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JUNE 2007

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

MEMBER OF THE IATROGENIC EUROPE UNITE ALLIANCE.ORG

THE INTRODUCTION OF AN
ELECTRONIC PATIENT RECORD:
REASONS WHY THIS IS PREMATURE,
CONTRARY TO PATIENT SAFETY
& SHOULD BE ABANDONED

Written on behalf of the Iatrogenic Patient

Co-Directors & Founder Members SIN
Emails:sinfo@boltblue.com & mag@sinfo.freeserve.co.uk
www.sin-medicalmistakes .org

Copies: MPs, Health Select Committee, NPSA, Media & other interested parties

iNTRODUCTION:

SIN has been concerned for some time on the intended introduction of The Electronic Patient Record and has intended to write a commentary on advantages and disadvantages of the introduction of an Electronic Patient Record. The impetus to produce this Paper came because of the Inquiry into The Electronic Patient Record held by the Health Select Committee June 2007 and the National Debate, which we hope will ensue.

" Sufferers of Iatrogenic Neglect" (SIN), is a patient support and pressure group which has a continuously growing membership spread throughout the UK, and is concerned about iatrogenic suffering and the promotion of Patient Safety. It was established in November 1998.

This group recognises that medical care within the NHS is of high standard for the majority, but unfortunately mistakes and poor practice do occur. It has now been accepted that approx. 850,000 patients in NHS hospitals , one patient in every ten, in the UK will experience a medical error every year. (Chief Medical Officer’s : “Organisation with a Memory” June 2000) Most will suffer no permanent damage but about 1% suffers severe damage. It is estimated that there are 34,000 unnecessary deaths every year due to a medical error, the approximate equivalent of two Jumbo jets crashing each week. Every year in the UK approximately 40,000 victims of medical errors are left permanently damaged, (some very seriously).

S.I.N. is aiming to improve standards of medical care in the NHS, to reduce medical errors and to help our members obtain the truth, justice and genuine medical care: to change the culture from secrecy and denial to one of openness and full disclosure irrespective of legal liability. We include with this submission a summary of SIN’s ‘Aims & Objectives’

ELECTRONIC PATIENT RECORDS

Stakeholders:
We hope that the Health Select Committee will receive Evidence for their Inquiry into Electronic Patient Records from a variety of Stakeholders. One main group of Stakeholders is, of course, patients. Since the Electronic Patient Record will hold patients’ sensitive and confidential medical information this should mean that the views and concerns of this specific group of Stakeholders should be of major importance. We trust that the Health Select committee has made contact with a variety of Independent Patient Support NGOs .

To quote from the recent NHS Document, “Safety First” December 2006 NHS, authorised by Sir Liam Donaldson, Chief Medical Officer, and written by Mrs. Pauline Philip of the WHO Patients for Patient Safety Alliance and Sir Ian Carruthers OBE, Acting Chief Executive of the NHS:

“Consumers of healthcare are at the heart of patient safety.”…..” Patients and their families have a unique perspective on their experience of healthcare and may provide information and insights that…… may not otherwise…. (be) known.” [Recommendation 13]

Theory:
We understand that the project of Electronic Patient Records will involve transferring sensitive, confidential medical information relating to specified named patients from previously held Manual /Paper Health Records, and registering this information onto an Electronic Data Base (computers) using specialised customer devised computer programmes. This information will then be available for any Health Professional, presumably with coded access, who has care of an individual patient. Such information once on an Electronic Data Base can be transmitted throughout the UK and indeed throughout the world. As far as we know, patients will not have access to their personal medical information stored on this Electronic Data Base. In theory one can see that immediate access to information about a patient by a Health Professional at the press of a computer key, could improve Patient Safety, particularly if it is an emergency situation, the patient is unconscious and, worse still, away from home. Instant access to blood type, allergies, medical conditions (Diabetes, Aids, pregnancy etc.), results of scans and X-rays and previous illnesses, would be of immense value. However, there are potentially very serious problems that could be counter productive to Patient Safety. These we shall outline in the following section on Potential Concerns/ Problems.

