14- 193 C.M.R. ch. 1, § C-IV

Current through 2024-51, December 18, 2024

Section 193-1-C-IV - INFORMED CONSENT TO TREATMENT AND/OR SERVICES

A. Recipients have the right to informed consent for all treatment and/or services.

B. Statement of purpose. This rule has the following purposes:

1. To promote respect for the individual autonomy and recipient participation in decision-making;

2. To ensure that the informed consent of a recipient is obtained prior to treatment and/or services;

3. To avoid the forcible imposition of any treatment and/or services;

4. To provide reasonable standards and procedural mechanisms for determining when to treat and/or serve 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 and/or service of recipients. All recipients with unimpaired capacity have the right to consent to or to refuse treatment and/or services, absent an emergency. Treatment may be provided to a recipient only when:

1. Informed consent for such treatment and/or services 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/or services, 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 and/or services pursuant to subsections D and E of this rule, the recipient is willing to comply with treatment and/or services and the provisions of E(2) have been followed.

D. Informed consent to treatment and/or services. Informed consent to treatment and/or services is obtained only where the recipient or his or her guardian possesses capacity to make a reasoned decision regarding the treatment and/or services and the recipient or his or her guardian is provided with adequate information concerning the treatment and/or services; and the recipient or guardian makes a voluntary choice in favor of the treatment and/or services. 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 and/or service. Recipients are legally presumed to possess capacity to give informed consent to treatment and/or services unless the recipient has been judged by a court to competent jurisdiction to lack capacity generally or to lack capacity to give informed consent to a particular treatment and/or service.

2. Adequate information. The licensed, certified or other qualified mental health professional recommending a particular treatment and/or service shall provide to the recipient, or guardian, all information relevant to the formulation of a reasoned decision concerning such treatment and/or service. The recipient, or his or her guardian, 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 time frames established for the service in question in the Licensing Standards, 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 or in writing, shall be communicated in terms designed ID 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 medication is intended to relieve;

b. The nature of the proposed treatment and/or service, 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/or service and the known risks that it entails, including precautions, contraindications, and potential adverse effects of any medication;

d. The anticipated duration of the treatment and/or service;

e. A statement of reasonable alternatives to the proposed treatment and/or service, if any;

f. Information as to where the recipient may obtain answers to further questions concerning the treatment and/or service; and

g. A clear statement that the recipient has the right to give or withhold consent to the proposed treatment and/or service.

3. Voluntary choice. Consent to treatment and/or services must be given willingly in all cases, and may not be obtained through coercion or deception.

A recipient or guardian's initial refusal of treatment and/or services shall not preclude renewed attempts to obtain the recipient's willing consent; and a recipient or guardian's initial willing consent shall not preclude the recipient from validly withdrawing such consent at any time before or during treatment and/or service.

4. Documentation. The informed consent of a recipient or guardian to a particular treatment and/or service shall be documented to show:

a. From whom consent is obtained, whether recipient, or guardian;

b. That adequate information, including at a minimum all the elements listed in section D(2) of this rule, was provided;

c. The signature of the recipient or, where applicable, the signature of a guardian, indicating consent, in the case of psychotropic medications only.

d. Exceptions. In cases of unanticipated treatment and/or service needs, the informed consent of a guardian may be obtained by telephone; but such 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 and/or service determines that, in his opinion, a recipient not having a guardian lacks clinical capacity to give informed consent to the treatment and/or service under subsection D of these rules, 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 and/or service.

a. Finding of capacity. Where the recipient is found to possess capacity to consent to treatment and/or service by the physician or licensed clinical psychologist, he shall be reined back to de 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 and/or service.

b. Finding of clinical incapacity. Where the recipient is found to lack clinical capacity to consent to treatment and/or service 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 a documented determination as to whether the recipient, notwithstanding lack of clinical capacity, is willing to comply with or refuses the proposal treatment and/or service.

Such determination must be based upon the provision to the recipient of adequate information as required by subsection D(2) of this rule.

If recipient is willing to comply with treatment and/or services, the procedure outlined in subsection E(2) shall be followed. If any recipient refuses treatment and/or services, the procedure outlined in subsection E(3) shall be followed.

Nothing shall. preclude the agency from pursuing guardianship in appropriate cases at any time after a determination of clinical incapacity.

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 and/or service shall notify the following persons of such finding:

i. 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;

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 and/or service and that notwithstanding such finding, the recipient may refuse treatment and/or service, absent court adjudication of incapacitation.

2. Outpatient recipients with clinical incapacity, compliant. This subsection shall apply where it is determined pursuant to subsection (E)(1)(b) that an outpatient recipient with clinical incapacity is willing to comply with the proposed treatment and/or service.

In such case treatment and/or service may be provided only if:

a. Protective proceedings are initiated in accordance with law;

b. A licensed, certified or other qualified mental health professional follows the procedures outlined in subsection (D) and, where applicable, subsection (E) on at least an annual basis.

3. 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 and/or service.

a. Alternative treatment meeting. The licensed, certified or other qualified mental health professional recommending the treatment and/or service 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 and/or service that may be available and that may include behavioral, psychological, medical, social, psychosocial or rehabilitative methods. The purpose of the meeting shall be to elaborate in an informal setting an alternative treatment and/or service that is both professionally justified and acceptable to the recipient. If agreement can be reached as to an alternative treatment and/or service, 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) above.

b. No agreement. Where no agreement can be reached as to an alternative treatment and/or service, the licensed, certified or other qualified mental health professional recommending the proposed treatment and/or service shall report in writing to the head of the program concerning the outcome of the meeting.

The head of the program may conclude that the recipient's termination from services is the only available option.

F. 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 Part C, Section IV.D. 1., 2., 3., and 4.a.-d. of these rules from

a. the recipient, or

b. from a court of competent jurisdiction, in the cast of a clinically incapacitated recipient, or

c. from a guardian or other legal decision-maker, in the case of a minor recipient or an incapacitated recipient; it ECT treatment shall not be authorized pursuant to Section III.E. -H. of this part.

G. Documentation. All documentation required by this rule shall be made a part of the recipient's clinical chart;

H. Seclusion and restraint are under no circumstances to be utilized in outpatient settings.

14- 193 C.M.R. ch. 1, § C-IV