Texas Register
.
Although most provisions in the new subchapter describe existing policies
and procedures followed by state MR facilities, a few notable requirements
are new. For example, §415.355(b) requires a state MR facility's interdisciplinary
team (IDT), with the involvement of a physician, to identify a newly admitted
individual's known physical or medical conditions that might constitute a
risk to the individual during the use of restraint. Further, the IDT is required
to identify other factors, such as the individual's cognitive functioning
level, size, weight, emotional condition (including whether the individual
has a history of having been physically or sexually abused), and age, which
must be taken into account if the use of restraint is considered. The IDT
must document this information, as well as any limitations on specific techniques
or mechanical devices for restraint identified by the IDT, in the individual's
record. Subsection (c) requires that at least annually, or whenever significant
changes occur in the identified conditions and factors, that the IDT must,
with the involvement of a physician, advanced practice nurse, or physician
assistant, review and update the identified conditions, factors, and limitations
in the individual's record. Other new requirements of note: in §415.356(e)-(g),
the state MR facility must designate staff as "restraint monitors" who, upon
being notified that restraint is in use in a behavioral emergency, must go
to the site of the restraint to provide supervision and oversight; and, in §415.362(a),
when an individual receives a serious physical injury or dies while in restraint
an report must be made immediately to the head of the state MR facility or
designee who must, within 24 hours of receiving the report, notify the department's
Central Office and initiate an investigation.
Restraint is defined in new §415.353(13) as the use of manual pressure,
except for physical guidance or prompting of brief duration, or a mechanical
device to restrict: (1) the free movement or normal functioning of the whole
or a portion of an individual's body or (2) normal access by the individual
to a portion of the individual's body. This definition is more prescriptive
than the prevailing operational definition of the term, i.e., restraint is
an intervention employed to address an individual's inappropriate behavior.
The premise of the new subchapter is that the use of certain techniques or
mechanical devices constitute restraint whether they are used to prevent injury
when an individual engages in voluntary, inappropriate behavior such as head
banging or to protect an individual who experiences involuntary movements,
such as violent seizures. The definition effectively re-categorizes as restraint
some techniques commonly used by state MR facilities to protect an individual
from involuntary self-injury, provide postural support to an individual, or
assist an individual in obtaining and maintaining normative bodily functioning.
The department explicitly states in §§415.355, 415.359, and 415.360
that some, but not all, techniques used by a state MR facility to protect
an individual from involuntary self-injury, provide postural support, or assist
in obtaining and maintaining normative bodily functioning meet the definition
of restraint. Techniques that do not meet the definition of restraint and
are not subject to the provisions of this subchapter include the placement
of wedges, bolsters, or cushions to position an individual in a bed or chair.
In §415.354, a state MR facility is required to develop and implement
written policies and procedures that, among other things, emphasize the department's
commitment to: providing treatment that is the least restrictive and most
effective alternative available for an individual; staff training that emphasizes
early recognition of situations and behaviors that, if not appropriately addressed,
could necessitate the use of restraint in a behavioral emergency; and reducing
the necessity for the use of restraint in the state MR facility.
General requirements for the use of restraint are detailed in §415.355,
many of which describe existing practices that all state MR facilities follow
to ensure the protection of an individual's rights and well-being. Most of
these practices have their basis in the federal regulations governing the
Intermediate Care Facilities for Persons with Mental Retardation (ICF/MR)
Program at Code of Federal Regulations (CFR), Title 42, §483.450(d),
concerning physical restraints, in the Conditions of Participation for Intermediate
Care Facilities for Persons with Mental Retardation.
In the next five sections, the department describes the five circumstances
under which the use of restraint is permitted: in a behavioral emergency (§415.356);
as an intervention in a behavior therapy program to address inappropriate
behavior exhibited voluntarily by an individual (§415.357); during a
medical or dental procedure if necessary to protect the individual or others
and to promote the healing of wounds (§415.358); to protect the individual
from involuntary self-injury (§415.359); and to provide postural support
to the individual or to assist the individual in obtaining and maintaining
normative bodily functioning (§415.360).
In §415.361, the department specifies that only those mechanical devices
designed specifically for the safe and relatively comfortable restraint of
humans may be used in the restraint of an individual in a state MR facility.
Such devices include commercially available devices acquired by the state
MR facility, devices that have been developed independently by or on behalf
of the state MR facility, or commercially available mechanical devices that
have been altered to accommodate an individual's specific physical needs (e.g.,
a physical impairment or obesity). In subsection (b), the department describes
the process a state MR facility must follow to obtain approval for use of
a mechanical device developed independently by or on behalf of the state MR
facility or the alteration of a commercially available device to accommodate
an individual's specific physical needs. The section also describes precautions
that staff must take in the use of mechanical devices, lists and describes
mechanical devices that are acceptable for use in a state MR facility, and
lists devices that must not be used.
Additional reporting and documentation requirements are described in §415.362
relative to the use of restraint. As noted earlier in this preamble, the most
significant provision is the requirement that the head of the state MR facility
must be notified immediately, but in no case more than one hour, after staff
learn of a serious injury to or death of an individual that occurs while the
individual is in restraint. The head of the state MR facility is required
to report the death or serious injury within one working day to the State
MR Facilities Division in the department's Central Office and to designate
staff to investigate the incident.
Requirements for initial and refresher training are set forth in §415.363.
The department developed the new subchapter and related new Subchapter
412, Subchapter I, governing behavior therapy in state mental retardation
facilities, which is adopted in this issue of the
Texas Register
, in response to recent and considerable interest at
the national and state levels by legislators and advocate/stakeholder groups
and by state and national media concerning the use of restraint in all institutional
settings.
Although recent new federal statutes and regulations have addressed the
use of restraint in acute care and psychiatric hospitals and residential care
facilities, new regulations have not been issued by the Centers for Medicare
and Medicaid Services (CMS) regarding ICFs/MR. State MR facilities' polices
and procedures concerning the use of restraint are based on the current federal
regulations governing the ICF/MR Program (42 CFR, §483.450(d), concerning
physical restraints) and on licensure rules issued by the Texas Department
of Human Services (Texas Administrative Code, Title 40, §90.42, governing
standards for facilities serving persons with mental retardation or related
conditions). Senate Bill 59 was introduced during the 78th Legislature in
spring 2003 addressed the use of restraint in certain health care facilities,
including state MR facilities and, although the bill was not passed, certain
provisions have been incorporated in this subchapter. One of those provisions
is found in §415.355(f), which forbids the use of restraint in a manner
that obstructs an individual's airway, impairs an individual's breathing by
putting pressure on the individual's torso, or interferes with an individual's
ability to communicate. A second provision of the failed bill is addressed
in §415.356(d), which directs that staff must avoid placing an individual
in a prone or supine position during the use of personal restraint and, if
the individual should roll into a prone or supine position during personal
restraint, restore the individual to a standing, sitting, or side position
as soon as possible. The department's Prevention and Management of Aggressive
Behavior (PMAB) curriculum addresses these concerns in detail.
The new subchapter is more prescriptive than the federal regulations governing
the ICF/MR Program. For example, the interpretive guidelines to the federal
regulations at 42 CFR §483.440(c)(6)(iv) specifically state that the
use of mechanical devices to protect an individual from injury due to the
individual's involuntary movements (i.e., during a seizure) or to position
or support an individual does not constitute restraint. As noted earlier in
this preamble, the new subchapter specifies that if the use of a mechanical
device to protect an individual from involuntary self-injury or to position
or support an individual meets the definition of restraint (i.e., a vest or
seat belt that restricts the free movement or normal functioning of the whole
or a portion of an individual's body or restricts normal access by the individual
to a portion of the individual's body), then that use constitutes restraint.
Minor language changes have been made throughout the subchapter to update
or correct references, for grammatical and organizational purposes, and for
consistency and clarification. The definition of "behavioral emergency" in §415.353
has been revised to add "self-injurious behavior" and to delete the phrase
"or overt or continual threats made by an individual." Definitions of "medical
intervention," "non-serious physical injury," and "serious physical injury"
have been added. Language has been added to the definition of "restraint monitor"
to mean the monitor meets the training requirements described in §415.363.
All references to "serious injury" in §415.355, §415.356, and §415.362
have been clarified as "serious physical injury." Language has been added
to §415.355(a)(5) stating that "... not all techniques used by a state
MR facility to provide postural support or assist in obtaining and maintaining
normative bodily functioning constitute the use of restraint (e.g., placement
of wedges, bolsters, or cushions to position an individual in a bed or chair)."
The general principle in subsection (k)(5) relating to when an individual
falls asleep while being restrained has been deleted and added as part of
new §415.356(n) under use of restraint in a behavioral emergency. The
provision in §415.355(l) concerning communications of staff at shift
change has been expanded to include specific documentation requirements. The
provision in §415.355(n) relating to an individual in restraint who experiences
a medical emergency has been expanded to include the requirement to obtain
a new order for restraint if the use of restraint at the time of the medical
emergency had been in response to a behavioral emergency and, after resolution
of the medical emergency, the individual continues to exhibit behavior that
constitutes a behavioral emergency. A provision has been added as new subsection
(q) stating that a state MR facility must ensure at least one restraint monitor
is on duty at all times to respond as required by the subchapter.
Language has been added as new §415.356(c)(2)(A) that requires documentation
of any action taken in accordance with (c)(2). Language was added to §415.356(g)
limiting the timeframe to no "later than one hour" for the restraint monitor
to report the use of restraint to a nurse. A new §415.356(k) has been
added to address situations in which personal items are removed from the individual
during the use of restraint in a behavioral emergency. A new §415.356(n)
has been added to address situations in which an individual falls asleep while
being restrained for a behavioral emergency. The requirement for the restraint
monitor to debrief staff who actively participated in the use of restraint
in a behavioral emergency has been added as new paragraph (4) of subsection
(p). Provisions have been added as new subsection (r) that relate to use of
restraint in a behavioral emergency when an individual is away from the state
MR facility.
Language has been added as a new §415.357(b) stating that the provisions
of the section must be followed by staff when implementing restraint as directed
in an individual's behavior therapy program both on and off the state MR facility
campus. References to "restraint monitor" in subsection (e) have been replaced
with "staff." Proposed subsection (h) concerning use of psychotropic medications
as part of a behavior therapy program has been deleted as unnecessary because
the use of psychotropic medications is addressed in other department rules.
Language regarding obtaining legally adequate consent in §415.359(a)(3)
and (d)(4)(B) and §415.360(a)(3) and (d)(4)(B) has been modified to clarify
that the individual provides legally adequate consent and the LAR provides
consent. Sections 415.359(a)(3)(C) and 415.360(a)(3)(C) have been expanded
to allow the head of the state MR facility to authorize the use of restraint
with a mechanical device in situations in which the individual's LAR has not
responded to the facility's attempts to obtain consent and the LAR has been
notified that the head of the state MR facility may authorize the use if the
LAR does not respond.
Reference to "non-serious injuries" in §415.362(d)(2) has been changed
to "non-serious physical injuries." Language has been modified in §415.363(c)(1)
to clarify that a restraint monitor must have successfully completed only
those sections of the department's PMAB curriculum that address the procedures
used at the state MR facility. A training requirement for a restraint monitor
in conducting and documenting staff debriefing has been added as new subsection
(c)(2)(E).
A hearing to accept oral and written testimony from members of the public
concerning the proposal was held on February 13, 2004, in Austin. Testimony
was offered by Advocacy, Inc., Austin; and Crisis Prevention Institute (CPI),
Brookfield, Wisc.
Written comments concerning the proposal were submitted by the parent/guardian
of a state MR facility resident, Garland; Advocacy, Inc., Austin; Crisis Prevention
Institute (CPI), Brookfield, Wisc.; Parent Association for the Retarded of
Texas (PART), Austin; The Arc of Texas, Austin; and Texas Council for Developmental
Disabilities, Austin.
Two commenters questioned why the new subchapter applies only to state
MR facilities. The commenters stated that state requirements for use of restraint
should be applied consistently in all ICFs/MR, and reflect the less restrictive
environments typical of smaller public and private ICFs/MR. The department
responds that the new subchapter has been promulgated by the department in
its role as a provider of residential services and is consistent with Texas
Department of Human Services standards for ICF/MR licensure at Texas Administrative
Code, Title 40, §90.42(e)(4), concerning the use of restraint, which
apply to all ICFs/MR in Texas. The department further explains that state
MR facilities are intended to serve individuals who cannot be adequately and
appropriately habilitated in less restrictive settings.
Two commenters observed that the subchapter does not describe how the state
MR facility will safeguard an individual's personal possessions while that
individual is in restraint. The department agrees and has added new §415.356(k)
describing steps to be taken by staff when personal items, including clothing
must be removed from an individual during the use of restraint in a behavioral
emergency.
A commenter stated that restraint should not be used as part of treatment,
punishment, or as coercive means to force compliance, but should be used only
to protect the individual and assure that the state MR facility provides the
individual with quality care. The department agrees and directs the commenter
to §415.355(e)(1)-(3), which states that staff are prohibited from using
restraint for "disciplinary purposes, for the convenience of staff or other
individuals, or as a substitute for effective treatment or habilitation".
A commenter stated that the subchapter should require a debriefing process
after every occurrence of restraint. The commenter stated that during debriefing,
staff must evaluate and reinforce the prevention and intervention strategies
learned during training, determine what measures can be taken to reduce or
eliminate the use of restraint in the future, and carefully scrutinize and
revise, as necessary, the individual's treatment plan. The department agrees
that staff members who actively participate in the use of restraint in a behavioral
emergency should be "debriefed" and has added new §415.356(o)(4), which
requires the restraint monitor who responds to the report of restraint used
in a behavioral emergency to perform this function. The department also has
revised the training requirements for a restraint monitor in §415.363(c)
to require a restraint monitor to successfully complete a course on conducting
and documenting a debriefing.
A commenter stated that the subchapter should require that a state MR facility
employ a multidisciplinary team approach to the use of restraint, as well
as to debriefing techniques, in order to identify medical, psychological,
and emotional trauma risks for an individual who has been restrained. The
department responds that, as required by federal ICF/MR Program regulations,
each state MR facility employs an interdisciplinary team approach to treatment
and care issues. The department also explains that, as described in the previous
paragraph, new §415.356(o)(4) requires the restraint monitor who responds
to the report of restraint used in a behavioral emergency to debrief staff
who actively participated in the restraint.
