Texas Register August 19, 2022 Volume: 47 Number: 33

Texas Register Table of Contents

1 Texas Board of Nursing
- - 1.0.1 Proposed Rules Re:
2 Texas Health and Human Services Commission
3 Texas State Board of Pharmacy
- - 3.0.1 Adopted Rules Re:
4 Texas Department of State Health Services
- - 4.0.1 Adopted Rules Re:
    - 4.0.1.1 Amending 25 TAC §181.28 to update instructions and requirements for issuance of certified copies of vital records.
  - 4.0.2 Proposed Rule Reviews Re:
    - 4.0.2.1 Title 25, Part 1, Chapter 229, concerning Food and Drug.

Texas Board of Nursing

Proposed Rules Re:

Amending 22 TAC §213.28 to update requirements concerning the licensing of individuals convicted of sexual or threatening offenses.

CHAPTER 213. PRACTICE AND PROCEDURE
22 TAC §213.28

OVERVIEW

The Board is proposing amendments to §213.28, relating to Licensure of Individuals with Criminal History. The amendments are necessary to implement the statutory requirements of House Bill (HB) 1899, enacted by the 86th Texas Legislature, effective September 1, 2019.

BACKGROUND AND JUSTIFICATION

HB 1899 added Subchapter B to the Occupations Code Chapter 108. Subchapter B applies to health care professionals, including nurses, under the Occupations Code, Chapter 301.

Pursuant to HB 1899, the Board is required to deny or revoke the license of an individual who: (1) is required to register as a sex offender under the Code of Criminal Procedure Chapter 62; (2) has been previously convicted of or placed on deferred adjudication community supervision for the commission of a felony offense involving the use or threat of force; or (3) has been previously convicted of or placed on deferred adjudication community supervision for the commission of an offense: under the Penal Code §§22.011, 22.02, 22.021, or 22.04, or an offense under the laws of another state or federal law that is equivalent to an offense under one of those sections, committed in the course of providing services within the scope of the individual’s license and in which the victim of the offense was a patient of the individual. SB 1899 also simultaneously amended the Code of Criminal Procedure Article 42.0175 to require affirmative findings to be included in criminal judgments regarding whether an individual is required to register as a sex offender under Chapter 62; whether an individual used force or threat of force in the commission of the offense; and whether the victim of the offense was a patient of the individual and the offense was committed in the course of providing services within the scope of the individual’s license. HB 1899 also requires agencies like the Board to be notified of these disqualifying events by criminal trial courts and parole panels.

SECTION-BY-SECTION SUMMARY

Proposed amended §213.28(c) contains the Board’s Disciplinary Guidelines for Criminal Conduct (Guidelines). The proposed amendments to the Guidelines include a paragraph that references the requirements of the Occupations Code Chapter 108. Specifically, the proposed paragraph states that, in accordance with the Occupations Code Chapter 108, Subchapter B, the Board is required to deny or revoke, as applicable, the license of an individual who: (A) is required to register as a sex offender under the Code of Criminal Procedure Chapter 62; (B) has been previously convicted of or placed on deferred adjudication community supervision for the commission of a felony offense involving the use or threat of force; or (C) has been previously convicted of or placed on deferred adjudication community supervision for the commission of an offense: (i) under the Penal Code §§22.011, 22.02, 22.021, or 22.04 or an offense under the laws of another state or federal law that is equivalent to an offense under one of these sections; (ii) committed when the individual held a license as a health care professional in this state or another state and in the course of providing services within the scope of the individual’s license; and (iii) in which the victim of the offense was a patient of the individual. Further, the proposed paragraph states that an individual’s eligibility for reapplication or reinstatement of licensure will be governed by the Occupations Code Chapter 108, Subchapter B. These proposed provisions are consistent with the statutory requirements of Chapter 108.
The proposed amendments to §213.28(k) add a paragraph to subsection (k) that also references the requirements in the Occupations Code Chapter 108. Specifically, the proposed paragraph states that, pursuant to the Occupations Code Chapter 108, Subchapter B, the Board is required to deny or revoke, as applicable, the license of an individual who is required to register as a sex offender under the Code of Criminal Procedure Chapter 62; has been previously convicted of or placed on deferred adjudication community supervision for the commission of a felony offense involving the use or threat of force; or has been previously convicted of or placed on deferred adjudication community supervision for the commission of an offense: (i) under the Penal Code §§22.011, 22.02, 22.021, or 22.04 or an offense under the laws of another state or federal law that is equivalent to an offense under one of these sections; (ii) committed when the individual held a license as a health care professional in this state or another state and in the course of providing services within the scope of the individual’s license; and (iii) in which the victim of the offense was a patient of the individual. Further, the proposed paragraph states that an individual’s eligibility for reapplication or reinstatement of licensure is governed by the Occupations Code Chapter 108, Subchapter B. These proposed provisions are also consistent with the statutory requirements of Chapter 108.

