Hospital Reports Europe – Improving Laboratory Operations and Efficiencies – Cirdan Limited by Global Business Media

SPECIAL REPORT

Improving Laboratory Operations and Efficiencies Where Does the Future of LIS Lie? Behind the Scenes but at the Forefront of Treatment Complex Challenges and Digital Answers The Benefits and Challenges of a Digital Laboratory Information System Selecting the Future for a Clinical Laboratory

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The Future of LIS Security eOrders and eResults Communications Data Mining Capability Good Interoperability Highly Configurable Summary

Behind the Scenes but at the Forefront of Treatment

Publisher Kevin Bell

What NHS and Clinical Laboratories Do Interoperability Between the NHS and Laboratories Challenges Ahead

Business Development Director Marie-Anne Brooks

Complex Challenges and Digital Answers

Editor John Hancock Senior Project Manager Steve Banks Advertising Executives Michael McCarthy Abigail Coombes Production Manager Paul Davies For further information visit: www.globalbusinessmedia.org

The opinions and views expressed in the editorial content in this publication are those of the authors alone and do not necessarily represent the views of any organisation with which they may be associated. Material in advertisements and promotional features may be considered to represent the views of the advertisers and promoters. The views and opinions expressed in this publication do not necessarily express the views of the Publishers or the Editor. While every care has been taken in the preparation of this publication, neither the Publishers nor the Editor are responsible for such opinions and views or for any inaccuracies in the articles. ÂŠ 2018. The entire contents of this publication are protected by copyright. Full details are available from the Publishers. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical photocopying, recording or otherwise, without the prior permission of the copyright owner.

John Hancock, Editor

Camilla Slade, Staff Writer

Improving the Way Things are Done to Improve the Results that are Achieved Regulation and Other Pressures to Change New Technology for Laboratories A Digital Plan for the NHS

The Benefits and Challenges of a Digital Laboratory Information System

Peter Dunwell, Medical Correspondent

Big Data in Healthcare Cyber Security and Clinical Laboratories The Advantages of an Advanced Laboratory Information System Supporting Organisational Changes

Selecting the Future for a Clinical Laboratory

John Hancock, Editor

Key Factors When Selecting a Laboratory Information Management System What Lies Ahead â&#x20AC;&#x201C; The Future for Clinical Laboratories and Laboratory Information Systems

References 14

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SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

Foreword

LINICAL LABORATORIES are an important

that are over 10 years old, creating a major gap

component in the healthcare system. The

between what is needed by LIS and what they deliver.

figures are significant: NHS England conducts

Cirdan has conducted workshops and surveys to

300,000 patient healthcare related tests each

identify the priorities in filling this growing gap.

working day; that adds up to 800 million

The following article considers the clinical laboratory

biochemistry, haematology and other clinical

and the importance of the work undertaken within

tests performed annually or 14 for each person

those facilities. We look at their place in the healthcare

in England and Wales. In fact, 70 per cent of all

system, the growing trend of collaboration, how the

diagnoses made in the NHS involve pathology

systems they use are seen and what the future holds.

- the laboratory analysis of tests. Rising health

Camilla Slade then looks at the processes used in

expectations, an aging population and the growing

laboratories, what drives them and whatâ&#x20AC;&#x2122;s expected

prevalence of chronic and complex conditions as

of them as well as what ideas are now being explored

well as an increase in what is possible mean that

to ensure that clinical laboratories can continue to

laboratories are under huge pressure to deliver

deliver their high quality service into the future.

more results, faster but with no loss of quality:

Peter Dunwellâ&#x20AC;&#x2122;s article focuses on the application

however, in a climate of increased data regulation,

of systems in clinical laboratory processes and the

they are also under pressure to safely keep all

benefits of a powerful digital system, as well as the

the data they generate as well as sharing it for

challenges and responsibilities that accompany

research purposes. The need for better Laboratory

generating and managing big data. Finally, we look

Information Systems (LIS) has never been clearer.

at some ideas that might help when selecting and

This Special Report opens with an article by

implementing a digital LIS plus what the future might

Cirdan Ltd that looks at LIS and how the demand

hold for clinical laboratories and the systems they use.

on clinical laboratories is growing rapidly, while new technologies are placing ever greater requirements on them. It goes on to point out that many healthcare organisations are still using systems

John Hancock Editor

John Hancock, an Editor of Hospital Reports Europe, has worked in healthcare reporting and review for many years. A journalist for more than 25 years, John has written and edited articles, papers and books on a range of medical and management topics. Subjects have included management of long-term conditions, elective and non-elective surgery, wound management, complex health issues, Schizophrenia, health risks of travel, local health management and NHS management.

