A. Right to
informed consent. Recipients have the right to informed consent for all
treatment.
B. Statement of purpose.
This rule has the following purposes:
1. To
promote respect for individual autonomy and recipient participation in
decision-making;
2. To ensure that,
whenever possible, the informed consent of a recipient is obtained prior to
treatment;
3. To avoid, whenever
possible, forcible imposition of any treatment;
4. To provide reasonable standards and
procedural mechanisms for determining when to treat a recipient absent his or
her informed consent, consistent with applicable law; and
5. To ensure that the recipient is fully
protected against the unwarranted exercise of the state's parens patriae
power.
C. Treatment of
recipients. All recipients with unimpaired capacity have the right to consent
to or to refuse treatment absent an emergency. Treatment may be provided to a
recipient only when:
1. Informed consent for
the treatment has been obtained from the recipient; or
2. The recipient has been judged by a court
of competent jurisdiction to lack capacity to give informed consent to the
particular treatment, and the informed consent of the recipient's guardian has
been obtained; or
3. The recipient
has been found to lack clinical capacity to give informed consent to the
particular treatment pursuant to subsections D and E of this rule and:
a. in the case of an inpatient recipient
willing to comply with treatment, approval of the treatment is being processed
in a timely fashion or has been obtained in accordance with subsection E(2) of
this rule; or
b. in the case of a
recipient willing to comply with treatment in a residential facility or
program, the provisions of E(3) have been followed; or
c. in the case of an involuntary inpatient
recipient unwilling to consent to treatment, treatment may be provided in
accordance with the procedures and standards provided in subsection F of this
section; or
4. An
emergency exists, as defined in subsection H of this rule, and the emergency
procedures required by sub-section H are observed.
D. Informed consent to treatment. Informed
consent to treatment is obtained only where the recipient possesses capacity to
make a reasoned decision regarding the treatment, the recipient or the
recipient's guardian is provided with adequate information concerning the
treatment, and the recipient or guardian makes a voluntary choice in favor of
the treatment. Informed consent must be documented in each case in accordance
with this section.
1. Capacity. Capacity means
sufficient understanding to comprehend the information outlined in section
(D(2) and to make a responsible decision concerning a particular treatment.
Recipients are legally presumed to possess capacity to give informed consent to
treatment unless the recipient has been judged by a court of competent
jurisdiction to lack capacity generally, or to lack capacity to give informed
consent to a particular treatment.
2. Adequate information. The licensed,
certified or other qualified mental health professional recommending a
particular treatment shall provide to the recipient, or guardian, all
information relevant to the formulation of a reasoned decision concerning such
treatment.
The recipient shall have the right to have a person of his
or her choice present during the presentation of this information, provided
that the nominee can be available within 48 hours, or within such other
reasonable period as may be agreed upon; and the recipient, or guardian, shall
be informed of this right. The information may be provided orally, in sign
language or in writing, shall be communicated in terms designed to be
comprehensible to a lay person, and shall include, without limitation:
a. An assessment of the recipient's condition
and needs, including the specific signs, symptoms or behaviors that any
proposed medication is intended to relieve;
b. The nature of the proposed treatment, and
a statement of the reasons why the professional believes it to be indicated in
the recipient's case;
c. The
expected benefits of the treatment, and the known risks that it entails,
including precautions, contraindications, and potential adverse effects of any
proposed medication;
d. The
anticipated duration of the treatment;
e. A statement of reasonable alternatives to
the proposed treatment, if any;
f.
Information as to where the recipient may obtain answers to further questions
concerning the treatment; and
g. A
clear statement that the recipient has the right to give or withhold consent to
the proposed treatment.
3. Voluntary choice. Consent to treatment
must be given willingly in all cases, and may not be obtained through coercion
or deception. Special care shall be taken to assure that consent is voluntary
where the recipient's status as an involuntary inpatient militates against
truly voluntary consent.
A recipient or guardian's initial refusal of treatment
shall not preclude renewed attempts to obtain the recipient's willing consent;
and a recipient's initial willing consent shall. not preclude the recipient
from validly withdrawing such consent at any time before or during
treatment.
4.
Documentation. The informed consent of a recipient or his or her guardian to a
particular treatment shall be documented to show:
a. From whom consent is obtained, whether
recipient or guardian;
b. If
consent is given by the recipient, a signed statement that the recipient
possesses capacity to give informed consent;
c. That adequate information, including at a
minimum all the elements listed in section D(2) of this rule, was
provided;
d. The signature of the
recipient or, where applicable, the signature of a guardian, indicating
consent. In residential programs, a signature is necessary for psychotropic
medication treatment only.
e.
