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Part A - Patient Safety

  • A1. Essential of patient safety (3 Articles)

    Patient Safety and quality of care

    “Medicine used to be simple, ineffective, and relatively safe. It is now complex, effective, and potentially dangerous.”
    Sir Cyril Chantler (BMJ, 1998) 

    The complexity of healthcare is increasing day after day: increased scientific knowledge of the diseases; new technologies, treatments, and practices; high diversity of patients, many of them with multimorbidity and complex needs; large variety of healthcare providers. Intricate healthcare systems provide high volume of care. Therefore, healthcare organizations are continuously challenged to improve the results while pursuing the fundamental principle of ensuring safety: first, do not harm, a maxim attributed to Hippocrates. 

    A recent definition of Patient Safety, adopted by the WHO Global Safety Action Plan, recognizes the complexity of the discipline and the need of concentrated efforts:

    Patient Safety is a “framework of organized activities that creates cultures, processes, procedures, behaviours, technologies and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make errors less likely and reduce impact of harm when it does occur”.1  

    According to the Institute of Medicine 2, safety is an attribute of quality of care, along other dimensions:

    Dimensions of quality of care. Adapted from: Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm. Washington, D.C.: National Academies Press (US); 2001. 

    Quality of carethe degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” 2

     


     

    1. World Health Organization. Patient Safety Incident Reporting and Learning Systems: technical report and guidance. Geneva: World Health Organization; 2020. 
    2. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm. Washington, D.C.: National Academies Press (US); 2001. 
  • A2. Incident causes and impacts (3 Articles)

    From a blame culture to a systems approach

    By the end of the twentieth century, the focus of incident analysis was on the events closely surrounding an adverse event, and on the human acts or omissions immediately preceding the event itself. This person-approach was a long-standing and widespread tradition and viewed unsafe acts as arising primarily from processes such as lack of memory, distraction, poor motivation, carelessness, or negligence.1 At that time, it was frequent to hear the term “medical error” to describe healthcare induced harm and a blame culture prevailed.

    A blame culture increases overuse and defensive practice and discourages the health care workers to disclose their errors and to talk about their patient safety concerns (in section 07 we will take a closer look on the importance of speaking up). 

    Furthermore, as evidence shows, in the great majority of cases the serious failures aren’t simply due to the actions of the individuals involved. Clinical errors are usually the end of a chain that has, in origin, a system or organizational failure that favours (and sometimes determines) that a frontline professional in the care of a patient commits a mistake that sometimes causes harm (adverse event). To punish an individual when the conditions of work are prone to the occurrence of errors seems inappropriate.

    A systems approach focuses on the conditions under which people work and tries to build defences to avert errors or mitigate their effects. This approach recognizes that human errors, mistakes, and adverse events are inevitable and can’t be eliminated, but it’s impact could be reduced. Errors are seen as consequences rather than causes.1 

    Just because we accept that errors can happen does not mean that we allow them to happen without trying to avoid them. Precisely because we know that they occur, we have an obligation to detect the potential errors inherent in care activity in order to act accordingly. Not to do so is irresponsible and inadmissible. 

    As explained by Reason’s cheese model, a high-reliable system has several layers of protection (the slices of the cheese). These defensive barriers can be engineered (e.g., alarms, automatic shutdowns), people (e.g., surgeons, anaesthetists) or procedures and administrative controls. They protect on most occasions but sometimes there are some holes, arising from two reasons: active failures and latent conditions

     Reason’s model. From Reason J. Human error: models and management. BMJ. 2000;320:768–70

     

    The holes are constantly opening, closing, or realigning. Normally they don’t cause any bad outcome but when the holes in various defence layers are arranged in the same line, the trajectory of the accident occurs (as shown by the arrow).1 

    Active failures: ‘unsafe acts’ committed by those working at the sharp end of a system, which are usually short-lived and often unpredictable.

     Latent conditions: Malfunctions of organization or design that can contribute to the occurrence of active failures. They can develop over time and lie dormant before combining with other factors or active failures to breach a system’s safety defences. They are long-lived and, unlike many active failures, can be identified and removed before they cause an adverse event. 1 

    Differentiating active failures and latent conditions allows the distinction of human contribution in the occurrence of accidents. Nevertheless, regularly the two sets of factors contribute to an adverse event. Contrasting from active failures, latent conditions can be identified and remedied before an adverse event occurs.1 

    Focusing on the system that allows harm to occur is the beginning of improvement. Anticipating the worst requires an organizational culture determined to make the system as robust as possible, instead of preventing isolated failures. It’s a work-in-progress that aims to know the root causes, why things go wrong.  Although currently many organizations are focused on this pursuit, others are still taking the first steps. 

     

    Adverse events associated with an unwanted and avoidable outcome, such as those occurring in the case of chronic course processes, are clearly the most difficult to identify and prevent. Organizations that share an organizational culture that includes recognizing and talking about their failures and mistakes are the ones that manage to avoid them in the future. And this means creating an appropriate framework for doing so.

    One technique that risk management teams have been using to respond to the questions “what happened?”,” why it happened” and “how to prevent that it happens again?” is Root Cause Analysis. Looking beyond human error, it aims to identify the system failures behind, and to implement appropriate changes. The goal is to prevent future errors thus improving Patient Safety. 