It is worth noting that already many Trust Hospitals already have patient records on computer and this is the case with most GPs. Presumably the intention is to have all of this information in one universal computer programme. It is also worth noting that patients’ medical details are already computer coded using the International Disease Classification 10 (IDC10) which is, as the name suggests, international. These codes are extraordinarily detailed. Lists of the codes can now be found on the Internet for downloading. Every consultation, disease, operation, intervention, test and scan can be recorded with results and even, we understand, if the treatment is less than perfect. It is very difficult to access these codes. Many patients have tried to obtain their own medical IDC10 codes and, to our knowledge, only one succeeded and that was probably due to subterfuge. We believe that it is in these IDC10 codes that the most truthful and most accurate personal medical details can be found. We also believe that it is information taken from these Codes that is used for National Data. Presumably, these IDC 10 codes will be used (incorporated) as a base for the Electronic Patient Records?

Potential / Concerns Problems:

1. Flaws in the system: A computer programme is only as good as (a) the details of the specification and (b) the skills of the programmer. The track record of government introduced computer systems is not good. Already there are alarm bells ringing for this particular programme, partly because of its complexity and its huge scope (50 million patients in England) – 60 million if the whole population is included. There are also disputes as to what is to be included. We understand that Accenture, the Global International and Technology Group withdrew from the Project in September 2006.

2. Cost: Very difficult to obtain estimated cost. It was thought originally to be in the region of £3Billion, has risen to £12 billion and even to £20Billion (Lord Warner for all NHS IT programmes over 10 years). The National Audit Office has recently suggested that the cost may well be as much as $24Billion ( Baseline Magazine 18/06/06) – more than the cost of building the Channel Tunnel. Jon Keating, Chief Executive of Formic suggests £20bill over 10 years. We hope that in the interests of the Public Purse that the Health Select Committee will investigate and ask searching questions as to whether there is sufficient rigorous control and supervision of the budget and who is to be held accountable for the escalating cost.

3. Time scale: This is constantly changing. From information we have received it is at least two years behind schedule and probably more.

4. Confidentiality: This is of critical importance. Obviously patients are very worried about this aspect of the Project. The Foundation for Information Policy Research (FIPR) considers that the system is very flawed as far as confidentiality is concerned. Also, we understand that the BMA have also expressed its reservations about this issue. The Health Select Committee will need to satisfy itself that confidentiality of this sensitive personal information is absolutely assured.

5. Permission: The Electronic Patient Record project has been in progress for a number of years, yet in all this time when have patients been consulted? Have any Independent Patient Support Groups (NGOs) had their opinions sought? If not, then the Department of Health is failing to pay even lip service to its public pronouncements of : “Consumers of healthcare are at the heart of patient safety.” It is outrageous that it has not been thought appropriate to seek the permission of individual patients before transferring their sensitive, confidential medical details to what could be a very flawed system. This is a total dis-empowerment of the patient. We believe it is an infringement of a patient’s right to confidentiality and this is a breach of our Human Rights.

It is our opinion that written permission from each patient should be requested before any
transfer of medical information takes place, with a full explanation from the NHS of what the Electronic Patient Record will actually mean – the advantages and disadvantages. We know of a number of patients who have written to their GPs stating that they refuse permission for their medical records to be transferred onto computers. Unfortunately, there is no guarantee that their wishes will be followed. On a Radio 4 programme it was suggested that any patient who did withdraw from the Electronic Patient Data Base would not be able to receive care within the NHS. It is hoped that the Health Select Committee will clarify this issue and protect the personal rights of patients.

6. Accuracy:
Most people, if they ever take the trouble to read through their Manual Paper Health Records, are shocked when they note the number of inaccuracies the records entail. Most of these are minor but some a very serious and potentially dangerous. Some Records fail to mention allergies to steroids or antibiotics. Some fail to mention that the patient has had an appendectomy (or conversely incorrectly state that the patient has had this operation). Some may fail to mention the patient has AIDS or falsely state the patient has AIDS. Some female patients report on their gynaecology records being muddled with other patients with similar names. Sometimes the Blood Group may be wrong sometimes the test Result is incorrect and so is the diagnosis, or, very often, the diagnosis is missing.

