The safety and quality of health care: where are we now?

Supporting the workforceNational Standard for credentialling and defining the scope of clinical practice of medical practitioners (2004): The Council developed an agreed approach to credentialling and produced the National Standard. Support materials to assist in implementation were developed and distributed. National Patient Safety Education Framework (2005): The National Patient Safety Education Framework sets out the required skills, knowledge and behaviour in regard to patient safety. It recognises education as a foundation element for redesigning systems and facilitating a sustainable culture of safety and quality in health care. Already there is great interest in the Framework from universities and the vocational education and training sector, as well as international organisations. Measurement for improvementAgreed National List of Core Sentinel Events (2003): Sentinel events are adverse events that cause serious harm to patients. A national core set of sentinel events has been agreed with all jurisdictions, and a national report is being developed to measure and learn from events that cause death or serious harm to patients. Charting the safety and quality of health care in Australia (2005): This publication assembled data to provide health care providers, policy makers and consumers with a comprehensive overview of what is known about the safety and quality of the Australian health care system. Measurement for Improvement Toolkit (2005): This is a practical toolkit of ways to measure the safety and quality of clinical services. Patient Safety Risk Management Plans (2004): The Council worked with all jurisdictions to develop national specifications for incident reporting and management systems, including the use of root cause analysis. Each jurisdiction now has consistent incident management systems. Working with consumers10 tips for safer health care (2003): More than 100 000 copies of this booklet have been produced and distributed to help people understand health care safety and become more actively involved in their health care. It is also available in 15 community languages and is being widely distributed to patients at or before the time of admission. It has also been adopted by some private insurers. Open Disclosure Standard: a National Standard for open communication in public and private hospitals, following an adverse event in health care (2003): The Open Disclosure Standard was produced in 2003. It aims to encourage greater openness around adverse events, through acknowledging when things go wrong, and providing reassurance to patients and their carers that lessons learned will help prevent a recurrence of the event. Practice improvementsNational Strategy to Address Health Care Associated Infections (2003): Health care-associated infections are a leading cause of adverse events. There is national agreement on key definitions regarding health care-associated infections, as well as surveillance templates, and production of clinical guides for health professionals to reduce harm. High risk medication alerts (2003 and 2005): High risk medication alerts on intravenous potassium chloride (2003) and vincristine (2005) have been released, so that action is taken on known hazards with potentially catastrophic outcomes. Ensuring Correct Patient, Correct Site, Correct Procedure Protocol (2004): The Protocol was developed in 2004 to help prevent procedures being carried out on the wrong patient or body part, an event that can cause serious harm and distress to patients. This is an evidence-based tool that is being widely used by the Royal Australasian College of Surgeons, and in a wide variety of settings around Australia. Redesign and information technologyNational Inpatient Medication Chart (2004): The National Inpatient Medication Chart was developed in consultation with a wide group of stakeholders to reduce harm resulting from error in the prescribing, supply and administering of medications. All jurisdictions have participated in the pilot of the chart, which precedes a national roll-out of this initiative. Governance and investmentCentre for Research Excellence (2004): The Council has forged a partnership with the National Health and Medical Research Council to form a Centre of Research Excellence in Patient Safety, located at Monash University in Victoria. The Centre will provide the evidence base for sustainable and well researched improvements to the safety and quality of Australia’s health system. Australian Research Council Linkage Grant: The Council developed an industry partnership with ACT Health and the Australian National University, and was awarded an Australian Research Council Linkage Project Grant. This project aims to identify and develop promising regulatory strategies for improving safety and quality. The governance of health safety and quality discussion paper was published in July 2005 as the basis for the future directions of this project.

