Medical audit

Dr SEEMA VERMA
Department of Community medicine
PGIMS Rohtak Haryana INDIA

Contents
 Introduction
 Definition of Medical Audit
 History of medical audit
 Need, Advantages and approaches for medical audit
 Pre-requisites for medical audit
 Stages of medical audit
 Types of clinical audit
 Global scenario
 Problems in Medical audit
 Conclusions
 References

What is Audit?
• The word „audit‟ has been derived from Latin word
„audire‟ which means „to hear‟.
• A systematic and critical appraisal of planning,
implementation and evaluation of services; in terms
of efficiency, effectiveness and quality, within given
resources.
 Audit in the wider sense is simply a tool to find out
what you do now;
 what you have done in the past, or
what you think you may wish to do in the future.

Definitions
• In 1989, the White Paper Working for patients defined
medical audit as „the systematic critical analysis of
quality of medical care including the procedures used
for diagnosis and treatment, the use of resources and
the resulting outcome and quality of life for the patient‟
• Medical audit later evolved into clinical audit and a
revised definition was announced by the NHS
Executive: „Clinical audit is the systematic critical
analysis of the quality of healthcare, including the
procedures used for diagnosis, treatment and care, the
use of resources and the resulting outcome and quality
of life for the patient(1991).

Definitions
• Clinical audit -quality improvement process to
improve patient care and outcomes by systematic
review and implementing change.
• Aspects of patient care – including structure,
processes and outcomes – are selected and
evaluated against explicit criteria and, where
necessary, changes are implemented at an
individual, team or service level.
• Further monitoring can then be used to confirm
the improvements in healthcare delivery.
(NICE)

By 1994, the term „clinical audit‟
appeared to have largely replaced the earlier term
„medical audit‟
Medical Audit
Clinical Audit
Review of clinical care
of patients provided by
the medical staff only
review of all aspects of the
clinical care of patients by
medical and paramedical staff.

Background History
1853–1855:
Florence Nightingale
1750 BC :
Hammurabi
1869–1940:
Ernest Codman -
first true medical auditor

But it became operational only in 2007, after
the establishment of National Accreditation
Board for Hospitals and Healthcare
Providers (NABH) in 2005.
1962:
Mudaliar committee
1969:
Dr Sushila Nayar
Mid 1980s:
more formal audit
needed- accelerated
by publication of
the Confidential
Enquiry into Peri
operative Deaths
(CEPOD) in 1987
and the
Government White
Paper, entitled
„Working for
Patients‟ in 1989.

NEED FOR CLINICALAUDIT
2. For Society- To ensure safety of
public and protect them from care
that is inappropriate, suboptimal
& harmful.
1. For Professionals- Healthcare providers
can identify their lacunae/deficiencies and
make necessary corrections.
3. For health promotion- To reduce patient sufferings and avoid the
possibility of denial to the patients of available services or injury by
excessive or inappropriate service.

PURPOSE OF CLINICAL AUDIT
• 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.
• Regulatory in nature for- full & effective utilization of staff & facilities.
• Assess the effectiveness & efficacy of health programs & services.
• Describe and measure present performance
• Help developing explicit standards
• Suggests what need to be changed
• Help mobilize resources for change

Approaches of Clinical Audit
Care is evaluated at the time
it is taking place
CLINICALAUDIT
CONCURRENT
AUDIT
RETROSPECTIVE
AUDIT
Care is evaluated after it
has been completed
through records
 Audit may be Internal OR External

PRE-REQUISITES FOR CLINICAL AUDIT
MEDICALAUDIT COMMITTEE
HOSPITAL STATISTICS
WELL ORGANISED MEDICAL
RECORD

Medical Audit Committee (MAC)
• MAC should consist of hospital consultants, committed to
Medical audit.
• It should be constituted of Medical administrator
1. Chairman- Senior clinicial consultant.
2. Member Secretary-Medical record officer.
3. Members- clinicians, Pathologist, Radiologist, Matron (NS)
and representative of MS.
• The committee should meet once in a month and submit the
report to medical superintendent (MS) as confidential.

Hospital operational statistics
a) Hospital resources : Bed compliment, diagnostic and
treatment facilities, staff available.
b) Hospital utilization Rates : Days of care, operations,
deliveries, deaths, OPD attendance, laboratory
investigations etc.
c) Admission Data: Information, on patients i.e. hospital
morbidity and mortality statistics, average length of
stay, hospital infection rate, etc.
The procedure of collection and tabulation of hospital
statistics should be standardized.

