Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.10 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"Adrenoleukodystrophy" or "ALD" means a rare inborn disorder
				  that affects the brain, nervous system, and adrenal glands because the body
				  cannot break down certain fatty acids.
"Advanced practice registered nurse" means a person who is
				  licensed as an advanced practice registered nurse under the Nurse Practice
				  Act.
"Advisory Committee" means the Genetic and Metabolic Diseases
				  Advisory Committee appointed by the Director.
"Amino acid disorder" means a rare inborn disorder that
				  prevents the proper processing of amino acids, the building blocks of
				  proteins.
"ASHA 2019 Guidelines" means the "Year 2019 Position
				  Statement: Principles and Guidelines for Early Hearing Detection and
				  Intervention Programs" created by the Joint Committee on Infant Hearing of the
				  American Speech-Language-Hearing Association (ASHA) and incorporated by
				  reference in Section 661.20(c)(4).
"Audiologist" means a person who is licensed as an
				  audiologist by the Illinois Department of Financial and Professional Regulation
				  to provide audiological services under the Illinois Speech-Language Pathology
				  and Audiology Practice Act.
"Auditory Brainstem Response (ABR)", as used in the ASHA 2019
				  Guidelines, means electrophysiologic measurement of the brainstem's response to
				  the acoustic stimulation of the ear.
"Automated Auditory Brainstem Response (AABR)", as used in
				  the ASHA 2019 Guidelines, means objective electrophysiologic measurement of the
				  brainstem's response to acoustic stimulation of the ear, obtained with
				  equipment that automatically provides a pass/refer outcome.
"Authorized user" means an individual who has signed an
				  Individual User Agreement and Confidentiality Statement, and for whom the
				  Department has provided credentials authorizing that person access to the
				  Registry.
"Bilateral Pass", as used in the ASHA 2019 Guidelines, means
				  there is a low likelihood of significant hearing loss in both or either ear on
				  the day of the screening.
"Biotinidase deficiency" means a rare inborn disorder that
				  prevents proper use of a vitamin called biotin.
"Caregiver" means a person who directly attends to the needs
				  or concerns of a newborn, infant or child.
"Child" means a person between the ages of 12 months through
				  six years.
"Clinical and Laboratory Standards Institute" or "CLSI" means
				  a global nonprofit standards-developing organization that promotes the
				  development and use of voluntary consensus standards and guidelines within the
				  health care community.
"Clinical Laboratory Improvement Amendments" or "CLIA" means
				  federal regulations (Centers for Medicare and Medicaid Services, United States
				  Department of Health and Human Services) providing standards applicable to all
				  facilities or sites in the United States that test human specimens for health
				  assessment or to diagnose, prevent, or treat disease.
"Congenital adrenal hyperplasia" or "CAH" means a rare inborn
				  disorder in which the body cannot produce enough of the hormone cortisol or a
				  salt-retaining hormone.
"Congenital hypothyroidism" or "CH" means an inborn disorder
				  in which the body does not make enough thyroid hormone.
"Critical Congenital Heart Disease" or "CCHD" includes, but
				  is not limited to, the following heart defects present at birth: hypoplastic
				  left heart syndrome; pulmonary atresia with intact septum; tetralogy of Fallot;
				  total anomalous pulmonary venous return; transposition of the great arteries;
				  tricuspid atresia; truncus arteriosus, coarctation of the aorta, double outlet
				  right ventricle, Ebstein anomaly, interrupted aortic arch, single ventricle,
				  and other critical CHDs requiring treatment in the first year of life.
"Cystic fibrosis" or "CF" means an inborn disorder in which
				  the body produces thick, sticky mucus that causes respiratory and digestive
				  problems.
"Department" or "DPH" or "IDPH" means the Illinois Department
				  of Public Health or its designee.
"Director" means the Director of the Illinois Department of
				  Public Health or the Director's designee.
"Discharge" means a newborn, infant or child's release from
				  the premises of a medical care facility and into the care of the parent or
				  legal guardian.
"DSCC" means the Division of Specialized Care for Children at
				  the University of Illinois at Chicago.
"Early Hearing Detection and Intervention" or "EHDI" means
				  the program established to screen every infant for hearing loss prior to one
				  month of age, diagnose hearing loss prior to three months of age, and provide
				  intervention services prior to six months of age.
"Early Hearing Detection and Intervention Act" or "EHDI Act"
				  means the Early Hearing Detection and Intervention Act [410 ILCS
				  213 ].
