The ongoing impact of clinical harm: compounded harm to families
All too often in our casework, we see families who have already experienced the devastating consequences of avoidable harm suffer further distress because of the response they get from healthcare organisations.
This additional harm that people experience when interactions following patient safety incidents feel closed and defensive is known as ‘compounded harm’. Researchers have recognised the impact of compounded harm, ‘especially when people feel unheard or invalidated’ in the report 'Humanizing harm'.
Although the idea of compounded harm is not new, it is often neglected in the process of understanding the impact of avoidable serious harm. In this section, we look at evidence of compounded harm in our casework. We highlight the experiences of families who brought cases to us, as they described it during our interviews with them.
When we looked at our casework, we identified the following scenarios that are likely to contribute to compounded harm:
- failure to be honest when things go wrong
- a lack of support to navigate systems in the aftermath of an incident
- poor-quality investigations
- failure to respond to complaints in a timely and compassionate way
- inadequate apologies
- unsatisfactory learning responses.
A failure to be open and honest when things go wrong
The duty of candour requires organisations to be open and honest with patients as soon as possible after they realise something has gone wrong. But we know from our casework that this duty is not always met. In one example, we found the Trust did not disclose the contradictory opinions it had received from different reviewers when determining whether a delay to an operation had resulted in avoidable harm.
We judged that this review should have triggered action under the duty of candour, but there was no evidence the Trust had considered its responsibilities to inform the family.
In a case where a baby died after antibiotics were not given quickly enough, we found the Trust had not properly equipped its staff to acknowledge what had gone wrong. Important details about the sequence of events and the nature of the infection were not given to the parents until seven weeks after their son died. Staff even discussed deleting a recording made during a meeting when the parents temporarily stepped out of the room, because they realised what they had said might get the Trust into difficulty.
This complete failure of transparency created understandable mistrust and worsened the pain and distress of the family in their grief.
Duty of candour
The underlying principle of the duty of candour is that when something goes wrong in the provision of health and care services, patients and families have a right to receive a meaningful apology and explanations for what happened as soon as possible.
The statutory duty of candour was introduced in 2014 in regulations to the Health and Social Care Act 2008.
Regulation 20 puts a legal duty on health and social care to be open and transparent with people using services and their families. It sets out actions that providers must take when a ‘notifiable safety incident’ happens. Notifiable safety incidents:
- are unintended or unexpected
- happen during the provision of an activity the CQC regulates
- are incidents that – in the reasonable opinion of a healthcare professional – could, or already appear to have, resulted in death or severe or moderate harm to the person receiving care.
As soon as a notifiable safety incident has been identified, organisations must act promptly and are expected to:
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tell the relevant person, face-to-face, that a notifiable safety incident has taken place
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say sorry
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provide a true account of what happened, explaining what is known at that point
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explain what further enquiries or investigations will take place
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follow up by providing this information and the apology in writing, and giving an update on any enquiries
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keep a secure written record of all meetings and communications with the relevant person.
The CQC regulates compliance with the statutory duty of candour. Organisations must have clear policies and procedures in place and make sure staff understand their responsibilities. The CQC also expects senior managers to show they have a safe culture where staff feel able to speak up and are supported to carry out the duty of candour.
Failure to comply with the duty can result in enforcement activity ranging from warning or requirement notices to criminal prosecution.
Lack of support to navigate systems in the aftermath of an incident
All our interviewees spoke about the difficulties they had in knowing how to raise concerns about what happened to their family member. A lack of information was a common experience. One complainant explained: ‘we didn’t get any information in regards to letting them [the Trust] know about our experience, how we felt about my mum’s care; all of that was sorted by me and I didn’t get any family support either. I literally did it all by myself’.
Another commented:
‘Nobody gave me any information at all. I went online and googled what to do and that was it. Nobody gave me any advice on how to complain, on what to say, or anything like that.’
We also heard some concerns about a lack of independent advice, if it came from the same organisation where the incident took place:
‘I feel like it was a very distressing situation, there was no sort of advice around the complaint. I first complained to PALS which work in the hospital. I don’t actually think that this is a good way for patients to complain about the hospital because the people they complain to work within the hospital.’
