Summer Training Project Report

Undertaken at

BLK-Max Super Speciality Hospital

BLK-Max Super Speciality Hospital
BLK-Max Super Speciality Hospital
Submitted in Partial fulfilment of the Requirement for the Award of the Degree of

Master of Business Administration (HHM) (2021-23)

By
DR. Shweta
Roll no.- 21HHM032
Enrolment number- 21-04861

Under the Supervision of

DR. Pooja Sharma

Department of Hospital Management and hospice Studies (Faculty of management studies) Jamia
Millia Islamia, New Delhi – 110025
 Declaration

I, Shweta, a bona fide student of the MBA (Healthcare and Hospital Management) Programme at the
Centre for Management Studies, Jamia Milia Islamia, New Delhi, hereby declare that I have undergone
the Summer Training at BLK MAX Super speciality Hospital under the supervision of Dr. Deepak on and
from 24 June 2022 to 31 August 2022.
. I also declare that the present project report is based on the above summer training and is my original
work. The content of this project report has not been submitted to any other university or institute either
in part or in full for the award of any degree, diploma, or fellowship. Further, I assign the right to the
university, subject to the permission from the organization concerned, to use the information and contents
of this project to develop cases, case lets, the case leads, and papers for publication and/or for use in
teaching.

Signature of Student

Name of Student

Roll No
 ACKNOWLEDGEMENT

I have taken efforts in this project. However, it would not have been possible without the kind support
and help of many individuals. I would like to extend my sincere thanks to all of them.

Firstly, I would like to express my special gratitude towards DR.N.H MULLICK (HEAD OF
DEPARTMENT, DEPARTMENT OF HOSPITAL MANAGEMENT AND HOSPICE STUDIES,
JAMIA MILLIA ISLAMIA) for providing me such a great opportunity which helped me a lot in
exploring the unexplored fields of healthcare sector.

It has been great honour and privilege to undergo training at BLK-MAX SUPER SPECIALITY
HOSPITAL.

I am highly indebted to DR. DEEPAK TANWAR AND MS SANGEETA JOHN for their guidance
and constant supervision as well as for providing necessary information regarding the project and also for
their support in completing the project.

I would like to express my gratitude towards my parents and members of QUALITY AND
OPERATIONS MANAGEMENT TEAM for their kind support, cooperation and encouragement which
help me in completion of this project.

My thanks and appreciations also go to my FRIENDS in developing the project and people who have
willingly helped me out with their abilities.
 TABLE OF CONTENTS

Introduction
 Genesis
 Vision
 Mission
 Value
 Objective
 Form of organization
 Future Prospects
 Marketing Initiatives
 Organisational structure
 Staffing Pattern
 Recruitment policy
 Retention Policies
 Managerial concerns
TASK ASSIGNED

 Description of assigned task and responsibilities

 Nature of work
 Working hours
 Work expectations
 Procedure and methodology
 Learning Experience

Research topic
 Introduction
 Literature review
 Data analysis
 Discussion
 Conclusion
 Recommendations
 Annexure
RESEARCH TOPIC- TO ASSESS THE IMPLEMENTATION
OF CONSENT FORM

Shweta
21HHM032
BLK MAX SUPER SPECIALITY HOSPITAL
 GENESIS
Dr. B L Kapur, an eminent Obstetrician and Gynaecologist, set up a Charitable Hospital in 1930
at Lahore. In 1947, he moved to post-partition India and set up a Maternity Hospital at
Ludhiana. In 1956 on the invitation of the then Prime Minister, Dr. B L Kapur initiated the
project for setting up a 200-bed hospital in Delhi. The hospital was inaugurated by the Prime
Minister, Pt. Jawahar Lal Nehru on 2nd January, 1959.

Dr. B L Kapur's passion and dedication for achieving his dream was such that he would often add his
own income to the Hospital's coffers, sacrificing even his basic needs.

By 1984, when the Hospital celebrated its Silver

Jubilee, it was expanding and was well on its way of
becoming Delhi's premier Multi-Speciality Institute.
Services offered included General Medicine, Plastic
Surgery, General Surgery, Dialysis, Ophthalmology,
ENT, Dentistry Pulmonology, Intensive Care and
Orthopaedics, apart from Mother & Child Care.
The Hospital has always supported economically challenged patients and participated in all local
and national health programs.

BLK-Max Super Speciality Hospital was redeveloped and re-launched as a Multi Super Speciality
facility with 650 bed capacity including 125 beds dedicated to critical care and 17 modular
operation theatres, offering seamlessly integrated healthcare service to patients.
The Hospital became the youngest in India to achieve the prestigious NABH and NABL
accreditations.
BLK-Max has established multiple Centres of Excellence which provide the latest in health care to
patients.
These include:
 Cancer Centre
 Centre for Bone Marrow Transplant
 Heart Centre
 Centre for Neurosciences
 Institute for Digestive & Liver Diseases
 Centre for Renal Sciences & Kidney Transplant
 Institute for Bone, Joint Replacement, Orthopaedics Spine & Sports Medicine
 Centre for Chest & Respiratory Diseases
 Centre for Plastic & Cosmetic Surgery
 Centre for Child Health
 Centre for Critical Care
Hospital Management:

BLK Super Speciality Hospital is being managed by Radiant Life Care Private Limited. Prior to
taking over management of the Hospital, Radiant was responsible for financing and re-developing the
erstwhile facility. In order to manage the operations of the Hospital, Radiant has deputed the entire
leadership team including the CEO, CFO, Head Medical Services and Heads of Human Resources,
Marketing and Administration. In addition, Radiant has been effective in putting in place processes
and best-in-class global practices encompassing both clinical and administrative facets of Hospital
operations. Radiant aims at facilitating the ongoing pursuit of excellence at the Hospital by assisting
in bringing-in not only the best clinical and non-clinical talent but also the ultra-modern equipment
and technology enabling delivery of the highest standards of healthcare.
VISION

To create a patient-centric, tertiary healthcare organization focused on non-intrusive quality

care utilizing leading edge technology with a human touch.
Mission

 Achieve Professional Excellence in delivering Quality care.

 Ensure care with Integrity and Ethics.
 Push frontiers of care through Research and Education.
 Adhere to National and Global Standards in Healthcare.
 Provide Quality healthcare to all Sections of Society.
Value
Objective

At BLK-Max, we are passionate about delivering the highest standard of healthcare. Be it the
finest Doctors, cutting-edge medicine, state-of-the-art infrastructure or nursing with a smile.
When you are passionate about healing the lives that have been entrusted to us, nothing is too big
or small to ignore.

FORM OF ORGANISATION:

BLK Super Speciality Hospital is accredited by National Accreditation Board for Hospitals and
Healthcare Providers, and National Accreditation Board for Laboratories and Calibration, for its
processes and high-quality patient care.

BLK Super Speciality Hospital is the largest stand-alone private sector hospitals in Delhi and the range of
services offered at BLK make the Hospital a force to reckon with in the field of Super Speciality Tertiary
Healthcare. The Hospital has a capacity of 700 beds with dedicated 125 critical care beds, 17 modular
operation theatres and specialty-specific dedicated OPD blocks. The facility is equipped with the most
modern medical diagnostic & therapeutic equipment’s, to name a few Trilogies Tx Linear Accelerator
with cone beam CT for Radiation Oncology, Cyber-knife VSI, 128 Slice 3D CT scan, 1.5 Tesla MRI, Flat
panel combo Cath Lab with 3D reconstruction, Ultrasound with 3D and 4D imaging and dual head Spec
CT with variable angle Gamma Camera and the latest generation PET-CT.

