verbal and, when appropriate (as is most often the case), a written apology.
Fig. 2 e Total value of reported CNST claims by specialty as at 31/03/12 since the scheme began in April 1995.
72
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
There are many other elements to coping with adverse events, and if serious, consideration should be given to media awareness and appropriate handling of press, media and public. Those directly involved need time and support to provide information which will allow hospitals, health boards and trusts to keep the media and hence the public informed. Establishing the facts in these situations is of primary importance. Never Events constitute one example of the kind of error/ adverse event that will attract media attention. It goes without saying that in all instances the affected clinician should notify hospital management and professional indemnity organisations where advice is usually immediately available along with guidance concerning subsequent implications and events. What is clear, however, is that the “duty of candour” is finding increasing prominence in the minds of those responsible for statutory and contractual obligations within the NHS in the UK. The Care Quality Commission (CQC) has already explored the issue of that duty constituting a contractual term in the NHS standard contract, implementation awaits. In the meantime the consideration of the findings of the MidStafford enquiry11 suggests that one step further may need taken and that duty may ultimately be a statutory as opposed to a contractual one. Whether this constitutes an undermining of professional responsibilities or an underlining of same is a matter of opinion.
Disclosures Conflict-of-interest: None. Acknowledgement: I am grateful to Dr Jim Rodgers, Medical and Dental Defence Union for Scotland for his advice in preparation of the manuscript.
references
1. Vincent C. Understanding and responding to adverse events. N Engl J Med 2003;348:1051e6. 2. Department of Health. An organisation with a memory, report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer. London: The Stationery Office; 2000. 3. A promise to learn - a commitment to act; improving the safety of patients in England. National Advisory Group on the Safety of Patients in England; August 2013. p. 34. https://www.gov.uk/ government/uploads/system/uploads/attachment_data/file/ 226703/Berwick_Report.pdf. 4. Barach P, Small SD. How the NHS can improve safety and learning: by learning free lessons from near misses. Br Med J 2000;320:1683. 5. Listening and learning: the Ombudsman review of complaint handling by the NHS in England. http://www.ombudsman.org. uk/listening-and-learning-2012; 2011e12. 6. Raising and acting on concerns about patient safety. General Medical Council; 2012. http://www.gmc-uk.org/ interactiveflowchart/documents/Raising_and_acting_on_ concerns_about_patient_safety_FINAL.pdf. 7. Speak up for a healthy NHS: how to implement and review whistleblowing arrangements in your organisation www.pcaw. org.uk/files/SpeakupNHS.pdf. 8. Implementing & reviewing whistleblowing arrangements in NHSScotland PIN policy. http://www.scotland.gov.uk/ Publications/2011/12/06141807/10; May 2011. 9. NHS Litigation Authority: http://www.nhsla.com/search/ pages/Results.aspx?sq¼1&k¼Factsheet%203. 10. NHS Litigation Authority. A very brief guide for clinicians: http:// www.nhsla.com/Claims/Documents/A%20Very%20Brief% 20Guide%20for%20Clinicians%20-%20PDF%20Version.pdf. 11. Francis Robert. Report of the Mid Staffordshire NHS Foundation Trust public inquiry. Executive Summary, http:// www.midstaffspublicinquiry.com/report; 2013.
Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Matter for debate
Medical error and disclosure e A view from the U.K. George G. Youngson Royal Aberdeen Children’s Hospital, Foresterhill, Aberdeen AB25 2ZG, Scotland, United Kingdom
article info
abstract
Article history:
Whilst the steps for reacting to and communicating following a surgical error should be
Received 9 September 2013
clear to all, actual practice is punctuated by a range of failures which lead to the harm done
Received in revised form
by the error being compounded by inadequacies in the disclosure and subsequent pro-
26 October 2013
cesses. This article outlines best practice at the current time within the United Kingdom
Accepted 28 October 2013
when responding to a surgical error and it also reports the type of behaviours which result
Available online 7 December 2013
in poor levels of satisfaction from the patients’ perspective e often resulting in litigation being invoked.
Keywords: Surgical error
ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
Disclosure Apology Liability Litigation
“Sorry seems to be the hardest word”: Bernie Taupin/Elton John. 1976
Introduction It is self-evident that a medical error committed during an episode of surgical care should prompt recognition of the impact of that error for all concerned (primarily the patient), as well as issuing an apology and making every attempt to remedy any consequences of that error. In practice, however, that simplicity becomes necessarily more complex and in many circumstances, a range of other steps may be needed e each one having its own realm of importance. These include: 1. Detection, notification and documentation of the error which should be carried out in a timely fashion and should include an acknowledgement of the error.