Medical records
• All the junior staff (Residents) to be trained and retrained as
how to fill up the medical records.
• Being the primary source of data, all the medical records must
be complete in all aspects before sending to the records
department.
• A well trained medical record librarian should be present for
carrying out quantitative analysis.
• Records to be properly tied up, coded and indexed month-
wise/disease-wise for easy retrieval.
• A complete and correct medical record is the backbone of
medical audit.

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.

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.

STAGES OF MEDICALAUDIT
• Preparing for AuditStage 1
• Selecting CriteriaStage 2
• Measuring PerformanceStage 3
• Making ImprovementStage 4
• Sustaining ImprovementStage 5
• Re- AuditStage 6

Stage 1: PREPARING FOR AUDIT
USERS
INFORMATION
SELECTING
A TOPIC
PRIORITISE
AUDIT
DEFINING
THE
PURPOSE
PLANNING
AUDIT

1. USERS INFORMATION
o Focus of any audit- those receiving care.
o The concern of users - identified from various sources:
 letters containing comments or complaints
 critical incident reports
 individual patients‟ stories/ feedback from focus grps
 direct observation of care
 direct conversations.

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 (e.g. an acknowledged
variation in clinical practice, high-risk procedures,
complex management).
• 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).

3. MEASURE TO PRIORITISE
HIGH
COST
HIGH
RISK
SERIOUS
QUALITY
PROBLEM
POTENTIAL
FOR NAP
PRIORITY FOR
ORGANISATION
EVIDENCE
AVAILABLE
(EBR)

4. DEFINING THE PURPOSE
o Purpose must be established before appropriate methods for audit
can be considered.
o The following series of “action verbs” may be useful in defining
the aims of an audit
INCREASE
ENHANCE
IMPROVE
ENSURE
REDUCE
CHANGE

5. PLANNING
o Involve ALL the people concerned
o Fix time and plan resources
o Access the evidence
o Methodology for data collection
o Pilot study
o Report for action
o Re-audit
All these should
be documented

STAGE 2: SELECTION OF CRITERIA
DEFINITION
OF CRITERIA
SOURCES OF
EVIDENCE
APPRAISING
THE
EVIDENCE

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
– Specific – clear, understandable
– Measurable
– Achievable
– Relevant – to the aims of the audit
– Theoretically sound – based on current research.

1. DEFINING CRITERIA
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.

2. SOURCES OF EVIDENCE
Standards may be based on one, or any
combination, of the following:
• National guidance or standards (e.g. Patients‟ Charter).
• College or professional organisation guidelines.
• Laws (e.g. Mental Health Act 1983).
• Standards used locally by colleagues or competitors (e.g.
neighbouring trust, ward, etc.).
• Evidence based Research (from which standards can be
developed).
• Literature review of other clinical audits which have
published their standards/results.
• Current knowledge from clinical experience.

3. APPRAISING THE EVIDENCE
• Evidence needs to be evaluated to find out if it is valid, reliable
and important.
• Whether meeting:
o Aims/Objectives,
o Study methodology,
o Past results/conclusions
o Extent of applicability
• Likely bias/causes for concern

STAGE 3: MEASURING THE LEVEL OF
PERFORMANCE

1B. METHODS OF DATA
COLLECTION
 Do not try to collect too many items, keep it simple, short and
relevant to present study.
 Computer-stored data
 Case notes/Medical Records
 Local surveys through questionnaires, interviews, focus groups
 Prospective recording of specific data and compilation
 Keep focus on the objective of the audit.

1A. PLANNING DATA
COLLECTION
 The collected data- needs to be precise, essential and adequate.
 To conduct- pilot study.
 The reliability of data can also be improved by providing
appropriate training in data collection for the person
undertaking this task.
.

2. DATA ANALYSIS
 The following approaches may be used in analysing the data:
• descriptive statistics
• statistical tests
 When analysing the data, we generally want to try to reach to
conclusions about the general pattern of actual practice.

3. DISSEMINATION OF FEEDBACK
FINDINGS
 Health Information Exchanges (HIE) to be strengthened-
important that all 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 the project.