Amending 22 TAC §217.2 to provide additional clarity and statutory citations.

CHAPTER 217. LICENSURE, PEER ASSISTANCE AND PRACTICE
22 TAC §217.2

OVERVIEW

The Board is proposing amendments to §217.2, relating to Licensure by Examination for Graduates of Nursing Education Programs Within the United States, its Territories, or Possessions. The proposed amendments make non-substantive, editorial changes to the section and correct typographical errors.

SECTION-BY-SECTION SUMMARY

Proposed amended §217.2(a)(4) makes editorial changes to the paragraph to more clearly identify the types of programs that the paragraph is referring to. Proposed amended §217.2(a)(4)(C) corrects an incorrect statutory citation. Proposed amended §217.2(a)(4)(D) and (E) make editorial changes for additional clarity and better readability within the paragraphs. Finally, proposed amended §217.2(a)(4)(E)(ii) corrects a punctuation error.

Amending 22 TAC §217.5 to clarify requirements for an endorsement applications for nursing education programs.

CHAPTER 217. LICENSURE, PEER ASSISTANCE AND PRACTICE
22 TAC §217.5

OVERVIEW

The Board is proposing amendments to §217.5, relating to Temporary License and Endorsement. The amendments are necessary to clarify the Board’s existing educational requirements for endorsement applicants who graduated from an out of state nursing education program.

BACKGROUND AND JUSTIFICATION

In 2017, the Sunset Advisory Committee recommended amendments to the Occupations Code §301.157(d-4), (d-8), (d-9), (d-11), and (d-12). These changes related to substantially equivalent education standards for out of state nursing education programs and were codified in House Bill (HB) 2950. HB 2950 became effective September 1, 2017.

Pursuant to §301.157(d-4), the Board is required to adopt rules to ensure that out of state nursing education programs are substantially equivalent to the Board’s education standards. In the event that an out of state nursing education program’s standards are not substantially equivalent to the Board’s education standards, the statute requires the Board to develop a process for students graduating from such programs to still apply for an initial license in Texas.

At the April 2017 regularly scheduled Board meeting, the Board charged the Advisory Committee on Education (ACE) with recommending rules to: (1) define substantially equivalent education standards for the purpose of ensuring out of state nursing education programs are substantially equivalent to Board standards for licensure purposes; and (2) provide a pathway for initial licensure for graduates of out of state programs that are not substantially equivalent to Board standards for Texas education programs.

ACE met on June 22, 2017; July 25, 2017; and September 25, 2017, to consider the Board’s charge. The Board reviewed ACE’s recommendations at the October 2017 regularly scheduled Board meeting and approved rule amendments to §217.2 for publication in the Texas Register for public comment. The Board considered written comments at its January 2018 regularly scheduled Board meeting and voted to adopt the proposed amendments to §217.2 with changes. The adopted rule amendments to §217.2 were published in the Texas Register and became effective on February 28, 2018.

