Ella*’s 16-month-old daughter had a blood lead level of 3.5 micrograms of lead per deciliter (3.5 μg/dL) when she was tested last week.
That’s below the five micrograms that Australian guidelines consider the research threshold (the level at which a child’s blood test result should trigger a health response), but Ella is not reassured.
You know there is no safe level of lead, as the World Health Organization states. The New South Wales health department’s own internal documents say that Even 3.5 micrograms may be associated with reduced IQ and attention span, learning problems, hyperactivity, behavioral problems, growth problems, and hearing loss.
What’s more, her daughter’s previous test had returned a reading of 6.4 micrograms.
The blood tests are being offered on a voluntary basis to families with children under five in Broken Hill, where past and current mining has caused pollution.
The machine used to obtain both readings, LeadCare II, offers point-of-care testing, meaning all it takes is a finger prick for immediate results. However, the equipment has been recalled worldwide due to the possibility of incorrect blood lead test results.
The New South Wales government says it understands the team’s results may 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 outcomes. The Greens say no further support is being given.
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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 health directors in April 2018 that said: “The LeadCare II system has an error of +/- 6 ug/dL. There is a risk of false negative results that will go undetected.”
The TGA has a “special arrangement” with the Far West local health district to allow those point-of-care tests to continue to be used, NSW Health’s Dr Jeremy McAnulty said of the NSW budget estimates in December.
Internal NSW Health emails released under parliamentary summons to Greens MP Cate Faehrmann reveal stakeholders who used the LeadCare II machine to test Broken Hill residents were unaware of accuracy issues.
An email sent to a deputy director at NSW Health dated August 2023 says: “Two interested parties using this device recently discovered that the product had been revoked… One interested party has continued to use this device for clinical purposes and is now concerned about the validity of previous testing.”
In December 2023 Brad Astill, CEO of the Far West Local Health District, said in correspondence to McAnulty that The current screening machine is “considered at the end of its useful life.”
He wrote that “the transition to a process that requires conventional blood tests, and therefore follow-up appointments, is expected to have much lower community acceptance” and that the benefits of point-of-care testing performed with the machine “outweigh any inherent risks of the process.”
“We are aware that the current instrument may yield some results that are empirically inaccurate; however, the continued intent for these results to be used as an indicator of the need for more formal testing and empirically accurate results has not changed,” Astill wrote.
He proposed that, as an “interim measure,” the district continue to use its stock of test strips “until such time as we are unable to obtain test strips. This will allow time to investigate the availability and use of alternative screening instruments that will allow us to continue POCT (point-of-care testing).”
Meridian Bioscience, the parent company of Magellan Diagnostics that makes the equipment, said: “Magellan identified the root cause of the 2021 recall as a packaging issue. The issue has been fully mitigated. LeadCare blood lead tests are currently working as expected.”
However, a TGA spokesperson says it has “not been provided with additional data to demonstrate that the issues have been mitigated to support the restoration of ARTG entry.”
Other emails released as part of documents requested by parliament show a Queensland Health manager wrote to NSW Health in June 2024 that its chief health officer “is very nervous about the continued use of the machine in Mount Isa”.
New South Wales Chief health officer Dr Kerry Chant said in December of the budget estimates that an expert panel had been set up to work on a solution “as soon as NSW Health was made aware of the problem with the machine”.
“Screening tests, like point-of-care tests, are often not as accurate, but we compensate for that in terms of their detection, so if we have a very low threshold to detect something within a window, we then move on to venous blood to validate,” he said.
McAnulty told the budget estimates hearing that the state would consider purchasing 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 stated that children exceeding national guideline levels have received no support or medical intervention.
“I have met families in Broken Hill who have told me they receive little support even though their children have blood lead levels above national guidelines (5 μg/dL). They are sometimes sent home with wet wipes and cleaning products, told to mop more, wash their children’s hands more and perhaps avoid letting them play outside,” she said.
“If your children’s blood lead levels reach levels above 10, someone may come and test your home for lead contamination. And they can participate in what is essentially a home remediation lottery.”
Ella’s sister Alexis* says her children tested above the investigation threshold and received no support from NSW Health.
“There needs to be much more support for the children of this city,” Alexis says.
A spokesman for the New South Wales premier says the state government “recognizes that continued action is needed in Broken Hill to control lead levels in the community, and particularly in children.”
“The Prime Minister’s Department retains 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 social impacts of environmental lead in Broken Hill, particularly for children, and to manage any ongoing impacts on children.”
When a child registers an elevated blood lead level, health services are supposed to undertake interventions, which may include educational packages, risk management strategies (including home visits and counselling) and environmental assessments. When a child’s blood lead level is above 10 μg/dL, cases can be referred for home treatment and, above 45 μg/dL, for medical treatments such as chelation therapy.
However, the NSW Chief Engineer and Scientist’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 housing rehabilitation “limited by the current funding allocation”.
*Names changed for privacy.
