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Standards for general practices (4th edition)

including Interpretive guide for Aboriginal and Torres Strait Islander health services

Standard 3.1 Safety and quality

Our practice is committed to quality improvement.

Criterion 3.1.2

Clinical risk management systems

Our practice has clinical risk management systems to enhance the quality and safety of our patient care.

Indicators

► A. Our practice team can demonstrate how we:

  • regularly monitor, identify and report near misses and mistakes in clinical care
  • identify deviations from standard clinical practice that may result in patient harm.

► B. Our practice has documented systems for dealing with near misses and mistakes.

► C. Our practice team can describe improvements made to our systems to prevent near misses and mistakes in clinical care.

► D. Our practice monitors system improvements to ensure successful implementation of changes made to our clinical risk management systems.

► E. Our practice has a contingency plan for adverse and unexpected events such as natural disasters, pandemic diseases or the sudden, unexpected absence of clinical staff.

Explanation

Key points

  • There should be one member of the practice team with primary responsibility for clinical risk management systems (see Criterion 3.1.3 Clinical governance)
  • Near misses and mistakes in clinical care occur in all general practices
  • Practices need systems to recognise and analyse near misses and mistakes so solutions can be implemented to prevent their recurrence
  • Solutions need testing to ensure they work effectively
  • Deviations from standard clinical practice may be interpreted as deviations from practice which might reasonably be expected by the public or professional peers.

Allocation of responsibility

The practice should appoint one member of staff with primary responsibility for clinical risk management systems. Specific areas of responsibility can be delegated to other nominated members of the practice team and these particular responsibilities should be documented in the relevant position descriptions.

Defining mistakes and near misses

Mistakes are errors or adverse events that result in harm. (Adapted from the RACGP education module Thinking safety, being safer).

Near misses are incidents that did not cause harm but could have.

The core elements of risk management

The following information has been adapted from the Avant website. For simplicity’s sake, medicolegal risks and strategies can be classified into three areas.

1. Clinical knowledge and skill

Fundamental strategies here include:

  • keeping up-to-date
  • taking a thorough history and examination and documenting thoroughly in the clinical record
  • being aware of your own limitations and referring patients on appropriately
  • investigating further if treatment is not working
  • making use of protocols, checklists and diagnostic support aids
  • looking after yourself
  • preventing and dealing with fatigue
  • reporting your concerns if you feel unsafe work practices are enforced on you.

2. Communication

Risks can be minimised by:

  • building a doctor-patient relationship based on trust and honesty
  • listening to patients and showing empathy
  • minimising interruptions during consultations
  • managing unrealistic patient expectations
  • communicating with your practice staff
  • encouraging an environment in the practice where patients feel welcome and staff are skilled in all aspects of managing patients
  • fostering strong relationships with colleagues and other health professionals involved in the care of your patients
  • Keeping open channels of communication with health facilities you interact with (eg. hospitals, radiology practices)
  • Managing adverse events or complaints in a way that does not leave the patient feeling abandoned or that their concerns were ignored
  • Ensuring your consent process allows the patient to understand the implications of a proposed treatment, medication or procedure so they can make up their own mind as to whether they want to have it or not.

3. Systems

Systems which can be ‘fine tuned’ to decrease medicolegal risk include:

  • complaints handling process
  • tracking tests ordered and referrals made
  • recording of appointments, cancellation and any failure to attend
  • infection control procedures
  • recruitment, training and management of staff
  • managing confidentiality and privacy.

Mistakes happen

Near misses and mistakes in clinical care that might harm patients occur in all general practices. The evidence about the frequency of near misses and mistakes varies and the better constructed studies suggest even higher rates of occurrence.

Most GPs and practices already manage clinical risk on a daily basis. Many have informal and ad hoc methods of trying to prevent near misses and mistakes. Some GPs talk to other trusted peers or supervisors for advice. Other practices have a more formal process that includes practice discussions about what went wrong and how to reduce the likelihood of it happening again, or using structured techniques to analyse the causes of an error and reduce the likelihood of its recurrence.

Just and open communication is vital

A systems approach to thinking about adverse events and errors highlights a need to shift away from the immediacy of blaming individual practitioners to cultivating a just, open and supportive culture where individual accountability and integrity is preserved, but mediated by thoughtful and supportive response to error (see the RACGP education module Regaining trust after an adverse event).

The practice needs to have a process in place where members of the practice team know who and how to notify when a near miss or mistake occurs, or when there is an unanticipated adverse outcome. All members of the practice team, no matter how junior, should feel empowered to recognise and report near misses and mistakes without fear of recrimination.

