Queensland Health Patient Safety: From Learning to Action III

Transcription

1 Queensland Health Patient Safety: From Learning to Action III Third Queensland Health report on clinical incidents in the Queensland Public Health System 2007/8

2 ACKNOWLEDGEMENTS I would like to thank all the organisations and individuals who made this report possible. This includes: Ms Adele Gibson (Consumer Contributor) Staff of the Patient Safety Centre Staff of Queensland Health who have reported and managed incidents Patients and consumer groups who have shared their experiences of the healthcare system Queensland Health Patient Safety Officers, clinicians and others who have worked hard to promote patient safety within their health services Healthcare leaders who have committed time and energy to patient safety improvement Other partners and collaborators including the Australian Commission for Safety and Quality in Healthcare and the United States Veterans Health Administration National Centre for Patient Safety Dr Jillann Farmer (Lead Author) Medical Director Queensland Health Patient Safety Centre Brisbane Queensland Health Corporate Office Charlotte Street Postal Address: GPO Box 48 BRISBANE QLD 4001 Further copies of this document can be downloaded from the Queensland Health website: ISBN This work is copyright. It may be reproduced in whole or in part for study training purposes subject to the inclusion of an acknowledgement of the source. It may not be reproduced for commercial usage or sale. Reproduction for purposes other than those indicated above requires written permission from Queensland Health. Queensland Health May 2010 Page 1

3 TABLE OF CONTENTS Foreword...4 Consumer Foreword...6 Executive Summary...7 The Queensland Health Patient Safety System What is it and why are we still having adverse events?...7 What does this report tell us about patient safety in Queensland Health in 2007/8?...7 How is this information being used to improve patient safety for Queenslanders? 8 Key Programs and Initiatives...8 What does the future hold?...9 Introduction...10 What is this report about?...10 Does this report measure patient safety?...10 Some terminology to help with understanding this report...10 Clinical Incident Management...17 The 2007/2008 reporting year in detail...18 Significant Changes in 2007/ Summary data from PRIME CI for 2007/ Sentinel Events and SAC1 events reported using the Reportable Incident Brief system...19 Patient Harm in 2007/ Three Years Change for Safety...26 A steady growth in incident reporting...27 SAC 1 data From the Reportable Event Register...28 Increased reporting of no harm incidents...28 Changes in Proportion of SAC 1, 2 and 3 events...30 Types of Clinical Incidents...31 What do these changes mean?...33 Incident Analysis How we learn and improve our systems...35 Case 1: Death during transfer to another facility...36 Case 2: Death of a Baby...38 Case 3: Suspected Suicide in the Community...40 Case 4: A Fall...42 The challenges of measuring safety...45 Focus on high risk areas...46 Page 2

4 Falls Injury...46 Pressure Ulcer Prevention...53 Mental Health...58 Other Patient Safety Programs...62 Haemovigilance: Queensland Incidents In Transfusion...62 Clinical Handover...63 The Clinician Performance Team...63 Coronial Management...66 Ensuring Correct Patient, Correct Site and Side, Correct Procedure (3Cs)...67 Infection Surveillance and Prevention...68 The Informed Consent Program...69 Medical Fatigue Risk Management Strategy...71 Management of aggression and other patient behaviours that can lead to harm.71 Medication Safety...76 Open Disclosure Program...80 Patient Identification...81 Recognition and Management of the Deteriorating Patient...83 Directions for future work...84 Appendix 1: Procedures Involving the Wrong Patient or Body Part...85 National context...85 Queensland Health...85 Description and analysis of 27 cases...85 Extent of patient harm...87 Contributory factors...88 Compliance with four step safety protocol...88 Comparison with previous reporting period (2006/07 vs. 2007/08)...89 Appendix 2: Learning from Adverse Events...93 Final Analysis Findings...93 Key priorities identified for each of the categories are listed below Future Recommendations Analysis...97 Appendix 3: A review of the 2008 Mental Health Incident Analyses...98 Appendix 4: Strength of Recommendations References Page 3

5 Foreword On an average day in Queensland Health: 7832 people receive admitted care in acute public hospitals including 1114 people who receive same day admitted care 29,372 non admitted patient services are provided in acute public hospitals 4096 emergency services are provided for non admitted patients in acute public hospitals 115 babies are born in acute public hospitals 1457 people receive residential care in 21 aged care facilities 461 callers are given qualified and supportive advice on health concerns through the health hotline, 13HEALTH ( ) $21.1 million is spent on public health services $1.66 million is spent rebuilding and maintaining health facilities Queenslanders enjoy excellent health by world standards. We are justly proud of our healthcare system, which provides universal access to all residents, regardless of where they live. The vast majority of care delivered in our Queensland Health hospitals and health services is safe and effective. However, despite the excellent skills, training and best intentions of our staff, occasionally things do not go as expected. When this happens, particularly when the consequence is severe, it causes major distress for patients, families and staff. Publicity around these events can also lead to the community losing trust in their health system. Queensland Health recognises that patients have a right to the safest possible healthcare, and it is in everyone s interest that we keep improving. The first step in addressing a problem is acknowledging that it exists. Queensland Health has worked hard to develop a culture that actively encourages staff to report clinical incidents, and sees these as an opportunity to learn about and fix problems, rather than ignoring them. Sharing information in an honest and transparent way is fundamental to improving patient safety and building trust in both the community and our staff. This report builds on the First and Second Queensland Health Reports on Clinical Incidents and Sentinel Events Patient Safety: From Learning to Action I (2007) and II (2008). At first glance, it would be easy to conclude that the 21% increase in staff reporting of clinical incidents since the previous year, represents a worsening of patient safety in Queensland Health. On the contrary, almost all of this change relates to increased reporting of near misses. This is exactly the change we are looking for. As the culture improves, staff report more as they become more confident that concerns Page 4

