EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*hb0109*
HOUSE BILL 109
J1 2lr0689
(PRE–FILED) CF SB 242
By: Delegate Shetty
Requested: October 7, 2021
Introduced and read first time: January 12, 2022
Assigned to: Health and Government Operations
Committee Report: Favorable with amendments
House action: Adopted
Read second time: March 12, 2022
CHAPTER ______
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, subject to the approval of the State Advisory Council on Hereditary and 7
Congenital Disorders and the Secretary of Health; establishing certain requirements 8
related to the approval or disapproval of the inclusion of a condition and the 9
implementation of testing for a condition approved for inclusion in the system for 10
newborn screening; and generally relating to the system for newborn screening. 11
BY repealing and reenacting, with amendments, 12
Article – Health – General 13
Section 13–101 and 13–111 14
Annotated Code of Maryland 15
(2019 Replacement Volume and 2021 Supplement) 16
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 17
That the Laws of Maryland read as follows: 18
Article – Health – General 19
13–101. 20 2 HOUSE BILL 109
(a) In this subtitle the following words have the meanings indicated. 1
(B) “ADVISORY COUNCIL” MEANS THE STATE ADVISORY COUNCIL ON 2
HEREDITARY AND CONGENITAL DISORDERS. 3
[(b)] (C) “Commission” means the State Commission on Hereditary and 4
Congenital Disorders. 5
[(c)] (D) (1) “Congenital disorder” means a significant structural or 6
functional abnormality of the body that is present at birth. 7
(2) “Congenital disorder” does not include a condition that results from: 8
(i) An intrauterine infection; or 9
(ii) A birth injury. 10
[(d)] (E) “Hereditary disorder” means any disorder that: 11
(1) Is transmitted through the genetic material deoxyribonucleic acid 12
(DNA); or 13
(2) Arises through the improper processing of the information in the 14
genetic material. 15
13–111. 16
(A) (1) IN THIS SECTION , “SPECIALIZED TESTING EQUIPMENT” MEANS 17
EQUIPMENT NECESSARY TO RUN A TEST APPROV ED BY THE U.S. FOOD AND DRUG 18
ADMINISTRATION OR A L ABORATORY –DEVELOPED TEST . 19
(2) “SPECIALIZED TESTING E QUIPMENT” DOES NOT INCLUDE : 20
(I) TESTING REAGENTS ; OR 21
(II) DISPOSABLE LABORATORY EQUIPMENT. 22
(a) (B) The Department shall establish a coordinated statewide system for 23
screening all newborn infants in the State for certain hereditary and congenital disorders 24
associated with severe problems of health or development, except when the parent or 25
guardian of the newborn infant objects. 26
(b) (C) Except as provided in § 13–112 of this subtitle, the Department’s public 27
health laboratory is the sole laboratory authorized to perform tests on specimens from 28 HOUSE BILL 109 3
newborn infants collected to screen for hereditary and congenital disorders as determined 1
under subsection (d)(2) (E)(2) of this section. 2
(c) (D) The system for newborn screening shall include: 3
(1) Laboratory testing and the reporting of test results; and 4
(2) Follow–up activities to facilitate the rapid identification and treatment 5
of an affected child. 6
(d) (E) In consultation with the State Advisory Council on Hereditary and 7
Congenital Disorders, the Department shall: 8
(1) Establish protocols for a health care provider to obtain and deliver test 9
specimens to the Department’s public health laboratory; 10
(2) Determine the screening tests that the Department’s public health 11
laboratory is required to perform; 12
(3) Maintain a coordinated statewide system for newborn screening that 13
carries out the purpose described in subsection (c) (D) of this section that includes: 14
(i) Communicating the results of screening tests to the health care 15
provider of the newborn infant; 16
(ii) Locating newborn infants with abnormal test results; 17
(iii) Sharing newborn screening information between hospitals, 18
health care providers, treatment centers, and laboratory personnel; 19
(iv) Delivering needed clinical, diagnostic, and treatment 20
information to health care providers, parents, and caregivers; and 21
(v) Notifying parents and guardians of newborn infants that 22
laboratories other than the Department’s public health laboratory are authorized to 23
