Clinical governance is a framework through health service organizations are responsible for consistently developing the quality of services and upholding high standards of care by creating an environment in which excellence in clinical care will flourish (Moore and McAuliffe, 2011). Clinical governance provides an opportunity for understanding and developing fundamental components needed to felicitate the administration of quality health care; these include a learning culture, questioning, a no blame game, excellent leadership and an atmosphere where the staff is valued and given the necessary support as they create partnerships with patients.

The primary elements of clinical governance include research and development, clinical audit, risk management, openness, educational and training, and clinical effectiveness. The key pillars of clinical governance are less the same as the components of total quality management (TQM) which amongst others include teamwork, training, leadership, customer focus, measurement, and planning. TQM is a process designed to prioritize customer expectations, problems prevention, developing a commitment to constant improvement in every person and the enhancement of participative management.

Clinical governance aim is to consolidate the organizational, managerial and clinical approaches to improve health care quality. This relationship is rooted in the processes of quality improvement that drive clinical governance in the same way to the methods that drive business. The 2017- 2018 Hospital plan outlines five strategies plans focused on enhancing clinical governance, these include improving service quality, optimizing demand management, attracting and retaining competent staff, enhancing staff training and development, and driving responsible and efficient use of financial resources. This paper seeks to examine the application of clinical governance strategies and the Ishikawa fishbone analyzing and addressing the causes of retained surgical items.

Ishikawa Fishbone

Ishikawa fishbone also known as the cause and effect diagram is the original invention of Japanese Quality control expert Dr. Kaoru Ishikawa. It is a crucial graphics tool that helps in identifying, categorizing and displaying the possible causes of a problem or quality characteristics. The ishikawa fishbone has both its strengths and limitations as outlined below;

Strengths of Ishikawa Fishbone

· It allows a thoughtful analysis that avoids overlooking any possible root causes of a problem.

· Ishikawa fishbone technique is simple to implement and it creates an easily understandable visual representation of the causes and categories of the causes of a problem.

· It allows a group to focus on the big picture in relation to the possible causes or factors influencing a problem.

· Even after the problem has been addressed, ishikawa fishbone reveals areas of weakness that can be corrected before causing additional sustained difficulties.

· It can form a basis for experimental or data collection plan.

· It shows subordinate relationships.

Limitations of Ishikawa Fishbone

· The major categories must be identified in advance otherwise if any category is excluded, it can limit thinking.

· In case of many ideas and subcategories, the fishbone diagram can be cluttered and almost impossible to read.

· It does not help in evaluating the relative importance of ideas it represents.

· It cannot act as a substitute for numerical data.

Ishikawa Fishbone Analysis (Scenario One)

A patient underwent total hip replacement for osteoarthritis. “TIME-OUT” was performed in the operating theatre and the instrument count was checked and correct. The operation was uneventful. After the operation, staff revealed a broken drill bit with a loss of 1 cm at the tip. The surgeon was informed and following an x-ray examination showed a shadow. The broken drill bit was later removed from the patient’s lesser trochanter.

Figure 1.

Many factors contributed to the piece of drill bit remaining on the patient after surgery as shown in the figure above. The key contributing factors include metal fatigue, lack a system to detect metal fatigue, reuse of instrument and failure to recognize the missing part of the drill bit after use.

Lewin’s Field Force Analysis and Staff Change of Practice

Field force analysis is a problem-solving tool used in achieving change. It first came into use during the Second World War by Kurt Levin, a professor at the University of Iowa. Kurt invented the tool while researching meat purchasing preferences of homemakers. Field force analysis sees change as a struggle between two forces (Gottwald and Lansdown, 2014). Driving forces are the existing forces that help attain change while Restraining forces are the current forces that are blocking reform from taking place. Therefore, Field force analysis is the process of identifying the driving and restraining forces that sound any proposed change. Kurt Lewin identified three possible change strategies using this too; a staff team can decide to decrease the resisting forces, increase the driving forces or apply both. However, increasing the driving forces can yield unexpected results of reinforcing the resisting forces. Kurt thus suggests that the most effective way to enable change to occur is by decreasing the resisting forces

Employing clinical governance strategies to minimize sentinel event (scenario one)

Driving Forces Restraining Forces

· Minimizing pain and complications to patients

· Improving the Quality of patient care

· Promoting the image and reputation of the health facility

· Lack of efficient operating systems to prevent instrument fatigue

· Inefficient operating cultures i.e. reuse of instruments during operations.

· Resistance to change

Figure 2.

The field force analysis help staff to change practice by following the steps as outlined below.

1. Defining the desired change or action; the team must first agree on a simple statement describing the change they want to make. Example: Employing clinical governance strategies to minimize sentinel events (scenario one).

2. Brainstorming the driving forces; brainstorming is a free, unlimited generation of ideas generally in a group setting. By braining the staff can;

• Generate a wide range and a vast number of views on the change.

• Ensure that every staff member is involved in the problem-solving process.

• Ensure nothing is overlooked and ensuring that all possible solutions are included.

