Quality, Accreditation & Beyond – Winds of Change - Session 1

Dr. Girdhar Gyani
Director General, Association of Healthcare Providers - India
 Four decades of distinguished career in Teaching, R&D, Quality Conformity as applied to; Industry, Public Services, Education
and Healthcare, Environment etc.
 Secretary General, Quality Council of India (2003-12)
 Director International Accreditation Forum (2004-10)
 Director International Society for Quality in Health (2009-13)
 Members Academic Council MCI (2011-2013)
 Assessor for International Accreditation Bodies
 Director Indian Institute of Quality Management (1993-2003)
 Large number of publications in indexed journals
 Life time achievement awards by DRDO, FICCI & CAHO
 Widely travelled as global speaker on quality

Dr. Atul Kochhar
Chief Executive Officer - NABH, Quality Council of India
 Dr. Atul Mohan Kochhar obtained his MBBS and MD (Dermatology) from the prestigious Delhi University.
 He was awarded the University Gold medal for excellence in the field of Dermatology, Venereology and Leprology.
 He is also a Diplomate of National Board (DNB- Dermatology and Venereology), a Member of the National Academy of
Medical Sciences and a Fellow of the American Academy of Dermatology.
 He worked since 2003, as a Professor & Consultant in the Department of Dermatology & STD, Lok Nayak Hospital and
Maulana Azad Medical College and, New Delhi.
 Over the years he has held various Organizational positions viz. the President, Secretary, Vice President, and Executive
member of the IADVL –Delhi State branch and has successfully organized as Organizing Secretary various conferences of IADVL
– at State and National Level.
 He is the recipient of various state and national awards including the prestigious Sardari Lal Memorial Award for the year 2015.
 He is the current President – Society for Pediatric Dermatology and Founder Secretary -Scientific Cosmetological Society. He
has More than 70 publications, 4 books and many chapters and multimedia to his credit.
 An active practicing clinician, with a passion for quality in healthcare, a Principal Assessor with NABH since 2016, he has since
December 2019, taken over as the Chief Executive Officer of the National Accreditation Board for Hospitals and Healthcare
providers of India.
 Quality, promotion of patient safety and taking Best healthcare practices to the ‘poorest of the poor ’ are his mission in life

Dr. Sanjeev K Singh
Chief Medical Superintendent, Amrita Institute of Medical Sciences, Kochi
Lead Projects, Amrita Institute of Medical Sciences, Faridabad
 Dr. Sanjeev Singh is a pediatrician by training and did his masters in Hospital Management. He completed his PhD in Infection Control.
 He worked as a Regional Coordinator at WHO-India in a disease eradication program for couple of years before joining as Chief
Medical Superintendent at a 1350 bed university teaching super specialty hospital - Amrita Institute of Medical Sciences & Research
Center at Kochi.
 He has done his fellowship in Patient & Healthcare worker Safety from University of Virginia and fellowship on Health Technology
Assessment (HTA) from University of Adelaide.
 e is an Improvement Advisor at Institute of Healthcare Improvement (IHI), US. He is a faculty at Indian Institute of Management (IIM),
Kolkata (HEMP) and at IIM Bangalore.
 Dr. Sanjeev is also an Ambassador from India to Society of Healthcare Epidemiology of America (SHEA).
 He is the International surveyor at International Society for Quality (ISQua). He was member of Technical Committee at National
Accreditation Board for Hospitals, India (NABH).
 Previously, the Vice Chairman of Research Committee at NABH.
 Chairman of Technical Committee at AHPI, and Health Sector Council of India (Government of India).
 Member of Drug Safety Council (GOI), National Advisory Body on Occupational Exposures, Healthcare Committee at FICCI and Secy
of AHPI- Delhi-NCR. Awards
 "Best Practices" in Infection
Control" by GOI and Quality
Council of India (QCI) in 2010.
 "QIMPRO Quality award" for
Lean Six Sigma implementation
in Healthcare in 2012
 “Outstanding Healthcare
Professional” by ITP Publishing,
Dubai in 2014 and FICCI “Patient
safety” award in 2015.

