Procedure Guidance for Reporting of Serious Untoward Incidents

Published by the County of Durham Primary Care Trust

Introduction:

For more than two decades, the NHS has been aware of the importance of quality of care. However, the measures and steps that have been taken to create a better and safer care have not been sufficient. During the mid-1980s to the early parts of the new millennium, there have been a series of reported failures in the standards of medical care in NHS services. These failures hit the national headlines and included disastrous failings in screening services for breast and cervical cancers, excessive numbers of babies who died unnecessarily after being treated surgically for heart problems in the Bristol Royal Infirmary, and individual doctors who treated their patients inappropriately causing injury or damage. In many reports, the NHS has been criticised for having inappropriate methods to monitor quality, unreliable data, and no consensus about what comprised quality (Wright and Hill, 2003, p.2). On the other hand, many doctors and nurses believe that health service management has been over-emphasising on workload and financial targets at the expense of quality (Thoreya Swage, 2004).

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These factors mentioned above drove the quality of care to the top of the agenda and raised the challenge of providing the highest standards of quality of services to patients (Hallett and Thompson, 2001). As a result, the government published the White Paper, 'The New NHS: modern and dependable', issued in December 1997, which proposed a ten year modernisation strategy and a statutory duty of quality to be placed on all NHS organisations. Health Act and clinical governance arrangements were set out to ensure that this task was being met at a local level. Precisely, a quality framework was set out in the policy document 'A First Class Service: Quality in the New NHS'(DoH, 2007).

In this regard, it is necessary to determine the meaning and explain the basis of 'Clinical Governance' to be able to understand and critically evaluate the Clinical Governance report under discussion. Clinical Governance was defined by the Department of Health document (2008), as;

"The system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish."

(DoH, 2008)

In other words, it is the scheme in which NHS organisations regularly monitor and improve the quality of their services to make sure that they are safe (DoH, 2007). Furthermore, Clinical Governance is a framework which focuses on managerial, organisational, and clinical approaches and is supported by the twin themes: 'life-long learning' and 'professional self-regulations'. Thus, Clinical Governance intended to link the professional approaches of quality assessment and clinical audit with former managerial approaches of quality assurance and quality improvement (Buetow and Roland, 1999). Also, it placed a duty on all health care professionals and managers alike, to ensure that the quality of clinical service delivered to patients is 'satisfactory, consistent and responsive' (Thoreya Swage, 2004). Buetow and Roland believed that this gave clinicians the opportunity to lead a comprehensive strategy to improve the quality within provider organisations, even with an expectation of increased external accountability.

A key element of the NHS quality strategy was to initiate learning mechanisms, such as Continuing Professional Development (CPD), launching learning networks across the NHS institutions and setting up policies for adverse incident reporting (from the lecture notes, cited Halligan and Donaldson, 2001).

Background:

The concept of an untoward incident was used for a long time in the NHS and grew over the years. It is a loosely used term for which there is no standardised definition (DoH, 2000). However, it was defined in this policy as:

"An incident or near-miss occurring on health service premises or in relation to health services provided, resulting in sudden or unexpected death, serious injury or harm to patients, staff or the public, significant loss or damage to property or the environment, or otherwise likely to be significant public concern."

(County Durham, 2009)

In many references, a Serious Untoward Incident (SUI) has also been referred as a 'Patient Safety Incident' or an 'Adverse Event'. Thus, it is useful to know some of the main characteristics of SUIs:

A serious incident where a patient or patients were harmed or could have been harmed.

The event happened unexpectedly.

The event would probably give rise to a serious public concern or criticism of the service involved.

(DoH, 2000, pg. 50)

Serious incidents and failures of service may happen unpredictably considering the size and complexity of the NHS organisation. However, when failures occur, they can lead to devastating implications for patients and their families and can cause economic loss to the NHS (DoH, 2000, pg. 1). A decade ago, research-based estimates predicted that adverse events in which harm was caused to patients occurred in around 10% of admissions or at a rate in excess of 850,000 a year in NHS hospitals alone(DoH, 2000, pg. 1). It has been estimated that these incidents cost the service £2 billion a year in addition to hospital stays excluding any human or wider economic expenses (DoH, 2000, pg.1). In many cases, patient safety incidents have either involved systems failures, failure of the individual, or both.

Even though the NHS should have learned from these incidents, evidence suggested that it failed to do so. After the government raised its concerns over patient safety and set plans to promote a better quality of care in its 'White Paper', steps have been taken to enhance the way patient treatment is delivered.

