Expert Insight: How to Improve the Quality and Management of Your Point-of-Care Testing Environment

In a fully-accredited SelectScience webinar available on demand, Cameron Martin, point-of-care coordinator for all of Queensland, Australia, presents an overview of how one of the world’s largest point-of-care testing (POCT) networks achieved integration using POC informatics. He discusses his key findings from the project, evaluating how he created a single, centralized, open, and vendor-neutral POC informatics environment that is scalable and cost-effective, whilst conforming with ISO guidelines. He also explores the role of training and managing operators ‘by exception’.

Watch this webinar if you would like to:

• Understand how, with innovation, it is possible to establish a functional, high-quality POCT system and network
• Learn how disruptive changes can extend pathology into new areas, and new ways to improve your KPIs
• Understand how online training can help you better manage and train operators remotely, enabling you to manage access, track training, and know which operators are current
• Know how to train ‘by exception’

All webinar participants are eligible for P.A.C.E and ACCENT credits for continuing education purposes.

Think you could benefit from this webinar, but missed it? You can now watch it on demand at a time that suits you and find highlights from the live Q&A session below>>

Q: With so many operators spread out across the entire state, how do you properly maintain your operator training?

CM: Previously, this was all done through face-to-face training, but our network outgrew that method and we moved to an online system. This means that the training is now available 24-7 and we have a traceable record of people's completed training, when they are due for outstanding training, and when they are due for training renewals.

Q: Where do you see point-of-care middleware taking you in the future?

CM: That's an open-ended question. Every time we get a new analyzer to look at or someone poses a new problem or niche application, I think about how we can use our middleware to manage this. Therefore, I think the future of this will be driven by the market, by demand from conditions and, perhaps a little further down the road, by patients.

Q: Do you utilize some type of learning management system to manage your device operators?

CM: Yes, we have an online SCOM-compatible system, based on Queensland Health's main learning system where they keep most of their compulsory competencies. We're just another branch on that tree with our own modules, which is accessible through any Queensland Health computer at any time.

Q: What is the proper way to do QC for biochemistry and hematology? And how do you maintain registers?

CM: In Queensland's larger pathology laboratories, that run 24-7, all the chemistries and the hematology parameters get two or three levels of QC every shift. Any immediately obvious problems have to be fixed by the person on the shift, but anything that's minor or doesn't affect testing at the time, can be reviewed by the quality coordinator and or the lab manager the next day.

Q: What are the main benefits that you've achieved by implementing middleware?

CM: The main benefit is we actually can run that network. It would be impossible without it or, if we were still running with the paper-based system we had before 2014, it would be a much lower quality standard of testing.

Q: Could you describe how QC is reviewed across such a large area and between multiple systems and serial numbers?

CM: That's one of the benefits of middleware. The system largely tracks this automatically for us. Additonally, because we have our laboratories QC-ing our stuff in bulk, we don't have a huge variety of lots running around at any one time. By looking at middleware, we can see the results for each group and the results between groups, and if there's any trending between groups, we look to see if it's linked to a common lot number. Fortunately, this is not something that happens frequently as most manufacturers supply fairly high-quality materials now.

Q: Is training and competency signed off in this service, as ISO requires an observational element?

CM: Yes, and we do this by running a two-tiered network run strictly in accordance with the ISO. All our laboratories and the laboratory sites do the same training program as everybody else but they will be signed off by their superiors and the resultant training certificate is attached to their file. The more remote areas are a little harder to do and they're not all accredited sites, so we can be a little more flexible with them. In this case, when people are bought into the system, we ask that they send us the online training certificate that the system produces, which will then be signed off by their supervisors to confirm that they have not only done the course but have also satisfactorily completed the tests. Once again, we'll append that to their record. After that, we're managing by exception and we're looking at their level of performance. Are they having analysis issues? Are they having trouble with quality control? This is part of their ongoing management, which will reflect what happens when they come up for renewal.

Q: Do trainees have the opportunity to perform hands-on training during the initial and planning process?

CM: Yes, wherever possible. When an analyzer which is new to a site is set up for the first time, we will get one of our laboratory sites to go out and set up the analyzer and perform face-to-face training with everyone. We can either provide online training before the lab goes out to provide context to the face-to-face training or, depending on timing, we might do this after the visit as a form of refresher. Either way, we're using the lab to fill the gaps and the online training as a standardized set of training that will at least set the same basic standards.

Q: Have you established the measurement uncertainty of each point-of-care test and how do you communicate this to your users?

CM: Yes, this is part of our ISO as well. It was rather hard to do with point-of-care so it was done somewhat differently to the laboratory process. We used our pooled QC for our cartridge-based analyzers across the whole state. So, probably our measurement of uncertainty was a more reliable indicator because we've gone with multiple operators, multiple analyzers, multiple cartridge lots but all the same QC lot. And we worked out our MUs on that basis. And that is available on our website for anyone who wants it. We don't report it on the actual reports routinely, but it certainly is available and is there for the assessors when they come through.

Q: Why has ISO 22870-2016 not been used for point-of-care testing?

CM: In Australia, point-of-care has been lumped in with laboratory testing and all laboratories are currently covered under 15189. This does cause issues and in fact, it's giving cause to rethink whether we should split point-of-care off as there are certainly times when trying to use 15189 for the point-of-care round peg and it just does not fit the laboratory square hole. So, that is a good question and it's certainly something that's under review.

Q: Do you have a point-of-care testing management group and/or governance committee which could critically review the service and potentially agree to the extension of testing and allow implementation of new testing?

CM: We do. We actually have a couple of groups. Because point-of-care is a multidisciplinary type of operation, we've got our own point-of-care working group that looks at point-of-care as an overview, be it chemistry tests, hematology tests, or micro tests. We formulate broad guidelines on that basis, and then go to the individual disciplines to get their additional input before we'll implement a new test or a new instrument. Therefore, we work in tandem with our disciplines, which keeps everybody happy and ensures that we've always got specialist advice on any tests that we want to introduce or perhaps even remove.

Q: How do you approach using the manufacturer's QC material rather than third-party QC, which ISO states should be used where available?

CM: There have been times when we've had to make the point to accreditation agencies and accreditation officials that sometimes third-party material simply does not work with a point-of-care analyzer.  It is worth pointing out that another part of the ISO states that the manufacturer's recommendations should always be followed.

Q: Do you have a lab director who takes full responsibility for all of the results that you generate from point-of-care testing? And if not, how is this level of clinical oversight achieved?

CM: Because we're one pathology service across the whole state, we do have one lab director who, in theory, covers all the laboratories including the associated point-of-care testing. However, we also have our individual discipline directors who have oversight over those particular specialties. So, the clinical side of management will initially go to one of the discipline directors and, if necessary, it is then escalated to the overall director for a final decision.

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