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SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

Where Does the Future of LIS Lie? Cirdan Ltd

The Future of LIS

Security

Most Laboratory Information Systems (LIS) are no longer fit for purposea, with many healthcare organisations still using systems that are over ten years old. While the software industry has undergone rapid innovation, many of its benefits have not yet made their way into LIS. The pressure on clinical laboratories is increasing rapidly and new technologies are placing new demands on them. This is creating a major gap between what is needed by LIS and what they can deliver. Cirdan has conducted workshops and surveys to identify the priorities in filling this growing gap. Participants were presented with a series of thirty-one factors grouped into overarching themes: referrals, pre-analytical, analytical, postanalytical and other. They were then asked to rate each of these factors as very important, important, somewhat important, or not important. Participants were also given the opportunity to highlight any additional factors they felt should be considered. The graph below shows the significance of the average ratings given to each factor, with the most significant factors being greater than 0 and the least significant factors being less than 0. From the data collected we were able to identify some clear priorities for laboratories.

Security was the highest priority for the laboratory staff. Digital Health Intelligence supports these findings as in its NHS IT leadership survey (2017) 66% of respondents named cyber security as a priority. This is probably not a surprise, following the year when the NHS was hit by cyber-attacks culminating with the Wannacry attackb in May 2017. In the UK, the NHS was particularly badly hit, with around 50 trusts affected by the virus.c A further concern is the pending introduction of the EU General Data Protection Regulation (GDPR), which comes into force in May 2018. When the regulation comes into force, even minor data breaches need to be reported to the relevant authorities and there are heavy sanctions for infringements of the regulations, up to e20M.d The regulations also provide for an individual or a patient’s right to access the data stored about them. Surprisingly, ‘Patient Access’ was scored relatively low in the survey. Moving to a cloud-based system was also rated relatively low priority in the survey. However, more NHS trusts are beginning to see now that the cloud cannot only be trusted with security but that it can help to improve it. Cloud suppliers today, such as Microsoft and Amazon have greater resources and expertise to devote to cyber

FUTURE OF LIS - WEIGHTED AVERAGES

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SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

More NHS trusts are beginning to see now that the cloud cannot only be trusted with security but that it can help to improve it

security than any individual trust. The adoption of cloud has been slow within the NHS so far, but evidence suggests that it is growing as more see its benefits. Tara Athanasiou, Director of Research and Networks at Digital Health Intelligence said: “The take-up of cloud has historically been relatively slow because of the need to win hearts and minds, but as pieces of infrastructure come up for renewal, organizations are now seeing the benefits. From the CIOs I’ve spoken to, we’ll see a tipping point in the next two years. And within the next five years, NHS organizations will be delivering some or all of their infrastructure through the cloud.”e As many laboratories do not have the expertise for cyber security, moving the LIS in the cloud under a managed service contract would be the most cost effective and timely solution. We predict that, as cloud adoption grows throughout the NHS, over the next three years cloud will become of increasing importance to LIS. “ Frankly, I think the LIS space is a shambles and has been a major contributor to the decline of relevance of the clinical lab to clinical care.” Survey Participant

eOrders and eResults Communications The next two priorities that came out in the surveys were electronic Ordering (eOrders) and electronic Results (eResults) reporting functionality. Many laboratories still get some or all of their order requests on paper and manually input the information into the LIS. This is not only timeconsuming but increases the risk of human error. In addition, some laboratories still rely on sending out paper reports to clinicians, either using remote printers or even by FAX. All these practices impact on laboratory efficiency. Order requests on paper and sending out paper reports is a very inefficient way of working. Research has shown a “significant reduction of laboratory specimen labelling errors by implementation of an electronic ordering system”f. Even in laboratories that have started using electronic ordering and reporting, there can still be exceptions, for example, for acute or primary care or in some disciplines such as Anatomic Pathology. The main problem with electronic ordering and resulting is the lack of clear standards. This means having to treat each eOrders and eResults system as a unique bespoke interface, which increases the complexity and hence costs. As laboratories and trusts increasingly adopt hub and spoke models, the individual nature of each interface could involve having to implement and support a myriad of interfaces. To reduce the 4 |WWW.HOSPITALREPORTS.EU

problems, either Electronic Health Record (EHR) or GP software companies need to agree a set of standards towards improved interoperability. Alternatively, laboratories can take control of the interface and include it in their LIS. The onus will then be on EHR and GP software companies to provide better connectivity to the LIS. The latter approach will probably be more efficient in the longer term as the continual change to tests or the addition of new laboratory procedures will involve constant revision of the interface. “A new LIS needs to be able to keep up with

new developments and trends by having updates and upgrades delivered according to a pre-agreed schedule.” Survey Participant