A study by Maxfield et al3 highlights the critical importance of open communication. The study found that people see others make mistakes, violate rules or demonstrate dangerous levels of incompetence repeatedly and over long periods of time in ways that hurt patient safety and employee morale. However, they don’t speak up and the critical variable that determines whether they break this chain by speaking up is their confidence in their ability to confront. These findings give practices a powerful reason for focusing on open communication as a vital tool in clinical risk management.

Consistent use of risk management systems reduces clinical risk

The same mistake can have different causes on different occasions. Part of the quality improvement process is to make sure there is consistent use of clinical risk management systems, so that the causes of near misses and mistakes are identified and processes improved to reduce the likelihood of them occurring again.

If the practice does not make improvements after identifying a near miss or mistake, patients may be exposed to an increased risk of adverse outcomes and the GPs and practice staff may be exposed to an increased risk of medicolegal action. An example of this situation is where a clinically significant test result is not communicated to the patient or adequately followed up; the practice knows about this and makes no attempt to prevent a recurrence.

Another example might be when an important detail in a previous consultation is not considered by the GP at that patient’s next consultation, resulting in a problem being overlooked; the practice becomes aware of this and yet does not act to prevent it happening again. This second example is more likely with the use of certain electronic based record systems that do not show the previous consultation record when a patient’s record is opened.

The vast majority of near misses and mistakes do not lead to patient harm as they are ‘near misses’ that are caught before any harm occurs. An example of this is when the GP prescribes a medicine for a patient, who then tells the GP that they are allergic to that medicine. Another is when a GP notices that the general practice nurse has prepared an incorrect vaccine before the vaccination takes place and replaces it with the correct vaccine. These ‘near misses’ can provide opportunities for quality improvement.

Practices will have different systems in place to identify and reduce clinical risk. It is important, however, for practices to be able to demonstrate how and why they have made changes to improve clinical care.

Find it, fix it, confirm it approach

Poor performance and poor practice can too often thrive behind closed doors. Implementing a clinical governance framework should assist a practice in finding the balance of ‘find it’, ‘fix it’ and ‘confirm it’ functions in relation to improving the quality and safety of care.

  • ‘Find it’: practices can use tools such as clinical audits and performance indicators to identify where quality improvement programs could impact on the quality of care delivered and improve patient health outcomes
  • ‘Fix it’: once the gaps in quality care have been identified, practices can implement strategies to address the issue (eg. redesign of clinical services and the development of policies and procedures)
  • ‘Confirm it’: confirmation of the improvement can be measured through an effective evaluation process (eg. systematic re-audit of targeted indicators).

Event registers

Practices may find it beneficial to keep a record of de-identified near misses and mistakes to facilitate quality improvement initiatives. In April 2005 the RACGP obtained legal advice from Milstein and Associates which is pertinent to the use of event registers/records. The advice is still relevant.

Notifying your medical defence organisation is vital

The RACGP recommends that GPs notify their medical defence organisation of all events or circumstances that they perceive might give rise to a claim and certainly before any action is taken to resolve a complaint or apologise for a mistake involving clinical care.

Contingency plans

Practices need to have contingency plans for unusual events that may disrupt patient care such as natural disasters or disease outbreaks that overstretch the practice’s capacity, or the sudden, unexpected absence of key members of the clinical team.

Emergency communication from RACGP

Subscribers to the RACGP Fridayfacts bulletin (www.racgp.org.au/fridayfacts) will receive notification via special emergency bulletins of any notices issued by the Commonwealth Chief Medical Officer in relation to national emergencies (eg. adverse reactions to vaccination of under fives or responses to pandemic).

Resources

  • RACGP guide Using near misses to improve the quality of care for your patients is available at www.racgp.org.au/publications/orders.
  • RACGP Pandemic flu kit outlines disaster management and is available at www.racgp.org.au/pandemicresources. This section of the College website also provides links to the relevant departmental health units for up-to-the-minute information on areas such as human swine influenza.
  • RACGP Infection control standards for office based practices (4th edition) provide information on infection control principles for general practices to prepare for an influenza pandemic. Topics include: how micro-organisms are acquired and grown; the use of standard and additional precautions; the correct use of personal protective equipment; the correct use of high filtration and surgical masks (eg. N95/P2 masks); cleaning the practice environment and equipment; triage and disease surveillance systems in the general practice. A copy can be ordered via the RACGP website at www.racgp.org.au/publications/standards.
  • MBA Code of Conduct section 3.10 (available at www.medicalboard.gov.au/codes-and-guidelines.aspx) provides useful information on dealing with adverse events.
Standard 3.1 Safety and quality

Our practice is committed to quality improvement.

Criterion 3.1.2

Clinical risk management systems

Our practice has clinical risk management systems to enhance the quality and safety of our patient care.