BLK has India's largest Bone Marrow Transplant Centre and is known world over for excellent outcomes.
BLK Cancer Centre is one of the few centres in the world which provides comprehensive Cancer Care
with organ specific specialist teams in holistic manner. The Hospital offers advanced services for the
treatment of heart conditions including Minimal Access Cardiac Bypass Surgery. The Bariatric Surgery
(Weight Loss Surgery) program at BLK is one of the largest in the region. The Hospital provides a wide
spectrum of Super Speciality Services in the field of Neurology, Neurosurgery, Urology, Kidney
Transplant, Nephrology, Gastroenterology and Surgical Gastroenterology, Liver transplant, Orthopaedics
including Spine Surgery, Joint Replacement & Sports Medicine, Cosmetic & Reconstructive Surgery,
comprehensive Mother & Child care including advanced IVF. In addition, process driven Critical Care
services, along with the most advanced Diagnostic and Imaging facilities, provide the necessary backbone
for patient care for holistic, comprehensive and contemporary care to patients.

BLK Super Speciality Hospital is being managed by Radiant Life Care Private Limited. Prior to taking
over management of the Hospital, Radiant was responsible for financing and re-developing the erstwhile
 facility. In order to manage the operations of the Hospital, Radiant has deputed the entire leadership team
including the CEO, CFO, Head Medical Services and Heads of Human Resources, Marketing and
Administration. In addition, Radiant has been effective in putting in place processes and best-in-class
global practices encompassing both clinical and administrative facets of Hospital operations. Radiant
aims at facilitating the ongoing pursuit of excellence at the Hospital by assisting in bringing-in not only
the best clinical and non-clinical talent but also the ultra-modern equipment and technology enabling
delivery of the highest standards of healthcare.

FUTURE PROSPECTS:

Radiant Life Care, post-merger with Max Healthcare, plans to increase existing 3,500 beds to 5,500 beds
in Fly Offices in countries to enable this business. Presently, we have representations in Uzbekistan, Iraq,
Kurdistan, Myanmar, Fiji, Ethiopia, Nigeria, Nepal, Afghanistan and are planning to establish a presence
in Sudan, Cameroon, Kenya and Indonesia over the next few years. Our focus will be medical tourism

both domestically and internationally for high-end quaternary care.

In the next 4-5 years. We also plan to expand the capacity at BLK Hospital, Nanavati Hospital, and Max
Smart. At Vaishali (Delhi-NCR) Max, we intend to commission 100 beds in the next few weeks. In the
next 4-5 years, we are planning to add another 900 beds at Max Smart (Saket New Delhi) and 650 beds at
Nanavati Hospital. Similarly, beds will be increased at other Max units as well.
We as a country, have a significant competitive advantage compared to other nations. We are the largest
exporters of nurses, doctors and medical technicians to the world and happen to be not only the lowest
cost but also the highest skill destination in the world for medical services. Moreover, geographically we
are within 7 hours of flying time of 65% of the global population. We intend to focus a lot more on
International Medical Tourism going forward.

Over the next 2-3 years we plan to optimise our existing network while investing in growth and
developing asset light adjacencies. All our strategic priorities have been aligned with these three pillars –
Marketing Initiatives:

Max Healthcare has been deeply invested in creating brand differentiation and recognition of key
specialities in the Healthcare market in North India.

I. The flagship campaign of ‘More to Healthcare’ that worked upon highlighting the work that
goes behind the scenes in a hospital while treating a patient, continued from the previous year
with new communication. The campaign was extensively promoted online on various websites
and on social media and led to significant gains and PR for Max Healthcare in the Physician
community and general population. The Campaign also won the Economic Times Shark
Award in the Best Campaign for Consumer Health and Fitness Category.

II. ‘Nidarr hamesha’: Oncology is one of the fastest growing verticals at Max Healthcare. e.
Max healthcare launched multiple initiatives across our hospitals to highlight excellence in
cancer treatment including a 360 integrated campaign under the theme ‘Nidarr hamesha’ that
celebrated the relentless and undying spirit of cancer patients and their caretakers to fight and
beat this disease.
III. The campaign ‘Dimaag ki Suno’: The campaign ‘Dimaag ki Suno’, a unique creative
approach to promote the Neurosciences vertical was launched in digital media and outdoors
and aimed to educate masses about the most commonly occurring Neurological diseases.

IV. The theme – ‘Self less Wish’: For the Organ Transplant vertical, one of the means to create
visibility has been to promote the bigger cause of Organ donation across India. The campaign,
in association with NGO Mohan Foundation, during the Christmas season with the theme –
‘Self less Wish’ promoted organ donation. The campaign won 2 awards at Healthcare Ad
Awards USA in the 'Impact Total Ad campaign without TV' category.
V. Community First: Community outreach initiatives under ‘Community First’ were done in the
form of health awareness programmes, cleanliness drives, local area beautification and special
benefits to residents around the hospital. Over 40,000 people were enrolled in Customer
programmes like Citizen Plus, Healthy Family offering various service and discount benefits.
Over 1800 activities were conducted in the communities around the hospitals and through
various customer programmes and over 45,000 people reached.

VI. The International Digital campaign was initiated to utilize opportunity of medical tourism in
India. As part of the campaign search ads and different landing pages were prepared in
different languages mainly Arabic, Persian, Russian and English. Countries that were targeted
were Afghanistan, Nepal, Iraq, Turkmenistan, Nigeria, Fiji, Pakistan, USA, Sudan, Yemen,
Iraq and Bangladesh.

VII. The Appointment Campaign and Lead generation campaigns were targeted at people who
were looking for appointments with doctors online or searching for particular procedures and
specialities. Digital Campaigns in Upcountry markets were to support regular OPDs conducted
by our doctors in Tier 2 cities like Lucknow, Kanpur, Prayagraj, Meerut, Gwalior, Patna,
Ranchi, Saharanpur etc.
BLK-Max Hospital in association with Meer Foundation started a noble initiative
#ToGetHerTransformed

BLK-Max Hospital feels immensely proud to be associated with Meer Foundation's noble
initiative #ToGetHerTransformed. The event was graced by Shahrukh Khan who empowered the 120 acid
attack survivors towards living a quality life with equal opportunities.
Organisation Structure of MAX-Healthcare

Chairmen and Managing Director

IS: Informative Services
TS: Therapeutic Services
DS: Diagnostic Services
SS: Support Services
 Staffing Pattern

Staffing is a process of planning, employing and developing human resources at different levels of an
organization.

Objectives of Staffing
1. To ensure maximum utilization of human resources
2. To discover and obtain competent personnel.
3. To ensure the continuity and growth of organization.
4. To improve job satisfaction.
5. To be able to meet crisis situations.
6. To deliver good quality of care.

Functions in staffing
1. Identifying the type and amount of service needed by organization.
2. Determining the personnel categories that have the knowledge and skill to perform needed service
measures.
3. Predicting the number of personnel in each job category that will be needed to meet anticipated
service demands.
4. Obtaining, budgeted positions for the number in each job category needed to service for the
expected types and number of clients.
5. Recruiting personnel to fill available positions.
6. Selecting and appointing personnel from suitable applicants.
7. Orienting personnel to fulfil assigned responsibilities. 8. Assigning responsibilities for client
services to available personnel
RECRUITEMENT PROCESS
 RETENTION POLICIES

Salary Appraisal
• Sometimes to retain the
emplyoee we increse their
salaries.
Promotion
• To retain a very important
emplyoee we can also
promote the emplyoee after
two years.
 Special managerial concerns

1. High Turnover of employees: There is high turnover at BLK-MAX hospital.

2. Opening of new Amrita Hospital is also a important managerial concern for the management.
PART -B
 Description of the assigned task and responsibilities

During the tenure of my internship, I worked under the Quality Management Department and Operations
Department and was assigned different works under respective departments.

