LAWRENCE J. HOGAN, JR., Governor Ch. 265
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Chapter 265
(House Bill 109)
AN ACT concerning
Maryland Department of Health – System for Newborn Screening –
Requirements
FOR the purpose of requiring the system for newborn screening in the Maryland
Department of Health to include screening for each condition listed in the U.S.
Department of Health and Human Services’ Recommended Uniform Screening
Panel, subject to the approval of the State Advisory Council on Hereditary and
Congenital Disorders and the Secretary of Health; establishing certain requirements
related to the approval or disapproval of the inclusion of a condition and the
implementation of testing for a condition approved for inclusion in the system for
newborn screening; and generally relating to the system for newborn screening.
BY repealing and reenacting, with amendments,
Article – Health – General
Section 13–101 and 13–111
Annotated Code of Maryland
(2019 Replacement Volume and 2021 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Health – General
13–101.
(a) In this subtitle the following words have the meanings indicated.
(B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON
HEREDITARY AND CONGENITAL DISORDERS.
[(b)] (C) “Commission” means the State Commission on Hereditary and
Congenital Disorders.
[(c)] (D) (1) “Congenital disorder” means a significant structural or
functional abnormality of the body that is present at birth.
(2) “Congenital disorder” does not include a condition that results from:
(i) An intrauterine infection; or
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(ii) A birth injury.
[(d)] (E) “Hereditary disorder” means any disorder that:
(1) Is transmitted through the genetic material deoxyribonucleic acid
(DNA); or
(2) Arises through the improper processing of the information in the
genetic material.
13–111.
(A) (1) IN THIS SECTION , “SPECIALIZED TESTING EQUIPMENT” MEANS
EQUIPMENT NECESSARY TO RUN A TEST APPROV ED BY THE U.S. FOOD AND DRUG
ADMINISTRATION OR A L ABORATORY –DEVELOPED TEST .
(2) “SPECIALIZED TESTING E QUIPMENT” DOES NOT INCLUDE :
(I) TESTING REAGENTS ; OR
(II) DISPOSABLE LABORATORY EQUIPMENT.
(a) (B) (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) (C) (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) (E)(2) (d)(2) of this section.
(c) (D) (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) (E) (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;
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(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) (D) (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) (F) (e) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF
THE SECRETARY AND THE ADVISORY COUNCIL UNDER PARAGRA PH (2) OF THIS
SUBSECTION AND NOTWI THSTANDING ANY OTHER PROVISION OF LAW, THE
DEPARTMENT SHALL SCRE EN 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 DEPARTMENT SHALL
INCLUDE IN THE SYSTEM FOR NEWBORN S CREENING ANY CORE OR SECONDARY
CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL
SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO Ch. 265 2022 LAWS OF MARYLAND
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APPROVE THE INCLUSIO N OF A CONDITION IN THE SYSTEM FOR NEWBO RN
SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO
THE PANEL RECOMMENDED UNIFORM SCREENING PANEL.
(III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT
APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBORN
SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH :
1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE
CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE
DEPARTMENT SHALL PUBL ICLY 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 INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL
REGARDING THE INCLUS ION OF THE CONDITION ; AND
2. EACH YEAR AFTER THE I NITIAL DISAPPROVAL , THE
ADVISORY COUNCIL SHALL:
A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N
THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER
SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL
REEVALUATION OF THE INCLUSION OF THE CON DITION; AND
B. IF THE ADVISORY COUNCIL UPHOLDS ITS
DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE
GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT
ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROV AL.
(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 CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER
SUBSECTION (E) OF THIS SECTION, THE DEPARTMENT SHALL IMPL EMENT TESTING
FOR THE CONDITION WI THIN 1 YEAR AFTER THE DATE OF THE APPROVAL .
(G) (1) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE
INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER
SUBSECTION (F) OF THIS SECTION , WITHIN 1 YEAR AFTER THE DATE OF THE
APPROVAL, THE DEPARTMENT SHALL :
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(I) IF TESTING FOR THE CO NDITION CAN BE IMPLE MENTED
WITHOUT THE PROCUREMENT OF SPECIALIZED TESTI NG EQUIPMENT , IMPLEMENT
TESTING FOR THE COND ITION; OR
(II) IF THE IMPLEMENTATION OF TESTING REQUIRES THE
PROCUREMENT OF SPECI ALIZED TESTING EQUIP MENT, SIGN A FINAL
PROCUREMENT CONTRACT WITH A VENDOR FOR AL L EQUIPMENT NECESSARY TO
IMPLEMENT TESTING .
(2) FOR PROCUREMENTS REQU IRED UNDER PARAGRAPH (1)(II) OF
THIS SUBSECTION :
(I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE
DEPARTMENT MAY USE EX PEDITED PROCUREMENT UNDER § 13–108 OF THE STATE
FINANCE AND PROCUREMENT ARTICLE; AND
(II) THE PROCUREMENT CONTR ACT SHALL INCLUDE A CLAUSE
AUTHORIZING THE STATE TO TERMINATE TH E CONTRACT IF THE VE NDOR HAS NOT
FULFILLED THE CONTRA CT WITHIN 6 MONTHS.
(f) (H) (f) (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.
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take e ffect
October 1, 2022.
Approved by the Governor, May 12, 2022.