Hospital Reports Europe – Automating Immunohematology Testing – Ortho Clinical Diagnostics

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Automating Immunohematology Testing The Clinical and Economic Benefits Associated with Platform Solutions Standardising a Critical Process Safety Is an Automation Issue Ensuring the Testing Process Meets All the Needs Selecting What Will Work Today and Tomorrow

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SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

SPECIAL REPORT

Automating Immunohematology Testing The Clinical and Economic Benefits Associated with Platform Solutions Standardising a Critical Process

Contents

Safety Is an Automation Issue Ensuring the Testing Process Meets All the Needs Selecting What Will Work Today and Tomorrow

Foreword

2

Tom Cropper, Editor

The Clinical and Economic Benefits Associated with Platform Solutions

3

Ortho Clinical Diagnostics

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Published by Global Business Media

Challenges Faced by Transfusion Moving from Manual to Automated Systems Taking Automation to the Next Level

Published by Global Business Media

Standardising a Critical Process

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John Hancock, Editor

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A Valuable Procedure but Not Without Risk Immunohematology Testing Automation of Testing Conclusion

Safety Is an Automation Issue

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Camilla Slade, Staff Writer

Safety, Accuracy and Efficiency Automation Is Now the Standard Responsive Automation

Ensuring the Testing Process Meets All the Needs

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Peter Dunwell, Medical Correspondent

The Benefits of Automation Automation Is Not Always the Whole Answer Dealing with Change and Specific Requirements

Selecting What Will Work Today and Tomorrow

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John Hancock, Editor 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.

Thinking About What Is Needed A Rigorous Selection Process Factors to Consider Looking to the Future

References 14

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SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

Foreword

M

ANY PROCESSES are susceptible to

wounding and through surgery, but it carries a number

automation, but we might not immediately

of potential risks, which is why immunohematology

consider it appropriate for a clinical process.

testing is so important. In our following piece, Camilla

Nevertheless, all the factors that drive automation in

Slade considers that safety issue in greater depth and

other fields can be applied to healthcare, including

sets it against other important considerations as well

for immunohematology testing. It’s a process and,

as where automation might add value and how.

as demands on all healthcare systems increase,

Peter Dunwell then looks at how to make sure that

every opportunity to improve speed, accuracy and

any testing process meets the needs of the population

efficiency has to be considered. If, as an ancillary

it serves, how automation might contribute to that and

benefit, automation also reduces the volumes of

reminds readers that an automated testing process will

paperwork and improves record keeping, that

still need to meet all the stringent standards with which

will also be welcome. In this paper, we look at

any testing process must comply. Finally, we look at

several key aspects of immunohematology and

the sometimes fraught matter of how to choose a

consider some of the issues around automating

solution. We identify guides to which readers can refer

such a vital service.

and which set out some useful steps for a selection

The Report opens with an article by Ortho Clinical Diagnostics who have been transforming in vitro diagnostics for more than 75 years. It looks at the challenges faced by transfusion and examines the

process. Plus, of course, we take a look into the future or, at least, how some see the future.

We hope it all helps with your decision on automating immunohematology testing.

movement from manual to automated systems The next article gives an introduction to the blood service and the history of its central component, blood transfusions. It has been a huge boon for those suffering life threatening blood loss through

John Hancock Editor

John Hancock, an Editor of Hospital Reports Europe, has worked in healthcare reporting and review for many years. A journalist for nearly 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: AUTOMATING IMMUNOHEMATOLOGY TESTING

The Clinical and Economic Benefits Associated with Platform Solutions Ortho Clinical Diagnostics

THE GROWING POPULATION OF PEOPLE OVER 65 CONTINUES TO POSE CHALLENGES TO TRANSFUSION MEDICINE.

T

ODAY IT would seem that the only constant is change, with transfusion medicine laboratories being no exception.

Since the introduction of automation 20 years ago, much has changed for transfusion specialists globally. Laboratories have seen the gap between the resources they have and the resources they need widen tremendously, with the trend looking only to continue.

The developments in automation over the past two decades moved to minimise the gap in resource and reduce the pressure placed on staff.

Nevertheless, in order to deliver the clinical and economic benefits required within laboratories today and tomorrow, transfusion solutions had to evolve, and the industry had to innovate in partnership with healthcare professionals globally.

Challenges Faced by Transfusion Transfusion medicine laboratories play a critical role within hospitals, with transfusion specialists having to deliver optimal patient wellbeing through safe transfusions, while dealing with numerous challenges, daily.

