SEPTEMBER 2020, VOLUME 4 ISSUE 9 `200 INDIA MED TODAY www.indiamedtoday.com
EXPANDING THE FRONTIER IN COVID TESTING
SEPTEMBER 2020
INTERVIEW
Dr Barnali Das, Dr Sushil Shah, Jatin Mahajan
INFRASTRUCTURE
Hospital Pods fight COVID-19
PULSE
Reality Bites
APPROACH
Sense in Simplicity
17
September2020
EDIT NOTE www.indiamedtoday.com
September 2020 EDITORIAL Editor Neelam Kachhap editorial@ indiamedtoday.com
BOARD OF ADVISORS Dr Alexander Thomas
Don’t Let Your Guard Down!
Dr Girdhar Gyani Dr Prem Kumar Nair
Welcome to the latest edition of IndiaMedToday.
Dr Bhabatosh Biswas Dr Alok Roy Ramesh Kannan
ART & PRODUCTION WepApp Logic Shylesh
CONSULTING EDITOR
The vaccine for Covid-19 is almost in sight. While we celebrate positive results from clinical trials let’s not forget the sacrifices of the unsung heroes and Covid warriors. Even though it seems like the end let us not forget the beginning. Don’t let your guards down yet!
Dr Libert Anil Gomes Dr Salil Choudhary
ADVERTISING Gunjan Chauhan
Our cover this month looks at the huge impact Covid-19 has had on the laboratory diagnostics and IVD market. As the affected
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cases continue to rise, countries around the world face unprecedented challenges to diagnose and limit the spread of Covid-19. Although, the plight of those affected, directly or indirectly get a lot of media attention; we bring you, perspective from doctors, entrepreneurs and manufacturers who are working hard to supplement the government efforts in identifying and treating Covid-19 affected people. We bring you stories and first-hand narratives from frontline workers and innovators who are conquering their own fears to be able to deliver care to those in need. We also share with you out-of-box ideas that have helped solve some basic healthcare needs during this pandemic. We look deep into the making of some of the most extraordinary dreams that have shaped our Covid-19 responses.
Do write back and let us know your thoughts.
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SEPTEMBER 2020
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CONTENTS
14
29
OPENION
APPROACH
Challenges of Covid at Tertiary Care Trust Hospital
Explaining Everything
36
INFRASTRUCTURE
Hospital Pods fight COVID-19 UPFRONT
03 Editorial 05 Letters 06 News roundup 34 Drive INTERVIEW
Dr Barnali Das 22 MD, DNB, PGDHHM
Dr Sushil Shah 25 Founder-Chairman of Metropolis Healthcare
COVER STORY
16 31
COVID-19 Laboratory Diary: This too shall pass 4
September2020
Jatin Mahajan 27 Managing Director of J Mitra & Company
PULSE
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Reality Bites
CHECKIT OUT ONLINE
LETTERS On National Digital Health Mission
T
he announcement of the National Digital Health Mission by the Government of India under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) is the much-awaited digital push the healthcare sector needed. This scheme as we know will incorporate all the patient history, medical records and pharmacy visits at multiple points of care on a single ID card providing easy access to electronic health records. This will help in providing prompt and accurate treatment, especially in emergencies by avoiding repetition of medical history taking and unwarranted tests. Carrying bags full of reports to different hospitals and loss of physical reports will no longer be an issue. To achieve this paradigm shift in the storage and retrieval of medical records in the country, the digital integration of interfaces of various stakeholders in the healthcare sector will be of prime importance. Similarly, penetration of digital technology in rural areas will be the rate-limiting step. Overall, this move by the government of India may turn out to be a game-changer and lead the healthcare reforms in the country. Dr Hardik Ajmera- Deputy Medical Director, Saifee Hospital
The announcement of National Digital Health Mission (NDHM) by Hon’ble Prime Minister Narendra Modi is a commendable step towards further fuelling digitization in Indian healthcare. The digitized interoperable health ecosystem puts patients at the centre stage and provides power in their hands in the form of Unique ID for availing quality care and gaining better access to healthcare facilities and doctors. As we know, Electronic Health Records (EHR) can play a crucial role in transforming the way healthcare is delivered in the country. The government’s thrust on personal health records accessible through a unique ID validates the very fact. Use of machine learning and artificial intelligence techniques to analyse the data generated from the records will help learn disease patterns, predict onset of ailments and suggest seasonal outbreaks, bringing efficiencies and effectiveness in healthcare. In the later phases, the introduction of telemedicine and e-pharmacy will bring a lot more inclusivity. In the real sense, NDHM will take quality healthcare to rural masses and bridge the yawning divide which until now existed between urban and rural India. This digitization effort couldn’t have come at a more appropriate time than this when people are realizing the true potential of digital healthcare on the back of scenario created due to COVID-19.
PM Modi's renewed focus on 'AtmaNirbhar Bharat' and 'Vocal for
Dr Harshit Jain, Founder & CEO, Doceree
Johari Digital Healthcare Ltd
Local' show the seriousness of the Indian government to become self-reliant. The government's focus on creating a self-reliant economy will boost India's contribution to the world economy. New outlines on ‘Atmanirbhar’ Bharat was the focus of PM’s speech on Independence Day. NDHM will digitize an individual’s medical records which can be seen as an enabler for an effective Tele-consultancy and seamless cash transfer benefits under the Ayushman Bharat scheme. It will improve transparency and help the transformation of the Indian Healthcare sector. PM Modi's focus on Skill India is crucial as India as a country need to move beyond contract manufacturing, the 'Make in India' focus must go hand-in-hand with 'Make for the world', efforts should be intertwined with innovation for maximum output and reach of our products and services. Taking the help of technology to reach out to the masses and hitting the right chord with critical reforms and policies will take India to a New, Modern & Developed Era. Satyendra Johari, Founder & Chairman,
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NEWS ROUNDUP Asia’s First Bilateral Lung Transplant on Covid Positive Patient Chennai based MGM Healthcare, announced Asia’s first bilateral lung transplant on a COVID-19 positive patient and second lung transplant in the hospital since the lockdown began. MGM is the third hospital in the world to achieve this critical procedure. The transplant was led by Dr K R Balakrishnan, Chairman & Director of Cardiac Sciences and Director of the Heart and Lung Transplant Program at MGM Healthcare, and his team of transplant specialists including Dr Suresh Rao, Dr Srinath and Dr Apar Jindal. The transplant was performed on a 48 year old gentleman from Delhi, who was suffering from severe lung infection with COVID-19. Post the transplant, the patient is doing fine in the Transplant ICU at MGM Healthcare.
the prestigious Professor KP Bhargava Memorial Medal by the Indian National Science Academy (INSA) for the year 2020 for his pioneering work in the field of international diabetes research and medical sciences. The award was announced during the general body meeting of INSA held on August 7, 2020. Professor KP Bhargava Memorial Medal is awarded once every three years to a Fellow of INSA who has made outstanding research contributions in Medical Sciences. Internationally renowned, Dr. Mohan has worked tirelessly to address the challenges of diabetes in India and developing countries. He is actively involved in Indian Government health policy and advocacy programs related to diabetes, and he has served as President of the Research Society for the Study of Diabetes in India. Dr. Mohan’s comprehensive diabetes center boasts 40 branches with computerized clinical data on more than 400,000 patients.
Apollo Hospitals Marks 15 years of JCI Accreditation The Apollo Hospitals Group marked its 15th anniversary of JCI accreditation with a unique webinar on patient safety and quality of care in association with Joint Commission International, USA (JCI) and the National Accreditation Board of Hospitals and Healthcare Providers (NABH). It was in July 2005 that the Apollo Hospitals Group clocked a major milestone when Indraprastha Apollo Hospitals, New Delhi became the 1st hospital in the country and the 6th in Asia to be accredited by the JCI. Since then, eight hospitals in the group including the Apollo Proton Cancer Centre have joined the elite list of JCI accredited hospitals for best global practices, patient care and safety.
Dr V Mohan awarded Prof K P Bhargava Memorial Medal 2020 Dr
V
Mohan,
Diabetologist,
Dr
Chairman Mohan’s
and
Chief
Diabetes
Specialities Centre and President and Director,
Madras
Diabetes
Research
Foundation, Chennai has been awarded
6
September2020
Dr. V. Mohan
Experts deliberate on Covid community transmission, herd immunity at AHPI Webinar While India currently has low fatality rate and high recovery rate for Covid patients compared to many other nations like the US and Brazil, the country needs to stick to basics like wearing masks, physical
distancing and maintaining hand hygiene and surface disinfection till a safe and effective Covid vaccine is found and the pandemic abates. This was stated by distinguished panelists who took part in a Webinar organized by the Association of Healthcare Providers of India on the theme of “Covid Care: Community Transmission and Herd Immunity.” The discussion was chaired by Dr. Girdhar J. Gyani, Director General, AHPI, and included speakers such as Dr Alexander Thomas, President, AHPI; Dr. Vinay Aggarwal, MD, Pushpanjali Medical Centre; Dr. Alok Roy, Chair FICCI Health Services Committee & Chairman Medica Group of Hospitals; Dr. Narottam Puri, Advisor, FICCI Health Services Committee; Dr. Suneela Garg, Director Prof., Dept of Community Medicine, Maulana Azad Medical College, and Dr. Sanjeev Singh, Chief Medical Superintendent, Amrita Institute of Medical Sciences.
ACUTOM-32
First Indian Made CT Scanner installed at Chandigarh Chandigarh-based
Allengers
Medical
Systems said that it has installed the 1st CT Scan from the ACUTOM-32 product line at New Diagnostic CT Scan Centre, Chandigarh. This 32 slice CT scanner was launched at IRIA 2020 Ahmedabad. The CT scanner is jointly developed by Allengers and Canon Medical Systems Corporation, Japan. The company said that the CT will be manufactured using Canon Medical’s CT kit. “In the true spirit of Indo-Japan collaboration, this product embodies the entrepreneurial spirit of India and the engineering excellence of Japan,” Suresh Sharma, CMD, Allengers Medical Systems said. The inauguration was jointly done by Dr Inderjit Singh (MBBS, MD) Consultant Radiologist and Karan Sharma, Director, Allengers Medical Systems. The company
has said that it will supply the CT scanner to the Indian market and export to in 96 countries. The company has also said that the scanner will be priced, 15 per cent less than the imported CT scanner. Once the production is scaled up, the price will be further reduced to 25 per cent.
