SIN is concerned about iatrogenic suffering which relates to disorders, symptoms etc. caused inappropriately by any clinician through his/ her diagnosis, manner or treatment. © Nov. 1998

 1.  The scale of Adverse Medical Incidents (medical errors) in the UK

 1.1    ‘Sufferers of Iatrogenic Neglect’ (SIN), was established in November 1998 as a pressure group for improving standards within the NHS and for the support of patients and their families who were the innocent victims of serious Adverse Medical Incidents (AMI) that cause death or serious, permanent injury.  The inability of the NHS system to cope with AMIs in an honest and open manner has caused enormous problems to iatrogenic victims and their families: there is no mechanism that allows full disclosure of a serious AMI to the patient, nor can the patient be involved in the ‘causal analysis’.

1.2     Political pressure from damaged patients and their relatives resulted in the setting up of an Inquiry by the Health Select Committee into ‘Adverse Medical Incidents and their Outcomes’ in June/July 1999. Despite very little publicity, nearly 300 personal testimonies were submitted. The Health Select Committee discovered what damaged patients already knew: that there was little or no protection for victims of iatrogenesis. Following any serious incident truth, justice, accountability and even appropriate medical care was hard, if not impossible, to obtain. The systems in existence such as the NHS Complaints Procedure, the GMC and the Medico-Legal route were badly flawed.  The submissions publicly disclosed that patients and relatives are trapped in a dishonest culture of denial and cover up that was endemic throughout the NHS, which effectively meant that the victims were being * blacklisted, thereby preventing them from accessing the truth and/or appropriate medical care relating to the AMI. Lord Woolf,  Lord Chief Justice of England & Wales, in his Inaugural Lecture on 17th January 2001 on the state of the medico-legal system in the UK, acknowledged that iatrogenic victims could be blacklisted by doctors : “….the Health Service was not giving sufficient priority to avoiding medical mishaps and treating patients justly when mishaps occurred. They needed to recognise that because patients felt that they had been a victim of medical malpractice, this did not justify withdrawing treatment…”

 1.3     Several major medical scandals e.g. Bristol Babies and the consequential Kennedy Inquiry (1998 -2001), Ledward, Neale and Shipman focussed public attention on the subject of medical errors. All these were ‘cluster’ cases of patients damaged by the same doctor(s).  As far as the hospital doctors were concerned, their poor practices that had lead to numerous AMIs over many years, were well known to themselves and to colleagues, whilst the latter persistently averted the gaze irrespective of the suffering and damage sustained by the patient victims. Indeed, the GMC itself had had several previous reports from patients in the specific cases of Ledward, Neale and Shipman about poor clinical performance, all of which had been ignored or not taken sufficiently seriously.

1.4    In his document entitled ‘ Organisation with a Memory’ the CMO, Prof. Sir Liam Donaldson, points out that the true scale of all iatrogenic incidents has never been subjected to detailed recording and objective scrutiny in the UK. Even from the findings of limited sporadic studies it was apparent that 10% of all hospital admissions caused harm to patients (850,000 per year) and this did not include Out-Patient Clinics and GP treatment. Clearly, the extent of iatrogenic damage, its causes and the consequences to patients had been ignored and neglected for half a century, with dire consequences to standards throughout the NHS.

1.5    Further research conducted by Prof. Charles Vincent, the findings of which were published in March 2001, confirmed that there was genuine reason to be concerned about patient safety in the NHS at the start of the Twenty First Century.  His extrapolated findings from this research based on 1,000 sets of medical records determined that 68,000 died per year in the UK from AMIs, of these a half were classified as being terminally ill and would have died anyway. This still left **34,000 patients who died needlessly (the equivalent to the fatalities of two jumbo jets or 500 road coaches crashing every week). It was also estimated that at least 46,000 were permanently and seriously damaged in the UK every year from AMIs. These research figures could easily include clusters of cases similar to those previously mentioned, involving individual doctors who were malfunctioning. However, this type of generalised research was purely for statistical purposes. It is the real life, individual, isolated cases of iatrogenically damaged, suffering patients from these statistics who contact SIN for moral support and to press for change to the system and to have their serious concerns resolved.

* The Observer, Sunday, Oct.24th 19999: "Doctors 'blacklist' dissatisfied patients"
* * Daily Mail, Fri. March 2nd 2001: " 34,000 'dying needlessly every year' in NHS hospitals"

2    Setting up of a National Recording Data Base of AMIs

2.1    In February 2000, the BRI Inquiry Committee wrote to SIN requesting that SIN produce a Paper entitled: “Empowering the Public in the Health Care Process” for Phase Two of the Kennedy Inquiry which was looking at the NHS as a whole.

