Quality of Care: Can We Continuously Improve? Are complaints useful?

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1 PhysicianUpdate 2013 Overview The aim of Physician Update is to provide MDA National physician Members with a snapshot of the key medico-legal issues in medical practice today. Physician Update is designed to enhance your understanding and assist in minimising your medico-legal risk with a focus on perennial and emerging medico-legal issues. This edition discusses: quality of care and the role of complaints Coronial Investigations what our data shows as the main causes of claims against physicians. Please contact our Medico-legal Advisory Service about any specific cases or concerns on or advice@mdanational.com.au. We welcome your feedback on any specific issues you d like covered in future editions by ing us at specialtyupdates@mdanational.com.au. Quality of Care: Can We Continuously Improve? Are complaints useful? Guest writer Associate Professor David O. Watson During the summer break, I had cause to consider quality improvement in health care sparked by reading a couple of journal articles and several old literary friends. In the first of these journal articles, Mellor et al 1 noted that 90% of the off-label drugs prescribed for cancer patients at a major Australian cancer centre are not listed on the Pharmaceutical Benefits Scheme for the intended indications. Thus there was a potential additional expense to patients. There is also a potential for conflict. At MDA National we have some experience in handling matters related to off-label prescribing. In the British Medical Journal, Dyer 2 commented on a piece of legislation to be put before the House of Lords which would codify into law what constitutes best practice in relation to responsible medical innovation. The circumstances behind Lord Saatchi s proposed legislation related to the death of his wife and difficulties he saw with her care. Again, we have experience of a similar rare and difficult case at MDA National. It is timely to consider some of the progress made in improving quality of care over the past few years and what barriers may still face us. In particular, with a greater emphasis on making complaints what effects might this have for quality improvement? Minister for Health, Housing and Community Services (the Hon. B Howe) set up the first serious look at indemnity in health care. The Professional Indemnity Review (PIR) 3 as it came to be known started with a flourish and withered on an agenda too vast within a government losing interest and withdrawing support. Notwithstanding that, consultations were undertaken and a good deal of work done. It was no fault of the PIR that it could not predict some of the upheavals to come. While commenting on the risks of inadequate funding within the now superseded medical defence organisations in Australia, the PIR could not predict the crash of HIH. Equally, it could not have predicted the subsequent difficulties faced by the then United Medical Protection let alone the responses that followed. Similarly, the PIR could not have had an inkling of the departures, mergers and takeovers that have transformed the indemnity scene in Australia. Tort Law reform has had some impact on litigation but may be circumvented in time. Quality and safety initiatives are now mandated by the Australian Health Ministers Advisory Council and surgical mortality audits by the Royal Australasian College of Surgeons. There is now a national system of registration and regulation for medical practitioners and those in another thirteen professions. A bit of history I have chosen as my time-frame the past 21 years, not because I feel quality improvement has reached its majority; far from it. Rather, it is just over 21 years ago that the then Deputy Prime Minister and Improvements in care In the midst of mandating surgical mortality reviews, quality and safety activities in hospitals and an increased reliance on audit, many would give no credence for the Law having any role in this change.

