16 Del. Admin. Code § 4101-3.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4101-3.0 - Reporting Requirements

The provisions of this section shall apply to the Delaware Health and Social Services, Division of Public Health, Birth Defect Registry:

3.1 The registry shall collect information on any birth defect diagnosed in utero and postpartum on anyone who is a resident of the state of Delaware, or whose parent is a resident of Delaware, and who is diagnosed at any time prior to age five (5) as having a birth defect. For the purposes related to the registry the Division shall have access to any medical record of the child that pertains to a diagnosed or suspected birth defect. Prenatal information on the birth mother may be obtained with prior consent.

3.2 Any diagnosed birth defects shall be reported for all infants and children up to age 5, including those who have since died (if the data is still available).

3.3 For purposes of these reporting requirements, reportable diagnoses are those diagnoses, from the International Classification of Diseases (ICD), as listed in Appendix A of these regulations. The reportable diagnoses listed in Appendix A may be revised, upon notice, to reflect changes in publications accepted for use by the Centers for Disease Control and Prevention or State.

3.4 The following persons and organizations are required to report occurrences of birth defects within 30 days of diagnosis to the Division of Public Health.

3.4.1 Any physician, surgeon, dentist, podiatrist, certified nurse midwife, or other health care practitioner who diagnoses or provides treatment, or both, for a child under age 5 with birth defects who is not known to be previously reported;

3.4.2 The designated representative of any clinical laboratory that performs any test which identifies a child or children under age 5 with birth defects not known to be previously reported; and

3.4.3 The designated representative of any hospital, dispensary, clinic, or other similar public or private institution that diagnoses or provides treatment, or both, for a child or children under age 5 with birth defects who is not known to be previously reported.

3.4.4 This section of the regulations shall not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone.

3.5 The administrative officer of every health care facility shall be responsible for establishing reporting procedures at that facility, using the identified Birth Defect Registry reporting form. Reporting procedures must ensure that each infant initially diagnosed as having a birth defect shall be reported to the Division. Any presumptive or actual diagnosis in a child up to the age of 5 must be reported to the Division.

3.6 Reporting sources shall complete the Division of Public Health Birth Defects Surveillance Form for each reported case, and forward the completed form to the Division of Public Health Director or designee.

3.7 Reporting sources are required to submit annual follow-up information as requested through Birth Defect Program.

16 Del. Admin. Code § 4101-3.0