Where complainants were able to access independent advocacy services, this was a positive experience:
‘I did find an organisation that supported me called POhWER, they were really helpful. I was really upset and distressed and the first lady was very patient with me, very kind, very helpful, she told me the steps to complain. Then that lady left and they gave me another advocate and she was also really helpful … she read every single page with me, and she literally held my hand all the way through the process. So the advocates were helpful, but in regards to the hospital, there was no help from them.’
Local authorities have a statutory duty to fund independent NHS complaints advocacy. This type of advocacy is provided by trained, professional advocates who can give information, signposting and support with the complaints process. Professional advocacy can be a source of valuable information and guidance, and a way of supporting complainants through what can be a long and difficult process, although emotional or psychological support is not part of the role of professional NHS complaints advocates.
As we highlighted in ‘Making Complaints Count’, NHS complaints advocacy services are limited to helping people navigate the NHS complaints process. Complaints advocacy providers cannot give advice on the clinical parts of a complaint or other processes a complainant might be involved in or considering, such as coroner inquests or making a claim.
The benefit of access to advocacy is something the Harmed Patients Alliance recognised in a recent report. It said: ‘well-advised and supported people are more likely to take an active part in investigations without suffering compounded harm’, as well as being better able to take part ‘in a meaningful way in a patient safety investigation under the Patient Safety Incident Response Framework (PSIRF)’.
Poor-quality investigations
Organisations should provide clear, evidence-based explanations in response to concerns, provide reasons for their decisions, and consider the impact of any failings. We routinely see Trusts fail to accept errors or the extent of what has happened and its impact. In most cases where we found a death was avoidable, the Trust had not conducted a serious incident investigation. And there were no instances of Trusts themselves reaching the same conclusion as our investigation that errors in care led to the death of the patient. Because we use evidence that organisations would have had access to, it is reasonable to expect those organisations should also have been able to identify these errors.
In one case, after delaying its response by a whole year, the Trust responded to a complainant about her mother’s death by summarising what was said in a local resolution meeting (a meeting between the Trust and the complainant). We saw no evidence that the Trust conducted a full investigation into the complainant’s concerns or attempted to address them in any detail. In another case, there were contradictions in the Trust’s written responses and inaccuracies in its account of the care and treatment provided to the complainant’s wife, who had died of a brain tumour. The Trust provided two responses a year apart. The first response accepted there was a delay in identifying that the tumour was growing, while the second response explained events differently.
Some investigations are not as thorough as they should be and crucial parts are missed out. For example, a case in which a senior house officer failed to attend when bleeped was a significant moment in understanding failures in care and treatment. But the senior house officer was not interviewed as part of the serious incident investigation that followed. Nursing staff were asked to give statements, but the senior house officer was not. This meant the Trust was unable to explain why there was a delay in responding to the bleep and missed an opportunity to understand the context of the failing. This added to the distress felt by the patient’s partner, who was left with no answers to this important part of the incident.
In some instances, we found the Trust identified the clinical failings correctly but the local investigation failed to consider the impact of them. In one case, the Trust carried out an investigation and correctly identified the clinical failings that led to a mother’s death from sepsis. It made an action plan for improving process, which showed it aimed to learn from the incident, but it did not consider the impact of the failings, which was that the patient’s death would not have happened if they had received the right treatment at the right time. In another case, the Trust initially refused to accept that it should have identified clear abnormalities on an X-ray and did not believe this represented a missed diagnosis.
Trusts can sometimes use comorbidities (when someone has more than one, often chronic or long-term, disease or condition at the same time) to minimise the impact of any failings or omissions. For example, in a case where there was a significant delay in giving antibiotics, the Trust said the patient’s history of cardiac problems and low blood pressure would have limited the patient’s response to sepsis. But our critical care advisor said this was not supported by the information available. Examples like these suggest an ingrained defensiveness and lack of curiosity about the causes of harm, which is sadly still prevalent in some Trusts.
