The Laboratories Unit is responsible for State licensure of all laboratories that perform tests on specimens obtained from Maryland citizens and for federal certification of all laboratories located in Maryland. The unit also serves as the agent for federal certification in the Clinical Laboratory Improvement Amendments of 1988 Program, which is required for all clinical laboratory testing sites including those seeking Medicare reimbursement. The State licensing programs include those for blood, sperm and tissue banks, hospital laboratories, independent reference, physician office laboratories and point of care laboratories, cholesterol testing sites, employer drug testing, health awareness testing sites, blood drawing stations or blood test results, and cytology testing.
Health Awareness Testing
In Maryland, Health Awareness Testing means a test approved by the Secretary to be performed at a temporary laboratory; such as a health fair in a shopping mall. Health Awareness testing is limited to: Tests that are performed soley for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions; and that 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. If you plan to perform Health Awareness Testing in Maryland please review the regulations set forth in COMAR 10.10.06.12, 10.10.06.13 and 10.10.06.15. You must also inform the OHCQ by phone or in writing of the date, time, location, and on-site supervisor's name for a testing event at least 14 days before the event is to take place, per COMAR 10.10.06.14. For questions regarding Health Awareness Testing the contact person may be reached by email
or by telephone at 410-402-8023. COMAR regulation can be searched here:http://www.dsd.state.md.us/comar/searchall.aspx
Maryland Cytology Proficiency Testing Program
The Maryland Cytology Proficiency Testing Program was established in 1988 to satisfy the requirements outlined in the State‘s Code of Maryland Regulations 10.10.05.04 and 05 and the Code of Federal Regulations 493.855, the Clinical Laboratories Improvement Amendment. All laboratories possessing a current Maryland laboratory license in the discipline of gynecologic cytology must enroll in an annual proficiency test. All pathologists and cytotechnologists must pass the test with a score of at least a 90% in order to continue screening and diagnosing Pap slides, the diagnostic test most known for detecting various stages of pre cancer and cancer in the female reproductive system. The coordinator of the Program may be reached by email at email@example.com
or by telephone at 410-402-8029.
Explore comprehensive information on our Laboratories program in the sections below: