4. Medical Audit is a planned programme
• which objectively monitors and evaluates the clinical
performance of all practitioners,
• which identifies opportunities for improvement, and
• provides mechanism through which action is taken to
make and sustain those improvements.
5. Medical Audit vs. ClinicalAudit
• Medical audit is defined as the review of the clinical care
of patients provided by the medical staff only.
• Clinical audit is the review of the activity of all aspects of
the clinical care of patients by medical and paramedical
• By 1994, the term ‘clinical audit’ appeared to have largely
replaced the earlier term ‘medical audit’
• 1750 BC: the 6th king of Babylon, Hammurabi instigated
audits for the clinicians.
• Modern medicine (1853–1855): Florence Nightingale
conducted first clinical audit during the Crimean War. She
applied strict sanitary routine & hygiene standards that
decreased the mortality rates from 40% to 2%.
• 1869–1940: Ernest Codman became known as the first
true medical auditor following his work in 1912 on
monitoring surgical outcomes. Codman's "end result idea"
was to follow every patient's case history after surgery to
identify errors made by individual surgeons on specific
• A growing requirement for more formal audit in the middle
1980s was accelerated by publication of the Confidential
Enquiry into Perioperative Deaths (CEPOD) in 1987 and
the Government White Paper, entitled ‘Working for
Patients’ in 1989.
• 1961: Report of Mudaliar committee stressed on
encouragement of medical audit in India.
• 1969: Then Health Minister of India Dr Sushila Nayyar
introduced medical audit in India.
• But it became operational only in 2007, after the
establishment of National Accreditation Board for Hospitals
and Healthcare Providers (NABH) in 2005.
10. NEED FOR MEDICALAUDIT
1. Professional motives- Health care providers can identify
their lacunae & deficiencies and make necessary
2. Social motives- To ensure safety of public and protect
them from care that is inappropriate, suboptimal &
3. Pragmative motives- To reduce patient sufferings and
avoid the possibility of denial to the patients of available
services; or injury by excessive or inappropriate service.
11. PURPOSE OF MEDICALAUDIT
1. To plan future course of action
• it is necessary to obtain baseline information through
evaluation of achievements for comparison purpose
with a view to improve the services.
2. Regulatory in nature
• ensures full & effective utilisation of staff and facilities
3. Assess the effectiveness of efficiency of health
programmes & services put into practice.
1. Hospital operational statistics
a. Hospital resources : Bed compliment, diagnostic and
treatment facilities, staff available.
b. Hospital utilisation Rates : Days of care, operations,
deliveries, deaths, OPD investigations, laboratory
c. Admission Data: Information on patients i.e. hospital
morbidity statistics, average length of stay (ALS),
operation morbidity, outcome of operation etc.
2. The procedure of collection and tabulation of hospital
statistics should be standardised.
3. Primary source of this data is medical records, hence
accurate and complete medical record should be ensured.
4. A well trained Medical Record librarian should be present
for carrying out quantitative analysis.
5. Hospital planning and research cell should be established
at state level to tabulate and analyse data, with
recommendations for improvement.
14. MEDICAL AUDITCOMMITTEE
• Medical audit committee should consist of hospital
consultants, who are committed to Medical audit.
• The committee should meet once in a month and submit
the report to medical superintendent (MS) as confidential.
• It should be constituted of
• Senior clinical consultant
• Consultants from concerned clinical depts
• Representative of MS
• Medical record officer Member Secy.
1. Health authorities and medical staff should define
explicitly their respective responsibilities for the quality of
2. Medical staff should organise themselves in order to fulfil
responsibilities for audit and for taking action to improve
3. Each hospital and specialty should agree a regular
programme of audit in which doctors in all grades
4. The process of audit should be relevant, objective,
quantified, repeatable, and able to effect appropriate
change in organisation of the service and clinical practice.
5. Clinicians should be provided with the resources for
6. The process and outcome of medical audit should be
7. Medical audit should be subject to evaluation.
17. FIVE STAGES
Preparing for audit
18. AUDITING THE MANAGEMENT
OF ACUTE ABDOMINAL PAIN IN THESURGICAL
UNITS OF BANGOUR GENERAL HOSPITAL, UK-
All patients referred urgently for general surgical problems
are seen first in the accident and emergency department by a
registrar or house officer.
A six-month survey showed that 10%, of all new patients
presented with acute abdominal pain.
The management of these patients was analysed. Junior staff
in the accident department made a correct diagnosis in 57%
of the patients while the most senior clinicians, who saw the
patients later, achieved an accuracy of 80 %.
GRUER R, GUNN A A, RUXTON A M. Medical audit in practice .BritishMedical_rournal,1977;
Increase the proportion of correct diagnoses made by the
junior accident and emergency staff from 57% to 80%-(the
standard of the senior consultants).
