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.
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
bkeller@dhmh.state.md.us or by telephone at 410-402-8029.
Explore comprehensive information on our Laboratories program in the sections below:
