§ 633.16 - Protection of Individuals Receiving Services in Facilities Operated and/or Certified by OPWDD

Protection of Individuals Receiving Services in Facilities Operated and/or Certified by OPWDD

This section establishes protection standards for individuals receiving services in facilities operated or certified by New York's Office for People With Developmental Disabilities (OPWDD), including all OPWDD-certified residential facilities, family care homes, day habilitation programs, prevocational services, community habilitation, and intermediate care facilities for individuals with intellectual/developmental disabilities. Operators must develop and implement individualized behavior support plans using positive behavioral approaches, obtain informed consent and behavior plan/human rights committee approval before using any restrictive or intrusive interventions, and comply with detailed requirements governing physical intervention techniques, mechanical restraints, exclusionary time-out, and psychotropic medication use. Aversive conditioning is prohibited, and agencies must maintain sufficient safeguards to protect the dignity, safety, health, welfare, and civil rights of all persons served.

N.Y. Comp. Codes R. & Regs. Tit. 14 § 633.16 - Protection of Individuals Receiving Services in Facilities Operated and/or Certified by OPWDD 

 State Regulations 

 Compare

(a)

Applicability.

(1)
 This section
 applies to: 
(i)
 all residential facilities
 certified or operated by OPWDD, including family care homes;

(ii)
 all facilities certified by OPWDD,
 except:
(a)
 free standing respite, except as
 described in section
 
635-10.5
(h)
 of
 this Title;

(b)
 clinic treatment
 facilities (see Part 679 of this Title); and

(c)
 diagnostic and research clinics (see Part
 676 of this Title);

(iii)

 day habilitation services (whether or not provided in a certified
 facility);

(iv)
 prevocational
 services (whether or not provided in a certified facility); and

(v)
 community
 habilitation.

(2)
 The
 requirements of this section concerning the use of medication only apply to
 residential facilities which are certified or operated by OPWDD, including
 family care homes.

(3)
 Intermediate
 Care Facilities (see Part 681 of this Title) should note that they must also
 comply with the requirements of 42 CFR 
483
 . In some instances, these Federal
 requirements are more stringent than the requirements of this
 section.

(b)

Definitions.

As used in this section.

(1)

Approve/approving
. The
 determination by the behavior plan/human rights committee established pursuant
 to subdivision (f) of this section, that it has authorized the implementation
 of a proposed behavior support plan which incorporates restrictive/intrusive
 interventions and/or limitations on a person's rights as specified in paragraph
 (f)(3) of this section.

(2)

Assessment, functional behavior
. A process intended to:
 identify and operationally describe challenging behavior(s); identify the
 function(s) or purpose(s) for challenging behavior; and to identify the
 specific environmental stimuli or conditions that are maintaining the
 challenging behavior(s). (See subdivision (d) of this section.)

(3)

Aversive conditioning
.
 See conditioning, aversive.

(4)

Behavior, challenging
. Challenging behavior may take many
 forms, including undesirable and/or socially unacceptable behavior that
 interferes with the acquisition or use of desired skills or knowledge,
 interferes with the performance of everyday activities, undermines the
 potential for increased self-determination and independence, interferes with
 the rights of others, disrupts social functioning, and/or causes injury to self
 or others. These may include psychiatric symptoms or overt reactions to
 symptoms that may be expressed as challenging behaviors (
e.g
.,
 manic behavior, aggressive behavior, compulsive behavior or verbal threats
 based on paranoid beliefs or perceptions).

(5)

Behavior support plan
.
 See plan, behavior support.

(6)

Behavior, modifying/managing challenging
.
 
Modifying/managing
 means using behavioral interventions and/or
 other psychological treatment approaches that are expected to result in the
 prevention or elimination of challenging behavior, foster the development of
 new adaptive (replacement) behaviors, increase or maximize existing adaptive
 behaviors, or minimize undesirable behaviors.

(7)

Behavior, controlling
 challenging
. 
Controlling
 means using interventions in
 a behavioral event to prevent or contain challenging behavior, so as to
 constrain, restrain or otherwise limit or restrict that behavior for the
 protection of the person and/or others.

(8)

Behavioral intervention
 specialist
 (see specialist, behavioral intervention.)

(9)
 Blocking pad. See pad, blocking

(10)
 Clothing, modified (for use). Clothing
 that does not restrict free movement, but is designed or used to decrease or
 prevent challenging behavior (e.g., jumpsuit, leotard, or custom-designed
 clothing such as shirts or pants made of non-shreddable cloth) by limiting or
 preventing access to a portion or portions of a person's body or by using
 material that cannot easily be ripped, torn or shredded. "Modified" refers to
 modified use of clothing such that it is clothing that is being used for a
 specific reason related to challenging behavior. Modified clothing is
 considered a type of mechanical restraint.

(11)

Committee, behavior plan/human
 rights
. A committee which has the responsibility to protect the rights
 of persons whose behavior support plans incorporate the use of any
 restrictive/intrusive intervention and/or limitation on a person's rights in
 order to prevent, manage, and/or control challenging behavior, and which
 exercises this responsibility through the process of reviewing and approving
 proposed behavior support plans.

(12)

Committee, informed
 consent
. A committee which has the authority to give informed consent
 for:
(i)
 a behavior support plan incorporating
 the use of any restrictive/intrusive intervention and/or the use of medication
 to treat a co-occurring diagnosed psychiatric disorder;

(ii)
 the short-term use of medication with no
 behavior support plan; or

(iii)
 the
 use of medications or interventions used as part of Medical
 Immobilization/Protective Stabilization (MIPS) and Sedation for Medical/Dental
 Appointments, when the individual lacks capacity to consent and there is no
 other authorized surrogate available (except for a court). (See subdivision (g)
 of this section.)

(13)

Conditioning, aversive
. The contingent application of a
 physical stimulus or device to a person's body or senses in order to modify or
 change behavior. Such a stimulus or device must be reasonably considered to be
 uncomfortable, painful, or noxious to the person when applied. Examples of such
 stimuli may include, but are not limited to: water and other mists or sprays,
 noxious odors (
e.g
., ammonia), noxious tastes
 (
e.g
., hot sauce), corporal punishment (
e.g
.,
 slapping, spanking, hitting, or pinching), air blasts, blindfolds, white noise
 helmets, and electric skin shock (see paragraph (17) of this
 subdivision).

(14)

Conflict
 of interest
. See Interest, conflict of.

(15)

Consent,
 informed.

(16)

Device, mechanical restraining
. Any physical apparatus or
 equipment placed on or worn by the individual and used to limit or control
 challenging behavior, that does not meet the definition of modified clothing
 (see paragraph (10) of this subdivision). This apparatus or equipment cannot be
 easily removed by the person and may restrict the free movement, or normal
 functioning, or normal access to a portion or portions of a person's body, or
 may totally immobilize a person. (See paragraph (j)(4) of this section for
 requirements specific to the use of mechanical restraining devices.)

(17)

Electric skin shock
.
 The application to a person's body of an electronic skin shock device in an
 effort to modify or change behavior. Such a device is reasonably considered to
 be uncomfortable, painful, or noxious to the person when applied. This
 definition is not applicable to the use of electroconvulsive therapy provided
 in a hospital setting and used as a treatment for specific psychiatric
 disorders.

(18)

Emergency
. A term that describes a situation posing an
 immediate health or safety risk to the person or to others that is unexpected,
 unforeseen, or unanticipated, and for which procedures have not been specified
 in a person's behavior support plan to address how the staff is to handle the
 emergent situation.

(19)

Functional behavior assessment
. See assessment, functional
 behavior.

(20)

Guardian
. A party appointed by a court of competent
 jurisdiction to make or assist a person to make personal and/or financial
 decisions in situations in which the person is deemed not to have capacity to
 make those decisions.

(21)

Immobilize, totally
. The complete curbing of the movement of
 both arms and both legs, and/or torso through the use of (but not limited
 to):

(22)

Instructor
. A party employed by OPWDD, or by an agency
 certified or authorized by OPWDD, who has been approved to teach a curriculum
 approved by OPWDD on the use of positive behavioral approaches, strategies
 and/or supports and physical intervention techniques.

(23)

Instructor-trainer
. A
 party employed by OPWDD, or by an agency certified or authorized by OPWDD, who
 has been approved to teach a curriculum approved by OPWDD on the use of
 positive behavioral approaches, strategies and/or supports and physical
 intervention techniques and further certified by OPWDD to train, mentor and
 certify new Instructors in the teaching and implementation of the training
 curriculum. An instructor trainer also reviews and/or approves modified
 physical intervention techniques as necessary.

(24)

Interest, conflict of
.
 Any real or perceived financial, personal or other interest, which may impede
 the impartial discharge of the party's duties.

(25)

Intervention, physical
.
 Those intervention techniques, or the adaptations of such, that either include
 hands-on techniques that deflect, protect from, or release hits, kicks or grabs
 by persons receiving services toward others in their environment, or holds of
 limited duration that may reduce, limit, or restrict an individual's freedom of
 movement in order to interrupt or control challenging behavior that is posing
 an immediate health or safety risk to the person or to others. (See paragraph
 (j)(1) of this section for requirements specific to the use of physical
 intervention techniques.) There are three categories of physical intervention
 techniques:
(i)
 protective techniques, which
 include blocks, deflection strategies and grab releases;

(ii)
 intermediate techniques, which include
 holds and escorts /removals intended to maintain a person in a standing or
 seated position to reduce or limit movement, to maintain health and safety,
 and/or to remove a person from an unsafe location or situation; and

(iii)
 restrictive techniques, which include
 holds that restrict freedom of movement in order to interrupt or control
 behavior that is posing an immediate health or safety risk to the person or to
 others and involve taking a person from a standing position to the floor and
 holding the person on the floor.

(26)

Intervention,
 restrictive/intrusive
. These interventions include the following: 
 
(i)
 intermediate and/or restrictive physical
 intervention techniques (see paragraph (j)(1) of this section);

(ii)
 the use of exclusionary time-out (see
 paragraph (j)(3) of this section);

(iii)
 the use of any mechanical restraining
 device with the intent to modify or control challenging behavior (see paragraph
 (j)(4) of this section);

(iv)
 the
 use of each medication for the purpose of preventing, modifying, or controlling
 challenging behavior that is not associated with a co-occurring diagnosed
 psychiatric disorder (see paragraph (j)(5) of this section); and

(v)
 other professionally accepted methods to
 modify or control behavior which are determined by agency/facility policy to be
 restrictive/intrusive interventions because they may present a risk to a
 person's protection or encroach unduly on a person's normal activities
 (
e.g
., response cost, overcorrection, negative practice,
 non-exclusionary time out, and satiation). 
 
Physical intervention techniques and/or mechanical
 restraining devices used to facilitate emergency evacuations/drills or
 medical/dental exams, procedures, and related healthcare activities (and to
 protect individuals, healthcare providers, and others during such exams,
 procedures, and activities) are not considered to be restrictive/intrusive
 interventions that require inclusion in a behavior support plan. Such
 interventions may be incorporated in other individualized plans to address
 these situations.

(27)
 Limitation, Rights. The limitation of a
 person's rights as specified in section
 
633.4
 of this Part including, but
 not limited to: access to mail, telephone, visitation, personal property,
 electronic communication devices (e.g., cell phones, stationary or portable
 electronic communication or entertainment devices, computers), program
 activities and/or equipment, items commonly used by members of a household,
 travel to/in the community, privacy, or personal allowance.

(28)

Master trainer
. A party
 employed by OPWDD who has been approved to teach a curriculum approved by OPWDD
 on the use of positive behavioral approaches, strategies and/or supports and
 physical intervention techniques, and further certified by OPWDD to train and
 mentor new instructor-trainers and instructors in the teaching and
 implementation of the training curriculum. The master trainer serves in a
 leadership role overseeing the quality of Instructors, quality and consistency
 of trainings, and coordinating and monitoring implementation of the curriculum.
 The master trainer also reviews and approves new or modified physical
 intervention techniques as necessary.

(29)

Mechanical restraining
 device
. See device, mechanical restraining.

(30)

Medication
. For the
 purposes of this section, a pharmaceutical agent prescribed and used either to
 prevent, modify, or control challenging behavior, or to treat the symptoms of
 co-occurring diagnosed psychiatric disorders, by altering thoughts, feelings,
 mental activities, mood, or behavior. This definition includes medications
 which are not usually classified as psychotropic, when they are prescribed for
 their psychotropic effects such as mood stabilization or impulse control. (See
 subparagraph (j)(5)(vi) of this section for requirements specific to the use of
 medications used to treat a co-occurring diagnosed psychiatric
 disorder.)

(31)
 Pads, blocking. Any
 type of freestanding protective equipment or device (e.g. foam pads, mats,
 shields, bolsters, cushions, etc.), used to prevent or minimize harm from
 challenging behavior. This may include devices to block aggression towards
 others or block efforts related to self-injurious behavior. This definition
 does not include the use of a gel pad or dense foam pad used to prevent
 headbanging or other self-injury as part of a physical intervention
 procedure.

(32)
 Modified clothing.
 See clothing, modified.

(33)

Plan, behavior support
. A written plan that outlines specific
 interventions designed to support, develop or increase replacement or
 alternative behaviors and/or modify or control a person's challenging behavior.
 The plan is a component of a person's overall plan of services. Agencies may
 use other equivalent terms for such plans. (See subdivision (e) of this
 section.)

(34)

Plan,
 monitoring
. A plan developed by a licensed psychologist, licensed
 psychiatric nurse practitioner, psychiatrist, licensed clinical social worker,
 or a behavioral intervention specialist that identifies the target symptoms of
 a co-occurring diagnosed psychiatric disorder that are to be prevented,
 reduced, or eliminated. The plan shall specify interventions that will be used
 to address associated challenging behaviors that may occur, and methods by
 which progress in symptom control and functional improvement will be measured,
 documented, and reviewed.

(35)

Psychiatrist
. For the purposes of this section, a physician
 licensed in the state of New York and who is board certified in psychiatry by
 the American Board of Psychiatry and Neurology.

(36)

Restrictive/intrusive
 intervention
. See intervention, restrictive/intrusive.

(37)

Senior member of the
 staff
. See staff, senior member of the.

(38)

Specialist, behavioral
 intervention (BIS).

(i)
 Level 1 BIS.
 In order for a party to be a Level 1 BIS, the party must: 
 
(a)
 have the following educational
 background:
(1)
 at least a Master's degree
 from a program in a clinical or treatment field of psychology, social work,
 school psychology, or applied psychology as it relates to human development and
 clinical interventions, and documented training in assessment techniques and
 behavior support plan development; or

(2)
 a national board certification in
 behavior analysis (BCBA) or a NYS license as a Behavior Analyst (LBA); or

(3)
 a New York State license in
 mental health counseling; and

(b)
 have at least three years of experience: 
 
(1)
 working directly with individuals with
 developmental disabilities, including the development, implementation, and
 monitoring of behavior support plans; and/or

(2)
 providing supervision and training to
 others in the implementation of behavior support plans; or

(c)
 have been employed as a Level 2 BIS, at
 the master's degree level, for three years.

(ii)
 Level 2 BIS. In order for a party to be
 a Level 2 BIS, the party must meet the qualifications outlined in clauses
 (
a
), (
b
), or (
c
) of this
 subparagraph:
(a)
 The party must have a BCBA
 or an LBA; or

(b)
 The party must: 
 
(1)
 have either: 
 
(i)
 a Master's degree in a clinical or
 treatment field of psychology, social work, school psychology, applied
 psychology as it relates to human development and clinical intervention, or a
 related human services field; or

(ii)
 a New York State license in mental
 health counseling; and

(2)
 have or obtain OPWDD-approved specialized
 training or experience in functional assessment techniques and behavior support
 plan development; or

(c)

 The party must:
(1)
 have a Bachelor's degree
 in a human services field; and

(2)

 have provided behavioral services for an agency in the OPWDD system as of, and
 continuously since, December 31, 2012; and

(3)
 either: 
 
(i)
 is actively working toward a Master's
 degree in an applied area of psychology, social work, or special education;
 or

(ii)
 completes at least one
 graduate-level course in an applied health service area of applied psychology,
 social work, or special education each year.

(iii)
 The qualifying Master's degrees
 referenced in this paragraph, including any degree obtained through an online
 educational or distance learning program, must have been awarded by a
 regionally accredited college or university, or one recognized by the NYS
 Education Department as following acceptable educational practices. If the
 Master's degree was awarded by an educational institution outside the United
 States and its territories, the party must provide independent verification of
 equivalency from one of the approved entities used by the NYS Department of
 Civil Service for educational equivalency reviews.

(iv)
 Notwithstanding any other provision of
 this section, parties who are employed by New York State and function in a
 title included in a New York State Civil Service title series shall provide
 behavioral services or supervision of such services described in this section
 as included in their job descriptions.

(v)
 Notwithstanding any other provision of
 this paragraph, a party may be considered a BIS in the event that OPWDD has
 approved a waiver of a specific required qualification upon application of a
 provider (see paragraph (c)(12) of this section).

(39)

Staff, senior member of the
. As used in this section, that
 staff member, by whatever title he or she may be known who is designated by the
 chief executive officer (CEO) as a senior member of the administrative
 structure of an agency, and as such, may carry out designated responsibilities
 delegated by the CEO. This may be someone who is responsible for a group of
 facilities (
e.g
., team leader, residence manager, head of
 shift, unit supervisor).

(40)

Team, program planning
. For the purposes of this section, the
 program planning team includes at least a licensed psychologist, a licensed
 clinical social worker, or psychiatrist; a behavioral intervention specialist,
 the person, the service coordinator or party designated with the responsibility
 for coordinating a person's plan of services, the person's advocate or
 correspondent (including the Consumer Advisory Board for Willowbrook class
 members that it fully represents), and any other party deemed necessary for
 identifying a person's behavioral needs and developing an appropriate plan to
 address those needs (
e.g
., direct support professional, health
 care professional). A registered nurse or other medical professional shall be a
 member of the team when the use of medication is part of the plan.

(41)

Time-out
. Time-out is a
 n intervention in which a person is temporarily removed from positive
 reinforcement or denied the opportunity to obtain positive reinforcement and
 during which the person is under constant visual and auditory contact and
 supervision. Time-out interventions include: 
 
(i)
 placing a person alone in a specific
 time-out room, commonly referred to as exclusionary time-out (See paragraph
 (j)(3) of this section for requirements specific to the use of exclusionary
 time out.);

(ii)
 removing the
 positively reinforcing environment from the individual, commonly referred to as
 non-exclusionary time-out.

(c)

General provisions.

(1)
 Every agency with oversight
 responsibilities for one or more programs that serve people in need of behavior
 support plans shall develop behavior intervention policies and procedures that
 are in conformance with this section.

(2)
 All behavioral interventions designed to
 prevent or modify challenging behaviors shall be in conformance with applicable
 laws and regulations and agency-specific policies/procedures. Interventions and
 intervention plans must be individualized and designed for the purpose of
 enhancing the individual's quality of life, relationships with others, and
 ability to function as independently as possible. Such interventions shall
 actively include positive approaches, strategies and/or supports designed to
 establish or increase the person's adaptive (replacement) behaviors.

(3)
 Behavioral interventions shall be
 designed and implemented for the purpose of developing or increasing adaptive
 behaviors (a.k.a. replacement behaviors) that support more independent and
 personally successful living, and eliminating or decreasing the frequency of
 challenging behaviors, but never employed for the convenience of staff, as a
 threat, as a means of retribution, for disciplinary purposes, or as a
 substitute for treatment or supervision.

(4)
 Positive behavioral approaches,
 strategies, and supports that are consistent with standards of professional
 practice shall always be the preferred method for addressing challenging
 behavior, with the overall goal of increasing the person's repertoire of
 appropriate behaviors and skills. These positive approaches should include a
 variety of proactive strategies that may include prevention strategies, setting
 event strategies, teaching replacement or alternative behaviors such as
 functional communication and social skills, stress management skills, positive
 reinforcement, shaping, differential reinforcement procedures, etc.

(5)
 OPWDD discourages the use of
 restrictive/intrusive interventions. General and specific requirements
 regarding the use of restrictive/intrusive interventions are imposed in order
 to limit the use of these interventions to those situations when necessary.
 Unless there is a clear risk to the health or safety of the person or others,
 or a violation of others' basic personal rights, any restrictive/intrusive
 intervention or limitation on a person's rights as specified in a behavior
 support plan shall be employed only after less intrusive or more positive
 interventions have been tried and have not been sufficiently
 successful.

(6)
 The use of aversive
 conditioning methods is prohibited.

(7)
 There shall be sufficient safeguards and
 supervision to ensure that the dignity, safety, health, welfare, and civil
 rights of a person have been adequately protected. No behavior support plan
 shall:
(i)
 incorporate sleep deprivation as a
 consequence of challenging behavior; or

(ii)
 deprive a person of a balanced and
 nutritious diet;
(a)
 meals shall be served at
 appropriate times and in as normal a manner as possible;

(b)
 the composition or timing of regularly
 served meals shall not be altered for disciplinary (punishment) purposes, or
 for the convenience of staff;

(c)

 restrictions of the amount of food or type of diet (including food/beverage
 consistency requirements) that a person consumes, or other health-related
 limitations may be made for clinical reasons related to the person's specific
 healthcare status, pursuant to documentation and order by a qualified
 healthcare professional, which shall specify the clinical justification for the
 restriction and the time period that such restriction shall be in effect, and
 which shall be included in the individual's written service plan, and in
 accordance with section
 
636-1.4
 of this Title;

(d)
 nothing in this subparagraph shall be
 deemed to limit the ability of a facility or agency to adopt policies or
 procedures to promote the health of each person and a safe and sanitary
 environment; or

(iii)

 incorporate the use of food such that the form of the food served is altered as
 a consequence of challenging behavior.