GRUER R, GUNN A A, RUXTON A M. Medical audit in practice .BritishMedical_rournal,1977;
20. Implementingchange:A structured one-page record form was
introduced to the accident and emergency department.
• The form acted as a check list, ensuring that the
medical staff recorded all the clinical features
necessary for diagnosing acute abdominal pain and
enabling them to see at a glance this information set
• The medical staff were told the results of the
analysis of each group of 100 consecutive forms.
Diagnostic accuracy rose from 57%, to 71%;
the proportion of patients admitted fell from 81 % to
the proportion who had unnecessary laparotomies
fell from 20% to 7 %.
• Diagnostic guidelines on the more common causes
of acute abdominal pain were issued to the accident
and emergency staff.
Diagnostic accuracy rose further to 77% and
admissions fell to 66%.
And this cycle of the audit continued.
Audit started in hospital and was extended, with the
help of a community physician, to cover the practice of
a group of general practitioners with the aim of
reducing "unnecessary“ referrals..
Preparing for audit
25. 1. INVOLVINGUSERS
• The focus of any audit project must be those receiving
• Users can be genuine collaborators, rather than merely
sources of data.
• The concerns of users can be identified from various
• letters containing comments or complaints
• critical incident reports
• individual patients’ stories or feedback from focus
• direct observation of care
• direct conversations.
26. 2. SELECTINGATOPIC
• Topic should be of concern to service users and has
potential to improve service user ‘outcomes’.
• It should be of clinical concern (e.g. an acknowledged
variation in clinical practice, high-risk procedures, complex
• It should be financially important (either very common
and/or very expensive).
• It should be of local and/or national importance (e.g. a
Department of Health initiative).
27. 2. SELECTINGATOPIC
• It should be practically viable (e.g. can be measured and
you will be able to implement change or effect the
implementation of change).
• There should be new research evidence available on the
• the incidence of wound infection following hernia repair
28. AREAOF MEDICALAUDIT
1. Indirect: ‘Structure' factors that influence efficiency of
medical care e.g. staff, equipment, physical facilities and
a) Process: Measures what a provider does to and for a
patient (e.g. ordering ECG for patient with chest pain) It
also means the 'way' a patient is moved through a
medical care systems
b) Out come: reflects what happened to the patient in terms
of palliation, treatment, cure or rehabilitation. It is
expressed primarily as the result of medical treatment vs
patients pre-hospitalisation state of health.
29. 3. DEFINING THEPURPOSE
• The following series of “action verbs” may be useful in
defining the aims of an audit
• To improve
• To enhance
• To increase
• To change
• To ensure
30. 3. DEFINING THEPURPOSE
• to improve the blood transfusion processes within the trust
• to increase the proportion of patients with hypertension whose
blood pressure is controlled
• to ensure that every infant has access to immunisation against
diphtheria, tetanus, pertussis, polio before 6 months of age.
31. 4. PLANNING
• Involve ALL the people concerned
• Time and resources
• Access the evidence
• Data collection instrument
• Report and action
Preparing for audit
33. STAGE 2. SELECTION OF
1. Defining criteria
2. Sources of evidence
3. Appraising the evidence
34. 1. DEFININGCRITERIA
• The audit criteria will provide a statement on what should
• the standards will set the minimum acceptable
performance for those criteria.
• The criteria and standards must be
• Specific – clear, understandable
• Relevant – to the aims of the audit
• Theoretically sound – based on current research.
35. Audittitle- the incidence of wound infection following
Criteria- there should be no wound infection in such
Standard-95%, i.e. practice is satisfactory if less than5%
of cases have wound infection.
36. 1. DEFININGCRITERIA
• The basic types and sources of criteria:
• Statistical (empirical) criteria
• Normative (consensus) criteria
• Optimal care (general consensus)
• Essential (critical)
• Scientific (validated) criteria
37. STATISTICAL (EMPIRICAL)CRITERIA
• Derived from regional or national statistics on length of
stay, current practices, complications, mortality.
• These are derived from statistics on actual practice.
• They define what physicians presently do in the care of
• These statistics may come from the individual hospital's
records or, more commonly, from hospital data abstracting
38. NORMATIVE (CONSENSUS) CRITERIA
Represent the judgment of physicians regarding what ought
to be done in the care of patients with certain diagnoses.
1. Optimal care (general consensus):
• Consensus of physicians on procedures that constitute
good medical care for a particular condition.
• They cannot be used to assess the technical quality of
• The fundamental shortcoming of optimal care criteria is
their lack of relationship to outcomes.
39. NORMATIVE (CONSENSUS) CRITERIA
2. Essential (critical):
• Consensus of experts in a particular disease or condition
on efficacious treatment and achievable clinical results for
• Essential criteria apply to almost every patient with a
specified condition because they stipulate elements of care
known to produce the desired clinical results in patients
with that condition.
