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May
4th 2004
DEPARTMENT OF
HEALTHREFORMING THE NHS COMPLAINTS PROCEDURE:
CONSULTATION UPON DRAFT REGULATIONS
RESPONSE
SUBMITTED
ON BEHALF OF THE IATROGENIC PATIENT
BY
SUFFERERS OF IATROGENIC NEGLECT
BY
SUFFERERS OF IATROGENIC NEGLECT
Gillian
M Bean & Margaret MacRae
Co-Directors & Founder Members SIN
© March 200
Submitted to Department of Health April 2004
e-mail:sinfo@boltblue.com & mags@sinfo.freeserve.co.uk
www.sin-medicalmistakes.org
1. Introduction:
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 (AMIs) that cause death or serious, permanent injury.
1.2 It is important to bear in mind the backcloth against which patients complain if they believe that they have received substandard care within the NHS.
1.3 For too long the NHS has been reluctant to cope with medical mistakes. Recent research has estimated that annually 68, 000 people die in Uk hospitals, half of these are terminally ill and would have died anyway, however, that still leaves 34,000 who die needlessly and 40,000 patients who are permanently and seriously damaged by medical error [ Research. Prof. Charles Vincent, University College London March 2001]. The Chief Medical Officer, Prof. Sir Liam Donaldson in his document ‘Organisation with a Memory’ acknowledges that 10% of all hospital admissions caused harm to patients. This does not include GP referrals or A & E appointments. These AMIs are all potential complaints.
1.4 No health professional rushes round to inform the patient or relative that the injury or death has been the result of a medical error. The inability of the NHS to deal with this problem in an honest and open manner has caused enormous difficulty and distress to iatrogenic victims and their families.
1.5 The only route available for the iatrogenic patient or relative is to pursue their complaint through the NHS Complaints Procedure in order to seek the truth, accountability and justice. Unfortunately, there has been very widespread criticism of the 1996 NHS Complaints Procedure for it failed to deliver these basic demands.
1.6 SIN has produced several documents on this subject. The first was entitled “ The Emperor Has No Clothes”: A Critique of the NHS Complaints Procedure” which was submitted to the BRI Inquiry in September 1999, to the Health Select Committee in October 1999 and to the D.o.H.. SIN continued to voice criticism in its Paper 2 “ The Patient’s Voice For Equity: Empowerment of the Public in the Health Care Process” written and submitted at the request of the BRI Inquiry Committee June 2000 and to the D.o.H. Our criticisms can be read in Section 4 “Empowerment via the NHS Complaints Procedure” and in Section 11 headed “Conclusion”.
1.7 We returned again to this subject in our Paper 3 entitled “Balancing the Scales: SIN’s Case for Victim’s Compensation Fund”, produced February 2002 . This paper was submitted to the Chief Medical Officer, D.o.H. in response to a consultative paper: “Clinical Negligence: What are the Issues and Options for reform?” Our continuing criticism can be read in Section 2: headed “The Present System dealing with clinical Negligence: The Flaws - NHS Complaints Procedure”.
1.8 The concluding opinion of our members is that the 1996 NHS Complaints Procedure was a confidence trick played on the trusting patient at the tax-payer’s expense. SIN had four major criticisms of the 1996 NHS Complaints Procedure and will be concerned to see if the new Act “The National Health Service (Complaints) Regulation” resolves these criticisms in the interest of patients.
2.1 Blame is not to be apportioned.
It was clearly stated in the D.o.H. NHS Complaints Procedure Guidelines, page 13 para. 4.28 , to quote: “… the purpose of the Complaints System is not to apportion blame…”. It was astonishing to read such a statement. The word ‘blame’, in our opinion, should never be used because it is an emotive word. The dictionary gives the definition of ‘blame’ as ‘establishing accountability' or
'responsibility '. What possible use is a complaints system that is expressly devised NOT to establish accountability when it is the essential aim of every good Complaints System; particularly when the complaint is likely to be concerned with serious medical errors that have caused the death or serious damage to patients? How else is the system to be improved?
Will the new regulations allow for the establishment of accountability?
2.3 The ‘Independent Review’ was not ‘Independent’
In the 1996 NHS Complaints Procedure it was possible to move to a second stage : “The Independent Review” if it were considered that the complaint involved clinical issues. However, the Convener, who was a non–executive member of the Trust Board “…not only makes the decision…whether a panel should be established to consider a complaint or not, but also decides whether the complaint raises clinical issues…seeks advice…from clinical advisers”.[ Independent Review: a briefing pack for Clinical Assessors NHS Executive 'The Convener' para. 8 page 20] We understand these were Medical Directors of the same Trust against which the complaint had been made. Again, very little in the way of true ‘independence’ in this aspect of the system. We wonder how many ‘Independent Reviews’ were blocked by Medical Directors?
2.4 Some patients were granted an ‘Independent Review’ which meant that Two Clinical Assessors were assigned to consider the clinical issues arising from the complaints. These Assessors came from outside the area. However, it was discovered that the Clinical Assessors could only operate under tightly prescribed regulations. To quote from the ‘Independent Review: a briefing pack for Clinical Assessors, NHS Executive ‘Indemnity’ para 5.2 page 11:
“ The Independent review process is not a disciplinary hearing….you ( Clinical Assessor) will not have been asked to consider disciplinary or negligence matters ….. nor would your report be eligible to be treated as expert witness testimony in any legal case…. As an assessor, you will be offered indemnity by your appointing Trust or Health Authority”.
2.5 We understand from our members that it was very difficult if not impossible to obtain signed statements written by the appointed Clinical Assessors.
2.6 Will the new NHS Complaints Procedure be able to consider clinical negligence or disciplinary matters? Considering that there are an estimated 100.000 medical errors per year in the UK that cause either death or serious, permanent injury, it is realistic to assume that a significant proportion of the complaints brought against the NHS must involve sub-standard care relating to clinical negligence or disciplinary issues.
3.0 An appeal to the NHS Health Commissioner’s Office is useless if the complaint has a legal remedy.
3.1 If a patient is dissatisfied (and about 75% are) with the outcome of the complaint it was possible to appeal to the Health Service Ombudsman. However, the Health Service Commissioner’s Act 1993 Section 4 states: “A Commissioner shall not conduct an investigation in respect of action in relation to which the person aggrieved has or had:- b) a remedy by way of proceedings in any court of law”.
3.2 Surely, the inference to be drawn from this is that the Health Ombudsman is unable by law to investigate any serious matter which has a remedy through the legal system Does this explain why approximately 85% of cases submitted to the Ombudsman were not investigated?
3.3 Will the new Complaints Procedure continue to use the Health Service Commissioner as the final arbiter under the 1993 Health Commissioner’s Act?
