Chapter 253

253.11(3) (3) Any person who violates this section may be required to forfeit not more than $1,000.

253.11 History History: 1979 c. 221; 1987 a. 332; 1993 a. 27 s. 314; Stats. 1993 s. 253.11.

253.115 253.115 Newborn hearing screening.

253.115(1) (1) Definitions. In this section:

253.115(1)(a) (a) “Hearing loss” means an inability in one or both ears to detect sounds at 30 decibels hearing level or greater in the frequency region of 500 to 4,000 hertz that affects speech recognition and auditory comprehension.

253.115(1)(b) (b) “Hertz” means a unit of frequency equal to one cycle per second.

253.115(1)(c) (c) “Hospital” has the meaning given in s. 50.33 (2).

253.115(1)(d) (d) “Infant” means a child from birth to 3 months of age.

253.115(1)(e) (e) “Newborn hearing screening program” means a system of a hospital under which an infant may be tested, using currently available medical techniques, to determine if the infant has a hearing loss.

253.115(2) (2) Screening program report. Beginning July 1, 2002, the department shall annually collect information from hospitals for the previous calendar year concerning the numbers of deliveries in each hospital and the availability in each hospital of a newborn hearing screening program. From this information, by July 31, 2003, and annually thereafter, the department shall determine the percentage of deliveries in this state that are performed in hospitals that have newborn hearing screening programs and shall report this information to the appropriate standing committees of the legislature under s. 13.172 (3).

253.115(3) (3) Hospital screening program. If, by August 5, 2003, the department determines that fewer than 88 percent of all deliveries in this state are performed in hospitals that have a newborn hearing screening program and so notifies the hospitals, every hospital shall, by January 1, 2004, have a newborn hearing screening program that is available to all infants who are delivered in the hospital.

253.115(4) (4) Screening required. Except as provided in sub. (6), the physician, nurse-midwife licensed under s. 441.15, or certified professional midwife licensed under s. 440.982 who attended the birth shall ensure that the infant is screened for hearing loss before being discharged from a hospital, or within 30 days of birth if the infant was not born in a hospital.

253.115(5) (5) Referral to follow-up services. The department shall provide referrals to intervention programs for hearing loss.

253.115(6) (6) Exceptions.

253.115(6)(a) (a) Subsection (4) does not apply if the parents or legal guardian of the child object to a screen for hearing loss on the grounds that the test conflicts with their religious tenets and practices.

253.115(6)(b) (b) No screening may be performed under sub. (4) unless the parents or legal guardian are fully informed of the purposes of a screen for hearing loss and have been given reasonable opportunity to object under par. (a) to the screen.

253.115(7) (7) Screening results.

253.115(7)(a) (a) The physician, nurse-midwife licensed under s. 441.15, or certified professional midwife licensed under s. 440.982 who is required to ensure that the infant is screened for hearing loss under sub. (4) shall do all of the following:

253.115(7)(a)1. 1. Ensure the parents or legal guardian are advised of the screening results.

253.115(7)(a)2. 2. If the infant has an abnormal hearing screening result, ensure the parents or legal guardian are provided information on available resources for diagnosis and treatment of hearing loss.

253.115(7)(a)3. 3. Send to the state laboratory of hygiene board screening results and the infant’s risk factors to contract a hearing loss.

253.115(7)(b) (b) The state laboratory of hygiene board shall send the information provided under par. (a) 3. to the department.

253.115(8) (8) Confidentiality. Except as provided under sub. (7) (a) 3. and (b), no information obtained under this section from the parents or legal guardian may be disclosed except for use in statistical data compiled by the department without reference to the identity of any individual and except as provided in s. 146.82 (2).

253.115 History History: 1999 a. 9, 185; 2009 a. 279; 2011 a. 260.

253.12 253.12 Birth defect prevention and surveillance system.

253.12(1) (1) Definitions. In this section:

253.12(1)(a) (a) “Birth defect” means any of the following conditions affecting an infant or child that occurs prior to or at birth and that requires medical or surgical intervention or interferes with normal growth and development:

253.12(1)(a)1. 1. A structural deformation, disruption or dysplasia.

253.12(1)(a)2. 2. A genetic, inherited or biochemical disease.

253.12(1)(b) (b) “Pediatric specialty clinic” means a clinic the primary purpose of which is to provide pediatric specialty diagnostic, counseling and medical management services to persons with birth defects by a physician subspecialist.

253.12(1)(c) (c) “Infant or child” means a human being from birth to the age of 2 years.

253.12(1)(d) (d) “Physician” has the meaning given in s. 448.01 (5).

253.12(2) (2) Reporting.

253.12(2)(a) (a) Except as provided in par. (b), all of the following shall report in the manner prescribed by the department under sub. (3) (a) 3. a birth defect in an infant or child that is specified under sub. (3) (a) 2. or (d):

253.12(2)(a)1. 1. A pediatric specialty clinic in which the birth defect is diagnosed in an infant or child or treatment for the birth defect is provided to the infant or child.

253.12(2)(a)2. 2. A physician who diagnoses the birth defect or provides treatment to the infant or child for the birth defect.

253.12(2)(am) (am) Any hospital in which a birth defect is diagnosed in an infant or child or treatment is provided to the infant or child may report the birth defect in the manner prescribed by the department under sub. (3) (a) 3.

253.12(2)(b) (b) No person specified under par. (a) need report under par. (a) if that person knows that another person specified under par. (a) or (am) has already reported to the department the required information with respect to the same birth defect of the same infant or child.

253.12(2)(c) (c) If the department determines that there is a discrepancy in any data reported under this subsection, the department may request a physician, hospital or pediatric specialty clinic to provide to the department information contained in the medical records of patients who have a confirmed or suspected birth defect diagnosis. The physician, hospital or pediatric specialty clinic shall provide that information within 10 working days after the department requests it.

253.12(2)(d) (d) The department may not require a person specified under par. (a) 1. or 2. to report the name of an infant or child for whom a report is made under par. (a) if the parent or guardian of the infant or child states in writing that he or she refuses to release the name or address of the infant or child.

253.12(2)(e) (e) If the address of an infant or child for whom a report is made under par. (a) is included in the report, the department shall encode the address to refer to the same geographical location.

253.12(3) (3) Department duties and powers.

253.12(3)(a) (a) The department shall do all of the following:

253.12(3)(a)1. 1. Establish and maintain an up-to-date registry that documents the diagnosis in this state of any infant or child who has a birth defect, regardless of the residence of the infant or child. The department shall include in the registry information that will facilitate all of the following:

253.12(3)(a)1.a. a. Identification of risk factors for birth defects.

253.12(3)(a)1.b. b. Investigation of the incidence, prevalence and trends of birth defects using epidemiological surveys.

253.12(3)(a)1.c. c. Development of primary preventive strategies to decrease the occurrence of birth defects without increasing abortions.

253.12(3)(a)1.d. d. Referrals for early intervention or other appropriate services.

253.12(3)(a)2. 2. Specify by rule any birth defects the department determines the existence of which requires a report under sub. (2) to be submitted to the department and that the council under sub. (4) does not unanimously decide should be reported.

253.12(3)(a)3. 3. Specify by rule the content, format and procedures for submitting a report under sub. (2).

253.12(3)(a)3m. 3m. Require persons specified under sub. (2) (a) that are required to report to notify a parent or guardian of the infant or child who is diagnosed with a birth defect of the option to refuse to release the name and address of the infant or child to the registry.

253.12(3)(a)4. 4. Notify the persons specified under sub. (2) (a) of their obligation to report.

253.12(3)(b) (b) The department may monitor the data contained in the reports submitted under sub. (2) to ensure the quality of that data and to make improvements in reporting methods.

253.12(3)(d) (d) The secretary, after reviewing recommendations of the council under sub. (4), shall maintain a list of specific birth defects the existence of which requires a report under sub. (2) to be submitted to the department and that the council unanimously decides are required to be reported.

253.12(4) (4) Council on birth defect prevention and surveillance. The council on birth defect prevention and surveillance shall meet at least 4 times per year and shall do all of the following:

253.12(4)(a) (a) Make recommendations to the department regarding the establishment of a registry that documents the diagnosis in the state of an infant or child who has a birth defect, as required under sub. (3) (a) 1., the specific birth defects for which a report is required under sub. (2) on which the council unanimously decides, the rules that the department is required to promulgate under sub. (3) (a) 3., and on the general content and format of the report under sub. (2) and procedures for submitting the report. The council shall also make recommendations regarding the content of a report that, because of the application of sub. (2) (d), does not contain the name of the subject of the report.