A commenter recommended that the department consider permitting state MR
facilities the flexibility of choosing from other training programs in addition
to Prevention and Management of Aggressive Behavior (PMAB), the department's
proprietary risk management curriculum. The commenter explained that individuals
and state MR facility staff who may respond more positively to a crisis moment
through a different approach have limited access to other nationally recognized
best practices. The commenter noted that the subchapter allows for the use
of state MR facility developed, as well as commercially produced mechanical
devices. The department disagrees with the commenter's recommendation and
responds that the concurrent use of different risk management systems by a
state MR facility would result in confusion among staff and a reduction in
the effective and appropriate use of verbal and physical interventions in
a behavioral emergency.
Two commenters recommended that §415.351(1) be revised to state that
the subchapter's purpose includes protecting the rights of an individual's
LAR as well as those of the individual. The commenters stated that many of
the rights of the individual are transferred to the guardian by the court
and that the subchapter must acknowledge this. The department disagrees with
the commenters' recommendation and responds that the rights of the individual
protected by the rules do not "transfer" to a court-appointed guardian. These
rights include protection from exploitation and abuse, access to appropriate
treatment and services, freedom from mistreatment, and freedom from unnecessary
medication.
Concerning the definition of "behavioral emergency" in §415.353, two
commenters stated that the language seems to allow for a restraint in response
to destruction of property. The commenters stated that this is very problematic
and that while a state MR facility's concerns about property are valid, the
possible risk of bodily harm to or death of an individual as a result of restraint
does not seem warranted. The department does not agree that the definition
permits the use of restraint if an individual's "severely aggressive, destructive,
or violent behavior" results in the destruction of property. The department
notes that subparagraph (A) of the definition states that the individual's
behavior must pose "a substantial risk of imminent probable death of or substantial
bodily harm to the individual or others" before the use of restraint may be
used.
Also concerning the definition of "behavioral emergency" in §415.353,
a commenter stated that the phrase "overt or continual threats made by an
individual" implies that an individual may be restrained for making threats
if a behavior therapy program addressing "overt or continual" threats has
not been approved for that individual. The commenter expressed concern that
the definition might encourage the inappropriate use of restraint. The department
agrees with the commenter's objection and has deleted the phrase from the
definition.
Two commenters stated that the department, in attempting to reduce the
use of restraint in state MR facilities, has deliberately created processes
that are burdensome to staff and do not ensure the protection of an individual
who is restrained or of others. The commenters stated that the definition
of "behavioral emergency" in §415.533, which prohibits the use of restraint
unless an individual's behavior poses "a substantial risk of imminent death
of or substantial bodily harm to the individual or others" is too extreme.
The department does not agree with the commenters' assessment that the processes
described in the proposed rules are burdensome to staff. The department explains
that most of the requirements in the proposed rules currently are being followed
at the state MR facilities. The department also does not agree that the definition
of "behavioral emergency" is "extreme" because data collected by state MR
facilities, other Texas agencies, and agencies in other states concerning
injuries to individuals and staff during the use of restraint in behavioral
emergencies indicate that the use of restraint presents significant risks.
The department declines to make any changes to the language as proposed.
Two commenters stated that the definition of "mechanical device" in §415.353
describes a process on the use and application of a mechanical device, but
does not define the term. The commenters stated that the confusion is caused
by the use of the term "device" instead of "restraint," and recommended that
the subchapter should instead define "mechanical restraint" as the application
of a device restricting the movement of the whole or a portion of an individual's
body to control physical activity. The commenters stated that this definition
is consistent with the language in the Federal regulations that apply to psychiatric
hospitals and residential treatment facilities. The department responds that
the rules do not use the term "mechanical restraint" and declines to include
the recommended definition.
Concerning the definition of "restraint" in §415.353, two commenters
stated that physical guidance or prompting can be restraint if it is involuntary
and the individual resists. The commenters recommended that the definition
should focus, not on the length of time involved, but on whether the intervention
is voluntary. The commenters further recommended that the definition should
be consistent with the Children's Health Act of 2000, the federal condition
of participation concerning patient's rights (Code of Federal Regulations,
Title 42, §482.13(f)(1)), the department's recently adopted rules which
address the use of restraint in mental health facilities (Texas Administrative
Code (TAC), Title 25, Chapter 415, Subchapter F), and rules of the Texas Department
of Family and Protective Services concerning child care licensing (40 TAC §720.1001).
The commenters also recommended including a definition of "escort or brief
physical prompt", to read as follows "An individual may be assisted to move
from one location to another when guidance is needed. The individual must
agree verbally or with gestures and be able to cooperate with the staff member
who is attempting to assist the individual to move." The department responds
that the proposed definition of restraint is consistent with current federal
regulations governing the ICF/MR Program (42 CFR, §483.450(d), concerning
physical restraints) and declines to make the recommended revisions. The department
also declines to add the recommended definition of "escort or brief physical
prompt" because the term is not used in the rules.
Also concerning the definition of "restraint" in §415.353, a commenter
stated that the use of psychotropic medications to reduce or alter inappropriate
behavior in an emergency situation constitutes restraint and recommended that
the definition be revised accordingly. The department declines to make the
recommended revision because a state MR facility's use of psychotropic medications
in a behavioral emergency is addressed elsewhere in department rules and the
relevant reference is provided in §415.356(s).
A commenter recommended that a definition of "serious injury" be added
to §415.353 because the phrase is used repeatedly throughout the subchapter
and state MR facility staff must understand when an injury that occurs during
the use of restraint is considered "serious" and must be reported as required
in §415.362. The department agrees and, to be consistent with usage in
the department's rules concerning abuse, neglect, and exploitation in department
facilities, has changed "serious injury" to "serious physical injury" throughout
the subchapter and has added a definition of "serious physical injury" in §415.353.
A commenter recommended that the definition of "restraint monitor" in §415.353
be revised to include a reference to the training and experience requirements
outlined in detail in §412.363(c). The department agrees and has made
the recommended revision.
Concerning the definition of "restraint monitor" in §415.353, two
commenters asked how many restraint monitors a state MR facility will be required
to hire and what services will be cut to pay for the additional staff. The
department responds that a state MR facility will not have to hire additional
staff because existing staff who have the required training are functioning
as restraint monitors. The department further responds that no services have
been eliminated as a result of the use of restraint monitors.
A commenter recommended that §415.354(a)(2)(A), which addresses the
department's commitment to "providing treatment that is the least restrictive
and most effective alternative available for an individual," be revised to
describe how the effectiveness of recommended alternative interventions will
be evaluated, especially those interventions that have not be attempted for
an individual. The department does not agree with the commenter's recommendation
that the rule should articulate prescriptive requirements for the IDT process,
which the department believes must remain highly individualized.
Two commenters recommended that §415.354 be revised to require a state
MR facility's written policies and procedures to incorporate certain protections
contained in rules that address the use of restraint and seclusion in public
and private inpatient mental health settings. The department responds that §415.354(a)(1)
requires that a state MR facility's written policies and procedures must not
conflict with the subchapter or the federal regulations governing the ICF/MR
program. The department notes also that many of the specific requirements
listed by the commenters already are addressed in the subchapter. Further,
the department notes that the new language recommended by the commenters addresses
the use of seclusion in a behavioral emergency, and responds that state MR
facilities must comply with the federal ICF/MR regulations that do not address
the use of seclusion but do permit the use of time-out rooms as part of an
approved behavior therapy program. The following five paragraphs describe
the commenters' recommendations of specific language for inclusion in a state
MR facility's written policies and procedures, and the department's responses.
The two commenters' were joined by a third commenter in recommending that §415.354
be revised to state that restraint must be used only as an intervention of
last resort after less restrictive measures have been found to be ineffective
or have been judged unlikely to protect the individual or others from harm.
The department responds that §415.356(b) requires that staff must first
attempt the verbal or other de-escalative interventions to address an individual's
inappropriate behavior that appears to be escalating into a behavioral emergency.
Only if those interventions fail to prevent the individual's behavior from
escalating into a behavioral emergency are staff permitted to use restraint.
The department further explains that the definition of "behavioral emergency"
in §415.353 provides that "severely aggressive, destructive, violent,
or self-injurious behavior" constitutes a behavioral emergency only if the
behavior "has not abated in response to attempted preventive de-escalatory
or redirection techniques".
The two commenters recommended that §415.354 be revised to state that
restraint and seclusion, when determined by staff to be the appropriate intervention
in an behavioral emergency, must be used for the shortest period necessary
and be terminated as soon as the individual demonstrates the release behaviors
specified by the physician. The department responds that §415.355(f)(1)
requires staff to restrain an individual during a behavioral emergency only
for the shortest period of time necessary to ensure protection of the individual
and others. The department has added new §415.356(n) to clarify that
an individual who is restrained during a behavioral emergency must be released
as soon as the individual no longer poses a risk of imminent physical harm
to self or others.
The two commenters recommended that §415.354 be revised to require
staff to respect and preserve the rights of an individual during restraint.
The department responds that §415.355(j)(4) requires staff to implement
restraint without violating the individual's rights as described in department
rules at 25 TAC Chapter 405, Subchapter Y.
The two commenters recommended that §415.354 be revised to state that
an individual placed in restraint or seclusion must be provided with a protected,
private, and observable environment that safeguards the individual's personal
dignity and well-being. The department responds that §415.355(h)(5) requires
staff to implement restraint in a manner that safeguards the individual's
dignity, privacy, and well-being.
The two commenters recommended that §415.354 be revised to state that
staff must avoid causing undue physical discomfort, harm, or pain to the individual
when restraint or seclusion is used. The commenters also recommended that
the section require that only the minimal amount of physical force that is
reasonable and necessary for staff to implement restraint is to be used and
that psychoactive medication may be used in an emergency only in accordance
with department rules at Chapter 405, Subchapter B, which addresses the prescribing
of psychotropic medications in a state MR facility. The department responds
that §415.355 addresses most of the commenters concerns; subsection (h)(4)
requires staff to implement restraint in a manner that reduces the risk of
injury or undue physical discomfort to the individual; subsection (i)(1) requires
that staff implement restraint using only the minimal amount of force or pressure
that is reasonable and necessary to ensure the safety of the individual and
others; subsection (i)(3) requires that staff to implement restraint without
causing pain that restricts the individual's movement; subsection (k)(1) requires
staff to provide immediate relief to an individual, which may include immediate
release from restraint, and to notify a nurse to check the individual if the
individual shows signs of symptoms of physical distress; and subsection (k)(4)
requires staff to monitor the individual to the extent necessary to protect
the individual from physical distress, self-injury, or injury by another individual.
In addition, the department responds that §415.356(t) requires staff
to follow the provisions of §405.31 in the subchapter cited by the commenters
if the use of psychotropic medications in a behavioral emergency is deemed
necessary by a physician.
A commenter recommended that §415.355(b)(1) and (h)(1) be revised
to describe those conditions that are known risk factors in the use of restraint.
The commenter stated that these factors include, but are not limited to obesity,
heart disease, respiratory diseases, traumatic brain injury, prescription
and illegal drug use and abuse, and other medical conditions. The department
disagrees with the commenter's recommendation and responds that a state MR
facility's IDT and physicians is afforded no practical guidance by a listing
in the rules of all physical and medical conditions that might possibly be
risk factors during restraint. The department believes that it has taken the
most prudent and responsible approach by requiring the state MR facility's
IDT and physician to assess an individual, review the medical documentation
provided in the individual's admission application and to identify the individual's
known physical or medical conditions that might constitute a risk to the individual
during the use of restraint. The department further believes that the subchapter
provides an added level of assurance and protection by requiring the IDT and
physician in §415.355(b)(1)(B) to also consider other factors including--but
not limited to--an individual's cognitive functioning level, size, weight,
emotional condition (including whether the individual has a history of having
been physically or sexually abuse), and age.
Two commenters recommended that §415.355(d) be revised by adding "each"
between "Before" and "restraint" to clarify that the requirement for staff
to determine whether less restrictive, less intrusive interventions will be
ineffective is "episode specific" and not just upon admission to the facility.
The department responds that the provision is a general requirement and is
not intended to be "episode specific" and, therefore, declines to make the
recommended revision. The department notes that the commenters' concern appears
to be related to the use of restraint in a behavioral emergency and explains
that §415.356(b) requires staff to attempt verbal or other de-escalative
interventions before using restraint to address a behavioral emergency.
Two commenters recommended that §415.355(f) be revised to specify
that when restraint or seclusion is the determined to be the appropriate intervention,
staff should use it for the shortest period necessary and should terminate
it as soon as the individual demonstrates the release behaviors specified
by the physician. The department declines to make the recommended revision
and responds that §415.355(f)(1) provides that staff may restrain an
individual during a behavioral emergency only for the shortest period of time
necessary to ensure protection of the individual and others, and §415.355(f)(2)
requires staff to restrain an individual for the shortest period of time necessary
to ensure therapeutic effectiveness as part of a behavior therapy program,
a medical or dental procedure, or in protecting against involuntary self-injury.
The department has added new §415.356(n) to clarify that an individual
who is restrained during a behavioral emergency must be released as soon as
the individual no longer poses a risk of imminent physical harm to self or
others.
Concerning §415.355(g), two commenters commended the department for
incorporating this provision of Senate Bill 59, 78th Legislature, even though
the bill was not approved by the legislature. A third commenter recommended
that §415.355(g)(1) be revised to add "or restricts circulation" and §415.355(g)(2)
be revised to substitute "respiratory or cardiovascular functions" for "breathing"
and to prohibit staff from putting pressure on an individual's neck. The department
acknowledges the two commenters' commendation. The department declines to
make the revision recommended by the third commenter because the intent of
the provision is to prohibit certain techniques that have been found to contribute
to death by asphyxiation during the use of restraint.
A commenter recommended that §415.355(k)(3) be revised to allow an
individual to be released from restraint during mealtime and to require that
an individual's IDT to determine whether the individual should be provided
with snacks while in restraint. The department responds that the commenter's
concerns appear to be related to the use of restraint in a behavioral emergency,
and that the suggested revision would not be appropriate if applied to all
instances of restraint addressed by the rules. For instance, an individual
who is in restraint to promote healing after a medical or dental procedure
may be harmed if released prematurely, as might an individual who is in restraint
to prevent involuntary self-injury or an individual who is in restraint in
order to maintain postural support. The department notes that an individual's
IDT addresses appropriate nutrition under all circumstances, including whether
an individual should receive snack while in restraint. The department declines
to make the recommended revisions.
Three commenters recommended that §415.355(k)(4) be revised to require
that an individual who is restrained in a behavioral emergency must be monitored
continually. Two of the three commenters also recommended adding language
requiring staff to maintain "continuous face-to-face observation" of an individual
who is in restraint with a mechanical device and that the staff person observing
the individual be of the same gender as the individual unless contraindicated
by the individual's history or other factors. The two commenters further requested
the addition of language requiring that an individual in personal restraint
must be under continuous face-to-face observation by a staff person who is
not physically involved in the restraint. The department disagrees that with
the commenters' recommendations and responds that §415.355(k)(4) requires
an individual who is restrained to be "monitored to the extent necessary,
with consideration given to the individual's position, level of agitation,
and the identified conditions and factors documented in the individual's record".
The department further explains that if an individual is restrained in response
to a behavioral emergency, §415.356 (e)(2) requires a restraint monitor
to be summoned who will observe and ensure that the restraint is properly
used. Regarding the recommendation that the rules require an individual who
is restrained using a mechanical device to be under "continuous face-to-face
observation" by a staff of the same gender, the department declines to add
the requirement because it is unnecessary, noting that §415.355(i)(5)
requires restraint to be implemented in a manner that safeguards the individual's
dignity, privacy, and well-being.
Two commenters recommended that §415.355(k)(5) be revised to require
that an individual who falls asleep while in restraint using a mechanical
device must be released immediately and that staff must maintain continuous
face-to-face observation of the individual while asleep. One of the two commenters
observed that the individual no longer meets the criteria for a behavioral
emergency. The two commenters recommended that the provision be revised to
require that the individual, upon awakening, be evaluated by an advanced practice
nurse for evidence of behaviors requiring restraint and, if the nurse determines
that the further restraint is necessary, the nurse will obtain a new physician's
order for restraint. A third commenter recommended that an individual who
falls asleep not be released if the individual's behavior therapy program
specifies otherwise. The department responds that §415.355(k)(5) has
been deleted and new subsection (n) has been added in §415.356, which
addresses the use of restraint in a behavioral emergency, to require staff
to release an individual from restrain when the individual no longer poses
a risk of imminent physical harm to self or others and when the individual
falls asleep while being restrained in a mechanical device. Concerning the
recommendation for face-to-face observation of the individual, the department
directs the commenters' attention to §415.355(l), which provides that
an individual will be monitored to the extent necessary while in restraint.
Concerning the commenters' recommendation that an advanced practice nurse
evaluate an individual upon awakening, the department responds that the commenters'
concern is addressed in §415.356(h)(3), which requires a nurse to conduct
a face-to-face evaluation of the individual for injuries and overall well-being
after an individual is released from restraint. The department further responds
that if the individual, upon awakening, exhibits behavior that staff believe
is likely to escalate into a behavior emergency, staff will respond as described
in §415.356(b) and (c). The department agrees with the third commenter
that an individual who is restrained with a mechanical device as provided
in the individual's behavior therapy program and falls asleep during the restraint
should not be released if the behavior therapy program directs otherwise.
Two commenters recommended that §415.355(l), which addresses communication
between staff at shift change, be revised to require that appropriate staff
on the concluding shift must review the status of an individual in restraint
with appropriate staff on the new shift. The commenters stated that the review
must include the time restraint was initiated, the individual's current physical,
emotional, and behavioral condition, medications administered, and type of
care needed. The commenters also recommended that the review must be documented
in the individual's record. The department agrees and has revised the provision
to address the commenters' concerns.
Two commenters recommended that proposed §415.355(p), which addresses
the response of staff if an individual experiences a medical emergency while
in restraint, be replaced with language from department rules applicable to
public and private inpatient mental health settings. The department responds
that the only significant provision recommended by the commenters that is
not present in the proposed language is a requirement to obtain a new order
for restraint if the individual was in restraint in response to a behavioral
emergency. The department has added such a requirement as new §415.355(p).
Two commenters recommended that §415.355(q), which requires staff
to "respond as described in the state MR facility's policies and procedures
to ensure the individual's safety" if an emergency evacuation or evacuation
drill occurs while an individual is in restraint, be revised to require staff
to implement "established procedures" under those circumstances. The department
the language as proposed more than adequately addresses the commenters' concerns
that the state MR facility must have procedures in place that address the
appropriate response.
Two commenters objected to §415.356(c)(2), which permits staff to
take such actions as are reasonably believed to be immediately necessary to
avoid imminent harm to the individual or others, including the use of a mechanical
device, as long as those actions do not include acts of unnecessary force,
in the rare instance when an individual's behavior escalates into a behavioral
emergency and staff are unable to safely apply the personal restraint techniques
described in the department's Prevention and Management of Aggressive Behavior
(PMAB) curriculum. The commenters characterized the provision as a "loop hole
due to lack of accountability" and stated that it would permit staff to routinely
indicate that they were forced to take actions not addressed in the PMAB curriculum.
The commenters stated that, at a minimum, the rule must require staff to document
in writing why PMAB personal restraint techniques could not be safely applied
and to justify the actions that were taken. The department has revised the
provision to require that if staff are unable to safely apply PMAB personal
restraint techniques, a description of the actions taken and the reason why
the PMAB techniques could not be safely applied must be added to the individual's
record.
Two commenters recommended that §415.356(d) be revised to specify
that a "prone or supine hold shall not be used except to transition an individual
into another position and shall not exceed one minute in duration." A third
commenter commended the department's effort through the provision to limit
the restraint of an individual while in a prone or supine position. The commenter
stated, however that the provision appears to support the use of restraint
of an individual in a side position on the floor. The commenter suggested
that the provision should ban all floor restraints because such restraints
place an individual at a higher risk of restraint-related positional asphyxia
and other injury or death. The department believes that the language as proposed
provides appropriate protection for individuals and declines to make the recommended
revisions.
Concerning §415.356(e)-(g), which addresses the responsibilities of
a restraint monitor when an individual is in restraint in response to a behavioral
emergency, a commenter recommended the addition of language requiring the
state MR facility to have a restraint monitor on duty at all times. The commenter
also recommended that the rules require that a staff person who is not physically
involved in the restraint of an individual must observe the individual until
a restraint monitor arrives and that all staff be trained to serve as observers.
The department agrees and, noting that state MR facilities currently have
at least one restraint monitor on duty at all times, has added the recommended
language in new §415.355(r).
Two commenters recommended that §415.356(g) be revised to specify
that a restraint monitor must report the use of restraint in a behavioral
emergency to a nurse within an hour rather than "as soon as reasonably possible."
The commenters also asked whether the "nurse" to whom the restraint monitor
must make report is can be either a registered nurse or a licensed vocational
nurse. The department responds that the nurse to whom the restraint monitor
reports can be either a registered nurse or a licensed vocational nurse.
Two commenters submitted language from department rules applicable to public
and private inpatient mental health settings that address the use of restraint
in response to a behavioral emergency occurring off facility premises or during
transportation. The commenters recommended that the language replace §415.356(p),
which requires staff to contact a state MR facility nurse "as soon as reasonably
possible" if staff use restraint with an individual during a behavioral emergency
while absent from the state MR facility. The department has revised the subsection
by adding language that requires staff accompanying an individual away from
the state MR facility to follow the general principles and specific procedures
described in the subchapter if restraint must be used in response to a behavioral
emergency. The department further responds that some of the commenters' concerns
are addressed in those general principles and specific procedures while other
recommendations are outside the scope of the proposed rules. The following
four paragraphs summarize the commenters' detailed recommendations for revisions
and the department's responses.
The two commenters recommended revising §415.356(p) to require that,
if staff believe an individual may require medical attention, medication,
or use of restraint while being transported away from the state MR facility,
then a registered nurse or physician assistant, as appropriate, must accompany
the individual. The department does not believe that the recommended revision
will result in the reasonable and appropriate use of limited professional
staff resources. In addition, the department explains that if staff are able
to anticipate inappropriate behavior that will necessitate the use of restraint
while an individual is transported from the state MR facility, a behavior
therapy program should be approved to address that behavior. The department
explains further that a behavioral emergency, as defined in §415.353,
arises when an individual's inappropriate behavior "could not reasonably have
been anticipated." The department further notes that medical attention and
medication administration responsibilities are outside the scope of these
rules. The department declines to revise the subsection as suggested.
The two commenters recommended revising §415.356(p) to require that
staff not restrain an individual while away from a state MR facility campus
unless the criteria for a behavioral emergency are met, a physician orders
the restraint, and the transport is "medically necessary with documented clinical
justification." The commenters further recommended the inclusion of requirements
to contact a registered nurse for assistance in obtaining a physician's order
and ensure that all implementation, monitoring, documentation, and reporting
requirements described in the subchapter are observed. The department declines
to require that each transport of an individual away from the state MR facility
be documented as being "medically necessary." The department notes that individuals
residing in state MR facilities frequently leave the campus in department-owned
vehicles accompanied by staff to attend school, go to work, and participate
in local community activities. The department believes that defining such
trips as "medically necessary" is inappropriate, and that to restrict an individual's
excursions to only those that are "medically necessary" is a significant limitation
of an individual's rights. In addition, as described two paragraphs earlier,
the department has revised the subsection to require that staff accompanying
an individual off the campus must follow the general principles and specific
procedures described in the subchapter for use of restraint in a behavioral
emergency, which include requirements for staff to contact a nurse at the
state MR facility as soon as is reasonably possible to obtain a physician's
order and address the implementation, monitoring, documentation and reporting
requirements in the subchapter.
The two commenters recommended revising §415.356(p) to require that
staff must not implement restraint prior to an individual being transported
to another state MR facility unless the situation meets the criteria for a
behavioral emergency. If the individual is restrained, the commenters stated
that a registered nurse must accompany the individual. The commenters also
recommended requiring that a female staff member must accompany a female individual
and including requirements that appear elsewhere in the rules. The commenters
further stated that if the duration of the trip exceeds the maximum allowable
time of restraint on the original order and a behavioral emergency continues
to exist, the registered nurse who accompanies the individual must obtain
a physician's order by phone to renew the restraint. The commenters also stated
that staff at the originating state MR facility must fax required documentation
about the restraint to the destination facility on the day of transport, and
staff at the destination facility must to file the documentation in the individual's
medical record. The department believes that provisions in the federal regulations
governing the ICF/MR Program and the department's essential elements for state
MR facilities require a state MR facility to ensure the health and welfare
of an individual jointly weigh against the possibility that any state MR facility
will attempt to move an individual to another state MR facility while the
individual is in restraint as a result of a behavioral emergency. The department
declines to make the recommended revision.
The two commenters recommended revising §415.356(r) require staff
to provide an individual with reasonable opportunities for food and water
and to use the bathroom if the individual must be restrained in a behavioral
emergency while being transported from the state MR facility. The department
responds that the commenters' concerns are addressed in §§415.355(l)
and 415.356(j), but notes that the §415.356(r) has been revised to require
staff accompanying an individual off campus to follow the general principles
and specific procedures described in the subchapter for use of restraint in
a behavioral emergency.
Concerning §415.356(s), which requires an individual's IDT to review
alternative strategies for addressing an individual's inappropriate behavior
if restraint must be used in a behavioral emergency of a specified frequency
or duration, two commenters recommended that the provision be revised to require
the review to occur "in conjunction with a consultant who is not part of the
IDT and who may view the episode with a more objective eye." The department
believes the members of an individual's IDT are best prepared and qualified
to review alternative strategies for addressing inappropriate behavior under
the circumstances described in this provision. The department explains that
IDT members, which include an individual's physician, psychologist, and other
appropriate professionals and paraprofessionals, are familiar with the individual,
as well as other individuals and staff who may have been targets of or witnesses
to the inappropriate behavior that resulted in restraint being used in a behavioral
emergency. The professional and paraprofessional members of the individual's
IDT are knowledgeable about environmental, physiological, and medical factors
that may be critical in formulating a plan to address an individual's inappropriate
behavior. The department, therefore, declines to require the involvement of
a consultant in the IDT's review of alternative strategies under the circumstances
described in this provision.
Two commenters stated that §415.356(u)(2), which prohibits the use
of a restraint board during a behavioral emergency but permits use of a restraint
board as part of an approved behavior therapy program, is not consistent with
a policy negotiated by the department and Advocacy Inc. and described in a
department memorandum dated April 11, 2001. The department disagrees that
the provision conflicts with the policy memorandum, and explains that the
policy, which remains in effect, permits the use of restraint boards under
certain circumstances.
Two commenters recommended that §415.358(e), which requires an individual's
IDT to consider what steps may be taken to reduce the need for restraint during
medical or dental care, be revised to qualify that any steps considered by
the IDT must be "possible or appropriate". The commenters stated that for
some individuals no other steps are possible or appropriate. The department
declines to make the recommended revision and explains that the provision
clearly expects that an IDT will recommend only steps that it anticipates
might be successful in reducing the need for restraint during medical or dental
care.
A commenter recommended that the department include requirements for daily
documentation and monitoring in §415.359, which addresses the use of
restraint to prevent involuntary self-injury, and §415.360, which addresses
the use of restraint to provide postural support. The commenter further recommended
adding language to require that staff monitoring of an individual must not
inappropriately restrict the individual's right to privacy. The department
responds that the provisions in the two sections and in §415.355(h)(5)
adequately address the issues of documentation and monitoring without inappropriately
restricting the individual's right to privacy. The department declines to
make the recommended revisions.
Two commenters requested that §415.361(f), which lists mechanical
devices for use in restraint, be revised to specify that certain of the devices
can be used to secure an individual to a stationary object while the individual
is seated. The department believes the descriptions adequately describe the
mechanical devices and their intended use and declines to make the recommended
change. The department further notes that the §415.355(i)(2) prohibits
staff from securing an individual to a stationary object while the individual
is in a standing position.
Concerning §415.363, which addresses training requirements, one commenter
recommended a minimum requirement of annual refresher training for everyone
who may become involved in de-escalation of potentially violent situations
or in the implementation of a restraint in any capacity. The commenter stated
that even staff not involved in restraint should have a clear understanding
of the philosophy and approach supported by the policy and training. The commenter
also recommended that the rules require training to address more than simply
recognizing signs of distress. The commenter stated that staff must be educated
about the risks inherent in every restraint, particularly those leading to
takedown procedures. The department responds that §415.363(e) requires
an employee to demonstrate competency annually in the appropriate training
components if the employee's work responsibilities require the employee to
participate in restraint. The department further notes that all staff, including
those employed in the Central Office, are required to complete courses that
address the department's philosophy about the rights of individuals and the
responsibility of staff to ensure that individuals are protected from abuse,
neglect, and exploitation. The department also notes that state MR facility
training in use of restraint addresses the risks inherent in the use of restraint
for individual and for staff.
Two commenters recommended that §415.363(c)(2)(B) be revised to specify
that a state MR facility's training module on rights must address not only
the rights of individuals but of LARs. The commenters stated that "many of
the rights of the individual are transferred to the LAR by the court and this
must be acknowledged here and in all TDMHMR documents." The department disagrees
with the commenters' recommendation and responds that the new subchapter is
designed to protect certain rights of the individual that do not "transfer"
to a court-appointed guardian. These rights include protection from exploitation
and abuse, access to appropriate treatment and services, freedom from mistreatment,
and freedom from unnecessary medication. The department declines to make the
recommended revision.
