Building foundations to support patient safety

Sentinel event program annual report 200910

Building foundations to support patient safety

Sentinel event program annual report 200910

Sentinel event program annual report 200910

Acknowledgements
The Department of Health thanks Victorias public health services, hospitals and participating private facilities for their ongoing contribution to the sentinel event program. The department wish to acknowledge the consultative councils and expert advisory groups that work closely with the department to provide recommendations to health services on system issues. The department also acknowledges the patients and their carers who have experienced adverse patient outcomes.

If you would like to receive this publication in an accessible format, please phone 03 9096 7201 using the National Relay Service 13 3677 if required, or email sentinel.events@health.vic.gov.au This document is also available in PDF format on the internet at www.health.vic.gov.au/clinrisk Published by Quality, Safety and Patient Experience Branch, Victorian Government Department of Health, Melbourne, Victoria
Copyright, State of Victoria, Department of Health, 2010 This publication is copyright, no part may be reproduced by any process except in accordance with the provisions of the Copyright Act 1968. Authorised by the State Government of Victoria, 50 Lonsdale Street, Melbourne. Printed on sustainable paper by On-Demand, 323 Williamstown Road, Port Melbourne 3207. December 2010 (1012012)

Foreword
Delivering a high-quality health system in Victoria is a major priority for the government. To ensure the system is safe, it is important to review and examine clinical incidents where things dont go as planned, and in particular those events deemed to be sentinel. Investigation of clinical incidents identies where the breakdowns in the health system occur, and allows health services to identify these risks and develop ways to reduce or remove the risk where possible. The Department of Health works together with health services, clinicians and consumers to promote a culture of reporting when things go wrong. It is only when we are aware of something not working that we can act to change this. This is the eighth annual public report of the sentinel event program and it presents information on the 57 sentinel events reported within Victorian health services during 200910. The focus of the program remains on lessons learnt in order to prevent similar sentinel events in the future, and will evolve in 201011 to incorporate a broader report on patient safety and all reported clinical incidents within our health system.

Hon David Davis MLC Minister for Health

Sentinel event program annual report 200910

Contents
Summary Sentinel event data Themes in 200910 Working together to enhance patient safety Consumer participation Clinical effectiveness Effective workforce Risk management Glossary Appendices Appendix 1: Incident severity rating (ISR) Appendix 2: Incident management process Appendix 3: Source data Clinical governance compliance checklist 1 3 13 15 17 21 25 27 33 33 33 36 37 41

Sentinel event program annual report 200910

Summary
The Department of Health (the department) is responsible for the provision of health services within Victoria and is committed to improving the quality of these services. Review of incidents and near miss events plays an important part in this, particularly those events deemed to result in harm or death. In-depth investigation of these events identies breakdowns in the often complex health system and allows health services to identify risk and develop ways to reduce or eliminate the risk of reoccurrence. In 200910 the department was notied of 65 potential sentinel events. Eight events were withdrawn either because they resulted from known complications of the patients condition or required procedure, or because no system or process issues could be identied. Therefore 57 actual sentinel events are included and analysed in this report. In February 2010 the department began a phased 12-month rollout of the Victorian health incident management system (VHIMS). This standardised data collection for clinical incidents provides the department with a mechanism to analyse not only rare and potentially fatal events that are sentinel in nature, but also the precursor for identifying system issues for less serious events. This annual report will evolve to include all reported clinical incidents and patient safety issues and initiatives as we progress the implementation of the VHIMS. Snapshot of the Victorian health system The Victorian health system is a complex and busy environment. In the 200910 reporting period, the Victorian Government dedicated an estimated $12,335 million1 to health care, employed around 74,4132 EFT (equivalent full-time) staff, managed approximately 1.5 million1 admissions to public health facilities, and performed more than 273,7293 surgical procedures.

1 Department of Health 2010, Your hospitals: a report on Victorias public hospitals July 2009 to June 2010, State Government of Victoria, Melbourne. 2 Department of Health 2010 Workforce minimum dataset (excludes denominational and Mildura Hospital), State Government of Victoria, Melbourne. 3 Department of Health, 2010 Victorian admitted episodes dataset, State Government of Victoria, Melbourne.

Sentinel event program annual report 200910

Sentinel event data

In the 200910 nancial period, 57 sentinel events were reported by Victorian public health facilities. This number represents a decrease compared to previous years. While fewer events were reported, overall trends remain consistent and the number represents a low incidence rate considering Victorian public health facilities throughput and activity for the 200910 period. Figure 1 highlights the reported sentinel event classications expressed as a percentage. The total number of events reported to the sentinel event program (n=57) is the lowest since the program began in 200203. It is difcult to determine the exact reasoning as to why this gure continues to decline. Generally where events are reported voluntarily, it is assumed that the number of events reported would rise over time with improved identication, reporting and condence in the system. There has been considerable investment by Victoria in quality and safety throughout the last decade by Government and by individual health services. This decline in the total number of reported events may be reective of the Victorian health system developing as a mature learning culture.

Figure 1: Reported events by classication as a percentage of total (n=57) 200910

The development of a patient-safety culture is critical to a successful clinical risk management program. To successfully achieve quality patient care this requires individual health services, and the department, to become learning organisations. In such organisations, staff are genuinely encouraged to raise quality and safety issues with anyone in authority, and these issues are responded to quickly. Responsibility and ownership for patient safety cannot be delegated. All stakeholders including frontline staff and senior executives are actively involved in analysing adverse events and determining action to minimise reoccurrence of similar events in the future.

Sentinel event program annual report 200910

A total of nine sentinel event classications are reported in Victoria, eight are national classications and one is unique to Victoria. Figure 2 illustrates the eight national sentinel event classications reported since the Victorian program began in 2002. Trend analysis on historical sentinel event data spanning 20022009 has not identied any signicant emerging trends as illustrated in Figure 2 other than a spike in procedures involving the wrong patient or body part in 200708. In 2009 the Australian Commission on Safety and Quality in Health Care (the commission) amended the denition of this sentinel event to specify only events resulting in death or major permanent loss of function. Since the revised denition, Victoria has not received any reports of events under this classication.