The excuse given for not checking that information to be transferred onto the Electronic Data Base may be inaccurate, is that Health Records have always been inaccurate. We suggest this reason is illogical, there is no excuse whatsoever for transferring information without verification for accuracy. Not to do this is endangering Patient Safety and putting individual patients at risk. Accuracy is critical.

The other source of inaccuracy is human fallibility – the transfer of one set of data to another Data Base opens up more scope for inaccuracies to creep in.

7. No Procedures to check accuracy:
As far as we are aware, there are no procedures for checking accuracy. In our opinion this is a dangerously cavalier attitude to Patient Safety, and we hope the Health Select Committee addresses this issue. The patient is excluded once again – a total dis-empowerment of the patient.

8. No Procedures For Correction:
Again, as far as we are aware, there are no procedures in place that enable the patient to correct factual inaccuracies. The patient is excluded once again – a total dis-empowerment of the patient. Yet these Records will be transmitted over the UK and indeed, presumably the world.

9. How correct are our Medical Records?
We must remember that medical errors are a fact of life, they are inevitable. It is now accepted that somewhere in the region of 10% of patients entering UK hospitals will be subjected to a medical error, mostly minor although 1% have very serious outcomes such as death or permanent disability (Chief Medical Officer’s Document: Organisation with a Memory). It is reasonable to assume that many of these medical errors remain on our records, indeed, it is estimated that 50% are errors of diagnosis. Similar medical error figures are estimated for all Developed countries. These estimates only refer to hospitals; there are no figures, estimated or otherwise for GP mistakes.

It is amazing that in the UK patients have only had the legal right to receive copies of their
medical records since the early nineties. It is extraordinarily difficult for a patient to get any medical mistake rectified, even with factual evidence. It is extremely worrying to read of the regulations devised by civil servants that give General Practitioners (GPs) virtual carte blanche to change or remove any item they think fit from a patient’s medical records. The changing of medical records occurs without reference to the individual patient: the dis-empowerment of the patient is complete. The following section is a quote from official regulations as set out by the civil servants of the DH. Please, note that there is absolutely no reference to the patient as having any part to play in maintaining their own medical records. The doctor is in full control.

Section 31 of the Health Service Circular 1998/217. The use of Clinical records reads as follows:

“ General Practitioners ( GPs) are required by the terms of their service to keep adequate (?)records. The records are used by doctors to help them in their diagnosis and treatment of their patients, and provide a history of a patient’s encounters with his/her GP. This means neither that it is necessary to retain every piece of paper or record every item of data received in connection with a patient, nor that everything which is added to a record can never be deleted. The Department’s view is that the notes should record what is in the patient’s best interests (sic) and the details of any product which has been used in the course of treatment. Otherwise, it is a matter for the judgement of health professionals acting on the advice of professional bodies and organisations to consider what is adequate for the purpose” (page 5)

10. Medical records and the iatrogenic patient:
The iatrogenic patient, for the purposes of this Evidence , is one who has been seriously injured by an Adverse Medical Incident ( AMI).

We live with a health system of ‘denial and cover-up’. The former Secretary of State for Health , Mr Alan Milburn, stated on the Department of Health’s (D.H) . website in 10th.July 2001 that :"Mistakes happen & cover-ups occur”. There was a leaked document from the D.H. published in a newspaper 28th December 2001 Daily Mail which claimed that “50 scandals a year of very serious patient abuse were being covered-up by the D.H” Unfortunately, an iatrogenic patient is not considered to be in need of care and counselling, but is immediately transformed into an adversary, a potential litigant. Once a patient has suffered death or a serious iatrogenic injury all medical evidence suddenly becomes “sub judice”. Nothing that could indicate legal liability should be released. What cannot be disclosed must be covered up.

The NHS controls all the evidence, and instantly the barriers come down. The more serious the damage, the greater the inaccuracies within the Records, presumably because the greater the potential claim. Medical records for an iatrogenic patient are a nightmare, for critical documents go missing, test results are falsified and documents are changed to the patient’s knowledge and, in addition, there are numerous misleading statements and written derogatory remarks in order to discredit the patient. In their Health Survey of 1998, the Association of Community Health Councils for England and Wales (ACHCEW) stated that : “most CHCs had had clients who have discovered judgmental or other inappropriate remarks in their Records” .

