Montana Code 50-19-203. Newborn screening and followup for metabolic and genetic disorders
50-19-203. Newborn screening and followup for metabolic and genetic disorders. (1) A person in charge of a facility in which a child is born or a facility in which a newborn is provided care or a person responsible for the registration of the birth of a newborn shall ensure that each newborn is administered tests designed to detect inborn metabolic and genetic disorders as required under rules adopted by the department. The department shall initiate rulemaking to add testing for a new metabolic or genetic disorder to the newborn screening panel on occurrence of the following:
Terms Used In Montana Code 50-19-203
- Contract: A legal written agreement that becomes binding when signed.
- Department: means the department of public health and human services provided for in 2-15-2201. See Montana Code 50-19-201
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Newborn: means an infant under 28 days of life. See Montana Code 50-19-201
- Person: means an individual, firm, partnership, association, corporation, or other entity, whether organized for profit or not. See Montana Code 50-19-201
- United States: includes the District of Columbia and the territories. See Montana Code 1-1-201
(a)a reliable test or series of tests for screening newborns for a genetic or metabolic condition using dried blood spots or other testing is developed and registered with the United States food and drug administration;
(b)quality assurance testing methodology is available and approved by the United States centers for disease control and prevention;
(c)necessary materials for the testing and quality assurance testing are commercially available; and
(d)the newborn screening advisory committee has recommended that the test be added to the newborn screening protocol.
(2)(a) The tests must be done by an approved laboratory. An approved laboratory must be the laboratory of the department or a laboratory approved by the department.
(b)A laboratory shall destroy any genetic materials submitted for a newborn if requested by a parent or guardian as provided in 50-19-206.
(c)A facility that collected samples for tests required under this section shall destroy any excess genetic material that was collected and was not sent to an approved laboratory for testing.
(3)The department shall contract with one or more providers qualified to provide followup services, including counseling and education, for children and parents of children identified with metabolic or genetic disorders to ensure the availability of followup services.