The new subchapter is adopted under the Texas Health and Safety
Code (THSC), §532.015(a), which provides the Texas Mental Health and
Mental Retardation Board (board) with broad rulemaking authority; THSC, §591.004,
which requires the board to ensure the implementation of the Persons with
Mental Retardation Act (THSC, Title 7, Subtitle D); and THSC, §592.002,
which requires the board to ensure the implementation of certain rights enumerated
in THSC, Chapter 592.
§415.353.Definitions.
The following words and terms, when used in this subchapter, have the
following meanings unless the context clearly indicates otherwise.
(1)
Behavior therapy--Systematic efforts to increase adaptive
behaviors and to modify maladaptive or problem behaviors and replace them
with behaviors that are adaptive and socially acceptable.
(2)
Behavioral emergency--A situation in which severely aggressive,
destructive, violent, or self-injurious behavior exhibited by an individual:
(A)
poses a substantial risk of imminent probable death of,
or substantial bodily harm to, the individual or others;
(B)
has not abated in response to attempted preventive de-escalatory
or redirection techniques;
(C)
could not reasonably have been anticipated;
(D)
is not addressed in a behavior therapy program; and
(E)
does not occur during a medical or dental procedure.
(3)
CFR (Code of Federal Regulations)--The compilation of federal
agency regulations.
(4)
IDT (interdisciplinary team)--Mental retardation professionals
and paraprofessionals and other concerned persons, as appropriate, who assess
an individual's treatment, training, and habilitation needs and make recommendations
for services.
(A)
Team membership always includes:
(i)
the individual;
(ii)
the individual's LAR, if any; and
(iii)
persons specified by a state MR facility who are professionally
qualified and/or certified or licensed with special training and experience
in the diagnosis, management, needs, and treatment of individuals with mental
retardation.
(B)
Other participants in IDT meetings may include:
(i)
other concerned persons whose inclusion is requested by
the individual or the LAR; and
(ii)
at the discretion of the state MR facility, persons who
are directly involved in the delivery of mental retardation services to the
individual.
(5)
Individual--A person with mental retardation who resides
in a state MR facility.
(6)
IPP (individual program plan)--A plan developed by an individual's
IDT that identifies the individual's training, treatment, and habilitation
needs and describes appropriate services and supports to meet those needs.
(7)
LAR (legally authorized representative)--A person authorized
by law to act on behalf of an individual with regard to a matter described
in this subchapter, and may include a parent, guardian, managing conservator
of a minor individual, or a guardian of an adult individual.
(8)
Legally adequate consent--A term consistent with provisions
of the Texas Health and Safety Code (THSC), Title 7, §591.006, which
states, in essence, that consent obtained from an individual with mental retardation
is legally adequate when each of the following conditions has been met:
(A)
legal status: The individual giving the consent:
(i)
is 18 years of age or older, or younger than 18 years of
age and is or has been married or had the disabilities of minority removed
for general purposes by court order as described in the Texas Family Code,
Chapter 31; and
(ii)
has not been determined by a court to lack capacity to
make decisions with regard to the matter for which consent is being sought.
(B)
comprehension of information: The individual giving the
consent has been informed of and comprehends the nature, purpose, consequences,
risks, and benefits of and alternatives to the procedure, and the fact that
withholding or withdrawal of consent shall not prejudice the future provision
of care and services to the individual with mental retardation; and
(C)
voluntariness: The consent has been given voluntarily and
free from coercion and undue influence.
(9)
Mechanical device--A piece of equipment or an apparatus
used in the safe and relatively comfortable restraint of individuals.
(10)
Medical emergency--A situation in which acute, non-psychiatric
signs and symptoms, including severe pain, exhibited by an individual require
immediate attention by a physician or nurse:
(A)
to preclude serious impairment to normal functioning of
one or more of the individual's body parts or organs; or
(B)
if the individual is a pregnant woman, to prevent irreversible
harm to the woman or the woman's unborn child.
(11)
Medical intervention--Treatment by a licensed medical
doctor, osteopath, podiatrist, dentist, physician's assistant, or advanced
practice nurse (APN). For the purposes of this subchapter, the term does not
include first aid, an examination, diagnostics (e.g., x-ray, blood test),
or the prescribing of oral or topical medication.
(12)
Non-serious physical injury--Any injury requiring minor
first aid and determined not to be serious by a registered nurse, advanced
practice nurse (APN), or physician.
(13)
PMAB (Prevention and Management of Aggressive Behavior)--The
department's proprietary risk management curriculum that is intended to reduce
the likelihood of injuries caused by the aggressive behavior of individuals
receiving department services. The curriculum presents a graduated system
of interventions that rely on the least restrictive approaches possible to
respond to a behavioral emergency.
(14)
Qualified mental retardation professional (QMRP)--A state
MR facility employee responsible for integrating, coordinating, and monitoring
an individual's IPP who meets the requirements of 42 CFR §483.430.
(15)
Restraint--The use of manual pressure, except for physical
guidance or prompting of brief duration, or a mechanical device to restrict:
(A)
the free movement or normal functioning of the whole or
a portion of an individual's body; or
(B)
normal access by the individual to a portion of the individual's
body.
(16)
Restraint monitor--An employee of the state MR facility
who:
(A)
has experience working directly with persons with mental
retardation;
(B)
is designated to:
(i)
go to a site where restraint in a behavioral emergency
is implemented; and
(ii)
provide supervision and oversight; and
(C)
meets the training requirements described in §415.363
of this title (relating to Staff Training in the Use of Restraint).
(17)
Serious physical injury--Any injury requiring medical
intervention or hospitalization or any injury determined to be serious by
a physician or advanced practice nurse (APN).
(18)
State MR facility--A state mental retardation facility,
i.e., a state school or state center operated by the department that provides
residential services to individuals with mental retardation.
§415.354.General Provisions.
(a)
Each state MR facility must have and implement written
policies and procedures that:
(1)
do not conflict with this subchapter or those provisions
of the Conditions of Participation for Intermediate Care Facilities for Persons
with Mental Retardation (42 CFR §483.410-483.480, et. seq.) concerning
the management of inappropriate behavior;
(2)
emphasize the department's commitment to:
(A)
providing treatment that is the least restrictive and most
effective alternative available for an individual;
(B)
staff training that emphasizes early recognition of situations
and behaviors that, if not appropriately addressed, could necessitate the
use of restraint in a behavioral emergency; and
(C)
reducing the necessity for the use of restraint;
(3)
detail requirements for documenting and reporting the use
of restraint, including instances when an individual:
(A)
receives a serious physical injury or dies while in restraint
during a behavioral emergency or as part of a behavior therapy program; or
(B)
dies within 24 hours after being released from a restraint
used during a behavioral emergency or as part of a behavior therapy program;
and
(4)
detail the training and demonstration of competence requirements
for state MR facility staff.
(b)
The standards in this subchapter take precedence over other
applicable standards, including the ICF/MR Conditions of Participation, whenever
the other applicable standards are less restrictive.
§415.355.General Principles for the Use of Restraint.
(a)
The general principles listed in this subsection apply
to the use of restraint in each of the following circumstances, unless explicitly
stated otherwise:
(1)
in a behavioral emergency;
(2)
as an intervention in a behavior therapy program that addresses
inappropriate behavior exhibited voluntarily by an individual (e.g., prevention
of gouging of the individual's own eyes through the use of elbow immobilizers);
(3)
during a medical or dental procedure if necessary to protect
the individual or others and as a follow-up after a medical or dental procedure
or following an injury to promote the healing of wounds;
(4)
to protect the individual from involuntary self-injury
(e.g., helmet for an individual who, during seizures, looses consciousness,
falls to the floor, and risks head injuries), although not all techniques
used by a state MR facility to protect an individual from involuntary self-injury
constitute the use of restraint; and
(5)
to provide postural support to the individual or to assist
the individual in obtaining and maintaining normative bodily functioning,
although not all techniques used by a state MR facility to provide postural
support or assist in obtaining and maintaining normative bodily functioning
constitute the use of restraint (e.g., placement of wedges, bolsters, or cushions
to position an individual in a bed or chair).
(b)
Upon an individual's admission to a state MR facility,
an IDT must:
(1)
with the involvement of a physician, identify:
(A)
the individual's known physical or medical conditions that
might constitute a risk to the individual during the use of restraint; and
(B)
other factors that must be taken into account if the use
of restraint is considered including, but not limited to, the individual's
cognitive functioning level, size, weight, emotional condition (including
whether the individual has a history of having been physically or sexually
abused), and age; and
(2)
document the identified conditions and factors and, as
applicable, limitations on specific techniques or mechanical devices for restraint,
in the individual's record.
(c)
At least annually, or when significant changes occur to
the extent and nature of the identified conditions and factors documented
in the individual's record, the IDT must ensure that a physician, advanced
practice nurse, or physician assistant reviews and updates, as necessary,
the identified conditions, factors, and limitations on specific techniques
or mechanical devices for restraint documented in the individual's record.
(d)
Before restraint is used with an individual, state MR facility
staff must determine that less restrictive, less intrusive interventions will
be ineffective.
(e)
Staff are prohibited from using restraint:
(1)
for disciplinary purposes;
(2)
for the convenience of staff or other individuals; or
(3)
as a substitute for effective treatment or habilitation.
(f)
Staff may use restraint only for the shortest period of
time necessary to ensure:
(1)
protection for the individual or others in a behavioral
emergency; and
(2)
therapeutic effectiveness;
(A)
as part of a behavior therapy program;
(B)
as part of a medical or dental procedure; and
(C)
in protecting against involuntary self-injury.
(g)
Staff are prohibited from using restraint in a way that:
(1)
obstructs the individual's airway;
(2)
impairs the individual's breathing by putting pressure
on the individual's torso; or
(3)
interferes with the individual's ability to communicate.
(h)
Staff may use restraint only in a manner that:
(1)
takes into consideration the individual's known physical
or medical conditions that might constitute a risk to the individual during
restraint, as documented in the individual's record in accordance with subsections
(b)(2) and (c) of this section;
(2)
takes into consideration other factors, including the individual's
cognitive functioning level, size, weight, known physical, medical, and emotional
condition, and age, as documented in the individual's record in accordance
with subsections (b)(2) and (c) of this section;
(3)
is consistent with the limitations on specific techniques
or mechanical devices for restraint documented in the individual's record
in accordance with subsections (b)(2) and (c) of this section;
(4)
reduces the risk of injury or undue physical discomfort
to the individual; and
(5)
safeguards the individual's dignity, privacy, and well-being.
(i)
Staff must implement restraint:
(1)
with only the minimal amount of force or pressure that
is reasonable and necessary to ensure the safety of the individual and others.
(2)
without securing the individual to a stationary object
while the individual is in a standing position;
(3)
without causing pain that restricts the individual's movement;
and
(4)
without violating the individual's rights as described
in §405.625 of this title (relating to Rights of Clients Receiving Residential
Mental Retardation Services).
(j)
Staff may use restraint only if it is authorized as described
in:
(1)
§415.356 of this title (relating to Use of Restraint
in a Behavioral Emergency);
(2)
§415.357 of this title (relating to Use of Restraint
in a Behavior Therapy Program);
(3)
§415.358 of this title (relating to Use of Restraint
During Medical or Dental Procedures and to Promote Healing);
(4)
§415.359 of this title (relating to Use of Restraint
with a Mechanical Device to Protect an Individual from Involuntary Self-Injury);
or
(5)
§415.360 of this title (relating to Use of Restraint
with a Mechanical Device to Provide Postural Support).
(k)
When an individual is restrained, staff must ensure that
the individual is:
(1)
provided immediate relief, which may include immediate
release from restraint, and checked by a nurse if the individual shows signs
or symptoms of physical distress;
(2)
provided with medications as prescribed;
(3)
offered regular meals and snacks or, as appropriate, a
nutritionally equivalent substitute; and
(4)
monitored to the extent necessary, with consideration given
to the individual's position, level of agitation, and the identified conditions
and factors documented in the individual's record as described in subsection
(b)(2) and (c) of this section to:
(A)
prevent the individual from choking or aspirating food
or fluid; and
(B)
protect the individual from physical distress, self-injury,
or injury by another individual. (For example, an individual in four-point
restraint should be monitored continuously by staff, while an individual wearing
a helmet or mittens may not require continuous monitoring.)
(l)
At shift change, staff going off-duty must review the status
of an individual who is in restraint as a result of a behavioral emergency
or as part of a behavior therapy program with staff who are coming on-duty.
The review must be documented in the individual's record and must address:
(1)
time the restraint was initiated;
(2)
individual's current physical, emotional, and behavioral
condition;
(3)
medications administered during the restraint; and
(4)
type of care needed.
(m)
All communication with an individual concerning the use
of restraint must be:
(1)
conducted in a language or method that is understandable
by the individual;
(2)
tailored to the individual's ability to comprehend; and
(3)
responsive to any visual or hearing impairment the individual
is known to have.
(n)
If an individual in restraint experiences a medical emergency,
staff must:
(1)
release the individual from restraint as soon as possible
as indicated by the medical emergency;
(2)
ensure that the medical emergency is promptly addressed
as described in the state MR facility's policies and procedures concerning
management of a medical emergency; and
(3)
obtain a new order for restraint, if the use of restraint
at the time of the medical emergency had been in response to a behavioral
emergency and the individual continues to exhibit behavior that constitutes
a behavioral emergency.
(o)
If an emergency evacuation or an evacuation drill occurs
while an individual is in restraint, staff will respond as described in the
state MR facility's policies and procedures to ensure the individual's safety.
(p)
If an individual is involved in a program outside the state
MR facility, e.g., attending public school or working, the state MR facility
will:
(1)
coordinate with staff from the outside program in the assessment
and development of interventions with the goal of consistency in the use of
restraint:
(A)
in a behavioral emergency; and
(B)
as an intervention in a behavior therapy program; and
(2)
invite staff of the outside program to participate in IDT
meetings at which interventions, including behavior therapy programs, are
discussed.
(q)
A state MR facility must ensure that at least one restraint
monitor is on duty at all times to respond as described in §415.356(e)(2),
(g), and (p) of this title (relating to Restraint in a Behavioral Emergency).
§415.356.Use of Restraint in a Behavioral Emergency.
(a)
A physician must not issue a standing or "as needed" order
for the use of restraint in a behavioral emergency.
(b)
If an individual exhibits behavior that staff believe is
likely to escalate into a behavioral emergency, staff first should attempt
verbal or other de-escalative interventions in which they have been trained
as described in §415.363(b) of this title (relating to Staff Training
in the Use of Restraint).
