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Foreword

Prasanthi PotluriEditor

Rx for TransformationFocusing on value-based healthcare

has tried to improve outcomes for knee and hip replacement surgeries for California Public Employee Retirement System (CalPERS) retirees by identifying 16 facilities and covering all the procedures.

To succeed in this new era, organisations need to bring fundamental changes to their ways of working and focus on improving processes that have a bearing on the outcomes for a patient. Healthcare players will need to enhance competencies, incorporate technologies that enable connected care and drive a culture of evidence-based decision making across the spectrum in order to transition from a fee-for-service to fee-for-outcomes health delivery systems.

The cover story in this issue by Phillip Polakoff, Senior Managing Director and Chief Medical Executive, Health Solutions Practice, FTI Consulting, US, elaborates on the need for a balanced healthcare transformation. Furthermore, the story analyses how the US and Asian healthcare sectors are facing problems of unsustainable costs and explains strategies that could possibly address these challenges.

Factors such as ageing populations, rise in spending by organisations and healthcare delivery centres, rise in income levels, ups and downs of countries’ per-capita GDP, etc. are driving healthcare costs.

According to the Centers for Medicare & Medicaid Services (CMS), total US healthcare costs are projected to reach nearly US$4.8 trillion by 2021. According to SwissRe's projections, Asia-Pacific’s healthcare costs are expected to reach US$2.7 trillion by 2020.

In the US the Patient Protection and Affordable Care Act (PPACA) passed on March 23, 2010 to directly regulate healthcare providers, insurance companies, individuals and employers. The PPACA will guide 34 million more non-elderly Americans obtaining health insurance by 2021. In cooperation with the Centers for Medicare & Medicaid Services (CMS), the Act aims to reduce payments for hospitals by increasing the list of applicable conditions for fiscal year 2015. These trends have increased the pressure on all healthcare industry participants to move on to customer-centric, connected and value-based healthcare.

New strategies are already emerging for a change in the healthcare delivery system and trying new approaches by introducing and implementing new digital technologies would reduce cost and expand the reach of healthcare services. Blue Shield, in California, for example,

2 AsiAn HospitAl & HeAltHcAre MAnAgeMent issUe - 29 2014

Contents

32 Lean Team EngagementFive key aspects for a successful projectJennie-Mae Evans, Vice President, HKS, USA

Sherry Valentine, Director, Center of Operational Excellence, Akron Children, USA

38 Major Issues and Trends Impacting Health and Hospital Planning, Design, Construction, Operation and MaintenanceRonald L Skaggs, AP and Chairman Emeritus, HKS, USA

Joseph G Sprague, Principal and Senior Vice President, HKS, USA

George J Mann, Endowed Professor, Health Facilities Design, Texas A&M University, USA

information teChnology45 Culture of Health Information TechnologyWhere are we?Christopher Wasden, Global Healthcare Innovation Leader, Managing Director, PwC, US

Rana Mehta, Executive Director, Healthcare Leader, PwC, India

Shib Pramanik, Managing Consultant, PwC, India

49 Interoperability Standards Key to Connected Health SuccessChuck Parker, Executive Director, Continua Health Alliance, USA

meDiCal sCienCes10 The Relevance of PET-CT in Cancer Response EvaluationSagar C Patel, Resident Physician, Radiation Oncology, University of Iowa Carver College of Medicine, US

Sudershan Bhatia, Department of Radiation Oncology, University of Iowa Carver College of Medicine, US

Markus Van Tol BS, Department of Electrical and Computer Engineering, University of Iowa College of Engineering

Reinhard Beichel, Department of Electrical and Computer Engineering, University of Iowa College of Engineering, US

John M Buatti, Chairman, Radiation Oncology, University of Iowa Carver College of Medicine, US

DiagnostiCs16 Molecular DiagnosticsRapid evolution of technologies holds out much promiseStephen Bustin, Professor, Anglia Ruskin University, UK

Gemma Johnson, Postgraduate Medical Institute, Faculty of Health, Social Care and Education, Anglia Ruskin University, UK

faCilities & operations management24 Lean Rapid PrototypingImproving healthcare designJoyce Durham, Senior Partner, Executive Vice President, Global Health Service Network (GHSN), USA

32

24

05 COVER STORY

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EditorPrasanthi Potluri

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5w w w . a s i a n h h m . c o m

01.Phillip Polakoff

The US is not the only country wrestling with the problem of rising and unsustainable

healthcare costs, nor is its healthcare system the only one attempting to control those costs while improving the quality of care.

The challenges of healthcare trans-formation are universal, as is the goal of improving outcomes at lower cost.

In the US, total healthcare costs are projected to reach nearly US$4.8 trillion by 2021, up from less than US$3 trillion in 2013. In Asia and

Australasia, according to a 2012 Econ-omist Intelligence Unit study, per capita healthcare spending more than doubled between 2001 and 2011.

The increase in Asian healthcare costs is being driven by many factors, including rising household incomes that correlate

IMPROVED HEALTHCARE

OuTCOMES AT LOWER COST

The US has some of the best healthcare in the

world and, by a wide margin, the most expensive.

Under relentless pressure to deliver better quality

for less, leading providers and payers are balancing

huge changes with the need to remain viable today.

This article delineates strategies and tactics for

organisations to migrate successfully from a fee-

for-service to a value-based delivery system.

Phillip Polakoff, Senior Managing Director and Chief Medical Executive

Health Solutions Practice, FTI Consulting, US


with the higher life expectancies that create a larger population of older, sicker patients consuming a greater portion of healthcare resources. Rising incomes also are associated with the increased incidence in Asia of the chronic, non-communicable diseases long-associated with developed economies: diabetes, hypertension, and cancer, among others. (India and China now have the largest diabetic populations in the world and experts expect diabetes rates to rise rapidly throughout Asia.) These conditions have a profound and long-term impact on healthcare costs, even as they point the way toward the new healthcare models required to address them.

In the US right now, payers and providers alike are attempting to develop new business models and programmes that will address these diseases, including accountable care models, preventative care programmes, and wellness initia-tives. At the same time, both payers and providers must balance the demands of a present in which hospital and physician revenues are falling (and promising to fall further), requiring a focus on controlling internal costs, and a future in which new payment models and new technologies demand new investment, necessitating innovation in business models and serv-ice offerings.

The prescription for a balanced approach to this transformation is devel-oping and implementing a clear, over-arching strategy that will:

Improve current operations•Try new approaches•Create the agile structures and proc-•esses that will allow the organisation to do both simultaneously.

Despite the many differences between healthcare in the US and Asia, the goal of every healthcare system everywhere is the same: to improve care, benefit patients, and do so in a cost-effective, sustainable way.

Improving the current gameWhile Asia’s poorer economies face shortages of doctors and drugs, and its

wealthier nations struggle with resource allocation and finding an optimal division of responsibility between public and private sector payers and providers, the US is also trying to figure out answers to some of these same problems. In the very near future there will be less money in the US healthcare system available to hospitals and physicians. Indeed, value-based reimbursement programmes that pay for outcomes, not services, driven in large part by the 2010 Affordable Care Act (commonly called Obamacare) that is now taking effect will put six-to-ten per cent of US hospital and physician income at hazard. To survive, every US healthcare player will need to develop new strategies, capabilities and tactics to remain competitive by lowering costs while simultaneously improving their current operations by optimising their resources, clinical expertise and financial discipline.

These new strategies are already emerging. Blue Shield, in California, for example, has tried to improve outcomes for knee and hip replacement surgeries for California Public Employee Retire-ment System retirees. It identified 16 facilities with a history of strong results for knee and hip replacements, and announced that it no longer would fully cover CalPERS members' costs for these procedures if performed at any other facilities.

An analysis by research company HealthCore Inc. found that this strategy

lowered CalPERS' health plan costs for these procedures by 19 per cent between 2010 and 2011.

Meanwhile, in the Pacific North-west, Group Health Cooperative asked more than two dozen surgeons and over a dozen physician assistants to create Evidence-based Medicine (EBM) deci-sion tools for making go or no-go deci-sions on knee and hip replacements. Implementing these guidelines over an 18-month period from 2009 to 2010, Group Health reported a 38 per cent reduction in knee replacements and a 26 per cent reduction in hip replace-ments, lowering costs by 12 per cent to 21 per cent.

In January 2014, the state of Mary-land announced, in cooperation with the Centers for Medicare & Medicaid Services (CMS), a new plan in which its hospitals will shift from Medicare payments per admission to reimburse-ment based on quality improvements such as reducing readmission rates and hospital-acquired conditions. These and other fee-for-quality initiatives are expected to save Medicare US$330 million over the next five years, and are part of a growing nationwide emphasis on prevention and wellness.

As these examples illustrate, a great part of improving the current game lies in eliminating inefficiencies to preserve and enhance revenue. In some cases, this can mean looking outside the noto-riously inefficient healthcare industry for innovative ideas.

A decade ago, for example, ThedaCare, a northeast Wisconsin health delivery system with more than 6,000 employees, looked to a nearby power company that had reaped the benefits of lean philosophies and tech-niques to improve its own processes and reduce waste.

Applying the lessons of lean and the Toyota Production System, ThedaCare created the ThedaCare Improvement System. Leaders engage staff in week-long process improvement projects that have reduced costs, eliminated waste

In the US, total healthcare costs are projected to reach

nearly US$4.8 trillion by 2021, up from less than

US$3 trillion in 2013.

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and improved patient outcomes. From 2006 to 2009, TIS enabled ThedaCare to increase employee productivity by 12 per cent, saving the hospital more than US$27 million.

As a further benefit, these cost savings have allowed ThedaCare to increase its prices at a far lower rate than its competitors. By improving quality of care even as the organisa-tion keeps its costs among the lowest in the state, ThedaCare strengthened its relationships with both insurers and patients.

Trying new approachesAsia historically has been a fast adop-ter of new digital technologies. These tools can lower costs and expand the reach of healthcare providers through wireless access and mobile devices, helping to deliver care to previously underserved rural patient populations. Just as importantly, they can enhance the integration of clinical resources

that has been demonstrated to improve care while driving down costs.

Geisinger Health System, for example, serves more than 2.6 million residents in central and northeastern Pennsylvania. Its 2011-2015 Vision statement expresses the organisation's ambition to serve as a model for inte-grated health services organisations. At Geisinger, this means a physician-led system that incorporates multi-disciplinary group practices, clinical programmes, a research programme and an insurance provider (Geisinger Health Plan), all integrated on a sophisticated IT platform.

One of the most powerful elements of the Geisinger system is the standardisation of best practices i.e. the creation and deployment of a ProvenCare® model of treating certain conditions and performing specific procedures with the same protocols at all its facilities. Developed in partnership with its clinical and

health plan divisions, the ProvenCare model requires Geisinger physicians to follow EBM best-practice guidelines. The ProvenCare model holds multiple members of the surgical team responsible for patient care through a system of checks and balances that are documented and cross-referenced in a patient’s electronic health record.

In its 2011 system report, Geisinger analysed five years of data available since implementing the first ProvenCare model for coronary artery bypass graft patients and found that ProvenCare protocols had lowered in-hospital mortality by 67 per cent and reduced the likelihood that a patient would need blood products during surgery by nearly 50 per cent. Geisinger is so confident that ProvenCare will deliver favourable surgical outcomes that it promises to cover the entire cost of any follow-up care provided by a Geisinger clinician in a Geisinger facility for Geisinger Health Plan members who

STRATEGIC VISIOn

Technology & Analytics•Multi-Stakeholder Engagement•Population Health•Governance•Communication•

CREATInG AGILITY

Creating Scale•Clinical Integration•Payer / Provider •Convergence (Taking on Risk)Innovative Offerings•

TRYInG nEW APPROACHES

Performance Optimisation• - Revenue Enhancement

- Expense Management

- Clinical Variation

IMPROVInG CuRREnT GAME



Au

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Phillip Polakoff is a Senior Managing Director and Chief Medical Executive in the Health Solutions practice of FTI Consulting. Dr. Polakoff is involved with clients (both providers and payers) in designing and implementing value based reimbursement initiatives, constructing clinical integration organisations, facilitating physician hospital alignment and structuring population health management programs. Dr. Polakoff’s career in healthcare spans thirty-five years and includes product development, network development, care management, organisational and business development, policy formulation, communications and financing.

experience avoidable complications within 90 days of a ProvenCare procedure.

The key to benefiting from the implementation of new technologies is accurate, actionable data. Govern-ments, healthcare institutions, and both public and private organisations should be mobilised to amass a broad and deep pool of patient information that can be stored in data warehouses and then queried by analytic tools to assess current gaps in capabilities and outcomes and provide a roadmap for improving treatment (as Geisinger did) while increasing patient engage-ment, the lynchpin of improved health management.

Healthcare integration is critical to the management of chronic diseases, and their costs, and must reach beyond the four walls of the hospital or clinic. This is especially important in Asia, where healthcare outside urban areas is most often fragmented and difficult for poorer patients to access. But while the goals of integrated, technology-assisted healthcare are universally understood and accepted, current payer models do not reward physicians and institutions for reaching into communities with preventative programmes, wellness initiatives and treatment follow-up networks to manage the health of patient populations outside the clini-cal environment. To do so requires the development of new business models that emphasise the importance of scale, and take a new approach to risk. And both demand organisational agility.

