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Patient safety
Improving patient safety and and quality
quality
What are the challenges and gaps in
introducing an integrated electronic adverse 107
incident and recording system within health
care industry?
Kerry Walsh and Jiju Antony
Caledonian Business School, Glasgow Caledonian University,
Glasgow, United Kingdom

Abstract
Purpose – The purpose of this paper is to present the challenges and gaps in using an electronic
adverse incident recording and reporting system from a commercial supplier to an acute health care
setting.
Design/methodology/approach – The paper used action diary, documentation and triangulation
to obtain an understanding of the challenges and gaps.
Findings – The paper provides health care with further understanding of the complexity, challenges
and gaps of using an electronic adverse incident recording system to improve patient safety.
Originality/value – This paper explains the important views of clinicians and managers in relation
to improving patient safety by using an electronic adverse incident management system.
Keywords Quality management, Patients, Safety measures, Quality costs
Paper type Conceptual paper

Introduction
The majority of care in the National Health Service is of a high clinical standard, the
envy of other health care systems across the world. Pollock (2004) argues that:
. . . for more than fifty years the United Kingdom has been the model for universal health care,
its system design copied throughout the world.
Incident reporting systems have only recently been introduced into health care as a
mechanism to improve patient safety. Johnson (2003) emphasises that many industries
such as aviation, chemical production, military, nuclear power and railways have used
incident reporting systems, which have been intended as a “means of preserving
safety”.
It is envisaged that an integrated electronic quality management reporting system
will be of a method of providing quality information on adverse incidents by
integrating claims and complaints activity into one holistic system. With this
information it is anticipated that quality of patient care will be continually improved as International Journal of Health Care
clinicians and managers learn from each adverse incident, claim and complaint. This Quality Assurance
Vol. 20 No. 2, 2007
would provide patient safety information to address new and specific long-standing pp. 107-115
quality issues with the introduction of specific targeted clinical and management joint q Emerald Group Publishing Limited
0952-6862
action plans. DOI 10.1108/09526860710731807
IJHCQA There is limited research and knowledge of managers and clinicians views of
20,2 designing, implementing and evaluating an integrated electronic adverse incident
recording and reporting system in order to improve patient care.

Literature review
Quality, patient safety and information collection on adverse incidents is not a modern
108 issue for the health care organisations and clinicians. Woodham-Smith (1952)
biography of Florence Nightingale reflected on her writing about her observations at
Scutari, in 1854, with the establishment of a medical school in the Crimea, Florence
Nightingale pledged for medical statistics to improve the soldier’s quality and
organisational performance by arguing that:
. . . No statistics are kept as to between what ages most deaths, etc. etc. etc. . . . Our
registration is so lamentably defensive that only record is a man died on such and such a day.
Recent modern age health disasters and crises have brought a new focus on
organisations and managerial processes, which allow these events to occur (Power,
2004; Poortinga and Pidgeon, 2003). Patient safety has now become a major concern for
the public, clinicians, managers and politicians with a focus to promote quality in
health care organisations. The Institute of Medicine’s (2001) Crossing the Quality
Chasm attempts to explain by arguing, “ Health care today is characterised by more to
know, more to manage, more to watch, more to do and more people involved.” Linking
this with the intricacy of medical technology, the growing age of the population with
chronic illnesses, and the complexity of health care systems against constant
organisational change, provides challenges to all involved to bring about a reduction in
errors.
Bristol Royal Infirmary Public Inquiry (2001) into the Children’s Heart surgery at
the Bristol Royal Infirmary 1984-1985 described an imperfect system of care, with
insufficient team working between professionals. Bristol Royal Infirmary Public
Inquiry (2001) also stated that there was “too much power in too few hands”. The
Department of Health (DOH, 2002) response to the report argued that using and
expanding information technology for patient safety could achieve significant health
improvements and potentially challenge the climate of fear and blame.
In North America, the publication of the Institute of Medicine, To Err is Human:
Building a Safe Health Service (Kohn et al., 1999), shocked the public and reporters, and
sounded a warning to organisations that quality and patient safety were issues that
needed to be addressed. It reported that 44,000 to 98,000 incidents were the result of
medical error in the USA, which resulted in a million injured. This report made a
number of recommendations and initiatives, which included setting up systems to
capture information on adverse incidents and create a focus for organisations to
develop action plans in the interest of patient safety (Kohn et al., 1999). The report
emphasised to the US federal government that medical errors were the eighth
commonest cause of death, listed above road traffic accidents, breast cancer and
HIV/AIDS. The cost is estimated to be $9 billion and it is anticipated that more patients
will suffer a similar pattern in the UK.
A report by The Comptroller And Auditor General (2005), “A safer place for
patients: learning to improve patient safety”, argued that there are also high costs
associated with adverse events in the UK, which cost the National Health Service
around £2 billion per year. With a potential £1 billion per year attributed to Patient safety
hospital-acquired infections and clinical negligence claims resulting in costs of more and quality
that £420 million per year. The report also highlighted that the probability of a patient
experiencing an adverse event while in hospital is estimated at 8.9 per cent. The
Department of Health Report (2000), “An organisation with a memory” stated that the
National Health reporting and information systems were “patchy and incomplete”. The
Department of Health Report argued that: 109
.
400 people die or are seriously injured in adverse events involving medical devices.
.
Nearly 10,000 people are reported to have had experienced serious adverse reactions to
drugs.
.
Around 1,150 people who have been in recent contact with mental health services commit
suicide.
.
Nearly 28,000 written complaints are made about aspects of clinical treatment.

