The Maryland Department of Health and Mental Hygiene (MDHMH) proposes to expand the scope of mandatory reporting of blood lead level testing, which currently applies only to certain medical labs.  41 Md. Reg. 26 at 1584-1585 (December 26, 2014).   The proposed regulation will now require physician offices and “point-of-care laboratories” (which perform whole blood lead testing on Clinical Laboratory Improvement Amendment (CLIA) waived analyzers) to report blood lead levels to the Maryland Department of the Environment’s (MDE).   The CLIA waived analyzers are simple analyzers with a low risk of error, which the Food and Drug Administration has exempted from other CLIA requirements.  Information that must be reported to MDE includes: demographic data, specimen type, name and address of clinic and/or draw site, blood lead levels and additional information as may be required by MDE.  The data will be added to MDE’s childhood lead registry.

According to MDHMH’s analysis, there will be no economic impact and  only “minimal impact” to small businesses.

Comments to the proposed regulation must be submitted to MDHMH on or before January 26, 2015.

For more information, concerns or comments about the proposed regulation, see a member of the Environmental Practice, including Amanda Neidert Kesler. 

Opinions and conclusions in this post are solely those of the author unless otherwise indicated. The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. The author has provided the links referenced above for information purposes only and by doing so, does not adopt or incorporate the contents.