MAHARISHI MARKANDEHSHWAR (DEEMED TO BE

UNIVERSITY) MULLANA, AMBALA

RESEARCH REPORT ON
“A Study on Consent form Compliance and Quality
Improvement at Private Hospital”
SUBMITTED IN PARTIAL FULFILLMENT OF THE
REQUIREMENT FOR
THE AWARD OF DEGREE OF
MASTER OF BUSINESS ADMINISTRATION (MBA)
(2023-2025)

SUBMITTED To:- SUBMITTED BY:-

Dr.Rajit Verma Dr.Sanjana Singh
(PROFESSOR) MBA - 4A
MMIM,Mullana,Ambala 12237039

1
 STUDENT DECLARATION

I hereby declare that this project report entitled CONSENT

FORM COMPLIANCE AND QUALITY
IMPROVEMENT AT PRIVATE HOSPITAL was carried
out by me for the degree of MBA under the guidance and
supervision of Dr. Rajit Verma, Professor at Department of
Management, Maharishi Markandeshwar (Deemed To Be
University).The interpretations put forward are based on my
reading and understanding of the original texts and they are
not published anywhere in any form. The other books, articles
and websites, which I have made use of are acknowledged at
the respective place in the text. This research report is not
submitted for any other degree or diploma in any other
University.

Place: MULLANA, AMBALA

Name of the Student: Dr. SANJANA SINGH CHHOKAR
Class &Section: MBA 4A

1
 CERTIFICATE

It is certified that the work contained in the Research project

report titled Consent form compliance and quality
improvement at private hospital by Dr.Sanjana Singh
Chhokar, has been carried out under my/our supervision and
that this work has not been submitted elsewhere for a degree.

Signature of Supervisor:…………….
Name:
Dr.Rajit Verma
(Professor)
Department: MMIM
Maharishi Markandeshwar University April, 2025

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ACKNOWLEDGEMENT
I am Dr.Sanjana Singh Chhokar, a student pursuing
MBA at Maharishi Markandeshwar University,
Mullana, Ambala, would like to express my heartfelt
gratitude for providing me with the opportunity to
work on the Research project titled "Consent form
compliance and quality improvement at private
hospital” Your support and encouragement have been
instrumental in the successful completion of this
project.
I would like to extend my sincere appreciation to
Dr.Rajit Verma, my research project guide, for their
invaluable guidance and supervision throughout the
research. Their expertise and constant encouragement
helped me stay focused and motivated during the entire
project duration.
I have made efforts in this project. However, it would
not have been possible without the kind support and
help of many individuals and my supervisor.
I would like to express my gratitude to my parents for
their kind co-operation and encouragement which
helped me in the completion of this project.
I would like to express my special gratitude and thanks
to the industry for giving me such attention and time.
My thanks and appreciations also go to my colleague
in developing the project and the people who have
willingly helped me out with their abilities.

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Dr.SANJANA SINGH CHHOKAR

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 TABLE OF CONTENT
Student Declaration 1 I
Certificate 2 I
Acknowledgement 3 I
Executive summary 7 V
CHAPTER CHAPTER TITLE PAGE
NO.
NO.
1111
Introduction
 Introduction to Industry 10-16
1
 Introduction to the Company 17-24
 Introduction to topic of the Research 25-27
Literature Review 28-32 2
2
Research Methodology
 Research Aim and Objectives 34
 Scope of the study 34
3  Research Design 35
 Sample Design 36
 Data collection 37
 Tool 38

4 Data Analysis and Interpretation 40-61 2

Findings and Suggestions, 4
5
Recommendation Of the Study, Discussion 62-67
and Conclusion
6 Reference & Bibliography 68-71 5

7 Annexure 72-73

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 LIST OF TABLES
Table no TABLE TITLE Page no.
1.1 Checklist for consent form compliance for OT patients 39
2.1 Consent form compliance percentage for each speciality 41
2.2 Consent form compliance (count of 1) 43
3.1 Cardiology Count of Grade 43
3.2 Cardiology consent forms (non-compliance %) 43
3.3 Cardiology consent forms (compliance % ) 43
4.1 ENT Count of grade 45
4.2 ENT Consent forms (non-compliance %) 45
4.3 ENT Consent forms ( compliance % ) 46
5.1 Gastro – Enterology Count of grade 47
5.2 Gastro-Enterology consent forms (non-compliance % ) 47
5.3 Gastro- Enterology consent forms (compliance %) 48
6.1 General surgery Count of grade 49
6.2 General surgery Consent forms ( non-compliance %) 49
6.3 General Surgery consent forms (compliance %) 50
7.1 Neurology count of grade 51
7.2 Neurology consent form (non-compliance % ) 51
7.3 Neurology consent form (compliance %) 52
8.1 Neurosurgery count of grade 53
8.2 Neurosurgery consent forms (non-compliance %) 53
8.3 Neurosurgery consent forms (compliance % ) 54
9.1 Orthopedics count of grade 55
9.2 Ortho consent forms (non-compliance %) 55
9.3 Ortho consent forms (compliance %) 56
10.1 Urology count of grade 57
10.2 Urology consent form (non-compliance %) 58
10.3 Urology consent form (compliance %) 58
 LIST OF FIGURES
S.No Title Page No.
1.1 Speciality: Non- compliance 41
1.2 Speciality: Compliance 42
2.1 Cardiology: Non –compliance 44
2.2 Cardiology: Compliance 45
3.1 ENT: Non-compliance 46
3.2 ENT :Compliance 46
4.1 Gastroenterology: Non-compliance 48
4.2 Gastroenterology: Compliance 49
5.1 General surgery: Non-compliance 50
5.2 General surgery: Compliance 51
6.1 Neurology: Non-compliance 52
6.2 Neurology: Compliance 53
7.1 Neurosurgery: Non-compliance 54
7.2 Neurosurgery: Compliance 55
8.1 Orthopaedics : Non-compliance 56
8.2 Orthopaedics : Compliance 57
9.1 Urology : Non-compliance 58
9.2 Urology : Compliance 59

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EXECUTIVE SUMMARY
This project report explores the critical area of consent form compliance and
the corresponding quality improvement initiatives undertaken at a private
hospital to enhance patient safety, legal adherence and clinical accountability.

Informed consent is an essential legal and ethical requirement in clinical

practice .Properly completed consent forms serve to protect patient’s rights,
ensure transparency and minimize medico-legal risks for healthcare providers.
Preliminary interval audits at the hospital revealed inconsistencies in consent
form documentation including incomplete entries, lack of specific procedural
details and missing patient or physician signatures. These lapses raised
concerns regarding the quality of care, patient autonomy and institutional
liability.

A phased quality improvement methodology was adopted using the Plan-Do-

Study-Act (PDSA) cycle. The project began with a retrospective audit of
randomnly selected consent forms at OT. Quantitative indicators included
completeness of documentation, presence of signatures, clarity of procedural
explanation and documentation of risks and alternatives. Qualitative data were
collected through staff interviews and observation of consent taking processes.
Common deficiencies included:-
 Missing patient or witness signatures.
 Generic procedure descriptions lacking specific information.
 Inadequate documentation of risks, benefits and alternatives.
 Inconsistent use of updated consent templates.
Root causes were attributed to staff turnover, lack of standardization, time
constraints, and insufficient training on legal and ethical aspects of consent.
The interventions implemented were:-
 Standardized consent templates:- Redesigned consent forms tailored to
specific procedures with mandatory fields.
 Training and sensitization sessions:- Workshops for clinical staff focusing
on legal implications, patient communication and best practices.
 Checklist Integration:- A consent quality checklist was introduced to ensure
completeness before proceeding with any procedure

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 Monitoring and Feedback loop:- Monthly audits were conducted post-
intervention, and feedback was shared with department heads.
Post –intervention audits demonstrated a significant in compliance rates,
which rose to 91%within three months. Staff demonstrated increased
awareness and adherence to documentation protocols. Patient satisfaction
regarding the clarity of procedure explanation also improved as reported.
This project highlights the importance of systematized consent procedures in
improving clinical governance and patient engagement. The combination of
standardized tools, continuous training and accountability mechanisms proved
effective in elevating documentation standards.
To ensure long-term sustainability, it is recommended that:-
 Consent compliance be integrated into routine quality assurance audits.
 Digital consent systems be explored for better tracking and storage.
 Refresher training sessions be conducted biannually to maintain staff
competency.

8
 CHAPTER 1
INTRODUCTION

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1.1 INTRODUCTION TO INDUSTRY
Healthcare has become one of India’s largest sectors, both in terms of revenue
and employment. Healthcare comprises hospitals, medical devices, clinical
trials, outsourcing, telemedicine, medical tourism, health insurance and
medical equipment. The Indian healthcare sector is growing at a brisk pace
due to its strengthening coverage, services, and increasing expenditure by
public as well as private players.India’s healthcare delivery system is
categorized into two major components - public and private. The government,
i.e., the public healthcare system, comprises limited secondary and tertiary
care institutions in key cities and focuses on providing basic healthcare
facilities in the form of Primary Healthcare Centers (PHCs) in rural areas. The
private sector provides most secondary, tertiary, and quaternary care
institutions with a major concentration in metros, tier-I, and tier-II cities.