• Create an atmosphere of creativity and openness in the approach to change of practice.

3. Brainstorming the restraining forces; the restraining forces are the factors which are currently inhibiting the staff from implementing the quality improvement actions in their practice. Examining the driving forces will likely help the team generate restraining forces which are the opposite of the driving forces.

4. Prioritizing the driving forces: At this stage, the staff will discuss the driving forces for change and determine their relative importance. They will then prioritize the forces through an open discussion, a vote or a forced ranking by the majority. However, it is best practice to employ an open discussion as it would give each staff member an opportunity to raise his or her opinion. For example from the above scenario, the staff is likely to reach a consensus on the most active driving forces to include minimizing risks to patients, improving the quality of healthcare and enhancing hospital reputation respectively.

5. Prioritizing the restraining forces: In a process similar to step four, the staff will also choose by consensus and prioritize the restraining forces per their relative importance (figure, 2).

6. Listing Actions to be taken: planning change of practice will require the staff to generate a set of actions to increase the chances of success. The team can generate these actions by;

· Discussing how they can reinforce or use the high priority forces to smooth the path of change or

· Considering how to minimize, eliminate or reverse the effects of the significant restraining forces.

7. Prioritizing action steps; the staff will then prioritize which action step they will take on the path towards changing the practice.

Despite being a useful tool in change management, field force analysis also has some disadvantages or limitation. One of the demerits is that it requires the participation of all the staff members to provide the accurate information needed for a valid analysis. It can be a limiting factor when full attendance is not possible, the result being an analysis that does not reflect a realistic picture of the supporting and opposing forces (Gottwald and Lansdown, 2014). There is also the possibility that field force analysis may fail to reach a consensus among the staff member and it the worst scenario, it can cause division amongst the members of staff between those supporting the decision and those resisting it.

Clinical Governance Strategies

(a) Risk management

Risk management is the process of raising the quality and safety of healthcare services. It is an approach to enhancing the quality of health care with particular emphasis on incidents in which patients experience harm or complications by their treatment (Attree, 2007). A risk management strategy involves systems for incident reporting and investigation as well as learning from rising complaints. In summary, a risk management strategy minimizes risks to patients by;

• Identifying what can go wrong or does go wrong during health care.

• Understanding the factors that influence the occurrence of such incidences.

• Learning lessons from the existence of any adverse events.

• Ensuring appropriate steps are taken to prevent recurrence the same

• Establishing systems in place to minimize risks.

Risks to clinicians are reduced by ensuring they are immunized against infectious diseases, enhancing a safe working environment using best practice recommendations and encouraging them to take part in quality assurance programmes in a learning setting.

Risk management strategy is crucial in providing solutions to the critical causes identified in the Ishikawa fishbone analysis. After identifying material fatigue a fundamental reason for retained surgical items during operations, a practical clinical risk management strategy will ensure a system is in place for detection and replacement of fatigue instrument. It would provide for the redesign of the apparatus checking processes to ensure timely integrity checks.

(b) Clinical effectiveness

Clinical effectiveness is the process of applying the knowledge derived from clinical experiences, research and patient preferences to attain optimum processes and outcomes of health care for patients (Sale, 2005). This process involves an established framework for informing, changing and monitoring clinical practice. Clinical effectiveness minimizes causes and resistors of better health care by;

Ensuring that clinical staff is given support in developing and applying critical appraisal skills, change management skills and skills in literature searching.

• Ensuring that stakeholders including clinical officers, patients, and managers get access to the best available evidence-based practice.

• Ensuring that evidence justifies the traditional clinical practice by providing sound information to clinicians on which interventions work and vice versa.

• The development, implementation, monitoring and timely review of evidence-based clinical guidelines and care pathways.

• Recognizing that therapeutic measures should rely on scientific study, rather than unstructured observation or clinical opinion.

The above measures would ensure that staff are well informed and prepared for the changes that required in the process clinical governance. It would create a staff culture that embrace change thus reducing the resisting forces in the change management process.


Clinical audit is the structured analysis of the quality of healthcare, including the diagnosis procedures, treatment, and care, the use of resources and resulting income and the quality of life for patients (Alhatmi, 2010). It is a quality improvement circle that involves the measurement of the effectiveness of health care system against set standards for high-quality performance, and taking action to bring practice by these standards to enhance the quality of care and health outcomes.

The primary health care providers must ensure that audit is actively utilized as a tool for promoting patient safety and improving the quality of patient care and that clinically useful services are offered and commissioned in line with up to date evidence (Alhatmi, 2010). The measures are achieved by

· Establishing annual audit programme that incorporated a planned re-audit programme.

· Ensuring proper quality data is available to auditors.

· Ensuring that staff receives the necessary support they need in developing and applying appropriate audit skills.

· Collaborative working and team development as well as encouraging a multi-disciplinary approach to the audit processes

· Efficient sharing of information in audit findings.

· Practical application of the recommendations presented in the audit report.

Aims of Audit

The primary objectives of carrying out audit include;

• To promote and enable the desired healthcare practices.

