New York Codes, Rules and Regulations › Title 14 - DEPARTMENT OF MENTAL HYGIENE › Chapter XIV - Office for People With Developmental Disabilities › Part 681 - Intermediate Care Facilities for Individuals with Intellectual Disabilities › Section 681.13 - Informed consent for service plans which involve untoward risk to an individual's protection or rights when the individual is a resident of an ICF/DD

Current through Register Vol. 46, No. 28, July 10, 2024
Note:
Between April 1, 2013 and May 31, 2014, the requirements of
				  this section are not effective with regard to behavior support plans which have
				  been developed in accordance with section
				  633.16 
				  of this Part and with regard to informed consent that has been obtained in
				  accordance with section
				  633.16 
				  of this Part. On April 1, 2013, requirements concerning the specially
				  constituted committee are no longer effective. The requirements of this section
				  are no longer in effect on or after May 31, 2014.
(Please note that this section is presented in a principles
				  of compliance [see glossary, section
				  681.99  of
				  this Part] and standards of certification [see glossary, section
				  681.99  of
				  this Part] format.)
(a)
Principles of compliance.
(1)
				Principles of compliance represent those requirements with which an
				agency/facility must comply, but against which the agency/facility will not be
				routinely surveyed for recertification purposes. However, evidence of failure
				to comply with the principles may be the basis for decertification in
				accordance with article 16 of the Mental Hygiene Law.
(2) No service plan (see glossary, section
				681.99  of
				this Part) which involves an untoward risk to an individual's protection or
				rights, including those designed to manage inappropriate behavior and inclusive
				of those employing medication for such purposes, shall be implemented until
				informed consent is obtained in conformance with this section.
(3) Nothing in this section shall be deemed
				to limit the availability of medical, dental, health, and hospital services,
				which may be rendered to an individual of any age without seeking informed
				consent when, in the physician's judgment, an emergency exists creating an
				immediate need for attention.
(4)
				Nothing in this section shall be deemed to limit the necessity for informed
				consent for professional medical treatment as required by section
				633.11  of this
				Title.
(5) Determining whether a
				service plan constitutes an untoward risk to an individual's protection or
				rights (see glossary, section
				681.99  of
				this Part), and committee approval of such plans:
(i) An individual's interdisciplinary team
				shall review each service plan developed to determine whether the proposed plan
				constitutes an untoward risk to the individual's protection and
				rights.
(ii) If an
				interdisciplinary team considers that a proposed service plan constitutes an
				untoward risk to an individual's protection or rights, the plan shall be
				referred to the specially constituted committee charged with the responsibility
				for reviewing programs that may involve untoward risks to an individual's
				protection or rights pursuant to the provisions of
				42 CFR
				483.440(f)(3).
(iii) The specially constituted committee,
				upon receipt of a service plan referred to it from an interdisciplinary team,
				shall determine whether or not the service plan constitutes an untoward risk to
				an individual's protection or rights.
(iv) If the specially constituted committee
				determines that a service plan constitutes an untoward risk to an individual's
				protection or rights, it shall approve or disapprove the implementation of the
				plan and, if approved, ensure that the requirements of this Part are
				met.
(6) Role of the
				facility when obtaining informed consent for a proposed service plan that
				constitutes an untoward risk to an individual's protection or rights:
(i) The administrator shall ensure the
				obtaining of written informed consent by or on behalf of an individual whose
				service plan is under consideration. As it is the intent of this section to
				ensure an individual's participation in granting or withholding informed
				consent for any service plan affecting him or her, it is, therefore, necessary
				to ensure that the presentation to the individual be in terms and a manner that
				will most easily facilitate understanding by that individual.
(a) In every case it shall be the duty of the
				administrator to ensure that the individual is personally afforded an
				appropriate explanation of the proposed service plan.
(b) If an individual with the ability to give
				consent (see glossary, section
				681.99  of
				this Part), gives his or her informed consent, and does not object, one of the
				following parties, in the order of priority stated, shall be informed of the
				proposed service plan before implementation:
(1) an individual's actively involved (see
				glossary, section
				681.99  of
				this Part) adult spouse;
(2) an
				individual's actively involved parent;
(3) an individual's actively involved adult
				child;
(4) an individual's actively
				involved adult family member (see glossary, section
				681.99  of
				this Part); and
(5) the consumer
				advisory board for the Willowbrook class (for a class member only).
(c) The party receiving notice as
				listed above shall be informed of the right to appeal service plan decisions
				pursuant to section
				633.12 
				of this Title.
