Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0310 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) "Benefit"
			 means, but is not limited to, eligibility for insurance or employment, access
			 to or participation in a drug rehabilitation or mental health program, parole
			 or probation, school attendance or attendance in school activities.
(2) "Chain of custody" or "custody chain"
			 means the handling of specimens in a way which supports legal testimony to
			 prove that the sample integrity and identification of the sample have not been
			 violated, as well as the documentation describing these procedures from
			 specimen collection to final report.
(3) "Confirmatory test" means a highly
			 specific test to identify a substance of abuse or metabolite after a positive
			 screening, based on a different analytical method than that of the initial
			 screening test, at or below the cutoff concentration used for the screening
			 test.
(4) "Control" means a
			 material, the expected testing results of which are known, which is analyzed to
			 ensure that the expected results are obtained.
(5) "Cutoff concentration" means the mass of
			 a substance of abuse per unit volume of specimen, at or above which a test
			 result is considered positive.
(6)
			 "Director of a substances of abuse screening laboratory" or "Director" means
			 the person who plans, organizes, directs and participates in any or all of the
			 technical and administrative operations of a substances of abuse laboratory,
			 including but not limited to reviewing laboratory procedures and their results,
			 and the training and supervising of laboratory personnel.
(7) "Drug control manager" means the
			 individual who works for the inspector general of the Department of
			 Corrections, and oversees drug interdiction efforts of the Oregon Department of
			 Corrections. This includes supervision of urine drug screening.
(8) "Easily portable screening test" means
			 manual, non-automated, substance of abuse methods\kits.
(9) "Entity" means an individual,
			 partnerships, corporation, company, district, local\county\state agency. An
			 entity may be multiple sites under common ownership.
(10) "Local correctional facility" means any
			 institution or facility used specifically for the confinement of inmates
			 operated by a city or county.
(11)
			 "Medical testing" means any test performed at the request of a physician,
			 dentist, or other licensed health care professional for diagnosis and treatment
			 or assessment of health, including testing for rehabilitation or placement into
			 a rehabilitation or mental health program.
(12) "Non-medical testing" means substance of
			 abuse (SOA) screening not for diagnosis and treatment or assessment of health,
			 with or without an order from a physician, dentist or other licensed health
			 care professional, including but not limited to, employment, pre-employment, on
			 the job accident or injury, screening of students in schools, testing for
			 insurance eligibility or eligibility for plasmapheresis.
(13) "Operator of a substance of abuse
			 on-site screening facility" or "operator" means the person who plans,
			 organizes, directs and participates in any or all of the technical and
			 administrative operations.
(14)
			 "Owner of a substances of abuse screening laboratory" or "Owner" means a person
			 who owns the laboratory, or the State, county or municipality operating the
			 laboratory, or the owner of any institution operating the laboratory or any
			 non-profit organization operating the laboratory.
(15) "Parole, probation and post-prison
			 supervision" means any program operated for offenders by the Department of
			 Corrections or local correctional agencies.
(16) "Proficiency testing" means performance
			 of tests on specimens whose expected results are unknown to anyone in the
			 laboratory, known only to an external agency, and later revealed to the
			 laboratory as an aid to laboratory improvement and/or a condition of
			 licensure.
(17) "Quality control"
			 means methods used to monitor the performance of laboratory tests to detect
			 errors and prevent the reporting of incorrect results.
(18) "Screening" means performing initial
			 tests designed to separate substances of abuse at a particular minimum
			 concentration from those below that minimum concentration (positive versus
			 negative).
(19) "Special category
			 laboratory" means a laboratory that initially screens urine, blood, or other
			 body fluids for substance of abuse, but does not perform confirmation testing
			 by any method.
(20) "Specimen"
			 means body fluids obtained from a live person.
(21) "Standard" means an authentic sample of
			 the analyte of known purity, or a solution of the analyte of a known
			 concentration.
(22) "State
			 correctional facility" means any institution operated by the Oregon Department
			 of Corrections.
(23) "Substances of
			 abuse" or "SOA" means ethanol and controlled substances, except those used as
			 allowed by law and as defined in ORS chapter 475 or as used in ORS
			 689.005.
(24) "Substances of abuse
			 on-site screening facility" or "on-site facility" means a location where
			 on-site tests are performed on specimens for the purpose of screening for the
			 detection of substances of abuse.
(25) "Substances of abuse on-site screening
			 test" or "on-site test" means a substance of abuse test that is easily portable
			 and is approved by the Food and Drug Administration for commercial distribution
			 or an alcohol screening test that meets the requirements of the conforming
			 products list found in the
United States Department of Transportation
			 National Highway Traffic Safety Administration Docket No. 94-004
and
			 meets the standards of the
United States Department of Transportation
			 Alcohol Testing Procedure
,
49 C.F.R. part 40
, in effect on
			 October 23, 1999.
(26) "Substances
			 of abuse screening laboratory" or "SOA laboratory" means a facility where
			 initial biochemical examinations are performed on a specimen for the purpose of
			 screening for the detection of substances of abuse for medical purposes or
			 non-medical purposes by automated methods. This includes licensed clinical
			 laboratories screening for substances of abuse.
(27) "Substance of abuse testing program
			 manager" means an individual who is responsible for all aspects of SOA testing
			 in the facility including the quality control, proficiency testing, method
			 selection, equipment maintenance, training, record keeping, and qualifications
			 of individuals performing substance of abuse testing at each state or local
			 correctional facility or parole, probation office site.
Publications: The publication(s) referenced in this rule are
				  available from the agency.
Stat. Auth.: ORS 438.050, 438.130, 438.435(4), 438.435(5)
				  & 438.435(6)
Stats. Implemented: ORS 438.050, 438.130, 438.320 &
				  438.435