Section 383.14 - Screening for metabolic disorders, other hereditary and congenital disorders, and environmental risk factors(1) SCREENING REQUIREMENTS.-To help ensure access to the maternal and child health care system, the Department of Health shall promote the screening of all newborns born in Florida for metabolic, hereditary, and congenital disorders known to result in significant impairment of health or intellect, as screening programs accepted by current medical practice become available and practical in the judgment of the department. Any health care practitioner present at a birth or responsible for primary care during the neonatal period has the primary responsibility of administering screenings as required in ss. 383.14 and 383.145. As used in this subsection, the term "health care practitioner" means a physician or physician assistant licensed under chapter 458, an osteopathic physician or physician assistant licensed under chapter 459, an advanced practice registered nurse licensed under part I of chapter 464, or a midwife licensed under chapter 467 .
(a)Blood specimens for newborn screenings.-Newborn screenings must be performed by the State Public Health Laboratory, in coordination with Children's Medical Services, at such times and in such manner as is prescribed by the department after consultation with the Genetics and Newborn Screening Advisory Council .(b)Release of screening results.-Notwithstanding any law to the contrary, the State Public Health Laboratory may release, directly or through the Children's Medical Services program, the results of a newborn's screenings to the newborn's health care practitioner, the newborn's parent or legal guardian, the newborn's personal representative, or a person designated by the newborn's parent or legal guardian. As used in this paragraph, the term "health care practitioner" means a physician or physician assistant licensed under chapter 458; an osteopathic physician or physician assistant licensed under chapter 459; an advanced practice registered nurse, registered nurse, or licensed practical nurse licensed under part I of chapter 464; a midwife licensed under chapter 467; a speech-language pathologist or audiologist licensed under part I of chapter 468; a dietician or nutritionist licensed under part X of chapter 468; or a genetic counselor licensed under part III of chapter 483.(2) RULES.- (a) After consultation with the Genetics and Newborn Screening Advisory Council, the department shall adopt and enforce rules requiring that every newborn in this state shall: 1. Before becoming 1 week of age, have a blood specimen collected for newborn screenings ;2. Be tested for any condition included on the federal Recommended Uniform Screening Panel which the council advises the department should be included under the state's screening program. After the council recommends that a condition be included, the department shall submit a legislative budget request to seek an appropriation to add testing of the condition to the newborn screening program. The department shall expand statewide screening of newborns to include screening for such conditions within 18 months after the council renders such advice, if a test approved by the United States Food and Drug Administration or a test offered by an alternative vendor is available. If such a test is not available within 18 months after the council makes its recommendation, the department shall implement such screening as soon as a test offered by the United States Food and Drug Administration or by an alternative vendor is available; and3. At the appropriate age, be tested for such other metabolic diseases and hereditary or congenital disorders as the department may deem necessary . (b) The department shall adopt such additional rules as are found necessary for the administration of this section and ss. 383.145 and 383.148 , including rules providing definitions of terms, rules relating to the methods used and time or times for testing as accepted medical practice indicates, rules relating to charging and collecting fees for the administration of the newborn screening program authorized by this section, rules for processing requests and releasing test and screening results, and rules requiring mandatory reporting of the results of tests and screenings for these conditions to the department.(3) DEPARTMENT OF HEALTH; POWERS AND DUTIES.-The department shall administer and provide certain services to implement the provisions of this section and shall: (a) Assure the availability and quality of the necessary laboratory tests and materials.(b) Promote education of the public about the prevention and management of metabolic, hereditary, and congenital disorders .
(c) Maintain a confidential registry of cases, including information of importance for the purpose of follow-up services to prevent intellectual disabilities, to correct or ameliorate physical disabilities, and for epidemiologic studies, if indicated. Such registry shall be exempt from the provisions of s. 119.07(1).(d) Supply the necessary dietary treatment products where practicable for diagnosed cases of metabolic diseases for as long as medically indicated when the products are not otherwise available. Provide nutrition education and supplemental foods to those families eligible for the Special Supplemental Nutrition Program for Women, Infants, and Children as provided in s. 383.011.(e) Promote the availability of genetic studies, services, and counseling in order that the parents, siblings, and affected newborns may benefit from detection and available knowledge of the condition.(f) Have the authority to charge and collect fees for the administration of the newborn screening program. A fee not to exceed $15 will be charged for each live birth, as recorded by the Office of Vital Statistics, occurring in a hospital licensed under part I of chapter 395 or a birth center licensed under s. 383.305 . The department shall calculate the assessment for each hospital and birth center, and this assessment must be paid quarterly. The department shall generate and issue each hospital and birth center a statement of the amount due.