6 will be addressed. The analysis of these incidents continues to help us better understand the root causes of incidents, and implement changes aimed at improving safety. Lessons learned from clinical incidents continue to inform the extensive Queensland Health patient safety improvement program. This Report summarises the major state wide patient safety improvement work led by the Patient Safety Centre and other state wide and local units devoted to addressing the major causes of preventable patient harm. This work is already delivering real improvements in patient safety. For example, improvements in pressure ulcer prevention over the last three years are saving an estimated 20,000 patients each year from this painful and preventable condition. With each pressure ulcer adding an average 3 days extra stay per patient, this equates to 60,000 bed days every year that are freed up for other patient care; the equivalent of a new 160 bed hospital. Queensland continues to be a national leader in the development of new patient safety initiatives that will lead to improved safety in the future. Initiatives such as the Children s Early Warning Tool (CEWT) will support staff, particularly in rural hospitals, in rapid identification and management of sick children. Queensland Health is at the forefront of many such programs that aim to provide real support to staff at the bedside, to improve patient safety. Consumers of healthcare have a direct stake and active role to play in their own safety. Through partnerships between the Patient Safety Centre and the newly formed Health Consumers Queensland, I am delighted to see that consumers are becoming active partners in developing and implementing patient safety programs across the state. It is only right that consumers are involved in the preparation of this Report and I welcome the consumer foreword and comments. Whether you are a member of the Queensland community, or a staff member of Queensland Health, I hope this report achieves its goal of raising awareness of patient safety issues and what is being done to address them. Continued improvements in patient safety can only be achieved with the combined efforts of all that work in, manage and use the Queensland public health system. Dr John Wakefield Senior Director Queensland Health Patient Safety Centre Page 5

7 Consumer Foreword To be a patient within any health environment means to make oneself vulnerable to the expertise of others. In that state of vulnerability, the extent of trust between all of those involved holds the key to patient safety. In a society where health systems have become fraught with problems, pressures and complexities, the only lasting solution for positive change lies in the forging of a solid partnership between those who seek health care, and those who plan, fund and provide it. The Patient Safety Centre is the ideal hub for that partnership. It was gratifying to represent Queensland at a national patient safety workshop recently, as a State that has shown extended initiative and commitment to the area of patient safety in the last few years. The Queensland level of support and dedication to this cause clearly equalled and excelled that of other States. During my involvement with the Patient Safety Centre over the last two years, I have watched closely as so much has been achieved through its work often providing a ray of hope upon a backdrop of negativity. A multitude of initiatives and specific projects, research and training, are supporting a healthier, safer culture in this State. With the foundations for firm partnerships between all stakeholders laid, the future looks infinitely brighter for consumers. Consistent support for the PSC and its endeavours, close and respectful partnerships between all concerned, all within an environment of openness and honesty, will ensure the continued positive progress of patient safety in Queensland. I am glad to have had the opportunity to participate in this, and I urge all consumers of health services in Queensland to support the Patient Safety Centre into the future. The only true waste in this life is the error not recognised and learnt from. Adele Gibson Consumer Representative Patient Safety Centre Advisory Committee Page 6

8 Executive Summary This is the third edition of "From Learning to Action". Queensland Health remains committed to transparency in sharing information about adverse clinical events. This report is therefore for all Queenslanders, but in particular, for the staff of Queensland Health and for members of the community who are interested in what Queensland Health is doing to improve patient safety. It is also for anyone who wants to share in, and benefit from, the things that we have learned as we have introduced a comprehensive Patient Safety System into Queensland Health. The Queensland Health Patient Safety System What is it and why are we still having adverse events? The Patient Safety System is made up of policies, processes and supporting tools that ensure we constantly learn from and prevent clinical incidents. More important, however, are the organisational culture and the people who make such systems work. Queensland Health s Patient Safety System could achieve nothing without the vigilance and responsiveness of Queensland Health staff. Clinical incidents (adverse events and near misses/near hits) occur in every health system in the world. Sometimes, patients are harmed. Queensland has recognised this reality, and has responded by the development of the Queensland Health Patient Safety System. The goal of this system is to minimise preventable patient harm. We have not yet eliminated it, and that is why we continue to receive reports of adverse events. We are still quite early in a process that will take many years, but the gains to date are significant. Every time an incident occurs, we seek to learn from it and find ways in which to prevent its recurrence. It is only by having a system that allows us to recognise, report, analyse and learn from incidents, that we can improve and ultimately reduce preventable harm. What does this report tell us about patient safety in Queensland Health in 2007/8? The most striking feature of the data in this report is that we have been successful in capturing reports of more clinical incidents than ever before, with our staff making 57,018 voluntary reports of clinical incidents using our clinical incident reporting system, PRIME CI. This represents an overall increase of 21.3% compared with the previous year, and an overall increase of 58% since the first "Learning to Action". Because these reports are voluntary that is, it depends on staff recognising and then making a decision to report, an increase in the number of reports is not a measure of an increase in actual incidents; rather it demonstrates the successful implementation of policies, systems and cultural reform that encourage staff to report problems. A 58% growth over 3 years in incident reports represents a fundamental cultural shift, and it is the single greatest predictor that we will succeed in a goal of minimising preventable patient harm. Encouragingly, incidents reported Page 7