• To assess and improve patient care in addition to ensuring professional standards in clinical practice are taken into account.

• To enhance stronger relations between patients, clinicians, managers and clinical teams in a mutual effort to improve the quality of healthcare.

• To avail opportunities for education and training.

• To strengthen continuous improvement in service delivery and patient outcome

• To create a culture of clinical development in the clinical environment.

• To create an opportunity for increased job satisfaction.

The Audit Cycle

Stage 1; Preparation

This stage involves choosing a topic of high priority for the organization. It maybe areas with high volume of work, high costs of care, high risks or areas identified as a priority by patients.

Stage 2: Select criteria

In this stage, the requirements of the audit process and the desired standards defined. It can be a minimum or optimal standard depending on the clinical scenario at hand.

Stage 3: Measuring level of performance

Data collected from computerized or manual sources is analyzed, and the actual performance compared to the set standards.

Stage 4: Making improvements

The results are presented and discussed with the relevant teams within the health organization. The result is then used to develop a comprehensive action plan specifying what needs to be done to improve care services, how it would be done, who is responsible and when it’s going to be executed.

Stage 5; maintaining improvements

It involves a re-audit to determine whether the actions taken are sufficient or whether further improvements are necessary. Re-audit ensures the service delivery actions implemented are functional and continuously improve the quality of healthcare.

Figure 3; Quality cycle.

To ensure the services continuously improve going forward, I would employ the following audit methods;

(a) Process audit – This would involve a regular verification exercise to ensure that clinical processes are working within established limits. I would evaluate the clinical operation procedures, like in this case hip replace, against predetermined standards to measure conformance to these standards and the effectiveness of the rules. It would also involve;

• Examination of the equipment’s used to avoid instances of metal fatigue, the work environment to ensure it’s favorable for clinical operations, the procedures to ensure they conform to the established best practices, and the measures taken to determine process effectiveness.

• Checking the adequacy and of the process controls established work instructions, flow charts, procedures, training and Process specifications

(b) System audit – This would be an activity to verify the applicable elements of the operating systems to ensure that they are useful. Safety system audits would avoid sentinel events in clinical operations by preventing surgical errors resulting from systems malfunction or lack safety systems (Alhatmi, 2010). The development of tracking system to detect and replace fatigue surgical instruments is a result of system safety audits.

Audit Standards (SMART)

Specific- Audits should be clear, unambiguous and free of jargons in such a way that all the intended healthcare stakeholders can read and understand it.

Measurable- the outcome of the audit process must be measurable and presentable.

Agreed- the audit process must be agreed upon by all the stakeholders in the specific area of health care being audited.

Relevant – it must be connected to the area of care being under audit or the issue of concern raised by patients or clinicians warranting the audit exercise.

Theoretically sound- the audit process must rely on evidence of best practice, reviewed and updated as new evidence are made available.

SMART standards

S.M.A.R.T standards are Specific, Measurable, Attainable, Realistic and Timely.

Specific; means the standards must be precise and easy to understand to anyone who has basic knowledge of the desired outcome.

Measurable; the standards must be able to predict and measure the outcome of change practice.

Attainable; the standards must be achievable by all stakeholders including clinicians and patients

Realistic; the set standards must not be ambiguous, they must not be too high or too low.

Timely; the standards must be achievable within the set time frame.

Importance of SMART standards

Reducing health care risks; smart standards outline the specific threshold or level of performance required of health practitioners and as such promote delivery of high quality of care services and consequently the reduction in health care risks.

Clear focus; standards set a clear focus on healthcare practice. It outlines the expectation from healthcare stakeholder in the short and long-term achievements.

Optimal use of resources; standards ensures optimal use of resources in clinical governance. It ensures that resources are appropriately allocated in areas of health care that need change only.

Monitor progress; smart standards enable health practitioners to monitor the progress of their current practices in comparison to the desired practices and make the necessary adjustment to remain on course if their current methods do not much the expected standards.

Reduce patient wait time; setting standards outlining the average time of engagement between a patient and a health practitioner reduce time wastage and enhance service delivery

In conclusion, quality of health care is increasingly becoming a primary issue of concern in all medical settings around the world. To improve the quality of healthcare requires a holistic approach that involves all clinical stakeholders including patients, clinicians, and managers. Clinical governance strategies such as risk management, educational and training, quality cycles, clinical audit, integrated care pathways and clinical effectiveness are central to realizing adequate health care. Applying risk management strategies enable experts to predict loopholes in the clinical operations and employ proper systems to minimize sentinel events such as retained surgical items (drill bit). Education and training equip medical practitioners with up to date skills and knowledge to enable them to keep up with the changes in medical technology and ensure continuous improvement in their areas of practice. The underlying causes of inadequate health care such poor communication, lack of equipment’s, bad clinical cultures and lack of efficient standard procedures can be unearthed by carrying out a regular clinical audit and consequently implementing the audit report recommendations as a key to quality improvement. Finally, carrying out proper clinical audit processes ensures systems integrity, standards compliance and sound operating procedures thus reducing risks to patients and consequently improves the quality of healthcare.

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