Research Article
Open Access
An Innovative Risk Assessment Tool for
Prospective Risk Analysis to Improve the
Quality in Health Care: The Bow-Tie
Haitham Shoman* and Samer Ellahham
Sheikh Khalifa Medical City (SKMC) Managed by Cleveland Clinic, Abu Dhabi, UAE and Cleveland Clinic Foundation, Ohio, USA
*Corresponding author: Haitham Shoman, SKMC Managed by Cleveland Clinic, Abu Dhabi, UAE and Cleveland Clinic Foundation, Ohio, USA, E-mail:
@
Received: January 17, 2018; Accepted: February 05, 2018; Published: March 05, 2018
Citation: Shoman H, Samer E (2018) An Innovative Risk Assessment Tool for Prospective Risk Analysis to Improve the Quality in Health Care: The Bow-Tie. Int J Pharmacovigil 3(1):1-3. DOI: http://dx.doi.org/ 10.15226/2476-2431/3/1/00120
Abstract
In order to improve the quality of health care, it is very important
to assess the risks that might affect the service delivery and quality of
health intervention. This will help other health care professionals to
work on ensuring minimum risks are maintained in delivery a certain
intervention to the patients. There are several models used in the
the health care industry that helps in conducting a risk assessment,
but there have been a gap in demonstrating a user-friendly model
for the health care professionals. The Bow-tie model is a prospective
risk assessment tool that can be conducted by several health care
professionals to assess the potential risks in a certain department
or intervention and offers a pictorial graphical presentation for easy
understanding for all staff.
Keywords: Risk assessment; Bow-tie; Quality; Health care;
Keywords: Risk assessment; Bow-tie; Quality; Health care;
Introduction / Background
In healthcare, serious adverse events and medical errors can easily
occur jeopardizing patient safety and continuity of treatment
[1]. However, studies have revealed that identifying risks and
working on analyzing and mitigating them, have proven to lower
down undesirable and preventable healthcare associated events
[2]. The Health and Safety Executive defines hazard as ‘’ anything
that may cause harm, such as chemicals, electricity, working
from ladders, an open drawer etc.’’ and risk as ‘’the chance,
high or low, that somebody could be harmed by these and other
hazards, together with an indication of how serious the harm
could be’’ [3]. In healthcare, there are several events that could be
prevented such as falls in hospitals, surgical site infections, drugs’
side effects and post-operative complications and having a risk
assessment model in place would help deployment of barriers to
prevent the occurrence of these events.
In order to improve patient safety and ultimately the quality of healthcare, one should systematically analyze and assess the risks for healthcare errors, and determine their possible causes. Reducing and preventing morbidity and mortality in healthcare is of paramount importance in the medical profession and in healthcare politics [4]. There are a few risk analysis models like the Health-Care Failure Mode And Effect Analysis (HFMEA), Root Cause Analysis (RCA), the Swiss Cheese model and the Bow-tie model [5-7]. In this study the Bow-tie risk analysis model is being explored due its extensive use in several industries and its ability to provide a pictorial presentation of the risk assessment process and potentially being the lead healthcare risk analysis tool.
The history of the Bow-tie extends to 1979 where diagrams were drawn in the Imperial Chemistry Industry course notes at the University of Queensland, Australia but the exact origin is not yet clears [8]. After the catastrophic Piper Alpha platform incident in 1988, Lord Cullen mentioned the critical importance of having systematic approach in identifying, assessing and controlling hazards [8]. The Bow-tie was then adopted by the Royal Dutch / Shell group in the early nineties as a standardized methodology for risk assessment and control across their world sites [8].
Industries such as the oil and gas, aviation, nuclear, transport and petrochemical are full of hazards and healthcare is no less. The Bow-tie model was originally developed to analyze hazard and accidents in high risk industries as such in Europe and Australia; it is being used to conduct risk assessment and to prevent hazards [9]. Since 2010, as with many risk assessment tools, it has been adopted by many industries and it is spreading widely in other fields where the healthcare sector is one of them [9-12]. Following the extensive use of Proactive Risk Assessment (PRA) in hazardous industries, there has been a growing need for having PRA methods that can identify, eliminate or prevent contributing factors leading to adverse and hazard events [13,14]. Despite the existence of several PRA, only a limited number has been applied and not widely used [15]. The Bowtie model is a risk analysis tool that prospectively analyses and visualizes risks, causes and consequences of potential hazards and adverse events. In healthcare, the Bow-tie methodology is a barrier analytical tool that systematically identifies, prioritizes and controls clinical risks that can threat patient safety [1]. It brings together causes, errors, preventive and recovery measures and consequences, and observes the significance and causes of current safety risks. Thus, it prospectively prioritizes riskminimizing interventions illustrating the relationship between causes and consequences of undesirable events in a simple comprehensible way and visualizing shortcomings and gaps as unsuccessful or missing safeguards and barriers [16]. The Bowtie methodology incorporates both prospective and retrospective approaches offering users the convenience to understand the situations before and after the incidence of an event [1]. A review of the literature shows that the Bow-tie model as a risk assessment tool in healthcare has only been used in a very limited number of studies and proved to be effective [1,4,16]. This article discusses the Bow-tie model showing a pictorial presentation of its application in risk assessment and how would it fit in the healthcare sector.