Creating agilityTo move from a fee-for-service health-care model to a value-based one, every type of organisation will need to analyse the costs and benefits of assuming or shifting risk.

For payers, this could mean shift-ing risk toward consumers by empha-sising cost awareness and preventa-tive care. It could mean negotiating contracts with providers that include

pay-for-outcomes models with global or partial capitation. Some payers have even entered the provider space, creating integrated healthcare systems where they have direct control over the cost and quality of care, and a greater ability to reap economies of scale.

For providers, this could mean viewing the assumption of risk as a competitive advantage. For example, a provider could compete by offering a fix fee for covering an employee popu-lation instead of charging for each service provided. To take on this risk profitably, providers need more effi-cient ways to treat costly conditions by developing predictive models and redesigning organisational processes.

Managing risk in these new ways is best accomplished by building scale. Investing in the advanced technologies that can improve care through EBM, leveraging them by rolling out digitised patient health records, and distributing them broadly to engage large patient populations in the management of their own care requires enormous resources. Every type of healthcare organisation will need to invest in these technolo-gies, but they will need scale to do so.

This means that larger players will have an advantage as the indus-try as a whole moves to payment for outcomes, and smaller players will need to look for opportunities to part-ner with organisations their own size or larger. In the US, regional Blue Cross and Blue Shield organizations are already pooling their resources across state lines. Hospitals will continue to acquire smaller competitors and, as has

increasingly been the case, they will employee physicians directly to own the care continuum. In Asia, coopera-tion between community care centers and urban hospitals, between schools and family clinics will become increas-ingly important.

The other crucial part of creat-ing agility is to possess a governance structure that allows and enables it. An organisation is agile when it can direct resources appropriately and ensure accountability. In healthcare, that means developing a strong partner-ship between physicians, administra-tion, and staff, and making sure that the organisation’s strategy is clear and broadly communicated to all stake-holders.

A commonality of concernThe downside of Asia’s rising standard of living is the increased prevalence of the chronic, lifestyle-related diseases formerly associated with the more pros-perous West. At the same time, Asia is still dealing with the age-old plague of infectious diseases. Combined with the urban-rural split in healthcare availability and sophistication, char-acteristic of all but a few Asian coun-tries, Asia confronts a highly-complex, singular path to healthcare transforma-tion. However, as the region’s health profile evolves, and its cost-curve rises, the challenges that US healthcare is confronting mirrors many of Asia’s, and the strategies evolving to address them in a balanced way may contain lessons as useful to Asia as they are to the US.



The Relevanceof PET-CT inCancerResponse EvaluationAdvanced functional imaging in oncology is essential in decision making for cancer care. As our understanding of the biology and pathogenesis of cancer improves, the impact of functional imaging will become increasingly important. Research into the standardisation and automation of PET/CT criteria in determining treatment response in cancer are vital.

Cancer is a significant cause of mortality worldwide. A criti-cal component in the clini-

cal management of cancer is advanced imaging modalities including PET, CT and MR. Imaging in oncology is essen-tial in the diagnosis, staging, prognosis, treatment planning, treatment delivery, treatment response assessment, and ulti-mately decision making for cancer care. As the oncologists’ understanding of the complex biology of tumour response and functional status has evolved, so have the abilities to integrate these facets with imaging. Along with this evolu-tion, there has been a progressive recog-nition that quantitative methods can be applied to the resultant images and that

quality control and robust computerised approaches to measurement can improve the accuracy of interpretation. However, there is simultaneously a growing impe-tus for cost-effective, cost-conscious care that provokes the need for stand-ardisation of imaging techniques and automated measurement tools to repro-ducibly measure efficacy and response in clinical trials and cancer care more generally. These changes in oncology healthcare practice have the potential to improve outcomes and reduce global resource utilisation.

The article reviews current stand-ards for image-based treatment response assessment in cancer based on anatomic criteria alone, generally with CT or MR


assessment of cancer are discussed and addressed.

Current standards of image-based treatment responseThe most common metric to describe tumour response is defined by the RECIST Criteria. This method uses cross sectional anatomic imaging, most often CT, to define the single longest dimension of the tumour. This is determined by the radiologist who is generally using a meas-urement tool and is subjectively defined by that physician. More recent analyses have employed the sum of the two longest dimensions in any two orthogonal planes. Based on slice differences on subsequent follow-up scans as well as the imperfect

measurement paradigm, RECIST cate-gories for response are relatively impre-cise. These categories include Complete Response (CR): disappearance of all tumour foci for at least four weeks; Partial Response (PR): a decline of at least 30 per cent in the tumour diameter for at least four weeks; Stable Disease (SD): neither partial response nor progressive disease; and Progressive Disease (PD): at least a 20 per cent increase in the sum of tumour diameter from the initial tumour size. These criteria are then generally applied to determine whether or not therapy is to be continued or not: success versus failure of therapy. Assessment of five to ten lesions is a standard protocol used for metastatic disease.

scans using the RECIST criteria. The discussion then centres on the role func-tional imaging techniques might play in response assessment and specifically the role that FDG-PET/CT can have on evaluation of treatment response in cancer. Identification of the current and future applications of the PET/CT imaging technique is provided. Some practical clinical examples of PET/CT utilisation for evaluation of treatment response are depicted and described. In addition, developing tools for the stand-ardisation and automation of quantita-tive metrics using PET/CT with global application are discussed. Hence, the current impact and future implications of PET/CT imaging in the treatment

Sagar C PatelResident Physician, Radiation Oncology University of Iowa Carver College of Medicine, US

Sudershan BhatiaDepartment of Radiation Oncology University of Iowa Carver College of Medicine, US

Markus Van Tol BSDepartment of Electrical and Computer Engineering, University of Iowa College of Engineering, US

Reinhard BeichelDepartment of Electrical and Computer Engineering, University of Iowa College of Engineering, US

John M BuattiChairman, Radiation Oncology University of Iowa Carver College of Medicine, US


Figure 4: A. before treatment B. 3 months after chemoradiation therapy

Figure 3: Oesophageal Cancer: A pre-treatment B. 1 month post therapy -persistent activity indicating residual disease.

GASTRO-InTESTInAL CAnCERS a. Oesophageal Cancer

PET-CT RESPOnSE In HEAD AnD nECK CAnCER

Figure1: An example of a volume based semiauto-mated PET segmentation generated with minimal user interaction. The user roughly specifies a point at the centre of a lesion, and the algorithm automatically identifies its boundary.

Figure 5: Anal Cancer A, before and B, 3 months after chemoradiation with good response.

b. Anal Canal

CLASSIC CLInICAL ExAMPLES

meDiCal sCienCes


relevance reside in determining how the measurement and change in meta-bolic activity in PET/CT imaging after treatment correlates to overall clinical response, prognosis, survival, toxicity, and morbidity in the individual cancer patient. Significant data analysing the role of FDG PET in head and neck cancer response assessment are well published.

Most imaging-based response with PET/CT is based on the tracer 18-FDG radioactive isotope, which is an analogue of glucose and the most commonly used PET tracer. This analogue is transported across the cell membrane through facilitated trans-port proteins such as glut 1 and glut 3 down a concentration gradient. These transport proteins are over-expressed in tumour cell membranes compared to normal tissues. The phosphorylated form of FDG cannot be further metab-olised and consequently accumulates in cells after measured glycolytic activ-ity and energy expenditure. FDG-PET uptake in tumours correlates with high rates of glycolysis, far greater than in normal tissues. These high rates of glycolysis and consequent uptake are likely indicative of the tumour’s biol-ogy and behaviour.

The most common measurement of tumour metabolic activity used by PET is the Standardised Uptake Value (SUV). It is defined by tumour activity

per dose injected per body mass. SUV is proportional to the metabolic rate of glucose in normal tissue when a normal serum glucose concentration is present. A metabolic response within the tumour is most commonly defined by the percentage change of post-therapy SUV from the pre-therapy SUV. The relative percentage change and the maximum SUV value and/or cutoff may serve as predictive and prognostic markers in cancer. However, an optimally accurate, standard, and reproducible means to capture the relationship between tumour metabolic activity and treatment response through PET/CT imaging is yet to be fully described and determined. Whether a maximum value, a mean value or a metabolic tumour volume is most important is not entirely clear. In addition a full analysis of potential imaging features within the vast amount of information contained in a volumetric PET image with a dynamic character of FDG uptake is poorly studied. Future development of robust tools that include detailed analysis of a spectrum of imaging features when combined with bio-informatics and outcome data is highly likely to lead to improvement in the predictive value of PET/CT. An example of a semi-automated tumour contour on a PET/CT image derived from a novel algorithm is shown in Figure 1. Such methods have the promise of more consistently identifying metrics within a scan that will enable more consistent comparisons for tumour response. Furthermore, the algorithms make robust analysis more feasible.

Standardisation and automation of PET/CT imaging in cancer treatment response

While functional imaging, as illustrated by FDG PET/CT, better captures the complex nature and biology of cancer and improves our understanding of treatment response based on associated change in tumourmetabolic activity,

Although the RECIST criteria are well established and practically accept-able and achievable, there are limita-tions in its ability to accurately and reproducibly define an image-based treatment response. The potential for misclassifications and variance in response is more apparent when a different reader completes the initial and subsequent follow up studies, although repeated measurements by the same reader on different days also often reveals discrepancies. In addi-tion, the RECIST criteria do not completely measure all the biologic and metabolic changes manifest within the cancer that may further define and determine a more accurate imaged-based treatment response assessment. It is well recognised that inflamma-tory responses may increase the size of lesions which can then be followed by lesion involution. The need for evaluating treatment response beyond anatomic measurement is evident and has led to research and development of quantitative functional-based imag-ing to assess metabolic and biologic parameters in cancer for more accurate response assessment.

Quantitative Imaging using PET/CT for response assessment A prime example of quantitative imag-ing that combines the functional metabolic sensitivity of PET and the temporal and spatial resolution of CT is PET/CT imaging. Applications of PET/CT imaging have become a standard response assessment tool for many cancer sites, and further more, in initial diagnosis and staging. A key advantage of PET/CT imaging is its ability to evaluate treatment response through quantitative assessment, measurement, and understanding of the metabolic activity in a tumour. In addition, changes in the tumour volume that may or may not corre-late with outcome can be viewed with knowledge of the associated meta-bolic changes. Its clinical impact and

The increased utilisation of functional imaging and in particular PET/CT for

cancer is driving both the development of improved

tools for application as well as the study of optimal

protocols.

meDiCal sCienCes


EVALuATIOn Of RESPOnSE In LunG CAnCER

Figure 2: Lung cancer response:A, before and B, 1 month after radiation therapy with good response.

Figure 8: Melanoma patient:A, pretreatment; BandC, 1 and 4 months post radiation therapy

with good response.

MELAnOMA

GYnAECOLOGIC CAnCERSa. Cervix cancer

Figure 6: Cervix cancer A, before and B, 4 months after chemoradiation with good response.

Figure 7: Vaginal cancer: A, at diagnosis; B, response to treatment at 2 months of therapy; C, recurrence 7 months after complete response.

b. Vaginal cancer

meDiCal sCienCes


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Markus VanTol is a graduate student in engineering working to create meaningful, user-friendly semi-automated methods for analysis of quantitative imaging.

Sagar Patel is a second year Resident Physician in Radiation Oncology at the University of Iowa Hospitals and Clinics. He has a strong interest in clinical research and public policy along with global health initiatives. He majored in Classics and Economics as an undergraduate at Brown University.

Reinhard Beichel is an Associate Professor of Electrical and Computer Engineering and Internal Medicine at the University of Iowa and works on development of computer based algorithms and methods for analysis of quantitative and anatomic images.

With a clinical emphasis on gastro-intestinal and gynecological cancers, Sudershan Bhatia’s practice at the University of Iowa Hospitals and Clinics specialises in the use of high-dose rate (HDR) brachytherapy. His published use of 3T MRI imaging for HDR brachytherapy is gaining acceptance as a novel imaging modality.

John Buatti is the Chairman of Radiation Oncology at the University of Iowa Hospitals and Clinics. His innovation in implementing im-age-guided radiation therapy informs daily clinical practice where Stereotactic, PET/CT, MR and 4-D imaging are routinely used. A dedication to adopting standardised imaging modalities drives his research into quantitative imaging.

there is no standardised criteria and means to quantify the exact treatment response and its clinical implications in a reproducible, automated, and cost-effective manner. Appropriate patient preparation, image acquisition, data transfer, and post-processing data analysis are necessary components in order to develop a robust approach in the measurement and assessment of treatment response with PET/CT imaging. There is also a need for automated, objective, quantitative metrics to differentiate true tumour cell killing from other physiologic changes such as inflammation, infection, cell injury, fibrosis, etc. As described above, a potential quantitative measurement of early treatment induced changes and post-treatment response is the SUV. The determination of SUV is dependent on identical patient preparation and adequate scan quality that is similar between baseline and follow up studies. Furthermore, imaging should be capable of producing exactly the same quantitative measurement for a given uptake on one day versus another and on one scanner versus another. A standardised phantom for absolute calibration of PET/CT scanners has been lacking. Working together through the Quantitative Imaging Network funded by the National Cancer Institute there are now new ways being developed to achieve this endeavour such basic tools for standardisation as well as for automated analysis will be critical in the future application of imaging to clinical trials.

