- law
legislation (enacted by Australian parliaments) and case law (law made by judges hearing a case).
- patient safety incident
‘an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient’ (WHO, 2009, p. 22). Incidents include adverse events, near misses, and no-harm incidents.
After highlighting some legal strategies used to communicate patient safety, two practice examples are presented. The practice examples highlight different aspects of patient safety law and are indicative of communication issues commonly faced in practice. The first practice example focuses on the role of the coroner in communicating patient safety. It highlights the investigative role of the law in relation to patient safety (knowing). It also showcases the preventing element in respect of the significant number of communication errors that can occur in a multidisciplinary, networked health system. The main focus of the second practice example is responding to health service providers’ and professionals’ miscommunication (and subsequent incidents) during treatment; however, it also touches upon knowing and preventing.
- patient safety law
a body of law that functions to protect the patient by reducing patient safety incidents within the healthcare system (Downie et al., 2006).
Introduction
Law is increasingly being used as an instrument for improving system-wide performance in the interest of patient safety (Healy, 2011). This involves, on the one hand, greater legal focus on prevention and avoidance of incidents and provider-caused harm. On the other hand, it involves the more traditional legal approach of identifying negligence and compensating injured patients after an incident occurs.
- harm
impairment of structure or function of the body and/or any deleterious effect arising therefrom, including disease, injury, suffering, disability and death; and may be physical, social or psychological (WHO, 2009, p. 23).
The law communicates patient safety in three main ways: preventing patient safety incidents, knowing when they do occur, and responding to them (Downie et al., 2006).
Patient safety law that aims to prevent patient safety incidents can generally be said to do so by controlling or influencing one of three variables: where care is delivered, who delivers care, and what is delivered.
‘Knowing’ relates to how the law can be seen to work to support the discovery and open discussion of patient safety incidents (Downie et al., 2006). To achieve this, the law engages in two related yet somewhat contradictory practices: protecting certain information from being publicly promulgated and, at the same time, ensuring information is disclosed.
When a patient has received unsafe care resulting in harm, legal attention shifts to ensuring both accountability and compensation to redress the wrong (Downie et al., 2006; Vines, 2005, 2007). This is the responding dimension of the law. That is, the law responds by holding those who are responsible for the act and the harm accountable, whether through coronial investigation, disciplinary action or, on rare occasions, criminal prosecution (Yeung & Horder, 2014). In appropriate cases, the law provides compensation to the person who has been harmed. The preventing, knowing and responding elements of the how law communicates patient safety are discussed in more detail in the ‘Theoretical links’ section later in this chapter.
- accountability
holding of responsibility by individuals, organisations, and government for their actions and omissions.
With this as brief background, let us turn to the first practice example, focusing on a child death in hospital and the coroner’s findings about the case.
Jacob Belim, aged 8 years, died of septic shock from a ruptured appendix on 28 March 2009. The events leading up to his death are set out by New South Wales Deputy State Coroner Mitchell in his findings of 15 August 2011 (Jacob Belim, 0839/09).
On 23 March 2009, Jacob complained of abdominal pain and vomiting. His mother took him to First Care Medical Centre (FCMC) where Dr Khan, a general practitioner (GP), examined him and prescribed an elixir to settle the pain. Dr Khan did not diagnose Jacob’s appendicitis.
As Jacob’s symptoms persisted, a couple of days later he was taken back to FCMC to see Dr Gounder, his regular doctor. Dr Gounder diagnosed appendicitis, and thought Jacob’s appendix may have ruptured, requiring urgent surgery. She phoned an ambulance to take Jacob to hospital; it arrived promptly. At the ambulance handover Dr Gounder gave the officers a referral letter describing Jacob’s ‘distended, tender, rigid’ abdomen and diagnosed ‘appendicitis’. Dr Gounder did not identify a specific service, and Jacob was therefore taken to Liverpool Hospital (hereafter called ‘Liverpool’). The treating ambulance officer chose Liverpool because it was one of the closest hospitals capable of taking paediatric patients, and had not exceeded its admissions quota. The officer had not been told that sick children requiring surgery should not be taken to Liverpool. As he seemed ‘reasonably stable’, Jacob was categorised as ‘non-urgent’.
About three hours after Jacob left, Dr Gounder phoned Liverpool and told the nurse in the Paediatric Emergency Department, ‘This boy looks like having a ruptured appendix. Please investigate.’ This message failed to draw anybody’s attention to Dr Gounder’s correct diagnosis.
