Md. Code Regs. 10.10.13.04

Current through Register Vol. 51, No. 25, December 13, 2024
Section 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.

Md. Code Regs. 10.10.13.04

Regulations .04 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490); amended effective 44:8 Md. R. 404, eff. 4/24/2017