While imaging is expensive today, the cost of delayed determination of treatment efficacy or lack thereof is substantial both in human terms to the individual patient as well as in the economic cost of continued therapy that may be ineffective. The increased utilisation of functional imaging and in particular PET/CT for cancer is driv-ing both the development of improved tools for application as well as the study of optimal protocols for imaging the

response in terms of the timing of scans relative to therapy and the specific agents that are being applied. The combination of possibilities is large and the potential for improvement is great with the promise of a non-invasive way to both predict the best therapy for patients as well as early determina-tion of effectiveness. This will lead to personalised therapies based on these functional image based responses.

ConclusionsFunctional imaging is a critical component in the delivery and management of optimal oncologic healthcare of the individual cancer patient. As the oncologists’ understanding of the complex biology and pathogenesis of cancer improves,

the impact of functional imaging and its many applications will increase and become even more paramount. The future of PET/CT imaging is indeed bright especially in the improved evaluation of treatment response in current oncologic practice. Its potential to become a critical component and biomarker in future clinical trials and the delivery of minimally invasive molecular targeted therapies with the least toxicity and morbidity can both preserve quality of life and decrease cost-expenditures. Increased awareness and heightened research in the standardisation and automation of PET/CT criteria in determining treatment response in cancer are essential and will drive the future of oncology care for patients worldwide.

All references are available at www.asianhhm.com

meDiCal sCienCes


MolECulAR dIAgnoSTICS

Rapid evolution of technologies holds out much promise


Molecular diagnostics comprises a rapidly evolving range of assays for the detection and analysis of nucleic acid sequences and proteins. These enable the detection of pathogens, estimation of viral loads; help with the selection of antibiotic and antiviral therapies, diagnosis of cancer and other diseases and offer prognostic assessments as well as assistance with treatment selection and drug treatment efficacy monitoring. Inappropriate use of molecular technologies is also leading to serious issues with the clinical relevance of many molecular biomarkers in use today. There is an urgent need for standardisation of assay designs, laboratory practices, measurement methods and data management.

Stephen BustinProfessor, Anglia Ruskin University, UK

gemma JohnsonPostgraduate Medical Institute, Faculty of Health Social Care and Education, Anglia Ruskin University, UK

Molecular diagnostics is becoming increasingly important as an essential

tool for the rapid, accurate and cost-effective delivery of safe and effective therapy for many diseases. Its uptake is driven by (i) continuous innovation in underlying technologies, (ii) constant identification of new or improved biomarkers, (iii) steady decrease in associated costs and (iv) increasing automation that enables even complex molecular assays to be performed in a wide range of health care settings. Tests may be relatively unsophisti-cated, such as those used for the detec-tion of pathogen-specific genomic sequences; they may involve the iden-tification of complex disease-associated mutational and epigenetic changes in DNA sequences or differential expres-sion patterns of RNA and proteins or they may allow the identification of a predisposition to a particular disease

or screen for diseases that are present but asymptomatic. The information provided by genomic sequencing is crit-ical for our understanding of the inter-actions that determine an individual’s health at a molecular level and whereas the first draft sequence of the human genome took ten years of world-wide effort and cost in the region of US$2.7 billion, it is now possible to sequence a complete human genome in less than a day at a cost of around US$1,000. This is beginning to allow the identification of every individual's unique molecular characteristics and to apply them to personalised diagnosis, treatment and susceptibility prediction (Figure 1).

However, it is essential that labora-tory methods and procedures are fully validated and verified before their use in clinical testing to ensure that assays are carried to clear standards. Biomar-kers need to be chosen carefully to understand the complex relationship

between predictive and prognostic biomarkers. Furthermore, techno-logical advance has been such that the ability to collect and analyse data has become a major bottleneck, especially with data generated by Next Genera-tion Sequencing (NGS) methods. This requires the development of integrated and dynamic data collection methods that are standardized between science and healthcare. Finally, the regulation of genetic testing, together with ethical considerations within an appropriate legal framework constitutes to chal-lenge society as a whole and must be resolved to ensure the proper future of molecular diagnostics.

MethodsMolecular diagnostics comprises a huge range of technologies ranging from comparatively simple techniques such as the real-time Polymerase Chain Reaction (qPCR) for the quantification

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of nucleic acids to complex technologies such as Mass Spectrometry (MS), which analyses protein-based biomarkers and NGS, which allows the definitive identification of specific nucleic acid sequences. Most assays follow a general workflow that involves some kind of extraction, amplification and final detection steps (Figure 2). In general, Nucleic Acid-based Tests (NATs) are most widely used and encompass a range of amplification technologies and sophisticated detection methods that are readily adaptable for use in the diagnostic laboratory. However, reliance on knowledge of the nucleic acid sequence introduces an important limitation of most NATs (NGS is

the exception). Assay design requires comprehensive information on sequences and sequence variations for targeted cellular targets or pathogens. In their absence, most NATs cannot detect unknown mutations or pathogens. However, as with the human genome, the availability of genome sequences for more than 1,000 bacterial, 3,000 viral and nearly 100 fungal genomes, including representatives of all significant human pathogens, has revolutionised the fields of microbiology and infectious diseases. It permits the increasing penetration of NATs into pathogen diagnosis and genotyping as well as the detection of novel virulence and

antibiotic resistance markers. These developments are entrenching NATs as the benchmark for diagnosis of an ever-increasing range of pathogens, and their use is driving improvements in disease management whilst helping to decrease the costs associated with patient care.PCRPCR is the most widely used technol-ogy in molecular diagnostics, with other techniques such as NGS often relying on its powerful amplification ability to generate target molecules for further investigation. Other NATs are used in molecular diagnostics and their characteristics are discussed else-where. Today qPCR is at the heart of

Figure 1. Molecular diagnostics interrogates the status and interaction of cellular processes and uses this information to identify disease as well as predict the efficacy of treatment.

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throughput testing but also reduces cost and the time taken to complete the assay:

HPV testing provides an excellent •example of the usefulness of PCR-based testing for pathogen screen-ing, which is used to identify HPV subtypes associated with an increased risk of cervical cancerCystic Fibrosis (CF) is a disease with •numerous common mutations in the CF Transmembrane Regulator (CFTR) gene and multiplex PCR is an example of a screening/diagnostic test that helps identify carriers or can be used for foetal CF assessmentDetection of KRAS mutations is •an example of a molecular diagnos-tic test that helps with personalised therapeutic decision-making, since

numerous diagnostic assays, with its potential for quantification enabling assessment of DNA copy number vari-ation, differential RNA expression levels and pathogen load. It can even be combined with disease- or patho-gen-specific antibodies in a method termed ‘proximity ligation assay’, an innovative immunoassay platform that combines the exquisite sensitiv-ity and dynamic range of qPCR with antibody-based detection of proteins and other analytes to quantify protein levels, providing a more sensitive alter-native to conventional ELISAs.

Whereas the original PCR proto-cols assessed individual markers, the trend now is towards testing for multi-ple targets in a single assay (“multi-plex”), which not only allows for high

tumours harbouring mutations in this gene fail to respond to drugs such as Erbitux and Vectibix that target the Epidermal Growth Factor Receptor (EGFR).

Despite its ubiquity, there are several weaknesses to PCR in general and qPCR in particular. First, a high degree of performance variability has been observed between different DNA tests due to poor standardisa-tion of PCR assay designs. Second, the requirement for purified nucleic acids limits the practicality of qPCR in a clinical setting, since it increases the time needed for sample prepara-tion and introduces the likelihood of contamination. qPCR is also sensitive to environmental inhibitors that are concentrated along with target nucleic

Molecular Tool Kit

DNA and / or RNAand / or protein

and / or metabolites

Target amplification

PCR, RT-PCR

Isothermal assays

Ligase chain reaction

Signal amplification

Branched DNA assay

Proximity ligation assay

Sample

Extraction Amplification detection

Whole blood Serum / Plasma Blood Spots Clothing soil Buccal Cells Cultured Cells

Fresh / frozen tissue Archival tissue Cerebrospinal fluid Bronchoalveolar lavage Amniotic Fluid Faeces Urine

Electrophoresis

Sequencing

Hybridisation

Real-Time Fluorescence

Melt Curve

Fluorescence

In Situ Hybridisation

ELISA

MS

Figure 2. A molecular toolkit for diagnostics. Detection and quantification offers the choice of a wide range of target samples, extraction procedures, amplification and detection methods with their individual advantages and disadvantages, some of which are described in the text.

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during sample processing. However, Cepheid’s GeneXpert technology, which uses an integrated microfluidic-based cartridge system to automati-cally extract nucleic acids and carry out multiplex qPCR assays points the way to how these problems are being overcome.

Third, especially important for pathogen detection, the increasingly small volumes assayed may lead to false-negative results because of low patho-gen counts or titers. Consequently, for many diagnostic applications there is no advantage to carrying out PCR reactions in nanolitre volumes, which has the benefit of making the assay workflow less specialised and reliant on expensive instrumentation.

Fourth, since PCR only detects nucleic acids, a positive result offers no conclusive evidence of pathogen viabil-ity or active growth. Hence the detec-tion of an organism’s DNA in a sample does not directly indicate the presence of an active infection and, therefore, can lead to a false-positive result. This is a problem with infectious aspergil-losis, where early initiation of systemic antifungal therapy is compromised by a lack of definitive diagnostic criteria and antibody detection lacks the ultimate sensitivity required to detect pathogens at the earliest stages of infection. More-over, DNA tests are highly susceptible to environmental contamination, since dormant Aspergillus spores are ubiqui-tous. PLA may offer a solution to this challenge, as it offers several advantages over traditional ELISAs, including 10 to 100-fold better sensitivity, broader dynamic range, simpler workflow and faster time to results. By using PLA to detect quantitatively proteins expressed exclusively by actively growing fungi, this assay could provide early confirma-tion of active infection.

A major problem with all PCR-based assays is that the basic protocols, whilst superficially simple, are persist-ently poorly performed. The most egre-gious example of the misuse of PCR

technology is illustrated by the publica-tion of seriously flawed data purporting to show the presence of measles virus in the intestinal epithelium of autistic children 30. Three recent surveys of the qPCR-based literature suggest that a very high percentage of these publi-cations are likely to contain biologi-cally or clinically meaningless results, a situation that probably explains the many discordant results found in the peer-reviewed literature. This is due to variable pre-assay conditions, absent quality controls, poor assay design and incorrect data analysis. In addition, the problem of published data that are often inconsistent, inaccurate and wrong is exacerbated by a lack of transparency of reporting, with the details of technical information inadequate for the purpose of assessing the validity of published qPCR data. Undoubtedly this is in part responsible for the lack of progress in many areas that rely on accurate analy-sis of gene expression profiles and the resultant translation to clinical tests.

The MIQE (minimum information for the publication of quantitative real-time PCR) guidelines were published in 2009 with the twin aims of providing a blueprint for good real-time quan-titative Polymerase Chain Reaction (qPCR) assay design and encouraging the comprehensive reporting of qPCR

protocols. MIQE represents a major milestone in the transformation of the qPCR into a reliable technology fit for purpose as a diagnostic technique and has been augmented by complementary guidelines for digital PCR. Unfortu-nately, inadequate qPCR-based publica-tions continue to appear, adding to the vast numbers already published, which report contradictory and not reproduc-ible data, without any obvious criteria to distinguish a genuine result from a technical artifact.BiochipsMicrochips, often referred to as “biochips”, are arrays of immobilised biomolecules that allow rapid analysis and sequencing of DNA and detec-tion of RNA as well as of proteins. For DNA microarrays, thousands of spots are arrayed in orderly rows and columns on a solid surface (usually glass). Each spot contains multiple identical strands of DNA, with the DNA sequence on each spot being unique and represent-ing one gene.The precise location and sequence of each spot is recorded in a computer database. In addition to the biochips, this technology requires instruments to handle the samples, read the reported molecules and analyse the resulting wealth of data. They allow massively parallel analysis of many target molecules in many samples, allowing the identification of disease-associated mutations or mRNA/miRNA expres-sion patterns.

In general, DNA-targeting approaches are sufficiently robust and reliable for the American College of Medical Genetics (ACMG) to recom-mend the use of microarrays as the first-tier diagnostic test in postnatal cytogenet-ics for detecting Copy Number Variants (CNVs) associated with intellectual disa-bility, developmental delay, and dysmor-phicfeatures.Illumina have developed their MiSeqDx Cystic Fibrosis System, which can detect 139 clinically relevant CFTR variants and identifies all variants in the protein coding regions and intron/exon boundaries of CFTR.

Molecular diagnostics comprises a huge range of technologies ranging

from comparatively simple techniques such as the real-time Polymerase

Chain Reaction (qPCR) for the quantification of

nucleic acids to complex technologies such as Mass

Spectrometry (MS).

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Au

th

or

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Stephen Bustin obtained his PhD in molecular genetics from Trinity College, University of Dublin. He was previously Professor of Molecular Science at Queen Mary, University of London and he was also visiting Professor of Molecular Biology at the University of Middlesex. His research group’s general areas of interest are molecular diagnostics and bowel-associated pathologies.

gemma Johnson has a BA and MA in Genetics from the University of Cambridge (2004). She is an experienced researcher, having developed and validated molecular pathogen detection methods at Barts Health NHS Trust (2005-2010) and Queen Mary University of London (2010-present). Gemma is currently completing a PhD in diagnostic tool development for invasive fungal infections.