In quality department I was assigned to do:

 Active file audit-The systematic evaluation of the quality of medical records is crucial. Internal
audits are not just measurement activities but a necessary activity to support the organization in
achieving its objectives and assessing the quality of clinical care and maintaining high quality
professional performance.

 International Patient Safety Goals (IPSG) audit- The International Patient Safety Goals (IPSG)
were developed in 2006 by the Joint Commission International (JCI). The goals were adapted from
the JCAHO's National Patient Safety Goals.
o Goal 1: Identify patients correctly.
o Goal 2: Improve effective communication.
o Goal 3: Improve the safety of high-alert medications.
o Goal 4: Ensure safe surgery.
o Goal 5: Reduce the risk of health care-associated infections.
o Goal 6: Reduce the risk of patient harm resulting from falls.

 Calculation of Standard Mortality Rate under seven ICU’s (ICCU, CTVS, PICU,NICU, NSICU,
MICU, SICU )- The intensive care unit (ICU) is an integral part of any acute care health facility,
as it provides highly specialized and intense close monitoring for critically ill patients with life
threatening conditions, the very nature of services and interventions provided in an ICU such as
mechanical ventilation, diagnostic procedures, invasive monitoring techniques, and the utilization
of medications and blood products lead to increased expenditure and daily costs per patient, this in
addition to the development of complications , furthermore, expenses in ICU are also dependent
on the severity of illness assumed to be highest in an ICU patient.
There are Seven ICUs in BLK-MAX Hospital:
1. Intensive Critical Care Unit
2. Cardiothoracic Vascular Surgery
3. Paediatric ICU
4. Neonatal ICU
5. Neurosurgical ICU
6. Medical ICU
7. Surgical ICU

Each ICU has a different Mortality indicator. Acute Physiology and Chronic Health Evaluation
(Apache Score), Physiological and Operative Severity Score for the enumeration of Mortality and
Morbidity (Possum Score), The sequential organ failure assessment score (Sofa Score),
Score for Neonatal Acute Physiology-Perinatal Extension II (Snappe Score), paediatric Index of
Mortality 3 (PIMS).
 1. Consent Form audit before the surgery - I was assigned to check the application of consent form
before any surgical procedure.

 Communicate with the patient’s attendant before the commencement of surgery to increase the
patient satisfaction, and to reduce the anxiety.

In Operation Department I worked under Ms. Sangeeta john Manager Patient Experience Department of
Medical Administration:

 I used to do ward rounds in the morning. During my wards rounds I was supposed to take
feedback /appreciation from the patients regarding their issues and concerns and to solve any issue
they face during the period of their stay at the hospital. I use to solve every issue by myself with
the help of my mentor Ms. Sangeeta.
Nature of Work, working hours, work expectation
 Working hours were of eight hours. I was supposed to work 9am to 5pm.
 I was supposed to report everyday about the status of the task assigned.
 During the wards rounds I was supposed to solve every difficulty faced by the patients or the
patient’s attendant by myself or with the help of the patient experience manager.
 Procedure and methodology

1.Active file audit: Active file audit is done by its checklist.

MONTH-
FOCUSED AUDIT CHECKLIST

MAX ID

CONSULTANT

DOA
UNIT

INITIAL ASSESSMENT
TIME OF ARRIVAL
TIME OF ASSESSMENT
SOURCE OF HISTORY / PAST HISTORY
ALLERGIES
PROVISIONAL DIAGNOSIS
PAIN ASSESSMENT
CURRENT MEDICATION
PLAN OF CARE
FAMILY HISTORY
FAMILY EDUCATION
DATE, TIME, SIGN & NAME OF
DOCTOR PRESENT
PATIENT & FAMILY EDUCATION &
COMMUNICATION
PATIENT AND FAMILY EDUCATION
FILLED & SIGNED BY DOCTOR
PATIENT AND FAMILY EDUCATION
FILLED & SIGNED BY NURSE
PATIENT AND FAMILY EDUCATION
FILLED & SIGNED BY
PHYSIOTHERAPIST
PATIENT AND FAMILY EDUCATION
FILLED & SIGNED BY DIETICIAN
PATIENT AND FAMILY EDUCATION
FILLED & SIGNED BY ATTENDANT
PATIENT AND FAMILY
COMMUNICATION RECORD FILLED
FOR EACH DAY OF ICU STAY
PROGRESS NOTES
DOCTOR SIGN, DATE, NAME, TIME,
BLK ID, MENTIONED IN PROGRESS
NOTE
ANY CUTTING OR OVER WRITING IN
THE RECORD
LEGIBLE HANDWRITING
NON-DRUG
LAB (PHY. NAME, SIGN, BLK-ID, DATE,
TIME)
RADIOLOGY (PHY. NAME, SIGN, BLK-
ID, DATE, TIME)
REHAB (PHY. NAME, SIGN, BLK-ID,
DATE, TIME)
NUTRITION (PHY. NAME, SIGN, BLK-ID,
DATE, TIME)
SPECIFIC (PHY. NAME, SIGN, BLK-ID,
DATE, TIME)
CONSENT
ABBRIVIATIONS IN CONSENT
ALTERNATIVES, INDICATION, RISK,
BENEFITS MENTIONED IN CONSENT
SIGNATURE OF ATTENDANT
ANAESTHESA
ANAESTHESIA/ SEDATION CONSENT
PRE-ANAESTHESIA ASSESSMENT
ANAESTHESIA RECORD
MODIFIED ALDRETE SCORE
SURGICAL SAFETY CHECKLIST
SIGN IN DOCUMENTATION
TIME OUT DOCUMENTATION
SIGN OUT DOCUMENTATION

INTENSIVE CARE UNIT

ADMISSION CRITERIA
DISCHARGE CRITERIA
OPERATION NOTE
COMPLIANCE
START TIME OF SURGERY
END TIME OF SURGERY
PRE/POST OPERATIVE DIAGNOSIS
NAME OF PROCEDURE
INCISION
PROCEDURE PERFORMED
OPERATIVE FINDINGS AND STEPS
APPROXIMATE BLOOD LOSS
BLOOD AND BLOOD PRODUCTS (IF
ANY)
POST OP INSTRUCTIONS
COMPLICATIONS (IF ANY)
SPECIMEN FOR HPE/ TISSUE FOR PPE
 CONDITION AT THE END OF
PROCEDURE
SURGEON'S SIGNATURE, DATE, NAME,
TIME, BLK ID
DISCHARGE SUMMARY
ABBRIVIATIONS IN DISCHARGHE
SUMMARY
ROUTE OF MEDICATION IN
DISCHARGE SUMMARY

During Active file audit we used to check files of the patients who are presently admitted in hospital for
their treatment according to this checklist and write compliance or noncompliance as per NABH

s in To
improvement
specific
promote
guidelines.