The proposed amendments to §217.5 are necessary to clarify that the amendments previously adopted by the Board in February 2018 apply not only to applicants for initial licensure by examination, but also to applicants for initial licensure by endorsement. Initial licensure in Texas may occur either through examination by successfully passing the National Council Licensure Examination for Registered Nurses (NCLEX-RN®) or National Council Licensure Examination for Practical/Licensed Vocational Nurses (NCLEX-PN®) or through endorsement of a nursing license issued from another state. When the Board originally adopted the rules regarding substantially equivalent education standards in February 2018, they were placed in §217.2. Section 217.2 contains the Board’s requirements that generally apply to initial licensure by examination. Section 217.5 contains the requirements that generally apply to initial licensure by endorsement. Even though the amendments that were adopted in February 2018 also apply to applicants for initial licensure by endorsement, they were not also placed in §217.5 when the Board originally adopted them in 2018. The proposed amendments, therefore, place those requirements in §217.5 to provide additional clarity and congruency among the Board’s rules. The Board considered the proposed amendments to §217.5 at its July 2022, regularly scheduled Board meeting and voted to propose the amendments in the Texas Register for public comment.

SECTION-BY-SECTION SUMMARY

Pursuant to proposed amended §217.5(a)(1)(A), an endorsement applicant must have graduated from an approved Texas nursing education program or a program with substantially equivalent education standards to a Texas approved nursing program. A professional nursing education program operated in another state may be determined to have substantially equivalent education standards to a Texas approved nursing program if: (i) the program is approved by a state board of nursing or other governmental entity to offer a pre-licensure professional nursing program of study that awards a nursing diploma or degree upon completion; (ii) the program includes general education courses providing a sound foundation for nursing education for the level of preparation; (iii) the program’s nursing courses include didactic content and supervised clinical learning experiences in medical-surgical, maternal/child health, pediatrics, geriatrics, and mental health nursing that teach students to use a systematic approach to clinical decision-making and safe patient care across the life span; and (iv) for baccalaureate degree nursing programs, nursing courses must also include didactic content and supervised clinical learning experiences, as appropriate, in community, research, and leadership. These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(A).
Pursuant to proposed amended §217.5(a)(1)(B), a vocational nursing education program operated in another state may be determined to have substantially equivalent education standards to a Texas approved nursing program if: (i) the program is approved by a state board of nursing or other governmental entity to offer a pre-licensure vocational/practical nursing program of study that awards a vocational/practical nursing certificate, diploma, or degree upon completion; (ii) the program’s nursing courses include didactic and supervised clinical learning experiences in medical-surgical, maternal/child health, pediatrics, geriatrics, and mental health nursing that teach students to use a systematic approach to clinical decision-making and safe patient care across the life span; and (iii) the program includes support courses providing a sound foundation for nursing education for the level of preparation. These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(B).
Pursuant to proposed amended §217.5(a)(1)(D), if an applicant does not have substantially equivalent education as set out in proposed amended subparagraph (A) or (B), the applicant may become eligible for licensure if the applicant enrolls in an approved Texas program and completes the necessary educational requirements. These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(D).
Pursuant to proposed amended §217.5(a)(1)(C), a clinical competency assessment program shall be deemed substantially equivalent to a Texas approved nursing program while compliant with the requirements of the Occupations Code §301.157(d-8) and (d-9). However, a clinical competency assessment program will be deemed to not be substantially equivalent to a Texas approved nursing program if the program fails to meet applicable requirements of the Occupations Code §301.157(d-11) and (d-12). These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(C) and are consistent with the statutory requirements of §301.157(d-8), (d-9), (d-11), and (d-12).
Pursuant to proposed amended §217.5(a)(1)(E), if an applicant for licensure as a registered nurse has completed a clinical competency assessment program which is deemed not to be substantially equivalent to Board standards for Texas programs under proposed amended subparagraph (C), the Board may issue a provisional license to the applicant once the applicant has passed the NCLEX-RN®. The applicant will be eligible for full licensure if the applicant completes 500 hours of clinical practice under the direct supervision of an approved preceptor. The applicant, prior to beginning practice, must submit the name and license number of a potential preceptor for Board approval. After completion of 500 hours of clinical practice under direct supervision of the approved preceptor and the preceptor’s signature that the applicant is competent and safe to practice nursing, the applicant may be eligible for full licensure. These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(E)(i).
The applicant may also be eligible for full licensure if the applicant completes an educational program at an approved Texas program which is designed to assess and improve clinical skills for applicants who have not completed supervised clinical experiences in their prior educational program. The applicant must seek and receive the Board’s approval prior to entering into the program to ensure that the program will allow the applicant may be eligible for full licensure. The applicant must provide the Board evidence of completion of the approved program. These proposed requirements are the same requirements that currently appear in §217.2(a)(4)(E)(ii).
Finally, proposed amended §217.5(a)(1)(F) allows an applicant for licensure as a registered nurse who has completed a clinical competency assessment program which is deemed not to be substantially equivalent to Board standards for Texas programs under proposed amended subparagraph (C), in lieu of completing the requirements of proposed amended subparagraph (E), to submit proof, for Board review and approval, of at least 500 hours of clinical practice as a nurse in a single employment setting that is verified by a licensed nursing supervisor. The licensed nursing supervisor’s signature shall evidence that the applicant is competent and safe to practice nursing.
This is the only proposed provision that is not also currently in §217.2. This proposed provision only applies to endorsement applicants because they will have received a nursing license previously issued by another state, and the Board recognizes that they may have already practiced nursing successfully in that state of licensure. This would not apply to applicants applying for initial licensure by examination because they will not have been issued a nursing license by any other state since they have not yet passed the NCLEX-RN®. For endorsement applicants, however, the proposed amendment is intended to provide them with an alternative method of demonstrating nursing competency that may be less onerous.