4.0 Our fourth and last serious objection to the 1996 NHS Complaints Procedure is that it was unlawful, being a breach of the Human Rights Act 1998 Article 6 to quote:
4.1 “ The right to a fair hearing: In determination of his civil rights and obligations …everyone is entitled to a fair and public hearing, within a reasonable time, by an independent and impartial tribunal, established by law, Judgement shall be pronounced publicly …except where publicity would prejudice the interest of justice.”
4.2 The ACHCEW’s ( Association of Community Health Councils in England & Wales) document entitled the ‘Implications of the Human Rights Act 1998 for Patients and CHCs” illustrated that the 1996 NHS Complaints Procedure did not comply with this Act. To quote:
“ ….it is clear the operation of the NHS Complaints Procedure does not comply with Article 6 (The Human Rights Act 1998), particularly when relevant judgements of the European Court of Human Rights are considered. The First Stage of the Complaints Procedure, involving as it does consideration of the complaint by the person complained about, is clearly a breach of the requirement that there be a fair, independent and impartial hearing. Review Panels are arguably not independent or impartial. The way Panel hearings are conducted does not comply with requirements of the Article. Complainants do not have the right to be represented. The delays, which often characterise the Complaints Procedure, mean that matters are not considered within reasonable time. There is no adequate right of appeal to a higher court. The Health Service Commissioner does not fit the requirements of a suitable appellate body and the process of judicial review is not suited to consideration of the merits. The requirements that cases be heard in a public forum and judgements be made publicly available is not met in the majority of cases”.
4.3 Will the new NHS Complaints Procedure Comply fully with Article 6 of the Human Rights Act 1998?
5.0 Consideration of the new regulations
5.1 The following comments, from a lay perspective, will be of necessity brief because of time constraints and will bear in mind the serious flaws of the 1996 NHS Complaints Procedure.
Part 11 Nature and Scope of Arrangements
5.2 Section 3 ( 3) “The arrangements must be accessible and such as to ensure that complaints are dealt with speedily and efficiently, and that complainants are treated courteously and sympathetically and as far as possible involved in decisions about how their complaints are handled and considered”.
5.3 As it stands this is a satisfactory statement. It must always be understood that the patient who complains should be seen as the victim and not the villain. SIN maintains that the patient should be fully involved in the ‘causal analysis’ of what went wrong because only the patient or a close relative will know certain details of the clinical events and procedures which led to the complaint.
5.4 The complainant should have the right to receive copies of written comments made by the health professional(s) against whom the complaint has been made before the final statement is issued by the NHS Health Care Provider, in order that any inaccuracies may be challenged by the complainant and rectified.
6.0 Matters excluded from consideration under the arrangements
Section 8 (e) a complaint which has been investigated by the Health Service Commissioner.
6.1 We are not quite sure what this means. Does this mean a complaint that has been submitted to the Ombudsman, but which was dismissed by a letter without any investigation, remembering that in any year only about 13% go to full investigation? Or does it mean any complaint that has been submitted the HSC’s Office and has been dismissed whether by investigation or letter? However, if the Section 4 ( b) of the 1993 Health Commissioner’s Act is still law, then this means that nothing has changed. Since the HSC cannot investigate anything that is serious enough to have a remedy by law, it implies that a patient with a very serious complaint has nowhere to go except to the Courts. Most, however, cannot afford to do this. How are very serious complaints to be investigated and resolved? How is the patient to obtain justice and accountability? How is the NHS to improve standards?
7.0 General Duty to Co-operate
7.1 Section 9 (2) “The general duty to co-operate required by paragraph (1) in particular a duty to -
(i) answer questions reasonably put by the body carrying out the investigation,
(ii) provide any information relating to the complaint which is reasonably requested by the body carrying out the investigation ; and
(iii) attending any meeting reasonably required to consider the complaint.
[SIN's emphasis]
7.2 This Section is unsatisfactory: the word “reasonably” is too vague and open to interpretation.
7.3 SIN advocates that there should be a statutory duty for any health professional involved in a serious complaint that involves sub-standard care or a medical error, to tell the truth. If any health professional has committed, or has been a witness to a colleague(s) committing, a medical error that resulted in harm to a patient, those health professionals must have a statutory obligation to disclose that a medical error has harmed a patient. We believe that the patient has a right to the truth about the circumstances surrounding their medical care and should have a statutory right to be fully informed of the extent of any damage caused through a medical error or sub-standard care.
7.4 In part (ii) we believe that a patient must have the statutory right to all information including medical documents, test results, scans, X-rays etc. relating to the complaint. Too often critical documents go missing; others, known to the patient, have been retrospectively changed; and others give misleading statements whenever a medical error has occurred and the patient has sustained serious and permanent injury.
7.5 Is the aim of the new NHS Complaints Procedure to establish the truth and accountability when sub-standard care has occurred, regardless of the legal liability of the Health Care Provider? It is reasonable to assume that, with all the medical evidence available to the Health Care Provider , the health professionals of this body will be fully aware if sub-standard care / medical error has resulted in death or serious iatrogenic injury.
7.6 Is the new NHS Complaints devised to be honest, open and transparent with all complainants, the majority of which will be iatrogenic victims or relatives of iatrogenic victims; or is it devised to obscure the truth and to protect the Health Care provider from all legal liability for iatrogenic injuries sustained?
7.8 If the latter is the case, then it is arguably a waste of the time and money of all participants and ultimately the tax-payer will shoulder the monetary burden of this procedure. If the former is the case, then the local Health Care Provider against whom the complaint is made, will be able to disclose full details of the iatrogenic injury and calculate any reasonable redress / compensation.
7.9 The loose terminology of this Section 7 “ General Duty to Co-operate’ suggests that the new NHS Complaints Procedure, like its predecessors, is still more likely to protect its employees and itself from legal liability than it is to openly disclose and admit liability.
8.0 Complaints which need not be considered
8.1 Section 14. Presumably parts (a ) and ( b) i.e. the staff and the complainant must be in agreement if the complaint is not pursued?
9.0 Time Limit for making a Complaint
9.1 Section 1 (a) & (b) This is an improvement over the 1996 NHS Complaints Procedure when six months was the time limit. One year from the time of the event, or one year from the date from which the matter which is the subject of the complaint came to the complainant’s notice, is an acceptable time scale.
9.2 Section 2 Where a complaint is made after the expiry date perhaps a third part should be added:
(c) when the complaint raises a very serious matter which in the interests of patient safety it should be investigated.
10 Acknowledgement and record of Complaint
10.1 Section 16 ( 5) “The acknowledgement sent to the complainant under paragraph (1) must include information about the right to assistance from independent advocacy services provided under section 19A of the 1977 Act.”