It is well known that serious inaccuracies are invariably found in the records of iatrogenic patients. In the 1998 Health Survey previously mentioned, the Community Health Councils stated that “ more than two thirds of their clients have discovered factual inaccuracies in their records”. This survey also drew attention to the fact that former Health Minister, Simon Burns, was aware of this problem in 1996 and he suggested the “possibility of ‘blanking out text’ which includes inaccurate or misleading information.”

Iatrogenic patients have been aware for many years, ever since they received the legal right to have copies of their Medical Records (1992), that their records are changed, although this is , presumably, a criminal offence. That medical records (of iatrogenic patients) are subjected to changing or ‘tampering’ has been acknowledged publicly in the House of Commons.

In answer to a question on this matter a Minister for Health John Denham replied on 16th March 1999 [75922]:
“ There was no evidence that tampering with medical records occurs to the extent that would warrant a national assessment”.

SIN believes that tampering (falsification) is endemic – how else can the cover-ups be perpetuated considering there are thousands of needless deaths and thousands of permanent and seriously damaged patients each year? Dr Phil Hammond in his book “ Trust me, I’m a doctor” states: ”Hide the notes a burn the X-rays are the stock solution to another tired old cock-up.” It is on record that in 1988 a lay member of the GMC requested that ‘tampering’ with medical records should be considered as ‘gross professional misconduct ‘ and thereby worthy of severe sanctions. Astonishingly, this was refused. Does this mean that a tax collector can tamper with our tax returns, that a bank clerk can tamper with our bank statements? If these people were to do this it would surely be considered to be a criminal offence? Yet to tamper with medical records which can affect ‘life and death issues’ appears to be of no or little consequence!

We believe that by now the reader will understand why all patients and in particular that very vulnerable group, the iatrogenic patient, should be very concerned about the introduction of the Electronic Patient Records, and that such a Data Base would be counter productive for Patient Safety, and actually put patients at risk, for we have already illustrated the difficulty of obtaining a complete set of accurate medical records.

The following quote is from a former Master of the Rolls. Lord Donaldson : ‘Duty of Candour’ and did not increase our confidence in the system.

“Whilst it is arguable that doctors had a duty not to falsify medical records under common law before Powell v Boladz 1997 there was no binding decision of the courts as to the existence of such a duty. As the law stands now, however, doctors have no duty to give parents of a child who died as a result of their negligence a truthful account of the circumstances of the death, nor even to refrain from deliberately falsifying records.”

Whilst there are no safeguards to prevent inaccuracies from being transposed onto this new Data Base, the Reader can see why, with evidence, we have little confidence that the new Electronic Patient Record will improve Patient Safety and provide satisfactory medical care

The ease with which patients’ records can be retrospectively changed is obvious, and computer kept records are even easier to alter. We know that the hard drive of a computer retains the original record and in the case of Dr Harold Shipman it was using computer experts to examine the hard drive of his computers that enabled the police to prove that Dr Shipman had been retrospectively changing his patients’ records. However, that was in the case of Dr Shipman who was thought, quite correctly, to have murdered several hundred elderly patients, it is hardly likely that the individual patient can obtain a computer expert to inspect a health professional’s computer should there be a suspicion that records had been changed. Nor would the police wish to get involved for an individual patient.

In the case of Robbie Powell (1989), his father had paper evidence that the GPs involved with Robbie’s negligent death had retrospectively changed his son’s Records. He also had an independent witness to corroborate his statement, a Methodist Minister. Yet, it took him sixteen years to have a chance of delivering the evidence in court. Few people have Mr.W.C.l Powell’s stamina and few are able to obtain such conclusive evidence. If Robbie’s Records had been on an Electronic Data Base, we doubt whether his father would have been able to obtain the necessary evidence to prove that Robbie’s Records had been deliberately changed in order to protect the GPs. The GPs in question were fully aware that the changes had taken place, thus showing that health professionals were not averse to collusion.

It is obvious that an Electronic Data Base of our Medical Records will be at risk of change whenever a health professional gets something wrong, for at a touch of a button whole sections can be deleted and new ones written. Manual Paper Health records can be altered, but are much more difficult to change, and changing them involves risk.

