Patient safety fundamentals

Learn about the fundamentals of paediatric patient safety theory and discover resources from across the patient safety community, including the NHS patient safety syllabus, courses, conferences and must-read papers.

Patient safety is a framework of organised activities that creates cultures, processes, procedures, behaviours, technologies, and environments in healthcare that consistently and sustainably lower risks, reduced the occurrence of avoidable harm, make error less likely and reduce its impact when it does occur.

WHO, Global Patient Safety Action Plan 2021-2030

Patient safety has been a part of the NHS in the United Kingdom and Northern Ireland since the since its inception in 1948. In this timeline the development of safety programs in the UK is demonstrated.

In the United States the publication of the Harvard study in the 1990’s on adverse events documented the challenges of patient safety. This was followed by the first assessment of what needs to be done to achieve safety: To Err is Human.

In the UK, the  publication of the report ‘An Organisation with a Memory’ by the CMO Liam Donaldson for the Department of Health in 2000 led to patient safety becoming a key component of health care policy. When health was devolved to the four home countries, each country assumed responsibility for patient safety. Programmes have been developed that are specific to each country. Nonetheless, there are synergies in the policies and programmes and one can use all from across the UK.

A 2022 meta analysis of case note reviews using a trigger tool reports on harm has suggested a wide prevalence range of adverse events and harm in paediatrics.  The UK trigger tool study reported that 1 in 7 children experience harm during admission to hospital in UK (Chapman et al, 2014). A 2019 systematic review on the prevalence of preventable harm in adults and children reported that one in 20 patients are exposed to preventable harm in medical care.

Patient safety has several approaches and theories and all are important in delivering safe care. Initially the focus has been on reactive processes looking retrospectively at what went wrong and why harm occurred. This includes incident reporting, root cause analysis to understand causes of adverse events, guidelines to recommend safe care and goals to be achieved. The improvement plans that come from safety investigations include individual or team training, introduction of targets, or the creation of new guidelines. There are benefits in understanding why an adverse event has happened, but we need to adopt other approaches to achieve safe care. These approaches include human factors and ergonomics, service redesign, understanding how systems work, reliability interventions and a proactive approach to safety.

Developing reliable systems that are resilient includes focussing on how things go right within the complex, unpredictable, adapting healthcare system. Healthcare professionals are in a constant state of adapting and problem-solving which creates resilience within the healthcare system. A proactive approach allows us to understand how best to achieve safety and how to prevent harm before it occurs and ensure high quality care in challenging circumstances.

Safety is an essential domain of quality healthcare. Without safe healthcare systems and processes, we cannot deliver quality care.

Quality care is:

  • Safe
  • Effective
  • Efficient
  • Accessible & timely
  • Equitable
  • Patient-centred
  • Eco-friendly

Patient safety must be co-produced with healthcare professionals, patients and their families, in a system that is transparent, just, person centred, respectful, holistic, kind, resilient, and well-led. The most important component of developing a safe system is that it is embedded in everything that we do.


The WHO principles for patient safety are:

  • Engage patients and families as partners in safe care.
  • Achieve results through collaborative working.
  • Analyse data to generate learning.
  • Translate evidence into measurable improvement.
  • Base policies and action on the nature of the care setting
  • Use both scientific expertise and patient experience to improve safety.
  • Instil a safety culture into the design and delivery of healthcare.


To be safe we need to manage risk proactively. There are several theories or approaches, all of which are complimentary, to achieve safe care:

  • Individual responsibility and accountability are essential, but healthcare will only be safe if individuals practice within a safe system.
  • Risk/Critical Incident management e.g., root cause analysis to identify causes of safety incidents and highlight areas for improvement is important for learning. This does not necessarily ensure a safe system.
  • Human factors and Ergonomics: a discipline that states that safe practice is created from the successful interaction between humans, the environment and the technologies required to complete complex tasks.
  • Reliability theory involves designing highly reliable processes that mitigate risk e.g. by standardising process and care pathways
  • Systems theory highlights that healthcare systems are complex and ever-changing with no linear processes. Due to this complexity safety must be consistently planned and managed. There is no single solution for safety. Each clinical microsystem must understand in depth how its system works and how the systems responds to change or stressors. Incidents are not caused by a single action but by dynamic interactions between people, technology and working conditions.
  • Resilience theory involves looking at safety as occurring continuously within a system that is constantly adapting to changing conditions. It includes the system’s ability to:
    • respond to problems when they occur
    • learn from experience and share the learning.
    • monitor and respond to problems that are identified.
    • anticipate future needs.
  • Psychological safety is an essential part of a safe system and allows healthcare professionals to engage in effective teamwork and to promotes patient safety. It underpins the foundations of a safe system within a culture of safety.