10.2 Presumably this used to refer to the CHCs. However, we believe it is correct to say that few complainants received in writing the advice to seek help from a CHC representative. Furthermore, nothing was ever stated as to the statutory duties and obligations that this body had towards the complainant. We also raise the question as to whether the CHC could be described as truly ‘independent’ when it was under the authority of the Regional Office D.o.H. It is assumed that ICAS will be the new agency. If ICAS is used, then the patient should be full informed as to the range of their statutory responsibilities.
11.0. Matters subject to concurrent investigation
11.1 Section 18 (1) (b) (c) or (d) When the NHS body or primary care provider is taking or is proposing to take in relation to the complaint against a person who is the subject of the complaint : disciplinary proceedings / referred the matter to the police or other health regulatory body / or which is a subject of any statutory inquiry or other investigation ----
11.2 The complainant should be kept fully informed and consulted.
12.0 Referral to the CHAI or to the Health Service Commissioner
12.1 Section 19 …at any stage …..a complaints manager may ….
( 1) (a) refer a complaint to the CHAI for consideration by the CHAI under part 1V of these regulations; or
(b) refer a complaint to the Health Services Commissioner for him to consider whether to investigate it under the Health Service Commissioner’s Act 1993
(2) A referral under paragraph (1)(a) may be made only with the consent of the complainant and the agreement of CHAI.
12.2 It would appear that CHAI can only be involved in a complaint if the complaints manager, the complainant and CHAI are in agreement. The complainant seems to have little autonomy in this process.
12.3 What is the significance of (1) (b) ? Does this mean that the Complaints Manager has the power to refer the complaint to the HSC, even if the complainant is not in agreement? If the position remains that the HSC cannot investigate a complaint that is serious enough to have a legal remedy- would this mean that the Complaints Manager has the responsibility to distinguish between serious complaints and the not so serious? Would this be put in writing to the complainant?
13.0 Investigations
13.1 20 (1) ….the complaints manager must investigate the complaint to the extent necessary and in the manner which appears to him most appropriate to resolve it speedily and efficiently.
Speed and efficiency may not be the same as investigating ‘honestly and thoroughly’. This appears to be a very subjective statement and could be to the detriment of the complainant. The complaints manager is not an independent investigator, being an employee of the Health Care Provider and may be biased which is contrary to Article 6 of the Human Rights Act 1998.
13.2 (2) “A complaints manager may request any person or body to produce such information and documents as he considers necessary to enable a complaint to be considered properly”.
This appears to be another very subjective statement and relies solely on the judgement of the complaints manager who is an employee of the Health Care Provider, and is therefore not independent. There should be a statutory obligation on the Health Care Provider to release all documentation and medical records connected with the complaint. The patient should have a statutory right to request whichever documents the complainant believes is relevant to the complaint, and indeed should have a statutory right to have copies
of all the documents.
13.4 (4) the complaints manager may not make a request under paragraph (2) for information which is confidential and relates to a living individual unless either:-
(a) the individual to whom the information relates has consented to its disclosure and use for the purposes of the investigation of the complaint; or -
(b) it can be supplied in a form from which the identity of the individual cannot be ascertained.
13.5 This is a worrying paragraph for this could restrict the extent of the investigations. Under the data Protection Act 1998, surely, the complainant is entitled to see any document or data on which their name is mentioned, regardless of the wishes of the person who was responsible for creating the data. We understand that even if a ‘third party’ is not known to the complainant, the complainant has the statutory right to have copies of what is written about them. Nor is there any reason why the third party name should be removed for, surely, the whole point of the Data Protection Act is that no one can write untrue or malicious information in anyone’s file and not accept responsibility for what is written. The Health Care Provider has a legal obligation to ensure that the data relevant to the complaint is accurate.
13.6 If an investigation is to be carried out into a serious complaint it must have access to all the necessary relevant information, otherwise this paragraph could be used to obstruct the complainant from obtaining information that may be detrimental to the Health Care Provider. Under the Data Protection Act information cannot be withheld even though such information could prove legal liability
13.7 (5) The complaints manager may -…..
(a) invite the complainant and any other person who he considers would be in a position to assist with the resolution of the complaints to be interviewed.
13.9 It is not clear whether this means holding meetings with the complainant and the health professional(s) against whom the complaint has been made. Should such interviews take place then we suggest that a tape recording is made, a copy given to each side. There were many instances in the 1996 NHS Complaints Procedure when the summary statements from the Health Care Providers were criticised as being muddled, misleading, omitting critical facts and often containing fabrications and false statements. The poor quality of these summary statements was criticised by the Health Select Committee in their Inquiry into ’Adverse Medical Incidents and their Outcomes in June 1999’. Furthermore, in acknowledgement of these serious criticisms the Health Select Committee recommended that in future all reports of investigations from Health Care Providers should be able to stand up to the full rigour of the courts [Recommendation (K)]. It is hoped that the new Regulations will comply with this recommendation.
13.10 (b)……where he thinks it appropriate and with the agreement of the complainant, make arrangements of conciliation , mediation……
Does mediation in this case cover any financial redress?
13.11 The complaints manager appears to have considerable power and responsibility to make decisions with regards to the complaint. Is the complaints manager a layperson or medically qualified? Is it obligatory that either clinical advice is sought from, a senior Nursing Officer in the case of a complaint involving nursing standards, or from a senior doctor if the complaint is medical? Will this be written advice and is this advice available to the complainant? To whom is the complaint manager answerable? Who is ultimately responsible for the handling of the complaint, is this the Chief Executive of the Health Care Provider as in previous Complaints Procedures? It is, surely essential that someone of very senior rank is in overall charge?
15 .0 Response
15.1 Section 21 (1) The complaints manager must prepare a written response to the complainant which-
(a) summarises the nature and substance of the complaint… to… (b)
It is suggested that before any final summary is issued, a draft copy should be sent to the complainant so that it can be checked for accuracy.
PART IV
HANDLING AND CONSIDERATION OF COMPLAINTS BY THE COMMISSION FOR HEALTHCARE AUDIT AND INSPECTION ( CHAI)
16.0 Complaints to CHAI
16.1 Section 22 [It would appear that CHAI has replaced the ‘Independent Review’ of the 1996 NHS Complaints Procedure]. If a complainant is dissatisfied with the investigation of the Care Provider or if the investigation has not been concluded within 6 months or if the care provider makes a decision – the complaint may be sent to the CHAI.
16.2 All documentation relating to the complaint must be sent to the CHAI. It is suggested that CHAI sends written notification to the complainant of all the documentation that has been received.
17.0 Decision on handling of complaint
17.1 Section 23 The CHAI must make a decision within 10 working days as to which of several options available it is taking. One of the options is to refer the complaint to a health regulatory body, presumably this means the GMC or the equivalent body for nursing or dentistry.
