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Oregon Bulletin

December 1, 2013

Oregon Health Authority, Addictions and Mental Health Division: Mental Health Services, Chapter 309

Rule Caption: Temporary amendments to OAR 309-114 entitled Informed Consent By Patients in State Institutions.

Adm. Order No.: MHS 12-2013(Temp)

Filed with Sec. of State: 10-29-2013

Certified to be Effective: 10-29-13 thru 4-27-14

Notice Publication Date:

Rules Amended: 309-114-0000, 309-114-0010, 309-114-0020

Subject: These rules prescribe standards and procedures to be observed by personnel of state institutions operated by the Addictions and Mental Health (AMH) Division, in obtaining informed consent from patients, for use of significant procedures, as defined by these rules.

Rules Coordinator: Nola Russell—(503) 945-7652

309-114-0000

Purpose

Purpose. These rules prescribe standards and procedures to be observed by personnel of state institutions operated by Division in obtaining informed consent to significant procedures, as defined by these rules, from patients of such state institutions. These rules do not apply to routine medical procedures. Administration of significant procedures without informed consent is permitted as described in OAR 309-114-0010(1)(b). The purpose of these rules is to assure that the rights of patients are protected with respect to significant procedures.

Stat. Auth.: ORS 179.040

Stats. Implemented: ORS 179.321, 426.070 & 426.385

Hist.: MHD 3-1983, f. 2-24-83, ef. 3-26-83; MHS 14-2007(Temp), f. 11-30-07, cert. ef. 12-1-07 thru 5-29-08; MHS 2-2008(Temp), f. & cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08; MHS 12-2010, f. & cert. ef. 9-9-10; MHS 12-2013(Temp), f. & cert. ef. 10-29-13 thru 4-27-14

309-114-0010

General Policy on Obtaining Informed Consent to Treatment and Training

(1)(a) Basic Rule. Patients, or parents or guardians of minors, or guardians on behalf of legally incapacitated patients, may refuse any significant procedure and may withdraw at any time consent previously given to a significant procedure. Any refusal or withdrawal or withholding of consent shall be documented in the patient’s record.

(b) Personnel of a state institution shall not administer a significant procedure to a patient unless written informed consent is obtained from or on behalf of the patient in the manner prescribed in these rules, except as follows:

(A) Administration of significant procedures to legally incapacitated patients as provided in section (6) of this rule;

(B) Administration of significant procedures without informed consent in emergencies under OAR 309-114-0015;

(C) Involuntary administration of significant procedures with good cause to persons committed to the Division under OAR 309-114-0020; or

(D) Involuntary administration of significant procedures pursuant to a valid court order.

(2) Capacity of the patient: In order to consent to, or refuse, withhold, or withdraw consent to significant procedures, the patient must have the capacity to make a decision concerning acceptance or rejection of a significant procedure, as follows:

(a) Unless adjudicated legally incapacitated for all purposes or for the specific purpose of making treatment decisions, a patient shall be presumed competent to consent to, or refuse, withhold, or withdraw consent to significant procedures. A person committed to the Division may be deemed unable to consent to or refuse, withhold, or withdraw consent to a significant procedure only if the person currently demonstrates an inability to reasonably comprehend and weigh the risks and benefits of the proposed procedure, alternative procedures, or no treatment at all including, but not limited to, all applicable factors listed in (3)(a) of this rule. The patient’s current inability to provide informed consent is to be documented in the patient’s record and supported by the patient’s statements or behavior; and may be evidenced in the treating physician’s or psychiatric nurse practitioner’s informed consent form, the evaluation form by the independent examining physician and forms approving or disapproving the procedure by the superintendent or chief medical officer;

(b) A person committed to the Division shall not be deemed unable to consent to or refuse, withhold, or withdraw consent to a significant procedure merely by reason of one or more of the following facts:

(A) The person has been involuntarily committed to the Division;

(B) The person has been diagnosed as mentally ill;

(C) The person has disagreed or now disagrees with the treating physician’s or psychiatric nurse practitioner’s diagnosis; or

(D) The person has disagreed or now disagrees with the treating physician’s or psychiatric nurse practitioner’s recommendation regarding treatment.

