Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 71 - REGULATIONS GOVERNING VIRGINIA NEWBORN SCREENING SERVICES › Section 12VAC5-71-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter shall
				  have the following meanings unless the context clearly indicates
				  otherwise:
"Abnormal screening results" means, in 12VAC5-71-210 through
				  12VAC5-71-250 only, all results that indicate the newborn has not passed the
				  CCHD screening .
"Attending physician" means the physician in charge of the
				  infant's care.
"Board" means the State Board of Health.
"Business days" means Monday through Friday from 9 a.m. to 5
				  p.m., excluding federal and state holidays.
"Care Connection for Children" means a statewide network of
				  centers of excellence for children with special health care needs (CSHCN) that
				  provides leadership in the enhancement of specialty medical services, care
				  coordination, medical insurance benefits evaluation and coordination,
				  management of the CSHCN pool of funds, information and referral to CSHCN
				  resources, family-to-family support, and training and consultation with
				  community providers on CSHCN issues.
"Care coordination" means a process that links individuals
				  and their families to services and resources in a coordinated effort to
				  maximize their potential and provide them with optimal health care.
"Certified nurse midwife" means a person licensed to practice
				  as a nurse practitioner in the Commonwealth pursuant to § 54.1-2957 of the
				  Code of Virginia and in accordance with Part II (18VAC90-30-60 et seq.) of
				  18VAC90-30 and
				  18VAC90-30-121, subject to
				  18VAC90-30-160.
"Chief executive officer" means a job descriptive term used
				  to identify the individual appointed by the governing body to act in its behalf
				  in the overall management of the hospital. Job titles may include
				  administrator, superintendent, director, executive director, president,
				  vice-president, and executive vice-president.
"Child" means a person less than 18 years of age and includes
				  a biological or an adopted child, as well as a child placed for adoption or
				  foster care unless otherwise treated as a separate unit for the purposes of
				  determining eligibility and charges under these regulations.
"Commissioner" means the State Health Commissioner, his duly
				  designated officer, or agent.
"Confirmatory testing" means a test or a panel of tests
				  performed following a screened-abnormal result to verify a diagnosis.
"Core panel conditions" means those heritable disorders and
				  genetic diseases considered appropriate for newborn screening. The conditions
				  in the core panel are similar in that they have (i) specific and sensitive
				  screening tests, (iii) a sufficiently well understood natural history, and
				  (iii) available and efficacious treatments.
"Critical congenital heart disease" or "CCHD" means a
				  congenital heart disease that places a newborn at significant risk of
				  disability or death if not diagnosed and treated soon after birth. The disease
				  may include, but is not limited to, hypoplastic left heart syndrome, pulmonary
				  atresia (with intact septum), tetralogy of fallot, total anomalous pulmonary
				  venous return, transposition of the great arteries, tricuspid atresia, and
				  truncus arteriosus.
"CCHD screening" means the application of screening
				  technology to detect CCHD.
"Department" means the state Department of Health.
"Dried-blood-spot specimen" means a clinical blood sample
				  collected from an infant by heel stick method and placed directly onto
				  specially manufactured absorbent specimen collection (filter) paper.
"Echocardiogram" means a test that uses an ultrasound to
				  provide an image of the heart.
"Guardian" means a parent-appointed, court-appointed, or
				  clerk-appointed guardian of the person.
"Healthcare provider" means a person who is licensed to
				  provide health care as part of his job responsibilities and who has the
				  authority to order newborn dried-blood-spot screening tests.
"Heritable disorders and genetic diseases" means pathological
				  conditions (i.e., interruption, cessation or disorder of body functions,
				  systems, or organs) that are caused by an absent or defective gene or gene
				  product, or by a chromosomal aberration.
"Hospital" means any facility as defined in § 32.1-123
				  of the Code of Virginia.
"Infant" means a child less than 12 months of age.
"Licensed practitioner" means a licensed health care provider
				  who is permitted, within the scope of his practice pursuant to Chapter 29
				  (§ 54.1-2900 et seq.) or Chapter 30 (§ 54.1-3000 et seq.) of Title
				  54.1 of the Code of Virginia, to provide care to a newborn.
"Low protein modified foods" means foods that are (i)
				  specially formulated to have less than one gram of protein per serving, (ii)
				  intended to be used under the direction of a physician for the dietary
				  treatment of an inherited metabolic disease, (iii) not natural foods that are
				  naturally low in protein, and (iv) prescribed as medically necessary for the
				  therapeutic treatment of inherited metabolic diseases.
"Metabolic formula" means nutritional substances that are (i)
				  prescribed by a health professional with appropriate prescriptive authority;
				  (ii) specifically designed and formulated to be consumed or administered
				  internally under the supervision of such health professional; (iii)
				  specifically designed, processed, or formulated to be distinct in one or more
				  nutrients that are present in natural food; and (iv) intended for the medical
				  and nutritional management of patients with limited capacity to metabolize
				  ordinary foodstuffs or limited capacity to metabolize certain nutrients
				  contained in ordinary foodstuffs.
