S. P. MANDALI’S PRIN L. N.

WELINGKAR INSTITUTE OF MANAGEMENT

DEVELOPMENT & RESEARCH

SUMMER INTERNSHIP PROJECT REPORT

ON

BROWNFIELD PROJECT (MUMBAI)

GREEN FIELD PROJECT (SRINAGAR)
MOLECULAR DIAGNOSTICS

BY

SHIVANI SHARMA

PGDM HC 2018 – 20 TRIMESTER IV

SPECIALISATION: PHARMACEUTICAL & LIFESCIENCES MANAGEMENT

ROLL NO.: 33

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2
 NO PLAGIARISM DECLARATION BY THE STUDENT

I, the undersigned, hereby declare that the project titled “Brownfield Project (Mumbai), Green
Field Project (Srinagar), Molecular Diagnostics Secondary Research”
(a) Has been prepared by me towards the partial fulfillment for the award of Post Graduation
Diploma in Management – Healthcare under the guidance of Prof. Anjali Kumar,
S. P. Mandali’s Prin. L. N. Welingkar Institute of Management Development and Research,
Mumbai.
(b) This work is original and has not been submitted for any degree/diploma in this or any other
Institute/Organization.
(c) The information furnished in this dissertation is genuine and original to the best of my
knowledge and belief.
(d) I have not indulged in plagiarism. The project report has been checked for plagiarism and
output report has been attached.

Shivani Sharma Signature

Place: Mumbai Date: 04/07/2019

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 Acknowledgement

The satiation that accompanies the successful completion of the project would not be possible
without mention of the people who guided me throughout my project.

I would like to take the opportunity to thank and express my deep sense of gratitude to my
industry mentor Mr. Dhanraj Chandriani & faculty mentor Prof. Anjali Kumar. I respect and
thank them for providing me an opportunity to do the project in Technecon Healthcare Pvt. Ltd.

I owe my deep gratitude to my industry mentor Mr. Dhanraj Chandriani who took keen interest in
my project work giving me all support and guidance which made me complete the project duly. I
am extremely thankful to him for providing me such a nice support and guidance, although he had
a very busy schedule managing the corporate affairs. The experience and knowledge gained in
Technecon Healthcare Pvt. Ltd. helped me to understand different elements of healthcare
industry. I perceive this opportunity as a big milestone for the development of my career.

I want to thank my faculty mentor Prof. Anjali Kumar for continuous encouragement and
moreover her timely support and guidance. I am also grateful to her for taking part in useful
decisions and giving necessary advices till the completion of my project..

I will strive to use gained knowledge in the best possible way. I will continue to work on the
improvement of my skill set in order to attain desired career objectives. I hope to continue
cooperation with both of you in the future.

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 Table of contents

Contents Page no.

I. Acknowledgement 4
II. List of tables/charts/graphs/figures 6
III. Abbreviations 7
IV. Executive summary 8
V. Introduction 9
VI. Company background 10
VII. Project 1
a. Aims and objectives 11
b. About 12-13
c. Clinical specialists 14-17
d. In-patient department 18-21
e. Operating theater 22-23
f. Central sterile supply department 24
g. Financial analysis 25-28
h. SWOT analysis 29-30
i. Major key findings 31
j. Service Line Analysis & operational management advisory 32-33
VIII. Project 2
a. Demographic overview 34-35
b. Healthcare demographic 35-37
c. Conclusion 37
IX. Project 3
a. Introduction 38
b. Market Segmentation Based on Healthcare Segments 39-40
c. Types of test done in basic molecular diagnostic laboratory 40-41
d. Key players 41
e. Design considerations 41-44
f. Molecular diagnostic market scenario in India 45-47
g. Conclusion 47
X. References 48

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List of tables

Picture 1: Showing the doctors’ name captured twice because of change in spelling
Table 1: Showing the different clinical specialties offered in Patient Care Hospital & total number
of doctors in each specialty
Table 2 : Showing the percentage contribution of Doctors in Patient Care Hospital in FY 2018-19
Table 3: Showing percentage contribution of diagnostic tests in IPD revenue
Table 4: Showing difference in CBC charges for different patients
Table 5: Showing difference in RMO charges for different patients
Table 6: Showing calculations of Hospital potential for OT
Table 7: Showing current Hospital revenue
Table 8: Showing sensitivity analysis of hospital capacity utilization in comparison to potential
revenue generation
Figure 1: Showing the inconsistent data entries
Figure 2: Showing the format of financial data provide by Patient care hospital
Figure 3: Financial statement showing blank entries
Figure 4: Showing pharmacy rent in expenses
Figure 5: Showing the income, expenditure and profit/loss of Patient care hospital for FY 2018-
2019
Figure 6: Showing the financial data of FY 2018-19 month wise in chart format
Figure 7: Showing SWOT analysis of Patient Care Hospital
Figure 8: Showing the ideal Hospital operational model
Figure 9: Showing design of molecular laboratory
Figure 10: Represent Indian diagnostic market size from year 2006-2008
Figure 11: Showing global molecular diagnostic size
Chart 1: Showing the percentage distribution of type of doctor in hospital facility
Chart 2: Showing the percentage contribution of Doctors in total IPD revenue
Chart 3: Showing the urban v/s rural distribution of population of Budgam district
Chart 4 : Showing the factors responsible for deaths in four different age groups

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Abbreviations

1. AMC: Annual maintenance contract

2. ANC: Antenatal Care
3. CSSD: Central sterile supply department
4. CMC: Comprehensive maintenance contract
5. CU: Clean Utility
6. DU: Dirty Utility
7. DNA: Deoxy-ribonucleic acid
8. ENT: Ear-nose-throat
9. HIV: Human Immuno-virus
10. ICU: Intensive care unit
11. IVD: In-vitro diagnostics
12. IPD: In-Patient department
13. NICU: Neonatal intensive care unit
14. NABH: National accreditation board of hospital
15. NFHS: National Patient Health Survey
16. OT: Operating Theatre
17. OPD: Out-Patient department
18. PCR: Polymerase chain reaction
19. PPE: Personal protective equipment
20. RNA: Ribonucleic acid
21. TFR: Total Fertility Rate
22. TB: Tuberculosis
23. UV: ultraviolet

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 Executive summary
This is the internship report on the two month internship program that I had successfully
completed at ‘Technecon Healthcare Pvt. Ltd.’ in Hospital Operations and Advisory department
in May-June 2019 as a requirement of my PGDM program. As being new to corporate setting,
every hour spent in the company was presenting a new source of learning and gave me the
amount of experience which helped me to set up a new milestone for developing my skills. The
learning experience and the type of platform provided were very useful for my career.

In these two months I worked on three different projects which were in the field of hospital
consultancy, project management, feasibility analysis and secondary research. In this report I have
included the detailed description of the company I have worked in and the projects on which I
was working.

First project on which I have worked is a Brownfield project in which the requirement of client
was to improve the efficiency of their hospital. The project was “Patient Care Hospital”, Mumbai.
It is a 100 bed size, multispecialty hospital. The hospital was running in loss and was leased to
Patient Care group. The whole project was divided into phases which includes secondary
research, primary survey/auditing of the hospital, monetary and non-monetary data analysis,
report preparation and preparation of roadmap for infrastructural and process changes. In roadmap
a one year plan was prepared based on the analysis to induce major changes in infrastructure,
standard operating procedures, technological up-gradation and staffing.

Second and third project was based on the secondary research analysis. Second project was a
green field project where client requirement was to build a “Mother and Child Care” specialty
50-100 bed size hospital. During analysis it was found that it is very difficult to prepare a
feasibility report based on secondary research as all the elements for analysis is not available of
Srinagar area.