(c) If a court has determined that a patient is legally incapacitated, then consent shall be sought from the legal guardian.

(3) Procedures for Obtaining Informed Consent and Information to be Given: The person from whom informed consent to a significant procedure is sought shall be given information, orally and in writing, the substance of which is to be found on the treating physician’s or psychiatric nurse practitioner’s informed consent form. In the case of medication, there shall be attached a preprinted information sheet on the risks and benefits of the medication listed on the treating physician’s or psychiatric nurse practitioner’s form. All written materials under this rule will be provided in English. However, if the institution has reason to believe a patient has limited English language proficiency or the patient requests it, then the institution will make reasonable accommodations to provide the patient with meaningful access to the information, such as providing the patient with copies of the materials in the patient’s native language if the materials are readily available in that language or providing the opportunity to have an interpreter orally translate written materials into the patient’s native language. Specific information about significant procedures of a similar class will not be provided to or discussed with the patient.

(a) The information shall describe:

(A) The nature and seriousness of the patient’s mental illness or condition;

(B) The purpose of the significant procedures listed on the treating physician’s or psychiatric nurse practitioner’s form, the intended outcome and the risks and benefits of the procedures;

(C) Any alternatives, particularly alternatives offering less material risks to the proposed significant procedure that are reasonably available and reasonably comparable in effectiveness;

(D) If the proposed significant procedure is medication, facility medical staff shall give the name, dosage range, and frequency of administration of the medication listed on the treating physician’s or psychiatric nurse practitioner’s form, and shall explain the material risks of the medication at that dosage range.

(E) The side effects of the intended medication or electro-convulsive therapy;

(F) The predicted medical, psychiatric, social, or legal consequences of not accepting the significant procedure or any comparable procedure, including any potential risk the patient represents to the health and safety of the patient, or others, which may include, but is not limited to, a consideration of the patient’s history of violence and its relationship to mental health treatment if he or she does not receive the significant procedure;

(G) That consent may be refused, withheld or withdrawn at any time; and

(H) Any additional information concerning the proposed significant procedure requested by the patient.

(b) A medication educator shall assist by providing information to the patient that explains the proposed significant procedure, as described in subsection (3)(a) of this rule;

(c) The treating physician or psychiatric nurse practitioner intending to administer a significant procedure shall document in the patient’s chart that the information required in subsection (3)(a) of this rule was explained and that the patient, parent or guardian of a minor or guardian of a legally incapacitated patient explicitly consented, refused, withheld or withdrew consent. The treating physician or psychiatric nurse practitioner may document this by completing the informed consent form and make it part of the patient’s record.

(4) When discussing the significant procedure with the treating physician or psychiatric nurse practitioner and the medication educator, the patient may request additional information about the significant procedure pursuant to OAR 309-114-0010(3)(a)(H) and present additional information relevant to making his or her decision.

(5) Voluntary Consent: Consent to a proposed significant procedure must be given voluntarily, free of any duress or coercion. Subject to the provisions of OAR 309-114-0020, the decision to refuse, withhold or withdraw consent previously given shall not result in the denial of any other benefit, privilege, or service solely on the basis of refusing, withholding or withdrawing consent. A voluntary patient may be discharged from the institution if offered procedures are refused.

(6) Obtaining Consent with Respect to Legally Incapacitated Patients: A state institution may not administer a significant procedure to a legally incapacitated patient without the consent of the guardian, or, in the case of a minor, the parent or guardian, except in the case of an emergency under OAR 309-114-0015, where the institution has good cause to involuntarily administer a significant procedure under 309-114-0020, or pursuant to a valid court order. In order to prove good cause, the institution must prove 309-114-0020(1)(a) and (1)(d) in reference to the guardian and 309-114-0020(1)(b) and (1)(c) in reference to the patient.

(7) Reports of Progress: A patient, the parents or guardian of a minor patient, or the guardian of a legally incapacitated patient shall, upon request, be informed of the progress of the patient during administration of the significant procedure.

