Current through Register Vol. 61, No. 4, April 1, 2022
As used in these rules:
(1) "Colorimetric assay" means a qualitative
laboratory procedure to detect the presence of the enzyme biotinidase which,
when present, produces a color change.
(2) "Congenital disorder" means a condition
that is present at birth. This includes but is not limited to cystic fibrosis,
endocrine, hemoglobinopathy, metabolic, and immunodeficiency disorders.
(3) "County health department"
means those county and district health departments formed under ORS 431.416.
(4) "Cystic fibrosis" means a
disorder, usually due to a single enzyme deficiency of genetic origin, in which
the individual is completely or partially unable to produce a functioning
transmembrane conductance regulator protein that results in progressive
multi-organ dysfunction and the accumulation of trypsinogen in the blood during
the newborn period.
"Diagnostic laboratory" means a laboratory approved to perform testing for the
congenital disorders listed herein to rule out a specific disorder suspected by
newborn screening or for screening infants older than six months of age.
(6) "Division" means the Public
Health Division of the Oregon Health Authority.
(7) "Dried blood specimen" means a blood
specimen obtained from an infant by means of capillary-puncture or
skin-puncture (heel stick), not by means of venipuncture or any other method,
which is placed on special filter paper kits and allowed to air dry.
(8) "Endocrine disorders" means disorders
related to hormone production or utilization resulting in abnormal growth and
development, fluid and electrolyte imbalance or other disturbance, including
hypothyroidism and congenital adrenal hyperplasia.
(9) "Fluorescent immunoassay" means a
competitive binding or direct assay creating specific antibody-antigen
reactions to detect thyroxin, thyroid stimulating hormone,
17-alpha-hydroxyprogesterone and immunoreactive trypsinogen.
(10) "Fluorescent spot test" means a
biochemical laboratory test procedure utilizing certain naturally occurring
enzymes in erythrocytes and added chemicals used to detect galactose in blood
specimens as a screening test for galactosemia. It is described occasionally in
the scientific literature as a "Hill test."
(11) "Hemoglobinopathy" means one of a group
of disorders which results in abnormal structure and function of hemoglobin
that leads to variable degrees of anemia, hemolysis and other complications.
These include sickle cell disease and other clinically significant
performance liquid chromatography" means the utilization of a separation column
to detect various hemoglobin proteins based on their retention time.
(13) "Immunodeficiency disorders" means a
group of disorders in which the immune system is not functioning properly. This
includes severe combined immunodeficiency (SCID), a primary immune disorder
characterized by a defect in T-cell production and function. SCID is also
described as the "bubble boy disease".
(14) "Isoelectric focusing" means a
laboratory procedure in which protein, hemoglobin in blood, is subjected to an
electric field in a gel medium with a gradient pH causing it to migrate to its
pH and isoelectric point, revealing specific patterns for each type of
(15) "Kit" means any
or all parts of the combined materials, laboratory slips, tubes, mailing
containers, or other components provided by the state public health laboratory
for the purposes of collection or submission of specimens for laboratory tests.
(16) "Metabolic disorders" means
those disorders of intermediary metabolism and hormone production, regulation,
or utilization in which the individual is completely or partially incapable of
normal metabolism of biotin, single amino acids, galactose, or fatty acids
resulting in the abnormal accumulation of those and other metabolites in the
blood. These include phenylketonuria and medium-chain acyl-CoA dehydrogenase
screening panel" means those disorders identified by the Oregon Health
Authority in these rules for which all infants shall be tested, except if the
infant is being reared as an adherent to a religion the teachings of which are
opposed to such testing.
"Practitioner" means a person duly and regularly licensed by the proper
authority to practice medicine, naturopathy or chiropractic or to be a nurse
practitioner. For purposes of OAR
only, this definition is extended to include the licensed or unlicensed person
who takes responsibility for delivery or the health care of the baby; or being
none, the person responsible for the health care of the mother prior to birth
of the baby.
(19) "Precision" of
an assay means a quantitative measure of reproducibility of a laboratory
procedure in assaying a particular chemical under defined conditions. Examples
include, but are not limited to, statistically determined values of standard
deviations from the mean and coefficients of variation.
(20) "Sensitivity" of an assay means the
lowest concentration or quantity of a particular chemical that can be reliably
detected or measured by a laboratory assay procedure under defined conditions.
(21) "Specificity" of an assay
means the accuracy with which a laboratory assay procedure can reliably
identify or measure the quantity of a particular chemical to distinguish it
from other related or unrelated chemicals under defined conditions.
(22) "Specimen for newborn screening" means a
dried blood specimen from an infant submitted to the state public health
laboratory to detect congenital disorders included on the newborn screening
(23) "State public
health laboratory" means the Oregon State Public Health Laboratory of the
Public Health Division, 3150 NW 229th Avenue, Hillsboro, Oregon 97124.
(24) "Tandem mass spectrometry"
means a laboratory procedure in which amino acids and acylcarnitines are
detected and quantified in a sample taken from a dried blood spot.
(26) "TREC assay" means a DNA polymerase
chain reaction method to detect T-cell receptor excision circles. An absence or
reduction in TRECs can be used as an indicator for severe combined
immunodeficiency or other primary immune deficiencies.