Experts develop a new breakthrough genetic risk score for Heart Disease in South Asia MedGenome Labs, genomics and clinical data-driven diagnostics and research company, has conducted a first-ever study on Indian population that validates a novel ‘CAD-PRS’ (coronary artery diseasegenome-wide polygenic risk score) to precisely predict the risk of developing a coronary artery disease/myocardial infarction (MI) using a person’s genetic makeup. MedGenome Labs collaborated with researchers from Broad Institute of MIT and Harvard; Massachusetts General Hospital, Boston; Narayana Health, Bangalore;
Eternal Hospital, Jaipur; Madras Medical Mission, Chennai; KMCH, Coimbatore and a few other institutes to conduct this firstever research capturing the PRS of disease for South Asia populations and its findings are now published in the Journal of the American College of Cardiology (JACC). “Looking at all the available scientific evidence and our study results we are convinced
that
there
exists
a
good
opportunity to combine both clinical and genetic risks (polygenic risk score based) and significantly improve the primary prevention of coronary artery disease (CAD). We firmly believe that incorporating validated
genetic
risk
scores
would
help in better stratification of high-risk individuals if implemented at population level," said Dr. Vedam Ramprasad, CEO, MedGenome Labs. This unique study is based on the principle of Genome-wide Polygenic Risk Score (PRS) which uses a genome-wide analysis of an individual to quantify the risk of developing heart disease.
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7
NEWS ROUNDUP neck cancer and all geriatrics patients. According to a member of the team, the group will be divided into working committees based on four zones- North, South, East and West. The working committee will have multidisciplinary members of doctors dietitians speech language pathologists and academicians. The committee will strive to design protocols and share knowledge to work as a team in their centres to tackle dysphagia. "The aim of the dysphagia core group is to improve the nutritional aspect thereby improving quality of life of an individual affected by dysphagia. This core group adapts multi and interdisciplinary approach to achieve the same," said, Dr. B. S. Premalatha, Professor, In-charge of Dysphagia clinic at Dr. S. R. Chandrasekhar Institute of Speech and Hearing, Bangalore.
Canister bag
Canister bag that solidifies infectious secretions like COVID 19 can save health workers from exposure For the safe management of infected respiratory secretions, the researchers at Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), has come up with a method for safe handling and disposal of respiratory secretions in hospitals for ICU patients or those with copious respiratory secretions treated in the wards. They have developed canister bags lined with super-absorbent material containing an effective disinfectant, named AcryloSorb. Infectious secretions from contagious diseases such as, COVID 19, tuberculosis (TB), and influenza poses high risk for healthcare workers. Their exposure to the high-risk hazard while handling the waste can soon be controlled with this canister bag that solidifies the secretions rapidly, making disposal safer. The canister bags can absorb 500 ml of secretions and solidify it immediately. In addition to that, the whole system
8
September2020
will be decontaminated within no time because of the presence of disinfectant. The liner structure has a patented design which allows the progressive absorbent availability upwards. Solidification and immediate disinfection that occurs inside these bags eliminate risk of secondary infections by avoiding spilling and aerosol formation, and thereby protect healthcare workers and promote safe workplace management. Canister bags are enclosed in a customizable sealer bag which can pack it as spill-proof decontaminated biomedical
waste
disposable
through
incineration. The product has been tested as per the international standards.
E-launch of Dysphagia Core group A team of multidisciplinary members of doctors, dietitians, speech language pathologists and academicians have come together to form a Dysphagia Core Group. First of it's kind in India, the group aims to help manage dysphagia in the best possible way. Dysphagia - difficulty in swallowing is very common in Covid patients, those suffering from neurological disorders, head and
“This is a unique platform where all the interdisciplinary members have formed a team to help persons with dysphagia and to prevent malnutrition" said, Sreemathy Venkatraman, Executive Director, Dysphagia Core Group. "I congratulate IAPEN Bangalore chapter for launching Dysphagia Core group. It is a great step in helping patients suffering from swallowing disorders. I wish them success in achieving their mission and vision," said Dr Chamania, National President, IAPEN India.
Medtronic to expand Hyderabad Center with INR 1200 crores investment Medtronic plc, the global medical device manufacturer, will invest INR 1200 crores in scaling up and expanding the current R&D center into a state-of-theart engineering and innovation center in Hyderabad. Medtronic Engineering & Innovation Center (MEIC) will be the largest global R&D center outside of the United States for Medtronic. This investment planned over five years will provide a boost to Telangana’s MedTech plans and cement Hyderabad’s position as the Medical Devices hub in India. Making the announcement Omar Ishrak, Executive Chairman and Chairman of
the Board, Medtronic said, “Research and Development leads to innovation and innovation is crucial to our growth strategy. Medtronic’s investment in India is a testament to our commitment to the region and we are proud to be collaborating with the Government of Telangana on this major investment in the country. The expansion of MEIC will help us serve the Medtronic Mission to use medical technology to alleviate pain, restore health and extend life for patients around the world, which is also aligned with the government’s vision to improve access to healthcare for patients in India.”
Wockhardt announces COVID-19 vaccine partnership with UK Government the
global
pharmaceutical
and biotechnology major said that it has entered into an agreement with the UK Government to fill finish COVID-19 vaccines.
The
undertaken a
manufacturing
at
subsidiary
CP
of
will
be
Pharmaceuticals,
Wockhardt
based
in
Wrexham, North Wales. As per the terms of the agreement the company
has
reserved
manufacturing
capacity to allow for the supply of multiple vaccines to the UK Government in its fight against COVID-19, including AZD1222, the vaccine co-invented by the University of Oxford and its spin-out company, Vaccitech and licensed by AstraZeneca.
Anand K is the new SRL CEO
Despite tireless efforts of researchers and doctors across the world, no vaccine or medicine has come up yet to cure or to curb this global pandemic. It has taken away millions of lives and is consistently bringing new life-threatening conditions. Cytokine Storm is one of such conditions, which turns against the immune system fuelling COVID-19 infection, posing threat to life.
SRL announced the appointment of Anand K as its new CEO. He takes over from Arindam Haldar, who has decided to pursue opportunities outside of SRL after leading the company over the last four years.
“Cytokines, under normal conditions, are extremely essential for maintaining a healthy immune system by the body. In the case of COVID-19, a Cytokine Storm is highly likely to damage the lung tissues. When this happens, respiratory distress syndrome follows, and the organ begins to fail. A similar process is followed by the rest of the organs as well, leading to an event known as ‘multi-organ failure’ which results in death,” said Dr Dilip Bhalla, Director, Max Super Speciality Hospital, Patparganj, Max Multi Speciality Centre, Noida, Max Super Speciality Hospital, Vaishali.
Anand has over 25 years of experience in the healthcare industry in India and international markets. Prior to joining SRL, he was with Apollo Group, based in Hyderabad, leading the diagnostics business of Apollo Health and Lifestyle. He has been associated with Neuberg Diagnostics, Metropolis and others in the diagnostics sector. He is reportedly known for his strong record of building and leading great teams whilst delivering exceptional results. Anand is a graduate in Medical Laboratory Technology from JIPMER, Pondicherry and a Postgraduate in Management.
While Cytokine Storms can surely be deadly in nature, several strategies for its control have been devised since the outbreak of COVID-19. Blood purification has also proved to be beneficial when it comes to the management of such cytokine storms. Several strategies for blood purification are in use now to control the deadly phenomenon-these include plasma exchange, absorption, perfusion, blood/ plasma filtration etc.
Omar Ishrak
Wockhardt,
Filters to Manage Cytokine Storm
Filters to manage Cytokine Storms can play a significant role in managing COVID-19 patients who are critically or severely ill. Early reports from China have revealed that up to 20% of COVID-19 patients may fall under this criterion. “The Oxiris filter set, used for more than a decade in Europe and Asia, works like a sponge to capture and absorb cytokines along with toxins released by bacteria called endotoxins which also induce cytokines, as well as toxins typically filtered by the kidneys called uremic toxin,” said Dr Sachin Gupta, Senior Consultant & Head, Anaesthesia & Critical Care, Narayana Superspeciality Hospital, Gurugram.
Anand K
Glenmark appoints Dipankar Bhattacharjee to its Board of Directors Glenmark Pharmaceuticals, a researchled, integrated global pharmaceutical company, announced the appointment of Dipankar Bhattacharjee as independent non-executive Director on the Board of the organization for a period of five years with effect from 14th August, 2020. Bhattacharjee comes with over 30 years
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9
NEWS ROUNDUP of global experience in leading Generics, Specialty and OTC Pharma, Medical Devices, and FMCG businesses. He has led high performing teams to develop and execute business strategies across all stages of business cycles, driving growth and value through commercial innovation and focused R&D investments.
potential COVID-19 vaccine started about two weeks back. If successful, it may be available by end of the year. Zydus is the 3rd of the 7 vaccine manufacturers in the running.
In his previous role, Bhattacharjee held various senior leadership positions at Teva Pharmaceutical Industries, including President & CEO – Global Generics Medicines, Officer and Member Teva Executive Committee (TEC), and Co-chair in JVs with P&G and Takeda Pharmaceuticals. With strong orientation towards stakeholders including investors, customers and consumers, and deep understanding of payers and regulators, he has consistently delivered short term and long term results across multiple geographies and business environments.
“The outbreak of COVID-19 has taught the importance of infection prevention practices like hand-hygiene to all. The focus has shifted to single use disposable consumables from reuse consumables and especially a change has been seen in higher deployment of auto-disable syringes even for curative injections. WHO and. UNICEF also recommend that auto-disable syringes be used for administering vaccines— particularly in mass immunization programs.Moreover, WHO has suggested the use of auto-disable syringes to collect blood samples of Covid 19 patients, which in turn, helps to avoid the transmission of disease through healthcare equipment,” explained Nath.