Amending 22 TAC §221.12 to update the scope of Advanced Practice Nurses (APRN) training and practice.

CHAPTER 221. ADVANCED PRACTICE NURSES
22 TAC §221.12

OVERVIEW

The Board is proposing amendments to §221.12, relating to Scope of Practice. The amendments are necessary to clarify the scope of practice for advanced practice registered nurses (APRNs).

BACKGROUND AND JUSTIFICATION

At its regularly scheduled October 2021 Board meeting, the Board charged the Advanced Practice Nursing Advisory Committee (Committee) with reviewing §221.12 and recommending any necessary changes. The Board issued this charge to the Committee based upon an increased number of questions and complaints from the public regarding certain procedures and patient care activities being performed by APRNs. The Committee convened on March 3, 2022, and June 13, 2022, to consider the Board’s charge. The Board considered the Committee’s recommendations for amendments to §221.12 at its July 2022, regularly scheduled Board meeting and voted to propose the amendments in the Texas Register for public comment.

SECTION-BY-SECTION SUMMARY

Proposed amended §221.12(a) and (b) re-organize existing text within the current rule regarding APRN practice. First, proposed amended §221.12(a) establishes the foundational premise that an APRN may, within his/her authorized role and population focus area, provide a broad range of health care services to patients in a variety of practice settings. Proposed amended §221.12(b) re-iterates that, within that role and population focus area, only those functions that are also within the APRN’s authorized scope of practice and are consistent with the Nursing Practice Act, Board rules, and other laws and regulations affecting the APRN’s practice may be performed.
An APRN’s educational preparation and continued advanced practice experience, as well as the accepted scope of professional practice for the APRN’s specialty, all inform the APRN’s scope of practice. Because each APRN’s history will also often include unique experiences, however, the proposed amendments to §221.12(c) are intended to clarify how the Board will determine if a particular patient care activity falls within an APRN’s authorized scope of practice. The Board recognizes that not all of the factors contained in proposed amended subsection (c) will necessarily apply in every instance. The Board will, therefore, consider only those factors that are present in an instant case.
The Board typically only reviews an activity performed by an APRN when a complaint is received from a member of the public or when a question about a specific action is addressed to the Board. In such situations, when reviewing the particular activity of the APRN, the Board will always consider whether the APRN received training regarding the performance of the activity in his/her advanced educational program. This factor is identified in proposed amended §221.12(c)(1). If the APRN’s advanced educational program included training regarding the performance of the particular activity, the action will generally be found to fall within the APRN’s scope of practice. As with all actions within an APRN’s scope of practice, however, the APRN still must be able to demonstrate that he/she is currently competent in performing the action in conformity with the applicable standard of care.
Pursuant to proposed amended §221.12(c)(2), the Board will also consider whether the action falls within generally acceptable standards of care appropriate for the APRN’s role and population focus area, as determined by a professional specialty organization. While the particular position of a specialty organization is not necessarily dispositive of a particular scope of practice issue, the Board will consider a specialty organization’s position. Specialty organizations often offer specialty specific continuing education, role-related competencies, and educational conferences that are intended to enhance nursing practice, keep pace with changing practice environments, and encourage evidence-based practice in specialty roles. To that end, they can be a helpful resource in informing nursing practice.
The Board will also consider whether an APRN has demonstrable clinical competence and/or clinical experience in performing an action in the role of an APRN, as obtained through supervision and/or training by a qualified practitioner. The Board recognizes that APRNs will often obtain new skills by observing, and then demonstrating, the skill to a supervisor or peer. Proposed amended §221.12(c)(3) provides flexibility to practitioners regarding the kind of training that an APRN may complete in order to demonstrate clinical competence in a new skill or activity.