Whilst challenges emerge directly from the laboratory, various macro factors are also having a direct impact. For example, the growing

population of over 65s and the emergence of new treatments and procedures, such as immune cancer therapies with monoclonal antibodies and stem cell transplantation, not only drive increase in demand but also introduce further complexity in testing. Factors such as these require transfusion specialists to have a high level of knowledge and skill, in order for them to be able to effectively support their service. However, in conflict with this is the disturbing statistic that approximately 19% of transfusion medicine specialists are expected to retire in the next 5 yearsa, leaving laboratories with a knowledge gap that is being further challenged by the drive towards multidisciplinary skill sets for laboratory staff.

An element of pathology that is not projected to grow, is the budget that is allocated year on year to each of the disciplines. Therefore, funding to minimise the gap in knowledge and support transfusion specialists to enhance their skills via external trainings and national congresses is limited. There is a heavy reliance on in-house training, which can provide a further drain on the limited staff resource.

Today laboratories account for around 5% of the hospital’s budget but the results generated by each of the departments impact over 60%

Taking automation in Tranfusion Medicine to the next level.

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The Ortho Vision® Platforms were introduced to the market in 2015, and took automation within the transfusion discipline to the next level

THE ORTHO VISION® PLATFORMS OFFER THE LATEST INNOVATION IN AUTOMATION.

of the clinical decisions takenb. With budgets under pressure annually, laboratory managers and pathology directors need to identify new cost saving initiatives and, where possible, income generation opportunities to meet the hospital key performance indicators. Regional solutions that have been proposed across Europe have been to drive further laboratory consolidation, which have helped but have not always fully delivered the desired efficiencies.

In addition to the need for cost savings, the changing skill mixes and the service consolidation, laboratory directors, more than ever before, need to be mindful of increased vigilance by regulatory and accreditation bodies. Inspectors from both are scrutinizing laboratories, demanding complete traceability and transparency in order to ensure ultimate patient safety. These challenges listed are amongst the most common across Europe and certainly do not represent the exhaustive list. Nevertheless, they do present an opportunity for transfusion specialists and industry to work hand in hand together to implement innovative approaches in order to provide the necessary solutions.

Moving from Manual to Automated Systems The 1990s saw the introduction of the first fully automated system into hospital transfusion laboratories, which transformed the discipline radically and moved laboratories away from the historical manual testing methodologies.

Analyzers, such as the Ortho AutoVue ® System, reduced subjectivity and hands-on time significantly, in turn decreasing the risk of human error. Nevertheless, as the discipline continued to be challenged, the need for automation to evolve grew. The next generation automation had to 4 |WWW.HOSPITALREPORTS.EU

build upon and surpass the functionalities of the first and second generations in order to address the growing challenges. Fundamentally, the next generation of systems had to drive predictability and traceability, whilst maximizing service uptime and efficiencies through reliability and usability.

Further to this and due to the increasing complexities faced, the need for a total value offering emerged. Automation as a standalone system can no longer meet the needs and demands of laboratories - only in harmony with supporting products and services can transfusion providers offer the solutions that laboratories require.

Taking Automation to the Next Level The Ortho Vision® Platforms were introduced to the market in 2015, and took automation within the transfusion discipline to the next level. Ortho pioneered a platform approach for transfusion, in order to address the challenges faced by consolidation. The platform solution includes the Ortho Vision® Analyzer and the Ortho Vision® Max Analyzer, which offer unrivalled levels of standardization, providing identical hardware and software for users across networked and stand-alone laboratories The solution offers the latest innovations to optimize testing performance and offers a diverse range of tests beyond groups and screens, including serial dilution capabilities, extended phenotyping, antibody identification and user defined profiles. This expansion of the testing menu not only reduces the levels of subjectivity within testing, it offers laboratories cost saving opportunities. These opportunities lie within the ability to reduce the number of samples

SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

sent-away for testing to reference laboratories, therefore minimizing the associated costs and reducing the turn-around-times for receipt of result. Furthermore, with the changing skill mixes and the continuation of multi-discipline staffing, by bringing the testing in-house, it helps to bridge the knowledge gap and enables staff to have confidence in the outcomes.

The core objective of any blood transfusion laboratory is to get the right blood products out at the right time. Therefore, perhaps the most critical aspect of a solution will always be the predictability of the analyzers, in terms of the turnaround times for normal routine testing and, more importantly, in urgent situations. A trickle-feed and load-on-the fly approach means that systems can respond to the needs of the laboratory without any delay, optimizing the service offered to clinicians. This predictability not only improves clinical services but can lead to better patient experience. An example of this is patients being drawn and tested on the morning of surgery rather than the day before, minimizing the interruption to their day-to-day life. An economic benefit that can be associated to this is also the ability to reduce the bed stay time of a patient, and with a hospital stay costing a minimum of £400 per dayc, the savings can be significant.