(8) These rules will be effective as of December 1, 2007 on all new orders for administration of significant procedures without informed consent. This includes new orders written after expiration of the previous order. This rule will be effective for existing, unexpired orders as of January 1, 2008, on a phased-in schedule that will accommodate as many new hearings as is practicable to schedule each week.

Stat. Auth.: ORS 179.040

Stats. Implemented: ORS 179.321, 426.070 & 426.385

Hist.: MHD 3-1983, f. 2-24-83, ef. 3-26-83; MHD 3-1988, f. 4-12-88, (and corrected 5-17-88), cert. ef. 6-1-88; MHS 14-2007(Temp), f. 11-30-07, cert. ef. 12-1-07 thru 5-29-08; MHS 2-2008(Temp), f. & cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08; MHS 1-2009(Temp), f. & cert. ef. 1-23-09 thru 7-22-09; MHS 3-2009, f. & cert. ef. 6-26-09; MHS 12-2010, f. & cert. ef. 9-9-10; MHS 12-2013(Temp), f. & cert. ef. 10-29-13 thru 4-27-14

309-114-0020

Involuntary Administration of Significant Procedures to Persons Committed to the Division with Good Cause

(1) Good cause: Good cause exists to administer a significant procedure to a person committed to the Division without informed consent if in the opinion of the treating physician or psychiatric nurse practitioner after consultation with the treatment team, the following factors are satisfied:

(a) Pursuant to OAR 309-114-0010(2), the person is deemed unable to consent to, refuse, withhold or withdraw consent to the significant procedure. This determination must be documented on the treating physician’s or psychiatric nurse practitioner’s informed consent form and the independent examining physician’s evaluation form. It must include the specific questions asked and answers given regarding the patient’s ability to weigh the risks and benefits of the proposed treatment, alternative treatment and no treatment including, but not limited to all relevant factors listed in 309-114-0010(3)(a).

(b) The proposed significant procedure will likely restore or prevent deterioration of the person’s mental or physical health, alleviate extreme suffering or save or extend the person’s life. This factor is established conclusively for purposes of a hearing under OAR 309-114-0025 by introducing into evidence the treating physician’s or psychiatric nurse practitioner’s informed consent form and the independent examining physician’s evaluation form, unless this factor is affirmatively raised as an issue by the patient or his or her representative at the hearing.

(c) The proposed significant procedure is the most appropriate treatment for the person’s condition according to current clinical practice all other less intrusive procedures have been considered and all criteria and information set forth in OAR 309-114-0010(3)(a) were considered. This factor is established conclusively for purposes of a hearing under 309-114-0025 by introducing into evidence the treating physician’s or psychiatric nurse practitioner’s informed consent form and the independent examining physician’s evaluation form, unless this factor is affirmatively raised as an issue by the patient or his or her representative at the hearing.

(d) The institution made a conscientious effort to obtain informed consent from the patient. This factor is established conclusively for purposes of a hearing under OAR 309-114-0025 by introducing into evidence the treating physician’s or psychiatric nurse practitioner’s informed consent form and the medication educator’s form or progress note, unless this factor is affirmatively raised as an issue by the patient or his or her representative at the hearing. If the institution has reason to believe a patient has limited English language proficiency or the patient requests it, the institution will make reasonable accommodations to provide the patient with meaningful access to the informed consent process, such as providing the patient with the opportunity to have an interpreter orally translate written materials into the patient’s native language and provide translation during the treating physician’s or psychiatric nurse practitioner’s attempts to obtain informed consent and the medication educator’s attempt to provide information about the significant procedure. A “conscientious effort” to obtain informed consent means the following:

(A) The patient’s treating physician or psychiatric nurse practitioner made at least two good faith attempts to obtain informed consent by attempting to explain the procedure to the patient and documenting those efforts in the patient’s record; and

(B) The medication educator made at least one good faith attempt to provide the information required in OAR 309-114-0010(3)(a) and explain and discuss the proposed procedure with the patient.