Under the proposed amendments to §221.12(c)(4), the Board will also consider whether an APRN has been credentialed by a health care facility’s credentialing body and/or holds a privilege to perform the action at a health care facility. Because credentialing is intended to ensure that patients receive the highest level of care, healthcare professionals who undergo facility credentialing are generally subjected to stringent scrutiny of their qualifications and competencies. This deliberate vetting process would be considered by the Board when determining if the APRN’s performance of a certain activity falls within the APRN’s scope of practice.
Proposed amended §221.12(c)(5) specifies additional factors the Board will consider when reviewing any additional training obtained by an APRN. As a threshold matter, the training must include education obtained by the APRN post-APRN licensure. Second, the training must be in, or consistent with, the APRN’s authorized role and population focus area. Finally, there must be a method of objective, verifiable participant competency following completion of the training. Once those threshold matters have been met, the Board will consider a variety of factors to determine if the training is adequate for the action being performed by the APRN. Again, the Board recognizes that not all of the proposed factors will necessarily be present in a particular case. The Board will, therefore, consider only those factors that are present in the matter under consideration.
Those factors include the type of instruction provided, such as online instruction, in-person instruction, didactic instruction, or clinical instruction; the learning objectives, content, materials, and methods for evaluating participation contained in the training curriculum; the length and/or quantity of the training; the qualifications of the person/entity providing the training; whether the training has been certified or recognized by a professional specialty organization for the APRN’s role and population focus area; whether the training is consistent with evidence-based practice; whether the training is sponsored by an educational institution, such as a formal fellowship or precepted experience; and whether the training is provided by an entity in conjunction with the use of the entity’s product, drug, or medical apparatus/equipment. Because the Board recognizes that additional education may be obtained in a variety of ways, the proposed factors are not intended to be overly prescriptive or limiting in nature. Instead, the training must only be sufficient to ensure safe and competent patient care.
Proposed amended §221.12(d) makes it clear that it is the responsibility of the APRN to maintain records of all completed training and competencies. While the records may be maintained in any format and medium, they should be appropriately detailed and organized to demonstrate the sufficiency of the training and/or competency completed by the APRN. The manner in which they are maintained, however, may be determined by each individual APRN and will not be prescribed by the Board.
Proposed amended §221.12(e) and (f) are necessary to ensure that the intent of the entire section is not misconstrued. First, in order to be licensed as an APRN in Texas, an individual must first hold licensure as a registered nurse. Therefore, because an APRN is also a registered nurse, an APRN may practice in the role of a registered nurse. The proposed rule does not require an APRN to practice in an advanced practice role only, nor does the proposed rule prevent an APRN from practicing in a registered nurse role. It remains the choice of the licensed individual as to which role he/she practices in at any given time.
Second, neither the proposed amendments nor the current rule text should be construed in a manner that would authorize an APRN to practice in a role or population focus area for which the APRN has not been licensed. Therefore, the proposed amendments do not in any way expand an APRN’s licensure to extend into new roles or population foci. Rather, the proposed amendments clarify an APRN’s scope of practice for his/her existing licensure level only.
Finally, proposed §221.12(g) reminds licensees of the importance of ensuring that all patient care activities are performed in conformity with their respective scopes of practice. If an APRN is unsure if a particular action falls within his/her scope of practice, the proposed amendments are intended to provide additional clarity as to the factors that should be reviewed and considered before performing the activity or action. Performing a procedure or patient care activity outside of an APRN’s scope of practice may subject the APRN to disciplinary action by the Board.

