Oregon Revised Statutes
As used in ORS 438.010 to 438.450, unless the context requires otherwise: “Authority” means the Oregon Health Authority. “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). “Clinical lab…
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). A clinical laboratory may not operate in t…
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. An employer may enter into a contract with a third party to provide health screen testing to the employees of the employer…
A clinical laboratory may apply for a permit to conduct health screen testing by submitting an application to the Oregon Health Authority. 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. …
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 clinic…
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 Chiropracti…
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 reporte…
(Miscellaneous)
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. A person may not report the result of any test, examination, or analysis of a specimen submitted for evidence of human disease exc…
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. The operator o…
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.
The Oregon Health Authority shall make such rules as are necessary for carrying out ORS 438.010 to 438.450.
ENVIRONMENTAL LABORATORIES
As used in ORS 438.605 to 438.620, 448.280 and 448.285: “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 Director of Agriculture or des…
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. In developing standards under subsection (1) of this section, the authority shall coop…
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.
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. Prior to imposing the fee under subsection (1) of this secti…
As used in ORS 438.705 to 438.720 and 438.994: “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. “Donor” has the meaning given that term in ORS 97.953. “Nontransplant anatomical research recovery organization” means a person that engages in the recovery or distribution of anato…
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. The authority shall adopt rules establishing an application process and fees for obtaining and renewing a nontransplant anatomical research recovery organ…
A nontransplant anatomical research recovery organization shall maintain a record of each donor from whom the organization obtains anatomical material. The record must include: Documentation showing that the donor donated the anatomical material for the purpose of research or education; The name and address of each person that had possession of the anatomi…
The Oregon Health Authority may: Adopt rules to implement ORS 438.705 to 438.720 and 438.994; 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 In lieu of conducting inspections authorized under paragraph (b) of this subsection,…
Violation of ORS 438.040 is a Class A misdemeanor. Each day of continuing violation shall be considered a separate offense.
In accordance with ORS chapter 183, the Oregon Health Authority may: Impose a civil penalty in an amount not to exceed $1,000 for each violation of ORS 438.710 or 438.715; and Suspend or revoke a license issued or renewed under ORS 438.710 for a violation of ORS 438.715. The authority shall deposit penalties collected under this section into the Oregon He…