(8)
 Additional requirements apply to the use
 of "restrictive/intrusive interventions." These interventions include the
 following:
(i)
 any intermediate and/or
 restrictive physical intervention techniques (see paragraph [j][1] of this
 section);

(ii)
 the use of
 exclusionary time-out (see paragraph (j)(3) of this section);

(iii)
 the use of any mechanical restraining
 device with the intent to modify or control challenging behavior (see paragraph
 [j][4] of this section);

(iv)
 the
 use of medication to prevent, modify, or control challenging behavior (see
 paragraph (j)(5) of this section); and

(v)
 other professionally accepted methods to
 modify or control behavior which are determined by agency/facility policy to be
 restrictive/intrusive interventions because they impose a risk to a person's
 protection or encroach unduly on a person's normal activities
 (
e.g
., response cost, overcorrection, negative practice,
 non-exclusionary time out, and satiation).

(9)
 Additional requirements apply to
 behavioral interventions which impose a limitation on a person's rights as
 specified in section
 
633.4
 of this Part, including
 behavioral consequences negatively impacting the person's dignity (see
 paragraph [j][2] of this section), and, where applicable, as specified in
 section 
636-1.4
 of this Title concerning
 requirements for documentation of rights modifications in the person-centered
 service plan.

(10)
 Any objection to
 a person's current or proposed behavior support plan or to a proposed revision
 of a current plan must be made following the process specified in section
 
633.12
 of this Part, except for
 objections to the use of restrictive/intrusive interventions by the party
 providing informed consent and objections to medication use by an individual
 receiving services. (See subdivision (h) of this section.)

(11)
 Restrictive/intrusive interventions may
 not be used in an emergency, except for intermediate and restrictive physical
 intervention techniques and medication. (See paragraphs [j][1] and [5] of this
 section). Limitations on a person's rights may also be used in an emergency
 (see paragraph [j][2] of this section).

(12)
 Notwithstanding any other provision of
 this section, a party lacking the specified credentials may perform the
 functions of a Level I BIS, Level II BIS, or supervising clinician, as
 specified in this section if OPWDD has granted a waiver of a specific required
 qualification for that particular party. The waiver may limit the functions
 that may be performed by such party.
(i)
 OPWDD
 may approve a waiver upon application of the provider if all of the following
 conditions are met:
(a)
 the provider documents
 that it is unable to employ, or access contractual services from, a party who
 meets the requirements for a Level 1 BIS, Level 2 BIS, licensed psychologist,
 licensed clinical social worker, or psychiatrist; and

(b)
 the provider has demonstrated a sustained
 hardship condition concerning its ability to obtain the necessary clinical
 services.

(ii)
 In the
 event that New York State law requires licensure for parties to legally provide
 any of the services specified in this section, a party performing such services
 pursuant to a waiver which are inconsistent with the law may no longer perform
 those services.

(d)

Functional behavior
 assessment.

(1)
 Prior to the
 development of a behavior support plan to address challenging behavior that is
 not solely the result of a co-occurring diagnosed psychiatric disorder, a
 functional behavior assessment must be completed by a clinician with training
 in functional behavior assessment techniques to obtain relevant information for
 effective intervention planning. A functional behavior assessment must: 
 
(i)
 identify/describe the challenging
 behavior in observable and measureable terms;

(ii)
 include identification and consideration
 of the antecedents for the behavior(s);

(iii)
 identify the contextual factors or
 setting events, including cognitive, environmental, social, physical, medical
 and/or psychiatric conditions, that create or may contribute to the
 behavior;

(iv)
 identify the likely
 reason(s) or purpose(s) for the challenging behavior;

(v)
 identify the probable consequences that
 may maintain the behavior;

(vi)

 determine whether further assessments are needed to rule out a contextual
 factor that could be contributing to challenging behavior(s);

(vii)
 include an evaluation of preferred
 reinforcers or preference assessment;

(viii)
 consider multiple sources of data
 including, but not limited to:
(a)
 information
 gathered through direct observations of the individual;

(b)
 information gathered from interview
 and/or discussion with the individual, parent/caregiver, and other relevant
 service providers; and

(c)
 a review
 of available clinical, medical, behavioral, or other data from the individual's
 record and other sources;

(ix)
 not be based solely on an individual's
 documented history of challenging behaviors; and

(x)
 provide a measurable and quantifiable
 baseline of the challenging behaviors that may include frequency, duration,
 intensity and/or latency across settings, activities, people, and times of
 day.

(2)
 In exceptional
 circumstances (
e.g
., unexpected admission to a residential
 program) a behavior support plan may need to be developed or modified primarily
 on the basis of historical information to assure staff or the family care
 provider have sufficient tools and safeguards to manage potentially dangerous
 behaviors of the person who is beginning to receive services. In these cases, a
 functional behavior assessment shall be completed within 60 days of admission
 or the commencement of services.

(3)

 The functional behavior assessment should be reviewed and revised, as
 appropriate, when the behavior support plan is reviewed or
 revised.

(e)
Behavior support plan.

(1)
 Level 1 Behavioral Intervention
 Specialists (BIS) may develop and/or provide supervision for behavioral support
 plans or services that do not include restrictive/intrusive interventions.
 Level 2 BIS may develop behavioral support plans or services that do not
 include restrictive/intrusive interventions under the supervision of Level 1
 BIS. Behavior support plans or services which include restrictive/intrusive
 interventions may be developed by a Level 1 or a Level 2 BIS under the
 supervision of a licensed psychologist, licensed clinical social worker (LCSW),
 or a psychiatrist (see paragraph (3) of this subdivision).

(2)
 All behavior support plans must: 
 
(i)
 be developed by a BIS, licensed
 psychologist, licensed clinical social worker, or psychiatrist with training in
 behavioral intervention techniques;

(ii)
 be developed or updated in consultation,
 as clinically appropriate, with the person receiving services and/or other
 parties who are or will be involved with implementation of the plan;

(iii)
 be developed on the basis of a
 functional behavioral assessment of the target behavior(s);

(iv)
 include a concrete, specific description
 of the challenging behavior(s) targeted for intervention;

(v)
 include a hierarchy of evidence- informed
 behavioral approaches, strategies and supports to address the target
 behavior(s) requiring intervention, with the preferred methods being positive
 approaches, strategies and supports;

(vi)
 include a personalized plan for actively
 reinforcing and teaching the person alternative skills and adaptive
 (replacement) behaviors that will help or reduce challenging behaviors and
 enhance or increase the individual's personal satisfaction, degree of
 independence, or sense of success;

(vii)
 include the least restrictive or least
 intrusive methods possible in the behavioral approaches, strategies and
 supports designed to address any behaviors that may pose an immediate risk to
 the health or safety of the person or others;

(viii)
 provide a method for collection of
 adaptive (replacement) and challenging behavioral data with which treatment
 progress may be evaluated; and

(ix)

 include a schedule to review the effectiveness of the interventions included in
 the behavior support plan no less frequently than on a semi-annual basis,
 including examination of the frequency, duration, and intensity of the
 challenging behavior(s) as well as the replacement
 behaviors.

(3)
 A behavior
 support plan which incorporates a restrictive/intrusive intervention and/or a
 limitation on a person's rights (see paragraph (c)(9) of this section) shall be
 designed in accordance with the following: 
 
(i)
 Level 1 and /or Level 2 BIS who develop
 and/or provide behavior support services to implement behavior support plans
 which include restrictive/intrusive interventions shall function under the
 supervision of a licensed psychologist, licensed clinical social worker, or
 psychiatrist.

(ii)
 A plan that
 incorporates a restrictive/intrusive intervention and/or a limitation on a
 person's rights must include the following additional components: 
 
(a)
 a description of the person's behavior
 that justifies the incorporation of the restrictive/intrusive intervention(s)
 and/or limitation on a person's rights to maintain or assure health and safety
 and/or to minimize challenging behavior;

(b)
 a description of all positive, less
 intrusive, and/or other restrictive/intrusive approaches that have been tried
 and have not been sufficiently successful prior to the inclusion of the current
 restrictive/intrusive intervention(s) and/or limitation on a person's rights,
 or a clear justification of why the use of less restrictive alternatives would
 be inappropriate or insufficient to maintain or assure the health or safety or
 personal rights of the individual or others;

(c)
 designation of the interventions in a
 hierarchy of implementation, ranging from the most positive or least
 restrictive/intrusive to the least positive or most restrictive/intrusive, for
 each challenging behavior being addressed;

(d)
 the criteria to be followed regarding
 postponement of other activities or services, if necessary and/or applicable
 (
e.g
., to prevent the occurrence or recurrence of dangerous or
 unsafe behavior during such activities);

(e)
 a specific plan to minimize and/or fade
 the use of each restrictive/intrusive intervention and/or limitation of a
 person's rights, to eliminate the use of a restrictive/intrusive intervention
 and/or limitation of a person's rights, and/or transition to the use of a less
 intrusive, more positive intervention; or, in the case of continuing medication
 to address challenging behavior, the prescriber's rationale for maintaining
 medication use;

(f)
 a description of
 how each use of a restrictive/intrusive intervention and/or limitation on a
 person's rights is to be documented, including mandated reporting;
 and

(g)
 a schedule to review and
 analyze the frequency, duration and/or intensity of use of the
 restrictive/intrusive intervention(s) and/or limitation on a person's rights
 included in the behavior support plan. This review shall occur no less
 frequently than on a semi-annual basis. The results of this review must be
 documented, and the information used to determine if and when revisions to the
 behavior support plan are needed.

(iii)
 A behavior support plan incorporating
 the use of restrictive physical interventions and/or exclusionary time-out
 rooms is prohibited in family care homes and community habilitation. However, a
 behavior support plan incorporating restrictive physical interventions in
 hourly community habilitation may be permitted if specifically authorized by
 OPWDD.

(4)
 Prior to
 implementation of a behavior support plan which incorporates a limitation on a
 person's rights and/or a restrictive/intrusive intervention the plan shall be
 approved by the behavior plan/human rights committee established pursuant to
 subdivision (f) of this section.

(5)
 Prior to the implementation of a behavior
 support plan which incorporates a restrictive/intrusive intervention or a
 limitation of a person's rights as specified in section
 
636-1.4
 of this Title written
 informed consent shall be obtained from the individual or appropriate
 consent-giver for restrictive/intrusive interventions.

(6)
 If a behavior support plan is necessary
 in more than one service setting, the agency developing such a plan shall
 consult and coordinate with other service settings, in order to prevent
 conflicting or inappropriate strategies.

(7)
 If an agency will be using a behavior
 support plan developed by a different service setting/agency, the agency that
 developed the plan shall provide documentation to the other service
 setting/agency regarding current informed consent for the plan and its approval
 by a behavior plan/human rights committee.

(8)
 Nothing in this subdivision shall be
 construed to prevent the use of physical intervention techniques in an
 emergency when used in conformance with paragraph (j)(1) of this
 section.

(9)
 Nothing in this
 subdivision shall be construed to prevent the use of limitations on a person's
 rights in an emergency when used in conformance with paragraph (j)(2) of this
 section.

(10)
 Nothing in this
 subdivision shall be construed to prevent the use of medication to prevent,
 modify, or control challenging behavior in an emergency when used in
 conformance with subparagraph (j)(5)(iv) of this section.

(f)

Behavior plan/human rights
 committee.

(1)
 Every agency with
 oversight responsibilities for one or more programs that serve people in need
 of behavior support plans that include restrictive/intrusive interventions
 and/or rights limitations shall establish a behavior plan/human rights
 committee to protect the rights of persons whose behavior support plans
 incorporate the use of restrictive/intrusive interventions and/or a limitation
 on a person's rights. It may be a separate committee created solely for the
 purpose of meeting the requirements of this section, or it may be part of
 another committee.

(2)
 Agencies
 shall create their own behavior plan/human rights committee, if needed, or may
 coordinate with other agencies in the creation of a shared behavior plan/human
 rights committee.

(3)
 Prior to the
 implementation of the proposed behavior support plans, the committee shall
 approve or refuse to approve, in writing, proposed plans which contain a
 limitation on a person's rights (see paragraph (c)(9) of this section) and/or
 utilize one or more restrictive/intrusive interventions specified in paragraph
 (c)(8) of this section, except for monitoring plans in which medication is used
 solely for the treatment of a co-occurring diagnosed psychiatric disorder. The
 term 
psychiatric disorder
 means those psychiatric disorders
 which are recognized as such by the American Psychiatric Association or World
 Health Organization. For the purposes of this section, the term
 
co-occurring psychiatric disorder
 does not refer to the
 following: intellectual disability, specific learning disorder, motor
 disorders, communication disorders, autism spectrum disorder, social (pragmatic
 communication disorder), attention-deficit /hyperactivity disorders and
 disruptive, impulse-control, and conduct disorders.

(4)
 The committee must review the behavior
 support plans identified in paragraph (3) of this subdivision to verify that
 all required components are included (see subdivision (e) of this
 section).

(5)
 The committee
 chairperson must verify that:
(i)
 the proposed
 behavior support plans presented to the committee are approved for a time
 period up to one year and are based on the needs of the person; and

(ii)
 written informed consent is obtained
 prior to the implementation of the approved behavior support plan that contains
 restrictive/intrusive interventions or specific rights limitations as
 identified by section
 
636-1.4
 of this Title. If written
 informed consent cannot be obtained prior to the initiation or continuance of a
 plan, verbal consent may be accepted only for the period of time before written
 informed consent can be obtained. Verbal consent must be witnessed by two
 members of the staff, and documented in the person's record. This verbal
 consent is valid for a period of up to 45 days and may not be
 renewed.

(6)
 The
 committee must specifically approve (or refuse to approve): 
 
(i)
 the use of a mechanical restraining
 device that is not commercially available or is not designed for human use
 (
e.g
., modification of a commercially available device)
 pursuant to subclause (j)(4)(ii)(
a
)(
2
) of
 this section; and

(ii)
 modification
 of intermediate and restrictive physical intervention techniques, and new
 intermediate and restrictive physical intervention techniques, consistent with
 the provisions of subparagraph (j)(1)(iii) of this section.

(7)
 The committee shall review and make
 suggestions to the agency's management and/or governing body about its
 policies, practices, and programs as they relate to topics addressed by this
 section.

(8)
 Behavior plan/human
 rights committee membership.
(i)
 A behavior
 plan/human rights committee must have a minimum of four members including: 
 
(a)
 a licensed psychologist or a behavioral
 intervention specialist, with training in assessment techniques and behavioral
 support plan development;

(b)
 a
 clinician, currently licensed, certified, or registered in New York State as
 one of the following: social worker, physician, physician assistant, nurse
 practitioner, registered nurse, speech pathologist, occupational therapist,
 physical therapist, or pharmacist; and

(c)
 an additional party, preferably with no
 ownership, employment relationship, or other interest in the agency. This party
 may be, but is not limited to:
(1)
 someone
 charged with the responsibility for advocating for a person's rights
 (
e.g
., an ombudsperson, a volunteer, or an advocacy
 organization representative); or

(2)
 an individual with a developmental
 disability, or a guardian or family member of someone with a developmental
 disability.

(ii)

 A committee member must recuse himself/herself from reviewing a plan for a
 person for whom he/she is actively involved in the delivery of
 services.

(iii)
 The committee must
 have a minimum of three members present to proceed with its
 deliberations.

(9)

 Temporary approval by the behavior plan/human rights committee
 chairperson/designee may be provided for urgent situations in which a behavior
 plan has been created or updated to include a restrictive/intrusive
 intervention or rights limitation and appropriate informed consent, where
 required, has been obtained. In such cases, temporary approval may continue
 only until the committee is able to review and may not exceed 45
 days.

(g)

Informed
 consent.

(1)
 Written informed consent
 shall be obtained in accordance with this subdivision. 
 
(i)
 Written informed consent is required
 prior to implementation any time that a restrictive/intrusive intervention or a
 rights modification as specified in section
 
636-1.4
 of this Title is included
 in a behavior support plan to modify or control challenging behavior. However,
 if written informed consent cannot be obtained prior to the initiation or
 continuance of a plan, verbal consent may be accepted only for the period of
 time before written informed consent can be obtained. Verbal consent must be
 witnessed by two members of the staff, and documented in the person's record.
 This verbal consent is valid for a period of up to 45 days and may not be
 renewed.

(ii)
 Written informed
 consent is required prior to implementation of a physician's order for planned
 use of medication to treat a cooccurring diagnosed psychiatric disorder (see
 subparagraph (j)(5)(ii) of this section). However, if written informed consent
 cannot be obtained prior to the initiation or continuance of a medication,
 verbal consent may be accepted only for the period of time before written
 informed consent can be obtained. Verbal consent must be witnessed by two
 members of the staff, and documented in the person's record. This verbal
 consent is valid for a period of up to 45 days and may not be
 renewed.

(iii)
 Written informed
 consent is also required for short-term use of medication when there is no
 behavior support plan. If it is necessary for the medication to be administered
 before written informed consent can be obtained, verbal consent may be accepted
 for only the period of time before written informed consent can be obtained,
 but no longer than 45 days. Verbal consent must be witnessed by two members of
 the staff and documented in the person's record.

(2)
 Written informed consent shall be
 documented and kept in a person's clinical record.

(3)
 Written informed consent obtained in
 accordance with this subdivision shall be valid for up to one year.

(4)
 The agency shall ensure, in every case,
 that the person (or surrogate consent giver) be personally afforded an
 appropriate, clear explanation of the proposed plan.

(5)
 When an emergency exists,
 restrictive/intrusive interventions may be applied to a person of any age
 without seeking informed consent if such use is permitted in accordance with
 this section.

(6)
 Informed consent
 for behavior support plans that include restrictive/intrusive interventions
 shall be obtained as follows:
(i)
 If a person
 is less than 18 years of age, consent shall be obtained from one of the
 surrogates listed, in the order stated:
(a)
 a
 guardian lawfully authorized to give such consent;

(b)
 an actively involved (see section
 
633.99
 of this Part)
 spouse;

(c)
 a parent;

(d)
 an actively involved adult sibling (see
 section 
633.99
 of this Part);

(e)
 an actively involved adult family member
 (see section
 
633.99
 of this Part);

(f)
 a local commissioner of social services
 with custody of the person pursuant to the social services law or family court
 (if applicable); or

(g)
 an informed
 consent committee (see paragraph (8) of this subdivision) or a court of
 competent jurisdiction.

(ii)
 If a person is 18 years of age or older
 and has capacity to give informed consent, the plan shall be initiated only
 upon the person's informed consent. If the person withholds consent, see
 subdivision (h) of this section.

(iii)
 If a person is 18 years of age or
 older, but lacks the capacity to give informed consent regarding the proposed
 plan, or a determination of insufficient capacity has been made pursuant to
 paragraph (7) of this subdivision, informed consent shall be obtained from one
 of the surrogates listed, in the order stated: 
 
(a)
 a guardian lawfully authorized to give
 such consent;

(b)
 an actively
 involved spouse;

(c)
 an actively
 involved parent;

(d)
 an actively
 involved adult child;

(e)
 an
 actively involved adult sibling;

(f)
 an actively involved adult family
 member;

(g)
 the Consumer Advisory
 Board (see section
 
633.99
 of this Part) for the
 Willowbrook Class (only for class members it fully represents); or

(h)
 an informed consent committee (see
 paragraph [8] of this subdivision) or a court of competent
 jurisdiction.

(iv)
 If
 more than one party exists within a category on the list in subparagraph (i) or
 (iii) of this paragraph utilizing the standard of active involvement, consent
 shall be sought first from the party with a higher level of active involvement
 or, when the parties within a category are equally actively involved, consent
 shall be sought from any of such parties.

(v)
 If the first surrogate on the list in
 subparagraph (i) or (iii) of this paragraph is not reasonably available and
 willing, and is not expected to become reasonably available and willing to make
 a timely decision given the person's circumstances, application shall be made
 to the next surrogate on the list, in the order of priority stated.

(vi)
 Lack of informed consent, including the
 refusal or withdrawal of informed consent and objections are addressed in
 subdivision (h) of this section.

(vii)
 ICFs must also comply with 42 CFR
 
483
.

(7)
 Determination
 of capacity to give informed consent for persons who have not been judicially
 determined to be incapable of giving informed consent to restrictive/intrusive
 interventions. 
(i)
 In the first instance, it
 shall be the program planning team's responsibility to determine the person's
 capacity to give informed consent for each proposed restrictive/intrusive
 intervention. The team's determination and documentation shall be included and
 available in the person's record.

(ii)
 In those instances when a person's
 program planning team unanimously agrees that the person does not have the
 capacity to give informed consent to the proposed restrictive/intrusive
 interventions:
(a)
 The team shall prepare a
 written opinion and sufficiently detailed analysis of why it considers the
 person to be unable to provide informed consent. If the program planning team
 does not include a New York State licensed psychologist or New York State
 licensed physician, this opinion and analysis must be reviewed independently as
 outlined in clause (
b
) of this subparagraph.