Jacob arrived at Liverpool at about 10:22 a.m. The ambulance officers handed over the referral. He was marked ‘category 2’ (‘to be seen within 10 minutes’) at triage, but waited about 80 minutes to be seen by the Emergency Department Registrar, Dr Ferreira, and was only seen then because a nurse asked that he be seen out of turn. Dr Ferreira ordered some tests, but not an abdominal ultrasound, despite Jacob’s mother urgings given the GP’s statements about appendicitis. Soon after the tests, Dr Ferreira knew (by 11:30 a.m.) that an operation was highly likely, and that it would need to be undertaken elsewhere. Test results showed possible shock and dehydration. Dr Ferreira also knew Jacob’s C reactive protein level was at 380.0 mg/L, which was grossly elevated and consistent with appendicitis and/or peritonitis. At about 3:30 p.m. Dr Ferreira telephoned the visiting medical officer, who directed her to transfer Jacob to Royal Alexandra Hospital for Children at Westmead (hereafter called ‘Westmead’).
Dr Ferreira telephoned Westmead and spoke to Dr Patel, stating that Jacob required paediatric surgical review for a possible bowel obstruction, but did not mention appendicitis, peritonitis or possible septic shock. Despite knowing that surgery was inevitable and urgent, and a decision having already been made to transfer Jacob, Dr Ferreira asked paediatric registrar, Dr Nassar, to review him and assess treatment urgency. Dr Nassar appeared on the ward at about 2:10 p.m., but did not review Jacob until about 40 minutes later. He agreed Jacob had an acute abdomen and should be transferred to Westmead. During Dr Nassar’s half-hour review, he examined Jacob, took a history from Mrs. Belim, but did not speak to Jacob. He did not see Dr Gounder’s referral (although it was with the hospital notes), or read the ambulance notes. Dr Nassar’s notes recorded that Jacob had ‘acute abdomen – bowel obstruction’ secondary to faecalith, malrotation and/or infection, but did not mention appendicitis or peritonitis despite Jacob’s mother’s urgings. Dr Nassar told Mrs Belim that Jacob needed surgery at Westmead because they did not operate on children at Liverpool. By then Jacob had been at Liverpool for about four and a half hours.
Jacob left Liverpool by ambulance at about 5:23 p.m., almost seven and a half hours after arriving. He arrived at Westmead just after 6:00 p.m. The Liverpool misdiagnosis of ‘bowel obstruction’ was recorded on the admission documents at Westmead, and the triage nurse repeated that ‘X-ray shows bowel obstruction’. No mention was made of appendicitis. Jacob underwent further tests, some of which had already been undertaken at Liverpool. Despite ample evidence Jacob was suffering from a burst appendix, the decision to operate was not taken until around 9:00 p.m., after an ultrasound. Surgery commenced at 11:00 p.m., some twelve and a half hours after Jacob’s arrival at Liverpool and about five hours after his arrival at Westmead.
While at Westmead, Jacob was treated by several doctors. Dr Hale determined that postoperatively Jacob was to remain in the ward with hourly observations. This was found to be inadequate given the severity of his condition, including a very high heart rate post-surgery and the high volume of fluid required during surgery (indicating possible septic shock). Dr Thacker, Paediatric Registrar on duty, saw Jacob at 4:30 a.m. the next morning and then again, due to a concern, at 6:30 a.m. On both occasions, the heart rate was 162 – ‘worryingly high’. Dr Thacker did not refer Jacob to the Intensive Care Unit (ICU) immediately, but telephoned the ICU, and was told to wait for the ICU registrar’s review. When the ICU registrar arrived, he recommended more fluid but before Dr Thacker could respond, Dr Patel came on to the ward and responsibility passed to him. Dr Patel was surprised to see that the ICU review had not taken place but, shortly after, handed over Jacob and went off duty. Jacob remained on the ward until late on 27 March 2009 with his condition steadily deteriorating.
