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Code · Oregon · ORS Chapter 438 · Laboratories; Anatomical Material

438.435 Substances of abuse on-site screening facilities; permits; rules; fees

652 words·~3 min read·/or/ors-chapter-438/laboratories-anatomical-material/438-435·

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438.435 Substances of abuse on-site screening facilities; permits; rules; fees.
(1)The Oregon Health Authority by rule shall set standards for substances of abuse on-site screening facilities that engage only in the initial testing for substances of abuse in the body, including application procedures and permit eligibility requirements for a facility to obtain a permit to conduct substances of abuse on-site screening tests.
(2)The operator of a substances of abuse on-site screening facility may use substances of abuse on-site screening tests if the test results are not for use in diagnosing or preventing disease and are not for use by physicians, dentists or other licensed health care professionals in treating humans. Any entity using the test shall pay a yearly filing fee established by rule by the authority, and file a permit application form as provided by rule of the authority that:
(a)States the current name and address of the entity, the telephone number of the entity, if any, and the name of a contact individual at each on-site facility operated by the entity; and
(b)Certifies that:
(A)The tests are being administered according to the federal Food and Drug Administration package insert that accompanies the test;
(B)The tests are being administered according to the instructions of the manufacturer;
(C)Custody chain procedures are being followed;
(D)Operators of the substances of abuse on-site screening facility are trained in the use of the substances of abuse on-site screening tests by the manufacturer; and
(E)If the substances of abuse on-site screening facility obtains a positive test result on a specimen and the entity indicates that the test result is to be used to deny or deprive any person of employment or any benefit, or may otherwise result in adverse employment action, the same specimen shall be submitted to a clinical laboratory certified under ORS 438.040 or an equivalent out-of-state facility and the presence of a substance of abuse confirmed prior to release of the on-site test result.
(3)The authority by rule shall set reasonable standards for substances of abuse on-site screening by correctional agencies of adults in custody within state and local correctional facilities and offenders on parole, probation or post-prison supervision for substances of abuse. The standards shall include, but not be limited to, the establishment of written procedures and protocols, the qualifications and training of individuals who perform screening tests, the approval of specific technologies and the minimum requirements for record keeping, quality control and confirmation of positive screening results.
(4)If an initial test by a substances of abuse on-site screening facility shows a result indicating the presence of a substance of abuse in the body, a confirmatory test shall be conducted in a clinical laboratory certified under ORS 438.040 if the results are to be used to deprive or deny any person of any employment or benefit. If a screening test of an adult in custody in a state or local correctional facility is positive for a substance of abuse, the adult in custody may be held in a secure facility pending the outcome of the confirmatory test. If the confirmatory test is positive, the adult in custody may be held in a secure facility pending the outcome of any hearing to determine what action will be taken.
(5)If any test for substances of abuse is performed outside this state the results of which are to be used to deprive or deny any person any employment or any benefit, the person desiring to use the test shall have the burden to show that the testing procedure used meets or exceeds the testing standards of this state.
(6)Notwithstanding the provisions of this section, a clinical laboratory certified under ORS 438.040 may perform substances of abuse on-site screening testing. [1987 c.669 §2; 1991 c.808 §1; 1997 c.355 §2; 1999 c.739 §2; 2001 c.104 §175; 2009 c.595 §711; 2019 c.213 §103; 2025 c.624 §33]
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