Oregon Statutes - Chapter 438 - Clinical and Environmental Laboratories

• 438.010   Definitions for ORS 438.010 to 438.510.
  As used in ORS 438.010 to 438.510, unless the context requires otherwise: (1) “Clinical laboratory” or “laboratory” means a facility where the microbiological, serological, chemical,...
• 438.030   Policy.
  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...
• 438.040   Laboratory license; out-of-state laboratory permit; qualifications of director.
  It is unlawful: (1) For any owner or director of a clinical laboratory to operate or maintain a clinical laboratory without a license issued under...
• 438.050   Application; exceptions.
  (1) ORS 438.010 to 438.510 apply to all clinical laboratories and laboratory personnel within the State of Oregon, except: (a) Clinical laboratories operated by the...
• 438.055   Exemption.
  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...
• 438.060   Permit for health screen testing; exception.
  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...
• 438.070   Personnel; rules.
  The Department of Human Services shall establish by rule the qualifications and responsibilities of technical and clinical consultants, general and technical supervisors and testing personnel....
• 438.110   Standards for issuance and renewal of laboratory license.
  (1) The Department of Human Services shall establish four levels of laboratory licenses as follows: (a) A high complexity laboratory license; (b) A moderate complexity...
• 438.120   Standards for licensing specialties; exceptions.
  (1) In determining the specialties that are authorized to be performed in a clinical laboratory, the Department of Human Services shall consider laboratory personnel, with...
• 438.130   License application; fees; expiration and renewal.
  (1) The application for a license for a clinical laboratory shall be made on forms provided by the Department of Human Services and shall be...
• 438.140   License content; display; nontransferability; voidability; special permit when director changes.
  (1) A license issued to the owner of a clinical laboratory shall show on its face the names of the owners and directors, the location...
• 438.150   Temporary permit; fees; health screen testing permit; conditions and limitations; rules.
  (1) In addition to the license of a clinical laboratory required by ORS 438.040, the Department of Human Services may issue a temporary permit valid...
• 438.160   Refusal to issue or renew license; suspension or revocation of license or permit.
  Subject to ORS chapter 183, the Department of Human Services may refuse to issue or renew the license, or may suspend or revoke the license...
• 438.210   Qualifications of laboratory director.
  A person is qualified to act as a laboratory director of a clinical laboratory if: (1) The person is a pathologist certified in clinical or...
• 438.220   Special qualifications for laboratory director at chiropractic college.
  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...
• 438.310   Inspection of laboratory premises; owner to submit reports and findings on communicable disease; information confidential.
  (1) The Department of Human Services or its authorized representative may: (a) At reasonable times enter the premises of a clinical laboratory licensed or subject...
• 438.320   Laboratory evaluation system; rules; quality control systems.
  (1) The Department of Human Services shall institute a laboratory evaluation system, as defined in ORS 438.010, and shall make such rules as are necessary...
• 438.410   [Formerly 433.310; repealed by 1971 c.650 §51]
• 438.420   Communicable disease reports to be from licensed laboratory.
  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...
• 438.430   Examination, specimens; reports and results.
  (1) 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...
• 438.435   Testing for substance of abuse; rules; fees.
  (1) 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...
• 438.440   Disposition of fees.
  All moneys received by the Department of Human Services under ORS 438.010 to 438.510 and 438.990 shall be credited to the Public Health Account and...
• 438.450   Rules.
  The Department of Human Services shall make such rules as are necessary for carrying out ORS 438.010 to 438.510 in accordance with ORS 183.330. [Formerly...
• 438.510   Prohibited acts.
  It is unlawful for the owner of a clinical laboratory or the director of a clinical laboratory to: (1) Operate or maintain a clinical laboratory...
• 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...
• 438.610   Standards for accreditation; rules.
  (1) The Department of Human Services, in concurrence with the accrediting authority, may adopt by rule standards for any laboratory seeking accreditation and performing environmental...
• 438.615   Environmental laboratory accreditation program; rules.
  The Department of Human Services, in concurrence with the accrediting authority, shall establish by rule and implement an environmental laboratory accreditation program. The standards for...
• 438.620   Accreditation fees; disposition of fees.
  (1) In conjunction with the environmental laboratory accreditation program established under ORS 438.615, the Department of Human Services may establish and collect a fee for...
• 438.990   Penalties.
  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....

Last modified: August 7, 2008