34 sections in this chapter.
ORS 438.010 Definitions for ORS 438.010 to 438.450. As used in ORS 438.010 to 438.450, unless the context requires otherwise
2.6K chars
(1) “Authority” means the Oregon Health Authority. (2) “Certificate” means a certificate issued by the authority or the federal government to a clinical laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a). (3…
ORS 438.030 [1969 c.685 §1; 2001 c.104 §169; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.040 Clinical laboratory qualifications and certifications. (1) The Oregon Health Authority shall verify the qualifications of each clinical laboratory in this state and shall issue or facilitate the issuance of a certificate to a clinical laboratory that satisfies the requirements of the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a)
0.2K chars
(2) A clinical laboratory may not operate in this state without a certificate issued by the authority or the federal government under this section. [1969 c.685 §3; 1999 c.341 §1; 2005 c.22 §298; 2025 c.624 §27]
ORS 438.050 [1969 c.685 §§4,20; 1973 c.829 §54; 1979 c.193 §1; 1993 c.109 §4; 2001 c.104 §170; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.055 [1993 c.109 §12; 1999 c.341 §2; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.060 Permit for health screen testing; exception. (1) Except as provided in subsection (2) of this section, a clinical laboratory in this state or out of this state may not perform health screen testing in this state without a permit issued by the Oregon Health Authority under ORS 438.150
0.2K chars
(2) An employer may enter into a contract with a third party to provide health screen testing to the employees of the employer if the third party has a permit issued under ORS 438.150. [1989 c.776 §3; 2009 c.595 §699; 2025 c.624 §28]
ORS 438.070 [1993 c.109 §2; 2009 c.595 §700; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.110 [1969 c.685 §5; 1971 c.650 §18; 1993 c.109 §5; 1999 c.341 §3; 2001 c.104 §171; 2009 c.595 §701; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.120 [1969 c.685 §6; 1993 c.109 §6; 1999 c.341 §4; 2009 c.595 §702; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.130 [1969 c.685 §7; 1977 c.284 §3; 1979 c.696 §2; 1989 c.776 §5; 1991 c.703 §6; 1993 c.109 §7; 1999 c.341 §§5,6; 2007 c.768 §4; 2009 c.595 §703; 2023 c.602 §5; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.140 [1969 c.685 §8; 2009 c.595 §704; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.150 Health screen testing permit; fees; rules. (1)(a) A clinical laboratory may apply for a permit to conduct health screen testing by submitting an application to the Oregon Health Authority
1.0K chars
(b) The authority may issue a permit to a clinical laboratory to conduct health screen testing if the clinical laboratory satisfies the requirements established by the authority by rule under subsection (2) of this section. (2) The authority shall adopt rules to administer this s…
ORS 438.160 Revocation, suspension, refusal to issue or renew certificates or permits. Subject to ORS chapter 183, the Oregon Health Authority may refuse to issue or renew or may suspend or revoke a certificate described in ORS 438.040, a permit for health screen testing described in ORS 438.150 or a permit for substances of abuse on-site screening testing described in ORS 438.435 if the authority finds that the owner or director of the clinical laboratory or substances of abuse on-site screening facility has
1.7K chars
(1) Intentionally made false statements on an application for a certificate described in ORS 438.040, a permit for health screen testing described ORS 438.150, a permit for substances of abuse on-site screening testing described in ORS 438.435 or any other documents required by t…
ORS 438.210 [1969 c.685 §12; 1993 c.109 §8; 2007 c.71 §123; 2009 c.595 §707; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.220 Special qualifications for laboratory director at chiropractic college. A person is qualified to act as the laboratory director of the clinical laboratory at any accredited chiropractic college in this state for the benefit of chiropractic patients if that person is a chiropractic physician licensed by the State Board of Chiropractic Examiners, and possesses special qualifications, as determined by the State Board of Chiropractic Examiners, that enable that person to perform as a laboratory director. [1979 c.303 §2; 2025 c.624 §31]
0.0K chars
[Repealed or reserved.]
ORS 438.310 Owner or director of clinical laboratory to submit reports and findings on communicable disease. The Oregon Health Authority or its authorized representative may require the owner or director of a clinical laboratory certified under ORS 438.040 to submit initial laboratory findings indicative of communicable disease as defined by law or by rule. Each report shall include the name of the person from whom the specimen was obtained, if the name was reported to the laboratory, and the name and address of the physician for whom such examination or test was made. Such reports shall not be construed as constituting a diagnosis nor shall any laboratory making such report be held liable under the laws of this state for having violated a trust or confidential relationship. [1969 c.685 §13; 1993 c.109 §9; 2001 c.104 §173; 2009 c.595 §708; 2025 c.624 §32]
0.0K chars
[Repealed or reserved.]
ORS 438.320 [1969 c.685 §14; 1983 c.740 §154; 1993 c.109 §10; 2009 c.595 §709; repealed by 2025 c.624 §37]
0.0K chars
[Repealed or reserved.]
ORS 438.410 [Formerly 433.310; repealed by 1971 c.650 §51]
0.0K chars
[Repealed or reserved.]