HMD to make a Billion Auto Disable Immunization Syringes for Covid-19 Vaccination
Chola Partners with SS Sanjeevani Hospital to Provide Free Heart Treatment to Kids
As India gets ready for COVID-19 Vaccine, Hindustan Syringes & Medical Devices Ltd (HMD), one of the largest manufacturers of disposable syringes in the world and the largest for auto disable syringes, has said that the company is scaling up production to a billion by the first half of 2021.
Cholamandalam Investment & Finance Company Limited (Chola), the financial services arm of Murugappa Group, has partnered with Sri Sathya Sai Sanjeevani Hospitals to provide free heart treatment and care to children of truck drivers, cleaners and mechanics from anywhere in the country. Chola has pledged to support the surgical heart procedures on these children whose ages range from new born upto 18 years with a total outlay of INR 132 lakhs towards the ‘Healing Little Hearts Programme’ during 2019 – 2021.
“We have received orders from UNICEF to increase our supply of immunization AD syringes to the organisation to around 300 million to build up a stockpile of around 140 million syringes for Covid-19 by the end of the year,” said Rajiv Nath, Managing Director, HMD. As the race for a ‘safe and effective’ vaccine against coronavirus infection is on the horizon, Pune based drugmaker Serum Institute of India is all set to start the advance clinical trial of University of Oxford vaccine, while continuing to work alongside on four more vaccines candidates. In addition, Covaxin, India’s first coronavirus vaccine has been developed by Bharat Biotech, Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The clinical trial to verify the safety of the
10
September2020
Commenting on the initiative, Arun Alagappan, Managing Director, Cholamandalam Investment & Finance Company Limited said, “Trucking is today one of the most important links that facilitates productivity and competitive efficiency, leading to rapid economic development of the country. It also plays a key role in bringing about the development of the remote regions by opening them to trade and investment and integrating them with the mainstream economy. Yet the lives of truck drivers, cleaners and mechanics are adversely affected by inconveniences, poor facilities,
and the absence of rules and regulations. The stressful and challenging nature of the work influences their physical as well as mental health. This initiative is a small step from our end to bring some de-stress and happiness into their lives.” Truck drivers, cleaners or mechanics whose children are suffering from Congenital Heart Disease may approach Sri Sathya Sai Sanjeevani Hospitals to avail of the free treatment.
Zoya Brar Resigned, Steps Down from the Board
Zoya Brar After eight years as CEO, Zoya Brar, is resigning from the Board of CORE Diagnostics and leave office by August 31, the company said today. The company statement said that Brar is moving on but she will continue to support the company as an advisor to the board and the CEO. “I am going to take some personal time before letting my love for entrepreneurship take over my life again,” Brar said. Brar founded CORE Diagnostics in 2012. It is a high-end clinical laboratory that provides next-generation diagnostics for preventive healthcare, precise disease stratification and therapy selection. Headquartered in the National Capital Region, CORE has a sprawling 20,000 Sq.ft lab space which is accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL). Dinesh Chauhan, the current COO, will be
the new CEO starting September 1, 2020. He will also join the board of directors of the company. Dinesh is a founding member of the company and joined CORE in 2013. He has over 30+ years of experience in
the right use of technology and data to enable more precise diagnoses, informed decisions and determine better treatment strategies to ensure the best possible patient health,” he added.
the diagnostics industry. “Taking over from a Founder-CEO is never easy but I am looking forward to all the opportunities and challenges this next phase will bring,” Chauhan said. CORE Diagnostics is backed by Artiman Ventures, F-Prime, and Eight Roads. Dr Ajit Singh, the Executive Chairman of the board said, “When Zoya founded this company in 2012, everything about it was nascent, true to the literal meaning of the word – the entrepreneur, the business idea, and the readiness of the market. In the years that followed, CORE has become synonymous with innovative molecular diagnostics and a clear market leader in the field. On behalf of the board of directors of the company, I want to congratulate Zoya and her team for these remarkable achievements, and wish Dinesh the very best.”
Emerging Technology and Data Key to Improving Vascular Health A new study shows that using advanced technologies can enable more precise diagnoses
and
strategies to
ensure
better the
treatment best possible
results. The recently released research, Beyond vascular
Intervention: care
Personalized
through
technological
innovation, was designed to examine the current state of vascular care and how health care leaders, physicians and patients view the importance of incorporating data and technology into treatment pathways. “Technological providers
advances
select
and
can
treat
the
help right
patients, at the right time, with the right approach, thereby on
patients,
easing the burden
healthcare
workers
and
healthcare systems,” said Nick West M.D., chief medical officer and divisional vice president of Medical Affairs at Abbott’s vascular business. “This research identifies how physicians and administrators can improve patient care—and the need for
Path breaking Reforms in Higher Medical Education Welcomed by ANBAI The Association of National Board Accredited Institutions (ANBAI) welcomed the Government’s move to improve higher medical education in India by introducing post-graduate diploma courses in eight medical specialties under the National Board of Examinations. In a press conference, Dr Abhijat Sheth, President and Dr Pawanindra Lal, Executive Director, National Board of Examinations along with Dr CN Manjunath, Director, Sri Jayadeva Institute of Cardiovascular Sciences & Research; Dr Devi Shetty, Chairman, Narayana Health; Dr Naresh Trehan, Chairman, Medanta Hospitals along with ANBAI President, Dr Alexandar Thomas; Dr Girdhar Gyani and other members of the association shed light on these reforms. A gazette notification from Ministry of Health and Family Welfare, published on August 6, 2020 said that the PG diploma course is a two-year courses that can be undertaken after completing the MBBS degree. According to the regulations, these structured training programs can be run by any well-equipped public or private hospital with over 100 beds and staffed with senior medical specialists “The regulatory change brought about by this notification will transform healthcare in India, making ours the first nation in the world to dissociate healthcare from affluence,” said Dr Devi Shetty, at the ANBAI ePress Conference. Every year, approximately 1,70,000 doctors write the NEET post-graduate exam to apply for about 50,000 post-graduate seats under the Medical Council of India and the National Board of Examinations (this includes 15,000 non clinical seats). This means that, annually, the remaining 1,20,000 doctors who do not get one of these seats will not return to clinical work. They may waste two to five years attending coaching classes in Kerala or
Kota and in the end, some even give up on becoming doctors. Adding a few thousand seats in post-graduate diploma courses will immediately bring these doctors back to patient care in accredited government or private hospitals. It also gives them the option to apply for an MD or MS seat after completion of the course. It is an attractive alternative for bright young doctors from poor families, because the diploma course is available at a nominal cost, and they earn a stipend during the program which can be used to support their families.
PHANA Demands Inquiry into Suicide of Dr Nagendra SR
Late Dr Nagendra SR Nanjangud Taluk Health Officer (THO) Dr Nagendra SR, committed suicide on Thursday allegedly due to work pressures. He had been working continuously in Covid-19 duty since the pandemic broke out in March this year. The Private Hospitals and Nursing Homes Association, (PHANA) Bangalore, has condemned such toxic work environment. “We urge the Govt of Karnataka to create a conducive environment for medical professionals who are at the forefront of Covid care to work without any undue pressure,” said Dr Prasanna HM, President Elect, PHANA. The association expressed heartfelt condolences to the family of Dr Nagendra
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NEWS ROUNDUP SR, on his untimely death and urged the government to investigate the death of the frontline worker. “We urge the Govt to conduct a high level impartial enquiry regarding the circumstances and events leading to the unfortunate suicide by one of our esteemed colleague,” Dr Ravindra R, President PHANA said in a press statement. In support of the call given by the IMAKSB, all PHANA Members, doctors, nurses, paramedical and support staff wore a black badge/Ribbon on August 21- 22, 2020 and held candlelight protest in all the hospitals, to demonstrate solidarity with the medical fraternity and pray for the departed soul of Dr Nagendra and the scores of healthcare personnel and Covid warriors who have sacrificed their lives for the wellbeing of the society. “We do not seek appreciation or glory and are working relentlessly for the wellbeing of the community in these difficult times, in spite of the many shortcomings. The government and administration, are insensitive to our sacrifices and adding to the problem rather that supporting the medical fraternity, healthcare personnel and private hospitals,” the association said. “We strongly condemn the insensitive bureaucracy and administration for handling a public health pandemic by enforcing the disaster management Act and being insensitive to the problems and stress of the healthcare personnel,” PHANA statement said.
Europe’s Largest Initiative to Accelerate Therapy Development for COVID-19 Launched CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative
Medicines
public-private
Initiative
partnership
(IMI)
announced
its launch to accelerate the discovery and development of urgently needed medicines virus
that
to
treat
causes
SARS-CoV-2, COVID-19.
With
the a
grant totaling € 77.7 million, CARE is funded by cash contributions from the European Union (EU) and cash and inkind contributions from eleven European
12
September2020
Federation of Pharmaceutical Industries and Associations (EFPIA) companies and three IMI-Associated Partners. CARE is a 5-year project bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the US, and is led by VRI-Inserm (French National Institute of Health and Medical Research, Paris, France), Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium), and Takeda Pharmaceuticals International AG, (Zurich, Switzerland). It integrates partners’ COVID-19 projects ongoing since February 2020. As a member of the CARE consortium, Boehringer Ingelheim will be leading the work stream of the consortium focusing on the development of virus neutralizing antibodies. Furthermore the company will provide antiviral molecules from its legacy HIV and HCV portfolio and small molecule candidates from a complete screen of its molecule library.
that can complement diagnostic prognostic tools in clinical use.
The team has devised a novel, simple, intube assay for the assessment of specific T cell immune responses to stimulation by SARS CoV-2 proteins. Traditional tests for T cell immunity require complex processing to separate different cells from blood samples and use technology that is not readily available. This test can be done with a small sample of whole blood. The solution simplifies the testing process which can be done at smaller labs without specialised equipment. The blood doesn’t require any special treatment. The results can be obtained in 24 hours, by measuring chemical called cytokines. A positive reading indicates good specific cellular immunity. The team is in the process of applying for a patent for this assay. Further development of this test would include testing virus sequences specific to India and matched to Indian populations.
