Medical Errors and Adverse Events: Managing the Aftermath: Managing the Aftermath

Copyright © 2011 by David Waluube.

ISBN:         Hardcover                               978-1-4653-5401-3

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Contents

Preface

Acknowledgements

Chapter 1

Definitions of Terms Used in the Text

Chapter 2

Training of Doctors and Practising Medicine as a Profession

Chapter 3

Classification of Medical Errors

Chapter 4

Incidence of Medical Errors and Adverse Events in the UK and USA

Chapter 5

Underlying causal factors in the occurrence of Medical Errors and Adverse Events

Chapter 6

Common Causes of Medical Errors

Chapter 7

Informed Consent: Other Theories of Consent and their relevance to Medical Errors and Adverse Events

Chapter 8

Learning Medical Fallibility

Chapter 9

Psychology of Medical Disasters: Risk Assessment of Medical Disasters

Chapter 10

Doctors’ professional obligations to their Patients

Chapter 11

Doctor-Patient relationship: Its effect on the Outcome of Medical Errors and Adverse Events

Chapter 12

Doctors’ response to Medical Error Outcomes: Mechanisms used to cope with the Aftermath

Chapter 13

Managing the Aftermath of Medical Errors and Adverse Events: Cleaning up afterwards and reducing the threat of Litigation

Chapter 14

Medical Errors and Litigation: Why do Patients sue Doctors?

Chapter 15

The process of Litigation in the Medical profession in UK and USA

Chapter 16

Reducing the occurrence of Medical Errors and Adverse Events

Chapter 17

Prevention of Medical Errors and Adverse Events

Chapter 18

Medical Devices, Equipments, and Medical Errors

Chapter 19

Medical Errors in Prescribing and Dispensing of Drugs

Conclusion

Glossary

About the Author Dr David Daniel Falijala Waluube

Dedicated to Mary, my mother, Mary, my wife,

my children, and grandchildren.

Preface

In health care, the rising complexities and reach of modern medicine have produced startling levels of risk and harm to patients. Serious or potentially serious medication errors occurred in 6.7 per cent of patients in one study in two highly regarded hospitals in the world, admittedly, many years ago now. The Harvard Medical Practice Study of 1984, which reviewed 30,000 hospital records in New York State, USA, found injuries from medical care to occur in 3.7 per cent of hospital admissions. Over 50 per cent of these injuries were preventable and 13.6 per cent of these were fatal. The cost of medical errors is high, both in financial, social, and professional terms. Statistics like these have influenced the ongoing mobilisation of public and professional sentiments to redesign health care products and devices, improve on faulty systems, and make health products and devices much safer.

When medical errors and adverse events occur, the reaction in medical settings is most commonly an attempt to fix blame and to punish someone. This, usually, is counterproductive. Fear, reprisal, and punishment produce not safety, but rather defensiveness, secrecy, and enormous human anguish. In complex systems, safety depends not on exhortation, but rather on the proper design of equipments, job planning, support systems, and organisations. Safer care systems do produce safer care.

In the USA, effective safety improvements have happened since the formation of the National Patient Safety Foundation (NPSF) by the American Medical Association (AMA). The Veterans Health Administration (VHA) undertook sweeping changes in its health-care system to reduce medical errors. It established centres of excellence to foster the much-needed, multidisciplinary research and design of safer systems of medical care.

A significant proportion of leading scientific research work on patient safety and medical error reduction in complex systems has also come from European researchers.

In the UK, there is now a system in place to record and monitor medical errors, near misses, and adverse events occurring both in the National Health Service (NHS) and within private health-care providers’ institutions. In the past, the NHS concentrated on dealing with individual errors rather than the environment that predisposed people to err.

In everyday life, we all employ a common human defence mechanism whenever we think of the unthinkable, which is that ‘it will never happen to me’. Medical errors and adverse events do happen, sometimes when we least expect them. If errors could be predicted, they would be avoided altogether. Medical errors do produce major psychological trauma in doctors as much as in those members of staff who witness them. This psychological damage may last for a very long time, sometimes for life. Members of the medical profession and their patients should maintain a good doctor-patient relationship, honesty, and good communication. Following the occurrence of medical errors, different organisations, with different hierarchies and responsibilities, will be drawn together to deal with the aftermath. These organisations have different expertise, different priorities, and different jurisdiction.