In contrast, although cDNA microarray-based results are claimed to be comparable across multiple labora-tories, problems of platform compat-ibility, standardisation and data analy-sis remain and have contributed to the publication of numerous discordant results.

Whole transcriptome shotgun sequencing (“RNA-Seq”), which offers an alternative approach for high-throughput transcriptome analysis and is used to calculate the prevalence of transcripts, provides new possibilities for biomarker identification. However, it relies on the enzymatic conversion of RNA into DNA (‘reverse transcrip-tion’), which is known to be variable and can distort quantitative results. Reliable application of this technol-ogy will require not just improvements in sample preparation and sequencing methods, but a more thorough under-standing of the limitations of the RT step in quantitative analysis. In addi-tion, clinical NGS testing will place significant demands on laboratory infrastructure, as it requires invest-ment in extensive instrumentation as well as bioinformatics expertise if it is to transfer successfully into clinical practice.

Mass spectrometryMS is used in molecular diagnostics as a high specificity tool for identifying and quantifying disease associated mole-cules and proteins. There are different types of MS in use, most commonly Liquid Chromatography (LC-MS), Gas Chromatography (GC-MS), and Matrix-Assisted Laser Desorption/Ionization/Time-Of-Flight (MALDI-TOF MS). MS technology can be used for a wide range of applications that include diagnosis of viral infec-tions, disease screening, diagnosis, detection of metabolic disorders and therapeutic monitoring. The main challenges to a more widespread adop-tion of this technology lie in complex sample preparation procedures, instru-

ment-specific molecule databases, labo-ratory information system interfacing and inter-instruments standardisation.

Fluorescence In Situ Hybridization (FISH)FISH is a well-established technique that has traditionally been used to detect specific DNA sequences on chro-mosomes and is now widely used for the diagnosis, prognosis and therapeutic monitoring of cancer. One of the most exciting new developments in FISH is termed Stellaris, which allows simulta-neous detection, localisation and quan-tification of individual RNA molecules at the sub-cellular level in fixed samples using wide field fluorescence micro-scopy. A set of Stellaris FISH Probes comprises multiple oligonucleotides with different sequences each with a fluorescent label that collectively bind along the same target transcript to produce a punctate signal. The Stellaris technology uses a simple protocol with standard reagents and is inexpensive and platform-independent. Its ability to quantify accurately very low copy number targets, together with improve-ments to the hybridization protocols that speed up the time taken to complete the assay, makes it a useful candidate for the detection of disease-associated tran-scripts and splice variants, for example those expressed by micrometastases. ConclusionsIncreased throughput, development of nanotechnology and the introduc-

tion of Point of Care (POC) devices are confirming molecular diagnostics as a transformative procedure. With molecular techniques increasingly moving from research laboratories into mainstream clinical applications, they are being translated into methods for helping health workers improve clinical outcomes for their patients. This proc-ess is still very much in its infancy and the combination of increased under-standing of the biological mechanisms underlying disease with the rapid evolution of molecular technologies holds out much promise for the future of molecular diagnostics. The future is likely to see the establishment of new disease/gene associations, widespread use of personalised therapy and the introduction of predictive tests, open-ing the path to prevention of some diseases. However, accurate diagnos-tics requires the validation of clinically relevant biomarkers, sound methodol-ogies, reliable methods and transparent reporting of research results and clini-cal trials. Unfortunately, this is an area that poses significant challenges, but is widely ignored. Finally, there remain concerns about regulatory and ethical considerations being able to keep up with the relentless pace of innovation, requiring informed input from a wide range of stakeholders, most of which have only the vaguest understanding of the challenges associated with this area.

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All references are available at www.asianhhm.com


Vela DiagnosticsThe power of standarized versatility

Vela Diagnostics is a worldwide supplier of integrated molecular diagnostics workflows that address individual testing needs. Established in 2011 with its global headquarters in Singapore, Vela Diagnostics provides innovative test and data reporting solutions for Real-Time PCR and Next-Generation Sequencing.

As a one-stop provider for an entire workflow, from instruments and reagents to software and consumables, Vela Diagnostics develops assays for clinical and research use, compliant with local regulatory frameworks.

Sentosa® instruments are the automation platforms which Vela Diagnostics offers for qPCR and NGS applications. Sentosa® SX101 is the front-end product and common denominator for both workflows, capable of lysis, extraction and PCRset-up for qPCR as well as library preparation for NGS. Automated PCR set-up reduces manual and tedious pipetting of reagents and thereby minimizing human error. This also reduces CAPEX and redundancy in the laboratories. Vela Diagnostics has assays validated on the Rotor-Gene® Q instrument for qPCR and Sentosa® SQ301 for downstream NGS.

Vela Diagnostics covers nine disease areas: Bloodborne Viruses, Gastroenteritis, Leukemia, Immunosuppression, Microbiology, Oncology,

Respiratory Infections, STD and Tropical Infections. For more details, please visit www.veladx.com.

The entire Sentosa® workflow is managed on Sentosa® Link, which provides IT interfaced connectivity that aids in sample traceability. The workflow ends with Sentosa® SA Reporter and SQ Reporter, respectively for qPCR and NGS automated result analysis. This reduces the need for clinicians and lab management to analyze individual sample result. The ability to link up the customer’s LIS/LIMS with Sentosa® Link enables the download of sample IDs to the workflow and the upload of results back to the LIS/LIMS.

The open-channel capability of Sentosa®

instruments also provides different customer segments with the ability to adapt their own homebrews or LTDs.

The unique ability to leverage both qPCR and NGS solutions to test for infectious diseases and oncologic targets answers current diagnostic questions and enables laboratories to meet tomorrow’s complex diagnostic challenges. Reliable and multi-purpose instruments help reduce the cost for optimal efficiency across laboratories of all sizes. With scalability and open-channel capabilities, laboratories also benefit from the flexibility and versatility of the systems available. Regulatory status of products is based on regional availability.

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THE POWER OF STANDARDIZED VERSATILITYVela Diagnostics is a worldwide supplier of integrated molecular diagnostics work�ows that address indi-vidual testing needs. Established in 2011 with its global headquarters in Singapore, Vela Diagnostics pro-vides innovative test and data reporting solutions for real-time PCR and Next-Generation Sequencing. The unique ability to leverage both qPCR and NGS solutions to test for infectious diseases and oncologic targets answers current diagnostic questions and enables laboratories to meet tomorrow’s complex diagnostic challenges. Reliable and multi-purpose instruments help reduce the cost for optimal e�ciency across labo-ratories of all sizes. With scalability and open-channel capabilities, laboratories also bene�t from the �exibil-ity and versatility of the systems available. Regulatory status of products is based on regional availability.

www.veladx.com


This article summarises the recent trend in healthcare design of using Lean-inspired rapid prototyping to develop, refine and evaluate clinical processes and space allocation very early in the design process. The article presents a brief description of the Lean philosophy, a description of the rapid prototyping process, steps to conducting a rapid prototyping event, typical outcomes of an event and, finally, recommendations for conducting a successful rapid prototyping event.

Joyce durham, Senior Partner, Executive Vice President, Global Health Service Network (GHSN), USA

The term Lean refers to a management strategy that, simply, creates value by eliminating waste. Although the Lean management concept is most closely associated with Japanese manufactur-ing, particularly, the Toyota Produc-tions System, it has been extensively applied to healthcare in the last decade.

lean Rapid PrototypingImproving healthcare design

There is a new Lean-inspired trend in healthcare planning in which planners, design profes-

sionals, and care providers can be seen moving cardboard walls around in large warehouse-type spaces to simulate high-intensity healthcare areas such as the emergency department, surgical suite,

oran imaging center. These groups are most likely participating in a rapid prototyping event designed to quickly test, communicate and evaluate opera-tional and facility solutions.

To understand rapid prototyping, a Lean tool, it is important to have a basic understanding of the Lean philosophy.

faCilities & operations management

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Experts estimate that 30 to 40 per cent of healthcare production is waste and rapid prototyping is one of the Lean tools that can assist organisations in streamlining operations and removing waste during the planning of a renova-tion or replacement project.

In manufacturing, rapid prototyp-ing has been used extensively to quickly test one’s understanding of a problem and new ideas. But, most importantly, rapid prototyping is a way to commu-nicate thoughts, options, and potential solutions with others. Historically, in healthcare design, mock-ups or proto-types of rooms were developed after the design of the room had been completed. Then, users had input into the final details of the room such location of the clock and supply cabinetry. Rapid prototyping is different. It is a process being used to provide users input into the earliest room concepts and depart-mental layout thereby, allowing them to challenge the way care is delivered by quickly exploring alternate approaches. As a result, organisations are investing in full-scale prototyping of a proposed area to carefully test patient flow, streamline operations, and optimise the allocation of resources, in particular, space and equipment.

A rapid prototyping process is the opposite of the change process, common to healthcare, in which multi-ple discussions occur and, then, there is a prolonged review and approval proc-ess. Often, initial design decisions are made based on existing facilities or in essence, the status quo. Therefore, clini-cians have limited input in the funda-mental decisions related to how care is delivered. Rapid prototyping addresses both of these issues; it allows clinicians to rapidly test care delivery options and develop recommendations to improve the delivery of care.

The rapid prototyping processThe first step in the rapid prototyping process is determining if it is the right process. Rapid prototyping is expensive

in terms of professional’s time, rental or acquisition of space, and participant’s amenities (e.g., transportation, food and drink, etc.). This article focuses on full-scale rapid prototyping, which is obviously more expensive than partial scale, or virtual prototyping. There-fore, careful thought must be given to how full-scale rapid prototyping is used. Typically, it may not be of much value for low intensity clinical or office space but it is very productive for high intensity, high cost departments such as surgery, the emergency department, obstetrics and imaging where careful study of operations can improve patient flow, reduce staffing costs and minimise space requirements.

Rapid prototyping events involve a cross-functional team, led by facilitators trained in Lean principles, who come together to solve a problem or improve a process. Participants do not need a detailed knowledge of all relevant clini-cal processes and, in fact, sometimes a limited knowledge of the processes will make a participant more open to questioning the status quo. Therefore, careful consideration must be given to participants. Suggested criteria includes knowledge of some component of

the process, interest in improving the delivery of care, openness to change, and a willingness to commit the neces-sary time to the event. Facility plan-ners, designers, and engineers may be included on the teams but must have an equal commitment to exploring new ideas.

In organising the event, the materi-als the teams work with should be:Inexpensive:• allows participants to tear apart and recreate solutions with-out concern for cost; typical materials for the event include cardboard, duct tape, markers and other similar mate-rialsQuick:• materials must allow partici-pants to quickly test ideas, evaluate them, and, then, proceed to the next iteration; a large open space with a common shared area for materials works bestMinimal:• utilising simple, mini-mal components will facilitate the thought process and rapid iterations; tables can be used for beds, boxes can be used for sinks, etc.Testable:• providing minimal but real-istic materials will allow patients to lie in a simulated bed, use cardboard walls to understand the size of a room,

A phone made of inexpensive materials and taped to a cardboard wall during a rapid prototyping event.



or tape a box to the wall to determine the optimal height of a sinkMeasurable:• quantifying findings is essential for participants must to document their recommendations (e.g., square footage of a room, loca-tion of equipment, etc.); therefore, participants will need tape measures, flip charts, cameras, or similar equip-ment

The process, whether in a parking lot or in a warehouse, is similar. Typi-cally, to initiate an event, participants meet as a group and are oriented to the

rapid prototyping process and the goals of the particular event. It is important to emphasize to participants that a final finished room design is not the goal of the event. Rather, small incremental changes achieved through an iterative process (e.g. location of the stretcher, height of a charting station, solution to storage of patient belongings, etc.) are valuable findings.

Then, participants are directed to the rapid prototyping area where they will use cardboard walls and various pieces of real or simulated equipment to conduct

small rapid experiments to determine the optimal processes and required organisa-tion of the space. Typically, in facility-oriented rapid prototyping events, a clinician and facility planning profes-sional are asked to lead each team. These individuals are oriented to the Lean philosophy and group facilitation tech-niques prior to the event.

Typically, teams are instructed to:Observeprocessesandcollectdata• , which can occur prior to the event or be gathered by simulating processesBrainstorm• opportunities to improve the process through discus-sion or, preferably, by acting out scenariosSetgoals• for what the group would like to achieve (e.g. faster patient throughput, less movement of patients, fewer staff steps, etc.)Start testing options• quickly but making sure findings and results are recordedExperimentandrefinechanges• for the preferred approachStandardise the process• by testing it for different types of patients and situationsPresent the findings• to the other groups and document comments and suggestionsCelebrate success• possibly with a snack break or photograph of the team and their solution.

Obviously, this approach will vary with the situation but, most importantly, the group should drive the prototyping process. At a recent rapid prototyping event, four groups of participants were asked to rapidly prototype a similar space. Each group approached the problem a little differently but there were many similarities:

Most groups started with role playing •and assigned each member of the group a role (e.g. patient, family member, physician, nurse, housekeeper, etc.)Half the groups mocked-up the space •similar to an existing room and worked on ways to improve it; the other half A rapid prototyping team begins to define the process.



started from scratch and designed an optimal spaceThe groups actively listened to one •another and, often, demonstrated activities (e.g. starting an IV, assisting a patient out of bed, etc.) to ensure all team members had a common under-standing of processes.

