Oregon Bulletin
January 1, 2011
Rule
Caption: Define “dangerousness” and “grave
disability”; and add to the definition of “good cause” in OAR 309-114.
Adm.
Order No.: MHS 13-2010(Temp)
Filed with Sec. of
State: 11-19-2010
Certified to be
Effective: 11-19-10 thru 5-18-11
Notice Publication
Date:
Rules Adopted: 309-114-0040, 309-114-0050, 309-114-0060, 309-114-0070
Rules Amended: 309-114-0005, 309-114-0020, 309-114-0030
Subject: Oregon State Hospital has requested that the
Addictions & Mental Health Division amend the “Informed Consent treatment
and Significant Procedures in State Institutions” rules in order to define the
terms “dangerousness” and “grave disability” in OAR 309-114-0005 and to add to
the current definition of “good cause” in OAR 309-114-0020.
Rules Coordinator: Richard Luthe—(503) 947-1186
309-114-0005
Definitions
As used in these rules:
(1) “Authorized Representative” or “representative”
means an individual who is an employee of the system described in ORS
192.517(1) and who may represent a party in a contested case hearing; the
representative must be supervised by an attorney that is licensed by the Oregon
State Bar and employed by the same system described in 192.517(1).
(2) “Chief Medical Officer” means the physician
designated by the superintendent of each state institution pursuant to ORS
179.360(1)(f) who is responsible for the administration of medical treatment at
each state institution.
(3) “Dangerousness” means either:
(a) A substantial risk that physical harm will be
inflicted by an individual upon his own person, as evidenced by threats,
including verbal threats or attempts to commit suicide or inflict physical harm
on him or her self. Evidence of substantial risk may include information about
historical patterns of behavior that resulted in serious harm being inflicted
by an individual upon him or herself as those patterns relate to the current
risk of harm;
(b) A
substantial risk that physical harm will be inflicted by an individual upon
another individual, as evidenced by recent acts, behavior or threats, including
verbal threats, which have caused such harm or which would place a reasonable
person in reasonable fear of sustaining such harm. Evidence of substantial risk
may include information about historical patterns of behavior that resulted in
physical harm being inflicted by a person upon another person as those patterns
relate to the current risk of harm; or
(c) A substantial risk that physical harm will be
inflicted by an individual upon the property of others, as evidenced by
behavior which has caused substantial loss or damage to the property of others.
(4) “Division” means the Addictions and Mental Health
Division of the Oregon Health Authority.
(5) “Guardian” means a legal guardian who is an
individual appointed by a court of law to act as guardian of a minor or a
legally incapacitated individual.
(6) “Legally Incapacitated” means having been found by
a court of law under ORS 426.295 to be unable, without assistance, to properly
manage or take care of one’s personal affairs.
(7) “Material Risk.” A risk is material if it may have
a substantial adverse effect on the patient’s psychological or physical health,
or both. Tardive dyskinesia is a material risk of neuroleptic medication. Other
risks include, but are not limited to, raised blood pressure, onset of diabetes
and metabolic changes.
(8) “Medication Educator” means a Qualified Mental
Health Professional (QMHP) who provides information about the proposed
significant procedures to patients.
(9) “Patient” means an individual who is receiving care
and treatment in a state institution for the mentally ill.
(10) Patient with a “grave disability” means a patient
who:
(a) Is in danger of serious physical harm to his or her
health or safety absent the proposed significant procedures; or
(b) Manifests severe deterioration in routine
functioning evidenced by loss of cognitive or volitional control over his or
her actions which is likely to result in serious harm absent the proposed
significant procedures.
(11) “Person Committed to the Division” means a patient
committed under ORS 161.327, 161.370, 426.130, or 427.215.
(12) “Psychiatric Nurse Practitioner,” means a registered
nurse with prescription authority who independently provides health care to
clients with mental and emotional needs or disorders.
(13) “Qualified Mental Health Professional” (QMHP)
means any individual meeting the following minimum qualifications as documented
by the state institution:
(a) Graduate degree in psychology;
(b) Bachelor’s or graduate degree in nursing and
licensed by the State of Oregon;
(c) Graduate degree in social work or counseling;
(d) Graduate degree in a behavioral science field;
(e) Graduate degree in recreational art or music
therapy;
(f) Bachelor’s degree in occupational therapy and
licensed by the State of Oregon; or
(g) Bachelor’s or graduate degree in a relevant area.
(14) “Routine Medical Procedure” means a procedure customarily
administered by facility medical staff under circumstances involving little or
no risk of causing injury to a patient including, but not limited to physical
examinations, blood draws, influenza vaccinations, tuberculosis (TB) testing
and hygiene.
(15) “Significant Procedure” means a diagnostic or
treatment modality and all significant procedures of a similar class that pose
a material risk of substantial pain or harm to the patient such as, but not
limited to, psychotropic medication and electro-convulsive therapy. Significant
procedures do not include routine medical procedures. For purposes of these
rules, human immunodeficiency virus (HIV) testing shall be considered a
significant procedure.
(16) “Significant Procedures of a Similar Class” means
a diagnostic or treatment modality that presents substantially similar material
risks as the significant procedure listed on the treating physician’s or
psychiatric nurse practitioner’s informed consent form and is generally
considered in current clinical practice to be a substitute treatment or belong
to the same class of medications as the listed significant procedure.
(a) For purposes of these rules, medications listed in
subsections 14(a)(A) through 14(a)(F) of this rule will be considered the same
or similar class of medication as other medications in the same subsection:
(A) All medications used under current clinical
practice as antipsychotic medications, including typical and atypical
antipsychotic medications;
(B) All medications used under current clinical
practice as mood stabilizing medications;
(C) All medications used under current clinical
practice as antidepressants;
(D) All medications used under current clinical
practice as anxiolytics;
(E) All medications used under current clinical
practice as psychostimulants; and
(F) All medications used under current clinical
practice as dementia cognitive enhancers.
(b) Significant procedures of the same or similar class
do not need to be specifically listed on the treating physician’s or
psychiatric nurse practitioner’s form.
(17) “State Institution” or “Institution” means all
Oregon State Hospital campuses and the Blue Mountain Recovery Center.
(18) “Superintendent” means the executive head of the
state institution listed in section (15) of this rule, or the superintendent’s
designee.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
183.458; 426.070 & 426.385
Hist.: MHD 3-1983, f. 2-24-83, ef.
3-26-83; MHD 3-1988, f. 4-12-88, (and corrected 5-17-88), cert. ef. 6-1-88; MHS
14-2007(Temp), f. 11-30-07, cert. ef. 12-1-07 thru 5-29-08; MHS 2-2008(Temp),
f. & cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08;
MHS 1-2009(Temp), f. & cert. ef. 1-23-09 thru 7-22-09; MHS 2-2009(Temp), f.
& cert. ef. 4-2-09 thru 7-22-09; MHS 3-2009, f. & cert. ef. 6-26-09;
MHS 6-2009, f. & cert. ef. 12-28-09; MHS 5-2010(Temp), f. & cert. ef.
3-12-10 thru 9-8-10; MHS 12-2010, f. & cert. ef. 9-9-10; MHS 13-2010(Temp),
f. & cert. ef. 11-19-10 thru 5-18-11
309-114-0020
Good Cause for the Involuntary
Administration of Significant Procedures
Good cause exists to administer a significant procedure
to an individual committed to the Division without informed consent if in the
opinion of the treating physician or psychiatric nurse practitioner after
consultation with the treatment team each of the following factors are
satisfied:
(1) Pursuant to OAR 309-114-0010(2), the person is
deemed unable to consent to, refuse, withhold or withdraw consent to the
significant procedure. This determination must be documented on the treating
physician’s or psychiatric nurse practitioner’s informed consent form and the
independent examining physician’s evaluation form and include the specific
questions asked and answers given regarding the patient’s ability to weigh the
risks and benefits of the proposed treatment, alternative treatment, and no
treatment, including but not limited to all relevant factors listed in
309-114-0010(3)(a).
