Richard Craven, chief executive of CliniSys, considers how the tumultuous events of 2020 will impact on 2021, and how they will affect the company, the NHS, and the world of pathology for years to come. Twenty-twenty was an exceptional year. I doubt any of us will forget the arrival of the coronavirus or the impact […]Read full article
Welcome to the CliniSys Group Blog
With over 30 years’ experience in developing and installing healthcare IT solutions, our skilled and dedicated teams have much to share. From useful advice from a recent multi-site deployment to generic handy hints to support and maintain IT solutions in a critical 24/7 healthcare environment, our blog posts are designed to educate, inform and interest all.
The new coronavirus which causes the COVID-19 illness still has the world under its spell. Medical laboratories worldwide geared up their PCR testing capacity the last months to detect the virus. This testing involves many consumables to perform a PCR-test and comes with logistic challenges for all laboratories worldwide to maximize the throughput in the lab with their existing equipment and available reagent and supplies to perform the test.
This is where pooled testing comes into the play. Pooled testing, in which biological specimens from multiple subjects are combined and tested in one single test, can substantially improve the efficiency and turn-around-time of a test. Globally there are many laboratories which have developed techniques to perform these pooled tests, and more specific in the countries where MIPS is active, we see an interest and demand in this pooled testing.
MIPS is supporting our customers in many ways, in their quest to increase PCR-testing capacity, and is a supplier of GLIMS and CyberLab in the Belgian national testing platform and to the French government for the SIDEP project in France.
Our next level of support for our international customer base is that we can provide support of pooled testing in GLIMS. We are supporting many different workflows to implement pooled testing by means of configuration in GLIMS. Our teams have worked out guidelines for our customers how to rapidly implement this.
This confirms the value we bring to our customer base with a product like GLIMS.
If you are thinking to implement pooled testing in your lab, reach out to your MIPS contact to learn how this can be applied in your configuration.
Beginning a new job during a global pandemic isn’t the ideal situation, but it was the one facing Christian Reynolds, a Service Project Manager in the CliniSys Service Portfolio Team. “On my first day in the office, after a short induction, I was given a laptop, second screen and asked to head home because of lockdown restrictions.” While not quite the start he imagined, Christian had to hit the ground running as the real impact of COVID-19 became apparent. Here’s how he delivered exceptional customer service in a national crisis.
Christian is part of the CliniSys team delivering critical services to healthcare organisations. The team provides after sales project support across the entire CliniSys customer base including but not exclusive to, interface solutions, Point of Care testing and connections to the National Pathology Exchange (NPEx) system for laboratory testing – all crucial elements in the NHS response to the pandemic.
So, what’s an average working day? “I work on fast-moving, aftersales projects that range from one to 20+ days in terms of effort,” Christian explains. “My role is to manage projects and deliver solutions that meet the customers’ need.”
During the initial phases of the COVID crisis, Christian found much of his work was in enabling the rapid expansion of testing capacity. Laboratories needed to add new analysers to process tests and to integrate these with their CliniSys LIMS.
“It was challenging, but because COVID was a priority, everyone faced the same issues with resourcing,” says Christian. “Whoever I was working with – the supplier, customer, Trust, or CliniSys colleagues – we all pulled together to get the job done.”
In one incredible example of what’s possible, Christian and his colleagues were asked to upgrade a LabCentre system at East Suffolk and North Essex NHS Foundation Trust to enable the processing and sharing of coronavirus test results in just four weeks – a project that would typically take at least four months.
“It was a tremendous effort to complete the project,” explains Christian. “Everything was accelerated. The kit was installed and configured, end-to-end testing was completed, and the project was successfully delivered.”
Writing to the CliniSys team Heiko Kausch, Head of IT Project Delivery at the Trust, was full of praise: “We acknowledge activities were relentless, and tensions were high; however, with persistence, motivation, commitment and perseverance, you managed to deliver the project successfully without any major issues, significant costs or delays.”