(ii)
				Obtaining informed consent for service plans that constitute an untoward risk
				to an individual's protection and rights if the individual is less than 18
				years of age:
(a) Consent shall be sought
				from the parties listed below, in the order stated:
(1) an individual's court appointed guardian
				(see glossary, section
				681.99  of
				this Part);
(2) a married
				individual with the ability to give consent;
(3) an individual's actively involved adult
				spouse;
(4) an individual's
				actively involved parent;
(5) an
				individual's actively involved adult family member;
(6) the consumer advisory board for the
				Willowbrook class (for a class member only); and
(7) a consent committee pursuant to paragraph
				(10) of this subdivision.
(b) When a married individual has been
				determined to lack the ability to consent but the first available party on the
				above list disagrees with that determination, and the agency/facility considers
				implementation in the best interest of the individual, the plan shall only be
				implemented after application to a court of competent jurisdiction; notice of
				such application shall be given to the party who disagreed with the
				determination.
(c) If the first
				available party on this list objects to the proposed service plan, and the
				agency/facility considers implementation to be in the best interest of the
				individual, application shall be made to a court of competent jurisdiction;
				notice of such application shall be given to the objecting party.
(d) If no party is available and the
				agency/facility considers implementation of the service plan to be in the best
				interest of the individual, application shall be made to a court of competent
				jurisdiction.
(e) If a party or
				parties on the list is either unwilling to consent to or object to the proposed
				service plan, application may be made to subsequent parties on the list; if no
				party is willing to give consent and the agency/facility considers
				implementation to be in the best interest of the individual, application shall
				be made to a court of competent jurisdiction.
(iii) Obtaining informed consent for service
				plans that constitute an untoward risk to an individual's protection and rights
				if an individual is 18 years of age or older and has the ability to understand
				appropriate disclosures regarding a proposed service plan:
(a) Such service plan shall be initiated only
				with the individual's informed consent.
(b) In the absence of a determination to the
				contrary (
e.g.,
appointment of a guardian, or a determination
				in accordance with paragraph [8] of this subdivision), it shall be presumed
				that the individual has the ability to understand appropriate disclosure
				regarding the proposed treatment.
(c) If an individual should object at any
				time to the administration of medication as part of a behavior management plan,
				regardless of his or her ability to give informed consent, the provisions of
				paragraph (9) of this subdivision shall apply.
(iv) Obtaining informed consent for service
				plans that constitute an untoward risk to an individual's protection and right
				if an individual is 18 years of age or older and a determination of
				insufficient capacity has been made by a court of competent jurisdiction:
(a) Consent shall be secured pursuant to the
				terms of the order of said court.
(b) If a legal guardian has been appointed
				pursuant to section 17-A of the Surrogate's Court Procedure Act, consent shall
				be sought from said guardian except as provided for in subparagraph (10)(ii) of
				this subdivision.
(v)
				Obtaining informed consent for service plans that constitute an untoward risk
				to and individual's protection and rights if an individual is 18 years of age
				or older and a determination of insufficient ability to give informed consent
				has been made pursuant to paragraph (8) of this subdivision.
(a) Consent shall be sought from the parties
				listed below, in the order stated:
(1) an
				individual's actively involved adult spouse;
(2) an individual's actively involved adult
				child;
(3) an individual's actively
				involved parent;
(4) an
				individual's actively involved adult family member;
(5) the consumer advisory board for the
				Willowbrook class (for a class member only); and
(6) a consent committee pursuant to paragraph
				(10) of this subdivision.
(b) When an individual has been determined to
				lack the ability to consent, but the first party on the above list disagrees
				with that determination, and the agency/facility considers implementation in
				the best interest of the individual, the plan shall only be implemented after
				application to a court of competent jurisdiction; notice of such application
				shall be given to the party who disagreed with the determination.
(c) If the first available party on this list
				objects to the proposed service plan, and the agency/facility considers
				implementation to be in the best interest of the individual, application shall
				be made to a court of competent jurisdiction; notice of such application shall
				be given to the objecting party.
(d) If no party is available and the
				agency/facility considers implementation of the service plan to be in the best
				interest of the individual, application shall be made to a court of competent
				jurisdiction.
(e) If a party or
				parties on this list is either unwilling to consent to or object to the
				proposed service plan, application may be made to subsequent parties on the
				list; if no party is willing to give consent and the agency/facility considers
				implementation to be in the best interest of the individual, application shall
				be made to a court of competent jurisdiction.
(vi) The administrator shall furnish an
				individual, and/or other parties, committee, or court reviewing an individual's
				ability to understand treatment and considering consent thereto, with all
				necessary information, including medical risks, benefits, and alternatives to a
				proposed service plan.
(vii)
				Documentation of consent shall be included in an individual's record.
(viii) Whenever consent is sought from other
				than an authorized guardian or the parents of a minor (see glossary, section
				681.99  of
				this Part), for individual's who are residents of a developmental center or
				those on conditional release from a developmental center, the Mental Hygiene
				Legal Service shall be notified.