Dr. Lallu Joseph
Quality Manager & Accreditation Coordinator, CMC Vellore
Secretary General – Consortium of Accredited Healthcare Organizations, India
 Dr. Lallu Joseph is the Quality Manager and Accreditation Coordinator of Christian Medical College, Vellore, which is the largest
hospital in the country to be accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH).
 Prior to joining healthcare, she was the vice president of a software company and was a teaching assistant at Rotman School of
Management, University of Toronto.
 A Mechanical Engineer by profession, she went on to complete her masters and doctorate in business administration and a
diploma in CQI from the Canadian Healthcare Administration.
 Completed one year Executive General Management Program (EGMP) of Indian Institute of Management (IIM), Bangalore in
2016.
 She is the principal assessor of NABH. Involved in training quality implementation across the country through NABH,CAHO, AHPI
and also the faculty of many hospital administration programs.
 She was part of developing the entry level guidelines of NABH standards, a joint initiative of NABH and world bank.
 She was involved in overseeing the implementation of QMS in selected Government Hospitals of Karnataka through Consortium
of Accredited Healthcare Organizations (CAHO).
 She developed the Basic and advance Certified Professionals for Quality Implementation in Hospitals (CPQIH) programs for CAHO,
which are well sought after and also 12 programs of CAHO Awards
 Proud recipient of the Young
Quality Achiever Award of
2016.
 The Dr. M.S. Ashraf Award,
Indian Medical Association, TN
State for 2018
 Recipient of D. L. Shah
Award QCI for the
project on Clinical Audit
and BMJ South East
Asian Award in 2017

Mr. Rajiv Nath
Managing Director, Hindustan Syringes & Medical Devices Ltd.
Forum Coordinator, Association of Indian Medical Device Industry (AiMeD)
 He is President of All India Syringes & Needles Mfg. Association (AISNMA).
 Jt. Coordinator of Indian Medical Device Regulatory Review Group (IMDRRG)
 Jt. Coordinator of UdaiMeD (Forum of User – Developer – Academia – Industry – Medical Device Development interface with the
Govt.)
 Board Member of Kalam Institute of Healthcare Technology
 Member National Medical Device Promotion Council
 Chairman IPC Committee on Medical Device Standard
 Chairman – Technical Committee – ICMED Certification by QCI
 Member of Expert Advisory Group (EAG) for Biomedical Device and Technology Development (BDTD) by Dept. of Science &
Technology
 Member of Medical Devices – Expert Advisory Group to CDSCO for Regulation in India.
 He has widely travelled all over World to over 58 Countries and has attended various Meetings of WHO/ ICASA/SIGN / ISO / Stop TB
 Member of ISO / TC 84

 A seasoned Healthcare Management Professional, Rajarajan is a powerful blend of a visionary leader with a global perspective
and strong business acumen who is currently pursuing Executive General Management Program from IIM, Trichy, India
 He has been associated with various successful ventures in India and abroad especially in areas of Multi-specialty Hospitals,
Oncology, Cardiology, Diagnostics and in his penultimate assignment in Bengaluru, India - he was the COO of a flagship unit of an
Oncology giant wherein with P&L responsibility increased the monthly revenue from 15 to 20 Crores/ month in a span of 30
months
 He is a member of American College of Healthcare Executives (ACHE), Life Member of Consortium of Accredited Healthcare
Organizations(CAHO), The Research Foundation for Hospitals and Healthcare Administration (RFHHA) & Telemedicine Society of
India. He is also an active volunteer with India Turns Pink.
 At Global Mantra Innovations, he leads QurHealth, India from Bengaluru as their Sr. Vice President for Health-Tech solutions and
partnerships like Family Health Book Suite, Telehealth, etc.
Rajarajan S
Sr. Vice President - QurHealth

QurHealth, India is a Division of GMI
Empower Healthcare Ecosystem
to generate value through their data
Bio-Statistics, Data Analytics, Natural Language Processing, Deep
Neural Network, Artificial Intelligence and Machine Learning
Scalable Multi-layer
Architecture Platform
150 mil. USD Company
Managing 800k Providers in US + 800 Dialysis
Centres + 43 Peta Bytes of HealthCare Data
Strong Leadership
700+ Team Members in US + India
Global Mantra Innovations – Research & Innovations centre for Ventech Solution Inc., USA
www.qurhealth.com info@qurhealth.com +91 9566 200 555

The AHPI Way – Advocating Quality, Accreditation & Beyond
1. Belief in Management that QUALITY is continuous journey and needs long term sustained commitment, as
evident through; Shared Vision, Mission and SMART Objectives
2. Transformational leadership & team of empowered staff at all levels including managers, clinicians, nursing staff
& allied health workers, through continuous education and training and re-training.
3. Documented systems: Transparent, Objective and Dynamic;
• What is to be done (Scope)
• By Whom (credentialing/ privileging)
• How (SOPs)
• On What basis (Established Protocols/ STGs)
4. Patient Safety and Operational Efficiency are taken as overarching strategic objectives to deliver value-based
care.