Figure 2: Reported events by classication 200210

* Excludes other catastrophic classication which is specic to Victoria * Source data is available in appendix three

The ninth classication, other catastrophic event, is unique to Victoria. Events reported in this classication include signicant near-miss events and cases where health services have identied an unexpected patient outcome unrelated to the patients condition that warrants review of causation and potential contributing factors.

The 200210 data relating to the other catastrophic event classication is illustrated in two distinct groups: complications of management in Figure 3a and other reported events in Figure 3b. This separation best illustrates the emergent trends over eight years. It is pleasing to see both groups demonstrate a predominantly downward trend. The rebound spike in 200809 (n=21) of Figure 3b coincides with the commissions denition change for procedures on the wrong patient or body part. All procedures reported under the previous denition that had not resulted in death or permanent loss, were moved to the other catastrophic classication.

Figure 3a: Reported events classied as other catastrophic complication of management 200210

* Source data is available in appendix 3

Sentinel event program annual report 200910

Figure 3b: Reported events classied as other catastrophic events other reported events 200210

* Source data is available in appendix 3

Victoria continually seeks to proactively manage clinical incidents and to understand the valuable lessons that can be learnt from both actual incidents and near miss events. A key component of VHIMS is the methodology to determine the incident severity rating (ISR). This methodology provides a standardised quantier of harm, or degree of impact, for actual patient outcome as a result of an incident, as opposed to the popular risk-rating methodology that is more subjective. ISR is a process of classifying incidents and provides a standardised approach to the level of investigation and expected organisational response. The severity is divided into four levels ranging from one being the highest level of harm, through to four (near miss). ISR is determined by an algorithm that incorporates three factors: degree of impact, level of care and treatment required as a result of the incident. Denitions of the individual ISR factors are detailed in Appendix 1.

We have used the ISR to analyse the 200910 sentinel event data as outlined in Figure 4. Not surprisingly, ISR 1 events were the highest category for the sentinel event classications. Notably, the classication other catastrophic event was the most frequently ranked classication in this grouping together with suicide. If we were to concentrate only on the eight national sentinel event classications, this picture would be quite different. Considering the maturity of the Victorian sentinel event program and the impact VHIMS will have in monitoring multi-severity level incidents, the departments sentinel event program will focus on high degree of impact incidents, that is ISR 1 incidents in the future. Victoria will continue to report sentinel event data nationally as required.

Figure 4: Reported events by severity rating and classication (n=57) 200910

ISR 1: Severe (including death)

ISR 2: Moderate

ISR 3: Mild

ISR 4: No harm (includes near miss)

Sentinel event program annual report 200910

Figure 5: Reported events by degree of impact (n=57) 200910

Figure 6: Reported events by level of care (n=57) 200910

*Not applicable due to death of patient

Sentinel event program annual report 200910

Figure 7: Reported events by treatment required (n=57) 200910

* Not applicable due to death of patient

Not all ISR 1 incidents will be the equivalent of a sentinel event. If, on initial review by the health service, the incident outcome was directly related to system or process issues, a root cause analysis (RCA) should be undertaken to determine causation and indentify contributing factors. On the other hand, if the initial review identies that major contributing factors were related to the patients illness or management phase of their chronic illness, then an RCA is not warranted. These cases may be reviewed using an in-depth case review to determine if any system issues contributed to the patients outcome. All incidents, irrespective of their ISR rating, should be reviewed in order to identify opportunities for system improvement. The incident management process that underpins VHIMS is outlined in Appendix 2. This process map illustrates how a single incident reported by frontline staff can result in service improvement. The department expects all public-funded health services to report clinical incidents through VHIMS. This expectation will be supported by the implementation of the Victorian health incident management policy in 2011.

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Open disclosure
Open disclosure is the process of open communication with the patient or their carer following an adverse event. Its important that patients and their carers are informed when an unexpected outcome is identied. In accordance with the Victorian Charter of Human Rights and Responsibilities Act 2006 (Vic), public entities (including public health services) have a legal obligation to discuss adverse events with the affected patient or their carer. In 2002 the former Australian Council for Safety and Quality in Health Care (now the commission) developed the National Standard on Open Disclosure. This was endorsed at the Australian Health Ministers Conference in July 2003 and reviewed in 2008. The standard outlines a clear and consistent process which includes: an apology or expression of regret a factual explanation of what occurred, including actual and potential consequences, and the steps being taken to manage the event and prevent its recurrence. Open disclosure is closely linked to the incident management process, and is incorporated into the clinical governance policy framework. Guidelines and implementation toolkits were developed in 2008, and in 2009 the department conducted a series of workshops designed to up-skill staff and provide some practical resources to manage the disclosure process. An open disclosure e-learning package has been developed to build on this work and previous toolkits. This online package can be accessed at: http://www.health.vic.gov.au/clinrisk/opendisc.htm

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Themes in 200910
During 200910, a total of 301 contributing factors were identied. An analysis of these factors underpins the health services development of a risk reduction action plan to minimise similar events reoccurring. Often events involve more than one contributing factor therefore the number of contributing factors can be greater than the number of events. While a range of contributing factors were identied, analysis of the data shows that procedures and guidelines, human resources/staff issues and communication were the most consistently reported contributing factors identied with sentinel events for 200910. This continues the trend from previous years as outlined in Figure 8 and the nding is consistent with national and international trends.4 5 6

Figure 8: Reported events by contributing factors expressed as a percentage 200210

*Source data is available in appendix 3

4 World Health Organization 2008, Summary of the evidence on patient safety: implications for research World Health Organization, Geneva. 5 Clinical Excellence Commission and NSW Department of Health 2010, Clinical Incident Management in the NSW Public Health System 2009, Government of New South Wales, Sydney. 6 WA Department of Health 2009, WA sentinel event report 200809, Government of Western Australia, Perth.

