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
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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|
|188.8.131.52 Equipment acceptance testing|
|184.108.40.206 Equipment instructions for use|
|220.127.116.11 Equipment calibration and metrological traceability|
|18.104.22.168 Equipment maintenance and repair|
|22.214.171.124 Equipment adverse incident reporting|
|126.96.36.199 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.
What genomic laboratory hubs can learn from pathology networks; why is the first lesson ‘implement a single LIMS?’
What can the mobilising genomics laboratory hubs learn from the more advanced pathology networks? CliniSys marketing manager Matthew Fouracre put the question to programme manager Tony Oliver and genomics consultant Steve Abbs, who agreed the first lesson would be: implement a single laboratory information system to drive standardisation.
The NHS in England is changing the way its laboratories are organised. Pathology labs are being encouraged to form networks, while genomics labs are being brought into hubs. The most advanced pathology networks have been in place for five years or more, so there are many things that hubs can learn from their experience.
One is that a single laboratory information management system is essential; so hubs should be looking to work with an IT supplier with a deep knowledge of pathology networks and a LIMS built to meet their requirements. Matthew Fouracre talks over the issues with Tony Oliver and Steve Abbs.
Matthew: Let’s start with some background. Why are pathology networks being formed?
Tony: Pathology consolidation has been happening for many years, but it is accelerating. It is being driven by national reviews, particularly the first review of NHS productivity and efficiency carried out by Lord Carter of Coles in 2015, and by NHS England/Improvement’s proposal to create 29 pathology networks in 2017.
The most recent ‘state of the nation’ report said that 97% of labs are engaged and 76% are on track to have a network in place by the end of the year. The argument is that networks will pull out cost while improving quality by consolidating and standardising a lot of the work that is done.
Matthew: Steve, from the genetics perspective, does this sound familiar?
Steve: It does. Genetics labs have historically been linked to research programmes and several of them are small and provide highly specialised services. Following the 100,000 Genomes Project that ran from 2014-18, NHS England created a national Genomic Medicine Service, with seven genomic laboratory hubs or GLHs.
A big part of that is about improving quality by getting more work done at scale and with more consolidation of testing services. Equity of service is also a driver. If you are testing siblings, and one lives in one part of the country, and another lives in another part of the country, then you need to make sure that the tests that go to different laboratories are done in the same way and generate the same result.
Matthew: Where are the GLHs at on their journey?
Steve: The GLHs were awarded via open procurement in 2018. The idea is that one lab in each hub should conduct the majority of tests for their region, to capitalise on economies of scale. In particular, this applies to diagnostic sequencing tests, as these larger labs will be able to utilise the large capacity of high throughput next generation sequencers.
The other labs in a GLH network will continue to perform tests where there are fewer benefits from centralisation, for example because they are performing specialist tests on a supra-regional or even national level, often in association with expert clinical and academic colleagues.
In addition, one national laboratory will perform whole genome sequencing for the whole country, for a specific range of clinical indications where the underlying genetic defects could be in any one of a large number of genes. For these disorders – and the list is likely to increase over time as costs come down – sequencing the whole genome is a practical and efficient way of making a molecular diagnosis.
The mobilisation period has been more protracted than was originally envisaged, but this is a very ambitious programme. It is bringing together disciplines that have traditionally been separate, bringing together labs that may not be used to working together, and pushing for standardisation – while looking for financial savings!
Matthew: The pathology network managers that we work with say a single LIMS is key. Why is that?
Tony: As Steve has just been explaining, it’s easy to say that labs should conduct tests and issue results in the same way, but it is very difficult to achieve. To most of the NHS, labs are a bit of a black box – orders go in and results come out – and that makes it difficult to find levers for change.
Even when trusts have agreed to form a pathology network, they can find it hard to make progress because each of the labs involved will have different contracts and cultures and ways of doing things.
It takes determination and skill to break down those barriers; and taking the decision to deploy a single LIMS can help. In order to deploy a network LIMS, you need director-level guidance and a design authority. What typically happens is that the LIMS programme becomes the catalyst for change. You get people together with their peers, and you get them to focus on issues in great detail – right down to the level of how to report a full blood count – and then the LIMS is built to execute those agreed, standardised workflows.