India's competitive advantage lies in its large pool of well-trained medical

professionals. India is also cost-competitive compared to its peers in Asia and
Western countries. The cost of surgery in India is about one-tenth of that in the
US or Western Europe. The low cost of medical services has resulted in a rise
in the country’s medical tourism, attracting patients from across the world.
Moreover, India has emerged as a hub for R&D activities for international
players due to its relatively low cost of clinical research.

MARKET SIZE
The Indian Healthcare industry continued its healthy growth in FY23 and
reached a value of US$ 372 billion driven by both the private sector and the
government. As of FY24, the Indian healthcare sector is one of India’s largest
employers as it employs a total of 7.5 million people. Progress in telemedicine,
virtual assistants, and data analytics is expected to create 2.7-3.5 million new
tech jobs.India’s public expenditure on healthcare is expected to be 1.9% of
GDP in FY26, compared to 2.5% in FY25, as per the Economic Survey 2024-
25.As on January 20, 2025, 36 States/ UTs have set up 53 Tele MANAS Cells
and have started Tele mental health services. More than 17.6 Lakh calls have
been handled on the helpline number.The government announced Rs. 9,406

10
crore (US$ 1.08 billion) outlay for PMJAY in the Union Budget FY26, an
increase of 28.8% from budget FY25.India's pharmaceutical industry is
anticipated to undergo significant growth, with exports projected to reach Rs.
30,76,500 crore (US$ 350 billion) by FY47, representing an increase of 10 to
15 times from current levels of Rs. 2,37,330 crore (US$ 27 billion).As on
January 20, 2025, more than 73 crore Ayushman Bharat Health Accounts
(ABHA) have been created successfully and there are more than 5 lakh health
professionals registered.Between April 2000-September 2024, the FDI inflow
for the drugs and pharmaceuticals sector stood at Rs. 2,00,148 crore (US$
23.04 billion).Inflows in sectors such as hospitals and diagnostic centres and
medical and surgical appliances stood at Rs. 97,208 crore (US$ 11.19 billion)
and Rs. 32,403 crore (US$ 3.73 billion), respectively, between April 2000-
September 2024.India's healthcare workforce has already exceeded 6 million
as of CY24. However, this represents only the beginning, as the sector is
anticipated to experience substantial growth, with over 6.3 million additional
jobs expected by CY30.The telemedicine market is expected to reach US$ 5.4
billion by FY25, driven by increased demand for remote healthcare solutions
and advancements in technology.In FY24 (Till February 2024), premiums
underwritten by health insurance companies grew to Rs. 2,63,082 crore (US$
31.84 billion). The health segment has a 33.33% share in the total gross
written premiums earned in the country.

The health-tech sector is set for significant expansion, with hiring projected to
rise by 15-20% in 2024, reflecting the increasing demand for innovative
healthcare solutions and the integration of technology in medical
services.Indian medical tourism market was valued at US$ 7.69 billion in 2024
and is expected to reach US$ 14.31 billion by 2029. According to India
Tourism Statistics, around 634,561 foreign tourists came for medical treatment
in India in 2023, which was nearly 6.87% of the total international tourists
who visited the nation. With US$ 5-6 billion size of Medical Value
Travel(MVT) and 500000 International patients annually, India is among the
global leader destinations for international patients seeking advanced
treatment.The e-health market size is estimated to reach US$ 10.6 billion by
FY25.As per information provided to the Lok Sabha by the Minister of Health

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 & Family Welfare, Dr. Bharati Pravin Pawar, the doctor population ratio in the
country is 1:854, assuming 80% availability of 12.68 lakh registered allopathic
doctors and 5.65 lakh AYUSH doctors.

INVESTMENTS/ DEVELOPMENTS
 Apollo Hospitals, and the University of Leicester have established the Centre
for Digital Health and Precision Medicine in Chittoor, Andhra Pradesh. This
initiative seeks to transform healthcare by advancing research and education in
digital health, precision medicine, and specialized healthcare programs.

 Ishwarya Hospital launched in Chennai with twelve-story building features 14

operational rooms and 72 clinical service departments. It is equipped with AI-
powered CT and MRI machines, a catheterization lab, advanced surgical
interventions, and specialized therapies in cardiology, orthopedics, and
neurology.

 In February 2025, Metropolis Healthcare has partnered with Roche

Diagnostics India to launch a self-sampling HPV DNA test for cervical cancer
screening. This innovative test empowers women to take charge of their health
by allowing them to collect their samples for testing in a comfortable and
convenient manner.

 Tata Group has partnered with the Indian Institute of Science (IISc) to
establish Tata IISc Medical School at the institute’s Bangalore campus and
will contribute Rs. 500 crore (US$ 57.6 million) to support it.

 The Indian medical devices sector has witnessed remarkable growth in recent
years and is expected to reach Rs. 4,34,350 crore (US$ 50 billion) by FY31
driven by increasing demand for quality healthcare, advancements in
technology, and favourable government policies. Start-ups in this sector have
been instrumental in fostering innovation, improving accessibility, and
reducing costs.

 In 2024, DNA Wellness announced a Rs. 200 crore (US$ 23.98 million)
investment to establish over 100 cervical cancer screening labs across India by

12
 2027. They have exclusive rights to the CERViSure DNA Ploidy Test, a quick
and non-invasive cancer detection method. The first lab opened in
Ahmedabad, with more planned in Vadodara, Rajkot, and Surat by October
2024. This initiative aims to improve access to cervical cancer screening,
addressing the significant health burden of approximately 130,000 new cases
and 80,000 deaths annually in India.

 Apollo 24|7 has merged with Keimed in a Rs. 2,475 crore (US$ 296 million)
deal, with Advent International acquiring a 12.1% stake in the new entity
valued at Rs. 22,481 crore (US$ 2.69 billion). Apollo Hospitals will maintain a
majority stake of at least 59.2%.

 DocPlix, a health-tech startup, raises Rs. 1.2 crore (US$ 0.14 million) in a
bridge round led by Inflection Point Ventures (IPV), aiming to digitize health
records for India's 1.4 billion population and enhance healthcare accessibility.

 IIT Bombay partners with Blockchain for Impact (BFI) to receive a US$
900,000 investment aimed at developing affordable healthcare technologies, as
part of a broader US$ 15 million BFI-Biome initiative to address urgent health
challenges and advance biomedical innovation.

 In May 2023, Temasek, a Singaporean investment company, invested US$ 2

billion in Manipal Health Enterprises, a leading healthcare provider in India,
highlighting the growing interest in the Asian healthcare market.

 In September 2023, Nirma a diversified Indian conglomerate, acquired a 75%

stake in Glenmark Life Sciences, a pharmaceutical company, for US$ 689
million. This transaction marked one of the biggest Indian healthcare M&A
deals of the year.

 As of August 1, 2023, a total of 24.33 crore Ayushman cards have been

created. To prevent, detect, and deter healthcare fraud and to ensure that
eligible beneficiaries receive adequate treatment, the Government of India is
using Artificial Intelligence (AI) and Machine Learning (ML). As of October
2023, a total of 26 crore Ayushman cards have been created.

13
 As of February 20, 2023, more than 220.63 crore COVID-19 vaccine doses
have been administered across the country. While as of May 11, 2023, more
than 2.20 billion COVID-19 vaccine doses have been administered across the
country.

 As of July 15, 2023, India has exported 30.12 crore vaccine doses.

 Multinational healthcare company Abbott has committed to converting 75

Primary Health Centers (PHCs) to Health and Wellness Centers (HWCs) in
nine Indian States, in collaboration with Americares India Foundation, a
nonprofit organisation dedicated to relief and development in the field of
health. This will benefit over 2.5 million people from under-resourced
communities every year.

GOVERNMENT INITIATIVES
Some of the major initiatives taken by the Government of India to promote the
Indian healthcare industry are as follows:
 The government has allocated Rs. 99,858 crore (US$ 11.50 billion) to the
healthcare sector in the Union Budget 2025-26 for the development,
maintenance, and enhancement of the country's healthcare system. This
reflects a 9.78% increase from the previous allocation of Rs. 90,958 crore
(US$ 10.47 billion) in FY25.

 On January 25, 2025, India's Prime Minister, Mr. Narendra Modi, and
Indonesia's President, Mr. Prabowo Subianto, signed a Memorandum of
Understanding (MoU). This MoU aims to establish quality assurance standards
for traditional medicine, representing a significant advancement in the pursuit
of global standards in this field.

 Union Ministers of State for Health and Family Welfare, Mr. Prataprao
Ganpatrao Jadhav and Mrs. Anupriya Singh Patel, recently unveiled three key
initiatives at the Ayushman Bharat, Quality Health event. These initiatives aim

to enhance healthcare quality and facilitate ease of doing business in India,

including a virtual NQAS assessment for Ayushman Arogya Mandirs, an

14
 IPHS compliance dashboard for real-time monitoring of public health
facilities, and a spot food licence initiative for food vendors.

 Union Minister of Health and Family Welfare and Chemicals & Fertilizers Dr.
Mansukh Mandaviya, virtually launched 'MedTech Mitra,' a platform designed
to support young Indian innovators in the MedTech sector by aiding in their
research, development, and regulatory approvals, aiming to reduce import
dependence and transform India into a leading US$ 50 billion MedTech
industry by 2030, while fostering indigenous development of affordable,
quality medical devices and diagnostics, in line with the vision of Viksit
Bharat and Atmanirbhar Bharat.

