The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts amendments to §90.3 and §90.42, and adopts new §90.328 in Chapter 90, Intermediate Care Facilities for Persons with Mental Retardation or Related Conditions. The amendments to §90.3 and §90.42 are adopted with changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1253). New §90.328 is adopted without changes to the proposed text.

The amendments and new section are adopted to implement Senate Bill (SB) 325, 79th Legislature, Regular Session, 2005, which added Chapter 322 to the Texas Health and Safety Code. Chapter 322 requires DADS to prohibit certain restraints in a variety of health care facilities, including an intermediate care facility for persons with mental retardation (ICF/MR) licensed by DADS under Chapter 252 of the Texas Health and Safety Code.

To comply with Chapter 322, the amendments to §90.3 and §90.42 are adopted to (1) define acceptable restraint holds (referred to in the adopted rules as "personal holds"), (2) add a definition for "seclusion" to reflect its definition in Chapter 322, (3) develop practices to decrease the frequency of the use of restraint and seclusion, (4) allow less use of restraint than allowed by the rules in the chapter, (5) permit prone and supine holds only as transitional holds, and (6) ensure that each resident and the resident's legally authorized representative are notified of the rules and policies related to restraint and seclusion. In addition, the amendments are adopted to clarify and update rule language, including replacing references to the former Texas Department of Human Services with references to DADS.

New §90.328 is adopted to comply with Health and Safety Code, §322.054, which prohibits a facility from retaliating against a person because the person in good faith provides information relating to the misuse of restraint or seclusion at the facility or against a resident because someone on behalf of the resident in good faith provides information relating to the misuse of restraint or seclusion at the facility.

DADS received written comments from Advocacy, Inc., and the Private Providers Association of Texas. A summary of the comments and the responses follow.

Comment: A commenter stated that, although Senate Bill 325 focused on the use of restraint and seclusion in emergency situations, the proposed amendments and new section address the use of restraint not only in emergency situations but also as an approved intervention in behavior therapy programs. The commenter stated that this creates confusion in interpreting the rules, particularly concerning the use of mechanical devices.

Response: The agency does not agree with the commenter's reasoning that ICF/MR providers will be confused. Providers use restraints as an intervention in a behavioral therapy program plan and now will be allowed to use them as a response to a behavioral emergency. The agency believes rules addressing both situations are necessary.

Comment: Concerning §90.3(7)(A), a commenter stated that the phrase "substantial bodily harm" is ambiguous and has the potential to result in significant variation in its interpretation by direct support staff and, hence, significant variation in their judgment about whether or not an incident constitutes a behavioral emergency allowing for protective restraint. The commenter recommends clarification of the phrase or that the agency provide examples of what it considers "substantial bodily harm."

Response: The agency declines to provide examples, as it is up to the provider to document the justification for the use of the restraint and to have trained staff in the use of emergency restraints.

Comment: Concerning §90.3(7)(C), a commenter stated that the phrase "could not reasonably have been anticipated" is ambiguous. Does the phrase refer to the specific circumstances, time, and place in which the behavior occurs or more generally to the aggressor's behavioral history, which may include infrequent, but occasional, aggressive behavior or frequent aggressive behavior?

Response: The agency agrees with the comment and has deleted "could not reasonably have been anticipated" from the rule language.

Comment: Concerning §90.3(25) and §90.3(44), a commenter stated that the definition of "large facility" parallels the definition of "large facility" in the ICF/MR licensure rules but differs from the definition used in the Home and Community-based Services Program rules (§9.153 (22)) and the ICF/MR reimbursement methodology rules (1 TAC §355.456(b)(1)). The commenter also pointed out that the definition of "small facility" parallels the definition of "small facility" in the ICF/MR licensure rules but differs from the definition used in the ICF/MR reimbursement methodology rules. The commenter recommended that the definitions be consistent across all rules, or that the basis for differences be explained in the rules.

Response: The agency declines to change the definition of "large facility" and "small facility." The agency believes the definitions used in this chapter are appropriate for its purposes. Including an explanation of the differences between the definitions in this rule and other rules that use the terms "small" and "large" facility is beyond the scope of the proposed rules.

Comment: Concerning §90.3(37), two commenters requested clarification of the definition of "personal hold." One of the commenters was unclear about what differentiates "physical guidance or prompting of brief duration" and "restraint" and what amount of time is "brief"? Another commenter stated that the definition of "personal hold" implies that an intervention that restricts the free movement or normal functioning of all or a portion of an individual's body is not a restraint if the reason it is used is for physical guidance or prompting of brief duration. The determining factor of whether a hold is a restraint should be whether it is voluntary or if the person is resistant. Physical guidance or prompting may still be a restraint if the individual resists the guidance or prompt either verbally or by their actions. The commenter suggested that "except for physical guidance or prompting of brief duration" be deleted from the definition and that additional language be added to indicate restraint does not include physical guidance or prompting if it is voluntary.

Response: The agency agrees in part with the comments and has added language to §90.3(37) to indicate that physical guidance or prompting of brief duration becomes a restraint if the individual resists the guidance or prompting. However, the agency did not remove the phrase "except for physical guidance or prompting of brief duration," because there are situations in which physical guidance or prompting can calm the individual or prevent the situation from escalating.

Comment: Concerning §90.3(42), a commenter asked that if the use of mechanical restraints is allowed, more direction be provided on their use, particularly care and safety issues. The commenter recommended that future versions of the rule provide more direction related to who can initiate, who can order, what assessments occur and how frequently, time frames, safety and protection issues, and release procedures.

Response: The agency believes that the definition of restraint is adequately addressed by the proposed rules but agrees to consider the commenter's concerns in future revisions of the rules.