Bengaluru Doctors Develop India’s first Successful Specific T cell Immunity Test Bengaluru-based doctors Dr Sonal Asthana, Hepatobiliary and Transplant Surgeon, Aster CMI Hospital and Dr Vishnu Kurpad, Consultant Surgical Oncologist, Sri Shankara Cancer Hospital have jointly developed India’s first-ever test to examine specific T Cell immunity for Covid-19. CoVID affects people in different ways. Most of the affected patients develop mild symptoms, while a relatively small number patients require intensive medical care. Immunity plays important role in the body’s response to SARS CoV-2 infection. It is now understood that apart from antibody response, a strong T cell response can help in conferring protective immunity to CoVID infection. Most tests focus on serology, which relies on antibody production after CoVID infection. However, some affected people do not develop antibodies, while antibody levels can reduce significantly after 6-8 weeks of infection. There is no simple ready-to-use test for cellular immunity
and
Dr. Sonal Asthana
Dr. Vishnu Kurpad
OPINION
Challenges of Covid at Tertiary Care Trust Hospital Have hospitals been overcharging or reeling under losses this pandemic? This article
aims to summarise the
the
decreased
manpower
available.
experiences of many tertiary care trust
Some ICUs like the CCU and cardiac
hospitals in India while they battle with
surgery ICU were shut down, thus freeing
the ever-changing specter of the Covid
equipment like monitors and ventilators
pandemic. I have been going through
for use in Covid ICU, apart from providing
it myself and many colleagues of mine
much-needed
are also dealing with the same, as no
doctors other than emergency medicine,
one knows how long this will continue.
respiratory medicine).
manpower
(nurses
and
The agenda here is to paint a picture, as
Dr Ashish Banerji,
realistic as possible, to dispel many myths
The apprehensions regarding the cost of
about hospitals making hay while the sun
treatment for Covid acquired by staff, and
shines!
death, were dealt with by investing a huge
MBBS, MS (General Surgery)
sum of money for medical insurance and
Challenges faced by Indian Hospitals All hospitals had to deal with the changing dynamics of the Covid management in addition to
incremental rise in covid
positive patients, massive problems with staff at all levels and new directives from ICMR and local municipal corporations. The challenge of managing Covid patients, who had to remain in the hospital without seeing their loved ones, was a different ball game altogether. Human resource challenges were perhaps the most difficult ones to deal with, as junior doctors and staff at all levels were either staying away or refusing to work in Covid wards and ICUs after a couple of duties. The ever-present threat of falling prey to Covid infecting family members at home (including parents and small children), and dealing with the fear of death was always a huge issue, demanding out-of-the-box solutions.
Changing Dynamics
14
September2020
one-time death settlements. Although, this step did serve to alleviate some anxieties, many staff members still stayed away from duty. The extra ICUs for COVID put a strain on the main ICU, which still had to admit critical non-COVID cases. Treatment protocols kept changing, and many patients were admitted from lower socio-economic strata. Govt gradually laid down very low rates for claiming treatment costs, and many expensive medicines like Remdesivir and Tocilizumab were way beyond the cost hospitals could claim. RT-PCR tests could only be done on admitted patients initially, and this meant admitting patients who had suspicious symptoms. The city did not have any private lab offering RTPCR tests, and results were received 24-36 hours after collection of samples. Patients had to be discharged or shifted to confirmed Covid wards and ICUs after receiving test reports. This also posed many problems. Indian patients are used to staying with their loved ones 24/7, even in the hospital,
We had to create an isolation ward
and eating home food. The absence of
complex, with separate access, and with
both created a fresh set of problems, and
innovative methods of daily counseling by
reduced. Hospital revenues were impacted
the Covid consultants had to be created.
significantly, due to decreased numbers,
Access to general wards and ICUs was
but also due to the daily losses in under-
increased by providing more landlines and
billing of Covid patients (as per Govt
cell-phones within wards, and tablets (like
directives), and refusal of relatives to
iPads) were used to show relatives videos
pay the hospital dues if their patient
of their patients in the isolation ward.
died. Death was inevitable, we could not
Are Hospitals Bleeding Financially?
refuse patients; we were only admitting moderate to severe cases, with multiple co-morbidities, and elderly age.
Nurses, junior doctors, and even a few consultants got infected with Covid during
Revenues came down to 30-40 per cent
the course of last few months. Contact
of pre-Covid levels, salaries were reduced
tracing revealed more positive cases, and
in a slab-wise manner, exempting all
the ripples kept spreading with more cases
those earning less than INR 50000 per
testing positive every week! This had a
month. Consultants on the payroll had
serious impact on medical and nursing
significant pay cuts, while consultants on
care, which was partly met with new
‘fee for services’ obviously earned much
recruitments.
lower fees. The continuing pressure from
All in all, the pandemic is going on, but hospitals are NOT making hay while the sun shines. Quite the contrary, they are bleeding financially! They are facing unprecedented challenges, the likes of which they have never faced before
municipal corporation to increase Covid All this time, other specialties and super-
beds impacted certain super-specialties,
specialties were losing out on patients. OPD
as
numbers dropped from 400 - 20 per day!
not available, so admissions had to be
Surgeries and procedures were drastically
curtailed.
non-Covid
ICU
beds
were
simply
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15
COVERSTORY
Expanding the Frontier in Covid testing
As infection mounts the need for rapid and reliable diagnostics increases M Neelam Kachhap
Y This number should be one in 20 simply and means that testing is still suboptimal and the outbreak is growing
ou cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected. We have a simple message for all countries: test, test, test, Dr Tedros Adhanom Ghebreyesus, WHO DirectorGeneral, famously said. Nowhere is this more evident than in India, where the Covid-19 cases are still rising.
parts of the country expanding access to
Recently, India's single-day tally (78,761) reported on August 30, surpassed the oneday increase of 77,299 reported by the United States on 17 July. While, the Indian Council for Medical Research (ICMR) has said that, India is ramping up testing (10 lakhs test per day), experts say that testing per million remains low. Noted virologist Dr Shahid Jameel, CEO, Wellcome Trust/ DBT India Alliance has said that among the top 10 virus infected countries, testing per million is among the lowest in India. "We are still finding one positive in every 11 to 12 tests. This number should be one in 20 simply and means that testing is still sub-optimal and the outbreak is growing,� he said.
testing (pooled sample testing). Dr Balram
With Covid cases still rising in many
testing is the only way to limit the spread of COVID-19 in the community. ICMR has ensured that specific testing platform are made available addressing general testing (RT-PCR), high-throughput testing (COBAS), testing at remotest places and PHCs (TrueNAT, CBNAAT), in containment areas (rapid antigen testing) and for large number and migrant population Bhargava, Director General, ICMR said that in a diverse country like India, for equitable access to testing, optimisation of resources based on the evolving epidemic is an essential part of the sustainable scaling up. Starting with one single laboratory at the National Institute of Virology (NIV) in Pune, Maharashtra, as on 21st August 2020 the total number covid-19 specific testing laboratories count has reached 1511. Among these are 983 dedicated government laboratories and 528 private.
RT-PCR As soon as the pandemic broke-out in Wuhan, China a number to institutes took
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17
COVERSTORY it on themselves to identify the virus. It was the efforts of such scientist that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA was identified and became the backbone of accurate testing. To help battle the surging coronavirus epidemic, several manufacturers made Covid-19 reverse transcription polymerase chain reaction (RT-PCR) based tests at breakneck speed.
In contrast, the Truenat SARS COV 2 targets the RdRp gene that confirms the positives, found positive by the Truenat Beta COV assay.” The company is also working on a third assay. “The third assay, Truenat COVID 19, will have both the E & ORF 1a genes which will confirm both negatives and positives in the same assay,” Dr Nair said. “This assay will be launched in the market in the
The first diagnostic assay to be published by the WHO as a guideline for COVID-19 diagnostic detection was developed at the German Center for Infection Research in January 2020. Since then impressive progress has been made in diagnosing Covid-19 infections. TrueNat is one of the first tests to be made and deployed in India. “Truenat is the first POC, WHO endorsed - RTPCR multi assay platform that has decentralised and democratised molecular diagnostic testing right upto the CHC/PHC levels,” says Sriram Natarajan, Founder Director and CEO, Molbio Diagnostics. “As of now, there are more than 2500 systems in use in both the private and public sector markets in India,” he adds. Dr Chandrashekhar Nair, Chief Technical Officer, Molbio Diagnostics said, “The gene targets for the CVID -1 9 testing are as per the WHO guidelines. The Truenat Beta COV targets the E gene and acts as a screening assay, confirming the negatives.
18
September2020
first half of September,” he added. Although, RT-PCR tests are hailed for their sensitivity and have widely been used for early detection of Covid-19, it has its limitations. “RT-PCR requires skilled personnel and sophisticated equipment. These equipment are often expansive and have to be housed in temperature and air circulation controlled rooms,” says a renowned molecular pathologist from Kolkata. “The failure to detect virus in infected patients is a huge problem in places that do a large number of tests daily. The correct operation of the test is crucial,” he reiterates. The turn-around times of 24-hrs also limits the use of RT-PCR in rapid, pointof-care applications. There are a number of challenges for RT-PCR in India but the main one is the shortage of reagents and the number of unreliable reagent manufacturers mushrooming everywhere.
Antigen tests
The third assay, Truenat COVID 19, will have both the E & ORF 1a genes which will confirm both negatives and positives in the same assay
In June, 2020, ICMR issued an advisory on rapid antigen test for Covid-19, endorsing a stand-alone antigen detection kit called Standard Q COVID-19 Ag detection kit. An antigen test detects viral proteins which are found on the surface of the virus than nucleic acids. The viral proteins detected would reveal if the person is currently infected with the virus. Antigen based tests gained precedence in countries with rising infection that needed a reliable point-of-care rapid detection test with good sensitivity. Weapon of mass testing, rapid antigen test has become a tool for test, track and treat strategy. A quick test is also needed at healthcare settings to allay anxiety and fear of healthcare workers. Antigen tests are far less complex technology than molecular testing and a fraction of the cost of RT-PCR testing. However, there have been concerns regarding the accuracy of the tests. Earlier in July, the media reports talked about the false negative test. Besides, to know how well the diagnostic test picks out the infection, it’s important to share data and get it analysed by both government and non-government scientists. India does not share data on the number of tests conducted by different methods. According to expert estimates 25-30 per cent of the country’s daily tests now are rapid antigen tests. The human factor is also very important in diagnosing diseases. “Doctors use their expertise to analyse the patient and judge the probability of the occurrence of a disease. Clinical correlation is also important,” the pathologist quoted above said. “No assay manufacturer gives 100% guaranty for their tests. When these tests are validated they are done in ideal lab conditions, but on ground realities are different. Many factors can affect the accuracy of tests like the timing of test, sample collection and handling etc,” he added.
a person has been exposed to the virus previously. In the light of new information on asymptomatic patients and community transmission, antibody test for Covid-19 seems like a good option. Antibody tests are important because of the recent increase interest in convalescent plasma therapy. These tests are also well suited for sero-survey, screening of highrisk groups and trace clusters. However, the tests have had a roller coaster ride over the past month, with many researchers questioning the accuracy of commercially available antibody tests. India saw antibody based tests as early as April, 2020 but soon was rejected because of a number of reports of false negatives. In fact, India stopped testing for two days on April 21-22 because of wide variations in the imported antibody test results. Following this ICMR published a list of validated and approved antibody test. The apex research body also announced a self-made test, COVID Kavach ELISA IgG kits and shared the technology for mass production.