 Poshan Abhiyan is a Centrally Sponsored Scheme with the implementation of

the scheme being done by States/UTs. To ensure that all Anganwadi Centres
are equipped with Smart phones and Growth Monitoring devices (GMDs)
such as Infantometer, Stadiometers, and Weighing Scale for Mothers and
Infant, the Ministry has released revised guidelines for technical specifications
and replacement of GMDs by the States.

India's healthcare industry is a major economic sector, experiencing rapid

growth and significant expansion in recent years. Driven by both government
and private sector initiatives, it is a large employer, contributing to the
country's overall economic development.
Key aspects of the Indian healthcare industry:
 Significant Growth:
The industry has seen substantial growth, with projections indicating
continued expansion in the coming years.

 Major Employer:

The healthcare sector is one of India's largest employers, with a workforce

exceeding 7.5 million people.

 Government Initiatives:

Government policies like the National Health Policy and Ayushman Bharat
are enhancing accessibility and affordability of healthcare.

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  Digital Transformation:

The adoption of digital technologies, including telemedicine and virtual

assistants, is revolutionizing healthcare delivery and creating new job
opportunities.

 Infrastructure Development:

Expansion of healthcare infrastructure, including AIIMS and medical

colleges, is contributing to improved healthcare services.

 Medical Tourism:

India's cost-competitive healthcare and high-quality medical facilities have

made it a popular destination for medical tourism.

 Pharmaceuticals and Biotechnology:

India is a global leader in pharmaceuticals and vaccines, with a strong focus

on innovation and R&D.

 Challenges and Opportunities:

While the industry faces challenges like resource utilization and scaling, it
also presents numerous opportunities for investment and growth, particularly
in areas like digital health and preventative care.

1.2 INTRODUCTION TO COMPANY

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Max Healthcare is a large healthcare organization in India with multiple
hospitals, a homecare service (Max@Home), and a pathology service (Max
Labs). They operate across various states in North India, offering a wide range
of specializations and advanced medical technologies
Key aspects of Max Healthcare:
 Extensive Network:

Max Healthcare operates a network of hospitals in Delhi, NCR, and

neighboring states.

 Specializations:

They offer a comprehensive range of medical specialties, including cardiac

sciences, neurosciences, orthopedics, and more.

 Advanced Technology:

Max Hospitals are equipped with advanced medical technology, including

robotic surgery, MRI imaging, and more.

 Focus on Patient Care:

Max Healthcare emphasizes patient-centric care and aims to provide a world-

class healthcare experience.

 International Patient Services:

Max Healthcare offers special services for international patients, including

travel and accommodation assistance.

 Awards and Recognition:

The Max Healthcare group has received awards for its excellence in the
healthcare sector.

 Max@Home:

This service provides health and wellness services at the patient's home.

 Max Labs:
This service provides pathology services outside the hospital network.

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22 facilities 5000+ beds 5000+ clinicians
35000+ employees
ABOUT MAX HOSPITAL

Max Healthcare Institute Limited ("Max Healthcare") is one of India’s largest

healthcare organizations. We operate 22 healthcare facilities (5000+ beds),
30+ specialities and 5000+ clinicians across the NCR Delhi, Haryana, Punjab,
Uttarakhand Maharashtra and Uttar Pradesh. Almost 85% of our bed capacity
is in Metro/Tier 1 cities. Apart from hospitals, Max Healthcare also operates a
homecare business and pathology business under brand names Max@Home
and Max Labs respectively. Max@Home offers health and wellness services
at home while Max Lab provides Pathology Services outside our hospital
network.Max Healthcare is promoted and led by Abhay Soi as its Chairman
and Managing director.The present amalgamated company was formed
subsequent to the acquisition of 49.7% stake in erstwhile Max Healthcare
Institute Limited by Radiant Life Care Pvt. Ltd. ( “Radiant”) and the
amalgamation of Max Healthcare with Radiant thereafter. The amalgamated
entity assumed the name Max Healthcare Institute limited. Prior to the
amalgamation, Radiant was led and promoted by Abhay Soi.

At Max Healthcare, our vision is to be the most well regarded healthcare

provider in India committed to the highest standards of clinical excellence and
patient care, supported by latest technology and cutting edge research.
We ask more of ourselves, so we can give more to our patients. We push the
boundaries of excellence in everything we do, so we can deliver the highest
standards in patient-centred care.Every day we come to honour a higher
purpose - To serve. To excel.

VALUES:-

COMPASSION

We have a deeper level of patient understanding and are always empathetic to

their needs. This encourages a culture of providing a higher standard of
patient-centered care. We respect each other and our patients, and ensure that

18
 their needs are met with dignity. We rise to the occasion each time for we
recognize the positive social impact we can create.

EXCELLENCE

We ask more of ourselves and are always passionate about achieving the
highest standards of medical expertise and patient care. We understand that
being the best is a continuous journey of becoming better versions of ourselves
every day.

EFFICENCY

We create a responsive healing environment, by being nimble to the needs of

our patients and delivering what they really need with precision and timing.
We are focused yet fast, personal yet practical, advanced yet seamless in
delivering the exact care our patients need.

CONSISTENCY

We always deliver on our commitment and ensure the highest level of patient
care is met at every stage, every time. We believe that only through
consistency can we achieve our patients’ trust and fulfill our goals.
 2012
Max Super Speciality Hospital, Dehradun

Max Super Speciality Hospital, Dehradun, Max Healthcare opened its first
Super Speciality hospital in Uttarakhand in May 2012

Best Hospital in India: A Comprehensive Guide to World-Class

Medical Care
India has emerged as a global hub for medical tourism, attracting patients from
around the world seeking high-quality, affordable healthcare. With its blend of
advanced medical technology, skilled professionals, and cost-effective
treatments, India offers a compelling choice for those in need of medical care.
Why Choose India/Why India is a Preferred Destination for

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Medical Care
India has become a top choice for medical care for several reasons:
Cost-Effectiveness: One of the most compelling reasons to choose India for
medical care is the cost. Treatments in India are often a fraction of the cost
compared to Western countries, without compromising on quality. This
significant cost advantage makes India an attractive destination for those
seeking affordable medical solutions.
World-Class Medical Facilities: India boasts numerous hospitals equipped
with state-of-the-art technology and advanced medical facilities. Many
hospitals are accredited by international organizations, ensuring that they meet
global standards of care.
Skilled Medical Professionals: Indian doctors and medical professionals are
renowned for their expertise and training. Many have received their education
and training from prestigious institutions worldwide, bringing a wealth of
knowledge and experience to their practice.
Comprehensive Care: Indian hospitals offer a wide range of services, from
routine procedures to complex surgeries. The comprehensive care model
ensures that patients receive holistic treatment that addresses all aspects of
their health.
Shorter Waiting Times: Compared to many Western countries, waiting times
for medical procedures in India are significantly shorter. This is particularly
beneficial for patients requiring urgent or elective surgeries.
Cultural Sensitivity and Language: India is known for its warm hospitality,
and many hospitals have staff who speak multiple languages. This makes it
easier for international patients to communicate and feel comfortable during
their stay.
International Patient Services: Many hospitals offer dedicated international
patient departments that assist with visa arrangements, travel logistics, and
accommodations. These services ensure a smooth experience for patients
traveling from abroad.

Major Treatments Best Hospitals in India Cover

Indian hospitals cover a vast array of medical treatments and specialties.

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Here’s a look at some of the key areas for which people come to India:
Cardiology: India is renowned for its advanced cardiac care, including
treatments for heart disease, coronary artery bypass surgery, angioplasty,
and heart valve replacement. Hospitals in India offer cutting-edge technologies
and experienced cardiologists to manage complex heart conditions.
Orthopedic Surgery: From knee replacements to spinal surgeries, Indian
hospitals excel in orthopedic treatments. Techniques such as minimally
invasive surgery and advanced prosthetics are available, providing effective
solutions for bone and joint issues.
Oncology: Cancer treatment in India is highly advanced, with options
including chemotherapy, radiation therapy, and surgical interventions.
Hospitals often have specialized cancer centers that offer personalized
treatment plans and access to the latest therapies.
Neurology and Neurosurgery: India’s top hospitals offer comprehensive care
for neurological disorders and complex neurosurgeries. Treatments for
conditions such as epilepsy, brain stroke, and brain tumors are performed with
the latest technology and expert care.
Gastroenterology: Indian hospitals are well-equipped to handle a wide range
of gastrointestinal issues, including endoscopic procedures, liver transplants,
and treatments for chronic digestive disorders.
IVF and Infertility: India is a leading destination for assisted reproductive
technologies, including in vitro fertilization (IVF), egg donation, and
surrogacy. The success rates are high, and the costs are significantly lower
compared to other countries.
Bariatric Surgery: For those seeking weight loss solutions, India offers
various bariatric procedures such as gastric bypass and sleeve gastroectomy.
The hospitals provide comprehensive pre- and post-operative care to ensure
successful outcomes.
Aesthetic & Reconstructive Surgery: India’s hospitals are known for their
expertise in cosmetic and reconstructive surgery, offering procedures ranging
from facial rejuvenation to reconstructive surgeries for trauma victims.
How to Choose the Best Hospital in India
Selecting the right hospital for your needs can be a crucial decision. Here are

21
some tips to help you choose the best hospital in India:
Accreditations and Certifications: Look for hospitals that have accreditation
from recognized international bodies such as the Joint Commission
International (JCI) or the National Accreditation Board for Hospitals &
Healthcare Providers (NABH). These certifications ensure that the hospital
adheres to high standards of care.
Reputation and Reviews: Research the hospital’s reputation by reading
patient reviews, testimonials, and ratings. Consulting with previous patients
can provide valuable insights into the quality of care and the hospital’s overall
environment.
Expertise and Specialization: Consider hospitals that specialize in the
treatment you need. Hospitals with dedicated centers of excellence for specific
conditions often provide superior care and access to advanced treatments.
Facilities and Technology: Evaluate the hospital’s facilities and technological
capabilities. Hospitals equipped with modern diagnostic tools and advanced
treatment options are more likely to offer effective care.
Cost and Transparency: Ensure that the hospital provides transparent
information about costs and payment options. A clear understanding of the
financial aspects can help avoid unexpected expenses and make planning
easier.