2.2     In June 2000 SIN completed its submission to the BRI Inquiry entitled ‘The Patient’s Voice For Equity’, Paper 2, in which a call was made for the establishment of “…a National Data Base of all NHS complaints. Such a public register would be the first steps towards the break-up of the sinister ‘closing of the ranks syndrome’ which allows effective cover-up of medical errors. This would be the biggest advancement of patient empowerment since the inception of the NHS.”  Therefore, SIN was gratified to read in a document entitled ‘ Building a Safer NHS for Patients’ produced by the CMO in May 2001, that wheels were set in motion for the setting up of one such National Data Base, to be called the National Patient Safety Agency (NPSA). The NPSA was officially launched in July 2001 to address the CMO’s concerns about patient safety by: “ …the introduction of a National System for reporting and identifying adverse events, near misses and professional errors in health care, to gather information on causes and to learn and act to reduce risk and prevent similar events occurring in the future”. One of its early tasks was to instigate a Pilot Scheme of 28 hospital sites the goal of which was the recording, coding, classifying and analysing adverse medical incidents.

2.3    To quote in more detail from the NPSA website dated November 2002,:“ NPSA  will collect and analyse incident and other patient safety information and provide timely and relevant feedback to healthcare organisations, clinicians and other health care professionals, and patient/carers in a way that promotes learning and risk reduction through environment and/or systems changes, and/or changes in organisational, management or clinical practice". These are very laudable objectives.

2.4     A further objective of the NPSA for Patient & Public Involvement is:  “…developing memoranda of understanding with other key health care organisations that have an interest or involvement in patient safety”. In keeping with this, and following on from our first meeting with NPSA on 10th February 2003, the NPSA arranged a further meeting for members of SIN to contribute to the development of the format of the Patient Incident Reporting Form.  SIN was also invited to register its objection to the existing principle of  anonymity, which currently underpins all data collection, since in our opinion it is contrary to patient safety and will simply perpetuate the status quo of the previous 50 years. Whilst the recording of AMIs anonymously may lead to a general improvement of ‘systems and equipment failures’ it will fall far short of the potential inherent in this information to support failing doctors and to weed out malpractising ones who are putting patient safety in jeopardy, and leaving individual iatrogenic patients at risk. Such an anonymous system will not ensure that vulnerable, seriously damaged  patients receive the necessary remedial health care to which they are entitled. In memory of the lives lost and the trauma and suffering caused by AMIs the opportunity to rectify this present unacceptable state of affairs cannot be lost.

3    Present Position:  Incident Reporting form for Health Professionals: Anonymity Guaranteed

3.1    It is our understanding that there is currently no statutory requirement for health professionals who are a party to or who witness a medical error either at an NHS Hospital Trust or a Primary Care Trust (PCT) to complete an AMI form, irrespective of the cause/seriousness of the incident in question. Those members of staff who do make the decision to complete the forms have the option of omitting names including their own, and completed forms are subsequently sent to the Trust’s Risk Assessment Department (TRAD). At this point in time Trusts/PCTs are under no obligation whatsoever to notify the NPSA about those incidents which are brought to the attention of the TRAD. Any reporting which does take place between Trusts and the NPSA is done so anonymously and even if the names and status of individual doctor(s) and patient{s) were happened to be divulged, no further action could be taken by the Agency.

3.2   Such anonymous information received by the NPSA can only be used for statistical purposes, so that “lessons can be learned” to prevent a similar incident occurring again in the health service. It is not submitted for the purpose of bringing to light malpractising/poorly performing health professionals or to safeguard the patient who has been harmed. This position obviously rules out any way of knowing whether or not a particular event was due solely to human error, for whatever reason. Such an anonymous gathering of information without any input from the patient involved with the AMI, means that it is impossible to carry our any worthwhile   ‘root cause analysis’ which is another of the NPSA’s important objectives. The “lessons learnt” will, therefore, of necessity be very limited in scope, as long as anonymity prevails.

3.3    Furthermore, it highlights the fact that the NHS has had for some time measures in place for internal reporting of Adverse Medical Incidents through the Trusts’ systems of Risk Assessment Management and the Medical Director.  What measures were taken by these people to protect patients against Ledward, Neale and the Bristol surgeons? The error reporting system at local level has failed, it does not have the confidence of the public, and the present decision to anonymise all information received by the NPSA from health professionals will continue to leave patients at risk. The present, recently acknowledged, disgraceful   ***“no blame, denial and cover-up culture” will persist.

