This document provides an overview of medical audit, including: - Definitions of medical audit as the retrospective evaluation and analysis of medical records to monitor clinical performance. - The history of medical audit from ancient codes to its modern establishment in India in 2007 through the National Accreditation Board for Hospitals. - The purposes of medical audit which include planning improvements, ensuring regulatory standards, and assessing health program effectiveness.

1. MEDICAL AUDIT
Guided by – Presented by –
Dr. Holambe mam Dr. Jagdish Bansode
Asso. Professor Junior Resident - 2
Dated 04/07/2016

2. CONTENTS
• Definitions
• History
• Need and Purpose
• Prerequisite
• Medical audit committee
• Principles
• Stages
• Types
• Benefits
• Limitations
• Place of medical audit in modern medicine

4. DEFINITION
Medical Audit -
• Retrospective evaluation of quality of medical
care through the scientific analysis of medical
records.
• 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. • The review of the professional work that could take
place whenever the medical staff meet to analyze the
hospital clinical work ( Dr. Mudaliar in health survey
& planning committee report 1959-61,vol. 1,GOI )
• Medical care - only those elements of care which
are provided by or under specific direction of
physician.

6. - Quality of medical care – appropriate application of
medical knowledge with due regards to hazards
inherent in every medical intervention & the benefits
expected from it.( Dr. Avedis Donabedian, prof. public
health, university of Michigan ).
- Evaluation – carried out by matching the procedures
against approved standards.
- Standards – laid down on the basis of knowledge
which provide us with information about what should be
done in order to achieve the best results.

7. HISTORY
• 1750 BC: the 6th king of Babylon, Hammurabi
formulated audits for the clinicians in CODES OF
HAMMURABI, also first ever enlistment of charges
for services.
• 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.

8. - Codman's "end result idea" was to follow every
patient's case history after surgery to identify errors
made by individual surgeons on specific patients.
- Mayers and Slee 1956 suggested that a medical
audit should answer following 4 questions .
1) What did the patient have ?
2) What was done for him ?
3) Was the treatment optimum ? If not then why not ?
4) Was the outcome satisfactory ?If not then why not?

9. • December 15th 1951 – Joint Commission on
Accreditation of Hospitals/JCAH.
• 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 MEDICAL AUDIT
1. Professional motives - Health care providers can
identify their lacunae & deficiencies and make
necessary corrections.
2. Social motives - To ensure safety of public and
protect them from care that is inappropriate,
suboptimal & harmful.
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 available.
3. Assess the effectiveness of efficiency of health
programmes & services put into practice.

12. PREREQUISITES
1. Who will evaluate the services provided.
2. How often will it be done.
3. Hospital operational statistics
a. Hospital resources : Bed availability, diagnostic
and treatment facilities, staff available.
b. Hospital utilisation Rates : Days of care,
operations, deliveries, deaths, OPD investigations,
laboratory investigations etc.
c. Admission Data: Information on patients i.e.
hospital morbidity statistics, average length of stay
(ALS), operation morbidity, outcome of operation
etc.

13. PREREQUISITES
4. Standardized procedures of collection and tabulation
of hospital statistics.
5. Accurate and complete medical record should be
ensured.
6. A well trained Medical Record librarian , for carrying
out quantitative analysis.
7. Hospital planning and research cell should be
established at state level to tabulate and analyse data,
with recommendations for improvement.

14. MEDICAL AUDIT COMMITTEE
• 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 -
- Medical administrator
- Senior clinicians
- Pathologist
- Radiologist
- Matron
- Medical record officer

15. PRINCIPLES
1. Health authorities and medical staff should define
explicitly their respective responsibilities for the
quality of patient care.
2. Medical staff should organise themselves in order to
fulfil responsibilities for audit and for taking action to
improve clinical performance.
3. Each hospital and specialty should agree a regular
programme of audit in which doctors in all grades
participate.

16. PRINCIPLES
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
medical audit.
6. The process and outcome of medical audit should be
documented.
7. Medical audit should be subject to evaluation.

17. STAGES OF MEDICAL AUDIT
Stage 1. Preparing for audit
Stage 2. Selection of criteria
Stage 3. Measuring level of performance
Stage 4. Making improvements
Stage 5. Sustaining improvements

18. STAGE 1. PREPARING FOR AUDIT
1. Involving users
2. Selecting a topic
3. Defining the purpose
4. Planning

19. 1. INVOLVING USERS
• The focus of any audit project must be those receiving
care.
• The concerns of users can be identified from various
sources, including:
• letters containing comments or complaints
• individual patients’ stories or feedback from focus
groups
• direct observation of care
• direct conversations.

20. 2. SELECTING A TOPIC
• Topic should be of concern to service users and has
potential to improve service user ‘outcomes’.
• It should be of clinical concern
• 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).