(Some call resilience theory approach: ‘Safety 2’ and class all the other theories as ‘Safety 1’)

A Roadmap for Safety

In the review of Patient Safety following the Francis Report, Berwick provided recommendations reflect the view that “the quality of patient care should come before all other considerations in the leadership and conduct of the NHS, and that patient safety is the keystone dimension of quality. The pursuit of continually improving safety should permeate every action and level in the NHS.” These recommendations provide a roadmap to a safe system.

  1. Recognise with clarity and courage the need for wide systemic change: All improvement begins with clear recognition and acknowledgement of the need to improve.
  2. Abandon blame as a tool to achieve change.
  3. Reassert the primacy of working with patients and carers to set and achieve health care goals.
  4. Use quantitative targets with caution. Goals in the form of such targets can have an important role en route to progress but should never displace the primary goal of better care.
  5. Recognise that transparency is essential and expect and insist on it at all levels and with regard to all types of information (other than personal data).
  6. Ensure that responsibility for functions related to safety and improvement are vested clearly and simply in a thoroughly comprehensible set of agencies, among whom full cooperation is, without exception, expected and achieved:
  7. Give the people of the NHS – top to bottom – career-long help to learn, master and apply modern methods for quality control, quality improvement and quality planning.
  8. Make sure pride and joy in work, not fear, infuse the NHS

Safe care in paediatrics relies on integrated care with strong clinical leadership and a culture of patient-parent engagement, governance, teamwork, and education. Everyone should have a sound knowledge of patient safety and we need to build capability for safety and quality improvement.

There are 10 key safety risks for children in healthcare:

  1. Medication error
  2. Failure to recognise deterioration.
  3. Failure to recognise life threatening illness early
  4. Hospital acquired infections.
  5. Preventable pain and distress
  6. Tissue injury from extravasation or pressure ulcer
  7. Failure to recognise early and manage procedural or surgical complications.
  8. Failure to recognise safeguarding concerns early.
  9. Unnecessary admissions, investigations, procedures and treatments
  10. Psychological harm or not providing a positive experience of healthcare.

In 2007 the Confidential Enquiry into Maternal and Child Health (CEMACH) report ‘Why children die’ found there were preventable factors in 26% of reviewed cases; most were related to poor communication and delayed recognition of the deteriorating child.

We need to focus on providing highly reliable care to all children and preventing avoidable harm but there are several challenges that are expressly different from the adult population. Children have changing physiology as they develop. Woods et al characterised the factors that influence safety in children:


Differences from adults How does this affect children? What are the safety implications?
Development Children progress through developmental stages which impacts on weight, physiology & psychology Clinicians must have sound child development knowledge to diagnose and treat effectively.

With age and size there is variation in the following:

–          Vital sign parameters

–          Drug dosing and metabolism

–          Ability to understand and communicate.

–          Type of equipment needed.

Dependency Children rely on advocates to speak up for them There may be:

–          Inadequacies in acknowledging parental concern.

–          Poor communication between children, their carers and the multidisciplinary team.

–          Lack of focus on the child’s mental health

–          Lack of focus on the voice of the child especially in safeguarding situations.

Differential Epidemiology of disease varies as children suffer from different diseases at different ages Care is delivered in generalist settings:

–          Lack of specialist paediatric knowledge leading to missed diagnoses or deterioration.

–          Adult oriented environments with inappropriate equipment.

–          Under-resources services such as mental or adolescent health

Those with chronic illness and special healthcare needs are at higher risk of harm in hospital.

Demographics Children are impacted by social determinants of health –          Poverty, ethnicity, economic crises, natural disasters impact children

–          Educational settings provide important access to healthcare and to the identification of safeguarding concerns, but are highly variable


Watch recordings from a series of educational webinars conducted by the London School of Paediatrics in 2020 on patient safety:

Intro to patient safety


Patient Safety Checklists and Huddles

QI and Patient Safety


Safety Culture Change


In England, NHS England and The Academy of Medical Royal Colleges and eLearning for Healthcare have developed patient safety training materials as part of the NHS England Patient Safety Strategy The English National Patient Safety Syllabus, emphasises a proactive approach to identifying risks to safe care and includes systems thinking and human factors.

The training materials are on the eLearning for Healthcare hub. The first level, ‘Essentials for patient safety’, provides the fundamentals of patient safety and all staff should complete the course . Level two, ‘Access to practice’ is intended for those who have an interest in understanding more about patient safety and those who want to go on to access the higher levels of training. NHS patient safety specialists now have a level 3 and 4 course to expand their knowledge.

