Scoping the Priorities for Quality in the Health and Disability Sector

Chapter 2

A Standardised Approach to Incident Management

Introduction
This chapter discusses the need for a consistent national approach to the management of incidents that occur in the health and disability sector and a plan for achieving that over the next two years.
Definitions used in this chapter
/ Healthcare incident
An event or circumstance which could have, or did lead to unintended and/or unnecessary harm to a person, and/or a complaint, loss or damage.”[1]
Sentinel event
A sentinel event is an event in which death or serious harm to a patient has occurred”.[2]
Root Cause Analysis
A method used to investigate and analyse a serious incident to identify the root causes and factors that contributed to the incident and to recommend actions to prevent a similar occurrence.[3]
Severity Assessment Code
A numerical score applied to an incident based on the type of the event, its consequences and it’s likelihood of recurrence.[4]
Incident classification
The process of capturing relevant information about an incident to ensure that the complete nature of the incident is documented and understood.
Clinician
A doctor, nurse or allied health professional.
Open disclosure
The process of open discussion of adverse events that result in unintended harm to a patient while receiving health care and the associated investigation and recommendations for improvement.[5]
Near miss
An incident that did not cause harm.”[6]
Background
Why is incident management a priority?
/ Health care is one of the most complex activities that humans engage in and there are inherent risks associated with the delivery of that care for patients, clinicians and for organisations that provide the care. Several studies[7][8][9] have reported the level of harm that is experienced by patients in western health services.
Most harm to patients results from errors made by health care providers because health care providers are human and therefore prone to error, and because the systems of care do not support providers in their efforts to manage the “human condition” and provide safer care. Errors occur at all levels of an organisation. It is the result of the errors that is important. Seemingly minor mistakes in one circumstance will have minor consequences but in different circumstances will have major consequences resulting in an adverse event for a patient. The overall number of errors or adverse events is far less important than the action that is taken to prevent their recurrence.
Traditionally, health services have hidden mistakes and failures. However over the past approximately eight years, the “Patient Safety” movement has become very prominent in the minds and activities of western health care providers.
This has resulted in the development of safety systems that are designed to:
•identify
•analyse
•treat
•monitor
•review[10]
the risks associated with the clinical and corporate processes of care delivery.
Incident management is a key strategy being used by health services, for managing the risks of clinical care as well as for managing corporate risk. When implemented correctly, incident management is an effective mechanism for systematically identifying problems and failures in the system and for informing the development of preventive strategies.
It is important to remember however, that incident management is not the only strategy that should be used for the management of risk in the health care setting. It should be one plank in a raft of activities that are implemented in all health services to manage risk and achieve effective clinical governance.
What is an incident?
/ In any health system,it is expected that many thousands of incidents occur each day. An incident is defined as “an event or circumstance which could have, or did lead to unintended and/or unnecessary harm to a person, and/or a complaint, loss or damage.”[11] As previously stated, some of these incidents have significant major consequences, some result in no harm. Some incidents are what is referred to as “near misses” that is “an incident that did not cause harm.”[12]A sentinel event on the other end of the spectrum is an event in which death or serious harm to a patient has occurred”.[13]
The following diagram represents the incidence of health care incidents.