(b)
 If the program planning team which
 determined a lack of capacity did not include a New York State licensed
 physician or New York State licensed psychologist, the opinion and analysis of
 the team shall be reviewed by a New York State licensed psychologist, or a New
 York State licensed physician (neither of whom is a member of the person's
 program planning team), who may or may not be an employee of the
 agency/facility. Such professional shall review the material provided and, in
 writing, document whether he/she agrees with the team's determination of the
 person's capacity to give informed consent. If the licensed professional
 disagrees with the team or cannot readily concur with the team's
 recommendation, the professional will examine the individual personally and
 document the findings of this examination in the person's record.

(c)
 In the event that a development or
 reinstatement of a person's capacity for consent is unlikely, the person does
 not need to be re-evaluated annually, but the program planning team should
 review this opinion for currency annually. The assessment and capacity
 determination must be maintained in the person's current clinical
 record.

(iii)
 If the
 program planning team is unable to unanimously agree or if the professional who
 conducted the personal examination disagrees with the team's decision regarding
 whether or not a person has the capacity to give informed consent, it shall be
 the responsibility of the agency's chief executive officer or designee to: 
 
(a)
 obtain from the person's program planning
 team, its written opinion and analysis of the person's ability to understand
 the proposed restrictive/intrusive intervention(s), and of the person's
 capacity to give or withhold informed consent;

(b)
 obtain from a New York State licensed
 psychologist, or New York State licensed physician, either of whom has
 specialized training in developmental disabilities, a written opinion and
 analysis of the person's ability to understand each proposed
 restrictive/intrusive intervention, and of the person's capacity to give
 informed consent.
(1)
 The psychologist's or
 physician's written opinion shall be based upon a personal examination of the
 person.

(2)
 Said professional shall
 not be a member of the person's planning team and may or may not have an
 employment relationship with the agency/facility.

(c)
 decide, after considering the opinions of
 the program planning team and the licensed psychologist or licensed physician,
 whether the person does or does not have the capacity to give informed consent,
 whether it is appropriate to obtain consent from a party or surrogate decision
 maker 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 program
 planning team, the licensed psychologist or physician, and the decision of the
 agency's chief executive officer or designee, are documented in the person's
 record and communicated to that person and to his or her actively involved
 adult family member or the Consumer Advisory Board, as appropriate, unless the
 person is an adult who has been determined to have the capacity to give
 informed consent and objects to such notice being made.

(iv)
 Consent shall be considered to be in
 effect, once given (up to a maximum of one year), as long as the scope of the
 restrictive/intrusive intervention(s) remains within that proposed by the
 behavior support plan that was reviewed by the surrogate decision maker, and/or
 until such time as the need for the intervention has ceased, unless a lesser
 specific time limit has been stated at the time the consent was given. However:
 
(a)
 any increase in the schedule of
 restrictive/intrusive intervention(s) beyond that originally presented, or the
 need for a different restrictive/intrusive intervention, requires a new consent
 from the person or appropriate surrogate; and

(b)
 if there is a change in the medical or
 psychological condition of the person receiving services which may affect the
 person's capacity to consent, the situation shall be reviewed immediately by
 the program planning team in consultation with the responsible clinician, and
 the outcome of this review will be documented. The continuing appropriateness
 of the proposed restrictive/intrusive intervention shall also be reviewed by
 the team.

(v)
 Consent
 may be withdrawn by the consent giver in writing at any time, except that
 consent may be withdrawn by the person receiving services in the same manner as
 originally given (
e.g
., verbally, in writing) if he/she is the
 provider of consent. Documentation of the withdrawal of consent shall be
 included in a person's record. (Also see subdivision [h] of this
 section.)

(8)
 Informed
 consent committee.
(i)
 This committee (see
 subdivision [b] of this section) need not be a "standing" committee. It may be
 a committee convened on an as-needed basis for the purpose of reviewing a
 request(s) for informed consent when the individual lacks capacity to give
 informed consent and there is no authorized surrogate reasonably available and
 willing.

(ii)
 Agencies shall
 arrange for the creation of an informed consent committee or may coordinate
 with other agencies in the creation of a shared informed consent
 committee.

(iii)
 Informed consent
 committee membership shall:
(a)
 consist of a
 minimum of three members;

(b)

 include at least one member having no ownership, employment relationship or
 other interest in the agency that would result in a real or perceived conflict
 of interest; or

(c)
 include at
 least one person who does not serve on the behavior plan/human rights committee
 which reviewed the behavior support plan; or

(d)
 include at least one professional holding
 a license or certification appropriate to their discipline, and who has
 specialized training or at least one year of professional experience in
 treating or working with people with developmental disabilities (see specific
 qualifications for each discipline under "professional, qualified" in section
 
690.99
 of this Title);
 and

(e)
 not include anyone who is
 involved in the delivery of services to the person whose service plan is under
 review; and

(f)
 include an
 individual with developmental disabilities, a guardian or family member of an
 individual with developmental disabilities, an advocate, or a party with
 experience in the field of developmental disabilities.

(iv)
 The Mental Hygiene Legal Service (MHLS)
 may represent, before this committee, the interests of persons who are
 residents of a facility operated or certified by OPWDD, and shall be notified
 of any informed consent committee meetings involving such individuals who lack
 capacity.

(v)
 The committee shall
 reach its decision within 15 business days of receiving an application for
 informed consent.

(vi)
 The
 committee's decision shall be by majority vote and shall be provided without
 delay to the person, the person's program planning team and other relevant
 parties.

(h)

Objections.

(1)
 Any objection to
 a person's proposed behavior support plan or a proposed revision of a current
 plan (except those relating to restrictive/intrusive interventions or rights
 modifications specified in section
 
636-1.4
 of this Title), must be
 made in accordance with the process that is outlined in section
 
633.12
 of this Part.

(2)
 Lack of informed consent. 
 
(i)

Lack of informed consent

 is considered to be:
(a)
 the withdrawal of a
 previously stated informed consent by the consent giver; or

(b)
 the refusal of the consent giver to
 provide informed consent.

(ii)
 The following applies to the use of
 restrictive/intrusive interventions (except for the refusal of the person
 receiving services to take medication as described in paragraph (3) of this
 subdivision) and rights modifications specified in section
 
636-1.4
 of this Title. If there is
 lack of informed consent, and the agency considers use of the
 intervention/treatment /specified rights modification to be necessary to
 provide services safely and appropriately to the individual, the agency must
 apply for court approval for the use of such intervention/treatment /specified
 rights modification. Notice of such application shall be sent to MHLS at the
 time of filing. While such a court application is pending, the agency may only
 use the restrictive/intrusive intervention in accordance with the emergency use
 provisions set forth in paragraphs (j)(1) and (5) of this section. Agencies may
 also impose limitations on the person's rights in an emergency (see paragraph
 (j)(2) of this section). However, if a surrogate consent giver has withdrawn
 consent for the administration of medication, and the immediate cessation of
 the administration of the refused medication would be harmful or dangerous to
 the person, then the medication shall be suspended in accordance with accepted
 medical practice. The surrogate shall be advised regarding the accepted medical
 practice for the suspension of the medication that is being followed by the
 agency.

(3)
 Medication
 refusal. If an individual receiving services refuses to take medication to
 prevent, modify, or control challenging behavior or to treat a co-occurring
 diagnosed psychiatric disorder, regardless of whether or not he or she is
 self-consenting (
i.e
., informed consent is provided by the
 individual receiving services), the administration of the refused medication
 must be suspended or not commenced.
(i)
 If the
 immediate cessation of the administration of the refused medication would be
 harmful or dangerous to the person, then the medication shall be suspended in
 accordance with accepted medical practice.

(ii)
 Notification of an individual's refusal
 of medication shall be provided as soon as possible to the grantor of informed
 consent if the consent is given by a surrogate.

(iii)
 Following the initial refusal of
 medication, the agency must continue to make attempts to provide the medication
 and to provide counseling to the individual regarding the need for the
 medication.

(iv)
 If repeated
 attempts to resolve the issue of refusal of medication intended to modify or
 control challenging behavior or to treat a diagnosed psychiatric disorder are
 unsuccessful, and the agency considers the administration of the medication to
 be necessary for effective treatment of the individual's disorder, such agency
 must apply to a court of competent jurisdiction for a hearing to determine
 whether the individual has the capacity to make a reasoned decision with
 respect to the proposed medication use and whether the medication should be
 administrated over objection. Notice of any such application shall be given to
 the authorized surrogate decision maker, if any, and MHLS.

(i)

Training.

(1)
 Staff, family care providers and respite
 substitute providers responsible for the support and supervision of a person
 who has a behavior support plan must be trained in the implementation of that
 person's plan.

(2)
 Staff, family
 care providers and respite substitute providers responsible for the support and
 supervision of a person whose behavior support plan includes the use of a
 restrictive/intrusive intervention shall be trained in the particular
 intervention(s) to be utilized with a specific person, prior to use.

(3)
 Staff who are responsible for
 implementing behavior support plans that incorporate the use of any physical
 intervention technique(s) must have:
(i)

 successfully completed an OPWDD-approved training course on the use of positive
 behavioral approaches, strategies and/or supports and physical intervention
 techniques; and

(ii)
 been certified
 or recertified in the use of positive behavioral approaches, strategies and/or
 supports and the use of physical intervention techniques by an instructor,
 instructor-trainer or master trainer within the year. However, in the event
 that OPWDD approves a new curriculum, OPWDD may specify a period of time
 greater than one year before recertification is required.

(4)
 Supervisors of such staff shall receive
 comparable training.

(5)
 If
 permitted by their graduate programs, graduate level interns may implement
 restrictive/intrusive interventions with appropriate supervision. The graduate
 level intern must also meet the requirements for training and certification
 specified in paragraphs (1)-(3) of this subdivision. Volunteers and
 undergraduate interns are not permitted to implement restrictive/intrusive
 interventions.

(6)
 Retraining of
 staff, family care providers and respite/substitute providers as described in
 paragraphs (1) and (2) of this subdivision shall occur as necessary when the
 behavior support plan is modified, or at least annually, whichever comes
 first.

(7)
 The agency must maintain
 documentation that staff, family care providers, respite/substitute providers,
 and supervisors have been trained and certified as required by this
 subdivision.

(j)

Specific interventions.

(1)

 Physical intervention techniques (includes protective, intermediate and
 restrictive physical intervention techniques). 
 
(i)
 The use of any physical intervention
 technique shall be in conformance with the following standards: 
 
(a)
 the technique must be designed in
 accordance with principles of good body alignment, with concern for circulation
 and respiration, to avoid pressure on joints, and so that it is not likely to
 inflict pain or cause injury;

(b)

 the technique must be applied in a safe manner;

(c)
 the technique shall be applied with the
 minimal amount of force necessary to safely interrupt the challenging
 behavior;

(d)
 the technique used to
 address a particular situation shall be the least intrusive or restrictive
 intervention that is necessary to safely interrupt the challenging behavior in
 that situation; and

(e)
 all parties
 using the technique must have current certification or recertification in the
 use of positive behavioral approaches, strategies and/or supports and the use
 of physical intervention techniques by an instructor, instructor-trainer, or
 master trainer.

(ii)
 The
 agency shall provide adequate monitoring and oversight of all use of physical
 intervention techniques.

(iii)

 Modification of existing techniques and new techniques. 
 
(a)
 Modification of existing techniques. 
 
(1)
 If any protective, intermediate or
 restrictive physical intervention technique needs to be modified
 (
e.g
., due to a particular person's physical disability), the
 modification shall be designed through consultation with an instructor-trainer
 and a health care professional.

(2)

 Notification of the modification of any physical intervention technique must be
 made in writing to a master trainer prior to use.

(3)
 Modification of intermediate and
 restrictive physical intervention techniques must be approved by the agency
 behavior plan/human rights committee prior to use.

(4)
 The modification of any physical
 intervention technique shall only be implemented with the person for whom it is
 designed.

(b)
 New
 techniques.
(1)
 If any new protective,
 intermediate or restrictive physical intervention technique needs to be
 developed (
e.g
., due to a particular person's physical
 disability, current or existing techniques are not effective), the new physical
 intervention technique shall be reviewed by a master trainer and a health care
 professional.

(2)
 The new technique
 must be approved by a master trainer prior to use.

(3)
 New intermediate and restrictive physical
 intervention techniques must be approved for use by the agency behavior
 plan/human rights committee prior to use.

(4)
 Any new physical intervention technique
 shall only be implemented with the person for whom it is designed.

(iv)
 The use of any
 intermediate or restrictive physical intervention technique shall be terminated
 when it is judged that the person's behavior which necessitated application of
 the intervention has diminished sufficiently or has ceased, or immediately if
 the person appears physically at risk. In any event, the continuous duration
 for applying an intermediate or restrictive physical intervention technique for
 a single behavioral episode shall not exceed 20 minutes.

(v)
 The use of any restrictive physical
 intervention technique must only be in response to a person engaging in
 behaviors that pose an immediate health or safety risk to the person or to
 others.

(vi)
 After the use of any
 physical intervention technique (protective, intermediate, or restrictive), the
 person shall be inspected for possible injury as soon as reasonably possible
 after the intervention is used. The findings of the inspection shall be
 documented in the form and format specified by OPWDD or a substantially
 equivalent form. If an injury is suspected, medical care shall be provided or
 arranged. Any injury that meets the definition of a reportable incident (Per
 section 
624.3
 of this Title) or notable
 occurrence (per section
 
624.4
 of this Title) must also be
 reported in accordance with Part 624 of this Title.

(vii)
 Each use of a restrictive physical
 intervention technique shall be reported electronically to OPWDD in the form
 and format specified by OPWDD.

(viii)
 Whenever any intermediate or
 restrictive physical intervention technique has been used in an emergency, the
 service coordinator or party designated with the responsibility for
 coordinating a person's plan of services, and the appropriate clinician, if
 applicable, must be notified within two business days after the intervention
 technique has been used.

(ix)

 Whenever any intermediate or restrictive physical intervention technique has
 been used in an emergency, the person's guardian, parent, actively involved
 family member, representative of the Consumer Advisory Board (for Willowbrook
 class members it fully represents), correspondent, or advocate must be notified
 within two business days after the intervention has been used, unless the
 person is a capable adult who objects to such notification.

(x)
 The use of any intermediate or
 restrictive physical intervention technique in an emergency more than two times
 in a 30-day period or four times in a six month period shall require a
 comprehensive documented review by the person's program planning team, in
 consultation with a licensed psychologist, a licensed clinical social worker,
 psychiatrist, or behavioral intervention specialist. The team shall determine
 if there is a need for a behavior support plan to address the exhibited
 behavior(s), a need to change an existing plan, or to establish the criteria
 for determining if a plan will need to be developed in the future.

(xi)
 The use of restrictive physical
 intervention techniques is not permitted in family care homes. The use of
 restrictive physical intervention techniques is not permitted in community
 habilitation unless specifically authorized by OPWDD.

(xii)
 The use of an intermediate or
 restrictive physical intervention technique that is not in conformance with the
 requirements of this section is considered to be a reportable incident and must
 be reported pursuant to Part 624 of this Title (except as noted in subparagraph
 (xiii) of this paragraph).

(xiii)

 Notwithstanding any other provision of this section, any physical contact that
 is necessary to address an immediate health or safety risk to the person or to
 others, and which does not involve the use of more force than necessary, shall
 not be considered a reportable abuse or restraint incident pursuant to Part 624
 of this Title or a violation of the requirements of this section. However, in
 the event that the level of physical contact would be considered to be
 comparable to an intermediate or restrictive physical intervention, the agency
 must comply with the provisions of subparagraphs (vii) -(ix) of this paragraph
 concerning visual inspection for possible injury and notifications. In
 addition, the person's program planning team must be notified. The person's
 program planning team shall consider whether changes might be needed in an
 existing behavior support plan or whether a plan needs to be
 developed.

(2)
 Rights
 limitations.
(i)
 The limitation of a person's
 rights as specified in section
 
633.4
 of this Part (including but
 not limited to: access to mail, telephone, visitation, personal property,
 electronic communication devices (
e.g
., cell phones,
 stationary or portable electronic communication or entertainment devices
 computers), program activities and/or equipment, items commonly used by members
 of a household, travel to/in the community, privacy, or personal allowance to
 manage challenging behavior) shall be in conformance with the following: 
 
(a)
 limitations must be on an individual
 basis, for a specific period of time, and for clinical purposes only;
 and

(b)
 rights shall not be limited
 for the convenience of staff, as a threat, as a means of retribution, for
 disciplinary purposes or as a substitute for treatment or
 supervision.

(ii)
 In an
 emergency, a person's rights may be limited on a temporary basis for health or
 safety reasons. A clinical justification must be clearly noted in the person's
 record with the anticipated duration of the limitation or criteria for removal
 specified.

(iii)
 The emergency or
 unplanned limitation of a person's rights more than four times in a 30 day
 period, or an ongoing limitation in place for more than 30 days, shall require
 a comprehensive documented review by the program planning team in consultation
 with the licensed psychologist, licensed clinical social worker, psychiatrist,
 or behavioral intervention specialist. The team shall determine if there is a
 need for a behavior support plan to address the exhibited behavior(s), a need
 to change an existing plan, or to establish the criteria for determining if a
 plan will need to be developed in the future.

(iv)
 Where applicable, documentation of
 rights modifications in the person-centered service plan is required in
 accordance with section
 
636-1.4
 of this Title.

(3)
 Time-out. 
 
(i)
 Time-out is a n intervention in which a
 person is temporarily removed from positive reinforcement or denied the
 opportunity to obtain reinforcement and during which the person is under
 constant visual and auditory contact and supervision. Timeout interventions
 include: 
(a)
 placing a person alone in a
 specific time-out room, commonly referred to as exclusionary
 time-out;

(b)
 removing the
 positively reinforcing environment from the individual, commonly referred to as
 non-exclusionary timeout.

(ii)
 Time away, when a person is redirected
 to a quieter or less stimulating area of the program and where staff do not
 actively prevent egress from that area, is not considered a form of
 exclusionary time-out.

(iii)

 Exclusionary time-out shall not be used in an emergency.

(iv)
 Requirements for the use of exclusionary
 time-out rooms.
(a)
 The placement of a person
 alone in a room from which his or her normal egress (ability to leave) is
 prevented by a staff member's direct and continuous physical action shall be
 considered exclusionary time-out (see glossary). The use of a time-out room
 shall be in conformance with the following: 
 
(1)
 such action shall be taken only in
 accordance with a person's behavior support plan;

(2)
 constant auditory and visual contact
 shall be maintained. If at any time the person is engaging in behavior that
 poses a risk to his or her health or safety staff must intervene.

(b)
 The use of a time-out room
 where normal egress is prevented, or placement of a person in a secured room or
 area from which he or she cannot leave at will, and which is not in conformance
 with the requirements of this section is considered a reportable incident,
 pursuant to Part 624 of this Title.

(c)
 The maximum duration of time a person can
 be placed in a time-out room shall not exceed one continuous hour. Use of a
 time-out room on five or more occasions within a 24-hour period shall require
 the review of the behavior support plan by the program planning team in
 consultation with the licensed psychologist, licensed clinical social worker,
 psychiatrist, or behavioral intervention specialist within three business
 days.

(d)
 Each use of a time-out
 room in accordance with an individual's behavior support plan shall be reported
 electronically to OPWDD in the form and format specified by OPWDD.

(e)
 Any time a room is to be used for
 exclusionary time-out, that room must meet the following stipulations: 
 
(1)
 The room must be designated for time-out
 use by the chief executive officer and approved by the agency's governing body.
 Both the design and statement of intended use shall be approved by
 OPWDD.

(2)
 Time-out rooms are not
 permitted in family care homes.

(3)

 Environmental requirements are set forth as follows. Except as provided in
 subclause (
4
) of this clause, the room shall conform to the
 following requirements:
(i)
 Size: The minimum
 measurements of the room shall be 6' length x 8' wide x 8' height.

(ii)
 Decoration: Colors are selected to
 create a calm, relaxed atmosphere.

(iii)
 Electrical: 
 
(A)
 There shall be no electrical fixtures,
 outlets, switches, or wiring which may cause harm or injury to a
 person.

(B)
 There shall be no
 protruding light fixtures on any ceiling lower than 10' in height.

(C)
 There shall be no protruding light
 fixtures on any wall.

(D)
 Recessed
 light fixtures shall be designed to withstand tampering or destruction by the
 person in the room.

(E)
 Sprinkler
 heads, if provided, shall be the concealed type.

(iv)
 Pipes: There shall be no exposed pipes.
 Coverings shall be designed to prevent the possibility of any pipes being
 grasped by the person.

(v)
 Holes:
 There shall be no exposed holes.

(vi)
 Protrusions: There shall be no
 protrusions on which a person might be injured. There shall be no protruding
 doorknob in the room. If the door is sufficiently padded to recess the knob,
 but still cause it to be accessible, this is permissible.

(vii)
 Glass: The use of glass shall be
 minimized and unbreakable glass should be used whenever possible. Coverings for
 glass that is breakable are to be designed in such a way as to prevent being
 grasped by the occupant. Mirrors must be non-breakable.

(viii)
 Padding: Padding or resilient wall
 covering shall be affixed to walls and the floor in such a fashion that it
 cannot be easily removed by the occupant. Provisions shall be made for the
 removal of the padding or wall covering for cleaning, repairing or altering of
 any such material (
e.g
., padding fastened securely to plywood
 panels which are then screwed to the walls), unless the wall surface cover is
 such that it can be cleaned, maintained, and repaired in place. In facilities
 where the interior finish rating is required (
i.e
., Life
 Safety Code compliant facilities) the finish rating of the wall or floor
 surfaces shall be equal to or greater than that required by the Life Safety
 Code.

