The Texas Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts new Chapter 15, Licensing Standards for Prescribed Pediatric Extended Care Centers. New §§15.3, 15.5, 15.101, 15.105, 15.107, 15.118 - 15.121, 15.205 - 15.207, 15.209 - 15.211, 15.301, 15.309, 15.402, 15.404, 15.406, 15.409, 15.410, 15.415, 15.502, 15.507, 15.508, 15.511, 15.607, 15.901, 15.1101, 15.1102, and 15.1207 are adopted with changes to the proposed text published in the April 4, 2014, issue of the Texas Register (39 TexReg 2413). New §§15.1, 15.2, 15.4, 15.102 - 15.104, 15.106, 15.108 - 15.117, 15.122, 15.201 - 15.204, 15.208, 15.302 - 15.308, 15.310, 15.311, 15.401, 15.403, 15.405, 15.407, 15.408, 15.411 - 15.414, 15.416 - 15.419, 15.501, 15.503 - 15.506, 15.509, 15.510, 15.601 - 15.606, 15.608, 15.701 - 15.708, 15.801 - 15.803, 15.902 - 15.906, 15.1001 - 15.1004, 15.1201 - 15.1206, 15.1208 - 15.1224, 15.1301 - 15.1305, and 15.1401 - 15.1409 are adopted without changes to the proposed text and will not be republished.

The adoption establishes rules to license and regulate prescribed pediatric extended care centers (centers) in Texas in response to Senate Bill 492, 83rd Legislature, Regular Session, 2013, which enacted Texas Health and Safety Code (THSC) Chapter 248A. A center provides services to individuals younger than 21 years of age who are medically and technologically dependent.

The adoption authorizes a licensed center to provide a location where individuals with medically complex conditions may receive daily medical care in a non-residential setting. When prescribed by a physician, an individual may receive medical, nursing, psychosocial, therapeutic, and developmental services in a center for up to 12 hours per day if the services are appropriate to the individual's medical condition and developmental status.

The adoption establishes licensing procedures and requirements, provides definitions for the program, establishes minimum standards designed to protect the health and safety of individuals served by a center, and establishes procedures for enforcement actions that DADS may take against a center.

Senate Bill 492 prohibits the operation of a center without a license after December 31, 2014.

In §15.5(13), (43), (65), (77), (98), regarding definitions, the agency clarified the use of restraints by classifying certain devices as protective in nature and restricting the definitions related to restraints. Thus, the agency amended the definitions of "chemical restraint," "quiet time," "protective device," "sedation," "restraint," and "physical restraint," and added a new definition for "mechanical restraint." The definition of "chemical restraint" was amended to clarify that a chemical restraint restricts the free movement of a minor's body. The new definition of mechanical restraint was added to distinguish it from physical and chemical restraint. The definition of "physical restraint" was amended to be substantially similar to definitions used in other agency programs. The definition of "protective device" was revised and a reference to sedation was added. The definition of "quiet time" was amended to allow it to be initiated by center staff or by the minor. The definition of "timeout" was deleted because it is covered by the revised definition of "quiet time," which is person-centered in focus.

In §15.105(a), the agency deleted the requirement that an alternate administrator, nursing director, and alternate nursing director must complete the pre-licensing training before an applicant may submit an initial license application. The agency determined it is sufficient for only the administrator to complete the training as part of the responsibilities of the position before submitting the license application. Additionally, the persons holding these positions will not be identified on an application for an initial license.

In §15.105(b)(3) and §15.108(c)(3), the agency amended the section to allow DADS to accept documentation other than a letter of credit to demonstrate an applicant's financial viability because a letter of credit, which guarantees payment of an amount under specified circumstances, may not be the appropriate instrument to show financial viability.

In §15.119(a), the agency removed the requirement that the center must report any changes in the individuals serving in the roles of alternate administrator, nursing director, and alternate nursing director because these individuals will not be identified on the initial application or other agency records.

In §15.120, the agency made a minor grammatical correction to the section, revising "at the center" to "in the center" and making "center" possessive to clarify the meaning of the section.

In §15.121, the agency made a minor grammatical correction to the section, revising "at the center" to "in the center."

In §15.205(b), the agency restructured the subsection for ease in readability and deleted the specific information that must be provided on the DADS Fire Drill Report Form.

In §15.206, in accordance with other changes to the chapter to distinguish the use of protective devices from the use of restraints, which may only be used in an emergency, the agency explicitly prohibits the use of any planned restraint or timeout as part of a minor's person-centered guidance program. This change was made to clarify that these actions are not considered positive behavior support. The term "timeout" has also been replaced with "quiet time." In addition, the section has been revised to provide that during quiet time a minor may not be placed in a room alone, regardless of whether the room is locked. This change was made to increase the supervision and safety of a minor who is having quiet time. The agency made other minor corrections and removed unnecessary and duplicative wording.