After a 90-minute prototyping session, the groups came together and shared their findings, as well as, issues that remained unresolved. Although many of the findings were similar, many varied and there were several outstanding issues. All of the groups were eager to start a second session to further refine their solution and address the outstanding issues.

In the reporting sessions, some of the insightful comments made by group members were:

I have designed a room like this many •times but never really knew what nurses doOur room has everything and will be •too expensive, but, now, we can go back and prioritiseMuch of this equipment is unneces-•sary so, why is it in the roomThis is duplicative, why are we moving •a patient from here to there?

From a facility planning perspec-tive, experience with this type of event has shown that prototyped rooms rarely significantly exceed the current typical

size of a similar room or area. Without specific direction, but consistent with the Lean philosophy, most groups seek to minimise the space allocation and optimise the use of the space.

At the completion of a rapid proto-typing event, the value of the event becomes clear: it is an effective way to engage clinicians and facility planners in developing specific operational and facility recommendations in a short timeframe. Participants often find the meaningful dialogue between clinicians and facility planners to be the most valuable take-away from the event.

Why rapid prototyping worksRapid prototyping involves taking a group of clinicians and facility planners away from their work for a significant amount of time so many are cautious about utilising this process without understanding why it has received such positive reviews. The primary reason is that it leads to learning as defined by the Lean philosophy:

Experts estimate that 30 to 40 per cent of healthcare production

is waste and rapid prototyping is one of the Lean tools that can

assist organisations in streamlining operations and removing waste

during the planning of a renovation or replacement project.

An initial layout of the space prior to testing alternatives.


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Learning results from experimentation •and making mistakesLearning occurs through small, incre-•mental changesLearners cannot be afraid to try new •thingsPeople learn best and remember when •solving problems

It is easy to see how rapid prototyp-ing reflects these principles and results in a meaningful learning experience.

Integrating patients and familiesFortunately, patients and their families have not been forgotten in this proc-ess. Most organisations using rapid prototyping to find a way to integrate patient and family feedback into the process. Patient and family input may be incorporated:At the beginning of the processPatients and families may be invited to share their healthcare experience with the group prior to beginning the actual prototyping. In Lean terminology, asking patients and families to share their experience allows the customer to define value, which, in turn, will provide valuable input into the proto-typing process.During the processHaving patients and families partici-pate in the prototyping process has been used but detailed staff discussions of processes may not be of interest to patients; therefore, there should be careful consideration of their time if this approach is used.After the processPatients and families may be invited to review the prototype and provide input. This is particularly appropriate if they have defined what they consider value and can see how it has been incorpo-rated into the prototype.

Keys for conducting a successful rapid prototyping eventAs one might imagine, considerable time and thought are required for organising a rapid prototyping event. Key recom-mendations for conducting a successful event include:

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Joyce durham is a Senior Partner and Executive Vice President at Global Health Service Network (GHSN), an international health services development and management firm. Ms Durham’s unique background as both a registered nurse and registered architect has supported her 25-year career in healthcare operations and facility planning. In her current role, she focuses on the development of efficient, affordable and sustainable healthcare facilities in countries with emerging economies.

Invest in planningSpend the necessary time to develop a detailed agenda, find the appropriate space, and assemble the needed mate-rials. A well-organised and orchestrated event will show respect for the clinician’s and design professional’s time.Pay attention to peopleInvite the right people; participants that are interested, want to contribute, and are eager to learn. Because participants will be from many different disciplines, allow time for participants to introduce and sharing something about them-selves during the orientation session. Team facilitators should make sure all members are participating and being heard.Be hospitableMost rapid prototyping events occur away form the workplace in a ware-house or large conference room so consideration should be given to the comfort needs of the participants such as transportation, food and drink, restrooms etc.

Provide feedback

Participants will want to feel that what they did and the time they invested mattered. Therefore, findings from the event should be documented and shared will all participants along with a note thanking them for their participation and time.Start smallGiven the complexity of a major rapid prototyping event, an organisation should consider starting with a small event to refine the processes and, then, gradually, expand the scope.

ConclusionAs the Lean philosophy has moved into healthcare arena, many of the Lean tools are being tailored for use in healthcare facility planning. Recently, a process for full-scale rapid prototyping of high intensity clini-cal areas has become a frequent tool in early facility planning. Although historically, mock-ups have been used to refine designs in healthcare, rapid prototyping is now being used in the early stages of planning as a tool to understand patient flow, streamline work processes, and optimise the space utilisation. And, early experi-ence is showing that this Lean-driven learning process provides signifi-cant benefits to the facility planning process and has been enthusiastically received by clinicians and healthcare facility planning professionals. Look-ing toward the future, it is hoped that findings from these events will be shared so they can be used as a basis for on-going improvements in clinical processes and facility design.

Rapid prototyping events involve a cross-functional team, led by facilitators

trained in Lean principles, who come together to solve

a problem or improve a process.



Lean planning and design goes beyond traditional design by gaining the voice of the customer and involving the customer in actual design development. A successful Lean Design project requires strategic pre-planning to choose the right team members, design the process and provide tools to envision the new work environment.

Jennie-Mae Evans, Vice President, HKS, USASherry Valentine, Director, Center of Operational Excellence, Akron Children, USA

lean Team EngagementFive key aspects for a successful project



Healthcare facility design is evolving to use lean principles in more phases of the design

process. To date, the majority of the lean principles and tools have been used during the construction process which has demonstrated to reduce waste in the schedule and save the owner money. When Akron Children’s Hospital recog-nised the need for additional critical care beds and emergency department rooms, the decision was made to integrate the latest lean principles in the pre-design stage. Using lean principles in pre-design required the skill set of the hospital’s operational excellence Lean Six Sigma team. It also required hiring a design team for their understanding of lean principles and the need to include the voice of the customer in the early phases of design. This article provides the five key elements of preparing for lean opera-tional planning in the building design process. This method will break down the steps your hospital team will be taking during a lean design effort.

The focusAkron Children’s Hospital (Akron) is one of the largest paediatric facilities in Ohio and cares for more than 600,000 children annually, including over 60,000 children in the emergency department and 1,800 neonatal intensive care admis-sions. With that volume, the emergency department had outgrown its facilities and the model of four-patient pods in the NICUs needed to be updated. In 2011, Akron recognised the need fora new patient tower to include additional and updated critical care space to match the trend of single patient rooms.

In 2008, Akron developed a new department dedicated to continuous improvement and operational excellence using Lean Six Sigma methodology. Akron leadership viewed lean methodology as a perfect match to create the vision to plan this new patient care tower. Lean activities seek to drive out waste in several forms including defects, overproduction,

waiting, non-utilisation of employee skills, transportation, inventory, motion and excessive processing waste all with the intent of providing value to the end-user or customer.The primary principles of lean include:

Identify what creates value in the eyes 1. of the customerIdentify the steps in the process and 2. look to eliminate the wasteCreate value by adding steps that 3. enhance the value for the customerCreate flow by the pull from the 4. customerContinuous, ongoing improvement5.

1. The Customer

Determining the right mix of people for a design team is a challenge for any hospi-tal leader. Design is a long and demand-ing effort and requires early adopters, cheerleaders, communicators and influ-encers. Leadership needs to look at the cross section of the team and consider a mix of formal and informal leaders along with introverts and extroverts. It is important to create a culture that gives the team the opportunity to develop and grow with the project.

The philosophy of lean depends on the voice of the customer to successfully meet the customer’s needs



and expectations. In facility design there are multiple customers who all add equal value to the project. Patients and families provide their perspective and expectations of the facility, and it is equally important to hear the voice of the physicians, nurses and ancillary staff including pharmacy, lab, rehabilitation, social workers and case managers who will be working within the space. Materials management, security and environmental service staff, who bring supplies, maintain and protect the space, also need involvement so they can work through their processes in support of the new space.

Although the design team can become large very quickly, it is impor-tant to bring key stakeholders in at the right time. Design process events must be coordinated with busy providers and tight staffing schedules. Akron scheduled design events three months in advance

to optimise the availability and partici-pation of medical staff. Even with the best planning, emergencies arise making flexibility important. Working with a surgeon’s office staff to be sure he or she is available when their specific operat-ing room design was being discussed or holding specific equipment or design presentations after office hours are exam-ples of the flexibility required.2. The PreparationPreparation of the clinical team for this work is as important as selecting the right members for the team. Critical to the use of lean concepts is for the team to have a good understanding of lean principles and tools as well as providing a common language for all participants.

For Akron’s new hospital tower project, all design team members were required to attend a 2-day/20-hour Lean Boot Camp. The Boot Camp consisted of both didactic and hands-on learning.

Mindful of the principles of adult learn-ing, the Boot Camp instructors utilised a variety of instructional tools and intro-duced learning by doing activities often during the two eight-hour sessions. Participants were introduced to a mix of lean based Power Point presentations and video clips of actual lean tools in use such as huddles, 5S (lean method of organisation) implementations and visual management examples. Learning by doing was accomplished with the use of games to emphasise the lean concepts of one piece flow, standardisation and the advantages of visual management to create and enhance flow. A common understanding of lean principles and language was developed for the team.

During Boot Camp, a foundation of lean principles and tools were shared and adopted to aid the team in their process improvement activities. The learning in these sessions included the principles of lean related to: the voice of the customer, the eight wastes of healthcare, flows associated with healthcare and respect for people at all levels of the organisa-tion and the construction team. The Boot Camp also included a review and hands-on learning of the lean tools. The tools included fishbone mapping, one piece flow versus batching exercises, value stream mapping and takt time calcula-tion (demand/hours of operation).

The goal of the Lean Boot Camp was to encourage the team to have a true and deep understanding of their current state and to develop the tools and skills needed to transform into the future, ideal state the team envisioned. That future state would be the elimination of the iden-tified wastes most prevalent in facility design including the wastes of motion, transportation and inventory manage-ment and process. The Boot Camp is educational and motivational for the attendees and energises the participants to make changes in their work place.3. The future State Establishing guiding principles and Conditions of Satisfaction (COS) early in the design process is a fundamental

Lean PrinciplesIdentify What Creates Value In The Eyes Of The Customer1. Identify The Steps In The Process And Look To Eliminate The 2. WasteCreate Value By Adding Steps That Enhance The Value For 3. The CustomerCreate Flow By The Pull From The Customer4. Continuous, Ongoing Improvement5.



requirement used throughout the dura-tion of the project. The principles drive decision making, establish priorities, and determine what is in and what is out of the project. COS is a lean term often used to describe what will make the project successful for the team, which included clinicians, design team, consultants and contractors for Akron. The COS are also used to describe overall project success and to establish baseline metrics.

At Akron, the team’s guiding principles were used consistently to determine the best room type adjacencies, the correlation between patient satisfaction and operational process changes and among staff efficiency, elimination of waste and operational processes. For example, the NICU design team adopted a guiding principle that all patient rooms would have an exterior window. Knowing the NICU needed 75 beds based on their volume and length of stay, and knowing the building currently planned did not allow enough parameter space, the architect designed an alternate of the building for the team.

Once the team has been prepared and educated, the design work begins.

The design team, armed with the knowledge and tools of Lean, can now objectively assess their current state. For example, they can identify and meas-ure the waste of hoarding patient care supplies in multiple storage areas around the unit. Using takt time, they can calcu-late how many rooms are actually needed because they have measured the current amount of time the patient occupies the room and the number of patients that enter for care. The team begins to realise that more and bigger is not always better and are able to see the future potential of what their design work can contribute to the patient and staff experience.

Using a blank sheet of paper repre-senting the unit and paper cutouts repre-senting spaces within the unit, the team went through the design process. By doing so, they appreciated the concept of adjacencies and created procedural flow by linking key spaces, thereby, reduc-ing the amount of walking for staff and reducing the time transporting supplies and equipment.

4. The VenueIndividual room mockups have been used as a design tool in building projects for some time. Akron went a step further and used a full-scale department mock up for each department. Patient care scenarios, including family representa-tives, were used to identify adjacencies, space requirements and ease of people and material flow.

Bringing the medical staff, care staff and support staff into this type of design environment can be challenging. For full size mock up design work, the venue is often a warehouse and the space is very foreign to the healthcare staff. Warehouses

5s Sort

Set In Order

Shine

Standardise

Sustain



are large, often cool and use lighting that is much different compared to their daily work unit. Beyond the actual design work, there is a tremendous amount of learning and discussion. Planning must include amenities to keep the team engaged and energetic, including meals and snacks, access to light and outlets for creativity and energy are essential.

Breaks should be short and frequent and include a game or activity that keeps the team fresh. Adequate technology links must be available to attendees in orderto access the hospital for communi-cation needs. In addition, Akron found it beneficial to set up a classroom envi-ronment for team learning, discussion

and facilitation activities during the full scale mock up sessions.5. The Transformation of Plan into Reality

The clinical design team was chosen not only for their clinical expertise, but for their ability to communicate and lead. With design complete, the real work of putting operations in place within the department begins. In his book, ‘Manag-ing Transitions: Making the Most of Change,’ William Bridges says change is situational and easier to plan for than the transition that people go through moving from the current state to the new or future state. Akron, remaining true to lean principles of engaging the

front line worker, implemented a change engagement strategy to ensure transition success.

