Current Medicine Research and Practice 10 (2020) 110e115

Contents lists available at ScienceDirect

Current Medicine Research and Practice

journal homepage: www.elsevier.com/locate/cmrp

Review Article

The importance of clinical audit in India

Uma Perumal a, *, Meeta Rajivlochan b, Samiran Nundy a
a
Department of Surgical Gastroenterology and Liver Transplantation, Sir Ganga Ram Hospital, New Delhi, India
b
National Commission for Women, Government of India, India

a r t i c l e i n f o a b s t r a c t

Article history: Clinical audits, by comparing patient care processes with self-defined standard protocols, encourage a
Received 17 April 2020 healthcare model that is more responsible and patient-centric. They also provide valuable feedback to
Accepted 20 May 2020 medical practitioners, hospital managements and policy makers although there is a fear that a set of
Available online 26 May 2020
norms imposed from above may restrict the context-dependent judgment of practitioners. For clinical
audit to work in a country as diverse as India, we suggest a bottom-up model of clinical audit rather than
Keywords:
one which is top-down. Since clinical audit provides feedback to practitioners, it is important to involve
Clinical audit
them in developing the audit norms. Standardized protocols are the key to a health system that cares for
Healthcare in India
Optimal treatment
patients and clinical audits will always be needed even after greater resources for healthcare become
Better resource utilisation available here - indeed they are mandatory in most Western countries. They also have the potential of
establishing a stronger bond of trust between patients and healthcare providers.
© 2020 Sir Ganga Ram Hospital. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights
reserved.

1. Introduction
A universal healthcare system in India in the near future is a
distinct possibility. However as and when such a system comes into
being, it is important for us to radically re-orient our current
practice and create a patient-centric model. We suggest that one
strategy to achieve this could be, to encourage the compulsory use
of clinical audits which, by comparing patient care processes with
standard protocols, encourage the use of the best healthcare
models and provide valuable feedback to practitioners and makers
of policy.
The intrinsic value of the idea of a clinical audit lies in providing
systematic feedback to healthcare providers so that they might be
able to learn from experience and improve patient care. To say that
learning from experience is possible, presumes that there is scope
for improvement to begin with. To that extent, medical audit pre-
sumes that healthcare facilities across space and time have varying
levels of care independently of the health profile and disease profile
of patients treated. This idea has existed in the Western world since
the 1850s but it continues to generate concern in the medical
community till today.
There are two kinds of concerns expressed in the debate over
* Corresponding author.
E-mail address: uperumal@icloud.com (U. Perumal).
clinical audit. The first is that an admission that the quality of care
can vary depending on a large number of factors specific to the
healthcare facility rather than to the patients treated, in itself
presumes comparison of facilities and providers by third parties,
whether government or public, on the basis of some data. It also
presumes the existence of medical error or deviation from protocol.
Given that patient care routinely sees life threatening situations, to
question treatment decisions can be full of danger. Hence any
genuine effort at clinical audit must consciously refrain from
degenerating into a fault-finding exercise. No doubt, for any degree
of objectivity, it would be important to associate an external agency
with a clinical audit. However, it is even more important to involve
those who provide care within the facility with the conduct of
audit, and to provide them systematic feedback.
The second area of concern follows from the first. A clinical audit
or rather any audit is only possible against some established or well
accepted norms for providing care. Insofar as medical practices vary
widely not only within the country but within the same region, city
and even village, many doctors often contest the idea of following
any set of norms that claim to guide them or to supersede their
independent judgement. Today there are hardly any standard
treatment protocols in India even for widely prevalent diseases. The
efforts made by institutions like the National Accreditation Board
for Hospitals (NABH) to set up some norms have little currency in
India-the numbers of facilities accredited by the NABH numbered
only 662 till March 2020.1 And it does not seem as if the situation

https://doi.org/10.1016/j.cmrp.2020.05.010
2352-0817/© 2020 Sir Ganga Ram Hospital. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.
 U. Perumal et al. / Current Medicine Research and Practice 10 (2020) 110e115 111