Case study: failure to make the right diagnosis and poor-quality investigation
A patient with a long-standing autoimmune disease went to a Trust’s emergency department with symptoms including dizziness, poor balance and blurred The Trust kept the patient overnight for further investigations.
A doctor carried out a brief initial assessment of the patient and noted they looked unwell and Later in the evening, a nurse took blood samples for testing and examined the patient using a MEWS score (Modified Early Warning Score, an early warning system based on clinical observations). This was recorded as 1.
The Trust transferred the patient to the acute medical unit to wait for a full medical assessment.
Later in the night, a doctor assessed the patient and noted nystagmus (involuntary flickering eye movements) in addition to earlier symptoms including blurring of vision and dizziness.
The doctor made a working initial diagnosis of The doctor started a care plan to continue with IV fluids, to monitor IV fluids in and urine out, and to refer the patient to the ophthalmic team if the visual changes did not improve with rehydration.
Afterwards, the nursing team noted further heart rate increase and that the patient had not passed urine since they went to the acute medical The Trust recorded a MEWS score of 4-1 for the increased heart rate and 3 for the lack of urine output.
The patient told the doctor who attended for review that they were unable to pass The patient was catheterised for urine drainage, which eased their discomfort.
The following morning, a family member reported a rapid change in the patient’s condition. They were concerned about the patient becoming drowsy and unable to speak. This prompted the immediate escalation of their treatment.
Tests and scans were ordered to try to identify the underlying cause of the Shortly after, the patient’s condition suddenly got worse and they eventually lost consciousness.
The CT head scan results showed signs of hydrocephalus (fluid pressure in the brain caused by a blockage stopping fluid from draining out of the skull) and a bleed on the The patient was immediately transferred to the nearest Regional Neurosurgical Department for surgery to relieve the pressure and stop the bleed.
Despite having two operations to try saving their life, sadly the patient never regained consciousness and died a few days later.
The surgeon’s notes show they found a growth in the brain during surgery, which caused the hydrocephalus and eventually had also been the source of a bleed on the brain.
We found several failings in the care the Trust gave the patient.
We found a failing to complete a full neurological assessment and order a CT head scan in response to signs of nystagmus noted by the doctor at the acute medical Although the nystagmus was identified correctly, the doctor missed the significance.
This led to a missed opportunity to diagnose and treat the patient’s condition and potentially avoid their death.
We found there was failure to make sure the MEWS score was monitored hourly following the MEWS score of 4 being recorded.
We also found that the Trust’s complaint investigation failed to identify and address these issues, which added to the distress and grief suffered by the patient’s
The Patient Safety Incident Response Framework
The Patient Safety Incident Response Framework (PSIRF) is being rolled out across the NHS, with a deadline for implementation of autumn 2023. While this is too recent to be relevant to the cases in this report, it represents the future for the approach to patient safety in the NHS.
What the PSIRF is changing
The PSIRF replaces the Serious Incident Framework. Unlike the Serious Incident Framework, it is not an investigation framework that prescribes what to investigate (although there are still circumstances where a patient safety investigation will be mandatory: incidents meeting the ‘learning from deaths’ criteria; Never Events – safety events that are ‘wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers’; deaths of patients detailed under the Mental Health Act (1983) or where the Mental Capacity Act (2005) applies).
Instead, the PSIRF promotes a range of system-based approaches for learning from patient safety incidents. This includes alternatives to an investigation such as a multidisciplinary team review and a ‘swarm huddle’ – when staff gather to quickly analyse what happened immediately after an incident and decide how to reduce future risks.
The PSIRF is intended to be more flexible, allowing organisations to tailor their response to patient safety so that it is relevant for their contexts and the populations they serve. This flexibility will allow organisations to focus resources on where they can really make an impact, rather than having to always conduct an investigation where that might not lead to new learning or create change. The framework represents a move away from root cause analysis and towards approaches that look at the wider system and human factors.
Under the framework, NHS organisations need to develop a plan and a policy outlining how they will respond to patient safety incidents. There is a focus on compassionate engagement with patients and families, with specific guidance on how to do this well.