3.4    Based on the existing NPSA Incident Reporting Form for health professionals, a possible scenario could be that an anonymous Trust’s RAD had  identified another ‘Richard Neale’ and would report to NPSA that an unnamed gynaecologist operating at an unnamed Trust in an unnamed Region  was regularly cutting through urethras, nerves, and damaging bladders and colons. Therefore, at the present time, a doctor such as Neale would remain unidentifiable and NPSA could do nothing to protect patients from such a surgeon ‘…who had no respect for the internal structures of the body’, and whose mistakes encroached on the valuable operating time of other surgeons, brought in to repair and reduce the damage.

3.5    It follows that whilst the numerous Adverse Medical Incidents of Ledward, Neale, Shipman etc. would be carefully recorded and ‘analysed’, nothing could be done to rescue patients or to prevent further damage and deaths by exposing the malpractising doctor. We believe that when very expensive structures and resources have been put in place as a direct consequence of scandals such as Ledward or Shipman, failure to prevent any reoccurrences when the means have been provided and are available would be wholly unacceptable to the public. It is indefensible, amoral and a waste of money and resources. How could anyone, patient, doctor or otherwise condone such an unethical system?   For the reasons outlined and for the sake of patient safety, which is after all the ‘raison d’être’ for the establishment of NPSA, we believe that it is imperative that anonymity for health professionals should be waived and that this position adopted as soon as possible.
*** D.o.H. website: New clinical compensation scheme for the NHS 10th July 2001 Alan Milburn: "....mistakes are hidden and cover-ups can occur."

Daily Mail 28th december 2001: " Haunted by 50 scandals a year....the NHS expects up to 50 scandals a year in which doctors have maimed, or killed patients in botched operations[misdiagnoses] or subjected them to verbal [ written], physical or sexual abuse.."

4    Why the Demand for Anonymity?

4.1    One justification for the demand for anonymity appears to be that Trusts claim only then can a full and honest account of the AMI be given. It is a sad indictment of the British Medical Profession that they can only be persuaded to be honest if there is a guarantee that they will experience ‘no blame’ in other words, will not be held ‘accountable’ or not required to assume ‘responsibility’ for their actions. Patients pay a very high price for this indefensible insistence on a ‘no blame culture’, for the guarantee of anonymity for the health professional(s) means that the patient(s) who has been harmed cannot be identified either. Why should patients be sacrificed for this reprehensible demand for a ‘no blame and cover–up culture’?. What reputable profession would demand that they must never be held accountable or be expected to assume responsibility for their actions? Individual responsibility is a moral obligation. Obviously, anonymity  permits a continuation of the culture which prevented the exposure of the Bristol babies, Ledward and Neale who were allowed for many years, with full knowledge of their colleagues, to kill and maim hundreds of innocent patients who trustingly to put their lives and well - being into their hands.

4.2    The second justification for anonymised reporting to the NPSA appears to be the fear that health professionals naming a colleague(s) whose actions resulted in harm to a patient would be ostracised and victimised as a ‘whistle-blower’. The most publicised victimisation of such a whistle –blower was Dr. Stephen Bolsin who was unable to obtain further work in the UK after he had exposed the high mortality rates of paediatric cardiac surgery at the Bristol Royal Infirmary that eventually led to the BRI Inquiry. He was forced to start a new life in Australia.  It is a disgrace and an indictment of the whole system if the existing unhealthy ‘bully-boy culture’ is allowed to continue unchallenged, the whole aim of which is to protect the malfunctioning health professional, and reduce legal liability of the Hospital and Primary Care Trusts. The desire for anonymity has kept this ‘culture of no blame, denial and cover-up’ in place and has resulted in whistle-blowing doctors being victimised, many of whom ultimately leave the profession or become suspended for indefinite periods.  The BMJ/BMA Conference ‘whistleblowers’ December 1999 made this clear as doctor after doctor testified to the poor treatment they had received after attempting to expose poor practice.  ****Health professionals who name colleagues who are incompetent or malpractising lose their careers, and patients who whistle blow about Adverse Medical Incidents are blacklisted and put their specialist medical care in jeopardy.

4.3    SIN believes that it should be made a statutory offence to “turn a blind eye” when patients are knowingly maimed and killed.  It is worth pointing out that  a study at Chesterfield (BMJ 3rd. March 2001) showed that when disciplinary action is threatened for failure to report an adverse incident within 48 hours, such incident reporting increased by 150%. In other words, potential sanctions promoted patient safety. Whilst any anonymous system would allow for broad generalisations to be made, the NPSA would be unable to carry out a thorough root cause analysis and consequently improvements for patient safety could not be fulfilled at local level.