In third project a secondary research was done on Molecular Diagnostic Laboratory to assess
current market scenario, design consideration, equipment requirement and type of tests
performed. Molecular diagnostics is comparatively a new concept where genetic tests are
performed in the segments like oncology, infectious diseases & auto-immune diseases. There are
three different levels of molecular laboratory basic, intermediate & advanced based on the type of
tests done, complexity and equipment & techniques used. This research was done to fulfill the
company’s requirement to present new viable options for establishment of new technology to
potential clients

Disclaimer: Patient care is an artificial name given to the hospital as client does not want to reveal
its identity

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 Introduction

Mumbai also known as financial capital of India is the most densely populated city in the country.
As per reports of Census India the total population estimated to be 22 million. Mumbai has a
network of 6504 hospitals out of which 403 are public hospitals and remaining 6,101 are private.
The public hospitals can serve 20,000 patients; private hospitals can handle 22,000 patients every
day. As competition is getting fierce among the private healthcare sector day by day not all
hospitals manage to survive.

Hospital is a complex adaptive system with processes interdependent on each other. The growth
of the institution is conceptualized as five dimensional process which comprises of infrastructure,
location, doctor, patient & process. These factors can be measured in both qualitative and
quantitative manner. The strategic balance between all five is very important.

Hospital performance and quality is defined according to the achievement of specific targets
either clinical or administrative. Targets may relate to additional hospital functions, such as
diagnostic, treatment, patient care and rehabilitation. Measurement is a central concept of quality
improvement. It provides a means to define what hospitals actually do and to compare that with
the original targets or expectations in order to identify the opportunities for improvement.

The study in this document sets out the framework for evaluating and improving the performance
of Patient Care Hospital (Mumbai) in following key functions:
1. Providing services
2. Creating resources
3. Technological evaluation
4. Standard operating procedures
5. Administrative roles and responsibilities
6. Oversight

The information provided in this report is obtained through survey, data analysis, process analysis
and financial analysis. Data analysis and financial analysis is done on the basis of information and
data provided by the hospital of FY 2018-2019. The report will pay attention to data management,
inventory management, and financial management. This report will highlight the major strengths
and weaknesses of the hospital while providing some information and explanation for observation
and inferences. The report will comment on the prospects of the hospital and make
recommendations that would further improve Patient Care Hospital’s current performance.

This report also consists of two more secondary research studies apart from brown field project.
One is secondary research on demographics (general and healthcare) for a client to establish a
“Mother & child care hospital” in Srinagar area. Report will define the viability and feasibility
analysis for the setup.
Secondly, secondary research on Molecular diagnostic laboratory on some key aspects such as
laboratories in Mumbai area dealing in molecular diagnostic tests, level of technology (Basic,
Intermediate and Advanced), types of tests performed and equipments.

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 Company Background

Technecon Healthcare Pvt. Ltd. which is established in 1998 in Mumbai (Maharashtra) is one of
the leading healthcare companies in India. The organization is associated with over 90 hospital
and healthcare projects in India and overseas. They provide customized solutions for the entire
spectrum of healthcare institutions.

Managing director: Mr Dhanraj Chandriani

Director: Mr Harsh Chandriani

Company’s vision:

“To Provide services through an interactive approach with unsurpassed service, quality and
creativity”

Company’s value proposition:

 Over nine decades of collective experience across several practices in healthcare sector
 Pioneers in the field of healthcare consultancy
 Visualization and implementation of one’s ideas right about their healthcare project from
inception through project completion
 Professional and personalized approach
 Versatile team

Services:
1. Hospital Project Consultancy: project conceptualization by defining roadmap for its
execution and desirable outcome.
2. Healthcare Architecture: Planning of sustainable and evidence based architecture with
elegance and refinement to enhance and enrich patient care outcomes.
3. Hospital Operations Management Consultancy: By providing efficient management,
robust financial control, systemic inventory management and synergy with the staff to lead
healthcare organization onto the path of achieving its potential.
4. Medical Equipment Planning, Procurement & Advisory: By integrating appropriate
medical technology coherent with the institution’s vision, operational requirements, and
technology trends and patient & staff safety while maintaining the project budgets.
5. Quality Standard & Accreditation: they redefine quality standards and operational
competency of institutions and help them to enhance their safety through enrichment of
care giving.
6. Online Consultancy: They assist healthcare facilities by providing them with pertinent
information related to their designing, equipment planning, staffing & operational needs.

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 XI. Project 1: Brownfield project
Project name: Patient Care Hospital (Mumbai)
Period of study: 45 days

a. Project Aims & Objectives

The aim and objective of this study is to evaluate and improve the hospital in terms of
processes and services as well as revenue generation. The evaluation of the performance of an
organizational structure is done by utilizing both monetary and non monetary data. The
objectives are further classified on the basis of long term and short term goals into macro and
micro.
Macro objectives:
1. Preparation of roadmap to improve revenue
2. Clinical goals: Improve of efficiency of departments such as OPD, IPD, OT,
diagnostics and others
3. Improvement of departmental location and interdepartmental synchronization
4. Operational goals:
 Improvement of services & processes
 Designing of various policies and methodologies to review hospital
performance
 NABH accreditation
 Formulation of marketing strategies
5. Management policies to improve work culture

Micro objectives:

1. Medical technology review & procurement as per requirement

2. Staffing
3. Staff training
4. Designing of standard operating procedures
5. Procurement of new HIS
Work design

Methodology:
 Secondary research about hospital
 Hospital survey : Duration-1 week
 Data collection (monetary & non monetary)
 Data analysis

Problem statement: Patient Care Hospital erstwhile known as XYZ hospital which is located in
Mumbai is in a major financial crisis from last many years.

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 b. About Patient Care Hospital:

Patient care hospital which was earlier known as XYZ Hospital was leased out to Patient Care
group on January 2018. Patient care group own 3 hospitals under same brand in Mumbai. The
Patient Care Hospital in Mumbai is a multispecialty hospital with size of 100 beds as per
statement of the hospital authorities.
Basic Infrastructure:
 Total no. of floors- 2
 No. of lifts - 1 (7’x 4’-strecher compliant)
 Staircase - 2
 Main entrance -1
 Emergency entrance-1

Floor wise facilities in Patient Care Hospital:

Ground floor: 1st floor: 2nd floor:

Reception Clinical laboratory ICU- 2 ( 12 beds)
Pharmacy Ophthalmology room NICU -1 (4 beds)
Waiting area Dental room OT-2
Billing area ENT CSSD
OPD consultation rooms (5) General Ward -1 male, 1 female Endoscopy room
X ray room (9 beds each) Dialysis room – 1 (2 beds)
Emergency- 1 bed Triple sharing room- 1 (3 beds) AC economy ward- 1 (9 beds)
Minor OT Twin sharing room - 1 (2 beds) Deluxe rooms – 3 (3 beds)
Nursing station Gynaec ward- 1 (6 beds) Relative’s resting area
Canteen Nursing station (common)
Ultrasonography
Cath Lab
Labour room with OT
Conference hall
Physiotherapy room

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Ideal consideration of departmental planning considering the current departmental location
comparison:

1. Diagnostics facilities should be of ground floor except clinical laboratory which could be
on any floor but sample collection room should be on ground floor
2. Wards should be located on same floor to minimize excessive vertical movements
3. Relative’s resting area should be on same floor where wards are located to minimize the
excessive movement on critical floor
4. Labour room & OT and NICU should be on same floor
5. Cath lab should always be near OT

c. Key findings:

1. Total number of beds when calculated during survey is found out to be 59 in number
2. Staircase 2 is not as per ideal dimensions
3. Number of specialties claimed on Hospital website were 30 but during survey it is found
that they have doctors for only 23 specialties (list of specialties and doctors is given in
table 1)
4. Many of the departments like ophthalmology, dental, endoscopy, Ultrasonography,
physiotherapy are non functional/partially functional
5. Cath lab is a new setup which is under process
6. 1st floor is partially operational except for clinical laboratory and female general ward