Ensuring confidence in results is a further requirement of solutions today. Laboratories require full traceability of their testing not only for their peace of mind but also to ensure their accreditation can be maintained. Features such as the proprietary Intellicheck™ technology used by the Ortho Vision® platforms monitor every critical step along the testing pathway and provide users with an easily retrievable and comprehensive report for every test run.

In addition to system functionalities, it is imperative that laboratories have system

reliability. The need to maximize the uptime of solutions and ensure continual system readiness, proactive monitoring and predictive technologies has emerged. Ortho utilizes a proprietary technology, e-Connectivity™ that allows engineers to inform laboratories of potential problems before they can interrupt the laboratory workflow and processing. By offering this solution and maintaining this critical service, Ortho can help reduce the unnecessary costs associated with downtime.

Nonetheless, automation on its own is not the only way to meet all of today’s challenges.

With consolidation and network formation, the need for laboratory managers to support more than one laboratory at any given time has developed and the demand for interconnectivity and remote capabilities is now at an all-time high. Whilst systems alone can provide remote review and validations, middleware solutions, such as ORTHO Connect™, are evolving to provide a seamless flow of information that centralizes lab management activities across multiple instruments and laboratories. This middleware has been developed specifically for blood transfusion laboratories and can support managers with remote monitoring, menu configuration, workflow management and quality control through a single connection point.

Since the introduction of automation in the 1990s, the field has evolved and there is no doubt that over the next 20 years it will continue to do so. As the demands and challenges continue to develop, so must the technology in order to provide the clinical and economic benefits that hospitals and laboratories seek. Whilst no-one can foresee the future, it is clear that, as the journey continues, strong partnerships between like-minded industry and health care professionals globally will be essential.

Taking automation in Tranfusion Medicine to the next level.

References: a Kimberly Scott. The Laboratory Workforce Shortage Demands New Solutions; 2015 Available: https://www.aacc.org/publications/cln/articles/2015/november/the-laboratory-workforce-shortage-demands-new-solutions b

The Lewin Group, Inc. The value of diagnostics innovation, adoption and diffusion into health care; 2005. Available: https://dx.advamed.org/sites/dx.advamed.org/files/resource/Lewin%20Value%20of%20Diagnostics%20Report.pdf

c

Data.Gov.UK. NHS Hospital Stay;2015 Available: https://data.gov.uk/data-request/nhs-hospital-stay

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Standardising a Critical Process John Hancock, Editor

To ensure blood for transfusions is safe, it must be tested, and a better quality of testing means safer blood

Immunohematology is a specialized branch of laboratory medicine which involves the study of blood group antigens and antibodies. The processes of quality testing include quality control, basic laboratory techniques and safety

A Valuable Procedure but Not Without Risk Although the principles of blood transfusion were known as early as the seventeenth century1, it wasn’t until the nineteenth century that the process was recognisable as we know it today with the beginnings of infection control; and it was the very start of the twentieth century when the critical discovery of the different blood types was established. These days, the availability of blood transfusion is taken for granted in most countries, but that familiarity should not minimise the significance of the process or the risks that still accompany it. In fact, in modern times, as well as the need to ensure type compatibility, we have seen a number of hitherto unknown and/or unidentified risks that have brought hazard into the process. Hepatitis, HIV, CJD… the list continues to grow, and all have the potential to be dangerous for a patient receiving a blood transfusion.

As the UN World Health Organisation (WHO) explains in ‘Screening Donated Blood for Transfusion-Transmissible Infections’2 it isn’t simply about blood but, “the provision of adequate supplies of safe blood and blood products…” (Editor’s emphasis) that is required. The recommendations continue to list a number of steps “for the provision of safe blood and blood products and safe, efficacious blood transfusion” including “Quality-assured screening of all donated blood for transfusiontransmissible infections… as well as testing…”

That is where we come to the subject of this paper – immunohematology testing and its automation.

But first, let’s look at the process and discipline.

Immunohematology Testing Immunohematology is nicely explained in the eponymous ‘Immunohematology’ published by Austin Community College3, “Immunohematology is a specialized branch of laboratory medicine which involves the study of blood group antigens 6 |WWW.HOSPITALREPORTS.EU

and antibodies. The processes of quality testing include quality control, basic laboratory techniques and safety.” Testing is integral to immunohematology to ensure that no blood borne infections, pathogens or incompatibility will be introduced into a transfusion recipient.

There are times and conditions that make this more vital than ever, including during pregnancy or when undergoing surgery or a transplant. The Blood Transfusion Centre of Slovenia4 sums up the value of tests, “Immunohematological tests enable safe blood transfusion and transplantation of haematopoietic tissue, as well as preventing undesired immune-related phenomena after transfusion, transplantation and during pregnancy.”

