HB 77 — Newborn Screening Panel, procedure for addition of conditions to panel, further provided for

HB77 INTRODUCEDENROLLED HB77 4VUHR33-14VUHR33-2 By Representative Rigsby RFD:

01-Feb-24 Page 0 4VUHR33-1HB77 01/31/2024Enrolled GPEnrolled, (L)lgAn 2023-3577Act, 2Relating 4to SYNOPSIS:newborn screening;

Underto existingamend law,Section each22-20-3, newbornCode childof is screened for certain heritable diseases and conditions, as determined by the Alabama State1975; Board of Health.

This bill would require the State Board of Health to add any condition on the Recommended Uniform Screening Panel (RUSP).

This bill would require the State Board of Health to adopt rules relating to the use of the Newborn Screening Panel.

This bill would provide a timeline for conditions with RUSP approval to be included on the panel and would require a written report to the State Health Officer if the timeline is not met.

This bill would also provide that the duties of the State Laboratory relating to testing for certain heritable diseases and conditions are contingent on the availability of funding.

A BILL TO BE ENTITLED AN ACT Relating to newborn screening;

to amend Section Page 1 HB77 INTRODUCED 22-20-3, Code of Alabama 1975;

to require newborns with a family history of a disease to be tested for that disease under certain circumstances;

Page 1 HB77 Enrolled Section 2.

"§22-20-3 (a) For the purposes of this section, the following Page 2 HB77 INTRODUCED terms have the following meanings:

(b) It shall be the duty of the The administrative officer, or other persons individuals in charge of each institution caring for infants newborn children 28 days or less of age old or younger, or the physician attending a newborn child, or the person individual attending a newborn child that was not attended by a physician to shall cause to have administered to every such infant or newborn child in his or her carecare: a reliable test for conditions on the Newborn Screening Panel, including hypothyroidism and a reliable test for phenylketonuria (PKU), such as the Guthrie test, or any other test considered equally reliable by the State Board of Health and a reliable test for sickle cell anemia, sickle cell trait, and/or abnormal hemoglobin and such other tests Page 3 HB77 INTRODUCED relating to mental retardation or other genetic, metabolic, or other heritable diseases and conditions as are designated approved for inclusion on the Newborn Screening Panel by the Board of Health board, pursuant to Section 22-20-3.2,.

(i) testing for any disease for which the newborn has a known family history and which can be diagnosed at Page 2 HB77 Enrolled birth;

and (ii) a reliable test for conditions on the Newborn Screening Panel, including hypothyroidism and a reliable test for phenylketonuria (PKU), such as the Guthrie test, or any other test considered equally reliable by the State Board of Health and a reliable test for sickle cell anemia, sickle cell trait, and/or abnormal hemoglobin and such other tests relating to mental retardation or other genetic, metabolic, or other heritable diseases and conditions as are designated approved for inclusion on the Newborn Screening Panel by the Board of Health board, pursuant to Section 22-20-3.2,.

95 board and confirmatory tests shall be undertaken by such laboratory facilities as are designated by the attending physician or parent;

Page 3 HB77 Enrolled (b)(d) The State Board of Health board shall promulgate such adopt rules and regulations as it considers necessary to provide for the care and treatment of those newborn infants children whose tests are determined positive, including, but not limited to, advising dietary treatment for such infants newborn children.

The State Board of Health board shall Page 4 HB77 INTRODUCED promulgate adopt any other rules and regulations necessary to effectuate the provisions of this section, including the collection of a reasonable fee for the newborn child screening program." 95 Section 3.

(2) Any condition added to the RUSP prior to January 1, 2024, shall be added to the panel by the board no later than Page 4 HB77 Enrolled October 1, 2027.

Following its presentation to the State Health Page 5 HB77 INTRODUCED Officer, the board shall post the same written notice on its website.

Page 65 HB77 Enrolled ________________________________________________ Speaker of the House of Representatives ________________________________________________ President and Presiding Officer of the Senate House of Representatives I hereby certify that the within Act originated in and was passed by the House 22-Feb-24.

John Treadwell Clerk Senate 25-Apr-24 Amended and Passed House 25-Apr-24 Concurred in Senate Amendment Page 6