Clinical audit: A Simplified Approachs

D. Suryaprabha*

Chief Clinical Pharmacist, Kauvery Hospitals, India

*Correspondence: Tel: +91 98414 86267 Email:


Background: Clinical audit is a proven method of quality improvement. It gives a systematic way of looking at their practice and making improvements.

Methods: A summary of the stages of clinical audit are presented in the form of audit cycle, in these there are eight cycles of clinical audit explained.

Conclusion: Clinical audit, the cornerstone of clinical governance, ensures that the strategy is executed as planned, and in the process provides a framework to highlight and enable changes to be incorporated ensuring improved patient care. This paper reviews basis of clinical auditing, its methods.

Keywords: Clinical audit, Morbidity, Pilot, Quality, Tool, Evidence


Clinical audits are part of the continuous clinical quality improvement process that focus on specific issues or aspects of health care and clinical practice [1]. It could be retrospective/prospective in nature. It is a proven method of quality improvement. It is asystematic way of looking at clinical practices and making improvements [2]. Audit is a key component of clinical governance, which aims to ensure that the patients receive a high standard of care.

The clinical audit consists of measuring a clinical outcome or a process, against well-defined standards set by the principles of evidence-based medicine, in order to identify the changes needed to improve the quality of care. The topic for audit could be disease-based, cost-based, community-based or based on morbidity [2].

As per the NABH standards the organization shall conduct one clinical audit per department per year [2].


The cycle in clinical auditing [3] (Fig. 1):

(a) Stage I: Identify topic/problem to be audited,

(b) Stage II: Agree standards of best practice,

(c) Stage III: Define methodology,

(d) Stage IV: Pilot and data collection,

(e) Stage V: Analysis and reporting,

(f) Stage VI: Make recommendations,

(g) Stage VII: Implement change.

(h) Stage VIII – Re-audit


Fig 1. Clinical audit cycle and its stages

Stage I: Identify topic/problem to be audited

For the choice of an appropriate theme for a clinical audit [4], ensure that:

(a) The problem to be audited has an important impact in terms of outcomes, costs, resources, or risk,

(b) There is some strong scientific evidence available (guidelines, systematic reviews),

(c) The improvements made on the subject in question can be easily evaluated and be a source of important clinical/organizational consequence.

Stage II: Agree standards of best practice

The sources where criteria and standards can be drawn from may be: international guidelines, scientific literature, expert consensus, data obtained by other health care facilities and personal case studies.

Stage III: Define methodology

Method or type of audit process is chosen depending on audit objectives.

Stage IV: Pilot and data collection

Always do a pilot:

(a) Look at two or three patients, cases, or records,

(b) Check whether your audit design works by testing it on a few cases,

(c) If it doesn’t, re-design and pilot again,

(d) The data should enable you to measure practice against the standards.

Ways of collecting data

Data can often be collected from patient’s notes, or by interviewing patients of staff, or by using questionnaires.

Sample size

You don’t need a big, or statistically significant, sample for an audit, but you do need a fair sample that represents all the patients, cases or records. Ethical issues should be given due consideration. Data collected must relate only to the objectives. Patient and staff confidentiality need to be respected.

Stage V: Analysis and reporting

Data collected are analyzed. Results are compared with criteria and standards.

Stage VI: Make recommendations

Once the results of audit are analyzed and discussed and areas for potential improvement are identified, recommendations for improvement are formulated.

Stage VII: Implement change

Action plan should be made for implementing changes.

Stage VIII: Re-audit

After an agreed period of implementing changes the audit should be repeated. Same strategies used for the original audit should be used to ensure comparability. The re-audit should reveal that the changes have been implemented and improvement has been made.

Challenges that may be encountered

The main barriers to clinical audit can be classified as follows [5]:

(a) Lack of motivation,

(b) Lack of training,

(c) Lack of resources – Lack of time, staff and knowledge,

(d) Lack of expertise or advice in project design and analysis,

(e) Problems between groups and group members,

(f) Lack of an overall plan for audit,

(g) Organizational impediments,

(h) Administrative delays in changing practice [6],

(i) Failure to use nationally set standards, and the use of resources on many small local projects with ill-defined standards and aims.

Promoting clinical audit [7]

(a) Supportive organizational environment, sound leadership and direction of audit programmes,

(b) Sound leadership,

(c) Practical mechanisms to make data collection easier, including modern medical records systems,

(d) Information technology and improved links between routine data collection and audit,

(e) Dedicated staff,

(f) Strategy and planning in audit programmes,

(g) Resources and support for audit programmes,

(h) Audit can augment both career and professional development,

(i) Training in audit techniques,

(j) Review staff training programme.

Example of clinical audit

Statin drugs may be in use as “One size shoe fit all” [8]

Most protocols on management of ACS emphasize immediate loading dose of a Statin, followed by maintenance dose. Lipid profiles are not required to be done during the immediate Post-ACS stabilization phase.

For this study, we chose 30 patients with an ACS, of all ages, gender and complications. We studied both stain therapy on admission and first review.

In that, only five patients’ lipid profiles were tested during hospitalization (out of which all had suboptimal HDL and two had elevated TGL). No one was tested for lipid profiles on first review. After initiation or upon titration, lipid levels are required to be analyzed within 2-4 weeks and dosage adjusted as per FDA monograph. That was also not followed.

In this study of 30 patients, we observe that most patients get a statin like “One size shoe fit all” without an evidence-based analysis and management of an abnormal lipid profile. This leaves an important risk factor for coronary artery and cerebrovascular disease unmitigated.

The way forward

When done well, clinical audit has provided a way in which the quality of the care can be reviewed objectively, within an approach that is supportive and developmental. Changes in society have subjected all areas of professional practice to question and challenge.Clinical audit provides practitioners with a systematic response that compares the care provided to best practice while preserving the central role of the clinical team in agreeing and implementing plans for change. Clinical governance presents a new challenge – to take audit ‘at its best’ and incorporate it within organization-wide approaches to quality [7].


Clinical audit, the cornerstone of clinical governance, ensures that the strategy is executed as planned, and in the process provides a framework to highlight and enable changes to be incorporated ensuring improved patient care. If audit culture is to be successful, then there needs to be a “NO BLAME CULTURE”. There should be no “Blame, Name or Shame”. Focus should only be on the patient care.

It must be reiterated that research needs the word ‘investigate’ and audit needs the word ‘improve’.

The immense potential of clinical audit can be utilized only when open-mindedness and innovativeness are encouraged and evidencebased work culture is cultivated.


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