Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64C - Division of Children's Medical Services › Chapter 64C-7 - PRENATAL AND POSTNATAL RISK SCREENING AND INFANT SCREENING FOR METABOLIC, HEREDITARY, AND CONGENITAL DISORDERS › Section 64C-7.001 - Definitions

Current through Reg. 50, No. 138; July 16, 2024
(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.