Improving Healthcare: A Guide To Patient Safety Incident Investigations


There are over 2.5 million patient safety events recorded in the NHS each year and healthcare organisations naturally have a responsibility to ensure they are doing everything in their power to prevent the same problems from reoccurring. Depending on the nature of the event, an investigation into a patient safety incident may be required in order to enact positive change.

At Verita, we have wide-ranging experience of carrying out incident investigations, as well as reviewing failed ones, so we understand the complexities involved. Systems and processes, as well as human characteristics and behaviours can all contribute to failings and need to be investigated effectively in order for organisations to learn from incidents.

In this article we explore the purposes of a patient safety investigation, when one is required, what it entails, and what organisations can do to improve the effectiveness of an investigation to ensure effective learning takes place.


What is a patient safety incident investigation?

A patient safety incident investigation (PSII) is triggered by an incident or near-miss that suggests a risk to patient safety and holds potential for learning and improvement within the healthcare system. PSIIs are a crucial tool for enhancing patient safety and building a more resilient healthcare system.

A PSII prioritises understanding of how an organisation’s systems and processes can be improved. By recognising that errors can occur, a PSII analyses the bigger picture, exploring decision making or actions made as well as examining factors like equipment, technology, workplace environment, and staff processes as contributing factors to prevent similar incidents from happening again.

Here is a summary of what healthcare organisations can look to achieve through a PSII:

  • The ultimate goal of a patient safety incident investigation is to prevent future incidents and create a safer environment for patients and staff. By uncovering weaknesses in systems and procedures, therefore PSIIs can lead to better safeguards and improved patient care.
  • PSIIs provide a basis for learning and development, by identifying the root causes of the incident, not just the immediate actions or decisions taken by individuals. By understanding the systemic factors that contributed, as well as identifying areas where staff training and education might be beneficial, healthcare providers can learn and improve their processes to minimise future risks.
  • PSIIs can result in cost savings because preventing adverse patient events can save healthcare organisations significant financial resources. Reduced hospital stays, medication errors and unnecessary treatments all contribute to the bottom line.
  • A thorough PSII demonstrates a commitment to patient safety and fosters trust between patients, their families and staff. Highlighting the need for improved communication and collaboration among healthcare professionals will strengthen the transparency and trust within the healthcare setting.


What are the most frequently investigated patient safety incidents?

According to the World Health Organisation (WHO) more than three million deaths occur globally due to unsafe healthcare and that around 1 in every 10 patients is harmed in a healthcare setting. As reported by the WHO the most common course of patient safety incident is medication errors, with half of the avoidable harm in healthcare related to medications.

The NHS has recently launched the Learn from Patient Safety Events (LFPSE) service as a national initiative transforming how healthcare providers record and analyse patient safety incidents. This system aims to create a broader understanding of safety concerns by not only capturing details of incidents, but also near misses and positive safety practices.

By harnessing this collective knowledge, LFPSE empowers healthcare organisations to identify trends, address vulnerabilities in systems, and ultimately, deliver safer care for patients.

Determining the need for a patient safety incident investigation

Several factors can guide healthcare professionals in making the decision as to whether a patient safety incident requires an investigation; severity of the incident, potential for learning and Duty of Candour.

A rapid learning review should be completed within seven days of notification of the incident. The objective of this meeting is to identify and agree whether further investigation is required and the form that investigation should take. This flowchart outlines the typical process for a Rapid Incident Review Meeting within a healthcare organisation:

Note: This is a general flowchart, and specific steps or participants may vary depending on the Trust’s policies and procedures.


What are the key steps of a patient safety incident investigation?

A patient safety incident investigation is a crucial process for understanding and preventing future harm. By involving the patient, family, or carer throughout the PSII process, healthcare organisations can demonstrate transparency, gather valuable insights, and ensure the investigation addresses their concerns effectively to ensure lessons are learnt.

The following shows the key steps within the PSII process:

1. Initial conversation with patient/family/carer: The initial conversation sets the tone for collaboration by openly acknowledging the incident’s impact, offering a sincere apology in line with the Duty of Candour, and fostering trust through empathy.

2. Deciding on the investigation team: For a comprehensive and unbiased investigation, the PSII team excludes those that are directly involved and seeks relevant expertise knowledge (from nurses or doctors), and may seek the patient/family/carer’s input.

3. Deciding on the Scope of the Investigation: The investigator meticulously outlines the investigation’s boundaries to ensure it thoroughly addresses the specific incident.

4. Setting the Terms of Reference: To ensure transparency and manage expectations throughout the investigation, a clear and concise document called the “Terms of Reference” is established. This document outlines the investigation’s objectives, methodology and timeline.

5. Gathering Information: To gain a comprehensive understanding of the incident, the investigator gathers information from a multitude of sources. This includes reviewing medical records to understand the patient’s medical history, witness statements from staff members present during the incident and patient/ family member interviews.