The nursing director of each depart-ment, along with two to three other nurse leaders, met with an internal organisational effectiveness leader to outline the work to be done. In conjunc-tion with the architectural team, a four-hour work session outlined the mile-stones that needed to be accomplished to fill in the gaps between the current state and the future state. In addition to identifying milestones, a timeline was created with the milestones so all of the work was centralised in one location. This was used by the management team



as well as the unit specific staff to see how the unit’s progress was advancing. Exam-ples of this include the human resources team who reviewed the organisational structure and identified how new job descriptions or positions were required. Another example was identifying the training required for new equipment or technology. Documenting key mile-stones for these decisions and others on a timeline provided the department direc-tor and managers a more detailed work plan which became manageable and streamlined the information overload.

Additional responsibility and expectation for participation on the design team is sharing the information

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BIo Jennie-Mae Evans promotes family-centered care and operation-

ally efficient environments by integrating her healthcare experience into the design process and contributing to evidence based de-sign in the built environment. President of the Nursing Institute of Healthcare Design, Jennie is passionate about improving the envi-ronment of care for patients, families, and providers.

learned with those care team members remaining on the unit. Akron team members were creative in making that connection with their peers. Newslet-ters were developed with photos and plans that could be posted and shared. Town Hall Meetings were held for all shifts to share the activities of the team and to elicit ideas and feedback. Regular communication with all staff members proved to be well worth the time and effort invested because it helped foster excitement and engage-ment within the entire hospital staff.

Mentoring was provided by Akron’s leadership to give all staff the opportunity to address their concerns with the new facility. Some of their concerns included how changes to the private patient room in the NICU would alter workflow, teamwork and their ability to see one another. Providing opportunities for discus-sion gave staff the ability to identify their concerns and allowed manage-ment to strategically address them.

The Value Lean learning and application does not stop with the actual design proc-ess.

The result of lean methods in pre-design efforts provides an environ-ment that is attentive to the patient experience; something every hospital desires to achieve. The innovation achieved as a result of teamwork is phenomenal when the leadership of a hospital decides to invest in its staff. In the book ‘Patients Come Second: Leading Change by Changing the Way You Lead,’ authors Paul Spiegelman and Britt Berrett state that excellent patient care begins with ensuring the culture of care is implemented with employees. Using lean principles in design initiates that culture and brings together a team that recognises their opinion matters and that their employer recognises them as offer-ing value to the patient care environ-ment.

Over the past twenty years, the look of healthcare facilities has under-gone major changes. The once stark walls with minimal family accom-modations have been transformed into a warm, welcoming environment for everyone. Family-centred care has paved the way for families to be welcomed in all areas of the hospital. The family’s participation in the care of the patient has also changed becom-ing both positive and critical for opti-mal patient outcomes. Using lean principles in design creates the envi-ronment and the culture to promote a patient-focused, family-centred care environment. Akron would not have done it any other way.

PATIENT

FAMILY

PROVIDER / STAFF

MEDICATIONS

SUPPLIES

EQUIPMENT

INFORMATION

7fLOWS Of HEALTHCARE



Major Issues and Trends Impacting Health and Hospital Planning, design, Construction, operation and Maintenance



This article serves as a catalyst toward recognising some of the basic issues and trends that will be driving the design of health and hospital facilities in Asia, as well as in other regions of the world.

Ronald l Skaggs, AP and Chairman Emeritus, HKS, USAJoseph g Sprague, Principal and Senior Vice President, HKS, USAgeorge J Mann, Endowed Professor, Health Facilities DesignTexas A&M University, USA

Basic questions such as environ-mental, physical, mental and spiritual health and wellbeing are

often overlooked in the rush to design health and hospital facilities.

AccessIf the public cannot reach a healthcare facility because of its location or lack of infrastructure, it might as well not exist. Easy access by foot, bicycle, scooter and motorcycle, public transportation (buses, jitneys, taxis, vans, trains, ambu-lance), automobile and / or helicopter is vital.

QualityOnce people arrive, there must be a high level of quality and competent care, qualified and available physicians and allied health professionals that are readily available and accessible. Quality care can be measured and compared to national and international norms, aver-age life spans and causes of illness and death.

Alignment of care and expertiseDesigning and building health facilities without thoroughly thinking through the patient population and their health problems. the type of allied profession-als needed, and the type and scope of

health and hospital facilities needed is simply not solving the ‘whole’ problem

Care providers must develop compre-hensive disease-fighting strategies, rather than just constructing new buildings. This requires an understanding of the causes of illness and death in a region of the world and how to prevent, diagnose and treat and rehabilitate people from the effects of these diseases.

Funding, staffing and operating health and hospital facilitiesIn some parts of the world more competi-tion between health networks effectively lowers costs. In other parts of the world, collaboration and cooperative approaches work better in controlling costs. When designing and building health and hospi-tal facilities one must keep in mind that the life cycle project costs over the years dwarf the original construction costs. In some cases, expensive health and hospi-tal facilities have been built and a coun-try has not budgeted for the operating costs, or coordinated and planned the allied health professionals or the proper staffing requirements.

FactsFacts are essential for developing appropriate health facilities. There must be a multi-pronged effort of



pre-programming, research and discussion to determine the most appropriate planning, programming and design of facilities to treat disease. Health initiatives and health facilities should be designed to prevent illness, detect disease early on, treat and then rehabilitate the population.

demographicsTrends in demographic facts and the life expectancy of population sectors have to be determined. Some regional popu-lations are growing at an accelerating rate, while others have a significant aged population and fewer births.

understanding the causes of and prevention of illness and deathDifferent parts of the world face diverse threats to human existence, ranging from water-borne diseases to malaria and chronic diseases; each cause of illness and death requires a unique prevention and treatment approach. Many diseases can be prevented by undertaking proper and appropriate education and environ-mental measures. Numerous areas of the world have built an excellent system of curative care, but much more must

be done to create an equally excellent system of preventive care. Health educa-tion in the home, community at large and particularly in the school systems is vital.

The home and family structureA strong family structure has implica-tions in health education and home care as well as in the design of medical services. The home environment is the most basic and important health facility. There is also the important relationship of health education and school clinics, staffed by qualified allied health profes-sionals. In some parts of the world, entire communities and tribes come to the regional health centre or hospital to visit someone who is ill, for taking care and even cooking for them.

CommunityPeople in the community need to have the knowledge and the incentives for their family and individual to stay healthy. When designing health facili-ties throughout Asia as well as elsewhere around the world, health facility archi-tects must consider climate, culture, reli-gion, traditions, local economics, level of



education and health education and the difference between needs and wants.

Trendsnew channels for continuous careThe widely acknowledged focus on disease prevention and wellness contin-ues to be tremendously important. Non-communicable ailments such as heart disease, stroke and chronic respiratory diseases are becoming more prevalent, and chronic diseases continue to account for many healthcare costs. In response to this, forward-thinking healthcare provid-ers are expanding their services beyond the physical walls of hospitals and clinics. With strong informational and educa-tional components, these services include virtual consultations, remote monitoring

of vital signs, access to online medical records and targeted community health screening events. Crafting better-performing facilities through researchMore than ever, healthcare designers are responsible for crafting environments that provide quantifiable improvements in organisational effectiveness and patient outcomes and satisfaction. A cornerstone of this practice is evidence-based design, characterised by the use and generation of scientific evidence in order to support decision-making for more predictable outcomes. This framework is used to systematically analyse the outcomes of particular types of designs for areas such as patient rooms, nurse stations and surgical suites. An evidence-

based healthcare design should result in demonstrated improvements in the organisation’s clinical outcomes, economic performance, productivity, and/or customer satisfaction.Patient safety

One of the greatest issues in healthcare design and operation is patient safety, and a great amount of evidence demonstrates that planning and design decisions have a direct impact on this. Evidence-based design strategies to reduce safety concerns such as patient falls may include providing handrails, designing flush flooring transi-tions and requiring direct, unobstructed pathways to frequently-used areas such as bathrooms.SustainabilityA hospital building is one of the highest


consumers of energy, and sustainable design is essential in reducing the consumption of natural resources and reducing a facility’s life cycle costs. It is vital that the principles of lean design, lean operations and standardized design be applied to minimise waste of all types.

Impact and opportunities of technologyThe changes that have occurred and will occur due to constantly accelerat-ing rates of technological advances are enormous. These will include changes in:

Communications•Telemedicine•Energy•The potential possibilities of the cell •phone.

Healthcare systems and healthcare networksBecause of the accelerating sophistica-tion of technology and communications, large healthcare systems and healthcare

networks have become possible and manageable. These groups are delivering care to millions. One such system and network in the United States is Kaiser Permanente, which delivers healthcare to 9.1 million people in eight states and the District of Columbia1.

Many of these systems and networks consider the individual and their home the basic health facility. These networks also have community primary care centres, rural primary care centres, regional community health care centres and hospitals, acute care hospitals and major university teaching hospitals. If these networks are managed efficiently there are significant opportunities for cost savings due to possibilities of purchasing health and hospital supplies at lower prices, efficient management of information systems, and the ability to deliver healthcare to more individuals.

Innovations in facility planning and managementHand-in-hand with design, construc-tion and operation there must be quali-

TExAS A&M unIVERSITY'S ‘ARCHITECTuRE fOR HEALTH’ PROGRAMHKS has been an advisory teaching firm to the Texas A&M University's ‘Architecture for Health Program’ since 1972. Together they have collaborated on over 100 health- and hospital-related projects. This collaboration has been of great benefit to the students and the public by linking theory and the practice of architecture on actual case study projects.

Principals of HKS have generously supported the Texas A&M University ‘Architecture for Health’ Program:

Ronald L Skaggs, FAIA and Joseph G •Sprague, FAIA have established an Endowed Chair in ‘Health Facilities Design’Ronald L Skaggs and Sondra Skaggs •have established an Endowed Professorship in ‘Health Facilities Design’Craig Beale and Julie Beale have •established an Endowed Professorship in ‘Health Facilities Design’

Texas A&M University also co-founded, together with the University of Tokyo, - an association of Universities around the world interested in ‘Architecture for Health’ -(GUPHA) Global University Programs in Healthcare Architecture.

Utilising these funds Texas A&M University has also supported the UIA / PHG - International Union of Architects / Public Health Group: http://www.uia-phg.org/

fied innovations in facility management and planning such as Building Informa-tion Modeling and Integrated Project Delivery.

Speciality facilities and / or departmentsCritical care inpatient hospitals will have speciality units for (ICU) Inten-sive Care Units, (CCU) Coronary Care Units, (MICU) Medical Intensive Care Units, (SICU) Surgical Intensive Care Units, recovery rooms, and emergency rooms that require specialised facilities and departments.

Centres of ExcellenceThere is an international trend toward creating national and interna-tional centres of excellence for cancer


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Ronald l Skaggs has been engaged in the design of over 750 health-related institutions, including hospitals, clinics and academic health centres. He currently serves as an Adjunct Faculty Member at Texas A&M University’s College of Architecture. He is immediate past Chancellor of the College of Fellows of the American Institute of Architects, and a former President of the American Institute of Architects, and former President of the AIA Academy of Architecture for Health.

Joseph g Sprague has promoted design excellence within the healthcare industry for more than 40 years, serving as principal and technical advisor on numerous HKS healthcare projects. He is chairman emeritus of the FGI 2014 Guidelines for Design and Construction of Health Care Facilities and president emeritus of the Facility Guidelines Institute. He is also a past President of the AIA Academy of Architecture for Health.

george J Mann has an international reputation as a leader in health facilities design. George is a recognised international thought leader has had extensive international experience in the field of architecture for health through his research, teaching, consulting and practice. He is the former Director of the UIA/PHG (International).

(MD Anderson Cancer Center in Houston, Texas), heart disease (Parkview Heart Institute, Fort Wayne, Indiana) and children's health facilities (Riley Hospital for Children at IU Health in Indianapolis, Indiana). People will travel long geographic distances to receive health care in a centre of excellence.

Medical tourismSoaring costs in some countries is creat-ing a new industry in other countries, i.e. medical tourism. Medical tourism means traveling to another country for medical procedures that can cost much less than in one's own country. There are parts of the world where medi-cal care has become so expensive that people fly from one part of the world to another to receive medical care at a greatly reduced expense.

Advances in researchGenetic research and advances are in their infancy and will play a key role in preventing and predicting disease. New breakthroughs in the early detection of disease, new pharmaceuticals and treat-ment of disease will constantly change

the way health and hospital facilities will need to be designed, built, managed and operated.

ConclusionThe design of appropriate health and health facilities for large populations

requires above all a broad understand-ing of the overall culture, specific health issues and available health profession-als before appropriate facilities can be successfully planned, programmed, designed, built, operated and main-tained.



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Social, Mobile, Analytic and Cloud (SMAC) technologies now enable new business models in healthcare that can decrease costs, improve outcomes and create ubiquitous access. However, the adoption of SMAC requires a radically different culture within Healthcare IT (HIT), one that follows the principles of fast, frequent, frugal failure found in Agile development processes and lean startup approaches to innovation. This article addresses the current state of HIT culture and how we must transform it in order to overcome the challenges we face and achieve our innovative potential.

Christopher Wasden Global Healthcare Innovation Leader, Managing Director, PwC, US

Rana Mehta Executive Director, Healthcare Leader, PwC, India

Shib Pramanik Managing Consultant, PwC, India

Culture of Health Information Technology

Where are we?