Patient Safety and Hygiene Standards: Emphasize the hospital’s

commitment to patient safety, hygiene practices, and infection control
measures. This can be particularly important for international patients
concerned about healthcare standards.

Patient Support Services: Check if the hospital offers support services such
as international patient coordinators, language assistance, and accommodation
arrangements. These services can significantly enhance your experience and
ease the process.
Post-Treatment Care and Follow-Up: Find out about the hospital’s post-
treatment care and follow-up services. Ensuring that you will receive adequate
support after your treatment, whether remotely or in-person, is crucial for a
successful recovery.

22
Insurance and Payment Options: Verify whether the hospital accepts
international insurance or provides assistance with insurance claims.
Understanding the payment options available can help manage financial
planning.
Telemedicine Services: For ongoing consultations or follow-ups, see if the
hospital offers telemedicine services. This can be beneficial for patients who
need remote consultations or follow-up care.
Max Super Speciality Hospital, Dehradun, Uttarakhand

A). Hospital Address: Max Super Speciality Hospital, Dehradun, Mussoorie

Diversion

Road, Dehradun, Uttarakhand, 248001, India

B). Established Date: 2012

C). Number of Beds: 200 PLUS

D) Hospital Overview: The 220+ bed Max Hospital, Dehradun has been at
the forefront of delivering quality healthcare, serving over 10+ lakh patients to
date.
An ultra-modern facility, Max Hospital, Dehradun is equipped with 90 ICU
beds and 12 HDU beds. It provides integrated medical services across 27+
specialties, including Neurosciences, Cardiac Sciences, Orthopaedics,
Urology, Nephrology, Mental Health, and Behavioural Sciences, among
others. The hospital is proud to offer cutting-edge technologies such as the Da
Vinci Robot for surgeries (General, Obstetrics & Gynecology, Urology,
Bariatric, etc) and the Mako Robot for orthopedic surgeries, making it a leader
in advanced medical care in the state.
The hospital is staffed by a dedicated team of 159+ doctors, and 423+ trained
medical staff. It boasts seven high-end modular Operation Theatres, 29 OPD
chambers, two Cath Labs, and a wide range of specialized services. Max
Hospital, Dehradun is a pioneer in advanced cardiac care and the only center
in the state offering cardiac resynchronization therapy with CRT device
implantation for both single and dual chamber pacemakers.

23
Max Hospital, Dehradun is also the first private hospital in the state to offer
Kidney Transplant, Bone Marrow Transplant (BMT), and Cochlear implant
services. The hospital has been recognized as the only facility in the state
providing high-end interventional Pulmonology, Gastroenterology, and
Neurosurgery. It is also the first hospital to treat Abdominal Aortic Aneurysm
(AAA) using TVAR - Trans Endo Vascular Reconstruction by stenting &
EVAR - Endovascular Aneurysm Repair.

Max Hospital, Dehradun has received the first NABH and NABL accredited
hospital in the state, and the only hospital in the state accredited with NABH
in Nursing Excellence, and has been awarded the Best Private Hospital for
COVID in the State by honorable Chief Minister. The hospital is committed to
providing well-rounded and holistic care to every patient who walks through
its doors, continually setting new benchmarks in healthcare.

1.3 INTRODUCTION TO TOPIC

Patient consent procedures for medical treatments must be exact and

transparent in order to achieve excellence in clinical practice and a high level
of healthcare delivery. Patients who are having elective surgery in particular
need to be well educated before giving their consent. The importance of the
consenting process for doctors is emphasized in the General Medical Council's

24
guidelines, which are titled Consent: Patients and Doctors Making Decisions
Together. Almost always, the level of completion of the permission forms has
an impact on how well the consenting process works. Additionally, if
something goes wrong, physicians and the trust could be held accountable for
medical-legal acts due to missing information on consent forms.

Purpose of Consent forms

Informed consent has become the standard prototype for safeguarding

patient’s legal rights and directing the medical practice in an ethical direction.
It may be used for different purposes in different contexts: legal, ethical or
administrative. Although these purposes overlap, they are not identical, thus
leading to different standards and criteria for what constitutes “adequate”
informed consent.

Legal: Legally, Consent protects patients against assault in the form of

unwanted medical interventions. The higher standard of informed consent
further safeguards patient’s right to autonomy, self-determination and
inviolability. It is important for the decision maker to understand the relevant
information, he or she should also be able to appreciate the information’s
importance and use it to weigh treatment options in light of their values.

Ethical: It is morally correct to uphold patients' autonomy and their stated

objectives. The ethical purpose of informed consent is somewhat more abstract
and ideological, seeking to respect patient autonomy by ensuring that
treatment is directed toward the ends desired and is chosen by the patient. In
this context, informed consent is intended to shift the ethical prototype for
decision-making away from physician-centered models to more patient-
centered approaches. The ethics literature regarding informed consent also
emphasizes that it is not an event, but a process that precedes the “signing” of
the document and continues for as long as the choice remains relevant. Thus,
the consent to undergo dialysis or continue with chemotherapy is continually
re-evaluated (and may change). The consent form should not be confused with
the consent process; the form merely documents that the process has occurred.
Importantly, other parts of the patient record (e.g., clinic and/or operative

25
 notes) should corroborate details of the process.

Administrative: For the sake of compliance, the informed consent

document serves the administrative purpose of a systems-level check to ensure
that a consent process has occurred. Patients simply do not advance to the
operating room, for example, without a signed consent form. Unfortunately,
pressures for efficient work flow may shift the focus of the informed consent
process from robust conversation to the mere requirement of getting a
signature.
Stakeholders in the informed consent process agree on at least four basic
elements for discussions of informed consent: decision makers must have the
capacity to make decisions; the doctor must disclose enough details for the
decision maker to make an informed choice; decision makers must
demonstrate understanding of the information disclosed; and the decision
maker must freely authorize the treatment plan.
In present clinical practice, these four factors translate into five components
that must be included in the discussion in order to reach agreement: diagnosis,
suggested treatment, and risks and benefits associated with the treatment.
Alternative treatments, their risks and benefits, and the risks and benefits of
refusing treatment.

QUALITY IMPROVEMENT INTERVENTION APPLIED:-

1. Editing the consent forms.
2. Awareness and informative lecture session are conducted for RMO,
Surgeon, anesthetics, nurses, counselors who are involved in consent
taking.
3. Prepared do’s & don’ts list to be keeping in each file.
4. Ideal fully complete consent form displayed in each nursing station for
reference.
5. Daily auditing of consent form.
DO’s & Don’ts :-
DO’s:-
 The consent form to be filled by eligible person in legible handwriting only.

26
 Name of the patient to be mentioned which is to signed by the patient himself.
 Name of the surgery/procedure to be mentioned for which the consent is taken.
 Name and signature of the witness to be obtained in the specified column only.
 Name of the surgeon performing the procedure to be mentioned and to be
signed by him only.
 High risk consent to be signed by both surgeon and anesthetist with date and
sign.
 Each signature on the consent form bear the date and time.
 Mention the name of the person obtaining the consent.
Don’ts :-
 Strictly no abbreviations allowed.
 No consent form to be filled in the operating suite.
 Don’t leave the complications space blank, please mark it N/A.
 Don’t wheel the patient to operating suite without filling the consent form
completely.
 Don’t leave the tick boxes in the consent form blank, please tick which and
where applicable

27
 CHAPTER 2
REVIEW OF LITERATURE

REVIEW OF LITERATURE

Melliisa et al. (2000) Consent for procedure forms meet accepted

informed consent standards, suggested that the experiment conducted on
157 hospitals nationwide and 540 hospitals for informed consent form/
procedure forms were included and examined for Basic elements of informed

28
consent (nature of the procedure, risks, benefits, and alternatives) The authors
concluded that content of most forms did not meet accepted standards of
informed consent or patient-physician interactions. There is a need to support
the models of ideal informed consent and shared decision making.

Calle-Urra et al. (2013) Formal quality assessment of informed consent

documents in 9 hospitals, examined the design reliable formal quality criteria
of consent documents and their application in the evaluation of hospitals (184)
of a regional health services. The investigation designed for analysis of
existing regulations, previous studies and consultation with key experts. More
than 90% of the documents had defects in the information on consequences
and contraindications and did not mention copy to the patient. A tool obtained
to reliably assess the formal quality of the informed consent forms.