If this is the case, then it is assumed that the CHAI has decided that the complaint constitutes elements of clinical negligence or professional misconduct.
17.2 The CHAI could also refer the complaint to the HSC , if this is the case., then it implies that the complaint does not constitute a serious legal matter.
18.0 CHAI Investigation
18.1 Section 24. If the CHAI decides to investigate the complaint it must ….”send to the complainant and any other person to whom the notice was sent its proposed terms of reference for its investigation.” The complainant, and others involved in the complaint may comment on the terms of reference. This is a welcome initiative.
19.0 Panels
19.1 Section 25 The CHAI may set up an independent lay panel of three people one of which to Chair the investigation.
19.2There has been no mention of Independent Clinical Assessors, presumably they will be brought into to give advice? We welcome the preponderance of lay people, but should there not be a Clinical Assessor on the Panel, particularly when every doctor has an ethical and professional duty to “protect patients when you believe that a doctor’s conduct or performance is a threat to them.… the safety of patients must come first at all time”. [GMC Code of Conduct sections 23 & 24.]
19.3 (5) The participants must be given the opportunity of being heard in person. This is very welcome. The fact that all parties to the complaint will be informed as to the time and dates of the hearings suggests that the hearings will be open to all participants to attend. Will CHAI have any statutory powers to order people to attend for questioning or to request the release of further documentation thought relevant to the complaint? This Panel is closer to the requirements of the Human Rights Act Article 6,
19.3 The CHAI’s report must be completed as soon as reasonably practicable and in any event within 40 working days of the date on which the terms of reference for the investigation was agreed.
Will the CHAI have the power, at the end of the investigation, to refer health professionals to a professional regulatory body such as the GMC; to send the complaint to the police for possible criminal investigation; or to call for an Independent Government Inquiry?
19.4 It is interesting to note that if a complainant is not satisfied with the CHAI investigation they may refer their complaint to the HSC so the HSC will remain as the final arbiter, although the ACHCEW commented that this did not comply with the Human Rights Act 1998 : “The Health Service Commissioner does not fit the requirements of a suitable appellate body and the process of judicial review is not suited to consideration of the merits”.
20. Conclusion:
20.1 Will this new Complaints Procedure be able to establish accountability/ responsibility through impartial, thorough, transparent and honest investigations when a patient has received sub- standard care in the NHS regardless of the possible legal liability of the Health Care Provider? The local complaints manager does not appear to be sufficiently independent to comply with the Human Rights Act 1998 Article 6.
20.2 Will the Clinical Assessors, whose advice is required, be able to consider matters of clinical negligence and professional misconduct, contrary to the 1996 NHS Complaints Procedure? Will the Clinical Assessor be able to discuss the matter with the complainant or health professional involved with the complaint?. Will the Clinical Assessors’ written comments be available to the complainant?
20.3 Will health professionals have a statutory obligation to record any medical error that has harmed a patient/complainant?
20.4 Will there be a statutory obligation to inform the patient/ complainant if they have been damaged by a medical error; or relatives that a patient’s death was due to an iatrogenic injury?
20.5 Will there be a statutory obligation on the part of the Health Care Provider or the CHAI to ensure that the damaged patient/complainant receives any necessary remedial specialist care, regardless of legal liability?
20.6 Will there be a statutory obligation to inform the National Patient Safety Agency (NPSA) of any medical error which comes to light during the investigations?
20.7 The CHAI Panel goes some way to establishing the ‘independence’ demanded by Article 6 of the Human Rights Act 1998, but will the new NHS Complaints Procedure Regulations comply fully with this Act?
20.8 It must be recognised that, with an estimated 100,000 iatrogenic deaths and injury occurring every year in the UK, it is reasonable to assume that the vast majority of complainants who engage in the NHS Complaints Procedure will have been subjected to some kind of iatrogenic damage. These are some of the most vulnerable and traumatised people in the NHS system. These innocent victims must not be regarded by the Health Care Providers as potential litigants and so categorised as adversaries.
20.9 The question must be asked: what is the new NHS Complaints Procedure devised to achieve? Is it constructed to give honest and transparent disclosure of iatrogenic damage regardless of any potential liability of the Health Care Provider? On the other hand, is it created to obstruct and conceal the results of medical errors and substandard care in order to protect the health professional and the system? If it is the latter, then there has been no change in policy towards innocent victims of iatrogenic damage. It is our opinion that the public is demanding an open and honest culture of accountability, where mistakes are acknowledged and given a thorough causal analysis; where priority is given to caring for, and counselling of, the iatrogenically damaged patient. The problem with the present ‘denial and cover-up culture’ is that it puts iatrogenic patients at risk: many being denied further genuine specialist care, because to give them care would be to expose the iatrogenic damage sustained and so give evidence for a legal action. Not only is this inhumane but must, surely, be unlawful? Furthermore, an NHS Complaints Procedure that obstructs rather than truthfully discloses errors and the resultant iatrogenic damage, is arguably thwarting natural justice.
20.10 We wish to see a change from the present ‘denial and cover up ‘culture to one where doctors can be honest and open with patients when errors have been made, which have caused damage. The innocent victim of iatrogenic damage should be seen as a vulnerable human being in need of care, not as a potential litigant. Lord Woolf in his Inaugural lecture on 17th January 2001 expressed similar sentiments:
“ A new culture is required…. They needed to recognise that because patients felt they had been a victim of medical malpractice this did not justify withdrawing treatment. It meant that those who had the responsibility for treating the patient were under a particular duty to achieve the best result possible for the patient..."
20.11 SIN has been campaigning for over four years for the establishment of a Victim’s Compensation Fund as a way of making redress for seriously and permanently damaged patients for we believe that being perceived as a potential litigant, results in a denial of care. This organisation would like to see established an ‘NHS Compensation Assessment Unit’ with mediation, which would greatly reduce the huge medico-legal bill. Certainly, the 1996 NHS Complaints Procedure was a deeply flawed system for not only did it fail to protect iatrogenic patients it also failed to maintain standards of quality control and accountability. SIN hopes that any New Complaints Procedure will be merged into a system that entails full disclosure of iatrogenic damage linked with a Victim’s compensation Fund and mediation, rather than leaving the present unnecessary adversarial and costly medico-legal route. Such an integrated system based on an honest and open culture will better serve patients, health professionals and the whole ethos of the NHS.