It can be seen that of all health care incidents, there is a relatively small number of sentinel events, a very much larger number of incidents and a probably even larger number of near misses. It is essential to understand that all these incidents need to be managed in some way, but each category of events needs to be managed in a different way, to ensure the best use of health care resources and the best results for patients. For example, sentinel events will require a thorough investigationof the causes of the event and the implementation of strategies to ensure that the event will not recur. Incidents will often need to be aggregated into common events and reviewed utilising a practice improvement method to ensure system improvement. The action taken on near misses will be dependent upon the potential harm of the event and the likelihood of their recurrence.
What is incident management
/ Incident management is a continuous process that has many components. It is not simply about the reporting of incidents.
Incident management involves:
  1. Identification of incidents: Strategies need to be used to assist providers to understand what an incident is and how it differs from a complication of care. The identification of the largest possible number of incidents that occur is to be encouraged. The greater the number of incidents that are identified the better the analysis of the incidents will be.
  2. Immediate action to mitigate immediate harmful consequences of the incident. This may include support for the patient, their family and for the clinician(s) involved.
  3. Notification of the incident: All health care incidents need to be notified to someone who is responsible for action. There may to several people (in various positions) who are allocated responsibility for different action.
  4. Prioritisation of the incident: This is a simple process of allocating a score from 1 – 4 to the incident, to ensure that the right level of investigation and action takes place. The score is determined by rating the outcome or consequence of the event against the likelihood of its recurrence.
  5. Classification of the incident: This is the processof capturing relevant information about an incident to ensure that the complete nature of the incident is documented and understood and trending of the contextual components of the incidents can occur.
  6. Investigation of the incident. Different levels of investigation or review of incidents are required to ensure that causes are identified and preventive strategies can be implemented. The level of investigation will depend on the priority score that has been allocated to the incident.
  7. Analysis of the investigation: The analysis will result in a plan for action.
  8. Action: Action must be taken to ensure that improvement results and the likelihood of recurrence is reduced.
A nationally consistent approach to these components of incident management will create an environment of continuous learning, allow the lessons from one organisation to be disseminated to all health and disability organisations, reduce duplication of improvement effort, allow the identification of serious issues that would otherwise have gone unnoticed from the aggregation of single events and will ensure systems and practice change, as a result of the lessons learnt.
The required culture and environment
/ For all this to be possible, it is essential to develop the right culture and environment within which all components of incident management can occur.
Effective management depends crucially on developing a reporting culture.
Trust is a key element of any reporting culture and this inturn requires the existence of a just culture - one possessing a collective understanding of where the line should be drawn between “blameless’ and blameworthy actions. Engineering a just culture is an essential early step in creating a safe culture.
A fundamental component of the culture that is to be achieved is one that is caring and compassionate and one in which the disclosure of adverse events is opened and truthful. The elements of “opendisclosure” are an expression of regret, a factual explanation of what happened, the potential consequences and the steps taken to manage the event and prevent recurrence.
In July 2003 The Australian Council for Safety and Quality in Health Care, with Standards Australia, developed the National Open Disclosure Standard. To many, both inside and outside healthcare, the need for such a standard would appear to be somewhat doubtful. Saying “sorry” and telling the truth are lessons taught to us all in childhood. The implementation of this standard in the Australian healthcare system however, has had its difficulties.
The sensitivities that have surrounded the implementation of the standard include:
  • a belief by organisations and individuals that an expression of regret may constitute an admission of guilt
  • the belief in some jurisdictions that there needs to be statutory immunity provided for these activities
  • the difficulties experienced by some consumers in obtaining information about the adverse event they may have suffered
  • the various contractual arrangements that exist in the private sector with medical practitioners and the restraints imposed by these arrangements
  • the belief that admission that an adverse event has occurred will result in and increase in the number of law suits and compensation payments
  • the lack of evidence available to organisations and individuals about the benefits of open disclosure
  • a reluctance from the health insurers to agree to the implementation
  • a reluctance from lawyers representing both organisations and individuals to allow their clients to participate in the open disclosure of adverse events
Whilst the Ministry of Health “Reportable Events Guidelines” include the open disclosure of adverse events, it would appear that there is variable use and implementation of this process across health and disability services.
The required culture and environment (continued)
/ If effective incident management is to be achieved it is essential that full use of open disclosure is a priority. The health and disability environment and the legal and legislative framework that exists in the New Zealand health and disability sector is very different from the Australian healthcare environment.
The ACC’s new Treatment Injury and Patient Safety Legislation and processes provide a far more conducive context for the full and immediate implementation of this process. It is recommended that the Australian National Standard for Open Disclosure[14] is fully implemented in the NZ Health and Disability Sector.
A further essential requirement of a new culture is the provision of support for both the patients and their families who may have been effected by an adverse event and for the staff who have been involved in the event. The secondary ‘injury’ that is experienced by a clinician who is involved in a serious adverse event is often overlooked. The culture that is required to deal with this needs to be just, compassionate and fair.
Achieving the culture change
/ Such a culture can be achieved and has been achieved in many jurisdictions through a number of key strategies.
  • The development of appropriate policy that
ºprovides guidance to clinicians and managers on how to manage the systemic and the individual contribution to incidents and error
ºensures on the use of all components of open disclosure
ºprovides guidance on the management of blameworthy acts (such as criminal acts, deliberate patient harm, incidents that occur as the result of drug or alcohol abuse and deliberate unsafe acts) in a separate environment from the incident management environment.
ºidentifies responsibility for appropriate action and the consequences of inappropriate action.
  • Education and training of all healthcare provider; clinicians and managers on:
ºhuman factors
ºthe human contribution to health care incidents
ºincident management
ºopen disclosure
ºeffective communication
ºthe NZ legislative framework including the new Treatment Injury and Patient Safety Legislation and processes and the “protection” that the legislation provides
ºproviding support.
Review of international action
Introduction
/ Three key incident management programmes have been introduced in health systems internationally. These are in
  • The Veterans Administration in the United States
  • Various states in Australia (notably NSW)
  • The National Health Service in the United Kingdom
These systems are the most organised in their approach. A brief description of each is provided.
The Veterans (Health) Administration (VA)
/ In 1998 the Department of Veterans Affairs convened an Expert Panel on Patient Safety System Design. This panel was charged with identifying methods that would facilitate the reporting of adverse events that occurred in healthcare with the proviso to give special attention to techniques used in other environments such as the aviation industry.
The system that has resulted from that panel has been implemented in all Veterans Health organisations (approximately 190) across the US. The system has the components that have been described in the pervious section of this report. It is the system upon which NSW, followed by other states in Australia,Denmarkand a number of other countries have based their patient safety systems. The implementation of this system has resulted in the development and implementation of policy and strategies across all Veteran’s Hospitals that have resulted in proven and published safer and more effective systems and care.
The NSW Health System
/ In 2001 a decision was made in the NSW Department of Health to implement a Safety Improvement Program (known as the SIP). Following research on the best systems available in the world, the VA model was used. Members of the development team went to the US to be trained in the methods of Root Cause Analysis and incident management, by the VA team and implementation of the programme commenced in 2002.
There were two key components to the implementation. The development of the culture and environment within which incidents could be managed effectively and the identification and implementation of an information system to support health care providers to manage the incidents. The implementation of both components was completed by the end of 2004. This system too has resulted in proven benefits to patients and providers in the NSW health system.
Other states in Australia have since adopted the VA Patient Safety model, using many of the tools and methods that were adapted by NSW.
The National Health Service (NHS) in the UK
/ The NHS has also implemented a similar system, led by the National Patient Safety Agency (NPSA). This system also uses a nationally consistent approach to the management of health care incidents, the use of Root Cause Analysis for the investigation of serious adverse events, the classification of incidents and national reporting to allow the analysis of low volume but high harm events for the purposes of national action and improvement.
Statutory Protection
/ It needs to be noted that the implementation of each of these three systems has been accompanied by the development and enactment of statutory protection legislation. Whilst each piece of legislation is different they are all similar in that they provide
  • Protection for members of a Root Cause Analysis (RCA) team: that is protection from being call to give evidence in a proceedings against a person involved in an incident that they have investigated
  • Protection for various pieces of documentation of the RCA. In NSW a final report of the RCA is a public document, but the working papers of the RCA team are protected. In the VA all papers for the RCA are protected.
The actual incident reports are not protected under any scheme, but in some the report of a serious event to the equivalent of the Ministry of Health is protected.
It is the Project team’s opinion that the existence of the ACC legislation in NZ and the Health Practitioners Competence Assurance legislation negates the need for other protective legislation. However, further opinion should be sought on this matter.