21. • It should be practically implementable.
• There should be new research evidence available on
the topic.

22. AREA OF MEDICAL AUDIT
1. Indirect : ‘Structure' factors that influence efficiency
of medical care e.g. staff, equipment, physical
facilities and material supplies.
2. Direct :
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.

23. 3. DEFINING THE PURPOSE
• The following series of “actions” may be useful in
defining the aim of an audit – ( I.E. ICE )
• To Increase
• To Ensure
• To Improve
• To Change
• To Enhance

24. • to IMPROVE the blood transfusion processes within
the hospital.
• 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.

25. 4. PLANNING
• Involve ALL the people concerned
• Time and resources
• Access the evidence
• Data collection instrument
• Methodology
• Pilot
• Report and action
• Re-audit

26. STAGE 2. SELECTION OF CRITERIA
1. Defining criteria
2. Sources of evidence
3. Appraising the evidence

27. 1. DEFINING CRITERIA
• The audit criteria will provide a statement on what
should be happening.
• the standards will set the minimum acceptable
performance for those criteria.
• The criteria and standards must be - SMART
• Specific – clear, understandable
• Measurable
• Achievable
• Relevant – to the aims of the audit
• Theoretically sound – based on current research.

28. EXAMPLE
Audit title- the incidence of wound infection following
hernia repair
Criteria- there should be no wound infection in such
cases.
Standard- 95%, i.e. practice is satisfactory if less than
5% of cases have wound infection.

29. 1. DEFINING CRITERIA
• The basic types and sources of criteria:
• Statistical (empirical) criteria
• Normative (consensus) criteria
• Optimal care (general consensus)
• Essential (critical)
• Scientific (validated) criteria

30. 1) 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 their patients.
• These statistics may come from the individual
hospital's records or more commonly from hospital
data abstracting systems.

31. 2) 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
care.
• The fundamental shortcoming of optimal care criteria
is their lack of relationship to outcomes.

32. NORMATIVE (CONSENSUS) CRITERIA
2. Essential (critical):
• Consensus of experts in a particular disease or
condition on efficacious treatment and achievable
clinical results for that condition.
• 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.

33. 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."

34. 2. SOURCES OF EVIDENCE
Standards may be based on one, or any combination, of
the following:
• National guidance or standards
• College or professional organisation guidelines.
• Laws (e.g. Mental Health Act 1983).
• Current practice
• Standards used locally by colleagues or competitors

35. 2. SOURCES OF EVIDENCE
• Research evidence (from which standards can be
developed).
• Literature review of other clinical audits which have
published their standards/results.
• Current knowledge from clinical experience.

36. 3. APPRAISING THE EVIDENCE
Evidence needs to be evaluated to find out if it is valid,
reliable and important .

37. STAGE 3. MEASURING LEVEL OF
PERFORMANCE
1. Data collection
2. Data analysis
3. Comparing with standards set
4. Dissemination of feedback findings

38. 1. DATA COLLECTION
• Data can be collected from computer stored data,
case notes/medical records, surveys , questionnaires,
interviews, Focus Groups, Prospective recording of
specific data.
• The careful selection of an appropriate data collection
tool is also important.
• Do not try and collect too many items, keep it simple
and short.
• Always conduct a small pilot study.

39. • 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.
1. DATA COLLECTION

40. 2. DATAANALYSIS
• The following approaches may be used in analysing
data
- Descriptive statistics
- Statistical tests
- Qualitative analysis
• When analysing data, it is tried to reach conclusions
about the general pattern of actual practice.

41. 3. COMPARING WITH STANDARDS SET
Results may prove most meaningful if following
percentages are calculated:
• 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

42. 4. DISSEMINATION OF FEEDBACK FINDINGS
• 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.

43. STAGE 4. MAKING IMPROVEMENTS
1. Identifying barriers to change
2. Implementing change

44. 1. IDENTIFYING BARRIERS TO CHANGE
• Fear
• Lack of understanding
• Low morale
• Poor communication
• Culture
• Pushing too hard
• Consensus not gained

45. 2.IMPLEMENTING CHANGE
Develop a clinical audit action plan which specifies:
- What needs to change ?
- How change could be achieved – what actions need
to take place ?
- 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 ?

46. STAGE 5. SUSTAINING IMPROVEMENTS
1. Monitoring and evaluation
2. Re-audit
3. Maintaining and reinforcing
improvement

47. 1.MONITORING AND EVALUATION
• 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.

48. 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 delivery
• standards continue to be met (where no changes were
made).

49. AUDIT CYCLE

50. 3. MAINTAINING AND REINFORCING
IMPROVEMENT
Factors that have been identified for maintaining
improvements
• Reinforcing or motivating factors built in by the
management to support the continual cycle of quality
improvement.
• Strong leadership
• Integration of audit into organisation’s wider quality
improvement system

51. EXAMPLE
Problem :
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 action plan.
Audit title :
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.

