Florida Regulations 65E-5.170: Right to Express and Informed Consent
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(1) Establishment of Consent.
(a) Receiving Facilities. As soon as possible, but in no event longer than 24 hours from entering a designated receiving facility on a voluntary or involuntary basis, each person shall be examined by the admitting physician to assess the person’s ability to provide express and informed consent to admission and treatment. The examination of a minor for this purpose may be limited to the documentation of the minor’s age. The examination of a person alleged to be incapacitated for this purpose may be limited to the documentation of letters of guardianship. Documentation of the assessment results shall be placed in the person’s clinical record. The facility shall determine whether a person has been adjudicated as incapacitated and whether a guardian has been appointed by the court. If a guardian has been appointed by the court, the limits of the authority of the guardian shall be determined prior to allowing the guardian to authorize treatment. A copy of any court order delineating a guardian’s authority to consent to mental health or medical treatment shall be obtained by the facility and included in the person’s clinical record prior to allowing the guardian to give express and informed consent to treatment for the person.
(b) Treatment Facilities. Upon entering a designated treatment facility on a voluntary or involuntary basis, each person shall be examined by the admitting physician to assess the person’s ability to provide express and informed consent to admission and treatment, which shall be documented in the person’s clinical record. The examination of a person alleged to be incapacitated or incompetent to consent to treatment, for this purpose, may be limited to documenting the letters of guardianship or order of the court. If a person has been adjudicated as incapacitated and a guardian appointed by the court or if a person has been found to be incompetent to consent to treatment and a guardian advocate has been appointed by the court, the limits of authority of the guardian or guardian advocate shall be determined prior to allowing the guardian or guardian advocate to authorize treatment for the person. A copy of any court order delineating a guardian’s authority to consent to mental health or medical treatment shall be obtained by the facility and included in the person’s clinical record prior to allowing the guardian to give express and informed consent to treatment for the person.
(c) If the admission is voluntary, the person’s competence to provide express and informed consent for admission shall be documented by the admitting physician. Recommended form CF-MH 3104, Feb. 05, “”Certification of Person’s Competence to Provide Express and Informed Consent,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose. The completed form or other documentation shall be retained in the person’s clinical record. Facility staff monitoring the person’s condition shall document any observations which suggest that a person may no longer be competent to provide express and informed consent to his or her treatment. In such circumstances, staff shall notify the physician and document in the person’s clinical record that the physician was notified of this apparent change in clinical condition.
(d) In the event there is a change in the ability of a person on voluntary status to provide express and informed consent to treatment, the change shall be immediately documented in the person’s clinical record. A person’s refusal to consent to treatment is not, in itself, an indication of incompetence to consent to treatment.
1. If the person is assessed to be competent to consent to treatment and meets the criteria for involuntary inpatient placement, the facility administrator shall file with the court a petition for involuntary placement. Recommended form CF-MH 3032, Feb. 05, “”Petition for Involuntary Inpatient Placement,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose.
2. If the person is assessed to be incompetent to consent to treatment, and meets the criteria for involuntary inpatient or involuntary outpatient placement, the facility administrator shall expeditiously file with the court both a petition for the adjudication of incompetence to consent to treatment and appointment of a guardian advocate, and a petition for involuntary inpatient or involuntary outpatient placement. Upon determination that a person is incompetent to consent to treatment the facility shall expeditiously pursue the appointment of a duly authorized substitute decision-maker that can make legally required decisions concerning treatment options or refusal of treatments for the person. Recommended forms CF-MH 3106, Feb. 05, “”Petition for Adjudication of Incompetence to Consent to Treatment and Appointment of a Guardian Advocate,”” which is incorporated by reference may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter, and CF-MH 3032, “”Petition for Involuntary Inpatient Placement,”” as referenced in subFl. Admin. Code R. 65E-5.170(1)(d)1., or CF-MH 3130, “”Petition for Involuntary Outpatient Placement,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose.
(e) Competence to provide express and informed consent shall be established and documented in the person’s clinical record prior to the approval of a person’s transfer from involuntary to voluntary status or prior to permitting a person to consent to his or her own treatment if that person had been previously determined to be incompetent to consent to treatment. Recommended form CF-MH 3104, “”Certification of Person’s Competence to Provide Express and Informed Consent,”” as referenced in Fl. Admin. Code R. 65E-5.170(1)(c), properly completed by a physician may be used for this purpose.