9 where patients were not harmed formed the bulk of the growth, with "no harm" incidents up by 28%, and a growth of "harm" events of just 1.8%. 77% of all reported incidents were not associated with patient harm. From 2006/2007 to 2007/2008, there was growth in hospital activity of 7.4% (combined admitted and non admitted episodes of care)[1]. The much lower relative growth in reported "harm" incidents (1.8% growth) is another positive indicator that our endeavours to improve safety are having an impact. The increase in reporting is spread relatively evenly across all primary incident types, with falls (n=11,648, up from 10,931 last year) and medication incidents (n=8920, up from 7,483) continuing to be the most commonly reported. 22.2% of reported incidents resulted in patient harm, with some types of clinical incidents more likely to cause harm. Falls are the number one reported cause of patient harm, accounting for almost 35% of all harm from reported events. There were 3,949 falls reported as resulting in patient harm during the 2007/2008 financial year. Pressure ulcers are also an area of significant concern, accounting for 12.6% of reported harm. This data provides clear evidence that these continue to be high risk areas, deserving of continued prevention effort. How is this information being used to improve patient safety for Queenslanders? Merely collecting data about clinical incidents would be pointless without the underpinning analysis and learning. Significant effort goes into analysing what has occurred, why it has occurred, and what can be done to prevent recurrence. Appropriately, most effort goes into analysis of the most serious events. Root Cause Analysis is the preferred method of analysis for Severity Assessment Code (SAC) 1 events, with Human Error and Patient Safety (HEAPS) analysis providing another strong, system focussed analysis approach. Quantitative and qualitative data is available from PRIME CI, and extremely rich qualitative information flows out of analysis of SAC 1 events. Local management teams review lower category (SAC 2 and SAC3) events, using methods ranging from Root Cause Analysis to aggregated review. The local line managers have a key role in the identification and prioritisation of corrective actions for the incidents reported by their staff. PRIME CI data is increasingly providing a rich array of information about what goes wrong and how. The system is being continuously improved to allow better reporting, better analysis, and better data extraction. We now share de identified data internally and externally to further support patient safety improvement. Key Programs and Initiatives Incident reports guide the prioritisation of our work to improve Safety. Accordingly, Patient Safety Centre and other key units within Queensland Health have continued to work in the following areas: Page 8

10 Falls Injury Prevention Pressure ulcer prevention Mental health safety, including suicide prevention Blood transfusion safety Clinical handover Clinician performance Coronial management Ensuring correct patient, correct site and side, correct procedure (3cs) Infection surveillance and prevention Informed consent Medical fatigue risk management Management of aggression and other patient behaviours that can lead to harm Open disclosure Medication safety 3 new priority areas: o Clinical handover o Patient identification o Recognition and management of the deteriorating patient What does the future hold? We will continue to build on the early work of the three new priority areas, as we move from concept and design to strategy implementation. In particular, we are now in a position to make use of the wealth of information available in our incident reporting and analysis. The first of those analyses are included as appendices to this report, and the coming year will see a further development of this type of work. We will continue to participate in collaborative, national projects in areas of high priority, and will identify the next round of new priorities upon which to commence work. It is likely that these will be drawn from the incidents reported as "Deviations from Planned Care", which are one of the largest subgroup of incidents. Each year, Patient Safety Centre provides this report, and each year, concern is raised that the increased number of reported incidents reflects an increase in harm. Because of the way in which incidents are reported, and the linkage between reports and a "safety conscious" culture, volume of reports are not a measure of safety performance. Patient Safety Centre is committed to the development of a suite of Patient Safety Indicators, by which safety can be objectively measured. We acknowledge that we will never completely eliminate harm from clinical incidents, but the learning and actions that flow from a robust Patient Safety System give us hope of achieving our goal of minimising preventable patient harm. Page 9

