§ 19a-55 — (Formerly Sec. 19-21b). Newborn screening program. Tests required. Report to Department of Public Health. Exemptions. Regulations.

Connecticut § 19a-55

• Jurisdiction: Connecticut
• Title 19a: Public Health and Well-Being
• Ch. 368a: Department of Public Health

Text

(a) There is established a newborn screening program. The Commissioner of Public Health shall (1) administer the newborn screening program, (2) direct persons identified through the screening program to appropriate specialty centers for treatments, consistent with any applicable confidentiality requirements, and (3) set the fees to be charged to institutions to cover all expenses of the comprehensive screening program including testing, tracking and treatment, subject to the approval of the Secretary of the Office of Policy and Management. The fees to be charged pursuant to subdivision (3) of this subsection shall be set at a minimum of ninety-eight dollars. (b) The administrative officer or other person in charge of each institution caring for newborn infants, a nurse-midwife licensed pursuant to chapter 377 or a midwife shall cause to have administered to every such newborn infant in his or her care a blood spot specimen and an HIV-related test, as defined in section 19a-581 , except that the person responsible for testing may omit such test if the mother has had an HIV-related test pursuant to section 19a-90 or 19a-593 . The blood spot specimen shall be collected not earlier than twenty-four hours after the birth of the newborn infant and not later than forty-eight hours after the birth of such infant, unless the institution caring for newborn infants, nurse-midwife licensed pursuant to chapter 377 or midwife determines that a situation exists to warrant an early collection of the specimen or if collection of the specimen is medically contraindicated. Situations that warrant early collection of the specimen shall include, but not be limited to, the imminent transfusion of blood products, dialysis, early discharge of the newborn infant from the institution, transfer of the newborn infant to another institution or imminent death. If the newborn infant dies before a blood spot specimen can be obtained, the specimen shall be collected as soon as practicable after death. The institution licensed to care for newborn infants, nurse-midwife or midwife shall notify the Department of Public Health when a specimen is not collected within forty-eight hours after the birth of such infant due to: (1) The infant's medical fragility, (2) refusal by the parents when newborn infant screening is in conflict with their religious tenets and practice, (3) the newborn infant receiving comfort measures only, or (4) any other reason. Such notification shall be documented in the department's newborn screening system pursuant to section 19a-53 by the institution caring for newborn infants, nurse-midwife or midwife or sent in writing to the department not later than seventy-two hours after the birth of the newborn infant. The institution caring for newborn infants, nurse-midwife or midwife shall send the blood spot specimen to the state public health laboratory not later than twenty-four hours after the time of collection. The department may request an additional blood spot specimen if: (A) There was an early collection of the specimen, (B) the specimen was collected following a transfusion of blood products, (C) the specimen is unsatisfactory for testing, or (D) the department determines that there is an abnormal result. The state public health laboratory shall make and maintain a record of the date and time of its receipt of each blood spot specimen and make such record available for inspection by the institution caring for newborn infants, nurse-midwife or midwife that sent the blood spot specimen not later than forty-eight hours after such institution, nurse-midwife or midwife submits a request to inspect such record. (c) The Commissioner of Public Health shall publish a list of all the abnormal conditions for which the department screens newborns under the newborn screening program, which shall include, but need not be limited to, testing for (1) amino acid disorders, including phenylketonuria, organic acid disorders, fatty acid oxidation disorders, including, but not limited to, long-chain 3-hydroxyacyl CoA dehydrogenase (L-CHAD) and medium-chain acyl-CoA dehydrogenase (MCAD), hypothyroidism, galactosemia, sickle cell disease, maple syrup urine disease, homocystinuria, biotinidase deficiency, congenital adrenal hyperplasia, severe combined immunodeficiency disease, adrenoleukodystrophy, spinal muscular atrophy and any other disorder included on the recommended uniform screening panel pursuant to 42 USC 300b-10, as amended from time to time, and as prescribed by the Commissioner of Public Health, and (2) on and after July 1, 2025, cytomegalovirus. (d) In addition to the testing requirements prescribed in subsection (b) of this section, the administrative officer or other person in charge of each institution caring for newborn infants shall cause to have administered to every such infant in its care a screening test for (1) cystic fibrosis, and (2) critical congenital heart disease. Such screening tests shall be administered as soon after birth as is medically appropriate. (e) The clinical laboratory that completes the testing for cystic fibrosis shall report the number of newborn infants screened and the results of such testing, not less than annually, to the Department of Public Health into the newborn screening system pursuant to section 19a-53 . The administrative officer or other person in charge of each institution caring for newborn infants who performs the testing for critical congenital heart disease shall enter the results of such test into the newborn screening system pursuant to section 19a-53 . (f) The provisions of this section shall not apply to any infant whose parents object to the test or treatment as being in conflict with their religious tenets and practice. The commissioner shall adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section.