Data Mining Capability The ability to mine data coming from the LIS to visualize and understand trends was another high priority for survey participants. Identifying the trends presented by this data is key to updating knowledge, such as finding ways to spot potential chronic conditions before they become a problem and thus improving patient care. There are many hurdles which need to be overcome to provide effective data mining capabilityg. Most LIS’s collect a great deal of data but the quality needs to be addressed. Too often the data that is collected is limited to only meeting the needs of the management of performance targets i.e. checking turnaround times and collecting audit information. The scope of the data collected needs to be extended, but without adding excessive bureaucracy. Providing better interoperability of the LIS within the healthcare informatics field will help this. Another challenge is presented by data not being held in a single location but spread throughout a series of systems, some of which may even still be on paper records. Traditionally, point of care records are not held by the LIS. To provide a more holistic view, as much of the information as possible should be available to be mined. LIS’s are also not usually known for their ease of extracting information from. This needs to change. It can be readily addressed with modern databases. Greater insights would also be obtained if the data contained in multiple LIS’s could be collated. This will involve better standards within the LIS industry.

Good Interoperability Interoperability is a major challenge for laboratories today and was considered of high importance by our survey participants. The ability for LIS to integrate with other systems is of paramount importance as failure to do so can lead to entire networks of systems not being

SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

As healthcare moves towards becoming more digitized, it is vital that interoperability moves with it to meet expectations for data exchange.

Highly Configurable

able to function. It is, however, an area of active research. Much work has been carried out into providing ways of developing systems which have good interoperability. Health Level Seven (HL7) has been used for over 20 years as a framework to transfer information between healthcare systemsh. This has recently been improved with the new Fast Healthcare Interoperability Resources (FHIR) standardsi. These have built on previous versions of HL7 in an attempt to improve interoperability between legacy systems, mobile devices, and third-party applicationsj. Interoperability is also improved by using better international standards and, although the use of SNOMED CT did not feature as highly in the priorities, it is an important tool in delivering better connectivity between healthcare platforms. “ Important point to consider is that a lot of functionality aspired to may not need to reside in the LIS.” Survey Participant

Improving interoperability allows for patient care to become more co-ordinated, providing better performance and efficiency. It is also important to note that interoperability is more than just the exchange of information, it is also about how that information is used by the systems that receive it. This supports the introduction of service-based architectures in the development of healthcare systems, as the entire network becomes comprised of individual components which operate independently but are linked.

The survey results indicate that having a highly configurable LIS is viewed as being a priority for survey participants. Interestingly however, cost of ownership and having a readily installed system also scored highly. Configuring an LIS is a timeconsuming process and is therefore likely to incur greater costs for the laboratory, both to install and validate. Also, it is likely to limit the ability to keep the system suitably patched and hence secure. Increasing the configuration options of the LIS may also impact on its interoperability. It may be possible to examine where configuration is necessary and strike the balance between the ability of the LIS to be configurable and the other priorities such as the ease of implementation, cost, security or interoperability.

Summary Many observers concur that Laboratory Information Systems are probably the most complex of any healthcare informatics platform. For years, the priority placed on many laboratories has been to cut costs. It is therefore not surprising that laboratories have not invested in newer LIS’s. LIS manufacturers have also failed to provide sufficient investment in upgrading their products and have lagged behind developments occurring in other areas of the health informatics space. This now needs to change; the increasing demands being placed on laboratories and the requirements of Precision Medicine means that laboratories will only be getting busier and more complex. As we look to develop our vision of an ideal LIS, it is important we deliver the priorities first. Cirdan will continue to monitor laboratory priorities and seek to develop our LIS with these in mind. We will be able to explore the topic further and continue to evaluate the space at our annual Pathology Horizons conference.k

References: a https://www.digitalhealth.net/2018/01/pas-and-pathology-the-problem-with-old-systems/ b http://www.bbc.co.uk/news/technology-41753022 c http://www.bj-hc.co.uk/nhs-will-be-hit-more-cyber-attacks d https://www.gdpr.associates/what-is-gdpr/understanding-gdpr-fines/ e https://www.digitalhealth.net/2017/11/cyber-attack-cloud-solution/ f Hill, P.M., Mareiniss, D., Murphy, P., Gardner, H., Hsieh, Y.H., Levy, F. and Kelen, G.D., 2010. Significant reduction of laboratory specimen labelling errors by implementation of an electronic ordering system paired with a bar-code specimen labelling process. Annals of emergency medicine, 56(6), pp.630-636. g https://www.dddmag.com/article/2015/03/big-data-pathology-why-we-arent-there-yet h http://www.hl7.org/ i https://www.digitalhealth.net/2016/09/calling-the-fhir-brigade/ k https://pathologyhorizons.com/ WWW.HOSPITALREPORTS.EU| 5

SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

Behind the Scenes but at the Forefront of Treatment John Hancock, Editor Clinical laboratories make vital contributions to healthcare but what are they and how do they work

The challenge for pathology is to find other ways to promote its wider role in care pathways so that investment made in the lab or at the lab interface is linked to benefits manifested elsewhere

OST OF us, at one time or another, has cause to use a laboratory. Not that we’re all scientists but we’ll probably encounter some health-related issue that requires our clinician to find out what is happening in our body. They’ll conduct tests on us and take samples from us which will go to a pathology laboratory to identify the evidence of what we are carrying in our blood, other bodily fluids and tissue. That is far from all that laboratories in the healthcare sector undertake but it’s the function with which most people will have contact at some time. And, given what happens in clinical laboratories, it’s very clear that they are a vital component in the healthcare system. So, anything that can add to their efficiency and utility must always be welcome.