11 Introduction What is this report about? On one level, this is a report about the things logged into our clinical incident reporting system (PRIME CI) by the staff of Queensland Health. It provides a summary of the kinds of issues they have voluntarily reported, and a more detailed analysis of the serious events. This report is about the things that our staff have identified, reported, and acted upon. In the three years since we introduced a comprehensive incident reporting and management system, there has been a steady growth in reports. We are proud that our staff are proactively identifying and reporting incidents and risks. Nobody is better placed than front line staff to report these matters, and significant effort has gone into making it easier for them to report. Underpinning the reporting of incidents, however, is the transformation of patient safety culture. In just 4 years, Queensland Health has sought to establish a robust, transparent and accountable Patient Safety System. This report is also about the successes and challenges of that transformation. Does this report measure patient safety? This report is not, and never has been a comprehensive catalogue of the good and bad in the health care system. Because it is compiled from voluntary incident reports, it cannot measure how safe the health system is, other than by the indirect positive link between reporting and safety cultures. This report describes the steps we are taking to make Queensland Health safer for patients, but it does not attempt to measure safety performance. One section of the report is devoted to examining the issue of measuring patient safety, because development of methods to measure our progress is now due. In the future, as we implement a valid, reliable suite of patient safety indicators 1, they will be incorporated into subsequent reports. For now, the best measure of safety is in the evidence of cultural change and improved transparency. Some terminology to help with understanding this report There are some core concepts that will assist in interpreting this data. An overview of the Clinical Incident Management System is a good place to start. 1 The World Health Organisation defines an Indicator as a variable with characteristics of quality, quantity and time used to measure, directly or indirectly, changes in a situation and to appreciate the progress made in addressing it. Page 10

12 Reportable Incident Brief A Reportable Incident Brief (RIB) is a faxed document that districts send to the Patient Safety Centre to advise of a serious clinical incident. A RIB is completed for all Sentinel Events and all Severity Assessment Code (SAC) 1 events, in addition to the entry of information into the computerised reporting system (PRIME CI). Patient Safety Centre uses the RIB information to maintain a Reportable Events Register. Clinical Incident Management System The Clinical Incident Management System defines our recognition of and response to adverse events. The system is summarised in the following Figure 1. Figure 1: The Queensland Health Clinical Incident Management System Patient Experience Post Analysis Feedback Clinician Disclosure Formal Open Disclosure Page 11

13 Clinical Incident A clinical incident is any event or circumstance which has actually, or could potentially, lead to unintended and/or unnecessary mental or physical harm to a patient.[2] A clinical incident is not necessarily a mistake or an error. Some clinical incidents occur simply due to chance for example, a previously completely unknown allergy to a medication. We encourage staff to report all clinical incidents, not just those that they believe are due to error. The Quality in Australian Healthcare Study [3] showed that 70% of incidents were associated with human error, and 50% were not preventable with the knowledge available at the time of the study. Clinical Incident Management Implementation Standard The Clinical Incident Management Implementation Standard (CIMIS)[2] sets out what Queensland Health does in response to Clinical Incidents. The organisational response varies according to the severity of consequence to the patient. During the reporting period, CIMIS 2006 was the version in application, and the descriptors and definitions used in this report below relate to that document (which has subsequently been superseded). PRIME Clinical Incident (PRIME CI) PRIME CI is our clinical incident management information system. It is accessible from every networked computer in Queensland Health, and is available to all staff. It is also used by managers to read about and manage clinical incidents and record corrective actions for incidents that have been reported by staff in their area. Clinical Incident Report A clinical incident report is a voluntary entry made by staff into our clinical incident reporting system, PRIME CI. We rely on our clinical staff to report incidents. This means that they are often reporting something to which they may have contributed. Every clinical incident report in our system has been voluntarily lodged by staff, and the vast majority have been lodged by front line staff involved in clinical care, when they do or witness something that has harmed a patient, or that could have harmed a patient. Where our staff become aware that a patient has died after leaving hospital, this is also often logged as a clinical incident particularly in the case of Mental Health, where suicide in the community is specifically defined as a "SAC 1 Reportable Event" (see below). Severity Assessment Code SAC The Severity Assessment Code (or SAC rating) is the way in which we distinguish the most serious events from others. SAC ratings (based on the consequences to the patient of the adverse event) range from 1 to 3. SAC1 events are the most serious events, and are those where the patient has died, or has been seriously and permanently harmed. Examples of serious permanent Page 12