2. Immediate and appropriate treatment to mitigate against the error and prevent further harm. 3. Assessment of the circumstances surrounding the event and, if appropriate, establish an investigation team 4. Provision of a verbal and written apology with an accurate account of the facts known to date 5. An offer made of any practical or emotional help required and a communication plan established for any further information provision 6. There should be a timely and appropriately authorised response to queries 7. Any analysis of the event should detail practical examples of changes to practice and how they might be implemented These steps need to be contextualised. They may need modification in the event of the patient being a child, if the patient dies, if the patient has compromised cognitive ability,
E-mail address: [email protected]. 1479-666X/$ e see front matter ª 2013 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.surge.2013.10.011
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
(e.g. a patient with learning disability), in the face of cultural requirements or linguistic needs, or if there is contest with any aspect of the accounts given. The gravity of the error/ incident will likely affect the magnitude of the response and the introduction of scale or gradation of error is where complexity begins to affect the requisite response. That error e recognition e intervention e apology sequence, however, is influenced by a number of factors and these may modify the type of response required as is seen in the following examples. It is important to note however that an expression of contrition does not necessarily equate with acceptance of liability and an apology made out of empathy (with a careful choice of words) is considered an essential ingredient in all responses to a medical error.
Error-no harm-disclosure If no harm accrues to the patient as a consequence of the error, then disclosure of that error to the patient at least, may not be an obligation. The decision on whether or not the patient should be informed, depends upon a range of considerations including the magnitude of the error, the potential impact of the error, and how close to harm the patient came. A nondisclosure approach if no harm occurs runs the risk of non-reporting, no learning at individual, team nor institutional level, and little or no documentation of the events.1 A potential for recurrence may therefore seem more likely and the recording at least of “near miss incidents” appears to be the minimum action to be taken, e particularly if the incident could have affected the patient’s well-being. Intentional omission of disclosure also runs the risk of the patient subsequently discovering the event through informal means or communications and reacting to both the event and its concealment. If the safety event was of a magnitude deserving of documentation and reporting in spite of no harm, then informing the patient and explaining the circumstances is a consideration. Judgement of what constitutes such a magnitude is discretionary with a culture of openness and eagerness to effect learning as a consequence of adverse events progressively lowering the reporting/disclosure threshold. The scale of the problem of adverse events in the UK and how to report them, has been known for many years and first identified by Sir Liam Donaldson in his seminal report “An Organisation with a Memory”.2 It is of note however that very recently, the National Advisory Group on the Safety of Patients in England, set up under the chairmanship of Don Berwick in response to the Francis Enquiry, suggests that, e “where an incident qualifying as a serious incident occurs, CQC regulation should require that the patient or carers affected by the incident be notified and supported. We do not subscribe to an automatic “duty of candour” where patients are told about every error or near miss, as this will lead to defensive documentation and large bureaucratic overhead that distracts from patient care. However patients should be given all the information they ask for”.3 This is a position for further consideration and one for which there is no acknowledged evidence base. Little is known on the potential impact of disclosure of near misses upon patients and available literature reports wide variation in public opinion on whether or not being
69
informed of the near miss constitutes good practice or merely a source of unnecessary concern.4
Error-harm-no disclosure Whilst failure to report harm occurring as a consequence of error is a culpable act in terms of professional duties and responsibilities (and maybe answerable to the General Medical Council e GMC) so is the failure to report others who have caused an adverse event through their actions but have subsequently failed to disclose them. The term “whistleblowing” does little for the status of this process, e likening it to the responsibilities of a referee at a sporting event witnessing foul play and momentarily suspending the game; but the importance of relaying concern over the actions of a fellow surgeon particularly if that surgeon shows no intention of moderating or altering future actions, is now given significant weight by the GMC and others. Failure to report on the actions of others, is now considered to be of such significance as to constitute an unprofessional act, carrying with it liability if not culpability, with the GMC indicating “all doctors have a duty to act when they belief patients’ safety is at risk, or that patients’ care or dignity is being compromised”. The advice states that if a patient is not receiving care to meet their needs you must tell someone who is in a position to act “straight away”. Good Medical Practice goes on to state “if you are still concerned you must report this in line with our guidance and your workplace policy and make a record of the steps you have taken”.5e8
Error-harm-disclosure-to whom? Many clinical tasks and decisions are selected and chosen by senior doctors only to be performed by middle-grade and other junior surgical staff. Such delegation is commonplace. If the complexity of the tasks exceeds the capability of the recipient and the patient is harmed as a consequence, then the reporting of that episode will need considerable sensitivity and consideration before the obligate reporting to the patient. Was the complexity of the task such that the delegation was inappropriate e or was the clinical ability of the junior doctor inadequate and falling short of expectation? In either event, the clinical responsibility for informing the patient resides with the senior staff member/consultant and it should be that individual who is informed about the event in the first instance and who in turn, informs the patient of the cause of the medical accident and the sequence of events leading to it.
