1. D.Y .PATIL UNIVERSITY
SCHOOL OF MANAGEMENT
NAVI MUMBAI
Consent compliance and interventions for
quality improvement in hospital
SUBMITTED BY:
Dr Dipti Tawde
MBA Health & Hospital Management
UNDER THE GUIDANCE OF:
Dr. Amol Vaidya
Asst. Manager Medical Services
Fortis Hospital Mulund

2. ACKNOWLEDGEMENT
I would like to thank Dr Nitin Sippy, Associate professorDr D.Y. Patil
schoolof management studies for his constant supportguidance and
supervision during the courseof internship.
I am grateful to DrAmol vaidya assistant manager medical services Fortis
Hospital Mulund; for giving me an opportunity to study the Hospital as part
of my Internship.
I am indebted him for guiding me through and providing all the necessary
supportwhenever required.
I am grateful to Mrs lavina lal Quality coordinator Fortis Hospital Mulund
For supportand guidance for my project.
I would also like to thank Dr Supriya amey Head of medical service
Fortis Hospital Mulund for his valuable guidance. Last but not the least I
would like to thank all the Department Heads, Executive and staff
members of various Departments of the Hospital for extending their full
supportin completing my assignments and giving me the necessary time out
of their busy schedule.
I must conclude that my learning experience was very enriching and I got an
opportunity to overview operational issues of departments while undertaking
the case study.

3. INDEX.
Table of Contents
Sl. No. Section Page
1 Introduction to Fortis hospital 4-7
2 Abstract 8
3 Introduction of consent 9-15
4 Project work 16
5 Aim 17
6 Material and method used 18-19
7 Observation of retrospective consent data 20-21
8 Quality Improvement intervention used 22-23
9 Observation of live consent data 24-25
10 Results 26-27
11 Conclusion 28

4. Introduction of Fortis hospital Mulund.
Fortis Healthcare Limited is an established chain of super speciality hospitals based in
Delhi, also available in Amritsar, Kolkata, Navi Mumbai, Hyderabad, Mohali, Jaipur,
Chennai, Kota, Bengaluru, Gurgaon, Noida, Faridabad, Mumbai, Odisha.
1. Corporate Details
I. About Fortis -
Fortis Healthcare Limited is a leading integrated healthcare delivery service provider
in India. The healthcare verticals of the company primarily comprise hospitals,
diagnostics and day care specialty facilities.
Currently, the company operates its healthcare delivery services in India, Singapore,
Dubai, Mauritius and Sri Lanka with 55 healthcare facilities (including projects
under development), approximately 10,000 potential beds and 270 diagnostic
centers.
In a global study of the 30 most technologically advanced hospitals in the world, its
flagship, the Fortis Memorial Research Institute' (FMRI), was ranked No.2, by
'topmastersinhealthcare.com, and placed ahead of many other outstanding medical
institutions in the world.
ii. Vision
Saving and enriching values
iv Mission
To be globally respected healthcare organization known for clinical excellence
and distinctive patient care.

5. Values-
Patient centricity Commit to “best outcomes and
experience for our patients.
Integrity Be principled ,open and honest
Model and live our Values.
Demonstrate moral courage to speak up
and do the right things.
Team work Proactively support each other and
operate as one team.
Respect and value people at all levels
with different opinions, experiences and
backgrounds.
Put organization needs before
departments/self interest.
ownership

