Part 2: Competence areas for patient safety

Key Components

• Terms and concepts
• Patient safety in relation to other concepts and dimensions within healthcare
• Patient safety from the patient’s and relatives’ perspective

Description

This competence area deals with the terms and concepts used in the field of patient safety, and how they are defined and applied. It is essential to establish common terminology:

• In the work related to patient safety in healthcare facilities
• In management and governance to enhance patient safety
• When reading, writing, and researching within the field of patient safety. Definitions and concepts draw from legal regulations, national terminology databases regarding health and social care, and scientific literature.

The area also covers how patient safety relates to other perspectives within healthcare, such as good and integrated care as well as quality. It also addresses how patient safety intersects with other safety efforts in healthcare, including occupational safety, operational and functional safety, radiation safety, and information security.

Furthermore, this domain encompasses patient safety from the perspective of patients and their relatives, which is a crucial complement to the healthcare system’s viewpoint. For patients, the perception of security is vital. Therefore, patient safety is not only about ensuring safety from the healthcare system’s standpoint; it must also be perceived as safe by patients and their carers.

Key Components

• The legal regulation of patient safety
• Organization of work with patient safety

Description

This competence area focuses on the responsibilities and obligations related to patient safety for employees and officials at various levels within the system, as well as patient’s rights. It draws from both legal regulations and practical knowledge of how these regulations are applied in the context of patient safety. Legal regulation involves various forms of rules, including laws, ordinances and regulations.

The area also includes knowledge about how patient safety work is organized and conducted at local, regional, national, and international levels. It covers the responsibilities of individual practitioners, as well as those of governing bodies and healthcare providers. Topics addressed within this domain may include:

• Ensuring high patient safety and compliance with reporting obligations
• Organizing systematic patient safety efforts, such as incident reporting and learning
• Investigating, assessing, and managing events and risks
• Establishing structures for learning and professional development in patient safety
• Reporting incidents and notifying supervisory authorities.

Key Components

• Evolution of the perception of safety over time
• System understanding
• Safety in complex systems

Description

This competence area focuses on theories and frameworks for describing and understanding healthcare from a systems perspective. A systems perspective contributes to understanding, describing, simplifying, and gaining an overview of patient safety within healthcare.

The perception of patient safety has evolved over time. Healthcare has shifted from an individual-centric view of right or wrong actions to an understanding that patient safety is influenced by underlying factors. It is the sum of various components within the healthcare system.

System understanding is based on describing healthcare as a complex adaptive system. This means that different parts and levels of healthcare interact and influence each other. These interactions can occur unpredictably, necessitating continuous adaptations. Different aspects of healthcare carry their respective risks and challenges. Therefore, various approaches are needed to achieve and maintain patient safety.

This competence area also addresses how the system’s variability and adaptability impact opportunities and challenges related to patient safety. Additionally, it includes characteristics of organizations with a high awareness of safety and a strong ability to manage risks.

Key Components

• Involve patients and carers in their care and treatment
• Involve patients and carers in the design of care at all levels

Description

This competence area is about involving and engaging patients and carers in care and treatment, systematic patient safety work, and in the design of care at all levels. It concerns the participation of patients and carers as individuals, as a group, and/or as representatives of patient or carer organizations. The patient as a co-creator means that the patient is involved at all levels of the healthcare system, based on their own wishes and conditions for participation. It is essential to have knowledge about how the patient’s narrative and resources are utilized in the management, control, and design of care. Patients’ opportunities to participate in and influence certain issues that have direct significance for the design of care include, among other things, issues of accessibility, that the patient should receive certain information, and that the patient can be involved in how the care is designed and implemented. The patient’s carers should also have the opportunity to participate in the design and implementation of care, if it is appropriate and if provisions of confidentiality or professional secrecy do not prevent this. The competence area also includes how care can create conditions for patients and carers to participate in and contribute to the systematic patient safety work. This can be done by involving patients and carers in the development of care processes and working methods.

Key Components

• Physical, organizational, and social work environment
• How situational awareness and decision-making are affected by stress and fatigue
• Well-being and work capacity after involvement in events that have or could have led to healthcare injury
• The importance of ensuring care for healthcare workers after adverse events and how to ensure it.

Description

This competence area deals with how the physical, organizational, and social work environment affects employees’ ability to work in a way that promotes patient safety. For example, an imbalance between demands and resources can cause fatigue and stress. The same applies to the opportunity for recovery during and between work shifts. This, in turn, affects cognitive abilities, situational awareness, and the ability to make decisions. These are factors that are important for being able to perform work in a way that contributes to patient safety. The competence area also involves integrating systematic work environment efforts with systematic patient safety work. The work environment and how work is organized have consequences for employees’ health and psychological safety. These are also important factors for being able to recruit and retain competent staff.