Christian is modest about the achievement, but the project is an incredible example of what’s achievable when organisations and individuals work together toward a shared goal. Heiko Kausch signed off his message with personal thanks. “I take this opportunity to personally thank CliniSys for the courage, contribution and extensive hours worked to see this project through for us.”
Prioritising in a pandemic
So, what makes excellent customer service? “It’s about being transparent with customers about what’s realistic and achievable, particularly when it comes to timescales,” says Christian. “We have daily calls where we discuss new projects and booking dates. If we have the resource available, we’ll slot the job in.”
Understandably, projects related to COVID-19 have taken priority at CliniSys, something that customers with other issues have understood and respected. “As a team and as project owners, we set expectations at the beginning of every project and stick to them. This builds trust and ensures that we’re able to deliver to the agreed dates, rather than promising something that’s unrealistic or unachievable.”
A successful project is about collaboration – often involving multiple individuals and organisations working together, says Christian. “When dealing with this entirely unexpected pandemic, I’ve seen a unified approach from CliniSys and our customers too. As a collective – between customer and supplier – we’ve worked incredibly well together.”
Great customer service is about creating a successful relationship, which is based on mutual respect. Dealing with the emerging crisis has helped to strengthen the relationships between partners and providers, which will continue in the post-COVID world, Christian believes. “There’s a positive attitude and a genuine desire to do the best we can for one another,” he says.
So, just how is he enjoying his new role? “Never in my career have I have ever experienced anything like this before,” Christian says with a smile. “I love it.”
Effectively triaging ICT issues as soon as they arise is crucial for fixing them says Felice Di Rienzo, Services Director at CliniSys. The triage process involves critically analysing a pathology system to identify the component in the puzzle that’s failing. The quicker this can happen, the faster it can be resolved.
It’s about applying the right expertise at the right time, Di Rienzo believes. Here he provides five tips to improve your ICT triage in the unlikely event that problems arise.
Modern pathology laboratories rely heavily on their IT systems, with the performance of the lab intrinsically linked to a network of independent and interlinked systems, processes and technologies.
Pathology LIMS systems are a central part of a complex web of connections. Reassuringly, LIMS systems are remarkably robust and system failures are incredibly rare.
However, sometimes issues can develop elsewhere within a system that cause outages. A breakdown between the LIMS, PAS, EPRs and lab machinery, for example, can be catastrophic to productivity and disastrous to patients.
ICT triage is a rapid, methodical and meticulous process to assess an issue and analyse its root causes. If you become aware of a problem with your ICT system, the sooner you can identify its cause (or potential cause) you can act.
Here are five tips to help you get it right.
1. Collect an effective minimum data set (MDS)
Information is power when it comes to ICT. Creating a robust minimum data set and a clear description of the problem and your views on its cause can give providers and partners a head start on fixing your problems.
As a LIMS system software provider, these insights can help us to focus our efforts on the right areas. If you alert us to an issue but don’t provide sufficient supporting information, we’re fumbling around in the dark.
While experience can help us to diagnose issues rapidly, any additional information and insight you can provide can speed up this process.
2. Check any environmental issues which can impact ICT systems
There are always local environmental issues that can affect the performance of software, such as network outages. Before contacting your suppliers, conduct a series of simple checks to see whether the problem is local.
As a good starter, checking whether emails or internet access are working will tell you if there’s a network outage, for example.
3. Know your ICT platform and the suppliers who provide each part
Pathology laboratories use a mixture of software, systems and products sourced from a plethora of suppliers. By understanding who provides and supports each part of the system, you can get through to the right person quickly if you diagnose a fault.
At CliniSys, for example, we regularly receive calls from laboratories who are experiencing technical issues with hardware, that we can’t solve because it is supported and maintained by another party. This frustrates the customer and slows down the resolution process.
4. Don’t be a victim of circumstance
Laboratories can sometimes be victims of circumstance, with substantial changes to their environment, systems and supplies often conducted by external agencies and local ICT teams without their knowledge.