Comment: A commenter stated that the use of a mechanical device to restrain an individual, especially when the individual is placed in two- or four-point restraint, makes the individual vulnerable to harm, including harm by other individuals. The commenter further stated that the use of mechanical devices to restrain an individual requires that staff be physically present to provide continuous, one-on-one monitoring of an individual who is being restrained with a mechanical device. The commenter recommended that DADS add such a provision to ensure the protection of the individual.

Response: The agency declines to make continuous, one-to-one monitoring a requirement, as it may not be necessary in every instance in which a mechanical restraint is used. The proposed rule amendment at §90.42(e)(4)(D)(ii) requires a facility to "use the minimal amount of force.. to ensure the safety of the resident and others," and §90.42(e)(4)(D)(iii) requires a facility to "safeguard the resident's dignity, privacy, and well-being." The agency believes these provisions are adequate to ensure a facility appropriately monitors a resident in a mechanical restraint.

Comment: Concerning §90.42(e)(4)(A)(i)(III), a commenter stated that prohibiting the use of restraint in a manner that interferes with an individual's ability to communicate appears to preclude the use of restraint with an individual who communicates primarily with hands or eyes. The commenter explained that staff might be unable to effectively intervene to prevent injury to the individual or others and recommended that the provision be removed or modified to allow flexibility in the use of communication during restraint contingent on the situation and the individual's mode of communication.

Response: The agency declines to make the recommended revision and explains that Texas Health and Safety Code §322.051, as added by SB 325, requires the prohibition.

Comment: A commenter stated that the phrase "disciplinary purposes" at §90.42(e)(4)(A)(ii) is ambiguous and subject to multiple interpretations. The commenter suggested that the agency's intention appeared to be to prohibit penal, retaliatory, or vengeful use of restraint and recommended clarification of the phrase.

Response: The agency does not believe that the phrase is ambiguous and cites its use in federal ICF/MR regulations at 42 CFR §483.450(b)(3). The agency has revised the provision, however, to include "retaliation" and "retribution," which are clarifying terms the Centers for Medicare and Medicaid Services uses in its "interpretive guidelines" to the federal ICF/MR regulations.

Comment: Concerning §90.42(e)(4)(B)(ii) and (iv), a commenter requested clarification or reconsideration of the use of the word "voluntarily" to describe inappropriate behavior exhibited by an individual that may be addressed in a behavior therapy program and of "involuntary" to describe inappropriate and often self-injurious behavior from which an individual should be protected. The commenter stated that professionals disagree on "when, whether or not, and to what extent behavior is 'voluntary.'" The commenter further stated, "involuntary behaviors may also be therapeutically modified or managed through the appropriate use of restraint" and questioned why the distinction is necessary or useful.

Response: The agency has not changed the rule in response to the comment. The agency believes the distinction between "voluntary" and "involuntary" is both necessary and useful to distinguish those behaviors that can be successfully addressed through a behavior therapy program.

Comment: Concerning §90.42(e)(4)(C)(i), a commenter requested that clarification be included in the rule of whether the identification by an interdisciplinary team (IDT) of "conditions, factors, and limitations" for the use of restraint with an individual refers to the development of behavior therapy interventions utilizing restraint or only to the use of restraint to address a behavioral emergency. The commenter also recommended that the IDT be required to "consider" the conditions and factors in the design of a restraint intervention.

Response: The agency disagrees with the comment and has not changed the rule in response to the comment. Section 90.42(e)(4)(D)(i) requires a provider to "take into account the conditions, factors, and limitations on specific restraint techniques or mechanical restraint devices" identified by the IDT not only when restraining an individual in a behavioral emergency or as approved in a behavior therapy program, but also, in accordance with §90.42(e)(4)(B)(iii) - (v), a provider must take into account those conditions, factors, and limitations (1) in response to a medical or dental procedure or to promote healing, (2) to protect an individual from involuntary self-injury, and (3) to provide postural support to an individual or assist the individual in obtaining and maintaining normative bodily functioning.

Comment: Concerning §90.42(e)(4)(E)(i) - (ii), the provisions related to restraint techniques proposed in this section of the rule may place the resident and direct support staff at risk of injury. Why must staff be prone and perpendicular to the resident? It appears that their control and ability to monitor the resident would be diminished in this position. Their ability to control and monitor the resident would be enhanced if allowed to be in a kneeling position.

Response: The language the commenter referenced was not in the rule as proposed in the Texas Register.

Comment: Concerning §90.42(e)(4)(E)(ii)(I), a commenter requested clarification of the term "transitional hold."

Response: The proposed text of §90.42(e)(4)(E)(ii) reads: "if a resident rolls into a prone or supine position during a restraint, the facility must transition the resident to a side, sitting, or standing position as soon as possible. The facility may only use a supine or prone hold: (I) as a transitional hold." The agency believes that the definition of transitional hold is adequately addressed in the proposed rules and declines to make the recommended revision. Texas Health and Safety Code, §322.052(b), as added by SB 325, states that the rules must permit prone and supine holds only as transitional holds for use on a resident of a facility.

The amendment is adopted under Texas Government Code, §531.0055, which provides that the HHSC executive commissioner shall adopt rules for the operation and provision of services by the health and human services agencies, including DADS; Texas Human Resources Code, §161.021, which provides that the Aging and Disability Services Council shall study and make recommendations to the HHSC executive commissioner and the DADS commissioner regarding rules governing the delivery of services to persons who are served or regulated by DADS; Texas Government Code, §531.021, which provides HHSC with the authority to administer federal funds and plan and direct the Medicaid program in each agency that operates a portion of the Medicaid program; and Texas Health and Safety Code, Chapter 252, which authorizes DADS to license and regulate ICF/MR, and Chapter 322, which governs the use of restraint and seclusion in certain health care facilities, including ICF/MR.