Investigation of the incidence, prevalence and trends of birth defects using epidemiological surveys.
Development of primary preventive strategies to decrease the occurrence of birth defects without increasing abortions.
Referrals for early intervention or other appropriate services.
Specify by rule the birth defects the existence of which requires a report under sub. (2)
to be submitted to the department.
Specify by rule the content, format and procedures for submitting a report under sub. (2)
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.
The department shall, not more than 10 years from the date of receipt of a report under sub. (2)
, delete from any file of the department the name of an infant or child that is contained in the report.
(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:
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.
and regarding the rules that the department is required to promulgate under sub. (3) (a) 2.
on the birth defects to be reported under sub. (2)
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.
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.
Advise the secretary and make recommendations regarding the registry established under sub. (3) (a) 1.
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.
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:
The parent or guardian of an infant or child for whom a report is made under sub. (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.
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.
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.
The department may also release confidential information to a person proposing to conduct research if all of the following conditions are met:
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.
The research is for the purpose of studying birth defects surveillance and prevention.
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.
The person agrees in writing that the information provided will be used only for the research approved by the department.
The person agrees in writing that the information provided will not be released to any person except other persons involved in the research.
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)
The person agrees in writing to any other conditions imposed by the department.
(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.
Tests for congenital disorders. 253.13(1)
The attending physician or nurse certified under s. 441.15
shall cause every infant born in each hospital or maternity home, prior to its discharge therefrom, to be subjected to blood 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 certified 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 blood tests.
(1m) Urine tests.
The department may establish a urine test program to test infants for causes of congenital disorders. The state laboratory of hygiene board may establish the methods of obtaining urine specimens and testing such specimens, and may develop materials for use in the tests. No person may be required to participate in programs developed under this subsection.
(2) Tests; diagnostic, dietary and follow-up counseling program; fees.
The department shall contract with the state laboratory of hygiene to perform the tests specified under this section 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 sub. (1)
and follow-up counseling for the patient and his or her family. The state laboratory of hygiene board, on behalf of the department, shall impose a fee for tests performed under this section sufficient to pay for services provided under the contract and shall include as part of this fee and pay to the department an amount the department determines is sufficient to fund the provision of diagnostic and counseling services, special dietary treatment and periodic evaluation of infant screening programs under this section.
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. No tests may be performed under sub. (1)
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 or in sub. (1m)
to such tests.
(4) Confidentiality of tests and related information.
The state laboratory of hygiene shall provide the 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 specimens from the infant 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.
(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 and family 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.
A physician and parent may enter an agreement to perform a PKU test after the infant has left the hospital without violating (1). 61 Atty. Gen. 66.
Sudden infant death syndrome. 253.14(1)
The department shall prepare and distribute printed informational materials relating to sudden infant death syndrome. The materials shall be directed toward the concerns of parents of victims of sudden infant death syndrome and shall be distributed to maximize availability to the parents.
The department shall make available upon request follow-up counseling by trained health care professionals for parents and families of victims of sudden infant death syndrome.
History: 1977 c. 246
; Stats. 1977 s. 146.025; 1977 c. 447
; Stats. 1977 s. 146.026; 1993 a. 27
; Stats. 1993 s. 253.14.