2 Notwithstanding the widely held view that litigation in Tort is not a useful way of improving quality of care, ( he was made to answer another question so much to the point and so useless and he had to answer by yes or no 4 ) that is not always so. There are a number of examples to demonstrate this over the years at all levels of the legal system. Of course, the best known of such cases is the High Court s decision in Rogers v Whitaker 5 followed by another, somewhat less well-known case, from Perth. In Rosenberg v Percival 6 the Court took some of the Rogers v Whitaker arguments somewhat further. While this may always be a personal opinion, by insisting that patients were entitled to be advised of material risk, indicated by Gaudron J as giving no basis for treating the doctor s duty to warn of risks as different in nature or degree from any other duty to warn of real and foreseeable risks, the High Court altered the practice of medicine forever. In practical terms this has required doctors to put much more effort into providing information and facilitating discussion not only about elective procedures (the subject of the High Court s deliberations) but also any treatment recommendations. In amplifying this in Rosenberg v Percival the High Court indicated what it meant regarding material risk; in its view it had both an objective limb ( what a reasonable person in the patient s position would be likely to attach significance to ) it and a subjective one where ( the medical practitioner was, or should have been aware that the particular patient would be likely to attach significance to ) it. The role of AHPRA Healthcare professionals are now subject to national registration and regulation. At present 14 professions are involved. This is done through the Australian Health Practitioner Regulation Agency (AHPRA). Some of these health professions are very new to this regime and will need time to adjust. The outlines of good conduct are essentially the same for all. So are the obligations. What is also altered is the ease of notification from the public (including other health professionals) regarding what may be seen as poor treatment by practitioners. In these early days such complaints seem to have a life of their own and take many months and significant resources to resolve. At least in medical practice an AHPRA investigation may still lead to subsequent litigation further extending the time of resolution for all parties. It appears to me that AHPRA s processes are far from uniform across the nation, almost certainly reflecting the reality that, at least in medicine, the old state and territory registration and disciplinary apparatus is still in place, albeit under a new name. Complaints and improved care Just as the PIR amongst individuals and organisations questioned whether litigation in Tort had any positive effects on standards of care, so the same question should be put regarding complaints. The complexities of health care are such that it frequently requires more than one thing to go wrong before an adverse outcome occurs. It is also difficult, particularly in the very young and the very old to determine whether an adverse outcome resulted from poor care, the disease process or some other unexpected occurrence during care. Anyone who has been involved in quality activities such as Root Cause Analysis can attest to that. It is possible, as this complaints scenario unfolds, that complaints will be seen as an ineffective tool for improving care due to many being launched for emotional reasons, without the filtering reality of litigation stresses and expenses which will virtually not touch the life of the complainant. However, they seriously touch the life of the complaint recipient. Potential dangers Returning to the off-label prescription of drugs, this is a frequent occurrence. I have no hard data but experience shows it extends well beyond cancer therapy as discussed by Mellor et al. 1 The use of tricylic anti-depressant drugs for patients with irritable bowel and other non-inflammatory causes of diarrhoea is an example. The use of anti-convulsants as mood stabilisers and anti-psychotics in psychiatry is another. The issue we faced a decade ago over offlabel prescribing of a new anti-convulsant was that although the young plaintiff had an almost miraculous response after a prolonged period of psychosis it was at the expense of severe visual loss at a time when this was not a known complication of the drug. There were several other considerations as well. While the claim was considered defensible, the decision was made not to test the issues by going to Court as we did not want to risk jeopardising similar off-label prescribing in a very difficult area of psychiatry. Lord Saatchi s point in respect of his late wife, while made from an emotional basis, is that there is a potential risk that medical practitioners will delay treatment waiting for the evidence in part for fear of litigation. The question of whether fear of litigation stifles innovation is yet to be tested. Nevertheless, there are two important points here. The first is that if, for whatever reason, we wait for the evidence there is likely to be little progress in therapeutics. This is particularly so in respect of rarer conditions Lord Saatchi s point in respect of his wife s rare primary peritoneal carcinoma. Secondly, if complaints continue to be easy, soft and protracted, there is a risk that practitioners will see this as all too hard and may cease practice. Amongst the desirable moves to improve patient safety and the quality of care, we must guard against delaying therapeutic action while waiting for research data to be published. We must also not lose our clinical courage in the face of concerns about investigation of our actions; rather we must be very consultative and collaborative as we proceed. We are nowhere near solving the problems around professional development and measuring clinical competence in medicine. Summary The quality and safety movement has made great strides in improving care, some progress has been assisted by the law, however much is still to be done. AHPRA is at risk of impeding that progress with excessive investigations. Complaints are not likely to be a useful means of improving care. Quality improvement is a duty of individual healthcare practitioners as well as the institutions in which they work. How we measure clinical competence is an issue we are nowhere near solving. MDA National will continue to work on these questions. A/Prof. David Watson is a Consultant Physician and Director of the MDA National Mutual Board. 1 Mellor JD, Van Koeverden P, Yip SW, Thakerar A, Kirsa SW, Michael M. Access to anticancer drugs: many evidence-based treatments are off-label and unfunded by the Pharmaceutical Benefits Scheme. Intern Med J 2012; 42: Dyer C. New bill aims to embolden doctors to practise innovative medicine. BMJ 2012; 345:2. 3 Tito F (Chair). Compensation and Professional Indemnity in Health Care; Comm Dept of Health, Housing and Comm Services 1.1. A Discussion Paper, Feb An Interim Report, Feb A Final Report, Nov Conrad J. Lord Jim: A Tale. The Franklin Library (OUP), 1984;27. 5 Rogers v Whitaker [1992] HCA 58; 175 CLR 479 (19 November 1992). 6 Rosenberg v Percival [2001] HCA 18; 205 CLR 434; ALJR 734 (5 April 2001).

