Express Diagnostics (Vol.1, No.6) January 2020

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HORIBA Evolutive Laboratory Organisation

CONTENTS NEWS

ON THE EDGE

INSIGHT

Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty

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Editor Viveka Roychowdhury* BUREAUS Mumbai Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana

US FDA CLEARS ISRAELI STARTUP SIGHT DIAGNOSTICS’ FINGER PRICK BLOOD TEST

Delhi Akanki Sharma Bengaluru Usha Sharma Design Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Artists Rakesh Sharma Digital Team Viraj Mehta (Head of Internet) Photo Editor Sandeep Patil

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COLLEGE OF AMERICAN PATHOLOGIST AWARDS ACCREDITATION TO MEDGENOME LABS

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HCG BENGALURU COMPLETELY DIGITISES HISTOPATHOLOGY DIAGNOSIS

LAB IN FOCUS

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DRS TRIBEDI AND ROY DIAGNOSTIC LAB’S SUSTAINABILITY MANTRA

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A NOVEL DIAGNOSTIC DEVICE FOR CERVICAL CANCER SCREENING IN INDIA

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CENTRE OF EXCELLENCE FOR WELLNESS AND DIAGNOSTICS: A NEED OF TIME

DIGITISATION HAS BROUGHT EFFICIENCYAT EVERY STEP: DR BS AJAI KUMAR | P-18 TIMEOUT

MARKETING Douglas Menezes, Sunil kumar Debnarayan Dutta Ajanta Sengupta E Mujahid PRODUCTION General Manager BR Tipnis Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

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STRIVE TO BE A BETTER VERSION OF YOURSELF EVERY DAY

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EDITOR’S NOTE

Will 2020 see a Jio-fication of India’s lab diagnostic sector?

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ts already being called the ‘Jio-fication of diagnostics.’ Even as Idea-Vodafone struggles to stay afloat after Reliance Jio disrupted the telecom sector, the market buzz is that Reliance Life Sciences (RLS) has approached pathology labs across the country's hinterland to build a hub-and-spoke diagnostics network.

The sector has attracted funding from private equity as it is considered to have faster RoI than the hospitals, as it is a relatively asset-light model. Investments from a deep-pocketed player like the Reliance Group will increase competition but will fuel a fight for market share at the cost of revenues. Similar scenarios have played out in India's e-commerce and telecom sectors in the recent past.

RLS is not speaking on record but is reported to have offered entrepreneurs enticing partnerships, with revenues being shared 15:85. Settling for 15 per cent of net sales is obviously part of the group’s long-term strategy to open newer markets in towns and pin codes where today's established players do not have collection centres.

If customers were swept away by a data deluge in 2019, 2020 will be the year that families will be lured by bundled family health test packages. As per reports, RLS will set up around 20-30 reference labs of its own in major cities and also connect hundreds of smaller path labs, the equivalent of the neighbourhood kirana stores, to these reference labs.

As customers were rewarded with cheaper data, patients will get access to cheaper testing facilities, virtually at their doorsteps. The game will pivot from a high value-low volume play to a high volume-low value play, at least for the routine test packages.

It helps that diagnosis is one of the pillars of Ayushman Bharat so that beneficiaries accessing the planned 1.5 lakh wellness centres will now have the finance for diagnostic tests.

Bigger players like Thyrocare, Dr Lal Path Labs, Metropolis etc have already been on an expansion spree in 2019 and we are sure to see more consolidation in 2020, with pricing pressures mounting. Diagnostic service aggregators have already added another level of competition to the sector, encouraging patients and caregivers to shop around for the cheapest path test packages.

In this race to the bottom, will the patient benefit?

And for how long? How will the Reliance brand ensure that the test reports from all franchisee labs live up to its name?

Indeed, how are existing market leaders ensuring reliability? After all, 70 per cent of medical decisions are based on laboratory results. Thus a ‘path’ report is not a data download of the latest action flick but hopefully a treatment path out of illness towards health.

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How will the Reliance brand ensure that the test reports from all franchisee labs are ...well, reliable?

Also, how much of this increase in lab tests is clinically justifiable? Will doctors be incentivised by RLS and competitors to prescribe more tests? Will reps of diagnostic labs now rival pharma reps for space in doctors' clinics? Will more hospitals shut down their in-house path labs and outsource the service to RLS franchisees?

One way RLS' entry could benefit the patient and the sector, is if players raise quality and service standards, up their accreditation rate etc to play on the trust factor. Accreditation is still voluntary, with the result that less than one per cent of the existing labs are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL), even though they might be franchisees of leading diagnostic players.

Can accreditation and quality then become the differentiator to trump costs? Some of the current market- leading diagnostic labs/chains have indeed acquired global certifications, like from the College of American Pathology (CAP) precisely for this reason.

Smaller labs today have the option of also qualifying for basic, NABL-entry-level qualifications provided by institutes like the Quality and Accreditation Institute (QAI).

Most of these pain points are detailed in a report released in November by the Healthcare Federation of India-NATHEALTH during its 6th Annual Summit.

The report hopes that “going forward, the government and industry should come together and efforts should be made towards laying down minimum quality requirements, easing of custom duty and extending input tax credits for Goods and Services Tax (GST).”

Considering that as per the study, the medical diagnostics industry in India today employs a round 8 lakh people with almost 3–4 direct jobs and 3–6 indirect jobs created per new diagnostics establishment, RLS' entry could add to these numbers quite significantly. But will lab diagnostic players be able to train this huge workforce?

The NATHEALTH report makes an important point that service quality will drive market success. Patients today expect same-day delivery of reports and diagnostic labs have invested in taking the pain out of the process. Prices have remained flat or at best increased by 5–10 per cent in the last five years, while the consumer price index (CPI) price inflation has grown by around 30 per cent, as the NATHEALTH report points out.

Shaken or stirred, by threats of price control/ monitoring or newer entrants, 2020 promises to be a milestone year for the diagnostics sector in India.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

NEWS

US FDAclears Israeli startup Sight Diagnostics’finger prick blood test The regulator’s nod means that laboratories that run relatively lesser tests on a day to day basis may also be able to conduct the complete blood count (CBC) test with just two drops of blood

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sraeli startup Sight Diagnostics said the US Food and Drug Administration had cleared its device that can process results for the most commonly needed blood test in about ten minutes.

The regulator’s nod means that laboratories that run relatively lesser tests on a day to day basis may also be able to conduct the complete blood count (CBC) test with just two drops of blood.

“This could be a big change because at the moment a traditional analyser can be placed in laboratories that run thousands of tests every week,” said Sarah Levy, Chief Technical Officer, Sight Diagnostics.

CBC is a blood test that gives a snapshot of one’s overall health and can also be used

to detect leukaemia.

Sight said the FDA clearance could bring down costs at laboratories with lower volumes, as traditional CBC tests which use a technology known as flow cytometry, normally require dedicated personnel to maintain the device, adding to costs.

The device, Olo, digitises blood samples taken from either the finger or the veins, into images that are then interpreted by algorithms to process results in minutes, a procedure that can take as long as a day through traditional tests.

With the clearance, Sight is set to take on Quest Diagnostics and Laboratory Corp of America Holdings, the biggest players in the lab market.

Sight, which also has a system to detect malaria on the market, raised nearly $28 million in a series C funding in February.

The medical device maker keeps getting compared to Theranos, infamous for making false claims about its blood tests, over and over again, Levy said.

Levy said the company was taking a step-by-step approach to diagnose conditions with Olo unlike Theranos, which claimed it could use just one drop of blood to diagnose a range of conditions.

Theranos' founder Elizabeth Holmes was indicted here on charges of engaging in schemes to defraud investors and doctors in June last year.

The booster for those who boost the heaLthcare sector.

Reuters

When it comes to nourishing this sector, experts prescribe a regular diet of Express Healthcare. The magazine has been the source of a healthy dose of expert information, incisive category analysis and remedies for industry ailments since 20 years, thereby earning the trust of industry professionals. It’s no wonder then that the finest in the field trust the foremost in the field.