In order to improve patient safety and ultimately the quality of healthcare, one should systematically analyze and assess the risks for healthcare errors, and determine their possible causes. Reducing and preventing morbidity and mortality in healthcare is of paramount importance in the medical profession and in healthcare politics [4]. There are a few risk analysis models like the Health-Care Failure Mode And Effect Analysis (HFMEA), Root Cause Analysis (RCA), the Swiss Cheese model and the Bow-tie model [5-7]. In this study the Bow-tie risk analysis model is being explored due its extensive use in several industries and its ability to provide a pictorial presentation of the risk assessment process and potentially being the lead healthcare risk analysis tool.
The history of the Bow-tie extends to 1979 where diagrams were drawn in the Imperial Chemistry Industry course notes at the University of Queensland, Australia but the exact origin is not yet clears [8]. After the catastrophic Piper Alpha platform incident in 1988, Lord Cullen mentioned the critical importance of having systematic approach in identifying, assessing and controlling hazards [8]. The Bow-tie was then adopted by the Royal Dutch / Shell group in the early nineties as a standardized methodology for risk assessment and control across their world sites [8].
Industries such as the oil and gas, aviation, nuclear, transport and petrochemical are full of hazards and healthcare is no less. The Bow-tie model was originally developed to analyze hazard and accidents in high risk industries as such in Europe and Australia; it is being used to conduct risk assessment and to prevent hazards [9]. Since 2010, as with many risk assessment tools, it has been adopted by many industries and it is spreading widely in other fields where the healthcare sector is one of them [9-12]. Following the extensive use of Proactive Risk Assessment (PRA) in hazardous industries, there has been a growing need for having PRA methods that can identify, eliminate or prevent contributing factors leading to adverse and hazard events [13,14]. Despite the existence of several PRA, only a limited number has been applied and not widely used [15]. The Bowtie model is a risk analysis tool that prospectively analyses and visualizes risks, causes and consequences of potential hazards and adverse events. In healthcare, the Bow-tie methodology is a barrier analytical tool that systematically identifies, prioritizes and controls clinical risks that can threat patient safety [1]. It brings together causes, errors, preventive and recovery measures and consequences, and observes the significance and causes of current safety risks. Thus, it prospectively prioritizes riskminimizing interventions illustrating the relationship between causes and consequences of undesirable events in a simple comprehensible way and visualizing shortcomings and gaps as unsuccessful or missing safeguards and barriers [16]. The Bowtie methodology incorporates both prospective and retrospective approaches offering users the convenience to understand the situations before and after the incidence of an event [1]. A review of the literature shows that the Bow-tie model as a risk assessment tool in healthcare has only been used in a very limited number of studies and proved to be effective [1,4,16]. This article discusses the Bow-tie model showing a pictorial presentation of its application in risk assessment and how would it fit in the healthcare sector.
Discussion
The bow-tie methodology includes a risk management cycle that
covers hazard identification, risk evaluation and risk control
along with adverse events that may occur [17]. It commences by
identifying the major event which is the centre of the diagram
[17]. On the left-hand side are the threats that can trigger the
major event in the centre. On the right-hand side of the diagram
(right to the major event in the centre) lie the consequences.
After identifying the major event, threats and consequences,
barriers can then be identified [16]. Barriers can be preventive or
protective [1]. Preventive barriers are those that already exist in
the threats’ path to prevent their initiation and protective barriers
can protect or minimize the adverse events caused by threats [1].
Sometimes the barriers could be jeopardized by an escalation
factor. Barriers that are identified following the emergence of
escalation factors are called secondary barriers. A comprehensive
Bow-Tie diagram would have a pictorial presentation of the
threats, consequences, escalation factors and the barriers along
the pathways [4]. Recommendations and strategies could then be
proposed based on the preventive and protective barriers.