Progress in the New Zealand Health and Disability Sector,

Introduction
/ Incident management is certainly not a new concept to be introduced to the health and disability sector in New Zealand. A great deal of activity currently exists. However, there is no consistent approach to the way in which incidents are managed across District Health Boards, at the Ministry and between government organisations that all have a level of responsibility for doing so.
Policy directives or strategies to date
/ In 2001 The Reportable Events Guidelines were published by the Ministry of Health for use by all District Health Boards (DHBs). The Guidelines provide guidance to DHBs on the
  • policies and procedures that are required for managing incidents,
  • notification of reportable events
  • information for consumers
  • investigation of events
  • prevention of recurrence
  • information to employees
  • reporting and trends
  • reporting to external agencies
and other such matters.
It would seem however, that there is very variable implementation of and adherence to the guidelines across the country. The implementation plan suggested in this report will ensure that this occurs.
A number of government agencies have responsibility for various aspects of serious event reporting. The most notable of these is the Accident Compensation Commission (ACC). Under the ACCs new Treatment Injury and Patient Safety legislation the ACC receives notification of harm that occurs as a direct result of treatments provided in the health and disability sector. The ACC is gathering a wealth of information about treatment injury that can be used by the health and disability sector to identify, formulate and implement harm prevention strategies. Further, this reporting system can be used to evaluate the effectiveness of improvement strategies over the course of time.
If one considers that a complaint is generally an incident that has been notified by a consumer of services it will be recognised that the Health and Disability Commission also has a large amount of information about incidents that occur in the health and disability sector.There would be great benefit in the creation of a link between the complaints and dispute resolution system and the system improvement activities that will result from this standardised, national incident management system.
Policy directives or strategies to date (cont)
/ The Mental Health Directorate in the MoH has a relatively well developed process for national management of incidents that occur in the mental health sector. In this system the DHBs report defined incidents to the Mental Health Directorate where trending, analysis and appropriate actions are taken to develop prevention strategies for the whole sector. It is recommended that this system be combined with a nation health and disability incident management process.
In most DHBs at present, the incident management, complaints management and Coroners processes are completely separated from each other. These is great benefit to be gained from linking these system in order that further lessons can be learned and improvements implemented.
Results so far
/ A recent survey of DHBs which was undertaken to identify activity that relates to the six priorities for quality has revealed that a number of DHBs are developing their own systems for managing incidents. Some DHBs are providing training for staff in incident management including intensive training in the process of Root Cause Analysis.
Many DHBs are developing their own information systems for incident management. Other DHBs have identified “off the shelf” systems and are implementing them when possible. Eight DHBs in the north island have identified the one system and are working towards implementation.
There is every effort being made to have a consistent approach to this and this is being facilitated through the Quality and Risk Managers forum.
There seems to be agreement however that a more co-ordinated approach is required nationally. Consultation with the sector has identified a preference for the implementation of one integrated web based incident information management system across the country rather than the alternative approach that would provide:
  • a consistent minimum data set
  • the same classification system
  • the same prioritisation system
  • a requirement of a certain standard architecture
  • connectivity between the systems.

The recommended programme scope