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Timestamp: 2019-06-27 07:54:27
Document Index: 488250576

Matched Legal Cases: ['art 40', '§2', '§1', '§3', '§1', '§1', '§168', '§255', '§3', '§1', '§3', '§2', '§5', '§18', '§5', '§3', '§171', '§6', '§6', '§4', '§7', '§3', '§2', '§5', '§6', '§7', '§5', '§8', '§9', '§2', '§10', '§13', '§8', '§172', '§12', '§8', '§13', '§9', '§173', '§14', '§154', '§10', '§21', '§174', '§2', '§1', '§2', '§2', '§175', '§16', '§176', '§1', '§2', '§3', '§4', '§22', '§45']

Chapter 438 — Clinical and Environmental Laboratories
(1) "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.
(2) "Clinical laboratory specialty" or "laboratory specialty" means the examination of materials derived from the human body for the purpose of diagnosis and treatment of patients or assessment of health, employing one of the following sciences: Serology, microbiology, chemistry, hematology, immunohematology, immunology, toxicology, cytogenetics, exfoliative cytology, histology or pathology.
(3) "Clinician" means a nurse practitioner licensed and certified by the Oregon State Board of Nursing, or a physician assistant licensed by the Board of Medical Examiners for the State of Oregon.
(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.
(7) "Director of clinical laboratory" or "director" means the person who plans, organizes, directs and participates in any or all of the technical operations of a clinical laboratory, including but not limited to reviewing laboratory procedures and their results, training and supervising laboratory personnel, and evaluating the technical competency of such personnel.
(8) "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.
(9) "High complexity laboratory" means a facility that performs testing classified as highly complex in the specialties of microbiology, chemistry, hematology, diagnostic immunology, immunohematology, clinical cytogenetics, cytology, histopathology, oral pathology, pathology, radiobioassay and histocompatibility and that may also perform moderate complexity tests and waived tests.
(10) "High complexity test" means a procedure performed on materials derived from the human body that meet the criteria for this category of testing in the specialties of microbiology, chemistry, hematology, immunohematology, diagnostic immunology, clinical cytogenetics, cytology, histopathology, oral pathology, pathology, radiobioassay and histocompatibility as established by the department.
(11) "Laboratory evaluation system" means a system of testing clinical laboratory methods, procedures and proficiency by periodic performance and reporting on test specimens submitted for examination.
(12) "Moderate complexity laboratory" means a facility that performs testing classified as moderately complex in the specialties of microbiology, hematology, chemistry, immunohematology or diagnostic immunology and may also perform any waived test.
(13) "Moderate complexity test" means a procedure performed on materials derived from the human body that meet the criteria for this category of testing in the specialties of microbiology, hematology, chemistry, immunohematology or diagnostic immunology as established by the department.
(14) "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.
(15) "Owner of a clinical laboratory" means the person who owns the clinical laboratory, or a county or municipality operating a clinical laboratory or the owner of any institution operating a clinical laboratory.
(16) "Physician" means a person licensed to practice medicine by the Board of Medical Examiners for the State of Oregon.
(17) "Physician performed microscopy procedure" means a test personally performed by a physician or other clinician during a patient’s visit on a specimen obtained during the examination of the patient.
(18) "Physician performed microscopy procedures" means a limited group of tests that are performed only by a physician or clinician.
(19) "Specimen" means materials derived from a human being or body.
(20) "Substances of abuse" means ethanol and controlled substances, except those used as allowed by law and as defined in ORS chapter 475 or as used in ORS 689.005.
(21) "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.
(22) "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 conforming products list found in the United States Department of Transportation National Highway Traffic Safety Administration Docket No. 94-004 and meets the standards of the United States Department of Transportation Alcohol Testing Procedure, 49 C.F.R. part 40, in effect on October 23, 1999.
(23) "Waived test" means a procedure performed on materials derived from the human body that meet the criteria for this category of testing as established by the department. [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]
438.040 Laboratory license required; director to be qualified; permit required of out-of-state laboratory. On and after July 1, 1970, it shall be unlawful:
(3) For any person to serve in the capacity of director of a clinical laboratory without being qualified as a clinical laboratory director under ORS 438.210. [1969 c.685 §3; 1999 c.341 §1]
438.060 When permit required 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 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 clinical laboratory or a hospital, which is a permittee of the Department of Human Services as provided in this section. [1989 c.776 §3]
438.070 Personnel. 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. 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 requirements established by the department. Rules adopted under this section shall not be more stringent than comparable rules adopted under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and 263a). [1993 c.109 §2]
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:
(2) The department shall issue and renew licenses required under ORS 438.040 for any or all clinical laboratory specialties to the owners of clinical laboratories who demonstrate to the satisfaction of the department that:
(a) The clinical laboratory is in compliance with ORS 438.010 to 438.510 and the rules of the department adopted under ORS 438.450;
(c) The clinical laboratory has facilities for retaining and does retain complete laboratory records for an appropriate length of time as the department by rule may require; and
(d) The clinical laboratory meets the standards of the department for safety, sanitary conditions, plumbing, ventilation, handling of specimens, maintenance of equipment and requirements of general hygiene to insure protection of the public health. [1969 c.685 §5; 1971 c.650 §18; 1993 c.109 §5; 1999 c.341 §3; 2001 c.104 §171]
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 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.