Exceptions to Written Consent
In cases of unanticipated treatment needs, the informed
consent of a guardian may be obtained by telephone, but that oral consent shall
be confirmed in writing in accordance with this section as soon as
practicable.
E. Recipients with clinical incapacity
1. Administrative finding. Where a licensed,
certified or other qualified mental health professional recommending a
particular treatment determines that, in his or her opinion, a recipient not
having a guardian lacks clinical capacity to give informed consent to the
treatment under subsection D, he or she shall, by means of a written statement
to that effect, refer the recipient to a physician or licensed clinical
psychologist not directly responsible for the recipient's treatment for an
examination in regard to capacity. The physician or clinical psychologist to
whom the recipient is referred shall conduct the examination, and shall make a
documented finding that the recipient either possesses or lacks clinical
capacity to give informed consent to the particular treatment.
a. Finding of capacity. Where the recipient
is found to possess capacity to consent to treatment by the physician or
licensed clinical psychologist, he shall be referred back to the licensed,
certified or other qualified mental health professional recommending the
treatment for the processing of his or her informed consent to or refusal of
such treatment.
b. Finding of
clinical incapacity. Where the recipient is found to lack clinical capacity to
consent to treatment by le physician or licensed clinical psychologist, he
shall be referred back to the licensed, certified or other qualified mental
health professional recommending the treatment for a documented determination
as to whether the recipient, notwithstanding lack of clinical capacity, is
willing to comply with or refuses the proposed treatment
Such determination must be based upon the provision to the
recipient of adequate information as required by subsection D(2) of this
rule.
If an inpatient recipient is willing to comply with
treatment, the procedure outlined in subsection E(2) shall be followed. If a
recipient in a residential program is willing to comply with treatment, the
procedure outlined in subsection E(3) shall be followed. If any recipient
refuses treatment, the procedure outlined in subsection E(4) and, in the case
of inpatient recipients, if applicable, subsection (F) shall be
followed.
c. Notice. Where
the recipient is found to lack clinical capacity pursuant to this section, the
licensed, certified or other qualified mental health professional recommending
the treatment shall notify the following persons of such finding:
i. the Office of Advocacy and the rights
protection and advocacy agency of the Maine mental health system;
ii. the recipient's next of kin, if the
recipient does not object;
iii. the
recipient's designated representative, if the recipient has waived his or her
confidentiality with respect to such representative; and
iv. the head of the mental health facility.
Such notice shall include a copy of the documented
administrative finding, and shall state that the recipient has been found to
lack clinical capacity to give informed consent to a particular treatment; that
notwithstanding such finding, the recipient may refuse treatment; and that in
the case of involuntary, inpatient recipients, treatment shall not be
administered unless authorized by a hearing officer following an administrative
hearing held in accordance with subsection F of this rule.
2. Inpatient recipients
with clinical incapacity, compliant. This subsection shall apply where it is
determined pursuant to subsection E(l)(b) above that an inpatient recipient
with clinical incapacity is willing to comply with the proposed treatment. In
such case:
a. Treatment may be authorized by
the licensed, certified or other qualified mental health professional for a
period not to exceed 72 hours. Treatment may continue beyond such period only
if approval of the head of the mental health facility is obtained prior to
treatment in accordance with subsection E(2)(c) below. The professional shall
document:
i. the nature of the proposed
treatment, including expected benefits, Known risks and any alternatives and a
statement of the reasons why he believes the treatment to be a necessary part
of the recipient's treatment plan;
ii. that the recipient lacks clinical
capacity pursuant to the provisions of section E(l) above; and
iii. that the recipient is willing to comp1y
with the proposed treatment.
