Chapter 739 Oregon Laws 1999

Session Law

AN ACT

HB 3603

Relating to drug screening exams; amending ORS 438.010 and 438.435.

Be It Enacted by the People of the State of Oregon:

SECTION 1. ORS 438.010 is amended to read:

438.010. As used in this chapter, unless the context requires otherwise:

(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.

(6) "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.

(7) "Division" means the Health Division of the Department of Human Resources.

(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 division.

(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 division.

(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 illegal chemical substances or their metabolites that have mood altering effects.]

(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 the effective date of this 1999 Act.

(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 division.

SECTION 2. ORS 438.435 is amended to read:

438.435. (1) In addition to duties which a clinical laboratory may perform under this chapter, 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 this chapter and must employ qualified technical personnel to perform the tests, examinations and analyses.

(2) In order to perform such tests, examinations or analyses, the laboratory may examine specimens submitted by persons other than those described in ORS 438.430 (1) and shall report the result of any test, examination or analysis to the person who submitted the specimen. When the substance of abuse test is for nonmedical employment or pre-employment purposes, and a written request is provided, the test result shall be reported to the person from whom the specimen was originally obtained.

(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 Health Division 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 Health Division 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 Health Division of the Department of Human Resources 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;

(C) Custody chain procedures are being followed;

(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) [When] 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 licensed under ORS 438.110 and 438.150 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.

(6) The Health Division 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.

(7) If an initial test by a special category laboratory under subsection (4) of this section or a special category screening under subsection (6) of this section shows a result indicating the presence of a substance of abuse in the body, a confirmatory test shall be conducted in a licensed clinical laboratory if the results are to be used to deprive or deny any person of any employment or benefit. If a screening test of an inmate of a state or local correctional facility is positive for a substance of abuse, the inmate may be held in a secure facility pending the outcome of the confirmatory test. If the confirmatory test is positive, the inmate may be held in a secure facility pending the outcome of any hearing to determine what action will be taken.

(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.

Approved by the Governor July 15, 1999

Filed in the office of Secretary of State July 15, 1999

Effective date October 23, 1999

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