(2) No laboratory shall be licensed to perform examinations in the fields of surgical pathology, autopsy pathology, exfoliative cytology, or immunohematology, except as the Department of Human Services may establish exemptions from the requirements of this subsection in the field of immunohematology, unless its director is a physician or dentist specifically qualified in these fields.
(3) The list of waived tests, physician performed microscopy procedures and moderate and high complexity tests shall be established by the department. [1969 c.685 §6; 1993 c.109 §6; 1999 c.341 §4]
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 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 laboratory, or in the case of an institution, by the administrator of the institution. The application shall contain the names of the owner, the director or directors of the clinical laboratory, the location and physical description of the clinical laboratory, the laboratory specialties for which a license is requested and such other information as the department may require.
(2)(a) The application shall be accompanied by an annual or biennial license fee to be established by the department. The fee shall be based on test volume, test complexity, the number of specialties performed and private laboratory accreditation. For each level of laboratory testing, the fee shall be not more than 100 percent of the corresponding fee charged by the federal laboratory certification program known as the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on July 1, 1999. The fee for substance of abuse screening laboratories not certified under the Clinical Laboratory Improvement Amendments of 1988 shall be comparable to the clinical laboratory fee established under this section.
(b) The department may establish prorated fees for licenses issued for a year or less and when there is a change in the laboratory’s owner, director or address. A prorated license fee shall be issued to a laboratory accredited by an organization recognized by the department.
(3) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one- or two-year cycle following the date of issuance and shall be renewable in the manner prescribed by the department.
(4) Subject to prior approval of the Oregon Department of Administrative Services and a report to the Emergency Board prior to adopting the fees and charges, the fees and charges established under this section shall not exceed the cost of administering the regulatory program of the Department of Human Services pertaining to the purpose for which the fee or charge is established, as authorized by the Legislative Assembly within the department’s budget, as the budget may be modified by the Emergency Board. [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]
(2) A license issued to the owner of a clinical laboratory is not transferable. The license of the laboratory is voided 30 days after a change in its director if it has only one director or if all directors change or a change in the ownership or in the location of the laboratory. In case of death of a director, immediate notification to the Director of Human Services or a designee who shall be empowered to issue a special temporary permit of 30 days’ duration issued to a designated substitute director is required. If a license is voided or a special temporary permit is issued under this section, a new license application, accompanied by the nonrefundable license fee prescribed in ORS 438.130, shall be filed with the Department of Human Services. [1969 c.685 §8]
438.150 Temporary permit; health screen testing permit; conditions and limitations. (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 for a period, to be determined by the department, 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).
(2) In issuing the temporary permit, the department may require that:
(a) Plans for compliance with applicable laws and rules be submitted with the application for the temporary permit; and
(c) Special temporary provisions specified by the department upon application of the temporary permit be maintained for the protection of the public.
(3) If at any time the department determines that the clinical laboratory can no longer operate in a manner which protects the public health and safety or that the requirements imposed under subsection (2) of this section are not being maintained, the department shall cancel the temporary permit.
(4) One renewal of the temporary permit may be granted if deemed to be in the best interest of public health by the department. The fee for renewal is the respective required fee as described in ORS 438.130 (2).
(5) The department may issue permits for health screen testing.
(6) The department by rule shall specify:
(f) The procedure for reporting to the department the location of all health screening facilities.
(7) The department by rule may specify the maximum length of time a health screen testing service may remain in one location. [1969 c.685 §9; 1989 c.776 §2]
438.160 Refusal to issue or renew license; suspension or revocation of license or permit. Subject to ORS 183.310 to 183.550, the Department of Human Services 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:
(1) Intentionally made false statements on an application for a clinical laboratory license or any other documents required by the department, or made any misrepresentation in seeking to obtain or retain a license.