4.4    Yet a third reason for the desire for anonymity may come from the Trusts of Hospitals and Primary Care Groups. If anonymity prevails, this will ensure that the present inequitable situation that has been in existence for over five decades will continue: the damaged patient will remain in the unenviable situation of being denied the truth about the damage sustained and having to fight for truth, justice, accountability and medical care. The liability for damages will be obscured by a smoke screen of misinformation and down right lies, because the Trusts will perceive the iatrogenic patient as merely a potential litigant, and not a human being who urgently requires counselling and remedial care. In fact, a cover–up will undoubtedly take place when remedial care is denied, for to give such care would acknowledge that damage has been sustained. As Lord Woolf explained in his Inaugural lecture that ever since the inception of the NHS, the policy has been for hospitals and Health Authorities to defend in excess all suggestion of damage following serious Adverse Medical Incidents, regardless of the merits of the individual case. Lord Woolf went on to say: “ ..the courts can no longer rely on the hospitals and the medical profession to resolve patients justifiable complaints justly….”

4.5    A fourth reason for the desire to hang on to anonymity could come from the medico-legal lawyers who may  oppose an honest and open system of reporting errors with full information being given to the patient who has sustained a serious AMI. Such openness would remove the artificial adversarial legal system existing at the moment; and with the patient being in full knowledge of the cause of the AMI and the extent of the damage sustained, this would drastically reduce time taken in legal wrangling and so diminish  legal fees, a great saving to the tax payer.

4.6    To quote one enlightened doctor: ” We are not as good as we should like to be, we are not as good as you think we are. We make mistakes and sometimes damage occurs. If damage occurs let compensation be paid!” The waiving of anonymity would at a stroke allow for an honest and open acknowledgement of mistakes and any damage caused, this would allow for the introduction of a victim’s compensation fund, long advocated by SIN  and now under active consideration by the D.o.H.
****The Sun, Fri.January 3rd. 2003: "Victimised: Whistle-blowing doctors & patients....When staff blow the whistle they are hounded out.....'when the miisdiagnosis was finally discovered medics closed ranks and covered up...' "

5    Ensuring Safety and Equity for Patients in the 21st. Century : Removal of Anonymity

5.1    SIN believes that if the NPSA is to function for the safety of patients in accordance with the wishes of the public i.e. the Taxpayer, then there are two tenets which must be established and respected.

5.2    The First Tenet should be a statutory requirement for all named health professionals to complete an AMI Form whether they were directly and personally involved in an AMI or simply witnessed the event. Furthermore, not to do so should be deemed a criminal offence. It  is difficult  to comprehend how this position could be challenged ethically.

5.3    In SIN’s Paper 3 ‘Balancing the Scales’: a case for a Victim’s Compensation Fund " March 2002, it was stated: “The person responsible for, or anyone aware of the error or near miss will have a statutory obligation to report to the CLO (trained Clinical Liaison Officer) as soon as possible. It should be a criminal offence to ‘turn a blind eye’ when patients are knowingly being maimed and killed…” Page 8 para5.1.)

5.4     The Second Tenet is that there should be a statutory requirement for the patient or relative  to be informed should any iatrogenic damage be sustained. This information to be transmitted by a health professional or someone allocated and trained to impart such   information.

5.5    In this same Paper it was also stated: “There should be a legal obligation on health professionals (i.e. written into their contracts of employment), to inform patients of any treatment related damage”. Page 8 para5.1). On what possible moral grounds can it be argued that a patient should be denied precise knowledge as to their medical condition, when damage has occurred? Their body and their illness is their own; they, after all, will have to suffer the mental and physical consequences of iatrogenic damage: to have to do so in ignorance which is deliberately engineered by the now established ‘denial and cover – up culture’ endemic in the NHS is indefensible and disgraceful. Health professional are paid to provide a medical service; if things go wrong, as indeed they will, then the medical profession and the NHS must take responsibility for this, and not further burden the vulnerable and sick patient by denying access to the truth.

6        Incident Reporting Form for Patients – Anonymity to be Waived

6.1    We believe that patients, should they wish, be allowed to register Adverse Medical Incident(s) together with the names of the health professionals involved, the Trusts/GP Practice and the medical or surgical speciality where appropriate. This will ensure the identification of any incompetent or malpractising health professional sooner rather than later. Surely it is every bit as important to detect a human error as it is to locate an equipment failure or poor hygiene? Who can possibly argue against this commonsense position? We would like to hear the arguments from any medical ethics committee that would argue in favour of anonymity when poor clinical practices are called into question. Anonymity perpetuates bad practice, leaves patients at risk and does nothing to further the goal of patient safety.

