EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0109*
HOUSE BILL 109
J1 2lr0689
(PRE–FILED) CF 2lr0690
By: Delegate Shetty
Requested: October 7, 2021
Introduced and read first time: January 12, 2022
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Maryland Department of Health – System for Newborn Screening – 2
Requirements 3
FOR the purpose of requiring the system for newborn screening in the Maryland 4
Department of Health to include screening for each condition listed in the U.S. 5
Department of Health and Human Services’ Recommended Uniform Screening 6
Panel; and generally relating to the system for newborn screening. 7
BY repealing and reenacting, with amendments, 8
Article – Health – General 9
Section 13–111 10
Annotated Code of Maryland 11
(2019 Replacement Volume and 2021 Supplement) 12
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 13
That the Laws of Maryland read as follows: 14
Article – Health – General 15
13–111. 16
(a) The Department shall establish a coordinated statewide system for screening 17
all newborn infants in the State for certain hereditary and congenital disorders associated 18
with severe problems of health or development, except when the parent or guardian of the 19
newborn infant objects. 20
(b) Except as provided in § 13–112 of this subtitle, the Department’s public health 21
laboratory is the sole laboratory authorized to perform tests on specimens from newborn 22
infants collected to screen for hereditary and congenital disorders as determined under 23
subsection (d)(2) of this section. 24 2 HOUSE BILL 109
(c) The system for newborn screening shall include: 1
(1) Laboratory testing and the reporting of test results; and 2
(2) Follow–up activities to facilitate the rapid identification and treatment 3
of an affected child. 4
(d) In consultation with the State Advisory Council on Hereditary and Congenital 5
Disorders, the Department shall: 6
(1) Establish protocols for a health care provider to obtain and deliver test 7
specimens to the Department’s public health laboratory; 8
(2) Determine the screening tests that the Department’s public health 9
laboratory is required to perform; 10
(3) Maintain a coordinated statewide system for newborn screening that 11
carries out the purpose described in subsection (c) of this section that includes: 12
(i) Communicating the results of screening tests to the health care 13
provider of the newborn infant; 14
(ii) Locating newborn infants with abnormal test results; 15
(iii) Sharing newborn screening information between hospitals, 16
health care providers, treatment centers, and laboratory personnel; 17
(iv) Delivering needed clinical, diagnostic, and treatment 18
information to health care providers, parents, and caregivers; and 19
(v) Notifying parents and guardians of newborn infants that 20
laboratories other than the Department’s public health laboratory are authorized to 21
perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 22
and congenital disorders; and 23
(4) Adopt regulations that set forth the standards and requirements for 24
newborn screening for hereditary and congenital disorders that are required under this 25
subtitle, including: 26
(i) Performing newborn screening tests; 27
(ii) Coordinating the reporting, follow–up, and treatment activities 28
with parents, caregivers, and health care providers; and 29
HOUSE BILL 109 3
(iii) Establishing fees for newborn screening that do not exceed an 1
amount sufficient to cover the administrative, laboratory, and follow–up costs associated 2
with the performance of screening tests under this subtitle. 3
(e) (1) (I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE 4
DEPARTMENT SHALL SCRE EN FOR EACH CONDITION LISTED IN THE U.S. 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 6
SCREENING PANEL. 7
(II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 8
INCLUDE IN THE SYSTEM FOR NEWBORN SCREENING ANY CORE OR SECONDAR Y 9
CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL WITHIN 2 10
YEARS AFTER THE ADDITION OF THE CONDITION TO THE PANEL. 11
(2) Notwithstanding any other provision of law, if the Secretary of Health 12
and Human Services issues federal recommendations on critical congenital heart disease 13
screening of newborns, the Department shall adopt the federal screening recommendations. 14
(f) (1) The Secretary shall pay all fees collected under the provisions of this 15
subtitle to the Comptroller. 16
(2) The Comptroller shall distribute the fees to the Newborn Screening 17
Program Fund established under § 13–113 of this subtitle. 18
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 19
October 1, 2022. 20