Realistically, although mistakes can be minimised, they will never be entirely eliminated. Reporting, analysing and learning from such events as well as introducing change to avoid re-occurrence of similar events, has been indeed fundamental to minimising errors, and maintaining and improving quality of care in the NHS (Vincent, 2001).

Reporting and analysing of adverse incidents was a worthwhile exercise. However, Stanhope et al. (1999) believed that, at that time, not much was known about the effectiveness of the systems in detecting cases that may lead to complaints or claims, or about their exploit in enhancing the quality and safety of care provided. The situation in primary care was not much known, although it accounts for the majority of NHS patients contacts and can experience service failures causing serious harm to patients (DoH, 2000, pg.viii).

The NHS Litigation Authority (NHSLA) was established in 1995. It formed a Clinical Negligence Scheme for Trusts (CNST) to which all NHS trusts and PCTS currently belong (NHSLA, 2003a). The CNST requires from its members to establish a clinical incident reporting systems to comply with its risk management standards. Basic systems are mandatory in order to attain the most basic level required, however a comprehensive system would allow the organisation to reach the highest level (level 3) of CNST standards (NHSLA, 2003b). On the other hand, the introduction of Clinical Governance has granted NHS organisations a powerful imperative to focus on tackling adverse health care events and to develop local reporting systems (DoH, 2000). Furthermore, there has been an increasing awareness for the need to collect and analyse data from patient safety incidents to assist learning and to develop solutions. In November 2003, the National Patient Safety Agency (NPSA) managed a national reporting system on behalf of the NHS in England and Wales. This system is known as the National Reporting and Learning System (NRLS), which works on collecting incident data from acute hospitals. More than four million incident reports have been submitted over the past eight years (Hutchinson, et al., 2009) (NPSA, 2009a).

In fact, setting up regulating policies would provide a framework in which decisions can be made. Moreover, they provide consistency and continuity; which is particularly relevant when there are personnel changes (Connecting for Health). Vincent et al. (2000) argued that the use of a formal protocol ensures a systematic, comprehensive, and efficient investigation of incidents. In addition, it reduces the chance of simplistic explanations and routine assignment of blame.

Hislop (2008), defined a policy as; "a plan or course of action agreed by an organisation intended to influence and determine decisions, actions and other matters". Policies set the boundaries within which action will take place reflecting the philosophy of the department or organisation. Each policy must include:

a statement of purpose

a commitment to national policy

reference to other policies or guidelines

timescales; and

skill requirements of individuals

(Connecting for health, 2010)

For instance, this policy was developed to provide guidance, information and procedures with regards to incident reporting generally; and reporting, notifying and investigating SUIs particularly. It is intended to support and interface with the North East Strategic Health Authorities (SHA) SUI Policy and the National Reporting and Learning System (NRLS). The application of this policy would ensure that NHS County Durham complies with legislation, National, Regional and Strategic Health Authority and National Patient Safety Agency requirements.

(County Durham, 2009)

Policy Evaluation;

To evaluate the 'Clinical Governance' policy document, a look will be taken generally upon the content and structure, while focusing on the effectiveness of this policy in promoting incident reporting and minimising the occurrences of future SUIs. However, it is essential to bear in mind that some of the outcomes and benefits of applying this policy are not easily obtained. This is because the process, from incident identification towards preventing the re-occurrence of SUIs, goes through some more steps before any benefits could be perceived. Those steps are the components of the 'Incident Learning System' proposed by Cooke and Rohleder (2006). These components are: incident identification, reporting, investigation and analysis, making recommendations and finally learning and implementing corrective actions. Moreover, the learning outcomes are then shared with other organisations via networks. However, Cooke and Rohleder highlighted the importance of setting a safety management system in order for the incident learning system to operate effectively. Efficient management and application of this policy can ensure reaching the targets set by this policy.

The policy under discussion is concerned with incident reporting which is an important and essential part of the 'Incident Learning System' (refer to the policy pg. 27). Each trust provides either a handwritten form to record a SUI incident or a digital form using a database. Afterwards, this data is gathered, de-identified and submitted to the NLRS electronically from the local risk management systems. Alternatively, incidents can be directly reported through the Strategic Executive Information System (STEIS) which provides an open access to health care staff, reporting team and patients (NPSA, 2009a). This policy also adopted the NPSA tools and guidance templates for investigating, reporting and sharing untoward incidents. Nevertheless, the completed SUIs reports are then presented to the NHS County Durham Quality and Patient Safety Network to identify and exploit learning opportunities. This is performed through pathway re-design, service provisions and contract monitoring (refer to the policy pg. 6 and 14).

