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					Patient Safety – A Personal View

The Cost: Financial and Human

With a budget of £76.4 billion1, inevitably much of the focus in the NHS is on cost. We seem to lunge
from one financial crisis to another with some Trusts now said to be technically insolvent and a £620
million deficit predicted for this year.

The real focus however should be on patient safety. The suffering and despair associated with injuries
and death caused by inadequate care is inestimable. Substantial improvements in safety will lead not
only to reduced morbidity and mortality, but to a reduced demand on NHS services to treat what used
to be termed “iatrogenic” conditions.

Each year hundreds of thousands of patients are harmed by the NHS 2. Thousands more die because of
poor care and errors in medical treatment yet most of these deaths attract no attention. Far too little is
being done to address this appalling loss of life. What has happened to the Hippocratic doctrine of
First do no harm3. What lessons are being learned? Has anyone stopped to ask the financial cost to the
NHS and society of this intolerable human attrition?

Two proposed areas of legislation indirectly offer hope of improvements in NHS care: Coroners and
NHS Redress.


Openness in Improving Safety

Key to improving safety is the proper, effective and impartial investigation of incidents causing injury
and death. However, no such system exists which could form the basis of guidance and clinical
practice rules designed to avoid medical accidents. Clear standards have to be recognised against
which the provision of health care has to be judged before poor and unsafe practices can be eliminated.

Notwithstanding repeated attempts to persuade health care workers to be open about mistakes and
failures4, little progress has been made. In September 2005, the NHS National Patient Safety Agency
(NPSA) issued a “Safer Practice Notice”. It was entitled “Being Open when Patients are Harmed”. An
Australian project on openness was cited which showed patients were fully supportive of being open!
It is neither patient sensitivity nor a “blame culture” which is responsible for this lack of openness. At
best it is because of ignorance of the occurrence or cause of the harm suffered; at worst it is because of
a determination to cover up individual and systemic failings. Why should anyone expose themselves to
possible criticism, ridicule and censure by being open and truthful if such loss of pride and humility
can be avoided? The removal of the “litigation threat” would not remove the opprobrium of admitting
poor practice causing injury or death.

It is frequently said by the opponents of clinical negligence actions that the fear of litigation leads to a
lack of openness and that without a “blame culture” health care workers would be more forthcoming
about the circumstances in which patients are injured or die. But there is no evidence to support this
contention. Would those opposed to litigation in the NHS perhaps be in favour of a proper system of
impartial exploration of the facts? Would health care workers then be more forthcoming about their
failures? I doubt it.

The latest Safer Practice Notice offers help for those struggling with this openness concept but I have
yet to find anyone working in the NHS would has even heard of the notice. The NPSA has developed a
“Being Open” e-learning tool. One has to assume that this is some cyber device to encourage health
workers to tell the truth.


1
  More than the GDP of 155 nations
2
  No accurate figures exist; on the basis hospital diagnostic codes some put the figure at about
850,000/yr but adverse events may be under-recorded within hospital episode statistics
3
  Epidemics, Bk.I, Sect. XI: As to diseases, make a habit of two things: to help, or at least to do no
harm”
4
  eg: DOH June 2003 “Making Amends”


                                                                                                          1
Greatly to the credit of the Association of Surgeons of Great Britain and Ireland, a confidential
reporting system in surgery (CORESS) mirrored on the effective CHIRP 5 in the aviation and maritime
industries. These systems enable lessons to be learned from incidents which might not otherwise come
to light, but in themselves cannot afford a sufficient protection.


The Rôle of Litigation

Litigation has exposed many poor practices and brought about improved safety standards in health
care. Before the 1980s6, when there was no “litigation threat”, the medical profession enjoyed and
fostered a culture of secrecy. Such accountability as there was existed only through an entirely self-
regulated GMC7.

Even now a patient injured by potentially negligent medical treatment still has no means of compelling
those responsible to be called to account. Absent a public inquiry or a fully contested criminal or civil
trial, there is no means of exploring on oath and in public the facts and issues relating to medical
accidents. Neither the GMC nor the NHS Complaints system fulfils this function. Patients injured by
medical treatment are far more numerous than the civil claims made for damages. Medical Audit is
poorly co-ordinated at a multidisciplinary and national level with little learning benefit 8. It is still in its
childhood and, like Peter Pan, likely to remain there.

No one in the field of risk management can fail to appreciate that litigation, notwithstanding its
deficiencies, still remains the only way in which patients can compel a proper investigation of the
circumstances of their injuries.