II. International patient safety goals (IPSG):

Inter national Patient safety goals
International Patient Safety Goals (IPSG) help accredited organizations address specific areas of concern
in some of the most problematic areas of patient safety.
INTERNATIONALPATIENTSAFETY GOALS (JCISTANDARDS 5TH EDITION AS 2014):
1.Identify Patients Correctly
2.Improve Effective Communication
3.Improve the Safety of High-alert Medications
4.Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery
5.Reduce the Risk of Health Care–Associated Infections
6.Reduce the Risk of Patient Harm Resulting from Falls
Goal 1: Identify Patients Correctly Ask for two identifiers including the FULL NAME, and MEDICAL
RECORD NUMBER Verify patient identification before all invasive and diagnostic procedures.
Patient identification wristbands for inpatients. “Time-out” before starting all surgical and invasive
procedures (preventing wrong site, wrong procedure, wrong patient surgery) Not use these for
identification  Patients room numbers, locations
Goal 2: Improve Effective Communication Standards 2. Verbal/Telephone Order •The hospital develops
and implements a process to improve the effectiveness of verbal and/ telephone communication among
caregivers. Standard IPSG.2.1 •The hospital develops and implements a process for reporting critical
results of diagnostic tests. Standard IPSG.2.1 •The hospital develops and implements a process for
handover communication.
Ineffective Communication •Reporting critical test results –Potassium result was reported by lab to nurse
–Nurse hears result as a very low value of 2.7. –After the patient's laboratory results are entered on the
screen, it was seen as 8.7.
Effective communication, which is timely, accurate, complete, unambiguous, and understood by the
recipient, reduces errors, and results in improved patient safety. Reporting the critical test results, Verbal
and telephone orders that includes: writing down & reading back A standard communication method
including asking and answering questions during hand-offs SBAR Inappropriate abbreviations, symbols
and wordings Improve Effective Communication
Handovers of Patient Care within a Hospital Occur between health care providers, such as between
physicians and other physicians or health care providers, or from one provider to another provider during
shift changes; between different levels of care in the same hospital such as when the patient is moved
from an intensive care unit to a medical unit or from an emergency department to the operating theatre;
and From inpatient units to diagnostic or other treatment departments, such as radiology or physical
therapy.
Goal 3: Improve the Safety of High-alert Medications IPSG.3 The hospital develops and implements a
process to improve the safety of high-alert medications. IPSG.3.1 The hospital develops and implements a
process to manage the safe use of concentrated electrolytes.
Improve the Safety of High-alert Medications When medications are part of the patient treatment plan,
appropriate management is critical to ensuring patient safety. A frequently cited medication safety issue is
the unintentional administration of concentrated electrolytes Potassium chloride [2mEq/ml or more
concentrated], Potassium phosphate, sodium chloride [0.9% or more concentrated], Magnesium sulphate
[50% or more concentrated]. Inadequate orientation of staff members. Remove the concentrated
electrolytes from the patient care unit to the pharmacy. Areas where concentrated electrolytes are
clinically necessary, Emergency Department Operating Theatre, Critical care Area •How they are clearly
labelled and how they are stored
Goal 4: Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery •Ineffective or inadequate
communication between members of the surgical team. •Lack of patient involvement in site marking, and
lack of procedures for verifying the operative site. •Inadequate patient assessment and medical record
review, a culture that does not support open communication among surgical team members, problems
related to illegible handwriting and the use of abbreviations are frequent contributing factors. •The
essential processes found in the Universal Protocol are Marking the surgical site; A preoperative
verification process; and A time-out that is held immediately before the start of a procedure.
Marking the Surgical Site •Laterality, •Multiple structures (fingers, toes, lesions), or •Multiple Levels
(spine) •The mark should be; –consistent throughout the organization –should be made by the person
performing the procedure –should take place with the patient awake and aware, if possible, –and must be
visible after the patient is prepped and draped

Goal 5: Reduce the Risk of Health Care–Associated Infections Infection prevention and control.
Catheter-associated urinary tract infections, blood stream infections and pneumonia (often associated with
mechanical ventilation). Central to the elimination of these and other infections is proper hand hygiene.
Hand hygiene guidelines CDC – Bundles *CDC: centres for Disease Control and Prevention
Goal 6: Reduce the Risk of Patient Harm Resulting from Falls. Falls account for a significant portion of
injuries in hospitalized patients. Evaluate patients’ risk for falls, take action to reduce the risk of falling
and to reduce the risk of injury should a fall occur. The evaluation could include fall history, medications
and alcohol consumption review, gait and balance screening, and walking aids used by the patient. A fall-
risk reduction program
Preventing Patient Falls Trainings to patients and patient families Not leaving bed without any help
Nurse call and frequently used objects are placed near to the patient Bed height is fixed at the lowest
level. All side rails in the up position. Instruct the patient to wear non-skid footwear. Unused equipment is
removed from the room. Proper lighting
International patient safety goals (IPSG) audit is done by its checklist. We use different checklist for each
IPSG goals. Here is an example of the check list which we use for this audit.

IPSG 1- CORRECT IDENTIFICATION OF PATIENTS

CORREC DEPART COMPLI NON- TOT COMPLI NON-
MA T NAME MENT ANCE COMPLI AL ANCE % COMPLI
S.
DA X ENCRYP ANCE ANCE %
N
TE UH TED ON
o
ID ID
BAND
PATIENT
IDENTIFICATION
BAND

PATIENT
IDENTIFICATION
BEFORE ANY
PROCEDURE/MED
ICATION
Check list for second IPSG goal:
Check list for third IPSG goal:

IPSG 3 (IMPROVE THE SAFETY OF HIGH ALERT MEDICATION)

BLUE
PINK
HIGH COLO
HIGH COLO
RISK RED
RISK HIGH LASA RED
MEDI STICK
MEDI RISK DRU STICK PART
S CATI ER NON-
D DEPARTME CATI MEDI GS ER COM IAL TO COM
. ON ON COM
A NT/LOCATI ON CATI KEPT ON PLIAN COM TA PLIAN
N STOR SOUN PLIAN
TE ON LISTE ON SEPA LOOK CE PLIA L CE %
o ED D CE %
D LOCK RATE ALIKE NC
SEPA ALIKE
AREA ED LY MEDI
RATE MEDI
WISE CATI
LY CATI
ON
ON
Check list for Fourth IPSG goal:

IPSG-4 ENSURE SAFE SURGERY

SURGI Sign in
NAME Sig Document
CAL Document Time Out
MA OF n ation
SITE ation Document
DA X NA DEPART DOCT PROCED Ou Complianc
MARKI Complete ation
S. TE UH ME MENT OR URE
Complete
t e
ID PERFOR NG (A) (C (A+B+C)/3
N (B)
o MED ) *100

Fifth goal evaluation is done by the infection control team of the hospital.
Check list for IPSG sixth Goal:

IPSG 6-REDUCE THE RISK OF PATIENT HARM RESULTING FROM FALLS

MA
S. X NON- NON-
N DAT UHI NAM DEPARTME COMPLIAN COMPLIAN TOT COMPLIAN COMPLIAN
o E D E NT CE CE AL CE % CE %
SIDE
RAILS
UP IN
PATIE
NT
BEDS

No. of NON-
Patient NON- COMPLIANCE COMPLIANCE
DATE Observed COMPLIANCE COMPLIANCE % %
PATIENT
BEING
TRANSFERRED
WITH
SEATBELT ON
IN
WHEELCHAIR
 MA
X NON- NON-
DAT UHI NAM DEPARTME COMPLIAN COMPLIAN TOT COMPLIAN COMPLIAN
E D E NT CE CE AL CE % CE %
PATIENT
FALL RISK
ASSESSME
NT BY
MODIFIES
MORSE
SCALE

Modified MORSE Scale: The Morse Fall Scale (MFS) is a rapid and simple method of assessing a
patient’s likelihood of falling. A large majority of nurses (82.9%) rate the scale as “quick and easy to
use,” and 54% estimated that it took less than 3 minutes to rate a patient. It consists of six variables that
are quick and easy to score, and it has been shown to have predictive validity and interrater reliability.
The MFS is used widely in acute care settings, both in the hospital and long-term care inpatient settings.
Format of Modified MORSE Scale:
III. Calculation of Standard Mortality rate: There are seven ICUs in our Hospital and every ICU
have different mortality indicator:

A. Apache II Score : APACHE II ("Acute Physiology and Chronic Health

Evaluation II") is a severity-of-disease classification system, one of
several ICU scoring systems. It is applied within 24 hours of admission of a
patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed
based on several measurements; higher scores correspond to more severe disease
and a higher risk of death. Apache score is used in Medical Intensive Care Unit
(MICU), Neurosurgical Intensive Care Unit (NSICU).