Matthew: In other words, the LIMS drives standardisation?
Tony: That’s right. Also, as a company, we have developed our MasterBuild for the LIMS that is a good starting point for these discussions. It addresses the big challenges that labs face and incorporates the best workflows from the different labs that we work with, while enabling customers to do some things in the way that works for them.
Alongside that, we have a documented method for deployment, that shows what needs to be done and by whom. When customers sign it off, it becomes their way of doing things. That is what we hope to be able to do for genomics labs, in time.
Steve: I like the idea of the LIMS being the catalyst for standardisation. I’ve written another blog [hyperlink to genetics blog 2b] about the drivers and facilitators for standardisation in genomics labs, and I think that introducing a single LIMS is probably the most important facilitator.
The other thing GLHs will be thinking about is integration with the electronic patient record. When you are handling samples and results, you need to be able to identify the patient they relate to. The GLH regions are big geographical areas that don’t align with any of the NHS’s other regions, so the chances of them being able to use a single master patient index are not high. That means integration with hospital electronic patient records is essential. The CliniSys LIMS will integrate with any of the major EPRs out there.
Matthew: At a more basic level, a LIMS will also remove a lot of paper from genomics labs?
Steve: That’s true. At the moment, the process of ordering genomics tests, and of sending them from one lab to another, is very paper-based, and the cost of handling paper is huge.
With the model of centralising most tests to one lab within a genomics laboratory hub, centralising whole genome sequencing to a single national lab, and consolidating the specialised tests to say two or three labs in the country, there will be an enormous number of tests being sent from one lab to another.
If a GLH was to start using a single LIMS across all of its laboratories, it would certainly simplify the whole process of managing all the send-away tests within its network, by removing a lot of that administrative overhead. But imagine if that went a step further and all GLHs operated with the same LIMS !
Similarly, a lot of genomics labs are still using Excel spreadsheets to manage their workflows and re-keying information from analysers into LIMS. A LIMS that integrates with those analysers removes a lot of the cost and the clinical risk associated with transcription errors.
I wrote another blog [hyperlink to genetics blog 1] about the advantages GLHs could glean from introducing a modern LIMS, around efficiency, plus standardisation, plus integration with the electronic patient record. Without that, I don’t see how we are going to lay the foundations for the precision medicine that we are all so keen to deliver.
Matthew: So, in conclusion, what should genetics lab managers and GLH Operational Directors be looking to learn from pathology networks, as they move forward?
Steve: The GLHs are mobilising, but they are not all functioning yet as efficient networks. So, I think they should be asking: ‘what does it mean to be a network?’ and: ‘what do we want to achieve by becoming a network?’ and ‘what do we want to deliver for clinicians and patients?’
Tony: As they do that, I think there is a lot they can learn from other areas of pathology because the mature pathology networks have asked and answered those questions and they are delivering real benefits.
Also, the impact that can be achieved through the introduction of a single, modern LIMS should not be underestimated, because if there is one thing that all the successful pathology networks have done, it is to move to a single LIMS. That is what has enabled them to realise most of the benefits that they set out to achieve, and by taking the same approach those benefits can also be achieved in genomics.
One of the major drivers for forming genomic laboratory hubs is to ensure quality at scale and equitable testing, by encouraging greater standardisation. However, CliniSys genomics consultant Steve Abbs argues that hubs in themselves will struggle to achieve this, and other drivers and facilitators are needed – not least a single LIMS.
Genetic medicine has developed rapidly over the past thirty years, and the NHS is making increasing use of genomic testing to inform treatment decisions for cancer patients and those living with inherited diseases. To support these developments, NHS England has created a Genomic Medicine Service, with seven genomic laboratory hubs to deliver the National Genomic Test Directory.
Steve Abbs, genomics consultant to CliniSys, says genomics labs are aiming to adopt standardised ways of working in order to maintain quality and improve efficiency as they start to deliver the much greater volume of testing that will be required to support the development of precision medicine.
In this blog, he considers some of the factors that drive and support standardisation, based on 25 years’ experience of running genetics labs in Cambridge and London, and CliniSys unrivalled expertise in delivering LIMS to pathology networks.