In terms of oversight, the framework requires a PSIRF executive lead on each NHS Board, as well as an integrated care board lead who will work with providers on their responses to patient safety. The suggestion is that oversight focuses more on collaborative working and collecting qualitative data, rather than requiring lots of quantitative measures. As stated in the guidance, it ‘focuses on engagement and empowerment rather than the more traditional command and control’.
Who the PSIRF applies to
The PSIRF is a contractual requirement under the NHS Standard Contract so it will be mandatory for acute, ambulance, mental health and community healthcare providers. This includes maternity and all specialised services. Primary care providers (for example, GPs) may adopt the PSIRF but are not required to at this stage.
Failure to respond to complaints in a timely and compassionate way
As we are the final stage for unresolved complaints in the NHS, we usually expect people to complain to the organisation they are unhappy with first. This gives the organisation the chance to look into the concerns and, where needed, put things right. We frequently see examples of unacceptable and unreasonable delays in responding to complaints, and failures to keep families informed and updated about the progress of their case. These delays and failings in communication often cause more distress and frustration for complainants and their families at a difficult time.
Case study: failings in care and poor complaint handling
A patient with bipolar disorder (a mental health condition that affects your moods) attended a hospital’s emergency department by ambulance, due to shortness of breath they had been experiencing for a few days.
Staff arranged a chest X-ray and diagnosed inflammation of the This inflammation caused impaired oxygen absorption which resulted in respiratory failure. This resulted in low oxygen levels causing the patient to be confused and agitated.
The patient was admitted to the intensive care unit and prescribed antibiotics and continuous positive airway pressure (CPAP, a type of breathing support).
A few days later, the patient could breathe without respiratory support and maintain oxygen levels. The consultants considered the patient to be medically stable and transferred them to a ward.
A couple of days later, the patient had a cardiac The doctors resuscitated the patient and transferred them back to the intensive care unit.
Staff carried out an electrical brain wave test, which showed irreversible brain A neurology assessment also confirmed that recovery was unlikely.
The consultant decided to withdraw critical care The patient died later that week. The cause of death was recorded as severe hypoxic brain injury (when the brain does not get enough oxygen) and cardio-respiratory arrest (loss of breathing and heart function).
We found that staff failed to observe the patient as frequently as they should If this had happened, they may have recognised the patient’s health deteriorating earlier and called for senior medical input before the cardiac arrest happened.
We also found the Trust failed to provide planned, focused, one-to-one care for the patient during their time on the If the Trust had provided one-to-one care, staff would have identified the patient’s cardiac arrest much sooner.
In one case, a man who complained about the death of his wife from a brain tumour had to wait two years for the Trust to conclude its investigation.
In interviews we conducted, complainants described the process of trying to resolve their complaint with Trusts as ‘long and torturous’, ‘a long, dragging sequence of events’ and ‘very lengthy and distressing’.
Often, Trusts will explain that the complaint department was understaffed or dealing with high staff turnover. We know from previous research that complaint handlers in the NHS may not be sufficiently empowered or trained to resolve a complaint.
Treating complainants with dignity and compassion is an essential part of resolving a complaint, but we found instances where organisations failed to do this. For example, in one of the complainant interviews, a mother whose son died of a pulmonary embolism told us:
‘At some point a doctor from the Trust phoned my [other] son to tell him that his brother would have died anyway and there was really no point in carrying on with this.’
The same complainant told us she felt the Trust ‘just weren’t interested. It was over, it was done with, and they didn’t want to know’.
In another interview, the complainant told us their first meeting with the Trust took place in the same ward where her mother had recently died.
The complainant said this was so insensitive to her and her family that ‘it felt cruel’. The same complainant told us she did not feel like the Trust was interested in what she had to say:
‘I didn’t think they were interested. I felt like my mum had passed away and so it wasn’t a concern for them. It was almost like, you know, she’s gone now and that was it.’
The NHS Complaint Standards
We are committed to supporting and improving frontline complaint handling. We developed the NHS Complaint Standards to support organisations to provide a quicker, simpler and more streamlined complaint handling service. The Standards apply to NHS organisations in England and independent healthcare providers that deliver NHS-funded care.