Antibody tests are important because of the recent increase interest in convalescent plasma therapy
However, a couple of days later a number of manufacturers’ and importers’ license was cancelled following a similar action by the United States Food and Drug Administration (US FDA). Taking a que from USFDA the Central Drugs Standard Control Organisation (CDSCO), DCGI, cancelled kit import licences of three firms and suspended those of 15 others. Later, these kits were validated by ICMR and continue to be available in the Indian market.
Extending the Frontier On August 15, 2020 the saliva based test
Antibody tests Antibody tests are blood based assays for covid-19 testing. Antibody-based tests detect antibodies made in response to the particular organism, in this case SARS-CoV-2. This information tells us if
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19
COVERSTORY developed by Yale School of Public Health received US FDA approval. The emergency use authorization was given to SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection. Vivalytic VRI (viral respiratory tract infections) array is a universal test kit developed by Bosch Healthcare Solutions in collaboration with Randox Laboratories to rapidly detect a SARS-CoV-2 (Covid-19) virus infection in patients. The test is world's first multiplex molecular diagnostic tests that can identify COVID-19 and distinguish it from nine other respiratory infections with similar symptoms, like influenza. Incidentally, this device is still awaiting authorisation from Indian government to be deployed on field. At this moment none of the authorities around the world have authorised any at-home, sensitive, disposable test for COVID-19, similar to a pregnancy test. Even though companies have been developing such kits, finger-prick IgG, IgM based tests home kits, have been pulled up for mislabelling and fraudulent by the US FDA . Several companies working in this area have put their plans on hold till they get clarity from the authorities on the use of such kits.
Accelerating Availability Scientists uncover new information on SARS-CoV-2 every day and doctors are baffled with new clinical findings that have changed the way they manage Covid-19. Even then, efforts are underway around the globe to increase testing. Governments are working to scale up daily testing and overcoming bottlenecks in testing, as well as focusing on research into the development of new, superior tests.
20
September2020
Ramping up of testing facility across India is at the core of increasing testing per day in India. ICMR has said that it ensured the availability of specific testing platform to address general testing (RT-PCR), high-throughput testing (COBAS), testing at remotest places and PHCs (TrueNAT, CBNAAT), in containment areas (rapid antigen testing) and for large number & migrant population testing (pooled sample testing). ICMR has said that it established COVID-19 testing labs even in the remotest parts of the country that have difficult terrain. For example, ICMR has established COVID-19 testing lab at an altitude of 18 thousand feet in Leh, Ladakh. Apart from this, the scope of testing has been expanded by setting up a lab at Port Blair, Andaman & Nicobar. The ultimate goal is that testing should be available to everyone in need and no one should be left behind, the apex body said. Myriad uncertainties still surround the trajectory of the epidemic. On the positive side, containment efforts have yielded good results in some affected countries, but in India the challenge before us is enormous.
The emergency use authorization was given to SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection
COVERSTORY INTERVIEW COVID-19 Laboratory Diary: This too shall pass Association
for
Clinical
Chemistry)
India section Chair, she feels she has an important role to play in this current pandemic, so as to incorporate quality and safety in diagnostic care, bridging the gap between diagnosticians and clinicians & also to connect with all the stakeholders to fight against COVID 19. She also believes in Albert Einstein saying ‘Life is like riding a bicycle. To keep your balance you must keep moving’. And that’s what she has been doing throughout her career an achiever (Top Mumbai Doctor); knowledge a seeker, a research scientist and a go-getter. Dr Das speaks to IndiaMedToday about laboratory’s role in fight against COVID 19 pandemic.
What is the role of laboratory medicine department in the current pandemic? The role of laboratory physicians has been challenged many times in the past. Coronavirus disease 2019 (COVID-19) is a global threat to healthcare and patient safety, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This infection originating from Wuhan Dr Barnali Das, MD, DNB, PGDHHM
Dr Barnali Das, MD, DNB, PGDHHM, is
CEST, 6th September, 2020: 26,763,217
Kokilaben Dhirubhai Ambani Hospital &
confirmed cases) worldwide, and led to
Medical Research Institute, Mumbai; Chair,
deaths of over 876,616 deaths, people
American Association of Clinical Chemistry
across the globe.
Scientific Division, IFCC and College of American Pathologist Inspector & NABL Assessor.
The critical role of laboratory medicine in this pandemic extends far more than etiological course,
diagnosis
routine
of
COVID-19.
laboratory
Of
monitoring
Being Executive Committee Member of
of COVID-19 patients through testing is
IFCC (International Federation of Clinical
critical, but they also play a role in assessing
Chemistry
disease severity and progression, as well
and
Laboratory
Medicine)
Scientific division and AACC (American
September2020
million people (WHO dashboard; 2:14 PM
Consultant – Biochemistry & Immunology,
(AACC) India Section; Executive Member,
22
in China, has infected over twenty six
as monitoring therapeutic intervention.
What is the key test for Covid-19 diagnostics and how do you see its usability? According to ICMR directives, the choice of test in hospital set up should be RT-PCR or TrueNat or CBNAAT. Having said that, I would also like to point out that there is a sizable amount of data on false negatives. There are a lot of variables; from sample
The ongoing pandemic of COVID-19 is
Reactive Protein (CRP), Procalcitonin (PCT),
characterised by respiratory illness and
Lactate Dehydrogenase (LDH), D-Dimer,
diverse systemic clinical presentations,
Interleukin 6 (IL6), Ferritin, Blood Gases,
which in turn are reflected by routine
Aspartate aminotransferase (AST), Alanine
laboratory
on
aminotransferase (ALT), Albumin, Total
severity of disease presentation. The main
Bilirubin (T Bil), Creatinine, WBC count,
abnormalities,
based
laboratory changes encompass an array of increased inflammatory biomarkers, coagulation
parameters,
tissue-specific
tissue injury indicators (liver, kidney,
Neutrophil Count, Lymphocyte count and Platelet count, as markers for potential progression to critical stage of the illness and fatality.
collection to sample of different anatomic
cardiac) and derangement of the complete
sites like sputum, nasopharyngeal swabs,
blood count. Based on severity of disease,
Therefore,
bronchoalveolar lavage at different time
host inflammatory response to virus may
points in the disease course (very early
an essential role in patient admission
lead to cytokine storm that can cause
or late stage) can affect the results of
protocol, assessment of staging of disease
multi-organ
these tests. We also know that technical
according
inflammation, cardiac and muscle injury,
differences and skill sets of the technicians
liver and kidney function and coagulation
could also contribute to variable results.
measures
So, we must look at positive results
deranged in patients in the critical stage
as
ofCOVID-19.
confirmation
of
SARS-CoV-2
RNA
but we should not write off negative
damage.
were In
Biomarkers
also
of
significantly
hospitalized
patients,
there should be close monitoring of C
routine
to
biomarkers
severity,
play
prognostication,
patient monitoring and therapeutic guide.
Could you tell us about the importance of routine laboratory parameters monitoring in combating Covid-19?
results. Various guidelines have said that negative results in suspected cases should be carefully evaluated and correlated with clinical findings, patient history, epidemiological information, and chest CT scans. In most instances, tests are redone for negative results but clinically suspected cases.
What about serological tests? There are a number of serological tests for SARS-CoV-2 specific antibodies available in the market. Some of these are based on lateral flow immunoassays and enzymelinked immunosorbent assays (ELISAs) to
chemiluminescent
immunoassays.
Although, there are specific guidelines for all these tests from ICMR and these tests have their own benefits but they should be performed in a certified clinical laboratory and not as point-of-care. Of course, these tests are only meant to detect antibodies but
appropriate
interpretation
of
the
test results for seroconversion is very essential; be it for patient management or dynamic monitoring and surveillance at different stages of the disease.
Other than workload for Covid-19 testing what other testing are being done at hospitals?
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23
COVERSTORY We analysed the retrospective routine
from a range of hypothesis from lifestyles
laboratory data of around 528 COVID 19
to differences in chromosomal structure.
cases admitted in Kokilaben Dhirubhai Ambani
Hospital
&
Medical
Research
Institute to explain the role of routine laboratory
parameters
in
disease
monitoring, let’s demonstrate the routine lab parameters of one case.
In our set up, the distribution of cases indicates that more men are affected by coronavirus than women. The disease distribution varies according to ethnic variation. We have done a small study to test significance of routine laboratory
An elderly male with a known case of
markers in Kokilaben Dhirubhai Ambani
diabetes
hypertension,
Hospital & Medical Research Institute. A
presented to the hospital with complain of
total of 528 subjects were considered for
breathlessness and dry cough since 4- 5
the study which included 370 male (70%)
days. The patient had no travel or contact
and 158 female (30%) subjects. These
history. The patient was tested positive
subjects fall in the age group of 12 years
for SARS-CoV-2 by reverse transcriptase
to 93 years (median age 61 years). The
polymerase
(rRT-PCR)
routine laboratory findings supported the
using nasopharyngeal swab. HRCT Chest
diagnosis with elevated levels of markers.
mellitus
chain
and
reaction
showed extensive ground glass opacities in both lungs. The routine laboratory findings supported the diagnosis with elevated levels of Interleukin-6 (IL-6), C Reactive Protein (CRP), Procalcitonin, High SensitiveTropinin I (hsTnI), AST, ALT, Direct Bilirubin, D Dimer, Ferritin, LDH, Creatinine, Blood Urea Nitrogen (BUN), Neutrophil count, WBC Count, Lactate and decreased levels of Albumin, PCO2,
PO2 and SO2
percentage and Lymphocyte count. The patient was diagnosed with Pneumonia, multiorgan dysfunction syndrome, acute respiratory myocarditis,
distress ischemic
syndrome, hepatitis
viral and
acute kidney Injury. The patient was treated accordingly. Processes are now streamlined in laboratory medicine to ensure provision of reliable and timely test results, thus enhancing quality of care and patient safety.