(f) Any guardian advocate appointed by a court to provide express and informed consent to treatment for the person shall be discharged and a notice of such guardian advocate discharge provided to the court upon the establishment and documentation that the person is competent to provide express and informed consent.
(g) If a person entering a designated receiving or treatment facility has been adjudicated incapacitated under Florida Statutes Chapter 744, as described in Florida Statutes § 394.455(14), express and informed consent to treatment shall be sought from the person’s guardian.
(h) If a person entering a designated receiving or treatment facility has been determined by the attending physician to be incompetent to consent to treatment as defined in Florida Statutes § 394.455(15), express and informed consent to treatment shall be expeditiously sought by the facility from the person’s guardian advocate or health care surrogate or proxy.
(i) A copy of the letter of guardianship, court order, or advance directive shall be reviewed by facility staff to ensure that the substitute decision-maker has the authority to provide consent to the recommended treatment on behalf of the person. If the facility relies upon the expression of express and informed consent for person’s treatment from a substitute decision-maker, a copy of this documentation shall be placed in the person’s clinical record and shall serve as documentation of the substitute decision-maker’s authority to give such consent. With respect to a health care proxy, where no advance directive has been prepared by the person, facility staff shall document in the person’s clinical record that the substituted decision-maker was selected in accordance with the list of persons and using the priority set out in Florida Statutes § 765.401 When a health care surrogate or proxy is used, the facility shall immediately file a petition for the appointment of a guardian advocate.
(2) Authorization for Treatment.
(a) Express and informed consent, including the right to ask questions about the proposed treatment, to receive complete and accurate answers to those questions, and to negotiate treatment options, shall be obtained from a person who is competent to consent to treatment. If the person is incompetent to consent to treatment, such express and informed consent shall be obtained from the duly authorized substitute decision-maker for the person before any treatment is rendered, except where emergency treatment is ordered by a physician for the safety of the person or others. Florida Statutes Chapter 394, Part I, and this rule chapter govern mental health treatment. Medical treatment for persons served in receiving and treatment facilities and by other service providers are governed by other statutes and rules.
(b) A copy of information disclosed while attempting to obtain express and informed consent shall be given to the person and to any substitute decision-maker authorized to act on behalf of the person.
(c) When presented with an event or an alternative which requires express and informed consent, a competent person or, if the person is incompetent to consent to treatment, the duly authorized substitute decision-maker shall provide consent to treatment, refuse consent to treatment, negotiate treatment alternatives, or revoke consent to treatment. Recommended forms CF-MH 3042a, Feb. 05, “”General Authorization for Treatment Except Psychotropic Medications,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter, and CF-MH 3042b, Feb. 05, “”Specific Authorization for Psychotropic Medications,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used as documentation of express and informed consent and any decisions made pursuant to that consent. If used, recommended form CF-MH 3042a, “”General Authorization for Treatment Except Psychotropic Medications,”” as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), shall be completed at the time of admission to permit routine medical care, psychiatric assessment, and other assessment and treatment except psychotropic medications. The more specific recommended form CF-MH 3042b, “”Specific Authorization for Psychotropic Medications,”” as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), or its equivalent, shall be completed prior to the administration of any psychotropic medications, except under an emergency treatment order. The completed forms, or equivalent documentation, shall be retained in the person’s clinical record.
(d) No facility or service provider shall initiate any mental health treatment, including psychotropic medication, until express and informed consent for psychiatric treatment is sought from a person legally qualified to give it, except in instances where emergency treatment is ordered by a physician to preserve the immediate safety of the person or others.
(3) Receiving and treatment facilities shall request copies of any advance directives completed by persons admitted to the facilities, from the person or the person’s family or representative.
(4) In addition to any other requirements, at least the following must be given to the person before express and informed consent will be valid:
(a) Identification of the proposed psychotropic medication, together with a plain language explanation of the proposed dosage range, the frequency and method of administration, the recognized short-term and long-term side effects, any contraindications which may exist, clinically significant interactive effects with other medications, and similar information on alternative medications which may have less severe or serious side effects.