253.12(4)(b) (b) Coordinate with the early intervention interagency coordinating council to facilitate the delivery of early intervention services to children from birth to 3 years with developmental needs.

253.12(4)(c) (c) Advise the secretary and make recommendations regarding the registry established under sub. (3) (a) 1.

253.12(4)(d) (d) Beginning April 1, 2002, and biennially thereafter, submit to the appropriate standing committees under s. 13.172 (3) a report that details the effectiveness, utilization and progress of the registry established under sub. (3) (a) 1.

253.12(5) (5) Confidentiality.

253.12(5)(a) (a) Any information contained in a report made to the department under sub. (2) that may specifically identify the subject of the report is confidential. The department may not release that confidential information except to the following, under the following conditions:

253.12(5)(a)1. 1. The parent or guardian of an infant or child for whom a report is made under sub. (2).

253.12(5)(a)2. 2. A local health officer, a local birth-to-3 coordinator or an agency under contract with the department to administer the children with special health care needs program, upon receipt of a written request and informed written consent from the parent or guardian of the infant or child. The local health officer may disclose information received under this subdivision only to the extent necessary to render and coordinate services and follow-up care for the infant or child or to conduct a health, demographic or epidemiological investigation. The local health officer shall destroy all information received under this subdivision within one year after receiving it.

253.12(5)(a)3. 3. A physician, hospital or pediatric specialty clinic reporting under sub. (2), for the purpose of verification of information reported by the physician, hospital or pediatric specialty clinic.

253.12(5)(a)4. 4. A representative of a federal or state agency upon written request and to the extent that the information is necessary to perform a legally authorized function of that agency, including investigation of causes, mortality, methods of prevention and early intervention, treatment or care of birth defects, associated diseases or disabilities. The information may not include the name or address of an infant or child with a condition reported under sub. (2). The department shall notify the parent or guardian of an infant or child about whom information is released under this subdivision, of the release. The representative of the federal or state agency may disclose information received under this paragraph only as necessary to perform the legally authorized function of that agency for which the information was requested.

253.12(5)(a)5. 5. The state registrar, the vital records system, and other data systems maintained by the department or another state or federal agency for purposes including determining whether multiple reports are made for an infant or child, matching reported information on infants or children with vital records and other registries, and making referrals to intervention and treatment.

253.12(5)(b) (b) The department may also release confidential information to a person proposing to conduct research if all of the following conditions are met:

253.12(5)(b)1. 1. The person proposing to conduct the research applies in writing to the department for approval to perform the research and the department approves the application. The application for approval shall include a written protocol for the proposed research, the person’s professional qualifications to perform the proposed research and any other information requested by the department.

253.12(5)(b)2. 2. The research is for the purpose of studying birth defects surveillance and prevention.

253.12(5)(b)3. 3. If the research will involve direct contact with a subject of a report made under sub. (2) or with any member of the subject’s family, the department determines that the contact is necessary for meeting the research objectives and that the research is in response to a public health need or is for the purpose of or in connection with birth defects surveillance or investigations sponsored and conducted by public health officials. The department must also determine that the research has been approved by a certified institutional review board or a committee for the protection of human subjects in accordance with the regulations for research involving human subjects required by the federal department of health and human services for projects supported by that agency. Contact may only be made with the written informed consent of the parent or guardian of the subject of the report and in a manner and method approved by the department.

253.12(5)(b)4. 4. The person agrees in writing that the information provided will be used only for the research approved by the department.

253.12(5)(b)5. 5. The person agrees in writing that the information provided will not be released to any person except other persons involved in the research.

253.12(5)(b)6. 6. The person agrees in writing that the final product of the research will not reveal information that may specifically identify the subject of a report made under sub. (2).

253.12(5)(b)7. 7. The person agrees in writing to any other conditions imposed by the department.

253.12(6) (6) Information not admissible. Information collected under this section is not admissible as evidence during the course of a civil or criminal action or proceeding or an administrative proceeding, except for the purpose of enforcing this section.

253.12(7) (7) Funding. From the appropriation account under s. 20.435 (1) (gm), the department shall allocate $95,000 annually for the birth defect prevention and surveillance system under this section.