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Contributing factors may include many components: the procedures and guidelines grouping is made up of clinical guidelines, behavioural and physical assessment, physical patient observation process, patient or site identication and coordination of care human resources is a collective term that represents staff allocation, training, supervision, appraisals and staff recruitment communication represents communication between staff, between staff and patient or family, and translation and cultural and linguistic diversity issues physical environment represents environmental distractions and security or design issues, and facilities management represents transportation and inter-hospital issues. Comprehending the complexities of the Victorian healthcare system is fundamental for the department in targeting effective analysis and improvement strategies. The activity of direct patient care is often referred to as the pointy end of the system. The blunt end of the system is represented by the broader management and organisational aspects involved in supporting the healthcare system. It includes a wide variety of factors such as policies and guidelines, health information systems, stafng patterns and environmental factors. To understand why an adverse event occurs at the pointy end, it is necessary to examine and analyse the contributing factors at the blunt end.7

7 Canadian Patient Safety Institute 2006, Canadian root cause analysis framework, Canadian Patient Safety Institute, Edmonton.

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Working together to enhance patient safety

Quality of health care is increasingly recognised as one of the most signicant issues facing health systems. The department is committed to ensuring quality health care within Victorian hospitals. A key action for building capacity to facilitate quality health care is for organisations to work in partnership. The department supports building effective partnerships within health organisations, across health services and with other key stakeholders at state and national levels. Initiatives highlighting these partnerships have been included throughout this report.

Clinical governance framework

Clinical governance is dened as: the system by which the governing body, managers, clinicians and staff share responsibility and accountability for the quality of care, continuously improving, minimising risks, and fostering an environment of excellence in care for consumers, patients and residents.8 The Victorian clinical governance policy framework (the framework) was developed in 2008 to guide health services to implement a framework or review and further develop existing frameworks to ensure quality and safety mechanisms are monitored and reviewed.

8 Department of Health 2008 Victorian clinical governance policy framework, State Government of Victoria, Melbourne. http://www.health.vic.gov.au/clinrisk/publications/clinical_gov_policy.htm

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Domains of quality and safety

The framework is underpinned by the four domains of quality and safety: consumer participation clinical effectiveness risk management effective workforce. These domains provide the structure for activities and processes to enhance the delivery of clinical care. This report incorporates a clinical governance compliance checklist (see appendix) linking the domains of quality and safety with the Australian Council on Healthcare Standards (ACHS) EQuIP 4 mandatory criteria. Health services can use this checklist to ensure their strategies are congruent with the framework and the relevant ACHS mandatory criteria. The checklist has been designed as a tear-out section for health services looking to use the resource as a periodic compliance tool for the framework.

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Consumer participation
Consumer participation should occur at many levels of the organisation, through activities such as community consultation and consumer partnership on governance and management committees, and within improvement initiatives or clinical risk management activities. The department expects strategies should be in place to ensure: consumers are empowered to participate in their care there is clear, open and respectful communication between consumers at all levels of the health system services respond to the diverse needs of consumers and the community with humanity rights and responsibilities of patients are promoted to community, consumers, carers, clinicians and other health service staff.

Case study
An elderly patient accompanied by their son presented to an emergency department (ED). The patient took a seat in the waiting room whilst the son proceeded to register the patient. During patient registration the receptionist requested the patients name and date of birth (DOB). The son was unable to conrm the DOB therefore the receptionist searched the system without conrming the spelling of the surname. A patient with the same name and a different address was identied. The elderly patient was incorrectly registered as someone younger and with a different medical history. At no point was there verication of the patient with their details, and discussions with the patient and their family did not identify the error in date of birth or discrepancy of past history. The patient presented as articulate, didnt look unwell, observations were normal and reported that they had overdone it recently. A category four triage classication was allocated to the patient. The patient was reviewed by the ED intern who recorded a heart rate of 100bpm, longstanding shortness of breath, and back and shoulder pain. A diagnosis of a torn muscle was made and the patient was discharged following discussion with the ED senior doctor. Prior to the patients discharge a junior nurse recorded observations and noted a heart rate of 120bpm. There was no evidence that this was discussed with any nursing or medical staff. The patient re-presented to ED a number of hours later where it was identied that the patient was incorrectly registered on the rst presentation to ED. The patient was diagnosed with bilateral pneumonia which deteriorated rapidly and required intubation. How did the health service address the issues identied? changed the triage/registration process so that patients are seen rst by the triage nurse and then registered by the administration staff reinforced the verication of patient details to ensure name and date of birth are matched introduced an ED electronic tracking system to replace a paper-based system reviewed the patient monitoring and documentation process reviewed staff skill mix and rostering, and reviewed the patient identication policy and procedures for compliance with the commissions patient identication initiatives. This can be assessed at: http://www.safetyandquality.gov.au/ internet/safety/publishing.nsf/Content/PriorityProgram-04_Initiatives
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Accurate identication of patients can be a challenge in complex health care systems because a variety of circumstances may lead to incorrect patient identication. Patient characteristics such as small children who are unable to identify themselves or patients with communication difculties caused by dementia, impaired cognition or language barriers can increase the risk of incorrect patient identication. Additionally patients with the same or similar names can create complexity and confusion as the previous case study illustrated. Good health care is best achieved through an active and positive partnership between the patient and the health care professional. Consumers need to be encouraged to be involved as much as possible in every decision about their health. Consumers should ask questions when unsure about the care being provided. A booklet 10 tips for safer health care explains how and why things can go wrong, and how consumers can work in partnership with health care professionals. This is available at http://www.health.gov.au/internet/safety/publishing.nsf/Content/10-tips.

Monitoring patient experience

The patients perception of their hospital stay is a key indicator of health care quality. The department supports a range of initiatives that promote and support consumer involvement in decision-making about their treatment and care, in service development and quality improvement, and more broadly, in health policy developments. A key mechanism for monitoring patient experience for health services is the Victorian patient satisfaction monitor survey. Patient satisfaction may be thought of as the degree to which a patient feels they have received quality health care. Measurement of satisfaction is an essential part of quality assessment.9 Currently 108 health services participate in this survey. More information, including an annual report is available at: www.health.vic.gov.au/patsat/index.htm. Health services are provided with this collated information, benchmarked against like organisations, to enable areas of strength and opportunities for improvement to be identied.