The NHS Redress Bill

Whilst laudable in its stated objective of providing a “speedy and appropriate response when something
goes wrong” the Bill, in its present format, has little prospect of achieving it. Subject to proposed
amendments, it remains tort based with the NHS acting as both judge and jury on facts and law. Most
importantly it does not address the critical issue of why injuries occur and makes no provision for
effective independent investigation. Amendments tabled by Lord Howe would enable the Secretary of
State to confer appropriate powers upon “Patient Redress Investigators”. This is a commendable step
to a statutory investigative authority, independent of the NHS. Such an authority will need all the
appropriate powers of a court including the power to compel the production of documents and the
attendance of witnesses. Examination should be on oath and in public. Although its purpose should be
to investigate medical accidents, the authority should be limited to reaching conclusions of fact. Two
outcomes should follow: common law levels of financial compensation to those affected and rules of
practice to avoid repetition of injury or death.


The Rôle of the Coroner

When a death suspected to have resulted from poor medical practice/care occurs, the coroner’s inquest
is very often the only opportunity for the factual circumstances to be investigated. There are no national
figures but anecdotal evidence suggests between 7,000 and 13,000 of the 25,000 inquests each year
relate to deaths in hospitals. Thousands of deaths caused through incompetent care are never



5
  Confidential Human Factors Incident Reporting
6
  Consciousness of patient safety really began to develop at the beginning of the 1980s with the
publication of the first CEPOD and AVMA was formed to provide assistance to solicitors seeking to
bring claims against Health Authorities and doctors. Hitherto, advancing medical negligence actions
was enormously difficult. Solicitors did not have the experience to advance claims which were
considered simply to be a variant of personal injury claims. Experts were difficult to find and
inexperienced in giving evidence.
7
  BRI Inquiry July 2001 – Brief history of audit paras 23 & 29
8
  National Audit Office: A Safer Place for Patients 31 st October 2005


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investigated at all9 particularly those from amongst the most disadvantaged in our society. Of those
deaths which are investigated, the quality of the investigation is variable. Coroners are under financial
pressures from their local authorities and complain that they simply do not have the resources properly
to carry out such investigations. The present system is totally unsatisfactory 10. The anticipated “urgent
official attention”11 to the problem has only just resulted 12 in a government statement from Harriet
Harman QC. A Bill is expected at the end of the year.

Since 1995 coroners have relied upon the decision of the Court of Appeal in Jamieson13, to limit the
scope of investigation of how the death occurred, interpreting “how” as “by what means” rather than
“in what broad circumstances”. The pressure for proper investigations into hospital deaths has
increased since the Human Rights Act 1998 came into force and the new legislation will have to be
compatible with it.

Under the terms of Article 2 of the Convention for the Protection of Human Rights and Fundamental
Freedoms “Everyone's right to life shall be protected by law…”. It has been argued in a number of
coroners’ cases that in respect of unnatural deaths in NHS hospitals the state has an investigative duty
under Article 2 - what has come to be known as “Article 2 being engaged”. In Goodson14, where a man
died from peritonitis from an iatrogenic double bowel perforation, Richards J (as he then was)
recognised that the language of the Strasbourg cases is sometimes confusing, eliding the positive and
procedural obligations under the Article. The Court of Appeal have recently clarified the position in
Takoushis15 where a schizophrenic at high risk of self harm left a hospital without being seen within 10
minutes required by the system and committed suicide. Article 2 being engaged means that the state
itself has an obligation to investigate the death which, since Middleton, is usually done through the
medium of the coroner’s inquest16. A medical death where there is evidence to support a charge of
gross negligence manslaughter falls within this category17.

However, the majority of medical deaths are caused by simple negligence. In these cases Article 2 is
not engaged in the sense of the definition, but under Article 2 the state still has a positive obligation to
set up an effective judicial system. This includes the effective and practical investigation into medical
deaths. Importantly, civil proceedings cannot be assumed to be sufficient: the claim may only be for a
comparatively small sum such that it would not make practical or economic sense for civil proceedings
to be begun; a family may not be able to obtain legal aid; liability may be admitted. In each case an
independent investigation of the facts as part of the civil process is rendered impossible.