will change rapidly in the near future.
It is even possible that the NABH efforts are seen as an exercise
by a group of medical professionals to claim authority that others
are reluctant to grant them.
The absence of any country-wide health care norms either for
infrastructure in health facilities or for patient care processes
including treatment protocols, should not be taken to mean that
clinical audits are not possible. To insist that such countrywide
norms need to be generated first, would be self-defeating.
Any audit that can check the services provided by a healthcare
facility against norms standardized within the facility, can certainly
provide valuable feedback for learning to the staff. For such audits
to happen, the first step needed would be for the facility in question
to document whatever norms they do follow and to maintain these
as internal reference points. The second step would be to maintain
detailed records of treatment provided.
Issues of this nature are even more pertinent with the arrival of
programmes like the Ayushman Bharat that aim to provide secondary
and tertiary care to a substantial section of the population.
Documentation of health care norms and of treatment decisions,
whatever these might be, is essential for maintaining continuity of
care.
In this article we shall1 discuss the definition of what constitutes
a clinical audit and the steps involved2 briefly review the current
methodology for conducting clinical audits in the developed world3
review the situation in India today and discuss constructive ap-
proaches to clinical audit that might ‘work’ for India and4 sum-
marize the way forward.
2. Definition of clinical audit and the steps involved
Clinical Audit is a process used by healthcare professionals to
assess, evaluate and improve care of patients in a systematic way. It
measures current practice against a pre-defined set of standards
and provides a framework to enable improvements in care and to
safeguard and provide a high quality of clinical care to patients.
How those standards are defined, would have important implica-
tions for the overall acceptance of the process and its perceived
value among health care providers in India.
Clinical audit is based on three kinds of protocols that determine
quality of care2,3 those that govern1 structural facilities in a hospital
such as fitting out operation theatres, nurse-patient ratios and
qualifications of personnel,2 patient care processes in a hospital
such as clinical pathways followed in treating patients including
use of appropriateness criteria, use of surgical safety checklists and
constitution of infection control committees3 patient related out-
comes such as recovery and complications. All these protocols put
together are designed with one simple objective: to see that pa-
tients recover in the shortest possible time and that the health
status they achieve is sustained even after leaving a hospital. This is
the question that must be asked throughout the patient's journey in
the hospital and if possible, outside it as well.
operation. For complications there are now grades described
by Clavien and Dindo5 which are being followed worldwide
and make comparisons easy. The criteria should be unam-
biguous and we should define standards e.g. operative
mortality which should be relevant locally to be ‘minimal’ or
‘optimal’ always keeping in mind the ‘ideal’ results that have
been achieved elsewhere.
iii) Measuring level of performance e This is done by the
collection and analysis of data, comparing the actual per-
formance with the set standards, and if the standards are not
met, noting the reasons for this.
iv) Making improvements- This entails presenting the results
and discussing them with our colleagues in our hospital and
elsewhere. We should use the results to develop an action
plan, specifying what needs to be done, how it will be done,
who is going to do it and by when.
v) Maintaining improvements - This follows the previous stages
of the audit, to determine whether the actions taken have
been effective, or whether further improvements are
needed. It involves repeating the audit/re-audit process (i.e.
targets, results, discussion); hence the terms 'audit cycle' or
'audit spiral' and entails “closing of the loop” of the audit
cycle. It is the most crucial step in the whole process to
improve efficacy in the desired area of interest. For instance,
we found that our mortality after a Whipple's procedure
(pancreaticoduodenectomy for cancer) was 13% during one
year against an internationally accepted figure of less than
5%. When we audited our results, we found that the deaths
had occurred in patients who had serum bilirubin levels
above 15 mg/dl and who were in continuing sepsis. When,
by draining the bile ducts preoperatively using plastic stents,
we brought the bilirubin levels down and controlled the
infection in this subset of patients, the operative mortality
came down to 4%. This could only have been achieved
because we maintained and continue to maintain a strict
clinical audit.