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For any queries, call 022-67440000/22022627 or email at healthcare@expressindia.com.

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NEWS

College of American Pathologist awards accreditation to MedGenome Labs The accreditation programme is recognised as maintaining high standards for laboratory quality and having most up-to-date guidelines regarding diagnostic testing for diseases like cancer

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he accreditation committee of the ‘College of American Pathologist’-CAP awarded accreditation to MedGenome Labs again based on results of a recent on-site inspection as part of their accreditation programme.

Dr VL Ramprasad, Lab Director and COO, MedGenome Labs was congratulated for the excellence of the services being provided. He said, “CAP

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accreditation is the foremost benchmark for running a medical service such as genetic diagnostics. The certification is an encouragement for the team to continue the hard work and innovate to access more and more genetic data that can help us save lives.”

This accreditation programme is globally recognised as maintaining the highest standards for laboratory qual-

ity and having the most up-todate guidelines regarding diagnostic testing for diseases like cancer. The CAP checklist covers clinical pathology, anatomic pathology, cytopathology, molecular pathology, along with other disciplines plus the overall management and operation of the medical laboratory.

With this accreditation, MedGenome Labs are now one of more than 8,000 CAP -

accredited facilities worldwide, however, the only laboratory in India with CAP accreditation for whole genome sequencing.

Sam Santhosh, Chairman and Founder-MedGenome Labs said, “We are a firm believer in law and compliance especially when one works in the healthcare sector. This accreditation is yet another proof of the excellence we hold and

accuracy we offer”.

CAP accreditation process is designed to ensure the highest standard of care for all laboratory patients, inspect or examines the laboratory records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety programme and record, and overall management.

HCG Bengaluru completely digitises histopathology diagnosis Digital diagnosis is now default diagnosis of lab for surgical pathology and 100 per cent of FFPE slides are digitally scanned into high-resolution digital images

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ealth Care Global became the first hospital in the country to completely digitise histopathology workflow for primary diagnosis at the HCGStrand Laboratory at KR Road, Bengaluru. The hospital had introduced a US FDA approved digital pathology solution from Philips Intellisite Pathology Solutions and now the laboratory at HCG has successfully transformed to a 100 per cent digital lab for histopathology and computational pathology. The lab is also now accredited by College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL), India, for its digital pathology facility in the fields of histopathology, cytopathology, frozen section facility as well as artificial intelligencebased breast algorithm.

Digital diagnosis is now the default diagnosis of the lab for surgical pathology and 100 per cent of FFPE slides (formalinfixed paraffin-embedded) are digitally scanned into high-resolution digital images. These are then viewed, analysed, annotated and shared with other pathologists in the network in real time. Majority of the pathologists in the laboratory are now working digitally.

100 per cent of digital histopathology labs help patients by providing more accurate results and ease of access to expert opinions. It significantly improves the turnaround time for reports as well as cost-saving in terms of glass logistics of slides and blocks.

(L to R) Philips Digital Pathology Solutions with Dr Veena R, Consultant Pathologist, Head of Histopathology, Strand Life Sciences, Bangalore and Dr BS Ajaikumar, Chairman & CEO, HealthCare Global Enterprises

Digitisation also means there is no longer worry about the risk of losing or damaging specimens in the transit.

Speaking on the occasion, Dr BS Ajaikumar, Chairman and CEO, HCG said, “With 100 per cent digitalisation of histopathology services, HCG has moved further in revolutionising cancer treatment, making it possible to focus on improved outcomes for patients. These digital images are powerful tools for pathologists, helping them to analyse samples and prepare

histopathology reports more accurately and efficiently. This technology marks a step forward in cancer treatment through precision, speed, efficiency and ease of use with immense potential to provide significant clinical benefits to both the physicians and patients.”

Dr Veena R, Consultant Pathologist, Head of Histopathology, Strand Life Sciences, Bengaluru said, “With an increasing incidence of cancer cases, pathologists have to manage the increasing workload more efficiently and

this is possible through streamlining the workflow, sharpening diagnostic skills and facilitating partnership. Digital pathology helps in improving the efficiency of pathologists and quality of cancer diagnosis by enhancing collaboration across care teams. A pathologist takes almost one hour to report a case of Radical Prostatectomy while on digital slides it can be reported in 30 minutes more accurately. In the era of precision medicine, where treatment options are tailor-made for each patient, pathologists

adapting to the latest technological advancements, such as digital pathology is a welcome sign. Corporate hospitals abroad have successfully transformed to 100 per cent digitisation, and now India is following.

While digital pathology improves workflow in histopathology, computational pathology is helping the pathologists to use digital images in more varied and efficient ways. Smart image recognition algorithms, in future, will help the pathologists to focus on the things that matter most”.

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NEWS

Indian diagnostic industry critical in achievement of UHC,SDGs: NATHEALTH Study According to study, Indian laboratory diagnostics industry, estimated at $6 billion, is growing at of 13–14 per cent per annum

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he Indian diagnostic industry plays a critical role in the achievement of the vision of universal health coverage (UHC) as well as the sustainable development goals (SDGs). The industry, however, suffers from a limited focus on quality standards and cost pressures driven by high custom duty and the Goods and Services Tax (GST) structure, reveals a diagnostic study, released by Healthcare Federation of India-NATHEALTH. “Going forward, the government and industry should come together and

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efforts should be made towards laying down minimum quality requirements, easing of custom duty and extending input tax credits for GST,” highlights NATHEALTH Diagnostic Study that was released by Dr Vinod Paul, Member (Health), NITI Aayog during the 6th Annual Summit of the Federation, held recently in New Delhi. The study highlights the challenges and opportunities in the diagnostic segment which is an important pivot to India’s response to the twin challenges of communicable and non-communicable diseases.

“The lab diagnostics industry plays a significant role in the care continuum. The growing importance of evidence-based medicine has provided a fillip to the industry.

Along with its core objective of diagnosis, the industry offers additional benefits, be it employment generation, availability of specialised tests, improved access and technological advancements, among others,” the study points out.

Commenting on the findings of the study, Dr Sudarshan Ballal, President,

NATHEALTH said, “A robust diagnostic ecosystem is critical for the success of schemes like Ayushman Bharat to establish minimum quality requirements, easing of custom duty and extension of input tax credits for the Goods and Services Tax (GST). Such policy measures would support the diagnostic segment to ensure that the benefits of quality diagnostics and wellness can be delivered to the country as a whole.”

The Indian medical diagnostics industry today employs around 0.8 million people

with almost 3–4 direct jobs and 3–6 indirect jobs created per new diagnostics establishment, says the study.

According to the study, the Indian laboratory diagnostics industry, estimated at $6 billion, is growing at a healthy rate of 13–14 per cent per annum. With more than one lakh labs in India, the industry is highly fragmented and the largest of the organised players have a market share of less than 5 per cent. The industry plays a significant role in the care continuum, be it for diagnosis, prevention,

monitoring or treatment. Today, 70 per cent of medical decisions are based on laboratory results. The industry today is governed by forces of supply and demand, with service quality driving market success.

The value chain in the industry today has three core components – clinical, retail and logistics. Concerning the clinical component, the industry has matured and today offers a comprehensive array of tests at affordable prices. The industry operates at one of the lowest price points in the world. Even at these low rates, the Indian medical diagnostics industry has been able to provide people living in remote areas access to modern diagnostics facilities.

The prices have remained flat or at best increased by 5–10 per cent in the last five years, while the consumer price index (CPI) price inflation has grown by around 30 per cent. The retail component is highlighted by the doorstep presence of the industry, same-day delivery of

THE INDIAN MEDICAL DIAGNOSTICS INDUSTRY TODAY EMPLOYS AROUND 0.8 MILLION PEOPLE WITH ALMOST 3–4 DIRECT JOBS AND 3–6 INDIRECT JOBS CREATED PER NEW DIAGNOSTICS ESTABLISHMENT, SAYS NATHEALTH DIAGNOSTIC STUDY

lab reports, high customer satisfaction and other advances made in making the whole experience a relatively pleasant one.

