Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 181 - SPECIAL HEALTH PROGRAMS
Chapter 2 - SCREENING OF INFANTS FOR INHERITED AND CONGENITAL INFANT OR CHILDHOOD-ON SET DISEASES
Section 181-2-002 - DEFINITIONS
Current through September 17, 2024
For purposes of these regulations, the following definitions are hereby adopted.
002.01 CONFIRMATORY TEST. A test or a panel of tests performed following a presumptive positive screening test which provides additional, more specific diagnostic information concerning the existence or non-existence of diseases screened for.
002.02 CUTOFF VALUE. A value on a screening test for a specific disease which gives a high degree of probability that all newborns with a greater or lower value, depending on the test method, will not have the disease.
002.03 DEPARTMENT. The Department of Health and Human Services of the State of Nebraska.
002.04 HOSPITAL Any facility defined under Neb. Rev. Stat. § 71-419.
002.05 INSTITUTIONAL REVIEW BOARD (IRB). An Institutional Review Board qualifying and complying with requirements in the Code of Federal Regulations (CFR) Title 45 Part 46 Protection of Human Subjects, Effective July 14, 2009.
002.06 LABORATORY. A facility for the biological, microbiological, serological, chemical, immunological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.
002.07 NEWBORN SCREENING ADVISORY COMMITTEE (NBSAC) - APPROVED PROTOCOLS. Follow-up practices recommended by the Newborn Screening Advisory Committee (NBSAC) and adopted by the Nebraska Newborn Screening Program, to rule out or help diagnose conditions in response to screening results that are out-of-range.
002.08 NEWBORN. An infant who is 28 days old or less.
002.09 NEWBORN SCREENING. A laboratory test applied to newborn specimens in a search for newborns with inherited or congenital infant or childhood-on set diseases. Screening will detect a high proportion of newborns with the disease (true positive). Some newborns who do not have the disease will be identified by the screening test as possibly affected (false positive).
002.10 NEWBORN SCREENING ADVISORY COMMITTEE. A committee whose membership is determined by the Department's Chief Medical Officer which is comprised of a minimum of 15, and maximum of 25, stakeholders and representatives from, but not limited to, the following areas: Newborn and pediatric primary health care providers; medical and allied professionals from the sub-specialties associated with treatment for the disorders screened; clinical laboratorians; and consumers with technical, professional, or personal experience with newborn screening for congenital and inherited disorders.
002.11 PHYSICIAN. A person licensed to practice medicine and surgery or osteopathic medicine and surgery pursuant to the Medicine and Surgery Practice Act.
002.12 PRESUMPTIVE POSITIVE. A screening test result that is above or below the cutoff value or outside the normal range or value determined by an algorithm for assigning an interpretation of presumptive positive, depending on the test method.
002.13 PUBLIC HEALTH. The art and science dealing with the protection and improvement of community health by organized community effort and including preventive medicine and sanitary and social science.
002.14 PUBLIC HEALTH EMERGENCY. The condition that requires the Governor to declare a state of public health emergency. An occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or a novel and highly fatal infectious agent or biological toxin that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability (World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC), 2001). The declaration of a state of public health emergency permits the Governor to suspend state regulations or change the functions of state agencies, or both.
002.15 PUBLIC HEALTH RESEARCH. Research intended to generate or contribute to generalizable knowledge to improve public health practice. Generalizable knowledge is new information that has relevance beyond the population or program from which it was collected. Intended benefits of the research project may or may not include study participants, but always extends beyond study participants, and usually to society. Data collected exceeds requirements for care of the study participants or extend beyond the scope of the activity.
002.16 RESIDUAL DRIED BLOOD SPOTS. The portion of the initial or repeat dried blood spot specimen remaining, after all punches have been removed for testing of the specimen for newborn screening purposes.
002.17 SUBMITTER. The person who sends the Collection and Reporting (CARe) Form to the testing laboratory for initial, repeat, or confirmatory screening tests, including, the hospital, the laboratory, or the physician.
002.18 TEST METHOD. A laboratory examination which measures blood constituents associated with screened diseases.