Vincent et al. (2001) reinforced this by the results of the first epidemiological study
which showed that 10.8 per cent of patients had experienced an adverse event. The
results demonstrated that this is a national and international quality issue which
governments, political institutions and regulatory bodies responsible for patient safety
have little or no understanding (Naylor, 2002). In the UK, the introduction of clinical
governance in the National Health Service placed quality as a priority for health
organisations in order to improve clinical outcomes and improve patient care by
reviewing processes, procedures and outcomes (Scally and Donaldson, 1998).
Leape (1999) studied the level of medical error rates in medicine and compared its
limited approach to error management within aviation. Leape (1999) also found that
there were main differences in approaches to error detection in which aviation accepts
that people will make mistakes and incidents will occur. Leape (1999) argued that
generally medicine would not accept that mistakes occur and that this can be detected
currently in health care. Milligan and Robinson (2003) reflected that one of the main
challenges to health is that medicine is seen as a profession, and sees itself as being
above investigation and scrutiny. Leape (1999) also supports the approach that in order
to achieve a reduction in adverse incidents and to understand the underlying problems
there requires full integration between human, technological and system factors.

Electronic adverse incident reporting and recording systems

Information on dissatisfaction or poor quality has tended to be managed in health care
separately by departments within different line management structures. This has
resulted in fragmentation and non-integration with information not being fully
understood. Wald and Shojania (2001) reflected that medical errors have traditionally
been revealed through morbidity and mortality committees and malpractice claims.
Battles et al. (1998) argues that important information on adverse incidents may go
completely undetected and provides no data on the actual causes of the incident.
Walshe (2001) reinforces this by arguing that the collection of data on medication
errors, managing complaints and litigation had limited ownership at corporate level
and that, “linked processes for identifying, analysing and then controlling risk-were
definitely not in place.”
Walsh (2002) undertook a review of internal systems across four acute hospital sites
with clinical directors and found that the organisations operated manual paper
IJHCQA pre-printed forms, which were subsequently entered into a database system on
20,2 completion. The review showed that the system did not capture all adverse incidents,
particularly in clinical areas, in part due to medical staff reluctance to use the
methodology and concerns in relation to confidentiality of data. The paper driven
system became inflexible to reporting, as there was no facility for the creation of ad hoc
reports from clinicians and managers.
110 Managers and clinicians responded to the inflexibility by developing single
stand-alone databases. These individual databases had separate processes, procedures
and classifications, for example Pharmacy Department collected information on
medication errors; gynaecologists collected and supported their own in-house risk data
collection system. Larger departments such as claims and complaints had no process to
link information together in relation to common trends or issues. The claims
department also developed a local in-house database, which was insufficient to meet
the requirements of capturing all relevant information. Lack of feedback to all concern
within individual adverse incidents was also sighted as a problem.
The organisation’s processes to support the paper system were also problematic. All
the forms arrived at one location where a part time administrator had the task of
entering the data manually (in excess of 4,500 reports annually) into an Access
database. Problems were encountered with the linear flow of adverse incident
information, when departments sent large batches of forms, sometimes numbering
over a hundred. The administrator also had to analyse each report to determine if the
incident required to be reported to the Health and Safety Executive as required by
RIDDOR regulations. There were no automatic flagging arrangements to meet health
and safety and urgent corrective quality action to be taken in the interest of patient
safety.
Further this process resulted in increased manpower resources in order to enter the
completed forms by hand into the database to meet a growing awareness of patient
safety issues. The system used outdated reporting categories, which led to confusion
and the inability to present data against categories used nationally. The paper forms
were in A3 double-sided carbonated form with triplicate copies. The copy routing
identified on the forms caused significant confusion. The form also had few tick boxes
that would allow staff to quickly complete the form with the appropriate information.
Poor hand writing caused significant difficulty when entering the adverse information
into the database. The lack of information contained within some reports also made it
difficult to establish the right fit of category and whether the incident was actually
clinically based or health and safety. The amendment to the Data Protection Act
calling for the removal of paper copies from accident books, contributed further to the
loss of incident trending at local management level. The “unfriendly” paper based
format further contributed to the lack of adverse and near misses reporting.
In response to the above challenges the organisation recognised the need to develop
an adverse incident system to capture efficiently all adverse and near misses. To
achieve this a detailed specification was developed with a clear operational
requirement in partnership with Health and Safety, Clinical Governance, and
Information Management and Technology. It became clear there was no national
specification document, which could assist in the design, development, characteristics
and implementation of an adverse incident reporting system against national
guidelines and directives.
 The organisation set out a statement of purpose to support the introduction of a new Patient safety
adverse incident system by emphasising the importance of collection, reporting and and quality
analysis of incidents in accordance with national guidelines. The organisation also set
out corporate objectives to support the importance of the design and implementation of
the risk management system by stating:
.
To provide a comprehensive, high quality and cost effective recording, grading and
reporting system, which is robust and intuitive in terms of user input. 111
. To support “fast-track” reporting of serious incidents by use of incident grading methods.
.
To safeguard and enhance the quality of health care provided.
.
To provide and maintain a safe and secure environment for patients and staff.
.
To ensure effective, efficient and equitable utilisation of resources.