14 harm include things like paralysis, loss of limb or limb function, or other permanent disability. The formal CIMIS 2006 definition of SAC 1 event is as follows: Death(s) or permanent loss of function unrelated to the natural course of the underlying condition (includes defined Sentinel Event). SAC 2 events are defined as follows: Patients with temporary loss of function unrelated to the natural course of the underlying condition. Includes increased length of stay or surgical intervention as a result of incident. SAC 3 events are defined as follows: Patients with minor or no injury. No increased level of care or length of stay. Open, In Process and Closed incidents An incident is reported by staff at the coalface, by logging on to any networked computer in Queensland Health. Once the incident is reported, it is given the status of Open. The incident management process requires that the manager (almost always a senior nurse or doctor) responsible for that work area then reviews the incident. This process can take as little as a few days, up to many weeks or months. The more serious the incident, the longer the analysis generally takes, because more sophisticated incident analysis methods are used. While the review is underway, the incident is given the status in PRIME CI of In Process. Once the analysis is complete, and all corrective actions (see below) are completed, the incident can be closed. Some corrective actions can be rapidly implemented, whilst some take months or even years to implement (e.g. capital works to improve the physical facilities of a health service). We do not close an incident until all of the agreed corrective actions have been completed. Only then is it reported as closed. Incident Analysis This is the process by which we learn from reported incidents. The level of analysis is usually proportional to the severity of the incident. For the most serious incidents, we usually perform a Root Cause Analysis (RCA). An RCA is a quality improvement technique that explores the chain of events responsible for adverse events in order to identify the factors which caused or contributed to the event, as well as the measures that may be implemented to prevent or reduce recurrence of the same type of event. The objective of an RCA is to understand how and why an event occurred, rather than to apportion blame or determine liability. The intense and structured review of an RCA also often uncovers other, unrelated opportunities for safety improvement, and these are incorporated into the RCA report as "Lessons Learnt". Page 13

15 RCA is a highly technical task, and is governed by specific legislative requirements (including release of the report). All RCA teams in Queensland are led by staff who have received training in this internationally recognised method of incident analysis. The Human Error and Patient Safety (HEAPS) method is an alternative analysis method used for incidents that are ineligible for, or do not require an RCA. HEAPS guides analysis teams to systematically examine the factors that may have contributed to the adverse event (patient factors, task factors, practitioner factors, team factors, workplace factors and/or organisational factors). Staff who lead this work have also usually received specific training. The vast majority of our incidents are analysed by front line healthcare workers and their line managers. For SAC 2 and SAC 3 incidents, line managers are able to work with their teams to rapidly identify and implement corrective actions where necessary, without the requirement for elaborate process. However, line managers have the option of requesting more detailed review if the issues are complex, or if there may be state wide lessons to be learned. The majority of line managers are capable of leading a HEAPS analysis if this should be considered necessary. Incident analysis is intended to work in parallel to, and not as a substitute for performance management, consumer feedback systems, staff complaints, professional standards regulation or legal processes (e.g., civil or coronial). Corrective actions Corrective actions are the things that we do to change our workplace or work methods to reduce the likelihood that this type of incident will happen again. This might include things like introducing a new system for administering blood, running training for staff or making changes to a building. Corrective actions are not all equal. Some are more effective than others. Policies and procedures are often not the most effective way of making patients safer, because there is a limit to the amount of policy that a clinician can carry in his or her head, ready to deal with every eventuality. Education can be an effective remedy, but requires ongoing effort to achieve sustained change. Physical changes to the workplace such as improved equipment or workspace layout are the strongest corrective actions, most inclined to result in lasting protection. Executive managers have a key role in ensuring that wherever feasible, strong corrective actions are chosen. For more information about Strength of Actions, see Appendix 4. Page 14

16 Harm We provide staff the option of recording whether they believe the clinical incident has harmed the patient. This is not an assessment of severity of harm, but gives a broad indication of how many events are being reported where staff perceive that a patient was hurt. Harm can range from a small skin tear all the way through to loss of life or limb. We collect data about severity of harm by using the SAC classification system, which is measured by the SAC code (see above), Sentinel Events Sentinel Events are rare events, and are defined in a list endorsed by the Australian Health Ministers. The definitions (listed below in Figure 2) do not all contain reference to patient harm. However, the overarching definition of Sentinel Events requires that these events have associated consequences of death or permanent loss of function. They comprise only a small percentage of incident reports. Out of the total number of incidents reported in Queensland Health during the reporting period, fewer than 0.05% were Sentinel Events. Sentinel Events formed the basis of original reporting schemes. However, experience in Queensland demonstrated the limitations of the national list, and our incident reporting scheme expanded the definitions to capture more events. This was done to maximise reporting, and therefore increase our ability to learn and improve the healthcare system. Figure 2: National Sentinel Event List National Sentinel Event List Source: Australian Council for Safety & Quality in Healthcare. 1. Procedures involving the wrong patient or body part 2. Suicide of a patient in an inpatient unit 3. Retained instruments or other material after surgery requiring reoperation or further surgical procedure 4. Intravascular gas embolism resulting in death or neurological damage 5. Haemolytic blood transfusion reaction resulting from ABO incompatibility 6. Medication error leading to the death of patient reasonably believed to be due to incorrect administration of drugs 7. Maternal death or serious morbidity associated with labour or delivery 8. Infant discharged to wrong family Page 15

17 We collect data about Sentinel Events (and SAC 1 events) in two ways electronically and manually. The dual data collection reflects the importance placed on these serious incidents. The electronic collection depends on the staff caring for the patient entering a report into the PRIME CI system. The manual system is activated by escalation of the incident to the District Chief Executive Officer (formerly District Manager), and entails a faxed notification (Reportable Incident Brief) to the Patient Safety Centre. Because the latter involves Patient Safety Centre review and discussion, where there is a conflict between the two sets of data, this report has made use of the manually collected data (called the Reportable Events Register). Page 16