© March 2004
Gillian M Bean B.Sc. & Margaret MacRae
Founder Members & Co-Directors SIN
GM Bean: Tel/Fax: 0115 9431 320
M. MacRae: Tel/Fax: 0192 4407 195
Emails: sinfo@bluebolt.com & mags@sinfo.freeserve.co.uk
Co-Directors & Founder Members SIN
© March 200
Submitted to Department of Health April 2004
e-mail:sinfo@boltblue.com & mags@sinfo.freeserve.co.uk
www.sin-medicalmistakes.org
SUFFERERS
of IATROGENIC
NEGLECT
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
REFORMING
THE NHS COMPLAINTS PROCEDURE:
CONSULTATION UPON DRAFT REGULATIONS
CONSULTATION UPON DRAFT REGULATIONS
1. Introduction:
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 (AMIs) that cause death or serious, permanent injury.
1.2 It is important to bear in mind the backcloth against which patients complain if they believe that they have received substandard care within the NHS.
1.3 For too long the NHS has been reluctant to cope with medical mistakes. Recent research has estimated that annually 68, 000 people die in Uk hospitals, half of these are terminally ill and would have died anyway, however, that still leaves 34,000 who die needlessly and 40,000 patients who are permanently and seriously damaged by medical error [ Research. Prof. Charles Vincent, University College London March 2001]. The Chief Medical Officer, Prof. Sir Liam Donaldson in his document ‘Organisation with a Memory’ acknowledges that 10% of all hospital admissions caused harm to patients. This does not include GP referrals or A & E appointments. These AMIs are all potential complaints.
1.4 No health professional rushes round to inform the patient or relative that the injury or death has been the result of a medical error. The inability of the NHS to deal with this problem in an honest and open manner has caused enormous difficulty and distress to iatrogenic victims and their families.
1.5 The only route available for the iatrogenic patient or relative is to pursue their complaint through the NHS Complaints Procedure in order to seek the truth, accountability and justice. Unfortunately, there has been very widespread criticism of the 1996 NHS Complaints Procedure for it failed to deliver these basic demands.
1.6 SIN has produced several documents on this subject. The first was entitled “ The Emperor Has No Clothes”: A Critique of the NHS Complaints Procedure” which was submitted to the BRI Inquiry in September 1999, to the Health Select Committee in October 1999 and to the D.o.H.. SIN continued to voice criticism in its Paper 2 “ The Patient’s Voice For Equity: Empowerment of the Public in the Health Care Process” written and submitted at the request of the BRI Inquiry Committee June 2000 and to the D.o.H. Our criticisms can be read in Section 4 “Empowerment via the NHS Complaints Procedure” and in Section 11 headed “Conclusion”.
1.7 We returned again to this subject in our Paper 3 entitled “Balancing the Scales: SIN’s Case for Victim’s Compensation Fund”, produced February 2002 . This paper was submitted to the Chief Medical Officer, D.o.H. in response to a consultative paper: “Clinical Negligence: What are the Issues and Options for reform?” Our continuing criticism can be read in Section 2: headed “The Present System dealing with clinical Negligence: The Flaws - NHS Complaints Procedure”.
1.8 The concluding opinion of our members is that the 1996 NHS Complaints Procedure was a confidence trick played on the trusting patient at the tax-payer’s expense. SIN had four major criticisms of the 1996 NHS Complaints Procedure and will be concerned to see if the new Act “The National Health Service (Complaints) Regulation” resolves these criticisms in the interest of patients.
2.0
The Four Major Criticisms of the 1996 NHS Complaints Procedure are:
2.1 Blame is not to be apportioned.
It was clearly stated in the D.o.H. NHS Complaints Procedure Guidelines, page 13 para. 4.28 , to quote: “… the purpose of the Complaints System is not to apportion blame…”. It was astonishing to read such a statement. The word ‘blame’, in our opinion, should never be used because it is an emotive word. The dictionary gives the definition of ‘blame’ as ‘establishing accountability' or
'responsibility '. What possible use is a complaints system that is expressly devised NOT to establish accountability when it is the essential aim of every good Complaints System; particularly when the complaint is likely to be concerned with serious medical errors that have caused the death or serious damage to patients? How else is the system to be improved?
Will the new regulations allow for the establishment of accountability?
2.3 The ‘Independent Review’ was not ‘Independent’
In the 1996 NHS Complaints Procedure it was possible to move to a second stage : “The Independent Review” if it were considered that the complaint involved clinical issues. However, the Convener, who was a non–executive member of the Trust Board “…not only makes the decision…whether a panel should be established to consider a complaint or not, but also decides whether the complaint raises clinical issues…seeks advice…from clinical advisers”.[ Independent Review: a briefing pack for Clinical Assessors NHS Executive 'The Convener' para. 8 page 20] We understand these were Medical Directors of the same Trust against which the complaint had been made. Again, very little in the way of true ‘independence’ in this aspect of the system. We wonder how many ‘Independent Reviews’ were blocked by Medical Directors?
2.4 Some patients were granted an ‘Independent Review’ which meant that Two Clinical Assessors were assigned to consider the clinical issues arising from the complaints. These Assessors came from outside the area. However, it was discovered that the Clinical Assessors could only operate under tightly prescribed regulations. To quote from the ‘Independent Review: a briefing pack for Clinical Assessors, NHS Executive ‘Indemnity’ para 5.2 page 11:
“ The Independent review process is not a disciplinary hearing….you ( Clinical Assessor) will not have been asked to consider disciplinary or negligence matters ….. nor would your report be eligible to be treated as expert witness testimony in any legal case…. As an assessor, you will be offered indemnity by your appointing Trust or Health Authority”.
2.5 We understand from our members that it was very difficult if not impossible to obtain signed statements written by the appointed Clinical Assessors.
2.6 Will the new NHS Complaints Procedure be able to consider clinical negligence or disciplinary matters? Considering that there are an estimated 100.000 medical errors per year in the UK that cause either death or serious, permanent injury, it is realistic to assume that a significant proportion of the complaints brought against the NHS must involve sub-standard care relating to clinical negligence or disciplinary issues.
3.0 An appeal to the NHS Health Commissioner’s Office is useless if the complaint has a legal remedy.
3.1 If a patient is dissatisfied (and about 75% are) with the outcome of the complaint it was possible to appeal to the Health Service Ombudsman. However, the Health Service Commissioner’s Act 1993 Section 4 states: “A Commissioner shall not conduct an investigation in respect of action in relation to which the person aggrieved has or had:- b) a remedy by way of proceedings in any court of law”.
3.2 Surely, the inference to be drawn from this is that the Health Ombudsman is unable by law to investigate any serious matter which has a remedy through the legal system Does this explain why approximately 85% of cases submitted to the Ombudsman were not investigated?
3.3 Will the new Complaints Procedure continue to use the Health Service Commissioner as the final arbiter under the 1993 Health Commissioner’s Act?