What NHS and Clinical Laboratories Do “The majority of UK laboratory services are based in NHS hospitals. They provide a comprehensive range of services both to the hospital and to the local primary care sectors.“ That’s how The Clinical Biochemist Reviews’, ‘The Modernisation of Pathology and Laboratory Medicine in the UK: Networking into the Future’1 explains the close relationship between laboratories and the NHS. The Royal College of Pathologists offers a summary of what goes on in a laboratory2, “Pathology is the study of disease and is central to diagnoses made in the NHS. The work of pathologists and scientists is vital for efficient and effective healthcare. Working in hospitals and the community, they are involved in preventing, diagnosing, treating and monitoring diseases to keep people as healthy as possible.” The NHS certainly doesn’t underestimate the importance of lab work in its National Pathology Programme report ‘Digital First’3, “Around 95% of clinical pathways rely on patients having access to efficient, timely and cost effective pathology services. Pathology touches all of our lives, from before we are born to, in many cases, after we die.” You couldn’t say more than that but to further 6 |WWW.HOSPITALREPORTS.EU

emphasise the point, the report continues, “… we rely on pathology to help: diagnose our illnesses; screen us for congenital diseases, cancer and other conditions and monitor the progress of disease and manage our therapies.” and then, getting to the nub of this paper, “The challenge for pathology is to find other ways to promote its wider role in care pathways so that investment made in the lab or at the lab interface is linked to benefits manifested elsewhere.” Cancer Research UK4 offers a practical example, “Pathology also plays a key role in screening for cancer; identifying early changes in cells that indicate that cancer may develop later if left untreated.” That said, not all the work in clinical laboratories is about today’s patients. Part of the role is to help prevent the spread of a disease in the population, for which an understanding of its condition is vital. There is also a great deal of research undertaken to use the knowledge gained in analysing specific cases and applying it to look for patterns and factors that might help in the fights against various conditions and diseases.

Interoperability Between the NHS and Laboratories Because they are an integral component in the healthcare delivery process, there need to be clear lines of communication between clinical practices and hospitals, and laboratories. NHS Improvement has been focused on this with its work to develop Pathology Networks5. In the report of that name, the scope of the contribution of laboratories is identified, “Analysis shows that the 105 hospitals in England which provide pathology services typically do 1.12 billion tests per year at a cost of £2.2 billion.” Anything that can reduce that cost while also improving the efficiency of the service is to be welcomed.

Communicating results When a test has been taken, the patient will usually worry about the results and so, as well as speed in the analysis process, once there is a result, it is important that it be communicated as rapidly as

SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

possible to the patient and their clinician. Faster communication also helps with the broader picture. As the Clinical Biochemist Reviews6 states, “Clinical laboratories play an important role in promoting patient safety by timely release and communication of critical results that may have significant impact on medical decisions and subsequent patient outcomes.” What the article also says is that, while processes in laboratories are improved increasingly with the application of technology, post analytical practices and critical results notification are still some way behind. NHS England with the Academy of Medical Royal Colleges has endeavoured to address the communication issue in ‘Standards for the communication of patient diagnostic test results on discharge from hospital’7 which refers to practices and processes as much as technology. But good practices and processes supply the right environment in which to invest in a better laboratory information system (LIS). The communication issue is also addressed by the Royal College of Pathologists in their paper ‘The communication of critical and unexpected pathology results’8 which includes the note that “… pathology providers should use electronic mechanisms for the automatic

selection of results for urgent communication based upon absolute results or associated changes from previous results.”

Communications between laboratories As well as the need to communicate results to clinicians and patients, laboratories often need to communicate with each other. “NPEx, the National Pathology Exchange, is the UK’s national solution to the challenge of connecting all pathology laboratories together… designed so that every single laboratory can send and receive lab tests and results to every other laboratory across the whole country.”9

Challenges Ahead Like every part of the UK’s NHS, laboratories have to find better ways to deliver more and higher quality services at the same or, preferably lower cost. There will be different ways to achieve this including changes in the corporate structure of laboratory services (privatisation or outsourcing). But it will be the introduction of digital technologies that will most likely reach the objective in the title of this paper, i.e. to improve laboratory operations and efficiencies

Like every part of the UK’s NHS, laboratories have to find better ways to deliver more and higher quality services at the same or, preferably lower cost. There will be different ways to achieve this

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SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

Complex Challenges and Digital Answers Camilla Slade, Staff Writer As patient and clinician expectations rise and regulation grows, laboratories must look to new technologies to ensure that they can meet both challenges

Rapid change has become a defining feature of pathology – but can this change power a new generation of laboratory software to shape the role of the clinical laboratory of the future?