(ix)
 Occupant comfort: 
 
(A)
 There shall be adequate measurement
 equipment to ensure control of temperature, humidity and circulation of air
 within the room.

(B)
 The floor
 surface covering shall be consistent with the needs of the person using the
 room.

(x)
 Soundproofing:
 If soundproofing of the time-out room is necessary for the comfort of other
 people receiving services, it shall be determined if there will be sufficient
 transmittal of sound (
e.g
., adequate to hear words spoken by
 the person within the room) through the observation window or whether other
 means of maintaining auditory contact are necessary.

(xi)
 Furnishings: There shall be no furniture
 or other objects in the room.

(xii)

 Observation:
(A)
 Observation windows shall not
 be covered by mesh, bars, or wire material.

(B)
 An opening containing only mesh, bars, or
 wire material shall be unacceptable as an "observation window."

(C)
 The viewing area shall be sufficiently
 large to maximize visual observation. The person shall be in at least partial
 view at all times (
i.e
., there must be no blind areas large
 enough for the person to be completely out of sight). This shall not be
 construed to mean that the design of the room must provide for the capability
 of observing every action, facial expression, etc., should the person be
 standing/sitting in such a position or location that limits the view.

(D)
 The viewing area shall be designed to be
 functional, taking into account the comfort and suitability for use by
 staff.

(xiii)
 Windows
 (other than observation windows) shall be completely covered with a false wall
 to ensure the person's safety and to eliminate distraction and/or visual
 stimulation in what is intended to be a non-stimulating environment.

(xiv)
 Doors shall swing outward from the
 inside. Doors may be locked only by the continuous physical action of staff.
 The door release mechanism must be designed in such a way that if staff are not
 applying pressure, or physically holding the release mechanism, the door lock
 automatically releases.

(xv)
 Door
 thresholds shall not protrude creating a trip hazard. These shall be flush with
 the floor or ramped.

(xvi)
 There
 shall be a clock visible to staff to monitor the duration of the
 time-out.

(xvii)
 The room must be
 cleaned and disinfected regularly and after each use.

(4)
 Exceptions to specific physical plant
 requirements in subclause (
3
) of this clause. 
 
(i)
 OPWDD may waive specific physical plant
 requirements upon the application of an agency.

(ii)
 Time-out rooms which were in existence
 on April 1, 2013 are not required to comply with the specific physical plant
 requirements if the time-out room was approved by OPWDD prior to April 1, 2013.
 A new OPWDD waiver is not required in this situation. However, OPWDD approval
 is required for any significant modification of such time-out room which occurs
 on or after April 1, 2013.

(5)
 If a time-out room must be secured when
 not in use, the mechanism used for this purpose shall be such that the door can
 be opened, at will, from the inside.

(4)

Blocking pads.

(i)
 General provisions. 
 
(a)
 Blocking pads shall be employed: 
 
(1)
 Only as a means to protect individuals or
 staff from harm.

(2)
 Only in a
 defensive or protective manner.

(b)
 Blocking pads may not be used: 
 
(1)
 In an offensive manner to move,
 physically redirect, push back, or physically contain a person.

(2)
 To strike or hit an individual.

(3)
 To remove an individual from an
 area.

(4)
 To trap or contain a
 person against a wall, corner, room, or ground.

(5)
 For the purpose of blocking or preventing
 a person from leaving a room or otherwise creating a situation that is
 effectively exclusionary "time out" as defined by this regulation.

(ii)
 The use of
 blocking pads to prevent or minimize harmful consequences related to
 challenging behavior shall be in conformance with the following: 
 
(a)
 Planned use of blocking pads shall be
 specified in the individual's behavior plan.

(b)
 Blocking pads are not to be viewed as
 therapeutic or used in lieu of an ongoing comprehensive treatment plan designed
 to reduce or eliminate challenging behavior.

(c)
 The use of blocking pads shall be
 documented.

(d)
 The use of blocking
 pads in an emergency situation without a behavior plan is permitted. If
 blocking pads have been used in an emergency more than six times in a six-month
 period, the team shall meet to determine whether the implementation of a
 behavior plan is necessary.

(e)

 Blocking pads shall be maintained in a clean and sanitary condition and in good
 repair.

(f)
 Agency
 policies/procedures governing the use of blocking pads shall address the
 sanitizing of the devices. 

(g)
 The
 behavior support plan shall specify the following conditions for the use of
 blocking pads: 
(1)
 the facts justifying the
 use of the pads;

(2)
 staff or
 family care provider action required when the pads are used;

(3)
 a description of how the use of the pads
 is expected to be reduced and eventually eliminated.

(5)
 Mechanical
 restraining devices. 
(i)
 General provisions. 
 
(a)
 Mechanical restraining devices shall be
 employed:
(1)
 in accordance with the
 principles of correct body alignment;

(2)
 in a manner that does not interfere with
 circulation and respiration; and

(3)
 with concern for a person's
 comfort.

(b)
 Mechanical
 restraining devices shall only be used in a manner consistent with the
 provisions of this section. Any other use shall be reported as a reportable
 incident in conformance with Part 624 of this Title.

(c)
 The use of mechanical restraining devices
 in an emergency is not permitted.

(d)
 Mechanical restraining devices used as a
 support to achieve proper body position, balance, or alignment, as part of a
 medical or dental procedure or as a medical or dental safeguard are not subject
 to the requirements of this section.

(e)
 Mechanical restraining devices shall be
 maintained in a clean and sanitary condition, and in good repair.

(f)
 Agency policies/procedures governing the
 use of mechanical restraining devices shall address the sanitizing and storage
 of, and methods of limiting access to, the devices.

(g)
 Helmets with any type of chin strap shall
 not be used while a person is in the prone position, reclining, or while
 sleeping, unless specifically approved by OPWDD.

(h)
 Barred enclosures and the use of bed
 linen employed to restrain movement shall be prohibited under all
 circumstances.

(i)
 Nothing in this
 section shall preclude the use of a mechanical restraining device(s) while a
 person is an inpatient or resident under the auspices of a non-OPWDD operated
 or certified facility, program or service (
e.g
., mental health
 provider, medical hospital, or jail). The use of a mechanical restraining
 device in these types of settings is not subject to the provisions of this
 section and is subject instead to the applicable policies and rules of that
 provider. The use of mechanical restraining devices in such settings is not
 subject to the requirements of this section or Part 624 of this
 Title.

(j)
 The use of devices to
 limit movement for the safe transport of the individual in vehicles,
 wheelchairs, etc., is not considered to be the use of a mechanical restraining
 device, and is not subject to the requirements of this section.

(ii)
 Planned use of mechanical
 restraining devices.
(a)
 Mechanical
 restraining devices to prevent or modify challenging behavior may only be used
 in accordance with a behavior support plan if the devices meet the following
 criteria:
(1)
 the device shall be designed and
 used in such a way as to minimize physical discomfort and to avoid physical
 injury;

(2)
 the device shall be
 commercially available (including situations in which a device has been
 specifically designed or adapted for the individual by a health care
 professional) and designed for human use. Alternatively, if the device is not
 commercially available or is not designed for human use (
e.g
.,
 modification of a commercially available device), it must be approved by the
 behavior plan/human rights committee and approved by OPWDD; and

(3)
 an occupational or physical therapist has
 been consulted if modification of the device is needed.

(b)
 The following types of devices (in the
 specified circumstances) may be used without specific OPWDD approval: 
 
(1)
 mittens, helmets, face masks, goggles,
 and sleeve boards (by whatever name known), modified clothing;

(2)
 lap trays, seatbelts, and harnesses; only
 when used to maintain an ambulatory person in a fixed location for the purpose
 of enhancing services; and

(3)
 the
 use of a seatbelt, harness, or mechanical brake to maintain a non-ambulatory
 person in a fixed location for the purpose of preventing risk to health or
 safety resulting from challenging behavior.

(c)
 The use of devices other than as
 specified in clause (
b
) of this subparagraph is permitted only
 if specifically approved by OPWDD.

(d)
 Application to obtain the approval of
 OPWDD to use a specific mechanical restraining device shall be submitted by the
 chief executive officer and shall include such information as may be required
 by OPWDD.

(e)
 The behavior support
 plan, consistent with the physician's order (see clause [g] of this
 subparagraph) shall specify the following conditions for the use of a
 mechanical restraining device:
(1)
 the facts
 justifying the use of the device;

(2)
 staff or family care provider action
 required when the device is used;

(3)
 criteria for application and removal and
 the maximum time period for which it may be continuously employed, see clause
 (
i
) of this subparagraph;

(4)
 the maximum period of time for monitoring
 the person's needs, comfort, and safety, see clause (
j
) of
 this subparagraph; and

(5)
 a
 description of how the use of the device is expected to be reduced and
 eventually eliminated.

(f)
 A behavior support plan may include the
 use of mechanical restraining devices to enable a person to participate safely
 and effectively in habilitative programming, recreation, social, and/or other
 activities. The plan shall be designed to reduce the frequency/severity of the
 challenging behavior so that non-restrictive/non-intrusive means of managing
 and eliminating challenging behavior(s) can be implemented.

(g)
 A physician's order is required for the
 use of a mechanical restraining device as part of a behavior support plan. The
 order shall be renewed as specified in the plan, but in all cases no less
 frequently than every six months. The order shall: 
 
(1)
 specify the type of device to be
 used;

(2)
 set forth date of
 expiration of the order;

(3)

 specify any special considerations related to the use of the device based on
 the person's medical condition, including whether the monitoring which is
 required during and after use of the device must incorporate specific
 components such as checking of vital signs and circulation; and

(4)
 be retained in a person's clinical record
 with a full record of the use of the device.

(h)
 Notwithstanding any other provision of
 this section, if the device is used solely to maintain an ambulatory person in
 a fixed location or position for the purpose of enhancing the delivery of
 services a physician's order is not required. This use must conform to all
 other requirements of this paragraph, including the requirements for release
 specified in clause (
i
) of this subparagraph.

(i)
 Release from the device: 
 
(1)
 Except when asleep a person in a
 mechanical restraining device shall be released from the device at least once
 every hour and fifty minutes for a period not less than 10 minutes, and
 provided the opportunity for movement, exercise, necessary eating, drinking and
 toileting. In the case of modified clothing only; removal from the clothing
 shall occur as specified in the physician's order and consistent with the
 behavior plan, and at other appropriate times (e.g., changing, toileting,
 comfort needs).

(2)
 If the person
 requests release for movement or access to a toilet before the specified time
 period has elapsed, this should be afforded to him/her as soon as
 possible.

(3)
 If the person has
 fallen asleep while wearing a mechanical device, opportunity for movement,
 exercise, necessary eating, drinking and toileting shall always be provided
 immediately upon wakening if more than one hour and fifty minutes has elapsed
 since the device was employed or the end of the last release period.

(4)
 If a physician specifies a shorter period
 of time for release, the person shall be released in accordance with the
 physician's order.

(j)

 At least once every 30 minutes (60 minutes for modified clothing), including
 when a person is asleep, or more frequently if directed by a physician or
 previously designated in a risk management or behavior support plan, the
 person's physical needs, comfort, and safety shall be monitored. Monitoring
 shall incorporate any specific components that are included in the physician's
 order (
e.g
., checking vital signs, skin integrity, and
 circulation). If the person is asleep, this monitoring shall be completed
 through observation only while not awakening the person. The person shall also
 be monitored after removal of the mechanical restraining device. Documentation
 of the monitoring and action taken must be entered in the person's clinical
 record.

(k)
 If, upon being released
 from a mechanical restraining device before the time limit specified in the
 order, a person makes no overt gesture(s) that would threaten serious harm or
 injury to self or others, the mechanical restraining device shall not be
 reemployed by staff unless the behavior which necessitated the use of the
 device reoccurs.

(l)
 The planned
 use of a device which will prevent the free movement of both arms or both legs,
 or totally immobilize the person, may only be initiated by a written order from
 a physician after the physician's personal examination of the person. The
 physician must review the order and determine if it is still appropriate each
 time he or she examines the person, but at least every 90 days. The review must
 be documented. The planned use of stabilizing or immobilizing holds or devices
 during medical or dental examinations, procedures, or care routines must be
 documented in a separate plan/order and must be reviewed by the program
 planning team on at least an annual basis.

(m)
 A device which will prevent the free
 movement of both arms or both legs or totally immobilize the person may only be
 applied under the supervision of a senior member of the staff or, in the
 context of a medical or dental examination or procedure, under the supervision
 of the healthcare provider or staff designated by the healthcare provider.
 Staff assigned to monitor a person while in a mechanical restraining device
 that totally immobilizes the person shall stay in continuous visual and
 auditory range for the duration of the use of the device.

(6)
 Medication. 
 
(i)
 General provisions. 
 
(a)
 All use of medication must be in
 conformance with Part 624 of this Title and sections
 
633.4
,
 
633.10
 and
 
633.17
 of this Part.

(b)
 The use of medication to prevent, modify,
 or control challenging behavior or to treat symptoms of a co-occurring
 diagnosed psychiatric disorder shall not: 
(1)

 replace the need to develop an appropriate program plan;

(2)
 be intentionally administered in amounts
 that interfere with a person's ability to participate in programming or other
 activities;

(3)
 be used for
 disciplinary purposes; or

(4)
 be
 used for the convenience of staff or as a substitute for supervision.

(c)
 The use of medication to
 prevent, modify, or control challenging behavior, or to treat a co-occuring
 diagnosed psychiatric disorder, not in conformance with this paragraph, shall
 constitute abuse and must be reported in conformance with Part 624 of this
 Title. The use of medication prescribed or administered to individuals in
 conjunction with, or to facilitate or relieve distress related to medical or
 dental examinations or procedures is not subject to the requirements of this
 section.

(d)
 A medication regimen
 review that includes any medications prescribed to treat a co-occurring
 diagnosed psychiatric disorder, or to prevent, modify, or control challenging
 behavior(s), must be conducted in accordance with section
 
633.17
 of this Part:The results of
 these medication regimen reviews shall be shared with the person's program
 planning team and the prescriber, and documented in the person's record, in
 order to assist healthcare providers and the team to evaluate whether the
 benefits of continuing the medication(s) outweigh the risk inherent in
 potential side effects.

(e)
 At
 least semi-annually, and more frequently as needed, staff shall consult with
 the prescriber regarding the administration and continued effectiveness of the
 medication.

(f)
 It shall be the
 responsibility of the agency to ensure that the person or the party granting
 informed consent has been given clear, necessary information regarding the
 proposed medication including, but not limited to, its purpose, and the dose or
 dosage range and route of administration. (See subparagraph [b][13][ii] of this
 section for the basic elements of the information necessary for informed
 consent.)

(g)
 Lack of informed
 consent for, or the refusal of, medication intended to prevent, modify, or
 control challenging behavior, or medication used to treat a co-occurring
 diagnosed psychiatric disorder is addressed in subdivision (h) of this
 section.

(ii)

 Planned/routine use of medication. 
(a)

 Medication to prevent, modify, or control challenging behavior, or to treat
 symptoms of a co-occurring diagnosed psychiatric disorder, must be administered
 only as an integral part of a behavior support plan or monitoring plan, in
 conjunction with other interventions which are specifically directed toward the
 potential reduction and eventual elimination of the challenging behavior(s) or
 target symptoms of the co-occurring diagnosed psychiatric disorder.

(b)
 Written informed consent shall be
 obtained prior to the use of the medication. If it is necessary for the
 medication to be administered before written informed consent can reasonably be
 obtained, verbal consent may be accepted for only the period of time before
 written informed consent can be obtained. Verbal consent must be witnessed by
 two members of the staff and documented in the person's record. This verbal
 consent may be considered valid for a period of up to 45 days.

(c)
 The use of medication shall have a
 documented positive effect on the person's behavior or target symptoms to
 justify its ongoing use.

(d)
 The
 effectiveness of the medication shall be re-evaluated at least semi-annually at
 the program plan reviews by the program planning team in consultation with a
 licensed psychologist, licensed clinical social worker, psychiatrist, or
 behavior intervention specialist, and a health care professional. The goal(s)
 of this aspect of the plan review include: ensuring that medication is at the
 minimum and most effective dose; identifying a potential need for a medication
 with fewer or less intrusive side effects; evaluating the evidence presented to
 support continuation of the medication at a maintenance level, or recommending
 reduction or discontinuation of medication use if clinically indicated and
 authorized by the prescriber.

(e)

 Additional requirements concerning the use of medication to treat a
 co-occurring diagnosed psychiatric disorder are found in subparagraph (vi) of
 this paragraph.

(iii)

 Planned use of as-needed orders for medication. 
 
(a)
 As-needed (also known as PRN) orders for
 medication to prevent, modify, or control challenging behavior, or to treat
 symptoms of a co-occurring diagnosed psychiatric disorder, are considered
 planned use and must be incorporated in and documented as part of a behavior
 support plan or a monitoring plan.

(b)
 The person shall have a recent documented
 history of displaying the behavior(s) or symptoms (occurring in the last 12
 months) for which the as-needed medication is being prescribed.

(c)
 The behavior support plan or monitoring
 plan, consistent with the prescriber's order, shall clearly state: 
 
(1)
 the conditions under which the as-needed
 medication is to be administered, including the nature and degree of the
 individual's behavior(s) or symptoms, and the prescriber's recommendations
 regarding proximity to any scheduled medication administration;

(2)
 the expected therapeutic effects;
 and

(3)
 if applicable, the
 conditions under which the medication can be re-administered, and the allowable
 frequency of re-administration.

(d)
 The staff person or family care provider
 who is responsible for support and supervision of a person who has a behavior
 support plan or monitoring plan must document in the person's clinical record a
 summary of the results of each medication use in behavioral terms.

(e)
 Results that are substantively different
 from the intended effect, and any adverse side effects, shall be reported to
 the prescriber immediately and the person's program planning team no later than
 the next business day.

(f)
 If any
 as-needed medication is administered on more than four separate days (one day
 equals 24 hours) in a 14-day period, the individual's program planning team, in
 consultation with the licensed psychologist, licensed clinical social worker,
 or behavioral intervention specialist and healthcare professional, must
 reassess the appropriateness of continuing the as-needed medication, or
 consider recommending that it be incorporated into the individual's regular
 drug regimen.

(g)
 Each use of an
 as-needed medication when used in conjunction with a restrictive physical
 intervention technique to prevent, modify, or control challenging behavior
 shall be reported electronically to OPWDD in the form and format specified by
 OPWDD.

(h)
 If the as-needed
 medication is not administered during a sixmonth period, the program planning
 team, in consultation with the licensed psychologist, licensed clinical social
 worker, psychiatrist, or behavioral intervention specialist, must review the
 behavior support plan and develop a recommendation to the prescriber regarding
 the appropriateness of continuing the as-needed medication as part of the plan.
 If the order is continued, a clear justification is to be documented in the
 record.

(iv)
 Emergency
 use of medication.
(a)
 Medication may be
 administered in an emergency, without informed consent, with the express intent
 of controlling a person's challenging behavior or acute symptoms of a
 co-occurring diagnosed psychiatric disorder when: 
 
(1)
 the person's behavior constitutes an
 immediate risk to the health or safety of the person or others; or

(2)
 in a physician's judgment, an emergency
 exists that creates an immediate need for the administration of such
 medication, and an attempt to secure informed consent would result in a delay
 which would increase the risk to the health or safety of the person or
 others.

(b)
 The
 administration of such medication may only continue for as long as one of the
 conditions in clause (
a
) of this subparagraph
 exists.

(c)
 The use of the
 medication, along with the prescription/order and a note on its effectiveness,
 shall be documented in the person's record.

(d)
 The emergency use of medication to
 control challenging behavior or acute symptoms of a co-occurring diagnosed
 psychiatric disorder in more than four instances in a 14-day period shall
 require a comprehensive review by the program planning team in consultation
 with the licensed psychologist, a licensed clinical social worker,
 psychiatrist, or behavioral intervention specialist within three business days
 of the fifth medication administration.
(1)

 The team shall determine if there is a need for a behavior support plan to
 address the behavior or symptom that necessitated the emergency use of
 medication, or a need to modify an existing plan, or to establish the criteria
 for a future decision that a plan will be needed. Such a determination shall be
 documented.

(2)
 The emergency
 administration of the medication may continue until the program planning team
 meets.

(e)
 Whenever it is
 or has been necessary to use any medication to control challenging behavior or
 acute symptoms of a co-occurring diagnosed psychiatric disorder in an
 emergency, the duly authorized surrogate consent giver in accordance with
 paragraph (g)(6) of this section, the service coordinator or party designated
 as responsible for coordinating a person's plan of services, and the
 appropriate clinician (
e.g.,
 licensed psychologist, licensed
 clinical social worker, behavioral intervention specialist, physician), if
 applicable, shall be notified within the next two business days.

(f)
 Each use of an emergency medication to
 control challenging behavior shall be reported electronically to OPWDD in the
 form and format specified by OPWDD.

(v)
 Short-term use of medication when there
 is no behavior support plan.
(a)
 This
 subparagraph does not apply to ICFs. (ICFs must comply with 42 CFR 
483

 .)