4.0 Our fourth and last serious objection to the 1996 NHS Complaints Procedure is that it was unlawful, being a breach of the Human Rights Act 1998 Article 6 to quote:
4.1 “ The right to a fair hearing: In determination of his civil rights and obligations …everyone is entitled to a fair and public hearing, within a reasonable time, by an independent and impartial tribunal, established by law, Judgement shall be pronounced publicly …except where publicity would prejudice the interest of justice.”
4.2 The ACHCEW’s ( Association of Community Health Councils in England & Wales) document entitled the ‘Implications of the Human Rights Act 1998 for Patients and CHCs” illustrated that the 1996 NHS Complaints Procedure did not comply with this Act. To quote:
“ ….it is clear the operation of the NHS Complaints Procedure does not comply with Article 6 (The Human Rights Act 1998), particularly when relevant judgements of the European Court of Human Rights are considered. The First Stage of the Complaints Procedure, involving as it does consideration of the complaint by the person complained about, is clearly a breach of the requirement that there be a fair, independent and impartial hearing. Review Panels are arguably not independent or impartial. The way Panel hearings are conducted does not comply with requirements of the Article. Complainants do not have the right to be represented. The delays, which often characterise the Complaints Procedure, mean that matters are not considered within reasonable time. There is no adequate right of appeal to a higher court. The Health Service Commissioner does not fit the requirements of a suitable appellate body and the process of judicial review is not suited to consideration of the merits. The requirements that cases be heard in a public forum and judgements be made publicly available is not met in the majority of cases”.
4.3 Will the new NHS Complaints Procedure Comply fully with Article 6 of the Human Rights Act 1998?
5.0 Consideration of the new regulations
5.1 The following comments, from a lay perspective, will be of necessity brief because of time constraints and will bear in mind the serious flaws of the 1996 NHS Complaints Procedure.
Part 11 Nature and Scope of Arrangements
5.2 Section 3 ( 3) “The arrangements must be accessible and such as to ensure that complaints are dealt with speedily and efficiently, and that complainants are treated courteously and sympathetically and as far as possible involved in decisions about how their complaints are handled and considered”.
5.3 As it stands this is a satisfactory statement. It must always be understood that the patient who complains should be seen as the victim and not the villain. SIN maintains that the patient should be fully involved in the ‘causal analysis’ of what went wrong because only the patient or a close relative will know certain details of the clinical events and procedures which led to the complaint.
5.4 The complainant should have the right to receive copies of written comments made by the health professional(s) against whom the complaint has been made before the final statement is issued by the NHS Health Care Provider, in order that any inaccuracies may be challenged by the complainant and rectified.
6.0 Matters excluded from consideration under the arrangements
Section 8 (e) a complaint which has been investigated by the Health Service Commissioner.
6.1 We are not quite sure what this means. Does this mean a complaint that has been submitted to the Ombudsman, but which was dismissed by a letter without any investigation, remembering that in any year only about 13% go to full investigation? Or does it mean any complaint that has been submitted the HSC’s Office and has been dismissed whether by investigation or letter? However, if the Section 4 ( b) of the 1993 Health Commissioner’s Act is still law, then this means that nothing has changed. Since the HSC cannot investigate anything that is serious enough to have a remedy by law, it implies that a patient with a very serious complaint has nowhere to go except to the Courts. Most, however, cannot afford to do this. How are very serious complaints to be investigated and resolved? How is the patient to obtain justice and accountability? How is the NHS to improve standards?
7.0 General Duty to Co-operate
7.1 Section 9 (2) “The general duty to co-operate required by paragraph (1) in particular a duty to -
(i) answer questions reasonably put by the body carrying out the investigation,
(ii) provide any information relating to the complaint which is reasonably requested by the body carrying out the investigation ; and
(iii) attending any meeting reasonably required to consider the complaint.
[SIN's emphasis]
7.2 This Section is unsatisfactory: the word “reasonably” is too vague and open to interpretation.
7.3 SIN advocates that there should be a statutory duty for any health professional involved in a serious complaint that involves sub-standard care or a medical error, to tell the truth. If any health professional has committed, or has been a witness to a colleague(s) committing, a medical error that resulted in harm to a patient, those health professionals must have a statutory obligation to disclose that a medical error has harmed a patient. We believe that the patient has a right to the truth about the circumstances surrounding their medical care and should have a statutory right to be fully informed of the extent of any damage caused through a medical error or sub-standard care.
7.4 In part (ii) we believe that a patient must have the statutory right to all information including medical documents, test results, scans, X-rays etc. relating to the complaint. Too often critical documents go missing; others, known to the patient, have been retrospectively changed; and others give misleading statements whenever a medical error has occurred and the patient has sustained serious and permanent injury.
7.5 Is the aim of the new NHS Complaints Procedure to establish the truth and accountability when sub-standard care has occurred, regardless of the legal liability of the Health Care Provider? It is reasonable to assume that, with all the medical evidence available to the Health Care Provider , the health professionals of this body will be fully aware if sub-standard care / medical error has resulted in death or serious iatrogenic injury.
7.6 Is the new NHS Complaints devised to be honest, open and transparent with all complainants, the majority of which will be iatrogenic victims or relatives of iatrogenic victims; or is it devised to obscure the truth and to protect the Health Care provider from all legal liability for iatrogenic injuries sustained?
7.8 If the latter is the case, then it is arguably a waste of the time and money of all participants and ultimately the tax-payer will shoulder the monetary burden of this procedure. If the former is the case, then the local Health Care Provider against whom the complaint is made, will be able to disclose full details of the iatrogenic injury and calculate any reasonable redress / compensation.
7.9 The loose terminology of this Section 7 “ General Duty to Co-operate’ suggests that the new NHS Complaints Procedure, like its predecessors, is still more likely to protect its employees and itself from legal liability than it is to openly disclose and admit liability.
8.0 Complaints which need not be considered
8.1 Section 14. Presumably parts (a ) and ( b) i.e. the staff and the complainant must be in agreement if the complaint is not pursued?
9.0 Time Limit for making a Complaint
9.1 Section 1 (a) & (b) This is an improvement over the 1996 NHS Complaints Procedure when six months was the time limit. One year from the time of the event, or one year from the date from which the matter which is the subject of the complaint came to the complainant’s notice, is an acceptable time scale.
9.2 Section 2 Where a complaint is made after the expiry date perhaps a third part should be added:
(c) when the complaint raises a very serious matter which in the interests of patient safety it should be investigated.
10 Acknowledgement and record of Complaint
10.1 Section 16 ( 5) “The acknowledgement sent to the complainant under paragraph (1) must include information about the right to assistance from independent advocacy services provided under section 19A of the 1977 Act.”
