Chapter 438 — Laboratories; Anatomical Material

2025 EDITION

LABORATORIES; ANATOMICAL MATERIAL

PUBLIC HEALTH AND SAFETY

CLINICAL LABORATORIES

(Generally)

438.010 Definitions for ORS 438.010 to 438.450

438.040 Clinical laboratory qualifications and certifications

438.060 Permit for health screen testing; exception

438.150 Health screen testing permit; fees; rules

438.160 Revocation, suspension, refusal to issue or renew certificates or permits

438.220 Special qualifications for laboratory director at chiropractic college

438.310 Owner or director of clinical laboratory to submit reports and findings on communicable disease

(Miscellaneous)

438.430 Examination of specimens; reports and results

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

438.440 Disposition of fees

438.450 Rules

ENVIRONMENTAL LABORATORIES

438.605 Definitions for ORS 438.605 to 438.620, 448.280 and 448.285

438.610 Standards for accreditation; rules

438.615 Environmental laboratory accreditation program; rules

438.620 Accreditation fees; disposition of fees

ANATOMICAL MATERIAL

438.705 Definitions for ORS 438.705 to 438.720 and 438.994

438.710 Licensure of nontransplant anatomical research recovery organizations; rules; fees

438.715 Organization operations

438.720 Rules; inspection of organization premises and records

PENALTIES

438.990 Penalties for ORS 438.040

438.994 Penalties for ORS 438.710 and 438.715

CLINICAL LABORATORIES

(Generally)

438.010 Definitions for ORS 438.010 to 438.450. As used in ORS 438.010 to 438.450, unless the context requires otherwise:

(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) “Clinical laboratory” or “laboratory” means a facility where the microbiological, serological, chemical, hematological, immunohematological, immunological, toxicological, cytogenetical, exfoliative cytological, histological, pathological or other examinations are performed on materials derived from the human body, for the purpose of diagnosis, prevention of disease or treatment of patients by physicians, dentists and other persons who are authorized by license to diagnose or treat humans.

(4) “Custody chain” means the handling of specimens in a way that supports legal testimony to prove that the sample integrity and identification of the sample have not been violated, as well as the documentation describing those procedures from specimen collection to the final report.

(5) “Dentist” means a person licensed to practice dentistry by the Oregon Board of Dentistry.

(6) “Health screen testing” means tests performed for the purpose of identifying health risks, providing health information and referring the person being tested to medical care.

(7) “Operator of a substances 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 of a substances of abuse on-site screening facility.

(8) “Physician” means a person licensed to practice medicine by the Oregon Medical Board.

(9) “Specimen” means materials derived from a human being or body.

(10) “Substances of abuse” means ethanol, cannabis and controlled substances.

(11) “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.

(12) “Substances of abuse on-site screening test” or “on-site test” means a substances of abuse test that is easily portable and can meet the requirements of the federal Food and Drug Administration for commercial distribution or an alcohol screening test that meets the requirements of the United States Department of Transportation National Highway Traffic Safety Administration for conforming products. [1969 c.685 §2; 1989 c.776 §1; 1993 c.109 §3; 1997 c.355 §1; 1999 c.739 §1; 2001 c.104 §168; 2001 c.900 §255; 2009 c.595 §698; 2017 c.21 §62; 2019 c.358 §13; 2024 c.73 §89; 2025 c.624 §26]

438.030 [1969 c.685 §1; 2001 c.104 §169; repealed by 2025 c.624 §37]

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).

(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]

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]

438.055 [1993 c.109 §12; 1999 c.341 §2; repealed by 2025 c.624 §37]

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.

(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]

438.070 [1993 c.109 §2; 2009 c.595 §700; repealed by 2025 c.624 §37]

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]

438.120 [1969 c.685 §6; 1993 c.109 §6; 1999 c.341 §4; 2009 c.595 §702; repealed by 2025 c.624 §37]

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]

438.140 [1969 c.685 §8; 2009 c.595 §704; repealed by 2025 c.624 §37]

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.

