Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0205 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
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.
(5)
			 "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
			 hemoglobinopathies.
(12) "High
			 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
			 hemoglobin.
(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
			 deficiency.
(17) "Newborn
			 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.
(18)
			 "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
			 333-024-0215(1)
 
			 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
			 test panel.
(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.
(25) "These rules" means OAR
			 333-024-0205  through
			 333-024-0240.
(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.
Stat. Auth.: ORS 431.310
Stats. Implemented: ORS 433.285, 433.290 &
				  433.295