Texas Health and Human Services Commission

Proposed Rules Re:

Amending 26 TAC §748.43 to add new terms and definitions for general residential operations.

CHAPTER 748. MINIMUM STANDARDS FOR GENERAL RESIDENTIAL OPERATIONS
SUBCHAPTER B. DEFINITIONS AND SERVICES
26 TAC §748.43

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §748.43 in Title 26, Texas Administrative Code, Chapter 748, Minimum Standards for General Residential Operations.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

H.B. 1540, SECTION 19, made the following changes to HRC §42.042: (1) added subsection (e)(9), which requires HHSC Child Care Regulation (CCR) to promulgate minimum standards that ensure a child’s health, safety, and welfare are adequately protected on the “grounds” of a child-care facility or registered family home; (2) amended subsection (g) to allow CCR to recognize and treat differently the “grounds appurtenant to” child-care facilities, registered family homes, listed family homes, child-placing agencies, and foster homes when promulgating minimum standards for each operation type; and (3) amended subsection (g-2) to require CCR to consider precautions required for a general residential operation (GRO) to protect trafficking victims and the vulnerability of the victims on the “grounds” of a residential treatment center (RTC) when adopting minimum standards.

H.B. 1540, SECTION 20, added HRC §42.068, which requires (1) CCR to develop “no trespassing” notices that meet specific criteria and to provide them at no charge to each RTC; and (2) each RTC to post the “no trespassing” notices at specific locations on the grounds of the operation.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §748.43 (1) adds the new term “grounds” and its definition; (2) renumbers the paragraphs accordingly; and (3) adds the term “premises” and a definition that refers directly to the term “grounds” and its definition.

Amending 26 TAC §748.3319 and §748.3321 to require no trespassing signs for general residential operations.

CHAPTER 748. MINIMUM STANDARDS FOR GENERAL RESIDENTIAL OPERATIONS
SUBCHAPTER P. PHYSICAL SITE
26 TAC §748.3319, §748.3321

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §§748.3319 and 748.3321 in Title 26, Texas Administrative Code, Chapter 748, Minimum Standards for General Residential Operations.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

Proposed new §748.3319 provides that an RTC must post “no trespassing” signs meeting certain criteria at the locations specified in the rule.
Proposed new §748.3321 describes additional responsibilities for an RTC, including (1) ensuring that the “no trespassing” signs are legible and reflect under whose authority the signs are currently posted; and (2) requesting new signs from CCR, as needed, to comply with rules.

Amending 26 TAC §748.4553 to clarify required written policies for general residential operations for trafficking victims.

CHAPTER 748. MINIMUM STANDARDS FOR GENERAL RESIDENTIAL OPERATIONS
SUBCHAPTER V. ADDITIONAL REQUIREMENTS FOR OPERATIONS THAT PROVIDE TRAFFICKING VICTIM SERVICES
26 TAC §748.4553

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §748.4553 in Title 26, Texas Administrative Code, Chapter 748, Minimum Standards for General Residential Operations.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §748.4553 clarifies that a GRO providing trafficking victim services must have written policies that ensure safety and security of trafficking victims and employees on the grounds of the GRO.

