COMAR 10.10.01.02. Scope

A. This subtitle contains the standards and requirements that a medical laboratory shall meet to:

(1) Obtain and retain a license to offer to perform or perform tests on human specimens; and

(2) Certify chemists and analysts in crime laboratories to perform approved testing procedures for controlled dangerous substances.

B. This subtitle does not apply to:

(1) A research facility that tests human specimens and does not:

(a) Report any patient-specific test results for use in connection with the diagnosis and control of human disease or the assessment of the health, nutritional, or medical condition or job-related alcohol and controlled dangerous substances evaluation of individual patients or clients, or

(b) Provide test results to the patient, the patient's family, or a health care provider;

(2) A medical laboratory operated by the federal government, unless the laboratory or tissue bank is directed by a federal agency to meet the requirements of this subtitle; and

(3) A crime laboratory operated by the federal government.