What drives standardisation in clinical genomic testing laboratories?
There is a requirement to achieve laboratory accreditation to ISO 15189 Standards for Medical Laboratories. However, while the standards specify the generic aspects that medical laboratories should abide by through use of a quality management system, they do not specify how different tests should be performed.
- External quality assessment
Achieving satisfactory performance in external quality assessment schemes is a requirement of ISO 15189. EQA assesses a laboratory’s ability to achieve a “consensus” outcome for a given test. Again, the process does not specify how the different tests should be performed in order to achieve this “consensus” outcome.
However, as a general rule, if a lab is applying the same testing methodology as all the others, it would expect to achieve the same results; so adopting “consensus” testing methodology helps a lab to achieve the “consensus” results it needs in EQA.
Clinical genetics laboratories are testing for genetic variants that are inherited within families, so it is essential that relatives with the same genetic variant receive the same information about that variant. This makes it particularly important for genetics labs to standardise their testing and reporting practise.
For example, if two siblings affected with the same inherited disorder are tested in different laboratories because they live in different parts of the country, an element of standardisation is required to make sure that they both receive the same quality of testing (sensitivity and specificity) so the causative genetic variant present is actually detected in both individuals.
At the same time, an element of standardisation is required to make sure that the genetic variant found in both siblings is interpreted in a consistent manner by the two reporting laboratories, both in terms of what that variant means (is it pathogenic or benign?) and what the implications are for those individuals and their clinical management.
Without standardisation, there is the possibility of two siblings with identical genetic variants being clinically managed very differently; this would likely come to light in time, and the two laboratories would need to review their results and reach a consensus. However, damage may have been done before the difference was realised.
What facilitates standardisation?
- Professional best practice guidelines
Labs and clinicians working in them have access to disease specific guidelines (for DMD, Cystic Fibrosis, Huntington disease, and so on) and generic guidelines (for reporting, prenatal testing, variant classification, etc) and both types of guideline encourage a standardised approach.
Laboratories are likely to follow best practice guidelines or BPGs because they are developed using a consensus approach by the profession. Often, there is a workshop at which key experts will gather and reach a consensus on the best approaches, after which the guidelines undergo a formal review and consultation process, giving everybody in the profession the opportunity to contribute to and express their opinions.
This whole process is overseen by the Quality Sub-Committee of the Association for Clinical Genomic Science in the UK, and by the European Molecular Quality Network at a European level. These two organisations often “join forces” to share and endorse each other’s guidelines and avoid unnecessary duplication.
Often, the BPGs will form the basis for developing the marking criteria that are used in EQAs, and therefore it is in laboratories’ interests to follow the guidelines if they hope to achieve satisfactory EQA performance.
A key aim of the formation of laboratory networks is to enable economies of scale through the consolidation of testing into larger, higher throughput, highly efficient laboratories. The process of consolidating certain tests into a single laboratory obviously brings about standardisation for those tests and for the population covered by that network.
But it does not ensure standardisation between networks. Indeed, there is no guarantee that tests that are still performed in more than one lab within a given network will be standardised. They may be, but this will require co-ordination and instructions from the network management.
As a result, networks are a facilitator rather than a driver of standardisation. Not least because the journey towards standardisation can be lengthy and stressful, since there is little real incentive for those directly involved in the testing to move in this direction.
- A single laboratory information management system (LIMS)
Without a LIMS, procedures in a laboratory have to be managed using a combination of paper and spreadsheets. As laboratories expand and take on more work, both through consolidation and through increasing demand for tests, a high-quality LIMS becomes an essential tool for doing this work.
A LIMS can help to make the daily functions of a laboratory more efficient, through bringing together all the information that is needed to conduct a test, to interpret the results, and to generate a clinical report. All the data will be stored in the LIMS, making it readily accessible to managers, who can see at a glance the status of any operation.
That means they can spot bottlenecks immediately, before they generate large backlogs, and deploy resources to avoid such problems. That helps to ensure continual high efficiency.
At the same time, the experience of the development of pathology networks in England demonstrates that the introduction of a common LIMS across all laboratories within a network can act as a real catalyst towards standardisation in those labs.