Key Components

• Teams in healthcare, interprofessional teamwork and multiteam system
• Communication and patient safety

Description

This competence area deals with teamwork and communication that contribute to patient safety, as well as communication within and between teams. It also concerns how good communication with patients and relatives can contribute to security, comprehensibility, and participation, which in turn contributes to patient safety. The team is one of the most common working methods in healthcare. Teams can look different in different operations. They can be permanent or temporary, physical or virtual. They can be close to the patient or bridge different parts of the patient’s care process. Management teams and teams at the administrative and political level also affect patient safety. A prerequisite for teamwork that promotes patient safety is to train regularly. It involves training both common routine situations and the ability to handle and recover from disturbances and unexpected situations. Deficiencies in teamwork and communication are a common contributing cause of avoidable harm. Therefore, the competence area deals with organizational conditions for teamwork, as well as how the team members contribute their respective professional competencies to the work. Common working methods in team situations are also included. These methods involve:

• Collaborating and communicating
• Establishing security in the team
• Formulating goals and maintaining a common understanding of the task
• Identifying risks
• Making decisions based on common priorities
• Reflecting and learning together after both every day and escalating situations

The competence area also deals with the ability to recognize and manage goal and value conflicts based on the team’s, the patient’s, and the carers’ different perspectives on the situation.

Key Components

• The potential of organizational culture to promote or hinder patient safety
• Evaluating how organizational culture affects patient safety

Description

This competence area concerns how organizational culture affects patient safety and how it can be developed to promote patient safety. Organizational culture can be described as the fundamental values, assumptions, and behaviours shared by the people in an organization. The culture of an organization affects how we view issues that are significant for developing and maintaining patient safety. This includes competence at the individual and group level, our structures, processes, technology, and behaviours. The culture can both promote and hinder patient safety. Therefore, the competence area also deals with:

• How an organizational culture is developed
• What is meant by an organizational culture that promotes patient safety
• How it can contribute to promoting or preventing the development of patient safety
• The concept’s relation to the concept of safety climate.

The competence area also involves evaluating organizational culture from a patient safety perspective, including the strengths and weaknesses of different approaches.

Key Components

• Risks in complex sociotechnical systems
• Risk awareness

Description

This competence area deals with how risks arise, develop, and change over time in healthcare. Healthcare can be described and understood from a system perspective as a complex sociotechnical system. This means that different parts and levels of healthcare interact and affect each other, and that there is an interplay between humans, technology, and organization in all parts.
Risks develop over different time perspectives. Some risks occur here and now in daily work. Other risks arise over a longer period. Some risks are expected while others are not. Therefore, the area also deals with risk awareness and how patient safety is constantly created and maintained at all levels of the healthcare system.
The competence area also involves identifying, analysing, and managing risks, and anticipating and handling the variations that occur in daily work. Proactive approaches within different parts of healthcare and for different risk situations, such as care transitions, during organizational changes, or when there is a shortage of care places, are also included.

Key Components

• Identify and report
• Investigate events
• Utilize patients’ and relatives’ experiences, viewpoints, and complaints

Description

This competence area is about identifying, reporting, investigating, and learning from deviations and events. It can be events that have resulted in or could have resulted in harm to a patient or other deviations. Healthcare professionals must be familiar with any legal requirements regarding management of deviations and the investigation of events. Central parts of the feedback and learning process may also involve what has contributed to maintaining or strengthening patient safety. Feedback in the form of analysis results and conclusions after deviations and events creates conditions for continuous learning. They also provide a basis for systematic improvement work at all levels of healthcare. The area also involves utilizing the experiences, viewpoints, and complaints of patients and relatives. They are a source of learning and development of patient safety work.

Key Components

• Monitor and evaluate patient safety

Description

This competence area deals with various aspects, perspectives, and measures to monitor and evaluate organizations and operations that provide healthcare from a patient safety perspective, at all levels. Examples of aspects include the presence of safety, the absence of harm, and proactive and reactive approaches. Different perspectives on the follow-up could, for example, be operation, care, patient, and resources.

Measurements and analysis of collected data need to be a basis for leading, directing, and organizing systematic patient safety work. Data can, for example, show how organizational conditions, changes in operations, and behaviours affect patient safety risks. Data can also indicate opportunities for improvement work. Therefore, the competence area also includes data sources and methods for data collection, as well as their strengths and weaknesses.

Key Components

• Designing organization, processes, and work methods in complex systems
• Introduction and phasing out of processes, work methods, and techniques
• Secure information transfer and continuity during care transitions within and between care providers

Description

This competence area is about how organization, processes, and work methods can be designed to strengthen patient safety in various operations with varying degrees of complexity. The area includes how patient safety aspects can be highlighted and managed when new processes and work methods are developed and implemented. This can be done, for example, through systematic improvement work as well as clinical education, training, and simulation. The competence area also includes “de-implementation” as the phasing out of processes, work methods, and techniques that no longer create value or that involve too great risks.

