Description
A health awareness test means a test approved by the Secretary to be performed at a temporary or mobile laboratory, such as a health fair in a shopping mall. A health awareness test is limited to tests that are performed solely for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions; are performed on a CLIA waived testing device; and measure glucose, lipids, or other clinical values which the Secretary has concluded are in the interest of public health to be measured at a health awareness event.
Maryland Regulations
Regulations related to health awareness testing sites is found in
COMAR 10.10. To order copies of COMAR regulations, contact Tarshia Neal at the Maryland Division of State Documents at 410-260-3874 or
[email protected]. Regulations are also available at public libraries - Find your nearest
public library.
Licensure
To apply for a license for a Health Awareness Testing Laboratory, please mail with original signatures both the
Maryland State Compliance Application and
CLIA application with supporting documents outlined on the state application checklist page, to the address on the state application.
There is no fee to apply for a Maryland laboratory license. CMS will bill you for CLIA fees. After a completed application and all requested information is received by OHCQ, it takes 2 - 3 weeks to receive a Health Awareness Testing laboratory license and CLIA certificate. To report any changes to your license, please use the
Laboratory Licensing Change Form.
After receipt of license, please submit the
OHCQ Health Awareness Testing Request Form to request approval to conduct a Health Awareness Testing event in Maryland. Please submit a separate request for each screening event.
Site approvals will be sent via email that to the address provided in the form. The document(s) should be printed and posted at the screening event(s). For questions regarding Health Awareness Testing, please contact the Health Awareness Testing team at
[email protected].