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 d. CLINICAL SPECIALISTS

S.R.NO. SPECIALTY NO. OF FULL ON CALL

DOCTORS ON TIME
PANEL DOCTORS
1 Urology 2 1 1

2 Cardiology 2 - 2

3 Diabetes And Thyroid 2 - 2

4 Dermatology And Cosmetology 1 - 1

5 Dietician And Nutritionist 2 - 2

6 Ent 3 - 3
7 General Medicine 2 - 2
8 General And Laproscopic Surgery 2 - 2
9 Gynaecology 2 1 1
10 Gastrology 1 - 1
11 Haematology 1 - 1
12 Nephrology 2 - 2
13 Neurology 2 - 2
14 Neurosurgery 1 - 1
15 Oncology 2 - 2
16 Orthopaedics 2 - 2
17 Opthalmologist 1 - 1
18 Pediatrics 2 - 2
19 Pulmonology 2 - 2
20 Physiotherapist 4 - 4
21 Psychatrist 2 - 2
22 Plastic Surgery 1 - 1
23 Vascular Surgery 1 - 1

Table 9: Showing the different clinical specialties offered in Patient Care Hospital & total number of doctors in each
specialty

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 As per the list provided by the hospital there are total 49 doctors currently empanelled with the
hospital with the hospital out of which they are further segregated into 3 categories as follows:

 Full time doctors - 2

 “On call” consultants -40
 RMO’s (BHMS/BAMS) – 7

Total no. of Doctors

Full time(Specialist) On call(Specialist) RMO (BHMS/BAMS)

4%

14%

82%

Chart 5: Showing the percentage distribution of type of doctor in hospital facility

Key findings:

1. In FY 2018-2019 total 118 doctors conducted patient activities in IPD, ICU and OT
2. The total revenue from doctors was ₹ 26,802,002 for financial year 2018-19
3. During analysis it is found out that 20% (23) of the doctors who conducted patient
activities in aforementioned departments contributed in 92% (₹ 24,632,146) of the total
revenue hospital made in FY 2018-19 ( as shown in chart 2)
4. If the cut off is set at 1 lakh revenue per doctor than only 21 doctors managed to
generate the total revenue above one lakh per doctor in FY 2018-19 (shown in table 2)
5. Dr. Shyam Gautam who contributed above 6 lakh revenue in FY 2018-19 was not
found in the list provided by the hospital ( as shown in table 2)
6. Only Dr. B. Bhawani who is a full time consultant and director of the hospital is
contributing more than 50% in the revenue as shown in table (shown in table 2)
7. There are errors in data capturing because of which it gets difficult to analyze data
correctly (as shown in picture 5)

*Note: All inferences drawn in this report is based on the data provided by the hospital. As the HIS is
inefficient to capture the data in proper format and there are some errors in matching the financial
figures provided by the hospital in financial sheet with the calculations done from excel sheets extracted
from HIS during data analysis. Hospital authority is well aware of this significant difference.

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 Percentage of doctors v/s
Revenue generation in FY
2018-19
100%
90%
80%
70% Number of
60% doctors
50%
Percentage
40% Contribution
30%
20%
10%
0%
Chart 6: Showing the percentage contribution of Doctors in total IPD revenue

S.r. no. Revenue (FY2018-19) (in mn Percentage

Doctor name
Rs) contribution
1 B. Bhawani ₹ 13,949,622 52.05%
2 Dilip Patel ₹ 2,264,198 8.45%
3 Harpreet Singh Suri ₹ 1,178,661 4.40%
4 Melville Alvarez ₹ 772,679 2.88%
5 Shipra Tyagi ₹ 733,707 2.74%
6 Shyam Gautam ₹ 695,739 2.60%
7 Priyam Mishra ₹ 659,460 2.46%
8 Rohit Singh ₹ 556,759 2.08%
9 Preeti Dixit ₹ 547,552 2.04%
10 Anil Kumar ₹ 440,176 1.64%
11 Amit Wagh ₹ 385,150 1.44%
12 Sanjay Karkhanis ₹ 293,252 1.09%
13 Dr.Hitesh Jain ₹ 286,400 1.07%
14 Umesh Singh ₹ 285,001 1.06%
15 Kamlesh Kumar Pandey ₹ 260,021 0.97%
16 Bhakti Talekar ₹ 236,988 0.88%
17 Abhijit Aklujkar ₹ 222,799 0.83%
18 Dharmendra V Dubey ₹ 198,950 0.74%
19 Mahavir Patil ₹ 170,965 0.64%
20 Maruti Pujari ₹ 150,900 0.56%
21 Prashant Patil ₹ 147,407 0.55%
22 Abhijit Bodke ₹ 124,880 0.47%
23 Mangesh Pawar ₹ 98,401 0.37%

Table 10 : Showing the percentage contribution of Doctors in Patient Care Hospital in FY 2018-19

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 Picture 1: Showing the doctors’ name captured twice because of change in spelling

Recommendations:

1. Engagement of full time dedicated, qualified Intensivist

2. Ideal nurse to bed ratio: 1:2
3. Well planned training program for critical care staff
4. Biomedical waste management , infection control and hygiene needs more attention
5. Doctor’s room is essentially required
6. Preferred central air conditioning
7. Clean utility and dirty utility rooms required
8. Isolation room for infected / immuno-compromised patients

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 e. In-Patient Department:

In- Patient department generally deals with patient admissions in the hospital for 24x7 doctor
supervision. It consists of the patients who get admitted in the hospital due to any health
complication & after undergoing surgery. In-Patient department comprises of wards & Intensive
Care Units (ICU). ICU is critical care unit hence needs more care and caution. ICU is further
categorized into ICU (adults) & NICU (Neonatal ICU).

Key Findings in Department:

1. Total no. of wards – 1 A.C Economy(9 beds), General ward- 2 :1-male,1-female (9 beds
each), Gynaec ward – 1 (6 beds), triple sharing room-1, double sharing room-1, deluxe
room- 3 (1 bed each)
2. General (male, female) and Gynaec ward is located on 1st floor
3. Average occupancy rate in general wards is 7 patients per week which is less than 20%
4. Total no. of ICU are 2 and total beds are 12
ICU 1: 5 beds (functional), ICU2 -7 (non-functional)
5. NICU- 1 (4 beds)
6. In ICU average occupancy rate is 3 patients/ week (25%)
7. Doctor to current patients ratio in ICU is 1:5 & Doctor to bed ratio: 1:12
8. Nurse to current patients ratio in ICU is 1:3 & Nurse to bed ratio : 1:12
9. Nursing station is common for both ICU and general ward second floor and on 1st floor
nursing station is between male and female general ward both nursing stations are facing
the main lobby.
10. Average occupancy rate in NICU is 2 patients per week
11. There is no separate feeding room for mothers in NICU. Mother feed baby inside NICU
12. No Isolation room in ICU
13. It was reported that AC’s are not functioning properly inside the ICU
14. ICU norms and protocols are not well adhered to
15. No dedicated, qualified Intensivist
16. No clean utility (CU) and dirty utility (DU) on the floor
17. Relative’s resting area is on 2nd floor next to ICU ward

Recommendations:
1. Engagement of full time dedicated, qualified Intensivist for ICU
2. Ideal nurse to bed ratio in ICU should be 1:2
3. Well planned training program for critical care staff
4. Biomedical waste management , infection control and hygiene needs more attention
5. Doctor’s room in ICU
6. Preferred central air conditioning in critical care unit.
7. Clean utility and dirty utility rooms required
8. Isolation room for infected / immuno-compromised patients
9. Separate feeding area for mothers of babies in NICU
10. Nursing station should face towards the ward for better sight of patient
11. Relative’s resting area should be shifted to 1st floor to minimize excessive vertical
movement and movement on critical floor

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 Other Findings:
Diagnostics facilities in IPD: Following are the diagnostic services provided by the Patient Care
hospital and their percentage contribution in total IPD revenue as shown in table 3.