2.1. How it is done. The audit cycle

a. Audit is usually conducted in five stages.4

i) Preparation e This consists of choosing a topic which is a
high priority for the organization involved. For instance, in
our department, we choose to audit demographic data on
the patients we admit, data on what procedures we perform,
what complications follow and whether there is post-
operative mortality.
ii) Select criteria e the next step is to unambiguously define the Fig. 1. Schematic representation of an Audit cycle.
criteria. Even for mortality we may choose death during the
same hospital admission or within 30 days or 90 days after
112 U. Perumal et al. / Current Medicine Research and Practice 10 (2020) 110e115
The audit cycle is diagrammatically depicted in Fig. 1 and an
example of the audit we follow is in Fig. 2a, b and c.
3. Current clinical audit methodology in developed countries
In the developed world, increasingly there are laws to take
care of structural factors in healthcare facilities. Laws mandate
the qualifications of medical practitioners and paramedics who
may be employed in a healthcare facility and what procedures
they may perform. There are rules that make it mandatory for
healthcare facilities to have generator backup for operation
theatres. Accordingly, the focus of clinical audits in the devel-
oped world has increasingly shifted to process and outcome
measures.
Clinical audits in those countries have existed in some form or
another for over one hundred years. Conscious efforts are made
to record various parameters of patient care processes and to
Fig. 2. (a). Trends in the number of emergency and elective procedures performed between 1997 and 2019. (b). Procedures performed according to organ systems. (c). Data
illustrating all procedures done on Stomach with Morbidity rates.
improve patient care. All these learnings have been put together
in various Quality Improvement programmes for healthcare
outcomes. In the United Kingdom, the National Health Service
has a special audit department called The National Clinical Audit
and Patient Outcomes Programme (NCAPOP)6 and the USA has
the National Surgical Quality Improvement Program (ACS
NSQIP®)7 which is a nationally validated, risk-adjusted, out-
comes-based programme to measure and improve the quality of
surgical care.
Under the National Surgical Quality Improvement Program, a
study of data regarding 87,078 operations at 44 Veterans Admin-
istration centers in USA worked out risk adjusted mortality and
morbidity rates respectively for different surgical specialties.8,9 The
relationship between structure, process and outcomes was vali-
dated.10 Some estimates say that as a result of the Quality
Improvement programs, morbidity and mortality rates saw re-
ductions of 45% and 27% respectively.11
 U. Perumal et al. / Current Medicine Research and Practice 10 (2020) 110e115
Most of these countries follow a top-down approach to clinical
audit. A central authority is invested with legal status and the re-
sources to demand compliance.
3.1. Is there evidence that audit is effective?
The effectiveness of clinical audit continues to be a controversial
issue.12 Audit and feedback have not been consistently found to be
reliable. A systematic review13 found that providing health practi-
tioners with data on their performance in the form of evaluations
and feedback could help enhance their practice. However, the re-
sults of the assessments included in the analysis varied widely,
from obvious negative to very significant positive results. The ef-
fects were mainly small to moderate when they were successful.
The analysis concluded that the efficiency of the audit and feedback
was likely to be higher when baseline adherence to the prescribed
protocol was improved and feedback was more intensive. Part of
clinical governance is to determine whether patients are being
provided the best level of care. It is therefore important that we
monitor the process of care and recognize when it is required to
improve it. Audit provides us with the best available method to
accomplish this goal, and hence should be widely practiced.
a) Advantages of the audit process - Many doctors who practice
clinical audit feel that it helps them improve professionally,
improves communication among various disciplines and
various levels of personnel involved and encourages good data
keeping and research. Good audit probably improves patient
care and provides professional validation for the healthcare
provider
b) Disadvantages of audit e However many perceive it to be a
waste of time and feel that it detracts from patient care. Some
are reluctant to criticize others in order not to cause offense, or
be questioned themselves, in turn. They may also refuse to adopt
the standards defined, perceive audit as a professional threat,
with fear of unfair criticism, intimidation and ridicule. A further
serious objection, especially in developing countries where the
resources are so limited, is that a strict audit may curb profes-
sional creative freedom, restricting practice to a prescribed
policy and discourage innovation. There is an oft quoted saying