(2) The proposed significant procedure will likely
restore, or prevent deterioration of, the person’s mental or physical health;
alleviate extreme suffering; or save or extend the person’s life. This factor
is established conclusively for purposes of a hearing under OAR 309-114-0025 by
introducing into evidence the treating physician’s or psychiatric nurse
practitioner’s informed consent form and the independent examining physician’s
evaluation form, unless this factor is affirmatively raised as an issue by the
patient or his or her representative at the hearing.
(3) The proposed significant procedure is the most
appropriate treatment for the patient’s condition according to current clinical
practice, and all other less intrusive procedures have been considered and all
criteria and information set forth in OAR 309-114-0010(3)(a) were considered.
This factor is established conclusively for purposes of a hearing under
309-114-0025 by introducing into evidence the treating physician’s or
psychiatric nurse practitioner’s informed consent form and the independent
examining physician’s evaluation form, unless this factor is affirmatively
raised as an issue by the patient or his or her representative at the hearing.
(4) The institution made a conscientious effort to
obtain informed consent from the patient, as detailed in OAR 309-114-0010. This
factor is established conclusively for purposes of a hearing under OAR
309-114-0025 by introducing into evidence the treating physician’s or
psychiatric nurse practitioner’s informed consent form and the medication
educator’s form or progress note, unless this factor is affirmatively raised as
an issue by the patient or his or her representative at the hearing. If the
institution has reason to believe a patient has limited English language
proficiency or the patient requests it, then the institution will make
reasonable accommodations to provide the patient with meaningful access to the
informed consent process, such as providing the patient with the opportunity to
have an interpreter orally translate written materials into the patient’s
native language and provide translation during the treating physician’s or
psychiatric nurse practitioner’s attempts to obtain informed consent and the
medication educator’s attempt to provide information about the significant
procedure. A “conscientious effort” to obtain informed consent means the
following:
(a) The patient’s treating physician or psychiatric
nurse practitioner made at least two good faith attempts to obtain informed
consent by attempting to explain the procedure to the patient and documenting
those efforts in the patient’s record; and
(b) The medication educator made at least one good
faith attempt to provide the information required in OAR 309-114-0010(3)(a),
and explain and discuss the proposed procedure with the patient.
(5) Because of the preliminary nature of their
commitment, the following additional findings must be made for patients
committed under ORS 161.370 jurisdiction:
(a) Medication is not requested for the sole purpose of
restoring trial competency; and
(b) The patient is being medicated because of the
patient’s dangerousness or to treat the patient’s grave disability.
Stat. Auth.: ORS 179.040
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHD 3-1983, f. 2-24-83, ef.
3-26-83; MHD 3-1988, f. 4-12-88, (and corrected 5-17-880, cert. ef. 6-1-88; MHS
14-2007(Temp), f. 11-30-07, cert. ef. 12-1-07 thru 5-29-08; MHS 2-2008(Temp),
f. & cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08;
MHS 1-2009(Temp), f. & cert. ef. 1-23-09 thru 7-22-09; MHS 3-2009, f. &
cert. ef. 6-26-09; MHS 6-2010(Temp), f. & cert. ef. 3-24-10 thru 9-20-10;
MHS 12-2010, f. & cert. ef. 9-9-10; MHS 13-2010(Temp), f. & cert. ef.
11-19-10 thru 5-18-11
309-114-0030
Independent Evaluation and
Documentation for Determination of Good Cause
(1) Prior to granting approval for the administration
of a significant procedure for good cause to a person committed to the
Division, the superintendent or chief medical officer shall:
(a) Obtain consultation and approval from an
independent examining physician, or
(b) If a patient refuses to be examined, document that
an independent examining physician made at least two good faith attempts to
examine the patient.
(2) The superintendent or chief medical officer shall
maintain a list of independent examining physicians and shall seek consultation
and approval from independent examining physicians selected on a rotating basis
from the list.