In §15.207, the agency renamed the section "Protective Devices and Restraints" in an effort to distinguish between the use of restraints and protective devices, and to clarify the permitted uses of protective devices. The changes clarify the agency's intent to prohibit use of restraints as part of person-centered direction and guidance. The changes reorganize the section to ensure protective devices are used only as part of a therapeutic regimen; during medical, nursing, diagnostic, and dental procedures, as prescribed by a physician's order; and in a medical emergency to protect the health and safety of a minor.

In §15.209(c)(1), the agency made a minor grammatical correction by deleting the word "or."

In §15.301(f), the agency added the phrase "in writing" to clarify that a license holder must designate an administrator in writing. This change is consistent with other sections requiring similar documentation.

In §15.309, in accordance with the modified requirement regarding designation of the nursing director and the alternate nursing director in §15.105, the agency changed the requirement for the completion of pre-licensing program training to be later in the licensing process. The training by the nursing director and alternate nursing director must be completed before designation to the position.

In §15.402, §15.404, §15.406, §15.409, and §15.411, the agency made amendments to allow center administration to recruit and train staff with less work experience, while providing additional oversight, supervision, training, and direction until the staff are fully qualified for the positions for which they are hired.

DADS received written comments from Disability Rights Texas, EveryChild, Inc., Texas Council for Developmental Disabilities, Texas Education Agency, and The Arc of Texas. A summary of the comments and the responses follows.

Comment: Concerning §15.3(c), four commenters stated that the rule should be revised to more clearly indicate a center cannot accept delegation of responsibility from a local education agency to provide a minor's free and appropriate public education.

Response: The agency agrees with the comment and has revised §15.3(c) to prohibit a center from acting as the primary education provider or accepting delegation of responsibility for a minor's education from an education provider, such as a local education agency.

Comment: Four commenters requested that the United States Code citation for the Individuals with Disabilities Education Act (IDEA) be included in the rule.

Response: The agency agrees the citation would be helpful and has amended the section to include the citation for IDEA, as well as for §504 of the Rehabilitation Act.

Comment: Concerning §15.3, one commenter recommended that the rule clarify that centers are not intended to provide a place for school-age children to receive educational services but, instead, are intended to provide specialized care for children before and after school and on days that public schools are closed.

Response: The agency responds that a center is required to ensure a minor receives basic services, as defined in Texas Health and Safety Code, §248A.001(1), based on the needs of the minor and as ordered by the minor's prescribing physician. While §15.508 prohibits a center from acting as the primary education provider for a minor, prohibiting a center from serving minors during public school hours would deny access to a less restrictive environment for minors who are currently homebound. Section 15.508 allows educational services to be provided at a center only if it is determined, by the education provider, that the center is the least restrictive environment for the delivery of educational services to the minor. Additionally, §15.508 prohibits a center from interfering with a minor's compulsory school attendance requirements. The agency did not revise the rule as requested.

Comment: Concerning §15.5(9)(A)(ii), three commenters requested the definition of "basic services" be revised to include that the protocol of care is approved by a minor's parent or an adult minor to ensure family oversight and choice.

Response: The agency responds that the definition of "basic services" is consistent with the statutory definition in Texas Health and Safety Code, §248A. 001. Section 15.607 requires a plan of care to be developed in collaboration with and approved by a minor's parent and an adult minor. The agency did not revise the rules as requested.

Comment: Concerning §15.5(10), three commenters requested the definition of "behavioral emergency" be revised to narrow the scope of what is considered to be a behavioral emergency. The commenters requested the term "imminent" be replaced with "immediate" and the term "considered" be removed so a behavioral emergency only occurs after techniques have been attempted.

Response: The agency agrees that "immediate" is a more appropriate word in this context because, to constitute a behavioral emergency, death or serious bodily harm may only be "probable," rather than certain, but the risk must be immediate, meaning it will occur without delay. In addition, the agency agrees that, to constitute a behavioral emergency, preventative and de-escalating techniques must be tried, not just considered. The reference to "oral" techniques has been eliminated because the techniques must be aimed at preventing or de-escalating the dangerous situation, regardless of whether the techniques are oral or through other means of communication. In addition, the requirement that the minor attempt to harm the minor or others is not relevant if the situation results in the described outcome. The agency has revised the definition to reflect these differences.

Comment: Concerning §15.5, three commenters requested the addition of a definition for "critical incident" and requirements for centers to analyze and report to DADS critical incidents occurring at the center. Additionally, the commenters requested that centers be added to the DADS Long Term Care Quality Reporting System (QRS) to allow members of the public to obtain information about the performance of centers and compare services provided by centers to identify centers that meet their families' needs.

Response: Section 15.1002 requires a center to develop, implement, and maintain a quality assessment and performance improvement program that includes a system for collecting and analyzing data to measure the quality, effectiveness, and safety of services provided to minors and identify opportunities for improvement, but the term "critical incident" is not used in the rule and the agency does not believe the term is necessary. Therefore, the agency did not revise §15.5 to include a definition for "critical incident" or revise the rules to require centers to report those incidents to DADS. The agency agrees with the comment to add centers to the DADS QRS site to help the public evaluate the quality of center services but that does not require a revision to the rule.