The last component, logistics, is highlighted in the processes deployed by labs to collect samples from collection centres and transfer them to the central lab for processing.

These three components have transformed the industry into a service industry, with retail and logistics component accounting for more than 50

per cent of the costs. This has enabled access to modern diagnostics in more than 50 per cent of the aspirational districts of the country.

“The study has assessed India’s Laboratory Diagnostic Industry and highlights the role played by the Industry in improving Indian Healthcare in terms of accessibility, affordability, and accountability.

The industry has created social capital in the form of nearly eight lakh jobs and skilling opportuni-

ties. We, at NATHEALTH, are committed to partner with the government to achieve the SDG 2030,” commented Siddhartha Bhattacharya, SecretaryGeneral, NATHEALTH. The launch of Ayushman Bharat is a significant step towards achieving the goal of UHC. The lab diagnostics industry would need to play a key role in the realisation of this goal.

“Wellness centres are an important pillar for Ayushman Bharat, with the government

aiming to set up 1.5 lakh such centres across the country.

NITI Aayog has called for making these centres operational by 2022–23 to ensure sufficient coverage and lower the burden on secondary and tertiary care. The diagnostics industry will play a critical role in making this a reality while working closely with the government,” the study emphasises.

Given the right impetus, the industry can play an important role in the health and economic well-being of the country by:

Creating job opportunities ◗ Increasing access to diagnostics ◗ Becoming a diagnostics centre of excellence in the region ◗ Providing entrepreneurship opportunities ◗ Advanced personalised test menu increase trained and highly skilled manpower ◗ Ensuring the success of Ayushman Bharat

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COVER STORY

Balancing risk and rewards, cost and impact and having a patient-first approach are the key to success for PPPs in diagnostics

By Raelene Kambli

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n a partnership, it is important that partners align with each other to produce meaning and value,” says Dr Avinash Phadke, Founder, Dr Avinash Phadke Labs, President & Mentor, SRL Diagnostics. This is something he told me in a recent tête-àtête. Giving an example of a successful alliance with Roche -his company's technology partner for more than 17 years, Dr Phadke spoke about how both partners understand each other’s needs, share the same vision and possess similar business values. He said that his partnership with the company continues to grow stronger as both parties have kept the right balance between risk and reward, quality and outcomes.

This got me thinking about how India can successfully implement strategic partnerships between government and private sector players in diagnostics that are truly meaningful and creates value for patients.

Strengthening India’s healthcare system Well, we all know that PPP in diagnostics can act as a great tool to expand healthcare services in India. In the last few years, NITI Aayog has been encouraging state governments to adopt PPP models as part of the government's UHC programmes to improve infrastructure and care delivery at their regional and district-level hospitals and PHCs. States such as Maharashtra, Andhra Pradesh, West Bengal, Bihar, Odisha, Uttar Pradesh, Jharkhand, Haryana, and Uttarakhand all introduced PPP in diagnostics to expand healthcare services in smaller towns and remote villages. Moreover, to further strengthen the Ayushman Bharat scheme, the government plans to further expand PPP models to the national level.

However, unlike the power, water and the infrastructure sector, PPPs in healthcare have yet not become a panacea it was once touted to become. While there are some guiding examples (read Case Study 1 World economic forum example) that have reaped good patient and medical outcomes; cost factors, quality, talent retention and performance/ medical outcomes remain a major issue across various models. Besides these apprehensions, several other conundrums exist such as delayed regulatory clearances, delay in payments, unclear contracts, lack of political mandate, limited availability of long-duration instruments like pension funds and banks saddled with NPAs and accusations of weak governance.

We spoke to some stakeholders involved in PPPs to understand ways by which India can develop and implement effective models that are truly meaningful and creates value for all stakeholders. To begin with we asked them their experiences and key learnings and then they recommended ways by which they could improve and strengthen their strategic partnerships with the government while they deliver better diagnostics services.

Drawing an inference from his experience, Dr Amol Naikawadi, JMD, Indus Health Plus says, “PPPs can provide rapid needles of cash from private financiers, ensure delivery of quality services, and bring overall cost-effectiveness to the services which the public sector can’t achieve on its own. In the year 2017 – 18 we did a pilot for diagnostic service for community outreach in UP. The pilot project was community-level screening for the

diagnosis of lifestyle diseases in Varanasi. The free screening was largely for diabetes and basic health checkup for one lakh people in remote areas. Indus Health Plus partnered with the Govt under their CSR work for marginal communities. Our key learnings include that we have better integration of healthcare services. Both parties should have a common goal of building up a universally accessible and affordable healthcare screening facilities and the government should come up with similar diagnostic checkup model in different states. Moreover, the essentials for building the right partnership, in my opinion, trust and a win-win situation for both parties. The partners should ensure value for money in terms of project appraisals its costs, risk factors, and service quality. All the applicable processes of selecting, designing, costing, planning and awarding a contract to a business enterprise should be transparent.”

“Every project has only helped us grow and face new challenges eg- Our first PPP project in Himachal Pradesh taught us to work in extreme climatic conditions whereas our project in Uttar Pradesh taught us, how to deal at the remotest locations? The Municipal Corporation projects have been a different experience altogether, especially handling an urban crowd. The experience of effective governance and the use of technology has enriched us in knowing that a strong mechanism has been extremely beneficial for both the parties. It has played an important role to improvise payment mechanism, measurement metrics and improve the operations as well. Moreover, with such procedures in place, patients have started trusting public health systems and are getting benefitted from the same. Additionally, PPP is the best strategy for the government to shift from being a provider to a payer for better patient and doctor centric care as well as optimum utilisation of funds to patients care outcome. By allowing private players like Krsnaa and focussing on ‘pay-for-service’ model, PPP helps government defer immediate outlay, and at the same time manage its budget. Through this model, patients get quality and affordable diagnostics including increased access to healthcare in areas where earlier there was either no or limited access,” shares Pallavi Jain, MD, Krsnaa Diagnostics.

Similarly, Dr Phadke shares, “SRL has had a good experience in Himachal Pradesh PPP. We also had PPPs in UP and Bihar which had its own learning experiences. Getting and retaining appropriate manpower (qualified technicians and doctors) is the biggest challenge in operating a PPP in remote areas of Bihar and UP. As per the MCI guidelines, the reports have to be supervised and signed by an MD doctor only. Therefore, finding doctors and technicians becomes a huge problem. Secondly, dealing with the government takes a long time for payment recoveries.”

Patient-first approach The patient is not just another stakeholder in a PPP but is the very purpose of such initiatives. Although every PPP is different and requires a unique approach to bring about the best positive impact for patients, its foundation has to be laid keeping the patient at the heart of it. Hence, experts recommend opting for tools and techniques that cater to patient needs and ensure

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COVER STORY the best medical outcomes.

“With a motive to approach healthcare diagnostics from a patient-centric vision, and to constantly learn from other responsible PPP players and State NHM can strengthen good practices and eliminate bad execution. Patient-centric approach, leveraging technology for governance and monitoring financial stability will ensure PPPs are successful.

Technology-enabled qualitative and quantitative analysis besides robust patient feedback capture through independent structure and process. Periodic assessment of patient satisfaction. Availability of round the clock services at the remotest of locations,” proposes, Jain.

Open contracts on digital platforms While the government intends to strengthen and boast of its digital India initiative, it is time that we utilise digital platforms to monitor and govern PPPs in healthcare. Experts believe that this could be a turning point for both the private and public partners to ensure good governance and more. According to Dr Phadke, an effective PPP can be built and implemented successfully if a pool of money is allocated before, and tenders and contracts can be released on a digital platform.

“Just like we have the Sugam or the digital platform for start-ups the government should develop a platform to run and manage PPPs in healthcare. This can not maintain transparency but can act as a great tool for governance and monitoring of PPPs from time to time,” recommends Dr Phadke.

Moreover, experts also feel that the government should upload contract guidelines and T&Cs on a digital platform.