It is essential to have in place organised help and support for the doctors and those team members involved in the occurrence of medical errors. This support should be available locally in the initial stages of the aftermath. Medical defence organisations look after their members’ interests whatever the circumstances, and therefore, membership to these organisations is highly recommended. The General Medical Council (GMC) in the UK does police the conduct and other activities of doctors and, together with other agencies of state, may offer help and advice to individual doctors in an effort to rehabilitate and retrain such doctors. The General Medical Council actively encourages activities which improve self-regulation, continuing medical education, continuing professional development, and does supervise the revalidation and licensing of doctors.

Reading this book will be a step forward in the understanding of various factors which contribute to the occurrence of medical errors and adverse events and ways in which to deal with the aftermath. Prevention is better than cure.

Acknowledgements

This book would not have been produced without the encouragement and support of some of my consultant colleagues in the Directorate of Anaesthesia and Critical Care at the William Harvey Hospital, Ashford, Kent, East Kent Hospitals University NHS Foundation Trust, UK. I also wish to extend my gratitude to Ms Sharon Blackmore, secretary to the Directorate of Anaesthesia and Critical Care, for introducing me to many medical representatives working in the Kent area, who expressed interest in the book.

May I extend my appreciation to: Mr Andrew Grice, editor of Minerva Press (UK); Ms Grace Chisholm, executive editor of Pentland Books; Ms Carol Biss, managing director at The Book Guild Limited; Prof. Rory Shaw, ex-chairman of National Patients Agency; and last but not least, Mr Arnold J. Simanowitz of Action for Victims of Medical Accidents organisation, UK, who gave me encouraging testimonials about the book. It has been a long while since my last contact with these notables, but their appraisal of the manuscript gave me hope of getting this book on the shelves. Finally, I am grateful to Linda and Barbara, my daughters, for helping me with computer-based activities related to this publication.

Chapter 1

Definitions of Terms Used in the Text

Adverse Event or Incident: ‘an unintended injury that is caused, at least in part, by medical management (rather than by underlying disease) that prolongs the hospitalisation of a patient or produces a measurable disability at the time of discharge, or both of these’.

It should be noted that not every medical error produces injury to a patient and not every adverse event is a result of a medical error.

The Bolam Test—the required standard of medical care: In the UK, the legally required standard of medical care a doctor generally owes to a patient is based on the Bolam Test. The Bolam Test arose from a case where it was argued that the hospital was vicariously liable for the carelessness of a doctor who gave electroconvulsive therapy (ECT) to Mr Bolam without administering a muscle relaxant or restraining the convulsive movements to prevent injury. Mr Bolam sustained a fractured jaw during the procedure, and the case became known as the Bolam vs Friern Barnet Health Management Committee in 1957. The court sought the opinion of other doctors who worked in this area of medical practice, and they supported the actions of the accused doctor. Mr Bolam lost the case.

The key point that arose from this case was not the clinical situation and the adverse event which followed it, but it was the idea that the standard of care should be measured by other professionals who normally undertake the role of the defendant.

In the words of the judge, and I quote, ‘A doctor is not guilty of negligence if he/she has acted in accordance with a practice accepted as proper by a responsible body of medical men and women skilled in that particular art.’ Under English law, the Bolam Test was slightly modified following the case of Bolitho in 1997, which now means that an English court is not bound to hold that a particular practice is acceptable simply because there is a responsible body of medical opinion which supports it unless that body of opinion can demonstrate such opinion has a logical basis and that the experts have directed their minds to the question of comparative risks and benefits to reach a defensible conclusion.’

Clinical Governance: defined as ‘a framework through which the National Health Service (NHS) organisations in the UK are accountable for continuously improving the quality of their services and safeguarding high standards of health care by creating an environment in which excellence in clinical care will flourish’.

Critical Incident: defined as ‘any episode of patient care in which specific actions by a doctor or any other medical practitioner has specific beneficial or detrimental effects on a patient’. The term critical simply means that, very likely, the medical practitioner’s actions were directly responsible for the effects observed in the patient. Cooper et al defined a critical incident in anesthesiology as, ‘an occurrence that could have led, if not corrected in time, or did lead to an undesirable outcome ranging from increased length of stay in hospital or to death of the patient’.

Deposition: defined as ‘an out of court testimony of a witness recorded in writing under oath or affirmation’.

Disability: ‘a physical or mental state resulting from an injury or injuries, or abnormal development which limits normal activities by the patient. Disability can be temporary or permanent’.

Discovery: ‘a process whereby the parties and their legal teams attempt to uncover, review, and evaluate all evidence having any bearing on the facts of the case’.

Duty of Care: ‘reasonable care which avoids acts or omissions which one can reasonably foresee would be likely to injure a person directly affected by these acts or omissions’.