(b) A plain language explanation of all other treatments or treatment alternatives recommended for the person.
(5) If a change in psychotropic medication is recommended which is not included in the previously signed CF-MH 3042b, “”Specific Authorization for Psychotropic Medications”” form, as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), after an explanation and disclosure of the altered treatment plan is provided by the physician express and informed consent must be obtained from the person authorized to provide consent and be documented in the person’s clinical record prior to the administration of the treatment or psychotropic medication.
(6) The facility or service provider staff shall explain to a guardian, guardian advocate, or health care surrogate or proxy, the duty of the substitute decision-maker to provide information to the facility or service provider on how the substitute decision-maker may be reached at any time during the person’s hospitalization or treatment to provide express and informed consent for changes of treatment from that previously approved.
(7) Electroconvulsive treatment may be recommended to the person or the person’s substitute decision-maker by the attending physician. Such recommendation must also be concurrently recommended by at least one other physician not directly involved with the person’s care who has reviewed the person’s clinical record. Such recommendation shall be documented in the person’s clinical record and shall be signed by both physicians. Recommended form CF-MH 3057, Feb. 05, “”Authorization for Electroconvulsive Treatment,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose. If used, this form shall also be signed by the person, if competent, or by the guardian advocate, if previous court approval has been given, or by the guardian where the person has been found by the court to be incapacitated, or by the health care surrogate if the person had expressly delegated such authority to the surrogate in the advance directive. Express and informed consent from the person or his or her substitute decision-maker, as required by Florida Statutes § 394.459(3), including an opportunity to ask questions and receive answers about the procedure, shall be noted on or attached to recommended form CF-MH 3057, “”Authorization for Electroconvulsive Treatment,”” as referenced in subsection 65E-5.170(7), F.A.C., or its equivalent, as documentation of the required disclosures and of the consent. Each signed authorization form is permission for the person to receive a series of up to, but not more than, the stated number of electroconvulsive treatments identified on the form. Additional electroconvulsive treatments require additional written authorization. The signed authorization form shall be retained in the person’s clinical record and shall comply with the provisions of Florida Statutes § 458.325
Rulemaking Authority 394.457(5), 394.46715 FS. Law Implemented 394, Part I, 394.455(9), (14), (15), 394.459(3), 394.4625(1)(f), 394.4655, 458.325, 765.401 FS. History-New 11-29-98, Amended 4-4-05.
Terms Used In Florida Regulations 65E-5.170
- Examination: the integration of the physical examination required under Florida Statutes § 394. See Florida Regulations 65E-5.100
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
(b) Treatment Facilities. Upon entering a designated treatment facility on a voluntary or involuntary basis, each person shall be examined by the admitting physician to assess the person’s ability to provide express and informed consent to admission and treatment, which shall be documented in the person’s clinical record. The examination of a person alleged to be incapacitated or incompetent to consent to treatment, for this purpose, may be limited to documenting the letters of guardianship or order of the court. If a person has been adjudicated as incapacitated and a guardian appointed by the court or if a person has been found to be incompetent to consent to treatment and a guardian advocate has been appointed by the court, the limits of authority of the guardian or guardian advocate shall be determined prior to allowing the guardian or guardian advocate to authorize treatment for the person. A copy of any court order delineating a guardian’s authority to consent to mental health or medical treatment shall be obtained by the facility and included in the person’s clinical record prior to allowing the guardian to give express and informed consent to treatment for the person.
(c) If the admission is voluntary, the person’s competence to provide express and informed consent for admission shall be documented by the admitting physician. Recommended form CF-MH 3104, Feb. 05, “”Certification of Person’s Competence to Provide Express and Informed Consent,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose. The completed form or other documentation shall be retained in the person’s clinical record. Facility staff monitoring the person’s condition shall document any observations which suggest that a person may no longer be competent to provide express and informed consent to his or her treatment. In such circumstances, staff shall notify the physician and document in the person’s clinical record that the physician was notified of this apparent change in clinical condition.
(d) In the event there is a change in the ability of a person on voluntary status to provide express and informed consent to treatment, the change shall be immediately documented in the person’s clinical record. A person’s refusal to consent to treatment is not, in itself, an indication of incompetence to consent to treatment.