“

ECHNOLOGY INNOVATION such as standardisation of pathology reporting through the use of the National Laboratory Medicine Catalogue, digital techniques in histopathology and genetics will be essential to achieve quality improvement.” The words of Dr Ian Barnes PhD FRCPath, Chair, Pathology Quality Assurance Review Board NHS England, in the National Pathology Programme10, ‘Digital First’, would seem to be stating the obvious but sometimes even professional and qualified people get comfortable with the way things have always been done and need an informed nudge to progress.

Improving the Way Things are Done to Improve the Results that are Achieved While the National Pathology Programme addresses the modernisation of clinical laboratory practices and processes at a high level, Dr Barnes was also asked, “… to strengthen and refine the quality assurance process for pathology services in England.” The subsequent Independent review11 proposed “an upgrade of pathology safety checks to improve patient outcomes.” One area of modernisation in the clinical laboratory, informatics, is the subject of a paper in The Clinical Biochemist Reviews which summarises the challenge and points to a solution12, “The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting.” The paper continues, “Laboratory computing has been at the leading edge of health information systems application development for the past five decades… However, the health informatics landscape is changing with the development of ever more sophisticated electronic patient record systems and pathology computing is 8 |WWW.HOSPITALREPORTS.EU

in danger of falling behind.” Laboratory News13 asks in ‘A clinical look at the future of pathology’, “Rapid change has become a defining feature of pathology – but can this change power a new generation of laboratory software to shape the role of the clinical laboratory of the future?”

Regulation and Other Pressures to Change As well as the clinical challenges, laboratories are subject to ever greater scrutiny and regulation. The Pathologist, offered ‘The Path(ology) to Quality Improvement’14 to explain “What labs need to know about the importance of ISO 15189 accreditation”. According to the International Organisation for Standardization15, ISO 15189 “… can be used by medical laboratories in developing their quality management systems and assessing their own competence.” However, to attain the high standards of quality management envisaged by the standard would be almost impossible using a paper-based system. As in other sectors, clinical laboratories must turn to digital technology in order to ensure that they are equipped to meet not only the expectations of clinicians and patients but also the standards to which they must be accredited in order to operate. Back to the National Pathology Programme where the emphasis is on, “Quality improvement in a digital age” referring to a pathology modernisation programme with laboratories working, “in different ways to enhance care pathways, enable patients to take control of their chronic disorders and save resources outside the laboratory and across health economies.” The report cites an example of the gains realised from modernisation; “Where changes such as patient access to the results of their blood tests have been introduced, the main benefit has been in a reduction in the number of visits required by patients…”

New Technology for Laboratories It is clear that pathology laboratories need to continue to embrace new technologies and

SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

applications that will enable them to not only process more analyses but also do so whilst retaining the highest possible standards of quality. Dark Daily16 identifies the problem, “Endless flows of paper are the curse of clinical laboratories and anatomic pathology groups everywhere.” And offers some hope, “Several active trends hold the potential to allow more medical laboratories to eliminate all paper and achieve a true digital working environment.” Before drilling down to, “One trend involves new technologies specifically designed to make it easier to digitally capture information currently only found on paper documents. Associated with this is the trend of increased use of the Internet and cloud-based solutions…” Just a snapshot of laboratories’ workloads makes clear why a digital and paperless environment must be the goal. The Clinical Biochemist Reviews17 in ‘Informatics and the Clinical Laboratory’ reveals that, “Analysis of data from the UK suggest that an average multi-disciplinary pathology service typically handles between 1 and 3 million patient specimens per year each, generating 10-30 million reportable test results on populations ranging from 0.5 to 1.5 million. In the UK, the median laboratory repertoire of tests is 189; such a laboratory will serve approximately 500–1500 consultant clinicians and a similar number of general practitioners (GPs) within an average of 300 practices. Such operations are of industrial scale.” Fortunately, pathology and laboratory practice has always been open to technology, probably

because it is a science-based activity. In this, most laboratories will employ technology and automation to speed their processes and to maintain a consistency of output, for example using barcoding and voice recognition. But there is no case for resting on the laurels of past progress. As the National Pathology Programme explains, “The NHS is in a period of rapid change… wide-scale transformation is in progress… Review of the quality and value of services helps drive the culture of continuous improvement to serve the needs of the future.”

