Not harming patients has been a key principle of professional medical practice for centuries. The NHS does a great deal of good. In England it is estimated to have contact with about a million people every 36 hours without causing harm to the vast majority. Nevertheless, patient safety remains a concern. So do Coroners have a role to play in making patients safer?
A review of the conclusions of the Ministry of Justice in the first summary Report, following changes to Rule 43, would tend to suggest the changes have a positive role to play.
With effect from the 17 July 2008, the Coroners (Amendment) Rules 2008 amended Rule 43 of the Coroners’ Rules 1984. The amended rule provided that:
- Coroners have a wider remit to make reports to prevent future deaths.
- A person who received a Report sent by a Coroner must provide a written response within 56 days.
- Coroners must provide interested persons to the inquest and the Lord Chancellor with a copy of the Report and the response.
- The Lord Chancellor may publish the Report and response or a
summary of them.
The first Summary Report covers Reports received by the Lord Chancellor between 17 July 2008 and the 31 March 2009. It is planned that future bulletins will be published twice a year.
Between 17 July 2008 and 31 March 2009, Coroners in England and Wales issued Reports under the new Rule 43 in a total of 207 inquests. Unsurprisingly perhaps, Rule 43 Reports were most commonly issued in relation to hospital deaths and accounted for 28% of the Reports issued in this period (a total of 58 Reports). Of the 115 coronial jurisdictions in England and Wales, Reports were issued by 57. An analysis of to whom Rule 43 Reports have been sent demonstrates that the most common recipient was an NHS Trust, receiving a total of 78 Reports. By way of comparison, Ministers and central government departments received 19% of the Reports, while Local Authorities received a mere 14%.
149 responses to Rule 43 Reports have been received by the Lord Chancellor in respect of the 250 Reports issued within the timeframe. The summary Report names and shames those organisations who, despite having received a Report, have failed to respond within the 56 day deadline and have neither sent the Coroner an interim reply nor been granted an extension. Of those named and shamed, 50% are healthcare organisations.
“As this is the first summary bulletin, it is not possible to draw out many trends, but this is something that will be considered in future Reports. However, many mention the need for better communication and procedures within hospitals”. Greater detail can be found later in the Report concerning community healthcare and emergency services related deaths which have led to a Report and these include:
- Anaphylactic reaction to antibiotics.
- Communication breakdown between an out of hours GP service and an Ambulance Trust.
- Administration of intravenous Lignocaine, rather than Gelofusine.
- Failures in a discharge policy following bariatric surgery.
- The need for clearer guidelines and training to deal with the symptoms of diabetic ketoacidosis.
In order to see a Report and response in full, it is necessary to apply to the Lord Chancellor in writing stating reasons why the Report is likely to be “of interest or useful”. The plan is to supply a copy of the report, redacted as necessary, within 20 working days of receiving the request, or an explanation as to why it is not possible to release the Report (either at all or within this time frame).
So has this made patients safer? Speaking with NHS Trusts, the primary driver in avoiding a Rule 43 Recommendation has historically been the desire to avoid the heightened media interest that this may well create, which often leads to misleading reporting and inevitable damage to patient confidence in the local healthcare community. Before the changes to Rule 43, there was no obligation on an organisation to report changes introduced as a result of a Rule 43 recommendation. In reality, Rule 43 was toothless.
Does the new Rule 43 drive positive change in a way that the old
Rule 43 did not?
Again, probably. By way of example, the summary Report touches on a patient death following an anaphylactic reaction to antibiotics, which led to the Coroner writing to the Department of Health stressing the absence of a national allergy service. The Department of Health’s reply demonstrates that North West Strategic Health Authority have been asked to develop a pilot allergy centre to be evaluated and used as a model to be rolled out to other Strategic Health Authority regions.
The administration of an intravenous bag of 0.4% Lignocaine led to a coronial report to the National Patient Safety Agency (NPSA). In contrast, the response highlights that there is a disappointing lack of progress in respect of the industry’s readiness to adopt new design features to limit the possibility of intravenous infusion errors going forward. Perhaps this is why this error has been singled out in the Never Events Framework 2009/10 in relation to wrong route administration of chemotherapy.
Rightly, there is an increased focus on patient safety and a growing expectation that certain types of patient harm should no longer occur. The term, Never Event, was introduced by the National Quality Forum in the US in 2001 to refer to medical errors (such as wrong site surgery) that should never occur. Lord Darzi’s report “High Quality Care for All” has played an important part in highlighting Never Events within the UK. As a result, the National Patient Safety Agency has worked closely with the NHS to produce a framework for action on Never Events across the NHS in England. The framework was launched in March 2009. It contains eight core Never Events:
- Wrong site surgery.
- Retained instrument post operation.
- Wrong route administration of chemotherapy.
- Misplaced naso or orogastric tube not detected prior to use.
- Inpatient suicide using non-collapsible rails.
- Escape from within the secure perimeter of a medium or high security Mental Health Service Unit by patients who are transferred prisoners.
- In-hospital maternal death from postpartum haemorrhage after elective caesarean section.
- IV administration of mis-selected concentrated potassium chloride.
These Never Events have been chosen as they represent incidents which are avoidable if available preventative measures have been taken. The aim is that they will bring proactive change. In contrast, the principle obstacle to Rule 43 making patients safer is that it can only drive reactive change.
There are a great number of bodies who currently play a role the overall objective of making patients safer. It has been questioned whether there is sufficient clarity of role between the bodies concerned and, whether in the absence of clarity, there can be proper coordination of their respective efforts avoiding duplication and inefficient use of resources. This theme is developed in the House of Commons Health Commission Patient Safety Report released in July 2009. The government’s response includes the following paragraph:
“What all the complex panoply of organisations has actually achieved is called into question by the fact that these systems have been shown recently to have failed in several instances promptly to expose and address major instances of unsafe care. The case of Mid Staffordshire Trust has…exposed serious shortcomings in Monitor’s assessment process when granting authorisation. …there appears to be considerable potential confusion, and possibly conflict, regarding the respective roles of Monitor and the CQC”.
Whilst the response went on to acknowledge the important role that the NHS Litigation Authority has played in setting standards, the conclusion was that the role of indemnifying Trusts against litigation is quite distinct from the role of setting standards of safe care. The recommendation was that the current inspection process undertaken by the Litigation Authority should be subsumed within the work of the CQC. When historically patient safety has not achieved the same profile as other major issues, such as reducing waiting times, implementing national service frameworks and achieving financial balance, what is needed is a monumental shift of organisational culture. Much has, of course, been written about the need for healthcare organisations to create a positive safety culture. A shift to organisations which are open and where reporting and learning from errors is the norm, will produce the sort of proactive handling of patient safety issues that changes in Rule 43 can never achieve.