(11) Violated any provision of ORS 438.010 to 438.510. [1969 c.685 §10; 1993 c.109 §13; 1999 c.341 §8; 2001 c.104 §172]
438.210 Qualifications of a 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 anatomical pathology by a national organization or organizations recognized by the Department of Human Services, or is a physician who possesses qualifications equivalent to those required for such certification;
(3) The person has an earned degree of Doctor of Science or Doctor of Philosophy, or an acceptable degree as determined by the department, from an accredited college or university, with a major in the chemical, physical, or biological sciences and possesses special qualifications as described in the administrative rules of the department that enable the person to perform as a laboratory director;
(4) The person is the member of a group of five or more physicians who operate on November 4, 1993, a laboratory performing work only on their patients and who is designated by the group to be the director; or
(5) The person was responsible for the direction of a clinical laboratory for at least 12 months within the five years preceding January 1, 1970, and has had at least two years of pertinent clinical laboratory experience, as determined by the department. [1969 c.685 §12; 1993 c.109 §8]
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:
(2) The Director of Human Services or a designee, the department, or any employee thereof, shall not disclose information contained in reports on communicable diseases submitted to the department under subsection (1) of this section except as such information is made available to employees of the department and to local health officers for purposes of administering the public health laws of this state. However, information contained in such reports may be used in compiling statistical and other data in which persons are not identified by name or otherwise.
(3) The department shall by rule set standards for the recognition of private laboratory accrediting organizations whose standards meet or exceed federal standards. A laboratory that is accredited by a private laboratory accrediting organization recognized by the department under this section may submit proof of such accreditation to the department. Upon receipt of such proof, the department shall issue a license pursuant to ORS 438.130. [1969 c.685 §13; 1993 c.109 §9; 2001 c.104 §173]
438.320 Laboratory evaluation system; 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 to insure quality control of laboratory work.
(2) As part of this system, the department may require each laboratory to:
(b) Analyze test samples submitted by the department prior to, during or subsequent to the inspection; and
(c) Contract with, at the laboratory’s own expense, a department-approved source of test samples for such test samples to be submitted periodically to the laboratory and to be returned to that source for grading after testing. The test results shall be made available to the department.
(4) In addition to external quality control, each clinical laboratory shall establish an internal laboratory quality control system pursuant to rules of the department including but not necessarily limited to the testing of reference or control sera and other biological samples, verifying concurrent calibration standards and control charts recordings, and reporting on its control system as required by the department. [1969 c.685 §14; 1983 c.740 §154; 1993 c.109 §10]
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 such findings to be obtained by a clinical laboratory licensed by the Department of Human Services. [Formerly 433.325]
438.430 Specimens taken from and reports made only to persons authorized to use 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 other person authorized by law to use the findings of laboratory examinations.
(2) No person shall report the result of any test, examination, or analysis of a specimen submitted for evidence of human disease except to a physician, dentist, their agents, or other person authorized by law to employ the results thereof in the conduct of a practice or in the fulfillment of official duties. Reports shall not be issued to the patient concerned except with the consent of the physician or other authorized person. [1969 c.685 §21; 2001 c.104 §174]
438.435 Testing for substance abuse. (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 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 under the provisions of ORS 438.010 to 438.510 and must employ qualified technical personnel to perform the tests, examinations and analyses.
(3) When the specimen of a person tested for substances of abuse is submitted to the laboratory and the test result is positive, the laboratory shall perform a confirming test which has been designated by rule of the Department of Human Services as the best available technology for use to determine whether or not the substance of abuse identified by the first test is present in the specimen prior to reporting the test results.
(4) The department by rule shall set standards for special category laboratories that engage only in the initial testing for substances of abuse in the body, including registration procedures for such laboratories and personnel.
(5) 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, not to exceed $50, and file a registration form as provided by rule of the department that:
(6) The department by rule shall set reasonable standards for the screening by correctional agencies of inmates 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.
(8) 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. [1987 c.669 §2; 1991 c.808 §1; 1997 c.355 §2; 1999 c.739 §2; 2001 c.104 §175]
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 shall be used for payment of the expenses of the department in administering the provisions of ORS 438.010 to 438.510 and 438.990. [1969 c.685 §16]
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 433.335; 2001 c.104 §176]
(1) "Accrediting authority" means the official accrediting authority for the Oregon environmental laboratory accreditation program comprised of the Director of Human Services or designee, the Director of the Department of Environmental Quality or designee and the Director of Agriculture or designee.
(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 Department of Human Services, 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]
438.610 Standards for accreditation. (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 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 department 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]
438.615 Environmental laboratory accreditation program. 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 accreditation may be equivalent to, but may not exceed, standards adopted by national accreditation programs. [1999 c.1063 §3]
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 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 Department of Human Services shall obtain the approval of the Oregon Department of Administrative Services and report to the appropriate legislative committee.
(3) All moneys collected by the Department of Human Services under this section shall be deposited in a dedicated account of the department. Such moneys are continuously appropriated to the Department of Human Services to pay the costs of the Department of Human Services, 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]
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. [1969 c.685 §22; 1977 c.582 §45]