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Indian Journal of Surgery, Vol. 66, No. 1, Jan-Feb, 2004, pp. 13-14 Editorial Time to learn from our mistakes? Atul D. Garud Director, Clinical Audit, Ethics and Quality Improvement, P. D. Hinduja National Hospital and Research Centre, Veer Savarkar Marg, Mahim, Mumbai - 400016, India. Code Number: is04003 Last year, an unusual and unfortunate case was discussed at the disciplinary hearings of the General Medical Council of the U.K.1 The case related to a 32-year-old woman diagnosed as having acute abdominal pain due to gallstones. The details of her clinical condition are unknown, but it was reported that a decision to perform an emergency open cholecystectomy was made by a locum Consultant Surgeon, who delegated the surgery to a second-year registrar. During surgery, the registrar experienced some problems possibly due to difficult anatomy and divided the hepatic artery, mistaking it for the cystic artery. She then divided the common bile duct, and also inadvertently nicked the portal vein. At that point, the patient had lost a little more than a litre of blood, but the registrar managed to control the bleeding with a clamp and a pack. The consultant arrived after this and took over. However, in spite of his efforts, the patient, who had severe bleeding (about 5.5 litres), died 3 days later. Several questions arise from this unfortunate episode. Could this occur at any hospital, anywhere? How do we deal with this? How can we prevent it from happening again? What sort of safeguards do we have to protect our patients? What lessons do we learn from this? The easiest step, and one that must not be undertaken, is to name, blame and shame the person/s responsible. That will not solve anything. An individual is only the end product of a system. If the system has a faulty design, the fault is likely to percolate down, and unless the faulty design is rectified, the error is likely to occur again. The concept of `root cause analysis' has its origin in this theory. Healthcare is a complicated, high profile and risky profession. There is a certain amount of inherent risk, especially in every surgical procedure that we, as surgeons undertake. The degree of risk may vary with the specialty, but there is an irreducible minimum, legitimate hazard in our day-to-day activity. This is further compounded by the potential for errors at various stages of a patient's work-up and treatment. It is little wonder, therefore, that surgeons are constantly held responsible for adverse outcomes in patient care. What, if anything, can be done to minimize these errors and adverse outcomes? This question assumes special importance in the present climate of heightened consumer activism and higher public expectation as a result of explosion of knowledge and information on the Internet. Gone are the days when patients thought `my doctor knows what is best for me', although this situation may still be prevalent in our rural areas. Patients are becoming increasingly aware of their rights, especially the right to make informed choices or decisions. Undoubtedly, this is the way it should be. Where does this leave our profession? Centuries ago, Hippocrates warned us "Primum, non nocere!" (Above all, do NO HARM!) Despite this stern admonition, operations have been performed on wrong patients, on wrong parts, on wrong sides and worst of all, for wrong indications. In 1984, the now well known and oft quoted Harvard study2 indicated that nearly 4% of all hospital admissions end in adverse events. An Australian study in 19953 showed an even higher incidence of adverse events at 16%. These are alarming statistics indeed and one shudders to think what the figures might be in our over- populated, understaffed and poorly funded hospitals in India. Leaving aside criminal negligence and deliberate acts of commission, most errors are attributable to faulty system rather than faulty individuals. This is not to deny the existence of human errors, but most psychologists and those who have studied the epidemiology of errors feel that human errors are the consequence of, and not the cause of, a flawed system design. The premise that most humans are fallible at some point of time or another, and therefore, the concept of a `fail-proof' system has worked well in the aviation industry. Healthcare is not, and cannot be so mechanical operation theatres are not cockpits. Otherwise, we run the risk of `dehumanizing' the delivery of healthcare to our patients. This is a charge, which is often levied against the `high tech' environment of the critical care units. Epidemiological evidence has also shown that errors are likely to happen more often when clinicians are inexperienced or when new procedures are being introduced. They are seen more frequently in patients at extremes of age, in complicated illnesses, emergency situations and in patients with prolonged hospital stay.4 Factors like poor training, poor supervision, adverse working conditions, which may lead to lack of motivation all may play a part. In order to minimize the incidence of errors, a comprehensive strategy taking in to account all the factors listed above should be put in to practice. There are several recommendationsbroadly classified as follows:
Guiding principle in all these remedial measures is based on three pillars`non-punitive culture', full confidentiality and indemnity from prosecution, except in cases of criminal negligence. In this issue of the Journal, Drs. Bhattacharya and Catherine have addressed the subject of reporting of surgical errors, wherein they discuss the merits and demerits of voluntary and mandatory reporting. They rightfully point out that mandatory reporting may be necessary for certain serious errors such as perioperative death, but on the whole, a voluntary reporting system which seeks to impart knowledge, improve patient care and evolve a change in the system is more likely to succeed in the long run. It is important to understand that reporting systems alone will not bring about improvement. Information garnered from the reporting of events has to be analyzed in such a way as to provide direction for a change in the organisational process or system. Most errors occur as a result of some departure from safe and `good' practice protocols. Such protocols have to be set down taking in to account local needs and conditions. National Institute of Clinical Excellence (N.I.C.E.) in the U.K. has drawn several practice guidelines and protocols, which can be modified or adapted to our conditions. There is a great deal of debate about the role of accreditation in reducing errors. Drawing a parallel from industry, accreditation process is an attempt at continuous quality improvement. As a measure of compliance with the standards set, it goes a long way towards reducing the risk. Where does this leave the patients- the so-called `victims' of acts of omission facing the harm? Are they not entitled to any compensation? This is a much broader question and will require a lot of thinking from the government and the insurance companies. In a country such as the U.K. the National Health Service has recently announced a compensation package of remedial care, apologies and monetary compensation of up to £50,000 without the need for litigation.5 The patients (or the relatives) have the option of litigation, if they choose, but they will have to waive the litigation if they accept the package. In conclusion, once we accept the premise "To err is human…" we also concede that `zero error' and `zero tolerance' to error are both unattainable goals. What can certainly be done, however, is to minimize the disastrous consequences by regular clinical audits, and a shift of emphasis from blame to learning, from individuals to system and from fault finding to fact finding. Above all, an environment and culture must be created where it is safe to admit `I made an honest error, let me learn if I can prevent it from happening again', and for the organization to revamp the system which led to the error, without the spectre of blame and shame looming large. Atul D. Garud Director, Clinical Audit, Ethics and Quality Improvement,
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© 2004 Indian Journal of Surgery. |
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