Oregon Revised Statutes
As used in ORS 438.010 to 438.510, unless the context requires otherwise: “Authority” means the Oregon Health Authority. “Clinical laboratory” or “laboratory” means a facility where the microbiological, serological, chemical, hematological, immunohematological, immunological, toxicological, cytogenetical, exfoliative cytological, histological, pathological…
It shall be the declarative purpose of ORS 438.010 to 438.510 to ensure the quality of medical laboratory work in order to protect the health and welfare of the people of the State of Oregon by establishing a regulatory program for clinical laboratories.
It is unlawful: For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a license issued under ORS 438.110 or without a temporary permit issued under ORS 438.150 or to perform or permit the performance of any laboratory specialty for which the laboratory is not licensed except as specified under ORS 438.050, u…
ORS 438.010 to 438.510 apply to all clinical laboratories and laboratory personnel within the State of Oregon, except: Clinical laboratories operated by the United States Government. Clinical laboratories operated and maintained purely for research or teaching purposes, and that involve no patient or public health services. Nothing in ORS 438.010 to 438.5…
Clinical laboratories operated by physicians or clinicians that conduct only waived tests and physician performed microscopy procedures used exclusively for the diagnosis and treatment of their patients shall not be subject to regulation that is more strict than regulation imposed under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42…
Notwithstanding ORS 438.050, any person performing health screen testing must obtain a permit under ORS 438.150 (5). However, an employer providing health screen testing to employees of the employer is exempt from the applications of ORS 438.010, 438.130, 438.150 and this section if such employer contracts for the testing through a licensed physician, a clin…
The Oregon Health Authority shall establish by rule the qualifications and responsibilities of technical and clinical consultants, general and technical supervisors and testing personnel. A person is qualified to act as a technical or clinical consultant, a general or technical supervisor, or a testing person in a clinical laboratory if the person meets the …
The Oregon Health Authority shall establish four levels of laboratory licenses as follows: A high complexity laboratory license; A moderate complexity laboratory license; A physician performed microscopy laboratory license; and A waived laboratory license. The authority shall issue and renew licenses required under ORS 438.040 for any or all clinical la…
In determining the specialties that are authorized to be performed in a clinical laboratory, the Oregon Health Authority shall consider laboratory personnel, with particular emphasis on the qualifications of the director, laboratory equipment and any other relevant factors affecting the ability of the laboratory to perform different laboratory specialties. …
The application for a license for a clinical laboratory shall be made on forms provided by the Oregon Health Authority and shall be executed by the owner or one of the owners or by an officer of the firm or corporation owning the clinical laboratory, or in the case of a county or municipality, by the public official responsible for operation of the laborator…
A license issued to the owner of a clinical laboratory shall show on its face the names of the owners and directors, the location of the laboratory and the clinical laboratory specialties authorized under the license. The license shall be displayed at all times in a prominent place in the laboratory. A license issued to the owner of a clinical laboratory is…
In addition to the license of a clinical laboratory required by ORS 438.040, the Oregon Health Authority may issue a temporary permit valid for a period, to be determined by the authority, from the date of issuance in any or all clinical laboratory specialties upon payment of the respective required fees as described in ORS 438.130 (2). In issuing the tempo…
Subject to ORS chapter 183, the Oregon Health Authority may refuse to issue or renew the license, or may suspend or revoke the license or health screen testing permit, of a clinical laboratory if it finds that the owner or director has: Intentionally made false statements on an application for a clinical laboratory license or any other documents required by…
A person is qualified to act as a laboratory director of a clinical laboratory if: The person is a pathologist certified in clinical or anatomical pathology by a national organization or organizations recognized by the Oregon Health Authority, or is a physician who possesses qualifications equivalent to those required for such certification; The person is …
Notwithstanding ORS 438.210, 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 t…
The Oregon Health Authority or its authorized representative may: At reasonable times enter the premises of a clinical laboratory licensed or subject to being licensed under ORS 438.010 to 438.510 to inspect the facilities, methods, procedures, materials, staff, equipment, laboratory results and records of the clinical laboratory. Require the owner or dire…
The Oregon Health Authority shall institute a laboratory evaluation system, as defined in ORS 438.010, and shall make such rules as are necessary to insure quality control of laboratory work. As part of this system, the authority may require each laboratory to: Participate in on-site inspection and testing; Analyze test samples submitted by the authority…
No operative statutory text appears at this designation in the selected edition.
When the control or release of a case contact or carrier of a communicable disease is dependent on laboratory findings, the health officer may require such findings to be obtained by a clinical laboratory licensed by the Oregon Health Authority.
Except as otherwise provided in ORS 438.010 to 438.510, 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…
In addition to duties which a clinical laboratory may perform under ORS 438.010 to 438.510, a laboratory is authorized to perform appropriate tests, examinations or analyses on materials derived from the human body for the purpose of detecting substances of abuse in the body. All laboratories performing the tests, examinations or analyses must be licensed un…
All moneys received by the Oregon Health Authority under ORS 438.010 to 438.510 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 438.510 and 438.990.
The Oregon Health Authority shall make such rules as are necessary for carrying out ORS 438.010 to 438.510 in accordance with ORS 183.330.
It is unlawful for the owner of a clinical laboratory or the director of a clinical laboratory to: Operate or maintain a clinical laboratory unless the laboratory is under personal supervision of a director who is qualified to supervise the laboratory. Violate any provision of ORS 438.010 to 438.510.
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 of this section, the authority shall coopera…
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 of this section,…
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 any provision of ORS 438.040 or 438.510 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…