40. SCIENTIFIC (VALIDATED)CRITERIA
• Clinical research that objectively establishes the efficacy of
treatment and its clinical results in specific conditions.
• The ideal criteria for an audit are purely scientific criteria
derived from results of randomized clinical trials (RCT).
• Scientific study establishes the degree of efficacy or
effectiveness of drugs, treatments or operations in
reducing mortality, preventing complications or objectively
improving the patient's condition.
• Unfortunately, all this information is not assembled or
published in a form that permits audit committees to pick
out pre-specified "scientific criteria."
41. 2. SOURCES OFEVIDENCE
Standards may be based on one, or any combination, of the
• National guidance or standards (e.g. Patients’ Charter).
• College or professional organisation guidelines.
• Laws (e.g. Mental Health Act 1983).
• Current practice (observe and assess current practice)
• Standards used locally by colleagues or competitors (e.g.
your neighbouring trust, ward, etc.).
42. 2. SOURCES OFEVIDENCE
• Research evidence (from which standards can be
• Literature review of other clinical audits which have
published their standards/results.
• Current knowledge from clinical experience.
43. 3. APPRAISING THEEVIDENCE
Evidence needs to be evaluated to find out if it is valid,
reliable and important
Applicable to your patient group
44. EXAMPLE-WHO CRITERIA FOR CLINICAL AUDIT OF
QUALITY OF HOSPITAL BASED OBSTETRIC CAREIN
Precedence was given to
evidence from RCT>
Studies with less robust
design> Expert opinion
Preparing for audit
47. STAGE 3. MEASURING LEVEL OF
1. Data collection
2. Data analysis
3. Comparing with standards set
4. Dissemination of feedback findings
48. 1. DATACOLLECTION
• Data can be collected from computer stored data, case
notes/medical records, surveys , questionnaires,
interviews, Focus Groups, Prospective recording of
• The careful selection of an appropriate data collection tool
is also important.
• Do not try and collect too many items, keep it simple and
• Always conduct a small pilot study.
49. • The reliability of data can also be improved by providing
appropriate training in data collection for the person
undertaking this task.
• Ensure that your data is stored in such a way that it is both
secure and conforms to legal requirements.
50. 2. DATAANALYSIS
• The following approaches may be used in analysing data
• descriptive statistics
• When analysing data, it is tried to reach conclusions about the
general pattern of actual practice.
51. 3. COMPARING WITH STANDARDSSET
Results may prove most meaningful if following percentages
• percentage of cases meeting each standard.
• percentage of cases not meeting each standard
• percentage of cases considered non-applicable
• percentage of applicable cases meeting each standard
• percentage of applicable cases not meeting each standard
52. 4. DISSEMINATION OF FEEDBACKFINDINGS
It is important that all of the key stakeholders are made
aware of the findings of the project and are provided with
an opportunity to comment on them.
A combination of passive feedback (written information)
and active feedback (discussion of findings) is preferable
when communicating the findings of project.
Preparing for audit
55. 1. IDENTIFYING BARRIERS TOCHANGE
Lack of understanding
Pushing too hard
Consensus not gained
56. 1. IDENTIFYING BARRIERS TOCHANGE
Some methods are
• Interviews of key staff and/ or users
• Discussion at a team meeting
• Observation of patterns of work
• Identification of the care pathway
• Facilitated team meetings with the use of brain storming or
Develop a clinical audit action plan which specifies:
what needs to change
how change could be achieved – what actions need to
who needs to take these actions
when the proposed actions will begin
how these actions will be monitored and by whom
how and when to assess whether the actions taken have
achieved the desired outcome
Preparing for audit
60. 1.MONITORING ANDEVALUATION
• Although improving performance is the primary goal of
audit, sustaining that improvement is also essential.
• Only minimum number of essential indicators should be
included in monitoring.
• If performance targets have not been reached during
implementation, modifications to the plan or additional
interventions will be needed.
61. 2. RE-AUDIT
It is important to go around the clinical audit cycle for a
second time in order to discover whether:
• agreed actions have occurred
• changes have achieved the desired improvements – i.e.
closer to set target and, therefore, improvements in service
• standards continue to be met (where no changes were
62. 3. MAINTAINING ANDREINFORCING
Factors that have been identified for maintaining
• Reinforcing or motivating factors built in by the
management to support the continual cycle of quality
• Strong leadership
• Integration of audit into organisation’s wider quality
The Annual Report from Enhanced Surveillance for
Tuberculosis showed that the rate of completion for
tuberculosis treatment was only 40% for a District for all
cases notified in 2007.This was way below the recommended
standards recommended by WHO and in the CMO’s TB
Hence this audit was done for all the TB cases notified in
2007, in order to find the possible causes and take measures
to improve the completion rates.
