Ella\u2019s* 16-month-old daughter returned a blood lead level of 3.5 micrograms of lead per decilitre (3.5\u03bcg\/dL) when she was tested last week.<\/p>\n
That\u2019s under the five micrograms the Australian guidelines consider the investigation threshold \u2013 the level at which a child\u2019s blood test result should trigger a health response<\/a> \u2013 but Ella is not reassured.<\/p>\n She knows there is no safe level of lead, as the World Health Organization states<\/a>. The New South Wales Department of Health\u2019s own internal documents say that even 3.5 micrograms may be associated with reduced IQ and attention span, learning disabilities<\/a>, hyperactivity, behavioural problems, impaired growth and hearing loss.<\/p>\n What\u2019s more, her daughter\u2019s previous test had delivered a reading of 6.4 micrograms.<\/p>\n The blood testing is offered voluntarily for families<\/a> with children under five in Broken Hill, where past and current mining has led to contamination<\/a>.<\/p>\n The machine that was used to get both readings, LeadCare II, offers point-of-care testing \u2013 meaning a finger prick is all that is required to provide immediate results. But the equipment has had recalls globally<\/a> due to the potential for inaccurately low blood lead test results.<\/p>\n The NSW government says it understands the equipment\u2019s 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.<\/p>\n Sign up: AU Breaking News email<\/a><\/p>\n Australia\u2019s medicines regulator, the Therapeutic Goods Administration, suspended and then removed<\/a> 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: \u201cLeadCare II system has an error of +\/- 6 ug\/dL. There is a risk of false negative results that will go unnoticed.\u201d<\/p>\n The TGA has a \u201cspecial arrangement\u201d with the far west local health district to enable those point-of-care tests to continue to be used, NSW Health\u2019s Dr Jeremy McAnulty told NSW budget estimates in December<\/a>.<\/p>\n Internal emails within NSW Health<\/a> 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.<\/p>\n One email to an assistant director within NSW Health dated August 2023 states: \u201cTwo stakeholders using this device only found out recently that the product had been revoked \u2026 One of the stakeholders has been continuing to use this device for clinical purposes and is now concerned about the validity of past testing.\u201d<\/p>\n 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 \u201cconsidered end of life\u201d.<\/p>\n He wrote that the transition to a process requiring conventional blood testing and thus follow-up appointments was \u201cexpected to be of much lower uptake by the community\u201d and that the benefits of point-of-care testing from the machine \u201coutweighs any inherent risk of the process\u201d.<\/p>\n \u201cWe 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,\u201d Astill wrote.<\/p>\n He proposed that as an \u201cinterim measure\u201d the district continue to use its stock of testing strips \u201cuntil 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.\u201d<\/p>\n Meridian Bioscience, the parent company of Magellan Diagnostics which manufactures the equipment, said: \u201cMagellan 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.\u201d<\/p>\n However, a spokesperson for the TGA says it \u201chas not been provided with additional data to demonstrate the issues had been mitigated to support reinstatement of the ARTG entry\u201d.<\/p>\n 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 \u201cis very nervous about the machine\u2019s continued use in Mount Isa\u201d.<\/p>\n