The identification and reporting of incidents is fundamental in order for the learning process to take effect. However, figures suggest that many incidents still go unreported, whereas other incidents were reported more often than others. In this case, a database inspection and investigation would not be reliable if not all of the incidents were to be reported (Stanhope et al., 1999).

Many resources have related the variations in reporting figures to staff unwilling to communicate incidents to other team members or to their managers most often relying on someone else to do the task. Lawton and Parker (2002) argued that healthcare professionals, particularly doctors, were reluctant to report adverse events to a superior unless the incident involved the violation of a protocol with a bad outcome. Furthermore, Stanhope et al. (2009) believed that many doctors tend to report incidents to their consultant or at a morbidity meeting rather than reporting to a risk manager, while in maternity unit health care professionals would rather rely on midwives. Barriers to incident reporting include lack of awareness about how and what to report, fear of culpability, time limitations, lack of feedback and a marked lack of value in the reporting process (Hutchinson, et al., 2009). In fact, Stanhope et al. (2009) had correlated the absence of a risk manager to the reduced numbers of incidents reported. However, Lawton and Parker (2002) believed that when best practice was defined in the form of a written protocol, digression from these were more likely to be reported, especially by nurses and midwives.

Additionally, Hutchinson et al. (2009) argued that technical factors, such as connecting the national system to the many different local systems and developing a consistent framework for categorising incidents, would also contribute to the challenge. Another challenge which many different sectors face is the task of both learning from and minimising the risk of so-called 'one-off 'events. It is of course true to say that no specific disaster or serious incident occurs twice: each is in some way unique. However it is quite possible for an event which is on another level of analysis very similar to occur elsewhere; even in a completely different sector (DoH, 2000).

At this point, it is rather important to drag the attention to the influence of the reporting figures on rating of hospital services, especially after the introduction of the 'Choose and Book' system in 2009. Hutchinson, et al. has suggested the use of high-reporting rates as a positive marker of a safer patient service, rather than indicators of a less safe culture. That means hospitals could benefit from using high-reporting rates as markers to indicate achievements in creating a safer healthcare environment. Therefore, this process will attract patients who are key elements for attracting commissioners (Hutchinson, et al., 2009).

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The next component in the 'Incident Learning System' is the investigation and analysis of the incident. However, this step can be initiated once all the information and facts have been obtained. Investigations using the Root Cause Analysis (RCA) can identify what, how, and why patient safety incidents have happened. In fact, Vincent, et al. (2000) assumed that the use of the analysis of incidents is an essential method to learn about and enhance patient safety in healthcare organisations.

Incident analysis tends to focus instantaneously on the surrounding events; particularly on the human acts or omissions immediately preceding the event itself (DoH, 2000, pg. viii). For instance, when an error in health care occurs unexpectedly, one or more individuals are held responsible to carry on the blame. In this respect, Vincent et al. (2000) suggested that the analyses of clinical incidents should focus more on the organisational aspects, yet less on the individuals. Van Beuzekom et al. (2010) argued that the person-centred analysis, where individuals are blamed, must be substituted by a system-centred approach, where organisational factors are considered as precursors for individual errors. The system-centred approach is designed to focus on the working conditions surrounding staff to prevent them from committing and tolerating errors. This is because the possibility of errors could increase with unfavourable conditions, like gaps in knowledge, experience, or ability (Van Beuzekom et al., 2010). Nevertheless, Beuzekom et al. believed that these conditions are hardly spotted in the working environment; which adds to the many other challenges of SUIs prevention in health care.

Furthermore, Vincent et al. (2000) drew an important distinction between specific contributory and general contributory factors. For instance, if a communication failure has contributed to a care management problem in an isolated occurrence, then it is considered as a specific contributory factor. Alternatively, if the problem was quite communal, then it is considered as a general contributory factor. General factors have clear implications for the safe and effective running of the unit or hospital. However, in order to record a general contributory factor, investigators might consider these questions:

Does the lack of knowledge shown on this occasion imply that this member of staff requires additional training?

Does this particular problem mean that the whole clinical protocol needs to be revised?

Is the high workload due to a temporary and unusual set of circumstances or is it a more general problem affecting patient safety?