Such documentation shall be immediately forwarded to the
Clinical Director of a mental health institute or his or her equivalent in any
other mental health facility and to the resident advocate in a state mental
health institute.
b. Within 48 hours of any authorization to
treat under section E(2)(a) above, the Clinical Director or his or her
equivalent shall review the documentation required by that section and shall
make a written report to the head of the mental health facility as to whether
or not, in his or her opinion
i. the
recommendation of the proposed treatment is based on an adequately
substantiated exercise of professional judgment;
ii. the proposed treatment is the least
intrusive appropriate treatment available under the circumstances; and shall
include a brief statement of the reasons for his or her opinion. A copy of such
report shall be immediately forwarded to the resident advocate in a state
mental health institute.
c. If the Clinical Director or his or her
equivalent reports an affirmative opinion as to both elements set forth in
section E(2)(b)(i) and (ii) above, the head of the mental health facility may,
following due consideration of the circumstances of the particular case,
approve treatment on behalf of the recipient. Such approval shall authorize
administration Of the proposed treatment to the recipient for a period not to
exceed sixty days. The recipient shall be monitored throughout such period for
any change in regard to capacity, and at the latest upon expiration of such
period, the recipient shall be re-examined in accordance with section E(l)
above
d. If the Clinical Director
or his or her equivalent reports a negative opinion as to either element set
forth in sections E(2)(b)(i) and (ii) above, the head of the mental health
facility shall not approve treatment, and treatment shall not be continued
beyond the 72 hour period authorized in accordance with section E(2)(a) above
until informed consent for treatment can be obtained from a legal
decision-maker.
3.
Recipients in residential settings with clinical incapacity, compliant. This
subsection shall apply where it is determined pursuant to subsection (E)(1)(b)
that an recipient in a residential setting with clinical incapacity is willing
to comply with the proposed treatment. In such case treatment may be provided
only if:
a. Protective proceedings are
initiated in accordance with law; and
b. A licensed, certified or other qualified
mental health professional follows the procedures outlined in sub section (D)
and, where applicable, subsection (E) on at least an annual basis.
4. Recipients with clinical
incapacity, refusing. This subsection shall apply where it is determined
pursuant to subsection E(1)(b) above that a recipient with clinical incapacity
is refusing the proposed treatment
a.
Alternative treatment meeting. The licensed, certified or other qualified
mental health professional recommending the treatment and a representative of
the treatment team shall meet with the recipient to explore the reasons for the
recipient's refusal and to discuss any appropriate alternatives to the proposed
treatment that may be available and that may include behavioral, psychological,
medical, social, psychosocial or rehabilitative treatment methods.
The purpose of the meeting shall be to elaborate in an
informal setting an alternative treatment that is both professionally justified
and acceptable to the recipient. If agreement can be reached as to an
alternative treatment, review by the Clinical Director or equivalent and
approval by the head of the mental health facility, if appropriate, of such
treatment shall be processed in accordance with subsection E(2) or E(3)
above.
b. Voluntary or
outpatient recipient, no agreement. Where no agreement can be reached as to an
alternative treatment, and the recipient is a voluntary recipient at an
inpatient facility or a recipient at an outpatient facility, the licensed,
certified or other qualified mental health professional recommending the
proposed treatment shall report in writing to the head of the facility
concerning the outcome of the meeting held pursuant to subsection E(4)(a)
above.
The head of the inpatient or residential facility or
designee may discharge a voluntary recipient from the facility. Any such
discharge fill be made in accordance with the section III, subsection J and
section IV, subsection K of this part.
c. Involuntary recipient, no agreement:
request for hearing. Where no agreement can be reached as to an alternative
treatment in the case of a recipient who is an involuntary recipient at an
inpatient facility and the licensed, certified or other qualified mental health
professional recommending the proposed treatment continues to believe, in the
exercise of his or her professional judgment, that the proposed treatment would
be in the recipient's best interest, either the professional or the recipient
may request that an administrative hearing be held for the purpose of deciding
whether or not treatment may be administered, in accordance with subsection F
of this rule. Such request shall be directed to the head of the mental health
facility.
F.
Administrative hearing
1. When afforded an
administrative hearing for the purpose of deciding whether or not a proposed
treatment may be administered shall be afforded in all cases where each of the
following conditions is met:
a. Where an
involuntary recipient at an inpatient facility lacks clinical capacity pursuant
to subsection E(l) of this rule; and
b. Where it has been determined that the
recipient is refusing a proposed treatment pursuant to subsection E(l)(b) of
this rule; and
c. Where no
agreement as to an alternative treatment has been reached following a meeting
held pursuant to subsection E(4)(a) of this rule; and
d. Where the licensed, certified or other
qualified mental health professional recommending the proposed treatment
continues to believe, in the exercise of his or her professional judgment, that
the proposed treatment would be in the recipient's best interest pursuant to
subsection E(4)(c) of this rule; and
e. Where the licensed, certified or other
qualified mental health professional recommending the proposed treatment or the
recipient requests an administrative hearing pursuant to subsection E(4)(c) of
this rule.