(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 section, including rules establishing:

(a) Application procedures and permit eligibility requirements, including an application fee, permit fee or both;

(b) Appropriate quality assurance practices;

(d) A list of tests that a clinical laboratory may conduct;

(e) Counseling and referral standards for persons being tested; and

(f) Reporting standards for clinical laboratories to notify the authority of the location of any health screen testing facilities.

(3) The authority may establish by rule a maximum period of time a clinical laboratory conducting health screen tests may remain in a single location. [1969 c.685 §9; 1989 c.776 §2; 2007 c.71 §122; 2009 c.595 §705; 2025 c.624 §29]

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) 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 the authority, or made any misrepresentation in seeking to obtain or retain a certificate or permit.

(2) Demonstrated incompetence as defined pursuant to regulations promulgated after public hearing.

(3) Intentionally falsified any report.

(4) Referred a specimen for examination to an uncertified clinical laboratory in this state unless the laboratory is exempt from the application of ORS 438.010 to 438.450.

(5) Misrepresented the scope of laboratory service offered by the clinical laboratory or authorized by the certificate.

(6) Rendered a report on clinical laboratory work actually performed in another clinical laboratory without designating the name and address of the clinical laboratory in which the test was performed.

(7) Knowingly had professional connection with or permitted the use of the name of the clinical laboratory or its director by a clinical laboratory that is required to but has not obtained a certificate.

(8) Failed to perform or cause to be performed within the time specified analysis of test samples or failed to report on the results of such analysis within the specified time.

(9) Failed to permit within a reasonable time the entry or inspection authorized under the certificate.

(10) Violated any provision of ORS 438.010 to 438.450. [1969 c.685 §10; 1993 c.109 §13; 1999 c.341 §8; 2001 c.104 §172; 2009 c.595 §706; 2025 c.624 §30]

438.210 [1969 c.685 §12; 1993 c.109 §8; 2007 c.71 §123; 2009 c.595 §707; repealed by 2025 c.624 §37]

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]

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]

438.320 [1969 c.685 §14; 1983 c.740 §154; 1993 c.109 §10; 2009 c.595 §709; repealed by 2025 c.624 §37]

438.410 [Formerly 433.310; repealed by 1971 c.650 §51]

438.420 [Formerly 433.325; 2009 c.595 §710; repealed by 2025 c.624 §37]

(Miscellaneous)

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.

(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, examination or analysis under subsection (1) of this section notifies the clinical laboratory of a reasonable belief that an exception applies to the prohibition on information blocking under 42 U.S.C. 300jj-52; and

(b) A physician, dentist, their agents, or other person authorized by law to employ the results in the conduct of a practice or in the fulfillment of official duties.

(3) Except as provided in subsection (2) of this section, a clinical laboratory or the designee of the laboratory, after verifying the identity of the requester and after determining the results are ready for release, shall without unreasonable delay provide the results of a test, examination or analysis of a specimen submitted by a patient in writing to the patient or the patient’s authorized representative. [1969 c.685 §21; 2001 c.104 §174; 2003 c.376 §1; 2009 c.583 §1; 2021 c.285 §1]

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;

(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]

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]

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]

438.510 [1969 c.685 §11; 1987 c.669 §3; 2001 c.104 §177; repealed by 2025 c.624 §37]

ENVIRONMENTAL LABORATORIES

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) “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 designee.

(2) “Authority” means the Oregon Health Authority.

(3) “Environmental laboratory” means a fixed location or mobile facility that performs chemical, physical, radiological, microbiological or biological testing of environmental samples or the collection of environmental samples.

(4) “Environmental testing” means laboratory analysis of any matter, pollutant, contaminant or hazardous substance subject to regulation pursuant to:

(a) Rules adopted or enforced by the Oregon Health Authority, the Department of Environmental Quality or the State Department of Agriculture; or

(b) A federal environmental statute or regulation administered or enforced by the United States Environmental Protection Agency. [1999 c.1063 §1; 2009 c.595 §714]

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.

(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 monitoring.