Time to capitalise on past achievements and become more effective

Richard A Smallwood MD, FRACP, FRCP

An early initiative of the Australian Council for Safety and Quality in Health Care (ACSQHC) was to set up a mechanism for reaching agreement on preferred terms and definitions for safety and quality concepts. The aim was to devise a language with common meanings to facilitate discussion and research.1 This need had been recognised before the Council was formed,2 and a group of international experts had been asked to comment on proposed terms and definitions (see Acknowledgements). The group was emailed proposals, along with alternative definitions from the literature, and asked their opinions and preferences, as well as any additional terms which should be considered. Their comments were circulated regularly among the group. When ACSQHC was formed, I was asked to coordinate a process to advance this “Shared meanings” project. We created a website, listing terms with their preferred and alternative definitions, sources and comments on the definitions.3 Visitors to the site were invited to submit suggestions. In all, 149 terms and their preferred definitions were posted, with a further 296 alternate definitions, and 63 sources of information (eg, there were 16 definitions for “error”, 14 for “adverse event”, and five for “adverse drug event”). It was decided to choose terms and definitions with meanings as close as possible to those in colloquial use, and not to use terms which are potentially ambiguous (eg, “accident”, “complication”, “medicament”); 19 terms posted were designated “not for further consideration”. A project group was then formed (see Acknowledgements), and a series of meetings held to decide on preferred terms and their definitions. The group decided to avoid long definitions with several “qualifiers”, but instead to start with simple, basic definitions, and then to “build” by defining the key terms used in these. It is therefore necessary to read the terms and their definitions in the sequence provided in Box 1; an alphabetically arranged list is given in Box 2. In October 2004, the World Alliance for Patient Safety was launched under the auspices of the World Health Organization (WHO), and one of its first initiatives was to develop a classification for patient safety.4 At a meeting in October 2005, the WHO invited me to propose an underlying information model for this classification. The WHO classification group is hosting a web-based Delphi process5 to seek submissions from member countries as to which concepts should populate the classification and to propose preferred terms in their various languages. The ACSQHC terms and definitions shown in Box 2 have gained considerable currency (eg, many are used by the National Patient Safety Agency in the United Kingdom), and will be submitted for consideration for this worldwide patient safety classification, which is planned to become a member of the WHO Family of International Classifications.6 1 Sequence in which to read the terms in Box 2 1 Incident 12 Injury 23 Side effect 34 Blame 2 Health care incident 13 Suffering 24 Error 35 Negligence 3 Health 14 Disability 25 Root cause analysis 36 Monitor 4 Health care 15 Adverse event 26 System failure 37 Benchmark 5 Event 16 Near miss 27 System improvement 38 Standard 6 Circumstance 17 Safety 28 Quality 39 Accreditation 7 Agent 18 Hazard 29 Quality of health care 40 Credentialling 8 Harm 19 Outcome 30 Risk 41 Iatrogenic 9 Complaint 20 Health care outcome 31 Risk management 42 Nosocomial 10 Loss 21 Preventable 32 Liability 43 Stakeholder 11 Disease 22 Adverse reaction 33 Accountable 2 List of preferred terms and definitions devised by the Australian Council for Safety and Quality in Health Care Introduction * An asterisk indicates that there are further terms within that definition which are also defined. For example, the term “incident*” contains the additional terms (in bold) “event”, “circumstance”, “harm”, “complaint” and “loss”, which are themselves defined. The definition for “harm*”, in turn, contains the terms “disease”, “injury”, “suffering” and “disability”, each of which is also defined. Alternative definitions, comments and sources of information are available from the author. Terms and definitions Accountable Being held responsible. Accreditation* Being granted recognition for meeting designated standards for structure, process and outcome. Adverse event* An incident in which harm resulted to a person receiving health care. Adverse reaction* An adverse event where the correct process was followed for the context in which the event occurred but unexpected and unpreventable harm resulted. (For example, an adverse drug reaction will be said to