Many of the cases that clinical negligence practitioners work on have resulted in a “Serious Incident Investigation” by the hospital; but what is a “Serious Incident” and its investigation?
In March 2015, NHS England published a document entitled “Serious Incident Framework”, a policy document aimed at Clinical Commissioning Group Leaders, NHS Foundation Trust, and Care Chief Executives, and Medical and Nursing Directors. The framework is said to explain “the responsibilities and actions for dealing with Serious Incidents and the tools available, and outlines the process and procedures to ensure that Serious Incidents are identified correctly, investigated thoroughly and, most importantly, learned from to prevent the likelihood of similar incidents happening again”, and is revised framework from the one published in March 2013.
More recently, in March 2016, NHS England also published the “Serious Incident Framework - frequently asked questions” document, with this being a guidance document aimed at the same target audience. This document is described as “additional guidance to support implementation of the Serious Incident Framework”.
The Framework is a long, complex document, so the FAQs are a helpful short form of guidance to the Serious Incident Investigation (SII) process. There are 27 answered questions and they make for interesting reading.
The answers confirm that Serious Incidents (Sis) are not just those which result in harm (Q1&10) but include incidents which present risks to an organisation’s ability to deliver safe healthcare (Q1). The response to a SI should follow consistent and clearly defined principles and procedures, with a significant management focus and formal governance arrangements around reporting, investigation, learning, action planning, implementation, and closure.
It is emphasised (Q2) that the SII is to be “used for the purpose of learning and not to apportion blame” but that where there is evidence to suggest an individual has caused intended harm, is unfit to carry out their duties, or has acted in a grossly negligent manner, appropriate referral should be made and separately progressed. It confirms that the NHS Litigation Authority (NHS LA) agrees that organisations must investigate and identify the root cause(s) to prevent recurrence, but such identification will not necessarily result in civil liability.
It is notable that there is no definition of a SI per se, but the Framework does include a list of the types of incident that are to be included, including “unexpected or avoidable injury … that has resulted in harm”. The answers (Q5) confirm that this was deliberate to avoid expected or inevitable harm cases from requiring investigation. However, the answers specifically confirm that 12-hour waits for admission are not automatically an SI, nor are pressure ulcers (Q7&8). However, ‘Never Events’ (an event which should never occur) are automatically considered to be SIs (Q9).
Q15 confirms that all SI data is captured by the Strategic Executive Information System and reported to the National Reporting and Learning System (NRLS), in which actual harm caused is also reported. The NRLS enables the monitoring of adverse events in patients.
The scale and scope of the SI investigation must be proportionate to the incident (Q16). In the NHS, Root Cause Analysis is the standard system used, with two templates (i) concise (level 1), for less complex SI investigated at a local level and (ii) comprehensive (level 2), for complex issues investigated by a multidisciplinary team involving experts and/or specialist investigators. Level 3 investigations are not explained in the FAQs, but the Framework sets out an explanation that these are investigations in which the investigator and all members of the investigation team must be independent of the provider.
Q19 explains that a “good quality” investigation allows organisations to identify the what, how and why, and to develop effective solutions to prevent recurrence:
(a) ‘The What?’ is the problem(s) that contributed towards an SI, including lapses in care, acts or omissions;
(b) ‘The How?’ are the contributory factors leading to the problems, including environmental and human factors; and
(c) ‘The Why?’ is the root cause that needs to be addressed.
The lead investigator of a SII is required to be appropriately trained and educated with respect to such investigations (Q20) and any SII report should be completed within 60 days (Q23) (except for level 3 SIIs, which is 6 months).
SII reports are seen quite frequently in cases of clinical negligence and often provide valuable information; therefore, it is worth from a practitioners’ perspective being broadly familiar with both the Framework and its FAQs, not least so as to be able to identify whether such an investigation has been carried out in accordance with policy.