1. If the person is assessed to be competent to consent to treatment and meets the criteria for involuntary inpatient placement, the facility administrator shall file with the court a petition for involuntary placement. Recommended form CF-MH 3032, Feb. 05, “”Petition for Involuntary Inpatient Placement,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose.
2. If the person is assessed to be incompetent to consent to treatment, and meets the criteria for involuntary inpatient or involuntary outpatient placement, the facility administrator shall expeditiously file with the court both a petition for the adjudication of incompetence to consent to treatment and appointment of a guardian advocate, and a petition for involuntary inpatient or involuntary outpatient placement. Upon determination that a person is incompetent to consent to treatment the facility shall expeditiously pursue the appointment of a duly authorized substitute decision-maker that can make legally required decisions concerning treatment options or refusal of treatments for the person. Recommended forms CF-MH 3106, Feb. 05, “”Petition for Adjudication of Incompetence to Consent to Treatment and Appointment of a Guardian Advocate,”” which is incorporated by reference may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter, and CF-MH 3032, “”Petition for Involuntary Inpatient Placement,”” as referenced in subFl. Admin. Code R. 65E-5.170(1)(d)1., or CF-MH 3130, “”Petition for Involuntary Outpatient Placement,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose.
(e) Competence to provide express and informed consent shall be established and documented in the person’s clinical record prior to the approval of a person’s transfer from involuntary to voluntary status or prior to permitting a person to consent to his or her own treatment if that person had been previously determined to be incompetent to consent to treatment. Recommended form CF-MH 3104, “”Certification of Person’s Competence to Provide Express and Informed Consent,”” as referenced in Fl. Admin. Code R. 65E-5.170(1)(c), properly completed by a physician may be used for this purpose.
(f) Any guardian advocate appointed by a court to provide express and informed consent to treatment for the person shall be discharged and a notice of such guardian advocate discharge provided to the court upon the establishment and documentation that the person is competent to provide express and informed consent.
(g) If a person entering a designated receiving or treatment facility has been adjudicated incapacitated under Florida Statutes Chapter 744, as described in Florida Statutes § 394.455(14), express and informed consent to treatment shall be sought from the person’s guardian.
(h) If a person entering a designated receiving or treatment facility has been determined by the attending physician to be incompetent to consent to treatment as defined in Florida Statutes § 394.455(15), express and informed consent to treatment shall be expeditiously sought by the facility from the person’s guardian advocate or health care surrogate or proxy.
(i) A copy of the letter of guardianship, court order, or advance directive shall be reviewed by facility staff to ensure that the substitute decision-maker has the authority to provide consent to the recommended treatment on behalf of the person. If the facility relies upon the expression of express and informed consent for person’s treatment from a substitute decision-maker, a copy of this documentation shall be placed in the person’s clinical record and shall serve as documentation of the substitute decision-maker’s authority to give such consent. With respect to a health care proxy, where no advance directive has been prepared by the person, facility staff shall document in the person’s clinical record that the substituted decision-maker was selected in accordance with the list of persons and using the priority set out in Florida Statutes § 765.401 When a health care surrogate or proxy is used, the facility shall immediately file a petition for the appointment of a guardian advocate.
(2) Authorization for Treatment.
(a) Express and informed consent, including the right to ask questions about the proposed treatment, to receive complete and accurate answers to those questions, and to negotiate treatment options, shall be obtained from a person who is competent to consent to treatment. If the person is incompetent to consent to treatment, such express and informed consent shall be obtained from the duly authorized substitute decision-maker for the person before any treatment is rendered, except where emergency treatment is ordered by a physician for the safety of the person or others. Florida Statutes Chapter 394, Part I, and this rule chapter govern mental health treatment. Medical treatment for persons served in receiving and treatment facilities and by other service providers are governed by other statutes and rules.
(b) A copy of information disclosed while attempting to obtain express and informed consent shall be given to the person and to any substitute decision-maker authorized to act on behalf of the person.
