The government and the health service need to make this clear if future costly litigation is to be reduced.

In 2014 statutory regulation (Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20) saw the introduction of the duty of candour. The intention of this regulation was to ensure that healthcare providers would be more open and transparent in relation to the treatment and care they provided.

In fact the regulations set out some very specific requirements that healthcare providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, and providing truthful information as well as an apology.

The Care Quality Commission (CQC) was empowered to bring prosecutions for breaches of the regulations with or without warning and/or to take other regulatory action.

Another noteworthy but non statutory project was also launched in January 2015.

The Royal College of Obstetricians and Gynaecologists (RCOG) commenced work on a project with the specific aim of reducing the number of still-births, early neonatal deaths and brain injuries in the UK as a result of adverse incidents during full-term labour. The RCOG had identified that, of the some 500 babies a year that die or are left severely disabled because something went wrong in labour, not all of these deaths or injuries were unavoidable. They pledged to reduce the unnecessary suffering (caused to parents and families) and the loss of life by 50% by 2020.

From January 2015 all maternity units in the UK were expected to report cases/incidents as well as the results of their own internal incident investigations to the RCOG, with the collected data being analysed by the RCOG teams.

Then on 1st April 2016 a further new statutory direction came into existence (The National Health Service Trust Development Authority (Healthcare Safety Investigation Branch) Directions 2016) to provide for the establishment of a new organisation, the Healthcare Safety Investigation Branch (HSIB), with the remit to investigate incidents/accidents in medical and other healthcare settings and with a view to identification of:

  • Risks resulting in repeated, preventable or common occurrences of safety risks/harm to patients
  • Risks indicating a systemic problem with significant impact in more than one setting
  • Those involving new or novel forms of harm or new or novel risks of harm

On 3rd June 2016 an announcement was made that Keith Conradi (an air accident investigator) was to be appointed as the Chief Investigator of the HSIB which will begin its work in the autumn of this year with a budget of £3.6m and with a plan to investigate up to (only) 30 case reviews per year.

And so, are all of the above (and no doubt many other projects I haven’t mentioned) good news for patient safety? One would hope so but I for one am cynical. Why, you may well ask?

For starters the new HSIB will sit within NHS Improvement (a body already set up to oversee NHS Trusts), rather than being wholly independent. The HSIB is also apparently to model itself on the “no blame” approach taken when investigating air accidents and to offer a “safe space” for NHS staff, patients and their families, in which to raise awareness of serious risks to safe care and to allow hospitals to learn from their mistakes. These are all very laudable intentions, but can and should a “safe space” be encouraged for NHS staff? Yes, if that “safe space” is being offered to protect and reassure whistleblowers and other concerned NHS staff who might otherwise be in fear of being ostracised or losing their jobs, but not if this in any way puts secrecy above the guarantee of openness and honesty to which patients and other victims of medical incidents and accidents should be entitled. Furthermore, just how much can HSIB achieve with its limited budget and remit and how does this “safe space” fit alongside the statutory duty of candour? Are the two not incompatible? Only time will tell.

But what of the RCOG project. How does this fare a year on from the start? Well the RCOG has just published its preliminary report RCOG: Each Baby Counts: key messages from 2015. London RCOG, 2016, looking at how problems during labour are investigated. It’s worth noting that this report comes more than a year after the duty of candour was introduced. 921 eligible baby cases have been referred to the project in total and of the 204 cases involving an internal hospital investigation 27% have been reported as being of poor quality and “did not contain sufficient information to allow the care to be classified”.

The RCOG also found that out of 800,000 births after at least 37 weeks of pregnancy, in the UK in 2015, and of the 921 reported to them, that there were:

  • 655 babies classified as having severe brain injuries (higher than the original RCOG estimate of 500)
  • 147 neonatal deaths (within 7 days of birth)
  • 119 Stillbirths

Furthermore, the RCOG review also considered the number of cases where the parents of the baby had been involved in the hospital’s own investigation. In a quarter of instances (25%), parents were not even made aware that a local review was taking place. Just under half the time (47%), parents were made aware that the review was happening and informed of the outcome but were not invited to contribute and in just over a quarter of local reviews (28%), the parents were invited to contribute evidence if they wished to. Where was the operation of the duty of candour in a large proportion of these cases?

When patient safety incidents and accidents occur there is not only a huge personal and emotional cost for the families concerned but also a potentially huge cost to the NHS in terms of litigation and compensation pay-outs. That cost, particularly in relation to birth injury cases, is enormous.

Undoubtedly there are a large number of interested stakeholders in the general debate as to how patient safety can be improved and litigation costs reduced. This inevitably leads to conflicting views and approaches. Let us hope that the setting up of yet another statutory body in HSIB will lead to the production of open reports and findings from which the healthcare sector can improve and patients can be better protected.