The process of introducing a new LIMS, or a new procedure within an existing LIMS, requires considerable planning to make sure that optimal use is made of the system, that it contributes towards an efficient workflow, and that it captures the most appropriate data at different points in the workflow.
That process of planning is an ideal opportunity to assess workflows for opportunities to improve efficiency. Then, once an optimal workflow has been established, only a single approach is required within the LIMS to manage it. The result: all laboratories undertaking that procedure end up with the same process – immediate standardisation!
Time for genomics labs to invest in a LIMS
The big take-away here is that while a LIMS will help primarily in making laboratory procedures more efficient, the process of planning for and then deploying a LIMS will additionally ensure common procedures in all labs adopting that LIMS.
Indeed, while there are many drivers and facilitators for standardisation, a common LIMS can act as its catalyst, by making sure that all labs in a network adopt best practice approaches and optimal workflows.
If you are about to embark on going out to tender to find a CellPath LIMS supplier, what are the criteria you should consider in choosing a vendor? Sam Grobler, CliniSys product manager, offers some key recommendations.
1. Digital Pathology
This provides the ability to present digital images and having access and reporting on them from different areas of the globe and in different time zones. Having digital capability can significantly reduce turnaround times on pathology workload if, for instance, a specialist is located elsewhere globally from the laboratory. This creates an international 24 hour work routine.
Ability to share slides and communicate within a specialist group of pathologists, in real time, greatly reduces turnaround times. This needs a central laboratory information management system that is able to cope with sharing the data as part of the laboratory IT system.
Currently, there is a shortage of pathologists, which is compounded by the fact that not every pathologist specialises in every tissue. So we need specialists to be easily able to see the slides relevant to them. Giving them access to digital pathology ensures that the best and most appropriate person that you need is looking at the specimen.
2. Integrated reporting within LIMS
Another area of focus is ensuring there is the ability for production of an integrated report, collating results from multiple different areas. Another hugely valuable function of a LIMS for a pathologist is being able to see all pertinent information about a patient in one place without wasting time having to dig around in multiple different systems looking for a patient’s treatment history.
When reporting on a patient you want to see if the patient has had any other treatment, and if there are any results from other disciplines outside pathology, such as radiology. Genetics testing too is becoming more and more valuable within the resulting of a case.
We are beginning to see a large requirement in the UK, US and Australia to be able to register that a sample has been collected in the LIMS from a third party like the order comms system or hospital information system.
You want a LIMS system in which the key order information arrives without having people interact with it or chase up to find where the sample was taken, when and who took it. You also want a LIMS that sends out the results to all the pertinent people, not just the requesting clinicians but also regulatory bodies and bodies such as cancer services.
3. Track and Trace
This is the ability to track within your LIMS. You need a LIMS system that is going to track and trace specimens around the network. Currently third party systems are being used for track and trace but they are very limited and do not track all the way through the process.
The LIMS needs to track and trace from beginning to end and also in between, if specimens are moving from lab to lab. You need a LIMS that can scale up and scale down as much as you want it to, and that has the flexibility to work say only with CellPath but then also with very large networks with other disciplines.
Your LIMS should also be able to take the capacity and pressure that the laboratory is under. Some labs are doing only ten samples a week, some are doing 2,000 a day. You need that scalability.
Ideally, you want an ability for the overall process within the laboratory to be captured in the LIMS. Monitoring what is going on is much easier if it is captured in the LIMS in one place, it’s hugely valuable.
There should be integration of the LIMS generally, such as with hospital systems, slide strainers, and cassette labellers, but keeping the laboratory process and the laboratory integration separate is important, particularly with CellPath. There are though differing approaches on this in the UK compared with Europe.
6. A future road map
There have been so many changes in recent years in areas such as digital pathology and testing techniques, that you want a LIMS that is going to deliver not just now but also in ten years time. So look for a system that has a strategic eye on the future.
7. Support national reporting functionality
Lastly, your LIMS needs to be able to capture and maintain national reporting functionality and supporting delivery of SNOMED CT and national catalogues incorporation.