3 Snapshot Physician Investigations Chart 1 shows a breakdown of the types of investigation files involving physician Members. Approximately half of these cases involve a complaint to AHPRA, the Medical Board or state-based health complaint body. Just over a third of the investigation cases involving physicians are related to a Coronial Investigation. Chart 1: Causes of investigations involving physicians 35% Coroner s Case 31% Medical board 23% Complaint body 9% Misc inquiry/other 2% Medicare Coronial Investigations Medico-legal Adviser, Janet Harry The primary role of the Coroner is to determine: the identity of the person who died the date and place of death the manner and cause of death. Where a death has been reported, there will be an investigation by the Coroner to determine whether the matter can be dealt with and findings made without needing an Inquest (a Court hearing where witnesses give evidence on oath or affirmation). As part of this investigation, you may be asked to provide evidence either by written report or by interview and followed by a signed statement. It is vital that the report/ statement is accurate, complete, and easily understood. Our 24 hour Medico-legal Advisory Service can assist with this. We recommend you contact us no matter how straightforward the request may seem, as a carefully prepared report will assist the Coroner and can mean that giving oral evidence may not be required. Preparing reports for the Coroner A request for a report or statement for the Coroner will usually be received from medical administration, the hospital s solicitors or directly from the police assisting the Coroner. The request may be either verbal or in writing. If asked to prepare a report or statement for the Coroner, we recommend you immediately seek advice and assistance from MDA National. Reports or statements for the Coroner should include the following information: full name and date of birth of the patient the treating doctor s full name, qualifications and a summary of clinical experience the position in which you were working at the time of the event(s) a detailed and chronological summary of the treating doctor s direct involvement in the medical care of the patient, including relevant dates and times. The report or statement should always be prepared with reference to the medical records. As a general rule, only first-hand knowledge of the patient s medical care should be included. If other practitioners were involved in the patient s care, these practitioners should be identified. The Coroner can then determine whether it is necessary to obtain statements from any of these practitioners and can piece together the jigsaw of reports to provide a complete picture of the patient s recent illness and/or the events leading to their death. Preparing for an Inquest Occasionally, after reviewing the available evidence, the Coroner will decide that a matter needs to go to an Inquest. Again, it is recommended you contact MDA National immediately, whether or not you think that you will be summonsed to give evidence. In this situation, you may need to obtain legal representation to best protect your interests at the Inquest. Giving evidence in the Coroner s Court is a different experience to giving expert evidence, or even giving evidence in relation to a civil claim (for example, where a patient has been injured in a motor vehicle accident). MDA National has a wealth of experience in assisting doctors at all stages in relation to Coronial matters. It is vital you let us know as soon as possible, so we can ensure that your interests are protected.

