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 NHS².  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. 

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 CHIRP⁵ 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 benefit⁸.  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 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 unsatisfactory¹⁰.  The anticipated “urgent official attention”¹¹ to the problem has only just resulted¹² 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 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

199 Strand WC2R 1DR

0845 083 3000

http://www.medneg.co.uk