Testing is important at these times of potential risk but “The immunohematology/transfusion service, which provides type and crossmatching of blood to ensure the safety of blood transfusions, has been the last bastion of almost exclusively manual procedures in the clinical laboratory... [Yet] a single mistake can be devastating, even fatal.”5 The words are from Oxford Academic’s LabMedicine.

The 2010 article continued to consider the merits and pitfalls of automation in the testing process. “Automation, on the one hand, minimizes the potential risks of human failure, but, on the other hand, it must be robust enough to provide a guarantee of complete accuracy and safety.”

Automation of Testing Of course, automation is a feature of many processes these days and, with the growing sophistication and capability of software, its reach is extending to ever more fields.

Automation has many advantages that include improved quality of pre-analytical steps, reduced error rates and reduced individual exposure to biohazardous materials. Put that way, immunohematology testing is a process and so automation should be applicable. However,

SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

as with any process, there are several of matters to be considered, including cost and commensurate benefit.

reporting of test reactions is prone to some individual subjectivity, simply because they are evaluated manually.

The challenge of costs Nobody likes to include cost in a healthcare consideration, but it cannot be avoided and, the costing of pathology services in the UK NHS is not as straightforward as you might imagine. “…it has proved surprisingly difficult to obtain a reliable estimate of the total cost of providing pathology services within this country… because the pathology services are not currently managed in an integrated manner.”

This is a conclusion in ‘Report of the Review of NHS Pathology Services in England’6.

However, if we look back at the article in LabMedicine (above) and its comment that the immunohematology/transfusion service has been the last bastion of almost exclusively manual procedures in the clinical laboratory, then we might reasonably have concluded that, like other manual procedures, manual immunohematology testing was not the most efficient way in the long-term, i.e. there should be room to improve outcomes and improve speed per £ of cost notwithstanding the upfront investment. This has increasingly become the case since that article was written.

In the same article, Katharine Downes, MD, points out that automation has been in routine use in other areas of the laboratory and could add value to a transfusion service laboratory by reducing turnaround times, as well as standardizing the interpretations of test reactions.

In particular, automation has been shown to have a great advantage over manual patient specimen identification methods. Currently the

The challenge of automation with responsive automation Because of the cost opacity, “Compared with other countries England makes relatively little use of automated ‘front end’ technology…“ says the report (above) and, confirming the cost element, “it can be difficult for pathology professionals to argue successfully for investment in new technology when there is downward pressure across all hospital budgets.”

All that said, there has been automation, but it is a rigid process without the capacity to react to individual needs or changes within a laboratory.

To address this issue, Responsive Automation combines automation with the ability to anticipate and respond to change, and to monitor every step of the process. This doesn’t only improve the service but also makes it more efficient, i.e. less wasteful. So automation is not only available to immunohematology testing but, as Robert Yates, chief operating office at Ortho Clinical Diagnostics, puts it, “Labs are continuously pushed to accomplish more with fewer resources – including staff – and [a process based on full menu automation] can now ease those pressures in labs of every size and makeup for any level of testing complexity.”

Taking automation in Tranfusion Medicine to the next level.

Conclusion Immunohematology testing is a key component in the preparation and transfusion of blood products and the quality of outcome for patients using the service. Anything that can improve that quality must be welcome.

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Safety is an Automation Issue Camilla Slade, Staff Writer

To improve safety and outcomes, automation is a growing part of immunohematology testing but there are different levels of automation

Advances in safety of blood transfusion in clinical practice principally relate to preventing transfusion-transmitted infections (TTI).

Epidemiological studies of TTI have resulted in the development, standardization, and implementation of an expanding array of immunoassays

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Safety, Accuracy and Efficiency It goes without saying that safety is of paramount importance in the operation of every process in a transfusion laboratory; not least, immunohematology testing. It is also the case that safety, in this field, has continued to improve with advances in practice. As Elsevier Biologicals7 explains, “Advances in safety of blood transfusion in clinical practice principally relate to preventing transfusion-transmitted infections (TTI). Epidemiological studies of TTI have resulted in the development, standardization, and implementation of an expanding array of immunoassays employed worldwide in routine screening of blood donated by voluntary blood donors.” Various tests are now stipulated by United Kingdom Blood Services8 including the screening of blood for infectious agents as well as other tests to exclude prion-associated diseases such as Creutzfeldt–Jakob disease (vCJD), establish blood group and, to a growing degree, DNA testing/genotyping. All of this is to be welcomed, but it does increase the workload as well as creating further opportunities for human error.

