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Introduction
The NHS in England has undergone a significant shift in how it handles and investigates patient safety incidents. NHS England has updated the Serious Incident Framework, introducing a new approach that centres on learning, transparency, and preventing future harm.
One of the most important changes is that what were previously known as "Serious Incident Reports" are now called Patient Safety Incident Investigation Reports, or PSII Reports. While this may seem like simply a change in terminology, it represents a fundamental shift in how the NHS approaches patient safety and accountability.
For patients and their families, understanding these changes is crucial. Whether you're currently involved in a patient safety investigation or you're concerned that something went wrong during your care or a loved one's care, knowing your rights and what to expect can make a significant difference to your experience and your ability to seek justice if appropriate.
What Is the Duty of Candour?
The duty of candour is a statutory requirement in England that applies to all NHS and other CQC-regulated healthcare providers. Put simply, it's a legal obligation to be open and transparent with patients when something goes wrong with their care.
Under this duty, healthcare organisations must inform patients (or their families) when a patient safety incident has occurred that appears to have resulted in moderate harm. This isn't optional—it's a legal requirement designed to ensure honesty, promote trust, and support learning from mistakes.
What Should Patients Expect?
When the duty of candour is triggered, you should receive:
A Clear Explanation: Healthcare professionals should explain what happened in language you can understand, not medical jargon. They should outline the incident, its consequences, and any immediate actions taken.
An Apology: You should receive a genuine apology that acknowledges the incident and any harm caused. An apology is not an admission of legal liability, but it is an important part of being treated with dignity and respect.
You have the right to access your medical records and to receive a copy of any investigation report, including PSII Reports.
Regular Updates: Throughout any investigation process, you should be kept informed of progress, timelines, and findings. You shouldn't be left in the dark about what's happening.
The duty of candour applies from the moment a qualifying incident is identified and continues throughout the investigation and beyond. Healthcare providers should engage with you in a meaningful way, answer your questions, and support you through what is often a distressing time.
What Has Changed? The Shift from Serious Incident Reports to PSII Reports
In recent years, NHS England recognised that the old Serious Incident Framework had limitations. The previous system was often seen as bureaucratic, focused on blame rather than learning, and lacking in consistency across different NHS organisations.
The new Patient Safety Incident Response Framework (PSIRF) represents a more sophisticated approach to patient safety. PSII Reports are central to this new framework.
Key Changes in the New Framework
Focus on Learning, Not Blame: The new system emphasises understanding why incidents happen and what can be learned to prevent recurrence, rather than seeking to attribute fault to individuals.
Standardised Process: PSII Reports follow a more consistent, structured approach across the NHS, making it easier to compare findings and share learning between organisations.
Proportionate Response: Not every incident requires a full investigation. The framework encourages NHS organisations to use a range of response methods proportionate to the incident, from quick reviews to comprehensive investigations.
Improved Transparency: There's a stronger emphasis on involving patients and families throughout the investigation process, not just informing them of the outcome.
Clearer Timelines: The framework sets out expected timeframes for investigations, helping to manage expectations and ensure timely completion.
Systems Thinking: PSII investigations look at the wider system factors that contributed to an incident—staffing levels, communication processes, equipment issues, training gaps—not just individual actions.
What Does a PSII Report Look Like?
PSII Reports are structured documents that set out the investigation's findings in a clear format. They typically include:
- A description of the incident and its impact
- The investigation methodology
- Timeline of events
- Analysis of contributory factors
- Findings and conclusions
- Recommendations for improvement
- Action plans
The reports are intended to be accessible to patients and families, not just healthcare professionals, though medical terminology may still be present where necessary.
Why PSII Reports Matter for Patients
For patients and families affected by a patient safety incident, PSII Reports can be invaluable for several reasons.
Understanding What Happened
When something goes wrong with healthcare, patients and families often struggle to piece together what happened and why. Medical records can be complex and incomplete. Staff recollections may differ. A PSII Report should provide a clear, chronological account of events that helps you understand the full picture.
Identifying Systemic Issues
PSII investigations look beyond individual errors to identify systemic failures that may have contributed to harm. These might include:
- Diagnostic Delays: Failures in systems for reviewing test results, referring patients, or escalating concerns
- Treatment Errors: Issues with protocols, equipment, or prescribing systems
- Communication Gaps: Breakdown in handovers between shifts, departments, or healthcare settings
- Staffing Problems: Inadequate staffing levels, skill mix issues, or lack of supervision
- Preventable Harm: Failures in risk assessment, monitoring, or safety systems
Understanding these systemic issues can be important, not just for your own case, but to ensure lessons are learned and future patients are protected.
Evidence for Potential Legal Claims
If you believe you or a loved one has suffered harm due to substandard care, a PSII Report can be crucial evidence. While the report is not written with litigation in mind, it provides a contemporaneous, independent investigation of what happened.
The findings in a PSII Report may:
- Confirm that the care fell below expected standards
- Identify specific failings or missed opportunities
- Reveal systemic issues that contributed to harm
- Provide expert opinion on what should have happened
- Support your understanding of causation—how the failings led to harm
However, it's important to understand that PSII Reports have limitations. They are written by the NHS organisation involved in your care, which may affect objectivity. They may not address all the questions relevant to a legal claim. And they don't make findings about legal liability or negligence.