253.12 History History: 1987 a. 371; 1991 a. 178; 1993 a. 27 ss. 347, 349; Stats. 1993 s. 253.12; 1993 a. 335; 1995 a. 27 s. 9145 (1); 1995 a. 417; 1997 a. 164, 252; 1999 a. 32, 114, 186; 2001 a. 38; 2009 a. 28; 2017 a. 59.

253.12 Cross-reference Cross-reference: See also ch. DHS 116, Wis. adm. code.

253.13 253.13 Tests for congenital disorders.

253.13(1) (1) Tests; requirements. The attending physician or nurse licensed under s. 441.15 shall cause every infant born in each hospital or maternity home, prior to its discharge therefrom, to be subjected to tests for congenital and metabolic disorders, as specified in rules promulgated by the department. If the infant is born elsewhere than in a hospital or maternity home, the attending physician, nurse licensed under s. 441.15, or birth attendant who attended the birth shall cause the infant, within one week of birth, to be subjected to these tests.

253.13(2) (2) Tests; diagnostic, dietary and follow-up counseling program; fees. The department shall contract with the state laboratory of hygiene to perform any tests under this section that are laboratory tests and to furnish materials for use in the tests. The department shall provide necessary diagnostic services, special dietary treatment as prescribed by a physician for a patient with a congenital disorder as identified by tests under this section, and follow-up counseling for the patient and his or her family. The department shall impose a fee, by rule, for tests performed under this section sufficient to pay for services provided under the contract. The department shall include as part of the fee established by rule amounts to fund the provision of diagnostic and counseling services, special dietary treatment, and periodic evaluation of infant screening programs, the costs of consulting with experts under sub. (5), the costs of administering the hearing screening program under s. 253.115, and the costs of administering the congenital disorder program under this section and, except as otherwise provided in this subsection, shall credit these amounts to the appropriation accounts under s. 20.435 (1) (ja) and (jb). Beginning on July 7, 2023, the fee imposed by the department under this subsection cannot be less than $195. At least $75 of this amount shall be credited to the appropriation account under s. 20.285 (1) (i).

253.13(3) (3) Exceptions. This section shall not apply if the parents or legal guardian of the child object thereto on the grounds that the test conflicts with their religious tenets and practices or with their personal convictions. No tests may be performed under this section unless the parents or legal guardian are fully informed of the purposes of testing under this section and have been given reasonable opportunity to object as authorized in this subsection to such tests.

253.13(4) (4) Confidentiality and reporting.

253.13(4)(a) (a) The state laboratory of hygiene shall provide its laboratory test results to the physician, who shall advise the parents or legal guardian of the results. No information obtained under this section from the parents or guardian or from tests performed under this section may be disclosed except for use in statistical data compiled by the department without reference to the identity of any individual and except as provided in s. 146.82 (2). The state laboratory of hygiene board shall provide to the department the names and addresses of parents of infants who have positive test results.

253.13(4)(b) (b) The department may require reporting in connection with the tests performed under this section for use in statistical data compilation and for evaluation of infant screening programs.

253.13(5) (5) Related services. The department shall disseminate information to families whose children suffer from congenital disorders and to women of child-bearing age with a history of congenital disorders concerning the need for and availability of follow-up counseling and special dietary treatment and the necessity for testing infants. The department shall also refer families of children who suffer from congenital disorders to available health services programs and shall coordinate the provision of these programs. The department shall periodically consult appropriate experts in reviewing and evaluating the state’s infant screening programs.

253.13 History History: 1977 c. 160; 1983 a. 157; 1985 a. 255; 1987 a. 27; 1989 a. 31; 1991 a. 39, 177; 1993 a. 27 s. 316; Stats. 1993 s. 253.13; 1995 a. 27 s. 9126 (19); 2001 a. 16, 52; 2007 a. 20 s. 9121 (6) (a); 2009 a. 28, 279; 2011 a. 32; 2013 a. 135; 2023 a. 19.

253.13 Cross-reference Cross-reference: See also ch. DHS 115, Wis. adm. code.

253.13 Annotation A physician and parent may enter an agreement to perform a PKU test after the infant has left the hospital without violating sub. (1). 61 Atty. Gen. 66.