Culture When Failure is not an optionFailure of HIT systems can obviously have more devastating consequences than failure in other industries since the results could lead to life threaten-ing consequences or death. This rightly leads to a risk-averse culture. Even in industries where the consequences for failure are not as dramatic, IT leaders still support the running of the business of today in a cautious manner to ensure 99.999 per cent uptime. As a result, the culture is by nature conservative, prefer-ring to only implement systems that are tried and true with Six Sigma levels of quality and precision. (Six Sigma is generally recognised as a standard meth-odology for business process improve-ment.) This forces a type of mindless operational efficiency within HIT to ensure that no matter who performs the function or role you get the same outcome nearly all the time, or in Lean Six Sigma terms, no more than three errors in one million attempts.

of the future business. At its core, we are seeing that the past HIT culture has become a liability in this digital transfor-mation taking place within healthcare. A new culture must emerge that not only enables the use of, but also encourages and supports the experimentation with, SMAC technologies (social, mobile, analytic and cloud), which have trans-formed media, retail, and travel, and created the expectation among consum-ers that healthcare should leverage the same.

So what are the characteristics of the current HIT culture that blocks innova-tion? What should the new culture look like? And, how can HIT leaders create this culture to support their digital trans-formation?

The most powerful tension within all organisations is between running the business of today

and creating the business of tomorrow. This tension is magnified for Informa-tion Technology (IT) professionals. Their organisational identity is tied to the view that ‘failure is not an option,’ since the broader organisation’s current operations are wholly dependent upon IT working all the time in a flawless fashion.

After decades of healthcare lagging in IT innovations found in other indus-tries, healthcare IT (HIT) leaders now find themselves playing catch up, as they make up for massive underinvestment that is straining their capacity to keep the current business running let alone provide the foundations for the creation

information teChnology


For the purposes of this article, we define mindlessness as an activity that is so simple or repetitive it is performed ‘without thought’— one is merely following established standard operat-ing procedures. There is nothing wrong with this type of mindlessness; indeed, you can’t run the business of today with-out it. Mindlessness is the key require-ment to scaling any valuable innovation. While all innovations are born in mind-ful creativity, with conscious intent, they are only scaled through mindless operational excellence. And while most healthcare organisations have been slow to adopt Lean Six Sigma discipline to their operations, just as they have been slow to adopt IT innovations in general, they are now applying this process and reaping performance improvements.

Such a discipline creates a culture that is based on values, beliefs and deeply held assumptions around the ability

to predict with certainty the expected outcome of a process. It limits flexibility, creativity, agility, failure, experimenta-tion, and exploration. It requires historic reporting and a backward looking focus on past performance because it assumes that the future will be similar to the past. It forces the organisation to constantly improve operations in an incremental way, and not through breakthrough or radical innovations. And by doing so it imposes mindless structures and practices to support the organisation that operates at the edge of equilibrium. Normally this level of predictability enables a consist-ent mode of doing business but what if the marketplace is pushing your organi-sation towards the edge of chaos?

SMAC is Creating Chaos, demanding an Innovation CultureIf healthcare organisations were to continue operating in a state near

equilibrium for the foreseeable future, then the current culture based upon a Lean Six Sigma orientation would be all that was necessary to both support the business of today as well as the expected business of tomorrow. The problem is that SMAC has begun to disrupt healthcare and unravel historically stable business models just as it has in most other industries, pushing the healthcare system towards the edge of chaos, far from the stable environment required for Lean Six Sigma. This is because SMAC is now aligning with other areas of healthcare reform that are putting the patient/consumer at the centre of care and empowering them to make more of the decisions, pay for more of their care, and be more responsible for the outcomes. This demands a more mindful culture, the antithesis of that required in stability. These technological forces create powerful tensions within

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the organisation as HIT leaders try and figure out how to enable innovations at the edge of chaos without threatening the current business.

So how can HIT leaders and their organisations become ambidextrous enough to harness these tensions and create a culture that supports both mindlessness and mindfulness?

We have seen many HIT lead-ers address this challenge by creating a new culture, within their organisa-tions, that supports both Lean Six Sigma processes for the day-to-day activities while introducing new struc-tures and practices that support a Lean startup approach.

These ambidextrous leaders do four things to create a more mindful culture that is more tolerant of fast, frequent, frugal failure necessary for innovation and growth.Startup Values must Augment Existing ValuesCulture is defined as the values, beliefs and deeply held assumptions that are embedded in the structure, practices and artifacts of an organisation that drive the behaviours of the people within them. To create a more mind-ful culture, leaders need to embrace new values that are common among startups but rare and even antithetical to large organisations. These include the following:

Flexibility• – people need the ability to spend time not just on their day-to-day job but also on identifying new failures, pain points, and waste that create tensions, which can be eliminated through innovation. This means giving employees the license to spend time on mindful, creative activities as well as continuing to fulfill their roles in their mindless processes. Agility• – exploration of new solu-tions will always lead to learning through failure. The key to this kind of learning is to be agile enough to pivot from preconceived notions and/or hypotheses towards new and

better ones that you believe will be more effective. This requires flexibil-ity in funding and staffing to quickly pivot from one path to a better one. Non-linear thinking• – much of what we do in our mindless processes leads to improvement and incre-mental innovation along an existing linear trajectory. However, the more creative our mindful exploration the less linear it becomes and the more iterative we must be in our approach to discover and invent something valuable and new.Bias for action• – this requires an expectation that you spend less time thinking about what to do and more time doing it and then gathering ethnographic data to test your ideas. Building something and then test-ing it in the real world will tell you more than theorising about its value and benefits.Results-driven• – these real world tests will deliver data that will provide the evidence for failure or success. These results will then be the basis for making your decision to pivot from your current course or perse-vere in the same direction. Sense of urgency• – all of these values are augmented by the passion and energy of the employee to get outside of the current environment and get things done quickly and inexpensively.

Entrepreneurial Mindset and Beliefs Must Be Allowed to SurviveThese Startup Values will lead to beliefs that are common among entre-preneurs but often foreign within larger organisations. These beliefs will lead to different kinds of actions that are typical with HIT.

Emphasis on learning through exploration and experimentation will be viewed as the most important way to learn about new ideas, solutions, offerings, and opportunities.

Failearly, fail cheap will become the mantra of leadership because they understand that without failure there

is no learning. Mindful learning can be done for a fraction of the cost required to support the larger mindless structures and practices.

Selective risk taking will become the focus of leadership that allocates budg-ets for exploration and experimentation. Any investment made will lead to creat-ing a Minimal Viable Product (MVP), which helps test an idea to identify, quantify, and measure risks. The risks of each MVP should be well understood before the next version of an MVP is launched.

Tolerance for failure will be accepted if it brings significant learning. There-fore, employees that embark on creative experiments and exploration will not be penalised when failure occurs.

Passion for business success will be the motivation that drives individuals to take risks and explore and create new innovations. It is not about failure for failure sake, but failure as a means to business success.Innovation Cycle Practices Become the Application of Values and BeliefsThese values and beliefs will support practices that enable a cycle of inno-vation within the HIT organisation. This cycle is based upon the view that innovations are created to remove mala-daptive tensions within an organisa-tion or marketplace that have emerged from pain, waste and failure customers or employees experience with existing solutions.

To enable the practices required to drive the innovation cycle, leadership must apply design thinking and ethnographic research to truly understand the root cause of the failure, waste and pain. Then, it should enable and support exploration and experimentation to create MVPs that test out multiple new incremental, breakthrough or radical innovations that help remove those tensions. These innovation cycle practices will operate more as guidelines that allow for flexibility and agility, rather than as strictly applied standard operating



Most good ideas are in search of the right business model. In Acceleration you iterate towards the best business model that will be appropriate for the final phase, Scaling, which is where it is appropriate to apply Lean Six Sigma principles for success. Crawl, walk, then run to change your cultureWhat we have shared here is a very complete and robust approach to chang-ing the HIT culture and enabling an organisation to become ambidextrous in applying both mindfulness to create the

business of tomorrow and mindlessness to efficiently and effectively run the busi-ness of today. However, no organisation creates and deploys all the required struc-tures and practices necessary to achieve this cultural transformation in one fell swoop. The best have an implementa-tion plan and horizon that enables them to crawl, then walk, and then run. The outline we have provided above paints the picture of where the future culture needs to be, but each organisation must chart its own course to get there.

No CIO can survive in the short-term if they take their eye off the day-to-day operations where failure is not an option. But none will be around in the future if they aren’t able to drive innovation by enabling fast, frequent, frugal failure and the associate values, beliefs and deeply held assumptions to empower new behaviours among its people. As F Scott Fitzgerald said, “the test of first rate intelligence is the abil-ity to hold two opposed ideas in the mind at the same time, and still retain the ability to function.” Today’s CIOs must master this type of ambidexterity and create the culture that enables their employees to do the same.

procedures found in more mindless Lean Six Sigma disciplines. Innovation Lifecycle Structures Support Sustainable Cultural ChangeLeaders that seek to create a new ambi-dextrous culture that combines both mindfulness and mindlessness realise that to make this sustainable means that it can’t be limited to a single appli-cation or schedule. It must be applied consistently across time and the entire innovation lifecycle. We break this lifecycle up into four phases.

The first phase starts with the Discovery of new ideas that originate from anyone or anywhere within and outside the organisation. The ideas must be evaluated, refined, and the best ones selected. We have found in our work with existing HIT organisa-tions that the vast majority of ideas (in many cases 85-90per cent) are merely improvements or incremental innova-tions to existing mindless processes. These can be passed on to the existing operating functions to implement.

However, the rest of the good ideas require a different mindful struc-ture to further develop, de-risk and advance them; this is the role of the second phase of the innovation lifecy-cle, Incubation. During this phase the technical risks are identified, an MVP or successive MVPs are launched to test and remove technical risks and determine if the new idea could actu-ally work.

We have seen that as a rule of thumb, only about one-third of ideas incubated are successful enough to move to the next phase of the lifecy-cle, Acceleration. Here the commer-cial risks are removed by creating vari-ous business models that will require the commercial launch of the offering that will test its effectiveness in all four dimensions of a business model:

Stakeholders: Customer, Channel 1. and Partner Stakeholders Operating Capabilities2. Value Proposition Benefits, and3. Economic Outcomes. 4.

Emphasis on learning through exploration and experimentation will be viewed as the

most important way to learn about new ideas,

solutions, offerings, and opportunities.

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Chris Wasden is a Managing Director at PwC US and the Global Healthcare Innovation Leader. Prior to PwC he led nine startups that include corporate ventures, venture financed startups, incubators, and family-owned businesses. He has also authored over 40 reports and papers on innovation that have outlined his philosophy and approach for successful innovation transformation.

Rana Mehta is PwC India’s Healthcare Leader. With more than 18 years of experience, Mehta has worked with a host of Indian and international healthcare organisations, including over 50 hospitals in South Asia, to deliver services across the entire healthcare value chain and develop customised healthcare solutions to suit their needs within political, socio-economic, geographic and demographic imperatives.

Shib Pramanik focuses on Health Information Technology across the Payer and Provider industry segments. Shib has over 10 years of consulting experience in working with healthcare technology in-cluding ehealth program management, HealthIT solution selection, requirements elicitation, planning and roadmap development and fit-gap assessment of technology solutions to healthcare organiza-tion requirements.

Rana Mehta is PwC India’s Healthcare Leader. With more than 18 years of experience, Mehta has worked with a host of Indian and international healthcare organisations, including over 50 hospitals in South Asia, to deliver services across the entire healthcare value chain and develop customised healthcare solutions to suit their needs within political, socio-economic, geographic and demographic imperatives.

Shib Pramanik focuses on Health Information Technology across the Payer and Provider industry segments. Shib has over 10 years of consulting experience in working with healthcare technology in-cluding ehealth program management, HealthIT solution selection, requirements elicitation, planning and roadmap development and fit-gap assessment of technology solutions to healthcare organiza-tion requirements.



Responding to a convergence of pressures, connected health has experienced a wave of growth that is projected to continue. But if connected health is to become fully integrated into personal health self-management and healthcare delivery, we must commit to interoperability. Connected health technologies can improve the quality and efficiency of clinical care.

Chuck Parker, Executive Director, Continua Health Alliance, USA

Connecting the marketThe vision for connected health is one in which provider-implemented programmes can easily scale to thousands or even millions of patients with seam-less data relay between a variety of devices and systems. Furthermore, in order for healthcare systems to fully enable and participate in consumer-centric health-care delivery, mass market devices and services will need to achieve user-friendly connectivity with hospital EHR systems and a vast array of personal devices and services which consumers may choose to connect in pursuit of their individual health goals. In addition, individuals are beginning to connect their health infor-mation into social networking either for comparisons to friends or to seek out specific medical knowledge. Attaining this vision will necessitate investment in a new kind of healthcare infrastructure: interoperability standards.

Interoperability refers to mutual connectivity between devices, systems and services. Unfortunately, in today’s market vendors can legitimately claim interoperability when their products actually require a great deal

healthcare consumer, there is widespread concern about the ability to contain costs in nations of the Asia Pacific region, particularly those nations experiencing the most rapid population ageing.

