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Tool to close the loop between pathology labs and doctors

29 January 2019 | Avant media

Professor Leslie Burnett has invented a simple statistical survey tool that can produce a quantitative score of the accuracy, validity and utility of a pathology report.

“I have a strong view that no matter how hard you work, if a system is not right, it’s going to limit what you can do,” he says, a passionate teacher and communicator about the genetics and genomics revolution.

The project builds on Professor Burnett’s (pictured) previous work developing the world’s-first pre- and post-analytical quality assurance program which is now part of standard accreditation for laboratories in Australia.

Avant awarded the grant to Professor Burnett at Genome.One, a Division of Australian Clinical Laboratories, in association with the Kinghorn Centre for Clinical Genomics at the Garvan Institute of Medical Research. The grant will fund a pilot project to test the tool, which could then be similarly rolled out nationally.

“This tool will make a real difference to improving the accuracy, validity and utility of pathology reports,” Dr Penny Browne, Head of the Avant Foundation Board says. “This is integral to enhancing patient care and reducing clinical and medico-legal risks.”

“If this grant hadn’t come along, it would have been just another good idea that we never had time to get around to,” Professor Burnett says.

The tool will first be tested in genetics, but will be applicable to all pathology.

A quality career

The Principal Medical Geneticist at the Kinghorn Centre for Clinical Genomics within the Garvan Institute of Medical Research, and Medical Director at Genome.One, Professor Burnett specialises in genetic and chemical pathology, and bioinformatics. Over his illustrious career, he has pioneered the development of a number of pathology and genetics initiatives. This included eradicating Tay-Sachs disease from the target population in Australia’s first community genetic screen program, in operation since 1992.

Professor Burnett jovially remarks Genome.One were pipped at the post by colleagues in Alabama who were just two weeks ahead of them in achieving the status of the world’s first fully clinically-accredited diagnostic whole genome sequencing service. However, he notes the US laboratory’s accreditation was for their national scheme only, while Genome.One’s accreditation was international.

In the two years since opening, Genome.One is now a major thread in the fabric of the Australian genetic and pathology landscape. As he says, “This is absolute cutting edge of science. We sequence the whole of all the chromosomes, all the DNA, we get six billion results and we try to find the one that’s at fault. Pathology has really stretched the limits doing so”.

Right now, the majority of their specimens come from doctors who think their patients have genetic disorders such as polycystic kidney disease, cardiomyopathy, and rare paediatric disorders.

The Garvan Institute has recently announced a partnership with Australian Clinical Laboratories, to enable increasing numbers of patient’s access to the technology over time.

“You will never get a pathology report as complex as one of these. It’s got an element of everything,” he says. He wanted to work out how statistical measures could be applied to it, to measure how close to perfection a pathology report was, “This is in terms of being free from errors, free from defects and blemishes, while at the same time being readable and getting the right medical result,” he adds.

Measuring pathology report accuracy, validity and utility

Pathology is one of the most frequently used medical tools. The pathology report is a distillation of the analytical results which should be accurate and scientifically valid, and communicated in a timely manner and an understandable format.

There are already quality control tools for measuring the analytical quality of results and pre-analytical quality assurance tools to measure how well identified the patient is and any artefacts or confounding factors that prevent accurate results between the patient and the laboratory (Professor Burnett’s previous studies).

But naturally, Professor Burnett wanted to close the loop between the laboratory and the doctor, “I turned my mind to how you could measure the quality of that final pathology report. And we now have a quality tool to control all aspects of a pathology report,” he says.

The tool he has developed uses statistical process control methodology to produce a quantitative score of the accuracy, validity and utility of a report. The tool then generates actionable signals identifying both minor loss of quality control (known as blemishes) as well as major loss of quality control sufficient to exceed acceptable specifications (known as rejectables). These will be used to provide real-time closed-loop feedback for laboratories on their performance.

Professor Burnett says the tools gives practitioners, patients and the medical community great confidence in pathology. “Australia is very fortunate, we have an excellent health system and within that we probably have one of the best pathology services in the world. But every now and then, a doctor can get a report and think, ‘Hmmm that doesn’t look quite right,’ but with this tool, that will be a thing of the past,” he says.

According to Professor Burnett, this tool will be able to keep up with the extraordinary pace of change in technology and emerging areas of medicine, “So we can make sure that while we’re changing the underlying science, we don’t accidentally overlook some detail because that can be measured and controlled, so that nothing slips up during those other changes.”

The tool can be applied to other disciplines and areas of pathology, and is expected to be available from next year onwards.

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