Customer Orientation

Football Vs Hospital Football
GOAL KEEPER
BACKS
MIDFIELD
FORWARDS
C
PARA-MEDICAL
NURSING
RESIDENTS
CONSULTANTS

5. Patient wellbeing is imbibed in every aspect of hospital functioning. Patient satisfaction is measured through
independent sources.
6. Incident reporting mechanism in letter and spirit. All incidences i.e. sentinel event, adverse event, near miss,
etc. are recorded and analyzed for corrective and preventive measures
7. Regular monitoring of key performance indicators; managerial as well as clinical including benchmarking.
8. Establish Risk Assessment and Risk Management Plans.

9. Clinicians to assume leadership role in ‘Clinical Governance’, by undertaking clinical audits and demonstrating
clinical effectiveness.
10. Each specialty HOD to hold regular clinical governance meetings involving concerned clinicians, nursing staff,
diagnostic, pharmacy, admin etc. with pre-fixed agenda like; review of all cases in that period, incidents reported,
morbidity/ mortality, patient feedback, review of KPIs etc. Outcomes of such meetings to be discussed in MR
meetings.
11. Deploy quality tools like; KAIZEN, 5-S, Lean Management, Green, 7-QC tools etc. to improve operational
efficiency and financial sustainability.
12. Identify trained QUALITY facilitators in each functions/ department in addition to central coordinator.
Emphasize on capacity building to institutionalize quality across.

13. Regular Internal Audits and Management Reviews by CHAIRMAN/ CEO for monitoring, measuring of
organization objectives & process outcomes. Results of MR and IA are conveyed across the organization.
14. Invest in Health Information Technology and Information Communication Technology. Implementation of
Electronic Health Record (EHR) will encourage healthcare data collection, patient safety and appropriateness of
care.
15. Get the Hospital Accredited in furthering of the quality initiatives and reinforcing confidence to external
stakeholders including PATIENTS.
Final Outcome: We are engaged in an on-going journey of continuous, measurable improvements championed by
empowered individuals at all levels of the organization. Our leadership philosophy inspires teamwork, and a sincere
trust and belief in people which results in an enjoyable and productive work place, dedicated to the highest possible
level of customer satisfaction.

Panel Discussion - Session Overview and Highlights
Initiate your family and your Health
Records Management with MyFHB by
clicking and downloading from
https://cutt.ly/XyPT6Zm

NABH – Quality for the Last Man in the Line
Slides sent as PDF Link only for Registrants & Participants

Patient Reported Outcome Measures & Patient Reported Experience
Measures
Slides are not shared due to copyright/ plagiarism/ replication concerns

SHEELA – Your Personalized Healthcare Assistant Features
Device
Recordings
Prescription Reminder
Appointments Reminder
Sleep Work
Flow
Water Intake
Workflow
BMI
Calculations

Continuous Quality Improvement & The CAHO Movement
Quality
 Doing the right things, for the right patient, at the right time, in the right way to achieve the best possible results - AHRQ
 The degree to which health services for individuals and populations increase the likelihood of desired health outcomes
and are consistent with current professional knowledge - IOM
 AHRQ adopted the IOM definition in 2012.
Quality from Service Perspective
 Quality is meeting or exceeding the stated and implied needs of the patients every time
Quality from Clinicians Perspective Quality from Management Perspective

Quality Manager
1. Knowledgeable
2. Team player
3. Team leader
4. Assertive
5. Listener
6. Perseverance
7. Learner
8. Work around people
9. Communicator
10. Trainer
11. Presenter
12. Manipulator
13. Always smiling
14. Should remain calm
15. Public relations
16. Impartial

Challenges
 Lack of understanding of the intent and the standards
 Myths of clinicians and seniors
 Closure of deficiencies - low hanging fruits
 Not seen as a team exercise, but as the job of the QM
 Quality Team - seen as a police force
 Financial implications
 Standardization of assessment

Continuous Quality Improvement
 Continuous Quality Improvement is a management
philosophy used by organizations to reduce waste,
increase efficiency, and increase internal and
external customer satisfaction.
 It is an ongoing process that evaluates how an
organization works and ways to improve its processes.