"Early Hearing Detection and Intervention (EHDI) Service
				  Providers" means Physicians, advanced practice nurses, physician assistants,
				  otolaryngologists, audiologists, ancillary health care providers, early
				  intervention programs and providers, parent support, parent-to-parent support
				  programs, the Department of Human Services, and the University of Illinois at
				  Chicago Division of Specialized Care for Children.
"Early Intervention" means the Department of Human Services'
				  program described at 89 Ill. Adm. Code
				  500.10.
"Early intervention provider" means an individual providing
				  developmental services to a child with a suspected or confirmed hearing loss
				  and their family as part of a Part C or non-Part C early intervention service
				  delivery plan.
"Fatty acid oxidation disorder" means a rare inborn disorder
				  that causes the body to have trouble burning fat for energy.
"Formula" means a medically prescribed nutritional product
				  that is designed and used to treat an inborn metabolic disorder.
"Galactosemia" means a rare inborn disorder that impairs
				  digestion of a certain part of milk sugar called galactose.
"Guardian" means a person or entity legally responsible for a
				  newborn, infant or child.
"Hearing loss" or "atypical hearing", as used in the ASHA
				  2019 Guidelines, means a dysfunction of the auditory system of any type and
				  degree in one or both ears that is sufficient to interfere with the acquisition
				  of communication and language skills.
"Hearing screening" means the completion of one or more
				  objective, physiologic tests administered to screen the newborn, infant or
				  child's hearing in each ear. The screening automatically provides a pass/refer
				  outcome in each ear suggesting the need for further testing. The screening
				  shall be performed by individuals who have been appropriately trained and
				  utilize instrumentation and protocols recommended by the Joint Committee on
				  Infant Hearing.
"Hearing screener" means an individual who is trained in the
				  equipment and procedures to conduct newborn hearing screening.
"Hemoglobinopathies" means rare inborn disorders that impair
				  the red blood cells' ability to carry oxygen to the body's organs and
				  tissues.
"Homebirth" means any birth outside of a medical care
				  facility or a birth where the newborn is not admitted to a medical care
				  facility after birth.
"Hospital" means a facility licensed by the State of Illinois
				  under the Hospital Licensing Act [210 ILCS 85 ] and for the
				  purposes of this Part, that provides obstetrical and neonatal services. Also,
				  for purposes of this Part, "hospitals" include children's hospitals and free
				  standing birth centers that provide obstetrical and newborn nursery services.
				  (See "Medical care facility".).
"Incomplete hearing screening" means the required number of
				  screening sessions were not conducted prior to discharge.
"Individual user agreement" means a signed agreement stating
				  that the Registry user agrees that information that identifies a patient will
				  not be released to any other person without the written consent of the
				  patient.
"Infant" means a baby up to 1 year (through 12 months) of
				  age.
"Institutional Review Board" or "IRB" means the Department of
				  Public Health committee authorized to review research studies to ensure the
				  rights and well-being of people who are subjects in research are protected;
				  investigators are provided with thorough and timely review of their research
				  proposals; and persons participating in research are assured research is
				  conducted in an ethical and accountable manner.
"Lysosomal storage disorders" or "LSDs" means rare inborn
				  disorders in which the body is unable to break down or recycle certain types of
				  complex fats, proteins, and sugars, due to lysosomal dysfunction.
"Medical care facility" means a hospital, birthing center or
				  any other licensed facility that provides obstetrical and newborn nursery
				  services.
"Medical Diagnostic Evaluation" means, for the purposes of
				  this Part, the examination and medical procedures provided by personnel
				  qualified and licensed to perform the procedures prescribed for the specified
				  medical conditions for which an infant is being referred.
"Missed" means a newborn, infant or child did not complete
				  newborn screening.
"Neonatal Intensive Care Unit" or "NICU" means an intensive
				  care unit for high-risk newborns.
"Newborn" means a baby in the first month of life.
"Newborn blood spot screening" or "newborn blood spot
				  testing" means the testing of a dried blood spot sample for conditions defined
				  in the Newborn Metabolic Screening Act. At times, variant forms of some
				  disorders, or related conditions, may also be identified.
"Newborn hearing screening" means the completion of one or
				  more objective, physiologic, electronic tests administered as defined by the
				  Early Hearing Detection and Intervention Act to determine the infant's hearing
				  status in each ear and the need for further diagnostic testing by an
				  audiologist.
"Newborn heart screening" or "CCHD screening" means the
				  completion of one or more objective, physiologic tests administered to
				  determine the newborn's blood oxygen level and the need for further diagnostic
				  testing by a cardiologist.
"Newborn Metabolic Screening Act" means the Newborn Metabolic
				  Screening Act [410 ILCS 240 ].