The Standards have a strong focus on:
- early resolution by empowered and well-trained people
- all staff, particularly senior staff, regularly reviewing what learning can be taken from complaints
- how all staff, particularly senior staff, should use this learning to improve services.
The Complaint Standards are based on ‘My Expectations’, which sets out what patients want to happen when they make a complaint about health or social care services.
The Standards and the guidance modules describe how staff can meet those expectations.
We worked with 11 pilot sites and over 70 ‘early adopters’ across the NHS in 2021-22 to help test how the Standards, supporting materials and training can support frontline complaint handling.
Feedback from the pilot has been overwhelmingly positive, with NHS staff telling us the support on offer will make a real, practical difference and promote consistency. Throughout 2023, we will be working to embed the Standards across the NHS.
Inadequate apologies
Guidance from NHS Resolution makes it clear that apologising is not an admission of fault or liability. The same guidance highlights that organisations must make meaningful apologies when things go wrong. It states that a meaningful apology ‘is vital for everyone involved in an incident, including the patient, their family, carers, and the staff that care for them’.
But we still see organisations that fail to give a genuine apology. Organisations may say sorry and accept that failings happened, but it is rarer that they offer a clear and unreserved apology that shows they have understood the impact of those failings on the patient. In ‘Making Complaints Count’, we identified how a culture of defensiveness can result in staff feeling like they are not allowed to say sorry. Advocates also told us they often see organisations send apology letters that say ‘I’m sorry if you felt that…’ rather than offering a sincere apology.
In one case, the apology letter repeated that the Trust had been asked to accept the failings we found, but it did not go on to do this. Instead, it referred to what the Ombudsman ‘felt’, which suggests a lack of acceptance of our findings and the learning they offer. The apology letter did not accept responsibility for what happened or even refer to the patient or the fact that they died.
In another case, we considered that the Trust’s apology letter did not accept that its failings led to avoidable serious harm. In its first apology letter to the complainant, the Trust only apologised for the complainant having ‘had cause to raise concerns’. It was clear the Trust did not accept responsibility and had not apologised for the impact of the failings. It was only after repeated contact with the Trust on the content of the apology letter that it gave the complainant an unreserved apology for the avoidable serious harm it caused to the patient.
One complainant told us that after our investigation they felt the ‘Trust finally had to accept that they had got it wrong’. But they also said:
‘I don’t think that they did it with a good grace. I think it was just a formula … They weren’t sorry that they’d done it, they were sorry they’d been caught.’
Unsatisfactory learning responses
Most complainants want assurances that something is being done to prevent the same mistakes from happening again. In our recent research on motivations for complaining, 93% of respondents said ‘ensuring that others don’t face the same issues in the future’ was either very important or important in their decision to complain. Similarly, in our interviews with complainants, they all said part of the reason why they complained was to make sure the same thing does not happen to other patients, families and carers.
Being able to show that learning has happened is vital if families are to feel their complaint has achieved its purpose. Responses that do not feel meaningful can leave families feeling badly let down and frustrated.
While we do see good examples of thorough action plans, we frequently see less robust responses. These are a missed opportunity for learning from avoidable serious harm and taking action to prevent it from happening again. In one case, we had to follow up multiple times to make sure we were satisfied with the proposed action plan. The Trust did not plan to audit its proposed new processes, so there would be no way of knowing if they were effective.
In one interview, the complainant told us:
‘I knew that all the things they said they were going to implement to change things, wouldn’t change the way the ward was operated and the way nurses behaved, or the way that the actual patients on the ward felt. It was all just more rules, and probably just more bits of paper for the nurses to fill in, but not translating to an effect on the ward.’
Another complainant told us:
‘I don’t believe they’ve learned one lesson.’
It is clear that, far from being a process that promotes learning and provides resolution and healing, the response to families following an incident frequently creates further harm and distress. This is completely unacceptable. Reducing compounded harm must be an urgent priority for everyone working to improve patient safety.