STAGE 4: MAKING
IMPROVEMENTS
IMPLEMENTING
CHANGE
IDENTIFYING
BARRIERS TO
CHANGE

1. IDENTIFYING BARRIERS TO
CHANGE
 Fear
 Lack of understanding
 Low morale
 Poor communication
 Individual Culture
 Pushing too hard
 Doubt of outcome
 Consensus not gained

2. IMPLEMENTING CHANGE
A systematic approach needed for:-
 what needs to change
 how change could be achieved
 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
 Provide support for teamwork/Change culture

STAGE 5: SUSTAINING
IMPROVEMENT
Monitoring and
evaluation
Maintaining and
Reinforcing
improvement

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 not reached during implementation,
modifications to the plan/additional interventions will be
needed.
 Failed ICD-10 adoption approach in healthcare
settings- result in more intense regulatory
scrutiny and decrease financial results.

2. REINFORCING IMPROVEMENT
 Factors to be identified for maintaining improvement.
 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

STAGE 6: RE-AUDIT
After an agreed period, the audit should be repeated. The
same strategies for identifying the sample, methods and
data analysis should be used to ensure comparability
with the original audit. The re-audit should demonstrate
that the changes have been implemented and that
improvements have been made. Further changes may
then be required, leading to additional re-audits.
 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).

Audit Cycle
Select Topic
Identify best
Practices
Crieteria
/Standard
Collect Data
Analyse Data
Interpretation
Intervention
Reaudit

TYPES OF CLINICALAUDIT
CRITICAL
AREAAUDIT
STATISTICAL
AUDIT
DISEASE
AUDIT
DEATH
AUDIT
RESOURCE
UTILIZATION
OPERATION
CASES
RANDOM
CASE AUDIT
OBSTETRIC
CASES
INFECTION
CONTROL

1. STATISTICAL AUDIT
• Data on different indicators set by Audit committee are prepared
unit-wise on monthly basis.
• Data is generated, compiled and supplied by MRD.
• Data so obtained is critically examined and compared against
standard norms.
• Any deviation from standard norm warrants investigation to find
out possible cause and its remedial measure.

INDICATORS USED:
BED TURN
OVER RATE
BED
OCCUPANCY
AVERAGE
LENGTH OF
STAY
NET DEATH
RATE
ANAESTHETIC
DEATH
AUTOPSY RATE
CONSULTATION
RATE
INFECTION
RATE

2. AUDIT OF OPERATED CASES
• A group of patients who have been operated for a similar
surgical condition are analysed under this method.(e.g. Lap
Cholecystectomy).
• 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, PAC notes, Surgery and anaesthesia
operative notes, Postop infection rates are the points which are
investigated in this type of audit.
• Case sheets are examined against standard norms and
shortcomings are intimated to concerned unit for future
precaution and rectification.

3. AUDIT OF OBSTETRIC CASES
Indicators used are same as operative cases.
some additional points to be taken are-
• No. of C.S. done with indications.
• No. of forceps/ vacuum application.
• No. of Maternal Complications.
• No. of maternal or Neonatal deaths.

4. AUDIT OF DEATH CASES (Mortality Review)
• All the deaths taking place after 48 hrs. of admission to the
hospital should be subjected to review by the committee.
• Case sheets are examined for quantitative as well as qualitative
inadequacies and are then communicated to respective units
for remedial measures.
Various parameters used are :
A. Diagnosis, investigations, time of examination (delay)
B. Treatment given was acc. to standard treatment or not.
C. Type of consultations obtained and recorded.
D. Daily monitoring of Progress.

5. AUDIT OF RANDOM CASES
• Case sheets of discharged patients are randomly selected during a
month-TO STUDY QUALITY OF RECORD MAINTENANCE,
DIAGNOSTIC DEFICIENCY, TREATMENT & OUTCOME.
• Various parameters used:-
a) History, physical exam, diagnostic skills
b) Investigations done, treatment given, progress notes
c) Nursing care chart
d) Initial diagnosis is compared with final diagnosis.
e) Treatment given is judged against correctness, adequacy acc. to
norms.
f) End result of treatment is compared with patient condition at
discharge.
Any deviation from norms are intimated for improvement.

6. AUDIT OF DISEASE CASES
• All case sheets are arranged unit-wise and month wise.
• Group of physicians are asked to lay down certain norms
regarding specific disease with respect to:
a) Investigations to be done
b) Line of treatment
c) Average length of stay
d) Likely complications
Case sheets are examined against norms. The unit in which
shortcoming are found is directed to improve.
.