(c)
If the individual's behavior escalates into a behavioral
emergency, one or more staff may initiate:
(1)
personal restraint as instructed during Prevention and
Management of Aggressive Behavior (PMAB) training provided by the state MR
facility as described in §415.363(b) of this title (relating to Staff
Training in the Use of Restraint); or
(2)
in the rare situation when PMAB procedures cannot be safely
applied, staff may take such actions as are reasonably believed to be immediately
necessary to avoid imminent harm to the individual or others, including the
use of a mechanical device:
(A)
as long as those actions do not include acts of unnecessary
force; and
(B)
staff describe in the individual's record the actions that
were taken and the reason why PMAB personal restraint techniques could not
be safely applied.
(d)
Unless a physician's order specifically directs otherwise
as a result of the identified conditions and factors documented in the individual's
record as described in §415.355(b)(2) and (c) of this title (relating
to General Principles for the Use of Restraint), staff must:
(1)
not place an individual in a prone or supine position during
personal restraint; and
(2)
if the individual in personal restraint rolls into a prone
or supine position, restore the individual to a standing, sitting, or side
position as soon as possible.
(e)
Immediately after the individual is placed in restraint,
staff must:
(1)
explain to the individual that release from the restraint
will occur as soon as the individual no longer poses a risk of imminent physical
harm to self or to others; and
(2)
notify a restraint monitor, who will:
(A)
immediately go to the site of the restraint and ensure
that the restraint is properly used;
(B)
ensure that the individual is not at risk of serious physical
injury or death and is receiving proper care;
(C)
ensure that staff have explained to the individual that
release from the restraint will occur as soon as the individual no longer
poses a risk of imminent physical harm to self or others; and
(D)
determine whether consultation by a professional is necessary
(e.g., psychologist) and contact the appropriate professional, if deemed necessary.
(f)
If notified by a restraint monitor that consultation is
necessary, a professional (e.g., nurse or psychologist) will:
(1)
determine the nature of the restraint monitor's concerns;
(2)
go to the site of the restraint, if the professional determines
this is warranted by the circumstances; and
(3)
address the restraint monitor's concerns.
(g)
As soon as reasonably possible, but in no case later than
an hour after the individual was placed in restraint, the restraint monitor
must report the use of restraint to a nurse with the following information:
(1)
time the restraint was initiated;
(2)
description of the specific behaviors which necessitated
the use of restraint;
(3)
the type of restraint;
(4)
the duration of the restraint, if applicable; and
(5)
the physical and apparent emotional condition of the individual.
(h)
Upon being informed of the use of restraint, the nurse
will:
(1)
inform a physician, either in person or by phone, of the
information described in subsection (g) of this section;
(2)
document the physician's verbal order in the individual's
record to include the:
(A)
type of restraint;
(B)
behaviors that necessitated the use of restraint;
(C)
duration of the order, not to exceed 12 hours from the
time the restraint was initiated;
(D)
special instructions for the individual's care, if any,
while in restraint; and
(E)
time and date of the order; and
(3)
within 30 minutes or as soon as reasonably possible of
the individual's release from restraint or of being told of the individual's
release from restraint, conduct a face-to-face evaluation of the individual
for injuries and overall well-being.
(i)
A physician will sign and date the order no later than
the end of the next working day.
(j)
While an individual is being restrained, staff must ensure
that the individual is provided with:
(1)
privacy to the extent possible without compromising the
individual's safety or the safety of other individuals and staff; and
(2)
an opportunity for a period of not less than five minutes
during each one hour period:
(A)
for movement and exercise if the restraint restricts the
individual's range of motion in a limb or joint; and
(B)
to use toilet facilities and drink fluids.
(k)
If staff remove personal items, including clothing, from
an individual to ensure the safety of the individual or others during the
use of restraint in a behavioral emergency, staff must:
(1)
ensure that the personal items are secured from damage,
loss, or theft;
(2)
provide clothing as appropriate to ensure the individual's
dignity and privacy, if the personal items that were removed include clothing;
and
(3)
ensure that the personal items are returned to the individual
immediately upon release from restraint.
(l)
As the circumstances warrant, when releasing an individual
from restraint to provide an opportunity for movement and exercise as described
in subsection (j)(2)(A)-(B) of this section, staff may release one limb at
a time.
(m)
If an individual released from restraint as described in
subsection (j)(2)(A)-(B) of this section demonstrates behavior that would
constitute a behavioral emergency, staff will return the individual to restraint.
(n)
Staff must release an individual from restraint:
(1)
as soon as the individual no longer poses a risk of imminent
physical harm to self or others; and
(2)
when the individual falls asleep while being restrained
with a mechanical device.
(o)
After the individual is released from restraint, staff
will:
(1)
provide transition activities to facilitate the individual's
re-assimilation into the social milieu;
(2)
observe the individual for at least 15 minutes to ensure
a smooth assimilation with documentation in the individual's record;
(3)
if the individual's record directs that the individual
be provided with an opportunity to discuss the use of restraint, inform the
appropriate staff person; and
(4)
complete the state MR facility's restraint checklist documenting
the care of the individual while in restraint.
(p)
The restraint monitor:
(1)
will ensure that:
(A)
all necessary documentation is completed;
(B)
the individual's QMRP is notified and the notification
is documented in the individual's record; and
(C)
the appropriate professional staff (e.g., psychologist)
is notified if the restraint occurred within 24 hours of another restraint
of the individual in a behavioral emergency; and
(2)
must debrief staff who actively participated in the use
of restraint.
(q)
The state MR facility will ensure that, within 24 hours
of the individual's release from restraint, the individual's LAR (or the person
listed in the individual's record as primary correspondent) is notified that
the individual was restrained in a behavioral emergency with information about
the type of restraint and the individual's condition. The notification will
be documented in the individual's record.
(r)
If staff must use restraint to address an individual's
inappropriate behavior that escalates into a behavioral emergency while the
individual is away from the state MR facility, staff must comply with §415.355
of this title (relating to General Principles for the Use of Restraint) and
follow the procedures described in this section, with the following exceptions:
(1)
Instead of notifying a restraint monitor as described in
subsection (e)(2) of this section, staff who initiated the restraint must:
(A)
report the use of restraint to a nurse at the state MR
facility as soon as is reasonably possible; and
(B)
provide the nurse with the information described in subsection
(g) of this section.
(2)
Upon returning to the state MR facility, staff must notify
the restraint monitor who will comply with the provisions of subsection (p)
of this section.
(s)
An individual's IDT will meet to review alternative strategies,
which may include developing a behavior therapy program that targets for modification
or replacement those behaviors that resulted in behavioral emergencies, if
the individual is restrained in a behavioral emergency:
(1)
more often than twice within 30 calendar days;
(2)
in two or more separate episodes of any duration within
12 hours; or
(3)
for more than 12 continuous hours.
(t)
Staff will follow the provisions of §405.31 of this
title (relating to Emergency Use of Psychotropic Medications) if the use of
psychotropic medications in a behavioral emergency is deemed necessary by
a physician.
(u)
The following procedures must not be used in a behavioral
emergency, but may be used as part of an approved behavior therapy program,
as described in Chapter 415, Subchapter I of this title (relating to Behavior
Therapy in State Mental Retardation Facilities):
(1)
use of a time out room; and
(2)
restraint using a restraint board.
§415.357.Use of Restraint in a Behavior Therapy Program.
(a)
The use of restraint as an intervention in a behavior therapy
program must be approved and implemented as described in Chapter 415, Subchapter
I of this title (relating to Behavior Therapy--State Mental Retardation Facilities).
(b)
The provisions of this section must be followed by staff
when implementing restraint as directed in an individual's behavior therapy
program both on and off the state MR facility campus.
(c)
Immediately after an individual is placed in restraint
as directed in the individual's behavior therapy program, staff must explain
to the individual the conditions under which the individual will be released
from restraint, unless the behavior therapy program provides direction to
the contrary.
(d)
Unless a physician's instructions in the behavior therapy
program specifically direct otherwise as a result of the identified conditions
and factors documented in the individual's record as described in §415.355(b)(2)
and (c) of this title (relating to General Principles for the Use of Restraint),
staff must:
(1)
not place an individual in a prone or supine position during
personal restraint; and
(2)
if the individual in personal restraint rolls into a prone
or supine position, restore the individual to a standing, sitting, or side
position as soon as possible.
(e)
If staff determine that consultation by a professional
(e.g., nurse or psychologist) is necessary, staff will contact the appropriate
professional. The professional will:
(1)
determine the nature of staff's concerns; and
(2)
go to the site of the restraint, if the professional determines
this is warranted by the circumstances.
(f)
While an individual is being restrained, staff must ensure
that the individual is provided with an opportunity for a period of not less
than five minutes during each one hour period:
(1)
for movement and exercise if the restraint restricts the
individual's range of motion in a limb or joint; and
(2)
to use toilet facilities and drink fluids.
(g)
If an individual released from restraint as described in
subsection (f) of this section demonstrates behavior that would constitute
a behavioral emergency, staff will initiate restraint as described in §415.356
of this title (relating to Use of Restraint in a Behavioral Emergency.
(h)
Unless the individual's behavior therapy program directs
otherwise, a nurse must check the individual for injuries and overall well-being
after the individual is released from restraint.
§415.359.Use of Restraint with a Mechanical Device to Prevent Involuntary Self-injury.
(a)
Some techniques used by a state MR facility to protect
an individual from an injury that might result from involuntary movements
exhibited by the individual (e.g., falling and hitting head on floor as a
result of a seizure) may constitute restraint with a mechanical device. An
individual's IDT may authorize staff to use restraint with a mechanical device
if:
(1)
the IDT determines that less restrictive interventions
are inappropriate;
(2)
a physician concurs with the recommendation and signs an
order for use of the mechanical device; and
(3)
state MR facility staff obtains, for a period not to exceed
one year:
(A)
legally adequate consent from the individual who is able
to provide legally adequate consent;
(B)
consent from the individual's LAR; or
(C)
authorization by the head of the state MR facility if:
(i)
the individual is not able to provide legally adequate
consent and does not have an LAR; or
(ii)
the individual's LAR has:
(I)
not responded to the state MR facility's attempts to obtain
the LAR's consent; and
(II)
been notified that the head of the state MR facility may
authorize the use of restraint if the LAR does not respond.
(b)
The IDT must document the following in the individual's
record:
(1)
a description of the involuntary movements which necessitate
the use of restraint with a mechanical device;
(2)
the less restrictive interventions and alternative strategies
that have been attempted or considered;
(3)
the specific mechanical device recommended; and
(4)
instructions for safe use of the mechanical device.
(c)
Mechanical devices used as described in this section may
include:
(1)
helmet for an individual with a seizure disorder;
(2)
bedrails to prevent an individual from falling out of bed;
and
(3)
seat belt to prevent an individual from falling out of
a wheelchairs.
(d)
An individual's IDT must review the use of a mechanical
device for restraint as described in this section at least annually and whenever
changes in the extent and nature of the individual's involuntary movements
occur.
(1)
The IDT will consider whether less restrictive interventions
might be appropriate to protect the individual from involuntary self-injury.
(2)
The IDT may recommend continued use of the mechanical device
only if it determines that less restrictive interventions continue to be inappropriate
to protect the individual from involuntary self-injury.
(3)
The IDT must document in the individual program plan any
measures taken to alleviate the need for the mechanical device.
(4)
If the IDT recommends a change in the type of mechanical
device, the recommendation must be submitted to a physician for review.
(A)
If the physician concurs with the recommendation, the physician
will sign an order for use of the mechanical device.
(B)
Staff must obtain consent or authorization as described
in subsection (a)(3) of this section whenever the IDT recommends a change
in the type of mechanical device for restraint.
§415.360.Use of Restraint with a Mechanical Device to Provide Postural Support.
(a)
Some techniques used by a state MR facility if an individual
requires assistance to maintain postural support may constitute restraint
with a mechanical device. An individual's IDT may authorize staff to use restraint
with a mechanical device if:
(1)
the individual's IDT concurs with the recommendation of
a licensed occupational therapist or physical therapist that less restrictive
interventions are inappropriate and recommends the use of restraint with a
mechanical device;
(2)
a physician concurs with the IDT's recommendation and signs
an order for use of the mechanical device; and
(3)
state MR facility staff obtain, for a period not to exceed
one year:
(A)
legally adequate consent from the individual who is able
to provide legally adequate consent;
(B)
consent from the individual's LAR; or
(C)
authorization by the head of the state MR facility if:
(i)
the individual is not able to provide legally adequate
consent and does not have an LAR; or
(ii)
the individual's LAR has:
(I)
not responded to the state MR facility's attempts to obtain
the LAR's consent; and
(II)
been notified that the head of the state MR facility may
authorize the use of restraint if the LAR does not respond.
(b)
The IDT must document the following in the individual's
record:
(1)
a description of the condition which necessitates the use
of restraint with a mechanical device;
(2)
the expected therapeutic outcome;
(3)
the less restrictive interventions and alternative strategies
that have been attempted or considered;
(4)
the specific mechanical device recommended; and
(5)
instructions for safe use of the mechanical device.
(c)
Mechanical devices used as described in this section may
include, but are not limited to, vests and seat belts. They are considered
an adjunct to proper care of an individual and may not be used as a substitute
for appropriate nursing care.
(d)
An individual's IDT must review the use of a mechanical
device for restraint as described in this section at least annually and whenever
changes in the extent and nature of the individual's physical condition occur.
(1)
The IDT will consider whether less restrictive interventions
might be appropriate to assist the individual in maintaining postural support.
(2)
The IDT may recommend continued use of the mechanical device
only if it determines that less restrictive interventions continue to be inappropriate
to assist the individual in maintaining postural support.
(3)
The IDT must document in the IPP any measures taken to
alleviate the need for the mechanical device.
(4)
If the IDT recommends a change in the type of mechanical
device, the recommendation must be submitted to a physician for review.
(A)
If the physician concurs with the recommendation, the physician
will sign an order for use of the mechanical device.
(B)
Staff must obtain consent or authorization as described
in subsection (a)(3) of this section whenever the IDT recommends a change
in the type of mechanical device for restraint.
§415.361.Mechanical Devices for Use in Restraint.
(a)
A state MR facility must use only those mechanical devices
designed specifically for the safe and relatively comfortable restraint of
humans, to include:
(1)
commercially available devices; and
(2)
devices developed independently by or on behalf of the
state MR facility.
(b)
A state MR facility may use a commercially available mechanical
device that has been altered to accommodate an individual's specific physical
needs (e.g., a physical impairment or obesity) or a mechanical device developed
independently by or on behalf of the state MR facility only if its use has
been approved by the director of State MR Facilities in the department's Central
Office.