6. Milestones-
Fortis surgeons have performed many path breaking organ transplant surgeries.
· The surgeons at Fortis Malar Hospital, Adyar, Chennai, performed India’s first
permanent artificial heart implant (VAD) surgery. They have also been successful in
carrying out a heart transplant with the use of an artificial heart pump or Extracorporeal
Membrane Oxygenation (ECMO) to resuscitate the patient while waiting for a donor.
· At Fortis Hospital, Mulund, Mumbai, the first successful live donor adult to
adult liver transplant in West and Central India was performed in Sep 2006.
· At Fortis Hospital, Kalyan, Mumbai, a cadaver kidney transplant was done
without dialysis.
Fortis Healthcare’s Centre of Excellence for Bone and Joint was
· The first in Europe and Asia to offer custom fit Knee Replacement Surgery; this
innovative approach greatly reduces operating time and ensures perfect knee alignment
· The first in South India to use iPod assisted navigation in Total Knee
Replacement Surgery, another technical advancement towards more surgical precision
· The first in the state of Karnataka to conduct a Minimally Invasive Joint
Replacement Surgery; this procedure involves less blood loss, is less painful for the
patient and leads to faster recovery
· The first in the state of Karnataka to implement Fast Track Rehabilitation
Protocol; a multidisciplinary team approach to provide early mobility, often as early as
the day of surgery itself
· a pioneer in single stage sequential Bilateral Knee Replacement; this procedure
replaces both knees in one sitting, thereby leading to faster rehabilitation and reducing
the hospital stay and costs
· The first in the state of Karnataka to introduce a 5 day recovery programme …
the name says it all …from the hospital bed to your own bed in just 5 days

7. · The first in the state of Karnataka to perform Oxinium Total Knee Replacement
with optimized prosthetic fit for longevity of the implant and improved function; this
implant lasts for approximately 30 years
V Services
 Cataract Services
 Refractive Surgery Services
 Cornea Services
 Glaucoma Services
 Retina Services
 Paediatric Ophthalmology and Squint Services
 Oculoplasty Services
 UVEITIS
 Neuro-Ophthalmology
 Vision Rehabilitation Services
 Computer Vision Syndrome Clinic
 Contact Lenses

8. Abstract:
To achieve excellence in clinical practice and a high level of health care provision,
consent processes need to be clear and precise. In particular, patients who are to undergo
elective operations must be fully informed before consenting to treatment. The aim of this
study is to assess the quality of consent form completion by different health professionals
in our department and to identify areas for potential improvement.

9. Introduction
Consent to treatment is the principle that a person must give their permission before they
receive any type of medical treatment or examination. This must be done on the basis of a
preliminary explanation by a clinician.
Consent is required from a patient regardless of the intervention – from a physical
examination to organ donation.
The principle of consent is an important part of medical ethics and the international
human rights law.
It can be given:
Verbally – for example, by saying they are happy to have an X-ray.
In writing – for example, by signing a consent form for surgery.
Patients may passively allow treatment to take place – for example, by holding out an
arm to show they are happy to have a blood test. However, since the capacity to consent
has not been tested, and the benefits and risks have not been explained, this is not the
same as consent (see below).
"Capacity" means the ability to use and understand information to make a decision, and
communicate any decision made.

10. Defining consent
For consent to be valid, it must be voluntary and informed, and the person consenting
must have the capacity to make the decision. These terms are explained below:
Voluntary – the decision to either consent or not to consent to treatment must be made by
the person themselves, and must not be influenced by pressure from medical staff, friends
or family.
Informed – the person must be given all of the information in terms of what the treatment
involves, including the benefits and risks, whether there are reasonable alternative
treatments and what will happen if treatment does not go ahead.
Capacity – the person must be capable of giving consent, which means they understand
the information given to them, and they can use it to make an informed decision.
If an adult has the capacity to make a voluntary and informed decision to consent to or
refuse a particular treatment, their decision must be respected. This still stands even if
refusing treatment would result in their death, or the death of their unborn child.
If a person does not have the capacity to make a decision about their treatment, the
healthcare professionals treating them can go ahead and give treatment if they believe it
is in the person’s best interests. However, the clinicians must take reasonable steps to
seek advice from the patient’s relatives before making these decisions.
How to give consent
Consent should be given to the healthcare professional directly responsible for the
person's current treatment, such as the nurse arranging a blood test, the GP prescribing
new medication or the surgeon planning an operation.
If someone is going to have a major medical procedure, such as an operation, their
consent should ideally be obtained well in advance, so they have plenty of time to
examine any information about the procedure and ask questions. If they change their
mind at any point before the procedure, the person is entitled to withdraw their previous
consent.
If they are able to, consent is usually given by patients themselves. However, someone
with parental responsibility may need to give consent for a child to have treatment. Read
more about the rules of consent applying to children and young people