What variation have you seen between male and female patients with Covid-19?
This data adds to our understanding of sex-based differences in mortality from Covid-19. This gives us an opportunity to analyse risks based on sex, age and other factors.
Could you elaborate on the role of IFCC, AACC and other national bodies in current situation? In
recent
decades,
both
Federation
of
Clinical
Laboratory
Medicine
International
Chemistry (IFCC),
and
American
Association for Clinical Chemistry AACC and several other national and international societies of laboratory physicians, have been playing an active role in providing guidelines
in
standardisation
and
harmonisation of tests, methods, cut off and laboratory practices. These professional bodies provide regular updates on epidemiology, pathogenesis and laboratory diagnostics of COVID-19. They
also
collect
data
on
COVID-19
laboratory abnormalities from different
Not every country has sex-specific data,
members and labs and are the best
but a clear trend has emerged about a
platforms to come together for scientific
higher percentage of male patients in
knowledge sharing.
some places. The predominant view is that although the number of male cases is not dissimilar to the number of female cases,
What has been your learning from this pandemic situation?
men have about twice the risk of death
This COVID 19 pandemic has shown us the
from COVID-19. Experts have deduced this
reality of life.
24
September2020
I’m really proud of our unsung heroes, our laboratory technical team members, who are the frontline warriors in this pandemic; ready for any duty, filling our life with positive attitude. Laboratory medicine service is very much valuable for all of us, for hospital and for this country
INTERVIEW Unified approach with a single vision Needed to win against Covid-19 Here he talks about the contribution of private labs to fight Covid-19 in India.
Could you explain how Covid-19 testing evolved since the pandemic broke out in India? There were far few laboratories that were approved for the RT PCR testing in late March. The ICMR has been steadily adding labs across different states to improve the testing capacity and today there are more than 1500+ labs approved for testing. The RT-PCR remains the final confirmatory and the gold standard test for the diagnosis of Covid-19 in India. The test involves taking swabs from the nasal and oral tracts, extracting the viral RNA and amplifying it to make the final detection. Post the RTPCR test, TrueNat and GenXpert technology were approved for testing. Both these tests also works principally on the same level as PCR but the test Dr Sushil Shah
results are faster. This technology is in
Dr Sushil Shah is the Founder-Chairman
use for HIV and tuberculosis diagnosis
of Metropolis Healthcare. Beckoned by a strong academic career; Dr Shah embarked upon his educational journey with the prestigious Scindia School and went onto completing his MBBS in 1972 and MD in Pathology and Bacteriology in 1975; from Grant Medical College. In 1978, he received Research Fellowship at the esteemed Cornell Medical Centre in Endocrine Pathology. Thereon he held many prestigious academic positions and headed departments at recognised hospitals throughout his career. He has headed the RIA department at Breach Candy Hospital and Pathology Departments at Sir. H.N. Hospital, Saifee Hospital and Cumballa Hill Hospital. He has numerous scientific publications to his credit and has pioneered Radio Immunoassay Technique, HIV testing and In-Vitro Fertilisation for the first time in India.
and has now been extended for Covid-19 diagnosis. Many government labs across the country are already equipped with the TrueNat machines and hence it is easier to increase capacity of testing by adopting this technology. Most of the states have also added antigen testing however the concerns of false negatives with antigen testing remain. Antigen testing does allow for faster recognition of those who are positive but it is possible that some positives are missed. Antibody
testing
which
is
approved
by ICMR in late June is used for serosurveillance and not intended as a test for diagnosis or an immunity certificate. Today, India is conducting almost a million tests everyday and we have come a long way from the beginning of the pandemic
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25
COVERSTORY and I believe that we still have a long way to go.
labs are present in Mumbai, Thane, Pune,
How many private labs are testing for Covid-19 in India currently?
Bangalore.
There are more than five hundred private labs that have been approved for Covid-19 testing in India. Off these private lab chains that have good testing capacity have been doing a large number of tests on an everyday basis.
How has Metropolis helped in the fight against Covid-19? Metropolis was one of the first labs to be approved for Covid testing by the ICMR. We have been at the forefront of the pandemic since day one and is conducting a few thousand Covid related tests each day. Offering good quality and reliable testing to the patients in the hour of the need has set us apart in this fight against Covid-19. Metropolis has also been the preferred partner to many corporates and NGOs to conduct Covid testing for underprivileged. We have conducted tens and thousands of testing for the underprivileged through tie-ups through different CSR Programs.
What method is used for Covid-19 testing at Metropolis? Metropolis has eight Covid approved labs across the country and offers the RT PCR, antigen, and the antibody tests. Our
26
September2020
Chennai, Bangalore, Cochin, Delhi and
What are the main challenges for any lab to provide Covid-19 testing? The challenges were multifold in the beginning a
of
shortage
the of
pandemic
kits,
PPEs,
including restricted
movement within cities and inter-state travel movement also hampered smooth operations. With the country going into lockdown, testing numbers came down drastically
and
additional
expenses
like employee’s travel, accommodation and most importantly doing everything that we can to keep our employees and their families safe were our top priority. Today, while we are offering Covid tests across the country, it is also our duty and responsibility to take care of patients who need non-Covid tests and are apprehensive about availing these tests.
What measures could help labs provide better Covid testing? The private sector and public sector need to partner in a collaborative manner in all states for the greater good of the nation, be it laboratories or hospitals. We have not seen a unified approach with a single vision and that is a big lesson to take from this pandemic.
We have seen that over the decades, there has always been a trust deficit between the private and public health sectors, and we have truly not been able to respond to the pandemic in a participative approach
INTERVIEW IVD has found its true space What did the market for testing of communicable diseases look like before the pandemic broke out? The two most prevalent communicable diseases in India – TB and HIV have had a very long history, and India has been waging a concerted war against these. India has enough domestic production to meet its internal demands for these communicable diseases.
Jatin Mahajan
With respect to Covid-19, when the pandemic broke, India was not ready for the fight. There was not a single player manufacturing Covid test kits in India. J Mitra & Company now has two different Covid-19 test kit solutions which are doing very well in the market. In addition, we have an array of tests solutions for other communicable diseases, and we have been playing a significant role both nationally and globally across most segments.
Jatin
Mahajan
is
the
managing
director of J Mitra & Company, and the person responsible for spearheading the phenomenal
growth
and
international
forays for the last 18-years, and has steered the company to its present glory – regional leader, exporter to over 45 countries. Mahajan is a well-established name in the medical fraternity as a promoter of excellent quality medical diagnostic test solutions for the detection of various infectious diseases. His cost-effective, safe, and
international-standards
compliant
products are used by most of the big names, and his clientele reads like a who’s who of the medical diagnostic fraternity. It is this drive for quality and excellence that has resulted in the company bagging more than 55 patents in this industry, and the title of ‘India’s Patent King’ by Wall Street Journal. Here he talks about Covid-19 testing and how the pandemic has affected the IVD industry.
Has the pandemic amplified the IVD space in particular on the supply end? The pandemic has drawn a significant focus to the IVD space in India. A segment that was earlier ignore and neglected by the policy makers is now finding its true space. The Health Ministry and policy makers are recognising the stellar work being done by the industry, and also recognising the need to have rules, regulations and standard operating procedures that helps in the growth of this segment. As an industry body, AIMED has played a significant role in highlighting the factors that have stunted the growth of the segment, and working with policy-makers for a more level-playing field for the IVD segment in India.
From your perspective, and given the supply chain bottlenecks, how does the strained relationship between India and China impact medtech? From an industry perspective, there has
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COVERSTORY been a significant impact on the overall medtech space, since the industry has been heavily reliant on finished and raw material import from China.
ICMR has taken serious cognisance of
As a company, J Mitra & Company has not been impacted because we have spread our sourcing to both domestic and international players from various parts of the globe as part of a very strategic business continuity solution. This ensured that we had regular supply of raw material even as other companies were struggling to sustain adequate production. The supplies from China are yet to stabilise, and many companies are still reeling under the import bans and custom delays at various ports across the country.
for the Indian market. There were also
Without China, what other places are there in the supply chain that global companies can lean on during this time? Countries that were major suppliers in the initial phase of the pandemic were China and South Korea. But non-performance was a big dampner for most of these kits. ICMR and DCGI are the two government organisations that provide accreditation of tests and marketing approvals respectively for the Indian market. As Indian companies developed their own Covid19 test kits and received necessary approvals from ICMR and DCGI, they have come to the forefront and gained more and more traction in the domestic market. In order to meet the internal demand of the country, we are currently not allowed to export our tests, and hence the Indian companies have not been able to foray into the international market, but more and more countries are exploring the possibility of buying from Indian companies as soon as the restriction are lifted. It is just a matter of time when these Indian companies will play a very significant role in the global arena.
5) There has been a lot of talk about fraudulent (Non-authorised) Covid-19 tests. Could you explain what these are? I am not aware of fraudulent kits availability. But yes, there has been a lot of issues with non-performing and unreliable kits in the initial 2-3 months.
28
September2020
all these kits that have demonstrated bad performance, and has been quick to take them off the list of approved kits kits that were automatically approved by ICMR and DCGI because these kits had an existing USFDA approval, and they were subsequently taken off the approved lists once it came to light that they have lost their USFDA approval. Another aspect has been of doctors who may have duped test seekers by producing fraudulent reports where no proper tests were actually conducted. These are minor and stray incidents, that will not be able to sustain themselves.
How can doctors and labs in India access information about nonauthorised tests? ICMR has the list of approved kits on their website, and this list is regularly updated to reflect any changes – both addition and deletion of names from the list. Thus any entity looking forward to sourcing test kits should verify from the ICMR website, and source it directly from the manufacturers and not through any middlemen.