This competence area also emphasizes processes and work methods for secure information transfer and continuity. This is relevant when a patient is moved between care units or between care providers and principals, or when several care units are involved in the care of the patient.

Key Components

• The interaction between human and technology and the importance of a user perspective throughout the entire life cycle of a medical device
• Standards and regulations for medical devices

Description

This competence area is about considering patient safety at all levels when medical devices are developed, acquired, introduced, used, and phased out in healthcare. In the interplay between technology, humans, and organizations, risks can arise. They need to be identified and managed. This applies to all parts of a medical device’s life cycle.

The competence area also involves viewing the user as an active participant throughout the entire life cycle of medical devices. This can be done, for example, by considering the user’s experience and workflow throughout the entire design and implementation process of medical technology. It can also involve using a user-oriented method when introducing new technology.

The competence area also includes the legal regulations and standards in the field of medical technology, as well as methods for systematically evaluating and monitoring patient safety related to the use of medical devices.

Key Components

• Leading for safe care
• Management systems for patient safety
• Management systems for various conditions
• Support to employees

Description

This competence area concerns how work on patient safety is led, governed, and organized in healthcare. It deals with how decision-makers, leaders, managers, and individuals with medical management responsibilities can work to prioritize and integrate patient safety into work processes, decisions, and organizational changes.

It also involves the role of formal and informal leadership as a culture-creating force. This includes working methods to:

• Create trust and security in the operation
• Provide conditions for risks to be noticed, communicated, and managed
• Support employees who have been involved in events that have or could have led to patient harm

The competence area also includes how an integrated management system, where management systems for patient safety are integrated with management systems for quality and work environment, can be created and translated into practical patient safety work. It also deals with how a management system can help identify the need to change work methods, adapt goals, and reprioritize when needs exceed resources, a situation that can arise both in normal conditions and during crises.

Key Components

• Readiness and patient safety

Description

This competence area deals with how patient safety efforts are affected during extraordinary events, crises, wars, and disasters. It includes how an organization can identify the need to switch from normal operations to reinforcement mode, staff mode, or disaster mode, what this entails, and what it means for patient safety work.

The area also concerns principles for prioritization during crises or disasters and how goals for healthcare can be adapted through medical policy decisions. The area also includes patient safety aspects of preparedness work. This can involve:

• Readiness planning
• Vulnerability analyses
• How competencies and work methods in disaster or crisis situations are maintained through backup routines, crisis plans, crisis organization, inventory management, and disaster exercises

Key Components

• Specific risk areas
• Preventive work within specific areas of preventable patient harm
• Care situations with specific patient safety challenges

Description

The competence area deals with known risk and healthcare injury areas. For several known risk areas, there is a reason to highlight specific competence needs. There is also knowledge about different types of patient harm and how they can be prevented. For many of these risk areas and types of patient harm, there are specific methods and work practices. It is about methods and work practices to prevent risks and patient harm, and to follow and evaluate care from a patient safety perspective.

The competence area also deals with care situations that can lead to challenges. The treatment is fundamental for a trusting and mutual respect between healthcare workers and the patient. It is central to achieving participation and security. Factors such as age, gender, language, health literacy, socioeconomic factors, functional level, and religious beliefs can affect the meeting between the patient and healthcare workers. Deficiencies in treatment can lead to deficiencies in communication and information. This, in turn, can lead to patient safety risks.

There are also care situations that can be challenging because the patient has difficulty or does not want to participate in their care and treatment due to illness, health condition, or other conditions. It can also be about patients who are a risk to themselves or others. Examples are patients with acute confusion, dementia, psychosis, substance influence, etc.

Risks and types of patient harm vary in different parts of healthcare. Therefore, the competence needs differ between different operations and types of healthcare. The examples below illustrate which risk areas, types of patient harm, and specific care situations may be relevant. The list of examples is not complete.

• Examples of specific risk areas: Diagnostics, digital healthcare, medication management, home healthcare, surgical procedures, intensive care, emergency care and care transitions
• Examples of preventive work within specific areas of patient harm: Fall prevention, pressure ulcer prevention, preventing bladder overdistension, preventing healthcare-associated infections, preventing suicide as a healthcare injury
• Examples of care situations with specific patient safety challenges: Meeting all patients regardless of age, health literacy, socioeconomic status, language, religious beliefs, physical or intellectual functional level, etc., based on the patient’s needs; situations where the patient may pose a threat to themselves or others; situations where protective and restrictive measures may be applicable; situations where healthcare workers are faced with threats and violence.