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More than a third of NHS investigations regarding allegations of avoidable harm or avoidable death were inadequate and failed to identify when something had gone wrong, according to a review carried out by the Parliamentary and Health Service Ombudsman.

The Parliamentary and Health Service Ombudsman reviewed 150 complaints it had already investigated including upheld and not upheld cases.2 It looked at the quality of NHS Trusts' investigations into complaints alleging avoidable harm as well as complaints about events where a Serious Untoward Incident (SUI) 4 had taken place.

The review focused on acute trusts and a series of questions were asked about the quality of the NHS investigation and the evidence relied on. Questions included: whether the original investigation had access to all the relevant clinical records, had obtained written statements, interviewed key staff, and obtained a clinical review and whether that was independent.

The Parliamentary and Health Service Ombudsman's main findings show:

• Over one-third of NHS investigations were not good enough to identify if something had gone wrong.
• 28 of the 150 cases should have been investigated by the NHS as a Serious Untoward Incident (SUI).
• Of those 28 cases, 71% had a complaint that did not trigger an SUI investigation.

Parliamentary and Health Service Ombudsman, Julie Mellor, said:

'We are the final tier of the complaints system and see a range of complaints including allegations of avoidable death and harm. We reviewed 150 of these complaints and found significant variation in the quality of NHS investigations. Investigations weren't carried out when they should have been and when they were carried out they did not find out or explain why failings happened.

'When people make a complaint that they have been seriously harmed they should expect it to be taken seriously and thoroughly investigated.

'The NHS must tackle the variation in the quality of its investigations but also needs to recognise when to initiate an investigation.

'When the NHS makes a mistake their duty is to investigate – these investigations shouldn't be about attributing blame but should find out what happened and why in order to prevent the same mistakes from happening again. Our evidence too often shows this is not the case.'

In one case the Parliamentary and Health Service Ombudsman investigated a 77-year-old man who was admitted to hospital because he felt very unwell. His condition deteriorated and died two days later as the result of sepsis (a severe infection). The man's daughter discussed her concerns about his care with hospital staff. The hospital's head of nursing investigated the complaint but there is no evidence they interviewed or obtained statements from clinical staff. Our investigation found despite the man's poor health the clinical staff who saw him during the initial period did not recognise the severity of his illness, which meant he was not seen by a doctor for more than two hours, observations of his condition were not taken frequently, and antibiotics were not started until four hours later. We were unable to conclude the man's death could have been avoided but considered the hospital missed an opportunity to give him the best chance of recovery by failing to give him more timely treatment. None of these findings were identified in the hospital's investigation and if they had this may have triggered a serious untoward incident investigation.

The Parliamentary and Health Service Ombudsman investigated a case about a woman's labour. The baby's shoulders and the rest of his body were delivered seven minutes after his head. The baby's parents wrote to the Trust because they thought shoulder dystocia7had occurred. The Trust told them shoulder dystocia had not occurred and did not acknowledge any failings in care. The couple were not satisfied and paid £250 for an independent clinical review. The Trust then accepted failings in the care provided by the midwives, that shoulder dystocia had occurred, and put an action plan in place for a consultant to review what happened. However, the action plan did not address the lack of detailed investigation or the faults in care. The couple feel very let down by the Trust and have been caused distress and anxiety in the way their concerns have been dealt with. They feel they were 'belittled' and misled.

In a further case investigated, a one-day-old baby suffered permanent brain damage because a nurse and two doctors made serious mistakes during a blood transfusion. The Parliamentary and Health Ombudsman Service's investigation established that the Trust's SUI investigation was fundamentally flawed and did not identify glaring errors in the conduct and recording of the transfusion and ignored obvious explanations for what happened. The nurse and doctor conducting the transfusion made serious mistakes. The doctor supervising the transfusion also made serious mistakes when Baby F's condition started to deteriorate. As a result, they took out far more blood than they put in. They should have kept an equal balance. These mistakes led to Baby F's collapse and the brain damage she had afterwards. Following the Ombudsman Service investigation, the Trust acknowledged the mistakes it made in Baby F's care and the consequences they had. It wrote to the complainant to accept its failures and apologise for them. The Trust also agreed to carry out a root cause analysis to find out why the failures in this case happened, and to take action to make sure they never happen again.

A further case investigated by the Parliamentary and Health Service Ombudsman, a father aged 36 died after Accident and Emergency doctors failed to diagnose a life-threatening condition. With the right surgery, he would have had an 80% chance of survival. Yet hospital staff told the man's bereaved family they could not explain what had happened, and said relatives would have to take legal action to secure any answers. NHS staff should have carried out a full investigation at the local level. Following the Ombudsman's investigation, the Trust apologised to Mr M's family and paid them £15,000. They put together an action plan to ensure that lessons were learnt from this case.

The Parliamentary and Health Service Ombudsman receives complaints about incidents where the public say they have suffered harm because of treatment provided by the NHS. It is the final tier of the complaints system and is separate and independent of the health system so it can hold individual providers and the health system to account. Its role is to investigate complaints from individuals about the NHS in England as well as government departments and agencies which have not been resolved at the local level. The Ombudsman Service does not investigate serious untoward medical incidents.

Julie Mellor is appearing before the Public Administration Select Committee (PASC) on Tuesday 10 February which is looking into the issue of NHS complaints and clinical failure.

The Committee is examining the effectiveness of investigating and addressing safety issues within the NHS and the possible benefits of a new clinical accident investigation body.

Notes for editors

1. For further information contact press officer Marina Soteriou on 0300 061 4996 or at marina.soteriou@ombudsman.org.uk or out of hours on 07825781289.
2. Of the 150 cases we closed in 2014, 88 were fully or partly upheld 61 were not upheld and one was discontinued. Out of the 150 cases we looked at concerning allegations of avoidable harm or death, 40% of the NHS' investigations were inadequate and didn't identify that serious avoidable harm had occurred.
3. We concluded 3,189 investigations about the NHS in 2014. Of these concluded NHS investigations, 333 included allegations of avoidable death. Of these 333, we identified 150 as part of this review, which we considered raised issues of serious avoidable harm or death. 10,000 severe harm or death incidents are reported into the National Reporting and Learning System per year in acute care settings. This equates to 200 incidents per week.
4. A Serious Untoward Incident (SUI)  is one that resulted in:
   • unexpected or avoidable death of one or more patients, staff, visitors or members of the public
   • serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm);
   • allegations of abuse;
   • one of the core set of 'never' events e.g. wrong site surgery, retained instrument post-operation, wrong route administration of chemotherapy
5. An NHS incident is any case of error which causes injury or harm to a patient and could have been avoided. Incidents should be identified through routine incident reporting, by staff and patients, through staff whistleblowing, inspection, audit peer review and complaints. The system should not rely on the incident being identified through the complaints process.
6. The Department of Health states where a serious incident is alleged in a complaint it must initially be treated in the same manner as a serious incident suggested through any other mechanism.
7. A delivery that requires additional obstetric manoeuvers to release the shoulders after gentle downward traction has failed.  Royal College of Obstetricians and Gynaecologists (2005)