71st OREGON LEGISLATIVE ASSEMBLY--2001 Regular Session
 
NOTE:  Matter within  { +  braces and plus signs + } in an
amended section is new. Matter within  { -  braces and minus
signs - } is existing law to be omitted. New sections are within
 { +  braces and plus signs + } .
 
LC 1701
 
                         House Bill 2629
 
Sponsored by Representative WILLIAMS (at the request of Patricia
  Biggs)
 
 
                             SUMMARY
 
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
 
  Amends informed consent law for medical procedures. Directs
physicians to obtain informed consent of patients via signed
form.  Specifies that signed form is prima facie evidence of
informed consent. Allows health care representative to provide
consent for incapable patient. Specifies information to be
included on informed consent form. Requires physician to obtain
informed consent prior to administering procedure, treatment or
diagnosis.
  Specifies elements of proof necessary to prevail on claim
against physician for failure to obtain informed consent.
 
                        A BILL FOR AN ACT
Relating to informed consent requirements; creating new
  provisions; amending ORS 127.560, 433.045 and 659.710 and
  section 10, chapter 388, Oregon Laws 1981; and repealing ORS
  677.097.
Be It Enacted by the People of the State of Oregon:
  SECTION 1.  { + As used in sections 1 to 5 of this 2001 Act,
unless the context requires otherwise:
  (1) 'Medically recognized procedure' means any procedure,
administered by a physician licensed within the United States,
the existence and use of which should reasonably be known to
physicians practicing the type of medicine or medical specialty
practiced by the administering physician, to diagnose or treat a
disease or condition, without regard to whether the procedure may
be considered experimental.
  (2) 'Physician' means a physician or podiatric physician and
surgeon as those terms are defined in ORS 677.010.
  (3) 'Procedure' means any medical service involving physical
contact by a physician with a patient pertaining to the diagnosis
or treatment of diseases or conditions, whether or not a
particular medical service is offered by a patient's physician or
available within the physician's medical community.
  (4) 'Routine medical procedure' means a procedure customarily
administered by a physician under circumstances involving little
or no risk of causing injury to a patient.
  (5) 'Adult,' 'capable,' 'health care representative ' and
'incapable' have the meanings given those terms in ORS
127.505. + }
 