New workstations, operating system patches and network infrastructure changes can all disrupt a previously stable system, so ensure you’re on top of updates and changes. If you are aware that your ICT provider is due to carry out any routine maintenance or fixes, ensure everyone in the laboratory is aware.
5. Understand integration
Integration is undoubtedly one of the most complex areas of ICT support, with pathology lab systems involving multiple systems, suppliers and components. Issues with integration are the most frequent, and often more complex to identify and fix – because each problem can include numerous organisations, systems and teams.
It’s crucial that you understand and map the interactions within your laboratory. No external supplier, even one as embedded in your organisation as a LIMS system provider, can ever have the insight that you do.
Developing a systematic understanding of your system and the way it joins together will enable you to conduct rapid fault finding and analysis.
Knowledge is power
When it comes to tackling ICT issues, knowledge is power. If you are a CliniSys customer, our knowledge base is packed full of useful information and advice that could help you tackle your ICT issues.
If you need to contact someone about a CliniSys product, use our dedicated UK customer service portals.
Our chief executive, Richard Craven, reflects on some of the profound changes that the novel coronavirus has brought to CliniSys, to healthcare, and to pathology, and how they are likely to play out in a post-Covid future.
I was appointed chief executive of CliniSys a year ago, and it is certainly been an eventful year. We moved into our new offices in Chertsey on 1 February, and as part of the move we refreshed our IT.
All our key systems jumped to the cloud, we became virtually paperless, and we deployed the latest Microsoft collaboration technology and Oracle business systems. So, when the novel coronavirus arrived in the UK, we were well-equipped to work remotely.
Which was fortunate, because on 23 March that is what we all did, as prime minister Boris Johnson instructed the country to ‘stay at home’.
Supporting the NHS through Covid-19
Remote working has worked exceptionally well for us. There is still a place for the office and, as long as we can do it safely, we will use our new headquarters to get our teams together to share purpose, hold creative meetings, and re-energise our colleagues.
We will also need to start to visit our customers again, combining on-site working with the best of our new delivery methods. Yet, in four months, we did not skip a beat. We did not record a single business or customer issue related to remote working. And yet we have been exceptionally busy.
We engaged with Public Health England as it put its communicable disease surveillance onto a new footing. Data liquidity was key, so we sorted out lab to lab connectivity. We delivered more than 60 connections to the National Pathology Exchange, NPEx, and have just a few left to do.
We delivered something like 80 analyser integrations, to help labs play their part in getting to the government’s target of 100,000 tests per day. We also developed Covid-19 specific order sets and dashboards to help labs handle Covid-specific requirements.
Virtual LIMS deployments and ICE innovation
We were involved with the first three Nightingale Hospitals in London, Birmingham and Bristol. In Bristol, that meant responding rapidly to a request from Severn Pathology for a piece of integration work to link the IT systems used by the labs at North Bristol NHS Trust with the IT systems deployed at the Nightingale, which are run by another city trust that uses a different instance of ICE.
We had a number of virtual go-lives. Two big projects were for Black Country Pathology Services and the labs at Luton and Dunstable University Hospital NHS Trust, which have deployed WinPath Enterprise as part of the development of the pathology network with Bedford Hospital NHS Trust.
And we worked with customers who wanted to innovate. A great example was a piece of work that we did with Hampshire Hospitals NHS Foundation Trust, which wanted to integrate ICE with its communications system, so staff could be given negative results by text.
New product developments, a genomics launch and a plan for cloud
CliniSys was also very busy in Europe. In Belgium, we delivered a LIMS to a new reference lab that was set up in just eight weeks to conduct testing for the whole of the country.
We did something very similar in the Netherlands. While in France, we worked on a new system to get results back to hospitals and GPs nationwide. All of this has made us faster and more agile about deploying our products, and that will continue. That will be an ongoing change for us.
At the same time, we have continued to develop our products. We have made enhancements to ICE and to WinPath Enterprise. Most significantly, WinPath Enterprise 7.24 was released and is in beta in Black Country Pathology Services and a couple of other networks.
