How we investigate

HSSIB powers

The Health and Care Act 2022 (the Act) gives us powers and responsibilities when carrying out our patient safety investigations.

Protected disclosure

Health Services Safety Investigations Body (HSSIB) investigations do not apportion blame, civil or criminal liability, or decide whether any action needs to be taken against an individual by a regulatory body.

To support this, we use protected disclosure. This means specific evidence from our patient safety investigations must not be disclosed and HSSIB reports are not usually admissible evidence in legal proceedings. It is also an offence for any person to knowingly or recklessly disclose protected materials.

Exceptions to protected disclosure

There are limited circumstances under the Act in which HSSIB may disclose, or may be forced to disclose, protected information.

These are disclosures:

  • relating to safety risks
  • by order of the High Court
  • for purposes of investigations
  • relating to prosecution or investigation of offences.

The Act also includes the responsibility on any person not to disclose protected materials that are provided to us as part of our investigations, unless specific exemptions are met.

The Act allows for people and organisations to voluntarily share information with us for the purposes of our investigation functions. HSSIB can also request, collect and use your personal data under the General Data Protection Regulation (GDPR) in the performance of a public task.

Where we are unable to receive the information we need for our investigations in these ways, our investigators also have the power to:

  • Enter, investigate and seize items from premises.
  • Compel people to speak with us.

It is an offence under the Act for a person to obstruct our investigators from performing their duties.

More information on these powers and responsibilities can be found in the Health and Care Act 2022.

Evidence collection and analysis

We collect a range of evidence as part of our investigations, to help us understand concerns about patient safety and to produce our findings and safety recommendations.

Evidence collection

These are the sources of evidence that are usually included in our investigations:

  • Listening to patient, carers and families.
  • Speaking with NHS and healthcare staff.
  • Reviewing relevant medical records, local policies and incident reports.
  • Observation visits to understand how healthcare is delivered in practice.
  • Reviewing academic and professional research and literature.
  • Speaking with national organisations and reviewing national policies.
  • Speaking with or working alongside subject matter experts, including healthcare and non-healthcare professionals, and patients or patient groups.

Analysis

We analyse our evidence using a range of methods that adopt a human factors and ergonomics approach (sometimes referred to as ‘safety science’). Human factors is an established scientific discipline used in many other safety critical industries, such as aviation, rail transport and nuclear power stations.

Methods and tools

We use practical and academic models and tools to help us better understand how patient safety incidents occur. This allows us to adopt a systems perspective that does not find blame or liability with individuals or organisations.

Our investigation reports include information on the specific methods we have used to collect and analyse our evidence.

Subject matter advisors

It’s important that our investigations are informed by expert opinion. This helps us better understand patient safety concerns and allows us to produce robust findings, safety recommendations and other safety learning.

Our investigations always speak with patients, families, healthcare staff and national organisations to capture evidence and gain insight across multiple groups and help us check and challenge our investigations from different perspectives.

Sometimes we also identify the need for more specific subject matter advice to help us gain additional knowledge and insight into a specific patient safety concern. We can identify subject matter advisors in several ways, including engagement with professional bodies, academic institutions, voluntary and charitable groups, or other national organisations.

Findings and safety recommendations

Our investigations produce findings that identify where actions can be taken to improve patient safety. These are shared in full in our reports, which are published in the patient safety investigations section.

Our findings include:

  • safety recommendations
  • safety observations
  • safety actions
  • local-level learning.

Safety recommendations

Safety recommendations are made to national organisations and bodies best placed to take action to address a risk to patient safety at the national level. We do not make safety recommendations to local healthcare organisations. We do not have legal powers to enforce our safety recommendations.

The organisations we make safety recommendations to are named in our report. These organisations are asked to respond to our safety recommendations within 90 days and their responses are published on our website for transparency.

Where we do not receive a response to our safety recommendations, we work with organisations to make sure a response is provided. If no response is provided, we state this on the investigation page and what we have done to raise this concern with the wider healthcare system.

Safety observations

A safety observation describes important learning that can help to improve safety, and these are highlighted in our reports. A safety observation is usually made where the issue falls outside the key lines of enquiry for the investigation or where there is no national organisation best placed to do this work.

We may also make safety observations where we have not been able to find enough evidence to make a safety recommendation. Where this is the case, we can revisit a safety observation once we have more evidence to turn this into a safety recommendation.

Safety actions

A safety action describes an action a national organisation has completed to address a safety issue we raised during an investigation. Where an organisation completes work before our investigation is published, we credit this action in our reports to reflect the work that has been done. Without this work being completed we would likely have made a safety recommendation.

Local-level learning

HSSIB investigations may identify local-level learning for healthcare organisations or staff. This is intended to support organisations with practical prompts or questions that they can choose to use to help identify and think about how specific patient safety concerns could be responded to at the local level. They may decide to make changes as a result of this local learning.

HSSIB investigation reports may also identify specific learning for integrated care systems where a more joined up, regional response to a patient safety concern could help to improve care.