(g) Have the authority to bill third-party payors for newborn screening tests.(h) Create and make available electronically a pamphlet with information on screening for, and the treatment of, preventable infant and childhood eye and vision disorders, including, but not limited to, retino-blastoma and amblyopia. All provisions of this subsection must be coordinated with the provisions and plans established under this chapter, chapter 411, and Pub. L. No. 99-457.
(4) OBJECTIONS OF PARENT OR GUARDIAN.-The provisions of this section shall not apply when the parent or guardian of the child objects thereto. A written statement of such objection shall be presented to the physician or other person whose duty it is to administer and report tests and screenings under this section.(5) SUBMISSION OF NEWBORN SCREENING SPECIMEN CARDS. Any health care practitioner whose duty it is to administer screenings under this section shall prepare and send all newborn screening specimen cards to the State Public Health Laboratory in accordance with rules adopted under this section. As used in this subsection, the term "health care practitioner" means a physician or physician assistant licensed under chapter 458, an osteopathic physician or physician assistant licensed under chapter 459, an advanced practice registered nurse licensed under part I of chapter 464, or a midwife licensed under chapter 467.(6) ADVISORY COUNCIL.-There is established a Genetics and Newborn Screening Advisory Council made up of 15 members appointed by the State Surgeon General. The council shall be composed of two consumer members, three practicing pediatricians, at least one of whom must be a pediatric hematologist, a representative from each of four medical schools in this state, the State Surgeon General or his or her designee, one representative from the Department of Health representing Children's Medical Services, one representative from the Florida Hospital Association, one individual with experience in newborn screening programs, one individual representing audiologists, and one representative from the Agency for Persons with Disabilities. All appointments shall be for a term of 4 years. The chairperson of the council shall be elected from the membership of the council and shall serve for a period of 2 years. The council shall meet at least semiannually or upon the call of the chairperson. The council may establish ad hoc or temporary technical advisory groups to assist the council with specific topics which come before the council. Council members shall serve without pay. Pursuant to the provisions of s. 112.061, the council members are entitled to be reimbursed for per diem and travel expenses. It is the purpose of the council to advise the department about: (a) Conditions for which testing should be included under the screening program and the genetics program. Within 1 year after a condition is added to the federal Recommended Uniform Screening Panel, the council shall consider whether the condition should be included under the state's screening program.(b) Procedures for collection and transmission of specimens and recording of results.(c) Methods whereby screening programs and genetics services for children now provided or proposed to be offered in the state may be more effectively evaluated, coordinated, and consolidated.s. 1, ch. 65-519; ss. 19, 35, ch. 69-106; s. 1, ch. 71-140; s. 129, ch. 77-147; s. 1, ch. 78-245; s. 2, ch. 79-26; s. 1, ch. 82-46; s. 2, ch. 83-265; s. 8, ch. 86-220; ss. 1, 5, 6, ch. 89-93; s. 2, ch. 90-344; s. 22, ch. 91-282; s. 5, ch. 91-429; s.672, ch. 95-148; s.9, ch. 95-394; s.1, ch. 96-306; s.194, ch. 96-406; s.188, ch. 97-101; s.29, ch. 97-237; s.23, ch. 99-397; s.45, ch. 2000-139; s.18, ch. 2000-242; s.15, ch. 2000-337; s.14, ch. 2001-53; s.62, ch. 2001-277; s.3, ch. 2004-245; s.13, ch. 2004-350; s.7, ch. 2006-227; s.37, ch. 2008-6; s.4, ch. 2010-210; s.269, ch. 2011-142; s.8, ch. 2013-162; s.1, ch. 2014-121; s.1, ch. 2017-78; s.6, ch. 2017-181; s.11, ch. 2018-24; s.17, ch. 2018-106; s.43, ch. 2019-116; s.1, ch. 2020-79; s.7, ch. 2021-10; s.8, ch. 2021-52.Amended by 2024 Fla. Laws, ch. 246,s 3, eff. 7/1/2024.Amended by 2021 Fla. Laws, ch. 52, s 8, eff. 6/29/2021.Amended by 2021 Fla. Laws, ch. 10, s 7, eff. 7/1/2021.Amended by 2020 Fla. Laws, ch. 79, s 1, eff. 7/1/2020.Amended by 2019 Fla. Laws, ch. 116, s 43, eff. 7/1/2019.Amended by 2018 Fla. Laws, ch. 106, s 17, eff. 10/1/2018.Amended by 2017 Fla. Laws, ch. 181, s 6, eff. 7/1/2017.Amended by 2017 Fla. Laws, ch. 78, s 1, eff. 7/1/2017.Amended by 2014 Fla. Laws, ch. 121, s 1, eff. 7/1/2014.Amended by 2013 Fla. Laws, ch. 162, s 8, eff. 7/1/2013.