We also launched our genomics product into the UK, which is very significant because it takes us from the wet lab into the genetics space, and we announced that the next generation of our products will be cloud native applications.
Healthcare reaches a digital tipping point
Many of the changes that we have seen at CliniSys have been mirrored in healthcare. At the start of the outbreak, the NHS also deployed Microsoft Teams. It rolled it out to 1.2 million staff in just four days to enable remote working, and trusts are reporting that thousands of staff are now doing their jobs from home.
The corollary for patients has been a rapid expansion of virtual clinics and consultations. In 2019, just 7% of GP consultants were carried out online. In July, a survey by the Royal College of General Practitioners found that just 11% of GP consultations were carried out face to face.
Those changes are here to stay, and they have pushed healthcare to a digital tipping point. The pandemic delivered the ‘radical shock’ that was needed to overcome professional concern and resistance to change. It also created a new backdrop of data enabled services as the backdrop to people’s lives, as they visited family on Zoom and sent shopping on Amazon.
Changes to pathology
There hasn’t been quite the same impact on pathology. Laboratories have been disrupted by the pandemic and will need to get back to conducting a different balance of tests as the NHS looks to ‘reset’ and get on top of the enormous backlog of elective work that has built up.
However, some of the changes that we have seen over the past few weeks are here to stay. For example, I think the focus on surveillance and testing for infectious diseases will continue, if only because we are already seeing how important that will be to control localised outbreaks of Covid-19; and to head off any second wave.
I also think the focus on data will continue and that it will benefit pathology. We will be able to work on ‘computational pathology’, on bringing data together for multi-disciplinary team meetings, to create more sophisticated diagnostic tools, and to stand-up digital and precision medicine supported by machine learning and AI.
The post-Covid world
I further think some of those bigger technology trends will impact pathology in the longer term. If we can work from home, we can work from anywhere, and that has the potential to make pathology a global business.
Some years ago, I worked in Holland, and I have a friend from that time who now lives off the coast of Venezuela, in Aruba, for six months of the year. In the US, it is common for pathologists to work from home for clusters of hospitals.
Work is going to come to people, instead of people going to work, and as part of that rules and regulations will need to change. At the same time, I think we can expect more changes for patients. During the coronavirus outbreak, we built a simple portal to support home testing.
The challenge that initiatives like home testing face at the moment is the ‘last mile’ – getting tests through the door and getting samples back again. I think the answer will be Amazonification. We will run our laboratories, and we will integrate with organisations that are experts in covering the last mile.
The CliniSys road map recognises this; particularly in its focus on cloud computing, which has developed to enable systems to be deployed easily, accessed through browser technology, and scaled as required. In the shorter term, it will enable us to deliver smaller, more rapid upgrades, which is something I know that customers want!
The MTV Moment
A colleague suggested that the rapid changes in the adoption of technology that we have seen over the past four months mean that healthcare has had its ‘MTV moment’. Once MTV launched, the way people produced and consumed music was never the same again.
The impact of Covid-19 on some patients and their families has been terrible, and I want to thank everyone who has worked so hard through this crazy time to lessen its impact. But the impact of Covid-19 on CliniSys and pathology has also driven change that will be positive, because it will enable us to use technology to shift our focus from organisations to the work at hand and to delivering for patients.
Gaining ISO 15189 accreditation is just the start of the hard work, says Tony Oliver, Programme Manager and laboratory accreditation expert at CliniSys. The ongoing accreditation process is a challenge that involves everyone in the lab, with LIMS at its heart.
It’s evident that LIMS systems are critical to the functioning of every lab – but relatively few people understand the technical workings of the system. Even fewer understand what is required to satisfy ISO 15189 LIMS standards, a situation that can cause problems when the annual accreditation assessment takes place.
Learn why LIMS is crucial to achieving ISO 15189, and the areas you should focus attention on.