(7) Role of the individual, party, or
				committee giving consent.
(i) When an
				actively involved spouse, actively involved parent, actively involved adult
				child, actively involved adult family member, the consumer advisory board for
				the Willowbrook class (for class members only), or a consent committee reviews
				a request to give informed consent, the party or committee:
(a) shall review the ability of the
				individual to understand appropriate disclosures regarding the proposed service
				plan and, if appropriate, a range of related alternative treatment approaches;
				as well as the individual's ability to give or withhold consent thereto;
(1) may seek the services of an outside
				consultant to advise them on the individual's ability to give informed consent;
				and
(2) if such party or committee
				disagrees with a determination that an individual lacks the ability to give
				informed consent, no further action shall be taken until application is made to
				a court of competent jurisdiction; notice of such application shall be given to
				the party or committee who disagreed with the determination;
(b) shall, to the extent
				practicable, discuss a proposed service plan with the individual;
(c) shall, to the extent practicable, ensure
				that the individual's opinions, beliefs, and wishes are represented in the
				decision to consent or object to the proposed service plan; and
(d) shall consent to the proposed service
				plan only if the individual lacks the ability to give or withhold consent and
				the proposed service plan is determined to be in the individual's best
				interest.
(ii) When a
				court appointed guardian reviews a request to give informed consent, the
				guardian shall:
(a) to the extent
				practicable, discuss a proposed plan with the individual;
(b) to the extent practicable, ensure that
				the individual's opinions, beliefs, and wishes are represented in the
				guardian's decision to consent or object to the proposed service plan;
				and
(c) consent to the proposed
				service plan only if it is determined to be in the individual's best
				interest.
(iii) The
				individual, court appointed guardian, party or committee giving consent shall,
				based on the information provided by the interdisciplinary team, indicate the
				duration of the consent.
(a) Duration of
				consent shall not exceed one year from the date of decision.
(b) Any change to a service plan beyond the
				designated span of adjustments, or the development of a new service plan (even
				one using those proposed for consideration on a contingent basis) requires the
				informed consent of the appropriate party.
(iv) Consent may be withdrawn by an
				individual, court appointed guardian, party, or committee giving it, at
				anytime, in writing. Consent may be withdrawn by an individual in the same
				manner as originally given. Such withdrawal of consent shall be included in the
				individual's record.
(8)
				Determination of ability to give informed consent for individual's who do not
				have a guardian appointed pursuant to section 17-A of the Surrogate's Court
				Procedure Act.
(i) Given the complexity and
				interrelated elements when determining an individual's ability to understand
				his or her treatment and give informed consent thereto, the interdisciplinary
				team may prepare a plan with a span of interventions, with specific
				limitations, should adjustment be necessary. It may also present, for
				consideration on a contingent basis, a range of related treatment approaches.
				However, all such interventions and/or related treatment approaches shall have
				been described to the individual in terms and manner that would be most easily
				understood.
(ii) In those instances
				when an individual's interdisciplinary team considers, beyond any reasonable
				doubt, that the individual does not have the ability to give informed consent:
(a) The team, through its member having
				coordination responsibility, shall enter a written opinion and detailed
				analysis as to why it considers the individual to be unable to provide informed
				consent.
(b) The opinion and
				analysis of the team shall be reviewed by a New York State licensed
				psychologist, or a New York State licensed physician who is board certified or
				eligible to be certified as a psychiatrist, who is not a member of the
				individual's interdisciplinary team, and who may or may not be an employee of
				the agency/facility. Such professional shall review the material provided and,
				in writing, provide an opinion as to whether the individual has the ability to
				give informed consent. If the professional disagrees with the team, the
				requirements of subparagraph (iii) of this paragraph shall be
				followed.
(iii) If it is
				not clear to the interdisciplinary team that an individual does not have the
				ability to give informed consent, it shall be the responsibility of the
				administrator to comply with the requirements listed below. The administrator
				shall:
(a) obtain from the individual's
				interdisciplinary team, its written opinion and analysis of the individual's
				ability to understand the proposed service plan, and of the individual's
				ability to give or withhold informed consent thereto;
(b) obtain from a New York State licensed
				psychologist, or New York State licensed physician who is board certified or
				eligible for certification as a psychiatrist, a written opinion and analysis of
				the individual's ability to understand the proposed service plan, and of the
				individual's ability to give inform consent thereto. Said professional shall
				not have any ownership, employment relationship, or other interest in the
				agency/facility which would compromise his or her objectivity in
				decisionmaking;
(c) after
				considering the opinion of the interdisciplinary team and the psychologist or
				psychiatrist, determine whether it is appropriate to obtain consent from a
				party duly recognized by this section, and whether to proceed in accordance
				with the other provisions of this section; and
(d) ensure that the opinions of the
				interdisciplinary team and the psychologist or psychiatrist, and the decision
				of the administrator, are documented in the individual's record and
				communicated to that individual and to his or her actively involved adult
				spouse, parent, adult child, or adult family member; unless the individual is
				an adult who has been determined to have the ability to give informed consent,
				objects to such notice being made.
