A company that makes tests for lead poisoning has agreed to resolve criminal charges that it concealed for years a malfunction that resulted in inaccurately low results.

It’s the latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will , according to the Department of Justice.

While many of the fault-prone devices were used from 2013 to 2017, some were being recalled . The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.

Doctors don’t consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C., and Flint, Michigan, have struggled with widespread lead contamination of their water supplies in the last two decades, making accurate tests critical for public health.

It’s possible faulty Magellan kits were used to test children for lead exposure into the early 2020s, based on the recall in 2021. Here’s what parents should know.

What tests were affected?

The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily and accounted for more than half of all blood lead tests conducted in the U.S. from 2013 to 2017, according to the Justice Department. It was often used in physician offices to check children’s lead levels.

The other two could also be used with blood drawn from a vein and may have been more common in labs than doctor’s offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low” in June 2013 while seeking regulatory clearance to sell the product, the DOJ said. But it did not disclose that information and went on to market the tests, according to the settlement.

The agency said 2013 testing indicated the same flaw affected the LeadCare II device. A 2021 recall included most of all three types of test kits distributed since October 27, 2020.

The company said in a  announcing the resolution that “the underlying issues that affected the results of some of Magellan’s products from 2013 to 2018 have been fully and effectively remediated,” and that the tests it currently sells are safe.

What does a falsely low result mean?

Children are often tested during pediatrician visits at age 1 and again at age 2. Elevated lead levels can put kids at risk of developmental delay, lower IQ, and other problems. And symptoms, such as stomachache, poor appetite, or irritability, may not appear until high levels are reached.

Falsely low test results could mean parents and physicians were unaware of the problem.

That’s a concern because treatment for lead poisoning is, initially, mainly preventive. Results showing elevated levels should prompt parents and health officials to determine the sources of lead and take steps to prevent continued lead intake, said Janine Kerr, health educator with the Virginia Department of Health’s .

Children can be exposed to lead in a variety of ways, including by drinking water contaminated with lead from old pipes, such as in Flint and Washington; ingesting lead-based paint flakes often found in older homes; or, as reported recently, eating some 

What should parents do now?

“Parents can contact their child’s pediatrician to determine if their child had a blood lead test with a LeadCare device” and discuss whether a repeat blood lead test is needed, said , a pediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.

During an earlier recall of some Magellan devices, in 2017, the Centers for Disease Control and Prevention  if they were pregnant, nursing, or children younger than 6 and had a blood lead level of less than 10 micrograms per deciliter as determined by a Magellan device from a venous blood draw.

The 2021 recall of Magellan devices recommended retesting children whose results were less than the current CDC reference level of 3.5 micrograms per deciliter. Many of those tests were of the finger-stick variety.

Kerr, at the Virginia health department, said her agency has not had many calls about that recall.

The finger-stick tests “are not that widely used in Virginia,” said Kerr, adding that “we did get a lot of questions about the applesauce recall.”

In any case, she said, the “best course of action for parents is to talk with a health care provider.”

is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. Virginia Mercury maintains editorial independence. Contact Editor Samantha Willis for questions: info@virginiamercury.com. Follow Virginia Mercury on and .

This story mentions suicide.  If you or someone you know is contemplating suicide, please call or text the National Suicide and Crisis Lifeline at 988.

LOUISVILLE — Anthem Medicaid announced Wednesday it has launched a free digital mental wellness course, which is available to 1,512 students in 17 Kentucky schools.

The announcement comes during and as more adolescents, especially girls, .

Called “,” the interactive program is for students in grades eight to 10. According to EVERFI from Blackbaud, which designed the course, it contains , each 15 minutes long.

The course, Anthem says, exposes students “to the experiences of others in order to develop awareness and empathy, reduce stigma, and provide facts on the prevalence and symptoms of mental health conditions.”

Students then “explore their own mental health, identify challenges they may face, and develop concrete strategies for managing those challenges while increasing their awareness of resources and empowering them with the knowledge, skills, and language necessary to identify and support a peer in need or at risk.”

show a tour of mental health through the program, starting with a lesson on what mental health is and ending with the chance to create a personal wellness plan.