In order to improve Patient Safety SIN, as part of its ‘Aims & Objectives’ set out this solution in July 1999: Statutory / legal obligation for the patient to receive copies of medical records after any consultation, checked for accuracy, signed and dated by the patient. This will prevent subsequent changing of records and stop genuine mistakes and inaccurate information from being propagated. It will protect both patient and health professional. Copies of test results, X-rays, scans etc. should also be available on request, perhaps with a small charge. Basically, patients should have control over their own medical records. This cannot happen with an Electronic Data Base of Health Records.

11. Iatrogenic Patients denied care.
This is one of the most serious consequences of becoming an iatrogenic patient. It is a direct result of our ‘denial and cover-up culture’, for health professionals are unable to disclose when damage has occurred because of legal liability. It follows then that it is almost impossible for such a patient to obtain genuine specialist remedial care following a serious AMI, for to give remedial care would confirm that damage has occurred and so give evidence for a successful court case for compensation. The Health Select Committee in its 1999 “Inquiry into Adverse Medical Accidents and their Outcome”, came to the same conclusion after reading through nearly 300 submissions from patients and their relatives who had suffered a serious AMI.

In October 1999, a statement appeared in an article in the ‘Observer’ newspaper dated 24th October 1999 from the Chair of the Health Select Committee following on from its Inquiry into “Adverse Medical Incidents and their Outcomes" confirmed that iatrogenic patients were ‘blacklisted’. Denial of care was an outcome of being a seriously damaged patient.

Lord Woolf, the former Lord Chief Justice of England and Wales, in his Inaugural Lecture dated 17th January 2001 in a Review of Medico-Litigation, also came to the conclusion that iatrogenic patients could be denied care.

Lord Woolf, in his Inaugural lecture Jan 17th 2001, also confirmed this outcome: “ A new culture is required. ………the medical carers were able to sympathise with the patient. They needed to recognise that because a patient 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.”

12. CONCLUSION:
In spite of some ‘theoretical advantages’, it is our opinion that the Electronic Patient Record project should not be introduced because the disadvantages are so great. We have illustrated that there are too many flaws and problems and that such a project is premature and should be abandoned. We have argued that such a flawed Data Base is counter productive to Patient Safety and could be dangerous and put patients’ health and lives at risk:

(a) Escalating costs
(b) Escalating time scale.
(c) Technical problems with devising computer programmes
(d) Confidentiality of such sensitive information is not secure and cannot be guaranteed.
(e) Permission from patients has never been obtained and is therefore a breach of their Human Rights.
(f) Checking for accuracy and verification has not been incorporated into the procedures.
(g) Dis-empowerment of patients, who have no means of checking the veracity of their sensitive medical details, nor are there any procedures in place for corrections to be made.

It is obvious that, with human fallibility, a person’s medical records are most unlikely to be totally accurate. Most errors will be minor but some will be serious and potentially dangerous. We have pointed out that medical errors are all part of the NHS system of health care, they are inevitable. We have also demonstrated that that the NHS has never devised a system for being open and honest when things go seriously wrong and therefore health professionals are unable to disclose if serious damage has occurred because of legal liability. Within such a system the integrity of medical evidence is very vulnerable and there is no doubt that ‘tampering’ occurs because the system adopts a defensive and protective attitude whenever an Adverse Medical Incident happens.

We believe we have argued, with evidence, that all patients will be at risk if such a flawed and inaccurate Electronic Patient Record Data Base were to be introduced. However, the group of patients most at risk would be the traumatised and very vulnerable seriously damaged iatrogenic patients, who are being denied care because of legal liability. The following case study will demonstrate this:

This patient had been suffering excruciating back pain for a number of years with steady deterioration. Yet, in spite of numerous scans and X-rays orthopaedic consultants and neurologists could not explain the cause of his pain. He was unable to secure a diagnosis. Eventually, after many years he was offered an appointment at a Pain Clinic, but the treatment given made little difference. Another problem was that he was a manual, self-employed worker and his deterioration in his walking was a constant source of worry. The patient had always wondered whether an injection of Myodil dye (oil base) into his spinal cord in 1985, was the cause of his present pain. Myodil was banned in the USA for spinal injections in the 1970’s and in this country by the mid -eighties. Now, such a dye is known to cause inflammation of the spinal cord and nodes, like cysts, are formed which gradually enlarge. Eventually, these growing nodes exert pressure on the spinal cord that results in excruciating pain and can lead to paralysis, obviously, of great concern to this patient.