Particulars Revenue (FY2018- Percentage

19) (in mn Rs) contribution of total
revenue

Clinical Lab ₹ 2,788,896 6.00%

tests
OT ₹ 2,018,937 4.34%
ICU ₹ 1,102,950 2.37%
CT/MRI ₹ 608,000 1.31%
X-ray ₹ 296,265 0.64%
2D Echo ₹ 280,950 0.60%
Sonography ₹ 260,700 0.56%
ECG-EEG ₹ 162,313 0.35%
Angiography ₹ 51,000 0.11%
Table 11: Showing percentage contribution of diagnostic tests in IPD revenue

Inferences from data analysis:

1. Diagnostic services contribute around 17 % of the total IPD revenue
2. Clinical laboratory tests contribute 6 % of the total IPD revenue
3. CT,MRI,2D Echo, sonography & some clinical laboratory tests are outsourced
4. Radiologist & Pathologist are not full time
Problems in Data Entry:
1. Same test/ service was charged at different rates to different patient with no clear
percentage variations for the charges (as shown in table 4 & 5 )

SrNo OPD Bill Type PatientName Date Patient Reg NO Service Rate
IPDN Name
13 IPDBill SANDHYA OVHAL 4/1/2018 17956 CBC 255
32 IPDBill AJAY SINGH 8/1/2018 19291 CBC 238
58 IPDBill ASHOK KUSHWAHA 8/1/2018 19265 CBC 187
65 IPDBill ASHWIN M ASHER 8/1/2018 19262 CBC 238
81 IPDBill NASEEB SINGH 8/1/2018 19289 CBC 221
89 IPDBill TASNEEM M SHAIKH 8/1/2018 19297 CBC 255
102 IPDBill HALIMUNNISA 12/1/2018 20444 CBC 187
I.KHAN
108 IPDBill GIRISH SHAH 7/1/2018 20624 CBC 238
180 17565 IPDBill PHULKALI CHAUBEY 7/1/2018 18053 CBC 187
188 IPDBill SHARDHA SINGH 6/1/2018 18606 CBC 108

Table 12: Showing difference in CBC charges for different patients

Bill Patient Name Addmission Patient Reg ServiceName Rate

Type Type NO

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 IPDBILL SANDHYA OVHAL GENERAL 17956 RMO CHARGES 1000
IPDBILL AJAY SINGH GENERAL 19291 RMO CHARGES 1000
IPDBILL PRABHAKAR BHOIR GENERAL 19278 RMO CHARGES 200
IPDBILL NASEEB SINGH GENERAL 19289 RMO CHARGES 600
IPDBILL ABDUL RASHID GENERAL 19227 RMO CHARGES 200
ALDAR
IPDBILL TASNEEM M GENERAL 19297 RMO CHARGES 850
SHAIKH
IPDBILL MOHD. SHABBIR GENERAL 20653 RMO CHARGES 250
CHAUDHARY
IPDBILL PHULKALI GENERAL 18053 RMO CHARGES 200
CHAUBEY
IPDBILL B/O SONIDEVI GENERAL 18922 RMO CHARGES 1000
SUTAR
IPDBILL B/O BHAVNA SOMJI GENERAL 18605 RMO CHARGES 1000
IPDBILL LALIT KUMAR JAIN GENERAL 18608 RMO CHARGES 400
IPDBILL DINESH TAWDE GENERAL 18611 RMO CHARGES 850
IPDBILL SAYED GENERAL 18614 RMO CHARGES 1000
KAMARUDDIN
IPDBILL NEHA CHALAKKAL GENERAL 18288 RMO CHARGES 400
IPDBILL SARA JACOB GENERAL 18292 RMO CHARGES 200

Table 13: Showing difference in RMO charges for different patients

2. Inconsistent data entry:

Figure 12: Showing the inconsistent data entries

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Key findings:
1. Minor mistakes in data entry like missing or adding alphabet, spelling error, adding dot in
the name they tend to capture different data for same patient which further result in
difference in bill calculations ( as shown in figure 1)
2. There were instances where the captured data was not in proper format like date wise
entries
3. The difference in charges making interpretations complex

Recommendations:
1. Enhance the range of diagnostic services through appropriate technology and in
consonance with procedural requirements
2. It is imperative that most diagnostics services be offered in-house with the exception of
very high end capital intensive services, which could be outsourced
3. Automate test values into lab reports through DICOM and HIS compatible lab equipment.
This will reduce data entry time and assure accuracy & report reliability.
4. Prepare masters for procedures so as to maintain consistency in data capturing
5. Procure a good, professional HIS
6. Prepare detailed masters covering all components of hospital operations
7. Train staff to use HIS software efficiently
8. Monitoring and assessing HIS performance at regular intervals
9. HIS connectivity in all concerned departments such as reception, ICU, nursing stations,
clinical laboratory, other diagnostic departments, OT’s, pharmacy ,billing etc

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 f. Operating Theater (OT):
Operating theatre in a hospital is a facility where surgical procedures are carried out. In OT
everything is geared to maintain the

Key findings:

1. Number of OT’s - 3
2. Vinyl flooring and walls
3. HVAC- 2 split AC’s/ OT
4. Anesthesiologist room -1
5. Changing room- 1 (common for doctors and other staff)
6. OT zoning not maintained
7. HEPA filter only in one OT though not modular in design
8. No separate storage room inside OT complex
9. No pre and post operative rooms
10. Vinyl on the walls is coming apart as a result of which chances of infection is great
11. In FY 2018-19 as per stated by the hospital the revenue from OT was ₹ 1.25 cr
approximately.

Calculating the hospital potential in current scenario:

ASSUMPTIONS /POTENTIAL:

No. of OT's 3
Surgeries/OT/day 3
Surgeries/day 9 *Note: 25% share is
Working days/month 26 mentioned by the
Surgeries/month 234 hospital as their current
Surgeries/year 2,808 percentage distribution
Average charge/surgery ₹ 65,000
Total Surgery revenue/ year ₹ 18,25,20,000
Hospital share @25% ₹ 4,56,30,000

Table 14: Showing calculations of Hospital potential for OT

Considering that hospital’s share as 25% of current total revenue:

FY 2018-2019 Amount *Note: Current hospital

Current Hospital OT ₹ 1,25,34,064 OT revenue is the figure
revenue/year that hospital has given
Current Hospital share ₹ 31,33,516
(@25%)/year

Table 15: Showing current Hospital revenue

22
 Sensitivity analysis:

Capacity 100% 80% 60% 40% 20% 10% 7%

Utilization
Surgeries/year 2,808 2,246 1,685 1,123 562 281 197
Hospital share@ ₹ 4.56 ₹ 3.65 ₹ 2.73 ₹ 1.83 ₹ 0.92 ₹0 .46 ₹ 0.32
25% (in Cr)

Table 16: Showing sensitivity analysis of hospital capacity utilization in comparison to potential revenue generation

Hence, analysis is indicating that the hospital is earning < 7% of its potential in OT department

Recommendations:

1. Increase the number of surgeries by creating well priced packages

2. Cost all the common and essential surgeries to arrive at appropriate pricing
3. Ideally zoning is very essential
4. Modular OT with laminar air flow and HEPA filters
5. Pre and post operative rooms
6. Preferred central air conditioning
7. Requirement of separate changing room for male and female staff
8. Requirement of separate storage room inside the OT complex

23
 g. CENTRAL STERILE SUPPLY DEPARTMENT (CSSD)

CSSD basically deals with the sterilization all the equipments which are used in hospital premises
for patient evaluation and treatment. The CSSD location in Patient Care Hospital is 2nd floor in
between OT and AC economy ward. This department comprises of 2 rooms one is washing room
and second is sterile room. In washing room collection and washing of used and dirty equipment
is done by ultrasonic washer. In sterile room the autoclaving of the instruments are done. The
door of sterile room was kept open so as to maintain the room temperature. Room temperature
was getting elevated due heat generated from the autoclaves. There is only 1 person handling the
department. The dirty instruments are collected and delivered by the ward boy from and to the
respective departments. The CSSD person was doing rest of the work of washing, cleaning,
sterilizing and storing the instruments. There is a passing window between the two rooms to
transfer the instruments from dirty area to sterilization area.