In a nutshell

Minimising the level of risk to patient safety and care means that your health service needs to have documented systems in place to help it identify, monitor and change practices that cause mistakes and near misses. Risk management is also about planning for contingencies such as natural disasters, pandemic diseases or sudden, unexpected absence of clinical team members.

There are three core elements to risk management.

Clinical knowledge and skill

Clinical staff are expected to have the minimum core skills and knowledge required to do their job. This also includes an awareness of their skills limitations, and a willingness to appropriately refer patients. Thoroughly documenting clinical care in patient health records and investigating unsuccessful treatments are also good risk-preventive measures. Sound clinical skills need to be supported by a culture of open communication and reporting, so that concerns about unsafe work practices are identified and reported in a spirit of learning. Fundamental strategies include:

  • keeping up to date with evidence-based healthcare findings
  • taking a thorough history and examination and documenting it in the clinical record
  • being aware of your own limitations and referring patients appropriately
  • investigating further if treatment is not working
  • making use of protocols, checklists and diagnostic support aids
  • looking after yourself
  • preventing and dealing with fatigue
  • reporting your concerns if you think that unsafe work practices are forced on you.

Communication

Risks can be minimised where there is a culture of open, safe communication. At the consultation level, doctor–patient relationships based on trust and honesty encourage informed consent and safe clinical care. At the health service level, open and regular communication with other health professionals (internal and external) ensures early detection and identification of near misses and mistakes with a view to implementing change that prevents their recurrence. Risks can be minimised by:

  • building a doctor–patient relationship based on trust and honesty
  • listening to patients and showing empathy
  • minimising interruptions during consultations
  • managing unrealistic patient expectations
  • communicating with your health service staff
  • encouraging an environment in the health service where patients feel welcome and culturally safe and staff are skilled in all aspects of managing patients
  • keeping open channels of communication with the health and health-related facilities you interact with (for example hospitals, radiology practices, pharmacies)
  • managing adverse events or complaints in a way that does not leave patients feeling abandoned or that their concerns are ignored
  • ensuring your consent process allows patients to understand the implications of a proposed treatment, medication or other procedure so they can make up their own mind as to whether they want to have it or not.

Systems

A risk-management system is made up of a series of sub-systems that interconnect to ensure consistent quality and safety in patient care. These systems need to be regularly monitored and changed in response to adverse events, mistakes and near misses. It is not sufficient for adverse events, mistakes and near misses to be identified and managed as one-off events. Without identifying the causes of near misses and mistakes, and changing systems to prevent further occurrences, more serious and dire consequences will inevitably follow. Systems and processes that can be finetuned to decrease medico-legal risk include:

  • complaints-handling process
  • tracking of tests ordered and referrals made
  • documentation of clinical consultations
  • recording of appointments, cancellation and any failure to attend
  • infection-control procedures
  • recruitment, training and management of staff
  • management of confidentiality and privacy.

Key team members

  • Designated risk-management coordinator
  • Health service manager
  • CEO/director
  • Administrative and clinical staff
  • Board

Key organisational functions

  • Clinical risk-management policies and protocols
  • Staff recruitment, training and management
  • Communication policies (internal/external/patient–clinician)
  • Patient consent
  • Culturally safe and competent clinical practice
  • Documentation and maintenance of patient health records
  • Networking and collaboration with other health providers
  • Clinical staff personal safety and care

Indicators and what they mean

Table 3.2 explains each of the indicators for this criterion. Refer to Criterion 3.1.2 Clinical risk management systems of the Standards for general practices for more information and explanations of some of the concepts referred to in this criterion.

Table 3.2 Criterion 3.1.2 Clinical risk-management systems
IndicatorWhat this means and handy hints
▶ A. Our practice team can demonstrate how we:
  • regularly monitor, identify and report near misses and mistakes in clinical care
  • identify deviations from standard clinical practice that may result in patient harm.
Your health service should have a clinical risk-management system and protocols to help it regularly monitor, identify and report near misses and mistakes along with any potentially harmful deviations from standard practice in clinical care. The system should include the core elements of risk management (clinical knowledge and skill; communication; systems) and set out how your health service plans to minimise risks in these core areas.

Staff members need to:
  • receive training and be kept up to date with existing policies and protocols around the identification and reporting of near misses and mistakes
  • receive training and be kept up to date with standard clinical practice so they know how to identify deviations (changes) from standard practice that may result in patient harm
  • know the identity of the designated risk-management staff member, and reporting processes/protocols for near misses and mistakes
  • feel safe and empowered to recognise and report near misses and mistakes without fear or recrimination.
▶ B. Our practice has documented systems for dealing with near misses and mistakes. It is highly recommended that your service keep an event register to record de-identified near misses and mistakes. This register should be regularly reviewed and plans of action developed and implemented to address the problems identified.