6. Analysing Information: The investigating team meticulously analyses all the information gathered and focuses on identifying the underlying systemic factors that might have contributed to the event. This could include weaknesses in communication protocols, workflow inefficiencies, or a lack of training on specific procedures.

7. Reporting Findings: A clear and concise presentation of the investigation’s conclusions, including identified root causes and contributing factors are reported in a formal document. Recommendations are proposed and an action plan is highlighted to ensure lessons are learnt.


How can NHS Trusts ensure they conduct an effective patient safety incident investigation?

NHS Trusts can ensure effective PSIIs by prioritising several key areas. Firstly, fostering a Just Culture is paramount. This means acknowledging that mistakes happen and focusing on identifying systemic issues rather than assigning blame to individuals. This creates a safe space for staff to report incidents honestly, leading to a more comprehensive understanding of the root causes.

Secondly, to maximise learning and improvement, the PSII scope should go beyond immediate actions and delve into underlying factors like the way systems are designed, communication breakdowns or inadequate training. Regular updates and opportunities for feedback from patients and families throughout the process ensure their perspectives are incorporated and the investigation remains on track.

Finally, clear communication of the investigation’s outcome, including root causes and planned improvements, demonstrates transparency and commitment to patient safety. By adhering to these principles, NHS Trusts can leverage PSIIs to not only prevent future incidents but also cultivate a culture of continuous learning and prioritise patient safety at all levels.

How do PSIIs relate to PSIRF?

PSII sits within the Patient Safety Incident Response Framework (PSIRF) which is a set of guidelines used by the NHS to manage patient safety incidents. It outlines a structured approach for healthcare organisations to respond to and learn from incidents, with a focus on continuous improvement in patient safety.

The PSIRF is a key part of the NHS patient safety strategy. The NHS patient safety strategy describes how the NHS will continuously improve patient safety, building on the foundations of a safer culture and safer systems.

The PSIRF supports the development and maintenance of an effective patient safety incident response system that integrates four key aims: compassionate engagement and involvement of those affected; a system-based approach to learning; considered and proportionate responses; supportive oversight focused on strengthening response systems and improvement.

When is a patient safety incident investigation classed as a Never Event?

Patient safety incidents are a concern for any healthcare organisation, and the NHS takes steps to investigate them thoroughly. However, there’s a specific category of even more serious incidents known as Never Events. While a PSII is triggered by any event that could have harmed a patient, a Never Event represents a specific set of entirely preventable, high-risk incidents outlined by the NHS.


Can PSIIs be conducted externally?

While internal investigations conducted by a dedicated team within the NHS Trust are the most common approach, patient safety incident investigations (PSII) can also be externally commissioned in certain situations. This typically happens when the incident is particularly serious, resulting in significant harm or death, or when there’s a breakdown of trust within the healthcare setting itself.

In high-profile, complex, or sensitive cases, an external investigator can be a valuable asset. They bring an objective perspective, free from internal biases or pressures, potentially leading to a more rigorous investigation and uncovering factors that might have been missed internally. This fresh perspective, combined with a commitment to transparency throughout the process, can strengthen a culture of learning and prioritise patient safety above all else.

What are the benefits of an external investigation?

Firstly, an external investigation can help ensure impartiality and public confidence as it introduces a layer of objectivity. External investigators, with no prior connection to the Trust or the incident, are less susceptible to internal biases or pressures. This can lead to a more rigorous investigation and potentially uncover factors that might have been missed internally.

Secondly, an external investigation can be a sensitive situation for staff within the Trust. Clear communication and transparency throughout the process are essential to manage these anxieties and ensure cooperation and access to essential information, witness interviews, and medical records. The role of an external investigator here is to also ensure confidentiality for staff who participate in the investigation, protecting their identities and encouraging them to speak freely without fear of repercussions.

Finally, depending on the severity of the incident and the investigation’s findings, there could be reputational consequences for the Trust. Transparency throughout the process is key, and the trust should communicate openly with staff, patients and the public about the investigation’s outcome. The involvement of an external body can foster public confidence in the investigation’s impartiality and transparency. This can be particularly important in regaining trust after a serious incident.


In summary

Conducting a thorough and effective PSII hinges on following the right process. This structured approach ensures a comprehensive understanding of the incident, not just the immediate actions taken.

By gathering information from various sources, including patients, families and staff, the investigation goes beyond surface-level explanations and delves into the underlying factors that contributed to the incident. This meticulous approach, guided by a Just Culture, allows healthcare organisations to identify systemic weaknesses and implement targeted solutions to prevent similar incidents from happening again.


Verita helps independent and NHS healthcare organisations conduct incident investigations effectively as well as providing a training course to equip those involved with an understanding of the investigative process. If you would like to know more about patient safety incident investigations and how we can assist your team, please book a free consultation or contact Ed Marsden on 020 7494 5670 or [email protected].


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