A Digital Plan for the NHS The wider NHS also is well aware of the need to keep up to speed. NHS Digital18 states its purpose as ‘Information and technology for better health and care’; it has a digital business plan and includes among its goals to, “support organisations to get the best from technology, data and information.” Clearly, talking about digital developments in the NHS is pushing at an open door. But if an NHS Trust is going to go digital, it can’t be half-hearted or partial. To be fully effective, the digital change must include everything, including laboratories. In April 2017, The Guardian19 reported on Cambridge University hospitals NHS foundation trust’s digital transitions which, as Dr Afzal Chaudhry, chief medical information officer at the trust, explained, spanned, “all clinical areas – both inpatient and outpatient – including A&E, critical care, clinics, wards, surgery, pharmacy, laboratory and radiology services.” (author’s emphasis).

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SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

The Benefits and Challenges of a Digital Laboratory Information System Peter Dunwell, Medical Correspondent Data is a huge asset and it brings with it requirements and responsibilities on a similar scale

The clinical laboratory is a major source of health care data… Increasingly these data are being integrated with other data to inform health systemwide actions meant to improve diagnostic test utilization, service efficiency, and increase ‘meaningful use’

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N MANY ways, the process challenges facing clinical laboratories are the same as those that affect any organisation, which means that the solutions will also be similar. But, of course, how it affects them and how the solutions are applied will need to be tailored to suit the specific priorities and requirements of a laboratory environment.

GDPR (General Data Protection Regulation) seeks to create a harmonised data protection law framework across the EU and aims to give citizens back the control of their personal data, whilst imposing strict rules on those hosting and ‘processing’ this data, anywhere in the world.” (author’s emphasis).

Big Data in Healthcare

Cyber Security and Clinical Laboratories

Just as clinical laboratories are not isolated units away from the wider healthcare system but are integral and vital components in that system, so the data they generate can also be more widely utilised if it is properly managed. The Journal of Pathology Informatics paper, ‘Clinical laboratory analytics: Challenges and promise for an emerging discipline’20 reminds us that, “The clinical laboratory is a major source of health care data… Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and increase ‘meaningful use’.” But with big data come big responsibilities; as Tissue Pathology21 asks, “…what is the best way for healthcare organizations to go store and analyze these huge volumes of digital images safely and cost effectively?” And that ‘safety’ issue takes us to two major considerations: cyber security and pathology laboratories and something referred to by the snappy acronym GDPR, the EU’s General Data Protection Regulation. Even though the UK is leaving the European Union, any organisation that wishes to share or collaborate with an EU organisation will need to comply: that will include laboratories engaged in collaborative research programmes. As IBM’s paper on GDPR22 makes clear, “The

Whether it’s because their levels of security are perceived as low or because their disruption will cause disproportionate distress or because their systems are sometimes out of date, the healthcare sector in general seems attractive to hackers and cyber criminals. The May 2017 attacks on UK NHS systems was a warning of what might be to come and the fact that the malware got in on the backs of emails made it even more worrying. On the other side of the Atlantic, Medical Laboratory Observer23 tells us that, “Data breaches in the United States healthcare industry cost $6.2 billion each year. Over the past two years, roughly 90 percent of hospitals have reported a security breach.” The article continues to add that, “With expanding connectivity of information systems, laboratory work stations, and instruments to the Internet, the need to secure laboratory information is critical.” That truth is not lost on the Journal of Pathology Informatics24, ‘Privacy and security of patient data in the pathology laboratory‘ which states, “Data protection and security are critical components of routine pathology practice because laboratories are legally required to securely store and transmit electronic patient data.” This all plays right in to the responsibility under GDPR to keep patients’ data secure or face a fine in billions of Euros. And there is a lot of data as

SPECIAL REPORT: IMPROVING LABORATORY OPERATIONS AND EFFICIENCIES

Digital Health Age25 explained, “… a small slide scanner running 200 slides per day at medium resolution will generate over 20TB of data per year, which has to be stored, managed and kept secure over decade-long timescales, all the while taking into account the compliance, security, cost and data integrity requirements...”

The Advantages of an Advanced Laboratory Information System Each of the writers in this paper has referred to the NHS England National Pathology Programme (see references in previous articles) because it offers a comprehensive overview of new digital technologies and solutions in the context of NHS processes and requirements. In terms of advantages, the programme states, “We need to appreciate that digital is only an enabler – the first step is to understand how services can be designed to better serve patients while also delivering safer and more efficient care. Digital, by its nature, can open up new possibilities and can inspire different ways of thinking…” In fact, Richard Morroney writing for a 2015 Inspirata white paper, said it all in the title ‘The future of pathology: going digital’26. Specifically, in this sector, the Royal College of Pathologists has a ‘Diagnostic digital pathology strategy’27 in which several advantages for digital technology are highlighted including improved decision making “Consensus and expert opinion are more easily accessed…” and improved processes, “workload to be distributed evenly across a network of laboratories so that demand can be matched to capacity…” In addition to better processes leading to better

decisions, the ability to organise more efficiently and to store vast numbers of records electronically rather than in paper format will also reduce costs once the initial investment has been covered. Another major technology development that will be able to bring benefits to clinical laboratories will be the Cloud. Apart from providing the capacity for that vast storage requirement already mentioned, Cloud computing supports collaborative work and remote work, bringing city centre lab capabilities to the most remote communities. And it ensures that systems never go out of date, one cause of the 2017 NHS ransomware attacks. The Register cited the Cloud’s potential using one of the clinical laboratory’s tasks to make its point in ‘Digital pathology and the big Cs (that’s ‘cancer’ and ‘cloud’)28.