B. SOFA SCORE: The sequential organ failure assessment score (SOFA score),
previously known as the sepsis-related organ failure assessment score, is used
to track a person's status during the stay in an intensive care unit (ICU) to
determine the extent of a person's organ function or rate of failure. The score is
based on six different scores, one each for
the respiratory, cardiovascular, hepatic, coagulation, renal and neurological syste
ms.
Patient ID Sticker: Date: CCU

The Sequential Organ Failure Assessment (SOFA) score

Organ System Score

Respiratory system

Coagulation

Liver

Cardiovascular system

Central Nervous system

Renal system

Total Score

The Sequential Organ Failure Assessment Score (SOFA)

System 1 2 3 4
Respiratory 2400 <400 <300 <200 <100
(PaOJF102 mm
Hg)
Coagulation 2150 <150 <100
(Platelets)
Liver <1.2 1.2-1.9 2-5.9 6-11.9 212
(Bilirubin mg/dl)
Cardiovascular MAP 270 mm MAP mm Dopamine<5 Dopamine 5.1-15 or Dopamine >15
or Epinephrine 0.1 or
Hg Epinephrine > 0.1
Dobutamine Or
Norepinephrine 0.1 or
(any dose)
Norepinephrine >0.1

CNS 15 '13-14 10-12 6-9 <6

(GCS score)
Renal <1.2 1.2-1.9 2.0-3.4 3.5-4.9 >5. o
(Creatinine (mg/dl) Urine<500 Urine<200
Urine output,
ml/d)
Catecholamine Dose= gg/kg/min for at least I-hr
 C. Possum score: This score is used in Surgical Intensive Care Unit (SICU). The
POSSUM scale (Physiological and Operative Severity Score for the enumeration
of Mortality and Morbidity) is a scoring system that is used to predict risk -
adjusted mortality and morbidity rates in a wide variety of surgical procedures.

POSSUM for Operative Morbidity and Mortality

Risk
Estimates morbidity and mortality for general surgery patients.
Physiological score

Age

years
Cardiac
No failure
Diuretic, digoxin or angina/hypertension meds
Peripheral oedema, warfarin, or borderline cardiomegaly on chest X-ray (CXR)
Raised jugular venous pressure, or cardiomegaly on CXR
Respiratory
No dyspnea
Exertional dyspnoea or mild COPD on CXR
Limiting dyspnoea or moderate COPD on CXR
Dyspnoea at rest or fibrosis/consolidation on CXR
sBP
mmhg

HR
beats/min

GCS
Points
Hgb
g/L
WBC

× 10⁹ cells/L

BUN
mmol/L
Sodium
mmol/L
Potassium
mmol/L
ECG
Normal
Atrial fibrillation (HR 60-90)
5 ectopic beats/min, Q waves or ST/T wave changes
Any other abnormal rhythm

Operative severity score

Operative severity
See About section for examples of surgeries in each category.
Minor
Moderate
Major
Major+
Number of procedures
1
2
>2
Estimated blood loss
mL
Peritoneal soiling
None
Minor (serous fluid)
Local pus
Free bowel content, pus or blood
Presence of malignancy
Diagnosed before or during surgery
None
Primary only
Lymph node Mets
Distant Mets
Mode of surgery
Elective
Emergency (within 24h), resuscitation >2h possible
Emergency (within 2h)

Result:
 D. SNAPPE SCORE: SNAPPE-II (Score for Neonatal Acute Physiology with
Perinatal Extension-II) in Predicting Mortality and Morbidity in NICU.

SNAPPE-II Score (Score for Neonatal acute physiology with perinatal extension-Il)
1. Mean Blood Pressure mmHg
> 30 0
20-29 9
< 20 19
2. Lowest
Temperature
> 96 0
95-96 8
< 95 15
3. P02/Fi02
> 2.5 0
l- 2.49 5
0.3-0.99 16
< 0.3 28
4. Lowest serum PH
>7.2 0
7.1 - 7.19 7
<7.1 16
5. Multiple seizures
No 0
Yes 19
6. Urine Output ml/kg/hr
>1 0
0.1 - 0.9 5
< 0.1 18
7. APGAR score
>7 0
>7 18
8. Birth weight (gms)
> 1000 0
750 - 999 10
< 750 17
9. Small for gestational age
< 3rd percentile 12
Total Score:

E. PIMS Score: This score is used in Paediatric Intensive Care unit (PICU).
Paediatric index of mortality (PIM) 2 score is one of the severities scoring
systems being used for predicting outcome of patients admitted to intensive care
units (ICUs).
F. EURO SCORE: Euro SCORE II (European System for Cardiac Operative Risk
Evaluation) is used in CTVS (Cardio Thoracic Vascular Surgery). Euro SCORE is
a simple, objective and user-friendly system for assessing the risk of heart surgery
in adults. It is based on an international multicentre database.
 IV. Consent Form audit before the surgery: I was assigned to check the application of consent form before the
surgery. There are various consent forms available for different surgery like sedation consent form. I used to
check consent form in pre-operation room and Recovery room before the surgery and make a list of the checked
files in excel.

LEARNING EXPERIENCES:
I joined internship when NABH audit was going to be conducted at our hospital so I learned a lot during
this audit I worked under two departments Quality management and Medical Operations.

I learned a lot about the whole hospital during my internship tenure. It was a great experience working
along with the supervisor and my colleagues.

During the wards rounds a learned a lot about the managerial issues faced by the patients and their
attendants and how to resolve them. While resolving their issues I gained a lot of confidence and it
enhanced my communication skill a lot.

Under Quality Management Department I got to learn about the NABH guidelines for the Quality
management of hospitals.

RESEARCH TOPIC- TO ASSESS THE IMPLEMENTATION

OF CONSENT FORM IN ICU

OBJECTIVE OF THE STUDY

 To assess the compliance of specialized surgical consent form in

ICU.

 To analyse the compliance of the consent for specific surgeries

 Need of study

Increased medical legal disputes and the desire to give patients more control over their own care have
brought informed consent and its acquisition to light. A patient needs the right information in order to
make an informed decision about their therapy. This could come up in conversations with medical or
nursing staff, in the media or online, or in conversations with friends who have had a similar treatment.
However, it primarily happens when the dangers and advantages of any surgical operation are outlined
during the acquisition of informed consent.
If doctors use the specialised surgical consent form for their particular surgery, its implementation needs
to be evaluated.