As recently as 2014, Dovepress’ ‘Improving patient safety in transfusion medicine: contemporary challenges…’9 recorded, “Three major divisions of hazards and/or concerns can be identified: infectious, non-infectious, and logistical/administrative.” Adding, “Although the frequencies of many have been appreciably reduced, it is a discomforting reality that these challenges have not been fully eliminated.” In fact, in relatively recent times, those challenges were brought home with the discovery of AIDS and the sharper focus on testing of blood products that it stimulated. That, in turn, “led to new discoveries and technologies to reduce the risk of other transfusion complications such as hepatitis, bacterial contamination, and transfusion-associated graft-vs-host disease.” said Clinical Chemistry10. Inevitably, a crisis such

as AIDS put significant pressure on manual immunohematology testing. More recently, in the UK, the concerns about a possible CJD outbreak, while ultimately not realised, applied further pressure to the testing service. It is even possible that the quality of immunohematology testing in the UK was a factor in the avoidance of the anticipated CJD outbreak.

From the point of view of the subject in this paper, the Asian Journal of Transfusion Science11 offers, “[An] Immunohaematology laboratory functions 24 hours, 365 days and [is] responsible for supplying compatible blood. To prevent manual errors this laboratory should preferably have automation.”

And it isn’t only to prevent errors that automation should be considered in immunohematology.

As CLP Magazine ‘Building a Safer Blood Supply’ by Gary Tufel12, explains, “Around the world, fewer and fewer medtechs are graduating from universities, and those who do graduate are often drawn to research roles rather than to hospital lab work. On a practical level… this means that, more than ever, our customers need automated solutions” Without wishing to labour the point, as in many other fields of medicine, the elimination or, at least, minimising of human error in blood laboratories will clearly save lives and/or improve outcomes for patients. The arrival of automation offers a clear alternative to manual procedures including immunohematology testing. Over and above the safety issues, it also offers the benefit of patients less likely to contract additional conditions which would require further treatment, which would extend hospital stays, add to costs and could even lead to law suits.

Automation Is Now the Standard In light of the standardisations of processes mentioned above, immunohematology testing is an area where automation will find a natural home.

In the UK, testing of blood donations is mandatory

SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

in line with JPAC (Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee) guidelines13. Those guidelines also stipulate that “All mandatory tests must be performed using an automated test system in the first instance.” There is good reason for that: as JPAC affirms in another part of the guidelines14, “Fully automated ABO and D grouping procedures have significantly improved the accuracy and security of results…” A similar view emerges from Transfusion Medicine15, in that a lot of testing is still conducted manually with operator variations that “can result in a fatal transfusion outcome.”

In light of that, “Moving to automation or semiautomations is currently [2013] a major focus of transfusion laboratories.”

Another factor that has made automation a more practical solution has been developments in the techniques used for immunohematology testing. “The conventional test tube technique has given way to newer techniques such as column agglutination technique, solid phase red cell adherence assay, and erythrocyte-magnetized technique. These new technologies are adaptable to automation and major manufacturers in this field have come up with semi and fully automated equipment for immunohematology tests in the blood bank.” That is the conclusion of the Asian Journal of Transfusion Science ‘Automation in Immunohematology’16. The journal continues to explain the pitfalls and risks associated with

manual testing, “Large blood centres have a heavy workload and therefore there is a risk of errors when operation is manual which compromises blood safety. Often it is difficult to have a skilled staff. Automation eliminates manual errors, reduces manpower requirements and has uniform performance.”

Responsive Automation A great deal of healthcare and medical practice has been automated in recent years and, as we can see from the paragraphs above, automation is now an established reality in the transfusion service and immunohematology testing.

Automated processes guarantee standards and consistency plus they eliminate the possibility of human error, but traditional automation can be rigid. The process will follow the steps for which it is programmed but, should the environment or circumstances in which it is operating change, it is often unable to respond. And, because it is a fixed process, it cannot prioritise, i.e. everything is dealt with on a ‘first come, first served’ basis.

That’s fine for most industrial processes but not quite so useful where a lab technician undertaking, say, immunohematology testing might have had to make value judgements about priorities. A new level of automation, responsive automation, is better able to cope with changes in the environment and/or circumstances of its work. It offers the benefits of automation but with the ability to be customised.

Taking automation in Tranfusion Medicine to the next level.

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Ensuring the Testing Process Meets All the Needs Peter Dunwell, Medical Correspondent

Automation and semi-automation are great developments for testing, but they still need to be used properly

The importance of being able to respond to individual needs (what medications patients are taking, their underlying condition plus any complex issues they might have) seems selfexplanatory. It is, though, the case that testing blood and matching to patients is a lot more complex than it might at first appear

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O

FTEN THE most consistent factor in any field of work is change. Attitudes change, technology changes, people change plus there is a growing concern to match everything to the needs of the individual and that can vary. Usually, we think of it in terms of the goods and services we buy, but it is also a key consideration in the delivery of any clinical service. However, in this field, it is not so much a matter of consumer satisfaction, as a means to improve the targeting and quality of a process to ensure its outcome matche the needs of the recipient as closely as possible and, in the case of a clinical process, does not harm them. This is an important consideration in the matter of immunohematology testing where patients with increasingly complex health issues and individual needs have to be matched to blood within the parameters and to the requirements of a regulatory regime.