M.R. Sutton (2015) Informed consent in occupational therapy: Ethical

and practical considerations, explored the ethical and practical challenges
occupational therapists face in obtaining informed consent from patients.
Sutton highlighted the complexity of the consent process, especially for
patients with cognitive or physical impairments. The article discussed the
importance of ensuring that patients understand the implications of therapy,
including risks and benefits and suggests methods for improving patient
comprehension and compliance, such as clear communication and simplified
consent forms. The research stressed the need for therapists to assess patient
capacity and provide adequate time and support for decision making. It also
emphasized the importance of ensuring voluntary consent, especially in
settings where patients may feel pressured to comply.
H.L. Thompson (2016) Improving Consent Form Compliance in
Occupational Therapy: A patient-centered approach , discussed patient-
centered approaches to improving consent form compliance in occupational

therapy. Thompson examined the importance of clear communication and

establishing trust between patients and therapists. The article reviewed
research on how involving patients in decision making enhances their
understanding and willingness to comply with consent requirements. The
review concluded that creating a collaborative environment, where patients

29
feel empowered to ask questions and express concerns, leads to better
compliance with consent forms. Additionally, the use of visual aids and
interpreters for non-native speakers was recommended.
J.L. Morris & A. S. Johnson (2017) Factors influencing informed consent
in Rehabilitation settings, reviewed the factors affecting informed consent in
rehabilitation, with a focus on occupational therapy. Morris & Johnson
explored various barriers to obtaining valid consent, such as cognitive deficits,
language differences and patient anxiety. They also investigated how these
barriers can be overcome through better communication techniques and
support systems, including involving family members in the process. The
review suggested that patients with cognitive impairments, particularly those
with neurological conditions, may struggle to understand the information
presented in consent forms. The authors recommended the use of simplified
language, visual aids, and repeated explanations to improve compliance.

Bajada et al,(2017) Improving consent form documentation and

introduction of procedure-specific labels in a district general hospital,
explored that the investigation carried out to find if consent forms for
orthopedic procedures improve short- comings by at least 30% . Patient/
consenter details, procedure and legibility copy offered to patient and
adequacy of procedure-specific complications listed (Scored 0-3). The authors
concluded that Consent forms were not fully legible.
D.T. Williams & L. H. Chan (2018) Barriers to Informed consent in
occupational therapy practice, Williams and Chan focused on the specific
barriers that hinder the informed consent process in occupational therapy. The
article examined how factors such as time constraints, the complexity of
medical terminology, and patient trust impact the effectiveness of the consent
process in therapy settings. One of the key takeaways is that patients often feel
overwhelmed by the medical jargon used in consent forms. The authors
suggested training therapists to use clear and simple language and to create a
supportive, patient-centered environment during the consent process.
A. P. Brown & T. C. Edwards (2020) The role of caregivers in informed
consent for occupational therapy patients, examined the role of caregivers

30
in the informed consent process, especially for patients with cognitive
impairments. Brown and Edwards highlighted the importance of involving
family members in explaining therapy goals and the risks involved to ensure
the patient is fully informed. The study suggested that caregivers can act as
essential partners in the consent process, helping to clarify information for
patients who may have difficulty understanding complex consent forms. The
article emphasized the importance of collaboration between therapists,
patients, and caregivers in ensuring compliance with consent procedures.
F. L. Williams (2021) Patient autonomy and informed consent in
occupational therapy: explored the relationship between patient autonomy
and the informed consent process in occupational therapy. Williams examined
that assess how well patients understand their rights and the therapy they are
consenting to, as well as factors that affect their autonomy. The research
emphasized that occupational therapists must respect patient autonomy while
ensuring they fully comprehend the risks and benefits of therapy. The review
calls for more education on patient rights and decision making capacity for
both patients and therapists to improve consent form compliance.

Manta et al. (2021) From the Patient Perspective, Consent Forms Fall
Short of Providing Information to Guide Decision Making ,The study
gather the qualitative feedback on patient perceptions from 60 persons
interviewed for literacy and assessment of reactions, clarity of information of
informed consent forms to improve readability and utility for patient safety
and shared decision making. The results suggested that consent forms are too
complex and fail to achieve comprehension from the patient perspective.
Simplified educational tools needs to optimize communication and safety to
achieve health care decision making.
Aggarwal (2022) Essential principles of consent and the Indian law to
avoid litigations and unnecessary harassment, suggested that the courts
have assigned immense significance to the informed consent. It is the duty of
practitioner in India to provide all necessary information to the patient in a
language that is understandable. Whatever might be the difference of approach
in consenting, the study elaborated that medical practitioner is obligated to
provide the necessary information before obtaining consent from a patient.

31
Entry level certification’ under the National Accreditation Board for Hospitals
and Healthcare Providers (NABH) for quality services by Nair et al., (2023).
The NABH standards of Hospitals and care have guidelines have been defined
for consent form and needs to be followed. The study concluded that NABH
assessment of the hospitals (831) on most performance found gaps inspite of
improved facilities and care as per NABH standards. They recommended that
facility policies, protocols and training to the staff is required.
Morales et al. (2023) Evaluation of consent forms for clinical practice in
Spanish Public Hospitals, suggested that a study carried out a nationwide
survey across all public general hospitals (n = 223) in the Spanish Healthcare
System to evaluate the access, development, and quality of consents forms for
clinical practice within the Spanish Public Hospitals. The authors founded
variability on access, development and quality of written consent across the
Spanish Public Hospitals.
Bolado et al.(2023) Informed consent practices and associated factors
among health care professionals in public of hospitals of southern
Ethopia, assessed informed consent practices and associated factors among
health care professionals (399), institutional based mixed method study in
Ethopia. Hospital management and healthcare policy makers should plan and
intervene for appropriate training opportunities with health bureau and NGO
for quality services.

32
 CHAPTER 3
RESEARCH METHODOLOGY

RESEARCH METHODOLOGY
3.1 AIM AND OBJECTIVES:-
AIM: -The aim of this prospective study was to audit the quality of consent
forms in multi-disciplinary 220+ bedded hospital and to suggest measures
for improvement of practice.

33
 OBJECTIVES:-
 The project's goal was to evaluate the consenting procedures and identify the
area for improvement.
 To identify patterns of non-compliance.
 To suggest relevant measures for optimal consent taking procedure in order to
maintain best practices.
 To evaluate the effectiveness of the interventions and ensure sustainable
improvements.
3.2 SCOPE OF STUDY:-
This study focuses on evaluating the compliance of consent form practices with
legal and ethical standards in a private hospital setting, and exploring strategies for
quality improvement. The scope includes:-
 Assessment of current practices:- Analyzing how consent forms are
obtained, documented and stored across departments such as surgery.
 Compliance with legal and ethical standards:- Reviewing adherence to
national healthcare regulations, institutional policies and ethical guidelines
related to informed consent.
 Staff Awareness and Training:- Evaluating the knowledge and practices of
healthcare providers regarding informed consent procedures.
 Patient Understanding and satisfaction:- Assessing whether patients
comprehend the information provided and their satisfaction with the consent
process.
 Identification of gaps and risks:- Identifying areas of non-compliance risks
to patient safety and medico-legal liabilities.
 Recommendations for quality improvement:- Proposing practical measures
to enhance the clarity, consistency and documentation of consent processes.
 Implementation feasibility:- Studying the resource and training needs for
effective implementation of suggested improvements.
The study discusses in detail the Research Methodology selected by the
investigator in order to assess the consent form compliance for OT patients.
This study was carried out for a period of 2 months at main Operation Theatre
Complex at MAX Hospital.
The total bed complement of MAX Hospital is 200 plus. No. of OT in main

34
 OT are 5.The observations were made only for scheduled cases. The scheduled
elective theatre timings are 8.30 am to 8:30 pm. At the end of operations
performed under general anesthesia, minor operations under local anesthesia
continue to be performed till the list is completed. Regularly auditing and
reviewing each patient file before the patient goes for the major and minor
surgeries at operation theatre. Each O.T. works 6 days a week throughout the
year except on public holidays.
Emergency services were excluded. As it was a single-worker study, audit and
reviewing patients file was done for period of 6 consecutive days.

3.3 RESEARCH DESIGN:-

 Type of Study:-Descriptive Study
 Study Area:-Main OT area
 Duration of Study:-50 days
 Technique:-Direct observation
 Type of Data:-Qualitative data
 Data collection:-Primary And Secondary
Primary data collection was done by auditing the patient’s files in the OT to
look for the completion of different types of consent forms.
Secondary data was collected through internet by various data sources like
Google scholar for Review of Literature.
 Method of Rating:- Here we give ratings to the findings,
‘0’ Means the listed parameter is not documented in the form.
‘1’ Means the listed parameter is documented in the form.
‘3’ Means not applicable.
 Ethical consideration: - Ensuring that patients fully understand the proposed
treatment, potential risks and benefits, alternate options and have the capacity
to make an informed decision to consent, free from coercion, before signing
the form.
 Purpose statement:-To ensure that all the occupational therapy patients are
fully informed about their treatment plan, potential risks and benefits, alternate
options and their right to refuse treatment, thereby allowing them to make

35
 informed decisions about their care and participate actively in their therapy
process while upholding ethical and legal standards.