CAHO - Consortium of Accredited Healthcare Organizations
 Established to promote Quality, Safety and Accreditation
 Beyond accreditation and excellence
 Focus on continuous quality improvement
Accreditation & Quality
 Accreditation is a tool towards Quality Improvement
 Accreditation provides the framework
 If intent is not met, the acceptance of stakeholders is minimized
 If appropriate outcomes not measured, it is a non- value add service
 It is a team exercise
 Doorman to chairman

Focus - Quality Managers & Infection Control Professionals
 Training programs on standards
 Focussed programs (22 Programs- Fire, Quality Tools, GCP, Clinical Audit)
 Groups to handhold professionals

Involve Top Management
 Leadership Training
 Involve them in Webinars- Continuous learning
 Centres for Quality Promotion

Technology and Continuous Improvement

Sharing Best Practices
CAHOCON : A 3 - day international
conclave on a particular theme
addressing various challenges and
motivating the healthcare industry to
adopt quality practices.
CAHOTECH : 2 - day international
technology conference engaging
with stakeholders and healthcare
start-ups to share the concepts
and ideas leading the way for
early and better adoption of
technology in healthcare.

Competitions and Awards
 Quality Achiever
 Quality Champion
 Life Time Achievement Award
 Platform and Poster Presentation
 Video to promote quality
 Research Publication
 Clinical Audit
 CAHO - 3M CSSD Awards
 CAHO -QIMPRO Recognition
 Start-Up Innovation
 Hospital Innovation

Partnership with Industry Organizations

Value Add to Hospitals
 Fire - Third Party Audits
 Consents - Forms and Templates
 CONVERT- Incident Management
 License Management
 Corporate Social Responsibility
 Energy Efficiency Consultancy

Developing leaders in Quality

Systems awareness and systems design are important
for health professionals, but are not enough. They are
enabling mechanisms only.
It is the ethical dimension of individuals that is essential
to a system’s success.
Ultimately, the secret of quality is love.
You have to love your patient…., you have to love your
profession, you have to love your God.
If you have love, you can then work backward to
monitor and improve the system.
Avedis Donabedian

The Patient……
THE SOLE BREAD WINNER OF THE FAMILY,
HE IS THE FATHER OF A SMALL KID,
SON OF AN OLD FATHER,
HUSBAND OF A YOUNG LADY,
AND IS NOW YOUR RESPONSIBILITY
TO TREAT HIM AND SEND HIM SAFE TO HIS LOVED ONES
IMAGINE YOUR OWN THERE
TAKE CARE OF HIM LIKE YOUR BROTHER
By….. Dr. Lallu Joseph

Panel Discussion - Section Highlights

Consumables, Disposables, Equipment, Instruments, Electronics,
Diagnostics and Implants – The AIMED Impact
INDIA to be in the Top 5
manufacturing global hubs of
medical devices
VISION
NO REGULATIONS
INDIAN TRAFFIC
CHAOTIC
SLOWS YOU DOWN

REGULATIONS
THE GERMAN
WAY
BRINGS IN DISCIPLINE
You Can Speeden Up
Clear Expectations of Role & Responsibility

BACKGROUND
MEDICAL DEVICES
Lack of Trust in Indian Medical Devices
Incomplete and Incorrect Regulations
Reliance on 3rd Country Regulations
Incorrect Regulations Discouraged Investments
Unpredictable regulations confuse manufacturers
Result – 70-90% import Dependence
Need for Voluntary Certification
Respect for Indian Medical Devices

DRUGS & COSMETICS ACT MISFIT & UNPREDICTABLE EXPERIENCE
1989 - 30 Years since 1st set of Devices called a DRUG
2016 - Schedule MIII amended & Delinked from Schedule M
2017 - Medical Devices Rules Notified Separate from Drugs
2019 - Implants & Some Medical Electronics wef 2020

#1 - HOW TO ENCOURAGE
MAKE IN INDIA AND NOT
DISCOURAGE INVESTMENTS
IN A REGULATORY
ENVIRONMENT?

#2 - HOW SHOULD INDIA
ADDRESS PATIENT SAFETY
CONCERNS ?
A - Medical Devices Specific Patients Safety Law & Regulatory Framework
National Regulatory Authority?

#3 - HOW DO WE INVOLVE
STATES IN ENFORCEMENT?
A - Regulatory controls need to be split, shared & delegated
between Center , State & Conformity Assessment Bodies

OTHER KEY STRATEGIC ISSUES
#4 - Laboratory Infrastructure? Timelines ? Resources?
#5 - How to shift from Drug Act to New Medical Devices Regulations?
#6 - How to ensure Patient Safety but not throttle investments?