    Root Cause Analysis “ systematic iterative process whereby the factors that contribute to an incident are identified by reconstructuring the sequence of events and repeatedly asking “why” until the underlying root causes (contributing factors or hazards) have been elucidated.”2

     


     

    1. Reason J. Human error: models and management. BMJ. 2000;320:768–70. 
    2. World Health Organization. The conceptual framework for the international classification for patient safety – final technical report. Geneva: World Health Organization; 2009.
  • A3. Supporting the patients after an adverse event (3 Articles)

    More than representing just numbers and statistics, adverse events in healthcare have significant physical and psychological impact on patients, and the consequences could affect their work, social relationships, and families. 

    Patients have first-hand experience of harm and have needs that must be addressed. In this case we know what they need:

    • Medical and psychological care for recovery
    • To know what has happened and what can happen from now on.
    • Know what measures are being taken to ensure that it does not happen again.
    • Receive an apology.

    These measures could contribute to the recovery in short and long term. 

    Today it is consensual that to communicate openly with patients is an ethical duty, which lead us to the concept of open disclosure.

  • A4. Patient Safety Culture (2 Articles)

    As showed in section 03, behind an incident we can usually find latent conditions (failures of the organization and design) and active failures (caused by individuals). To tackle unsafe care, we must view the systems as a whole. Assuming this and to sustain the improvement efforts, there’s a need to instil a culture of safety in the design and delivery of health care.  A Patient Safety culture implies that the promotion of safety should be a priority of the organisations.

    Patient Safety culture has been defined as the set of values, attitudes, perceptions, beliefs, skills, and behavioural patterns that at the individual and group level determine compliance with quality and safety procedures, leadership styles and capacity to manage the risks to patients associated with healthcare.

    Safety culture is directly related to the outcome of the healthcare intervention and is linked to organisational factors, leadership styles, composition and operational capacity and decision-making by clinical teams.

    The Agency for Healthcare Research and Quality developed surveys to access the patient safety culture of healthcare providers from different settings (hospitals, medical offices, nursing homes, community pharmacies, and ambulatory surgery centres). This Surveys on Patient Safety Culture™ (SOPS®) could be used to identify strengths and opportunities of an organisation and to compare the results with the available Databases.

    The areas of patient safety culture assessed by the AHRQ SOPS® surveys include: 1

    • Communication About Error.
    • Communication Openness.
    • Organizational Learning—Continuous Improvement.
    • Overall Rating on Patient Safety.
    • Response to Error.
    • Staffing.
    • Supervisor and Management Support for Patient Safety.
    • Teamwork.
    • Work Pressure and Pace.

    You can use these surveys for free at your institution. They’re available at: https://www.ahrq.gov/sops/index.html


    1. What Is Patient Safety Culture? | Agency for Healthcare Research and Quality [Internet]. [cited 2022 Apr 12].
    Available from: https://www.ahrq.gov/sops/about/patient-safety-culture.html

  • A5. Psychological safety (2 Articles)

    An organisation with a strong patient safety culture will promote the psychological safety of its staff. Psychological safety refers to the shared belief that a team can deal with complex challenges when there is an atmosphere of mutual respect and trust. Thus, safer care is provided when the causes and ways to avoid clinical errors can be discussed and analysed without fear of criticism or sanctions.

    It relates to how:

    • Clinical errors are addressed.
    • Clinical decisions are made in an uncertain environment.
    • Feelings and concerns arising from overload are managed.

    There is growing concern about how to improve teams to cope with the workload. The COVID-19 pandemic crisis has highlighted the importance of this issue.

    Previous research has established that inclusive leadership behaviours, good interpersonal relationships, and supportive organizational practices can promote psychological safety. These factors have been critical during the pandemic.

  • A6. Barriers and gaps to be considered (1 Article)

    The culture of blame or shame experienced after an error does not contribute to learning from these incidents, which limits the possibilities of avoiding the repetition of risky situations for patients. Leadership styles and team dynamics that allow for self-criticism and discussion on how to do things better (psychological safety) also influence the experience of patients and healthcare workers.

    The existence of a national patient safety strategy or plan contributes to a better understanding of the experience of patients (their relatives) and professionals involved in safety incidents and in the most risky and complex situations involving a high level of stress. 

    The legal framework and in particular professional liability legislation is another key element to be considered. The same applies to options for compensating patients who have suffered a severe adverse event.

  • A7. How to respond to an AEs/incidents (4 Articles)

    It should be considered that while adverse events are the flip side of the patient safety coin, the management of the risks inherent in healthcare is the desirable goal and therefore an integral part of good clinical practice.

    This opens the way for the concept of resilience in healthcare organisations, understood as the degree to which a system prevents, detects, mitigates, or ameliorates hazards or incidents, enabling an organisation to “recover” as quickly as possible to its original ability to perform care functions after harm has occurred. Achieving this requires an appropriate environment.

    Although in practice we accept that adverse events may occur for several causes, we do not accept that these incidents occur repeatedly for the same reasons.

    When an adverse event occurs, like any other critical situation, different focal points require attention and timely response. The comprehensive management of adverse events and their impact requires the almost simultaneous approach of the multiple agents and levels affected (patient and family, healthcare professionals, institution). It implies tasks such as incident notification and analysis, frank communication with the first victim, or crisis communication if the adverse event has a media impact.

    Listed below are a set of recommendations that guide the analysis of the incident, the communication of what happened to the patient or their family, and the protection of the reputation of the healthcare institution and the professionals.

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