Jain suggests that the NHM should jointly help define a document for standardisation of tender and governance metrics. Consider PPP for Govt teaching college hospitals as a part of enhanced learning and

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DR AVINASH PHADKEFOUNDER

DR AMOLNAIKAWADI

Dr Avinash Phadke Labs, President & Mentor, SRL Diagnostics

JMD, Indus Health Plus

As per the MCI guidelines, the reports have to be supervised and signed by an MD doctor only.Therefore, finding doctors and technicians becomes a huge problem.Secondly, dealing with the government takes a long time for payment recoveries technology-driven policies to be considered so has to help clean governance, which in turn can help in smoothing the payment cycles and overall

service delivering.

Balancing risk and rewards, cost and impact The most challenging task in a

The natural assimilation of the method through which partners preserve long-term relationships is a key issue in maintaining social well-being, reducing health risk factors, and sustaining public health programmes PPP is balance risk, rewards, cost and impact. According to a report published by the Global Health Sciences, one of the central features and crite-

ria for success of a PPP involves the appropriate allocation of responsibility (risk) between the public and private partners. Any transfer of risk

must be closely monitored and managed, with clear roles and responsibilities laid out in the contract. Risks within PPP projects generally fall into three main categories: 1. General and financial risk 2. Planning/design and construction risk 3. Operating risk (including clinical performance) The report also mentions that many governments abroad have a stringent procedure for a proposed PPP project. In some EU countries, PPP projects go through a series of reviews before being tendered, to ensure alignment with legal frameworks and strategic plans, and to assess the costs and intended benefits of the project. These reviews help to mitigate potential fiscal risks— especially as projects that default or experience delays in government payments can impact future investor and bank interest. Some governments also engage external advisors to aid them in managing a range of issues related to project structuring, procurement, financing and risk evaluation.

Some countries (Turkey, for example), use additional mechanisms such as debt assumption undertakings, in which the government commits to taking on the debt of the PPP private partner should the contract be terminated, as a way of providing guarantees to lenders.

But all this needs a proper policy framework for PPPs which currently does not exist in India.

Speaking from his own experiences Naikawadi talks about how there can be better operational risk sharing done.

“The partnership should be looked at long term contracts and associations. The natural assimilation of the method through which partners preserve long-term relationships is a key issue in maintaining social well-being, reducing health risk factors, and sustaining public health programmes. In my view, the government should partner

PALLAVI JAIN MD, Krsnaa Diagnostics

The public partner leverages the private partner’s skills and assets to perform all significant aspects of the project in hand

with one or two service providers in a city or state to offer diagnostic facilities at primary healthcare centres in remote areas. The challenge at a healthcare centre in rural areas is the availability of resources in terms of doctors and trained medical staff and the latest diagnostic facilities.

Therefore, private partners can bring in the technology and manpower to provide accessible healthcare for the masses”, he says.

Likewise, Jain talks about financial risk-sharing. “The public partner leverages the private partner’s skills and assets to perform all significant aspects of the project in hand.

The economic-financial risks, including the high capital expenditure on investing in equipment and machines, on the private partner’s side, is addressed by the promise of increased demand for services from customer end, on the public partner’s side. If the Government gives a minimum volume guarantee especially in places where doctors’ presence is yet to pick up, Krsnaa with the extended leverage of our technology in diagnostics can help the needy avail benefits even in such places where doctors are not present, via teleradiology. With such patient-centric approach, the risks shall be mitigated equally.

Going ahead, escrow mechanism for predictable cash flow and robust

JAIN LISTS DOWN SOME ESSENTIALS THAT PPPS MUST BE BUILT UPON Understanding each other’s need – to execute any project together this plays an important role to understand each other’s needs and requirements to plan and execute.

Establish clear and regular methods of communication- Differences of opinions and expectations from the private partners are inevitable. Periodic meetings to assess progress, air any differences and dispute resolution are essential. For any project to be successful if clear communication is made a routine lot of issues can be resolved amicably.

Set timelines – Project execution timelines play an important role, working in the health industry and being present in the Government hospitals and health centres. we must meet timelines so that services are made available to people at the earliest.

Assign roles and responsibilities – When working on PPP projects it is essential each partner knows his roles and responsibility, to ensure smooth operations and processes.

Here are some of the recommendations from the industry that can help India build better PPPs in healthcare.

governance with suitable course correction shall be highly beneficial”, she adds.

Regulatory and policy framework for PPPs While most players in the PPP space talk about the significance of a well-defined contract that lays down rules for risk-sharing, transparency, good governance and more, they also feel that a robust policy can make a huge difference.

They feel that certain policy decisions related to PPPs need to be taken at the central level which can be executed at the state level.

Now, this perspective comes from the outlook that diagnostic services will henceforth become essential in the implementation of the Ayushman Bharat scheme.

“It’s extremely important that some important policy decisions are taken at the central level which can be passed at the state level for execution”, reiterates Jain. She further points out that the NHM should jointly help define a document for standardisation of tender and governance metrics. Likewise, technologydriven policies should be considered to help clean governance, which in turn can help in smoothing the payment cycles and overall service delivering. Jain also proposes to consider PPPs for government teaching colleges/hospitals as part of an enhanced learning programme.

In keeping with opportunities that lie ahead, both private and government partners must align with common goals to establish improved patient outcomes. Quick dispute resolution is also essential. It is imperative to focus on the value these PPPs create and ensure improved patient outcomes.

The government cannot abdicate its core functions when it comes to healthcare and private players need to rebuild the trust between healthcare providers and patients in future. raelene.kambli@expressindia.com

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INFOGRAPHICS

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January 2020

LAB IN FOCUS

Drs Tribedi and Roy Diagnostic Lab’s sustainability mantra Drs Tribedi and Roy Diagnostic Lab with its successful strategy implementation has been able to sustain itself in this competitive environment and hopefully will be able to do so in the long run

By Sanjiv Das

T

he diagnostics sector has become highly competitive in the last few years as players are leaving no stones unturned to become the number one provider. As new technologies evolve and automation and AI takes centre stage, the sector will witness a new era of lab efficiencies.

Undeterred by the massive changes in the diagnostics space, Kolkata-based Drs Tribedi and Roy Diagnostic Laboratory have been registering unhindered growth since the last few decades. So, how does Drs Tribedi and Roy manage to survive in this competitive environment and what is the secret behind its success?

The growth story Set up in 1956 by Dr BP Tribedi and taken over by Dr AR Roy in 1958, Drs Tribedi and Roy Diagnostic Laboratory is a wellknown landmark in Central Kolkata over the last five decades. The lab had a small set up during its initial days with 40-50 patient footfalls. The lab functions on a no-franchise model and all the tests are conducted under one roof. With this strategy, Drs Tribedi and Roy Diagnostic Laboratory ensures that patients get their reports on time. But as volumes increased along with public demand for more centres, Dr Roy was compelled to expand his services.

According to Dr Subhendu Roy, MD, Drs Tribedi and Roy

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Diagnostic Laboratory, another four centres have opened in different parts of the city. “The real growth happened during the late 80s and early 90s due to innovation in technology.”

Dr Roy says, “The lab runs through word-of-mouth and is not a corporate-run lab. We never advertise and our lab functions through word-ofmouth. We have certainly not grown like other chains, but it is a choice. We are under no pressure from the shareholders and PE holder.”

The lab ensures that patients have access to reports by late afternoon so that whoever is travelling to distant suburbs can go back home on time.

Introducing the barcoding system for labelling of samples has ensured that the reports are accurate and reach the right patients on time.

And to provide quick service without any interruptions, the lab has introduced barcoding of reports for billing process as well. So, it will be easy to locate the reports of the repeat patients.

In order to expand their services from a quality point of view, doctors at the lab also provide clinical advice and consultation. Says Dr Roy, “The USP of the lab is that it is controlled by a group of doctors since inception.”

At a time when there are news of sour relationships between doctor and patient, Drs Tribedi and Roy Diagnostic Laboratory has been able to bridge the gap by giving first-hand information of the disease to its patients. This has ensured that patients keep visiting the lab for future tests which have increased footfalls. The current footfall is between 1,000 to 1,500 on a daily basis.