Equipment: Autoclaves-2, Ultrasonic washer-1

Key findings:

1. No dedicated personnel for collection and distribution of the instruments

2. Records are maintained manually in a register
3. No separate sterile storage room
4. Sterile, non sterile material handling processes are inadequate

Recommendations:

1. Requirement of staff
2. Separate sterile storage room
3. Improve CSSD flow and processes

24
 h. Financial Analysis

Patient care hospital is running at a loss ranging from 10-23 lakh per month. It was important to
evaluate the expenditure and income of the hospital. During financial data analysis it was
recorded that there are some major errors which were putting question mark on the way it was
captured and formatted. Some of the key findings along with examples are mentioned below.
Key Findings:
1. The financial data provided by the hospital was not in proper format/ not standardized (as
shown in figure 2)
2. There were some unclear statements and the pattern was unorganized (as shown in figure
2&3)
3. Some of the entries were either left blank or were marked as Zero (as shown in figure 3)
4. Pharmacy rent is mentioned in the expenditure (as shown in figure 4) but as per hospital
statement pharmacy is owned by hospital from September’2018 onwards

Figure 13: Showing the format of financial data provide by Patient care hospital

25
Figure 14: Financial statement showing blank entries

Figure 15: Showing pharmacy rent in expenses

26
 Profit

Above
average
income

Figure 16: Showing the income, expenditure and profit/loss of Patient care hospital for FY 2018-2019

Figure 17: Showing the financial data of FY 2018-19 month wise in chart format

Figure 5 and 6 above is showing the profit/loss made by Patient care hospital in all months of FY
2018-19 except in September. Data of September month was not provided by the hospital. It is
clearly seen that Patient care hospital is making losses in all months except in January’2019. In

27
January’2019 they are making profit of Rs. 2.83 lakh approximately. During analysis it is found
that their supreme body checkup package for diagnostic test contributed majorly in making profits
in this month. Income from October’18 to March’19 is better comparative to other months due to
contribution of health package and other diagnostic services in this period.

Recommendations:

1. Prepare standard financial format

2. Review financial statement of previous months to analyze the improvement areas
3. Format standard protocols for internal audit of financial data
4. Assign responsible person for financial department management
5. Frame policies for regular internal audits

28
i. SWOT Analysis of Patient Care Hospital

STRENGTHS WEAKNESSES
• Located in well populated • Lack of staff.
neighborhood • Inadequate marketing
• Spacious building • Inadequate awareness among
• Good infrastructure potential patients
• Good & proactive current • Lack of internal
management Communication
• Inefficient medical planning of
the departments

OPPORTUNITIES THREATS
• Number of residential • 15 Established hospitals with
• societies in the in the radius of 5 km
• neighborhood • Multidisciplinary services
• Hospital has scope for offered by the competitors
• adding more beds and
• services
• Current management has
• intent & ability to establish a
• chain of hospitals

Figure 18: Showing SWOT analysis of Patient Care Hospital

29
 Figure 19: Showing the ideal Hospital operational model

Figure 8 represents the ideal hospital operation model which states following point:

1. Integrated, planned key inputs can result into possible facility output which ultimately
results in overall hospital performance.
2. It is very important to make strategies, analyze financial requirements, competitor
analysis, study demographics (general & healthcare) and community infrastructure
3. These aforementioned studies will help any setup to get good outputs in future is models
are planned accordingly considering opportunity spaces
4. Infrastructural and conceptual facility planning is only possible if customer need and
demands are mapped clearly

30
j. Major key focus areas for the hospital based on observations:

1. First step towards the hospital turn around would be a completely involved and a
proactive management
2. Increase external Physician and consultant referrals
3. Engage with all prominent consultants to partake in OPDs and increase patient footfalls
4. Increase productivity in diagnostic departments and surgeries
5. Formulate policies for visiting and full time doctors so as to create a win-win situation for
all concerned
6. Enhance pharmacy revenue through better product range, mix and appearance
7. Dialysis department should get impetus owing to continuous demand
8. Consider outsourcing only for high end capital intensive tests
9. Employ a full-time General Physician
10. Develop well planned and effective marketing and business development strategies
11. Improve communication within in-house staff and departments
12. Acquire appropriate HIS to data collection, record keeping and reporting
13. Bring all essential medical and non-medical devices under AMC/CMC
14. Introduce better signage and floor plans for improved way-finding and safety measures
15. Upgrade hospital website and engage in digital marketing

k. The Technecon Advantage

31
 l. Service Line Analysis & operational management advisory

Phase I - 12 months plan

A. Management policies:
1. Discuss with the management policies that they wish to inculcate in the hospital
2. Recommend any important/essential matters that they need to address and
introduce in their hospital management program

B. Infrastructure
1. Discuss with the Management and recommend possible infrastructural
changes/relocation/ up-gradation of
a. ICU
b. OT
c. Diagnostics
d. Pharmacy
e. CSSD
f. Nursing station/s
g. Dialysis department
h. Relative’s resting area
i. Labour room & Gynaec OT (1st floor)
j. Clean utility (CU) and dirty utility (DU)
k. Any other departments and patient areas
2. Work on hospital signage and information display

C. Medical Technology
1. Review all medical devices and prepare an ageing document
2. Suggest replacements, if any with budget
3. Recommend all medical devices that need to go under AMC/CMC
4. Assist in procuring medical equipment wherever required
5. Arrange and track training of technical staff on equipment operations & preventive
maintenance

D. HR
1. Review staff complement in the hospital (Type, quantity, qualifications, experience,
job profiles, current responsibilities and authorities)
2. Advise/assist management on essential staff recruitment where required
3. Meet the staff, inculcate the hospital ethos and policies as also understand their
requirements and expectations
4. Induction program for new staff

E. Operations
1. Discuss with management all administrative matters that need to be documented and
implemented in the hospital
2. Meet and discuss marketing strategies with the marketing team and provide
directions to promote hospital and on-board consultants

32
3. Marketing team to meet with the following specialists and try to onboard them as
visiting consultants. These consultants will comprise those from the past as well as
new ones
4. Two consultants from each specialization mentioned below:
 General Medicine
 General Surgery
 Orthopedics
 Cardiology
 Neurology
 Urology
 Gynecology & Obstetrics
 Gastroenterology
 ENT
 Ophthalmology
 Oncology

5. Review processes in the hospital & recommend basic changes

6. Assist the hospital in acquiring professional HIS and oversee its installation and
implementation
7. Review the hospital tariff and benchmark them with other hospitals wherever
possible
8. Carry out costing of essential/ critical services
9. Review the Clinical Lab services with the Lab head and determine tests that can be
offered in-house
10. Classification and pricing of surgical procedures (after the doctor/ consultants are on
board)
11. Design health package according to age, gender, and specialty and compare with
benchmarked packages of other hospitals
12. Evolve strategies for health campaigns
13. Evaluate and audit hygiene maintenance protocols and biomedical waste mangement
14. Structure patient grievance addressal system
15. Structure policies and methodologies to review hospital performance at predefined
intervals
16. Insurance and corporate tie-ups
F. NABH:
1. Documentation form formats for all concerned departments to guide operational
procedures to training of staff
2. Participate in NABH assessment and reassessment

33
 XII. Project 2: Green field project
Project name: MOTHER & CHILD CARE HOSPITAL, (SRINAGAR AREA)
Method of study: Secondary research

The proposed project: Client wants to build a Mother and Child care hospital in Srinagar area
within 3-5 km radius of Srinagar airport.

