Are Your Serum Lead Level Results Reliable?

By Susan Boisvert, BSN, MHSA, CPHRM, FASHRM
Lead is toxic to humans. Some organs and tissues, such as the brain and central nervous system, are at higher risk for damage caused by exposure to lead. Young children are particularly susceptible to the toxic effects of lead because their brains are experiencing rapid growth. Fetuses and breastfeeding infants are at risk for lead exposure from their mother. To identify and mitigate the risks posed by lead, infants, children, and pregnant/lactating women are routinely screened.

If you or your facility have provided care to pregnant or lactating women and children under six who had elevated serum lead levels using a Magellan Analyzer, these patients may need to have their levels rechecked. Serum blood tests run on a Magellan Diagnostics’ LeadCare® analyzer may result in falsely low readings.

Both the FDA and the CDC have issued communications and guidance: The CDC guidance contains an algorithm to help clinicians decide when retesting may be necessary.

What You Need to Do:
  • Determine the methodology used to assess lead levels. 
    • Finger stick, heel stick, and capillary blood lead levels are not affected.
    • For serum lead level assays – determine if the tests were run on a Magellan Analyzer. If lead tests are sent to an outside lab, contact the lab to determine the method used to evaluate serum lead levels. Serum lead levels determined by mass spectrometry atomic absorption methods are not affected.
If Your Practice Is Affected:
  • Follow the CDC guidelines noted above for retesting.
  • You may also receive communication from the FDA and/or Magellan directing you to contact potentially affected patients. 
    • If you have a policy for handling recalls, follow your policy.
    • If you do not have a policy and would like assistance, contact your Coverys risk management consultant.
  • If your practice has relied on Magellan LeadCare® serum lead levels, consider posting an advisory notice in your waiting room. Your state health department may have resources.
  • Keep a log of all actions related to serum lead level follow-up.
    • Document follow-up phone calls in the patient’s record.
    • If you send out notification letters, maintain a copy in the patient’s chart.
    • Track compliance with retesting requests and follow your test tracking policy.
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