Dr Roy further mentions, “We are a standalone lab and there are no tie-ups with hospitals and have no captive patients. 99 per cent of our patients are walk-ins.”

Drs Tribedi and Roy has another advantage when it comes to its employees who work in the lab. Says Dr Roy,

SERVICES OFFERED D

rs Tribedi and Roy has the following departments at its lab.

These are biochemistry, haematology, clinical pathology, microbiology and serology, immunology, histopathology and cytopathology. The lab conducts routine biochemistry tests and follows special biochemistry parameters.

The following tests are also conducted:

Histopatology ◗ Routine histopathology ◗ Immunohistochemistry panels ◗ Molecular tests - collaboration tie-up with Tata Trust Lab Mumbai under Dr Anita Borges and Dr Jay Mehta

Microbiology ◗ All types of routine microbiology tests ◗ Automated fungal culture ◗ PCR Lab - Hepatitis B Virus DNA viral load ◗ Hepatitis C virus RNA quantitative assay ◗ HIV viral load

Haematology: ◗ All types of routine haematology tests ◗ Leukaemia diagnosis by immunophenotyping ◗ Investigations for bleeding and clotting disorders including all types of coagulation factor assays and platelet aggregation study. ◗ Diagnostic tests for detection and monitoring of all types of cancers producing abnormal proteins. ◗ Thalassemia diagnosis

“Though employees work under tremendous pressure, the attrition rate is very low and some of the employees have been working here for more than 20 years.”

Although Dr Roy's views and techniques to build the brand by way of its no advertising rule, depending on word of mouth may sound old school for some, it has still helped him build a line of loyal customers. The goodwill built in so many years is certainly a fruit of the hard work, the value system and quality principles the lab follows. Dr Roy and his team have also thrived on technology, they are now adopting automation to enhance productivity and quality.

helped Drs Tribedi and Roy Diagnostic Laboratory to fully automate the clinical biochemistry, serology, haematology and immunohaematology departments. Automation has also helped the lab handle a higher number of samples and provide quality reports.

Dr Roy mentions, “Technologically, we have left no stones unturned. Over the years we have maintained a good relationship with big companies.

If they have to station an engineer so be it. It helps to ensure that there are no technical glitches while on service. We use the best reagents, quality control systems and online, IT technology.”

Automation — a game-changer

Quality checks

Adoption of automation has

At any given point of time while

conducting a test, if a particular parameter is above or below a certain level, it is considered as an alert. The test is again repeated at the operator level in the second instrument. According to Dr Roy, the ultimate aim is to provide the correct report.

The lab conducts quality checks twice a day for every parameter and has also ensured to duplicate everything to ensure that the machines are always on standby in case of any eventuality. Whenever there is a malfunction of the instrument or reagents, then the whole batch had some issue, but if there is a random error then thorough analysis needs to be done.

Says Dr Roy, “Machines can malfunction at any point of time and it is difficult for us to tell any patient that the machines are defective. We also ensure that there are no two visits by patients for collecting the report.”

Demineralised water, also known as demi water, is purified water and is often used in laboratory applications. The lab ensures that water is properly de-mineralised and de-ionised before it goes inside the machine. Dr Roy says, “The water is tested periodically and technology has helped us purify water and also eradicate bacterial contamination. Once a machine is installed, we also ensure that the filtration system is also installed.”

Going forward The lab's success is being measured by goodwill, which it has earned over the years.

However, it needs to be seen how Drs Tribedi and Roy will be able to manage costs, maintain quality and patient experience in the long run. On how it can sustain itself in this competitive world is what the future will tell. sanjiv.das@expressindia.com

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January 2020

ON THE EDGE I N T E R V I E W

Digitisation has brought efficiency at every step HCG Bengaluru has recently transformed into a 100 per cent digital lab for histopathology and computational pathology. The hospital becomes the first in the country to completely digitise histopathology workflow for primary diagnosis. The lab is also now accredited by College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL), India, for its Digital Pathology facility in the fields of histopathology, cytopathology, frozen section facility as well as artificial intelligence-based breast algorithm. Giving more details on this development, Dr BS Ajai Kumar, Chairman and CEO, HCG explains to Raelene Kambli how the lab will function henceforth

How can digitisation benefit the entire functioning and efficiency of your lab?

Digital pathology is the technology of converting glass slides with tissue sections on it into a digital image and requires US FDA certification for the image quality and the system. This image can then be acquired, annotated, archived and shared in a network.

With the digitisation of the lab, the pathologist spends less time on reporting on digital images, and reports are more accurate with several annotation tools and measurements. For instance, radical prostatectomy with 100 odd slides would take easily about 90 minutes to report on a microscope, while on digital

images, the reporting can be completed more accurately within 30-40minutes. This improves the efficiency of the pathologists and increases their productivity. The digitised images can be shared across a network and easy to get the expert opinions from subspecialists in our system.

The patient receives the right diagnosis for the first time itself. The glass logistics is minimised within the laboratory, saving space for storage. The digital images are less strenuous as they are seen on a medical-grade monitor.

With less movement of glass slides, the efficiency of technicians improves as there is no case assembly and submission to pathologists.

Digitisation curtails the logistics cost for shipment of slides and blocks can be saved

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Archival and retrieval of slides are very easy. Previous biopsy slides can easily be retrieved and compared. The conventional way of storing slides takes at least a day to recover the slides; however, with digital images, it's easy.

With bar-coding of glass slides and LIS integration, patient identification is ensured. Turn around time for reporting is faster. With digitisation and sharing of images, the efficiency of pathologists across the network can be optimised and effectively utilised.

How will the lab function differently after digitisation?

Digitisation has brought efficiency at every step, starting from specimen labelling, the capture of gross images, LIS integration of digital images and reporting.

With digitisation, faster and accurate reporting and with LIS integration, the turnaround time will reduce significantly.

Expert opinions are faster, physical transfer of slides and blocks is not necessary, thereby it saves time and cost. The pathologists now can read the slides on medical-grade

monitors rather than on microscopes. They can collaborate with subspecialists in within our network and give a consensus opinion. With the AI-based breast algorithm, reporting is more accurate, objective and evidence-based.

Will there be new processes?

If yes, please elaborate on the same.

The process of capturing gross images and incorporating them onto the digital scanner is one step for ease of operation. The process of slide and block making is refined now with the improved skill of the technical staff, and excellent quality sections are produced which get scanned. The change is in case assembly where unlike before the technicians load the slides into the scanner making

the pathologist's workstation go paperless.

How can patients benefit from this new development?

Digital pathology is a boon to the patients. At HCG, we believe in ‘RIGHT DIAGNOSIS THE FIRST TIME’ for effective management of cancer cases. We have a talent pool of subspecialist expert histopathologists. The digital images can be shared across the network through collaboration and opinion from expert histopathologists can be obtained.

Through digital images and annotation tools, the cancer classification and staging are more accurate and saves cost in glass logistics. Also, there is no risk of losing diagnostic material

in logistics. The turn around time of diagnosis is faster.

Most importantly, the risk of the wrong diagnosis, with wrong treatment and toxicity of therapy, can be mitigated.

With the AI-based breast algorithm, subjectivity in reporting of breast markers can be totally avoided as reports are from a calibrated IVD-CE certified app.

How will it impact the profitability of your lab?

With the increasing incidence of cancer cases and the complexity of cases, pathologists face the challenge of improving their efficiency and skills of reporting.

This also raises the need for subspecialist histopathologists.

As per recent publications, as high as 20-25 per cent of cases

are being wrongly diagnosed by inexperienced general pathologists, in a country like the US. With improved efficiency levels, the pathologists are able to take up more cases for reporting, with accurate reporting.

So over the years, the recruitment of pathologists can be reduced, saving the cost.

Digitisation curtails the logistics cost for shipment of slides and blocks can be saved.

What was the entire investment amount for the digitisation of the lab? What kind of ROI do you expect?

The investment is about Rs 10 crore. This technology requires huge investments and would take easily 2-3 years for scaling up.

Does this mean a cut on manpower?

Recruitment of less, but more efficient and skilled pathologists is what is needed.

How will you utilise your manpower in the lab now?

Bengaluru is the hub of histopathology. We have centres around the country and abroad, which have basic labs.

Through networking and scanners being placed in these peripheral centres, reporting will happen from the hub in Bengaluru. Where we have expert pathologists, the cases can be shared with them anywhere through our network to get an expert opinion. So there is an effective utilisation of our pathologists across the network. raelene.kambli@expressindia.com

www.expresshealthcare.in

For any queries, call 022-67440002 or email at healthcare@expressindia.com.

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January 2020

INSIGHT

Anovel diagnostic device for cervical cancer screening in India Meenu Grover Sharma, Delhi Pharmaceutical Sciences & Research University, New Delhi, Principal Consultant, BusinessAssociar Consultants and Prof JB Sharma, Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi, and Chairperson Urogycaecology FOGSI Society (2020-22), elucidate on the importance of timely screening and diagnosis of cervical cancer for proper treatment and prevention of morbidity

C

ervical cancer or cancer of the cervix is the cancer of the entrance to the uterus. The cervix is the narrow part of the lower uterus, often referred to as the neck of the womb. Cervical cancer occurs most commonly in women over the age of 30. One of the most common symptoms of cervical cancer is abnormal vaginal bleeding, but in many cases, there may be no obvious symptoms until cancer has progressed to an advanced stage.

Treatment usually consists of surgery (including local excision) in early stages, and chemotherapy and/or radiotherapy in more advanced stages of the disease.

Meenu Grover Sharma

20 EXPRESS DIAGNOSTICS January 2020

Dr (Prof) JB Sharma

one of the leading causes of cancer mortality in India with over 60,000 deaths annually, accounting for 12 per cent of all cancer deaths in India and nearly onethird of global cervical cancer deaths. ◗ 96,922 new cervical cancer cases are diagnosed annually in India ◗ Ranks as the 2nd leading cause of female cancer in India ◗ Also the 2nd leading cause of female cancer deaths in India ◗ About 60,000 cervical cancer deaths occur annually in India The prevalence and burden of cervical cancer is much higher among women of low

FIG: ESTIMATED AGE STANDARDISED INCIDENCE RATES (WORLD) IN 2018, CANCER CERVIX UTERI

Disease burden Cervical cancer is the 3rd most common cancer among women worldwide, with an estimated 569,847 new cases and 311,365 deaths in 2018. There is a wide variation in the incidence of cervical cancer across the globe. In the west, early detection through regular screening has significantly lowered the incidence of this disease. On the other hand, developing countries continue to bear a huge burden of this type of cancer with 80 per cent of the new cervical cancer cases occurs in developing countries, like India, which reports approximately onefourth of the world’s cases of cervical cancer each year.

Cervical cancer remains a formidable challenge in India with about 160 million women in

the age group 30-59 years being at the risk of developing cervical cancer. Lack of awareness and negligent attitude towards their own health contributes to a high burden of morbidity and mortality due to this dreaded disease among Indian women where they seek treatment only after cancer has already advanced making treatment and recovery difficult.

With about 100,000 new cases every year, India accounts for approximately 26 per cent of the global prevalence of cervical cancer and 75 per cent of total prevalence in South Central Asia. Cervical cancer is

Data Source: Globocan, 2018

socioeconomic status as well as among rural women in India.

The primary reason given for this is the lack of access to screening and health services, and lack of awareness of the risk factors of cervical cancer. Human papillomavirus (HPV) infection and precancerous lesions go unnoticed and develop into full-blown cancer before women realise they need to go for medical help. Moreover, due to difficulties of access and affordability, compliance to, and follow up of, treatment is much worse for women of this social strata, leading to further morbidity and mortality.

The economic burden of cervical cancer is also enormous. It causes loss of productive life due to early death and prolonged disability. Additionally, the high medical costs that are incurred by families due to cervical cancer especially since most cases are diagnosed at advanced stages when treatment is costly but prognosis poor, further impoverish individuals and communities.

Prevention through cervical cancer screening The enormous burden of cervical cancer is especially alarming because the disease is well preventable by screening women for precancerous cervical cancer lesions.

Cervical cancer has a very long pre-cancerous period, generally 10 to 15 years. It provides a considerable window of opportunity to detect it and treat it completely. Early detection of the pre-malignant conditions allows the disease to be cured completely.

If regular screening is made part of the routine check-up of all women who are susceptible, the onset of cancer can be detected and combated effectively.

The government has taken the first step towards increasing support for effective prevention by the formulation of ‘National Cancer Control Programme’ and by identification of ‘cervical cancer screening’ as one of the main goals of the state governments.

However,

TruScreen Ultra device

cervical cancer control in the country still remains suboptimal.

A few state governments, such as Tamil Nadu, have initiated pilot screening programmes in collaboration with bodies like the World Bank.

Several NGOs such as the Indian Cancer Society, Global Marwari Charitable Foundation, GAVI, etc. have also contributed to improving disease control. However, there is still no organised ‘national screening programme’ Awareness of women regarding risk factors and screening, diagnosis and treatment options remain dismally low.

Exfoliative cervicovaginal cytology, also known as Pap smear, is the most widely used tech-

nique for cervical cancer screening. In this technique, pap smear collection is obtained from the cervix and the endocervical canal by the use of an Ayre spatula and cytobrush. Samples taken are then smeared on a slide and fixed. The inaccuracy of these tests is about 5 per cent to 10 per cent cases which has been related to wrongfully taking the sample due to poor technique of sample collection.

The sensitivity of the Pap smear test is rated at 55-60 per cent and epidemiological data report suggests that it is unlikely to detect 60 per cent of the general cervical cancer cases.

Liquid-based cytology (LBC) is another method similar to that of the conventional Pap smear method

although a special sample collecting device that collects exfoliated cells from transformation zone of the cervix is used. The device is placed in a vial that contains preservatives. Although this technique provides more even distribution of cells with reduced cellular debris in the sample, there is no difference in specificity and sensitivity vs. Pap smear.

Visual screening involves direct inspection of the cervix without taking of samples and although it is less tedious in terms of preparation and inspection, it is considered much less accurate in identifying precancerous conditions.

HPV DNA screening aims at detecting virus associated with high-grade cervical

cancers, but the technique is laborious and tedious and not very suitable for clinical use because it demands the use of fresh tissue which is not easy to conduct especially in mass screening programmes.

Even though all screening techniques and treatment modalities are available in India, access to and affordability of these pose major challenges. The cervical cancer screening coverage in India is abysmally low at just 2.6 per cent of the population. India also lacks organised Pap smear programmes and screening has not reached the vast majority of women in need. This is primarily due to the following limitations of Pap smear: ◗ Difficulty in preserving cell

Feature

Benefit

Real-time results

Patient can be treated if necessary, at time of visit. Patient not lost to follow-up with delayed reporting

Objective result

Accurate results every time

No lab facility needed

No qualified cytologists needed. Suitable for remote areas and developing countries.

High sensitivity

Improved ability to detect disease and save lives. Economic savings to global healthcare systems.

Automated device

Consistent and accurate results.

Tissue samples NOT collected

No pain or discomfort to the patient

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INSIGHT samples and transporting slides ◗ Lag time between test and results ◗ Lack of trained lab technicians to analyse the results ◗ Difficulties in getting women back for follow-up tests and for treatment Thus, there is a need for a fast, effective and sensitive diagnostic test to screen and diagnose cervical cancer early for reducing the significant burden still existing in our country.

TruScreen Ultra – A novel, real-time cervical cancer screening device TruScreen Ultra is a real time solution for cervical cancer screening.

It is a novel, technologically advanced device that utilises optoelectric technology to detect the precancerous change by optical and electrical measurements of cervical tissue. This portable device provides an effective solution for population-based screening in areas where laboratory facilities are scarce. The technique has been extensively proven with high accuracy results. A pen-like wand touches various spots on the cervix to pick up electrical and optical signals from the cervical tissue. A single-use sensor with precision lens and electrodes is used to interface with the cervix and protect against cross-infection. The TruScreen console collects the data and provides immediate results, enabling the physician to immediately plan appropriate patient care. Unlike the Pap test, tissue samples are not collected, which minimises discomfort, and therefore the patient is more likely to return for a repeat screen.