Legislative History

(February, 1965, P.A. 108, S. 1, 2; P.A. 77-614, S. 323, 610; P.A. 78-193, S. 1, 2, 4; P.A. 92-227, S. 1, 2; P.A. 93-381, S. 9, 39; P.A. 95-257, S. 12, 21, 58; June 18 Sp. Sess. P.A. 97-8, S. 26; June Sp. Sess. P.A. 99-2, S. 30; P.A. 02-113, S. 1; June 30 Sp. Sess. P.A. 03-3, S. 5; P.A. 05-272, S. 43; P.A. 06-196, S. 210; P.A. 09-20, S. 1; June Sp. Sess. P.A. 09-3, S. 167; P.A. 11-48, S. 38; P.A. 12-13, S. 1; P.A. 13-242, S. 1; P.A. 15-10, S. 1; 15-242, S. 49; June Sp. Sess. P.A. 15-5, S. 346, 506; P.A. 16-66, S. 22; P.A. 17-146, S. 14; P.A. 19-117, S. 148; 19-176, S. 1; P.A. 21-121, S. 75; P.A. 23-204, S. 191.) History: P.A. 77-614 replaced department of health with department of health services, effective January 1, 1979; P.A. 78-193 included tests for hypothyroidism and galactosemia and transferred regulation power from department to commissioner; Sec. 19-21b transferred to Sec. 19a-55 in 1983; P.A. 92-227 amended Subsec. (a) to add sickle cell disease, maple syrup urine disease, homocystinuria and biotinidase deficiency to list of diseases for infant testing and to detail responsibilities of the commissioner in administering the program; P.A. 93-381 replaced department of health services with department of public health and addiction services, effective July 1, 1993; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health, effective July 1, 1995; June 18 Sp. Sess. P.A. 97-8 added congenital adrenal hyperplasia to the list of diseases tested for; June Sp. Sess. P.A. 99-2 amended Subsec. (a) by replacing “infants twenty-eight days or less of age” with “newborn infants”, adding HIV-related test, adding provision that tests be administered as soon after birth as is medically appropriate and that test may be omitted if done under other statutes, and adding “consistent with any applicable confidentiality requirements” in Subdiv. (2); P.A. 02-113 amended Subsec. (a) to add requirement for testing of “other metabolic diseases”, to add a minimum fee requirement of $28, and to add requirement that on or before January 1, 2003, the regulations shall include testing for amino acid disorders, organic acid disorders and fatty acid oxidation disorders; June 30 Sp. Sess. P.A. 03-3 amended Subsec. (a) by changing date for regulations requiring testing for certain disorders from January 1, 2003, to January 1, 2004, effective August 20, 2003; P.A. 05-272 amended Subsec. (a) by removing requirement that newborn screening regulations specify abnormal conditions to be tested for and manner of recording and reporting results and, instead, requiring Commissioner of Public Health to publish list of all abnormal conditions for which department screens newborns under newborn screening program, effective July 13, 2005; P.A. 06-196 made a technical change in Subsec. (a), effective June 7, 2006; P.A. 09-20 added new Subsec. (b) requiring that newborn infants be administered screening test for cystic fibrosis and redesignated existing Subsec. (b) as Subsec. (c); June Sp. Sess. P.A. 09-3 amended Subsec. (a) to increase fee from $28 to $56; P.A. 11-48 repositioned provision re adoption of regulations from Subsec. (a) to Subsec. (c) and amended Subsec. (b) by requiring screening test for severe combined immunodeficiency disease and by making a technical change; P.A. 12-13 amended Subsec. (b) by designating existing provisions re screening tests for cystic fibrosis and severe combined immunodeficiency disease as Subdivs. (1) and (2) and adding Subdiv. (3) re