Hazards can be identified from existing reports, events, conferences and team members’ input. Studies have shown that deploying adequate risk analysis methodologies in healthcare operations are effective in reducing harm and undesirable events to healthcare beneficiaries [1,4,16]. The Bow-Tie diagrams are also useful in presenting the relationship between the individual, organizational and cultural factors that contribute in the way risks are managed [1]. It is important to have a model that shows all barriers in an eye-friendly manner where the user can easily navigate easily through and look at all the threats in one place rather than having to flip over pages and sometimes lose track of the threats and what needs to be done. Non-healthcare industries that have plenty of risks associated with the nature of their work have been using the Bow-Tie and their staff have all contributed to its development in analyzing risk where some people have even referred to it being an goal oriented model to improve the quality of a service and mitigate risks effectively [17]. In this model, error detection and recovery is easily presented offering staff the insight of their role in different phases of the recovery process including identifying, preventing and fixing errors.
In addition, the three studies that used the Bow-Tie methodology in risk assessment, have shown that it was successful in promoting healthcare staff awareness about threats and errors and errors provoking conditions in their environments ad workplace.
Hazards can be identified from existing reports, events, conferences and team members’ input. Studies have shown that deploying adequate risk analysis methodologies in healthcare operations are effective in reducing harm and undesirable events to healthcare beneficiaries [1,4,16]. The Bow-Tie diagrams are also useful in presenting the relationship between the individual, organizational and cultural factors that contribute in the way risks are managed [1]. It is important to have a model that shows all barriers in an eye-friendly manner where the user can easily navigate easily through and look at all the threats in one place rather than having to flip over pages and sometimes lose track of the threats and what needs to be done. Non-healthcare industries that have plenty of risks associated with the nature of their work have been using the Bow-Tie and their staff have all contributed to its development in analyzing risk where some people have even referred to it being an goal oriented model to improve the quality of a service and mitigate risks effectively [17]. In this model, error detection and recovery is easily presented offering staff the insight of their role in different phases of the recovery process including identifying, preventing and fixing errors.
In addition, the three studies that used the Bow-Tie methodology in risk assessment, have shown that it was successful in promoting healthcare staff awareness about threats and errors and errors provoking conditions in their environments ad workplace.
Figure 1: The bow-tie diagram
Despite the usefulness, practicality and great potential of this
tool, it has its limitations. The Bow-Tie can be time-consuming
in its development requiring extensive work and awareness
on how to use it [1,4,16]. The practicality and reliability of the
outputs depends on the inputs given. Data gathering needs
to be adequately managed and should be of high quality for
reliable results [1,4,16]. Since it is considered a new model in
the healthcare industry, users of the model needs to be trained
on how to use it along with the necessary software for its
implementation with particular emphasis on the terminologies
of threats, consequences, hazards, escalation factors, hazards and
barriers [1,4,16]. Sometimes in a model, the results generated
cannot be generalized across all healthcare settings especially
when the inputs used were of explicit nature for a specialized
healthcare setting [1,4,16].
Bow-tie terminologies [17]
It is important to understand the terminologies and its
definitions while conducting a bow-tie analysis:
• Hazard: Anything related to the topic of interest with a potential to cause harm to safety, health, environment or reputation.
• Threat: A direct and independent potential cause that can lead to the hazard being released by producing the top event leading to a consequence.
• Top event: This is when the hazard is released; it is considered the first event in a series of negative events causing undesired consequences
• Control: Any action taken that can act against some undesired efforts in order to maintain a desired situation; Proactive controls (on the left side of the bow-tie diagram) prevent events from occurring and reactive controls (on the right side of the bow-tie diagram) minimize consequences.
• Escalation factor: A condition that jeopardizes the effectiveness of a control leading to increased risk.
• Consequence: The undesired event is a result of a released hazard that leads to loss or damage in safety, persons, environments, assets or reputation.
• Hazard: Anything related to the topic of interest with a potential to cause harm to safety, health, environment or reputation.
• Threat: A direct and independent potential cause that can lead to the hazard being released by producing the top event leading to a consequence.
• Top event: This is when the hazard is released; it is considered the first event in a series of negative events causing undesired consequences
• Control: Any action taken that can act against some undesired efforts in order to maintain a desired situation; Proactive controls (on the left side of the bow-tie diagram) prevent events from occurring and reactive controls (on the right side of the bow-tie diagram) minimize consequences.
• Escalation factor: A condition that jeopardizes the effectiveness of a control leading to increased risk.
• Consequence: The undesired event is a result of a released hazard that leads to loss or damage in safety, persons, environments, assets or reputation.
Conclusion
The Bow-Tie has been used in several industries as a
comprehensive risk assessment model. Health care is also
an industry where risks are always found. A few studies has
been conducted so far to show how this model was effective in
prospective risk assessment and mitigation of hazards to ensure
high quality of health care service delivery to the patients. More
studies are needed to explore the clinical effectiveness of this
model in several health care settings.
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