4 Causes of Physician Claims Chart 2 illustrates the underlying causes of claims involving physician Members. Of note, approximately one third of the claims against physicians involve an allegation of diagnostic error. Chart 2: Underlying cause of claims involving physicians Diagnostic error can be defined as any mistake or failure in the diagnostic process leading to a misdiagnosis, a missed diagnosis or a delayed diagnosis. Examples of diagnostic errors involving physicians include: aortic dissection in a patient presenting with chest pain pulmonary embolus in a patient presenting with dyspnoea phaeochromocytoma in a patient presenting with anxiety and palpitations. It has been estimated that 6.4% of all adverse events in hospitals are related to diagnostic errors and 83.3% of these errors are preventable. 1 An individual case involving diagnostic error may be the result of multiple errors of different types. 2 In diagnostic errors, more human and organisational causes related to lack of knowledge or problems with transfer of knowledge are identified, compared with other adverse events. Lack of knowledge, inappropriate application of knowledge, inadequate information transfer, urgency of decision making and lack of supervision all contribute to diagnostic errors. The underlying causes of diagnostic error are complex and typically involve both cognitive and system-related factors. 3 35% Diagnosis 26% Procedure complications 11% Treatment 10% Medication related 6% Other 5% General duty of care 4% Consent issues 3% Anaesthetic Cognitive errors involve flawed reasoning in the diagnostic process. Cognitive factors are thought to contribute to about three quarters of diagnostic errors in medical practice 3 and include: premature closure tendency to stop too soon without appropriate consideration of alternative possibilities availability tendency to judge diagnoses as more likely if they are more easily retrievable from memory base rate neglect tendency to ignore the true rate of disease and pursue rare but more exotic diagnoses representativeness tendency to be guided by prototypical features of disease and miss atypical variants confirmation bias tendency to seek data to confirm, not refute, the hypothesis. 4 The diagnostic process involves both intuitive reasoning (using heuristics rules of thumb or short-cuts) and analytic reasoning. The single most common cause of diagnostic error is premature closure 3 a failure to continue considering reasonable alternatives after an initial diagnosis is reached (see Case Study). This may manifest as a result of a failure to actually consider the correct diagnosis and/or failure to order an appropriate investigation. Studies of the diagnostic process have revealed that, within a few seconds to minutes of first seeing a patient, the clinician advances one or more diagnostic hypotheses. The single best predictor of diagnostic success is the occurrence of the correct diagnosis as a hypothesis early in the consultation. For medical practitioners this occurred approximately six minutes into the clinical encounter, and for medical students it was closer to 10 minutes. Thus, the critical aspect of the diagnostic thinking occurred with minimal information early in the clinical encounter. The most common system-related factors involved in diagnostic error are problems with policies and procedures, teamwork and communication, such as a delay in the reporting and receipt of critical test results or test results missing for patients moving across settings (e.g. hospital to community). Identifying and implementing strategies to minimise diagnostic errors is complex and difficult. However, an awareness of the underlying causes of diagnostic error, including the common breakdowns in the diagnostic process, will hopefully assist you in minimising the occurrence of these errors in your practice and any subsequent claims. 1 Zwaan L, de Bruijne M, Wagner C et al. Patient Record Review of the Incidence, Consequences, and Causes of Diagnostic Adverse Events. Arch Intern Med 2010; 170(12): Gandhi TK, Kachalia A, Thomas EJ et al. Missed and delayed diagnosis in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med 2006; 145: Graber ML, Franklin N, Gordon R. Diagnostic Error in Internal Medicine. Arch Intern Med 2005; 165: Norman GR, Eva KW. Diagnostic error and clinical reasoning. Medical Education 2010;44:

5 Medico-legal CASE STUDY Medico-legal Case Study This case study, involving a diagnostic error, outlines the claim process. Mrs A, 60 years of age, presented to her GP with a several-week history of left foot pain. The GP diagnosed gout and prescribed Colchicine, but after 10 days, Mrs A s symptoms worsened. Mrs A s past history included a coronary angiogram one month earlier which was normal. She was otherwise well and was not taking any regular medications. The GP referred Mrs A to physician, Dr Zee, for an opinion and ongoing management. When Dr Zee first consulted with Mrs A on 26 February 2011, he considered her symptoms were consistent with gout but that she had not been adequately treated to date. Dr Zee increased the dose of Colchicine and injected some local anaesthetic