11. If someone with little or no chance of recovery requires treatment for the sole purpose of
keeping them alive, and the person is unable to make a decision themselves, an
agreement about continuing or stopping treatment will need to be reached between the
healthcare professionals responsible for their care and the person's relatives and friends.
Read more about consent and end of life issues.
When consent is not necessary
There are a few exceptions when treatment can go ahead without consent.
For example, it may not be necessary to obtain consent if:
Treatment is needed in an emergency, and the person is unable to give consent because
they lack the capacity to do so.
When, during an operation, it becomes obvious that the person immediately requires an
additional procedure to treat a life-threatening problem that was not included in their
original consent.
A person with a severe mental health condition – such as schizophrenia, bipolar disorder
or dementia – lacks the capacity to consent to the treatment of their mental health.
However, in these cases, treatment for unrelated physical conditions still requires
consent, which the patient may be able to provide, despite their mental illness.
Informed consent means that you understand your condition and any proposed medical
treatment. You have a legal right to be told any information that relates to your medical
condition and treatment. Without this information, you are not able to make a fully
informed choice and give valid consent for treatment.
Doctor has a duty to explain patient his medical condition, the recommended treatment
(including the other treatment options available) and the benefits, risks and possible
complications of the recommended treatment. This is essential so that you can make a
decision.
This is known as ‘informed consent’. Once the information is given, the doctor may ask
patient to sign a consent form. When signed by the patient, this form gives the doctor
legal permission to perform the procedure.
The information that must be given to patient includes:
The diagnosis and likely outcome (prognosis) of condition
An explanation of the recommended treatment

12. The risks of the procedure and common side effects
Possible complications
Specific details of the treatment; for example, where it will be performed and who will
perform it
Any other options for treatment and their probability of success.
Informed consent is a process of finding out information about the recommended
treatment, and weighing up the benefits and risks involved. It is not about just signing a
form.
General consent form information
Before a planned surgical procedure, the surgeon will ask patient (or your legal guardian)
to sign a consent form. The doctor, not the nurse, must obtain the patient’s consent.
The form will have information specifically about the procedure. Generally speaking, a
typical consent form includes:
1. Your surname, given names, date of birth, sex and referring doctor
2. Whether or not an interpreter is required
3. An explanation of patient condition, in plain language
4. An explanation of the procedure, in plain language
5. General risks of anesthesia, which may be included in a separate form
6. General risks of surgery
7. Specific risks of this particular procedure, listed by the doctor
8. Whether or not the doctor has explained the risks and possible
Complications.
9. Whether or not the doctor has explained the risks of not having the proposed treatment

13. 10. Patient agreement that information has been provided
Patient agreement means that patient has understood that the procedure may not work or
may worsen the condition
Patient dated signature to confirm that he/she understand all of the above and want to
undergo the procedure.
Patient understanding is crucial
The signed consent form is considered a legal document.
Generally speaking, ‘informed consent’ depends on whether or not you as the patient
would have agreed to the surgery if he had known and understood the possible risks and
complications.
Things to remember
Patients have a legal right to be told any information that relates to their medical
condition and their treatment.
The signed consent form is considered a legal document.
Patients consent can be withheld or withdrawn

14. Treatment and procedures requiring prior Informed Consent include but are not limited
to:
i. Any procedure under any form of anesthesia/sedation
ii. Any form of anesthesia including conscious sedation and monitored
care
iii. All invasive diagnostic tests and procedures
iv. Other diagnostic procedures like Stress test, Contrast imaging
v. Angiographic procedures
vi. Angioplasty & Intravascular Catheter procedure
vii. All Interventional procedures (including Pacemaker insertion, Tumor
embolization etc.)
viii. Aspirations (including FNAC)
ix. Biopsy and Bone marrow aspiration
x. Catheterization of major vessels (Arterial cannulation, Central line,
PICC)
xi. Endoscopy procedures (Gastro Intestinal, Respiratory or others)
xii. High risk Consent where appropriate
xiii. HIV testing
xiv. Restraint
xv. Dialysis
xvi. Chemotherapy
xvii. Blood transfusion
xviii. Nuclear medicine tests
xix. Radiology investigations (X-Rays for female patients of child bearing age, CT,
MRI, Fluoroscopy, Mammography, Bone Densitometry etc.)
xx. Ultrasound (in Antenatal cases Refer PNDT Act)
xxi. Radiation therapy including Brachytherapy
xxii. Leaving Against Medical Advise (LAMA)
xxiii. Admission/General Consent