Example-
• Study subjects- All operated cases for gall bladder diseases at AIIMS,Delhi
• Study design- Retrospective study of medical records (During 1977)
• Methodology- Study carried in 3 phases:-
i. Phase1-
a) Cases were selected
b) Norms/Criteria were established as per their own standards (by surgeons
& anesthesiologists)
i. Phase 2- Medical records- relevant info abstracted
ii. Phase 3- Group discussion- To identify gaps & provide solution for
improvement
Results/Observations:
1) Overall,quality of patient care-quite satisfactory as per the norms set.
2) Problems & shortcomings- identified in certain parameters.
3) Use of antibiotics- Judicious & consistent.
4) Adequate PAC & monitoring- by anesthetists.
5) Post-operative infection rate & death rates- acceptable limits.
6) Post-op cases:
- Complication rates high
- Inadequate advise to pt at discharge.
- Follow-up record- Unavailable/Incorrect
- Length of stay before surgery-Longer than expected.
- Investigations for some pts- Not done/ Done without any reason
- Inadequate consultations with other specialties
- Poor recording of medical records
Solutions:
1) Remove communication gap between senior faculty members
and resident staff – Regarding appropriate guidelines- To
improve quality of pt care & medical records
2) Ensure proper programming of cases- for proper utilization of
available resources
3) Investigations without any specific reason- To be Avoided
4) Proper documentation & medical record maintenance- Stressed.
5) Reduce unnecessary delay- special investigations- radiology dept.
Recommendation:
Suitable clinical & administrative medical staff organization-
suggested for medical audit programs in large teaching

Medical Audit: Global View
USA: Medical audit became mandatory in 1974.
 Since the passage of Medicare & Medicaid in 1965, hospital-wide
quality assurance mechanisms are being implemented.
 Joint Commission on Accreditation of Healthcare Organisations
(JCAHO)- important role in implementation of quality assurance in
healthcare settings.
 American Medical Association (AMA) plays vital role in imparting
guidelines for diagnostic and therapeutic medical interventions.
 Patient Protection and Affordable Care Act (PPACA), 2010- Enacted
for better health outcomes, lower costs and improving methods of
distribution and accessibility of services by healthcare providers.

UK: Medical audit first got importance in 1989-91.
 British Govt. emphasized and proposed reforms in National
Health Services (NHS) for medical audit.
 National bodies provide guidelines, design, cost of quality
implications, training for support staff.
 King‟s Fund Center, London- houses Quality Assurance program
and Medical Audit program.
 Medical audit program contributed a lot through various articles
and publications worldwide.

Australia:
 Increase in National Health spending proved to be a stimulus
for development of formal audit program in 1970s.
 Australian Medical Association(AMA) together with
Australian Council on Healthcare Standards(ACHS) in 1979-
formed Peer Review Resource Center(PRRC)- so as to peer
review within medical profession and to identify barriers to
conduct the same.
 ACHS in 1983- made Quality Assurance mandatory standard
for accreditation in healthcare settings.
 PRRC also assists Royal Colleges in conducting national
surveys.

PROBLEMS IN MEDICALAUDIT
1. Lack of organized medical report, incomplete records, poor
quality maintenance.
2. Fear of action and lack of motivation of medical staff.
3. Ignorance of value of medical audit by hospital staff.
4. Suppression of facts, wrong reporting. Completion of records
after death restricts the true value of medical audit.
5. 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.”
6. Low number of auditors is also a concern for hospital audit in
this country.

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

Conclusions..
o Today, due to growing individual income, health has become a priority
for Indians.
o Patients put a lot of value to the quality of healthcare provided by the
hospitals.
o In recent years, with the mushrooming of hospitals, patients have an
array of hospitals to choose from.
o So the competition among the hospitals to maintain their standards
and improve them as and when required has become stiff.
o In addition, number of malpractice and negligence suits against the
providers of healthcare are increasing.

Conclusions..
o This also puts additional pressure on organizations and practicing
physicians to evaluate the quality of care provided.
o Hospitals have to create patient care and safety impact, the moment
a patient is admitted to the hospital through processes and
infrastructure.
o The process of audit ensures consistency in delivery of clinical and
non-clinical services; it also addresses the habit of continual
improvement

Conclusions
o 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.
o 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.

References
 „Medical Audit in India‟ 2nd ed- Book by Anjan Prakash,
Deepali Bhardwaj
 http://www.rfhha.org/images/pdf/Thesis_&_Dessertations/003
7.pdf
 Improving and strengthening use of ICD-10 and medical
record system in India,2005,CBHI,DGHS,MOHFW
 „Criteria based clinical audit‟ article by Pushpa
Kottur,Karnataka
 Internal audit capabilities and Needs survey-2014, Protiviti
 Various other articles from web.

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