TruScreen Ultra device TruScreen Ultra uses four different lights and three electrodes to send a combination of optical and electrical signals into the tissue so the returning signals can be examined. Precancerous changes affect how light is transmitted, reflected and refracted in tissue. Unlike Pap smear, TruScreen Ultra examines cells below the

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TruScreen Ultra working principle

NUMBER OF DOCTORS INDICATING SPECIFIC ADVANTAGES OF TRUSCREEN ULTRA FOR CERVICAL CANCER SCREENING

epithelium.

Light waves transmitted from the probe tip reach far enough into the tissue to detect changes in the basal and stromal layers. TruScreen Ultra also directs electrical pulses into the tissue and measures the resulting electrical decay curve. Depending on the underlying tissue, the electrical decay curves will differ.

TruScreen Ultra working principle A multi-centre trial by Singer et al. that was performed in 671 patients in 10 centres showed sen-

sitivities for histologically confirmed precancerous lesions by TruScreen, Pap, and a combination of these two techniques as 70 per cent, 69 per cent, and 93 per cent, respectively. In the same study, the sensitivities of the TruScreen, Pap, and the combined test were 67 per cent, 45 per cent, and 87 per cent, respectively. Two recent studies also describe TruScreen as a good and objective method for cervical screening with high sensitivity results. The sensitivity of TruScreen was 86.1 per cent and the negative predictive

value was 89.5 per cent.

TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing issues with Pap tests including failed samples, poor patient follow up, patient discomfort and the need for supporting laboratory infrastructure. Being highly accurate, the TruScreen system provides an instant report, thus preventing the risk of losing contact with the patient because of the delay associated with the transportation of samples to laboratories for analysis

and reporting.

TruScreen is also more acceptable to women than a Pap test because no cervical tissue needs to be taken during the test, meaning no or minimal discomfort, and real-time results are provided.

We conducted a sample survey of perception of gynaecologists towards TruScreen Ultra for cervical cancer screening in India. A total of 52 doctors were surveyed including those practising at their own private nursing homes, corporate hospitals, government hospitals and doctors have their own independent practice. ◗ PAP smear is the most preferred method for cervical cancer screening among the surveyed doctors followed by LBC. In other methods, some doctors also mentioned biopsy/colposcopy that they use in symptomatic patients. ◗ More than 50 per cent of surveyed doctors advise screening to all their patients while others advise based on symptoms or their clinical judgment ◗ A vast majority of surveyed doctors indicate that <50 per cent of patients advised screening actually undergo the test. ◗ Fear and discomfort associated with invasive tests being currently used are the major factors why the majority of patients advised screening do not actually take the test ◗ Over 60% of surveyed doctors had an extremely positive perception about the TruScreen device for Cervical Cancer Screening, rating it 4-5 on a scale of 1-5. ◗ Real-time results that avoid the need for patients to come back for results is the major advantage cited by the surveyed doctors. The second major advantage in their opinion is a simple set up with no need for sending the sample to the laboratory. ◗ This can help them initiate treatment immediately when required and thus facilitate better prognosis. The patients are less likely to be lost to follow up.

INSIGHT Centre of excellence for wellness and diagnostics : Aneed of time Dr Sameerkumar S Shah, Consultant Radiologist, Founder, Canpic Medical and Education Foundation, Pune roots for bridging knowledge deficit and skill gap in wellness and diagnostics with the help of a centre of excellence

G

rowing healthcare needs followed by ever-increasing cost is a global concern. $1 of every $5 spent will be on healthcare by 2024 in the US i.e. that government is expected to focus 20 per cent of its budget on healthcare spending. This is a huge growing burden and a leading cause of poverty. More than 70 per cent of the population in India spends ‘out- ofpocket’ for healthcare. It forces the poor to use expense coping mechanisms like high-interest loans, distress selling of assets, reducing consumption of food.

At times, poor people opt for death over treatment. Many countries spend less in terms of percentage of GDP spent on healthcare - e.g. in India only 1.4 per cent of its GDP. Public sector healthcare system in India is overburdened. Healthcare reforms are being attempted. Traditional solutions-to stabilise the rising cost with optimal quality in healthcare-are partially successful and hence novel approaches are necessary. Health insurance penetration is poor and cover for outpatient services is not mandatory.

“An ounce of prevention is worth a pound of cure.”

The types of prevention include primary prevention, controlling modifiable risk factors to avoid the occurrence of disease; secondary prevention, the early detection of disease before clinical symptoms are manifested; and tertiary prevention, the control of existing diseases to prevent more serious complications. It has been proved beyond any doubt that prevention reduces the cost of treatment.

Clinical based preventive services need to be practised on a larger scale as much as community- or population-based services.

The health insurance sector is a major market force and could play a major role in reduc-

ing the cost of healthcare services by various means. One of them is promoting health and disease prevention. 10 per cent reduction in spending by the health insurance sector may result in them saving ~ $250 billion in the US alone. This role of health insurance sector could further be complemented and catalysed by Centre of Excellence for Wellness And Diagnostics apart from the contribution of premier teaching institutes and hospitals offering clinical excellence.

Centre of Excellence for Wellness And Diagnostics (CEWA-D) A centre of excellence is a place whose mission is to provide the best practices around a particular area of interest by bridging up the knowledge deficit or skill gap.

It’s objectives include: ◗ Providing thought leadership and direction ◗ Establishing and promoting best practices ◗ Research and development, to provide appropriate recommendations ◗ Support and education CEWA-D is need of time to be started as a pilot project and will be replicated as a chain of centres in future. This centre will act as an engine to provide a solution to the problems in the healthcare sector and will provide services aiming at health promotion and disease prevention.

Centre will provide routine and specialised diagnostic services like sonography, X-ray imaging, pathology, ECG, etc. Clinical speciality, sub-speciality and super-speciality outpatient services will be added upon with utmost professional excellence e.g. diabetes and obesity clinic.

Infrastructure, equipment, human resource will be established at par with the latest tech-

nology and expertise. Ambulance services for transporting needy patients to and fro will be provided. Centre will be providing AYUSH services, gymnasium with supervised exercise programmes, restaurant for healthy and nutritious food, conference hall for academics and public lectures, library as well.

Services will be offered to patients, apparently healthy individuals and employees of any organisation focussing on routine and occupational health problems. Customised evidencebased clinical and diagnostic protocols will be a key feature.

Regular academic programmes will be undertaken for in house and other doctors, paramedics and support staff imparting highest academic excellence.

Apart from services, the centre will research in diagnostics and allied areas aiming at affordable innovations and promote novel applications. Patented products will be of immense help in scaling up the revenues enabling sustainability.

Integration of services, academics and researchers will be the policy to generate revenue from each. Cross subsidisation will be attempted using revenues from innovations, easing out the burden on patients from the lower socio-economic background.

Focus on cutting-edge technology-based activities e.g. appli-

cation of artificial intelligence in early detection of disorders using imaging modalities and other diagnostics creating a database.

The centre will design and undertake the clinical studies according to the loco-regional health issues. It will create and disseminate knowledge and evidence-based protocols especially on disease prevention to utilise it for target /beneficiary population. This will reduce the reliance on foreign clinical studies and data, enabling us to develop nomograms for our population.

It will promote novel applications of existing diagnostic and therapeutic modalities aiming at treatment cost reduction. Secondary prevention aims to reduce the impact of a disease or injury that has already occurred. e.g. sonographic mapping of insulin injection areas may save $3-4 billion per year in India.

Screening and detection of rectocele using pelvic floor ultrasound may save the cost of long -term medical management.

Diagnosing visceral adiposity in non-obese individuals and assessing risk of metabolic syndrome in patients who are referred for sonography for other reason. Including uncommon disorders like May Thurner Syndrome on Colour Doppler within the routine protocol to save cost, morbidity and mortality.