There are various surgeries for which particular consent forms are available:

INFORMED CONSENT: DIAGNOSTIC LAPROSCOPY

INFORMED CONSENT: LAPROSCOPIC APPENDICECTOMY
INFORMED CONSENT: VENTRAL/INCISIONAL/UMBLICAL HERNIA REPAIR
INFORMED CONSENT: OPEN APPENDICECTOMY
INFORMED CONSENT: LAPROSCOPIC CHOLECYSTECTOMY
INFORMED CONSENT: LAPROSCOPIC INGUINAL HERNIA REPAIR
INFORMED CONSENT: LAPROSCOPIC VARICOCELE REPAIR
INFORMED CONSENT: LAPROTOMY
INFORMED CONSENT: OPEN INGUINAL HERNIA REPAIR
INFORMED CONSENT: LIVER ABSCESS - SURGICAL DRAINAGE
INFORMED CONSENT: FISTULA IN ANO
INFORMED CONSENT: BREAST ABSCESS /HEMATOMA SURGERY
INFORMED CONSENT: BREAST FIBROADENOMA/CYST SURGERY
INFORMED CONSENT: ANTERIOR DISCECTOMY AND FUSION (ACDF)
INFORMED CONSENT: TPA ADMINISTRATION IN STROKE
INFORMED CONSENT: CAROTID STENTING
INFORMED CONSENT: CEREBRAL ANGIOGRAPHY
INFORMED CONSENT: CRANITOMY
INFORMED CONSENT: ENDOVASCULAR COILING FOR CEREBRAL ANEURYSM
INFORMED CONSENT: LUMBER DECOMPRESSION & FUSION
INFORMED CONSENT: LUMBER LAMINECTOMY
INFORMED CONSENT: LUMBER MICRODISCECTOMY
INFORMED CONSENT: OPEN DISCECTOMY
INFORMED CONSENT: STEREOTACTIC BRAIN BIOPSY
INFORMED CONSENT: TRANS SPHENOIDAL SURGERY
INFORMED CONSENT: VENTRICULO PERITONEAL SHUNT SURGERY
INFORMED CONSENT: CYSTOSCOPY & DJ STENT REMOVAL
INFORMED CONSENT: CYSTOSCOPY & DJ STENTING
INFORMED CONSENT: CYSTOSCOPY & TURBT
INFORMED CONSENT: CYSTOSCOPY, TURP & HoLEP
INFORMED CONSENT: HoLEP
INFORMED CONSENT: HYPOSPADIAS REPAIR
INFORMED CONSENT: PCNL
INFORMED CONSENT: PCNL & DJ STENTING
INFORMED CONSENT: PENILE IMPLANT
INFORMED CONSENT: TRANS URETHRAL RESECTION OF PROSTATE
INFORMED CONSENT: TURBT
INFORMED CONSENT: URETERORENOSCOPY
INFORMED CONSENT: URETERORENOSCOPY, RIRS & DJ STENTING
INFORMED CONSENT: CYSTOSCOPY
INFORMED CONSENT: CAPSULE ENDOSCOPY
INFORMED CONSENT: COLONOSCOPY
INFORMED CONSENT: ERCP
INFORMED CONSENT: LIVER BIOSY
INFORMED CONSENT: PEG
INFORMED CONSENT: SIGMOIDOSCOPY
INFORMED CONSENT: UPPER GI ENDOSCOPY
INFORMED CONSENT: Dynamic Hip Screw
INFORMED CONSENT: K-WIRES FIXATIONS
INFORMED CONSENT: FRACTURE
INFORMED CONSENT: PARTIAL KNEE REPLACEMENT
INFORMED CONSENT: AMPUTATION
INFORMED CONSENT: TOTAL HIP REPLACEMENT
INFORMED CONSENT: INTERLOCKING NAIL
INFORMED CONSENT: REDUCTION AND INTERNAL FIXATION
 INTRODUCTION

CONSENT-
 Consent means voluntary agreement, compliance, or permission.
 Consent refers to the provision of approval or agreement, particularly and especially after
thoughtful consideration and understanding.
 As per jurisprudence prior provision of consent signifies a possible defence (justification) against
civil or criminal liability by the doctor.
 Practitioners who use this defence claim that they should not be held liable for a tort or a crime, as
the consequence in question occurred with the prior consent and permission of the patient without
realizing whether it is a commission or an omission and the extent of negligence .

MEDICAL CONSENT
 Consent to treatment means a person must give permission before they receive any type of medical
treatment, test or examination.
 Must be done on the basis of an explanation by a clinician
 Consent from a patient is needed regardless of the procedure, whether it's a physical examination, organ
donation or something else.
 The principle of consent is an important part of medical ethics and international human rights law.
 The patient has a legal right to autonomy and self-determination enshrined within Article 21 of the Indian
Constitution.
 He can refuse treatment except in an emergency situation where the doctor may need not to get consent
for treatment.
 Consent is perhaps the only principle that runs through all aspects of health care provisions today.
 It also represents the legal and ethical expression of the basic right to have one’s autonomy and
self- determination.
 If a medical practitioner attempts to treat a person without valid consent, then he will be liable
under both tort and criminal law.
 Patient must give valid consent to medical treatment; and it is his prerogative to refuse treatment
even if the said treatment will save his or her life.
 The MCI guidelines are applicable to operations and not cover to the extent other treatments or
procedures These are covered under Implied and expressed consent.
 LAW AND MEDICAL CONSENT

 The patient has a legal right to autonomy and self-determination enshrined within Article 21 of the
Indian Constitution. He can refuse treatment except in an emergency situation where the doctor
need
not get consent for treatment.

 It also represents the legal and ethical expression of the basic right to have one's autonomy and
self-determination.

 The law also presumes that the medical practitioner is in a dominating position vis-à-vis the
patient; hence, it is his duty to obtain proper consent by providing all the necessary information.

 The consent obtained, of course, after getting the relevant information will have its own parameter
of operation to render protection to the medical practitioner. If the doctor goes beyond
these parameters, he would be treating the patient at his risk, as it is deemed that there is no
consent for such treatment at all. A doctor who went ahead in treating a patient, to protect the
patient's own interest, was held liable as he was operating without consent. The patient was
suspected to have appendicitis. After obtaining due consent, she was subjected to an
operation. However, upon incision, it was found that her appendix was normal and not inflamed.
To protect the interest of the patient, the doctor removed her gangrenous gall bladder. Later,
it was discovered that the kidney of the patient was affected. The doctor was held liable as
he was operating without consent. This case law also signifies the traditional notion of
paternalism prevalent among the members of the medical fraternity. It is a notion were
the doctor takes-up the role of a parent of the patient and starts deciding on behalf of the patient
himself. Unfortunately, the law does not accept this notion.
PURPOSE OF INFORMED CONSENT
 TYPES OF CONSENT

 INFORMED CONSENT
 ADVANCE CONSENT
 EXPRESSED CONSENT
 SURROGATE CONSENT
 IMPLIED CONSENT

IMPLIED CONSENT-

 Participation in a certain situation is sometimes considered proof of consent E.g. - Research

studies, Surveys, visiting doctor for routine check-ups
 When a patient presents himself at the doctor’s clinic or outpatient, it is held to imply that he is
agreeable to be examine
 Limited to simple procedures like:

 Inspection

 Palpation
 Percussion

 Auscultation
EXPRESSED CONSENT

● Specifically stated by the patient in distinct and explicit language

● It can be:
● Oral and/or verbal
 Oral/Verbal consent: For minor examination or therapeutic procedures
● Written consent: In presence of attendants for major diagnostic procedures, General anaesthesia
or operations Should be signed by the patient himself or patient’s attendants.

INFORMED CONSENT:

● A type of expressed consent.

● When a healthcare provider like a doctor, nurse, or other healthcare professional explains a
medical treatment to a patient before the patient agrees to it.
● This type of communication lets the patient ask questions and accept or deny treatment.

COMPONENTS:
Must contain these four vital components:
● Patient's mental capacity i.e., ability to understand the information.
● Complete information to be disclosed by the doctor.
● Voluntary acceptance of the procedure by the patient.
● Should be person and procedure specific.