The designated clinical risk-management staff member should have responsibility for monitoring the event register, investigating each event and developing, implementing and monitoring change processes that reduce or better manage clinical risk.

It is recommended that clinicians notify their medical defence organisation of all events or circumstances that they perceive might give rise to a claim. This should be done before any action is taken to resolve a complaint or apologise for a mistake in clinical care.
▶ C. Our practice team can describe improvements made to our systems to prevent near misses and mistakes in clinical care. Clinical staff members should be kept up to date about improvements made to systems in order to prevent near misses and mistakes. It is also important for staff to know the how and why of changes to systems.

Fostering a culture where the focus is on addressing problems and systems, rather than blaming individuals, is the most effective way to minimise risks at the clinical level.
▶ D. Our practice monitors system improvements to ensure successful implementation of changes made to our clinical risk-management systems. Monitoring, identification, implementation and further monitoring – a cyclical process – is a very effective way of ensuring continuing quality and safety in patient care. A strategy of ‘find it, fix it and confirm it’ could fulfil this function. The ‘confirm it’ step helps monitor improvements to make sure they are successful.

Find it: your health service could use clinical audits or monitoring of performance indicators to identify where improvements can be made to reduce risk, enhance quality of care and improve patient health outcomes.

Fix it: once gaps are identified, your health service could implement strategies to address the problem (for example, redesign clinical services, or revise policies and procedures).

Confirm it: make sure that changes implemented to reduce risk actually do this; confirmation can be measured by an evaluation process, such as a re-audit of health or service indicators.
▶ E. Our practice has a contingency plan for adverse and unexpected events such as natural disasters, pandemic diseases or the sudden, unexpected absence of clinical staff. Your health service needs to have contingency plans for unusual events that may disrupt patient care. Such events could include natural disasters or disease outbreaks that overstretch your service’s capacity.

It is recommended that the contingency plan be documented as a policy (with processes established to guide staff). The plan could include partial or complete closure of your health service (for example, where there is a sudden, unexpected absence of key members of the clinical team) or suspension of non-emergency services so that staff can focus on disease outbreaks. Your policy/protocol should also clearly designate a primary person responsible for coordinating and overseeing the contingency plan.

Case study

Below is a description of the ways in which an Aboriginal community controlled health service can participate in clinical risk-management activities. Not all of these good practices are required by the Standards, but they illustrate the many practical and creative things that ACCHSs can do to ensure they deliver services of high safety and quality to their community.

The health service recognises that near misses and mistakes happen, as do deviations from standard clinical practice. However, it is proactive in identifying, rectifying and continually trying to prevent near misses and mistakes in order to reduce clinical risk. This is a formal process that is documented in the service’s policy and procedures manual. The formal process includes having an incident report process, allowing time to formally discuss anything that went wrong and to implement change to reduce the likelihood of it happening again.

Sometimes the service uses a structured technique to understand the causes of an error as the basis for implementing change to reduce the likelihood of it happening again. One of these easy-to-use techniques is called root cause analysis, and it can be used in a team setting (see Module 10 Managing quality in the RACGP General practice management toolkit. Details in the Other information for Standard 3.1 section).

At the service, staff know who to report incidents to and feel comfortable doing so because there is a culture of open communication, support for staff and consistent use of clinical risk-management systems.

The board takes a great interest in clinical risk management and the service reports to it every quarter on the incidence of near misses and mistakes, and what it is doing to rectify problems.

The service has a policy and set of procedures for adverse and unexpected events that are possible in the local area. These include floods, bushfire and severe storms, pandemic disease or the sudden unexpected absence of clinical staff. These events can disrupt patient care and have the potential to damage health records and computer systems essential for ongoing, safe patient care.

The health service ensures it receives special emergency bulletins from government sources such as the Commonwealth chief medical officers, state centres for disease control and the Bureau of Meteorology.

Showing how you meet Criterion 3.1.2

Below are some of the ways in which an Aboriginal community controlled health service might choose to demonstrate how it meets the requirements of this criterion for accreditation against the Standards. Please use the following as examples only, because your service may choose other, better-suited, forms of evidence to show how it meets the criterion.

  • Maintain a clinical risk-management policy and protocol.
  • Maintain an incident or event register.
  • Maintain staff training records.
  • Keep records of staff members’ knowledge about and experience with adverse events, near misses and mistakes, and of changes implemented to prevent their recurrence.
  • Show that you conduct clinical audits demonstrating changes to clinical care that have reduced risk.
  • Maintain key performance indicators that demonstrate a reduced number of mistakes and near misses.
  • Keep minutes of team and planning meetings where risks are discussed.
  • Record revisions to policies and procedures that have been shown to reduce risk.
  • Maintain contingency plans for unexpected events, including floods and severe storms.
  • Show that you have a designated staff member with primary responsibility for risk management.
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