that we in developing countries follow every day - ‘Think global
but act local’- use the data generated elsewhere which is
appropriate, as well as applicable, to a particular patient
encounter.
4. Clinical audit in India
In 1959, the Ministry of Health and Family Welfare, Government
of India, set up a Committee to undertake the review of the de-
velopments that had taken place since the publication of the report
of the Bhore Committee in 1946 with a view to formulate further
health programs for the country in the subsequent five-year plan
periods. This committee headed by Dr. A. Lakshmanaswami
Mudaliar, submitted its report in 1962. In the report, amongst other
issues, emphasis was laid on the importance of medical audit (14
which was proposed as a standard function for all government
hospitals in India by Dr. Sushila Nayyar, Indian Minister of Health in
1969.
But despite all these good intentions, clinical audit came into
reality only after 2006, after accreditation bodies came into exis-
tence, like the NABH. This was established in 2005; it is a constit-
uent board of the Quality Council of India, set up to develop and
operate an accreditation system for healthcare organizations. It
streamlines the functions of hospitals at all levels and necessitates
audit process to establish continual improvement in the quality of
113
care provided. But the numbers of NABH accredited facilities re-
mains miniscule till today; nor do we have evidence that such
bodies have been able to popularize the concept of clinical audit.
In a survey of the attitude to medical audit of doctors from the
Nizam's Institute of Medical Sciences in Hyderabad, one of the
major super-specialty hospitals in this country, while 86% practi-
tioners thought that conducting audits was important, 0%, i.e. not a
single department, was ‘following an audit system’.15
Today, as individual incomes rise, there has been a significant in-
crease in health seeking behaviour among Indians and in health-
related expenditure. India has also become one of the major desti-
nations for medical tourism worldwide. Yet, an increase in health
expenditure has by no means created a demand for improvement in
the quality of care. Given the vulnerability of patients and the dearth
of well-informed patient centric discussions in public spaces, perhaps
it is unrealistic to have such expectations. Fortunately, in recent years
there has been a small body of physicians themselves who discuss
evidence-based medicine and who have tried in their own individual
ways, to set up mechanisms for clinical audit, wherever possible. In
the absence of legislation, these remain isolated efforts.
A significant change in the public health discourse in India has
been brought about by the entry of large government funded third
party insurance programs in the last two decades. These pro-
grammes seek to purchase the services of private providers for
insured families. Major states like Andhra Pradesh, Tamil Nadu,
Karnataka, Maharashtra, Gujarat have instituted such programmes.
The most recent entry has been the mega insurance scheme called
the Ayushman Bharat, funded by the Government of India. Today
these schemes account for almost one third of all health insurance
expenditure in India. While this has led to a serious infusion of
funds in healthcare, there has been no documented increase in
clinical audits or the use of accreditation mechanisms.
Such health insurance schemes could conceivably be used as a
platform to introduce quality of care indicators in the hospitals
empanelled with various governments at the state and the Centre.
However, till date, most state governments have tended to focus on
structural indicators of patient care like availability of well equip-
ped operation theatres, qualified staff etc. Such indicators are
concrete; easy to understand and evaluate. What is problematic is
that there is no clear established relationship between good
infrastructure and good clinical outcomes. In the absence of data on
outcomes, it is difficult to say that five-star and even seven-star
hospitals offer better patient outcomes than public hospitals.
The one case where some attempt was made to use process and
outcome indicators, was in the state of Maharashtra. In this state,
the government had partnered with public sector insurance com-
pany, the National Insurance Company, in 2012. In 2013, they
launched an appraisal tool for empanelment of hospitals using all
three categories of indicators-structure, process and outcome. This
tool included 85 standards to evaluate health care facilities.16 These
indicators were grouped into nine separate chapters, namely: 1)
Human resources 2) Infrastructure and Facilities 3) Infection Con-
trol 4) Medication Monitoring 5) Patient Medical Records 6) Stan-
dard Operating Protocols 7) Quality of Patient Care 8) Transparency
in Pricing and 9) Patient Satisfaction Indices. The appraisal tool is
being used till today in running the scheme.
While all these schemes routinely collect humongous data, the
data has not been made available in the public domain or even to
medical colleges for research purposes. Nor do we know whether