(Vincent, et al., 2000)

Finally, learning from SUIs, implementing corrective actions and making recommendations are the rewarding achievements of SUI reporting and the last component of the 'Incident Learning System'. An efficient feedback from incident reporting systems is crucial in order to detect any failure in the health care delivered to patients. Moreover, providing a feedback is essential to close the 'Incident Learning System' circle and trigger the first component of the process, i.e. the reporting of SUIs. Benn et al. (2009) argued that the absence of feedback could be discouraging to the willingness of staff to report. On the other hand, they also highlighted that a lack of evident feedback or clear actions emerging from reporting and investigating incidents may fade future reporting. Feedbacks should be processed in a timely and effective manner to assure reporters that their reports are acted upon and not been neglected. In many occasions when lessons are identified, true 'active' learning does not take place because the anticipated changes are not being properly applied in practice (Benn et al., 2009).

The inspection of the above components revealed the importance of each element in enhancing Serious Untoward Incident reporting routine. An effective system would reduce the harmful impact of errors by anticipating their occurrence and detecting them at an early stage. Since SUIs rarely have a single, isolated cause, attempts to prevent or mitigate adverse events need to address not just single event chains, but systems as a whole. While details of some future failure can hardly ever be predicted, protective measured will limit the possibility of their occurrence or limit their risk effect (DoH, 2000, 26).

Now, having a look at different 'Serious Untoward Incident' policies published by the local PCTs, I have noticed a considerable variation in the content and complexity of these protocols. For instance, I struggle understanding the roles of staff and process of incident reporting in the policy published by the county of Durham, while the London SUI Policy was better organised specially that it contained tables and diagrams for illustration. However, the Manchester SUI policy included a procedure for investigating SUI and many guidance notes that were not found in the other two policies above. In addition, the Manchester policy was unique in pulling the attention to key related policies, like the 'whistle blowing policy', and some other key principles, like a 'fair blame' culture.

Moreover, one of the main differences found between policies, is the inclusion of the near-miss incidents in the SUI reporting criteria. The policy under discussion has defined a SUI as an "incident or a near-miss". However, near-misses where not included in the criteria for reporting to commissioners nor was mentioned under any section of the policy. The Department of Health (2000, pg.38) suggested including the reporting of near-misses in all SUI reporting policies. The reason is that near-miss incidents have a great potential to produce serious injuries, however they can be avoided in practice either because of some intervention or compensation or simply through good fortune. For this reason, there should be an immediate response to correct any unsafe conditions contributing to the incident even if it did not take place after all (DoH, 2000, pg.38).

On the other hand, NHS trusts have acquired different systems for reporting incidents. Some hospitals are still using the handwritten forms while others have replaced them with a digital form using different databases. At the time of publishing the policy under discussion, serious incidents had to be reported to the NPSA and through the Strategic Executive Information System (STEIS). Other Trusts have approved the use of databases provided by private suppliers rather than the one provided by the NPSA. For instance, 'Datix', patient safety software, is used for healthcare risk management applications including incident, adverse event and near-miss reporting; safety alerts; risk assessment; policy distribution; patients experience; and feedback. It has also gives an option to submit reports remotely using an iPad, iPhone, BlackBerry or smartphone. In fact, this software is showing superiority over the STEIS.

Recently, a national framework for serious incident reporting has been released by the NPSA to replace serious untoward incident's reporting system in the National Health Service. Although STEIS was supposed to be substituted by the National Serious Incident Management System (SIMS) in late 2010, the new system did not take actual effect yet (Patient Safety Direct Programme Team, 2010). The framework is willing to provide a consistent definition of a serious incident, clarify roles and responsibilities, draw together legal and regulatory requirements, provide information on timescales and signpost tools and resources that support good practice. Moreover, it provides support to guarantee the engagement with relevant investigation bodies and facilitate openness, trust and continuous learning to improve the service (Patient Safety Direct Programme Team, 2010).

In general, these policies have shown variations in structure and content, listing of information and in reporting systems. The dissimilarities between these policies would probably be mystifying to some health professionals, particularly to junior doctors who change their training location frequently within different counties. Moreover, the routine incident reporting systems in many hospitals are still poor at identifying patient safety incidents, particularly those resulting in harm (Sari et al., 2006). This requires the NHS to develop a modern, comprehensive and effective system to report, investigate and learn from failures. Although a new framework has been established, this system will need time to perceive its advantages and benefits.

Recommendations:

The Department of Health (2000) addressed four key areas for improving the whole process of Serious Untoward Incident Reporting, these are;

A unified and integrated mechanism for reporting and analysis;

a more open culture, where adverse incidents or service failures can be reported and discussed;

mechanisms for ensuring that lessons are identified and that the necessary changes are put into practice;

and a wider appreciation of the value of the system approach in preventing, analysing and learning from errors.