Since the onset of COVID-19, In 2021, the Centers for Disease Control and Prevention found that sadness and hopelessness had increased from pre-pandemic levels, especially for teen girls. In 2017, 41% of female high school students and 21% of male high school students felt sad or hopeless. By 2021,, respectively.

“Young people need resources and education from trusted sources to protect their mental health,” Leon Lamoreaux, market president for Anthem Medicaid, said in a statement.

The Understanding Mental Wellness program “will help us reach students from all over the Commonwealth and equip them with tools and strategies that will make a positive difference in their lives for years to come,” Lamoreaux said.

Tom Davidson, the CEO of EVERFI, said the goal in creating this program was to “(benefit) those who are impacted by mental health challenges, those who want to build and maintain positive mental health and those who have the opportunity to positively .”

is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. Kentucky Lantern maintains editorial independence. Contact Editor Jamie Lucke for questions: info@kentuckylantern.com. Follow Kentucky Lantern on and .

Teens, mental health care professionals and crisis-line volunteers told state and federal leaders that youth need access to more culturally relevant mental health care and better communication about what services exist.

Addressing these two issues would go a long way toward combating a youth mental health crisis that has grown in the wake of the pandemic, they told Gov. Tina Kotek and Xavier Becerra, secretary of the U.S. Department of Health and Human Services.

The group convened at Faubion School in northeast Portland on Monday afternoon to discuss mental health issues facing students and resources available through state and federal dollars. Also present at the K-8 school were representatives of Portland Public Schools and the University of Oregon’s new Ballmer Institute for Children’s Behavioral Health. The institute was set up to address the lack of mental health care professionals by placing its first class of 200 undergraduates into Portland Public Schools as interns in the fall of 2023.

A survey of about one-third of Oregon students conducted in 2020 by the Oregon Health Authority and the Oregon Department of Education found nearly half felt sad or hopeless for more than a two-week period. And a report released in August by the found that the number of Oregon children struggling with mental health issues grew from 11% in 2016 to 16% in 2020.

Jaiyana Jones, an eighth grader at Faubion, said during a roundtable discussion that COVID and social media have increased mental health suffering among students over the last few years. She said some who don’t feel comfortable talking with counselors and school staff turn instead to abusing substances. Tanvi Vemulapalli, a volunteer for the nonprofit crisis hotline Lines for Life, said a lack of supportive adults is the number one reason young people say they call the hotline.

“It’s one of the biggest things, the lack of comfort reaching out to someone,” Vemulapalli said.

As a Black student, Jones said it would be helpful to have more Black counselors and mental health staff. “People who share some of what you experience,” she said.

Jeida Dezurny, a member of the Confederated Tribes of Siletz Indians and a youth representative of the Northwest Portland Area Indian Health Board, said there is a generational and cultural disconnect among many Native American youth to mental health care services. In the absence of more Native mental health care providers, Dezurnby said she and her colleagues have focused on training Native adults from all walks of life to talk with young people about suicide, opioids, mental health, sex and other topics that can feel uncomfortable to discuss.

“We start teaching the caring adults, the educators, the guardians, the community members,” she said, asking them: “How do you address mental health? We know that you probably have never addressed it in your life, and that’s OK, we’re gonna get past it, we’re going to educate you.”

To combat nationwide shortages of school counselors, psychologists and social workers, Becerra said the federal human services department is planning to launch a scholarship program that would help pay for graduate studies for people hoping to become mental health care professionals. In exchange, they would need to commit to three to four years of work in the field.

Becerra also touted the federal government’s investment in the launched in July, which connects callers and texters to counselors trained in helping people in a crisis. Becerra said the Biden administration is investing $500 million over two years to get the line established nationwide, but states will need to provide their own funding to sustain the service.

“I think it’d be a great challenge for the youth who are in this space to convince the leaders in your state – because there are only a few states today that actually provide a steady stream of money – to keep the 988 lifeline going,” he said.

In Oregon, Lines for Life oversees the service except in Marion and Polk counties, where Northwest Human Services is in charge. Kotek’s includes adding a fee of 40 cents per cell line to sustain the 988 Lifeline into the future.

The Legislature is considering several bills to target the mental health care workforce shortage and improve access to mental health care in schools.

Two bills, and , would require Portland State University and Southern Oregon University to educate and graduate more public mental health and addiction treatment providers over the next five years. would require every school district to ensure every school has a mental health professional and nurse.

