North Dakota § 25-17-00.1 - Definitions

§ 25-17-00.1. Definitions

As used in this chapter, unless the context otherwise requires: 1. "Confirmatory-diagnostic testing" means testing to prove or disprove the presence of a specific metabolic disease or genetic disease. 2. "Confirmatory-diagnostic testing laboratory" means a laboratory performing confirmatory-diagnostic testing. 3. "Department" means the department of health and human services. 4. "Licensed clinician" means a currently licensed physician, physician assistant, or advanced practice registered nurse. 5. "Low-protein modified food product" means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a licensed clinician for the dietary treatment of a metabolic disease. The term does not include a natural food that is naturally low in protein. 6. "Medical food" means a food that is intended for the dietary treatment of a disease or condition for which nutritional requirements are established by medical evaluation and is formulated to be consumed or administered under the direction of a licensed clinician. 7. "Metabolic disease" and "genetic disease" mean a disease as designated by rule of the department for which early identification and timely intervention will lead to a significant reduction in mortality, morbidity, and associated disabilities. 8. "Newborn screening program" means a program facilitating access to appropriate testing, followup, diagnosis, intervention, management, evaluation, and education regarding metabolic diseases and genetic diseases identified in newborns. 9. "Out-of-range screening result" means a screening result that is outside of the expected range of testing results established for a particular disease. 10. "Responsible clinician" means the licensed clinician, midwife, naturopath, or birth attendant attending a newborn. 11. "Screening" means initial testing of a newborn for the possible presence of metabolic disease or genetic disease. 12. "Screening laboratory" means the laboratory the department selects to perform screening.