Objective: The purpose of this study is to generate a feasibility report and to analyze the viability
that how successful this project will be based on the overall study of healthcare demographics.

a. Demographic overview of Jammu & Kashmir

Jammu and Kashmir comprises of 22 districts which are further categorized into 3 subdivisions
that are Jammu division, Ladakh division and Kashmir valley division. Our target area in which
international airport is located is under Budgam district of Kashmir valley division. More than
60% of the total population follows Islam

Economic overview:
The economy in Jammu & Kashmir is primarily services based and agri-oriented. With varied
agro-climatic conditions, the scope for horticulture is significantly high in the state. Food
processing and agro-based industries (excluding conventional grinding and extraction units)
flourish in the state. Kashmir region is known for its horticulture industry. The cottage handicrafts
industry provides direct and gainful employment to around 340,000 artists in the state. According
to 2011 census nearly 70% of the population in the state derives its livelihood directly or
indirectly from the agriculture sector.
According to an economic survey report of 2017, the monthly per capita income of J&K state in
rural areas is Rs 891 while it is Rs 988 in urban areas. as per report 67.44%(180174) rural
households have the income of less than 5000 per month and 14.35%(232753) have monthly
income between Rs 5,000- Rs 10,000.

Climate:
Srinagar has a humid subtropical and cooler climate due to its moderately high elevation &
northerly position. Winters are cool, with daytime temperature average to 2.5°C and drops below
freezing point at night. Moderate to heavy snowfall occurs in winter and the highway connecting
Srinagar with the rest of India faces frequent blockage. Summers are warm with a July daytime
average of 24°C. The average annual rainfall is around 720 mm. The spring is the wettest season
while autumn is the driest. The highest temperature reliably recorded is 38.3 °C and the lowest is
−20.0 °C.

34
Budgam district
According to 2011 census, the Budgam district enclosed within the area of 1361 square km with
density of 554 people per square km. It has a total population of 7.54 lakh with male to female sex
ratio of 1.12 (Male- 3,98,041 , Female-3,55,704). Total child population 1,55,202 within the age
0-6 yrs with male to female ratio is 1.20 (Male-84720, Female-70482). The average literacy rate
is 56.08%.

Rural v/s Urban population (Budgam)

13%

Urban
Rural
87%

Chart 7: Showing the urban vs rural distribution of population of Budgam district

The figure 1 shows the distribution of population in urban and rural areas of Budgam district of
J&K. 87% of total population lives in rural areas. The main source of income of majority of the
population is from cultivation and agriculture.

b. Healthcare Demographics of J&K:

According to National Patient Health Survey (2015-2016) data of Jammu & Kashmir:
1. The Total Fertility Rate (TFR) in Jammu & Kashmir is 2.0 children per woman, which is
slightly below replacement level fertility. Fertility declined by 0.4 children in the 10 years
between NFHS-3 and NFHS-4
2. 89% of last pregnancies in the five years preceding the survey ended in a live birth, and
the remaining 11 percent terminated in foetal wastage (abortion, miscarriage, or stillbirth).
Pregnancy outcome Eighty-nine percent of last pregnancies in the five years preceding the
survey ended in a live birth, and the remaining 11 percent terminated in foetal wastage
(abortion, miscarriage, or stillbirth).
3. Miscarriage is the most commonly reported type of foetal wastage, accounting for 6
percent of all pregnancies, and induced abortions accounted for 4 percent.
4. One in five women reporting an abortion reported having complications from the abortion.
5. Among young women age 15-19 years in Jammu & Kashmir, 3 percent have already had a
live birth or are pregnant with their first child. The percentage of women who have begun
childbearing rises sharply from 4 percent at age 18 years to 9 percent at age 19 years.
6. The infant mortality rate in Jammu & Kashmir in NFHS-4 is estimated at 32 deaths before
the age of one year per 1,000 live births
7. The under-five mortality rate is 38 deaths per 1,000 live births
8. Infant and child mortality rates are higher for boys than for girls. In fact, 1 in 25 boys die
before the age of five, compared with 1 in 28 girls
9. Children born to mothers age 30-39 are slightly more likely to die during infancy than
children born to mothers in the prime childbearing age (20-29 years)
10. Infant mortality rates are higher for Muslims than for Hindus

35
 11. Among mothers who gave birth in the five years preceding the survey, 90 percent received
antenatal care (ANC) for their last birth from a skilled provider
12. Eighty-one percent of mothers in Jammu & Kashmir received at least four antenatal care
visits for their last birth
13. More than four-fifths of women who received antenatal care for their last birth received
each of the services needed to monitor their pregnancy: having a urine and blood samples
taken (97% each), having their abdomen examined and their blood pressure measured
(96% each), and having their weight taken (87%). An ultrasound test was performed
during 86 % of pregnancies in the five years preceding the survey

Percentage contribution of top 10 causes of death by age group, both sexes, 2016

0-14 yrs(8% of total deaths) 15-39yrs(12.1% of total deaths)

4%
3%
7% 11% 7%
32% 15%
9% 10%
1%
2%
3% 10% 8%
1%
3%
2% 21% 8% 3%
36%

5%

40-69yrs(37.8% of total deaths) 70+ yrs(42.1% of total deaths)

1% 3% 2%
4%
4% 4%
5%
6% 8% 14% 2%

7% 8%
4%
15% 36% 2%
19% 37%

2% 14%

2%

Chart 8 : Showing the factors responsible for deaths in four different age groups

36
According to statistics issued by J&K government in Digest Statistics 2015-2016

1. Number of live births reported in Budgam in 2014 was 5.27% (8,157) of total deaths
(1, 54,676) in J&K, out of which 80.7% (6,588) births reported in rural area remaining
19.3% (1,569) in urban area.
2. Number of deaths registered in Budgam in 2014 was 6.18% (2,333) of the total (37,747)
of J&K. Out of which 55% were males and remaining 45% females.
3. In 2014, Kashmir division reported total number of infant deaths- 1,756, still births- 960 &
maternal deaths- 57.
4. Total disabled population in J&K 21800 (rural-18325, urban-3475). The life expectancy
according to 2016 data is Females: 71.8 years Males: 68.3 years.

Other key findings:

1. Number of major hospitals within 20km radius from proposed location are more than 25
2. 50% of these hospitals are multispecialty
3. 25% of total number of hospitals are public facilities
4. There are 3 multispecialty hospitals which are dealing in mother and child care

c. Conclusion:

Considering the healthcare demographic findings it is observed that opening a new “Mother and
Child Hospital” could be a good decision. It is observed that people are getting more inclined
towards healthcare institutions for health checkup and treatment especially women. It is very
difficult to find the data about the competitors, bed size of hospitals, facilities provided and other
market factors. It not possible to generate the viability/feasibility report to establishing a new
hospital in this Srinagar area based on secondary research.

