Ella’s* 16-month-old daughter returned a blood lead level of 3.5 micrograms of lead per decilitre (3.5μg/dL) when she was tested last week.
That’s under the five micrograms the Australian guidelines consider the investigation threshold – the level at which a child’s blood test result should trigger a health response – but Ella is not reassured.
She knows there is no safe level of lead, as the World Health Organization states. The New South Wales Department of Health’s own internal documents say that even 3.5 micrograms may be associated with reduced IQ and attention span, learning disabilities, hyperactivity, behavioural problems, impaired growth and hearing loss.
What’s more, her daughter’s previous test had delivered a reading of 6.4 micrograms.
The blood testing is offered voluntarily for families with children under five in Broken Hill, where past and current mining has led to contamination.
The machine that was used to get both readings, LeadCare II, offers point-of-care testing – meaning a finger prick is all that is required to provide immediate results. But the equipment has had recalls globally due to the potential for inaccurately low blood lead test results.
The NSW government says it understands the equipment’s results can be inaccurate but continues to use it to screen as many children as possible and then provide follow-up care within a wide range of results. The Greens say that follow-up support is not happening.
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Australia’s medicines regulator, the Therapeutic Goods Administration, suspended and then removed the LeadCare II blood testing system from the Australian Register of Therapeutic Goods in 2020, after sending a warning letter to state and territory chief health officers in April 2018 that said: “LeadCare II system has an error of +/- 6 ug/dL. There is a risk of false negative results that will go unnoticed.”
The TGA has a “special arrangement” with the far west local health district to enable those point-of-care tests to continue to be used, NSW Health’s Dr Jeremy McAnulty told NSW budget estimates in December.
Internal emails within NSW Health released under parliamentary call to the Greens MP Cate Faehrmann reveal that stakeholders using the LeadCare II machine to test Broken Hill residents were unaware of the accuracy concerns.
One email to an assistant director within NSW Health dated August 2023 states: “Two stakeholders using this device only found out recently that the product had been revoked … One of the stakeholders has been continuing to use this device for clinical purposes and is now concerned about the validity of past testing.”
In December 2023 Brad Astill, the chief executive of the Far West local health district, said in correspondence to McAnulty that the screening machine was “considered end of life”.
He wrote that the transition to a process requiring conventional blood testing and thus follow-up appointments was “expected to be of much lower uptake by the community” and that the benefits of point-of-care testing from the machine “outweighs any inherent risk of the process”.
“We are mindful that the current instrument may deliver some results that are empirically inaccurate however, the continued intent of these results being used as an indicator of the need for more formal testing and empirically accurate results is unchanged,” Astill wrote.
He proposed that as an “interim measure” the district continue to use its stock of testing strips “until such time as we are unable to obtain testing strips. This will allow time to investigate availability and use of alternate screening instruments which will enable us to continue POCT [point-of-care testing] screening.”
Meridian Bioscience, the parent company of Magellan Diagnostics which manufactures the equipment, said: “Magellan identified the root cause of the 2021 recall as a packaging issue. The issue was fully mitigated. The LeadCare blood lead tests are currently performing as intended.”
However, a spokesperson for the TGA says it “has not been provided with additional data to demonstrate the issues had been mitigated to support reinstatement of the ARTG entry”.
Further emails released as part of the documents compelled by parliament show a manager at Queensland Health wrote to NSW Health in June 2024 that its chief health officer “is very nervous about the machine’s continued use in Mount Isa”.
The NSW chief health officer, Dr Kerry Chant, told budget estimates in December that an expert panel was set up to work on a solution “as soon as NSW Health was aware of the issue with the machine”.
“Screening tests such as point of care are often not as accurate, but we trade off that in terms of their detection, so if we have a very low threshold that if they detect something within a window, we then move to venous blood to validate,” she said.
McAnulty told the budget estimates hearing that the state would look at buying a new generation of the machine when it is released, adding: “No test is 100% accurate. There are limitations.”
Faehrmann suggested NSW Health was applying less rigorous standards to levels of care in the far west.
Faehrmann also claimed children who do test above national guideline levels had not received support or medical intervention.
“I’ve met with families in Broken Hill who have told me that they receive little support despite their kids having blood lead levels above national guidelines [5μg/dL],” she said. “Sometimes they’re sent home with wet wipes and cleaning products, told to mop more, wash their kids hands more, maybe avoid letting them play outside.
“If their child’s blood lead levels get into the upper teens they may have someone come and test their home for lead contamination. And they may go into what is essentially a lottery for home remediation.”
Ella’s sister, Alexis*, says her children tested above the investigation threshold and did not receive support from NSW Health.
“There needs to be a lot more support for kids in this town,” she says.
A spokesperson for the NSW premier says the state government “recognises that ongoing action is needed in Broken Hill to manage lead levels in the community, and particularly in children”.
“The Premier’s Department maintains responsibility for the Broken Hill Environmental Lead Response Group. The Response Group coordinates a strategic, long-term, whole-of-government approach to reducing the community, health, and societal impact of environmental lead in Broken Hill, particularly for children, and to manage any ongoing impacts on children.”
When a child records an elevated blood lead level, healthcare services are supposed to undertake interventions, which can include education packages, risk management strategies (including home visits and counselling), and environmental assessments. When a child’s blood lead level is over 10μg/dL, cases may be referred for home remediation, and above 45μg/dL, medical treatments such as chelation therapy.
However, the NSW chief scientist and engineer’s report on Broken Hill delivered late last week found that “while some progress has been made in reducing environmental lead levels and community exposure, improvements have slowed in recent years”, including issues such as access to home remediation “limited by the current allocation of funds”.
* Names changed for privacy