In 2019, the state allocated more than $1 billion to the Student Success Act, which helped pay for mental health care in schools. Additionally, Oregon received millions from the American Rescue Plan during the pandemic, with directives to use some of it for mental health staff and programs.

is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. Oregon Capital Chronicle maintains editorial independence. Contact Editor Lynne Terry for questions: info@oregoncapitalchronicle.com. Follow Oregon Capital Chronicle on and .

Chris Riback: Council member Fournier, thank you for coming to our ELN studio.

April Fournier: Absolutely. Thank you for having me.

Chris Riback: What is the state of early childhood learning in Portland Maine today? Maybe give me both pre COVID and what’s happened since COVID.

April Fournier: Sure. I think pre COVID, just like a lot of places around the country, there’s just not enough spaces. And so we have so many parents that need childcare to work to make their household work, so that they have money coming in. Plus we also know the benefits of children being around each other socially, emotionally and being able to build their communication skills, learning how to create a community. When you don’t have all those spaces, you have children that really start to fall behind, especially as they enter public school. So I think before COVID we definitely had a shortage, but there were lots of small like family run childcares or in home childcares as well as lots of different centers.

I think what we’ve seen post COVID is a significant decrease in those programs. Whether the parents that would come and work in them couldn’t go back to the workforce because, they themselves couldn’t find childcare. Or we know that also early childcare workers are some of the lowest paid in the country. And so you’re coming out of COVID, you’re like, my bills are behind. I need to pay my mortgage. I need to pay my car and the job that I’m doing isn’t cutting it anymore, because I’m so behind.

And so you have a lot of people that have also left the workforce to go find something else that’s paying more. I think for Portland, we’re very much feeling that. What I hear on the council from a lot of families is, we need more spots. We need more childcare, or these children are just going to sit at home and then all of a sudden, they show up one day in kindergarten and they don’t know how to interact. They don’t know how to engage. And then I think you start to see, more that child’s a behavior problem, more that child is going to be tagged.

Chris Riback: It all connects.

April Fournier: Yes, absolutely.

Chris Riback: It all connects.

April Fournier: It’s critical.

Chris Riback: So you seem to be an extremely busy person. One role is council member. Can we talk about another of your roles?

April Fournier: Sure. Yes, absolutely.

Chris Riback: You currently are in a grant funded position that provides barrier free support to families within a pediatric practice setting.

April Fournier: Yes.

Chris Riback: What is the program? What are you doing it? And what do you see there?

April Fournier: Yes, so I’m an early childhood support specialist within the outpatient pediatric clinic. We see typically families who either require free care, or low cost healthcare, or Medicaid. So we have very few families that are private pay insurance. So these are often families that are living in poverty or within Portland, we have a lot of Asili families that have just newly arrived in the states.

My role is to help provide that connection. So pediatricians can spend 15 to 30 minutes often with a family and they’re really focused on the medical component. Then they have to go off to their next patient. But that doesn’t mean that they’ve been able to address some of those social determinants of health. Like, do you have safe and secure housing? Do you have enough food to feed your family on a regular basis?

Chris Riback: So does the family start with the pediatrician and then transition to you?

April Fournier: Yes. Yes.

Chris Riback: So it’s almost two separate, though, connected conversations?

April Fournier: Absolutely. I often will come in after the visit. So the pediatrician does their visit and then we have a quick little conference, before I go in and talk to the family. And so that could be, Hey, so mom mentioned that she’s working with this domestic violence agency to get some counseling because, her and dad were separated. Or this mom mentioned that she’s really struggling to get diapers on a regular basis. The baby has a diaper rash because, she’s trying to use diapers for longer periods of time because of that insecurity.

By having that quick little conference, I know what I’m walking into. I’m not asking the same questions. So the parents are like, I just told the doctor all this information. So one, it’s honoring that time for the family, but also jumping into the conversation that is most important for them.

Chris Riback: And you can really cover a wide range of risk factors.

April Fournier: Absolutely.

Chris Riback: I understand you collect data off of these conversations as well. What do the data show? What have you seen?