any of the data is provided to the empaneled hospitals by way of
feedback to improve current practice.
Given such a decentralized healthcare universe and the vastness
of India, it is worth exploring whether a bottom up approach, might
be more workable for us. It is here that the concept of clinical audit
becomes so valuable.
114 U. Perumal et al. / Current Medicine Research and Practice 10 (2020) 110e115
Clinical audits being protocol based, are in themselves very
patient-centric. Any universal healthcare system of international
quality, should prioritize better health status for patients over all
other factors. What are the kind of systems that care for patients?
The answer is simple: systems that are structured around standard
medical protocols actually care for patients. The availability of re-
sources is a subordinate issue. However much or little money is
pumped into the system, whether one condition or one thousand
are treated, the only way to build a patient centric system is to ask
what is the health status of the patient at every stage of treatment,
to record the answer and to collate the data.17 In the absence of this
focus, it is difficult to see how pumping money into the system
could in itself achieve any significant improvement in patient care
outcomes.
While the professional practice of medicine is protocol driven;
documentation of the underlying norms and treatment decisions
has been the exception rather than the rule. Continuous docu-
mentation of norms and treatment decisions, in itself, can be a
powerful force working towards greater accountability.
Clinical audits essentially compare patient care processes and
outcomes with standardized protocols and merely by doing so, they
encourage greater compliance with the protocols. To that extent
they are important to any healthcare system that hopes to provide a
high quality of care.
The healthcare market in India can only expand from this point
onwards. With the mushrooming of hospitals, patients have a wide
variety of hospitals to choose from. The competition between
hospitals to treat patients and increase footfalls has become
intense. In addition, the number of malpractice and negligence
cases against healthcare providers is rising. This places added
pressure on organizations and clinicians to determine the level of
care provided. Clinical audits, by demonstrating that standard
protocols have been followed, can protect healthcare providers
from malpractice suits. They can also help in building trust between
physician and patient. The process of audit ensures consistency in
delivery of clinical and non-clinical services; it also addresses the
habit of continual improvement.
No doubt any sustainable approach to medical audit would
require the existence of some third party to offer assistance to
health care facilities that wish to institute such an audit. However,
to arm such a third party with punitive authority or even authority
to dictate content, might well be counter-productive. The entire
objective of a clinical audit is to provide continuous feedback to
clinicians on the results of treatment provided by them. In such a
situation, it makes greater sense to involve the clinicians in the
development of the standards too.
Given the difficulty of securing consensus on a vast variety of
protocols, an alternative method could be to encourage physicians
to document whatever protocols they do follow on various pa-
rameters of patient care. A third party could provide an overall
framework and the parameters on which protocols should be
developed. The rest can be left to individual facilities and physicians
themselves. Reducing what is being done to writing, would be a
major step forward.
What the parameters of audit are, could be discussed. But the
need to document the norms and to maintain treatment records is
the basis of all patient care. Even such basic SOPs like writing
Operation Theatre notes instead of merely writing the name of the
procedure performed, are till date, not standardized in patient care
in the country.
Actually, we already have a successful model for accreditation
and audit that has been followed in the higher education sector in
India. The NAAC (National Assessment and Accreditation Council),
was set up in 1994 as an autonomous institute of the University
Grants Commission. Ever since those days, it has followed an
entirely voluntary model of accreditation. It was colleges and uni-
versities who realized that in a world driven by rankings, students
needed some reliable source of information about the credentials of
the institutions they were applying to. NAAC merely put all its
parameters in the public domain and positioned itself as a body
that would assist institutions of higher education. This simple fact
had the impact of improving the outcome of teaching and research.
NAAC charged for providing its services-institutions paid up will-
ingly. It is only in the last few years that state governments have
started saying that funds would only be released to NAAC
accredited institutions and not to others.
If such a voluntary model could be adopted for clinical audit in