6.2     The medical profession has the power of life and death and it is only reasonable that such a profession is carefully monitored and controlled. The most powerful case for naming health professionals who are providing sub-standard care for whatever reason, is that they can receive remedial help without which, they continue as a potential danger to patients. The advantage of having a named patient, who has been the victim of a serious Adverse Medical Incident, and is deemed to have sustained damage, is that this patient can receive immediate support and be assured of appropriate remedial medical care. In other words, by waiving anonymity, it is possible for NPSA to have a two-pronged approach giving it opportunities to help both the health professional and the patient.

7    Grading the Severity of Iatrogenic Damage : ‘Red Incident Alert’

7.1    It would seem to be a sensible measure for the clinicians to grade the severity of the iatrogenic damage and this appeared to have been the initial stance of the NPSA in that they had established the concept of a “red incident alert” which, sadly, was vetoed by a majority of Trusts. With this scheme the following would have taken place:

•    All incidents are graded according to the actual impact on the patient(s) ……
•    Incidents graded as ‘red’ are those where serious actual harm has resulted…
•    Incidents graded as red are reported to the NPSA within 3 working days of the date of occurrence. For red AMIs this information is also reported within 3 working days to the relevant Regional Office of the D.o.H.
•    Within 45 working days the result of the ‘root causal analysis’ carried out by the local organisation to be reported to the NPSA and the relevant Regional Office of the D.o.H.

7.2     SIN is concerned on four accounts.   Firstly, the patient appears not to be informed that they have been involved in a serious AMI. Secondly, it is not clear that the report of the assessment of the damage sustained has been given to the patient, although it has been given to the NPSA and the Regional Office. Thirdly, the patient does not appear to be involved with the ‘root cause analysis’ investigation carried out by the local organisation. This, in our opinion, would invalidate the result of this investigation. Lastly, there is no mention of the implementation of a remedial care plan for the patient. We consider this to be a very serious omission and not in accordance with patient safety.
 
7.3   With the above modifications, SIN urges that the “red incident alert scheme" is implemented.

7.4    Incorporating the ideas from the NPSA Pilot scheme, we would envisage that on receipt of  patient AMI information at the NPSA, a Clinical Specialty Adviser in Patient Safety (CLAPS) would objectively assess the clinical problem to determine the severity of damage and the degree of risk to the patient. The subsequent report would be submitted to the named Trust, and the CLAPS would advise the Trust to implement a Care Plan which should  include:

•    telling the patient or relative that a mistake has occurred
•    * telling the patient the extent of the damage (the implementation of a victim’s compensation fund would allow for a more honest system)
•    giving an apology for the harm or distress caused – *counselling if necessary
•    *formulating a remedial care plan – a guarantee of good quality care
•    establishing the root cause analysis of the AMI  - –* the patient to be involved in this since they will know personally what happened  - and communicating the results of the root cause analysis to the patient
•    *Later follow up – with patient comments – to  be logged  by NPSA

8     Conclusion:

8.1     SIN believes that anonymity for the reporting of AMIs should be removed in the interest of patient safety and this would be in accordance with the wishes of the British public. Briefly, our arguments are as follows:

•    The failing, incompetent or malfunctioning health professional can be located and remedial help, retraining, and support could be given. The seriously inadequate or malicious doctor could be weeded out, so that patients would be protected from further harm. Counselling would be available. The public would find it unacceptable if the NPSA is unable to identify another Ledward, Neale or Shipman by keeping anonymity, when it has the resources to do otherwise. 

•    The patients who have sustained severe AMIs suffering serious or permanent damage can be reached, they can be given the truth about their medical condition, remedial care if appropriate and they and their relatives can receive counselling if requested.

•    Root cause analyses of AMIs can include input from health professionals and patients and would therefore be thorough and valid.

•    There would be little chance of duplicate logging of AMIs.

•    An honest and open reporting of AMIs would allow for the introduction of a victim’s compensation fund.

8.2     The only groups of people who could possibly have anything to gain from enforcing anonymity are the failing health professionals; administrators who are more concerned with  legal liability than with patient care; and the medico-legal lawyers whose income would decline if such an open reporting system of AMIs were introduced.

8.3     On the other hand, health professionals who value the reputation of their profession should have no qualms with the removal of anonymity, and furthermore the NHS as a whole and patient safety have everything to gain by an open and honest reporting system. It is our opinion that the British public would be in favour of such a system.

                                        © June 2003