Your Standards aren’t flexible
Let’s start with the basics. An accreditation standard is an objective and well-crafted statement of the requirements of the laboratory. There’s no room for flexibility or negotiation.
A requirement within as standard is not an option; it must be fulfilled. Here’s a real-life example:
“5.3 Laboratory equipment, reagents, and consumables
NOTE 1 For the purposes of this International Standard, laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems.
The laboratory shall have a documented procedure for the selection, purchasing and management of equipment.”
The language here is unequivocal. You must have a documented procedure to hand. If it’s requested, you must be able to provide it – no if’s or but’s.
Assessors are likely to be peers, who understand the pressures of working in a laboratory. They are working from a presumption of innocence, not guilt. During an inspection, they’re not trying to catch you out, but they will recognise failures and raise them with you.
They want to see what procedures you have in place and what evidence there is to support your fulfilment of a standard. Increasingly, they’ll expect you to provide detailed written evidence to support your assertions – so bear that in mind when preparing for an inspection.
If you’re wondering where to start, the governance of LIMS system quality is covered by standards in sections 4 and 5.
Common LIMS errors
One of the most familiar LIMS-specific issues during an inspection is missing or incomplete documentation for systems. This includes both implementation and routine use.
The reasons are pretty typical. Over time, laboratory documentation can spiral out of control. A few documents can quickly become hundreds. Managing of this mountain of paperwork can eventually become impossible.
Laboratories have a habit of developing numerous small documents tailored to precise requirements. If you have 500 documents, you have to regularly review, store and manage 500 – which can become an onerous task. As a best practice, laboratories should seek to limit the number of documents they create. Not only will this reduce the documentary overhead, but it will also make it simpler to find the information you need during an inspection.
Spotlight on software
When it comes to software, laboratories must devote a significant amount of time to the validation and verification of changes to the system. This isn’t optional, it’s essential.
The systems and software you use in the laboratory are your responsibility. As a supplier, we maintain records of all software implementations, but these records will not cover decisions your organisation has made on changes. Ultimately, you are in control of the software – and must provide evidence if it’s requested.
During the assessment process, it can become apparent that senior managers and quality managers may not understand their LIMS sufficiently. This can result in a disconnect between the required standards and their interpretation in the real world. This divergence can lead to non-conformities. Similarly, laboratory IT managers may not be sufficiently well versed in how to achieve compliance with ISO standards.
In this situation, the knowledge, expertise, and evidence resides within the laboratory. It just needs to be unlocked through collaboration and communication between partners – ideally a long time before an assessment.
Within the laboratory, quality is often considered the Quality Manager’s job – but this is a mistake. Quality is everyone’s responsibility.
All staff who interact with the LIMS must understand the impact of Quality Control and Quality Assurance and the importance of governance of quality in the laboratory. Everyone must contribute to the documentation that safeguards, protects and improves quality.
When it comes to the LIMS system, specifically, you must identify an individual who understands both the importance of quality standards and the complex IT systems that power modern laboratories.
Ideally, this is a single person, but in many cases, a successful accreditation will involve the development of a close working relationship between the laboratory’s Quality Manager and the IT Lead.
Whoever is responsible for preparing the laboratory for its assessment, they must have the authority and confidence to lead and drive change.
Culture not process
The accreditation process is tough, but it is fair. You will be given a chance to prove yourself and be allowed to learn from your mistakes. But what happens when the assessors leave the laboratory?
Quality is about culture, not processes. If you can instil a commitment to excellence among all staff and an understanding of the critical importance of clear documentation, you’ll adhere to both the letter of the standards and their spirit.
5 tips for successful ISO 15189 accreditation
- Read the exam question. If you can’t answer it, then there’s a gap that must be filled. Pay particular attention to the language used, for example, words such as “shall” or “documented procedure” carry particular significance. Always ask how will I prove compliance?
- Ownership and recognition that LIMS is of enormous significance to the lab’s output.
- Create as few documents as you can get away with.
