Recently, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued warnings on blood lead results from Magellan Diagnostics LeadCare^® analyzers. This has substantial nationwide impact as Magellan is a major vendor for blood lead analysis, marketing point-of-care blood lead devices (used frequently in pediatric or family medicine physician offices) as well as larger analyzers for clinical laboratories. This issue impacts University of Iowa Healthcare since Magellan instruments are used both centrally in the main University of Iowa Hospitals and Clinics clinical laboratory as well as some of the outlying outpatient clinics.

The CDC alert is at the following link:  https://www.cdc.gov/nceh/lead/about/blood_lead_test_safety_alert.html

Various professional societies and news outlets have also reported on this issue.

The problem identified by the manufacturer and FDA involves only venous specimens (e.g., drawn in EDTA Vacutainer^® tubes used throughout UI Health Care) and NOT capillary/fingerstick draws. The exact mechanism of the issue is not completely understood, but one proposed cause is an interferent leaching from the caps of Vacutainer^® or equivalent tubes that can cause falsely low lead concentrations. The problem may be more likely in tubes with prolonged transport time and/or that were transported either sideways or upside down. This type of explanation may explain why the problem is spurious and currently not predictable. Note that further investigation by the FDA and manufacturer may reveal other factors.

The current guidance from the FDA/CDC is to re-test patients who are:
            • Younger than 6 years (72 months) of age at the time of alert (May 17, 2017) and
            • Had a venous blood test on a Magellan LeadCare^® analyzer

These recommendations are based on the FDA and manufacturer believing that the issue first appeared in 2014.  The CDC also recommends that healthcare providers re-test currently pregnant or lactating women who had a venous blood lead test performed using a Magellan LeadCare^® analyzer.

We are currently identifying patients that meet the above criteria and will work out mechanisms to notify patients and families and to facilitate re-testing. Within UI Health Care, the impact is lessened significantly by the predominant use of capillary and not venous specimens for patient testing.

The specimen used for blood lead analysis is documented by the laboratory and is visible in Epic Result and Chart Review as seen in the example screenshots below:

As an initial step, we will immediately begin referring all venous samples for lead analysis to a reference laboratory that uses an alternative methodology. This will use the existing Epic code LEAD, VENOUS CONFIRMATION BY ICP-MS [LAB7479].

As this issue develops, we will send out additional information.

Questions should be directed to Matthew Krasowski, MD, PhD, Vice Chair of Clinical Pathology and Laboratory Services (384-9380, matthew-krasowski@uiowa.edu).