have occurred when the right drug was used for the correct indication in the right dose given by the right route, but the patient suffered unexpected and unpreventable harm. Adverse reactions can also result from some diagnostic tests, therapeutic interventions or devices.) Agent One who, or that which, acts to produce a change. Benchmark A criterion against which something is measured. Blame To hold at fault (implies culpability). Circumstance* All the factors connected with or influencing an event, agent or person/s. Complaint An expression of dissatisfaction with something. Credentialling* The process of assessing and conferring approval on a person’s suitability to provide a defined type of health care. (Can be synonymous with clinical privileging.) 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. Disease A physiological or psychological dysfunction. Error Unintentionally being wrong in conduct or judgement. Errors may occur by doing the wrong thing (commission) or by failing to do the right thing (omission). Event Something that happens to or with a person. Harm* Harm includes disease, injury, suffering, disability and death. Hazard* A circumstance or agent that can lead to harm, damage or loss. Health* A state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity. Health care* Services provided to individuals or communities to promote, maintain, monitor, or restore health. Health care is not limited to medical care and includes self-care. Health care incident* An event or circumstance during health care which could have, or did, result in unintended or unnecessary harm to a person and/or a complaint, loss or damage. Health care outcome* The health status of an individual, a group of people or a population which is wholly or partially attributable to an action, agent or circumstance. Iatrogenic* Arising from or associated with health care rather than an underlying disease or injury. Incident* An event or circumstance which could have resulted, or did result, in unintended or unnecessary harm to a person and/or a complaint, loss or damage. Injury* Damage to tissues caused by an agent or circumstance. Liability Responsibility for an action according to the law or in a legal sense. Loss Any negative consequence, including financial. Monitor To check, supervise, observe critically, or record the progress of an activity, action or system on a regular basis in order to identify and/or track change. Near miss* An incident that did not cause harm. Negligence (civil or criminal)* An incident causing harm, damage or loss as the result of doing something wrong or failing to provide a reasonable level of care in a circumstance in which one has a duty of care. Nosocomial Pertaining to or originating in a hospital (synonymous with “hospital-acquired”). Outcome* The status of an individual, a group of people or a population which is wholly or partially attributable to an action, agent or circumstance. Preventable* Accepted by the community as potentially avoidable in the particular set of circumstances. Quality (degree of)* The extent to which a service or product produces a desired outcome or outcomes. Quality of health care (degree of)* The extent to which a health care service or product produces a desired outcome or outcomes. Risk The chance of something happening that will have a negative impact. It is measured in terms of consequences and likelihood. Risk management* In health care, designing and implementing a program of activities to identify and avoid or minimise risks to patients, employees, visitors and the institution; to minimise financial losses (including legal liability) that might arise consequentially; and to transfer risk to others through payment of premiums (insurance). Root cause analysis* A systematic process whereby the factors which contributed to an incident are identified. Safety* Freedom from hazard. Side effect* An effect, other than that intended, produced by an agent (see also “adverse reaction”). Stakeholder Those people and organisations who may affect, be affected by, or perceive themselves to be affected by, a decision or activity. Standard Agreed attributes and processes designed to ensure that a product, service or method will perform consistently at a designated level. Suffering* Experiencing anything subjectively unpleasant. This may include pain, malaise, nausea, vomiting, loss, depression, agitation, alarm, fear or grief. System failure A fault, breakdown or dysfunction within an organisation’s operational methods, processes or infrastructure. System improvement* The result or outcome of the culture, processes and structures that are directed towards the prevention of system failure and the improvement in safety and quality

