CHAPTER 86

FORMERLY

HOUSE BILL NO. 197

AS AMENDED BY HOUSE AMENDMENT NO. 1

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO BIRTH DEFECTS.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE (Two-thirds of all members elected to each house thereof concurring therein):

Section 1. Amend Chapter 2, Title 16 of the Delaware Code by striking Chapter 2 in its entirety and by substituting in lieu thereof the following:

"Chapter 2. Birth Defects Surveillance, Registration, and Treatment Program.

§ 201. Purpose.

(a) The intent of the General Assembly is to provide financial assistance for the treatment of children with birth defects and to require the establishment and maintenance of a birth defects surveillance system and registry for the State.

(1) Surveillance system and registry. Responsibility for establishing and maintaining the system and registry is delegated to the Department of Health and Social Services, along with the authority to exercise certain powers to implement the system and registry. To ensure an accurate and continuing source of data concerning birth defects, the General Assembly by this chapter requires certain health care practitioners and all hospitals and clinical laboratories to make available to the Department of Health and Social Services information contained in the medical records of patients who have a suspected or confirmed birth defect diagnosis. All confirmed birth defects shall be classified and coded using the medically recognized system of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), as well as the six-digit modified British Pediatric Association system (BPA/ICD-9), and all subsequent revisions to these publications which • are used by the Centers for Disease Control and Prevention. It is intended that the product of these efforts will be a central data bank of accurate, precise, and current information regarding all birth defects diagnosed or treated, or both, in this State.

(2) Treatment. The cost of treating children for birth defects can be prohibitive and impose a substantial burden upon the children's families beyond the resources of those families and beyond the resources of state, federal, or private agencies. The treatment of such children is in the best interest and welfare of the people and the State. It is the intent of this chapter to provide assistance with the cost of treatment for children so afflicted.

Treatment paid for under this program shall be provided, insofar as possible, within the State. The Secretary of the Department of Health and Social Services shall establish rules and regulations for the eligibility of persons requesting services under this chapter, including the ability of those persons to pay for services, and for the disbursement of funds appropriated for this program. However, this chapter will in no way affect the rights, liabilities, or duties of the Secretary of the Department of Health and Social Services, or of persons or guardians of persons requesting services under this chapter, from operation of laws or prior existing laws and, in particular, 29 Del. C. § 7940.

§ 202. Definitions.

The following words, terms, and phrases, when used in this chapter, shall have the meanings ascribed to them in this section, except where the content clearly indicates a different meaning.

(1) ‘Department’ means the State of Delaware Department of Health and Social Services.

(2) ‘Birth defect’ means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth that requires medical or surgical intervention or that interferes with normal growth or development.

(3) ‘Surveillance’ means the process of identifying and investigating birth defects in children under age 5.

(4) ‘Registry’ means a central data bank containing collected, classified, coded, and stored data relating to defects in children under age 5.

§ 203. Birth Defects Surveillance and Registry Program.

The Department may adopt, promulgate, amend, and repeal any rules and regulations necessary to accomplish the purpose of this chapter. These rules and regulations may include provisions for:

(a) The establishment and maintenance of an up-to-date registry that shall document every diagnosis or treatment, or both, of any birth defect in any child under the age 5 in this State;

(b) The establishment of a procedure for reporting to the Department, within 30 days of initial diagnosis or treatment, every occurrence of a birth defect in any child under age 5 in this State. The procedure shall include the reporting of specified information, through a combined system of active and passive surveillance, on every child under age 5 with one or more birth defects. specified information shall be deemed necessary and appropriate to accomplish the purpose of this chapter and in accordance with the recommendations from the Centers for Disease Control and Prevention, for the following reasons:

(1) To identify risk factors for birth defects;

(2) To investigate the causes and prevalence of birth defects;

(3) To develop preventive strategies to decrease occurrences of birth defects;

(4) To analyze incidences, prevalence, and trends of birth defects through epidemiological studies; or

(5) To investigate the morbidity and mortality rates resulting from birth defects.

(c) Those required to report to the Department occurrences of birth defects shall include:

(1) any physician, surgeon, dentist, podiatrist, or other health care practitioner who diagnoses or provides treatment, or both, for children under age 5 with birth defects;

(2) the designated representative of any hospital, dispensary, or other similar public or private institution that diagnoses or provides treatment, or both, for children under age 5 with birth defects; and

(3) the designated representative of any clinical laboratory that performs any test which identifies children under age 5 with birth defects;

(d) The establishment of a procedure for the publication and distribution of forms, instructions, and notices required by this chapter or necessary to accomplish the purpose of this chapter; and

(e) The establishment of a procedure to obtain follow-up information from those required to report occurrences of birth defects pursuant to this chapter. Any follow-up information, including family, physician, hospital, or laboratory contact deemed necessary by the Department, shall be submitted to the Department at least one time each year by those required to report occurrences of birth defects.

(f) The provisions of this chapter and any rules or regulations issued pursuant to this chapter 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.

(g) A parent, custodian, or guardian of an infant having any birth defect may refuse disclosure to the surveillance system and registry of the infant's name and identifying information on the grounds that such birth defect identification is contrary to the religious tenets and practices of the infant's parent, custodian, or guardian.

§ 204. Confidentiality of reports.

(a) Any report of the diagnosis or treatment, or both, of a birth defect made pursuant to this chapter shall not be divulged nor made public in any way that might tend to disclose the identify of the person, or family of the person, to whom it relates. However, patient-identifying information may be exchanged among authorized agencies as approved by the Department and upon receipt by the Department of satisfactory assurances by those agencies of the preservation of the confidentiality of such information.

(b) No individual or organization providing information to the Department in accordance with this chapter shall be deemed to be liable for, or held liable for, divulging confidential information.

§ 205. Compulsion prohibited.

Nothing in this chapter shall be construed to compel any person to submit to any medical or public health examination, treatment, or supervision.

§ 206. Violations.

Any person or entity who is required to report the diagnosis or treatment, or both, of any birth defect in any child under age 5 and who violates any provision of this chapter shall be fined up to $100.00 for each violation. Justices of the Peace Courts shall have jurisdiction of any offense under this chapter."

Section 2. If any provision of this Act or the application thereof to any person or circumstance is held invalid, such invalidity shall not affect other provisions or applications of the Act which can be given effect without the invalid provision or application, and to that end the provisions of this Act are declared to be severable.

Approved June 26, 1997