(b)
 In the absence of a behavior
 support plan that incorporates the use of specific medications to prevent,
 modify, or control challenging behavior, such medication may be administered on
 a short-term basis when all of the following conditions are met: 
 
(1)
 an untoward or unanticipated condition,
 reaction, symptom, event or situation has occurred which creates exceptional
 circumstances that, if left untreated could potentially lead to an emergency
 situation;

(2)
 the circumstances
 resulting from the event are expected to last for a time period longer than
 that which can be considered an emergency;

(3)
 the medication is deemed to be the most
 effective course of treatment; and

(4)
 the medication is ordered by a
 prescriber.

(c)
 Informed
 consent is required prior to the administration of the medication. If it is
 necessary for the medication to be administered before written informed consent
 can be reasonably obtained, verbal consent may be accepted for only the period
 of time before written informed consent can be reasonably obtained, but no
 longer than 45 days. Verbal consent must be witnessed by two members of the
 staff and documented in the person's record.

(d)
 Within five working days of the first
 administration of the medication or of the admission to such programs of a
 person with such a pre-existing medication regimen, a person's program planning
 team, in consultation with a licensed psychologist, licensed clinical social
 worker, psychiatrist, or behavioral intervention specialist, shall conduct a
 review of the circumstances which necessitated the use of such medication. The
 program planning team shall determine if it is necessary to develop a behavior
 support plan to prevent, modify, or control the behavior or to modify an
 existing plan of services, or shall establish the criteria for a future
 decision that a plan will be needed. All determinations shall be
 documented.

(e)
 Without
 incorporation into a behavior support plan and written informed consent, the
 administration of the medication shall not continue for more than 45
 consecutive days.

(vi)

 Medication use to treat a co-occurring diagnosed psychiatric disorder.
 Medication may be used as part of the treatment for the symptoms of a
 co-occurring diagnosed psychiatric disorder, including challenging behavior
 that occurs exclusively or almost exclusively as a result of that disorder. In
 such circumstances, the following requirements must be met. 
 
(a)
 In order to be considered "medication to
 treat a co-occurring diagnosed psychiatric disorder," the medication must be
 prescribed for the treatment of a specific psychiatric disorder, in a manner
 consistent with generally accepted psychiatric practice.

(b)
 The term 
psychiatric
 disorder
 means those psychiatric disorders which are recognized as
 such by the American Psychiatric Association or World Health Organization. For
 the purposes of this section, the term 
co-occurring psychiatric
 disorder
 does not refer to the following: intellectual disability,
 specific learning disorder, motor disorders, communication disorders, autism
 spectrum disorder, social (pragmatic) communication disorder,
 attention-deficit/hyperactivity disorder and disruptive, impulse-control, and
 conduct disorders.

(c)
 The use of
 the medication must be in conformance with the applicable requirements of
 subparagraph (j)(5)(i) of this section.

(d)
 The use of the medication shall be
 consistent with accepted standards of clinical practice, including treatment of
 the symptoms of the diagnosed psychiatric disorder.

(e)
 The symptoms and diagnosis of the
 co-occurring psychiatric disorder must be documented.

(f)
 Target symptoms for the psychiatric
 disorder shall be identified and documented in practical, operationally defined
 terms to permit reliable, ongoing data collection and assessment of treatment
 effectiveness.

(g)
 The use of
 medication and the target symptoms shall be specified and documented in a
 written monitoring plan. The plan must specify how progress reflected in
 symptom reduction and relevant functional improvement, or lack of progress,
 will be measured and documented. If all of the requirements of this clause are
 met, the agency is not required to conduct and document a functional behavioral
 assessment or develop a behavior support plan, as long as other behavioral
 interventions are not needed for the individual to address challenging
 behaviors which do not reflect the psychiatric symptomatology. The monitoring
 plan shall describe how challenging behavior(s) -- including those that reflect
 psychiatric symptomatology, should they occur -- will be addressed through the
 use of other appropriate interventions. If it is expected that the person might
 need restrictive/intrusive interventions, a functional behavioral assessment
 and behavior support plan must be developed.

(h)
 Informed consent must be obtained for the
 use of the medication.

Notes

N.Y. Comp. Codes
 R. & Regs. Tit. 
14

 §
 
633.16

Amended
 
New
 York State Register December 2, 2015/Volume XXXVII, Issue 48
,
 eff. 
12/2/2015

Amended
 
New
 York State Register September 21, 2016/Volume XXXVIII, Issue 38
,
 eff. 
9/21/2016

Amended
 
New
 York State Register September 27, 2017/Volume XXXIX, Issue 39
,
 eff. 
9/27/2017

Amended
 
New
 York State Register April 28, 2021/Volume XLIII, Issue 17
, eff.
 
4/28/2021

Amended
 
New
 York State Register June 14, 2023/Volume XLV, Issue 24
, eff.
 
6/14/2023

State regulations are updated quarterly; we currently have two versions available.
 Below is a 
comparison between our most recent version and the prior quarterly release.

 More comparison features will be added as we have more versions to compare.

(a)
 
Applicability.
 
(1)
 This section applies to: 
(i)
 all residential facilities certified or operated by OPWDD, including family care homes;
 
(ii)
 all facilities certified by OPWDD, except:
(a)
 Free standing respite, except as described in Part 635-10.5(h).
 
(b)
 clinic treatment facilities (see Part 679 of this Title); and
 
(c)
 diagnostic and research clinics (see Part 676 of this Title);

(iii)
 day habilitation services (whether or not provided in a certified facility);
 
(iv)
 prevocational services (whether or not provided in a certified facility); and
 
(v)
 community habilitation (both hourly and Phase II).

(2)
 The requirements of this section concerning the use of medication only apply to residential facilities which are certified or operated by OPWDD, including family care homes.
 
(3)
 Intermediate Care Facilities (see Part 681 of this Title) should note that they must also comply with the requirements of 42 CFR 
483
 . In some instances, these Federal requirements are more stringent than the requirements of this section.
 
(4)
 This section is effective on April 1, 2013.
 
(5)
 The requirements of this section are applicable for new behavior support plans (not revisions or renewals of previously existing plans) May 31, 2013. This includes provisions for obtaining informed consent for the plans, if required.
 
(6)
 The requirements of this section are applicable for behavior support plans which are revisions or renewals of previously existing plans May 31, 2014. This includes provisions for obtaining informed consent for the plans, if required.

(b)
 
Definitions.
 
As used in this section.
 
(1)
 
Approve/approving
. The determination by the behavior plan/human rights committee established pursuant to subdivision (f) of this section, that it has authorized the implementation of a proposed behavior support plan which incorporates restrictive/intrusive interventions and/or limitations on a person's rights as specified in paragraph (f)(3) of this section.
 
(2)
 
Assessment, functional behavioral
. A process intended to: identify and operationally describe challenging behavior(s); identify the function(s) or purpose(s) for challenging behavior; and to identify the specific environmental stimuli or conditions that are maintaining the challenging behavior(s). (See subdivision [d] of this section.)
 
(3)
 
Aversive conditioning
. See conditioning, aversive.
 
(4)
 
Behavior, challenging
. Challenging behavior may take many forms, including undesirable and/or socially unacceptable behavior that interferes with the acquisition or use of desired skills or knowledge, interferes with the performance of everyday activities, undermines the potential for increased self-determination and independence, interferes with the rights of others, disrupts social functioning, and/or causes injury to self or others. These may include psychiatric symptoms or overt reactions to symptoms that may be expressed as challenging behaviors (
e.g
., manic behavior, aggressive behavior, compulsive behavior or verbal threats based on paranoid beliefs or perceptions).
 
(5)
 
Behavior support plan
. See plan, behavior support.
 
(6)
 
Behavior, modifying/managing challenging
. 
Modifying/managing
 means using behavioral interventions and/or other psychological treatment approaches that are expected to result in the prevention or elimination of challenging behavior, foster the development of new adaptive (replacement) behaviors, increase or maximize existing adaptive behaviors, or minimize undesirable behaviors.
 
(7)
 
Behavior, controlling challenging
. 
Controlling
 means using interventions in a behavioral event to prevent or contain challenging behavior, so as to constrain, restrain or otherwise limit or restrict that behavior for the protection of the person and/or others.
 
(8)
 
Behavioral intervention specialist
 (see specialist, behavioral intervention.)
 
(9)
 
Committee, behavior plan/human rights
. A committee which has the responsibility to protect the rights of persons whose behavior support plans incorporate the use of any restrictive/intrusive intervention and/or limitation on a person's rights in order to prevent, manage, and/or control challenging behavior, and which exercises this responsibility through the process of reviewing and approving proposed behavior support plans.
 
(10)
 
Committee, informed consent
. A committee which has the authority to give informed consent for a behavior support plan incorporating the use of any restrictive/intrusive intervention and/or the use of medication to treat a co-occurring diagnosed psychiatric disorder, or for short-term use of medication with no behavior support plan, when the individual lacks capacity to consent and there is no other authorized surrogate available (except for a court). (See subdivision [g] of this section.)
 
(11)
 
Conditioning, aversive
. The contingent application of a physical stimulus or device to a person's body or senses in order to modify or change behavior. Such a stimulus or device must be reasonably considered to be uncomfortable, painful, or noxious to the person when applied. Examples of such stimuli may include, but are not limited to: water and other mists or sprays, noxious odors (
e.g
., ammonia), noxious tastes (
e.g
., hot sauce), corporal punishment (
e.g
., slapping, spanking, hitting, or pinching), air blasts, blindfolds, white noise helmets, and electric skin shock (see paragraph [15] of this subdivision).
 
(12)
 
Conflict of interest
. See Interest, conflict of.
 
(13)
 
Consent, informed.
 
(i)
 For the purposes of this section, 
informed consent
 shall mean the effective knowing consent by a person (or his/her legally authorized surrogate) with sufficient capacity to consent and so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion. Such consent shall be in writing, except in the case of the short-term use of medication pursuant to subparagraph (j)(5)(v) of this section and as provided in paragraph (g)(1) of this section.
 
(ii)
 The basic elements of information necessary to such informed consent include: 
(a)
 a fair explanation to the person or surrogate of the procedures to be followed, and their purposes;
 
(b)
 a description of any potential discomforts and risks which may reasonably be expected;
 
(c)
 a description of any benefits to the participant which may reasonably be expected;
 
(d)
 a disclosure of appropriate alternative procedures, if any; and
 
(e)
 an instruction that the person or surrogate is free to withdraw his or her consent at any time without prejudice.

(iii)
 No informed consent shall include any language through which the person or surrogate waives, or appears to waive, any legal right, including the release of any party, institution, agency, or any agents thereof, from liability from negligence.
 
(iv)
 Information about planned interventions must be presented in a manner that permits a knowledgeable evaluation and decision to be made. It must be presented in simple terms, in whatever language the party giving informed consent reads or understands most easily and clearly (
e.g
., English, Spanish, Mandarin), and in whatever manner he or she understands most easily and clearly (
e.g
., sign language, communications board, computer assisted technology, Braille). Consent, when given by a surrogate, should only be given if, in doing so, this will be in the person's best interest and takes into consideration, to the extent possible, the person's opinions, beliefs and wishes.

(14)
 
Device, mechanical restraining
. Any physical apparatus or equipment used to limit or control challenging behavior. This apparatus or equipment cannot be easily removed by the person and may restrict the free movement, or normal functioning, or normal access to a portion or portions of a person's body, or may totally immobilize a person. (See paragraph [j][4] of this section for requirements specific to the use of mechanical restraining devices.)
 
(15)
 
Electric skin shock
. The application to a person's body of an electronic skin shock device in an effort to modify or change behavior. Such a device is reasonably considered to be uncomfortable, painful, or noxious to the person when applied. This definition is not applicable to the use of electroconvulsive therapy provided in a hospital setting and used as a treatment for specific psychiatric disorders.
 
(16)
 
Emergency
. A term that describes a situation posing an immediate health or safety risk to the person or to others that is unexpected, unforeseen, or unanticipated, and for which procedures have not been specified in a person's behavior support plan to address how the staff is to handle the emergent situation.
 
(17)
 
Functional behavioral assessment
. See assessment, functional behavioral.
 
(18)
 
Guardian
. A party appointed by a court of competent jurisdiction to make or assist a person to make personal and/or financial decisions in situations in which the person is deemed not to have capacity to make those decisions.
 
(19)
 
Immobilize, totally
. The complete curbing of the movement of both arms and both legs, and/or torso through the use of (but not limited to): 
(i)
 securing of arms and legs directly to another object (
e.g
., straps on a chair, papoose board); or
 
(ii)
 four point restraints.

(20)
 
Instructor
. A party employed by OPWDD, or by an agency certified or authorized by OPWDD, who has been approved to teach a curriculum approved by OPWDD on the use of positive behavioral approaches, strategies and/or supports and physical intervention techniques.
 
(21)
 
Instructor-trainer
. A party employed by OPWDD, or by an agency certified or authorized by OPWDD, who has been approved to teach a curriculum approved by OPWDD on the use of positive behavioral approaches, strategies and/or supports and physical intervention techniques and further certified by OPWDD to train, mentor and certify new Instructors in the teaching and implementation of the training curriculum. An instructor-trainer also reviews and/or approves modified physical intervention techniques as necessary.
 
(22)
 
Interest, conflict of
. Any real or perceived financial, personal or other interest, which may impede the impartial discharge of the party's duties.
 
(23)
 
Intervention, physical
. Those intervention techniques, or the adaptations of such, that either include hands-on techniques that deflect, protect from, or release hits, kicks or grabs by persons receiving services toward others in their environment, or holds of limited duration that may reduce, limit, or restrict an individual's freedom of movement in order to interrupt or control challenging behavior that is posing an immediate health or safety risk to the person or to others. (See paragraph [j][1] of this section for requirements specific to the use of physical intervention techniques.) There are three categories of physical intervention techniques:
(i)
 protective techniques, which include blocks, deflection strategies and grab releases;
 
(ii)
 intermediate techniques, which include holds and escorts intended to maintain a person in a standing or seated position to reduce or limit movement, to maintain health and safety, and/or to remove a person from an unsafe location or situation; and
 
(iii)
 restrictive techniques, which include holds that restrict freedom of movement in order to interrupt or control behavior that is posing an immediate health or safety risk to the person or to others and involve taking a person from a standing position to the floor and holding the person on the floor.

(24)
 
Intervention, restrictive/intrusive
. These interventions include the following: 
(i)
 intermediate and/or restrictive physical intervention techniques (see paragraph [j][1] of this section);
 
(ii)
 the use of time-out (exclusionary and non-exclusionary) (see paragraph [j][3] of this section);
 
(iii)
 the use of any mechanical restraining device with the intent to modify or control challenging behavior (see paragraph [j][4] of this section);
 
(iv)
 the use of medication for the purpose of preventing, modifying, or controlling challenging behavior that is not associated with a co-occurring diagnosed psychiatric disorder (see paragraph [j][5] of this section); and
 
(v)
 other professionally accepted methods to modify or control behavior which are determined by agency/facility policy to be restrictive/intrusive interventions because they may present a risk to a person's protection or encroach unduly on a person's normal activities (
e.g
., response cost, overcorrection, negative practice, and satiation). 
Physical intervention techniques and/or mechanical restraining devices used to facilitate emergency evacuations/drills or medical/dental exams, procedures, and related healthcare activities (and to protect individuals, healthcare providers, and others during such exams, procedures, and activities) are not considered to be restrictive/intrusive interventions that require inclusion in a behavior support plan. Such interventions may be incorporated in other individualized plans to address these situations.

(25)
 
Master trainer
. A party employed by OPWDD who has been approved to teach a curriculum approved by OPWDD on the use of positive behavioral approaches, strategies and/or supports and physical intervention techniques, and further certified by OPWDD to train and mentor new instructor-trainers and instructors in the teaching and implementation of the training curriculum. The master trainer serves in a leadership role overseeing the quality of Instructors, quality and consistency of trainings, and coordinating and monitoring implementation of the curriculum. The master trainer also reviews and approves new or modified physical intervention techniques as necessary.
 
(26)
 
Mechanical restraining device
. See device, mechanical restraining.
 
(27)
 
Medication
. For the purposes of this section, a pharmaceutical agent prescribed and used either to prevent, modify, or control challenging behavior, or to treat the symptoms of co-occurring diagnosed psychiatric disorders, by altering thoughts, feelings, mental activities, mood, or behavior. This definition includes medications which are not usually classified as psychotropic, when they are prescribed for their psychotropic effects such as mood stabilization or impulse control. (See subparagraph [j][5][vi] of this section for requirements specific to the use of medications used to treat a co-occurring diagnosed psychiatric disorder.)
 
(28)
 
Plan, behavior support
. A written plan that outlines specific interventions designed to support, develop or increase replacement or alternative behaviors and/or modify or control a person's challenging behavior. The plan is a component of a person's overall plan of services. Agencies may use other equivalent terms for such plans. (See subdivision [e] of this section.)
 
(29)
 
Plan, monitoring
. A plan developed by a licensed psychologist, licensed psychiatric nurse practitioner, licensed clinical social worker, or a behavioral intervention specialist that identifies the target symptoms of a co-occurring diagnosed psychiatric disorder that are to be prevented, reduced, or eliminated. The plan shall specify interventions that will be used to address associated challenging behaviors that may occur, and methods by which progress in symptom control and functional improvement will be measured, documented, and reviewed.
 
(30)
 
Restrictive/intrusive intervention
. See intervention, restrictive/intrusive.
 
(31)
 
Senior member of the staff
. See staff, senior member of the.
 
(32)
 
Specialist, behavioral intervention (BIS).
 
(i)
 Level 1 BIS. In order for a party to be a Level 1 BIS, the party must: 
(a)
 have the following educational background:
(1)
 at least a Master's degree from a program in a clinical or treatment field of psychology, social work, school psychology, or applied psychology as it relates to human development and clinical interventions, and documented training in assessment techniques and behavior support plan development; or
 
(2)
 a national board certification in behavior analysis (BCBA) and a Master's degree in: 
(i)
 behavior analysis; or
 
(ii)
 a field closely related to clinical or community psychology that is approved by OPWDD; or

(3)
 a New York State license in mental health counseling; and

(b)
 have at least five years of experience:
(1)
 working directly with individuals with developmental disabilities, including the development, implementation, and monitoring of behavior support plans; and/or
 
(2)
 providing supervision and training to others in the implementation of behavior support plans.

(ii)
 Level 2 BIS. In order for a party to be a Level 2 BIS, the party must meet the qualifications outlined in clauses (
a
), (
b
), or (
c
) of this subparagraph: 
(a)
 The party must have a BCBA and a Master's degree in:
(1)
 behavior analysis; or
 
(2)
 a field closely related to clinical or community psychology that is approved by OPWDD; or

(b)
 The party must: 
(1)
 have either: 
(i)
 a Master's degree in a clinical or treatment field of psychology, social work, school psychology, applied psychology as it relates to human development and clinical intervention, or a related human services field; or
 
(ii)
 a New York State license in mental health counseling; and

(2)
 have or obtain OPWDD-approved specialized training or experience in functional assessment techniques and behavior support plan development; or

(c)
 The party must: 
(1)
 have a Bachelor's degree in a human services field; and
 
(2)
 have provided behavioral services for an agency in the OPWDD system as of, and continuously since, December 31, 2012; and
 
(3)
 either: 
(i)
 is actively working toward a Master's degree in an applied area of psychology, social work, or special education; or
 
(ii)
 completes at least one graduate-level course in an applied health service area of applied psychology, social work, or special education each year.

(iii)
 The qualifying Master's degrees referenced in this paragraph, including any degree obtained through an online educational or distance learning program, must have been awarded by a regionally accredited college or university, or one recognized by the NYS Education Department as following acceptable educational practices. If the Master's degree was awarded by an educational institution outside the United States and its territories, the party must provide independent verification of equivalency from one of the approved entities used by the NYS Department of Civil Service for educational equivalency reviews.
 
(iv)
 Notwithstanding any other provision of this section, parties who are employed by New York State and function in a title included in a New York State Civil Service title series shall provide behavioral services or supervision of such services described in this section as included in their job descriptions.
 
(v)
 Notwithstanding any other provision of this paragraph, a party may be considered a BIS in the event that OPWDD has approved a waiver of a specific required qualification upon application of a provider (see paragraph [c][12] of this section).

(33)
 
Staff, senior member of the
. As used in this section, that staff member, by whatever title he or she may be known who is designated by the chief executive officer (CEO) as a senior member of the administrative structure of an agency, and as such, may carry out designated responsibilities delegated by the CEO. This may be someone who is responsible for a group of facilities (
e.g
., team leader, residence manager, head of shift, unit supervisor).
 
(34)
 
Team, program planning
. For the purposes of this section, the program planning team includes at least a licensed psychologist, a licensed clinical social worker, or an behavioral intervention specialist, the person, the service coordinator or party designated with the responsibility for coordinating a person's plan of services, the person's advocate or correspondent (including the Consumer Advisory Board for Willowbrook class members that it fully represents), and any other party deemed necessary for identifying a person's behavioral needs and developing an appropriate plan to address those needs (
e.g
., direct support professional, health care professional). A registered nurse or other medical professional shall be a member of the team when the use of medication is part of the plan.
 
(35)
 
Time-out
. Time-out is a restrictive/intrusive intervention in which a person is temporarily removed from positive reinforcement or denied the opportunity to obtain positive reinforcement and during which the person is under constant visual and auditory contact and supervision. Time-out interventions include: 
(i)
 placing a person in a specific time-out room, commonly referred to as exclusionary time-out;
 
(ii)
 removing the positively reinforcing environment from the individual, commonly referred to as non-exclusionary time-out. (See paragraph [j][3] of this section for requirements specific to the use of time-out.)