Procuring a new pathology system is more than just finding the lowest cost supplier, says Darren Ransley, Sales Director at CliniSys. You should focus on identifying a provider who understands and shares your vision for pathology and can help you to achieve this. In this article Darren offers his five best-practice tips for pathology professionals embarking on their procurement journey.
When beginning the process towards procuring a new pathology system, there are so many questions and competing priorities. You have to do a service reconfiguration; you have to standardise and replace equipment and of course you have to select and embed a LIMS system all whilst undertaking a transparent, fair – and often accelerated – procurement process. So what comes first?
Instead of diving in, first take a step back and reflect. To help you in that process, here are my five best-practice pre-procurement tips.
1. Build a common understanding
Pathology redesign has the potential to change pathology services for the better, delivering higher quality outcomes more efficiently – but only if everyone shares the vision for the future and buys into it wholeheartedly.
Central to the success of any procurement process and system reconfiguration is a shared vision for the programme that’s simple to articulate.
Everyone involved, from the laboratory to the boardroom, needs to buy in to the potential for pathology service redesign. Building this common understanding at the start is fundamental.
You can formulate this vision into a roadmap for success that you can describe, share and, when necessary, revise.
2. Identify and agree on your network priorities
Pathology networks have emerged because they centralise experience. By bringing them together, experts can perform their critical functions more efficiently and effectively.
The driving force in pathology redesign is improving quality of care, not cutting costs, says NHS England. It’s about developing a sustainable and viable pathology service at a national, regional and local level.
When designing your procurement process, define and agree on your priorities as a charter and use these to guide you.
Procurement processes naturally focus on numbers, and there are cost savings to be made – but pathology service reconfiguration is more than that. It’s about centralising experience, sharing knowledge and improving the speed and quality of diagnostics.
At a practical level, you should seek to work with a supplier who understands and shares this vision. You’re not simply buying a LIMS system; you’re investing in a partnership, and you need a partner that will be supportive, responsive and effective.
3. Engage suppliers early
A successful procurement process is about getting the best value, not identifying and selecting the lowest cost supplier. The procurement process must be transparent and beyond reproach, but it should also focus on achieving the best outcomes for patients.
Personally, the best and most effective procurement activities I’ve been involved with have involved suppliers early in the process.
LIMS suppliers will actively seek to engage with you early as soon as possible. This isn’t about attempting to gain an unfair advantage, but about attaining an in-depth understanding of your requirements, priorities and vision as a network.
By listening to you and learning about you, we can shape our offer to your network and your needs. Supplier days – often funded by suppliers – offer a unique opportunity for all sides to develop this understanding and begin a dialogue.
Active and in-depth engagement with suppliers early in your procurement process will not only improve the quality of responses, but they can streamline the process too. Your chosen suppliers will provide better, richer and more relevant answers to your questions when we submit our answers to you.
4. Have a positive mental attitude
Pathology reconfiguration is a once in a generation chance to transform the way this life-changing service is designed and delivered. You’re shaping pathology for generations to come, which is both an incredible opportunity – and a huge responsibility.
Successful leaders approach significant challenges such as this with the right attitude. They have confidence in the process and a belief in the outcome. They share this with their teams, inspiring others to join the journey.
During the process, there will be setbacks and challenges. As your network begins to take shape, you must learn, adapt and evolve.
Having an overriding belief in what you’re doing can help you navigate this uncertainty and lead, even when the future is unknown.
5. Be realistic about time
Procurement processes take more time than you think, so build in some slack.
While there is pressure within the system and organisations to fast-track pathology procurement and reconfiguration, it’s something that you should resist. Compressing deadlines puts undue strain on those leading the process and sets unrealistic expectations to stakeholders.
Be realistic about the time taken to complete each of the procurement stages and introduce a contingency.
Pathology procurement isn’t something you can realistically do alongside a full-time job because it almost is a full-time job in itself.
Successful procurements involve experienced people who are dedicated to the project, with time ring-fenced to focus solely on the outcomes.
And remember, the procurement of a LIMS system is the first stage in a whole process of transformation. LIMS is the enabler of the network, but you will need to invest significant amounts of time on reconfiguring the service, communicating system redesign and culture change.
If you are interested in learning more about the pathology procurement process, you can contact Darren at 01932 581252 for an informal discussion.