(1)
Before the state MR facility requests approval from the
director of State MR Facilities to use such a mechanical device, a written
description of the mechanical device and its intended use (with pictures and
sketches, as appropriate) must be reviewed and approved by a committee at
the state MR facility that includes the following staff:
(A)
medical director or designee;
(B)
nursing director or designee;
(C)
director of psychology;
(D)
director of habilitation services;
(E)
safety officer; and
(F)
rights officer.
(2)
If the committee approves the mechanical device, a written
description of the mechanical device and its intended use (with pictures and
sketches, as appropriate) will be submitted to the head of the state MR facility,
who must decide within 10 working days whether to request approval from the
director of State MR Facilities to use the mechanical device.
(3)
Within 10 working days of receiving a request for approval
to use a mechanical device, the director of State MR Facilities must review
the request and notify the head of the state MR facility whether or not the
request has been approved.
(c)
Staff will inspect a mechanical device before and after
each use to ensure the device is in good repair and without tears or protrusions
that may cause injury. A damaged mechanical device must be repaired before
it can be used in the restraint of an individual. If a damaged mechanical
device cannot be repaired to make it safe for use in the restraint of an individual,
it must be discarded.
(d)
Staff must ensure that a mechanical device is not secured
so tightly that the individual's circulation or breathing is impaired or so
loosely that the individual's skin is chafed. Staff must exercise caution
when using mechanical devices such as a camisole or straitjacket that may
impair the individual's balance or interfere with the individual's ability
to break a fall.
(e)
Staff may use two or more mechanical devices simultaneously
in the restraint of an individual in a behavioral emergency if a physician
authorizes their use.
(f)
The following mechanical devices may be used in the restraint
of an individual.
(1)
Anklets--Padded bands of cloth or leather that are secured
around the individual's ankles or legs using hook-and-loop (e.g., Velcro brand)
tape or buckle fasteners and attached to a stationery object (e.g., bed or
chair frame).
(2)
Arm splints or elbow immobilizers--Strips of any material
with padding that extend from below to above the elbow and are secured around
the arm with ties or hook-and-loop (e.g., Velcro brand) tape. If appropriate,
they should be secured such that the individual has full use of the hands.
(3)
Belts--A cloth or leather band that is fastened around
the waist and secured to a stationery object (e.g., chair frame) or used for
securing the arms to the sides of the body.
(4)
Camisole--A sleeveless cloth jacket which covers the arms
and upper trunk and is secured behind the individual's back.
(5)
Chair restraint--A padded, stabilized chair which supports
all body parts and is used with anklets or wristlets to prevent the individual
from standing up without assistance.
(6)
Helmets--A plastic, foam rubber, or leather head covering,
such as sports helmets, that may include an attached face guard.
(7)
Mittens--A cloth, plastic, foam rubber, or leather hand
covering, such as boxing and other types of sport gloves, that are secured
around the wrist or lower arm with elastic, hook-and-loop (e.g., Velcro brand)
tape, ties, paper tape, pull strings, buttons, or snaps.
(8)
Restraint board--A padded, rigid board to which an individual
is secured face-up, unless that position is clinically contraindicated for
that individual. This device will not be used in the restraint of an individual
in a behavioral emergency.
(9)
Restraining net--Mesh fabric that is placed over an individual's
upper and lower trunk with the head, arms, and lower legs exposed; the net
is secured over a mattress to a bed frame and is never placed over the individual's
head.
(10)
Straitjacket--A heavy canvas jacket that is open in the
back and has sleeves that are stitched closed. The individual's arms are crossed
in front and the sleeves secured with ties at the back.
(11)
Ties--A length of cloth or leather used to secure approved
mechanical restraints (i.e., mittens, wristlets, arm splints, belts, anklets,
vests, etc.) to a stationary object (i.e., bed or wheelchair frame) or to
other mechanical restraints.
(12)
Transport jacket--A heavy canvas sleeveless jacket that
encases the arms and upper trunk, fastens with hook-and-loop (e.g., Velcro
brand) tape or roller buckles, and is held in place by a strap between the
legs.
(13)
Vest--A sleeveless cloth jacket which covers the upper
trunk of the individual. The vest may be secured to a stationary object (e.g.,
bed or chair frame).
(14)
Wristlets--Padded cloth or leather bands that are secured
around the individual's wrists or arms using hook-and-loop (e.g., Velcro brand)
tape or buckle fasteners and attached to a stationery object (e.g., bed or
chair frame).
(g)
The following mechanical devices must not be used in the
restraint of an individual.
(1)
metal wrist or ankle cuffs;
(2)
rubber bands, ropes, and cords, unless part of an approved
device;
(3)
long ties and leashes, including halter leashes;
(4)
restraining sheets attached to any stationary object other
than a bed;
(5)
padlocks; and
(6)
barred enclosures with tops, including crib-style bed with
mesh tops.
(h)
A mechanical device that is not described in subsection
(f) of this section but is not expressly forbidden in subsection (g) of this
section may be used in the restraint of an individual if its use is approved
as described in subsection (b) of this section.
§415.362.Additional Reporting and Documentation Requirements.
(a)
Reports to head of the state MR facility.
(1)
Staff will notify the head of the state MR facility or
designee immediately, but in no case more than one hour after learning of
a serious physical injury to or death of an individual that occurs while the
individual is in restraint.
(2)
Within one working day of receiving the notice described
in paragraph (1) of this subsection, the head of the state MR facility or
designee must:
(A)
notify the State MR Facilities Division in Central Office
of the serious physical injury or death; and
(B)
name one or more staff to investigate the serious physical
injury or death.
(3)
The staff named to investigate the serious physical injury
or death must submit a written report on the results of the investigation
to the head of the state MR facility or designee no later than five working
days after the notice of the serious physical injury or death required in
paragraph (1)(A)-(B) of this subsection.
(A)
The written report will be reviewed by the head of the
facility, who will take prompt appropriate corrective action, if determined
to be necessary.
(B)
A copy of the report will be submitted to the State MR
Facilities Division in Central Office.
(b)
Reports to Texas Department of Family and Protective Services.
If the serious physical injury or death is suspected to be the result of abuse
or neglect, staff must make a verbal report immediately, but in no case more
than one hour after suspicion or after learning of the incident, to the Texas
Department of Family and Protective as described in §417.505 of this
title (relating to Reporting Responsibilities of all TDMHMR Employees, Agents,
and Contractors: Reports to the Texas Department of Protective and Regulatory
Services (TDPRS)).
(c)
Reports required by MOU. If the serious physical injury
or death is a reportable incident as described in the memorandum of understanding
titled "Reportable Incidents in State Schools, State Centers, State Operated
Community-based MHMR Services, and Community Mental Health and Mental Retardation
Centers with Intermediate Care Facilities for the Mentally Retarded (ICF/MR)"
dated March 25, 1996, the head of the state MR facility will report the incident
as described in the MOU.
(d)
Reports to Central Office. Each state MR facility must
prepare and submit to the State Mental Retardation Facilities division in
Central Office a quarterly report on the state MR facility's use of restraint
in behavioral emergencies, as part of behavior therapy programs, and to prevent
involuntary self-injury. The report must include the following:
(1)
number of incidents and types of restraint and the number
of individuals restrained during each month of the fiscal year quarter, with
designation of how many individuals were under 18 years of age;
(2)
the number of serious physical injuries and non-serious
physical injuries and the injury rate for each month of the fiscal quarter,
with designation of how many individuals were under 18 years of age; and
(3)
number of deaths that occur within 24 hours of the use
of restraint for each month of the fiscal quarter, with designation of how
many individuals were under 18 years of age.
(e)
Analysis of data. The head of the state MR facility must
ensure ongoing analysis of data collected as described in subsection (d) of
this section to identify issues or emerging trends and to develop appropriate
responses.
§415.363.Staff Training in the Use of Restraint.
(a)
The state MR facility must inform each employee whose work
responsibilities involve direct contact with individuals of the employee's
roles and responsibilities under this subchapter and under written facility
policy and procedures.
(b)
Before an employee assumes work responsibilities that might
require the employee to participate in restraint, the state MR facility will
ensure that the employee receives training and demonstrates the competencies:
(1)
in the department's approved restraint training program
as outlined in the course descriptions in the TDMHMR Operating Instructions
of Internal Facilities Management for Human Resources: Minimum Training Requirements
(407. 12: §7);
(2)
in sections of the PMAB training program as appropriate
to the employee's position and responsibilities, and as required under the
TDMHMR Operating Instructions of Internal Facilities Management for Human
Resources: Minimum Training Requirements (407. 12. §7); and
(3)
related to the state MR facility's written policies and
procedures as appropriate to the employee's position and responsibilities.
(c)
An employee who is a restraint monitor must:
(1)
have successfully completed those sections of the department's
PMAB curriculum that address the procedures used at the state MR facility
and successfully complete subsequent refresher training annually; and
(2)
have successfully completed the state MR facility's training
in the following:
(A)
cardiopulmonary resuscitation (CPR) and successfully complete
subsequent refresher training every two years;
(B)
rights of an individual and successfully complete subsequent
refresher training annually;
(C)
abuse and neglect and successfully complete subsequent
refresher training annually;
(D)
use of restraint, to include the mechanical devices utilized
by the state MR facility and successfully complete subsequent refresher training
annually; and
(E)
conducting and documenting the debriefing of an employee
who actively participated in the restraint of an individual during a behavioral
emergency.
(d)
Before a nurse or physician assumes work responsibilities
that require participation in requesting, ordering, evaluating, or documenting
restraint, the state MR facility will ensure that the nurse or physician receives
training and demonstrates competence in:
(1)
recognizing facility procedures for requesting, ordering,
evaluating, or documenting restraint;
(2)
recognizing facility-approved personal restraint procedures
and mechanical devices;
(3)
identifying contraindications specific to facility-approved
personal restraint procedures and mechanical devices; and
(4)
recalling reporting procedures for restraint-related injuries
and deaths.
(e)
The state MR facility will ensure that each employee whose
work responsibilities require the employee to participate in restraint must
demonstrate competence annually in the areas described in subsection (b)(1)-(3)
of this section.
(f)
Documentation of training and demonstrated competence for
each employee will be kept by the state MR facility's human resource development
office. Documentation shall include the name of the training, the date of
training, the name of the instructor or person who assessed competence, a
list of successfully demonstrated knowledge and skills and the date knowledge
and skills were assessed.
§415.365.References.
Reference is made to the following statutes and rules of the department:
(1)
42 CFR §§483.410-483.480 et. seq., (Conditions
of Participation for Intermediate Care Facilities for Persons with Mental
Retardation);
(2)
42 CFR §483.430;
(3)
Chapter 405, Subchapter B of this title (relating to Prescribing
of Psychotropic Medication--Mental Retardation Facilities);
(4)
§405.31 of this title (relating to Emergency Use of
Psychotropic Medications);
(5)
§405.625 of this title (relating to Rights of Clients
Receiving Residential Mental Retardation Services);
(6)
Chapter 415, Subchapter I of this title (relating to Behavior
Therapy in State Mental Retardation Facilities);
(7)
§417.505 of this title (relating to Reporting Responsibilities
of all TDMHMR Employees, Agents, and Contractors: Reports to the Texas Department
of Protective and Regulatory Services (TDPRS)); and
(8)
"Reportable Incidents in State Schools, State Centers,
State Operated Community-based MHMR Services, and Community Mental Health
and Mental Retardation Centers with Intermediate Care Facilities for the Mentally
Retarded (ICF/MR)" dated March 25, 1996.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 3, 2004.
TRD-200403685
Rodolfo Arredondo
Chair, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: June 23, 2004
Proposal publication date: January 23, 2004
For further information, please call: (512) 206-5232
Subchapter I. BEHAVIOR THERAPY IN STATE MENTAL RETARDATION FACILITIES
25 TAC §§415.401 - 415.412
The Texas Department of Mental Health and Mental Retardation
(department) adopts new §§415.401 - 415.412 of new Chapter 415,
Subchapter I, governing behavior therapy in state mental retardation facilities.
The department adopts §§415.401, 415.403, 415.404, 415.406 - 415.408,
and 415.411 with changes to the text as proposed in the January 23, 2004,
issue of the
Texas Register
(29 TexReg 597).
The department adopts §§415.402, 415.405, 415.409, 415.410, and
415.412 without changes.
The new subchapter ensures that the health, safety, welfare, rights, and
privileges of an individual residing in a state mental retardation facility
(state MR facility) are protected when staff recommend utilizing highly restrictive
procedures or restricting rights or privileges to address the individual's
inappropriate behavior. Policies and procedures are outlined in the subchapter
that must be followed by a state MR facility when initiating, monitoring,
and reporting behavior therapy programs. In addition, the subchapter describes
provisions and principles that support and enhance the practice of applied
behavior analysis and behavior therapy.
The new subchapter replaces Chapter 405, Subchapter H, governing behavior
management--facilities serving persons with mental retardation, the repeal
of which is adopted contemporaneously in this issue of the
Texas Register
. The department developed the new subchapter and related
new Chapter 415, Subchapter H, governing the use of restraint in state mental
retardation facilities, which is adopted contemporaneously in this issue of
the
Texas Register
, in response to recent
and considerable interest at the federal and state levels by legislators and
advocate/stakeholder groups, and by Texas and national media in the use of
restraint in all institutional settings.
In §415.404, a state MR facility is required to develop and implement
written policies and procedures that, among other things, emphasize the department's
commitment to providing treatment and habilitation to an individual that is
the least restrictive and most effective alternative available and that is
supportive and positive. The state MR facility also is required to describe
the processes to be followed for obtaining consent or authorization before
implementing a functional analysis and a behavior therapy program and to detail
the training and demonstration of competence requirements for state MR facility
staff.
In §415.405, the department describes general principles for behavior
therapy programs that state, among other things, that behavior therapy programs
must use only the least intrusive or restrictive intervention that effectively
modifies or replaces a targeted behavior. Another principle states that staff
must ensure that an individual who exhibits inappropriate behavior is treated
with compassion and respect, in addition to being provided with effective
and appropriate services.
The development, implementation, and monitoring of effectiveness of behavior
therapy programs are addressed in §415.406. Subsection (a) specifies
the conditions under which a written behavior therapy program must be developed
for an individual. Subsection (b) specifies the requirements for implementing
a functional analysis. Criteria for the development of the behavior therapy
program are described in subsection (c). Review and approval procedures are
addressed in subsection (d), including approval by the IDT, the state MR facility's
Human Rights Committee, and the behavior therapy committee. If the behavior
therapy program will involve the use of a highly restrictive procedure, including
restraint, subsection (e) provides additional criteria for developing the
program. Subsection (f) addresses monitoring by the individual's qualified
mental retardation professional (QMRP) to ensure that the behavioral objectives
specified in the behavior therapy program are being met.