Australian Charter of Healthcare Rights in Victoria

The new Australian Charter of Healthcare Rights in Victoria was launched in September 2009, superseding the previous Victorian Public Hospital Patient Charter. The aim of the Charter is to ensure high quality health care provision, which embodies the seven health care rights. The Australian Charter of Healthcare Rights in Victoria brochure can be ordered in English, Braille and 25 other community languages and may be accessed as an audio le at: http://www.health.vic.gov.au/patientcharter/.

9 A. Chow, E. K. Mayer, A.W. Darzi, T. Athanasiou 2009, Patient-reported outcome measures: the importance of patient satisfaction in surgery. Surgery vol.146; Iss.3, pp 435-443.

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Doing it with us not for us: Strategic direction 201013

In September 2009, the Minister for Health and the Minister for Mental Health approved a new comprehensive set of standards and indicators for health services to report against to continue monitoring the Doing it with us not for us policy implementation. These standards and the intended outcome of the new strategic direction is for health services to work with consumers, carers and community members to improve health policy and planning, care and treatment, and the wellbeing of all Victorians. Health services have ve new standards and associated indicators to achieve and report on, and these are set out in the policy at: http://www.health.vic.gov.au/consumer/participate.htm

Cultural responsiveness framework

The Cultural responsiveness framework: guidelines for Victorian health services, was launched in September 2009. It consolidates the former Health Service Cultural Diversity Plan achievements, and aims to improve and extend health services capacity and performance in providing culturally and linguistically responsive health care. A copy of the framework can be accessed at: http://www.health.vic.gov.au/cald

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Clinical effectiveness
Clinical effectiveness mean ensuring the right care is provided to the right patient who is informed and involved in their care at the right time by the right clinician with the right skills in the right way. The department requires strategies to be in place to ensure: clinicians are empowered to improve clinical care delivery clinicians actively involve consumers as partners in their care clinical care is evidence-based standards of clinical care are clearly articulated and communicated, and quality improvement activities are reviewed externally. Clinical effectiveness is achieved through empowering clinicians to introduce, monitor and evaluate evidence-based practice which involves the use of performance measures, clinical indicators and clinical audits. To further enhance this work an evidence-based adult general observation chart is also being developed by the commission. The rst phase has been completed and consisted of a research project which compared existing charts to nd the best chart for recording observations. The results of this research may be accessed at:http://www.safetyandquality.gov.au/internet/safety/publishing. nsf/Content/RaRtCD_EBA-GOC

Retained instrument requiring further surgical procedure

Peri-operative practitioners play a vital role in enhancing the surgical patients safety through ensuring the correct surgical count. However, the retention of instruments or other material may occur in a variety of circumstances beyond operating theatres. These include procedural areas where invasive or diagnostic procedures take place such as wards, endoscopy, radiology and intensive care units. The World Health Organization (WHO) Surgical Safety Checklist was launched in 2009 and includes a core set of safety checks for use in any operating theatre environment. It is designed to improve safety by focussing on anaesthetic safety practice, ensuring correct site surgery, avoiding surgical site infection and improving communication within the operating team. To nd out more about the WHO surgical safety checklist visit: http://www.who.int/patientsafety/safesurgery/ss_checklist/en/ index.html There were nine events classied as retained instruments or other material reported to the sentinel event program in 200910. These incidents are distinct in that patients required re-operation or further surgical procedure to remove the foreign body. Although this classication accounted for the greatest number of events reported in 200910, the degree of impact from retained instruments or other material varied from no harm to temporary reduction in function as outlined in Figure 5.

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Case study
A patient underwent a diagnostic laparoscopy for severe abdominal pain. No cause of pain was found and the patient was discharged home the following day. The patient re-presented to hospital on numerous occasions with various complaints over the following months. A diagnostic laparoscopy was performed and a disposable item was found in the pelvis. A review of this incident identied that the supplied disposable item had been reported to the supplier as faulty prior to the event, and had been replaced by the supplier. Although there was a process for addressing defective disposable equipment, the item was still in use several weeks after the fault was reported to the supplier. Repeat supplies of this disposable item proved faulty again and subsequently this item was withdrawn and the product and supplier changed. How did the health service address issues identied: developed a defective equipment policy and procedure reinforced to staff that medical device adverse events should be reported to the Therapeutic Goods Administration (TGA) implemented an improved warning system for when suspected problems occur but the disposable equipment is still in use reviewed the peri-operative count sheet to include certain disposable operative equipment in the mandated operative count, and reminded staff of the need for vigilance when removing disposable instrumentation from patients during surgery.

Enhancing effective communication

Quality and safe patient care relies on effective communication because of the countless daily interactions that occur between health care providers. Lack of effective communication may occur between staff, across disciplines, units or hospitals, and between staff and patients or their family, carer or advocate. When effective communication is absent, patient care is compromised as evidenced by communication being among the most consistently reported contributing factors to sentinel events in Victoria for the past eight years. Improving communication requires a systems approach to include a culture that emphasises open communication. A range of initiatives are underway, both in Victoria and nationally to facilitate timely and clear exchange of communication between health professionals especially around the clinical handover process. When surveyed about the clinical handover process by the Victorian Quality Council (VQC), Victorian health services identied shift-to-shift handover and inter-hospital transfer as two signicant areas of concern. The VQC subsequently developed standardised handover tools and a range of clinical handover resources that may be accessed at: http://www.health.vic.gov.au/qualitycouncil/activities/ handover.htm