The Benefits of Automation Automation in analysis and testing has been around in clinical laboratories for more than half a century since its first appearance on the scene in the mid nineteen-fifties. It is a fact of life today and we have already mentioned the benefits it can deliver such as standardisation, consistency, speed, efficiency and accuracy, all of which can be accessed using automation. In the previous article, Camilla Slade mentioned the issue of traditional automated processes often being rigid and unable to easily adapt to changing conditions and priorities. She mentioned, also, the development of responsive automation and how that is improving the agility of automated processes in areas such as immunohematology testing. There is another driver for automation in this area. The Southampton NHS University Hospitals NHS Trust ‘Safe Transfusion Practice Workbook’ 17 (not untypical in the sector) highlights that the UK’s ‘Blood Safety and Quality Regulations (2005)’ make it a legal requirement,

“that every unit [of blood] issued for transfusion had to be fully traceable from donor to recipient, vein to vein traceability.” That is not a direct testing issue but, of course, testing will be a part of any record. The Southampton paper continues to explain, “To make this process easier most hospitals, if they have not already, are in the process of implementing an electronic tracking system to meet the above requirements. The laborious paper systems, which might be still in use in some hospitals, are unreliable…” In fact, the Journal of Laboratory Physicians18, highlights traceability as a key benefit of automation, “Documentation, traceability and archiving of results are other major advantages of automation.”

Automation is Not Always the Whole Answer There are, of course, cases where automation might not be ideal. For instance, it isn’t thought to be the best solution for some types of test where one-off cases are concerned. “In our study, the machine took longer time as compared to CTT when only one sample was processed for blood grouping.” Is the conclusion of the Journal of Laboratory Physicians’19 ‘Comparison between conventional and automated techniques for blood grouping and cross matching…’ However, the report found that automation is better where larger numbers of tests are required and that is more likely to be the experience in a busy hospital environment.

Also, automation isn’t always of the whole process or even the same throughout the process; sometimes, by choice or because automation of process steps has happened in a piecemeal way, there is semi-automation.

As Nordson EFD20 explains, semi-automation is, “a system in which a human operator or a small production line feeds a product to a robot, the robot performs a single task on that product, and then the human operator removes

SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

the product and completes the task.” Although it is possible to automate individual steps in the testing process, semi-automation, may be prone to the same issues as manual testing as the test has to be moved between steps and/or completed manually.

Dealing with Change and Specific Requirements But, as we’ve already seen, while traditional automation and semi-automation can improve the operation of steps in the testing process or even of the whole process, they have not so easily been able to deal with variations such as individual patient needs, priorities or changes in conditions when manual intervention has still been required. Equally, automation cannot be a substitute for training, As the Journal also explains, “automated systems can be incorporated into routine use in blood banks with a large workload. However, the high proportion of uninterpretable results emphasizes that training and standardization are required prior to its use. The competence of a trained technologist is required to validate the results of the automated system.”

The importance of being able to respond to individual needs (what medications patients are taking, their underlying condition plus any complex issues they might have) seems selfexplanatory. It is, though, the case that testing

blood and matching to patients is a lot more complex than it might at first appear. ClinLab Navigator21 sets out not only the complexity of testing requirements but also the identification and selection of alternatives where the ideal choice is not available. Equally, the capabilities and possibilities are always improving, and any automated system needs to be able to take account of that. If we add in the implementation of Blood Safety and Quality Regulations 2005 which has, in the terms of the Handbook of Transfusion Medicine22, “led to the development (and inspection) of comprehensive quality systems in hospital transfusion services and the reporting of serious adverse events and reactions to the Medicines and Healthcare Products Regulatory Agency (MHRA).” It can be seen how complex the testing task has become.

The handbook also refers to the underlying principle in blood management of Haemovigilance, the “systematic surveillance of adverse reactions and adverse events related to transfusion’ with the aim of improving transfusion safety… Haemovigilance can identify transfusion hazards and demonstrate the effectiveness of interventions.”

All of the above can introduce variables into the process of immunohematology testing whether with individual needs, changes in the medical environment or regulatory changes.

Taking automation in Tranfusion Medicine to the next level.

