64C-7.001. Definitions

(1) “Care coordination services” and “care coordination” mean Healthy Start services that link Healthy Start participants and their families with other Healthy Start services and those supports and services that complement, supplement, and assure continued participation in prenatal and infant health care as specified in Rule 64F-3.001, F.A.C.

(2) “CMS Audiologist provider” means an audiologist who has been approved by CMS.

(3) “Congenital disorder” means a disorder existing before or at birth, regardless of cause, that is designated by the department.

(4) “Environmental risk factor” means a physical, social, or economic factor in an individual’s environment which places him or her at risk for having or developing a health or health-related problem. These would be factors such as those delineated in Section 383.14, F.S.

(5) “Healthy Start infant” means an infant, less than twelve months of age, whose parent or family agrees to participate in Healthy Start care coordination and who may be at increased risk for impairment in health, intellect, or functional ability due to environmental, medical, nutritional, behavioral, or developmental risk factors as determined by the department’s risk screening instrument as defined in subsection 64C-7.008(2), F.A.C., or as determined by factors other than the score at the time of screening or subsequent to the initial screen.

(6) “Healthy Start participant” and “participant” mean a Healthy Start pregnant or postpartum woman or Healthy Start infant as defined in this section.

(7) “Healthy Start pregnant woman” means a pregnant woman who has agreed to participate in Healthy Start care coordination and may be at increased risk of pregnancy complications or poor birth outcome due to environmental, medical, nutritional, behavioral, or developmental risk factors as determined by the department’s prenatal risk screening instrument as defined in subsection 64C-7.008(1), F.A.C., or as determined by factors other than the score at the time of screening or subsequent to the initial screen.

(8) “Healthy Start services” mean those services provided to participants that maximize access to and participation in comprehensive prenatal and infant health care such as client and participant identification (case finding), care coordination, childbirth education, parenting education and support, nutritional counseling, psychosocial counseling, smoking cessation counseling, breastfeeding education and support, and other services that optimize health and developmental outcomes and improve access to care. Home visiting is a strategy for providing Healthy Start services. In addition to the home, Healthy Start services can also be provided in the neighborhood, school, workplace, or clinic; wherever the concerns, priorities, and resources of the participant or family can best be met. Healthy Start Coalitions have the responsibility to assess the maternal and infant health needs and services neceesary to have the greatest impact on pregnancy, health and developmental outcomes in their geographic regions.

(9) “Hearing risk factors” means selected risk factors having the potential to result in late onset hearing loss which are: family history, low birth weight (less than 1500 grams), PPHN (persistent pulmonary hypertension of a newborn), ECMO (extra corporeal membrane oxygenation), and hyperbilirubinemia or exchange transfusion.

(10) “Hearing Screening Information” means the section of the specimen card for reporting screening results including the last hearing screen date, last hearing screen results by ear, the last test method used, hearing risk factors or reason hearing was not screened.

(11) “Hereditary disorder” means a particular disorder designated by the department in accordance with Rule 64C-7.008, F.A.C., that is genetically transmitted from parent to offspring.

(12) “Infant (postnatal) risk screening” means the use of selected risk factors to identify infants at increased risk for mortality and morbidity, as designated in accordance with Rule 64C-7.011, F.A.C.

(13) “Newborn screening disorder” means a disorder designated by the department which may have pathologic consequences at birth or later in life.

(14) “Newborn screening” means a procedure requiring the use of selected laboratory criteria capable of detecting the presumptive presence of disorders.

(15) “Prenatal risk screening” means the use of selected risk factors to identify pregnant women at increased risk for pregnancy complications or adverse outcomes, as designated in accordance with Rule 64C-7.011, F.A.C.

(16) “Presumptive positive screening result” means an abnormal screening result with a specific value for an analyte or disorder that must be referred to a designated referral center.

(17) “Pulse Oximeter” means a U.S. Food and Drug Administration approved instrument for use in newborns to measure the percentage of hemoglobin in the blood that is saturated with oxygen.

(18) “Risk factor” means an element associated with an increased risk of pregnancy complications or infant mortality and morbidity.

(19) “Risk screening instrument” means a tool developed by the department containing selected risk factors in accordance with Rule 64C-7.011, F.A.C.

(20) “Satisfactory blood specimen” means a dried blood spot on which an accurate laboratory analysis can be performed.

(21) “Scoring mechanism” means a method used to ascertain potential risk based on the risk factors contained on the risk screening instrument.

(22) “Screening test” means a non-diagnostic laboratory procedure that is capable of detecting the presumptive presence of those disorders incorporated by reference in subsection 64C-7.002(1), F.A.C.

(23) “Unsatisfactory blood specimen” means any of the following:

(a) A specimen card on which an insufficient quantity of blood is obtained.

(b) A specimen card on which an accurate analysis or interpretation cannot be performed due to improper collection, handling, or submission.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.01, Amended 12-5-84, Formerly 10J-8.01, Amended 3-29-92, 9-20-94, 8-14-95, 3-28-96, Formerly 10J-8.001, Amended 4-1-08, 3-26-15, 8-20-17.