Simultaneously, connected health technologies have become available to make healthcare more efficient, effective and accessible, with potential to deliver cost savings over the long term. Perhaps the most predominant examples of connected health in the market today are remote home monitoring programmes implemented by hospitals. These programmes have demonstrated success for managing chronic conditions such as diabetes, asthma/COPD, and congestive heart failure.

At the other end of the spectrum, the consumer mass market is being flooded with mobile health apps and personal health devices that enable consumers to manage their health independently---and they’re responding. Global revenue for consumer medical devices was predicted to reach US$8.2 billion by the end of 2013, according to HIS, with the Asia Pacific region representing a substantial area of growth.

As a response to pressures on healthcare, and amidst mounting evidence that health technolo-

gies can help solve the healthcare crisis, connected health has experienced a wave of growth that is projected to continue.

There’s no doubt that connected health can improve the quality and effi-ciency of clinical care, but if it is to become fully integrated into personal health self-management and healthcare delivery, we must commit to user-friendly interoper-ability standards for devices, services and systems for the individual.

driversHealthcare systems are stressed by the burden of chronic diseases, which account for a majority of deaths globally and have a significant and growing impact on the overall human burden of disease. Lack of access to nutritious foods, sedentary life-style, poor food choices, smoking and the ‘westernisation’ of dietary habits in some nations are contributing to this state of affairs, as well as an unprecedented aging of the global population—which will lead to an even greater demand for healthcare in the future. In the context of the aging

Interoperability StandardsKey to connected health success



of back-end integration that defies the simplicity conveyed in the concept of interoperability. Furthermore, integration can create delays and cost increases, or simply discourage the integration of new products within a network of connected devices and cause further problems when upgrades occur. Authentic interoperability requires minimal implementation and focuses on user-friendliness, a critical characteristic of any technology aiming at widespread use, with a provision for backward compatibility. The solution is to adopt interoperability standards in connected health.

Continua Health Alliance publishes Design Guidelines for plug-and-play (simple, user friendly), end-to-end connectivity of personal connected health devices, systems and services.

‘End-to-end’ refers to connectivity from the device to the hub and on to the elec-tronic record system; and, between the consumer and the healthcare system that includes doctors, caregivers, family and other people in the consumer’s social circle. In December 2013, these Design Guidelines were recognised as a global standard by the United Nations’ Interna-tional Telecommunication Union (ITU), one of three global standards bodies.

When user-friendly interoperabil-ity is achieved, it shifts the value from device integration to data aggregation at both individual and population levels, enabling the capture, storage and analy-sis of health data across a 1-user, novel network created by a single consumer seeking a custom health management solution as well as access to billions of

data points to drive massive public health programming or targeted responses to meaningful sub-populations.

The concept of interoperability standards as a necessary healthcare infra-structure can be likened to the brick-and-mortar infrastructure of a nation’s roads and highways, which function as a fundamental support for commerce as well as the free exchange of ideas that leads to innovation. In this context, it can be said that the connected health market of today is focused on building the cars (devices) rather than the roads. Interoper-ability standards, like a system of roads, are foundational to seamless health data relay and innovation. There’s simply no better way to achieve scale in data access and exchange. Furthermore, investing in interoperability standards will yield

Positive Signs

There are some very early signs that health data generated in the mass market (outside of provider-implemented connected health programs) may become integrated into healthcare IT systems, which also must be accompanied by adoption of interoperability standards. Incorporating patient-collected data into the healthcare system is important because it will promote engagement of patients and physicians in a non-episodic model of care capable of addressing individual as well as population needs.

Partners Healthcare, a leading US healthcare system that serves 325,000 patients at its flagship Brigham & Women’s and Massachusetts General Hospitals together with its affiliated health centres, recently introduced an enhancement to its Longitudinal Medical Records system that makes patient-collected data part of the established clinical workflow. Designed by Partners’ Center for Connected Health, the system incorporates data collected by patients at home and transmitted from a computer or mobile device, including vital signs such as blood pressure, weight, and blood glucose. The user interface is designed to address physicians’ concerns about information overload by providing a simple visual cue within the main page of the patient record when such information is available and making the data accessible with a single click. According to Partners, there’s another reason for optimism: physicians are beginning to recommend their patients use health apps and tracking devices for managing weight loss, exercise or sleep.

Consumer interest in self-tracking is also showing positive signs. For example, as reported by futuregov.asia, a recent

Accenture survey showed that 63 per cent of patients surveyed in Singapore actively track their health. Roughly a third of Singapore consumers indicated they track a component of their health including: health indicators (36 per cent), physical activity (34 per cent), health history (32 per cent) and health symptoms (29 per cent).A 2013 Consumer Electronic Association (CES) survey of Americans found that one-third (33 percent) of mobile device owners had used their devices to track some aspect of their health in the previous 12 months, and 28per cent of those who had used their smartphone to track their health say they shared the information with their health care provider.

Device makers are moving toward products that offer more comprehensive tracking in one device. For example, Vancive’s Metria, a small, disposable chest patch, incorporates measurements of heart and breath rates, steps taken, skin hydration and sleep patterns. Proteus Digital Health gained Food and Drug Administration (FDA) approval for the first ingestible tracking device, which can measure heart rate, activity, rest and medication adherence. The latter application holds obvious interest for chronic disease management, ageing-at-home and drug development.

The industry can expect to see consumer data management platforms, which consolidate and facilitate analysis of data from several devices, as a next iteration in the mass market. If consumer engagement and empowerment are objectives for 21st century healthcare, interoperable platform products or services will have a durable place in the market for self-health management.



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tions of the Alliance. Chuck has over 20 years of experience in healthcare technology, policy, and the strategic design of evalua-tion and measurement strategies. He has led national programs for practice transformation and has served on national committees for assessing adoption requirements.

better returns on healthcare technology investment, since it facilitates the ability to repurpose interoperable devices and add different device types for clinical programme expansion.

Anticipated ImprovementsIf an interoperable ecosystem is achieved, healthcare will become more effective in three major areas: population health management, drug development and most importantly, personalised health-care.

Ubiquitous adoption of interoperabil-ity standards is the key, which will gener-ate new population insights to support enhanced preventive care and enable improved responsiveness to developing trends. Innovation will also result, with the flow of data on a large-scale between diverse sources and geographies spurring novel collaborations.

In drug development, interoperable big data will set off a stream of benefi-cial impacts: more accurate data collec-tion methods which will in turn facilitate faster, smaller, or deeper studies, with potential for decreased cost. One area of clinical research that seems particularly likely to benefit drug manufacturers is improved measures for adherence to ther-apies during trials, which inhibits accurate measures of effectiveness in current drug trials.

If cost decreases can be achieved in technology-enabled trials, trial sponsors may choose to undertake direct studies that lead to the recognition of sub-popula-tions for whom there are clinically signifi-cant difference in drug response, leading to the availability of more targeted thera-pies and the introduction of new clinical diagnostics for personalised medicine. Post-marketing studies or monitoring of individual patients taking a commercially available product may also yield beneficial information about adherence and drug response.

Progress in government Adoption of StandardsGovernment investment and interest in

interoperability and connected health are thankfully increasing. As the world’s predominant healthcare payers, govern-ments have a substantial role to play in helping to realise the vision for interop-erable, consumer-centric healthcare deliv-ery.

Over the past few years, govern-ments—notably in smaller nations—have made several important advancements in connected health. Japan, already a leader in mobile health, announced that it will create one of the world’s most advanced federal IT systems, to include health and wellness. In the US, the FDA formally recognised 25 standards for medical device interoperability that included applications of risk management for IT networks; health informatics related to point-of-care and personal device communication; and system security for industrial communi-cation networks. A senior policy advisor to the initiative said in a post on the FDA Voice blog:

"As medical devices become increas-ingly connected to other medical devices, hospital information systems and elec-tronic health records, there is a growing expectation that they will be interopera-ble--and that the data they transmit will be secure. Making sure devices are inter-operable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can 'plug and play.'"

Additionally, the Policy Committee of the US Office of the National Coordina-tor for Health Information Technology (ONC) announced that it’s considering including patient-generated health data from remote monitoring devices as a potential requirement of US Meaningful Use regulations, which provide incen-tives to healthcare providers for specific

achievements in the use of Electronic Health Records (EHR) systems used to provide care for patients covered by the government funded Medicare and Medicaid programs.

Denmark achieved a global mile-stone for interoperability in 2012, when it adopted Continua Health Alliance’s interoperability Design Guidelines across its healthcare system in 2012, becoming the first nation in the world to do so. Following guidance from the Industry Working Group of the UK’s 3million-lives telehealth campaign, Three Clini-cal Commissioning groups of the UK’s National Health Service also adopted Continua’s Guidelines in issuing their tender for the programme. Singapore’s Health Ministry is also looking toward interoperability standards, and will roll out the guidelines as part of its popu-lation-wide mhealth project, which initially aims to manage cardiovascular and diabetic risk.

Finally, there is new interest in adopt-ing interoperability guidelines for public safety and disaster recovery, where coor-dination of services (or lack thereof) can have life and death consequences.

In ConclusionInterest and investment in personal connected health is on the rise; there are also signs of increased demand for and awareness of interoperability as a critical means of facilitating effective healthcare and sound healthcare technology invest-ment over the long term. But achiev-ing interoperability, and thus enabling attainment of the vision for connected health, will depend upon implementa-tion of interoperability standards that set a high bar for simple, user friendly connectivity from consumer to provider.



Reliable results can only be achieved in urine diagnostics, if correct preanalytical conditions are ensured. Urine collection, specimen transport and further storage are critical influential factors for sample quality and can affect the results. Most important is the

stabilization of urine, if the specimen cannot be analysed within two hours(1). A particular problem is exponential bacterial growth, since certain bacteria divide every 20 minutes. This can lead to an overgrowth of pathogenic bacteria, making detection difficult.

new Stabilizer for urine SpecimensExtensive application opportunities in modern urine diagnostics


Furthermore, the lysis of cells is accelerated in native urine at room temperature, altering the concentration of various analytes constantly.

This problem is essential for longer transportation and processing times. It has been shown, that on average 15 per cent of urine samples intended for urine culture are contaminated(2).

Some additives that may have been used up to now for stabilization have proven not to be optimal, as often the additive does not dissolve quickly or fully.

To provide a practical and satisfactory solution for urine diagnostics, Greiner Bio-One has developed the new VACUETTE® Urine CCM Tube. The evacuated tube contains a stabilizer in powder form, which keeps the urine sample stable for up to 48 hours at 20 – 25°C. During this time period, the urine specimen can be stored or transported without refrigeration.

The analytical performance evaluation of the VACU-ETTE® Urine CCM Tube showed that quick tests, such as the standard urine test strips, can be applied with a few exceptions– leucocytes, erythrocytes and bacte-ria are sufficiently stable. Instrument and visual micro-scopic analysis of the typical formed elements in urine sediment also showed stability for up to 48 hours. All mandatory and facultative uropathogenic bacteria can be stabilized and reliably detected in the VACUETTE® Urine CCM Tube for up to 48 hours. (3, 4, 5).

A particular advantage is the high solubility of the stabi-lizer in powder form. By inverting the tube several times, the urine mixes completely with the stabilizer additive, ensuring quick stabilization of the urine sample.

The VACUETTE® Urine CCM tube can be used for various areas of application. The tube can be used for urine screening (strip test, sediment, clinical chemistry) and/or for microbiol-ogy, since sample stability is guar-anteed for up to 48 hours. The extensive application in urine diagnostics makes daily routine work easier and more efficient: one urine sample for a broad range of determinations. This is not only an advantage for medi-cal staff but also for the patient. Repeat sample collec-tion for replicate tests is not necessary.

The universal application has a positive effect, where applicable, from the logistical point of view, since it is not necessary to store two or more different types of tubes with stabilizers, where applicable.

The VACUETTE® Urine CCM tube with safety cap is user-friendly as it is especially easy to open. This allows for a hygienic operating method, with no risk of splashes or aerosols, as can occur with standard rubber stoppers from competitors. The VACUETTE® Urine CCM tube is made from highly transparent PET plastic and is virtually unbreakable.

After extensive clinical studies, the tube is now about to be launched. The market launch is planned for April this year.

literature:

CLSI. Urinalysis; Approved Guidline – Third Edition. 1. GP16-A3. Vol 29 No 4Berkeris LG Jones BA Walsh MK and Wagar EA: 2. Urin Culture Contamination: A Col-lege of Ameri-can Pathologists Q-Probes Study of 127 Laborato-ries, Arch Pathol Lab Med. 2008 132(6):913-917 Evaluation of VACUETTE® Urine CCM Tubes 3. for Urine Strip Testing. Internal Study from GBO. IN272Evaluation of the VACUETTE® Urine CCM Tubes 4. for Urine Sediment testing on the Sysmex UF-1000i flow cytometer. Internal Study from GBOScott, G. Greiner Bio-One VACUETTE® Urine CCM 5. Tube. White Paper from Iris Diag-nostics.

greiner Bio-one International Ag

Greiner Bio-One is specialised in the development, production and distribution of high quality laboratory products made from plastic. The company is a tech-nological partner for hospitals, laboratories, univer-sities, research institutes and the diagnostic, phar-maceutical and biotechnology industries. Greiner Bio-One consists of four business units: Preanalyt-ics, BioScience, Diagnostics and OEM. Today the company generates a turnover of 364 Mio. Euro. Greiner Bio-One is a member of the Greiner Group based in Kremsmünster (Austria).

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