10.2 Presumably this used to refer to the CHCs. However, we believe it is correct to say that few complainants received in writing the advice to seek help from a CHC representative. Furthermore, nothing was ever stated as to the statutory duties and obligations that this body had towards the complainant. We also raise the question as to whether the CHC could be described as truly ‘independent’ when it was under the authority of the Regional Office D.o.H. It is assumed that ICAS will be the new agency. If ICAS is used, then the patient should be full informed as to the range of their statutory responsibilities.
11.0. Matters subject to concurrent investigation
11.1 Section 18 (1) (b) (c) or (d) When the NHS body or primary care provider is taking or is proposing to take in relation to the complaint against a person who is the subject of the complaint : disciplinary proceedings / referred the matter to the police or other health regulatory body / or which is a subject of any statutory inquiry or other investigation ----
11.2 The complainant should be kept fully informed and consulted.
12.0 Referral to the CHAI or to the Health Service Commissioner
12.1 Section 19 …at any stage …..a complaints manager may ….
( 1) (a) refer a complaint to the CHAI for consideration by the CHAI under part 1V of these regulations; or
(b) refer a complaint to the Health Services Commissioner for him to consider whether to investigate it under the Health Service Commissioner’s Act 1993
(2) A referral under paragraph (1)(a) may be made only with the consent of the complainant and the agreement of CHAI.
12.2 It would appear that CHAI can only be involved in a complaint if the complaints manager, the complainant and CHAI are in agreement. The complainant seems to have little autonomy in this process.
12.3 What is the significance of (1) (b) ? Does this mean that the Complaints Manager has the power to refer the complaint to the HSC, even if the complainant is not in agreement? If the position remains that the HSC cannot investigate a complaint that is serious enough to have a legal remedy- would this mean that the Complaints Manager has the responsibility to distinguish between serious complaints and the not so serious? Would this be put in writing to the complainant?
13.0 Investigations
13.1 20 (1) ….the complaints manager must investigate the complaint to the extent necessary and in the manner which appears to him most appropriate to resolve it speedily and efficiently.
Speed and efficiency may not be the same as investigating ‘honestly and thoroughly’. This appears to be a very subjective statement and could be to the detriment of the complainant. The complaints manager is not an independent investigator, being an employee of the Health Care Provider and may be biased which is contrary to Article 6 of the Human Rights Act 1998.
13.2 (2) “A complaints manager may request any person or body to produce such information and documents as he considers necessary to enable a complaint to be considered properly”.
This appears to be another very subjective statement and relies solely on the judgement of the complaints manager who is an employee of the Health Care Provider, and is therefore not independent. There should be a statutory obligation on the Health Care Provider to release all documentation and medical records connected with the complaint. The patient should have a statutory right to request whichever documents the complainant believes is relevant to the complaint, and indeed should have a statutory right to have copies
of all the documents.
13.4 (4) the complaints manager may not make a request under paragraph (2) for information which is confidential and relates to a living individual unless either:-
(a) the individual to whom the information relates has consented to its disclosure and use for the purposes of the investigation of the complaint; or -
(b) it can be supplied in a form from which the identity of the individual cannot be ascertained.
13.5 This is a worrying paragraph for this could restrict the extent of the investigations. Under the data Protection Act 1998, surely, the complainant is entitled to see any document or data on which their name is mentioned, regardless of the wishes of the person who was responsible for creating the data. We understand that even if a ‘third party’ is not known to the complainant, the complainant has the statutory right to have copies of what is written about them. Nor is there any reason why the third party name should be removed for, surely, the whole point of the Data Protection Act is that no one can write untrue or malicious information in anyone’s file and not accept responsibility for what is written. The Health Care Provider has a legal obligation to ensure that the data relevant to the complaint is accurate.
13.6 If an investigation is to be carried out into a serious complaint it must have access to all the necessary relevant information, otherwise this paragraph could be used to obstruct the complainant from obtaining information that may be detrimental to the Health Care Provider. Under the Data Protection Act information cannot be withheld even though such information could prove legal liability
13.7 (5) The complaints manager may -…..
(a) invite the complainant and any other person who he considers would be in a position to assist with the resolution of the complaints to be interviewed.
13.9 It is not clear whether this means holding meetings with the complainant and the health professional(s) against whom the complaint has been made. Should such interviews take place then we suggest that a tape recording is made, a copy given to each side. There were many instances in the 1996 NHS Complaints Procedure when the summary statements from the Health Care Providers were criticised as being muddled, misleading, omitting critical facts and often containing fabrications and false statements. The poor quality of these summary statements was criticised by the Health Select Committee in their Inquiry into ’Adverse Medical Incidents and their Outcomes in June 1999’. Furthermore, in acknowledgement of these serious criticisms the Health Select Committee recommended that in future all reports of investigations from Health Care Providers should be able to stand up to the full rigour of the courts [Recommendation (K)]. It is hoped that the new Regulations will comply with this recommendation.
13.10 (b)……where he thinks it appropriate and with the agreement of the complainant, make arrangements of conciliation , mediation……
Does mediation in this case cover any financial redress?
13.11 The complaints manager appears to have considerable power and responsibility to make decisions with regards to the complaint. Is the complaints manager a layperson or medically qualified? Is it obligatory that either clinical advice is sought from, a senior Nursing Officer in the case of a complaint involving nursing standards, or from a senior doctor if the complaint is medical? Will this be written advice and is this advice available to the complainant? To whom is the complaint manager answerable? Who is ultimately responsible for the handling of the complaint, is this the Chief Executive of the Health Care Provider as in previous Complaints Procedures? It is, surely essential that someone of very senior rank is in overall charge?
15 .0 Response
15.1 Section 21 (1) The complaints manager must prepare a written response to the complainant which-
(a) summarises the nature and substance of the complaint… to… (b)
It is suggested that before any final summary is issued, a draft copy should be sent to the complainant so that it can be checked for accuracy.
PART IV
HANDLING AND CONSIDERATION OF COMPLAINTS BY THE COMMISSION FOR HEALTHCARE AUDIT AND INSPECTION ( CHAI)
16.0 Complaints to CHAI
16.1 Section 22 [It would appear that CHAI has replaced the ‘Independent Review’ of the 1996 NHS Complaints Procedure]. If a complainant is dissatisfied with the investigation of the Care Provider or if the investigation has not been concluded within 6 months or if the care provider makes a decision – the complaint may be sent to the CHAI.
16.2 All documentation relating to the complaint must be sent to the CHAI. It is suggested that CHAI sends written notification to the complainant of all the documentation that has been received.
17.0 Decision on handling of complaint
17.1 Section 23 The CHAI must make a decision within 10 working days as to which of several options available it is taking. One of the options is to refer the complaint to a health regulatory body, presumably this means the GMC or the equivalent body for nursing or dentistry.