18 Clinical Incident Management The processes that staff and managers must follow are set out in CIMIS, as explained above. During the current reporting period, for Sentinel Events and other SAC 1 events, CIMIS 2006 required that a Root Cause Analysis be performed for all inpatient events, except in those cases where a Root Cause Analysis was not permitted by law. The District Manager could choose not to perform an RCA in some additional circumstances (for example, suicide in the community), but alternative analysis was always required. For SAC 2 and 3 events, lower levels of analysis were permitted, such as HEAPS (Human Error and Patient Safety), or clinical review by an appropriately qualified senior clinician or group of clinicians. Many SAC3 events are managed immediately by the line manager, with local actions allowing a rapid response. SAC3 incidents can be managed individually, or by aggregated review, which helps to identify themes. SAC definitions and required actions from CIMIS 2006 are set out below. Figure 3: CIMIS 2006 Severity Assessment Code (SAC) definitions and required actions Page 17

19 The 2007/2008 reporting year in detail Significant Changes in 2007/2008 Queensland Health exists in a changing environment, and we are constantly seeking to improve the systems and processes for patient safety. Many such changes were implemented during the reporting period, but two in particular are worth noting, because of their impact on the way we work and on our data. Legislation for Root Cause Analysis In May 2007, legislation was enacted to provide for robust analysis of serious adverse events. The legislation commenced part way through the current reporting year. The legislation implemented recommendations from the Health Action Plan [4] and the Health Systems Review [5], and has the effect of providing qualified privilege for the inner workings of Root Cause Analysis. This legislation mirrors similar provisions in other safety conscious industries, for example, the Transport Safety Investigation Act 2003 (which applies to aviation investigations). The net effect of this privilege is that the identity of the team is protected, information gathered by the RCA team cannot be used in other processes, and is not able to be obtained through legal process. The purpose of this protection is to allow staff to participate in or provide information to analysis teams, without fear that this information could be used in proceedings against them or a colleague. The legislation requires release of a report from the RCA, facilitating timely and full Open Disclosure. The RCA is often the first source of answers, with other processes (for example legal proceedings, coronial investigations, or professional regulation) sometimes taking many years. This impact of this legislation is due for evaluation during Availability of SAC 1, 2 and 3 classification in PRIME CI The capacity for PRIME CI to capture information about SAC classification and whether or not the patient was harmed was introduced in the 2006/2007 year. The current reporting year reflects the first full year where this data has been available. Page 18

20 Summary data from PRIME-CI for 2007/2008 The following section presents data that has been entered into the PRIME CI system by Queensland Health Staff. SAC 1, 2 and 3 reports During the 2007/2008 reporting year, there were a total of 57,018 incidents reported. Of these, 0.4% (250 incidents) related to death or serious, permanent harm (SAC 1), and 3.5% (2,015 incidents) related to temporary, less severe harm (SAC 2). Figure 4: Incident reports in PRIME CI by SAC category 2007/2008 Sentinel Events and SAC1 events reported using the Reportable Incident Brief system As noted above, we have two reporting options for Sentinel Events and SAC 1 events staff report these in PRIME CI, but they also escalate them manually through the reportable incident brief system. There is a difference in the numbers collected for the two systems PRIME CI records 250 SAC 1 events, whilst the Reportable Event Register records only 169 reported SAC 1 events. There are a number of possible explanations for this, including: When CIMIS was first introduced in 2006, suicides were not routinely collected via the Reportable Incident Brief system. They were managed by Mental Health Branch, but staff still reported into PRIME. Some of this gap may be attributable to legacy practices. The definitions for reporting as it applied at the time period captured by this report meant that deaths due to underlying clinical conditions were not reportable. It is possible that there have been episodes where the staff Page 19

21 reporting through PRIME CI were unaware of the cause of death, but it became clear before the RIB was lodged that this was not a reportable event. We have identified this as an unacceptable gap in the reporting system, and a PRIME CI system change from December 2009 will ensure that there is no discrepancy for reports lodged after that date. In the meantime, from July 2009, a monthly reconciliation between Reportable Events and SAC 1 Reported Incidents in PRIME CI has been instituted. Sentinel Events are rare events, and are defined in a list endorsed by the Australian Health Ministers. During the reporting period, all Sentinel Events were managed in the same manner as SAC 1 events, even if the patient was not harmed. There were 19 SAC 1 Sentinel Events (that is, the consequence of the Sentinel event was death or serious, permanent harm). Figure 1 shows the reported SAC 1 Sentinel Events for 2006/2007 and 2007/2008. Figure 1: Sentinel Event Categories National Sentinel Event Number 2007/2008 Total SAC1 2006/2007 Total SAC 1 (SE #) Deaths Perm nt Loss of function Deaths NSE 1 Procedures involving the wrong patient or body part NSE 2 Suicide of a patient in an Perm nt Loss of function inpatient unit NSE 3 Retained instruments or other material after surgery, requiring re-operation or further surgical procedure NSE 4 Intravascular gas embolism resulting in death or neurological damage NSE 5 Haemolytic blood transfusion reaction resulting from ABO incompatibility NSE 6 Medication error resulting in death of a patient reasonably believed to be due to incorrect administration of drugs NSE 7 Maternal death or serious morbidity associated with labour or delivery (excluding neonates and babies) NSE 8 Infant discharged to the wrong family TOTALS A detailed report about procedures involving the wrong patient or wrong body part is included as Appendix 1. 1 Suspected suicide reports (Only the coroner can determine suicide as cause of death) under Coroners Act Page 20

