14- 193 C.M.R. ch. 1, § B-V

Current through 2024-51, December 18, 2024

Section 193-1-B-V - INFORMED CONSENT TO TREATMENT

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;

14- 193 C.M.R. ch. 1, § B-V