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Selecting What Will Work Today and Tomorrow John Hancock, Editor

Choosing an automated immunohematology testing solution and what the future holds

The first step in moving to automation is to take a close look at an entire process to see if there is a piece of that process which, if automated, would improve safety, performance, or productivity

T

HE INTRODUCTION of any new solution to a process must be subject to a number of factors. Automation can deliver huge benefits but it is not simply something to introduce without thought or consideration. Nordson EFD’23 paper ‘7 Critical Steps to Implement Semi-Automation to your Dispensing Process’, looking at a similar field, recommends, “Moving to automation is more than just deciding to automate –determining what to automate is key. The first step in moving to automation is to take a close look at an entire process to see if there is a piece of that process which, if automated, would improve safety, performance, or productivity.” As a general approach, that is correct. But there will be a number of specific considerations for any particular field of work and immunohematology testing is no exception.

Thinking About What Is Needed It is certainly the case in a Blood service that there are factors to consider. “When it comes to selecting one company over others, it is crucial for blood bank directors to define their workload.

Do they primarily batch test, or is their workflow more continuous over the course of a day? Does their patient population center on specific areas, such as obstetrics? Will creating new processes such as batch testing on specific days of the week help take advantage of efficient use of reagents for an analyzer?” That comes from Medical Laboratory Observer24.

A Rigorous Selection Process As with the testing process itself, the selection of automation into immunohematology needs to be rigorous. Lab Medicine25 explains, “Automation, on the one hand, minimizes the potential risks of human failure, but, on the other hand, it must be robust enough to provide a guarantee of complete accuracy and safety. Therefore, before a laboratory introduces any automation 12 |WWW.HOSPITALREPORTS.EU

into immunohematology, the automated system must be fully validated in very specific ways.”

You will also wish to check with potential automation system suppliers that their analysers will support laboratories to undertake their normal routine testing and STAT requests and furthermore that there is capacity for increase.

And, one can never entirely ignore the cost factor. Against the many advantages of automation that it lists, the SelectScience eBook ‘How to buy Blood Bank Analyzers’26 sounds a cautionary note, “One of the main disadvantages of automation is the large start-up cost – automated immunohematology is expensive and can require a significant initial outlay.” but continues to suggest, “It may be possible to draw up a reagent rental agreement with your chosen supplier, where the manufacturer supplies the instrument and maintenance for free, based on a projected workload, and the user agrees to a reagent contract.”

Factors to Consider In the paper, ‘Perspectives in Transfusion Medicine‘27, a number of factors are listed for consideration as part of an automation decision.

These include defining institutional needs, i.e. establish the testing process used; determine what type of automation will be appropriate; find out about reliability of the systems being considered; establish the solution’s ability to interface with other systems; consider where the system will be located to fit in with the rest of the lab and yet be accessible; and, always, the cost of automation. The paper concludes on a positive note, “Automation has great potential in transfusion services large and small. Selecting the best instrument for a laboratory requires consideration of a number of factors. While cost is a factor in selecting an instrument, other factors weigh heavily on the success of the installation and must be considered. The potential for adding immunohematology instrumentation to

SPECIAL REPORT: AUTOMATING IMMUNOHEMATOLOGY TESTING

an automation line and autoverification of routine test results will further streamline transfusion service operations.”

Not mentioned in the paper, but often used in decisions by system buyers in other technology areas is to see whether you can contact users of the solutions under consideration. This is not so much to get an ‘is it bad or is it good’ response as to find out how the automation solution actually performs in service and how the users find it. It might also help with specifying which model to choose, where a range of options is available.

As well as the formal institutional requirements, ask the technicians themselves what they would value in a solution and then build your questions around that.

As with selecting anything for the lab, automation for immunohematology testing must be a careful decision that will add real value to the process and service.

Looking to the Future The Asian Journal of Transfusion Science ‘Transfusion Medicine in the year 2025: Facts or Fantasy?’28 opens with the challenging thought of, ”whether this specialty would survive at all beyond 2025.” The reason for this is that the use of blood in procedures is reducing as better and less intrusive ways to deliver treatments are developed. Also, better equipment and the growing expertise of clinicians have contributed to a reduction in the demand for blood products in surgery. And we cannot ignore the development of substitutes for blood

components, requiring no testing because their quality will be assured at manufacture.

But, against that, the same article points out that there is a growth in other tissue banking such as bone, skin and sperm for which the processes and management skills used in blood banks will be ideally suited.

Other future views consider changes that will occur in the field covered in this paper. Business Wire’s ‘Immunohematology Market to Witness the Growing Use of Automated and Semiautomated Immunohematology Analyzers through 2020: Technavio’29 highlights 2017 research suggesting that molecular testing of blood groups is “the latest trend gaining traction in the market.” Technavio analyst Srinivas Sashidhar comments, “Molecular analysis helps in the detection of the molecular and genetic basis of any antigen. The procedure helps the physicians to understand the molecular basis of blood group antigen and blood typing. At present, the adoption rate of molecular immunohematology has increased coupled with serological typing and HLA typing.

