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Register October 2017 No. 742
Chapter DHS 116
WISCONSIN BIRTH DEFECT PREVENTION AND SURVEILLANCE SYSTEM
DHS 116.01   Authority and purpose.
DHS 116.02   Applicability.
DHS 116.03   Definitions.
DHS 116.04   Reporting of birth defects.
DHS 116.05   Confidentiality.
Ch. DHS 116 Note Note: Chapter HSS 116 was renumbered ch. HFS 116 under s. 13.93 (2m) (b) 1., Stats., and corrections were made under s. 13.93 (2m) (b) 6. and 7., Stats, Register, May, 1998, No. 509. Chapter HFS 116 as it existed on March 31, 2003, was repealed and a new chapter HFS 116 was created effective April 1, 2003. Chapter HFS 116 was renumbered chapter DHS 116 under s. 13.92 (4) (b) 1., Stats., and corrections made under s. 13.92 (4) (b) 7., Stats., Register January 2009 No. 637.
DHS 116.01 DHS 116.01Authority and purpose. This chapter is promulgated under the authority of ss. 227.11 (2) and 253.12 (3) (a), Stats., to implement the Wisconsin birth defect prevention and surveillance system established by s. 253.12, Stats. The purpose of the program is to provide for:
DHS 116.01(1) (1) Reporting to the department of information about birth defects in infants and children from birth to age 2.
DHS 116.01(2) (2) Analysis by the department of that information.
DHS 116.01(3) (3) Dissemination by the department of that information in a collective, non-identifying form for public policy formulation and epidemiological research uses.
DHS 116.01(4) (4) Release by the department of that information in certain circumstances in a form that specifically identifies a child only with informed written consent of the parent or guardian to selected persons and agencies.
DHS 116.01 History History: CR 02-117: cr. Register March 2003 No. 569, eff. 4-1-03.
DHS 116.02 DHS 116.02Applicability. This chapter applies to all of the following:
DHS 116.02(1) (1) The department.
DHS 116.02(2) (2) A physician who diagnoses a birth defect in a child, treats a child with a reportable condition or identifies a child with a suspected case of a reportable condition.
DHS 116.02(3) (3) A pediatric specialty clinic that diagnoses a birth defect in a child, treats a child with a reportable condition or identifies a child with a suspected case of a reportable condition.
DHS 116.02(4) (4) A hospital that diagnoses a birth defect in a child, treats a child with a reportable condition or identifies a child with a suspected case of a reportable condition.
DHS 116.02(5) (5) Local health officers, local birth to 3 programs, and agencies under contract with the department to administer the children with special health care needs program.
DHS 116.02(6) (6) Any other agency that requests reportable information from the department.
DHS 116.02(7) (7) A child about whom the department collects, maintains and discloses reportable information.
DHS 116.02(8) (8) The parent or guardian of the child about whom the department collects, maintains and discloses reportable information.
DHS 116.02(9) (9) Researchers who request reportable information from the department.
DHS 116.02 History History: CR 02-117: cr. Register March 2003 No. 569, eff. 4-1-03.
DHS 116.03 DHS 116.03Definitions. In this chapter:
DHS 116.03(1) (1) “Agency" means an organization that assists or uses information about persons with birth defects.
DHS 116.03(2) (2) “Birth defect" has the meaning given in s. 253.12 (1) (a), Stats.
DHS 116.03(3) (3) “Child" has the meaning given for “infant or child" in s. 253.12 (1) (c), Stats.
DHS 116.03(4) (4) “Child-identifiable data" means information that would identify a child, including the child's name, address or social security number, or the parent's or guardian's name, address or social security number.
DHS 116.03(5) (5) “Department" means the Wisconsin department of health services.
DHS 116.03(6) (6) “Guardian" has the meaning given in s. 48.02 (8), Stats.
DHS 116.03(7) (7) “Local health officer" has the meaning given in s. 250.01 (5), Stats.
DHS 116.03(8) (8) “Parent" has the meaning given in s. 48.02 (13), Stats.
DHS 116.03(9) (9) “Pediatric specialty clinic" has the meaning given in s. 253.12 (1) (b), Stats.
DHS 116.03(10) (10) “Physician" has the meaning given in s. 448.01 (5), Stats.
DHS 116.03(11) (11) “Registry" means a database comprised of birth defect or suspected birth defect reports submitted by pediatric specialty clinics, physicians, and hospitals.
DHS 116.03(12) (12) “Reporter" means a physician, pediatric specialty clinic or hospital that is required or authorized by s. 253.12 (2), Stats., to convey birth defect or suspected birth defect information to the department.
DHS 116.03(13) (13) “Suspected birth defect" means that, on the basis of recognized medical testing and evaluation, a child is thought to have a birth defect, but the results of the testing and evaluation are not conclusive.
DHS 116.03(14) (14) “Wisconsin birth defects prevention and surveillance system" means the program established by s. 253.12, Stats.
DHS 116.03 History History: CR 02-117: cr. Register March 2003 No. 569, eff. 4-1-03; correction in (5) made under s. 13.92 (4) (b) 6., Stats., Register January 2009 No. 637.
DHS 116.04 DHS 116.04Reporting of birth defects.
DHS 116.04(1) (1)Birth defects for which reporting is mandatory. Reporters shall report to the department a birth defect or suspected birth defect listed in Appendix A for children in whom the condition is diagnosed or treated by age 2.
DHS 116.04(2) (2)Responsibilities for reporting.