Error-harm-disclosure-by whom and when? The relationship in time between diagnostic and procedural errors may be quite different with most procedural errors in surgery being conspicuous by virtue of their immediate or proximal effect. By contradistinction, diagnostic errors may be delayed in their presentation/realisation or distant in time from any initial episode of care and therefore present to another subsequent doctor/surgeon who is unrelated to the initial care episode. Exchange of complete information
70
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
between both initial and current surgeon/doctor is important so that an accurate assessment can be made. As an example, e whilst unduly radical surgery for a lesion thought originally to be malignant but subsequently proving to be histologically/ biologically benign may be unsatisfactory, a poor outcome or even death magnifies the magnitude of such an error. By the same token, unduly conservative management of a lesion originally thought to be benign but subsequently proving to be malignant is similarly unsatisfactory and in both instances, an account of the original decision-making is best given by the individual responsible for the initial episode of treatment rather than the doctor who “discovered” the anomaly. In the event of circumstances making some form of disclosure by the current/attending doctor obligate, such information needs to be finite, give an account of facts and be relatively devoid of opinion or subjective comment with the provision that a subsequent consultation with the responsible/initial surgeon is assured. Most healthcare provision is now carried out by multidisciplinary teams and errors may constitute the end of a sequence of events which may involve many “contributors”. Whilst root cause analysis and significant event analysis seek to identify the origins of an error, the reality is that many factors, as opposed to a single event, may accumulate to produce an untoward incident as recognised by James Reason’s “Swiss Cheese” model of mistakes and errors. Nonetheless clinical responsibility is often a solitary duty and usually resides with the lead clinician/consultant who must bear the burden of the disclosure process (recognising that the clinical governance process involves more than clinicians and extends to institutional responsibility with the Chief Executive of the hospital having ultimate accountability).
Current trends The Parliamentary and Health Service Ombudsman (NHS England and Wales) is the agent responsible for dealing with unresolved complaints about the National Health Service and in the current year of reporting, (2011e12), she notes a 8% rise in complaints from the public about the NHS compared to the previous year.5 The ombudsman resolved 16,333 complaints in that year and examined 4399 closely. 2400 had no case to answer. In 950 complaints the NHS had put right. In 649 cases the ombudsman intervened with satisfactory outcome leaving 400 complaints, 60% of which were fully upheld and 19% partly upheld. The work of the ombudsman led to 474 apologies, 358 wider remedies and 333 compensation payments. Of the issues raised, the following were the basis of the 4739 complaints:
failure to act in accordance with law and relevant guidance e 6% In the same year in Scotland, the Scottish Public Services Ombudsman (SPSO), received 1002 complaints about Health Boards and resolved 937. This was approximately 12% more than the previous year. The highest portion of complaints related to clinical care, treatment and diagnoses (43%). Failure of the process of disclosure, therefore, appears to contribute substantially to the lack of resolution of the impact of a medical error or adverse effects of care.
Claims and litigation In England, the Clinical Negligence Scheme for Trusts (CNST) came into effect on 1 April 1995 to provide indemnity to clinicians in respect of clinical negligence claims. It is administered by the NHS Litigation Authority (NHSLA) in England and now has an extensive database of legal claims. Separate indemnity schemes for private practice are provided to clinicians by their own medical defence organisations. In Scotland members of NHS Scotland are covered by the Clinical Negligence and Other Risks Scheme (CNORIS). Surgery leads all specialties in the total number of clinical negligence claims since the inception of the CNST9 (Fig. 1). In cost terms, however, because of the high costs associated with birth-related neurological injury, Obstetrics is the most “expensive” specialty to be associated with adverse events (see Fig. 2). Approximately one third of all such claims are abandoned by claimants, one half (46%) are settled out of court, and 2.65% are settled by court action. The Document e “A Very Brief Guide for Clinicians”10 indicates for patients pursuing a litigation claim, that there is an obligation to prove: that the treatment fell below an accepted standard of competence; and that he/she had suffered an injury; and that it is more likely than not, that the injury would have been avoided or less severe with proper treatment. The time limit for making a claim in all countries of the UK is three years from the date of injury or longer if the patient is a child, when the three-year period begins on his/her 18th birthday; or the patient has a mental disorder thus considered to be incapable of managing his/her own affairs when the three-year period is suspended; and there is an interval before the patient realised/could have reasonably found out that he/ she suffered a significant injury related to his/her treatment.