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A national guide for improving clinical handover practices at shift change was endorsed by Health Ministers in April 2010. Further information on this national guide can be accessed at: http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram05#NCHIPP The Victorian Managed Insurance Authority (VMIA) is piloting a similar communication tool with a major Victorian tertiary health service. The Identity, Situational, Background Assessment Request (ISBAR) is a simple, practical tool to guide staff on how they structure and exchange information. This can be accessed at: http://www.vmia.vic.gov.au/display.asp?entityid=6556 Clinical handover has also been recommended to surgeons as an essential component of care by the Victorian Surgical Consultative Council (VSCC). Guidelines for clinical handover were issued by the VSCC in July 2010 and can be accessed at: http://www.health.vic.gov.au/vscc/vsccguidelines-_and_-practice-statements#c02 This guideline will be further enhanced by the statewide rollout of standardised documentation for post operative orders undertaken by VSCC in partnership with VMIA. Resources and tools can be accessed at: http://www.vmia.vic.gov.au/display.asp?entityid=6556 The Victorian TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) overseen by the VQC is another project that is underway to enhance effective communication. This program is an evidence-based teamwork training system designed to improve collaboration, communication and patient safety within health care. Information can be accessed at: http://www. health.vic.gov.au/qualitycouncil/activities/teamstepps.htm

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Effective workforce
All staff employed within health services must have, and be supported to have, the appropriate skills and knowledge required to full their roles and responsibilities within the organisation. Processes should be in place to support appropriate: selection and recruitment of staff credentialling of clinical staff including annual review of practice maintenance of professional standards, and control of the safe introduction of new therapies or procedures.

Case study
The patients post operative recovery was stable after undergoing elective abdominal surgery. On day two the patient experienced abdominal distension and vomiting. On day ve, oxygen therapy was commenced for suspected bilateral lung collapse and uid boluses were given, after which the patient appeared to improve. On day seven the attending surgeon went on leave without handing over to the on-call surgeon. The anaesthetist reviewed the patient and was concerned about the deteriorating patients condition and a scan was performed. The junior medical ofcer conveyed the scan results to the on-call surgeon who ordered a treatment plan. Over the next 24 hours the patients condition improved temporarily. Subsequently, the patient deteriorated over the next few days and was reviewed by the junior medical ofcer and the anaesthetist with telephone discussion with the on-call surgeon, and a treatment plan was put in place. Further review by the junior medical ofcer noted the patient was stable. The next day the patient deteriorated suddenly and following resuscitation required transfer to a tertiary hospital. How did the health service address issues identied: convened a multidisciplinary group to review the surgical care, clinical pathway, processes and resources provided to major or high risk cases and identify areas for improvement implemented a senior medical staff leave coverage process to include a notication and patient handover process educated senior medical staff on responsibilities and expectations in relation to supervising and supporting junior medical ofcers on rotation within the hospital updated the intern orientation manual to include general guidelines for junior medical ofcers working on the general wards reviewed the clinical instability and MET policy and staff training program, and developed a clinical escalation policy along with a staff training program.

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Recognising and responding to clinical deterioration

Patients who experience clinical deterioration may exhibit warning signs such as abnormal vital signs that are often not identied or poorly addressed leading to unexpected outcomes. Early recognition and response to clinical deterioration may prevent these events. The commission commenced its Recognising and Responding to Clinical Deterioration program in 2009. This program aims to improve the recognition of and response to patients who deteriorate in hospitals and other acute care facilities. A nationally agreed consensus statement regarding the essential elements for recognising and responding to clinical deterioration has been completed and endorsed by Health Ministers in April 2010. This generic document was developed to apply to all patients in all acute care facilities in Australia. An implementation and action guide will be developed to support use of the consensus statement and is expected to be completed in early 2011. Further information may be accessed at: http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/prog-patientsrisk-lp Recognising and responding to clinical deterioration is a key strategic priority in Victoria and nationally. It is one of the ve new draft standards being developed by the commission,10 and has been endorsed by the Australian Health Ministers Advisory Council and the Australian Health Ministers Conference.

Clinical Engagement Program

The department has released Partnering for performance: a performance development and support process (2010), which aims to support the process of regular performance appraisal, and review and strengthen the relationship between senior doctors and their health services. Partnering for performance provides a suite of processes and tools to support clinical practice and implementation of the Credentialling and dening the scope of clinical practice for medical practitioners in Victorian health services policy (2009). Included is a guide which provides tips and checklists to assist participants with reviewing performance, performance development conversations and goal setting. It also includes the Understanding clinical practice toolkit which incorporates tools to aid individual doctors, their peers and organisations to understand and monitor clinical practice. The tools included are: peer review adverse occurrence screening and targeted case note review mortality and morbidity reviews clinical audit clinical indicators, and patient satisfaction and complaints.

The department has recently engaged a consortium led by The Royal Australasian College of Medical Administrators (RACMA) to develop and deliver a training program to support the implementation of Partnering for Performance focusing on undertaking performance conversations. More information is available at: http://www.health.vic.gov.au/clinicalengagement

10 Australian Commission on Safety and Quality in Health Care, National Safety and Quality Heath Service Standards, August 2010. Accessed at: http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/home

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Risk management
Health services should have a risk management system in place which integrates the management of nancial, occupational health and safety, plant, equipment and clinical risk. Minimising clinical risk and improving safety of care requires a systems approach where it is difcult to make errors. It also requires a just culture where systems and processes are the focus of investigation rather than blaming individuals. Potential risks may be reactively identied or agged through incident reporting, screening medical records, or analysis of administrative data for clinical incident markers. Clinical risk management and improvement strategies should be integrated within improvement and performance monitoring functions.

Air embolus a rare occurrence

Air embolus or the accidental introduction of air into the blood circulation is associated with high morbidity or mortality.11 While air embolus may occur with trauma, it most commonly occurs during medical intervention such as intravascular catheterisation or surgery. Despite the potential risk of air embolism associated with medical intervention, only one case of air embolism has been reported in Victoria since the commencement of the sentinel event program in 2002. Although sentinel events are reported voluntarily, this rare occurrence is encouraging given that Victorian public hospitals are continuously treating a growing number of patients and performing more surgical procedures.2 Whilst the occurrence is rare, this single case warrants review given the potential to impact negatively on quality of life, independence, and function.

