How we investigate

Key principles for investigation

• HSSIB do not attribute blame or liability in our investigations.
• HSSIB underpin investigations with the most appropriate and robust safety science methodologies.
• HSSIB investigations take a system perspective and aim to reduce the likelihood of incidents happening.
• HSSIB involve patients, families, and healthcare staff in our investigations.
• HSSIB consider how to improve care for those subjected to health inequalities in all our investigations.
• HSSIB will have a multidisciplinary team approach to investigations using skilled investigators.
• HSSIB involve appropriate subject matter advisors in our investigations.
• HSSIB recommendations will be impactful, and will work with the system to ensure there is maximum effect.
• HSSIB will be open and transparent about how they work whilst protecting the disclosure of specific evidence that they gather during the investigations.
• HSSIB will undertake investigations in a timely manner, and in the most cost-effective way.

HSSIB powers

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

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 Health and Care Act 2022 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.

Sharing information

All relevant safety information that HSSIB obtains is provided in a patient safety investigation report. Our reports do not name individuals or organisations. This is so the focus is on the system issues that affect how care is provided to patients.

Duty of candour

During investigations we check that NHS and healthcare organisations have met their duty of candour responsibility to patients and families who have been harmed during their care.

The duty of candour requires registered providers and registered managers to act in an open and transparent way with people receiving care or treatment from them. The regulation also defines ‘notifiable safety incidents’ and specifies how registered persons must apply the duty of candour if these incidents occur.

Protected disclosure

HSSIB investigations cannot 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, protected disclosure means specific evidence from of 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 Health and Care Act 2022 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 Health and Care Act 2022 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.

Disclosures relating to safety risks

HSSIB may disclose protected material where:

• It reasonably believes that the disclosure of the material is necessary to address a serious and continuing risk to the safety of any patient or to the public.
• HSSIB believes that the person the disclosure is made to is in a position to address the risk.
• The disclosure is only to the extent necessary to allow the person to take steps to address the risk.

This type of provision may be familiar to clinical staff through their professional regulators. It’s similar to professional obligations when clinicians may be justified in disclosing confidential patient information.

HSSIB has asked to become a signatory to the Emerging Concerns Protocol. The purpose of the protocol is to provide a clearly defined mechanism for organisations which have a role in the quality and safety of care provision, to share information that may indicate risks to people who use services, their carers, families or professionals. When it is necessary to escalate a serious or continuing risk to national organisations, we can do this quickly and effectively.

Disclosure by order of the High Court

A person may apply to the High Court for an order that the HSSIB must disclose protected material.

The High Court may make an order for the HSSIB to disclose protected materials, but must consider:

• Any adverse impact on current and future HSSIB investigations by deterring persons from providing information for the purposes of investigations.
• Any adverse impact on securing the improvement of the safety of healthcare services provided to patients in England.

HSSIB can make representations to the High Court to contest the release of any information.

Disclosures for purposes of investigations

HSSIB can disclose protected materials where disclosure is reasonably necessary to carry out a HSSIB investigation. For example, where we need to share a draft investigation report for comments that contains information gathered during our investigation.

Disclosures relating to prosecution or investigation of offences

HSSIB can disclose information if it reasonably believes that the disclosure is necessary for the purposes of prosecuting or investigation of an offence under the Health and Care Act 2022. This is where someone may be suspected of unlawfully disclosing HSSIB protected information.

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:

• Speaking with patient 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 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.

Check and challenge

The organisations and contacts we have made are listed in our investigation reports to demonstrate the range of views we have taken within a specific investigation.

As part of our consultation process we share the report with a range of national stakeholders on consultation before we publish our final report. Our reports do not name individuals or local healthcare organisations but such sharing allows for further check and challenge of evidence and findings that would be included in our final report, including by patient and family representative groups.

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 take 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 action 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 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 can include prompts or questions to help identify and think about how specific patient safety concerns could be responded to at the local level.

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.