15. xxiv. Blood Donor consent
xxv. Termination of pregnancy (Refer MTP Act)
xxvi. Dental procedures like tooth extraction
xxvii. Invasive Cosmetic procedures including piercing of ear lobes
xxviii. Disposal of anatomical remains
xxix. Release of confidential information except as permitted or required by law
xxx. Any treatment/procedure/test where the treating doctor feels the need to obtain
consent
xxxi. Organ transplant (also refer THOA)
Consent is not required in the following conditions as per law:
i. Medical examination of persons brought for this purpose by police. Consent is
needed for treatment.
ii. When arrested person(s) are brought for collection of evidence (e.g. blood
sample)
iii. Medical examination directed by the Court (examination of genitalia in case of
rape victim needs consent in writing)
iv. Medical examination needed for statutory purposes (e.g. Armed Forces etc.)

16. Projectwork
 We audited total 340 different consent forms, 170 retrospective form and 170
live consent form after quality improvement interventions using a set
proforma to produce a final score for each form, in order to assess the quality
of consent completion and to recommend changes.
 We then implemented changes in our current clinical practice and
subsequently re-audited our performance.
Time period
16 May 2015 to 15 July 2015
From 16 May 2015 to 31 May 2015 Auditing of retrospective consent forms.
From 1 June 2015 to 15 June 2015 Quality improvement Interventions
applied.
From 15 June to 30 June 2015 Auditing of live consent form to see the
improvement.

17. Aim
 To assess the quality of consent form completion by different health
professionals in hospital and to identify areas for potential improvement.

18. Materials and methods Used
 We audited total 340 different consent forms, 170 retrospective form and 170
live consent form after quality improvement interventions using a set
proforma to produce a final score for each form, in order to assess the quality
of consent completion and to recommend changes.
 A special audit toll has been prepared and according to completion of consent
form 0, 1, NA scoring is done.
 And at the end compliance of consent form is calculated in percentage.
 The Following audit toll has been used to give the scoring.
Audit to be done by MS. One file to be audited daily (25 per month). If for any audit
point either/any criteria is not complied, please mark 0
S.
1
Does the consent form bear the name and signature/thumb
impression of person giving the consent (patient/surrogate)
Check consent form
2 For surrogate consent, is the name of the signatory &
relationship with the patient, recorded on the consent form
Check consent form
3
Does the consent form bear the name and signature/thumb
impression of person witnessing the consent
NA for HIV and some
other consents. Write NA
if not applicable
4
Does the consent form bear the name and signature/thumb
impression of interpreter
Applicable if interpreter
used, else NA
5
Does the consent form bear the name and signature of person
obtaining consent
Check consent form
6
Does the consent form bear the Date and time for each
signature on the consent
Check consent form
7
Does the consent form contain the Name of
procedure/treatment/test for which consent is being obtained
Check consent form
8
Are the potential major complications of undergoing the
planned procedure documented in the consent form
Check consent form
9
Does the consent form contain the name of the person who will
perform the procedure for which consent is being obtained
Check consent form
10
For procedure(s) carried out in the Ward/ICU, is the consent
taken by either Treating Consultant or Registrar or Ward
RMO?
Check consent form