Watch a short video introducing the English training resources below:

In Scotland, the Scottish Patient Safety Programme (SPSP)   provides collaborative programmes to improve safety and has a specific . paediatric component.  Training is in the Patient Safety Zone and provides a comprehensive programme on patient safety.

In Wales the patient safety programme Patient Safety Wales provides support for clinicians and organisations.

In Northern Ireland the DOH Patient Safety programme provides comprehensive approaches to the challenge of patient safety.

World Health Organisation

The 72nd World Health Assembly in 2019 adopted resolution WHA72.6 on global action on patient safety and mandated for development of  a global patient safety action plan. This global action plan was adopted by 74th World Health Assembly in 2021 with a vision of

“a world in which no one is harmed in health care, and every patient receives safe and respectful care, every time, everywhere”.

Find full details of this action plan here: WHO Global Action Plan

The WHO have developed a Multi-professional Patient Safety Curriculum (2011) aimed at universities and schools of dentistry, medicine, midwifery, nursing and pharmacy; as well as supporting on-going training of all health care professionals. To accompany this there is a package of lectures, videos, case studies and presentations walking through the following topics:

  • Measuring harm
  • Understanding Causes
  • Identifying solutions
  • Evaluating Impact
  • Translating Evidence into Safer Care

The resources can be found here: WHO Patient Safety Education and Training

Children’s Hospitals’: Solutions for Patient Safety, USA

This is a network of 140+ children’s hospitals in the USA who work together to help each individual hospital make progress on a journey to zero patient harm. It is specifically focused on improving paediatric and employee safety. Key aspects of it’s current vision are to:

  • Decrease rates of the most common serious patient and employee harms
  • Improve safety culture
  • Identify and eliminate safety disparities
  • Create robust learning systems for ambulatory safety

“Since 2012, this national effort has saved 23,036 children from serious harm and led to an estimated savings of $447.5 million, with a consistent upward trend in harm prevented every month (as of September 2022).”

Visit Solutions for Patient Safety

Initial reports on Safety

Donaldson L. An Organisation with a Memory. Clin Med (Lond). 2002 Sep-Oct;2(5):452-7.

Institute of Medicine (US). To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000.

Report following Francis Inquiry

Berwick DM. Improving the Safety of Patients In England – A promise to learn, a commitment to act. London: The Stationery Office (2013)  

Journal articles

The Journal: ​​​Pediatric Quality and Safety (PQS) is a peer-reviewed, open access, online periodical dedicated to providing healthcare professionals a forum to disseminate the results of quality improvement and patient safety initiatives that impact the lives of children from newborn to young adulthood. Find it here

There is also a topical collection in the Journal of Current Treatment Options in paediatrics, Vol 1, Issue 4 published in 2015 with a series of 12 articles focusing on paediatric patient safety. Find it here

Other great articles include:

Cheung R, Roland D, Lachman P. Reclaiming the systems approach to paediatric safety. Arch Dis Child. 2019 Dec;104(12):1130-1133. doi: 10.1136/archdischild-2018-316401. 

Nicolì S, Benevento M, Ferorelli D, Mandarelli G, Solarino B. Little patients, large risks: An overview on patient safety management in pediatrics settings. Front Pediatr. 2022 Sep 16;10:919710.

Fitzsimons, J., Vaughan, D. Top 10 Interventions in Paediatric Patient Safety. Curr Treat Options Peds 1, 275–285 (2015).

Roland D, et al. Paediatric early warning systems: not a simple answer to a complex question. Arch Dis Child. 2022 Jul 22:323951.

Taitz, J. Building a Culture of Safety in Pediatrics and Child Health. Curr Treat Options Peds 1, 253–261 (2015).


Donaldson, L., Ricciardi, W., Sheridan, S. & Tartaglia. Textbook of Patient Safety and Clinical Risk Management. Springer Cham. 2020.

Lachman P, John Brennan J, Fitzsimons J,Jayadev A, Runnacles J (Ed) OUP Handbook of Patient Safety  Oxford Professional Practice 2022

Leape, L. Making Healthcare Safe – The Story of the Patient Safety Movement. Springer Cham. 2021  

Vincent, C & Amalberti, R. Safer Healthcare: Strategies for the Real World  Springer Cham. 2016

Vincent, C The Essentials of Patient Safety  E-Chapter

Vincent, C., Burnett, S, Carthey, J. The measurement and monitoring of safety  The Health Foundation. 2013

World Health Organisation

WHO Global Action Plan

WHO Patient Safety Education and Training


Patient Safety and the Kings Fund

Patient Safety Learning- The Hub

Solutions for Patient Safety

Institute of Healthcare Improvement


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