(iv) The administrator shall ensure that
				these procedures for determining ability to give informed consent are also
				followed whenever:
(a) there is a significant
				departure from the material considered in relation to determining an
				individual's ability to understand the proposed treatment
				(
i.e.,
the service plan or originally proposed alternative
				treatment approaches);
(b) when a
				totally new service plan with a different approach is proposed;
(c) when there has been a change in the
				diagnosis of the individual; or
(d)
				when there has been a change in the determination of an individual's ability to
				give informed consent by the individual's interdisciplinary team or a
				psychologist.
Note:
Once ability to give informed consent has been determined, it
				  is not necessary to reevaluate such ability unless one of the above four
				  conditions occur.
(9) Objections to the medication component of
				a plan designed to manage inappropriate behavior may be made.
(i) Such objections may be made:
(a) by an individual 18 years of age or older
				who does not have a guardian lawfully empowered to give medical consent; or by
				an individual under the age of 18 where consent has not been derived from a
				lawfully empowered guardian or parent;
(b) irrespective of a judgement about the
				individual's ability to understand appropriate disclosures regarding a proposed
				service plan; and
(c) by conveying
				the objection in whatever manner is typically utilized by an individual to
				communicate a meaningful decision (which does not include stereotypic actions,
				reactions, or responses).
(ii) If all reasonable attempts to resolve
				the issue have not resulted in agreement to proceed with the use of medication,
				then the medication component of a service plan shall not be administered
				without an order of a court of competent jurisdiction. Notification of the
				individual's objection to medication shall be given to the party or committee
				having initially given consent.
(10) Consent committee.
(i) This committee need not be a "standing"
				committee. It may be a committee convened on an as-needed basis with
				appropriate representation for the purpose of reviewing a request(s) for
				informed consent.
(ii) Informed
				consent may be obtained from a committee convened for that purpose, for service
				plans, including ones designed to manage inappropriate behavior, and inclusive
				of those employing medication for such purpose, where such service plans
				constitute an untoward risk to the individual's protection or rights, if a duly
				appointed guardian or other parties authorized by this section to give informed
				consent are unavailable to do so.
(iii) Each B/DDSO shall arrange for the
				creation of a committee. Services of a committee may be made available to
				community-based facilities, whether State or voluntary agency
				operated.
(iv) Voluntary
				agencies/facilities may arrange for the creation of their own committee(s) or,
				if available, use the one provided by the B/DDSO.
(v) When a consent committee meeting is
				convened, it shall:
(a) consist of at least
				three individuals or parties, with a majority having no ownership, employment
				relationship or other interest in the agency/facility which would compromise
				his or her objectivity in decisionmaking.
(b) have at least one QIDP; and
(c) not include anyone who is involved in the
				care and treatment of an individual whose service plan is under
				review.
(vi) Membership
				shall be drawn from the following groups:
(a)
				staff members;
(b) staff members of
				another agency/facility;
(c)
				individuals receiving services from OPWDD-operated or certified
				facilities;
(d) parents, court
				appointed guardians, or family members of those with developmental disabilities
				who have demonstrated sensitivity to issues surrounding the treatment of those
				with such disabilities;
(e)
				advocates of those with developmental disabilities who have demonstrated
				sensitivity to issues surrounding the treatment of those with developmental
				disabilities; and
(f) parties who
				have either experience or training in contemporary practices to change
				inappropriate behavior.
(vii) The Mental Hygiene Legal Services may
				represent the interests of individuals before the committee where the
				individual is a resident of a developmental center or is on conditional release
				therefrom, and shall be notified of any committee meetings where the service
				plans of such individuals will be under consideration.
(viii) The committee shall reach its decision
				within 14 days of receiving an application for consent.
(ix) The committee's decision shall be by
				majority vote.
(11) All
				information required to be conveyed by the requirements of this section shall
				be communicated in whatever language or method is appropriate to ensure
				understanding by the individual and/or the individual's parent, guardian,
				spouse, adult child, or other adult family member. That is, the agency/facility
				personnel responsible for obtaining informed consent shall use the language,
				whether spoken or written, that the individual/party is most comfortable using
				and most clearly understands. Examples of acceptable forms of communication
				include, but are not limited to, sign language, a communications board, a
				computer-assisted technology, Braille, etc. There shall be agency/facility
				policies/procedures to implement this process as well as the process whereby
				individuals can be made aware of and understand, to the extent possible, the
				rights to which they are entitled pursuant to this section.