52. Findings & plans for improvement
• 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 Tuberculosis (ETS).
• It also became apparent that the TB nurse was not
supported adequately by the treating clinicians to
submit outcome forms to the hospital planning units
in a timely manner.

53.  Improvement plan
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 Programme.

54. 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.

55. AUDITING THE MANAGEMENT
OF ACUTE ABDOMINAL PAIN IN THE SURGICAL
UNITS OF BANGOUR GENERAL HOSPITAL , UK-1977
Problem :
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 analyzed. 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 %.

56. Objective :
Increase the proportion of correct diagnoses made by
the junior accident and emergency staff from 57% to
80%-(the standard of the senior consultants).

57. Implementing change:
• 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
out systematically.
• The medical staff were told the results of the
analysis of each group of 100 consecutive forms.

58. Results:
 Diagnostic accuracy rose from 57%, to 71%;
 the proportion of patients admitted fell from 81
% to 75 %;
 the proportion who had unnecessary
laparotomies fell from 20% to 7 %.

59. Sustaining improvement:
• 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%.

60. TYPES OF MEDICAL AUDIT

62. TYPES OF MEDICALAUDIT
• 1) Morbidity audit
• 2) Audit of obstetric cases
• 3) Audit of operated cases
• 4) On the spot audit

63. MORBIDITY AUDIT
• 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 category.
AUDIT OF OBSTETRIC CASES
• Done in more or less on the same line as in operated
cases
• Here percentage of C/S, forceps application, MMR,
NMR etc. are the important parameters.
• It is done ward/unit wise.

64. AUDIT OF OPERATED CASES
• 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.

65. • 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.
ON SPOT MEDICAL AUDIT
• 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.

66. Medical Audit vs. Clinical Audit
• 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 staff.
• By 1994, the term ‘clinical audit’ appeared to have
largely replaced the earlier term ‘medical audit’

67. DIFFERENCE BETWEEN RESEARCH AND CLINICAL
AUDIT
RESEARCH CLINICAL AUDIT
Aim is to establish what is best
practice
Aim is to evaluate how close
practice is to
best practice and to identify
ways of improving the
quality of health care provided
Is designed so that it can be
replicated and so that its results
can be generalized to other
similar groups
Is specific and local to one
particular patient group - results
are not transferable to other
settings
Aims to generate new
knowledge
Aims to improve services
Is usually initiated by
researchers
Is usually led by service
providers

68. Is theory driven Is practice-based
Is often a one-off study Is an ongoing process
May involve administration
of a placebo
Never involves a placebo
treatment
May involve a completely
new treatment
Never involves a completely
new treatment

69. LIMITATIONS
1. The major loopholes are on the part of commitment,
participation and seriousness for the audits.
2. 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.
3. Low number of auditors is also a concern for hospital
audit in this country.

70. 4. The techniques for doing this are imperfect and are
not standardized, despite the seemingly clear-cut
methods described in official publications.
5. Being retrospective and dependent entirely on
information contained in the record, auditing can only
assess limited aspects of the technical quality of care.

71. PLACE OF MEDICAL AUDIT IN MODERN
HEALTHCARE
• 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 become stiff.

72. • In addition, number of malpractice and negligence
suits against the providers of healthcare are
increasing.
• This also puts additional pressure on organizations
and practicing physicians to evaluate the quality of
care provided.
• 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

73. • 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.

74. Benefits of clinical audit
• PATIENT / PHYSICIAN / HOSPITAL / COMMUNITY
• Identifies and promotes good practice and can lead to
improvements in service delivery and outcomes for
users.
• Can provide the information you need to show others
that your service is effective ( cost-effective) and thus
ensure its development.
• Provides opportunities for training and education.
• Helps to ensure better use of resources and,
therefore, increased efficiency.
• Can improve working relationships, communication
between staff, staff and service users, and between
agencies.

75. REFERENCES
• Prakash a.,medical audit,jaypee brothers delhi,1st
edition 2002 Pp 1-100
• NHS, CHI, Royal College of Nursing. Principles for
Best Practice in Clinical Audit. University of Leicester
Radcliffe Medical Press; 2002. p.976.
• Goel SL, Kumar R, Management of hospitals,hospital
administration in 21st century,vol 2,deep and deep
publications delhi Pp 301- 310
• Sharma Y, Mahajan P. Role of Medical Audit in health
Care Evaluation. JK science.1999;1(4).193-6.
• Clinical Audit And Case Review: Guidance from the
Faculty of Public Health.UK. 2012

76. • Ashwini NS, Vemanna NS, Vemanna P. The Basics in
Research Methodology: The Clinical Audit. JNMR
2011;5(3).679
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book chapter 2 [cited on june. 2016] available from
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https://en.wikipedia.org/wiki/Clinical_audit
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