(a) The independent examining physician shall:
(A) Not be an employee of the Division; and
(B) Be a board-eligible psychiatrist; and
(C) Have been subjected to review by the medical staff
executive committee as to qualifications to make such an examination; and
(D) Have been provided with a copy of administration
rules OAR 309-114-0000 through 309-114-0030; and
(E) Have participated in a training program regarding
these rules, their meaning and application.
(3) The superintendent or chief medical officer shall
provide written advance notice of the intent to seek consultation and approval
of an independent examining physician for the purpose of administering the
procedure without the patient’s consent to a patient to whom a significant
procedure is proposed to be administered.
(4) The physician selected to conduct the independent
consultation shall:
(a) Review the patient’s medical chart, including the
records of efforts made to obtain the person’s informed consent; and
(A) Personally examine the patient at least one time;
or
(B) If the patient refuses to be examined, the
physician shall make two good faith attempts to examine the patient. If the
patient refuses to be examined during these two good faith attempts, the
independent consultation and approval requirement outlined in subsection (4)(a)(A)
and (4)(b) of this rule shall be deemed to be fulfilled.
(b) Discuss the matter with the patient to determine
the extent of the need for the procedure and the nature of the patient’s
refusal, withholding, or withdrawal or inability to consent to the significant
procedure.
(c) This determination must be documented in the
patient’s records as well as the supporting evidence in the form of the
specific questions asked and answers given regarding the patient’s ability to
weigh the risks and benefits of the proposed treatment, alternative treatment,
and no treatment;
(d) Consider additional information, if any, presented
prior to or at the time of examination or interview as may be requested by the
patient or anyone on behalf of thepatient; and
(e) Make a determination whether the factors required
under these rules exist for the particular patient or that one or more factors
are not present and complete a report of his or her findings, which provides
their approval or disapproval of the proposed significant procedure. The
written report must be provided to:
(A) The superintendent or chief medical officer; and
(B) The patient to whom a significant procedure is
proposed to be administered, with a copy being made part of the patient’s
record.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHS 2-2008(Temp), f. &
cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08; MHS
12-2010, f. & cert. ef. 9-9-10; MHS 13-2010(Temp), f. & cert. ef.
11-19-10 thru 5-18-11
309-114-0040
Superintendent’s Determination
(1) The superintendent or chief medical officer shall
approve or disapprove of the administration of the significant procedure to a
patient committed to the Division based on good cause, provided that if the
examining physician or psychiatric nurse practitioner found that one or more of
the factors required by section (1) of this rule were not present or otherwise
disapproved of the procedure. If the superintendent or chief medical officer
does not approve the significant procedure. it shall not be performed;
(2) Approval of the significant procedure shall be only
for as long as no substantial increase in risk is encountered in administering
the significant procedure or significant procedure of a similar class during
the term of a patient’s commitment, but in no case longer than 180 days. Disapproval
shall be only for as long as no substantial change occurs in the patient’s
condition during the term of commitment, but in no case longer than 180 days.
(3) Written notice of the superintendent’s or chief
medical officer’s determination shall be provided to the patient and made part
of the patient’s record. This notice must:
(a) Be delivered to the patient and fully explained by
facility medical staff and
(b) Include a clear statement of the decision to treat
without informed consent and
(c) Provide the specific basis for the decision and
(d) State what evidence was relied on to make the
decision and
(e) Include a clear notice of the opportunity to ask
for a contested case hearing with an administrative law judge if the patient
disagrees with the decision and
(f) Include the attached form with a simple procedure
to request a hearing.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHS 13-2010(Temp), f. &
cert. ef. 11-19-10 thru 5-18-11
309-114-0050
Contested Case Hearing
(1) The patient indicating in writing or verbally to
any staff member a desire to challenge the institution’s decision will be
sufficient to request a contested case hearing pursuant to OAR 309 114 0025.
(2) The patient shall have 48 hours to request a
contested case hearing after receiving the notice in 309-114-0040(3). If the
patient does not request a hearing within the 48 hour period or the patient
subsequently withdraws his initial hearing request and is not already receiving
the significant procedure, the institution may involuntarily administer the
significant procedure.