Such practices and protocols will be immensely beneficial to both patients and health insurance companies attracting them for a tie-up with the centre for preventive health check-ups.

Centre will provide a major section dedicated to work in areas to attain the goals of public healthcare schemes. The activities of the centre will be complementary to the goals set for ‘Ayushman Bharat’ and other public healthcare programmes.

A separate section will be provided for additional activities

as follows : ‘Innovation club' will be started at the centre to promote regular multidisciplinary interactions and thereby inviting ideas and projects from innovators. It will be a support activity for innovators. This club will act as a platform to promote affordable innovations in healthcare to be catalysed by the health insurance sector. It will involve all stakeholders in healthcare by linking it to an IT platform.

Leading health insurance companies, NGOs, industry, government agencies, venture philanthropists, venture capitalists etc. stakeholders will promote lateral thinking, co-operation and interaction. Affordable innovations in healthcare will offer a major solution to many health problems, will thereby stabilise the rising cost and promote the creation of wealth on the other hand through patented products - making it self-sufficient in the allocation of funds for healthcare services. This will in turn support ‘Make in India’ scaling up the low-cost manufacturing in medical devices and related domains in India, as compared to the ‘reverse engineering’ model adopted by few countries like China.

A talent hunt programme to reach out to innovators and an idea-challenge programme to address the major health challenges by inviting innovative solutions will be the features of this club.

“Following others is easy, but providing novel solutions to meaningful problems is innovation. It endows reasons with a new capacity to enhance performance and create growth.”

To conclude, Centre of Excellence for Wellness And Diagnostics (CEWA-D) is a need of time and will prove to be one of the best solutions to solve major challenges in the healthcare domain.

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January 2020

TIMEOUT

Strive to be a better version of yourself every day Dr Kalpana Jain, Senior Consultant Pathology, Chief of Laboratory Services, Columbia India Hospitals, Palm Vihar, Gurugram advocates being dedicated to any task one undertakes as she elaborates about her mantras for success

By Prabhat Prakash

T

alented young individuals from across the country are enabling progress in Indiaâ&#x20AC;&#x2122;s diagnostic sector. Let

24 EXPRESS DIAGNOSTICS January 2020

us introduce you to one of them â&#x20AC;&#x201D; Dr Kalpana Jain, Senior Consultant Pathology, Chief of Laboratory Services, Columbia In-

dia Hospitals, Palm Vihar, Gurugram. She joined this industry after completion of her MBBS and DNB (Pathology) from

Dr Sampurna Nand Medical College, Jodhpur, Rajasthan and has over 11 years of experience in pathology, including a stint as a

pathologist in the Indian army. She has also worked with various other reputed hospitals across the coun-

try and authored several articles in reputed peer journals. For instance, her article on ‘Expression of Her-2/neu in Colon Carcinoma and its correlation with the Histological Grades and the Lymph Nodes Status’ has been published in the Journal of Clinical and Diagnostic Research. Likewise, ‘A Study of Prevalence of Intestinal Worm Infestations and Efficacy of Anthelminthic Drugs’ has been accepted by Medical Journal Armed Forces India for publication.

A very motivated and dedicated professional, Dr Jain believes that caregiving is to extend help and time to support the vulnerable. Driven by this work ethos, she strives to ensure that her reports are accurate and delivered on time so that patients can seek treatment at the earliest. Thus, she is a meticulous and diligent individual when it comes to her work and considers hard work the key to success.

Acing work-life balance Dr Jain exemplifies the modernday, working woman who has to juggle her commitments to her professional and personal life, and this is no easy task. So, how does Dr Jain do it? Well, her approach is very practical - be organised, give equal priority to all areas of your life, manage your time effectively and use technology to make life easier.

She advises, “Manage to complete your work in your office time only. When you are at home then be completely at home and the same goes for the office too.” Emphasising on the importance of being organised, she states, “Noting down reminders are a great help.” Thus, armed with these simple yet highly effective techniques, she has managed to do justice to both, her work-life and personal life.

Pursing varied interests The devoted doctor is a travel enthusiast, music aficionado and gadget lover as well. Speaking about her love for travel, she says, “I like travelling a lot. Both in India as well as outside. You interact with different types of

people, different types of cultures and most importantly I usually travel with my family or friends. The time which you spend with them is your best quality time with them.” Dr Jain also thinks that travelling and taking time off from work helps her to recoup her energy and be more efficient at work.

Similarly, she finds that music helps her de-stress and revitalises her spirit. So, despite her busy schedule, she makes time for her music classes twice a week. She states, “Interaction with other professionals, new friends and climate is always rejuvenating and it helps in growing your social circle too.”

Likewise, a self-professed tech-buff, Dr Jain is very fond of her iPhone and iWatch and uses them regularly to simplify things and stay up to date with things happening across the globe.

She admits, “I like gadgets. It helps me to effectively manage my work and time.” Thus, her sensible and matter-of-fact demeanour is only one aspect of her multifaceted personality.

Message to peers Her counsel is simple - Strive to be a better version of yourself every day, both personally and professionally. She underlines, “Be faithful to your work as it always helps to improve your life.

And there is no doubt that if you are sincere in your work then it is always good in the long-term.” prabhat.prakash@expressindia.com

EXPRESS DIAGNOSTICS

25

January 2020

TRADE AND TRENDS

Evolving quality of laboratory through solutions: HELO from HORIBA HELO is a promising answer to the constantly evolving and upgrading work-flow of medical laboratories with increasing pressure from regulatory bodies

H

ELO (HORIBA Evolutive Laboratory Organisation) is a modern mélange of innovative design, robust manufacturing standards, undisputed efficiency, unflinching accuracy, standardization & bullet-proof patient data safety. Embedded with advanced technology analysers i.e. Yumizen H2500/H1500, having well-established & unbeatable analytical performance in Hematology diagnosis.

HORIBA Medical is well established and globally accepted for its unique automation solutions i.e. HELO, for high-end medical laboratories across the globe.

HELO is a promising answer to the constantly evolving and upgrading work-flow of medical laboratories with increasing pressure from regulatory bodies and accreditation agencies to maintain quality and accuracy without any compromise. Customers across the world are moving towards HELO automation workflows experiencing the difference in capacity, efficiency and reliability on results.

High-end laboratories have each step in the sample life-cycle from collection to dispatch of reports automated, thus assuring testing of the highest quality. The solution not just addresses customer’s routine needs but also assist them in the optimisation of TAT, reconfiguration of floor space, and ease of reagent storage and minimised reagent wastage.

P8000, a specially designed middleware platform acts as a

26 EXPRESS DIAGNOSTICS January 2020

HELO COMES ALONG WITH HORIBA’S ACCREDITATION ASSISTANCE PROGRAM WHICH HAS BEEN DEVELOPED IN ACCORDANCE WITH ISO:15189 CERTIFICATIONS

brain of HELO that performs automatic validation based on bespoke configurable rules like sample re-run, reflux to confirm results of critical samples, smear preparation or performing Reticulocyte count. This also helps to save time and least human intervention lead-

ing to improved TAT. QC rules are also configurable and errorfree MIS reports.

HELO comes along with HORIBA’s accreditation assistance program which has been developed in accordance with ISO:15189 certifications.

Unique automated slide prepa-

ration system (SPS) can easily smear and stain blood sample with a high throughput of 120 slides per hour. SPS has a specially engineered flexibility to regulate staining protocols i.e.

MCG, Wright or Wright Giemsa.

An inbuilt automated con-

veyor, T6000 has multi-configuration options having a special monitoring system of rack transfers to provide optimised flow and accurate results.

Digitalisation of slides with RBC & WBC sub-classification and an optional remote review software application along with a body fluid additional application is an added functionality of choice available to its users.

A uniquely optimized amalgamation of artificial intelligence and digital technological advancement, HELO is a promising solution of laboratories that requires reliable automation with high throughput and digital technologies enabling clinicians and pathologists to spend more time with patients, with technology doing the routine operations.

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