22 The sentinel event descriptors are quite restrictive, and are actually a small subset of clinical incidents that result in patient harm. Queensland Health has adopted a much more comprehensive stance on incident management, and requires the reporting of all SAC 1 events, even when they do not meet the definition of a National Sentinel Event. This means that we collect much more data about patient harm than we would under the pure Sentinel Event system. Deaths reported using the Reportable Incident Brief system We collected information about 122 deaths that were not part of the national Sentinel Event Reporting Scheme. In combination with the 10 deaths that were reported as Sentinel Events, this comes to a total of 132 deaths reported as clinical incidents in 2007/2008. Figure 6: Deaths reported using the Reportable Incident Brief System, Deaths Suspected Suicides Other Deaths Suspected suicide on hospital premises of an admitted 5 patient Suspected suicide in the community of patient under care 29 of Queensland Health, or who has recently attended an Emergency Department Maternal death associated with labour or delivery 0 Procedures Involving wrong body part 0 Medication event 5 Fall 7 Pressure Ulcer 0 Perinatal (Infants) 21 General Clinical Management Complications 18 Diagnosis 18 Inter hospital 3 retrieval/transfer Investigations 1 Observations 5 Transfer of Care 7 Treatment Total Suspected suicides are a major source of patient harm, accounting for over 25% of deaths reported as clinical incidents. We do not only collect data about suspected suicides in hospital suspected suicides of patients under our care in the community, or who have recently been seen in an emergency department are also recorded. 34 Page 21

23 Figure 7: Suspected suicides as a proportion of all deaths reported using the Reportable Incident Brief System Other Deaths 98 74% Suicide outside Hospital 29 22% In Hospital Suicide 5 4% Queensland Health s initiatives in Mental Health and suicide prevention are discussed in detail later in the report. Serious Harm reported using the Reportable Incident Brief System Just as we collect more data about deaths than is required by the national sentinel event list, we also collect additional data about serious harm. Figure 8 provides detail of all the serious harm events that were reported using the Reportable Incident Brief system during 2007/2008. Figure 8: All Serious Harm (SAC1) events reported using the Reportable Incident Brief System Severe Harm Not death Attempted Suicides resulting in severe harm Other incidents resulting in severe harm Attempted Suicide on hospital premises of an admitted patient Attempted Suicide in the community of patient under care of Queensland Health, or who has recently attended an Emergency Department Serious Maternal morbidity associated with labour 1 or delivery Procedures Involving wrong body part 8 Medication event 0 Fall 0 Pressure Ulcer 0 Perinatal (Infants) 5 General Clinical Management Complications 7 Diagnosis 6 Inter hospital 0 retrieval/transfer Investigations 0 Observations 1 Transfer of Care 2 Treatment 6 36 Total Page

24 Analysis of SAC 1 events CIMIS 2006 specified that Root Cause Analysis was mandatory for Sentinel Events and SAC 1 events, with certain exceptions. Mental Health services may choose to perform an alternative form of analysis (such as HEAPS) for suicides in the community. The Health Services Act 1991 specifies that an RCA may not be undertaken in circumstances where there is a prima facie blameworthy act. A Blameworthy act is defined in s38o of the Act as an intentionally unsafe act, deliberate patient abuse or conduct that constitutes a criminal offence. The Act also prohibits commissioning an RCA where there are reasonable grounds to believe that the capacity of a person who was directly involved in the provision of the health service during which the reportable event happened was impaired by alcohol or other drugs. In addition to these prohibited circumstances, there are other circumstances where an RCA may not be appropriate. For example, as RCA focuses on identifying systemic factors that contributed to an event, it is not an appropriate tool to investigate matters concerning the competence of individuals providing health services. These events are still subject to analysis, but not by RCA. In almost half of those SAC1 events where RCA is not commissioned, the HEAPS analysis method has been used. During the reporting period, 56% of SAC 1 events were reported in PRIME CI as having had an RCA undertaken, and a further 23% had a HEAPS analysis. Figure 9: Analysis methods of SAC 1 events as recorded in PRIME CI RCA % Not Specified in PRIME CI 6 3% Local Clinical Review 45 18% HEAPS 58 23% Page 23