INDIAN CERTIFICATION FOR MEDICAL DEVICES SCHEME
• AiMeD & QCI led initiative
• ICMED 9000
• ICMED 13485
• ICMED 13485 Plus

Technical Criteria

You can trust ICMED certified
companies to meet patient
safety needs.

NEXT STEPS
DESIRED……
Registration of all Manufacturers & Importers
ISO/IS 13485 Certification over 2 years
Incentivise QCI's ICMED 13485 Voluntary QA Certification
Build competence of Auditors , Medical Devices Officers,
& Manufacturers
Build Infrastructure of NABL Accredited Test Labs
Expedite Adoption /Adaption of ISO Stds as BIS Stds
Category wise Phased in Mandatory Regulations
Introduction of Separate Act on Medical Devices
Transplanting existing MDR into new Law

THE MEDICAL DEVICES (SAFETY, EFFECTIVENESS, AND INNOVATION) BILL
KEY FEATURES OF BILL
 Bring all medical devices under one regulatory regime in a phased manner
 Controls & Oversight Risk Classification Dependent
 Separate Medical Device Administration with 4 Divisions
 National Registry
 Enforcement via State Medical Devices Officers
 EODB , No Mfg. License
 Conformity Assessment requirements
 Boost innovation
 Reporting of adverse Events
 Introduces Civil Penalties & Compensation
 Self Declaration for Low Risk Devices - Class A
 Risk Management and controlling Risk

Composition of Medical
Devices Administration
Head,
Laboratories
& Medical
Devices
Testing
Division
Head,
Enforcement
Division
Head,
Conformity
Assessment
Division
Head,
Health &
Safety
Division
Member
Secretary,
Secretariat
Designated representatives from:
Bureau of Indian Standards (BIS)
Indian Council of Medical Research
(ICMR)
Co-Chairman, Indian Pharmacopoeia
Commission (IPC)
Department of Biotechnology
(DBT) Department of Science and
Technology (DST) Department of
Pharmaceuticals (DOP)
Heads of Divisions
( DDGHS)
6 ex-officio members
(DDGHS)
Medical Devices Administration
(MDA)
Chairperson (Additional DGHS
rank)

Organogram of MDA
Chairperson
Medical Devices
Administration Heads of Division (DDGHS):
Fulltime members Board
members: Part time members
(AdditionalDGHS)
Health & Safety
Division
Conformity
Assessment Division
Enforcement
Division
Laboratories and
Medical Devices
Testing Division
Secretariat
• Head of Division
• Executive Board
• 1 ex-officio
• 3 experts by
nomination
• Medical Device
Officers
• Adjudicating
Officers
• Executive Board
• 1 ex-officio
• 3 experts by
nomination
• Executive Board
• 1 ex-officio
• 3 experts by
nomination
Member
Secretary

OrganizationStructure
 Medical Device Administration will
be a parallel vertical to CDSCO.
MedicalDevices
Administration
(for medical
devices)
CDSCO (for
drugs and
cosmetics)
Directorate-General of Health Services
Special Director General of
Health Services (Medical
Products)

Panel Discussion - Q & A, Closing Comments
www.qurhealth.com info@qurhealth.com
Our Next Webinar
Quality Accreditation and Beyond – Winds of Change
Session 2 – 31st July, 2020 (1430 to 1630 IST)
Our Panelists:
1. Dr. B K Rana - CEO, Quality & Accreditation Institute (QAI)
& Board Member ISQua & ASQua
2. Dr. Alexander Varghese - Hospital Director, New Mowasat
Hospital, Kuwait
3. Ms. Mandakini Pawar - Head Healthcare Excellence, CII -
Institute of Quality
4. Dr. Umashankar Raj Urs - Sr. Manager - Quality & Strategic
Initiatives, Ramaiah Memorial Hospital & Karnataka State
Representative for CAHO
5. Prof. Rahul Rao - Professor – NITTE School of
Management, Bengaluru, Registered Consultant (NBQP,
QCI – GOI), Healthcare Quality Trainer at Dr. Reddy's
Laboratories & Growth Consultant - QurHealth
6. Ms. Rama Venugopal - Executive Director, Value Added
Corporate Services (P) Ltd., Chennai & President,
Consultants Consortium of Chennai
+91 9566 200 555

Thank You
"
"
Never doubt that a small group of thoughtful,
committed citizens can change the world;
Indeed, it’s the only thing that ever has.
-Margaret Mead

Quality, Accreditation & Beyond – Winds of Change - Session 1

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