How is India placed globally in terms of testing for covid-19? India is well poised to play a key role in the Covid-19 test kit segment at a global level once the restrictions on exports of these kits is lifted. India is faring very well, both in terms of quality and quantity of such kits. I am personally aware of various markets and entities who are keen to source from India, and are constantly monitoring and awaiting the restriction on exports to be lifted.
How do you see this trend going forward? India was already playing a significant role, and now we are moving towards playing a more significant role.
India is poised to become the hub for medtech products in the years driven by our quality-pricing aspects, and also due to the shift in global business patterns.
APPROACH
Explaining Everything A simple explanation for Corona virus testing Diseases
such as chickenpox can be
diagnosed at sight—that is without the aid of any lab tests. Unfortunately, not all diseases can be diagnosed so easily. For instance, it is not always easy to diagnose a
case
of
SARS-CoV-2
coronavirus
infection. This is because up to 40 per cent of those who have the infection do not show symptoms. Besides, those who show symptoms may not have anything more than a common cold in the beginning. Dr Rajeev Jayadevan, Senior Consultant Gastroenterologist and President, IMA, Cochin
In addition, there are a few individuals who do not show any symptoms in spite of having serious lung disease until they collapse at a later stage. Therefore, it is important to make a proper diagnosis at the earliest. Unlike many diagnostic tests such as treadmill test or blood sugar test that are done with the sole intention to treat certain diseases, testing in the case of COVID-19 holds a second, and perhaps more important purpose. That is to identify a person before he or she gets a chance to spread the virus in the community. Difficulty in understanding this dual-purpose concept has caused much confusion among the lay public as well as the policymakers.
Not as easy It is important to realise that there is no perfect test to diagnose COVID-19. This is also the case with many other conditions such as tuberculosis, Crohn’s disease, heart disease and many other disorders. Doctors commonly use a combination of history and examination of the patient, coupled with their extensive past experience to arrive at the diagnosis in many diseases. Not all diseases require a test for a diagnosis either, as seen in the example of chicken pox. In other words, unlike a pregnancy test that will invariably show a positive or negative test from a drop of urine, finding evidence of Corona virus infection is not straightforward.
Gold Standard The most commonly used test for COVID-19 in the early days was the RTPCR. This test detected the presence of RNA of the virus from the mucus of the nose or throat. RT-PCR could also detect fragments of RNA which means that even if no live virus was present in a patient, the test will show a positive result. This was observed among those who had fully recovered from COVID-19. Initially, many such patients were misdiagnosed as ‘reinfection’. In other words, RT-PCR can also detect a “dead” or disintegrated virus that is incapable of infecting other people. Thus, the presence of a positive RT-PCR does not necessarily imply that the patient has active Coronavirus infection. In fact, this test has remained positive in many patients for up to 2 months after recovery. This does not mean that the virus was “alive” during those two months.
Second Line of Defence The RT-PCR being expensive, cumbersome and not freely available, the arrival of the rapid antigen test has helped experts track the disease better than they could ever do before. The antigen test is cheap, easily available and has a high specificity which means that if the test is positive, we know that the person definitely has the infection. The problem with the rapid antigen test is that it is not very sensitive. This means that if the test shows a negative result, it does not always mean that the person has no infection. This is technical statistical jargon, simplified for easy reading for people with no prior training in medicine. Obviously if the test will miss people who are carrying the infection, it is a matter of concern. This can be minimised by using clinical acumen (the doctor’s knowledge and experience) along with the test. In other words, if the test is done in a person who is more likely to have the infection, the accuracy of the test is higher. This is the principle of ‘positive predictive
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APPROACH value’ (PPV), which again is an important statistical term associated with laboratory investigations. In other words, doing this test in a person who is at extremely low risk of infection is of no value. For instance, there is no need to test a healthy elderly and asymptomatic person who has been sitting at home without exposure to people with infection. Even without doing the test in such a setting, we know that it will be negative.
Serology Testing
finding of a scar on the body. We know from experience that the presence of a certain type of scar implies that there was a corresponding injury in the past. While doing serology tests, IgM antibodies indicate recent or active infection. IgG antibodies indicate past infection. The levels of antibodies are well known to drop with time, particularly with Coronavirus infections. Seroprevalence surveys are being done all around the world to determine how many people in each
Serology testing basically involves detection of antibodies against infection. Any viral or bacterial infection will result in the production of antibodies by the body. Not all of these antibodies provide protection from future infection. However, the presence of these antibodies in a person’s blood serves as a reminder of, or as a marker of recent infection.
community got the infection already. The
The concept of serology is almost like
The body responds differently to different
30
September2020
sensitivity and specificity of these tests can vary, depending on the manufacturer. Serology is not a very popular test for active infection, because in the early stage of infection, it will be negative. This is because antibodies take a few days to develop.
Immunity or Not
infectious agents. Immunity against coronaviruses is traditionally not longlasting. There are four other coronavirus that cause common cold infections. They are HCOV OC43, NL63, 229E and HKU-1. They cause infections every few months to years. In other words, even if we get a common cold from these coronaviruses, it does not mean that we will not get it again. It’s quite likely that the new virus which is closely related to the existing corona viruses will also behave similarly. The newly developed COVID-19 vaccines are known to stimulate the production of antibodies as well as other immune response in humans. However, the mere presence of antibody is not a guarantee against future SARS-COV-2 infection. It needs to be ascertained through clinical trials. Whether the vaccines will provide protection against the actual SARS-CoV-2 infection is being studied though phase 3 trials involving thousands of people.
PULSE
Reality Bites What it means to be frontline worker on COVID-19 duty Nikita Sushil Kumar
As the world pandemic,
the
continues to fight the
frontline
workers,
like
doctors, nurses and other medical staff are working on their toes to ensure complete safety of the patients. They are putting themselves at risk and serving the patients. Their work just doesn’t affect them physically, but also leaves a big psychological impact on them. To know more about the life of doctors while they are at COVID duty, we spoke to an intern doctor from a government hospital in Karnataka to understand what it means to be a frontline worker on Covid-19 duty. Speaking on the condition of anonymity because she is fearful of reprisal by her employer, the intern doctor shared the plight of her batch-mates.
Initial Training The first thing before joining Covid-19 duty is to learn about the safety measures and donning and doffing of PPE kits. Senior doctors explain instructions on PPE kits and protocol of donning and doffing to the batch. “There is an orientation program before our Covid duty starts where we learn about the donning and doffing of PPE kits and the other precautions to be taken,” the doctor said. In regular training medicine students learn about personal protection, but that is limited to gloves and masks and use of sanitizers. However, this PPE is lifesaving, so even if it is inconvenient, it is a necessity.
Duty Calls To minimise exposure to the healthcare workers, an 6hr shift of seven days is rotated with 14-day quarantine. “The schedule is of one week duty followed by one week of quarantine. Ours is a government set-up so living in either
Safety vs Inconvenience When asked about her experience working with the layers of PPE on, the doctor said that it was challenging. “The moment you wear your PPE kit along with the goggles/ face shield etc there is fogging of the glasses from your own respiration and your vision becomes blurry. It takes some time to adjust to this,” she shares. Further on she said that the layers of clothing make everyday tasks difficult. “You are wearing at least three layers of masks and gloves so the work which I would normally finish in 30-mins takes at least an hour. Imagine working with a blurry vision, decreased air circulation and gloved hands. It's definitely challenging, but as the first hour passes and you get engaged in your work, all these issues don't bother you anymore.” Removing (doffing off) the PPE is a daunting task. It is an uphill battle every day and very tricky scenario, even after you have gone through training, one needs to take extra care while doffing, making sure not to spread any infection anywhere else. “We normally have a 6-hour shift after which we doff the PPE kit and they do not allow us to enter the wards again,” the intern doctor shared. “The doffing part was a little scary for me as we need to be extra careful while we doff our PPE kit, one wrong step and we might infect ourselves,” said the doctor. Looking back at her experience the doctor says, “It scared me, the first day when I had to doff off my PPE kit. I had become psychological with everyone warning and guiding me to be very careful. There was a lot of stress. But as the days progressed, I overcame my fear.”
a hotel or any stay as arranged by the
Teamwork Pays
government,” she explained. “Before we
There is a team of doctors, nurses and other medical staff at each shift. The team looks after each other and also supports psychologically. “Normally in one shift we have two PGs, one intern, two nursing staff and two group-D workers. In addition,
go for the duty we need to take along all the things we will need during these 14days, because we don't get to go back to our houses/hostel rooms,” the doctor explained.
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31
PULSE there is a senior doctor who comes for rounds and is on call always in case of any emergency.”
to ensure that they are taken care of,” says
With the rising cases all over India, there has been a shortage of hospital beds and other equipment to care for Covid-19 patients. The story was no different here as well; this Davengere hospital also had a shortage of beds. “There are approximately 100 beds for Covid patients and 11 beds for ventilator ICU patients,” the doctor says. “Even when there are infrastructure challenges, we still managed to do the best with whatever is available and helped the patients in the best way possible,” she adds.
workers also anxious. “We were definitely
the young intern. At the same time the family of healthcare scared at the risk our child was taking,” said
the
doctor’s
parents.
“But
we
understand that as a doctor it is her duty to serve the patients,” they add. And yet they are anxious till they speak to their doctor daughter after her shift. Sharing their experience the parents said that the worst time was when they had to wait for her test results to get back. She tested negative. The family is happy
Apart from all the medical skills that I learnt another important lesson was that my patients' satisfaction and the pride in my parents’ eyes helped me overcome all my fears and self-doubts
and proud of the service their daughter is providing to the people, especially at this
Coming out Stronger The fear and uncertainty around Covid-19 is palpable among healthcare workers. “You can see colleagues sleepless and stressed. Some time you can even encounter someone crying in a corner. The mental health crisis among healthcare workers is real and steps should be taken
time of need. There is a lot to learn from this pandemic experience the doctor says. “This has been a challenging experience but is also learning and a motivating experience because your patients put their complete trust in you,” the doctor says.
