(a) The Department shall establish a coordinated statewide system for screening all newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development, except when the parent or guardian of the newborn infant objects.

(b) Except as provided in § 13-112 of this subtitle, the Department’s public health laboratory is the sole laboratory authorized to perform tests on specimens from newborn infants collected to screen for hereditary and congenital disorders as determined under subsection (d)(2) of this section.

(c) The system for newborn screening shall include:

(1) Laboratory testing and the reporting of test results; and

(2) Follow-up activities to facilitate the rapid identification and treatment of an affected child.

(d) In consultation with the State Advisory Council on Hereditary and Congenital Disorders, the Department shall:

(1) Establish protocols for a health care provider to obtain and deliver test specimens to the Department’s public health laboratory;

(2) Determine the screening tests that the Department’s public health laboratory is required to perform;

(3) Maintain a coordinated statewide system for newborn screening that carries out the purpose described in subsection (c) of this section that includes:

(i) Communicating the results of screening tests to the health care provider of the newborn infant;

(ii) Locating newborn infants with abnormal test results;

(iii) Sharing newborn screening information between hospitals, health care providers, treatment centers, and laboratory personnel;

(iv) Delivering needed clinical, diagnostic, and treatment information to health care providers, parents, and caregivers; and

(v) Notifying parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory are authorized to perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders; and

(4) Adopt regulations that set forth the standards and requirements for newborn screening for hereditary and congenital disorders that are required under this subtitle, including:

(i) Performing newborn screening tests;

(ii) Coordinating the reporting, follow-up, and treatment activities with parents, caregivers, and health care providers; and

(iii) Establishing fees for newborn screening that do not exceed an amount sufficient to cover the administrative, laboratory, and follow-up costs associated with the performance of screening tests under this subtitle.

(e) (1) (i) Subject to the approval of the Secretary and the Advisory Council under subparagraph (ii) of this paragraph and notwithstanding any other provision of law, the Department shall screen for each core condition listed in the U.S. Department of Health and Human Services’ Recommended Uniform Screening Panel.

(ii) On or after January 1, 2023, the Secretary and the Advisory Council shall determine whether to approve the inclusion of a condition in the system for newborn screening within 1 year after the addition of the condition to the Recommended Uniform Screening Panel.

(iii) If the Secretary or Advisory Council does not approve the inclusion of a core condition in the system for newborn screening under subparagraph (i) of this paragraph:

1. Within 1 year after the addition of the condition to the Recommended Uniform Screening Panel, the Department shall publicly post and submit to the General Assembly, in accordance with § 2-1257 of the State Government Article, a report that includes, as applicable, the Secretary’s justification for not approving the inclusion and the final vote of the Advisory Council regarding the inclusion of the condition; and

2. Each year after the initial disapproval, the Advisory Council shall:

A. Review the medical literature published on the condition since the initial evaluation and determine whether substantive updates have occurred that would merit formal reevaluation of the inclusion of the condition; and

B. If the Advisory Council upholds its disapproval of the condition, publicly publish and submit to the General Assembly, in accordance with § 2-1257 of the State Government Article, a report on the reason for the disapproval.

(2) Notwithstanding any other provision of law, if the Secretary of Health and Human Services issues federal recommendations on critical congenital heart disease screening of newborns, the Department shall adopt the federal screening recommendations.

(f) If the Secretary and the Advisory Council approve the inclusion of a condition in the system for the newborn screening under subsection (e) of this section, the Department shall implement testing for the condition within 1 year after the date of the approval.

(g) (1) The Secretary shall pay all fees collected under the provisions of this subtitle to the Comptroller.

(2) The Comptroller shall distribute the fees to the Newborn Screening Program Fund established under § 13-113 of this subtitle.