(3) The standards adopted under this section may address testing and sampling procedures or methods, record keeping, disposal or retention of testing materials or samples, or any other practice related to work performed by an environmental laboratory. [1999 c.1063 §2; 2009 c.595 §715]

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]

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.

(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 section shall be deposited in a dedicated account of the authority. Such moneys are continuously appropriated to the Oregon Health Authority to pay the costs of the authority, the State Department of Agriculture and the Department of Environmental Quality in administering the environmental laboratory accreditation program established under ORS 438.615. [1999 c.1063 §4; 2009 c.595 §717]

ANATOMICAL MATERIAL

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) “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 engages in the recovery or distribution of anatomical material from a donor for research or education purposes other than transplanting the anatomical material or therapy.

(b) “Nontransplant anatomical research recovery organization” does not include:

(A) A hospital or other health care facility, as those terms are defined in ORS 442.015;

(B) A public corporation, as defined in ORS 353.010;

(D) A clinical laboratory, as defined in ORS 438.010, that is:

(i) Certified under ORS 438.010 to 438.450; and

(ii) Owned or controlled by, or under common ownership with, a hospital described in subparagraph (A) of this paragraph. [2013 c.356 §1; 2025 c.624 §35]

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.

(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 issued or renewed under this section expires two years after the date of issuance or renewal.

(4) The license required by this section is in addition to and not in lieu of any other license required by law.

(5) The authority shall deposit fees collected under this section into the Oregon Health Authority Fund established in ORS 413.101. Moneys deposited in the fund under this subsection are continuously appropriated to the authority for the purposes of carrying out the duties, functions and powers of the authority under ORS 438.705 to 438.720 and 438.994. [2013 c.356 §2]

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:

(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) Documentation of the disposition of the anatomical material by the organization, including the name and address of each person that receives anatomical material from the organization.

(2) If a nontransplant anatomical research recovery organization returns any anatomical material to a relative or personal representative of a donor, the organization shall disclose to the relative or personal representative whether all or part of the donor’s body is being returned.

(3) A nontransplant anatomical research recovery organization shall dispose of any anatomical material not returned to a relative or personal representative of the donor in accordance with all laws pertaining to the disposition of human remains.

(4) If a nontransplant anatomical research recovery organization accepts an offer from an individual to donate anatomical material to the organization, the organization shall provide to the individual clear notice as to whether or not the organization guarantees the coverage of a cost related to transporting and disposing of the individual’s anatomical material, including coverage of costs in instances in which the individual or a relative or personal representative of the individual subsequently rescinds, or the organization later rejects, the offer of anatomical material. [2013 c.356 §3]

438.720 Rules; inspection of organization premises and records. (1) The Oregon Health Authority may:

(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 inspections authorized under paragraph (b) of this subsection, accept accreditation from an accrediting body approved by the authority.

(2) To be approved under subsection (1)(c) of this section, an accrediting body must:

(a) Require a nontransplant anatomical research recovery organization to document processes related to the recovery, handling and distribution of anatomical material and submit to the accrediting body that documentation.

(b) Require a nontransplant anatomical research recovery organization to keep and maintain all records related to the recovery or distribution of anatomical material for at least 10 years.

(c) Conduct, or have a designee conduct, regular on-site compliance inspections of a nontransplant anatomical research recovery organization’s records, processes and materials relating to:

(A) Donor intake;

(B) Acquisition, preparation, labeling, packaging, storage and distribution of anatomical material; and

(C) Any inspection of a facility owned or operated by the nontransplant anatomical research recovery organization. [2013 c.356 §4]

PENALTIES

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]

438.994 Penalties for ORS 438.710 and 438.715. (1) In accordance with ORS chapter 183, the Oregon Health Authority may:

(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 section into the Oregon Health Authority Fund established in ORS 413.101. Moneys deposited in the fund under this subsection are continuously appropriated to the authority for the purposes of carrying out the duties, functions and powers of the authority under ORS 438.705 to 438.720 and 438.994. [2013 c.356 §5]

CHAPTER 439 [Reserved for expansion]

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