PCR
COVID -19 RAPID TEST
32
September2020
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33
DRIVE
Sense in Simplicity Remote patient monitoring can benefit from simple devices Covid 19
has brought out the gap in
growing video-conferencing technology,
various aspects of our existing healthcare
wearables are set to bring healthcare into
infrastructure into the light. This has
patient’ homes.
shown us that in order to facilitate the
Simple System
provision of care to our patients; we should be willing to embrace tele-health as a tool that will change the way patient care is delivered in the future.
Dr Lakshmi Vaswani, Assistant Pathologist, Bhatia Hospital, Mumbai
at
an
ideal
remote
would look for a relatively simple system to operate, one that requires little training to use. All-in-one systems feature high
As lockdown and stay at home mandates
on the list, capable of monitoring several
were implemented globally, it became
parameters at one time and can transmit
difficult for patients to meet their doctors
values automatically to a central server
for follow up visits regularly, which
(preferably cloud based) accessible as
impacted the care that patients suffering
to treating doctors, hospitals or clinics
from chronic illnesses were receiving.
as a seamless extension of the patient’s
With the number of Covid 19 cases on
electronic health records. With smart
the rise, patients who had to be admitted
phone penetration at its highest, it is
in hospitals, for conditions other than
logical to use phone based applications
covid 19, were apprehensive as it left
with devices attached via blue tooth
them susceptible to catching infection at
to capture and transmit data. Although
their most vulnerable. In these cases, the
generic wearables are commonplace and
challenge was accessibility to a healthcare
have been used by athletes to monitor
provider, while still staying safe. This is
their performance in the past, medical
where remote patient monitoring (RPM)
grade devices should be validated and
proves to be a disrupter in the industry.
approved by appropriate licensing bodies
Traditionally remote monitoring meant loaning, renting or buying examination devices like blood pressure machines or
like the FDA or CE. The proverbial cherry on top would of course be if multi-lingual capabilities were also integrated, allowing truly multinational usage.
Glucometers and noting down the readings,
The tricky part when it comes to this
either with the help of a family member
large amount of data capture is of course
or having a trained medical aide or nurse,
data analytics. It is redundant to be
come home to take readings and sending
drowning in data, by tracking so many
them to a treating physician. This was of
parameters, but not analyzing it or finding
course personnel- intensive and was not
any
feasible in Covid times. This gave way to
from it. Analysis and flagging of values
wearables that may range from general
that are out of range, should be a part
consumer varieties like fitness bands or
and parcel of the monitoring system,
pedometers, to medical grade devices like
that also functions compatibly with a
pulse- oximeters or Glucometers.
hospital or organization’s existing HIS
In the world of wearables there seems to be a quest for the ‘Holy Grail’ of patient monitoring devices. It may look like a tall order, but many companies worldwide
September2020
looking
monitoring system, patients and doctors
Remote Patient Monitoring
Traditional Vs Modern
34
While
relevant,
actionable
information
(Hospital Information Software) and easily transitions
through
upgrades,
making
both healthcare providers and patients complaint to its continued use.
have stepped up their game and delivered
Artificial Intelligence has also been used
many promising models. Combined with
for the analysis of data received from
monitoring devices. It is promising if this
sensors and videoconferencing can make
type of “crystal ball� software can predict
clinically sound decisions that save lives
patient outcomes and can be used as
and prevent delays in urgent care due to
credible research data to establish better
patient transport to larger centers. This
treatment modalities for patients.
has added an extra layer of protection for
Rose and Thorns
patients. Many patients discharged from
The path to successful remote patient monitoring that seems to be paved with roses, may have some thorns that we need to consider. They bring forward questions about data privacy and protection of doctor patient confidentiality. If hospitals
an ICU or inpatient stay at the hospital and are provided with RPM wearable tools, through which they can communicate easily with their treating doctors, hand holding them through their transition phase to recovery.
working
The last few months have seen a creative
with third party technology providers,
and technological upswing as companies
the doctors, patients and the providers
released RPM wearables that are poised to
should be very clear about which party
be game changers. US based Med Wand ,
is responsible for the data and therefore
has come up with an all in one diagnostic
who becomes liable for any untoward
and examination tool, linked to proprietary
incident. This also gives way to the next
software that allows physicians to conduct
step; standardization. It is important to set
a virtual examination of their patients.
up legal, process based and quality control
Closer to home, Bangalore based Acculi
standards, to ensure that the patients
Labs Pvt Ltd, released an Android smart
benefit from great care.
phone based application, using sensor
Latest Developments
technology from the phone’s rear camera
or
healthcare
providers
are
The applications of remote monitoring tools can range from wearables (bands, watches,
patches,
cardiac
monitoring
vests) for a homecare set up to a
to determine biological parameters . Watch based sensors like the Apple Watch, with its ECG monitoring and fall detection apps, has received FDA approval for the same.
comprehensive tele-ICU set up as well.
Future Perspective
Tele- ICUs are instrumental in bringing
There is no doubt that the global pandemic
patients expert intensive medical care,
stretched
even in remote or rural locations. With
strained healthcare services. Yet, as we
an
onsite
team
seams
of
our
already
action
evolved, our existing world seems to be settling into two distinct eco-systems:
patient
Home-based and hospital based care.
and
physically
the
interventions, a remote team monitoring vitals
to
treatment
through
Stratification of patients based on their needs, into those who require intensive care in hospitals set ups as opposed to those who can take advantage of remote patient monitoring, will help to reduce the load on our health services, both in the private and public spheres. The myriad applications of tele-health can we leverage as we explore this new normal, and grab the silver lining behind this very dark cloud
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35
INFRASTRUCTURE
Hospital Pods Fight COVID-19 How to convert containers into hospitals and win the war on Covid Rudrani Ghosh
Covid-19
has disrupted the entire panorama of the our business ecosystem, but it has also kicked off a fresh wave of innovation in the healthcare sector to combat the deadly Coronavirus pandemic. Hospital pods are one such innovation that can go a long way to return the society to the new normal.
Build to Heal Covid-19 has ruthlessly exposed the inflexible nature of the Indian healthcare system. Inadequate infrastructure to treat an airborne disease, shortage of healthcare professionals, the growing disparity between affordability and accessibility of quality care in urban and rural areas are some of the voids in current healthcare system. While the overcrowded government hospitals are running on full capacity and the private hospitals witness an influx of Covid-19 patients daily, managing this situation and redesigning the facilities require immediate attention.
of projects got highlighted for building Covid-19 hospitals quickly. Some of these projects involved converting stadiums, exhibition halls and marriage halls into Covid hospitals. The main problem with these projects was the distance from nearest hospitals. It was difficult for medical staff to be moving from these facilities to the main hospital and the care continuum was affected. A
group
of
engineers
and
designers
including the design firm Carlo Ratti Associati came together to solve this problem and designed Connected Units for Respiratory Ailments (CURA). The idea was to convert a shipping container into a plug and play ICU with biocontainment and negative pressure. The first unit is built and installed at a temporary hospital in Turin, Italy. In India, a Bangalore based company Vevra in collaboration with InnoWave has developed a hospital pod called Vevra
A month into the pandemic a number
Image Courtesy: CURA, CRA-Carlo Ratti Association
36
September2020
Pods.
INFRASTRUCTURE
What is a Hospital Pod? A hospital pod is a small movable structure with all the features of an ICU. As each unit works autonomously and can be shipped anywhere, it is easier to deploy them as an extension of existing hospital to expand the ICU capacity or can be used to create independent field hospitals of varying sizes. The CURA pod can accommodate Twofour beds in its 20 foot long container and multiple containers can increase the bed capacity to 40 beds.
The average length of the Vevra pods
pod, making it a bio-containment zone,” he
ranges from 20-50 feet with a facility of
says.
4-5 patients in each pod. The infrastructure of the pods comprises antechamber airlock rooms to provide a safe area for healthcare professionals to do donning and doffing. These capsules also have strict control over the quantity and quality of the fresh air being circulated in and out of the room through HEPA filters, UVC lights, high-end exhaust system with PLC integrated air conditioning system to help in maintaining the temperature and humidity within. The pods also have additional features like
Individual pods are connected by an inflatable structure to create multiple modular configurations (from 4 beds to over 40), which can be deployed in just a few hours. Some pods can be placed in proximity to a hospital to expand the ICU capacity, while others could be used to create make-shift hospitals.
fire-resistant structure, anti-bacterial wall
Mahesh Krishnachari, Director-Founder, Vevra says that these pods can be used in a new hospital set up and also in an existing hospital including rural public health service hospital (PHS) which requires advanced hospital setup.
and surface, attached toilet, devices to measure oxygen level, RO water purifier, geyser, 500Litre water storage tank along with mobile sewage treatment plant.
Overcoming Challenges CURA has been developed as an opensource
project,
drawings
and
accessible
for
with
its
design
tech
materials
everyone
specs, made
online.
Such
collective endeavour has also created an opportunity for testing new methods for international design collaboration. While the first prototype becomes operative in Italy, more units are currently under construction in other parts of the world, from UAE to Canada. “We invested a few days to formulate the architectural design concept and a couple of more weeks to align the engineering services with electrical , HVAC, and the
Advanced tools
PHE design. To ensure the concept is fool-
AI-based tools and solutions can speed
states Krishnachari.
up the work help the doctor take better
prototype, we have done a lot of trial
care of the patients. "The pods are in-built
and error and spent days to confirm it
with various sensors to monitor real-
is a viable concept,” he further adds.
time environment condition, air quality,
Depending on the requirements, these
differential
smart pods can be customised and they
medical
pressure,
proof we spent substantial time on-site,”
UVC
gases/equipment
intensity, and
HVAC
“Since this was our
can range from INR 20 lakhs - 2 crores.
monitoring,” says Krishnachari. The CURA pod can accommodate all the equipment and monitors available in any standard ICU. In fact, a separate pod with imaging diagnostics or laboratory diagnostics could also be built next to the ICU.
38
September2020
Krishnachari
further
says
that
these
“We can also enhance these to add
fully equipped customised capsules work
telemedicine facility for centralised patient
autonomously
monitoring without visiting the patient-
shipped
area and helps in containing the airborne
country, adapting to the needs of the local
disease or microbial particles within the
healthcare infrastructure.
to
and any
can
location
be
promptly
around
the