Amending 26 TAC §748.4659 to describe required annual training for general residential operations regarding trafficking victim services.

CHAPTER 748. MINIMUM STANDARDS FOR GENERAL RESIDENTIAL OPERATIONS
SUBCHAPTER V. ADDITIONAL REQUIREMENTS FOR OPERATIONS THAT PROVIDE TRAFFICKING VICTIM SERVICES
26 TAC §748.4659

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §748.4659 in Title 26, Texas Administrative Code, Chapter 748, Minimum Standards for General Residential Operations.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §748.4659 clarifies that a GRO providing trafficking victim services must having annual training that addresses the external safety and security risks at the operation, including the grounds of the operation. The amendment also adds unapproved visitors and intruders as examples of safety and security risks.

Amending 26 TAC §749.43 to add new terms and definitions for minimum standards for child-placing agencies.

CHAPTER 749. MINIMUM STANDARDS FOR CHILD-PLACING AGENCIES
SUBCHAPTER B. DEFINITIONS AND SERVICES
26 TAC §749.43

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §749.43 in Title 26, Texas Administrative Code, Chapter 749, Minimum Standards for Child-Placing Agencies.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §749.43 (1) adds the new term “grounds” and its definition; (2) renumbers the paragraphs accordingly; and (3) adds the term “premises” and a definition that refers directly to the term “grounds” and its definition.

Amending 26 TAC §749.4053 to outline required written policies for child-placing agencies for trafficking victims.

CHAPTER 749. MINIMUM STANDARDS FOR CHILD-PLACING AGENCIES
SUBCHAPTER V. ADDITIONAL REQUIREMENTS FOR CHILD-PLACING AGENCIES THAT PROVIDE TRAFFICKING VICTIM SERVICES
26 TAC §749.4053

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §749.4053 in Title 26, Texas Administrative Code, Chapter 749, Minimum Standards for Child-Placing Agencies.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §749.4053 clarifies that a CPA providing trafficking victim services must have written policies that ensure safety and security of trafficking victims, caregivers, and employees on the grounds of the foster home.

Amending 26 TAC §749.4157 to require annual training for child-placing agencies for trafficking victim services.

CHAPTER 749. MINIMUM STANDARDS FOR CHILD-PLACING AGENCIES
SUBCHAPTER V. ADDITIONAL REQUIREMENTS FOR CHILD-PLACING AGENCIES THAT PROVIDE TRAFFICKING VICTIM SERVICES
26 TAC §749.4157

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §749.4157 in Title 26, Texas Administrative Code, Chapter 749, Minimum Standards for Child-Placing Agencies.

BACKGROUND AND JUSTIFICATION

The proposal is necessary to implement sections of statute that were added or amended by House Bill (H.B.) 1540, 87th Texas Legislature, Regular Session, 2021.

H.B. 1540, SECTION 18, amended Texas Human Resources Code (HRC) §42.002 to add the new term “grounds” and its definition.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §749.4157 clarifies that a CPA providing trafficking victim services must having annual training that addresses the external safety and security risks at a foster home, including the grounds of a foster home.

Adopted Rules Re:

New 1 TAC §353.8, describing certification and appeal requirements for certain Managed Care Organizations.

CHAPTER 353. MEDICAID MANAGED CARE
SUBCHAPTER A. GENERAL PROVISIONS
1 TAC §353.8

OVERVIEW

The Texas Health and Human Services Commission (HHSC) adopts new §353.8, concerning Certification of Managed Care Organizations Prior to Contract Awards.

Section 353.8 is adopted without changes to the proposed text as published in the May 13, 2022, issue of the Texas Register (47 TexReg 2821). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The adopted rule implements Texas Government Code §533.0035, added by Senate Bill 1244, 87th Legislature, Regular Session, 2021. Texas Government Code §533.0035 requires HHSC to evaluate and certify that any managed care organization (MCO) that is recommended for award following a solicitation is able to fulfill the terms of any proposed contract prior to contract award.