(c)
 
General provisions.
 
(1)
 Every agency with oversight responsibilities for one or more programs that serve people in need of behavior support plans shall develop behavior intervention policies and procedures that are in conformance with this section.
 
(2)
 All behavioral interventions designed to prevent or modify challenging behaviors shall be in conformance with applicable laws and regulations and agency-specific policies/procedures. Interventions and intervention plans must be individualized and designed for the purpose of enhancing the individual's quality of life, relationships with others, and ability to function as independently as possible. Such interventions shall actively include positive approaches, strategies and/or supports designed to establish or increase the person's adaptive (replacement) behaviors.
 
(3)
 Behavioral interventions shall be designed and implemented for the purpose of developing or increasing adaptive behaviors (a.k.a. replacement behaviors) that support more independent and personally successful living, and eliminating or decreasing the frequency of challenging behaviors, but never employed for the convenience of staff, as a threat, as a means of retribution, for disciplinary purposes, or as a substitute for treatment or supervision.
 
(4)
 Positive behavioral approaches, strategies, and supports that are consistent with standards of professional practice shall always be the preferred method for addressing challenging behavior, with the overall goal of increasing the person's repertoire of appropriate behaviors and skills. These positive approaches should include a variety of proactive strategies that may include prevention strategies, setting event strategies, teaching replacement or alternative behaviors such as functional communication and social skills, stress management skills, positive reinforcement, shaping, differential reinforcement procedures, etc.
 
(5)
 OPWDD discourages the use of restrictive/intrusive interventions. General and specific requirements regarding the use of restrictive/intrusive interventions are imposed in order to limit the use of these interventions to those situations when necessary. Unless there is a clear risk to the health or safety of the person or others, or a violation of others' basic personal rights, any restrictive/intrusive intervention or limitation on a person's rights as specified in a behavior support plan shall be employed only after less intrusive or more positive interventions have been tried and have not been sufficiently successful.
 
(6)
 The use of aversive conditioning methods is prohibited.
 
(7)
 There shall be sufficient safeguards and supervision to ensure that the dignity, safety, health, welfare, and civil rights of a person have been adequately protected. No behavior support plan shall:
(i)
 incorporate sleep deprivation as a consequence of challenging behavior; or
 
(ii)
 deprive a person of a balanced and nutritious diet;
(a)
 meals shall be served at appropriate times and in as normal a manner as possible;
 
(b)
 the composition or timing of regularly served meals shall not be altered for disciplinary (punishment) purposes, or for the convenience of staff;
 
(c)
 restrictions of the amount of food or type of diet that a person consumes may be made for clinical reasons, pursuant to documentation by a qualified healthcare professional, which shall specify the clinical justification for the restriction and the time period that such restriction shall be in effect, and which shall be included in the individual's written service plan;
 
(d)
 nothing in this subparagraph shall be deemed to limit the ability of a facility or agency to adopt policies or procedures to promote the health of each person and a safe and sanitary environment; or

(iii)
 incorporate the use of food such that the form of the food served is altered as a consequence of challenging behavior.

(8)
 Additional requirements apply to the use of "restrictive/intrusive interventions." These interventions include the following:
(i)
 any intermediate and/or restrictive physical intervention techniques (see paragraph [j][1] of this section);
 
(ii)
 the use of time-out (exclusionary and non-exclusionary) (see paragraph [j][3] of this section);
 
(iii)
 the use of any mechanical restraining device with the intent to modify or control challenging behavior (see paragraph [j][4] of this section);
 
(iv)
 the use of medication solely to prevent, modify, or control challenging behavior (see paragraph [j][5] of this section); and
 
(v)
 other professionally accepted methods to modify or control behavior which are determined by agency/facility policy to be restrictive/intrusive interventions because they impose a risk to a person's protection or encroach unduly on a person's normal activities (
e.g
., response cost, overcorrection, negative practice, and satiation).

(9)
 Additional requirements apply to behavioral interventions which impose a limitation on a person's rights as specified in section 
633.4
 of this Part, including behavioral consequences negatively impacting the person's dignity (see paragraph [j][2] of this section), and, where applicable, as specified in section 
636-1.4
 of this Title concerning requirements for documentation of rights modifications in the person-centered service plan.
 
(10)
 Any objection to a person's current or proposed behavior support plan or to a proposed revision of a current plan must be made following the process as outlined in section 
633.12
 of this Part, except for objections to the use of restrictive/intrusive interventions by the party providing informed consent and objections to medication use by an individual receiving services. (See subdivision [h] of this section.)
 
(11)
 Restrictive/intrusive interventions may not be used in an emergency, except for intermediate and restrictive physical intervention techniques and medication. (See paragraphs [j][1] and [5] of this section). Limitations on a person's rights may also be used in an emergency (see paragraph [j][2] of this section).
 
(12)
 Notwithstanding any other provision of this section, a party lacking the specified credentials may perform the functions of a Level I BIS, Level II BIS, licensed psychologist, or licensed clinical social worker as specified in this section if OPWDD has granted a waiver of a specific required qualification for that particular party. The waiver may limit the functions that may be performed by such party. 
(i)
 OPWDD may approve a waiver upon application of the provider if all of the following conditions are met: 
(a)
 the provider documents that it is unable to employ, or access contractual services from, a party who meets the requirements for a Level 1 BIS, Level 2 BIS, licensed psychologist, or licensed clinical social worker;
 
(b)
 the provider is in a rural area; and
 
(c)
 the provider has demonstrated a sustained hardship condition concerning its ability to obtain the necessary clinical services.

(ii)
 In the event that New York State law requires licensure for parties to legally provide any of the services specified in this section, a party performing such services pursuant to a waiver which are inconsistent with the law may no longer perform those services.

(d)
 
Functional behavioral assessment.
 
(1)
 Prior to the development of a behavior support plan to address challenging behavior that is not solely the result of a co-occurring diagnosed psychiatric disorder, a functional behavioral assessment must be completed by a clinician with training in functional behavior assessment techniques to obtain relevant information for effective intervention planning. A functional behavioral assessment must: 
(i)
 identify/describe the challenging behavior in observable and measureable terms;
 
(ii)
 include identification and consideration of the antecedents for the behavior(s);
 
(iii)
 identify the contextual factors, including cognitive, environmental, social, physical, medical and/or psychiatric conditions, that create or may contribute to the behavior;
 
(iv)
 identify the likely reason or purpose for the challenging behavior;
 
(v)
 identify the general conditions or probable consequences that may maintain the behavior;
 
(vi)
 include an evaluation of whether environmental or social alterations, or further assessments to rule out a contextual factor, would serve to reduce or eliminate the behavior(s);
 
(vii)
 include an evaluation of preferred reinforcers;
 
(viii)
 consider multiple sources of data including, but not limited to:
(a)
 information gathered through direct observations of the individual;
 
(b)
 information gathered from interview and/or discussion with the individual, parent/caregiver, and other relevant service providers; and
 
(c)
 a review of available clinical, medical, behavioral, or other data from the individual's record and other sources;

(ix)
 not be based solely on an individual's documented history of challenging behaviors; and
 
(x)
 provide a baseline of the challenging behaviors including frequency, duration, intensity and/or latency across settings, activities, people, and times of day.

(2)
 In exceptional circumstances (
e.g
., unexpected admission to a residential program) a behavior support plan may need to be developed or modified primarily on the basis of historical information to assure staff or the family care provider have sufficient tools and safeguards to manage potentially dangerous behaviors of the person who is beginning to receive services. In these cases, a functional behavioral assessment shall be completed within 60 days of admission or the commencement of services.

(e)
 
Behavior support plan.
 
(1)
 Level 1 Behavioral Intervention Specialists (BIS) may develop and/or provide supervision for behavioral support plans or services that do not include restrictive/intrusive interventions. Level 2 BIS may develop behavioral support plans or services that do not include restrictive/intrusive interventions under the supervision of Level 1 BIS. Behavior support plans or services which include restrictive/intrusive interventions may be developed by a Level 1 or a Level 2 BIS under the supervision of a licensed psychologist or licensed clinical social worker (LCSW) (see paragraph [3] of this subdivision).
 
(2)
 All behavior support plans must: 
(i)
 be developed by a BIS, or a licensed psychologist or a licensed clinical social worker with training in behavioral intervention techniques;
 
(ii)
 be developed in consultation, as clinically appropriate, with the person receiving services and/or other parties who are or will be involved with implementation of the plan;
 
(iii)
 be developed on the basis of a functional behavioral assessment of the target behavior(s);
 
(iv)
 include a concrete, specific description of the challenging behavior(s) targeted for intervention;
 
(v)
 include a hierarchy of evidence-based behavioral approaches, strategies and supports to address the target behavior(s) requiring intervention, with the preferred methods being positive approaches, strategies and supports;
 
(vi)
 include a personalized plan for actively reinforcing and teaching the person alternative skills and adaptive (replacement) behaviors that will enhance or increase the individual's personal satisfaction, degree of independence, or sense of success;
 
(vii)
 include the least restrictive or least intrusive methods possible in the behavioral approaches, strategies and supports designed to address any behaviors that may pose an immediate risk to the health or safety of the person or others;
 
(viii)
 provide a method for collection of positive and negative behavioral data with which treatment progress may be evaluated; and
 
(ix)
 include a schedule to review the effectiveness of the interventions included in the behavior support plan no less frequently than on a semi-annual basis, including examination of the frequency, duration, and intensity of the challenging behavior(s) as well as the replacement behaviors.

(3)
 A behavior support plan which incorporates a restrictive/intrusive intervention and/or a limitation on a person's rights (see paragraph [c][9] of this section) shall be designed in accordance with the following:
(i)
 Level 1 and Level 2 BIS who develop and/or provide behavior support services to implement behavior support plans which include restrictive/intrusive interventions shall function under the supervision of a licensed psychologist or licensed clinical social worker.
 
(ii)
 A plan that incorporates a restrictive/intrusive intervention and/or a limitation on a person's rights must include the following additional components: 
(a)
 a description of the person's behavior that justifies the incorporation of the restrictive/intrusive intervention(s) and/or limitation on a person's rights to maintain or assure health and safety and/or to minimize challenging behavior;
 
(b)
 a description of all positive, less intrusive, and/or other restrictive/intrusive approaches that have been tried and have not been sufficiently successful prior to the inclusion of the current restrictive/intrusive intervention(s) and/or limitation on a person's rights, and a justification of why the use of less restrictive alternatives would be inappropriate or insufficient to maintain or assure the health or safety or personal rights of the individual or others;
 
(c)
 designation of the interventions in a hierarchy of implementation, ranging from the most positive or least restrictive/intrusive to the least positive or most restrictive/intrusive, for each challenging behavior being addressed;
 
(d)
 the criteria to be followed regarding postponement of other activities or services, if necessary and/or applicable (
e.g
., to prevent the occurrence or recurrence of dangerous or unsafe behavior during such activities);
 
(e)
 a specific plan to minimize and/or fade the use of each restrictive/intrusive intervention and/or limitation of a person's rights, to eliminate the use of a restrictive/intrusive intervention and/or limitation of a person's rights, and/or transition to the use of a less intrusive, more positive intervention; or, in the case of continuing medication to address challenging behavior, the prescriber's rationale for maintaining medication use;
 
(f)
 a description of how each use of a restrictive/intrusive intervention and/or limitation on a person's rights is to be documented, including mandated reporting; and
 
(g)
 a schedule to review and analyze the frequency, duration and/or intensity of use of the restrictive/intrusive intervention(s) and/or limitation on a person's rights included in the behavior support plan. This review shall occur no less frequently than on a semi-annual basis. The results of this review must be documented, and the information used to determine if and when revisions to the behavior support plan are needed.

(iii)
 A behavior support plan incorporating the use of restrictive physical interventions and/or time-out rooms is prohibited in family care homes and hourly community habilitation. However, a behavior support plan incorporating restrictive physical interventions in hourly community habilitation may be permitted if specifically authorized by OPWDD.

(4)
 Prior to implementation of a behavior support plan which incorporates a limitation on a person's rights and/or a restrictive/intrusive intervention: 
(i)
 the plan shall be approved by the behavior plan/human rights committee established pursuant to subdivision (f) of this section; and
 
(ii)
 written informed consent shall be obtained from the appropriate consent-giver.

(5)
 If a behavior support plan is necessary in more than one service setting, the agency developing such a plan shall consult and coordinate with other service settings, in order to prevent conflicting or inappropriate strategies.
 
(6)
 If an agency will be using a behavior support plan developed by a different service setting/agency, the agency that developed the plan shall provide documentation to the other service setting/agency regarding current informed consent for the plan and its approval by a behavior plan/human rights committee.
 
(7)
 Nothing in this subdivision shall be construed to prevent the use of physical intervention techniques in an emergency when used in conformance with paragraph (j)(1) of this section.
 
(8)
 Nothing in this subdivision shall be construed to prevent the use of limitations on a person's rights in an emergency when used in conformance with paragraph (j)(2) of this section.
 
(9)
 Nothing in this subdivision shall be construed to prevent the use of medication to prevent, modify, or control challenging behavior in an emergency when used in conformance with subparagraph (j)(5)(iv) of this section.

(f)
 
Behavior plan/human rights committee.
 
(1)
 Every agency with oversight responsibilities for one or more programs that serve people in need of behavior support plans that include restrictive/intrusive interventions and/or rights limitations shall establish a behavior plan/human rights committee to protect the rights of persons whose behavior support plans incorporate the use of restrictive/intrusive interventions and/or a limitation on a person's rights. It may be a separate committee created solely for the purpose of meeting the requirements of this section, or it may be part of another committee. An agency is not required to have a behavior plan/human rights committee if:
(i)
 no individual served is in need of a behavior support plan that includes a restrictive/intrusive intervention; and
 
(ii)
 no individual served is in need of a behavior support plan that includes a limitation on the person's rights.

(2)
 Agencies shall create their own behavior plan/human rights committee or may coordinate with other agencies in the creation of a shared behavior plan/human rights committee.
 
(3)
 Prior to the implementation of the proposed behavior support plans, the committee shall approve or refuse to approve, in writing, proposed plans which contain a limitation on a person's rights (see paragraph [c][9] of this section) and/or utilize one or more restrictive/intrusive interventions specified in paragraph [c][8] of this section, except for monitoring plans in which medication is used solely for the treatment of a co-occurring diagnosed psychiatric disorder. The term 
psychiatric disorder
 means those psychiatric disorders which are recognized as such by the American Psychiatric Association or World Health Organization. For the purposes of this section, the term 
co-occurring psychiatric disorder
 does not refer to the following: mental retardation, learning disorders, motor skills disorders, communication disorders, pervasive developmental disorders, attention-deficit and disruptive behavior disorders, and impulse control disorders.
 
(4)
 The committee must review the behavior support plans identified in paragraph (3) of this subdivision to verify that all required components are included (see subdivision [e] of this section).
 
(5)
 The committee chairperson must verify that:
(i)
 the proposed behavior support plans presented to the committee are approved for a time period not to exceed one year and are based on the needs of the person; and
 
(ii)
 written informed consent is obtained prior to the implementation of the approved behavior support plan. If written informed consent cannot be obtained within a reasonable period of time prior to the initiation or continuance of a plan, verbal consent may be accepted only for the period of time before written informed consent can be reasonably obtained. Verbal consent must be witnessed by two members of the staff, and documented in the person's record. This verbal consent is valid for a period of up to 45 days and may not be renewed.

(6)
 The committee must specifically approve (or refuse to approve):
(i)
 the use of a mechanical restraining device that is not commercially available or is not designed for human use (
e.g
., modification of a commercially available device) pursuant to subclause (j)(4)(ii)(
a
)(
2
) of this section; and
 
(ii)
 modification of intermediate and restrictive physical intervention techniques, and new intermediate and restrictive physical intervention techniques, consistent with the provisions of subparagraph (j)(1)(iii) of this section.

(7)
 The committee shall review and make suggestions to the agency's management and/or governing body about its policies, practices, and programs as they relate to topics addressed by this section.
 
(8)
 Behavior plan/human rights committee membership.
(i)
 A behavior plan/human rights committee must have a minimum of four members including: 
(a)
 a licensed psychologist or a behavioral intervention specialist, with training in assessment techniques and behavioral support plan development;
 
(b)
 a clinician, currently licensed, certified, or registered in New York State as one of the following: social worker, physician, physician assistant, nurse practitioner, registered nurse, speech pathologist, occupational therapist, physical therapist, or pharmacist; and
 
(c)
 an additional party, preferably with no ownership, employment relationship, or other interest in the agency. This party may be, but is not limited to:
(1)
 someone charged with the responsibility for advocating for a person's rights (
e.g
., an ombudsperson, a volunteer, or an advocacy organization representative); or
 
(2)
 someone with a developmental disability, or a guardian or family member of someone with a developmental disability.

(ii)
 A committee member must recuse himself/herself from reviewing a plan for a person for whom he/she is actively involved in the delivery of services.
 
(iii)
 The committee must have a minimum of three members present to proceed with its deliberations.

(g)
 
Informed consent.
 
(1)
 Written informed consent shall be obtained in accordance with this subdivision. 
(i)
 Written informed consent is required prior to implementation any time that a restrictive/intrusive intervention is included in a behavior support plan to modify or control challenging behavior. However, if written informed consent cannot be obtained within a reasonable period of time prior to the initiation or continuance of a plan, verbal consent may be accepted only for the period of time before written informed consent can be reasonably obtained. Verbal consent must be witnessed by two members of the staff, and documented in the person's record. This verbal consent is valid for a period of up to 45 days and may not be renewed.
 
(ii)
 Written informed consent is required prior to implementation of a physician's order for planned use of medication to treat a co-occurring diagnosed psychiatric disorder (see subparagraph [j][5][ii] of this section). However, if written informed consent cannot be obtained within a reasonable period of time prior to the initiation or continuance of a medication, verbal consent may be accepted only for the period of time before written informed consent can be reasonably obtained. Verbal consent must be witnessed by two members of the staff, and documented in the person's record. This verbal consent is valid for a period of up to 45 days and may not be renewed.
 
(iii)
 Written informed consent is also required for short-term use of medication when there is no behavior support plan. If it is necessary for the medication to be administered before written informed consent can be reasonably obtained, verbal consent may be accepted for only the period of time before written informed consent can be reasonably obtained, but no longer than 45 days. Verbal consent must be witnessed by two members of the staff and documented in the person's record.

(2)
 Written informed consent shall be documented in a person's clinical record.
 
(3)
 Written informed consent obtained in accordance with this subdivision shall have a maximum duration of one year.
 
(4)
 The agency shall ensure, in every case, that the person (or surrogate consent giver) be personally afforded an appropriate, clear explanation of the proposed plan.
 
(5)
 When an emergency exists, restrictive/intrusive interventions may be applied to a person of any age without seeking informed consent if such use is permitted in accordance with this section.
 
(6)
 Informed consent for behavior support plans that include restrictive/intrusive interventions shall be obtained as follows:
(i)
 If a person is less than 18 years of age, consent shall be obtained from one of the surrogates listed, in the order stated:
(a)
 a guardian lawfully authorized to give such consent;
 
(b)
 an actively involved (see section 
633.99
 of this Part) spouse;
 
(c)
 a parent;
 
(d)
 an actively involved adult sibling (see section 
633.99
 of this Part);
 
(e)
 an actively involved adult family member (see section 
633.99
 of this Part);
 
(f)
 a local 
commissioner
 of social services with custody of the person pursuant to the social services law or family court (if applicable); or
 
(g)
 an informed consent committee or a court of competent jurisdiction (see paragraph [8] of this subdivision).

(ii)
 If a person is 18 years of age or older and has capacity to give informed consent, the plan shall be initiated only upon the person's informed consent. If the person withholds consent, see subdivision (h) of this section.
 
(iii)
 If a person is 18 years of age or older, but lacks the capacity to give informed consent regarding the proposed plan, or a determination of insufficient capacity has been made pursuant to paragraph (7) of this subdivision, informed consent shall be obtained from one of the surrogates listed, in the order stated: 
(a)
 a guardian lawfully authorized to give such consent;
 
(b)
 an actively involved spouse;
 
(c)
 an actively involved parent;
 
(d)
 an actively involved adult child;
 
(e)
 an actively involved adult sibling;
 
(f)
 an actively involved adult family member;
 
(g)
 the Consumer Advisory Board (see section 
633.99
 of this Part) for the Willowbrook Class (only for class members it fully represents); or
 
(h)
 an informed consent committee (see paragraph [8] of this subdivision) or a court of competent jurisdiction.

(iv)
 If more than one party exists within a category on the list in subparagraph (i) or (iii) of this paragraph utilizing the standard of active involvement, consent shall be sought first from the party with a higher level of active involvement or, when the parties within a category are equally actively involved, consent shall be sought from any of such parties.
 
(v)
 If the first surrogate on the list in subparagraph (i) or (iii) of this paragraph is not reasonably available and willing, and is not expected to become reasonably available and willing to make a timely decision given the person's circumstances, application shall be made to the next surrogate on the list, in the order of priority stated.
 
(vi)
 Lack of informed consent, including the refusal or withdrawal of informed consent and objections are addressed in subdivision (h) of this section.
 
(vii)
 ICFs must also comply with 42 CFR 
483
.