  SECTION 2.  { + (1) A physician shall obtain a patient's
informed consent prior to administering a proposed procedure to
diagnose or treat a disease or condition.
  (2) If a patient is capable of making health care decisions,
the physician may obtain the patient's informed consent by having
the patient sign a written consent form that sets forth, in
language the patient could reasonably be expected to understand,
the following information:
  (a) The nature and character of the proposed procedure;
  (b) The anticipated results of the proposed procedure;
  (c) Other possible medically recognized procedures available to
diagnose or treat the particular disease or condition, including
nontreatment, together with the nature and character of each
possible procedure, if any; and
  (d) The recognized risks, complications and anticipated
benefits associated with the proposed procedure.
  (3)(a) An informed consent form setting forth the elements of
subsection (2) of this section signed by the patient shall
constitute prima facie evidence that the patient gave informed
consent to the proposed procedure. This presumption may be
rebutted by a preponderance of the evidence to the contrary.
  (b) A signed informed consent form stating that the patient has
been given a general verbal explanation of the proposed procedure
and has been offered the information set forth in subsection (2)
of this section but has elected to consent to the procedure
without being informed in greater written detail satisfies the
requirements of this section.
  (c) Notwithstanding subsection (2) of this section, a physician
may obtain a general consent form signed by the patient that
gives continuing informed consent to all types of routine medical
procedures administered by the physician without a description of
the nature and character of those routine medical procedures.
  (4)(a) If a patient is incapable of providing informed consent,
a health care representative may make necessary judgments and
sign any informed consent form in place of the patient.
  (b) No minor shall be determined to be incapable to exercise
the right to give informed consent to obtain a medical diagnosis
or treatment if specifically authorized to obtain that diagnosis
or treatment by any Oregon statute.
  (5) Failure by a physician to use an informed consent form
prescribed by subsection (2) of this section shall be admissible
as evidence of a failure to obtain informed consent. In the
absence of such a signed informed consent form, the physician
shall have the burden to establish by a preponderance of the
evidence that the patient's informed consent was otherwise
obtained. + }
  SECTION 3.  { + (1) In giving or withholding informed consent
for an incapable patient, a health care representative shall act
consistent with the patient's known desires. If a patient's
desires are unknown, the representative shall act in what the
representative believes to be the best interests of the patient.
  (2) A patient's consent will be implied if:
  (a) A medical emergency exists;
  (b) The patient is incapable of giving informed consent; and
  (c) A health care representative for the patient is
unavailable. + }
  SECTION 4.  { + (1) For the purposes of this section, 'material
fact' means a fact to which a reasonably prudent person in the
position of the patient or health care representative would
attach significance in deciding whether or not to consent to a
proposed procedure.
  (2) In a civil negligence case or arbitration proceeding
involving a claim against a physician that alleges an injury
resulting from a failure to obtain informed consent to the
procedure administered, the following are necessary elements of
proof:
  (a) That the physician failed to inform the patient of a
material fact relating to the procedure;
  (b) That the patient consented to the procedure without being
aware of or being fully informed of a material fact relating to
the procedure;
  (c) That a reasonably prudent patient under similar
circumstances would not have consented to the procedure if the
patient had been properly informed of all material facts; and
  (d) That the procedure administered proximately caused the
injury of which the patient complains.
  (3) A material fact must be established by expert testimony and
must directly relate to:
  (a) The nature and character of the procedure administered;
  (b) The anticipated results of the procedure administered;
  (c) The alternative forms of medically recognized procedures
for a particular disease or condition, including nondiagnosis or
nontreatment; or
  (d) The recognized serious possible risks, complications and
anticipated benefits involved in the procedure administered and
in the other possible types of applicable medically recognized
procedures. + }
  SECTION 5.  { + Sections 1 to 5 of this 2001 Act shall be known
as the Oregon Medical Informed Consent Act of 2001. + }
  SECTION 6.  { + ORS 677.097 is repealed. + }
  SECTION 7. ORS 127.560 is amended to read:
  127.560. (1) Except as otherwise specifically provided, ORS
127.505 to 127.660 and 127.995 do not impair or supersede the
laws of this state relating to:
  (a) Any requirement of notice to others of proposed health
care;
  (b) The standard of care required of a health care provider in
the administration of health care;
  (c) Whether consent is required for health care;
  (d) The elements of informed consent for health care under
  { - ORS 677.097 - }   { + sections 1 to 5 of this 2001 Act + }
or other law;
  (e) The provision of health care in an emergency;
  (f) Any right a capable person may have to consent or withhold
consent to health care administered in good faith pursuant to
religious tenets of the individual requiring health care;
  (g) Delegation of authority by a health care representative;
  (h) Any legal right or responsibility any person may have to
effect the withholding or withdrawal of life-sustaining
procedures including artificially administered nutrition and
hydration in any lawful manner;
  (i) Guardianship or conservatorship proceedings; or
  (j) Any right persons may otherwise have to make their own
health care decisions, or to make health care decisions for
another.
  (2) The provisions of ORS 127.505 to 127.660 and 127.995 do not
in themselves impose civil or criminal liability on a health care
representative or health care provider who withholds or withdraws
or directs the withholding or withdrawal of life-sustaining
procedures or artificially administered nutrition and hydration
when a principal is in a health condition other than those
conditions described in ORS 127.540 (6)(b), 127.580 or 127.635
(1). The provisions of ORS 127.505 to 127.660 and 127.995 do not
abolish or limit the civil or criminal liability of a health care
representative under other statutory or common law if the health
care representative withholds or withdraws or directs the
withholding or withdrawal of life-sustaining procedures or
artificially administered nutrition and hydration when a
principal is in a health condition other than those conditions
described in ORS 127.540 (6)(b), 127.580 or 127.635 (1).
  SECTION 8. ORS 433.045 is amended to read:
 