perform postscreening confirmatory or diagnostic tests on newborn infants for hereditary 24
and congenital disorders; and 25
(4) Adopt regulations that set forth the standards and requirements for 26
newborn screening for hereditary and congenital disorders that are required under this 27
subtitle, including: 28
(i) Performing newborn screening tests; 29
(ii) Coordinating the reporting, follow–up, and treatment activities 30
with parents, caregivers, and health care providers; and 31
4 HOUSE BILL 109
(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) (F) (1) (I) NOTWITHSTANDING SUBJECT TO THE APPROV AL OF 4
THE SECRETARY AND THE ADVISORY COUNCIL UNDER PARAGRAPH (2) OF THIS 5
SUBSECTION AND NOTWI THSTANDING ANY OTHER PROVISION OF LAW, THE 6
DEPARTMENT SHALL SCRE EN FOR EACH CORE CONDITION LISTED IN THE U.S. 7
DEPARTMENT OF HEALTH AND HUMAN SERVICES’ RECOMMENDED UNIFORM 8
SCREENING PANEL. 9
(II) ON OR AFTER JANUARY 1, 2023, THE DEPARTMENT SHALL 10
INCLUDE IN THE SYSTE M FOR NEWBORN SCREEN ING ANY CORE OR SECO NDARY 11
CONDITION ADDED TO T HE RECOMMENDED UNIFORM SCREENING PANEL 12
SECRETARY AND THE ADVISORY COUNCIL SHALL DETERMI NE WHETHER TO 13
APPROVE THE INCLUSIO N OF A CO NDITION IN THE SYSTE M FOR NEWBORN 14
SCREENING WITHIN 2 YEARS 1 YEAR AFTER THE ADDITION O F THE CONDITION TO 15
THE PANEL RECOMMENDED UNIFORM SCREENING PANEL. 16
(III) IF THE SECRETARY OR ADVISORY COUNCIL DOES NOT 17
APPROVE THE INCLUSIO N OF A CORE CONDITIO N IN THE SYSTEM FOR NEWBO RN 18
SCREENING UNDER SUBP ARAGRAPH (I) OF THIS PARAGRAPH : 19
1. WITHIN 1 YEAR AFTER THE ADDIT ION OF THE 20
CONDITION TO THE RECOMMENDED UNIFORM SCREENING PANEL, THE 21
DEPARTMENT SHALL PUBL ICLY POST AND SUBMIT TO THE GENERAL ASSEMBLY, IN 22
ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, A REPORT 23
THAT INCLUDES , AS APPLICABLE , THE SECRETARY’S JUSTIFICATION FOR NOT 24
APPROVING THE INCLUS ION AND THE FINAL VO TE OF THE ADVISORY COUNCIL 25
REGARDING THE INCLUS ION OF THE CONDITION ; AND 26
2. EACH YEAR AFTER THE INITI AL DISAPPROVAL , THE 27
ADVISORY COUNCIL SHALL: 28
A. REVIEW THE MEDICAL LI TERATURE PUBLISHED O N 29
THE CONDITION SINCE THE INITIAL EVALUATI ON AND DETERMINE WHE THER 30
SUBSTANTIVE UPDATES HAVE OCCURRED THAT W OULD MERIT FORMAL 31
REEVALUATION OF TH E INCLUSION OF THE C ONDITION; AND 32
B. IF THE ADVISORY COUNCIL UPHOLDS ITS 33
DISAPPROVAL OF THE C ONDITION, PUBLICLY PUBLISH AND SUBMIT TO THE 34
GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT 35
ARTICLE, A REPORT ON THE REAS ON FOR THE DISAPPROVAL . 36
HOUSE BILL 109 5
(2) Notwithstanding any other provision of law, if the Secretary of Health 1
and Human Services issues federal recommendations on critical congenital heart disease 2
screening of newborns, the Department shall adopt the federal screening recommendations. 3
(G) (1) IF THE SECRETARY AND THE ADVISORY COUNCIL APPROVE THE 4
INCLUSION OF A CONDI TION IN THE SYSTEM F OR NEWBORN SCREENING UNDER 5
SUBSECTION (F) OF THIS SECTION , WITHIN 1 YEAR AFTER THE DATE OF THE 6
APPROVAL, THE DEPARTMENT SHALL : 7
(I) IF TESTING FOR THE COND ITION CAN BE IMPLEME NTED 8
WITHOUT THE PROCUREM ENT OF SPECIALIZED T ESTING EQUIPMENT , IMPLEMENT 9
TESTING FOR THE COND ITION; OR 10
(II) IF THE IMPLEMENTATION OF TESTING REQUIRES THE 11
PROCUREMENT OF SPECI ALIZED TESTING EQUIP MENT, SIGN A FINAL 12
PROCUREMENT CONTRACT WITH A VENDOR FOR AL L EQUIPMENT NECESSAR Y TO 13
IMPLEMENT TESTING . 14
(2) FOR PROCUREMENTS REQU IRED UNDER PARAGRAPH (1)(II) OF 15
THIS SUBSECTION : 16
(I) NOTWITHSTANDING ANY O THER PROVISION OF LA W, THE 17
DEPARTMENT MAY USE EX PEDITED PROCUREM ENT UNDER § 13–108 OF THE STATE 18
FINANCE AND PROCUREMENT ARTICLE; AND 19
(II) THE PROCUREMENT CONTR ACT SHALL INCLUDE A CLAUSE 20
AUTHORIZING THE STATE TO TERMINATE TH E CONTRACT IF THE VE NDOR HAS NOT 21
FULFILLED THE CONTRA CT WITHIN 6 MONTHS. 22
(f) (H) (1) The Secretary shall pay all fees collected under the provisions of 23
this subtitle to the Comptroller. 24
(2) The Comptroller shall distribute the fees to the Newborn Screening 25
Program Fund established under § 13–113 of this subtitle. 26
SECTION 2. AND BE IT FUR THER ENACTED, That this Act shall take effect 27
October 1, 2022. 28