Requirements for obtaining and documenting consent or authorization for
a functional analysis or a behavior therapy program are described in §415.407.
Section 415.409 describes the reporting requirements for a state MR facility
regarding behavior therapy programs that use highly restrictive procedures.
Minor language changes have been made throughout the subchapter to update
or correct references, for grammatical and organizational purposes, and for
consistency and clarification.
Language in §415.406(b)(3)(A) regarding when a written protocol must
be developed for a functional analysis has been revised to require such a
protocol when the functional analysis would involve systematic changes in
environmental and biological factors that might adversely impact the individual.
Language regarding obtaining legally adequate consent in §415.406(b)
and (c) and §415.407 has been modified to clarify that the individual
provides legally adequate consent and the LAR provides consent. Language has
been added to §415.406(c) to clarify that if an individual is involved
in a program outside the state MR facility (e.g., attending public school
or working), then the individual's IDT must invite staff of the outside program
to participate in the development of a behavior therapy program that will
be implemented while the individual is on the state MR facility campus.
The title of §415.407 has been modified to more accurately reflect
the rule's content and the definition of "legally adequate consent." In subsection
(a)(2), the requirement for a state MR facility to attempt (i.e., singular)
to obtain consent from the LAR has been changed to require the facility to
make reasonable attempts (i.e., multiple). Subsection (b) has been expanded
to allow the head of the state MR facility to authorize implementation of
a functional analysis or behavior therapy program in situations in which the
individual's LAR has not responded to the facility's attempts to obtain consent
and the LAR has been notified that the head of the state MR facility may authorize
implementation if the LAR does not respond.
A hearing to accept oral and written testimony from members of the public
concerning the proposal was held on February 13, 2004, in Austin. No one provided
testimony.
Written comments concerning the proposal were submitted by the parent/guardian
of a state MR facility resident, Garland; Advocacy, Inc., Austin; Parent Association
for the Retarded of Texas (PART), Austin; The Arc of Texas, Austin; and Texas
Council for Developmental Disabilities, Austin.
One commenter stated that the proposed subchapter places heavy emphasis
on the use of behavior analysis and behavior therapy to decrease specific
behaviors and largely neglects the potential for behavior analysis to assist
in building desired functional behaviors when not related to inappropriate
behaviors. The commenter further remarked that a state MR facility, because
it is certified as a Intermediate Care Facility for Persons with Mental Retardation
(ICF/MR), must provide active treatment as described in the federal ICF/MR
regulations and recommended that that the new subchapter emphasize the effectiveness
of such techniques in acquiring, developing, and shaping new skills to increase
an individual's level of independence. The department responds it agrees that
behavior analysis and behavior therapy can indeed assist in acquiring, developing,
and shaping new skills to increase an individual's level of independence.
The department explains, however, that the subchapter is intended to address
primarily those aspects of behavior therapy that have the potential to affect
the health, safety, welfare, rights, and privileges of an individual residing
in a state MR facility, which are the use highly restrictive procedures or
the restriction of rights or privileges and responds that clarifying language
has been added to the purpose section.
Two commenters questioned why the new subchapter applies only to state
MR facilities. The commenters stated that a state agency's requirements for
use of behavior therapy should be applied consistently in all ICFs/MR and
reflect the less restrictive environments typical of smaller public and private
ICFs/MR. The department responds that the new subchapter has been promulgated
by the department in its role as a provider of residential services, not as
a regulatory agency.
Two commenters recommended that §415.401(1) be revised to state that
the subchapter's purpose includes protecting the rights of an individual's
LAR as well as those of the individual. The commenters stated that when a
full guardianship of an individual is granted, many of the rights of the individual
are transferred to the guardian by the court and that the subchapter must
acknowledge this. The department disagrees with the commenters' recommendation
and responds that the rights of the individual protected by the rules do not
"transfer" to a court-appointed guardian. These rights include protection
from exploitation and abuse, access to appropriate treatment and services,
and freedom from mistreatment.
Two commenters stated that the department's current rules concerning behavior
management are much more specific in describing the behavior therapy committee
and its functions, and recommended that the language in current §405.161
be incorporated into the new subchapter to provide a fuller picture of the
qualifications of members, how they are appointed, the responsibilities of
the committee, and the expectations of the members. The commenters explained
that current rule language states, among other things, that members "shall
be knowledgeable regarding individual rights" and "shall have the technical
skills and knowledge of applied behavior analysis necessary to evaluate the
adequacy of proposed behavior intervention programs." The department responds
that it is unnecessary to articulate membership qualification and notes that
absence of such a requirement by rule would not automatically result in behavior
therapy committees having unqualified members.
Concerning the definition of "functional analysis" in §415.403, a
commenter stated that biological factors are difficult to assess through a
functional analysis performed by non-medical personnel. The commenter suggested
that "inappropriate" not be used in the definition because a functional assessment
may be used to evaluate the effect of environmental factors on appropriate
behavior, as well as inappropriate behavior. The department responds that
this subchapter is intended to address primarily those aspects of behavior
therapy that have the potential to affect the health, safety, welfare, rights,
and privileges of an individual residing in a state MR facility, which are
the use of highly restrictive procedures or the restriction of rights or privileges.
This intent is also reflected in the definition of "functional analysis."
The department declines to revise the definition as suggested by the commenter.
Concerning the definition of "restraint" under "highly restrictive procedure"
in §415.403, a commenter recommended that the word "normal" in the phrases
"normal functioning of the whole or a portion of an individual's body" and
"normal access by the individual to a portion of the individual's body" be
replaced with a more descriptive word when referring to behavior. The commenter
stated that "normal" is not well defined and carries negative connotations,
and suggested using "typical," "average," or acceptable" instead. The department
responds that use of "normal" in this definition refers to the individual's
physical movement or access, not to the individual's behavior. The department
declines to modify the language as recommended by the commenter.
Concerning the definition of "use of timeout room" under "highly restrictive
procedure" in §415.403, two commenters recommended specifying whether
the use of "time out" is voluntary. The commenters stated that if "time out"
is involuntary, staff should document the frequency and duration of use not
only for the individual, but "across units, facilities, and time." The department
responds that "use of a timeout room" is a highly restrictive procedure that
may be used only as part of a behavior therapy program for which consent (or
authorization) has been obtained; therefore, time out is considered voluntary,
and the department has not revised the rule language.
Two commenters recommended that the definition of "Human Rights Committee"
in §415.403 be revised to specify that at least one member of a state
MR facility's committee must be the LAR of an individual residing at that
state MR facility. The department responds that, although the proposed language
does not preclude an LAR from being a member of a state MR facility's HRC,
the department declines to require such membership by rule as recommended
by the commenters.
Two commenters recommended that the definition of "legally adequate consent"
in §415.403 be revised to specify that an LAR who has the right to consent
on behalf of an individual must be the person who is asked to provide legally
adequate consent to a behavior therapy program. The department responds that
it is unnecessary to revise the definition as recommended by the commenters
because an individual who has the ability to provide legally adequate consent
would not have an LAR with the right to consent on the individual's behalf.
The department notes that §415.407(a) requires the state MR facility
to make reasonable attempts to obtain consent from the LAR of an individual
who lacks the ability to provide legally adequate consent.
Two commenters recommended that §415.404(a)(2)(A)(i) be revised to
add "least intrusive" as well as least restrictive and most effective. The
department agrees and has revised the language as recommended by the commenters.
A commenter stated that §415.505(4), which states that "staff must
attempt to understand an individual's motivation for engaging in inappropriate
behavior...," is inconsistent with the principles of behavior analysis. The
commenter suggested that the intention of this statement is to clarify that
staff must be aware that all behavior serves a purpose, and recommended that
the statement be reworded to place the emphasis on staff, as part of the IDT,
"systemically developing an understanding of the likes/dislikes/behavioral
triggers of that individual and using that knowledge appropriately to prevent
inappropriate behavior." The department responds that it believes the proposed
principle provides adequate guidance to staff and declines to revise the language
as recommended by the commenter.
Two commenters suggested revising §415.406(b)(3)(D) and §415.406(d)(1)
to state that the written protocol for a functional analysis and the behavior
therapy program must be approved by the individual's LAR as well as the individual's
IDT, the Human Rights Committee, and the behavior therapy committee. The commenters
rejected a previous department explanation that the LAR is a member of the
IDT as inappropriately equating the rights of the IDT with the rights of the
LAR. The department responds that review and approval of the required written
protocol for a functional analysis or the written behavior therapy program
is the clinical responsibility of facility staff. Consent to a functional
analysis that requires a written protocol and consent to a behavior therapy
program is the responsibility of the individual or LAR. The department declines
to add the requirements as suggested by the commenters.
Concerning §415.406(e)(1)(A), which requires that before a highly
restrictive procedure is considered as part of a behavior therapy program
the individual's record must have evidence that other less restrictive, less
intrusive interventions have been employed and found to be ineffective in
modifying or replacing the targeted behavior, two commenters stated that the
state MR facility must search the individual's records "over many years or
decades" if necessary to determine whether such evidence exists. The department
responds that the revision suggested by the commenters is unnecessary. The
department notes that "evidence present in an individual's record" is not
limited to just a portion of the record or to recent evidence.
Two commenters recommended that §415.406(f)(2) be revised to require
the QMRP to notify the individual's LAR, in addition to the treating psychologist,
if the behavioral objectives specified in an individual's behavior therapy
program are not being met, or if significant changes in the individual's behavior,
functioning level, or physical or medical condition occur. The department
declines to add language as suggested by the commenters because the purpose
of the requirement is to monitor the behavior therapy program for effectiveness.
The department notes that the LAR may request notification from the state
MR facility if the behavioral objectives specified in an individual's behavior
therapy program are not being met, or if significant changes in the individual's
behavior, functioning level, or physical or medical condition occur.
Two commenters recommended that §415.407(a)(2) be revised to require
a state MR facility to make more than one attempt to contact an individual's
LAR for consent to implement a behavior therapy program. The department responds
by adding language stating the state MR facility will make reasonable attempts
to obtain consent from the LAR.
Two commenters recommended that §415.409 be revised to require the
state MR facility to include in its quarterly report to the department's Central
Office the date of the last review of each behavior therapy program that uses
a highly restrictive procedure. The department responds that the purpose of
the requirement recommended by the commenters is unclear and notes that review
dates for a behavior therapy program is significant to the individual, LAR,
and staff implementing the program. The department declines to add the requirement
because it would not provide meaningful data to Central Office.
The new subchapter is adopted under the Texas Health and Safety
Code (THSC), §532.015(a), which provides the Texas Mental Health and
Mental Retardation Board (board) with broad rulemaking authority; THSC, §591.004,
which requires the board to ensure the implementation of the Persons with
Mental Retardation Act (THSC, Title 7, Subtitle D); and THSC, §592.002,
which requires the board to ensure the implementation of certain rights enumerated
in THSC, Chapter 592.
§415.401.Purpose.
The purpose of this subchapter is to:
(1)
ensure that the health, safety, welfare, rights, and privileges
of an individual residing in a state mental retardation facility (state MR
facility) are protected when staff recommend utilizing highly restrictive
procedures or restricting rights or privileges to address the individual's
inappropriate behavior;
(2)
outline policies and procedures for developing, implementing,
monitoring, and reporting behavior therapy programs; and
(3)
describe principles that support and enhance the practice
of applied behavior analysis and behavior therapy.
§415.403.Definitions.
The following words and terms when used in this subchapter shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Behavior services director--A person appointed by the head
of the state MR facility to chair the facility's behavior therapy committee
and consult with program directors and who:
(A)
is knowledgeable in the specifics of behavior therapy principles
and theory;
(B)
is qualified to evaluate published behavior therapy research
studies; and
(C)
has applied experience with behavior therapy techniques.
(2)
Behavior therapy--The application of applied behavior analysis
principles, cognitive therapies, and skills acquisition to clinical problems
with the intent of increasing adaptive behaviors and modifying or replacing
targeted behaviors with behaviors that are adaptive and socially acceptable.
(3)
Behavior therapy committee--Persons designated by a state
MR facility who are knowledgeable about applied behavior analysis and who:
(A)
review, approve, and monitor behavior therapy programs;
and
(B)
review, monitor, and make suggestions concerning the state
MR facility's policies and procedures concerning behavior therapy.
(4)
CFR (Code of Federal Regulations)--The compilation of federal
agency regulations.
(5)
Functional analysis--An assessment of environmental and
biological factors that may influence inappropriate behavior exhibited by
an individual.
(6)
Head of the state MR facility--The superintendent of a
state school or the executive director of a state center.
(7)
Highly restrictive procedures--
(A)
Restraint--The use of manual pressure, except for physical
guidance or prompting of brief duration, or a mechanical device to restrict:
(i)
the free movement or normal functioning of the whole or
a portion of an individual's body; or
(ii)
normal access by the individual to a portion of the individual's
body.
(B)
Use of timeout room--Placement of an individual alone and
under constant, direct staff supervision in an enclosed area in which positive
reinforcement is not available and from which egress is denied by a closed
door in accordance with Code of Federal Regulations (CFR), Title 42, §483.450(c),
concerning timeout rooms. The term does not include circumstances in which
staff remain in close proximity to an individual who has been directed to
an area that is removed from regular activities.
(C)
Application of aversive stimuli--Application of any stimulus
that may be unpleasant or noxious, startling, or painful such that its intended
effect is the suppression of the targeted behavior upon which it is immediately
contingent. Such stimuli include olfactory, auditory, gustatory, tactile,
and other stimuli that may result in physical discomfort or pain.
(D)
Effortful task--An activity requiring physical effort by
an individual that is directed or manually guided by staff. Examples of effortful
tasks include, but are not limited to:
(i)
Required exercise--A procedure whereby an individual performs
and may be guided by staff to perform a series of physical movements that
are incompatible with the undesirable response they systematically follow.
An example would be the guided movement of a self-injurious individual's arms
through a series of positions away from the body.
(ii)
Negative practice--A procedure whereby an individual is
required to repeatedly engage in an effortful task that is topographically
similar to the undesirable response the procedure systematically follows.
An example is a program in which an individual who strikes others is required
to repeatedly hit a punching bag following each occurrence of striking others.
(iii)
Restitutional overcorrection--A procedure whereby an
individual is required to correct the consequences of a disruptive response
by performing a task that restores the environment to a state even more improved
than existed before the disruptive behavior. An example would be the requirement
that a disruptive individual polish all the tables in the residence as a consequence
of knocking over one of them.
(iv)
Positive practice overcorrection--A procedure whereby
an individual is required to repeatedly engage in an appropriate behavior
related to the function of the undesirable response the procedure systematically
follows. An example is a program in which an individual is required to repeatedly
practice an appropriate social behavior contingent upon exhibition of a targeted
behavior.