XI. Project 3: Secondary research- Molecular Diagnostics laboratory

37
 a. Introduction
Molecular diagnostics is the study of DNA & RNA in order to detect genotype, mutations or any
other biochemical changes in the body. The objective is to test for specific cause of disease. It is a
fast growing business which is made possible by understanding human genome. It consists of
more than 1000 types of tests under different categories. It has driven growth in diagnostic
industry. Molecular diagnostics is making possible to detect infectious diseases and cancer more
accurately at an earlier stage than before. The technology is also optimized for testing sexually
transmitted disease and also to monitor the therapeutic efficiency. In this way it has evolved to an
important business opportunity for in-vitro diagnostics.
It is expanding beyond just indentifying infectious diseases. It is also contributing in disease
management and therapy such as patient stratification, drug regimen selection, toxicity avoidance,
therapeutic monitoring and detection of predisposition to disease. Hospitals are also looking for
techniques with greater speed and reliability because they cannot afford and inaccurate and
missed diagnosis. The potent challenge of antibiotic resistance in certain diseases is also driving
the need of this technology.
Education the patient is the major challenge which is currently faced by this type of technology in
India. The healthcare paradigm is shifting from reactive to preventive but lack of knowledge in
medical community and users is to letting this technology to establish its base properly. A study
showed that more than50 emerging and re-emerging pathogens have been identified during last 40
years. Infectious disease testing represents a large portion of current market with the reemergence
of infectious threats like multidrug resistant TB, new strains of HIV and H1N1. According to
NCBI India accounted for 24% of the 5.7 million new and relapse TB cases notified globally in
2010. Nearly 11.2 lakh new cases of cancer were estimated in India in 2011. Pharmacogenomics
is the most immediate new opportunity.
Molecular Diagnostics Market is broadly classified on the basis of technology, applications,
products & services, end user, and region. Indian molecular diagnostic market is accounted for
1% of total IVD market share and expected to double its share by 2020. Growth of Indian IVD
market is driven by increase in awareness, insurance, clinical research market.
Indian IVD market composition segments
 Biochemistry, immunoassays and hematology dominate the market with 65 – 70 % share.
Segments percent share Size of Market (Rs Cr) Reagents (percent share to segment)
Equipment’s (percent share to segment) IVD 100 percent 4500 – 5000
 Biochemistry 23 – 25 %
 Immunoassays 22 %
 Hematology 18-20 %t
 Microbiology 5– 6 %
 Molecular Diagnostics 2%

38
 b. Market Segmentation Based on Healthcare Segments

o By Immunochemistry
 By Products
 Chemiluminescence immunoassay (CLIA) analyzers
 Immuno fluorescence (IFA) analyzers
 Enzyme immunoassay (EIA) analyzers
 Integrated analyzers
 Point of Care Testing (POCT) Devices (bench top and hand held)
 By Reagents (thyroid, infectious disease, fertility hormones, tumor marker, auto-
immune kits, cardiac markers, others)
 By Services
o By Clinical Chemistry
 By Products (Clinical Chemistry Analyzers)
 By Reagents (calibrators, controls, standards, other reagents)
 By Services
o By Hematology
 By Products
 Semi automated hematology analyzers
 Fully automated hematology analyzers
 POCT Devices (bench top and hand held)
 By Reagents (coagulation reagents, flow cytometer reagents, hematology reagents,
control plasmas, hematology stains, immuno-hematology reagents)
 By Services
o By Coagulation & Hemostasis
 By Products (fully automated and semi automated)
 By Reagents (prothrombin time (PT), activated partial thromboplastin time
(aPTT), factor assays, fibrinogen, fibrinolysis, thrombin time (TT), thrombophilic
profile, speciality assays)
 By Services
o By Clinical Microbiology
 By Products (microbiology analyzers)
 By Reagents (pathogen specific kits and general reagents)
 By Services
o By Molecular Diagnostics
 By Products (PCR, DNA sequencing, flow cytometry, mass spectrometry, others)
 By Reagents
 By Services
o By Biochemistry
 By Product (Automated and semi automated)
 By Reagents
 By Services
o By Others
 By Product
 By Reagents
 By Services

39
Based on Application

o Oncology
o Diabetes
o Infectious Disease
o Cardiology
o Autoimmune Disease
o Nephrology
o Drug Testing
o Others

Based on End User

o Hospitals
o Diagnostics/Pathology Labs
o Research and Development Centers (R&D)
o Home care Settings

c. Types of tests done in basic molecular diagnostic laboratory

1. Flow Cytometry
o Multiple Myeloma Panel
o Five Antibody Panel
o Acute Leukemia Panel
o PNH Analysis Panel
o Three Antibody Panel
o Chronic Lymphoproliferative Disorder Panel
2. Molecular Infectious
o TB DNA PCR
o EBV Quantitative PCR
o HIV Quantitative PCR Analyzer
o HIV QUALITATIVE PCR Analyzer
o CMV Qualitative PCR
o HIV Proviral DNA PCR.
3. Molecular Haemato Oncology
o BCR Quantitative PCR
o Flt3 Mutation PCR Tube
o Runx1 Qualitative PCR Analyzer
o Runx1t1 Qualitative PCR Analyze
o Pml Quantitative PCR Analyzer
o All Multiplex PCR
4. Molecular Pathology
o MTHFR mutation PCR
o FACTOR V mutation PCR
o FACTOR II mutation PCR
o Thrombophilia mutation panel PCR
o VKORC1 mutation PCR

40
5. Others
o Abl Qualitative PCR Analyzer
o FOUR Antibody Panel
6. Tests before transplant:
o Tissue typing
o Cross matching
o Strand displacement assay
o Nucleic acid test- BKV (Polyomavirus hominis1), EBV (Epstein-Barr virus)
o C-reactive protein (CRP)
o TNT (troponin T)
o Nt-Pro BNP (B-type natriuretic peptide (BNP)
o Fibrosis markers

d. Key players

 Roche Diagnostics
 Siemens
 Transasia Bio-Medicals Ltd.
 Accurex
 Bayer Healthcare
 Becton and Dickinson
 bioMerieux
 Nicholas Piramal
 Wipro Biomed
 Johnson and Johnson
 Olympus Diagnostics
 Sigma Aldrich
 Hitachi
 Ortho Clinical Diagnostic
 Ranbaxy Diagnostics
 Bio-Rad Laboratories

e. Design considerations:

DESIGNING THE SPACE FOR A MOLECULAR LABORATORY

Airflow is crucial to prevent contamination. Some of the rooms require positive air pressure and
others require negative air pressure.

 Positive pressure means the amount of supply air is greater than the exhaust which
prevents the reversal of the direction of air movement, which keeps contaminants from
entering the room.
 Negative pressure causes air to be removed at a higher rate than supplied so that the room
is under negative pressure to surrounding rooms and corridors. This prevents air from
migrating from the laboratory into adjacent areas. To maintain negative pressure doors
must remain closed.

The general rule of thumb is to use positive pressure to keep contaminants out of an area, and
negative pressure to capture contaminants and keep them from contaminating surrounding areas.
41
Laboratory Space Arrangement

A molecular laboratory should be designed in such a way so that the chance of contamination is
minimal. This can be achieved segregating areas for the different tasks involved in performing
molecular testing under strict guidelines when moving from one room to another. Ideally a
molecular laboratory is divided into three separate rooms:
1. Reagent preparation which use positive pressure to prevent the introduction of
contaminants.
2. Sample preparation area use negative pressure to keep template nucleic acids in the
room.
3. PCR room is used for the amplification & product detection. A negative pressure is used
to keep amplified nucleic acids in the room.

Reagent preparation
In this room the master mix (amplification reagents) and primers are prepared along with controls
and the prepared master mix and controls are then added to the PCR reaction tubes. Types of
equipment required in this area are refrigerators, computer, freezers, shelving for supplies,
disinfectants, micropipettes and tips, balances, measuring devices such as beakers and pipettes,
vortex, assorted racks, balances, ice machine, sinks microwave oven and PPE.

Concerns:
1. This room should be kept as far away as possible from any room where PCR amplicons
are detected or transferred.
2. If possible, this room should be separated into two spaces to separate work with controls
and primers from the master mixes.
3. Guard against any sharing of equipment, instruments, and supplies should be used in this
room with other work areas.
4. All solutions should be prepared as freshly as possible for each PCR run, and all solutions
should be kept cold until ready to load on the thermal cycler.
5. Reaction tubes/plates should be capped once the solutions are prepared and ready to leave
this work area.
6. Storage of primer and control DNA should be at -80oC for long term use.
7. Short-term storage of primer and control DNA, as well as the components of the
amplification master mix, should be stored in a manual defrost -20oC freezer.
8. PPE such as gloves and lab coats should be used by personnel working in this area at all
times, but should not leave this area.
9. If UV lighting is used to maintain contamination-free work area, care must be taken to
make sure that they are off when personnel are present.