ORS 438.420 [Formerly 433.325; 2009 c.595 §710; repealed by 2025 c.624 §37]
0.0K chars
(Miscellaneous)
ORS 438.430 Examination of specimens; reports and results. (1) Except as otherwise provided in ORS 438.010 to 438.450, a clinical laboratory shall examine specimens only at the request of a physician, dentist, or other person authorized by law to use the findings of laboratory examinations
1.2K chars
(2) A person may not report the result of any test, examination, or analysis of a specimen submitted for evidence of human disease except to: (a) The patient or the patient’s authorized representative, unless the physician, dentist or other person requesting the laboratory test, …
ORS 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
3.6K chars
(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…
ORS 438.440 Disposition of fees. All moneys received by the Oregon Health Authority under ORS 438.010 to 438.450 and 438.990 shall be credited to the Public Health Account and shall be used for payment of the expenses of the authority in administering the provisions of ORS 438.010 to 438.450 and 438.990. [1969 c.685 §16; 2009 c.595 §712]
0.0K chars
[Repealed or reserved.]
ORS 438.450 Rules. The Oregon Health Authority shall make such rules as are necessary for carrying out ORS 438.010 to 438.450. [Formerly 433.335; 2001 c.104 §176; 2009 c.595 §713; 2025 c.624 §34]
0.0K chars
[Repealed or reserved.]
ORS 438.510 [1969 c.685 §11; 1987 c.669 §3; 2001 c.104 §177; repealed by 2025 c.624 §37]
0.0K chars
ENVIRONMENTAL LABORATORIES
ORS 438.605 Definitions for ORS 438.605 to 438.620, 448.280 and 448.285. As used in ORS 438.605 to 438.620, 448.280 and 448.285
1.1K chars
(1) “Accrediting authority” means the official accrediting authority for the Oregon environmental laboratory accreditation program comprised of the Director of the Oregon Health Authority or designee, the Director of the Department of Environmental Quality or designee and the Dir…
ORS 438.610 Standards for accreditation; rules. (1) The Oregon Health Authority, in concurrence with the accrediting authority, may adopt by rule standards for any laboratory seeking accreditation and performing environmental testing for a fee or for determining compliance with environmental statutes, rules or regulations
0.6K chars
(2) In developing standards under subsection (1) of this section, the authority shall cooperate with and may seek advice from the United States Environmental Protection Agency and any other state or federal agency that may have adopted rules or regulations for environmental monit…
ORS 438.615 Environmental laboratory accreditation program; rules. The Oregon Health Authority, in concurrence with the accrediting authority, shall establish by rule and implement an environmental laboratory accreditation program. The standards for accreditation may be equivalent to, but may not exceed, standards adopted by national accreditation programs. [1999 c.1063 §3; 2009 c.595 §716]
0.0K chars
[Repealed or reserved.]
ORS 438.620 Accreditation fees; disposition of fees. (1) In conjunction with the environmental laboratory accreditation program established under ORS 438.615, the Oregon Health Authority may establish and collect a fee for laboratory accreditation under the program. A fee imposed under this section shall not exceed the cost of administering the program
0.7K chars
(2) Prior to imposing the fee under subsection (1) of this section, the authority shall obtain the approval of the Oregon Department of Administrative Services and report to the appropriate legislative committee. (3) All moneys collected by the Oregon Health Authority under this …
ORS 438.705 Definitions for ORS 438.705 to 438.720 and 438.994. As used in ORS 438.705 to 438.720 and 438.994
1.0K chars
(1) “Anatomical material” means the body of a dead human or a cell, group of cells or body part taken from the body of a dead human. (2) “Donor” has the meaning given that term in ORS 97.953. (3)(a) “Nontransplant anatomical research recovery organization” means a person that eng…
ORS 438.710 Licensure of nontransplant anatomical research recovery organizations; rules; fees. (1) A person may not act as a nontransplant anatomical research recovery organization unless the person is licensed as a nontransplant anatomical research recovery organization by the Oregon Health Authority
0.9K chars
(2) The authority shall adopt rules establishing an application process and fees for obtaining and renewing a nontransplant anatomical research recovery organization license. The fee for obtaining or renewing a license under this subsection may not exceed $1,750. (3) A license is…
ORS 438.715 Organization operations. (1) A nontransplant anatomical research recovery organization shall maintain a record of each donor from whom the organization obtains anatomical material. The record must include
1.6K chars
(a) Documentation showing that the donor donated the anatomical material for the purpose of research or education; (b) The name and address of each person that had possession of the anatomical material before the organization took possession of the anatomical material; and (c) Do…
ORS 438.720 Rules; inspection of organization premises and records. (1) The Oregon Health Authority may
1.4K chars
(a) Adopt rules to implement ORS 438.705 to 438.720 and 438.994; (b) Inspect the premises and records of a nontransplant anatomical research recovery organization as is reasonably necessary to determine compliance with ORS 438.710 and 438.715; and (c) In lieu of conducting inspec…
ORS 438.990 Penalties for ORS 438.040. Violation of ORS 438.040 is a Class A misdemeanor. Each day of continuing violation shall be considered a separate offense. [1969 c.685 §22; 1977 c.582 §45; 2025 c.624 §36]
0.0K chars
[Repealed or reserved.]
ORS 438.994 Penalties for ORS 438.710 and 438.715. (1) In accordance with ORS chapter 183, the Oregon Health Authority may
0.6K chars
(a) Impose a civil penalty in an amount not to exceed $1,000 for each violation of ORS 438.710 or 438.715; and (b) Suspend or revoke a license issued or renewed under ORS 438.710 for a violation of ORS 438.715. (2) The authority shall deposit penalties collected under this sectio…