2. Time
frame. An administrative hearing shall be held as soon as possible but in no
event later than 10 working days from the date of the request. On motion by any
party, the hearing may be continued for cause for a period not to exceed 10
additional working days.
3. Notice.
Upon receipt of a request for an administrative hearing pursuant to subsection
E(4)(c) of this rule, the head of a mental health facility or his or her
designee shall provide adequate and timely notice of such request and of the
date set for hearing at least 5 working days prior to the date set for hearing
to:
a. the recipient;
b. the recipient's attorney, if
any;
c. one person designated by
the recipient; and
d. the Clinical
Director of a mental health institute or his or her equivalent in any other
mental health facility.
4. Parties. The mental health facility and
the recipient shall be parties to the administrative hearing, and shall have
the right to call and cross-examine witnesses and introduce relevant
evidence.
5. Right to counsel. The
recipient shall have the right to be represented by counsel at the
administrative hearing. Upon receipt of a request for hearing pursuant to
subsection E(4)(c) of this rule, the head of the mental health facility or
designee shall inform the recipient of his or her right to counsel, and
ascertain whether the recipient is already represented by counsel, or
specifically desires to employ his or her own counsel. If the recipient is not
already represented, does not specifically desire to employ his or her own
counsel, and does not explicitly refuse representation by appointed counsel,
the head of the mental health facility or designee shall appoint counsel to
represent the recipient. The Bureau shall maintain a list of attorneys from
which such appointed counsel shall be selected. In cases where the recipient is
not represented by counsel and refuses representation by appointed counsel, the
head of the mental health facility or designee shall request that a
representative of the rights protection and advocacy agency of the Maine mental
health system contact the recipient in an effort to arrange to represent the
recipient. If the recipient refuses such representation, the representative of
the rights protection and advocacy agency shall nevertheless attend the hearing
as an observer.
6. Medical Records.
The recipient shall have access, upon request, to his or her medical records
to, prepare for the hearing within one working day of his or her
request.
7. Hearing officer. An
independent hearing officer shall preside at the administrative
hearing.
8. Informal setting;
mediation
a. The hearing shall be conducted in
an informal setting and atmosphere.
b. The hearing officer shall open the hearing
by exploring with the parties the reasons why they were unable to agree to an
alternative treatment pursuant to subsection E(3)(a) of this rule and shall
attempt to mediate a solution. Where no mediated solution is reached, the
hearing officer shall proceed with the hearing in accordance with subsections
F(9) - (11) below.
9.
Burden on facility. The hearing officer shall authorize treatment of the
recipient over his or her objection and absent his or her informed consent only
if the recipient fails to make the affirmative showing under subsection 10
below and the facility is able to make a clear and convincing showing on each
of the following four factors:
a. That the
recipient lacks capacity to make a decision in regard to the particular
treatment as outlined in subsection D of these rules. For purposes of this
showing, the administrative finding of clinical incapacity made pursuant to
subsection E(1) of this rule is not conclusive; and the recipient's refusal of
treatment is not evidence of incapacity; AND
b. That the proposed treatment is based on an
adequately substantiated exercise of professional judgment; AND
c. That the benefits of the proposed
treatment outweigh the risks and possible side-effects; AND
d. That the proposed treatment is die least
intrusive appropriate treatment available under die circumstances.
10. Affirmative showing by
recipient. The hearing officer shall not authorize treatment of the recipient
over his or her objection and absent his or her informed consent if the
recipient affirmatively shows that, if he possessed capacity, he would have
refused the proposed treatment on religious grounds or on the basis of other
previously expressed personal convictions or beliefs.
11. Decision
a. Ruling
i.
Denial of treatment
Where the facility fails to carry DM burden as required by
subsection F(9) above in any respect, or where the recipient makes the
affirmative showing pursuant to subsection F(10), the hearing officer shall
rule that the proposed treatment shall not be administered to the
recipient.
ii. Approval of
treatment
Where the facility carries its burden in all respects, and
the recipient fails to make the affirmative showing pursuant to subsection
F(10), the hearing officer shall rule that the proposed treatment shall be
administered to the recipient in the exercise of the state's parens patriae
power.
b. The
hearing officer may announce his or her decision at the conclusion of the
hearing and shall, in any event, issue a written decision detailing his or her
conclusions and reasoning within 3 working days of the hearing.