For these reasons, if you're considering a clinical negligence claim, it's essential to have the PSII Report reviewed by independent solicitors who specialise in this area.
Your Rights During a PSII Process
As a patient or family member involved in a patient safety incident, you have important rights throughout the PSII investigation process.
Right to Be Informed
You should be told promptly when a patient safety incident has occurred that has triggered the duty of candour. This notification should come directly from the healthcare organisation, usually from a senior clinician or patient safety lead.
Right to Participate
You should be invited to participate in the investigation process. This might include:
- Providing your account of what happened
- Raising questions or concerns you'd like the investigation to address
- Reviewing draft findings before the report is finalised
- Commenting on the accuracy of the report
Your perspective as a patient or family member is valuable and should be taken seriously throughout the process.
Right to Receive the PSII Report
Once the investigation is complete, you have the right to receive a copy of the final PSII Report. The organisation should provide this to you and offer to discuss the findings with you.
Right to Challenge Findings
If you believe the PSII Report is inaccurate, incomplete, or fails to address important issues, you have the right to raise these concerns. You can:
- Request clarification or additional information
- Ask for specific issues to be reinvestigated
- Escalate concerns to senior management or the trust board
- Make a formal complaint through NHS complaints procedures
- Contact the Parliamentary and Health Service Ombudsman if you remain dissatisfied
Right to Seek Legal Advice
You have the right to seek independent legal advice at any stage of the PSII process. You don't need to wait until the investigation is complete. In fact, seeking early advice can help ensure:
- Your rights are protected throughout the process
- Important evidence is preserved
- You understand what the findings mean for you
- You meet any legal time limits for bringing a claim
Healthcare organisations cannot prevent you from seeking legal advice, and doing so should not affect the duty of candour process or your ongoing care.
When to Seek Legal Advice
Not every patient safety incident amounts to clinical negligence, but there are situations where seeking legal advice is strongly recommended.
Signs That You May Have a Negligence Claim
Consider seeking legal advice if a PSII Report or your experience suggests:
Delayed Diagnosis or Treatment: The investigation reveals that a condition should have been diagnosed or treated earlier, and this delay caused additional harm.
Surgical Errors: The report identifies mistakes during surgery, wrong-site surgery, retained instruments, or complications that shouldn't have occurred.
Medication Errors: There were prescribing errors, wrong doses, drug interactions that weren't identified, or medication given to the wrong patient.
Failures in Monitoring or Escalation: Clinical observations were missed, deteriorating conditions weren't recognised, or concerns weren't escalated to senior staff appropriately.
Inadequate Staffing or Supervision: The investigation identifies that insufficient staff, inadequate skill mix, or lack of appropriate supervision contributed to harm.
Communication Failures: Crucial information wasn't shared between healthcare professionals, test results were lost or not acted upon, or discharge arrangements were inadequate.
Infection Control Failures: Preventable infections occurred due to lapses in hygiene, equipment sterilisation, or isolation procedures.
Birth Injuries: Incidents during pregnancy, labour, or delivery that resulted in harm to mother or baby.
Important Limitations to Remember
A PSII Report Is Not a Legal Investigation: PSII investigations are conducted by NHS organisations to promote learning and improvement. They are not designed to determine legal liability or negligence. An independent legal investigation may reach different conclusions.
Time Limits Apply: For adults, clinical negligence claims must generally be brought within three years of the incident or the date you became aware (or should reasonably have become aware) that you had grounds for a claim. For children, different rules apply. Early legal advice helps ensure you don't miss important deadlines.
The Duty of Candour Doesn't Replace Legal Rights: While the duty of candour process is valuable, it doesn't compensate you for losses or provide the comprehensive investigation needed for a legal claim. You're entitled to pursue both routes.
Evidence Can Be Lost: The sooner you seek legal advice, the easier it is to preserve crucial evidence, interview witnesses while memories are fresh, and ensure a thorough investigation.
How Duncan Lewis Solicitors Can Help
At Duncan Lewis Solicitors, we have extensive experience in clinical negligence and patient safety cases. Our specialist team understands the complexities of PSII Reports and how they relate to potential legal claims.
Our solicitors have the medical knowledge and legal expertise to understand technical content and identify the issues that matter for your case.
Conclusion
The introduction of Patient Safety Incident Investigation Reports represents an important step forward in NHS accountability and transparency. The duty of candour, when properly followed, ensures that patients and families receive honest explanations, genuine apologies, and meaningful involvement when things go wrong.
However, these processes, valuable as they are, don't replace your legal rights. If you or a loved one has been harmed by substandard care, you deserve not only an explanation and an apology but also appropriate compensation and the assurance that systemic changes will prevent similar incidents in the future.
PSII Reports can be complex documents, and understanding their implications for your situation requires specialist expertise. Whether you've received a PSII Report, believe the duty of candour hasn't been properly followed, or simply have concerns about care you or a family member received, we're here to help.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