3.4 SAMPLE DESIGN:-

Sample Design Using Stratified Random Sampling:-
SAMPLE SIZE: - 128 (by using cochran’s formula)
SAMPLING METHOD:- Non probability sampling
SAMPLE TECHNIQUE: - Stratified Random Sampling
A) Stratification: - Stratified random sampling will be used to ensure that the
sample represents the different surgical departments. The departments will
serve as the strata for the sampling process.
B) Sample Size Allocation:-The total sample size for the study is 128
patients, and it will be distributed across the 6 departments according to the
proportional allocation based on the number of surgeries performed in each
department. This ensures that each department contributes a proportional share
to the total sample.
C) Random Sampling within strata:-Within each department, the sample
will be selected randomly:
1. A sampling frame will be created for each department, consisting of all
patients scheduled for surgery.
2. Random selection will then be performed within each department to select
the required number of participants for the study.

3.5 DATA COLLECTION METHODS:-

A) Data on consent form compliance:

Data will be collected from the following sources:
1. Patient Records: -Review of patient medical records to confirm that a
consent form was signed prior to surgery.

36
 2. Surgeon/Nurse Interviews: - Discussions with the surgical team, surgeons,
nurses, anesthesiologists to gather information about the consent process,
including whether the patient was provided with adequate information.
3. Patient Interviews:-Direct interviews with patients to assess their
understanding of the consent form, if they felt informed about the procedure,
and whether they voluntarily agreed to the surgery.
B) Data to be collected:-
1. Patient demographics: Age, Gender, education level and Medical history.
2.Surgery Type: Type of surgery being performed.
3.Consent form Status:
Signed: Whether the patient has signed the consent form.
Understanding: Whether the patient understands information on
the consent form( risks, benefits, alternative options.
Voluntary Agreement: Whether the patient provided consent voluntarily,without
pressure.

3.6 TOOL USED:-

Checklist for consent form compliance for OT patients

S.N
O

37
 Does the consent form bear the name and signature /thumb Check
1
impression of person giving the consent (patient, surrogate) consent form

For surrogate consent, is the name of the signatory and Check

2
relationship with the patient, recorded on the consent form consent form
NA for HIV
and some
other
Does the consent form bear the name and signature/thumb
3 consents.
impression of person witnessing the consent
Write NA if
not
applicable
Applicable if
Does the consent form bear the name and signature/thumb
4 interpreter
impression of interpreter
used, else NA

Does the consent form bear the name and signature of person Check
5
obtaining the consent consent form

Does the consent form bear the date and time for each signature Check
6
on the consent consent form

Does the consent form contain the Name of Check

7
procedure/treatment/test for which consent is being obtained consent form

Are the potential major complications of undergoing the planned Check

8
procedure documented in the consent form consent form

Does the consent form contain the name of the person who will Check
9
perform the procedure for which consent is being obtained consent form

For procedures carried out in the ward/ICU, is the consent taken Check
10
by either treating consultant or registrar or ward RMO consent form

See consent
Was the Doctor/team member who explained and obtained the
form and
consent, physically present during the surgical/invasive
11 OT
procedure, procedure or a member of the defined team as per
/Procedure
the list available with medical admin
notes

38
 Check
Is the Anesthesia consent signed by the Anesthesiologist or an
12 Anesthesia
anesthesia team member
consent form

Is the procedure/treatment/test actually performed by the Check OT/

13 person, named to carry out the procedure in the consent form or procedure
his team member notes

Check
Is the actual procedure/treatment /test carried out same as the
14 OT/procedur
one named in the consent form
e notes

Check
15 Are any abbreviations used in the consent form
consent form
Applicable
only for high-
In case the procedure was high risk, has a separate high-risk
16 risk
consent was obtained, in addition to the procedure consent
procedures,
else NA
Applicable
only for high-
Does the high-risk procedure bear the signature of both the
17 risk
surgeon and Anesthesiologist?
procedures,
else NA
For procedures carried out frequently & /or regularly on the same
Check
18 patient, is a fresh written informed consent obtained at least
consent form
once every 30 days
For planned surgical /invasive procedures is the consent obtained Check
19
before the patient is wheeled out from the ward to the OT consent form

TABLE 1.1

39
 CHAPTER 4
DATA ANALYSIS AND
INTERPRETATION

DATA ANALYSIS
OBSERVATION:-
After auditing the retrospective consent form by using audit tool the
consent compliance is of following percentage:-

TABLE 2.1

40
 COUNTOF
SPECIALITY 0 %
CARDIOLOGY 247 24
ENT 42 4
GASTROLOGY 121 12
GENERALSURGERY 46 4
NEUROLOGY 155 15
NEUROSURGERY 220 21
ORTHOPAEDICS 139 13
UROLOGY 70 7

SPECIALITY: NON COMPLIANCE

CARDIOLOGY 24

NEUROSURGERY 21

NEUROLOGY 15

ORTHOPAEDICS 13

GASTROLOGY 12

UROLOGY 7

GENERALSURGERY 4

ENT 4

0 5 10 15 20 25 30

FIGURE 1.1

SPECIALITY COUNT OF 1 %
CARDIOLOGY 396 18
ENT 103 5
GASTROLOGY 234 10

41
 GENERALSURGERY 188 8
NEUROLOGY 130 6
NEUROSURGERY 616 27
ORTHOPAEDICS 420 19
UROLOGY 162 7

TABLE 2.2

SPECIALITY: COMPLIANCE
NEUROSURGERY 27

ORTHOPAEDICS 19

CARDIOLOGY 18

GASTROLOGY 10

GENERALSURGERY 8

UROLOGY 7

NEUROLOGY 6

ENT 5

0 5 10 15 20 25 30

FIGURE 1.2
CARDIOLOGY
GRAD COUNTOF
E GRADE
0 247
1 396

TABLE 3.1

CARDIOLOGY CONSENT FORMS NON- COMPLIANCE NON- COMPLIANCE%

Receiving Transfusion of Blood/Blood
12 5
Components

42
consent 35 14

General Consent for Admission 38 15

Informed Consent for Anesthesia 36 15

Informed Consent for Coronary

49 20
Angiography

Informed consent for HIV Testing 11 4

Informed Consent for Percutaneous

52 21
Transluminal Coronary Angioplasty

Informed consent for surgery 14 6

TABLE 3.2

CARDIOLOGY: NON COMPLIANCE

INFORMED CONSENT FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY
INFORMED CONSENT FOR CORONARY ANGIOGRAPHY
21

20

INFORMED CONSENT FOR ANAESTHESIA 15

GENERAL CONSENT FOR ADMISSION 15

CONSENT 14

INFORMED CONSENT FOR SURGERY 6

RECEIVING TRANSFUSION OFBLOOD/BLOOD
COMPONENTS5
INFORMED CONSENT FOR HIV TESTING4

05101520
25

FIGURE 2.1

43
CARDIOLOGY CONSENT FORMS COMPLIANCE COMPLIANCE%
Informed consent for surgery 12 3
Consent For Receiving Transfusion of
14 4
Blood/Blood Components
Informed Consent for Anesthesia 33 8
Consent 34 9
General Consent for Admission 52 13
Informed Consent for Percutaneous
74 19
Transluminal Coronary Angioplasty
Informed Consent for Coronary
87 22
Angiography
Informed consent for HIV Testing 90 23

TABLE 3.3

CARDIOLOGY:COMPLIANCE
INFORMED CONSENT FOR HIV TESTING INFORMED CONSENT FOR CORONARY ANGIOGRAPHY

23
22

INFORMED CONSENT FOR PERCUTANEOUS…19

GENERAL CONSENT FOR ADMISSION 13

CONSENT INFORMED CONSENT FOR ANAESTHESIA
CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/… 9
INFORMED CONSENT FOR SURGERY 8

0 5 10 15 20 25

44
 FIGURE 2.2
ENT
GRADE COUNT OF GRADE
0 42
1 103

TABLE 4.1

NON- NON-
ENT CONSENT FORMS
COMPLIANCE COMPLIANCE%
Consent 21 50
General Consent for
16 38
Admission
Informed Consent for
5 12
Anesthesia

TABLE 4.2

ENT: NON-COMPLIANCE

CONSENT 50

GENERAL CONSENT FOR ADMISSION 38

INFORMED CONSENT FOR ANAESTHESIA 12

0 10 20 30 40 50 60

FIGURE 3.1

ENT CONSENT FORM COMPLIANCE COMPLIANCE%

45
 Consent 17 17

General Consent for Admission 25 24

Informed Consent for
61 59
Anesthesia

TABLE 4.3

ENT: COMPLIANCE

INFORMED CONSENT FOR ANAESTHESIA 59

GENERAL CONSENT FOR ADMISSION 24

CONSENT 17

0 10 20 30 40 50 60 70

FIGURE 3.2

GASTROENTEROLOGY

GRADE COUNT
OF
GRADE

0 121

1 234

46
 TABLE 5.1
NON- NON-
GASTRO ENTEROLOGY CONSENT
COMPLIA COMPLIANC
FORMS
NCE E%
Consent For Receiving Transfusion of
3 2
Blood/Blood Components
Consent 40 33
General Consent for Admission 43 36
General Consent for Upper Gastro Intestinal
1 1
Endoscopy
Informed Consent for Anesthesia 5 4
Informed consent for HIV Testing 2 2
Informed Consent for Procedural Sedation 18 15
Informed Consent for Upper Gastro Intestinal
9 7
Endoscopy
TABLE 5.2