If this is the case, then it is assumed that the CHAI has decided that the complaint constitutes elements of clinical negligence or professional misconduct.
17.2 The CHAI could also refer the complaint to the HSC , if this is the case., then it implies that the complaint does not constitute a serious legal matter.
18.0 CHAI Investigation
18.1 Section 24. If the CHAI decides to investigate the complaint it must ….”send to the complainant and any other person to whom the notice was sent its proposed terms of reference for its investigation.” The complainant, and others involved in the complaint may comment on the terms of reference. This is a welcome initiative.
19.0 Panels
19.1 Section 25 The CHAI may set up an independent lay panel of three people one of which to Chair the investigation.
19.2There has been no mention of Independent Clinical Assessors, presumably they will be brought into to give advice? We welcome the preponderance of lay people, but should there not be a Clinical Assessor on the Panel, particularly when every doctor has an ethical and professional duty to “protect patients when you believe that a doctor’s conduct or performance is a threat to them.… the safety of patients must come first at all time”. [GMC Code of Conduct sections 23 & 24.]
19.3 (5) The participants must be given the opportunity of being heard in person. This is very welcome. The fact that all parties to the complaint will be informed as to the time and dates of the hearings suggests that the hearings will be open to all participants to attend. Will CHAI have any statutory powers to order people to attend for questioning or to request the release of further documentation thought relevant to the complaint? This Panel is closer to the requirements of the Human Rights Act Article 6,
19.3 The CHAI’s report must be completed as soon as reasonably practicable and in any event within 40 working days of the date on which the terms of reference for the investigation was agreed.
Will the CHAI have the power, at the end of the investigation, to refer health professionals to a professional regulatory body such as the GMC; to send the complaint to the police for possible criminal investigation; or to call for an Independent Government Inquiry?
19.4 It is interesting to note that if a complainant is not satisfied with the CHAI investigation they may refer their complaint to the HSC so the HSC will remain as the final arbiter, although the ACHCEW commented that this did not comply with the Human Rights Act 1998 : “The Health Service Commissioner does not fit the requirements of a suitable appellate body and the process of judicial review is not suited to consideration of the merits”.
20. Conclusion:
20.1 Will this new Complaints Procedure be able to establish accountability/ responsibility through impartial, thorough, transparent and honest investigations when a patient has received sub- standard care in the NHS regardless of the possible legal liability of the Health Care Provider? The local complaints manager does not appear to be sufficiently independent to comply with the Human Rights Act 1998 Article 6.
20.2 Will the Clinical Assessors, whose advice is required, be able to consider matters of clinical negligence and professional misconduct, contrary to the 1996 NHS Complaints Procedure? Will the Clinical Assessor be able to discuss the matter with the complainant or health professional involved with the complaint?. Will the Clinical Assessors’ written comments be available to the complainant?
20.3 Will health professionals have a statutory obligation to record any medical error that has harmed a patient/complainant?
20.4 Will there be a statutory obligation to inform the patient/ complainant if they have been damaged by a medical error; or relatives that a patient’s death was due to an iatrogenic injury?
20.5 Will there be a statutory obligation on the part of the Health Care Provider or the CHAI to ensure that the damaged patient/complainant receives any necessary remedial specialist care, regardless of legal liability?
20.6 Will there be a statutory obligation to inform the National Patient Safety Agency (NPSA) of any medical error which comes to light during the investigations?
20.7 The CHAI Panel goes some way to establishing the ‘independence’ demanded by Article 6 of the Human Rights Act 1998, but will the new NHS Complaints Procedure Regulations comply fully with this Act?
20.8 It must be recognised that, with an estimated 100,000 iatrogenic deaths and injury occurring every year in the UK, it is reasonable to assume that the vast majority of complainants who engage in the NHS Complaints Procedure will have been subjected to some kind of iatrogenic damage. These are some of the most vulnerable and traumatised people in the NHS system. These innocent victims must not be regarded by the Health Care Providers as potential litigants and so categorised as adversaries.
20.9 The question must be asked: what is the new NHS Complaints Procedure devised to achieve? Is it constructed to give honest and transparent disclosure of iatrogenic damage regardless of any potential liability of the Health Care Provider? On the other hand, is it created to obstruct and conceal the results of medical errors and substandard care in order to protect the health professional and the system? If it is the latter, then there has been no change in policy towards innocent victims of iatrogenic damage. It is our opinion that the public is demanding an open and honest culture of accountability, where mistakes are acknowledged and given a thorough causal analysis; where priority is given to caring for, and counselling of, the iatrogenically damaged patient. The problem with the present ‘denial and cover-up culture’ is that it puts iatrogenic patients at risk: many being denied further genuine specialist care, because to give them care would be to expose the iatrogenic damage sustained and so give evidence for a legal action. Not only is this inhumane but must, surely, be unlawful? Furthermore, an NHS Complaints Procedure that obstructs rather than truthfully discloses errors and the resultant iatrogenic damage, is arguably thwarting natural justice.
20.10 We wish to see a change from the present ‘denial and cover up ‘culture to one where doctors can be honest and open with patients when errors have been made, which have caused damage. The innocent victim of iatrogenic damage should be seen as a vulnerable human being in need of care, not as a potential litigant. Lord Woolf in his Inaugural lecture on 17th January 2001 expressed similar sentiments:
“ A new culture is required…. They needed to recognise that because patients felt they had been a victim of medical malpractice this did not justify withdrawing treatment. It meant that those who had the responsibility for treating the patient were under a particular duty to achieve the best result possible for the patient..."
20.11 SIN has been campaigning for over four years for the establishment of a Victim’s Compensation Fund as a way of making redress for seriously and permanently damaged patients for we believe that being perceived as a potential litigant, results in a denial of care. This organisation would like to see established an ‘NHS Compensation Assessment Unit’ with mediation, which would greatly reduce the huge medico-legal bill. Certainly, the 1996 NHS Complaints Procedure was a deeply flawed system for not only did it fail to protect iatrogenic patients it also failed to maintain standards of quality control and accountability. SIN hopes that any New Complaints Procedure will be merged into a system that entails full disclosure of iatrogenic damage linked with a Victim’s compensation Fund and mediation, rather than leaving the present unnecessary adversarial and costly medico-legal route. Such an integrated system based on an honest and open culture will better serve patients, health professionals and the whole ethos of the NHS.
© March 2004
Gillian M Bean B.Sc. & Margaret MacRae
Founder Members & Co-Directors SIN
GM Bean: Tel/Fax: 0115 9431 320
M. MacRae: Tel/Fax: 0192 4407 195
Emails: sinfo@bluebolt.com & mags@sinfo.freeserve.co.uk
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