  433.045. (1) Except as provided in ORS 433.080, no person shall
subject the blood of an individual to an HIV test without first
obtaining informed consent as described in subsection (2) or (7)
of this section.
  (2) A physician licensed under ORS chapter 677 shall comply
with the requirement of subsection (1) of this section through
the procedure in   { - ORS 677.097 - }  { +  sections 1 to 5 of
this 2001 Act + }. Any other licensed health care provider or
facility shall comply with the requirement of subsection (1) of
this section through a procedure substantially similar to that
specified in   { - ORS 677.097 - }  { + sections 1 to 5 of this
2001 Act + }. Any other person shall comply with this requirement
through use of such forms, procedures and educational materials
as the Health Division shall specify.
  (3) Regardless of the manner of receipt or the source of the
information, including information received from the tested
individual, no person shall disclose or be compelled to disclose
the identity of any individual upon whom an HIV-related test is
performed, or the results of such a test in a manner which
permits identification of the subject of the test, except as
required or permitted by federal law, the law of this state or
any rule, including any Health Division rule considered necessary
for public health or health care purposes, or as authorized by
the individual whose blood is tested.
  (4) Any person who complies with the requirements of this
section shall not be subject to an action for civil damages.
  (5) An HIV test shall be considered diagnosis of venereal
disease for purposes of ORS 109.610.
  (6) As used in this section:
  (a) 'HIV test' means a test of an individual for the presence
of human immunodeficiency virus (HIV), or for antibodies or
antigens that result from HIV infection, or for any other
substance specifically indicating infection with HIV.
  (b) 'Person' includes but is not limited to any health care
provider, health care facility, clinical laboratory, blood or
sperm bank, insurer, insurance agent, insurance-support
organization, as defined in ORS 746.600, government agency,
employer, research organization or agent of any of them. For
purposes of subsection (3) of this section, 'person' does not
include an individual acting in a private capacity and not in an
employment, occupational or professional capacity.
  (7) Whenever an insurer, insurance agent or insurance support
organization asks an applicant for insurance to take an HIV test
in connection with an application for insurance, the use of such
a test must be revealed to the applicant and the written consent
thereof obtained. The consent form shall disclose the purpose of
the test and the persons to whom the results may be disclosed.
  SECTION 9. ORS 659.710 is amended to read:
  659.710. (1) No person shall obtain genetic information from an
individual, or from an individual's DNA sample, without first
obtaining informed consent of the individual or the individual's
representative, except:
  (a) As authorized by ORS 181.085 or comparable provisions of
federal criminal law relating to the identification of persons,
or for the purpose of establishing the identity of a person in
the course of an investigation conducted by a law enforcement
agency, a district attorney, a medical examiner or the Criminal
Justice Division of the Department of Justice;
  (b) For anonymous research where the identity of the subject
will not be revealed;
  (c) As permitted by rules of the Health Division for
identification of deceased individuals;
  (d) As permitted by rules of the Health Division for newborn
screening procedures; or
  (e) As authorized by statute for the purpose of establishing
paternity.
  (2) A physician licensed under ORS chapter 677 shall seek the
informed consent of the individual or the individual's
representative for the purposes of subsection (1) of this section
in the manner provided by   { - ORS 677.097 - }  { +  sections 1
to 5 of this 2001 Act + }. Any other licensed health care
provider or facility must seek the informed consent of the
individual or the individual's representative for the purposes of
subsection (1) of this section in a manner substantially similar
to that provided by   { - ORS 677.097 - }  { +  sections 1 to 5
of this 2001 Act + } for physicians.
  (3) An insurance provider shall seek the informed consent of
the individual or the individual's representative for the
purposes of subsection (1) of this section in the manner provided
by rules adopted by the Department of Consumer and Business
Services. Any other person must seek the informed consent of the
individual or the individual's representative for the purposes of
subsection (1) of this section in the manner provided by rules
adopted by the Health Division.
  (4) The Health Division may not adopt rules under subsection
(1)(d) of this section that would require the providing of a DNA
sample for the purpose of obtaining complete genetic information
used to screen all newborns.
  SECTION 10. Section 10, chapter 388, Oregon Laws 1981, is
amended to read:
   { +  Sec. 10. + } (1) The patient, after being fully informed
in the manner described in   { - ORS 677.097 - }   { + sections 1
to 5 of this 2001 Act + } as to alternative methods of treatment
and their potential for cure and upon the patient's request for
the administration of DMSO by the practitioner, as defined in ORS
689.005, and before being treated with a DMSO preparation, shall
sign a written release, releasing the practitioner, and, when
applicable, the hospital or health facility or pharmacist, from
any liability therefor arising from the use of DMSO if the
practitioner, hospital, health facility or pharmacist meets
reasonable standards of care in the circumstances except where
the care amounts to gross negligence.
  (2) The practitioner shall inform the patient in writing if
DMSO has not been approved as a treatment or cure by the Food and
Drug Administration of the United States Department of Health and
Human Services for the disorder for which it is being prescribed.
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