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April 2008
Statistics suggest that 10% of all in patients in NHS hospitals suffer some type of significant adverse event i.e an event where the health and safety of the patient is affected.
A clinical incident is defined as any incident directly related to patient treatment or care which did or could have resulted in an adverse outcome eg treatment or medical equipment failure etc. Examples would be the wrong size drill being used in orthopaedic surgery or the wrong size of prosthesis being used in knee replacement surgery or failure to diagnose an ectopic pregnancy.
Usually, clinical incidents will be recognised at the time of happening but in addition, a pattern of failure for example may be identified through other routes such as a clinical audit.
Following the realisation that the current rates of adverse events and hospital error rates are associated with high financial and human costs a decision was taken to improve and standardise risk assessment in hospitals.
Under reporting was one issue to be addressed as the definition of what constituted an adverse incident varied from region to region meaning that a lot of hospitals avoided reporting incidents at all.
National risk management standards were first developed as long ago as 1995 and most NHS hospitals in England and Wales established reporting systems as part of their risk management programmes. New risk management standards have now been published by the National Health Service Litigation Authority (NHSLA) in 2007. They cover various areas of healthcare and have been specifically developed to reflect issues which arise in the negligence claims made against NHS Bodies. There are currently 5 sets of standards reflecting the different organisational clinical and non clinical risks faced by different kinds of healthcare organisations.
There is now a single set of risk management standards for each type of NHS healthcare organisation:
• Acute
• Ambulance
• Mental Health & Learning Disability
• Primary Care Trusts (PCTs)
• Maternity
Those for Acute and Specialist Hospital Trusts were rolled out with a pilot scheme during 2006/2007 with formal assessments beginning in April 2007. Revised standards for Mental Health and PCTs will have formal assessments in April 2008.
The aim is to reduce the number of negligent or preventable incidents by means of an upgraded and reviewed extensive risk management programme with a single set of risk management standards .
Relevant medical staff are to be trained in risk management in 5 key steps:-
• Risk awareness
• Risk identification
• Risk assessment
• Risk control
• Risk review
Training will include incident reporting and root cause analysis and encouraging an open approach with patients when things have gone wrong.
The new risk management standards aim to tackle various historic problems with hospital risk management such as under reporting. Retrospective case note review historically suggests that up to 95% of adverse events are not reported and that very few near misses are reported. Near misses are equally important in terms of teaching and learning exercises. The barriers to incident reporting have been shown to be fear of reprisals, concerns about litigation, concerns over anonymity, the ergonomics of incident reporting forms, confusion over what constitutes an adverse event, little immediate effect on improving quality of patient care and if nothing untoward happens as a result of an incident the conclusion was that there is no need to report, the lack of support from colleagues and the lack of feedback.
It is well recognised that nurses report most adverse events and that is partly because the incident reporting is part of nursing training and partly because they have more patient contact than any other professional group.
The standards now published and the associated assessment process is designed to provide a structured framework in order to deliver quality improvements in patient care and to encourage and support organisations in taking a proactive approach to improvement to reduce the level of claims by reducing the number of incidents or the likelihood of recurrence and assist in the management of adverse incidents and claims.
The standards now set out by the NHSLA require the hospital to have approved documentation which describes the process for managing the risks associated with the reporting of all internally and externally reportable incidents.
Until recently hospitals used to say to claimant solicitors in almost all cases that they had no such documentation.
The NHSLA has also issued separate clinical standards for maternity services. Starting in 2007/08 these standards will be revised with formal assessments against the new standards due to begin in April 2009. The maternity standards will continue to be clinical only.
In those standards, topics such as placental abruption, the management of ectopic pregnancy and shoulder dystocia are expected to be covered.
The policy documents make clear that wherever NICE (National Institute for Health and Clinical Excellence) has published specific guidelines it is expected that these will inform the local guidelines and that each guideline should be referenced and clearly stated on the individual guidelines.
The aim is for Trusts to be assessed against standards at least once every two or three years .
Work is ongoing therefore to improve incident reporting feedback and in training medical professions in both risk assessment and management. Clearly investigation into what happened, why did it happen and what can be done to prevent or reduce the chances of it happening again will hopefully enhance patient care.
Usually the investigation into a clinical incident will include a multi disciplinary team carrying out a root cause analysis involving the gathering of witness statements from personnel involved and securing the patient notes. Although it sounds obvious making sure notes are securely stored and retrievable is very important as significant problems in investigating sub standard patient care can be caused where the vital patient notes such as pregnancy scans and CTG traces have been lost.
As a patient, it is important to ensure that the complaints procedure is easily accessible when things go wrong. The new standards do make clear that information should be made available for members of the public as to how to complain and how that complaint will be handled. There is a commitment to develop a single comprehensive complaints procedure across health and social care by 2009.
As a lawyer, it is important to ensure that documents compiled in the adverse incident procedure are disclosed at the outset of the investigation into the case along with standard medical records. This documentation can be vital in establishing what actually happened and therefore what went wrong during the care of a patient.