and corticosteroid into Mrs A s left foot. Dr Zee reported to the GP that a synovial fluid sample would confirm the diagnosis of gout, but the letter did not say whether he had requested this or wanted the GP to arrange the test. Mrs A remained in severe pain and the increased dose of Colchicine was not alleviating her symptoms. On 5 March 2011 Mrs A s GP telephoned Dr Zee and queried whether there was anything else that could be causing Mrs A s pain. Dr Zee recommended that Dexamethasone be added to Mrs A s drug regimen and said that he would like to review her in one week. On 10 March 2011 Mrs A s pain was so severe she could not get out of bed. Her husband called an ambulance and Mrs A was taken to hospital. A stress fracture was initially suspected. A bone scan was performed which showed increased uptake at the third and fourth distal tarsals, and the first metatarsal joint of her left foot. A CT scan showed Mrs A had bony destructive changes and several collections in her left foot. She was diagnosed with septic arthritis, and probable septic emboli from an infected groin haematoma. She was hospitalised for almost one month, during which time she underwent several debridements. Medico-legal issues Mrs A commenced legal proceedings against Dr Zee in which she alleged that he was negligent in not promptly diagnosing septic arthritis. Mrs A s solicitor obtained expert evidence that was critical of Dr Zee s management. Dr Zee notified MDA National and a Claims Manager instructed a solicitor to protect his interests. The Claims Manager and Dr Zee attended a meeting at the solicitor s office in which Dr Zee discussed his recollection of Mrs A s presentation and the subsequent telephone discussion he had had with her GP. Following this meeting, the solicitor drafted Dr Zee s statement which served as the basis for briefing an independent expert physician to comment on his management. The expert physician was critical of Dr Zee for not taking any steps to definitively prove a diagnosis of gout and for failing to consider differential diagnoses (such as pseudo gout, septic arthritis, reactive arthritis, rheumatoid arthritis and psoriatic arthritis). Dr Zee s solicitor arranged for Mrs A to be examined by a rehabilitation physician and an occupational therapist, as a large proportion of her claim related to an alleged ongoing need for care and domestic assistance. When the relevant expert evidence was to hand, the Claims Manager arranged for the matter to be discussed at the Cases Committee.* The Cases Committee considered that Dr Zee s management was below the accepted standard of care. As the claim was not defensible a mediation was arranged and the matter was settled. *Our Cases Committees comprise practicing doctors from multiple specialties who provide advice on the standard of care provided, liability and causation, and overall medical insight to assist with the claims management process.

6 Resources for Physicians We provide a range of online resources designed specifically for physician Members, including: Practice Self-assessment Checklist Practice Self-assessment Handbook Annual Physician Update To access these resources visit mdanational.com.au Snapshot: Defence Update Online Members can now read Defence Update online for more detailed information and related links on emerging issues, case studies and practical medico-legal resources. Access our online publication at your convenience via your computer, smart phone or tablet today, share articles, save them to file and tell us what you think. Read Defence Update online at: defenceupdate.mdanational.com.au This initiative is a result of Member feedback for a greener alternative to the hardcopy version and provides Members with a choice on the way Defence Update is received. Freecall: Member Services Fax: peaceofmind@mdanational.com.au Web: mdanational.com.au Adelaide Unit Ward Street North Adelaide SA 5006 Ph: (08) Fax: (08) Brisbane Level 8 87 Wickham Terrace Spring Hill QLD 4000 Ph: (07) Fax: (07) Hobart GPO Box 828 Hobart TAS 7001 Ph: Fax: Melbourne Level Dorcas Street Southbank VIC 3006 Ph: (03) Fax: (03) Perth Level 3 88 Colin Street West Perth WA 6005 Ph: (08) Fax: (08) Sydney Level 5, AMA House, 69 Christie Street St Leonards NSW 2065 Ph: (02) Fax: (02) The information in Physicians Update is intended as a guide only. We recommend you always contact your indemnity provider when you require specific advice in relation to your insurance policy. The case history used has been prepared by the Claims and Advisory Services team and is based on actual medical negligence claims or medico-legal referrals; however certain facts have been omitted or changed by the author to ensure the anonymity of the parties involved. The MDA National Group is made up of MDA National Limited ABN and MDA National Insurance Pty Ltd (MDA National Insurance) ABN AFS Licence No Insurance products are underwritten by MDA National Insurance. Before making a decision to buy or hold any products issued by MDA National Insurance, please consider your personal circumstances, and read the Product Disclosure Statement and Policy wording available at mdanational.com.au