William B Runciman FANZCA, FJFICM, PhD

The pursuit of demonstrable safety and quality in health care is an evolving process; there has been notable progress in measuring safety and quality in Australia. The first attempts to measure outcomes were in the field of anaesthesia, while national perinatal mortality reports have provided clinically useful information for many years. Nationwide reporting by the Quality in Australian Health Care Study (QAHCS) in 2005 triggered a more systemic approach to safety and quality. Systemic reporting has begun to emerge in anaesthesia and surgery, for implantable devices, perinatal services and sentinel events; in some jurisdictions, statewide incident data are now reported annually. While debate continues about the issue of individual clinician performance, the real issue is the effectiveness of any reporting system to bring about change in both safety and quality.

Clifford F Hughes AO, FRACS, FACS, FACC · Patricia Mackay FRCA, FANZCA

Health care will always be associated with risk, but the Australian Council for Safety and Quality in Health Care has achieved much in bringing health care safety and quality into public consciousness and beginning systemic change for improvement. Work is underway to develop safety and quality standards, and infrastructure and systems for measurement and evaluation; to increase workforce understanding of how to improve health care delivery; to increase consumer engagement in health care management; and to develop policy and understanding of the barriers to progress. With this foundation of reform, the future of the new Australian Commission on Safety and Quality in Health Care is promising, but it is up to us as health professionals and managers, with the help of the community, to improve the safety and quality of health care.

Bruce H Barraclough AO, FRACS, FACS · Jim Birch

Measurement of safety and quality is fundamental to health care delivery. A variety of measures are needed to fully understand the system; quantitative and qualitative measures are both useful in different ways. Measures need to be valid, reliable, accurate, timely, collectable, meaningful, relevant and important to those who will use them. Clinicians value appropriate measures and respond to them.

Sarah Scobie BA, PhD · Richard Thomson MD, FRCP, FFPHM · John J McNeil PhD, FRACP, FFAPHM · Paddy A Phillips DPhil, FRACP, FACP

Self-regulation by the health professions, while improving, is no longer enough; external drivers for safer health care include governments, funders and consumers. Enforced self-regulation is often more promising than a “command and control” strategy. Research evidence on the responsive regulatory pyramid and its options offers lessons for health care policy makers and managers. Start at the base of the regulatory pyramid — try persuasion first; move up the pyramid to secure compliance, and then be willing to move back down. Use existing capacities and structures, and if possible avoid new bureaucracies of control.

Judith Healy PhD · John Braithwaite BA, PhD

National efforts to improve the quality and safety of health care present challenges for medical education and training. Today’s doctors need to be skilled communicators who know how to identify, prevent and manage adverse events and near misses, how to use evidence and information, how to work safely in a team, how to practise ethically, and how to be workplace teachers and learners. These competencies (knowledge, skills and attitudes) are set out in the National Patient Safety Education Framework (NPSF) of the Australian Council for Safety and Quality in Health Care. The NPSF is designed to help medical schools, vocational colleges, health organisations and private practitioners develop curricula to enable health professionals to work safely. The NPSF describes what doctors (depending on their level of knowledge and experience) can do to demonstrate competencies in a range of quality and safety activities. Medical schools, vocational colleges, health organisations and private practitioners need to work collaboratively with one another and with other health professionals to ensure that patient safety and quality curricula are implemented and evaluated, and that valid and reliable assessments of learning outcomes are developed. Interdisciplinary and vertically integrated education and training are needed, incorporating innovative methods, to create a safer health care system.

Merrilyn M Walton PhD · Susan L Elliott MD, FRACP

In 2001, the National Patient Safety Agency (NPSA) was created as part of a wider reform process to improve quality of care for patients in the National Health Services of England and Wales. The NPSA was charged with developing and implementing a national system for collecting and learning from reported patient safety incidents. Between 2003 and 2005, 303 447 incidents were reported from a wide range of health care settings. As a result, a range of interventions have been developed to improve safety. A number of lessons have been distilled from the experience of England and Wales, including that: clinical risk management system characteristics should be aligned with those of the national reporting system; and safety culture and information dissemination must be addressed at the same time as any new reporting system is implemented. These lessons should be of use to other countries implementing similar patient safety strategies.

Susan K Williams BA(Hons), IHM · Sue S Osborn BA(Hons), IHM

Improving the safety of patient care is now a global issue. In 2004, the World Health Assembly supported the creation of the World Alliance for Patient Safety to coordinate, spread and accelerate improvements in patient safety internationally. Australia has been at the forefront of international work on patient safety and is working closely with the World Alliance. The World Alliance is taking forward work in six main action areas: Patients for Patient Safety; Reporting and Learning; Taxonomy; Solutions; Research; and Global Patient Safety Challenge. Despite differences in context, there are many common challenges for countries seeking to establish patient safety programs and initiatives. Looking forward, long-term action on patient safety must be built and sustained with the commitment of policy makers and the active engagement of health care professionals.

Sir Liam J Donaldson MD, FFPHM, FRCP · Martin G Fletcher BSocStud, BA(Hons), MMan