Comment: Concerning §15.5(74), three commenters requested the definition of "prescribing physician" be revised to prohibit the center's medical director from acting as a prescribing physician. The commenters stated that allowing a medical director to act as a prescribing physician places a physician in the difficult position of balancing employment loyalty with the physician's fiduciary duty to a patient. Including this prohibition will ensure a minor has the benefit of both a center's medical director and an outside prescribing physician.

Response: The agency responds that the population served by a center is unique and has a limited resource of physicians. Prohibiting this relationship could create an access to care issue for minors and create a staffing issue for centers by requiring an already limited resource of physicians to act in only one of the two roles. The employment status of the physician should not interfere with the physician's duty of care to a patient. The agency did not revise the rule as requested.

Comment: Concerning §15.5, three commenters requested the addition of a definition for "transition support" to clarify a term used but not defined in §15.605(b) relating to initial and updated comprehensive assessments.

Response: The agency agrees with the comment and has revised §15.5 to add a definition for "transition support" to clarify the meaning of the term, which is used in §15.605(b) and (f).

Comment: Concerning §15.205, three commenters requested the addition of a requirement that a center ensure that minors served in the center are protected from the effects of second-hand smoke by prohibiting the use of tobacco-related products at the center and during center transport.

Response: The agency agrees with the comment and has revised §15.205 to prohibit the use of tobacco products at the center. Section 15.1102(d)(3) prohibits the use of tobacco in transportation vehicles.

Comment: Concerning §15.207, relating to restraints, three commenters requested the addition of a "purpose" statement to assist with interpretation of this section.

Response: The agency responds that adding a purpose statement to §15.207 and not to other sections would be inconsistent. The rule is intended to set forth the minimum standards with which a center must comply. However, DADS is committed to developing guidance through provider education to clarify the permissible use of restraints at a center. The agency did not revise the rule as requested.

Comment: Concerning §15.207, three commenters requested the addition of a requirement that the interdisciplinary team create a "special precautions plan" related to the use of restraints. The plan would minimize the frequency of restraints with the goal of eliminating the need for restraint completely; be developed in consideration of the minor's physical, mental, and medical conditions; identify the minor's known conditions to mitigate the risk of using restraints; and be evaluated and revised on a specified frequency.

Response: The agency responds that the requirements requested by the commenters are addressed in §15.504. The agency did not revise the rule as requested.

Comment: Concerning §15.207(b)(3), three commenters requested the addition of a requirement that postural support devices be used in accordance with an approved plan of care from a licensed occupational or physical therapist.

Response: The agency responds that §15.607 requires medical equipment, which includes postural support devices, to be used in accordance with an approved plan of care. The plan of care and prescription of the use of a postural device may be approved by disciplines other than a licensed occupational or physical therapist. The agency did not revise the rule as requested.

Comment: Concerning §15.207(h), three commenters stated the description of staff training requirements is vague and requested that the rule specify the type and frequency of staff training that must occur for staff whose job responsibilities will include the use of restraints.

Response: The agency agrees with the comment and revised §15.207(b)(5) to require that a staff member whose job responsibilities will include the use or application of restraints is properly trained in accordance with §15.415(b)(8)(G) relating to staff policies for staff orientation, development, and training. The agency added a new clause in §15.415(b)(8)(G) that outlines the training requirements as requested by the commenters.

Comment: Concerning §15.207(j), three commenters requested a requirement that a center obtain written or verbal authorization of a restraint within one hour after the initiation of a restraint. The commenters also requested that a center be required to review and update a minor's "special precautions plan" with a physician within 24 hours of each incident of restraint.

Response: The agency responds that §15.207(b)(6)(E) and (b)(7)(B)(iv) require an RN to conduct an assessment of the minor's condition immediately following a restraint and notify the minor's physician of the minor's condition if the assessment determines a change in the minor's condition or a negative reaction to the restraint. Within three days after the use of a restraint, an RN must conduct an assessment of the minor to determine if it is necessary to develop and implement a psychosocial treatment and services program for the minor, and review and update the minor's plan of care and psychosocial treatment and services program as appropriate. The agency did not revise the rule as requested.

Comment: Concerning §15.307, three commenters requested a limit be placed on the number of centers for which a physician may serve as medical director. The commenters stated this limit would help to ensure quality of care and medical oversight.

Response: The agency responds that there is a limited number of physicians specializing in the care of minors with medically and technologically dependent needs. Setting a limit on the number of centers for which a physician may serve as medical director could create a access to care and services staffing issue for centers. A center is responsible for ensuring a physician hired to serve as medical director performs all responsibilities described in §15.308. The agency did not revise the rules as requested.