c. If the hearing officer decides that
treatment may be administered, treatment may begin one full working day after
the decision is announced, unless stayed by order of court. The hearing
officer's decision shall be effective for a period not to exceed sixty days
from the date on which treatment is begun. The recipient shall be monitored
throughout such period for any change in regard to capacity, and, at the
latest, upon expiration of such period, the recipient shall be re-examined in
accordance with subsection E(l) of this rule.
d. The hearing officer's decision shall
constitute final agency action and may be appealed to Superior Court pursuant
to the Maine Administrative Procedure Act, 5 M.R.S.A. §11001et
seq. If the issue of incapacity of the recipient is raised on appeal,
the Superior Court may conduct a hearing de novo on such issue.
e. An electronic recording of the hearing
shall be made, and an accurate transcription thereof shall constitute the
administrative record for purposes of an appeal.
f. The hearing shall be confidential and no
report of the proceedings may be released to the public or press, except by
permission of the recipient, his or her counsel and with the approval of the
presiding hearing officer.
G. Notice: protective proceedings. In all
cases where an administrative finding of clinical incapacity is made, the head
of the mental health facility shall be notified immediately. If treatment is
authorized for a 60-day period pursuant to subsection E(2) (c) or subsection
F(11) of this rule, the head of the mental health facility or designee shall,
within such 60-day period, notify the family, public guardian or other
appropriate party of the potential need for protective proceedings. No renewal
of treatment pursuant to subsections E(2)(c) or F(11) shall be authorized
unless and until the notice required by this subsection has been given and
documented.
H. Emergency treatment
1. Definition. An emergency is defined as a
situation where, as a result of a recipient's behavior due to mental illness,
there exists a risk of imminent bodily injury to the recipient or to
others.
2. Declaration of
emergency. A licensed physician [or physician extender] may declare an
emergency when he reasonably believes an emergency exists as defined in
subsection G(l) above, and when
a. A
recognized form of treatment is required immediately to ensure the physical
safety of the recipient or of others; and
b. No-one legally entitled to consent on the
recipient's behalf is available; and
c. A reasonable person concerned for the
physical safety of the recipient or of others would consent under the
circumstances.
3. At no
time may a physician or physician extender declare an emergency merely because
the recipient refuses treatment.
4.
Documentation. When an emergency is declared, documentation of the emergency
shall be immediately entered into the recipient's permanent treatment record
and, if declared by a physician extender, endorsed within 24 hours by the
physician. Such documentation by the physician or physician extender shall
include the following:
a. A description of the
behaviors that he has observed, and that created the emergency;
b. The period, not to exceed 72 hours, during
which the medication may be administered;
c. The expected benefits of the order;
and
d. The specific behaviors or
physical responses that staff should monitor and record, and the means they
should use.
5. Emergency
treatment. Following a declaration of emergency pursuant to subsection H(2)
above, a licensed physician or a person acting under his or her direction may
administer a recognized form of treatment over the recipient's objection and
absent his or her informed consent. Treatment imposed following a declaration
of emergency may continue for a period not to exceed 72 consecutive
hours.
6. Notice and review. The
administrative head of the facility and the Clinical Director cm his or her
equivalent shall be notified, as soon as possible, of any emergency. Any
renewal of emergency treatment requires review by and the written authorization
of the Clinical Director of a mental health institute or his or her equivalent
in any other mental health facility. Additionally, an order for continued
medication may be entered only upon compliance with the foregoing provisions of
this sub-section and, if the recipient lacks capacity, only upon consent of the
guardian or initiation of administrative hearing proceedings described ha
sub-section (F) above.
I. Electroconvulsive Therapy (ECT). ECT
treatment shall not be administered to a recipient except as provided in these
rules. The authorized treating professional seeking to administer ECT treatment
shall:
1. Obtain written informed consent for
such procedure according to the procedures outlined in Section IV of this part
from:
a. the recipient, or
b. from a court of competent jurisdiction, in
the case of a clinically incapacitated recipient, or
c. from a guardian or other legal
decision-maker for an incapacitated recipient who has a guardian;
2. ECT treatment shall not be
authorized pursuant to Section IV(E)-(H) of this part.
J. Psychosurgery. Psychosurgery shall only be
performed on an adult recipient upon order of a court of competent
jurisdiction.
K. Documentation. All
documentation required by this rule shall be made a part of the recipient's
clinical chart;