- Don’t wait. If you’re expecting an assessment, have all documentation ready as soon as possible. Preparation gives confidence.
- If you believe you have satisfied the standard, make the point to the assessor, and provide the evidence.
Appendix A – ISO15189 Standards that impact on LIMS
|4.13 Control of records|
|4.5.2 Provision of examination results|
|5.2.2 Laboratory and office facilities|
|5.3 Laboratory equipment, reagents, and consumables|
|184.108.40.206 Equipment acceptance testing|
|220.127.116.11 Equipment instructions for use|
|18.104.22.168 Equipment calibration and metrological traceability|
|22.214.171.124 Equipment maintenance and repair|
|126.96.36.199 Equipment adverse incident reporting|
|188.8.131.52 Equipment records|
|5.4.6 Sample reception|
|5.8 Reporting of results|
|5.8.2 Report attributes|
|5.8.3 Report content|
|5.9 Release of results|
|5.9.2 Automated selection and reporting of results|
|5.9.3 Revised reports|
|5.10 Laboratory information management|
|5.10.2 Authorities and responsibilities|
|5.10.3 Information system management|
CliniSys has delivered a laboratory link for NHS Nightingale Hospital Bristol (Nightingale Bristol), so clinicians can request tests for patients and receive the results electronically.
We responded rapidly to a request from Severn Pathology for a piece of integration work. This work was to link the IT systems used by the labs at North Bristol NHS Trust with the IT systems used by the Nightingale Bristol. The IT systems used by the Nightingale Bristol are run out of University Hospitals Bristol and Weston NHS Foundation Trust. The integration enables the CliniSys WinPath laboratory information system used by North Bristol to pick up requests for tests placed in the version of CliniSys ICE used by the Nightingale Bristol and return the results through the ICE system. Pathology services manager David Gibbs explained: “The Nightingale Bristol is designed to provide the highest level of specialist care for critically ill coronavirus patients in the Severn area critical care network. “Diagnostics is vital to running an ITU, so as preparations were made for the new facility, we knew that it would need to be linked up with the labs at North Bristol, which can run all of the tests required.
“Getting NHS IT systems to talk to each other can be notoriously difficult, but CliniSys developed a plan and executed it very quickly, working over the Easter holidays. We went from the seemingly impossible to having a slick solution in a matter of days.”
Covid-19 is a respiratory condition. People who are critically ill with Covid-19 need oxygen while their lungs recover, and clinicians need to be able to measure the amount of oxygen in their blood to assess their condition. Severn Pathology, a partnership between North Bristol NHS Trust and Public Health England, has installed blood gas analysers and other point of care devices at the Nightingale Bristol to take these measurements. However, clinicians also need to conduct other tests that cannot be carried out on site.
Gibbs explained: “Patients with Covid-19 who are being ventilated are in an induced coma, so they cannot tell a nurse or a doctor that they are thirsty or tired. Clinicians need to check whether their kidneys and their circulatory system are working and find out whether they are anaemic or suffering from a secondary infection.
“It is critical for them to be able to order tests for those and many other conditions and for the results to be integrated into the patient management system they are using. The integration work that CliniSys carried out means
that clinicians have all the data they need together, in one place.” Mr Tim Whittlestone, medical director, NHS Nightingale Hospital Bristol, and deputy medical director at North Bristol NHS Trust, said: “The integration work required to ensure separate IT systems are able to talk to each other has been vital to support the wider health picture of people with Covid-19. “It was a daunting and complex exercise to ensure the pathology and testing aspects of the Nightingale Bristol project were put in place, but due to the expertise of CliniSys and the collaborative energy of those involved, it became one of the most straightforward. “Our work with CliniSys and other digital partners means that our hospital is completely paperless which not only increases our efficiency but supports the health and safety of patients and staff.” NHS Nightingale Hospital Bristol has been created within the University of the West of England (Bristol) campus. It is one of seven created across England, and officially opened on 27 April as an important part of the south west’s contingency planning for Covid-19.