19. 11
Was the doctor/ team member who explained & obtained the
consent, physically present during the surgical/invasive
procedure, procedure or a member of the defined Team as per
list available with Medical Admin
See consent form & OT/
Procedure notes
12 Is the anesthesia consent signed by the Anesthesiologist or an
anesthesia team member
Check consent form &
Anesthesia Notes
13
Is the procedure/ treatment/ test actually performed by the
person, named to carry out the procedure in the consent form
or his team member (applicable only to post-op cases)
Check OT/Procedure
Notes
14
Is the actual procedure/ treatment/ test carried out same as the
one named in the consent form (applicable only to post-op
cases)
Check OT/Procedure
Notes
15 Are any abbreviations used on the consent form Check consent form
16
In case the procedure was high risk, has a separate high-risk
consent been obtained, in addition to the procedure consent
Applicable only for High
Risk procedures,else NA
17
Does the High Risk Procedure bear the signature of both the
Surgeon & Anesthesiologist?
Applicable only for High
Risk procedures,else NA
18
For procedures carried out frequently &/or regularly on the
same patient (e.g. Dialysis), is a fresh written informed consent
obtained at least once every 30 days
19
For planned surgical/invasive procedures is the consent
obtained before the patient is wheeled out from the ward to the
OT
Check consent form
It contains total 19 different points to be checked in each consent form.

20. Observation
After auditing the retrospective consent form from by using audit tool the consent
compliance is of following percentage.
Compliance of different consents.
82%
87%
82%
86%
89%
94%
86%
76%
78%
80%
82%
84%
86%
88%
90%
92%
94%
96%
Compliance according to differentConsent
Compliance according to
different Consent

21. Compliance of different consents according to department
89%
78% 78%
83%
73%
90% 87%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Compliance according to Department
Compliance according to
Department

22. 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 dos and 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.

23. Do’s
1. The consentform to be filled by eligible personin legible handwriting
only.
2. Name of the patient to be mentioned which is to be signed by the
patient himself.
3. Name of the surgery/procedure to be mentioned for which the consent
is taken.
4. Name and signature of the witness to be obtained in the specified
column only.
5. Name of the surgeon performing the procedureto be mentioned and to
be signed by him only.
6. High risk consentto be signed by both surgeon and anesthetist with
date and sign.
7. Each signature on the consent form bear the date and time.
8. Mention the Name of the person obtaining the consent.
Don’ts
1. Strictly no abbreviations allowed.
2. No consent form to be filled in the operating suite.
3. Don’t leave the complications spaceblank, please mark it N/A.
4. Don’t wheel the patient to operating suite without filling the
consent form completely.
5. Don’t Leave the tick boxes in the consentform blank, please tick
which and where ever applicable.

24. After application of Intervention, following things are observed in consent compliance.
Compliance of different consents. After application of Intervention.
95%
99%
95%
98%
100%
94%
95%
91%
92%
93%
94%
95%
96%
97%
98%
99%
100%
101%
Compliance of differentconsent form
Compliance of different consent
form

25. Compliance of different consents according to department after
application of Intervention.
94%
99% 99%
89%
92%
100%
96%
82%
84%
86%
88%
90%
92%
94%
96%
98%
100%
102%
consent complience according to department
consent complience according
to department

26. Results
After comparing retrospective consent form and live consent form compliance, after
implementation of Quality improvement interventions following results are seen.
CONSENTTYPE
COMPLIANCE
Retrospective data
%
Live data %
after
intervention
Improvement
achieved%
Surgical 82 95 13
Anesthesia 87 99 12
High-risk 82 95 13
HIV 86 98 10
Blood Transfusion 89 100 11
Radiology 94 100 6
Surgical
interventional
procedures
86 95 9
If we put this data in graphs then it shows.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
82%
87%
82%
86%
89%
94%
86%
95%
99%
95%
98% 100% 100%
95%
Retropective data consent
compliance
After intervention consent
compliance

27. CONSENT
COMPLAIANCE
DEPARTMENTWISE
Retrospective
data %
Live data %
after
intervention
Improvement
achieved%
Cardiology 89 94 5
Orthopedic 78 99 11
Oncology 78 99 11
Urology 83 89 6
Neurology 73 100 27
OBGY 90 92 2
GeneralSx 87 96 9
If we put this data in graphs then it shows.
0
10
20
30
40
50
60
70
80
90
100
89
78 78
83
73
90
87
94
99 99
89
100
92
96
complience before intervention
complience after intervention

28. Conclusion
After auditing retrospective data we found that consent compliance was not up to the
mark and after applying necessary intervention compliance of consent is increased and
awareness and importance of taking complete consent is created among the clinical stuff.
This is very useful in tackling the medicolegal issue which may occur in day to day
working of hospital