In 2004 the operational requirement was distributed to 15 potential suppliers within a

specific timescale for a formal response. In addition to the functionality potential
suppliers were also asked regarding limitations on configuration, user training,
implementation/resource constraints, costs, approach to enhancement requests for
further development. Responses were received from eight companies, but three
companies were discounted due to costs being over budgeted or implementation being
out with requirements. This showed that there were a number of commercial
companies advocating their own adverse incident system, but not being able to met
robust specific operational specifications.
A formal evaluation of the remaining six different adverse incident systems using a
questionnaire and scoring system based on the specification document was used to
support the selection process. A multidisciplinary Users Group was established, which
had a remit to further evaluate the short listed companies based on demonstrations of
their software.
Five commercial suppliers and one in-house system were evaluated as meeting the
requirements. Yule and Logan (2004) found that Datix adverse incident recording
system met all the requirements as specified in the operational requirement and
business case in terms of functionality and budget allocation. The Medical Director
accepted the decision of appointing Datix as the adverse incident recording system, but
instructed that the system should be integrated as a fully electronic system. This
would be implemented across four acute hospital sites. It was envisaged that this
would potentially address current weakness in the paper system. The integration of
claims, complaints and adverse incidents, which the system had demonstrated
positively, would be of added value in order to identify quality issues. Full integration
of this system would assist the organisation to comply with national standards. The
organisation would then direct valuable resources to address specific patient safety
issues by developing joint action plans and monitor their effectiveness.
The electronic adverse recording and reporting system was introduced across the
four sites following a three-month pilot from January to March 2005 following which
the system was rolled out across four acute sites from April 2005. A multidisciplinary
steering group was established to monitor and evaluate progress and report to the
medical director. It soon became clear from the pilot sites that the electronic adverse
incident recording and reporting system raised both new and familiar issues.
Through a series of staff interviews (Walsh, 2006) a number of issues were
forthcoming. Staff reported issues, which were not necessary adverse incidents for
IJHCQA example post-partum haemorrages, or babies returning to hospital with weight loss.
20,2 Medical and clinical staff raised concerns regarding the information being collected
and its purpose and how the information could be accessed and used across all levels of
the organisation? Certain medical staff were also concerned how the data was going to
be used and who would have access to it. Double reporting of incidents raised concerns
that the process was open to inaccuracy and therefore misinterpretation, for example
112 ward staff reported an incident and then security would also report the same incident.
Furthermore, issues of violence and aggression appeared to be problematic as there
were a number of different approaches with linking contact details within the system.
There were also issues surrounding remedial cause fields to support the capturing of
the correct data, which created concerns with the Health & Safety Departments needs
to meet statutory requirements.
It was also noted through the interview process that medical staff did not complete
the electronic adverse incidents forms and relied on nursing staff to complete. Medical
staff used the patient notes to highlight concerns or record incidents. A number of
Medical staff raised concern over the relevance and appropriateness of the electronic
reporting system and were unable to use the information to inform junior medical staff
of any concerns or relevant service changes made since an adverse incident. Nursing
staff found that entering adverse incident information was time consuming and
removing them from the patient. It was not seen as a high priority.
Moreover, submitting staff statements to support the investigation phase of an
electronic reported incident were seen as a major concern in that statements could
possibly be legally interpreted and used inappropriately. Viewing and security of
information became a concern across the four hospital sites as information regarding
staff names and incidents could be seen by a number of staff. Different terminology
and definitions in use across the organisation still caused confusion to regarding:
.
what should be reported;
. to whom incidents should be reported; and
.
what was expected in order to close the quality loop.

