Or. Admin. R. 333-024-0205

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-024-0205 - Definitions

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.

Or. Admin. R. 333-024-0205

HD 18-1981(Temp), f. & ef. 9-11-81; HD 3-1982, f. & ef. 2-25-82; HD 10-1986, f. & ef. 6-11-86; PH 11-2014, f. 4-15-14, cert. ef. 5-1-14

Stat. Auth.: ORS 431.310

Stats. Implemented: ORS 433.285, 433.290 & 433.295