(e) Because of the preliminary nature of their commitment, the following additional findings must be made for patients under ORS 161.370 jurisdiction in order to show good cause under this rule:

(A) Medication is not requested for the sole purpose of restoring trial competency; and

(B)The patient is being medicated because of the patient’s dangerousness or to treat the patient’s grave disability.

(2) Independent Review: Prior to granting approval for the administration of a significant procedure for good cause to a person committed to the Division, the superintendent or chief medical officer of a state institution for the mentally ill shall obtain consultation and approval from an independent examining physician, or if a patient refuses to be examined, the superintendent or chief medical officer shall document that an independent examining physician made at least two good faith attempts to examine the patient. The superintendent or chief medical officer shall maintain a list of independent examining physicians and shall seek consultation and approval from independent examining physicians selected on a rotating basis from the list. The independent examining physician shall not be an employee of the Division, shall be a board-eligible psychiatrist, shall have been subjected to review by the medical staff executive committee as to qualifications to make such an examination, shall have been provided with a copy of administration rules OAR 309-114-0000 through 309-114-0030 and shall have participated in a training program regarding these rules, their meaning and application.

(3) The superintendent or chief medical officer shall provide to a patient to whom a significant procedure is proposed to be administered written advance notice of the intent to seek consultation and approval of an independent examining physician for the purpose of administering the procedure without the patient’s consent.

(4) The physician selected to conduct the independent consultation shall:

(a) Review the person’s medical chart including the records of efforts made to obtain the person’s informed consent and

(A) Personally examine the person at least one time; or

(B) If the patient refuses to be examined, the physician shall make two good faith attempts to examine the patient. If the patient refuses to be examined during these two good faith attempts, the independent consultation and approval requirement outlined in subsection (4)(a)(A) and (4)(b) of this rule shall be deemed to be fulfilled.

(b) Discuss the matter with the person to determine the extent of the need for the procedure and the nature of the person’s refusal, withholding or withdrawal or inability to consent to the significant procedure. This determination as well as the supporting evidence in the form of the specific questions asked and answers given regarding the patient’s ability to weigh the risks and benefits of the proposed treatment, alternative treatment and no treatment must be documented in the patient’s record;

(c) Consider additional information, if any, presented prior to or at the time of examination or interview as may be requested by the person or anyone on behalf of the person; and

(d) Make a determination whether the factors required under these rules exist for the particular person or that one or more factors are not present and complete a report of his or her findings which provides their approval or disapproval of the proposed significant procedure. The written report must be provided to:

(A) The superintendent or chief medical officer; and

(B) The person to whom a significant procedure is proposed to be administered with a copy being made part of the person’s record.

(5) Superintendent’s Determination:

(a) The superintendent or chief medical officer shall approve or disapprove of the administration of the significant procedure to a person committed to the Division based on good cause provided that if the examining physician or psychiatric nurse practitioner found that one or more of the factors required by section (1) of this rule were not present or otherwise disapproved of the procedure; the superintendent or chief medical officer shall not approve the significant procedure and it shall not be performed;

(b) Approval of the significant procedure shall be only for as long as no substantial increase in risk is encountered in administering the significant procedure or significant procedure of a similar class during the term of a person’s commitment, but in no case longer than 180 days. Disapproval shall be only for as long as no substantial change occurs in the person’s condition during the term of commitment, but in no case longer than 180 days;

(c) Written notice of the superintendent’s or chief medical officer’s determination shall be provided to the patient and made part of the individual’s record. This notice must be delivered to the patient and fully explained by facility medical staff. This notice must include a clear statement of the decision to treat without informed consent, specific basis for the decision, what evidence was relied on to make the decision and include a clear notice of the opportunity to ask for a contested case hearing with an administrative law judge if the patient disagrees with the decision. Attached must be a form with a simple procedure to request a hearing. The patient indicating in writing or verbally to any staff member a desire to challenge the institution’s decision will be sufficient to request a contested case hearing pursuant to OAR 309 114 0025. The patient shall have 48 hours to request a contested case hearing after receiving this notice. If the patient does not request a hearing within the 48 hour period or the patient subsequently withdraws his initial hearing request and is not already receiving the significant procedure, the institution may involuntarily administer the significant procedure. A patient retains the right to request an initial hearing on the decision to administer a significant procedure without informed consent at any time.

