More than 75% of laboratories in NATA’s accredited network have already transitioned to the new ISO 15189:2022 standard, just 15 months since NATA began assessing against it.
Coincidentally, NATA reached the milestone on International Pathology Day, an annual observation day celebrated on 6 November to highlight the important role of pathology in healthcare, and our health and wellbeing.
NATA began accrediting laboratories to the internationally recognised revised ISO 15189:2022 Medical laboratories – Requirements for quality and competence in August 2023.
ISO 15189:2022 emphasises a risk-based approach, improved quality control, and stronger integration with other standards, enhancing patient safety and care by focusing on accurate, timely, and easily understood test results as well as incorporating modern practices such as data integrity and technological advancements.
NATA Legal & Clinical Services Deputy Sector Manager, Gillian Treloar, said this achievement means that Australian laboratories are “well ahead” in transitioning to the new standard by the December 2025 deadline.
“NATA has put a lot of work into ensuring this was a smooth transition and it is paying off,” she said. “This is one of the biggest advantages of multisite accreditation and labs are reaping the rewards.”
Skills shortage continues
Accrediting to the new standard is taking place as Australian laboratories continue to face chronic shortages of skilled pathologists, scientists, and technical and support staff.
NATA Legal & Clinical Services Sector Manager, Andrew Griffin, said the impact of the workforce shortage was starting to show in assessment findings, with turnaround times “increasing significantly” in some areas.
“Stakeholders, including Federal Government, are working hard to put in place measures to mitigate this issue,” he said.
However, despite this skills shortage, most laboratories are meeting and retaining their accreditation to key standards, such as the aforementioned ISO 15189:2022.
“Even as the demand for pathology continues to grow year-on-year, Australian laboratories continue to provide world-class services,” Griffin said.
The technology challenge
Looking to the months ahead, Treloar expects the changes in in-vitro diagnostic products (IVD) and laboratory developed test (LDT) frameworks found overseas to influence Australian laboratories.
“Products that were previously registered have now been changed to ‘research use only’, meaning laboratories will have to validate their use,” she said. “And this includes for any associated software.”
Griffin added he expects the validation of In-house Software-as-a-Medical-Device to be a growing challenge for the pathology sector.
“We are seeing more software sold as research use only, which puts the onus on laboratories to validate,” Griffin said. “This is a difficult area for laboratories to manage, as it is not their core business.”
Like many organisations, NATA is currently carefully monitoring the introduction of AI into various sectors such as pathology.
Treloar said current applications of AI in pathology are static and typically augmenting the pathologist’s diagnosis. However, she predicts there are AI products on the horizon that will “change this completely.”