Supporting Organisational Changes Other examples of where digital technology is improving healthcare laboratory services can be found in the increasing adoption of digital requesting by clinicians for pathology tests. In a similar vein, the NHS is also moving to electronic web-based reporting of results. It’s all about using developing technology to improve the service to patients and clinicians. And it all sits well with the overall organisational direction in laboratory services as summarised by the Nuffield Trust in its paper, ‘Pathology: collaborate where possible, centralise where necessary’29. As in other sectors, the move into digital will itself open up new opportunities for the improvement of processes in clinical laboratories.

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Selecting the Future for a Clinical Laboratory John Hancock, Editor Knowing what the next few years will bring and selecting a Laboratory Information System to leverage the best from that future Words: John Hancock

Given the growth in what can be tested, clinician and patient expectations, the importance of speed and accuracy, and the need to comply with a variety of regulations as to processes and clinical standards; laboratory information systems will have to keep changing

S MIGHT be gauged from the plethora of information available, while the consensus is that clinical laboratories will benefit from adopting the latest practices, processes and digital software solutions, the next step, selecting and implementing such a system, is likely to be more challenging, given the choices. So what are the key factors to consider for those tasked with taking their laboratory systems into the future?

Key Factors When Selecting a Laboratory Information Management System The Clinical Biochemists Reviews30 offers a perspective on the broader considerations that might be taken into account, highlighting the growing complexity of the testing environment, “Larger test repertoires and greater use of new technologies including POCT [point of care testing] will almost certainly lead to increased service demand.” and suggests that, “Planning new IT systems requires a medium-to longterm approach…”

Requirements of the laboratory process Ben Tagger from the Computer Science Department at University of Wales, Aberystwyth, published ‘An Introduction and Guide to Successfully Implementing a LIMS (Laboratory Information Management System)’31 in which he recommends, “When selecting a LIMS, it is important to select one that is the ‘best fit’ for your requirements. There are obvious problems with selecting ones with less functionality than needed…” The paper identifies a number of generic capabilities that should be incorporated in the process of selection: portability – mobility is a growing feature of modern work; customisation – the system will need to be adaptable to the laboratory’s specific requirements; safety, security and reliability – given the materials being 12 |WWW.HOSPITALREPORTS.EU

tested, safety is critical and avoid contamination, also security to protect patients’ privacy and reliability because life changing decisions will turn on the results.

Requirements of the IT system Beyond that, many of the factors to take into account will be as for any IT system that needs to realise the potential of the latest hardware, software and processes. Is the system on offer configurable to meet the specific needs of the laboratory where it will work and to handle developments that are bound to take place during the time when it is in use? Also, will it be flexible to adapt to changing workflows, variable priorities and improvements in processes? Will it be easy to use, i.e. not require a burdensome training regime, and will it offer capabilities such as data mining to leverage the huge opportunities presented by big data? And will it be capable of interoperability and compliant with other systems, i.e. be able to work within a network and/or on collaborative projects with a variety of other parties who might also be interested in a particular test type?

Cost and support Then, of course, clinical laboratories are subject to one factor that affects every organisation; cost. But it is important to look beyond the initial outlay to include the benefits and any medium to long-term returns that will accrue from having a new and better software solution. Finally, there is support. No matter how good a system is, you’ll want to know that there is a support system in place so that, on those occasions when there is a new requirement, there will be expert assistance available to help fit it into the system and, when something goes wrong, expert help is at hand. Following the implementation of a new Laboratory Information System at Royal United Hospital Bath NHS Foundation Trust, Nigel Roberts, Haematology Lab Manager says,

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“It is very reassuring to have LIS support in place at any time of the day.”

What Lies Ahead – The Future for Clinical Laboratories and Laboratory Information Systems Given the growth in what can be tested, clinician and patient expectations, the importance of speed and accuracy, and the need to comply with a variety of regulations as to processes and clinical standards; laboratory information systems will have to keep changing to meet new requirements and challenges and exploit new opportunities. So, what does the future hold?

What will drive the changes? In 2016, Laboratory News32 took, ‘A clinical look at the future of pathology’ which opened with the question, “Rapid change has become a defining feature of pathology – but can this change power a new generation of laboratory software to shape the role of the clinical laboratory of the future?” The article considered future factors including the aging population and the rising prevalence of chronic conditions such as obesity and diabetes as well as the emergence of new testing capabilities and methods. One conclusion was that, “These trends present a formidable challenge to many of the existing laboratory information management system (LIMS)… pathology services will need modern, agile information systems that provide the functionality to capture, share, analyse, and act upon vast amounts of detailed data.”