CONTENT:
● Condition of the patient (diagnosis)
● Purpose and nature of intervention
● Consequences of such intervention
● Any alternatives available
● Risk involved
● Prognosis
● The immediate and future cost
FROM WHOM CONSENT TO BE OBTAINED

● The patient himself/herself if he/she is mentally stable, able to understand the information and must
be >= 12 years of age before performing medical examination.

● For performing major surgeries, major diagnostic procedures and general anaesthesia the age of
consent must be >= 18 years.

● For children < 12 years of age or mentally challenged individuals his/her guardian or the person in
custody can give the consent (Sec. 89 IPC).

● In case of emergency when the patient is unconscious, consent can be taken from parents, guardian or
lawful attendants.

● Loco parentis (Latin, ‘in place of a parent’): In emergency involving children where parents or
guardians are not available consent can be taken from the person-in-charge. E.g. - school teacher or
principal.

● In medico-legal cases of rape, pregnancy, delivery and abortion the consent of the women is required.

● In criminal or accused cases, the consent should be taken from both the criminal and the attending
police officer. However, if the police officer requests, the doctor can apply reasonable force for
examination (Sec. 53 (1) CrPC).

● If accused is a female, the examination shall only be made by or under the supervision of female
medical practitioner (Sec. 53 (2) CrPC).
WHEN CONSENT IS NOT REQUIRED

● Emergency cases - When the patient is unconscious and no attendant is available the doctor can start
medical procedure without the consent if he feels it is necessary to save the life of the patient (Sec 92
IPC).

● Medico-legal cases or criminal cases - Brought by the police under sec 53 of CrPC (For examination
only).

● Insurance policy - Patient undergoing medical examination under an insurance policy.

● Examination requested by the court.

● Prisoners.

● Therapeutic privilege - If the doctor feels that disclosing full information can cause negative effects on
the health of the patient (anxiety prone patients) the doctor in the interest of the patient may not need to
take the consent of the patient.

● However, doctor should take the consent from the relatives.

WHEN CONSENT IS INVALID

● If it is not an informed consent.

● Given for committing a crime or an illegal act, such as criminal abortion.

● Obtained by misrepresentation or fraud.

$

MEDICAL CONDITION AND PROCEDURE (to be filled by the patient or the Doctor to document in patient's own words)
The doctor has explained that I have the following medical condition:

and I have been explained and

advised to undergo the following treatment/ procedure

see patient information sheet - "Transcatheter Aortic Valve Implantation for more details

Procedure: Trans-catheter aortic valve implantation, or TAVR, is done-to replace the aortic valve in people who cannot
have open heart valve replacement. During this procedure, the old aortic valve is replaced with a new valve without the
use of open-heart surgery. It uses a thin tube, called a catheter that is guided into the artery to the heart and to the
aortic valve.

Anaesthesia: Please see your "anaesthesia Consent Form". This gives you information of the General Risks of Procedure.
If you have any concern(s), talk these over with your anaesthetist.

I
Potential Benefits:
Treatment with the new TAVR valve may give you both short- and long-term relief of your
symptoms.
It may give you normal aortic valve function and improve your overall heart function. This could
potentially increase your life expectancy and your quality of life.
 LITERATURE REVIEW

A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make
Better Decisions Wouter K. G. Leclercq
Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and
consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery
are probably outdated and may require major changes to adjust them to modern day legislation. IC should
be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best
practice and the daily practice of IC. An optimally informed patient will have more realistic expectations
regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and
file fewer legal claims. The use of interactive computer-based programs provides opportunities to
improve the SIC process.

Improving the Process of Informed Consent in the Critically Ill Nicole Davis, BS; Anne Pohlman,
RN, MSN; Brian Gehlbach, MD; et al
Patients receiving care in the intensive care unit (ICU) represent a highly vulnerable population with
regard to informed consent. While many invasive procedures often accompany the provision of life
support in the ICU and are frequently required for diagnostic or therapeutic purposes, critically ill patients
are often not capable of participating in the consent process. This is the result of the common incidence of
delirium complicating critical illness, related to both underlying illnesses and the use of sedatives and
analgesics to treat anxiety and pain. Because of this, proxies are often required to provide health decisions
for impaired patients. Yet the pace of critical illness is often rapid and unpredictable, and situations may
arise that do not permit sufficient time to locate a proxy to engage in the consent process. In some states
in which a delay in obtaining consent increases the risk of patient harm, physicians may perform
procedures without obtaining explicit consent. Implied consent assumes that most individuals would
assent to be treated in this situation; however, forgoing the usual dialogue that is the underpinning of the
consent process represents another potential encroachment on patient autonomy.

Informed consent for medical procedures *: local and national practices Authors: Constantine A.
Manthous, Angela DeGirolamo, Christopher Haddad and Yaw Amoat
There was no uniform practice of informed consent for commonly performed invasive medical
procedures. Consent was routinely obtained for GI endoscopy, bronchoscopy, and medical research, and
was not obtained for Foley catheterization and nasogastric intubation. The obtaining of consent for
vascular cannulation and diagnostic procedures was not routine in the ICUs of a substantial number of
respondents. Explicit standards that delineate specifically which procedures require consent may be
required to assure more uniform practices.
 Analysis and interpretation of data

Graph 1. Compliance and Non-compliance percentage

Count of CONSENT FORM by COMPLAICE/NON

COMPLAINCE

38%
COMPLIANCE
NON COMPLAINCE
62%

This graph shows that compliance rate is only 62% in ICU for specific surgeries and percentage of non-
compliance is 38%.
Graph 2. Count of Consent Form

Maximum used specialized surgical consent form for surgeries are:

 Coronary angiography (29.9%)

 Total/knee replacement (29.5%)
 Incision and drainage (12.6%)
 DISCUSSION

Informed consent is a foundational concept of medical ethics. Medical informed consent is essential to a
true patient-physician relationship. Patients need to participate in the informed consent process to
understand the risk-benefit relationship for the proposed treatment strategy; this understanding is essential
because patients are often psychologically regressed secondary to the realization that they are confronting
a life-preserving procedure.

Physicians need to participate in the informed consent process to provide patients with the best treatment
Though enveloped by challenges, informed consent is an important tool in clinical trials, which facilitates
the entry of new therapeutic interventions into the market. Physicians must recognize that informed
medical choice is an educational process and has the potential to affect the patient-physician alliance to
their mutual benefit. Physicians must give patients equality in the covenant by educating them to make
informed choices. When physicians and patients take medical informed consent seriously, the patient-
physician relationship becomes a true partnership with shared decision-making authority and
responsibility for outcomes.

Physicians need to understand informed medical consent from an ethical foundation, as codified by
statutory law in many states, and from a generalized common-law perspective requiring medical practice
consistent with the standard of care. It is fundamental to the patient-physician relationship that each
partner understands and accepts the degree of autonomy the patient desires in the decision-making
process. No research activity involving human subjects can be conducted and proceed unless informed
consent is completely sought. The responsibility of conducting trial ethically and genuinely lies in the
hands of those involved in it. Everyone must understand their obligations and should not misuse their
power for own benefit. Rights, safety and well-being of trial subjects should always prevail over the
interest of science and society, so that a layman never feels being deceived off in name of a social cause.