Case study
A patient was admitted for elective coronary artery bypass graft surgery. Prior to transferring the patient into the operating room, the surgeon wanted to trial a new room conguration to allow easier access. The patient was connected to the bypass machine and a pre-cardiopulmonary bypass checklist was completed. The patients heart was cannulated, the bypass machine was turned on, and the vent pump was turned on. It was observed that the air in the vent line was moving in the wrong direction, toward the patient. The cannula in the heart was removed immediately, the patient was placed into a trendelenburg position and the aorta was opened to allow air bubbles to escape. It was identied that a line had been placed incorrectly into the vent pump on the bypass machine, which was rectied prior to surgery recommencing. Post-operatively the patient was slow to wake with some initial seizure activity. An MRI showed changes that were reported as consistent with air emboli. The patient was discharged following an intensive care unit admission, and prolonged ward and rehabilitation admission.

11 S. Sviri, W. P. D. Woods, P. V. Van Heerden 2004, Air embolism: a case series and review. Critical Care and Resuscitation vol. 6 pp271-276.

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How did the health service address issues identied? improved the bypass machine setup to ensure easy visualisation and access to critical components applied permanent highly visible directional arrow markings to the vent pump on the bypass machine introduced new vent lines which contain a one-way valve, and introduced a policy where clamping the vent line and priming the cardioplegia prior to connection to the patient is incorporated into all cardiothoracic surgery practice.

Medication errors interruption during administration

Medication error may occur during any stage of the medication process of prescribing, dispensing, storage, preparation, administration and monitoring.

Case study
During the evening medication round in an aged care hostel, the staff member opened a residents dose administration aid and realised that the medication was prescribed for a non-routine administration time, and was not due for administration until two hours later. The medication was subsequently put aside on the drug trolley. The staff member continued with the medication round and administered medications to four other residents when the medication round was interrupted. Following the interruptions the staff member resumed the medication round and inadvertently dispensed the medication they had put aside on the drug trolley to another patient. The event was immediately reported and the resident was transferred to the afliated hospital. How did the health service address issues identied? introduced minimal interruption procedures and a highly visible vest for staff undertaking medication rounds to alert others not to disturb except in an emergency kept medications prescribed for non-routine administration times to an absolute minimum and agged these medications on the medication chart revised the Medication Management Procedure to include procedures for medications removed from the pack and not given immediately, and procedures for occasions when the resident is absent, and developed a staff education program on medication.

Beyond compliance strategy

Beyond compliance aligns and translates concepts of safety and quality in acute health to public sector residential aged care services (PSRACs), where appropriate, through integration within existing organisational governance and operational frameworks. It emphasises linking the domains of the Victorian clinical governance policy framework to promote an integrated, sustainable approach to safety and quality.

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There are 194 PSRACS in Victoria with at least 6,400 residential aged care beds. Through Beyond compliance investment in research and partnerships development, a range of initiatives has been developed. Further information can be accessed at: http://www.health.vic.gov. au/agedcare/publications/beyond_compliance.htm

Mental health
Case study
A patient with a diagnosis of borderline personality disorder was placed in seclusion with constant visual observation because of agitation and ongoing suicide attempts using clothing for strangulation. All bedding was removed and the consumer was left with a mattress and a pillow. An agency nurse was asked to conduct constant visual observations through the seclusion room window; however the patient was not in view as they had their back to the window. Shortly after commencement of seclusion, the agency nurse noticed the consumer tearing at the pillow. They had tied a strip of the material around their neck. There was a delay in reaching the patient as the agency nurse was not given a key to the seclusion room and had to seek assistance from another nurse. A medical emergency (Code Blue) was called; the patient was resuscitated and was transferred to the emergency department. The patient survived with no physical adverse outcome. How did the health service address issues identied? improving access to seclusion rooms key securely centrally located placed a non-breakable observation mirror in the corner to view obscured angles in the room improved orientation of agency staff to the unit to ensure awareness of emergency alarms and processes, and purchased non-shreddable mattress and pillows.

Victorian mental health quality framework

The department has developed the Victorian mental health quality framework. This framework identies the key dimensions of quality, collates existing quality and safety frameworks, and provides a reference source for national standards, legislative requirements and existing guidelines and policies.

National Standards in Mental Health Services and Clinical Review Program

A project to implement a revised National Standards for Mental Health Services is underway. This project aims to develop a national clinical audit tool, and to undertake promotional activities associated with the implementation of the revised national standards to ensure a consistent approach across all jurisdictions and sectors in Australia. The Ofce of the Chief Psychiatrist is embarking upon a new round of clinical service reviews, under the auspices of the Quality Assurance Committee. It will target select service settings and functions and practices such as, triage, community case management and seclusion and restraint practices.

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Working with the Suicidal Person: Clinical Guidelines for Emergency Departments and Mental Health Services
This evidence-based clinical guideline aims to assist clinicians in emergency departments and mental health services with the management and assessment of people who have either attempted suicide or are at risk of suicide. The guidelines will be published with a range of accompanying reference resources and is scheduled to be completed in 2010.

Restraint and seclusion practices

Restraint and seclusion practices in public mental health services, while regulated by legislation, are highly restrictive interventions that impact on the freedom and autonomy of patients. In 2005, restraint and seclusion was identied as one of four national safety priorities in mental health. The Chief Psychiatrist in partnership with the Victorian Quality Council, the Mental Health Drugs and Regions Division and the mental health sector has focussed effort on reducing the use of restraint and seclusion in Victoria. This effort targeted systemic practice changes, active participation in national projects, and implementation of several local projects, clinical leadership forums, the development and roll-out of statewide training and education programs, and a clinical audit program. The project report Creating safety, addressing restraint and seclusion practices (2009) recommended that health services reduce and where possible eliminate the use of restraint and seclusion. The new Mental Health Bill will introduce another level of safeguards to ensure restraint and seclusion practices are used as an intervention of last resort.