India, it can offer the great positive that it would actively involve
physicians in developing parameters that might work for them and
facilitate a buy-in. Putting these in the public domain would
encourage transparency.
5. Summary and the way forward
A healthcare system that incorporates regular clinical audits, is
built on the premise that a cycle of learning can lead to continuous
improvement. Even apart from the quantifiable benefits of clinical
audits in the sense of improvement in patient related outcomes,
there are several social benefits of audit that are worth considering.
Firstly, merely the act of comparing practice with protocol, en-
courages practitioners to comply with the protocols. Even the most
basic activity of recording patient history, if done consistently, can
lead to great improvements in continuity of care. Secondly, the
activity of conducting a clinical audit, builds up a large body of
documentation that is available for remedial action of any kind.
Without such data, the possibility of remedial action cannot exist.
Thirdly, ascertaining whether the protocols have been followed in
any given situation, can provide significant protection to healthcare
providers against malpractice suits. Fourthly and perhaps this is the
most important, by building a body of data, by documenting norms
and treatment decisions and by encouraging transparency in pa-
tient care, healthcare facilities can help rebuild trust between
physician and patient. All these factors put together, can truly help
India in putting together a system of universal health care that can
serve as a model for the rest of the world.
Acknowledgements
The authors acknowledge the inputs provided by Dr. Udit
Vinayak, Sancheti Institute for Orthopaedics & Rehabilitation, Pune
and Mr. Parmanand Tiwari, Sir Ganga Ram Hospital.
The views expressed in this article are personal.
References
1. National accreditation board for hospitals & healthcare providers (NABH)
[Internet]. Available from: https://www.nabh.co/frmViewAccreditedHosp.aspx.
Accessed April 7, 2020.
2. Donabedian A. Evaluating the quality of medical care. Milbank Q. 2005.
1966;83(4):691e729.
3. Mainz J. Defining and classifying clinical indicators for quality improvement. Int
J Qual Health Care. 2003;15(6):523e530.
4. National institute for clinical excellence, royal college of nursing, university of
Leicester, commission for health improvement. In: Scrivener R, ed. Principles for
Best Practice in Clinical Audit. Repr. Abingdon: Radcliffe Medical; 2004:196.
5. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a
new proposal with evaluation in a cohort of 6336 patients and results of a
survey. Ann Surg. 2004;240(2):205e213.
6. Foy R, Skrypak M, Alderson S, et al. Revitalising audit and feedback to improve
patient care. BMJ. 2020;368:m213.
7. National Surgical Quality Improvement Program [Internet]. Chicago, IL: American
College of Surgeons; 2005. Available from: www.acsnsqip.org. Accessed April 7,
2020.
8. Khuri SF, Daley J, Henderson W, et al. Risk adjustment of the postoperative
 U. Perumal et al. / Current Medicine Research and Practice 10 (2020) 110e115
mortality rate for the comparative assessment of the quality of surgical care:
results of the National Veterans Affairs Surgical Risk Study. J Am Coll Surg.
1997;185(4):315e327.
9. Daley J, Khuri SF, Henderson W, et al. Risk adjustment of the postoperative
morbidity rate for the comparative assessment of the quality of surgical care:
results of the National Veterans Affairs Surgical Risk Study. J Am Coll Surg.
1997;185(4):328e340.
10. Daley J, Forbes MG, Young GJ, et al. Validating risk-adjusted surgical outcomes:
site visit assessment of process and structure. National VA Surgical Risk Study.
J Am Coll Surg. 1997;185(4):341e351.
11. Khuri SF, Daley J, Henderson WG. The comparative assessment and improve-
ment of quality of surgical care in the Department of Veterans Affairs. Arch Surg
Chic Ill 1960. 2002;137(1):20e27.
12. Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an
overview of systematic reviews of interventions. Med Care. 2001;39(8):II2e45.
13. Jamtvedt G, Young JM, Kristoffersen DT, Thomson O'Brien MA, Oxman AD.
115
Audit and feedback: effects on professional practice and health care outcomes.
Cochrane Database Syst Rev. 2003;(3), CD000259.
14. Govt of India-Ministry of health and family welfare, NHP India [Internet].
Report of the Health Survey and Planning Committee; 1961. Available from:
https://www.nhp.gov.in/sites/default/files/pdf/Mudalier_Vol.pdf. Accessed
April 6, 2020.
15. Bhaskar NL. Are we geared up for medical audit? e an endeavour for
improvement of quality in health care. IOSR J Dent Med Sci. 2012;1(2):35e38.
16. Govt of Maharastra-RGJAY Empanelment Process and NABH Scoring and
Grading Criteria. available from: https://www.jeevandayee.gov.in/MJPJAY/
RGJAYDocuments/NABHcriteria.pdf. Accessed April 6, 2020.
17. Karthikeyan G, Shirodkar U, Lochan MR, Birch S. Appropriateness-based
reimbursement of elective invasive coronary procedures in low- and middle-
income countries: preliminary assessment of feasibility in India. Natl Med J
India. 2017;30(1):11e14.