Sec. 10.10.13.04. Permit

A. Eligibility.

(1) Except as set forth in a Departmental mutual aid agreement, the Department's public health laboratory is the sole laboratory that may hold a State permit to perform and that may perform a first-tier newborn screening test on a newborn infant.

(2) A medical laboratory other than the State's public health laboratory may obtain a permit to perform:

(a) A supplemental test;

(b) A second-tier test; or

(c) Supplemental and second-tier tests.

B. Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall:

(1) Obtain and maintain a valid:

(a) Permit issued by the Secretary to operate a medical laboratory; and

(b) CLIA Certificate from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; and

(2) Meet applicable standards and requirements for:

(a) A medical laboratory, as set forth in COMAR 10.10.01-.08; and

(b) Testing for hereditary or congenital disorders in a newborn infant as set forth in this chapter.