Best practice
Poor explanation e 33% no acknowledgement of mistakes e 32% inadequate financial remedy e 14% response incomplete e 12% inadequate other personal remedy e 12% factual errors in response to complaints e 10% unnecessary delay e 10% inadequate apology e 9%
The ombudsman indicates that a good action plan for responding to an adverse event should include the following explanations: what went wrong and the causes identified explain what action will be taken to stop it happening again give timescales from when the action took place
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
71
Fig. 1 e Total number of reported CNST claims by specialty as at 31/03/12. provide evidence of those actions explain how the organisation will check that the actions have been taken and are working The sooner that staff are asked about what happened, e the easier it is for them to describe and offer an apology
which must be accompanied by an explanation of what went wrong. If the patient has requested financial redress any decision not to pay compensation should be well reasoned and explained. This is, of course, in addition to a verbal and, when appropriate (as is most often the case), a written apology.
Fig. 2 e Total value of reported CNST claims by specialty as at 31/03/12 since the scheme began in April 1995.
72
t h e s u r g e o n 1 2 ( 2 0 1 4 ) 6 8 e7 2
There are many other elements to coping with adverse events, and if serious, consideration should be given to media awareness and appropriate handling of press, media and public. Those directly involved need time and support to provide information which will allow hospitals, health boards and trusts to keep the media and hence the public informed. Establishing the facts in these situations is of primary importance. Never Events constitute one example of the kind of error/ adverse event that will attract media attention. It goes without saying that in all instances the affected clinician should notify hospital management and professional indemnity organisations where advice is usually immediately available along with guidance concerning subsequent implications and events. What is clear, however, is that the “duty of candour” is finding increasing prominence in the minds of those responsible for statutory and contractual obligations within the NHS in the UK. The Care Quality Commission (CQC) has already explored the issue of that duty constituting a contractual term in the NHS standard contract, implementation awaits. In the meantime the consideration of the findings of the MidStafford enquiry11 suggests that one step further may need taken and that duty may ultimately be a statutory as opposed to a contractual one. Whether this constitutes an undermining of professional responsibilities or an underlining of same is a matter of opinion.
Disclosures Conflict-of-interest: None. Acknowledgement: I am grateful to Dr Jim Rodgers, Medical and Dental Defence Union for Scotland for his advice in preparation of the manuscript.
references
1. Vincent C. Understanding and responding to adverse events. N Engl J Med 2003;348:1051e6. 2. Department of Health. An organisation with a memory, report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer. London: The Stationery Office; 2000. 3. A promise to learn - a commitment to act; improving the safety of patients in England. National Advisory Group on the Safety of Patients in England; August 2013. p. 34. https://www.gov.uk/ government/uploads/system/uploads/attachment_data/file/ 226703/Berwick_Report.pdf. 4. Barach P, Small SD. How the NHS can improve safety and learning: by learning free lessons from near misses. Br Med J 2000;320:1683. 5. Listening and learning: the Ombudsman review of complaint handling by the NHS in England. http://www.ombudsman.org. uk/listening-and-learning-2012; 2011e12. 6. Raising and acting on concerns about patient safety. General Medical Council; 2012. http://www.gmc-uk.org/ interactiveflowchart/documents/Raising_and_acting_on_ concerns_about_patient_safety_FINAL.pdf. 7. Speak up for a healthy NHS: how to implement and review whistleblowing arrangements in your organisation www.pcaw. org.uk/files/SpeakupNHS.pdf. 8. Implementing & reviewing whistleblowing arrangements in NHSScotland PIN policy. http://www.scotland.gov.uk/ Publications/2011/12/06141807/10; May 2011. 9. NHS Litigation Authority: http://www.nhsla.com/search/ pages/Results.aspx?sq¼1&k¼Factsheet%203. 10. NHS Litigation Authority. A very brief guide for clinicians: http:// www.nhsla.com/Claims/Documents/A%20Very%20Brief% 20Guide%20for%20Clinicians%20-%20PDF%20Version.pdf. 11. Francis Robert. Report of the Mid Staffordshire NHS Foundation Trust public inquiry. Executive Summary, http:// www.midstaffspublicinquiry.com/report; 2013.