(7)
 Determination of capacity to give informed consent for persons who have not been judicially determined to be incapable of giving informed consent to restrictive/intrusive interventions. 
(i)
 In the first instance, it shall be the program planning team's responsibility to determine the person's capacity to give informed consent for each proposed restrictive/intrusive intervention. The team's determination and documentation shall be included in the person's record.
 
(ii)
 In those instances when a person's program planning team unanimously agrees that the person does not have the capacity to give informed consent to the proposed restrictive/intrusive interventions:
(a)
 The team shall prepare a written opinion and sufficiently detailed analysis of why it considers the person to be unable to provide informed consent. If the program planning team does not include a New York State licensed psychologist or New York State licensed physician, this opinion and analysis must be reviewed independently as outlined in clause (
b
) of this subparagraph.
 
(b)
 If the program planning team which determined a lack of capacity did not include a New York State licensed physician or New York State licensed psychologist, the opinion and analysis of the team shall be reviewed by a New York State licensed psychologist, or a New York State licensed physician (neither of whom is a member of the person's program planning team), who may or may not be an employee of the agency/facility. Such professional shall review the material provided and, in writing, document whether he/she agrees with the team's determination of the person's capacity to give informed consent. If the licensed professional disagrees with the team or cannot readily concur with the team's recommendation, the professional will examine the individual personally and document the findings of this examination in the person's record.
 
(c)
 In the event that a development or reinstatement of a person's capacity for consent is unlikely, the person does not need to be re-evaluated annually, but the program planning team should review this opinion for currency annually. The assessment and capacity determination must be maintained in the person's current clinical record.

(iii)
 If the program planning team is unable to unanimously agree or if the professional who conducted the personal examination disagrees with the team's decision regarding whether or not a person has the capacity to give informed consent, it shall be the responsibility of the agency's chief executive officer or designee to: 
(a)
 obtain from the person's program planning team, its written opinion and analysis of the person's ability to understand the proposed restrictive/intrusive intervention(s), and of the person's capacity to give or withhold informed consent;
 
(b)
 obtain from a New York State licensed psychologist, or New York State licensed physician, either of whom has specialized training in developmental disabilities, a written opinion and analysis of the person's ability to understand each proposed restrictive/intrusive intervention, and of the person's capacity to give informed consent.
(1)
 The psychologist's or physician's written opinion shall be based upon a personal examination of the person.
 
(2)
 Said professional shall not be a member of the person's planning team and may or may not have an employment relationship with the agency/facility.

(c)
 decide, after considering the opinions of the program planning team and the licensed psychologist or licensed physician, whether the person does or does not have the capacity to give informed consent, whether it is appropriate to obtain consent from a party or surrogate decision maker 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 program planning team, the licensed psychologist or physician, and the decision of the agency's chief executive officer or designee, are documented in the person's record and communicated to that person and to his or her actively involved adult family member or the Consumer Advisory Board, as appropriate, unless the person is an adult who has been determined to have the capacity to give informed consent and objects to such notice being made.

(iv)
 Consent shall be considered to be in effect, once given (up to a maximum of one year), as long as the scope of the restrictive/intrusive intervention(s) remains within that proposed by the behavior support plan that was reviewed by the surrogate decision maker, and/or until such time as the need for the intervention has ceased, unless a lesser specific time limit has been stated at the time the consent was given. However: 
(a)
 any increase in the schedule of restrictive/intrusive intervention(s) beyond that originally presented, or the need for a different restrictive/intrusive intervention, requires a new consent from the person or appropriate surrogate; and
 
(b)
 if there is a change in the medical or psychological condition of the person receiving services which may affect the person's capacity to consent, the situation shall be reviewed immediately by the program planning team in consultation with the responsible clinician, and the outcome of this review will be documented. The continuing appropriateness of the proposed restrictive/intrusive intervention shall also be reviewed by the team.

(v)
 Consent may be withdrawn by the consent giver in writing at any time, except that consent may be withdrawn by the person receiving services in the same manner as originally given (
e.g
., verbally, in writing) if he/she is the provider of consent. Documentation of the withdrawal of consent shall be included in a person's record. (Also see subdivision [h] of this section.)

(8)
 Informed consent committee.
(i)
 This committee (see subdivision [b] of this section) need not be a "standing" committee. It may be a committee convened on an as-needed basis for the purpose of reviewing a request(s) for informed consent when the individual lacks capacity to give informed consent and there is no authorized surrogate reasonably available and willing.
 
(ii)
 Agencies shall arrange for the creation of an informed consent committee or may coordinate with other agencies in the creation of a shared informed consent committee.
 
(iii)
 Informed consent committee membership shall:
(a)
 consist of a minimum of three members;
 
(b)
 include at least one member having no ownership, employment relationship or other interest in the agency that would result in a real or perceived conflict of interest; or
 
(c)
 include at least one person who does not serve on the behavior plan/human rights committee which reviewed the behavior support plan; or
 
(d)
 include at least one professional holding a license or certification appropriate to their discipline, and who has specialized training or at least one year of professional experience in treating or working with people with developmental disabilities (see specific qualifications for each discipline under "professional, qualified" in section 
690.99
 of this Title); and
 
(e)
 not include anyone who is involved in the delivery of services to the person whose service plan is under review; and
 
(f)
 include an individual with developmental disabilities, a guardian or family member of an individual with developmental disabilities, an advocate, or a party with experience in the field of developmental disabilities.

(iv)
 The Mental Hygiene Legal Service (MHLS) may represent, before this committee, the interests of persons who are residents of a facility operated or certified by OPWDD, and shall be notified of any informed consent committee meetings involving such individuals who lack capacity.
 
(v)
 The committee shall reach its decision within 15 business days of receiving an application for informed consent.
 
(vi)
 The committee's decision shall be by majority vote and shall be provided without delay to the person, the person's program planning team and other relevant parties.

(h)
 
Objections.
 
(1)
 Any objection to a person's proposed behavior support plan or a proposed revision of a current plan (except those relating to restrictive/intrusive interventions), must be made in accordance with the process that is outlined in section 
633.12
 of this Part.
 
(2)
 Lack of informed consent. 
(i)
 
Lack of informed consent
 is considered to be:
(a)
 the withdrawal of a previously stated informed consent by the consent giver; or
 
(b)
 the refusal of the consent giver to provide informed consent.

(ii)
 The following applies to the use of restrictive/intrusive interventions except for the refusal of the person receiving services to take medication as described in paragraph (3) of this subdivision. If there is lack of informed consent, and the agency considers use of the intervention/treatment to be necessary to provide services safely and appropriately to the individual, the agency must apply for court approval for the use of such intervention/treatment. Notice of such application shall be sent to MHLS at the time of filing. While such a court application is pending, the agency may only use the restrictive/intrusive intervention in accordance with the emergency use provisions set forth in paragraphs [j][1] and [5] of this section. Agencies may also impose limitations on the person's rights in an emergency (see paragraph [j][2] of this section). However, if a surrogate consent giver has withdrawn consent for the administration of medication, and the immediate cessation of the administration of the refused medication would be harmful or dangerous to the person, then the medication shall be suspended in accordance with accepted medical practice. The surrogate shall be advised regarding the accepted medical practice for the suspension of the medication that is being followed by the agency.

(3)
 Medication refusal. If an individual receiving services refuses to take medication to prevent, modify, or control challenging behavior or to treat a co-occurring diagnosed psychiatric disorder, regardless of whether or not he or she is self-consenting (
i.e
., informed consent is provided by the individual receiving services), the administration of the refused medication must be suspended or not commenced.
(i)
 If the immediate cessation of the administration of the refused medication would be harmful or dangerous to the person, then the medication shall be suspended in accordance with accepted medical practice.
 
(ii)
 Notification of an individual's refusal of medication shall be provided as soon as possible to the grantor of informed consent if the consent is given by a surrogate.
 
(iii)
 Following the initial refusal of medication, the agency must continue to make attempts to provide the medication and to provide counseling to the individual regarding the need for the medication.
 
(iv)
 If repeated attempts to resolve the issue of refusal of medication intended to modify or control challenging behavior or to treat a diagnosed psychiatric disorder are unsuccessful, and the agency considers the administration of the medication to be necessary for effective treatment of the individual's disorder, such agency must apply to a court of competent jurisdiction for a hearing to determine whether the individual has the capacity to make a reasoned decision with respect to the proposed medication use and whether the medication should be administrated over objection. Notice of any such application shall be given to the authorized surrogate decision maker, if any, and the Mental Hygiene Legal Service.

(i)
 
Training.
 
(1)
 Staff, family care providers and respite substitute providers responsible for the support and supervision of a person who has a behavior support plan must be trained in the implementation of that person's plan.
 
(2)
 Staff, family care providers and respite substitute providers responsible for the support and supervision of a person whose behavior support plan includes the use of a restrictive/intrusive intervention shall be trained in the particular intervention(s) to be utilized with a specific person, prior to use.
 
(3)
 Staff who are responsible for implementing behavior support plans that incorporate the use of any physical intervention technique(s) must have:
(i)
 successfully completed an OPWDD-approved training course on the use of positive behavioral approaches, strategies and/or supports and physical intervention techniques; and
 
(ii)
 been certified or recertified in the use of positive behavioral approaches, strategies and/or supports and the use of physical intervention techniques by an instructor, instructor-trainer or master trainer within the year. However, in the event that OPWDD approves a new curriculum, OPWDD may specify a period of time greater than one year before recertification is required.

(4)
 Supervisors of such staff shall receive comparable training.
 
(5)
 If permitted by their graduate programs, graduate level interns may implement restrictive/intrusive interventions with appropriate supervision. The graduate level intern must also meet the requirements for training and certification specified in paragraphs (1)-(3) of this subdivision. Volunteers and undergraduate interns are not permitted to implement restrictive/intrusive interventions.
 
(6)
 Retraining of staff, family care providers and respite/substitute providers as described in paragraphs (1) and (2) of this subdivision shall occur as necessary when the behavior support plan is modified, or at least annually, whichever comes first.
 
(7)
 The agency must maintain documentation that staff, family care providers, respite/substitute providers, and supervisors have been trained and certified as required by this subdivision.

(j)
 
Specific interventions.
 
(1)
 Physical intervention techniques (includes protective, intermediate and restrictive physical intervention techniques). 
(i)
 The use of any physical intervention technique shall be in conformance with the following standards: 
(a)
 the technique must be designed in accordance with principles of good body alignment, with concern for circulation and respiration, to avoid pressure on joints, and so that it is not likely to inflict pain or cause injury;
 
(b)
 the technique must be applied in a safe manner;
 
(c)
 the technique shall be applied with the minimal amount of force necessary to safely interrupt the challenging behavior;
 
(d)
 the technique used to address a particular situation shall be the least intrusive or restrictive intervention that is necessary to safely interrupt the challenging behavior in that situation; and
 
(e)
 all parties using the technique must have current certification or recertification in the use of positive behavioral approaches, strategies and/or supports and the use of physical intervention techniques by an instructor, instructor-trainer, or master trainer.

(ii)
 The agency shall provide adequate monitoring and oversight of all use of physical intervention techniques.
 
(iii)
 Modification of existing techniques and new techniques. 
(a)
 Modification of existing techniques. 
(1)
 If any protective, intermediate or restrictive physical intervention technique needs to be modified (
e.g
., due to a particular person's physical disability), the modification shall be designed through consultation with an instructor-trainer and a health care professional.
 
(2)
 Notification of the modification of any physical intervention technique must be made in writing to a master trainer prior to use.
 
(3)
 Modification of intermediate and restrictive physical intervention techniques must be approved by the agency behavior plan/human rights committee prior to use.
 
(4)
 The modification of any physical intervention technique shall only be implemented with the person for whom it is designed.

(b)
 New techniques.
(1)
 If any new protective, intermediate or restrictive physical intervention technique needs to be developed (
e.g
., due to a particular person's physical disability, current or existing techniques are not effective), the new physical intervention technique shall be reviewed by a master trainer and a health care professional.
 
(2)
 The new technique must be approved by a master trainer prior to use.
 
(3)
 New intermediate and restrictive physical intervention techniques must be approved for use by the agency behavior plan/human rights committee prior to use.
 
(4)
 Any new physical intervention technique shall only be implemented with the person for whom it is designed.

(iv)
 The use of any intermediate or restrictive physical intervention technique shall be terminated when it is judged that the person's behavior which necessitated application of the intervention has diminished sufficiently or has ceased, or immediately if the person appears physically at risk. In any event, the continuous duration for applying an intermediate or restrictive physical intervention technique for a single behavioral episode shall not exceed 20 minutes.
 
(v)
 The use of any restrictive physical intervention technique must only be in response to a person engaging in behaviors that pose an immediate health or safety risk to the person or to others.
 
(vi)
 After the use of any physical intervention technique (protective, intermediate, or restrictive), the person shall be inspected for possible injury as soon as reasonably possible after the intervention is used. The findings of the inspection shall be documented in the form and format specified by OPWDD or a substantially equivalent form. If an injury is suspected, medical care shall be provided or arranged. Any injury that meets the definition of a reportable incident or serious reportable incident must also be reported in accordance with Part 624.
 
(vii)
 Each use of a restrictive physical intervention technique shall be reported electronically to OPWDD in the form and format specified by OPWDD.
 
(viii)
 Whenever any intermediate or restrictive physical intervention technique has been used in an emergency, the service coordinator or party designated with the responsibility for coordinating a person's plan of services, and the appropriate clinician, if applicable, must be notified within two business days after the intervention technique has been used.
 
(ix)
 Whenever any intermediate or restrictive physical intervention technique has been used in an emergency, the person's guardian, parent, actively involved family member, representative of the Consumer Advisory Board (for Willowbrook class members it fully represents), correspondent, or advocate must be notified within two business days after the intervention has been used, unless the person is a capable adult who objects to such notification.
 
(x)
 The use of any intermediate or restrictive physical intervention technique in an emergency more than two times in a 30-day period or four times in a six month period shall require a comprehensive review by the person's program planning team, in consultation with a licensed psychologist, a licensed clinical social worker, or behavioral intervention specialist. The team shall determine if there is a need for a behavior support plan to address the exhibited behavior(s), a need to change an existing plan, or to establish the criteria for determining if a plan will need to be developed in the future.
 
(xi)
 The use of restrictive physical intervention techniques is not permitted in family care homes. The use of restrictive physical intervention techniques is not permitted in hourly community habilitation unless specifically authorized by OPWDD.
 
(xii)
 The use of an intermediate or restrictive physical intervention technique that is not in conformance with the requirements of this section is considered to be physical abuse and must be reported pursuant to Part 624 of this Title (except as noted in subparagraph [xiii] of this paragraph).
 
(xiii)
 Notwithstanding any other provision of this section, any physical contact that is necessary to address an immediate health or safety risk to the person or to others, and which does not involve the use of more force than necessary, shall not be considered to be physical abuse pursuant to Part 624 of this Title or a violation of the requirements of this section. However, in the event that the level of physical contact would be considered to be comparable to an intermediate or restrictive physical intervention, the agency must comply with the provisions of subparagraphs (vii)-(ix) of this paragraph concerning visual inspection for possible injury and notifications. In addition, the person's program planning team must be notified. The person's program planning team shall consider whether changes might be needed in an existing behavior support plan or whether a plan needs to be developed.

(2)
 Rights limitations.
(i)
 The limitation of a person's rights as specified in section 
633.4
 of this Part (including but not limited to: access to mail, telephone, visitation, personal property, electronic communication devices (
e.g
., cell phones, stationary or portable electronic communication or entertainment devices computers), program activities and/or equipment, items commonly used by members of a household, travel to/in the community, privacy, or personal allowance to manage challenging behavior) shall be in conformance with the following: 
(a)
 limitations must be on an individual basis, for a specific period of time, and for clinical purposes only; and
 
(b)
 rights shall not be limited for the convenience of staff, as a threat, as a means of retribution, for disciplinary purposes or as a substitute for treatment or supervision.

(ii)
 In an emergency, a person's rights may be limited on a temporary basis for health or safety reasons. A clinical justification must be clearly noted in the person's record with the anticipated duration of the limitation or criteria for removal specified.
 
(iii)
 The emergency or unplanned limitation of a person's rights more than four times in a 30 day period shall require a comprehensive review by the program planning team in consultation with the licensed psychologist, licensed clinical social worker, or behavioral intervention specialist. The team shall determine if there is a need for a behavior support plan to address the exhibited behavior(s), a need to change an existing plan, or to establish the criteria for determining if a plan will need to be developed in the future.
 
(iv)
 Where applicable, documentation of rights modifications in the person-centered service plan is required in accordance with section 
636-1.4
 of this Title.

(3)
 Time-out. 
(i)
 Time-out is a restrictive/intrusive intervention in which a person is temporarily removed from positive reinforcement or denied the opportunity to obtain reinforcement and during which the person is under constant visual and auditory contact and supervision. Time-out interventions include: 
(a)
 placing a person in a specific time-out room, commonly referred to as exclusionary time-out;
 
(b)
 removing the positively reinforcing environment from the individual, commonly referred to as non-exclusionary time-out.

(ii)
 Time away, when a person is redirected to a quieter or less stimulating area of the program and where staff do not actively prevent egress from that area, is not considered a form of time-out.
 
(iii)
 Time-out shall not be used in an emergency.
 
(iv)
 Requirements for the use of time-out rooms. 
(a)
 The placement of a person alone in a room from which his or her normal egress (ability to leave) is prevented by a staff member's direct and continuous physical action shall be considered a form of time-out (see glossary). The use of a time-out room shall be in conformance with the following: 
(1)
 such action shall be taken only in accordance with a person's behavior support plan;
 
(2)
 constant auditory and visual contact shall be maintained. If at any time the person is engaging in behavior that poses a risk to his or her health or safety staff must intervene.

(b)
 The use of a time-out room where normal egress is prevented, or placement of a person in a secured room or area from which he or she cannot leave at will, and which is not in conformance with the requirements of this section is considered a reportable incident, pursuant to Part 624 of this Title.
 
(c)
 The maximum duration of time a person can be placed in a time-out room shall not exceed one continuous hour. Use of a time-out room on five or more occasions within a 24-hour period shall require the review of the behavior support plan by the program planning team in consultation with the licensed psychologist, licensed clinical social worker, or behavioral intervention specialist within three business days.
 
(d)
 Each use of a time-out room in accordance with an individual's behavior support plan shall be reported electronically to OPWDD in the form and format specified by OPWDD.
 
(e)
 Any time a room is to be used for time-out, that room must meet the following stipulations: 
(1)
 The room must be designated for time-out use by the chief executive officer and approved by the agency's governing body. Both the design and statement of intended use shall be approved by OPWDD.
 
(2)
 Time-out rooms are not permitted in family care homes.
 
(3)
 Environmental requirements are set forth as follows. Except as provided in subclause (
4
) of this clause, the room shall conform to the following requirements:
(i)
 Size: The minimum measurements of the room shall be 6' length x 8' wide x 8' height.
 
(ii)
 Decoration: Colors are selected to create a calm, relaxed atmosphere.
 
(iii)
 Electrical: 
(A)
 There shall be no electrical fixtures, outlets, switches, or wiring which may cause harm or injury to a person.
 
(B)
 There shall be no protruding light fixtures on any ceiling lower than 10' in height.
 
(C)
 There shall be no protruding light fixtures on any wall.
 
(D)
 Recessed light fixtures shall be designed to withstand tampering or destruction by the person in the room.
 
(E)
 Sprinkler heads, if provided, shall be the concealed type.

(iv)
 Pipes: There shall be no exposed pipes. Coverings shall be designed to prevent the possibility of any pipes being grasped by the person.
 
(v)
 Holes: There shall be no exposed holes.
 
(vi)
 Protrusions: There shall be no protrusions on which a person might be injured. There shall be no protruding doorknob in the room. If the door is sufficiently padded to recess the knob, but still cause it to be accessible, this is permissible.
 
(vii)
 Glass: The use of glass shall be minimized and unbreakable glass should be used whenever possible. Coverings for glass that is breakable are to be designed in such a way as to prevent being grasped by the occupant. Mirrors must be non-breakable.
 
(viii)
 Padding: Padding or resilient wall covering shall be affixed to walls and the floor in such a fashion that it cannot be easily removed by the occupant. Provisions shall be made for the removal of the padding or wall covering for cleaning, repairing or altering of any such material (
e.g
., padding fastened securely to plywood panels which are then screwed to the walls), unless the wall surface cover is such that it can be cleaned, maintained, and repaired in place. In facilities where the interior finish rating is required (
i.e
., Life Safety Code compliant facilities) the finish rating of the wall or floor surfaces shall be equal to or greater than that required by the Life Safety Code.
 
(ix)
 Occupant comfort: 
(A)
 There shall be adequate measurement equipment to ensure control of temperature, humidity and circulation of air within the room.
 
(B)
 The floor surface covering shall be consistent with the needs of the person using the room.

(x)
 Soundproofing: If soundproofing of the time-out room is necessary for the comfort of other people receiving services, it shall be determined if there will be sufficient transmittal of sound (
e.g
., adequate to hear words spoken by the person within the room) through the observation window or whether other means of maintaining auditory contact are necessary.
 
(xi)
 Furnishings: There shall be no furniture or other objects in the room.
 
(xii)
 Observation:
(A)
 Observation windows shall not be covered by mesh, bars, or wire material.
 
(B)
 An opening containing only mesh, bars, or wire material shall be unacceptable as an "observation window."
 