GASTRO ENTEROLOGY: NON-COMPLIANCE

GENERAL CONSENT FOR ADMISSION
36

CONSENT 33

INFORMED CONSENT FOR PROCEDURAL SEDATION 15

INFORMED CONSENT FOR UPPER GASTRO INTESTINAL… 7

INFORMED CONSENT FOR ANAESTHESIA 4

INFORMED CONSENT FOR HIV TESTING2

CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/…2
GENERAL CONSENT FOR UPPER GASTRO INTESTINAL…
05
47
10 15 20 25 30 35 40
 FIGURE 4.1

GASTRO ENTEROLOGY CONSENT COMPLIA COMPLIA

FORMS NCE NCE%
Consent For Receiving Transfusion of
8 3
Blood/Blood Components
Consent 36 15
General Consent for Admission 35 15
General Consent for Upper Gastro Intestinal
12 5
Endoscopy
Informed Consent for Anesthesia 28 12
Informed consent for HIV Testing 7 3
Informed Consent for Procedural Sedation 58 58
Informed Consent for Upper Gastro Intestinal
51 22
Endoscopy

TABLE 5.3

48
 FIGURE 4.2

GASTRO ENTEROLOGY: COMPLIANCE

INFORMED CONSENT FOR PROCEDURAL SEDATION 25
INFORMED CONSENT FOR UPPER GASTROINTESTINAL
ENDOSCOPY22
GENERAL CONSENT FOR ADMISSION 15

CONSENT 15

INFORMED CONSENT FOR ANAESTHESIA 12

GENERAL CONSENT FOR UPPER GASTRO INTESTINAL
ENDOSCOPY5
INFORMED CONSENT FOR HIV TESTING 3
CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/BLOOD
COMPONENTS3
0510
15 20 25 30

GENERAL SURGERY
TABLE 6.1
GRADE COUNTOF GRADE
0 46
1 188

NON
NON COMPLIAN
CONSENT FORM OF GENERAL SURGERY COMPLIANCE CE%

Consent 16 35
General Consent for Admission 14 30
Informed Consent for Anesthesia 5 11
Informed consent for HIV Testing 3 7
Informed Consent for Laparoscopic Cholecystectomy 4 9
Informed Consent for Receiving Transfusion Of Blood/
Blood Components 2 4
Informed consent for surgery 2 4
Informed consent for surgery 2 11
TABLE 6.2

49
 GENERAL SURGERY:NON COMPLIANCE
CONSENT
35

GENERAL CONSENT FOR ADMISSION 30

INFORMED CONSENT FOR ANAESTHESIA 11

INFORMED CONSENT FOR LAPAROSCOPIC CHOLECYSTECTOMY9
INFORMED CONSENT FOR HIV TESTING7

INFORMED CONSENT FOR SURGERY 4

INFORMED CONSENT FOR RECEIVING TRANSFUSION
OF BLOOD/ BLOOD COMPONENTS4
051015
20 25 30 35 40

FIGURE 5.1

GENERAL SURGERY CONSENT

COMPLIANCE COMPLIANCE%
FORMS
Consent 22 12
General Consent for Admission 24 13
Informed Consent for Anesthesia 60 32
Informed Consent For Cholecystectomy 24 13
Informed consent for HIV Testing 7 4
Informed Consent For Laparoscopic
29 15
Cholecystectomy
Informed Consent For Transfusion Of
11 6
Blood/Blood Components
Informed consent for surgery 11 6

TABLE 6.3

50
 GENERAL SURGERY: COMPLIANCE
INFORMED CONSENT FOR ANESTHESIA
32

INFORMED CONSENT FOR LAPAROSCOPIC… 15

INFORMED CONSENT FOR CHOLECYSTECTOMY 13

GENERAL CONSENT FOR ADMISSION 13

CONSENT 12

INFORMED CONSENT FOR SURGERY 6

INFORMED CONSENT FOR TRANSFUSION OF BLOOD/… 6

INFORMED CONSENT FOR HIV TESTING 4

0 5 10 15 20 25 30 35

FIGURE 5.2

NEUROLOGY

GRADE COUNT
OF
GRADE
0 155
1 130
TABLE 7.1

NON NON
NEUROLOGY CONSENT FORMS COMPL COMPLAINC
AINCE E%
Consent For Receiving Transfusion of
4 3
Blood/Blood Components
Consent 60 39
General Consent for Admission 65 42
Informed Consent for Procedural Sedation 9 6
Informed consent for surgery 11 7
Informed Consent for Upper Gastro Intestinal
6 4
Endoscopy
TABLE 7.2
51
 NEUROLOGY: NON COMPLIANCE
GENERAL CONSENT FOR ADMISSION 42

CONSENT 39

INFORMED CONSENT FOR SURGERY 7

INFORMED CONSENT FOR PROCEDURAL

6
SEDATION
INFORMED CONSENT FOR UPPER GASTRO INTESTINAL ENDOSCOPY4
CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/ BLOOD COMPONENTS3
0510 15 20 25 30 35 40 45

FIGURE 6.1

COMPLI COMPLIAN
NEUROLOGY CONSENT FORMS
ANCE CE%

Consent For Receiving Transfusion of

9 7
Blood/Blood Components

Consent 41 32

Informed Consent for Surgery 43 33

Informed Consent for Procedural Sedation 15 12

General consent for Admission 3 2

Informed Consent for Upper Gastro Intestinal

19 15
Endoscopy

TABLE 7.3

52
 NEUROLOGY: COMPLIANCE
INFORMED CONSENT FOR SURGERY 33

CONSENT 32
INFORMED CONSENT FOR UPPER GASTRO INTESTINAL
15
ENDOSCOPY
INFORMED CONSENT FOR PROCEDURAL SEDATION 12
CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/
7
BLOOD COMPONENTS
GENERAL CONSENT FOR ADMISSION2

05 10 15 20 25 30 35

FIGURE 6.2

NEURO SURGERY
COUNT OF
GRADE
GRADE
0 220
1 616
TABLE 8.1

NON - NON
NEURO SURGERY CONSENT FORMS
COMPLIANCE COMPLIANCE%

Consent For Receiving Transfusion of Blood/

14 6
Blood Components
Consent 72 33
General Consent for Admission 78 35
Informed Consent for Anesthesia 29 13
Informed consent for HIV Testing 4 2
Informed consent for surgery 23 10

TABLE 8.2
53
 NEUROSURGERY: NON COMPLIANCE
GENERAL CONSENT FOR ADMISSION 35

CONSENT 33

INFORMED CONSENT FOR ANAESTHESIA 13

INFORMED CONSENT FOR SURGERY 10

CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/

6
BLOOD COMPONENTS

INFORMED CONSENT FOR HIV TESTING2

05 10 15 20 25 30 35 40

FIGURE 7.1

NON - NON
NEURO SURGERY CONSENT FORMS COMPLIAN COMPLIANC
CE E%
Consent For Receiving Transfusion of Blood/
122 20
Blood Components
Consent 79 13
General Consent for Admission 88 14
Informed Consent for Anesthesia 209 34
Informed consent for HIV Testing 5 1
Informed consent for surgery 113 18

TABLE 8.3

54
 NEUROSURGERY: COMPLIANCE
INFORMED CONSENT FOR ANAESTHESIA 34

CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/BLOOD

20
COMPONENTS

INFORMED CONSENT FOR SURGERY 18

GENERAL CONSENT FOR ADMISSION 14

CONSENT 13

INFORMED CONSENT FOR HIV TESTING

0 5 10 15 20 25 30 35 40

FIGURE 7.2

ORTHOPAEDICS
COUNT OF
GRADE
GRADE
0 13
1 420
TABLE 9.1

NON-
NON-
ORTHO CONSENT FORMS COMPLIANC
COMPLIANCE%
E
Consent For Receiving Transfusion of
8 6
Blood/ Blood Components
Consent 54 39
General Consent for Admission 48 35
Informed Consent for Anesthesia 8 6
Informed consent for HIV Testing 9 6
Informed consent for surgery 12 9

TABLE 9.2

55
 ORTHOPAEDICS: NON COMPLIANCE
CONSENT 39

GENERAL CONSENT FOR ADMISSION 35

INFORMED CONSENT FOR SURGERY 9

INFORMED CONSENT FOR HIV TESTING 6

INFORMED CONSENT FOR ANAESTHESIA 6

CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/

6
BLOOD COMPONENTS

0 51015202530354045

FIGURE 8.1

NON-
NON-
ORTHO CONSENT FORMS COMPLIANC
COMPLIANCE%
E
Consent For Receiving Transfusion of
29 7
Blood/ Blood Components
Consent 70 17
General Consent for Admission 61 15
Informed Consent for Anesthesia 168 40
Informed consent for HIV Testing 42 10
Informed consent for surgery 50 12

TABLE 9.3

56
 ORTHOPAEDICS: COMPLIANCE
INFORMED CONSENT FOR ANAESTHESIA 40

CONSENT 17

GENERAL CONSENT FOR ADMISSION 15

INFORMED CONSENT FOR SURGERY 12

INFORMED CONSENT FOR HIV TESTING 10

CONSENT FOR RECEIVING TRANSFUSION OF BLOOD/BLOOD

7
COMPONENTS

0 51015202530354045

FIGURE 8.2

UROLOGY
COUNT OF
GRADE
GRADE
0 70
1 162

TABLE 10.1

NON- NON-
UROLOGY CONSENT FORM
COMPLIANCE COMPLIANCE%

Consent 29 41
General Consent for Admission 30 43
Informed Consent for Anesthesia 5 7
Informed Consent for Procedural 3 4
Sedation
Informed consent for surgery 3 4

TABLE 10.2

57
 Figure 9.1

NON- NON-
UROLOGY CONSENT FORM
COMPLIANCE COMPLIANCE%

Consent For Receiving Transfusion of

12 7
Blood/Blood Component
Consent 30 19
General Consent for Admission 31 19
Informed Consent for Anesthesia 72 44
Informed Consent For Procedural
8 5
Sedation
Informed consent for surgery 9 6

TABLE 10.3

58
Figure 9.2

59
 QUALITY IMPROVEMENT INTERVENTIONS APPLIED:-
1. Editing the consent forms.
2. Awareness and informative lecture session are conducted for RMO,
Surgeon, anesthetics,
nurses, counselors who are involved in consent taking.
3. Prepared do’s & don’ts list to be keeping in each file.
4. Ideal fully complete consent form displayed in each nursing station for
reference.
5. Daily auditing of consent form.

