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 | MIPS 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 | MIPS 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.