(8)
Human Rights Committee (HRC)--Persons designated by a state
MR facility in accordance with 42 CFR §483.440(f)(3), concerning specially
constituted committee, who review, approve and monitor behavior therapy programs
and review, monitor, and make suggestions about the state MR facility's policies,
procedures, and practices concerning behavior therapy programs.
(9)
Interdisciplinary team (IDT)--Mental retardation professionals
and paraprofessionals and other concerned persons, as appropriate, who assess
an individual's treatment, training, and habilitation needs and make recommendations
for services.
(A)
Team membership always includes:
(i)
the individual;
(ii)
the individual's LAR, if any; and
(iii)
persons specified by a state MR facility who are professionally
qualified and/or certified or licensed with special training and experience
in the diagnosis, management, needs, and treatment of individuals with mental
retardation.
(B)
Other participants in IDT meetings may include:
(i)
other concerned persons whose inclusion is requested by
the individual or the LAR; and
(ii)
at the discretion of the state MR facility, persons who
are directly involved in the delivery of mental retardation services to the
individual.
(10)
Individual--A person with mental retardation who resides
in a state MR facility.
(11)
LAR (legally authorized representative)--A person authorized
by law to act on behalf of an individual with regard to a matter described
in this subchapter, and may include a parent, guardian, or managing conservator
of a minor individual, or a guardian of an adult individual.
(12)
Legally adequate consent--A term consistent with provisions
of the Texas Health and Safety Code (THSC), §591.006, which states, in
essence, that consent obtained from an individual with mental retardation
is legally adequate when each of the following conditions has been met:
(A)
legal status: The individual giving the consent:
(i)
is 18 years of age or older, or younger than 18 years of
age and is or has been married or had the disabilities of minority removed
for general purposes by court order as described in the Texas Family Code,
Chapter 31; and
(ii)
has not been determined by a court to lack capacity to
make decisions with regard to the matter for which consent is being sought.
(B)
comprehension of information: The individual giving the
consent has been informed of and comprehends the nature, purpose, consequences,
risks, and benefits of and alternatives to the procedure, and the fact that
withholding or withdrawal of consent shall not prejudice the future provision
of care and services to the individual with mental retardation; and
(C)
voluntariness: The consent has been given voluntarily and
free from coercion and undue influence.
(13)
State MR (mental retardation) facility--A state school
or state center operated by the department that provides residential services
to individuals with mental retardation.
(14)
Targeted behavior--An inappropriate behavior exhibited
by an individual that the IDT has identified for modification or reduction.
§415.404.General Provisions.
(a)
Each state MR facility must have and implement written
policies and procedures concerning behavior therapy that:
(1)
do not conflict with this subchapter or 42 CFR §483.450(b),
concerning the management of inappropriate behavior;
(2)
emphasize the department's commitment to:
(A)
providing treatment and habilitation to an individual that
is:
(i)
the least restrictive, least intrusive, and most effective
alternative available; and
(ii)
supportive and positive; and
(B)
reducing the necessity for the use of highly restrictive
procedures or other restrictions of the rights and privileges of an individual
in behavior therapy programs;
(3)
describe the process to be followed for obtaining, as appropriate,
legally adequate consent from an individual, consent from an individual's
LAR, or authorization from the head of the state MR facility before implementing
a behavior therapy program or a functional analysis that requires a written
protocol; and
(4)
detail the training and demonstration of competence requirements
for state MR facility staff.
(b)
The standards in this subchapter take precedence over other
applicable standards, including the Conditions of Participation for Intermediate
Care Facilities for Persons with Mental Retardation (42 CFR §§483.410-483.480
et. seq.), whenever the other applicable standards are less prescriptive.
§415.406.Development, Implementation, and Monitoring of Effectiveness of Behavior Therapy Programs.
(a)
When a behavior therapy program must be developed. An individual's
treating psychologist, with input from the individual's interdisciplinary
team (IDT), must develop a written behavior therapy program for the individual
if:
(1)
the IDT recommends the use of a highly restrictive procedure
or other restriction of the individual's rights or privileges to modify or
replace a targeted behavior; or
(2)
the individual is receiving medications intended primarily
for the treatment of a psychiatric disorder.
(b)
Functional analysis.
(1)
The individual's treating psychologist must implement a
functional analysis before developing a behavior therapy program.
(2)
If an individual participates in a program outside the
state MR facility (e.g., attending public school or working), the functional
analysis must involve the outside program. The state MR facility must invite
staff of the outside program to participate in the functional analysis.
(3)
The individual's treating psychologist must develop a written
protocol if the functional analysis will involve any of the following:
(A)
systematic changes in environmental and biological factors
that might adversely impact the individual;
(B)
evaluation of a highly restrictive procedure; or
(C)
a significant risk of injury to the individual or others
(e.g., the targeted behavior involves severe self-injury or aggression towards
others).
(4)
A written protocol, as required in paragraph (3) of this
subsection, must:
(A)
be developed by the treating psychologist;
(B)
describe the specific procedures or environmental variables
to be manipulated;
(C)
describe the length of time required for each phase; and
(D)
be reviewed and approved by:
(i)
the individual's IDT;
(ii)
the state MR facility's behavior services director; and
(iii)
the chair of the state MR facility's Human Rights Committee
(HRC).
(5)
Before implementing a functional analysis that requires
a written protocol a state MR facility must ensure that staff:
(A)
obtain legally adequate consent, consent, or authorization
in accordance with §415.407(a) or (b) of this title (relating to Requirement
to Obtain Legally Adequate Consent, Consent, or Authorization); and
(B)
document the legally adequate consent, consent, or authorization
in the individual's record.
(c)
Development of behavior therapy program.
(1)
If an individual participates in a program outside the
state MR facility (e.g., attending public school or working), the individual's
IDT must invite staff of the outside program to participate in the development
of a behavior therapy program that will be implemented while the individual
is on the state MR facility campus.
(2)
If the individual's treating psychologist and IDT determine
that an individual's behavior therapy program should include a highly restrictive
procedure, then the determination of which procedure to use must be based
on:
(A)
evidence documented in professional and scientific literature
of the probability that the specific technique or procedure:
(i)
will be effective in modifying or replacing a targeted
behavior; and
(ii)
is appropriate for an individual's cognitive functioning
level, size, weight, known physical, medical, and emotional condition, and
age; and
(B)
the results of the functional analysis.
(3)
As required by 40 TAC §90.42(e)(4)(A) (relating to
Standards for Facilities Serving Persons with Mental Retardation or Related
Conditions), if restraint is the highly restrictive procedure being considered
by the individual's IDT as an intervention in a behavior therapy program,
a physician must participate on the IDT concur with the IDT's recommendation
concerning the use of restraint.
(4)
An individual's behavior therapy program must be developed
and implemented as described in this subchapter and 42 CFR §483.450 (Condition
of Participation: Client Behavior and Facility Practices).
(5)
The written behavior therapy program must:
(A)
describe the targeted behavior;
(B)
describe reliable and representative baseline data indicating
the frequency and severity of the targeted behavior;
(C)
summarize the results of the functional analysis;
(D)
specify behavioral objectives;
(E)
describe detailed procedures for implementation of the
behavior therapy program to include:
(i)
the chosen intervention;
(ii)
the recommended replacement behavior and how it is to
be introduced; and
(iii)
the techniques to prevent the occurrence of the targeted
behavior;
(F)
provide instructions for an evaluation of the individual
by a nurse for injuries and overall well-being after the individual is released
from restraint, if restraint is the chosen intervention and the IDT determines
that an evaluation by a nurse is necessary;
(G)
describe methods for evaluating the program's effectiveness
to include collection and analysis of data;
(H)
describe procedures for making timely revisions to the
program based on an analysis of data if the specified behavioral objectives
are not met; and
(I)
specify the timeframes for reviewing the program.
(d)
Review and approval of and consent to a behavior therapy
program. Prior to implementation of a behavior therapy program, the state
MR facility must ensure that:
(1)
the behavior therapy program is reviewed and approved by:
(A)
the individual's IDT;
(B)
the state MR facility's HRC; and
(C)
the state MR facility's behavior therapy committee;
(2)
staff obtain legally adequate consent, consent, or authorization
in accordance with §415.407(a) or (b) of this title (relating to Requirement
to Obtain Legally Adequate Consent, Consent, or Authorization); and
(3)
staff document the legally adequate consent, consent, or
authorization in the individual's record.
(e)
Use of a highly restrictive procedure.
(1)
Except as described in paragraph (2) of this subsection,
a behavior therapy program utilizing a highly restrictive procedure will not
be approved by an individual's IDT, the state MR facility's HRC, or the state
MR facility's behavior therapy committee unless a behavior therapy program
that utilizes less restrictive procedures has been systematically attempted
and failed to modify or replace the targeted behavior. Procedures for teaching
replacement behaviors must be implemented simultaneously.
(A)
If a highly restrictive procedure is being considered,
evidence must be present in the individual's record that describes other less
restrictive and less intrusive interventions, including verbal or other de-escalative
interventions, that have been utilized and found to be ineffective in modifying
or replacing the targeted behavior.
(B)
If the highly restrictive procedure being considered is
restraint the individual's IDT must:
(i)
obtain written authorization from a physician, advanced
practice nurse, or physician assistant stating that the individual has no
known physical or medical condition that would constitute a risk to the individual
during the use of restraint;
(ii)
consider other factors that might be contraindications
to the use of restraint, including the individual's cognitive functioning
level, size, weight, emotional condition, including whether the individual
has a history of having been physically or sexually abused, and age; and
(iii)
limitations on specific techniques or mechanical devices
for restraint as documented in the individual's record in accordance with §415.355(b)(2)
and (c) of this title (relating to General Principles for the Use of Restraint).
(C)
If the individual's medical condition changes and becomes
a contraindication to the use of restraint, the physician must review the
authorization.
(D)
The state MR facility's HRC must approve any significant
increase in the intensity or duration of a highly restrictive procedure, unless
the behavior therapy program specifies the conditions under which an increase
may occur.
(2)
If an individual's inappropriate behavior is so severe
(i.e., life threatening) or of such duration that other therapeutic approaches
are currently precluded, the individual's IDT, the HRC, and the behavior therapy
committee may approve and the state MR facility may implement a behavior therapy
program that utilizes a highly restrictive procedure without first attempting
a behavior therapy program that utilizes less restrictive procedures.
(f)
Monitoring by qualified mental retardation professional
(QMRP).
(1)
The individual's QMRP, as defined in 42 CFR §483.430(a),
concerning qualified mental retardation professional, must review the behavior
therapy program to assess whether the specified behavioral objectives are
being met:
(A)
during the quarterly review of the Individual Plan of Care;
or
(B)
more frequently, if the QMRP believes changes in the individual's
behavior, functioning level, or physical, or medical condition warrant it.
(2)
If the individual's QMRP determines that the behavioral
objectives specified in the program are not being met, or that significant
changes in the individual's behavior, functioning level, or physical or medical
condition have occurred, the QMRP must notify the individual's treating psychologist.
§415.407.Requirement to Obtain Legally Adequate Consent, Consent, or Authorization.
(a)
Except as provided in subsection (b) of this section, a
state MR facility must obtain legally adequate consent or consent in accordance
with this subsection before implementing a functional analysis that requires
a written protocol or a behavior therapy program.
(1)
If an individual has the ability to provide legally adequate
consent, the state MR facility will attempt to obtain legally adequate consent
from the individual.
(2)
If an individual lacks the ability to provide legally adequate
consent and has an LAR, the state MR facility will make reasonable attempts
to obtain consent from the LAR.
(3)
Efforts taken by the state MR facility to obtain legally
adequate consent from an individual or consent from an LAR must be documented
in the individual's record.
(b)
The head of the state MR facility, in accordance with Texas
Health and Safety Code, §592.054, may authorize implementation of a functional
analysis that requires a written protocol or a behavior therapy program only
if:
(1)
the individual lacks the ability to provide legally adequate
consent and does not have an LAR; or
(2)
the individual lacks the ability to provide legally adequate
consent and the individual's LAR:
(A)
has not responded to the state MR facility's attempts to
obtain the LAR's consent; and
(B)
has been notified that the head of the state MR facility
may authorize implementation of a behavior therapy program if the LAR does
not respond.
(c)
An individual with the ability to provide legally adequate
consent or the LAR of an individual who lacks the ability to provide legally
adequate consent may:
(1)
withhold consent to the implementation of a functional
analysis that requires a written protocol or a behavior therapy program; or
(2)
withdraw consent at any time to the continued implementation
of a functional analysis that requires a written protocol or a behavior therapy
program.
(d)
If legally adequate consent is withheld or withdrawn by
an individual or if consent is withheld or withdrawn by an LAR as described
in subsection (c) of this section:
(1)
state MR facility staff must document in the individual's
record the time, date, and circumstances under which the withholding or withdrawal
of consent occurred; and
(2)
the individual's IDT must convene to discuss alternative
interventions to address the targeted behavior.
(e)
The consent or authorization to implement a behavior therapy
program must be reviewed by the individual's IDT and the state MR facility's
HRC at least annually and upon any substantive modification of the program
or significant change in the individual's medical condition.
§415.408.Use of Restraint.
If restraint is used as part of a behavior therapy program, it must
be implemented as described in §415.355 of this title (relating to General
Principles for the Use of Restraint) and §415.357 of this title (relating
to Use of Restraint in a Behavior Therapy Program).
§415.411.References.
Reference is made to the following statutes and regulations:
(1)
42 CFR §§483.410-483.480 et. seq., (Conditions
of Participation for Intermediate Care Facilities for Persons with Mental
Retardation);
(2)
42 CFR §483.430(a), concerning qualified mental retardation
professional;
(3)
42 CFR §483.440(f)(3), concerning specially constituted
committee;
(4)
42 CFR §483.450 (Condition of Participation: Client
Behavior and Facility Practices);
(5)
42 CFR §483.450(b), concerning the management of inappropriate
behavior;
(6)
42 CFR §483.450(c), concerning timeout rooms;
(7)
Texas Family Code, Chapter 31;
(8)
Texas Health and Safety Code (THSC), §591.006;
(9)
THSC, §592.054;
(10)
§415.355 of this title (relating to General Principles
for the Use of Restraint) and §415.357 of this title (relating to Use
of Restraint in a Behavior Therapy Program); and
(11)
40 TAC §90.42(e)(4)(A) (relating to Standards for
Facilities Serving Persons with Mental Retardation or Related Conditions).
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 3, 2004.
TRD-200403686
Rodolfo Arredondo
Chair, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: June 23, 2004
Proposal publication date: January 23, 2004
For further information, please call: (512) 206-5232