All the TB notification forms reviewed jointly with the TB
nurse, using the paper reports, and the electronic database
reports obtained from the National Enhanced Surveillance for
66. 30 notified cases in 2007
Outcome reports were
submitted for 16 cases
no record of outcome forms for
the other 14 cases
when the report was compiled at the Regional Office using the ETS
database, at 24 months after the initiation of treatment
one had died due to
one had moved out
2 were still on treatment
due to interruptions
caused by side effects
67. It also became apparent that the TB nurse was not
supported adequately by the treating clinicians to submit
outcome forms to the HPU in a timely manner.
Investigators set up systems within the HPU to monitor
submission of outcome reports, and worked to improve
engagement from treating clinicians in outcome surveillance,
as a part of the Hospital Trust’s Clinical Governance
68. Results of re-audit
In a re audit of cases notified in the following calendar year,
26 of the 28 cases had timely submission of outcome reports
with 24 cases completing treatment.
None of the patients were lost to follow up, and information
on the patients who had moved out was given in a timely
manner to the receiving HPUs.
70. TYPES OF MEDICALAUDIT
• A simple method of doing medical audit of a group of cases
suffering from a disease category.
• Findings are matched with predetermined norms and
standards of care laid down by medical staff for this disease
• It is done ward/unit wise.
71. AUDIT OF OPERATEDCASES
• A group of patients who have been operated for a similar
surgical condition are analysed under this method.
• Again a group of surgeons is asked to lay down the
desirable norms and standards.
• Particular emphasis is laid on the pathological reports of
the tissues during operation.
• The percentage of the preoperative diagnosis which tally
with the pathological diagnosis is an important parameter.
• Type of antibiotics used, the no. of postoperative infection,
the anaesthesia and operation notes are the points which
are investigated in this type of audit.
72. AUDIT OF OBSTETRICCASES
• Done in more or less on the same line as in operated
• Here percentage of C/S, forceps application, MMR, NMR
etc. are the important parameters.
73. AUDIT OF DEATH CASES IN THEHOSPITAL
• All the deaths which takes place after 48 hrs. of admission to the
hospital are normally subjected to a review by a committee
• also useful to review the deaths within 48 hrs (especially death in
• Case sheets are examined for quantitative as well as qualitative
74. ON SPOT MEDICALAUDIT
In this method medical audit team goes to a particular
ward and carries out audit when patient is still in ward and
treating medical team is available.
1. The major loopholes are on the part of commitment,
participation and seriousness for the audits. Audits in
Indian scenario are still more or less considered as an
obligation and are done only to fulfil the requirement of
various accreditation or other external agencies rather
than for the improvement of hospital processes and
quality in actual.
2. Low number of auditors is also a concern for hospital
audit in this country.
3. The techniques for doing this are imperfect and are not
standardized, despite the seemingly clear-cut methods
described in official publications.
4. Being retrospective and dependent entirely on information
contained in the record, auditing can only assess limited
aspects of the technical quality of care.
77. PLACE OF MEDICALAUDIT IN MODERN
• Today, due to growing individual income, health has
become a priority for Indians.
• Patients put a lot of value to the quality of healthcare
provided by the hospitals.
• In recent years, with the mushrooming of hospitals,
patients have an array of hospitals to choose from.
• So the competition among the hospitals to maintain their
standards and improve them as and when required has
• In addition, number of malpractice and negligence suits
against the providers of healthcare are increasing.
78. PLACE OF MEDICALAUDIT IN MODERN
• This also puts additional pressure on organizations and
practicing physicians to evaluate the quality of care
• Hospitals have to create patient care and safety impact,
the moment a patient is admitted to the hospital through
processes and infrastructure.
• The process of audit ensures consistency in delivery of
clinical and non-clinical services; it also addresses the
habit of continual improvement
79. PLACE OF MEDICALAUDIT IN MODERN
• Medical audit is far more important to a hospital than
financial audit. Financial deficits can be met eventually but
medical deficiencies can cost lives, or loss of health
thereby resulting in unwanted agony.
• Medical audit has just begun to gain momentum in India
and needs acceptability by the hospital systems and
medical fraternity as an improvement initiative rather than
a fault finding mechanism.
• NHS, CHI, Royal College of Nursing. Principles for Best Practice in
Clinical Audit. University of Leicester Radcliffe Medical Press; 2002.
• Sharma Y,Mahajan P.Role of Medical Audit in health Care Evaluation.
• Clinical Audit And Case Review: Guidance from the Faculty ofPublic
• Ashwini NS, Vemanna NS, Vemanna P.The Basics in Research
Methodology: The Clinical Audit. JNMR 2011;5(3).679-82.
• Sanazarop J.Medical Audit, Continuing Medical Education and Quality
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• Undertaking a clinical audit project: a step-by-step guide e book
chapter 2 [ cited on dec. 2012]
available from www.rcpsych.ac.uk/pdf/clinauditChap2.pdf