Lead can damage nearly every system in the human body, and has harmful effects on both adults and children. It is a serious environmental public health threat to children in Ohio.
The Ohio Healthy Homes and Lead Poisoning Prevention Program (OHHLPPP) addresses the needs of lead-poisoned children from birth through 6 years (72 months) of age. The program assists family members, medical care providers and other community members to reduce and prevent lead poisoning. OHHLPPP recognizes that children under the age of 3 years (36 months) are at greatest risk for lead poisoning.
This program is funded by the Centers for Disease Control and Prevention (CDC) for childhood lead poisoning prevention efforts in Ohio. OHHLPPP receives all blood lead laboratory reports on Ohio resident children and contributes to the national database on lead poisoning. The program also promotes the national lead poisoning prevention guidelines set forth by the CDC.
For Healthcare Systems and Administrators Impacted by Recall of Magellan Blood Lead Tests
Ensuring Patients Receive Required Tests
The Ohio Department of Health (ODH) has determined that some Ohio residents’ blood samples have been analyzed for the concentration of lead using a Magellan Diagnostics LeadCare® analyzer. According to a Centers for Disease Control and Prevention (CDC) Health Advisory dated Oct. 14, 2021, “Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued notifications about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020, to August 19, 2021. Additional LeadCare II product lots, including lots previously reported to be unaffected, were recalled due to a significant risk of falsely low results. The use of these devices may cause serious injuries because they might underestimate blood lead levels. The FDA has identified this as a Class I recall, the most serious type of recall.” If you are using a LeadCare analyzer in your facilities or are aware of their use in your area, please use or pass along this message to providers and complete the following actions, recommended by the CDC:
- Work with healthcare providers to ensure patients receive required blood lead tests. This outreach should include making providers aware of the need to conduct a capillary or venous test analyzed using higher complexity methods if LeadCare lead test kits are unavailable.
- Make providers aware that:
- By delaying blood lead testing for children due to the unavailability of LeadCare lead test kits, children exposed to lead risk are not being identified or receiving necessary treatment and services.
- If blood lead testing indicates blood lead levels are above the current CDC blood lead reference value or state or local action level, the healthcare provider or public health professional should refer to CDC guidelines or state/local guidelines for an appropriate follow-up action.
- State and public health laboratories may be able to help with additional demands for higher complexity testing.
- Follow recommendations for best practices when collecting a capillary blood sample for lead testing.
- Per CDC guidance, children with blood lead levels at or greater than CDC’s blood lead reference value should have had a subsequent test with a venous blood sample for confirmation. LeadCare instruments are currently approved for use only with capillary or finger/heel stick samples.
- Venous blood confirmation levels are performed with higher complexity testing, such as inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS), are generally considered more accurate, and are available from CLIA-compliant clinical laboratories.
Ohio Healthy Homes and Lead Poisoning Prevention Program
Bureau of Environmental Health and Radiation Protection
Ohio Department of Health
35 E. Chestnut St.
Columbus, OH 43215
Phone: 1-877-LEADSAFE (532-3723)
Fax: (614) 728-6793
Program Supervisor: Chris Alexander
Environmental Supervisor: Pam Blais
Case Management/Education: Kelly Harris
Principal Investigator: John Belt