DATA INTERPRETATION

Out of 200 files studied, maximum parameters listed in the form i.e.
Compliance was seen in Neurosurgery specialty followed by orthopedics and
cardiology.

 Out of 14 samples in cardiology, non-compliance was seen in 247 parameters

of consent form and compliance was seen in 396 parameters of consent forms.
Non compliance was highest seen in Informed Consent for Percutaneous
Transluminal Coronary Angioplasty and compliance was seen highest in
Informed consent for HIV Testing.
 Out of 7samples in ENT, noncompliance was seen in 42 parameters of consent
forms and compliance was seen in 103 parameters of consent forms.
Noncompliance was seen highest in Consent and compliance was seen highest
in Informed consent for Anesthesia
 Out of 12 samples of Gastro-Enterology, non-compliance was seen in 121
parameters of consent forms and compliance was seen in 234 parameters of
consent forms. Non compliance was seen highest in General consent for
Admission whereas compliance was seen highest in Informed consent for
Procedural Sedation.

 Out of 6 samples of General surgery, non-compliance was seen in 46

parameters of consent forms and compliance was seen in 188 parameters.
Noncompliance was seen highest in consent and compliance was seen highest
in Informed Consent for Anesthesia.

60
 Out of 16 samples in Neurology, non-compliance was seen in 155 parameters
of consent forms and compliance was seen in 130 parameters. Noncompliance
was seen highest in General consent for Admission whereas compliance was
seen highest in Informed consent for Surgery.
 Out of 23 samples of Neurosurgery, non-compliance was seen in 220
parameters of consent forms whereas compliance was seen in 616 parameters.
Noncompliance was highest seen in General Consent for Admission and
compliance was seen highest in Informed consent for Anesthesia
 Out of 18 samples of Orthopedics, non-compliance was seen in139 parameters
of consent forms and compliance was seen in 420 parameters. Noncompliance
was seen highest in Consent and compliance was seen highest in Informed
consent for anesthesia
 Out of 9 samples of Urology, noncompliance was realized in 70 parameters of
consent forms and compliance was seen in 162 parameters. Noncompliance
was seen highest in General consent for admission and compliance was seen
highest in Informed Consent for anesthesia.

61
 CHAPTER 5
FINDINGS AND SUGGESTIONS,
RECOMMENDATIONS,
DISCUSSION AND CONCLUSION

62
 FINDINGS AND SUGGESTIONS:-
FINDINGS:-
1. Incomplete consent forms :- A significant percentage of forms were found
to be missing crucial information such as risks or signatures of witnesses or
doctors.
2. Lack of Standardization:- Consent form varied across departments with no
standardized format, leading to inconsistencies in content and quality.
3. Poor patient understanding:- Many patients signed the forms without fully
understanding the procedure risks or their rights due to medical jargon or
rushed explanations.
4. Limited staff training :- Staff responsible for obtaining consent had varying
levels of understanding and training, affecting the quality of information
delivery.
5. Inadequate documentation practices :- Some consent forms were illegible,
improperly stored or not uploaded to the patients digital record.
6. Non- compliance with legal norms :- A few instances of procedures
conducted without proper informed consent were identified, posing legal and
ethical risks.

63
 SUGGESTIONS:-
1. Implement a Standardized consent form template:- Develop uniform,
department-wise consent forms that meet legal, ethical and institutional
standards.
2. Use simple and clear language:- Ensure all forms use plain, understandable
language and include visual aids or translated versions if necessary.
3. Conduct regular staff training:- Provide mandatory training for all staff
involved in obtaining consent, emphasizing communication skills and legal
responsibilities.
4. Introduce a consent audit system:- Regularly audit consent forms for
completeness, accuracy and compliance to identify and correct issues early.
5. Improve patient education :- Allocate time and resources for explaining
procedures to patients, possibly using videos or brochures before obtaining
consent.
6. Digitize the consent process:- Integrate electronic consent forms into the
hospital information system for better accessibility, storage and tracking.
7. Establish a consent compliance committee:- Form a multidisciplinary
committee to oversee consent practices, investigate deviations and implement
quality improvement initiatives.

64
 RECOMMENDATION
 PROCEDURE SPECIFIC STICKERS: Using procedure-specific
stickers in surgical and medical departments that employ consent forms that
require handwritten inputs is straight forward and may be easily generalized.
This implementation ought to be long-lasting given how simple and satisfying
it is to use.
 Printed leaflets and fact sheets: Additionally educating patients about the
clinical trial may also help them grasp it better.
 Audio-visual presentation: It has been shown that audio-visual methods are
effective at communicating informed consent information. With the use of this
instrument, textual knowledge can be immediately spoken reinforced,
facilitating efficient comprehension and retention.
 Extended discussions about informed consent: Encouraging extended
discussions between the patient, attendant, and medical team for greater
understanding and information retention is another strategic method to
improving the informed consent process.

65
DISCUSSION AND CONCLUSION
Although the historical evidence is somewhat ambiguous, informed consent in
the sense in which it is understood and practiced today appears to be a
relatively recent arrival in medical ethics. Consent has been an important area
of clinical surgery since the early 20th century, with shift in attitude of clinical
practice from an authoritative role of the physician or surgeon to a patient
centered-approach.
The “reference guide to consent” published by the department of health ,stated
that although not a legal requirement, the completion of consent forms is good
practice where an intervention is to be undertaken.
The NABH guidance regarding consent states that the task of seeking consent
is the responsibility of the doctor providing treatment. This responsibility may
be delegated to someone else as long as they are suitably trained and qualified.
In particular they must have sufficient knowledge of the proposed
investigation or treatment, and understand the risks involved.
Audiotape analysis showed that consent information provided to patients
through verbal discussion is often deficient. It has been reported that patient
recall of the informational the consent interview is generally poor. The NABH
guidance also states that information discussed with the patient and any
written information given as well as details of any decisions must be recorded
in the patient’s medical records or a consent form.
However, there remain concerns regarding the quality of documentation of the
consent process.
The aim of this study was to assess the documentation of the consent process
FMRI, Gurugram undertaking a wide range of invasive procedures in different
surgical specialities. In our study, we assumed that patients had a copy of the
consent form if the “patient scopy” was not found in the medical records.
Although the medical records were randomly selected, we believe that this
study represents the current practice.
Initiallyonly20-25 % of consent forms completely met NABH guidelines. This
demonstrates an alarmingly poor adherence to such guidance that plays a vital
role in patient safety, patient ethics autonomy, not to mention potential
66
medico-legal and clinical governance implications for surgical practice.
Our intervention has improved the quality of consenting within our hospital
according to these guidelines. With these interventions set to continue and
further develop, we expect that the quality of the consenting process will
continue to provide patients with all that it is designed to.
The results of this study led to several changes being made within the trust.
We have developed a presentation to be given to all new doctors starting at the
trust with the intention of giving appropriate training on the process of
consenting of patients and how related documentation should be completed.
We have also increased the availability of patient information leaflet so n
common procedures, by placing the monoclinic and wards. Staff awareness
regarding importance of securely filing consent forms and the process of
confirming consent in those patients consented in advance was increased.
To determine whether these interventions improved our adherence to
consenting guidelines we completed a re-audit exercise. This in volved the
random selection of adult patient medical records who were undergoing
procedures at our hospital. We examined the notes in the same way making
note of whether the NABH guidelines for consenting were adhered to.

67
 CHAPTER – 6
REFERENCES AND BIBILIOGRAPHY

68
 REFERENCES
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• Bajada, S., Dwamena., S Zabihullah A., Williams, R. and Owain E. (2017).

Improving consent form documentation and introduction of procedure-specific
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• Manta, J.C., Ortiz , j., Moulton, B.W and Sonnad, S.S. (2021). From the
Patient Perspective, Consent Forms Fall Short of Providing Information to
Guide Decision Making. J .Patient Saf. 1;17 (3):e149–e154.

• Valdivia, E.M., Bejarano, R.C., Brady, A.M., Mariscal-Crespo, M.L. (2023).

Evaluation of consent forms for clinical practice in Spanish Public
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Improving consent form documentation and introduction of procedure-specific
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71
ANNEXURE

SR. NO. NAME

Annexure1 Consent Form Layout
Annexure2 Generic Informed Consent Form

Annexure3 Informed Consent: Anesthesia

CONSENT FORM LAYOUTS

72
73