In 2006 he went with his family to India where his legs gave way and he collapsed. He was rushed to a local hospital where the anxious doctors gave him blood tests, scans and X-rays. Within hours the patient was given what had eluded him in the UK for many years – he was given a precious diagnosis. Not only did he get this, but he also got an apology from these Indian doctors who were compassionate enough to realise that the patient must have been in (unnecessary) excruciating pain for years. They apologised for all his suffering because of ‘mismanagement’ as they put it. This reduced this macho man to tears – it was the first time any health professional had shown him sympathy.

His diagnosis- was as he had suspected – Arachnoiditis. He had very large swellings on his spinal cord which were obvious from his scans, and was told he required an emergency operation. Unfortunately, his Medical Insurance would not pay for this, so he was sent back to the UK by air-ambulance. He now thought that his care would be guaranteed.

Back in the UK a Consultant Radiologist confirmed the diagnosis when he was shown the patient’s scans. The patient, perhaps naively, handed over his scans to the specialists under whose ‘care’ he had been for years. Unbelievably, his precious Indian scans were ‘lost’ and when he contacted the Indian hospital they said they had no more copies. Did our patient get his diagnosis from the UK doctors – NO. Did he get his emergency operation – NO.

What is the meaning of all this? Can so called Third World doctors be more expert than our own doctors? Very unlikely. Could it be that this poor patient had been denied his diagnosis and appropriate care because, through no fault of his own, he was considered to be an iatrogenic patient and therefore a legal liability? Is this why he was being denied care? The UK doctor’s defence would be that it is ‘the system’ – a very cruel and wicked system. If all doctors of integrity would undertake to put the needs of the patient first, above legal liability, then this inhumane system would be changed over night.

Let us consider what would have happened if this patient’s health records had been on an Electronic Data Base. Presumably, the Indian doctors would have entered his number into a computer, and up would have come his information. We speculate that this information would
not have contained his accurate diagnosis nor would the scans taken have shown any damage to his spine. There may even have been a code for ‘potential litigant’, thus indicating iatrogenic damage. This would have put the Indian doctors in a very difficult position, for with professional allegiance being strong, they may not have been so truthful.

At least with Manual Paper Records it gave the patient a chance of obtaining a genuine second opinion. He, at least, knows the truth.

It is our opinion that for the sake of Patient Safety the present culture of ‘denial and cover-up' must change to one of ‘full, open and honest disclosure regardless of legal liability’ whenever a serious AMI occurs. SIN, since July 1999, has been calling for a :

Statutory obligation for health professionals to register all medical errors no matter what the cause;
Statutory obligation for the patient/relatives to be informed if serious damage has occurred;
Statutory obligation for the damaged patient to receive genuine remedial care regardless of legal liability;
Statutory obligation for a full causal analysis into the medical error including the patient’s perspective; and where damage is severe, a

Statutory obligation for the patient to receive compensation against a National Tariff with Mediation. The recent Redress Bill is a beginning, although the capping is £20,000.

Statutory obligation for the patient to receive all medical records, including test results, immediately after each consultation, checked and signed by the patient.

In short, when the TRUTH prevails within our system of healthcare, then and only then, will it be appropriate to introduce an Electronic Patient Record Data Base.

Emails: sinfo@bluebolt.com & mag@sinfo.freeserve.co.uk www.sin-medicalmistakes.org
Member of the IEU-Alliance ( Iatrogenic Europe Unite) www.ieu-alliance.org

Footnote:

The Case mentioned in the Conclusion was recorded in the Media.

It was reported in the Sunday Times dated , 30th December 2007 that the BMA was concerned about the confidentiality of the Patient Electronic Record and that individual permission should be sought.The article suggested that patients who wished to opt out should do so by obtaininng a standard letter from the Internet.

The recent scandals ( November /December 2007) of several Electronic Data Bases going missing from various government departments emphases that the Public is not ready for the computerisation of personal confidential health data

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