DHS 116.04(2)(a)(a) Except as provided in par. (b), the following persons shall report a birth defect or suspected birth defect to the department:
DHS 116.04(2)(a)1. 1. A physician who diagnoses a birth defect or treats a child with a birth defect or identifies a suspected birth defect or treats a child with a suspected birth defect.
DHS 116.04(2)(a)2. 2. A pediatric specialty clinic that diagnoses a birth defect or treats a child with a birth defect or identifies a suspected birth defect or treats a child with a suspected birth defect.
DHS 116.04(2)(b) (b) No person specified under par. (a) 1. or 2. need report under this subsection if that person knows that another person specified under par. (a) 1. or 2. or par. (c) has already reported to the department the information required under sub. (3) with respect to the same birth defect or suspected birth defect of the same child.
DHS 116.04(2)(c) (c) A hospital that diagnoses a birth defect or treats a child with a birth defect or identifies a suspected birth defect or treats a child with a suspected birth defect may report the birth defect or suspected birth defect to the department.
DHS 116.04(2)(d) (d) The department may not require a reporter under par. (a), (b) or (c) to provide the name of a child to the department if the child's parent or guardian states in writing that he or she refuses to release the name or address of the child to the department.
DHS 116.04(3) (3)Report content and format.
DHS 116.04(3)(a)(a) Each report of a child with a birth defect or suspected birth defect shall include the core data items for collection listed in Appendix B, except as provided in sub. (2) (d).
DHS 116.04(3)(b) (b) Reports shall be submitted to the department on paper or electronically in a format prescribed by the department.
DHS 116.04 Note Note: Reports may be mailed to the Wisconsin Children with Special Health Care Needs Program - Attention Birth Defects Registry, 1 West Wilson Street, P.O. Box 2659, Madison, WI 53701-2659. Reports may be faxed to the Birth Defects Registry at 608-267-3824. A copy of the form to be used for reporting birth defects or suspected birth defects may be obtained by writing the Birth Defects Registry at the preceding address or by calling 608-267-9184 or by sending a fax to 608-267-3824.
DHS 116.04(4) (4) Timeliness of reports. A report shall be submitted to the department within 15 calendar days after a birth defect or suspected birth defect is identified.
DHS 116.04(5) (5)Department responsibilities.
DHS 116.04(5)(a)(a) The department shall establish and keep an up-to-date registry that complies with s. 253.12 (3) (a) 1., Stats.
DHS 116.04(5)(b) (b) The department shall do all of the following:
DHS 116.04(5)(b)1. 1. Review each report it receives for completeness and accuracy.
DHS 116.04(5)(b)2. 2. Review child-identifiable data to ensure each child is counted only once to maximize the utility of registry information for population-based epidemiological studies as needed.
DHS 116.04(5)(b)3. 3. Query reporting sources to substantiate conflicting data.
DHS 116.04(5)(b)4. 4. Resolve differences between inconsistent data.
DHS 116.04(5)(b)5. 5. Obtain missing or incomplete data.
DHS 116.04(5)(b)6. 6. Include submitted data in the registry within 60 calendar days of receiving the data.
DHS 116.04(5)(c) (c) If the department determines there is a discrepancy in any data reported to the department, the department may request that the reporter provide the department with related birth defect or suspected birth defect information contained in the child's medical records. The reporter shall provide the information to the department within 10 working days after the date the department transmits the request.
DHS 116.04(5)(d) (d) With informed consent, the department shall refer a child with a birth defect or suspected birth defect to a local health officer, a local birth to 3 program or an agency under contract with the department to administer the children with special health care needs program for information, referral or follow-up services.
DHS 116.04 History History: CR 02-117: cr. Register March 2003 No. 569, eff. 4-1-03; 2017 Wis. Act 59: am. (2) (d) Register October 2017 No. 742, eff. 11-1-17.
DHS 116.05 DHS 116.05Confidentiality.
DHS 116.05(1) (1)release of information. The department shall keep Wisconsin birth defects prevention and surveillance system reports confidential and may release information from them only in accordance with s. 253.12 (5), Stats., and following the procedures in s. 253.12 (2), Stats.
DHS 116.05(2) (2)Access to information.
DHS 116.05(2)(a)(a) The department may release child-identifiable data only to persons specified in s. 253.12, Stats., and to the following persons:
DHS 116.05(2)(a)1. 1. The parent or guardian of a child for whom a report was submitted under s. DHS 116.04 (3), and following a written request. The department may require verification of the parent's or guardian's identity. The department shall send the requested information to the parent or guardian within 10 calendar days following receipt of the written request.
DHS 116.05 Note Note: Written requests may be sent to the Wisconsin Children with Special Health Care Needs Program – Attention Birth Defects Registry, 1 West Wilson Street, P.O. Box 2659, Madison, WI 53701-2659. Questions may be directed to the CSHCN Program via telephone at 800-441-4576.
DHS 116.05(2)(a)2. 2. The local health officer, the local birth to 3 program, or an agency under contract with the department to administer the children with special health care needs program upon receipt of a written request for information and written informed consent from the parent or guardian of the child.
DHS 116.05(2)(a)3. 3. A reporter specified under s. DHS 116.04 (2) for the purpose of verifying information included in a report.
DHS 116.05(2)(a)4.a.a. A representative of a federal or state agency, upon written request from the federal or state agency, and to the extent the information is necessary to perform a legally authorized function of that agency. In its written request, the agency shall provide the department with written evidence of its legally authorized function.
DHS 116.05(2)(a)4.b. b. The department shall review and approve or disapprove specific requests by an agency for child-identifiable data.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.