"Metabolic supplements" means certain dietary or nutritional
				  substances intended to be used under the direction of a physician for the
				  nutritional management of inherited metabolic diseases.
"Midwife" means a person licensed as a nurse practitioner in
				  the category of certified nurse midwife by the Boards of Nursing and Medicine
				  or licensed as a midwife by the Board of Medicine.
"Newborn" means an infant who is 28 days old or less who was
				  born in Virginia.
"Newborn nursery" means a general level, intermediate level,
				  or specialty level newborn service as defined in
				  12VAC5-410-443 B 1, B 2, and B
				  3.
"Nurse" means a person holding a current license as a
				  registered nurse or licensed practical nurse by the Virginia Board of Nursing
				  or a current multistate licensure privilege to practice in Virginia as a
				  registered nurse or licensed practical nurse.
"Parent" means a biological parent, adoptive parent, or
				  stepparent.
"Pediatric Comprehensive Sickle Cell Clinic Network" means a
				  statewide network of clinics that are located in major medical centers and
				  provide comprehensive medical and support services for newborns and children
				  living with sickle cell disease and other genetically related
				  hemoglobinopathies.
"Physician" means a person licensed to practice medicine or
				  osteopathic medicine in the Commonwealth pursuant to Chapter 29 (§
				  54.1-2900 et seq.) of Title 54.1 of the Code of Virginia and in accordance with
				  applicable regulations.
"Pool of funds" means funds designated for payment of direct
				  health care services. Access to the pool is not an entitlement and is subject
				  to availability of funds and guidelines that govern its eligibility and
				  coverage of services. Pool of funds is a mix of federal Title V funds and state
				  matching funds.
"Population-based" means preventive interventions and
				  personal health services developed and available for the entire infant and
				  child health population of the Commonwealth rather than for individuals in a
				  one-on-one situation.
"Preterm infant" means an infant whose birth occurs by the
				  end of the last day of the 36th week following the onset of the last menstrual
				  period.
"Repeat specimen" means an additional newborn
				  dried-blood-spot screening specimen submitted to the testing laboratory
				  voluntarily or by request.
"Resident" means an individual who resides within the
				  geographical boundaries of the Commonwealth.
"Satisfactory specimen" means a newborn dried-blood-spot
				  screening specimen that has been determined to be acceptable for laboratory
				  analyses by the testing laboratory.
"Screened-abnormal" means a newborn dried-blood-spot
				  screening test result that is outside the established normal range or normal
				  value for that test method.
"Screening technology" means pulse oximetry testing in the
				  right hand and either foot. Screening technology shall also include alternate
				  medically accepted tests that measure the percentage of blood oxygen
				  saturation, follow medical guideline consensus and recommendations issued by
				  the American Academy of Pediatrics, and are approved by the State Board of
				  Health.
"Specialty level nursery" means the same as defined in
				  12VAC5-410-443 B 3 and as further
				  defined as Level III by the Levels of Neonatal Care, written by the American
				  Academy of Pediatrics Committee on Fetus and Newborn.
"Subspecialty level nursery" means the same as defined in
				  12VAC5-410-443 B 4.
"Testing laboratory" means the laboratory that has been
				  selected by the department to perform newborn dried-blood-spot screening tests
				  services.
"Total parenteral nutrition" or "TPN" means giving nutrients
				  through a vein for babies who cannot be fed by mouth.
"Treatment" means appropriate management including genetic
				  counseling, medical consultation, and pharmacological and dietary management
				  for infants diagnosed with a disease listed in
				  12VAC5-71-30 D.
"Unsatisfactory specimen" means a newborn dried-blood-spot
				  screening specimen that is inadequate for performing an accurate
				  analysis.
"Virginia Genetics Advisory Committee" means a formal group
				  that advises the department on issues pertaining to access to clinical genetics
				  services across the Commonwealth and the provision of genetic awareness,
				  quality services, and education for consumers and providers.
"Virginia Newborn Screening System" means a coordinated and
				  comprehensive group of services, including education, screening, follow up,
				  diagnosis, treatment and management, and program evaluation, managed by the
				  department's Virginia Newborn Screening Program and Virginia Early Hearing
				  Detection and Intervention Program for safeguarding the health of children born
				  in Virginia.
"Virginia Sickle Cell Awareness Program" means a statewide
				  program for the education and screening of individuals for the disease of
				  sickle cell anemia or the sickle cell trait and for such other genetically
				  related hemoglobinopathies.
Statutory Authority: §§ 32.1-12 and 32.1-67 of
					 the Code of Virginia.