The issue of informed consent in India is a challenge on the part of investigator as a lot of complexities
arise. Further, regulations are based on the western guidelines, which do not necessarily reflect the
requirements of India. The guidelines on informed consent in India should be based on complex factors
such as culture, level of education, demographics and risks involved.
Patients receiving care in the intensive care unit (ICU) represent a highly vulnerable population with
regard to informed consent. While many invasive procedures often accompany the provision of life
support in the ICU and are frequently required for diagnostic or therapeutic purposes, critically ill patients
are often not capable of participating in the consent process. This is the result of the common incidence of
delirium complicating critical illness, related to both underlying illnesses and the use of sedatives and
analgesics to treat anxiety and pain.
 Because of this, proxies are often required to provide health decisions for impaired patients. Yet the pace
of critical illness is often rapid and unpredictable, and situations may arise that do not permit sufficient
time to locate a proxy to engage in the consent process. In some states in which a delay in obtaining
consent increases the risk of patient harm, physicians may perform procedures without obtaining explicit
consent. Implied consent assumes that most individuals would assent to be treated in this situation;
however, forgoing the usual dialogue that is the underpinning of the consent process represents another
potential encroachment on patient autonomy.

Our data reveals that the ICU only has a 62% compliance rate with consent forms, and that the most
frequently utilised specialised surgical consent forms are for coronary angiography (29.9%), total/knee
replacement (29.5%), and incision and drainage (12.6%).

Our study demonstrates that K-wire fixation (0.4%), Fracture (0.4%) are the least used consent form.
Our study illuminates that consent procedures are not standardised, and informed consent is not always
used for invasive medical procedures.
To ensure more consistent practises, explicit criteria defining precisely which procedures need consent
may be necessary. One of the rights of patients is the right to get information in a way that is
understandable given their level of education and to be fully informed. Equal access to healthcare is
called into question if patients cannot comprehend written instructions or if information is not fully
revealed to them.
 Conclusion

The written IC form is not sufficient in assuring patients and making them fully aware of choices
they made for their health; pre-operative information that was delivered orally better served the
patients’ needs. To improve the quality of communication we suggest enhancing physicians’
communication skills and for them to use structured conversation to ensure that individuals are
completely informed before undergoing their procedures.
Informed consent creates trust between doctor and patient by ensuring good understanding. It also
reduces the risk for both patient and doctor. With excellent communication about risks and
options, patients can make choices which are best for them and physicians face less risk of legal
action.
Some specializations like oncology and plastic surgery do not have their consent form.
Usages of the surgical consent form are less in many surgeries.
Use of specific consent form for every surgery increases the trust on the doctor.
 Recommendations

1.Develop a practice of involving patients in decisions. This practice should be:

- sensitive to patients’ preferences for information and their decision-making styles

- consistently applied to all patients
- designed to systematically address not only the risks of care, but also the expected benefits,
relevant alternatives and what to anticipate before and after the procedure
- designed to ensure:
- the decision-making capacity of the patient or surrogate
- a voluntary choice free of undue influence
- comprehension (e.g., ask patients to repeat what they heard)

2. Creating awareness in hospital staff about the importance of informed consent.

3. Recognize that the informed consent process serves more than one purpose. Allow the process
sufficient flexibility to fulfil its varied purposes:
- legal purpose to protect patient rights
- ethical purpose to support autonomous self-determination and decision-making
- administrative compliance to promote efficiency in health care
- interpersonal purpose to build the trust necessary to proceed with therapeutic intervention
4. The process of obtaining consent for surgery should be thoroughly taught to hospital personnel.
 REFERENCES

1. Daniel E. Hall, Allan V. Prochazka and Aaron S. Fink Informed consent for clinical treatment.

2.ManthousConstantine A.MD, FCCP et.al Informed Consent for Medical Procedures*: Local and
National Practices

3. Michael C. Rowbotham, John Astin, Kaitlin Greene, Steven R. Cummings: Interactive Informed
Consent: Randomized Comparison with Paper Consents

4. MichaelKirschM.D. The myth of informed consent

5. Legal and Ethical Myths About Informed Consent Alan Meisel, JD; Mark Kuczewski, PhD

6. Medical Informed Consent: General Considerations for Physicians Author links open overlay
panelTimothy J.PaterickBAaGeoff V.CarsonJDcMarjorie C.AllenJDbTimothy E.PaterickMD, JD

7. Improving the Process of Informed Consent in the Critically Ill Nicole Davis, BS; Anne Pohlman, RN,
MSN; Brian Gehlbach, MD; et al
 ANNEXURE

COMPLAICE/NON
CONSENT FORM SPECIALIZATION
COMPLAINCE
TOTAL/PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
FRACTURE ORTHOPAEDICS NON COMPLAINCE
K WIRES FIXATION ORTHOPAEDICS NON COMPLAINCE
TRANS CATHETER AORTIC VALVE
CARDIOLOGY NON COMPLAINCE
IMPLANTATION
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
TOTAL/PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
CYSTOSCOPY UROLOGY NON COMPLAINCE
PACEMAKER IMPLANTATION CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
LUMBAR DECOMPRESSION & FUSION NEUROLOGY NON COMPLAINCE
TOTAL/ PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
OPEN REDUCTION AND INTERNAL FIXATION ORTHOPAEDICS NON COMPLAINCE
GENERAL
FISTULA IN ANO NON COMPLAINCE
SURGERY
IMPLANTABLE CARDIAC DEFIBRILLATOR CARDIOLOGY COMPLIANCE
CEREBRAL ANGIOGRAPHY CARDIOLOGY COMPLIANCE
TOTAL/PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
LAPROSCOPIC APPENDICECTOMY GIST COMPLIANCE
TOTAL/PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TURP UROLOGY NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
CORONARY ANGIOGRAPHY CARDIOLOGY NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
CRANIECTOMY NEUROLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
PFN ORTHOPAEDICS NON COMPLAINCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY NON COMPLAINCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
LAPROSCOPIC APPENDICECTOMY GIST COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
OPEN REDUCTION AND INTERNAL FIXATION ORTHOPAEDICS NON COMPLAINCE
PACEMAKER IMPLANTATION CARDIOLOGY COMPLIANCE
CEREBRAL ANGIOGRAPHY CARDIOLOGY COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
INGUINAL HERNIA REPAIR GIST COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
PACEMAKER IMPLANTATION CARDIOLOGY COMPLIANCE
CORONARY ANGIOGRAPHY CARDIOLOGY COMPLIANCE
CORONARY ANGIOPLASTY & STENTING CARDIOLOGY COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
CYSTOSCOPY UROLOGY COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS NON COMPLAINCE
CORONARY ANGIOGRAPHY CARDIOLOGY NON COMPLAINCE
UMBLICAL HERNIA REPAIR GEN AND MAS NON COMPLAINCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
UROLOGY SURGERY UROLOGY NON COMPLAINCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
HYSTEROSCOPIC POLYPE OBS AND GYNAE COMPLIANCE
TOTAL / PARTIAL KNEE REPLACEMENT ORTHOPAEDICS COMPLIANCE
LAPROSCOPIC CHOLECYSTECTOMY GEN AND MAS NON COMPLAINCE
ACL ORTHOPAEDICS NON COMPLAINCE
URS UROLOGY NON COMPLAINCE
LAPROSCOPIC CHOLECYSTECTOMY GIST COMPLIANCE
CRANIOTOMY NEURO SURGERY NON COMPLAINCE
CHEMOPORT INSERTION SURGICAL ONCO NON COMPLAINCE
CORONARY ANGIOGRAPHY CARDIOLOGY NON COMPLAINCE
INGUINAL HERNIA REPAIR PAEDS SURGERY NON COMPLAINCE
LIVER
LIVER TRANSPLANT COMPLIANCE
TRANSPLANT
LAPROSCOPIC CHOLECYSTECTOMY GIST NON COMPLAINCE