(d) If the patient withdraws his or her initial request for hearing or refuses to attend the initial hearing without good cause, the administrative law judge will issue a dismissal order pursuant to OAR 137-003-0672(3). A dismissal order will allow the institution to immediately administer the significant procedure without informed consent as if the patient had never requested a hearing. If a dismissal order is issued, the patient may request a second hearing. If the patient withdraws his second request for hearing or refuses to attend the second hearing without good cause, the hearing will occur as scheduled with the institution presenting a prima facie case pursuant to ORS 183.417(4) and the administrative law judge will issue a proposed order by default. The institution will then issue a final order by default.

(e) Records of all reports by independent examining physicians of the determinations of the superintendent or chief medical officer under this rule shall be maintained by the superintendent or chief medical officer in a separate file and shall be summarized each year. Such summaries shall show:

(A) Each type of proposed significant procedure for which consultation with an independent examining physician was sought;

(B) The number of times consultation was sought from a particular independent examining physician for each type of proposed significant procedure;

(C) The number of times each independent examining physician approved and disapproved each type of proposed significant procedure; and

(D) The number of times the superintendent or chief medical officer approved and disapproved each type of proposed significant procedure.

(f) The summaries referred to in subsection (5)(e) of this rule shall be public records and shall be made available to the public during reasonable business hours in accordance with ORS Chapter 192.

(6) When treatment is being administered without informed consent, the ward physician or psychiatric nurse practitioner will write a progress note addressing any changes in patient’s capacity to give informed consent every 60 days.

(7) At any time that a patient’s condition changes so that there appears to his or her treating physician or psychiatric nurse practitioner to be a substantial improvement in the patient’s capacity to consent to or refuse treatment, a formal re assessment of the patient’s capacity to consent shall occur as described in OAR 309-114-0010 and 309-114-0020. No order to administer treatment without informed consent in non-emergency situations shall be valid for longer than 180 days or the duration of the commitment, whichever is shorter, without re establishing the need for the order by following the procedures described in 309-114-0010 and 309-114-0020.

(8) When an individual is transferred to a state institution from a community hospital or another state institution where he or she was already being treated with a significant procedure without informed consent, the receiving institution must apply OAR 309-114-0000 through 309-114-0030 no later than 7 days after the date of admission to the new institution. A state institution can honor an existing order for involuntary administration of a significant procedure without informed consent if procedures such as those outlined in 309-114-0010 through 309-114-0030 have already been applied and all necessary documentation is in the patient’s file.

Stat. Auth.: ORS 179.040

Stats. Implemented: ORS 179.321, 426.070 & 426.385

Hist.: MHD 3-1983, f. 2-24-83, ef. 3-26-83; MHD 3-1988, f. 4-12-88, (and corrected 5-17-880, cert. ef. 6-1-88; MHS 14-2007(Temp), f. 11-30-07, cert. ef. 12-1-07 thru 5-29-08; MHS 2-2008(Temp), f. & cert. ef. 4-7-08 thru 10-4-08; MHS 6-2008, f. & cert. ef. 7-25-08; MHS 1-2009(Temp), f. & cert. ef. 1-23-09 thru 7-22-09; MHS 3-2009, f. & cert. ef. 6-26-09; MHS 6-2010(Temp), f. & cert. ef. 3-24-10 thru 9-20-10; MHS 12-2010, f. & cert. ef. 9-9-10; MHS 13-2010(Temp), f. & cert. ef. 11-19-10 thru 5-18-11; MHS 4-2011, f. & cert. ef. 5-19-11; MHS 12-2013(Temp), f. & cert. ef. 10-29-13 thru 4-27-14

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2012.

2.) Copyright 2013 Oregon Secretary of State: Terms and Conditions of Use

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