The nursing shift handover occurred at around 2:00 p.m. Nurse Idquival reviewed Jacob at 4:00 p.m. and again at 4:20 p.m. She was worried about his condition, so asked about Jacob’s treatment plan. The duty doctor said the plan was to bring down Jacob’s temperature. Because Nurse Idquival thought more should be done, she called paediatric ICU (PICU) and said Jacob was very sick, and asked for help. Then, after consulting with a nurse practitioner, she ‘called an arrest’ (to escalate the request for immediate care). The medical arrest team arrived quickly, but Jacob’s eyes rolled back, he passed out and could not be wakened. He was then transferred to PICU.
Jacob was admitted to PICU after about 6:30 p.m. on 27 March 2009. He ‘was in a critical and perilous condition. He was in profound shock, only minimally responsive with groaning to deep pain, had very poor peripheral perfusion, tachycardia and wide pulse pressure. He had marked abdominal distension … [and] life threatening septic shock and/or ischaemic gut.’
As Jacob was not responding to the maximum ICU treatment, once stabilised with a heartbeat of 134 and a temperature of 36 degrees C, he was taken back to theatre for an emergency laparotomy where he died at about 2:28 a.m. on 28 March 2009.
Analysis and reflection
Jacob’s death was investigated by the coroner. The Coroners Act in each jurisdiction requires coroners to inquire into certain kinds of deaths (such as where a person’s death was not the reasonably expected outcome of a health-related procedure carried out in relation to the person). Coronial investigations aim to determine a number of factors, including how they died and the medical cause of death. It is not the coroner’s role of find people guilty of criminal or civil offences. (See the coroners’ links in ‘Web resources’ at the end of the chapter).
The coroner found Jacob died when his heart failed as a result of septic and/or hypervolaemic shock consequent on a burst appendix leading to peritonitis. The coroner stated that the treatment Jacob received for his perforated appendix was inadequate in several respects, including communication and clinical issues leading to failure to suspect appendicitis, and unnecessary delays.
Communication and clinical issues leading to failure to suspect appendicitis
The coroner found that it should have been obvious to any medical practitioner dealing with Jacob at Liverpool that his situation was very serious, and that he needed urgent surgery without delay. The coroner found Dr Ferreira’s care to be wanting in several respects. Some concerns related to communication issues – for example, Dr Ferreira’s failure to adequately consult the notes and read the GP’s referral letter during her examination.
Other concerns related to clinical failings, which affected communication with subsequent treating health professionals, including Dr Ferreira’s failure to consider appendicitis, at least as a differential diagnosis, and her failure to arrange an ultrasound. This contributed uncertainty, confusion and delays in Jacob’s subsequent treatment. The coroner also mentioned Dr Nassar’s communication and clinical failures, including his failure to speak to Jacob on examination; his failure to read Dr Gounder’s letter or the ambulance notes; his description of the boy as being only ‘mildly unwell’; the paucity of his notes on examination; and his failure to draw any conclusion from the rigidity of Jacob’s abdomen (a diagnostic marker for a ruptured appendix). All this suggested Dr Nassar’s ‘fixed view’, producing a less than adequate care intervention.
Unnecessary delays
The coroner found that communication issues also underpinned the unnecessary delays during the almost seven hours Jacob spent at Liverpool en route to surgery at Westmead. More specifically, while at Liverpool, Jacob’s history was taken, ignoring or missing his mother’s concerns and his treating GP’s findings. X-rays were taken, but not an ultrasound (a better diagnostic tool). Jacob was misdiagnosed and was left significantly dehydrated; antibiotic medication was delayed; surgical review was missed; and his transfer to Westmead occurred hours later than required. The coroner concluded that ‘[i]n short, his visit to Liverpool was a tragic waste of time’. In addition, communication problems underpinned the unnecessary delays during the almost four and a half hours that Jacob was at Westmead before going to theatre. In particular, it was found that performing a laparotomy for peritonitis earlier would have significantly increased Jacob’s likelihood of survival.
Implications for practice
Based upon their investigation, coroners are empowered to make recommendations to improve public health and safety (see Studdert & Cordner, 2010, and the coroners’ links in the ‘Web resources’ section at the end of the chapter). It appears, however, that coronial recommendations are not always implemented by health services or other policy-makers such as government (Sutherland et al., 2014). The coroner made a number of specific recommendations, namely that:
- steps be taken to ensure the ready availability to medical and nursing staff at the hospital emergency departments;
- a guideline be developed regarding the circumstances in which appendicitis may call for urgent surgical treatment and the steps to be taken in such instances;
- a protocol be developed to ensure the prompt and efficient transfer of paediatric patients requiring surgery not to be performed at the hospital;
- steps be taken to keep paediatricians, general practitioners and the New South Wales Ambulance Service advised of the availability of paediatric surgical services.