Location of incidents became a concern so that the electronic adverse incident reporting
system could identify the correct site of the incident. A number of wards and
departments shared facilities and no one individual was responsible.
The complaint and claims categories were found to be predominately English by
design and did not relate to Scottish systems and procedures both internally and
externally. This caused confusion and undermined the confidence of the system. There
was limited facility to assess the likehood and severity of the adverse incident to any
risk matrix. This restricted the ability for benchmarking and organisational learning to
take place.
Walsh (2006) reflected that while ward nursing staff were trained in the electronic
system in patient time, no resources were allocated to back fill staff which resulted in a
conflict of interest between patient care, quality and safety. Budgets to manage and
provide training for the system became a concern as executive management viewed the
trainer and management co-ordinator as a temporary resource. An individual in-house
trainer who had developed local skills and knowledge, left to obtain a permanent
contract. This resulted in a new trainer being appointed against the uncertainty of their
position and different delivery of training being provided to managers and staff, which
caused more potential confusion. There was no facility to link adverse incidents to Patient safety
quality cost so the interpretation of adverse incident information had its limited impact and quality
on management to support appropriate decisions and improve patient safety.
Further, not all departments wished to be linked to the adverse incident system and
preferred to remain with their local in-house systems. For example the radiology
department remained committed to recording incidents in a book and not sharing the
information outside the department. This opportunist approach to adopt out of the 113
electronic system would result in not collecting the right information across all
departments and levels of the organisation. This showed despite all the planning and
commitment by the users group, that the electronic system had not been fully
integrated against agreed time scales. This resulted in a loss of vital information not
being entered into the database resulting in false conclusions on adverse activity and
trends.
It was also noted that executive management questioned the overall costs of
managing, modifying improving and maintaining the system. It appeared to executive
management that there were no clear outcomes following implementation, both
potentially to the organisation and the community it served. This showed that there
was no overall business, quality and patient safety strategy in the medium and long
term, to provide a cost reduction approach to adverse incidents.

Conclusion
The electronic adverse incident reporting and recording system continues to challenge
the organisation, clinicians and managers in all aspects of quality and patient safety.
Directors, managers and staff have seen little or no impact on patient care or staff
welfare despite the growing collection of data. It remains unclear that the electronic
adverse incident data being collected across the organisation is appropriate or
presented in the correct format. The steady and consistent changes to the commercial
system implemented since April 2005 to meet clinical and managerial requirements
remains fragmented especially in communication to staff, in why or how the changes
have come about.
Adverse incident data, which is being introduced into the electronic adverse
incident reporting system is not quality assured by managers and Heads of
Departments, especially in the area of not enforcing correct completion of forms. The
attitude of staff in the completion of the data entry and investigation phase appears not
to be seen as a priority in the quality and accuracy of reports.
The growing awareness of adverse incidents and the benefits to patient safety is
being totally undervalued in the clinical care area by the lack of computer expertise
and the difficulties of staff to undertake training, which is set against constant
conflicting pressures and targets. Staff predominately are not aware of any changes in
practice from adverse incidents or investigations.
There remains a strong information and technology support and partnership
working across Health & Safety, Claims and Clinical Governance to develop further
and address the gaps within the commercial electronic system. The organisation
responded very quickly that the commercial system needed to be further developed if it
was to achieve the corporate objectives. There was no readily available knowledge to
address these challenges and gaps. Solutions are continually being developed and
tested in order to explore improving the approach to designing, modifying,
IJHCQA implementing and evaluating an electronic adverse incident reporting system, in
20,2 partnership with the commercial company, managers and clinicians.
The importance of seeking clinical and managers views in relation to further
understanding electronic adverse incident recording and reporting within an acute
health setting forms part of a bigger research study. The challenges, gaps and
solutions will be further discussed in forthcoming papers.
114
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Further reading
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Systems Safety Conference, Unionville, VA, USA, pp. 175-86.
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National Transport Safety Board of Canada (1999), Marine Investigation Report: Engine-room
Fire. The Self-unloading Bulk Carrier “Nanticoke” at 39 degrees, 20’ N, 072 degrees 22’ W,
Western North Atlantic Ocean, 20 July 1999, Technical Report M99FOO23, National
Transport Safety Board of Canada, Hull, Quebec.
O’Leary, M. and Chappell, S.L. (1996), “Confidential incident reporting systems create vital
awareness of safety problems”, ICAO Journal, pp. 11-13.
Woods, D. (2000), “Estimate of 98,000 deaths from medical error is too low, says specialist”,
British Medical Journal, Vol. 320, p. 1362.

Corresponding author
Jiju Antony can be contacted at: j.antony@gcal.ac.uk

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