screening test for critical congenital heart disease; P.A. 13-242 added new Subsec. (c) re test for adrenoleukodystrophy and redesignated existing Subsec. (c) as Subsec. (d); P.A. 15-10 amended Subsec. (b) by designating existing provisions re screening tests to be administered as Subdiv. (1), redesignating existing Subdivs. (1) to (3) as Subparas. (A) to (C) and adding new Subdiv. (2) re screening test for infant who fails a hearing screening, added new Subsec. (d) re reporting cases of cytomegalovirus and redesignated existing Subsec. (d) as Subsec. (e), effective July 1, 2015; P.A. 15-242 amended Subsec. (d) by making a technical change, effective June 30, 2015; June Sp. Sess. P.A. 15-5 amended Subsec. (a) to replace “fifty-six” with “ninety-eight” re minimum fees, effective July 1, 2015, and deleted former Subsec. (c) re development and validation of reliable methodology for screening for adrenoleukodystrophy and added new Subsec. (c) re agreement with New York State Department of Health to screen for adrenoleukodystrophy, effective October 1, 2015; P.A. 16-66 amended Subsec. (a) to add reference to severe combined immunodeficiency disease and adrenoleukodystrophy, amended Subsec. (b)(1) to delete former Subpara. (B) re severe combined immunodeficiency disease and redesignate existing Subpara. (C) re critical congenital heart disease as Subpara. (B), deleted former Subsec. (c) re screening test for adrenoleukodystrophy and redesignated existing Subsecs. (d) and (e) as Subsecs. (c) and (d); P.A. 17-146 amended Subsec. (b) by adding provision re entering results of testing for critical congenital heart disease into newborn screening system; P.A. 19-117 amended Subsec. (a) by adding provision re screening for any other disorder included on recommended uniform screening panel subject to approval by the Secretary of the Office of Policy and Management and made technical changes; P.A. 19-176 amended Subsec. (b)(1) by adding Subpara. (C) re spinal muscular atrophy and making technical changes; P.A. 21-121 substantially revised section including by adding provision re approval of fees by Secretary of the Office of Policy and Management in Subsec. (a)(3), moving existing provisions re specific screenings from Subsec. (a) to new Subsec. (b) and amended same by adding provisions re screenings performed using bloodspot specimens and re timeframes for specimen collection and notification, designating existing provisions in Subsec. (a) re commissioner to publish list of abnormal conditions as new Subsec. (c) and amending same to add additional amino acid disorders, redesignating existing Subsec. (b) as new Subsec. (d) and amending same to delete Subdiv. (1)(C) re spinal muscular atrophy and provisions re funding for cytomegalovirus screening test and reporting re congenital heart disease in Subdiv. (2), adding Subsec. (e)(1) re reporting requirements, redesignating existing Subsec. (c) as Subsec. (e)(2) and amending same to add provisions re newborn screening system and patient's insurance status or source of payment, redesignating existing Subsec. (d) as Subsec. (f) and making technical and conforming changes, effective July 6, 2021; P.A. 23-204 amended Subsec. (c) by designating existing provisions as Subdiv. (1) and adding Subdiv. (2) re cytomegalovirus, Subsec. (d) by deleting former Subdiv. (2) re cytomegalovirus and making technical changes, and Subsec. (e) by deleting former Subdiv. (2) re cytomegalovirus and Subdiv. (1) designator, effective June 12, 2023.