(c) When presented with an event or an alternative which requires express and informed consent, a competent person or, if the person is incompetent to consent to treatment, the duly authorized substitute decision-maker shall provide consent to treatment, refuse consent to treatment, negotiate treatment alternatives, or revoke consent to treatment. Recommended forms CF-MH 3042a, Feb. 05, “”General Authorization for Treatment Except Psychotropic Medications,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter, and CF-MH 3042b, Feb. 05, “”Specific Authorization for Psychotropic Medications,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used as documentation of express and informed consent and any decisions made pursuant to that consent. If used, recommended form CF-MH 3042a, “”General Authorization for Treatment Except Psychotropic Medications,”” as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), shall be completed at the time of admission to permit routine medical care, psychiatric assessment, and other assessment and treatment except psychotropic medications. The more specific recommended form CF-MH 3042b, “”Specific Authorization for Psychotropic Medications,”” as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), or its equivalent, shall be completed prior to the administration of any psychotropic medications, except under an emergency treatment order. The completed forms, or equivalent documentation, shall be retained in the person’s clinical record.
(d) No facility or service provider shall initiate any mental health treatment, including psychotropic medication, until express and informed consent for psychiatric treatment is sought from a person legally qualified to give it, except in instances where emergency treatment is ordered by a physician to preserve the immediate safety of the person or others.
(3) Receiving and treatment facilities shall request copies of any advance directives completed by persons admitted to the facilities, from the person or the person’s family or representative.
(4) In addition to any other requirements, at least the following must be given to the person before express and informed consent will be valid:
(a) Identification of the proposed psychotropic medication, together with a plain language explanation of the proposed dosage range, the frequency and method of administration, the recognized short-term and long-term side effects, any contraindications which may exist, clinically significant interactive effects with other medications, and similar information on alternative medications which may have less severe or serious side effects.
(b) A plain language explanation of all other treatments or treatment alternatives recommended for the person.
(5) If a change in psychotropic medication is recommended which is not included in the previously signed CF-MH 3042b, “”Specific Authorization for Psychotropic Medications”” form, as referenced in Fl. Admin. Code R. 65E-5.170(2)(c), after an explanation and disclosure of the altered treatment plan is provided by the physician express and informed consent must be obtained from the person authorized to provide consent and be documented in the person’s clinical record prior to the administration of the treatment or psychotropic medication.
(6) The facility or service provider staff shall explain to a guardian, guardian advocate, or health care surrogate or proxy, the duty of the substitute decision-maker to provide information to the facility or service provider on how the substitute decision-maker may be reached at any time during the person’s hospitalization or treatment to provide express and informed consent for changes of treatment from that previously approved.
(7) Electroconvulsive treatment may be recommended to the person or the person’s substitute decision-maker by the attending physician. Such recommendation must also be concurrently recommended by at least one other physician not directly involved with the person’s care who has reviewed the person’s clinical record. Such recommendation shall be documented in the person’s clinical record and shall be signed by both physicians. Recommended form CF-MH 3057, Feb. 05, “”Authorization for Electroconvulsive Treatment,”” which is incorporated by reference and may be obtained pursuant to Fl. Admin. Code R. 65E-5.120, of this rule chapter may be used for this purpose. If used, this form shall also be signed by the person, if competent, or by the guardian advocate, if previous court approval has been given, or by the guardian where the person has been found by the court to be incapacitated, or by the health care surrogate if the person had expressly delegated such authority to the surrogate in the advance directive. Express and informed consent from the person or his or her substitute decision-maker, as required by Florida Statutes § 394.459(3), including an opportunity to ask questions and receive answers about the procedure, shall be noted on or attached to recommended form CF-MH 3057, “”Authorization for Electroconvulsive Treatment,”” as referenced in subsection 65E-5.170(7), F.A.C., or its equivalent, as documentation of the required disclosures and of the consent. Each signed authorization form is permission for the person to receive a series of up to, but not more than, the stated number of electroconvulsive treatments identified on the form. Additional electroconvulsive treatments require additional written authorization. The signed authorization form shall be retained in the person’s clinical record and shall comply with the provisions of Florida Statutes § 458.325
Rulemaking Authority 394.457(5), 394.46715 FS. Law Implemented 394, Part I, 394.455(9), (14), (15), 394.459(3), 394.4625(1)(f), 394.4655, 458.325, 765.401 FS. History-New 11-29-98, Amended 4-4-05.