Specimen preparation

Specimens are processed and undergo nucleic acid isolations by many different methods,
depending on the type of tissue. For example, fresh whole blood is centrifuged to remove red
blood cells and to isolate the buffy coat for some assays, and plasma or serum will be used
directly for other assays. Frozen solid tissue is defrosted briefly then sampled and refrozen
immediately. Solid tissue sample is chopped before DNA isolation. DNA isolation kits are used
after being validated and quality checked to isolate nucleic acids, following the manufacturers’
protocols and specifications. The kit used depends on the type of tissue and the type of test
requested. Some kits will use solid-phase extraction techniques in which a vacuum manifold or

42
slow-speed microcentrifuge is required. Other kits uses the liquid extraction techniques in which a
high speed microcentrifuge is required. Tubes (Micropipettes and microcentrifuge) of all sizes are
required for all isolations. DNA samples are isolated from specimens and then added to the PCR
master mix reaction tubes/microplate wells in this room.
Equipment needed in this area consists of a computer, micropipettes, transfer pipettes, serological
pipettes, centrifuges, assorted racks, containers to transfer samples into, centrifuges, refrigerators
and freezers.A biological cabinet with laminar-flow HEPA air filtration, a dead-air box with an
optional UV light, disinfectants, sinks, and PPE.

Concerns:
1. Ventilation filters, and decontamination procedures must be used to minimize risk of
cross-contamination between specimens.
2. Efforts should guard against any sharing of equipment, instruments, and supplies used in
this room with other work areas.
3. Specimens should be stored separately from other reagents.
4. Dry baths are preferred over water baths since water baths can contaminate specimens
through seepage into poorly stoppered tubes.
5. To avoid specimen-to-specimen contamination, plugged (aerosol-barrier) pipette tips or
positive-displacement tips should be used.
6. All solutions should be prepared as freshly as possible for each PCR run, and all solutions
should be kept cold until ready to load on the thermal cycler
7. PPE such as gloves and lab coats should be used by personnel working in this area at all
times, but should not leave this area.
8. If UV lighting is used to maintain contamination-free work area, care must be taken to
make sure that they are off when personnel are present.

PCR

In this area the Amplification-ready reactions are added to the thermal cyclers and the PCR
products (amplicons) are detected. The PCR room should contain two functional work areas: a
pre-amplification (pre-PCR) and post-amplification (post-PCR) area. These two areas ideally
should be in totally separate rooms. If there is limited space then the creation of separate work
stations is acceptable as long as the supplies and equipment are dedicated to each area and are
NEVER interchanged between the two areas. To perform clean preparations a laminar flow hood
should be used.

Equipment needed in the PCR area consists of a computer, micropipettes, microtubes,

microcentrifuge, assorted racks, vortex, disinfectants, heat blocks, thermocyclers, ice machine,
electrophoresis equipment (gel boxes, power supplies, transilluminators), gel documentation
system, sinks and PPE.

Concerns:
1. This room should be divided into two work spaces (pre- and post-PCR), if possible, to
minimize contamination of thermal cyclers from aerosols created where reaction
tubes/microplate wells are opened. Then the PCR reaction for detection by gel
electrophoresis is performed.

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 2. If PCR analysis is real-time PCR then the reaction tubes need not be opened except to
validate or clarify a result with gel electrophoresis.
3. Reaction tubes/microplates should be kept in chilled and sealed environment until ready to
load into the thermal cycler.
4. Seals should be tight enough to avoid evaporative losses during high prolonged
temperatures of the thermal cycling.
5. Ventilation and decontamination procedures must be used to minimize risk of
contaminating the room and equipment with amplicon target DNA.
6. Efforts should guard against any sharing of equipment, instruments, and supplies used in
this room with other work areas.
7. To avoid specimen-to-specimen contamination, plugged (aerosol-barrier) pipet tips or
positive-displacement tips should be used.
8. PEP such as gloves and lab coats should be used by personnel working in this area.
9. If UV lighting is used to maintain contamination-free work area, care must be taken to
make sure that they are off when personnel are present.

Sample design:

Figure 20: Showing design of molecular laboratory

f. Molecular diagnostic market scenario in India:

According to a report by medical equipment industry:
Molecular Diagnostics Market is broadly classified on the basis of technology, applications,
products & services, end user, and region. Indian molecular diagnostic market is accounted for
1% of total IVD market share and expected to double its share by 2020. Growth of Indian IVD
market is driven by increase in awareness, insurance, clinical research market.

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Indian IVD market composition segments:
Biochemistry, immunoassays and hematology segment dominate the market with 65 – 70 %
share.

 Biochemistry 23 – 25 %
 Immunoassays 22 %
 Hematology 18-20 %
 Microbiology 5– 6 %
 Molecular Diagnostics 2%

The global molecular diagnostic market is poised to grow at a CAGR of 6.1% to USD 81 billion
by 2020. India accounts for only 1% of the global IVD market. Its market share is expected to
double by 2020 with an estimated CAGR of 15-20% (USD 1.5-1.7 billion). Roche is a leader with
14% of market share. Transasia is the largest domestic player with at least 5-6 segments of IVD
market.
Growth drivers:
 Health awareness
 Prevalence of certain diseases
 Changing demographics
 Increasing corporate presence in healthcare
 Growing number of insurances
 Clinical research market development

Figure 21: Represent Indian diagnostic market size from year 2006-2008

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 Figure 22: Showing global molecular diagnostic size

g. Conclusion
Molecular diagnostic lab is a technology which comprises of the procedures not performed in the
diagnostic labs in which routine blood investigations are performed. Its ability to detect the
presence and/or read the sequence of genetic material i.e. DNA & RNA differentiates its
properties and its associated benefits. In-spite of being a complex and costly procedure it’s a boon
for the society as it is capable of finding the cause of any disease and its probability of happening
in next generation in a Patient chain.
Though molecular diagnostics is fully established in the foreign countries, but in India it is just
spreading its roots to form a strong base. The genetic tests in India are mostly done with doctor’s
prescription. In India major tertiary care hospitals do not own a molecular diagnostic laboratory
in-house because of low demand. Doctors in India are also not recommending the tests unless it’s
of utmost importance. Lack of awareness among common population is the reason behind it.
Molecular diagnostic market is a rapidly growing segment of in-vitro diagnostics. With increase
in awareness, health insurance coverage and healthcare spending molecular diagnostic industry
will offer promising growth in near future. Oncology segment will witness 8% CAGR from 2018
to 2014. This will grow our fundamental knowledge of disease mechanism at molecular level.
Understanding of wide range of diseases at its molecular level will enable us to determine the
exact cause and will determine the risks in future. It will also help us in preventive diagnostics
and in making tailor made treatment plans.

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References:
https://www.medicalbuyer.co.in/the-indian-ivd-market-to-double-its-global-ivd-market-share-by-
2020/
https://www.gminsights.com/industry-analysis/molecular-diagnostics-market-report
https://www.ncbi.nlm.nih.gov/pubmed/23992007
https://www.prnewswire.com/news-releases/molecular-diagnostics-market-growing-at-a-cagr-of-
91-during-2016-to-2021---reportsnreportscom-627951203.html
https://www.nabl-india.org/nabl/file_download.php?filename=201902120217-NABL-112-
effective-from-01.06.2019-doc.pdf
https://www.marketresearch.com/product/sample-8651719.pdf
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HoBRD5ARIsAPIPenen6x9Ckfp4O0n7_3YYV5RrDBeL7F8vHfX7jXlTVGuy7_9_bhWmX1wa
Au64EALw_wcB
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survey

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