What will be the changes? Looking to the future and IT, John J O’Leary, writing for the Pathology Society’s ‘Pathology 2026: The Future of Laboratory Medicine and Academic Pathology’33 suggests that, “Information technology will feature very prominently in laboratories in the year 2026.” One current major development in IT is Blockchain technology. In Dark Daily, the title of Donna Marie Pocius’ article, ‘Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data’34 highlights the importance of this new technology to deliver many of the key factors cited above and in earlier articles in this paper; interoperability, security, transparency and, perhaps most important, the ability to handle big data. As she says, “Medical laboratories and anatomic pathology groups are keenly aware that connected, secure, interoperable health records are critical to smooth, efficient workflows.” Blockchain will deliver that and is already a growing force in the financial and engineering sectors. The future will bring change and require clinical laboratories to embrace their own changes; and, more importantly, healthcare systems are aware of that. Reaction Data’s report ‘Trends in Clinical Lab & Digital Pathology’35 sums up current attitudes. “Digital pathology is in the cards for nearly 35% of hospitals within the next three years, which suggests this market is about to finally take off after many years of promise.” A fitting point on which to close.

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References: 1

The Clinical Biochemist Reviews www.ncbi.nlm.nih.gov/pmc/articles/PMC2423316/

Royal College of Pathologists www.rcpath.org/discover-pathology/news/fact-sheets/pathology-facts-and-figures-.html

NHS England – National Pathology Programme www.england.nhs.uk/wp-content/uploads/2014/02/pathol-dig-first.pdf

Cancer Research UK

scienceblog.cancerresearchuk.org/2015/11/05/peering-behind-the-pathology-lab-door-a-day-in-the-life-of-a-pathologist/ (copy and paste this link)

NHS Improvement, Pathology networks improvement.nhs.uk/resources/pathology-networks/ (copy and paste this link)

The Clinical Biochemist Reviews www.ncbi.nlm.nih.gov/pmc/articles/PMC3529552/

NHS England improvement.nhs.uk/uploads/documents/discharge-standards-march-16.pdf

The Royal College of Pathologists www.rcpath.org/asset/BB86B370-1545-4C5A-B5826A2C431934F5/

The National Pathology Exchange NPEx www.npex.nhs.uk/howitworks

NHS England – National Pathology Programme www.england.nhs.uk/wp-content/uploads/2014/02/pathol-dig-first.pdf

NHS England www.england.nhs.uk/2014/01/pathology-safety/

The Clinical Biochemist Reviews www.ncbi.nlm.nih.gov/pmc/articles/PMC4204239/

Laboratory News, Feb 2016 www.labnews.co.uk/features/clinical-look-future-pathology-23-02-2016/

The Pathologist thepathologist.com/issues/0216/the-pathology-to-quality-improvement/

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The Clinical Biochemist Reviews www.ncbi.nlm.nih.gov/pmc/articles/PMC4204239/

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The Guardian, ‘How a digital NHS saves time and money – and transforms care‘

www.theguardian.com/healthcare-network/2017/apr/25/digital-nhs-saves-time-money-care (copy and paste this link)

Journal of Pathology Informatics www.ncbi.nlm.nih.gov/pmc/articles/PMC4355825/

Tissue Pathology tissuepathology.com/2016/08/23/is-big-data-volume-in-digital-pathology-a-big-problem/#axzz56XjOgxHW

IBM http://bit.ly/2Enn4Si

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Journal of Pathology Informatics www.ncbi.nlm.nih.gov/pmc/articles/PMC3624703/

Digital Health Age digitalhealthage.com/how-to-better-manage-data-in-digital-pathology/

Inspirata www.inspirata.com/the-future-of-pathology-going-digital/

The Royal College of Pathologists www.rcpath.org/asset/2248BB71-B773-4693-945BFFDA593F2F2F/

The Register www.theregister.co.uk/2015/04/03/digital_pathology_and_the_big_c_cancer_cloud/

Nuffield Trust www.nuffieldtrust.org.uk/news-item/pathology-collaborate-where-possible-centralise-where-necessary

The Clinical Biochemist Reviews www.ncbi.nlm.nih.gov/pmc/articles/PMC4204239/

University of Wales, Aberystwyth www0.cs.ucl.ac.uk/staff/B.Tagger/LimsPaper.pdf

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Dark Daily www.darkdaily.com/blockchain-technology-could-impact-how-clinical-laboratories-and-pathology-groups-exchange-lab-test-data-929

Reaction Data reactiondata.com/wp-content/uploads/2015/09/Lab-and-Pathology-2015-Quick-Report.pdf

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