(C)
 The viewing area shall be sufficiently large to maximize visual observation. The person shall be in at least partial view at all times (
i.e
., there must be no blind areas large enough for the person to be completely out of sight). This shall not be construed to mean that the design of the room must provide for the capability of observing every action, facial expression, etc., should the person be standing/sitting in such a position or location that limits the view.
 
(D)
 The viewing area shall be designed to be functional, taking into account the comfort and suitability for use by staff.

(xiii)
 Windows (other than observation windows) shall be completely covered with a false wall to ensure the person's safety and to eliminate distraction and/or visual stimulation in what is intended to be a non-stimulating environment.
 
(xiv)
 Doors shall swing outward from the inside. Doors may be locked only by the continuous physical action of staff. The door release mechanism must be designed in such a way that if staff are not applying pressure, or physically holding the release mechanism, the door lock automatically releases.
 
(xv)
 Door thresholds shall not protrude creating a trip hazard. These shall be flush with the floor or ramped.
 
(xvi)
 There shall be a clock visible to staff to monitor the duration of the time-out.
 
(xvii)
 The room must be cleaned and disinfected regularly and after each use.

(4)
 Exceptions to specific physical plant requirements in subclause (
3
) of this clause. 
(i)
 OPWDD may waive specific physical plant requirements upon the application of an agency.
 
(ii)
 Time-out rooms which were in existence on April 1, 2013 are not required to comply with the specific physical plant requirements if the time-out room was approved by OPWDD prior to April 1, 2013. A new OPWDD waiver is not required in this situation. However, OPWDD approval is required for any significant modification of such time-out room which occurs on or after April 1, 2013.

(5)
 If a time-out room must be secured when not in use, the mechanism used for this purpose shall be such that the door can be opened, at will, from the inside.

(4)
 Mechanical restraining devices. 
(i)
 General provisions. 
(a)
 Mechanical restraining devices shall be employed:
(1)
 in accordance with the principles of correct body alignment;
 
(2)
 in a manner that does not interfere with circulation and respiration; and
 
(3)
 with concern for a person's comfort.

(b)
 Mechanical restraining devices shall only be used in a manner consistent with the provisions of this section. Any other use shall be reported as a reportable incident in conformance with Part 624 of this Title.
 
(c)
 The use of mechanical restraining devices in an emergency is not permitted.
 
(d)
 Mechanical restraining devices used as a support to achieve proper body position, balance, or alignment, as part of a medical or dental procedure or as a medical or dental safeguard are not subject to the requirements of this section.
 
(e)
 Mechanical restraining devices shall be maintained in a clean and sanitary condition, and in good repair.
 
(f)
 Agency policies/procedures governing the use of mechanical restraining devices shall address the sanitizing and storage of, and methods of limiting access to, the devices.
 
(g)
 Helmets with any type of chin strap shall not be used while a person is in the prone position, reclining, or while sleeping, unless specifically approved by OPWDD.
 
(h)
 Barred enclosures and the use of bed linen employed to restrain movement shall be prohibited under all circumstances.
 
(i)
 Nothing in this section shall preclude the use of a mechanical restraining device(s) while a person is an inpatient or resident under the auspices of a non-OPWDD operated or certified facility, program or service (
e.g
., mental health provider, medical hospital, or jail). The use of a mechanical restraining device in these types of settings is not subject to the provisions of this section and is subject instead to the applicable policies and rules of that provider. The use of mechanical restraining devices in such settings is not subject to the requirements of this section or Part 624 of this Title.
 
(j)
 The use of devices to limit movement for the safe transport of the individual in vehicles, wheelchairs, etc., is not considered to be the use of a mechanical restraining device, and is not subject to the requirements of this section.

(ii)
 Planned use of mechanical restraining devices.
(a)
 Mechanical restraining devices to prevent or modify challenging behavior may only be used in accordance with a behavior support plan if the devices meet the following criteria:
(1)
 the device shall be designed and used in such a way as to minimize physical discomfort and to avoid physical injury;
 
(2)
 the device shall be commercially available and designed for human use. Alternatively, if the device is not commercially available or is not designed for human use (
e.g
., modification of a commercially available device), it must be approved by the behavior plan/human rights committee and approved by OPWDD; and
 
(3)
 an occupational or physical therapist has been consulted if modification of the device is needed.

(b)
 The following types of devices (in the specified circumstances) may be used without specific OPWDD approval:
(1)
 mittens, helmets, face masks, goggles, sleeve boards (by whatever name known), clothing (
e.g
., jumpsuit, leotard, or custom-designed clothing such as shirts or pants made of non-shredable cloth), bolsters, and mats used to safely contain a person;
 
(2)
 lap trays, seatbelts, and harnesses; only when used to maintain an ambulatory person in a fixed location for the purpose of enhancing services; and
 
(3)
 the use of a seatbelt, harness, or mechanical brake to maintain a non-ambulatory person in a fixed location for the purpose of preventing risk to health or safety resulting from challenging behavior.

(c)
 The use of devices other than as specified in clause (
b
) of this subparagraph is permitted only if specifically approved by OPWDD.
 
(d)
 Application to obtain the approval of OPWDD to use a specific mechanical restraining device shall be submitted by the chief executive officer and shall include such information as may be required by OPWDD.
 
(e)
 The behavior support plan, consistent with the physician's order (see clause [g] of this subparagraph) shall specify the following conditions for the use of a mechanical restraining device:
(1)
 the facts justifying the use of the device;
 
(2)
 staff or family care provider action required when the device is used;
 
(3)
 criteria for application and removal and the maximum time period for which it may be continuously employed, see clause (
i
) of this subparagraph;
 
(4)
 the maximum period of time for monitoring the person's needs, comfort, and safety, see clause (
j
) of this subparagraph; and
 
(5)
 a description of how the use of the device is expected to be reduced and eventually eliminated.

(f)
 A behavior support plan may include the use of mechanical restraining devices to enable a person to participate safely and effectively in habilitative programming, recreation, social, and/or other activities. The plan shall be designed to reduce the frequency/severity of the challenging behavior so that non-restrictive/non-intrusive means of managing and eliminating challenging behavior(s) can be implemented.
 
(g)
 A physician's order is required for the use of a mechanical restraining device as part of a behavior support plan. The order shall be renewed as specified in the plan, but in all cases no less frequently than every six months. The order shall: 
(1)
 specify the type of device to be used;
 
(2)
 set forth date of expiration of the order;
 
(3)
 specify any special considerations related to the use of the device based on the person's medical condition, including whether the monitoring which is required during and after use of the device must incorporate specific components such as checking of vital signs and circulation; and
 
(4)
 be retained in a person's clinical record with a full record of the use of the device.

(h)
 Notwithstanding any other provision of this section, if the device is used solely to maintain an ambulatory person in a fixed location or position for the purpose of enhancing the delivery of services a physician's order is not required. This use must conform to all other requirements of this paragraph, including the requirements for release specified in clause (
i
) of this subparagraph.
 
(i)
 Release from the device: 
(1)
 Except when asleep a person in a mechanical restraining device shall be released from the device at least once every hour and fifty minutes for a period not less than 10 minutes, and provided the opportunity for movement, exercise, necessary eating, drinking and toileting.
 
(2)
 If the person requests release for movement or access to a toilet before the specified time period has elapsed, this should be afforded to him/her as soon as possible.
 
(3)
 If the person has fallen asleep while wearing a mechanical device, opportunity for movement, exercise, necessary eating, drinking and toileting shall always be provided immediately upon wakening if more than one hour and fifty minutes has elapsed since the device was employed or the end of the last release period.
 
(4)
 If a physician specifies a shorter period of time for release, the person shall be released in accordance with the physician's order.

(j)
 At least once every 30 minutes, including when a person is asleep, or more frequently if directed by a physician or previously designated in a risk management or behavior support plan, the person's physical needs, comfort, and safety shall be monitored. Monitoring shall incorporate any specific components that are included in the physician's order (
e.g
., checking vital signs and circulation). If the person is asleep, this monitoring shall be completed through observation only while not awakening the person. The person shall also be monitored after removal of the mechanical restraining device. Documentation of the monitoring and action taken must be entered in the person's clinical record.
 
(k)
 If, upon being released from a mechanical restraining device before the time limit specified in the order, a person makes no overt gesture(s) that would threaten serious harm or injury to self or others, the mechanical restraining device shall not be reemployed by staff unless the behavior which necessitated the use of the device reoccurs.
 
(l)
 The planned use of a device which will prevent the free movement of both arms or both legs, or totally immobilize the person, may only be initiated by a written order from a physician after the physician's personal examination of the person. The physician must review the order and determine if it is still appropriate each time he or she examines the person, but at least every 90 days. The review must be documented. The planned use of stabilizing or immobilizing holds or devices during medical or dental examinations, procedures, or care routines must be documented in a separate plan/order and must be reviewed by the program planning team on at least an annual basis.
 
(m)
 A device which will prevent the free movement of both arms or both legs or totally immobilize the person may only be applied under the supervision of a senior member of the staff or, in the context of a medical or dental examination or procedure, under the supervision of the healthcare provider or staff designated by the healthcare provider . Staff assigned to monitor a person while in a mechanical restraining device that totally immobilizes the person shall stay in continuous visual and auditory range for the duration of the use of the device.

(5)
 Medication. 
(i)
 General provisions. 
(a)
 All use of medication must be in conformance with Part 624 of this Title and sections 
633.4
, 
633.10
 and 
633.17
 of this Part.
 
(b)
 The use of medication to prevent, modify, or control challenging behavior or to treat symptoms of a co-occurring diagnosed psychiatric disorder shall not: 
(1)
 replace the need to develop an appropriate program plan;
 
(2)
 be intentionally administered in amounts that interfere with a person's ability to participate in programming or other activities;
 
(3)
 be used for disciplinary purposes; or
 
(4)
 be used for the convenience of staff or as a substitute for supervision.

(c)
 The use of medication to prevent, modify, or control challenging behavior, or to treat a co-occuring diagnosed psychiatric disorder, not in conformance with this paragraph, shall constitute abuse and must be reported in conformance with Part 624 of this Title. The use of medication prescribed or administered to individuals in conjunction with, or to facilitate or relieve distress related to medical or dental examinations or procedures is not subject to the requirements of this section.
 
(d)
 A medication regimen review that includes any medications prescribed to treat a co-occurring diagnosed psychiatric disorder, or to prevent, modify, or control challenging behavior(s), must be conducted in accordance with section 
633.17
 of this Part:The results of these medication regimen reviews shall be shared with the person's program planning team and the prescriber, and documented in the person's record, in order to assist healthcare providers and the team to evaluate whether the benefits of continuing the medication(s) outweigh the risk inherent in potential side effects.
 
(e)
 At least semi-annually, and more frequently as needed, staff shall consult with the prescriber regarding the administration and continued effectiveness of the medication.
 
(f)
 It shall be the responsibility of the agency to ensure that the person or the party granting informed consent has been given clear, necessary information regarding the proposed medication including, but not limited to, its purpose, and the dose or dosage range and route of administration. (See subparagraph [b][13][ii] of this section for the basic elements of the information necessary for informed consent.)
 
(g)
 Lack of informed consent for, or the refusal of, medication intended to prevent, modify, or control challenging behavior, or medication used to treat a co-occurring diagnosed psychiatric disorder is addressed in subdivision (h) of this section.

(ii)
 Planned/routine use of medication. 
(a)
 Medication to prevent, modify, or control challenging behavior, or to treat symptoms of a co-occurring diagnosed psychiatric disorder, must be administered only as an integral part of a behavior support plan or monitoring plan, in conjunction with other interventions which are specifically directed toward the potential reduction and eventual elimination of the challenging behavior(s) or target symptoms of the co-occurring diagnosed psychiatric disorder.
 
(b)
 Written informed consent shall be obtained prior to the use of the medication. If it is necessary for the medication to be administered before written informed consent can reasonably be obtained, verbal consent may be accepted for only the period of time before written informed consent can be obtained. Verbal consent must be witnessed by two members of the staff and documented in the person's record. This verbal consent may be considered valid for a period of up to 45 days.
 
(c)
 The use of medication shall have a documented positive effect on the person's behavior or target symptoms to justify its ongoing use.
 
(d)
 The effectiveness of the medication shall be re-evaluated at least semi-annually at the program plan reviews by the program planning team in consultation with a licensed psychologist, licensed clinical social worker, or behavior intervention specialist, and a health care professional. The goal(s) of this aspect of the plan review include: ensuring that medication is at the minimum and most effective dose; identifying a potential need for a medication with fewer or less intrusive side effects; evaluating the evidence presented to support continuation of the medication at a maintenance level, or recommending reduction or discontinuation of medication use if clinically indicated and authorized by the prescriber.
 
(e)
 Additional requirements concerning the use of medication to treat a co-occurring diagnosed psychiatric disorder are found in subparagraph (vi) of this paragraph.

(iii)
 Planned use of as-needed orders for medication. 
(a)
 As-needed (also known as PRN) orders for medication to prevent, modify, or control challenging behavior, or to treat symptoms of a co-occurring diagnosed psychiatric disorder, are considered planned use and must be incorporated in and documented as part of a behavior support plan or a monitoring plan.
 
(b)
 The person shall have a recent documented history of displaying the behavior(s) or symptoms (occurring in the last 12 months) for which the as-needed medication is being prescribed.
 
(c)
 The behavior support plan or monitoring plan, consistent with the prescriber's order, shall clearly state: 
(1)
 the conditions under which the as-needed medication is to be administered, including the nature and degree of the individual's behavior(s) or symptoms, and the prescriber's recommendations regarding proximity to any scheduled medication administration;
 
(2)
 the expected therapeutic effects; and
 
(3)
 if applicable, the conditions under which the medication can be re-administered, and the allowable frequency of re-administration.

(d)
 The staff person or family care provider who is responsible for support and supervision of a person who has a behavior support plan or monitoring plan must document in the person's clinical record a summary of the results of the medication use in behavioral terms.
 
(e)
 Results that are substantively different from the intended effect, and any adverse side effects, shall be reported to the prescriber immediately and the person's program planning team no later than the next business day.
 
(f)
 If any as-needed medication is administered on more than four separate days (one day equals 24 hours) in a 14-day period, the individual's program planning team, in consultation with the licensed psychologist, licensed clinical social worker, or behavioral intervention specialist and healthcare professional, must reassess the appropriateness of continuing the as-needed medication, or consider recommending that it be incorporated into the individual's regular drug regimen.
 
(g)
 Each use of an as-needed medication when used in conjunction with a restrictive physical intervention technique to prevent, modify, or control challenging behavior shall be reported electronically to OPWDD in the form and format specified by OPWDD.
 
(h)
 If the as-needed medication is not administered during a six-month period, the program planning team, in consultation with the licensed psychologist, licensed clinical social worker, or behavioral intervention specialist, must review the behavior support plan and develop a recommendation to the prescriber regarding the appropriateness of continuing the as-needed medication as part of the plan. If the order is continued, a clear justification is to be documented in the record.

(iv)
 Emergency use of medication.
(a)
 Medication may be administered in an emergency, without informed consent, with the express intent of controlling a person's challenging behavior or acute symptoms of a co-occurring diagnosed psychiatric disorder when: 
(1)
 the person's behavior constitutes an immediate risk to the health or safety of the person or others; or
 
(2)
 in a physician's judgment, an emergency exists that creates an immediate need for the administration of such medication, and an attempt to secure informed consent would result in a delay which would increase the risk to the health or safety of the person or others.

(b)
 The administration of such medication may only continue for as long as one of the conditions in clause (
a
) of this subparagraph exists.
 
(c)
 The use of the medication, along with the prescription/order and a note on its effectiveness, shall be documented in the person's record.
 
(d)
 The emergency use of medication to control challenging behavior or acute symptoms of a co-occurring diagnosed psychiatric disorder in more than four instances in a 14-day period shall require a comprehensive review by the program planning team in consultation with the licensed psychologist, a licensed clinical social worker or behavioral intervention specialist within three business days of the fifth medication administration.
(1)
 The team shall determine if there is a need for a behavior support plan to address the behavior or symptom that necessitated the emergency use of medication, or a need to modify an existing plan, or to establish the criteria for a future decision that a plan will be needed. Such a determination shall be documented.
 
(2)
 The emergency administration of the medication may continue until the program planning team meets.

(e)
 Whenever it is or has been necessary to use any medication to control challenging behavior or acute symptoms of a co-occurring diagnosed psychiatric disorder in an emergency, the duly authorized surrogate consent giver in accordance with paragraph (g)(6) of this section, the service coordinator or party designated as responsible for coordinating a person's plan of services, and the appropriate clinician (
e.g.,
 licensed psychologist, licensed clinical social worker, behavioral intervention specialist, physician), if applicable, shall be notified within the next two business days.
 
(f)
 Each use of an emergency medication to control challenging behavior shall be reported electronically to OPWDD in the form and format specified by OPWDD.

(v)
 Short-term use of medicationwhen there is no behavior support plan.
(a)
 This subparagraph does not apply to ICFs. (ICFs must comply with 42 CFR 
483
 .)
 
(b)
 In the absence of a behavior support plan that incorporates the use of specific medications to prevent, modify, or control challenging behavior, such medication may be administered on a short-term basis when all of the following conditions are met: 
(1)
 an untoward or unanticipated condition, reaction, symptom, event or situation has occurred which creates exceptional circumstances that, if left untreated could potentially lead to an emergency situation;
 
(2)
 the circumstances resulting from the event are expected to last for a time period longer than that which can be considered an emergency;
 
(3)
 the medication is deemed to be the most effective course of treatment; and
 
(4)
 the medication is ordered by a prescriber.

(c)
 Informed consent is required prior to the administration of the medication. If it is necessary for the medication to be administered before written informed consent can be reasonably obtained, verbal consent may be accepted for only the period of time before written informed consent can be reasonably obtained, but no longer than 45 days. Verbal consent must be witnessed by two members of the staff and documented in the person's record.
 
(d)
 Within five working days of the first administration of the medication or of the admission to such programs of a person with such a pre-existing medication regimen, a person's program planning team, in consultation with a licensed psychologist, licensed clinical social worker, or behavioral intervention specialist, shall conduct a review of the circumstances which necessitated the use of such medication. The program planning team shall determine if it is necessary to develop a behavior support plan to prevent, modify, or control the behavior or to modify an existing plan of services, or shall establish the criteria for a future decision that a plan will be needed. All determinations shall be documented.
 
(e)
 Without incorporation into a behavior support plan and written informed consent, the administration of the medication shall not continue for more than 45 consecutive days.

(vi)
 Medication use to treat a co-occurring diagnosed psychiatric disorder. Medication may be used as part of the treatment for the symptoms of a co-occurring diagnosed psychiatric disorder, including challenging behavior that occurs exclusively or almost exclusively as a result of that disorder. In such circumstances, the following requirements must be met.
(a)
 In order to be considered "medication to treat a co-occurring diagnosed psychiatric disorder," the medication must be prescribed for the treatment of a specific psychiatric disorder, in a manner consistent with generally accepted psychiatric practice.
 
(b)
 The term 
psychiatric disorder
 means those psychiatric disorders which are recognized as such by the American Psychiatric Association or World Health Organization. For the purposes of this section, the term 
co-occurring psychiatric disorder
 does not refer to the following: mental retardation, learning disorders, motor skills disorders, communication disorders, pervasive developmental disorders, attention-deficit and disruptive behavior disorders, and impulse control disorders.
 
(c)
 The use of the medication must be in conformance with the applicable requirements of subparagraph (j)(5)(i) of this section.
 
(d)
 The use of the medication shall be consistent with accepted standards of clinical practice, including treatment of the symptoms of the diagnosed psychiatric disorder.
 
(e)
 The symptoms and diagnosis of the co-occurring psychiatric disorder must be documented.
 
(f)
 Target symptoms for the psychiatric disorder shall be identified and documented in practical, operationally defined terms to permit reliable, ongoing data collection and assessment of treatment effectiveness.
 
(g)
 The use of medication and the target symptoms shall be specified and documented in a written monitoring plan. The plan must specify how progress reflected in symptom reduction and relevant functional improvement, or lack of progress, will be measured and documented. If all of the requirements of this clause are met, the agency is not required to conduct and document a functional behavioral assessment or develop a behavior support plan, as long as other behavioral interventions are not needed for the individual to address challenging behaviors which do not reflect the psychiatric symptomatology. The monitoring plan shall describe how challenging behavior(s) -- including those that reflect psychiatric symptomatology, should they occur -- will be addressed through the use of other appropriate interventions. If it is expected that the person might need restrictive/intrusive interventions, a functional behavioral assessment and behavior support plan must be developed.
 
(h)
 Informed consent must be obtained for the use of the medication.

Notes

N.Y. Comp. Codes R. & Regs. Tit. 
14
 § 
633.16

Amended 
New York State Register December 2, 2015/Volume XXXVII, Issue 48
, eff. 
12/2/2015

Amended 
New York State Register September 21, 2016/Volume XXXVIII, Issue 38
, eff. 
9/21/2016

Amended 
New York State Register September 27, 2017/Volume XXXIX, Issue 39
, eff. 
9/27/2017

Amended 
New York State Register April 28, 2021/Volume XLIII, Issue 17
, eff. 
4/28/2021

The amended version of this section by 
New York State Register June 14, 2023/Volume XLV, Issue 24
, eff. 
6/14/2023
 is not yet available.

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