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Glossary
The following terms are used frequently in this report. The department acknowledges that their usage varies and that a number of denitions are used in the literature.
adverse event an unintended injury or complication that results in disability, death or prolongation of hospital stay and is caused by health care management rather than the patients disease a system for classifying human blood based on the antigenic components of blood cells and their corresponding antibodies processes involved in establishing a patients cognitive state, particularly whether the patient is at risk of wandering, absconding or causing harm to staff any policy, procedure or guidelines concerning the processes involved in the clinical management of patients an approach to improving quality in health care that places special emphasis on identifying circumstances that put patients at risk of harm and then acting to prevent or control those risks a health service boards accountability for ensuring a framework and rigorous systems are established so health care safety and quality are monitored, evaluated and continuously improved a treatment regime agreed by consensus that includes all the elements of care, regardless of the effect on patient outcomes direct and indirect activities involving a negative impact, including injury, death, increased length of stay, time loss, money loss, service disruption, and reputation, political and intangible losses death, disease, injury, harm, suffering or disability experienced by a person a source of potential harm or a situation with a potential to cause loss an event or circumstance resulting from health care that could have, or did, lead to unintended or unnecessary harm to a person and/or a complaint, loss or damage a method to quantify the actual or potential consequences of an incident or near miss to check, supervise, observe critically or record the progress of an activity or system on a regular basis to identify change incidence of disease death rate an incident that did not cause harm the chance of something happening that will have an impact on objectives; it is measured in terms of consequence and likelihood the overall process of risk analysis and risk evaluation the process used to determine risk-management priorities by comparing the level of risk against predetermined standards, target risk levels or other criteria the culture, processes and structures that are directed to the effective management of potential opportunities and adverse effects

ABO blood group behavioural assessment clinical guidelines clinical risk management clinical governance clinical pathway cost

harm hazard incident incident severity rating (ISR) monitor morbidity mortality near miss risk risk assessment risk evaluation risk management

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root cause root cause analysis (RCA) risk-reduction action plan sentinel event

a signicant factor that contributed to an incident a systematic process where the factors that contributed to an incident are identied strategies required to reduce the risk of similar adverse patient outcomes occurring in the future a relatively infrequent, clear-cut event that occurs independently of a patients condition; it commonly reects hospital system and process deciencies, and results in unnecessary outcomes for the patient the systems or process-cause that allow for the proximate cause of an event to occur Victorian Admitted Episodes Data Set Victorian Health Incident Management System

underlying cause VAED VHIMS

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Appendices
Appendix 1: Incident severity rating (ISR)
The VHIMS ISR methodology was developed following analysis of methodologies used nationally and internationally. This included methodologies suggested by the World Health Organization and used by the National Health Service in the United Kingdom. The ISR methodology provides a more consistent classication of incident severity. It also allows Victorian incident data to be mapped to a variety of other methodologies. The ISR methodology can be consistently applied across all clinical (patient) and occupational health and Safety (OHS) incidents. The ISR is based on: the actual and potential impact to those involved in the incident the actual and potential impact to the organisation. The impact to the people involved is automatically derived from three related questions, these are: 1. degree of impact 2. level of care 3. treatment required. VHIMS will derive an ISR depending on the values selected by the end user in each of the three lead questions. Following are the specic details relating to each element of the ISR algorithm.

ISR scale
1 2 3 4 Severe/death Moderate Mild No harm/near miss

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Denition degree of impact

Where Harm includes disease, injury, suffering, disability and death:12 disease a physiological or psychological dysfunction injury damage to tissues caused by an agent or circumstance suffering experiencing anything subjectively unpleasant. This may include pain, malaise, nausea, vomiting, loss (any negative consequence, including nancial) depression, agitation, alarm, fear or grief disability any type of impairment of body structure or function, activity limitation and/or restriction of participation in society, associated with a past or present harm.
No harm did not reach the subject No harm did reach the subject No harm signicantly inconvenienced Harm but no loss or reduction in functioning Harm temporary reduction in functioning Harm temporary loss in functioning Harm permanent reduction in functioning Harm permanent loss in functioning Harm death Unknown There was no harm to the subject, that is, the incident did not reach the subject. The incident reached the subject, but there was no harm caused. The subject was signicantly inconvenienced in relation to time, travel, wages, lifestyle and family impact as a result of the issue and/or incident. The subject experienced harm but did not have a loss or reduction in functioning as a result of the incident. One or more systems/components of the subjects body are able to operate, fullling their purpose or role, but not to the level they could prior to the incident. The subject is likely to recover from this reduction in the short-medium term. One or more systems/components of the subjects body are no longer able to operate normally, fullling their purpose or role. The subject is likely to recover from this loss within the short-medium term. One or more systems/components of the subjects body are able to operate, fullling their purpose or role, but not to the level they could prior to the incident. The subject is not likely to recover from this reduction. One or more systems/components of the subjects body are no longer able to operate normally, fullling their purpose or role. The subject is not likely to recover from this loss. The subject died unexpectedly at the time of, or following the incident. The degree of harm caused to the subject, due to the incident, is not known at this time.

12 Australian Commission for Safety and Quality in Healthcare (ACSQHC)

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Denition level of care

No signicant change Current setting increased observation, monitoring and/or length of stay Internal transfer to a higher level of care and/or specialled External transfer non inpatient External transfer inpatient admission Not applicable Unknown The subject did not require any signicant extra care or increased length of stay and/or higher care as a result of the incident. The subject required increased observation, monitoring and/or length of stay within their current setting, for example, ward. The subject was not transferred elsewhere to a higher level of care.

The subject was transferred internally within current organisation to a higher level of care, for example, ICU and/or required specialling that is one-on-one care.