25 Further information from the analysis, learning and actions relating to SAC1 events is provided in the later section on incident analysis which takes a more in depth look at deaths of Queensland Health patients. Patient Harm in 2007/ /2008 represents the first year of full data where our staff have had the capacity to advise if the patient was harmed or not. Of the total number of reported clinical incidents, 78% were reported as involving no harm to the patient. Figure 10: Total incidents (SAC 1, 2 and 3) and Harm 2007/ ,353 78% 12,665 22% Harm No Harm Of the 12,665 harm incidents, 249 (2%) resulted in death or serious permanent harm, 2015 (16%) resulted in temporary loss of function, and 10,401 (82%) resulted in minor harm. SAC 1 and 2 incidents, by their definitions, are events where patients are harmed. The degree of harm is specified in the definitions, outlined in the introduction to this report. Rarely, an incident may be reported as a SAC 1, because it met the definition of one of the sentinel events, but the patient was not harmed. There was one SAC 1, no harm event in 2007/2008, where a deciduous (milk) tooth was removed by mistake. As this was a wrong site surgery, it meets the definition of a sentinel event, but because the tooth was going to fall out anyway, the staff who reported it classified it as no harm. All other SAC 1 events (n=249) and SAC2 (n=2015) were reported as harm. Page 24

26 Figure 11: Harm incidents 2007/2008: Harmful incidents subclassified by SAC category SAC 3 10,401 82% SAC 2 2,015 16% SAC % SAC 1 SAC 2 SAC 3 The data where the harm/no harm categorisation is of most use is in understanding the SAC 3 data, because by definition, all SAC1 and SAC2 incidents involve harm. SAC 3 incidents can be minor harm (such as a bruise), or no harm, for example, where staff identify and intercept an event before it causes any harm at all. In the full 12 months data of 2007/2008, 81% of the reported SAC 3 incidents were in the no harm category. Figure 12: SAC 3 incidents and Harm 2007/ ,352 81% 10,401 19% Harm No Harm Page 25

27 Three Years Change for Safety This is the third edition of From Learning to Action. Our processes and systems have evolved during that time, and we have been focussing on improving the overall patient safety culture of Queensland Health. It is easy to talk about improving culture, but what does this actually mean? Lucian Leape[6] has recently proposed six major changes for building a safety culture in healthcare: Figure 13: Leape's Major Changes for Safety Culture Leape s Major Change We need to move from looking at errors as individual failures to realizing they are caused by system failures. We must move from a punitive environment to a just culture. We do not punish for errors, but we do not tolerate misconduct. We move from secrecy to transparency. Instead of hiding errors, we discuss them and learn from them. Patients are honestly and completely informed of their care and when problems arise. Similarly, we are open to the public. We have no right to hide what we do. In a safe culture, transparency and openness are part of everything we do. Care changes from being provider centred to being patient centred. We move our models of care from reliance on independent, individual performance excellence to interdependent, collaborative, interprofessional teamwork. Accountability is universal and reciprocal, not top down. At every level, we are accountable we take responsibility for safety for all aspects of safety, and we expect those above us to do so as well. Queensland Health Change Human Error and Patient Safety Training and analysis tools Root Cause Analysis legislation Clear definition of blameworthy acts Introduction of non disciplinary pathway for medical performance concerns Publication of From Learning to Action Open Disclosure Program Clinical Incident Reporting System Informed consent program Open Disclosure Program Human Error and Patient Safety (HEAPS) training and tools Team based training such as Crew Resource Management (CRM) CIMIS defines accountability for incident management from bedside clinicians right through to the Director General Incorporation of safety measures into District CEO agreements. Incident Reporting system Reporting and follow up of corrective actions Page 26

28 We provide this report each year because transparency is such a critical element in the transformation to a safe culture. We report the growth in reported incidents, knowing that this will be interpreted by some as a sign of worsening safety. Any harm to a patient is a result of a system failure. Creating an environment where our staff report to us, and where we in turn disclose to the public, and use this information to improve, is not a failure. It is the first, critical step in reforming the system to reduce harm. We have made significant progress against Leape s six major changes, but the work is not yet complete. This report, viewed in tandem with its predecessors, clearly marks out that progress. A steady growth in incident reporting The most striking feature of the three editions of From Learning to Action is that the number of incidents reported has gone up each year. When we first started collecting state wide data in July 2005, there were 2333 incidents reported in that month. In the month of June 2008, there were 5202 incidents reported. This growth in reported incidents is consistent with experience in other newlyintroduced reporting systems in Australia and internationally growth in the number of incidents voluntarily reported by staff is expected as they learn how and when to report, and grow in confidence that reporting is worthwhile, and leads to change for the better. Figure 14: PRIME CI Total Monthly Reported Clinical Incidents July 2005 to June ,000 5,000 Reported Incidents 4,000 3,000 2,000 1,000 Jul 05 Sep 05 Nov 05 Jan 06 Mar 06 May 06 Jul 06 Sep 06 Nov 06 Jan 07 Month Mar 07 May 07 Jul 07 Sep 07 Nov 07 Jan 08 Mar 08 May 08 Page 27