"Newborn Screening Registry" or "Registry" or "Registries"
				  means a data collection, follow-up, tracking, and reporting information system
				  that is designed to support the Department's newborn screening program,
				  including blood spot screening, hearing screening, and heart screening.
"Organic acid disorder" means a rare inborn disorder in which
				  the body cannot remove certain waste products from the blood.
"Otoacoustic Emissions Testing", as used in the ASHA 2019
				  Guidelines, means a specific test method that elicits a physiologic response
				  from the outer hair cells in the cochlea, and may include Transient Evoked
				  Otoacoustic Emissions (TEOAE) and/or Distortion Product Otoacoustic Emissions
				  (DPOAE).
"Otolaryngologist" means a physician trained in the medical
				  and surgical management and treatment of patients with diseases and disorders
				  of the ear, nose, throat (ENT), and related structures of the head and
				  neck.
"Otologist" means a physician who specializes in treatment of
				  the ear.
"Outpatient newborn hearing screening" means hearing
				  screening completed after the newborn, infant or child is discharged to
				  home.
"Parent support" means support services provided to parents
				  and families of children who are deaf or hard of hearing by trained providers
				  who support the EHDI principals.
"Parent-to-parent support" means support services provided to
				  parents and families of children who are deaf or hard of hearing by trained
				  providers who are also parents of children who are deaf or hard of hearing and
				  who support the EHDI principals.
"Part C" is a section of the Individuals with Disabilities
				  Education Act (IDEA) that defines the rights of a parent of a child, birth
				  through age two with disabilities, who is receiving early intervention
				  services.
"Pediatric audiologists" means audiologists with the
				  equipment and experience to test children birth through six years of age for
				  hearing loss and related issues, and who perform hearing tests and evaluations
				  to determine the presence, extent, and reason for hearing loss in accordance
				  with best practices and the Year 2019 Position Statement: Principles and
				  Guidelines for Early Hearing Detection and Intervention Programs.
"Plan of care" means an outline of care showing the newborn,
				  infant or child's needs and the steps to take in meeting those needs.
"Primary healthcare provider" means the physician, physician
				  assistant, advanced practice registered nurse or their agent who provides the
				  newborn, infant, or child's routine medical care in the area where they reside
				  after discharge.
"Provider site" means a health care provider or certified
				  local health department to which the Department may release information from
				  the Registry.
"Provider site enrollment" means the agreement that is signed
				  by the provider or designee, who assumes responsibility for the proper use and
				  protection of Registry data at the site.
"Public health surveillance" means the ongoing, systematic
				  collection, analysis, and interpretation of health-related data essential to
				  planning, implementation, and evaluation of public health practice.
"Risk factor" means an indicator associated with a higher
				  risk of congenital, late-onset or acquired childhood hearing loss.
"Quality control" means a procedure or set of procedures to
				  assure the accuracy of results reported by the laboratory.
"Severe combined immunodeficiency" or "SCID" means a group of
				  rare inborn disorders affecting the white blood cells responsible for fighting
				  off infections.
"Sickle cell disease" and "sickling disorder" means a rare
				  inborn disorder that impairs the red blood cells' ability to carry oxygen to
				  the body's organs and tissues. A change in the shape of the red blood cells may
				  occur, at times resembling a sickle shape.
"Significant Hearing Loss" means a dysfunction of the
				  auditory system of any type or degree that is sufficient to interfere with the
				  acquisition of speech and language skills.
"Site manager" means the person at the provider site who
				  assumes responsibility for the proper use and protection of the Registry at the
				  site.
"Special Care Baby Unit" or "SCBU" means a nursery that
				  provides intermediate intensive care to newborns and infants.
"Spinal muscular atrophy" or "SMA" means a genetic disorder
				  characterized by muscle weakness and atrophy caused by a loss of motor
				  neurons.
"Supplemental test" means any test approved by the United
				  States Food and Drug Administration or validated under a laboratory's CLIA
				  certification that is used to further characterize a newborn screening specimen
				  that had received a positive (i.e., abnormal) result when initially screened by
				  the laboratory.
"Tandem mass spectrometry" or "MS/MS" means use of a tandem
				  mass spectrometer and associated software to test a newborn screening
				  sample.
"T-cell lymphopenia" means a state in which there is a
				  reduced level of thymus derived lymphocyte count in the bloodstream.
"Total parenteral nutrition" or "TPN" means a method of
				  feeding that bypasses the gastrointestinal tract by infusing nutrient solution
				  directly into a blood vessel.
"Transfer" means that the newborn, infant, or child is moved
				  from the birth location to the responsible medical care facility or moved
				  between medical care facilities.
"Using accepted statistical techniques" means using
				  techniques that have been published in peer reviewed scientific
				  literature.