The subject was transferred externally to another health care provider for care, but was not admitted. The subject was transferred externally to another health care provider, for a higher level of care, for example ICU. The Level of Care is set to Not applicable when the degree of impact was Death. The change in level of care required by the subject, due to the incident, is not known at this time

Denition treatment required

No treatment Minor treatment including rst aid Advanced treatment Not applicable Following a clinical review, intervention was deemed not required. The subject required a simple/minor intervention as a result of the incident. For example: blood tests, xray, dressings, medications e.g. panadol, peripheral IVT, urinary catheter insertion, nasogastric tube etc. The subject required signicant medical, diagnostic or surgical intervention as a result of the incident. For example; MRI, CT, medications such as adrenaline, insertion CVC or PICC line. The treatment required is set to Not applicable when the degree of impact was Death.

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Appendix 2: Incident management process

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Appendix 3: Source data

Table 1: Source data for reported events by classication 200210
Classication of event 2002 03
Procedure involving the wrong patient or body part resulting in death or major permanent loss of function Suicide in an inpatient unit Retained instruments or other material after surgery requiring re-operation or further surgical procedure Haemolytic blood transfusion reaction resulting from ABO incompatibility Medication error leading to the death of patient reasonably believed to be due to the incorrect administration of drugs Maternal death or serious morbidity associated with labour or delivery Infant discharged to wrong family Intravascular gas embolism resulting in death or neurological damage Other catastrophic event (includes near miss events) 16

Frequency 2003 04
14

2004 05
25

2005 06
25

2006 07
20

2007 08
37

2008 09
0 #

2009 10
0 #

5 9

1 8

4 5

7 6

11 8

7 11

7 3

6 9

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 1

42

55

77

49

37

37

53

36

Total

79

85

122

91

82

102

68

57

# From 2007-08, the national denition was revised to focus only on events that resulted in death or major loss of function.

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Sentinel event program annual report 200910

Table 2: Source data for events classied as other catastrophic events including near miss events 200210
Other catastrophic events sub-categories
Complication of emergency management Complication of anaesthetic management Complication of surgical management Foetal complication of delivery Complication of inpatient fall (death or serious morbidity) Complication of fall (not resulting in death or serious morbidity) Patient absconding from inpatient unit with adverse outcome Infection control breach Hospital process issue Medication error (not resulting in death) Misdiagnosis and subsequent management Communication of test results Other mental health management Other unspecied A good catch/near miss Procedure involving the wrong patient or body part NOT resulting in permanent loss or death * * * *

2002 03
9 * 9 3 2 * 2

2003 04
11 6 10 0 10 * 1

2004 05
6 1 6 1 11 18 1

2005 06
4 0 5 2 4 1 2

2006 07
2 0 3 2 5 0 0

2007 08
1 0 6 0 7 0 1

2008 09
4 2 5 2 5 0 1

2009 10
0 1 5 2 2 0 1

6 9 * * * * 2

7 7 * * * * 3

8 0 9 4 3 4 5

3 6 7 3 1 3 8

2 0 3 3 0 6 8 3 *

2 3 5 1 0 7 4 0 *

2 0 1 2 1 6 1 0 21

2 2 0 4 0 6 5 0 6

Total

42

55

77

49

37

37

53

36

*Sub-category not reported during the reporting period

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Table 3: Comparisons of events by contributing factors expressed as a percentage 200210

Contributing factor 20023
#

Percentage of total contributing factors per reporting period 20034

#

20045
#

20056
#

20067
#

20078
#

20089
#

200910
#

n=210
32 17 16 7 7 9 6 * * 6

n=283
41 17 17 9 7 6 3 * * 0

n=291
31 24 27 4 4 6 1 * * 3

n=337
43 14 20 2 5 4 3 5 3 1

n=305
32 15 18 12 4 6 2 6 1 4

n=302
43 18 16 9 7 2 2 3 0 0

n=332
36 15 20 8 8 3 3 7 0 0

n=301
34 23 17 7 10 4 1 1 3 0

Procedures/ guidelines Human resources Communication Health information Equipment Physical environment Facilities management Patient behaviour Course of disease * Other

Total

100

100

100

100

100

100

100

100

*Contributing factor not reported for reporting period #n= total number of contributing factors for reporting period

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Clinical governance compliance checklist

Domain
Consumer participation

Domain descriptor
Consumers are empowered to participate in their care. Services respond to the diverse needs of consumers and the community with humanity. There is clear, open and respectful communication between consumers at all levels of the health system. Consumers provide feedback on clinical care and services delivery and services learn from the feedback.

Equip 4.0 (Mandatory criterion)

1.1.2 1.1.1 1.1.2 1.1.4 1.1.4 1.1.2 2.1.1 2.1.1 2.1.1 1.12 3.1.5 1.1.4 1.1.4 2.1.2 3.1.3 3.1.3 2.1.3 2.1.2 2.1.3 3.2.1 2.1.3 3.1.5 3.1.5

Yes

WIP

No

Clinical effectiveness

Clinicians are empowered to improve clinical care delivery. Clinicians actively involve consumers as partners in their care. Clinical service delivery processes are streamlined and efcient. Clinicians participate in designing systems and processes. Quality improvement activities are planned, prioritised and have sustainability strategies in place. Clinical care delivery is evidence-based. Standards of clinical care are clearly articulated and communicated. Performance of clinical care processes and clinical outcomes are measured. Clinical performance measures, peer review and clinical audit are used to evaluate and improve performance. New procedures and therapies are introduced assuring quality and safety issues have been considered.

Effective workforce

Workforce development is planned and provides appropriate skills and professional group mix. The health workforce has the appropriate qualications and experience to provide safe, high quality care.

Risk management

Clinical incidents are identied, reported and investigated and underlying systems issues are identied. Risks are proactively identied, assessed and reported. Organisational culture supports open communication and a systems approach to learning from incidents. Clinical processes and technology supports are designed to minimise error and ensure clear, unambiguous communication. A system for managing complaints or concerns about a clinician is in place, promoted and is regularly reviewed. Legislation and relevant Australian Standards are complied with. Policies and protocols are reviewed and managed.

This checklist provides a broad overview of the relationship between the Victorian clinical governance policy framework and the ACHS EQuIP 4.0 mandatory criteria. Each domain is linked to the major mandatory criterion however other criterion may also apply.

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