In this chapter, the following terms have the meanings indicated. Terms Defined. Birthing Facility. “Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants. “Birthing facility” includes a: Birthing service that is licensed or accredited as a unit of a hospital; and Freestanding birthing center as defined in COMAR 10.05.02.01B. Blood-Spot Specimen. “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot specimen collection test requisition card for the purpose of performing screening tests. “Blood-spot specimen” includes: The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth; The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and A blood-spot specimen collected subsequent to a specimen specified in §B(2)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.10.13. Congenital Disorder. “Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth. “Congenital disorder” does not include a condition that results from: An intrauterine infection; or A birth injury. “Council” means the State Advisory Council on Hereditary and Congenital Disorders. “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested. “Department” means the Maryland Department of Health. “Diagnostic test” means a test that is used to establish or confirm the presence of a: Specific disease; or Hereditary or congenital disorder. “First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth. “First-tier test” means a blood test performed on a newborn infant's blood that: Indicates the probable presence or absence of a hereditary or congenital disorder; or Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder. “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in Regulation .12 of this chapter. Hereditary Disorder. “Hereditary disorder” means a disorder that: Is transmissible through the genetic material deoxyribonucleic acid (DNA); or Arises through the improper processing of information in the genetic material. “Hereditary disorder” includes: Hemoglobin disorders; Metabolic disorders; and Endocrine disorders. “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility. “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified to practice under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(12) of this regulation. “Metabolic disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by: Direct analysis of the enzyme, hormone, or protein; or Testing for a substance whose metabolism is altered as a result of the defect. “Milk feeding” means feedings received for 24 hours by: A healthy newborn infant on a diet of milk; and An ill or premature newborn infant on parenteral feedings providing a minimum of 1 gram of protein per kilogram of body weight per day and 75 kilocalories per kilogram of body weight per day. “Newborn” or “newborn infant” means an infant: Born in Maryland; Born on federal property within Maryland; Born outside of Maryland to parents whose residence is in Maryland; From whom a blood-spot specimen was collected and submitted to the State’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth; Who has a screening test requested by the Follow-Up Unit: For first-tier screening follow-up; For confirmation of a previous screening test result; or To assist with the infant's diagnosis, therapy, or follow-up care; or Who is in Maryland. Newborn Screening or Screening. “Newborn screening” or “screening” means one or more first-tier tests. “Newborn screening” or “screening” includes: First-tier testing on a first, second, or subsequent blood-spot specimen; and Supplemental first-tier testing. Newborn Screening Program. “Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that: Newborn infants are given the opportunity to be tested; At risk newborn infants who are tested are identified and located; Newborn infants are given access to necessary follow-up testing; Diagnostic tests are available and the diagnosis is made or ruled out; and Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment. “Newborn Screening Program” includes: The Department's public health laboratory as the sole screening laboratory; Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a formal Departmental mutual aid agreement; Supplemental and second-tier testing performed by a state public health laboratory or by a licensed commercial or research laboratory; The Follow-Up Unit; and The State Advisory Council on Hereditary and Congenital Disorders. “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal. Second-Tier Test. “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result. “Second-tier test” includes a test that: Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder; Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or Is diagnostic because it confirms the presence of a hereditary or congenital disorder. “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is: Used to detect a hereditary or congenital disorder not specified in Regulation .05 of this chapter; or Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.10.13. “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in COMAR 10.10.13.21B and C.