The inquest thus fulfils a vital role in discharging the state’s obligation under Article 2 even into
medical deaths where Article 2 is not “engaged”. The hearing still has to be a full, fair, practical and
effective public investigation into the facts in which the family is able to take a full part. Indeed, the
only practical difference between Article 2 being “engaged” and not being “engaged” is that in the
former, the investigation has to be initiated by the state per se. Although the Court of Appeal was
bound by the decision in Jamieson, looking at the way the Court approached the facts, it is clear that
Takoushis extends the interpretation of “how” the deceased came by his death well beyond the
Jamieson restriction. The new inquest ordered in Takoushis obliges the coroner to conduct a full and
proper investigation of the operation of the system at the hospital which allowed the deceased to leave


9
  Some put the figure of deaths caused by poor medical care at 40,000/year: Dr Foster BMJ 14 Aug
2004; 329
10
   See: Death Certification and Investigation in England, Wales and Northern Ireland: The Report of a
Fundamental Review 2003 (Cm 5831) (June 2003); Shipman Inquiry 3rd Report
11
   Lord Bingham of Cornhill, Oct 16 2003: para 33 R (Amin) v Secretary of State for the Home
Department [2004] 1 AC 653
12 th
   6 February 2006
13
   R v HM Coroner for North Humberside and Scunthorpe Ex p. Jamieson 1995 QB 1
14
   R (on the application of Goodson) v Bedfordshire and Luton Coroner (Luton and Dunstable Hospital
NHS Trust, interested party) [2005] 2 All ER 791
15
    R (on the application of Helen Takoushis) v HM Coroner for Inner North London and Guys and St
Thomas’s Hospital NHS Trust and The Commissioner of the Metropolitan Police (CA) 30/11/05
16
   R(Middleton) v West Somerset Coroner and Another [2004] 2AC 182 para 47
17
   Regina (Khan) v Secretary of State for Health [2003] EWCA Civ 1129, [2004] 1 WLR 971


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before being seen by a psychiatrist. In practice the inquest into “how” a medical death occurred has
become, as it should, an investigation into both the means and the circumstances of the death.

The proposed new legislation on coroners must embrace these principles. Coroners will be full time
specialists. Given sufficient training, proper funding and the independent medical expert assistance
they undoubtedly require when investigating medical deaths, the inquest in its developing format could
satisfy the need for proper inquiries into medical deaths. The full participation of the family of the
bereaved will probably require public funds to be made available for representation in appropriate
cases. Given an appropriate system for recording and reporting such inquiries, essential lessons for
future patient safety can be learned.



The Medical Accidents Investigation Authority

There should be a new statutory authority mirrored on the highly successful and well respected model
of the Air Accidents Investigation Branch (AAIB). A comparable authority such as a Medical
Accidents Investigation Authority (MAIA) would need to be completely independent of the NHS,
although ultimately responsible to the Secretary of State.

Given the enormous number of patients injured or whose deaths are materially contributed to by
unacceptable levels of care, the MAIA could not investigate every case. Nevertheless it should have
the power to investigate any case referred to it.

Notwithstanding the potential for the revised coronial system, the coroner should have the power to
adjourn an inquest in order for a medical death to be investigated by the MAIA. Under the present
legislation a simple amendment to S.17A of the Coroners Act 1988 (Adjournment of Inquest in the
Event of Judicial Inquiry) 18 would be required. Unless there was an exceptional reason for doing so the
coroner could have a discretion not to resume an inquest after a full MAIA investigation.

The MAIA would silence the argument that it is the fear of litigation which is stultifying openness.
Openness is insufficient in the presence of ignorance. A proper exploration of the facts is still required
and the MAIA would fill an important gap in the NHS Redress Bill. Such an authority would be costly
but in the long run the quality of care within the health service would improve and resources presently
wasted in treatment of those injured by the NHS would be conserved. The new coronial service could
also have the benefit of effectively removing at least some medical deaths from its jurisdiction. Given
the enormous reluctance of many coroners presently in office to embark upon medical inquests, I
would also expect such an arrangement to be welcomed by the Coroners Society.


Conclusion

Without a Medical Accidents Investigation Authority, notwithstanding the NHS Redress legislation,
litigation will remain the only means of ensuring a proper investigation is carried out at least in those
cases where liability for injury is not admitted. Similarly, full inquests will continue to be required
under the coronial system in its present or future format into all medical deaths unless a suitably
empowered MAIA can assist in discharging the state’s Convention obligations.

Effective, independent investigation provides the key to ensuring that lessons from medical accidents
really are learned. All those working within the health sector should be pleased to be subject to close
scrutiny. This is essential to ensure high standards and improve morale. The NHS plays a major role
in our society. We need to be confident and justly proud of the quality of care it provides.


Dr Michael J Powers QC

Clerksroom, London

18
  Inquest into the death of the government scientist, Dr David Kelly, not resumed after Lord Hutton’s
Inquiry (January 2004)


                                                                                                        4
199 Strand WC2R 1DR

0845 083 3000

14th February 2006




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