Vincent et al. (2000) argued that the effectiveness of the reporting policy is relatively associated with the willingness of staff to report incidents. Therefore, health care organisations should educate their staff about the importance of incident reporting and encourage them to admit errors without fear of blame or recrimination. Moreover, health care professionals are expected to be introduced and familiarised with the Serious Untoward Incident Reporting policy on the induction day, when joining a new trust. Vincent et al. (2000) assumed that although the basic ideas in the protocol can be grasped relatively quickly, the full method can take longer to be absorbed. For this reason, it will be helpful to assign specific members of staff in each department to provide continuous training for staff and ensure proper adherence to the policy. Moreover, roles must be clearly identified and duplication of duties and responsibilities should be avoided. For instance, reliability might be enhanced if the senior midwife on each shift holds the major accountability for identifying and reporting occurring incidents.

The NPSA (20011) suggests that incidents should be reported and submitted to the NRLS quickly and on a monthly basis while ensuring quality reporting. Nevertheless, trusts who report regularly are believed to propose a stronger organisational culture of safety (NPSA, 20011). Moreover, it is recommended that chief executives share their organisation's report with the Board, risk and integrated governance team, and clinical staff in order to stimulate reporting within organisations and validate the importance of reporting (NPSA, 20011). On the other hand, improving feedback in the form of newsletters and information dissemination at monthly departmental meetings has been found to increase reporting rates (Ben et al., 2009).

On the other hand, it could be suggested to add to the nursing notes an entry or tick box where health care professionals are required to document any SUI or adverse reaction that occurred during the patient's treatment journey. Sari et al. (2006) Suggested using structured case note reviews to investigate the routine incident reporting and associated quality improvement programmes. It ensures that related investigation has taken place and that incident and interim report forms are completed and submitted to relevant parties (Sari et al., 2006).

Managers should ensure a proficient leadership at all levels and strong internal and external communication skills and detect any deficiencies in training, whereas staff should learn about the aims of clinical risk management (Clements, 1995). Nevertheless, communication should take written and verbal means, both between staff and between staff and patients.

Moreover, it has been suggested that in order for a SUI reporting system to be more effective, it should contain some important characteristics, such as, the ability to collect information on "near misses"; providing a rapid, useful, accessible and comprehensible feedback to the reporting community; the ease of making a report; and the potential for confidential or de-identified reporting.

(DoH, 2000, pg.45)

Moreover, there should be a standardised reporting system within the NHS to overcome the variances in practice methods, policy contents and SUI reporting forms and databases. Nevertheless, the NRLS has updated its system to a standardised and integrated national framework. This is to replace the other systems on a national scale and encourage using the STEIS online database. Although the policy under discussion is already using the STEIS reporting system provided by the NRLS, they should be aware of the new updates and changes to the system.

Nevertheless, the focus should be on the organisational learning, with the aim to encourage participation in the overall process and support staff. However, it has been recommended to consider an alternative means of organisational learning that relies on the early identification and prevention of system failures, while ensuring a fast, fair and effective resolution of problems when they do occur (Lawton and Parker, 2002) (DoH, 2000, pg. 3).

Conclusion:

The purpose of this essay was to critically evaluate the document 'Policy and Procedure Guidance for Reporting and Management of Serious Untoward Incidents (SUIs)' published by the County of Durham. This policy contains protocols that aim to guide staff in the process of reporting, managing and investigating SUIs. The SUI reporting system is designed to alert the Department of Health and the Strategic Health Authorities of any incident taking place requiring an urgent attention to protect patients, NHS resources and the organisation's reputation. Nevertheless, it is rather important to point out that the purpose of this policy is not to apportion blame to any individual, but rather to identify problems and find solutions to ensure clinical excellence.

The adherence to this policy is essential to enhance clinical practice and achieve the targets set by Clinical Governance. However, the evaluation of this policy was necessary to predict any possible issues that can affect the effectiveness of this policy or the adherence of staff to the reporting practice. In fact, the effectiveness of this policy is much related to the efficiency of each component in the 'Incident Learning System' proposed by Cooke and Rohleder (2006). Moreover, an organised structure and a clear content are essential in understanding the goals of SUI reporting, staff roles and routine procedures following an incident.

Nevertheless, the current SUI reporting system needs a fundamental re-thinking to improve the way that the NHS approaches the challenge of reporting, investigating, analysing and learning from adverse health care events. In this case it essential to identify areas of change and set out proposals to completely modernise and improve the system of SUI reporting. This is should be accompanied with a much greater emphasis on prevention, early recognition and fast, fair and effective resolution of problems when they do occur (DoH, 2000, pg. 3).

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