April Fournier: So the things that we’re looking at is, as we’re having these conversations are they identifying a housing need, or a social services need, or diaper insecurity, food insecurity? It’s a brand new mom who’s 19 years old and is trying to figure out, I don’t know how to bathe my baby. I don’t know how to do sleep routines or I’m not sleeping. So it’s really taking this holistic look at how do we help this family be successful, so that as this child develops, as this family develops, they have the best possible outcome. So I’m taking data, asking questions and then we’re able to pull that from our medical record system to see, we met this family when the baby was three days old.

Now the baby’s four months old, what progress has this family made with this intervention? And it’s amazing what we’re seeing, we’re just seeing really, really great results. They’re not diaper insecure or they’ve been able to connect to community resources that help them with housing or getting connected to wick, or even just getting health insurance. So they’re not getting these bills from the hospital that create anxiety and fear and I don’t know how to pay this. So it’s really helping connect all of the things for the family to help them be successful.

Chris Riback: In learning about your story, I realized as well, this is personal for you.

April Fournier: Absolutely.

Chris Riback: I mean you underwent quite a career change. Inspired, I believe, by your son.

April Fournier: Yes. Absolutely. I was on a trajectory with an insurance company, or in the financial services industry to be project manager or operational development.

Chris Riback: Or CEO of a multinational bank? Yes. Something.

April Fournier: One day. And so my youngest son, I had twins. So I actually have four children, but the youngest are twins. We noticed around age two, they weren’t exactly developing the same. They had some language development, but he was starting to do things like lining things up or he would get really frustrated and hit himself, or bang his head off the ground. And it was just like, I have no idea what’s happening with this kiddo. It just doesn’t make sense. And so the pediatrician did some screenings for autism and said, well, let’s go ahead and do some evaluation. Because he’s really kind of hitting all these different flags. And so after going through that evaluation, he was diagnosed with autism and it was like, I have no idea what to do.

Thankfully Maine has a program called Child Development Services that comes in to do early intervention. So it’s really around teaching parents, how do you work on your routines so that you’re able to bring language out or create social connections within the scope of your everyday life? Not every parent can take time off to do all of this development. So how can you do it within what you’re already doing?

And so in watching his transformation, his language development, he started to come back to us. And be like, Hey, I’m checking back into my family and I’m learning these things and we’re seeing less aggressions or less self-harm. Like, why wouldn’t you want to do something that’s going to do that for children. And just what it did for our family was incredible. So rather than going to graduate school for project management or financial services, I went to graduate school for early childhood special education.

Chris Riback: A different kind of education.

April Fournier: Absolutely. Yes.

Chris Riback: One both in school and in the classroom, but also in real life.

April Fournier: Absolutely. Absolutely. So then in doing different roles, I worked doing in-home services for families who have a child with autism. How do you connect them to community? How do you plan a grocery trip, knowing that you’re going to have tantrums, or knowing that you’re going to have behaviors that happen? How do you help families meet their goals?

I taught in a special education classroom and I worked connecting families in to that transition to kindergarten. And how do you work with public schools on implementing special education services? And then worked in head start. So lots of different facets to figure out, how do we most help these families within our community?

Chris Riback: Council member, what does it mean to you to be an indigenous Diné woman on the city council? What level of responsibility does that make you feel?

April Fournier: I’m honored to hold that space. There are so many people that came before me to make it possible. Not necessarily in Portland specifically, but on a national level back in my homelands. Being able to see Deb Holland, secretary Holland as part of the cabinet, it’s just incredible. And so by claiming these spaces and creating spaces for indigenous officials to walk into, it just allows us to have the next generations come along with us. So my children are seeing me run for city council, or they’re seeing me take advocacy space, or they’re seeing me take pictures in Washington, in our capital doing this work.

And so I think, when you’re a minority or when you’re part of a marginalized group, it’s hard to walk through some doors. And so if you see someone who looks like you, who has the same type of life experience, has a similar identity, it’s so much easier and comfortable to walk through that door and take that space as well. I’m again, incredibly honored to be in this space. I take my responsibility, very, very seriously and I am just so excited to do it.

Chris Riback: I’m sure that you do, I’m sure that you are. Your children see you, your community sees you.

April Fournier: Yes.

Chris Riback: Thank you.

April Fournier: Of course, thank you.

Chris Riback: Thank you for the work you do and for coming to the studio.

April Fournier: Awesome. Thank you for having me.