Both Liverpool and Westmead have sought to implement the coroner’s recommendations. Liverpool has made a number of systemic changes based upon the recommendations. For example, the hospital has reinforced and improved access to surgical review, regardless of the age of the patient. The Ministry of Health (New South Wales) has also released a policy directive entitled Recognition and management of patients who are clinically deteriorating (NSW Health, 2013), which sets out principles for improving the recognition, response to and management of all patients who are clinically deteriorating. The directive includes a clinical emergency response system and escalation matrix (Appendix 8.2) that describes the role delineations of staff and the appropriate response and escalation process for all patients in Ministry of Health facilities, including paediatric patients.
Theoretical links
As noted in the introduction to this chapter, the law plays a role in preventing incidents and harm (‘preventing’), ensuring we have information about what goes wrong in health care (‘knowing’), and responding to adverse events (‘responding’). These three dimensions form a theoretical link between law and communication in patient safety. This section elaborates on these three dimensions.
- adverse events
incidents in which harm resulted to a person receiving health care (WHO, 2009, p. 23).
Preventing
Patient safety law that aims to prevent patient safety incidents can generally be said to do so by controlling or influencing one of three variables: where care is delivered, who delivers care, and what is delivered.
In Australia, where care is delivered is regulated by the Australian Commission on Safety and Quality in Health Care (ACSQHC): an organisation does not automatically qualifiy as a healthcare provider. ACSQHC’s National Safety and Quality Health Service Standards ensure that heath care services are accredited against its standards (ACSQHC, 2011).
Who delivers care is set out under the Health Practitioner Regulation National Law Act 2009 (hereafter the ‘National Law’), as adopted in each state and territory (see the ‘Web resources’ section at the end of the chapter). It is important to note that the National Law has been modified in some jurisdictions. You should refer to the legislation relevant to the jurisdiction where you work. The National Law provides for accreditation, registration, and performance and conduct standards to be applied to health service providers (for example, see Parts, 6, 7 and 8 of the Health Practitioner Regulation National Law (NSW) No 86a). The Australian Health Practitioner Regulation Agency (AHPRA) is responsible for the implementation of people’s registration, which currently applies to 14 health professions. The registration requirements regulate health professionals’ training and registration to prevent unsafe care. Disciplinary processes, which focus on the health, performance and conduct of individuals, determine who should and should not be entitled to deliver care. This regulatory framework is therefore preventive in that it seeks to protect the public by imposing minimum standards that all registered health practitioners must meet.
The law also prescribes what can be delivered in the Therapeutic Goods Act 1989 (Cth). In aiming to prevent patient safety incidents, the Therapeutic Goods Administration is responsible for ensuring that medicines and medical devices (therapeutic goods) available for supply in Australia are safe and fit for their intended purpose prior to their consumption and usage.
Knowing
‘Knowing’ relates to how the law can support the discovery and open discussion of patient safety incidents (Downie et al., 2006). What constrains knowing are healthcare providers’ fears about the consequences of acknowledging patient safety incidents. One such fear is damage to one’s reputation, and another is exposure to civil liability (Studdert, Piper & Iedema, 2010).
Qualified privilege protects the confidentiality of certain documents and communications against demands for disclosure in legal proceedings (Studdert & Richardson, 2010). The policy rationale for this protection is to encourage candour and the free flow of information for investigation of adverse events, where this is in the public interest. There are subtle variations however between state jurisdictions as to the nature and extent of qualified privilege protection (Studdert & Richardson, 2010).
Similarly, ‘apology laws’ contained in civil liability legislation provide protection for health professionals who offer apologies (as defined in each jurisdiction’s legislation) to patients involved in incidents. Like qualified privilege legislation, apology laws vary between state jurisdictions (Vines, 2005, 2007, 2013; McLennan & Truog, 2013). Apology laws are focused on reassuring healthcare providers that apologies are not determinative of liability.
- apology
a statement of regret that includes the word ‘sorry’. There is a difference between ‘We are sorry that this happened’ and ‘We are sorry that we did the wrong thing’. The latter expression is admissible in some states’ courts of law as constituting an acknowledgement of liability (all states except New South Wales and the Australian Capital Territory).
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