Several blood banks and hospitals across the world are using this method.”

Perhaps the most practical influence in the future will simply be demand as, in the UK, hospitals, the largest users of immunohematology, continue to experience exponential growth in demand for their services. In that context, the quality and capability of automation will be an increasingly important factor in meeting expanding patientdriven demand for this vital service.

Taking automation in Tranfusion Medicine to the next level.

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References: 1

AABB www.aabb.org/tm/Pages/highlights.aspx

World Health Organisation (WHO) ‘Screening Donated Blood for Transfusion-Transmissible Infections’ www.who.int/bloodsafety/ScreeningDonatedBloodforTransfusion.pdf 2

3

Austin CC www.austincc.edu/mlt/bb/bb

4

The Blood Transfusion Centre of Slovenia www.ztm.si/en/diagnostic-services/immunohematological-tests/

5

Lab Medicine academic.oup.com/labmed/article/41/4/243/2504944

Report of the Review of NHS Pathology Services in England www.networks.nhs.uk/nhs-networks/peninsula-pathology-network/documents/CarterReviewPathologyReport.pdf 6

7

Science Direct www.sciencedirect.com/science/article/pii/S1045105609000062

8

UKBS ‘Handbook of Transfusion Medicine’ file:///C:/Users/John%20Desktop/Downloads/5th%20Handbook%20of%20Transfusion%20Medicine.pdf

Dovepress ‘Improving patient safety in transfusion medicine…’ www.dovepress.com/improving-patient-safety-in-transfusion-medicine-contemporary-challeng-peer-reviewed-fulltext-article-IJCTM 9

10

Clinical Chemistry clinchem.aaccjnls.org/content/46/8/1270

11

PMC www.ncbi.nlm.nih.gov/pmc/articles/PMC4455106/

12

CLP Magazine ‘Building a Safer Blood Supply’ by Gary Tufel www.clpmag.com/2016/09/building-safer-blood-supply/

13

JPAC www.transfusionguidelines.org/red-book/chapter-12-donation-testing-red-cell-immunohaematology/12-10-mandatory-testing-of-blood-donations

14

JPAC www.transfusionguidelines.org/red-book/chapter-13-patient-testing-red-cell-immunohaematology/13-3-pre-transfusion-testing

15

Transfusion Medicine (preview only): No hyperlink, so copy and paste the address. http://bit.ly/2zjtAXF

16

PMC, NCBI Resources www.ncbi.nlm.nih.gov/pmc/articles/PMC3439752/

17

Southampton University Hospitals NHS Trust ‘Safe Transfusion Practice Workbook’ www.uhs.nhs.uk/Media/suhtideal/CommonStatutoryAndMandatoryTraining/BloodTransfusionSafeTransfusionPractice/SafeTransfusionPracticeWorkbook.pdf

18

NCBI www.ncbi.nlm.nih.gov/pmc/articles/PMC4559636/

Journal of Laboratory Physicians www.jlponline.org/article.asp?issn=0974-2727;year=2015;volume=7;issue=2;spage=96;epage=102;aulast=Bhagwat 19

20

Nordson EFD file:///C:/Users/John%20Desktop/Downloads/Nordson_EFD_7_Critical_Steps_to_Implement_Semi_Automation.pdf

21

ClinLab Navigator: No hyperlink, so copy and paste the address www.clinlabnavigator.com/compatibility-testing.html

22

Handbook of Transfusion Medicine file:///C:/Users/John%20Desktop/Downloads/5th%20Handbook%20of%20Transfusion%20Medicine%20(1).pdf

23

Nordson EFD file:///C:/Users/John%20Desktop/Downloads/Nordson_EFD_7_Critical_Steps_to_Implement_Semi_Automation.pdf

24

MLS ‘Automation in the blood bank: things to think about’ www.mlo-online.com/automation-in-the-blood-bank-things-to-think-about.php

25

Lab Medicine academic.oup.com/labmed/article/41/4/243/2504944

SelectScience eBook ‘How to buy Blood Bank Analyzers’ www.selectscience.net/downloads/articles/SelectScience_Blood_Bank_Analyzers_Buying_Guide.pdf 26

27

Perspectives in Transfusion Medicine https://pdfs.semanticscholar.org/adf3/3e0b2068a79d8e6f5867e7b8528ef3589e55.pdf

28

Asian Journal of Transfusion Science ‘Transfusion Medicine in the year 2025: Facts or Fantasy?’ www.ncbi.nlm.nih.gov/pmc/articles/PMC2798755/

29

Business Wire www.businesswire.com/news/home/20161017005492/en/Immunohematology-Market-Witness-Growing-Automated-Semi-automated-Immunohematology

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