(3) A patient retains the right to request, at any
time, an initial hearing on the decision to administer a significant procedure
without informed consent.
(4) If the patient withdraws his or her initial request
for a hearing or refuses to attend the initial hearing without good cause, the
administrative law judge will issue a dismissal order pursuant to OAR
137-003-0672(3). A dismissal order will allow the institution to immediately
administer the significant procedure without informed consent as if the patient
had never requested a hearing.
(5) If a dismissal order is issued, the patient may
request a second hearing. If the patient withdraws his or her second request
for a hearing or refuses to attend the second hearing without good cause, the
hearing will occur as scheduled with the institution presenting a prima facie
case pursuant to ORS 183.417(4) and the administrative law judge will issue a
proposed order by default. The institution will then issue a final order by
default.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHS 13-2010(Temp), f. &
cert. ef. 11-19-10 thru 5-18-11
309-114-0060
Records of the Informed Consent
and Significant Procedure Processes
(1) Records of all reports by independent examining
physicians and of the determinations of the superintendent or chief medical
officer under this rule shall be maintained by the superintendent or chief
medical officer in a separate file and shall be summarized each year. Such
summaries shall show:
(a) Each type of proposed significant procedure for
which consultation with an independent examining physician was sought; and
(b) The number of times consultation was sought from a
particular independent examining physician for each type of proposed
significant procedure; and
(c) The number of times each independent examining
physician approved and disapproved each type of proposed significant procedure;
and
(d) The number of times the superintendent or chief
medical officer approved and disapproved each type of proposed significant
procedure.
(2) The summaries referred to in subsection (5)(e) of
this rule shall be public records and shall be made available to the public
during reasonable business hours in accordance with ORS Chapter 192. (3) When
treatment is being administered without informed consent, the ward physician or
psychiatric nurse practitioner will write a progress note addressing any
changes in patient’s capacity to give informed consent every 60 days.
(4) At any time that a patient’s condition changes so
that there appears to his or her treating physician or psychiatric nurse
practitioner to be a substantial improvement in the patient’s capacity to
consent to or refuse treatment, a formal re assessment of the patient’s
capacity to consent shall occur, as described in OAR 309-114-0010 and
309-114-0020. No order to administer treatment without informed consent in non
emergency situations shall be valid for longer than 180 days, or the duration
of the commitment, whichever is shorter, without re establishing the need for
the order by following the procedures described in 309-114-0010 and
309-114-0020.
(5) When a patient is transferred to a state institution
from a community hospital or another state institution where he or she was
already being treated with a significant procedure without informed consent,
the receiving institution must apply OAR 309-114-0000 through 309-114-0030 no
later than 7 days after the date of admission to the new institution. A state
institution can honor an existing order for involuntary administration of a
significant procedure without informed consent if procedures such as those
outlined in 309-114-0010 through 309-114-0030 have already been applied and all
necessary documentation is in the patient’s file.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHS 13-2010(Temp), f. &
cert. ef. 11-19-10 thru 5-18-11
309-114-0070
Notice to Patients, Residents, and
Employees
(1) Upon a patient’s admission, the state institutions
shall inform the patient, orally and in writing, of the rights, policies and
procedures set forth in these rules. In addition, a clear and simple summary of
the contents, including the title, number and purpose of these rules and
instructions on how to obtain a copy of the rules and advice about their
content shall be prominently displayed in areas frequented by patients in all
state institutions.
(2) All employees of state institutions involved in
patient care shall be notified in writing at the commencement of his or her
employment or for present employees, within a reasonable time after the
effective date of these rules, of the rights, policies and procedures set forth
in these rules. These employees shall participate in a training program
regarding the rules, their meaning and application.
Stat. Auth.: ORS 179.040 &
409.050
Stats. Implemented: ORS 179.321,
426.070 & 426.385
Hist.: MHS 13-2010(Temp), f. &
cert. ef. 11-19-10 thru 5-18-11
Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.
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