Expert Witness: ‘a medical or other professional whose evidence to a court may prove that the defendant violated the applicable standard of care in treating the patient’.

Correspondingly, an expert may testify as to the compliance of the defendant with standards of care, the appropriateness of decisions and actions, and in some cases, perhaps the inevitability of the patient’s outcome even with the best of care.

Fallibility: ‘quality of being fallible, i.e. liability to err’.

Informed Consent: ‘voluntary and continuing permission of a patient or legal authority to receive specified medical treatment based on an adequate knowledge of purpose, nature, likely effects, and risks of that treatment, including the likelihood of its success or failure, and any alternatives to it’.

Medical Error: ‘an unintended act of commission or omission or one that does not achieve its intended outcome; or an unanticipated negative consequence of a medical intervention or non-intervention here called commission or omission’. Unanticipated negative consequence of a medical intervention is defined as ‘patient reactions which increase morbidity or pain or results in death of a patient’. Medical interventions include diagnosis, test procedures, and prescribing drugs, among others.

Medical Device: ‘any health-care product, excluding drugs, which is used for a patient in the diagnosis, treatment, prevention, or alleviation of illness or injury’.

Medical Equipment: ‘the necessary article or machinery for a medical purpose’.

Medical Mistake: ‘an unanticipated negative consequence of medical intervention’.

Medical Negligence: ‘care that falls below the standard expected of a doctor in his/her community or a failure to meet the standard of practice of an average qualified doctor practicing in the same specialty under the same conditions on a similar patient’.

Negligence occurs not merely when there is an error, but when the degree of error exceeds the expected norm. The presence of error is necessary but not sufficient condition for the determination of negligence. Medical negligence is a composite of three essential elements: First is duty of care. The plaintiff (accuser) must show that the defendant owed him/her a duty of care. Second is breach of duty. The plaintiff must show that the defendant (accused), here the doctor, breached this duty of care by failing to provide the required standard of care. Third is actual cause of harm. The plaintiff must prove that this failure to provide the required standard of care by the doctor actually caused him/her the harm.

Post-traumatic Stress Disorder: ‘a process which follows the occurrence of a disastrous experience by an individual or group of individuals; manifested by the occurrence of nightmares, major sleep disturbance, phobias of places, including workplace, or anything associated with the disaster’. These difficulties are referred to as post-traumatic stress disorder.

Professionalism: ‘is the acceptable practice of an occupation which one professes to be skilled in and to follow’. Professionalism can be practiced as a vocation in which a professed knowledge of some department of learning or science is used in its application to the affairs of others or in the practice of an art founded upon it.

Re-validation (or Re-certification): ‘is an ending examination of the roles, rights, and responsibilities of the medical profession’. It is a process whereby doctors demonstrate to their peers, patients, as well as to their employers that they are worthy and fit to be on the medical register of the General Medical Council in the UK.

Self-Regulation: ‘a process whereby the clinical work of individual doctors can be judged by clinicians with at least the same level of specialist knowledge and experience as the doctor concerned’. Under this scheme, senior doctors appraise colleagues in other hospitals who work in the same specialty. Under this principle, the Parliament of the UK gives doctors the privilege of professional independence embodied in self-regulation.

Stress: ‘is a body’s reaction to actual or anticipated difficulties in life, difficulties which may be related to daily activities or more complex and unusual situations’. People do need a certain amount of stress to perform at their best, but too much stress produces many negative effects.

System: ‘is a set of elements interacting to achieve a shaped aim, or a methodically arranged set of ideas, methods, or procedures to achieve a specified outcome’.

References

1. Lisby et al., How Are Medication Errors Defined? A Systematic Literature Review of Definitions and Characteristics, International Journal for Quality In Health Care, 2010, 22(6), 507-18.

2. Naomi Engel, Jennifer Dmetrichuk, and Anne-Marie Shanks, Medical Professionalism: Can It and Should It Be Measured? British Medical Journal, 2009, 161-2.

3. Green M., Zick A., Makaul G., Defining Professionalism from the Perspective of Patients, Physicians, and Nurses, Acad. Med., 2009, 84, 556-73.

4. Levenson R., Dewar S., Shepherd S., Understanding Doctors: Harnessing Professionalism, King’s Fund and Royal College of Physicians, 2008.

5. Report of a Working Party of the Royal College of Physicians of London 2005, Royal College of Physicians, Doctors in Society: Medical Professionalism in a Changing World, Royal College of Physicians, 2005.

6. Nicola Woolcock