Adopted §353.8(a) sets forth that HHSC awards a contract to an MCO only if HHSC certifies the MCO as reasonably able to fulfill the terms of the contract, including all requirements of applicable federal and state law.

To establish the certification process, adopted §353.8(b) sets forth that HHSC determines whether to certify an MCO following the evaluation of proposals submitted in response to a solicitation and that certification does not impact the MCO’s final score, but failure to obtain certification results in no further consideration of the MCO for the contract award.

Adopted §353.8(c) sets forth that in its certification determination, HHSC reviews the MCO’s past performance, including materials required to be monitored by a state’s managed care program under 42 Code of Federal Regulations §438.66(c).

Adopted §353.8(d) sets forth that HHSC may request additional information and assurances from the MCO for purposes of the certification determination and may review materials submitted by the MCO in response to the solicitation. To establish an appeals process, adopted §353.8(d) sets forth that HHSC provides notice of approval or denial of certification by electronic mail to the MCO and that a notice of denial sets forth the reasons for the denial of certification. It also sets forth that if an MCO is denied certification, the MCO may appeal the denial by submitting an appeal to the solicitation’s sole point of contact no later than 10 business days after the date HHSC transmits the notice of denial of certification.

Adopted §353.8(e) sets forth that an appeal must specifically address the reasons for the denial of the certification and precisely state the argument and authorities the MCO offers in support of its appeal.

Adopted §353.8(f) sets forth how HHSC resolves an appeal by dismissing the appeal as untimely, upholding the denial of certification, or reversing the denial of certification and certifying the MCO.

Adopted §353.8(g) sets forth that after the expiration of the appeal period and the resolution of any pending appeals, MCOs that obtained the required certification will proceed to the next phase of the contract award process.

Adopted §353.8(h) sets forth that HHSC’s determination not to certify an MCO is not a contested case proceeding under the Texas Administrative Procedure Act, Texas Government Code Chapter 2001.

Proposed Rule Reviews Re:

Title 26, Part 1, concerning licensing standards for Prescribed Pediatric Extended Care Centers.

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes to review and consider for readoption, revision, or repeal the chapter listed below, in its entirety, contained in Title 26, Part 1, of the Texas Administrative Code:

Chapter 550, Licensing Standards for Prescribed Pediatric Extended Care Centers

Subchapter A, Purpose, Scope, Limitations, Compliance, and Definitions

Subchapter B, Licensing Application, Maintenance, and Fees

Subchapter C, General Provisions

Subchapter D, Transportation

Subchapter E, Building Requirements

Subchapter F, Inspections and Visits

Subchapter G, Enforcement

This review is conducted in accordance with the requirements of Texas Government Code §2001.039, which requires state agencies, every four years, to assess whether the initial reasons for adopting a rule continue to exist. After reviewing its rules, the agency will readopt, readopt with amendments, or repeal its rules.

Title 26, Part 1, concerning licensing standards for assisted living facilities.

OVERVIEW

The Texas Health and Human Services Commission (HHSC) proposes to review and consider for readoption, revision, or repeal the chapter listed below, in its entirety, contained in Title 26, Part 1, of the Texas Administrative Code:

Chapter 553, Licensing Standards for Assisted Living Facilities

Subchapter A, Introduction

Subchapter B, Licensing

Subchapter D, Facility Construction

Subchapter E, Standards for Licensing

Subchapter F, Additional Licensing Standards for Certified Alzheimer’s Assisted Living Facilities

Subchapter G, Inspections, Investigations, and Informal Dispute Resolution

Subchapter H, Enforcement

Title 26, Part 1, concerning licensing standards for home and community support services agencies.

OVERVIEW

Chapter 558, Licensing Standards for Home and Community Support Services Agencies

Subchapter A, General Provisions

Subchapter B, Criteria and Eligibility, Application Procedures, and Issuance of a License

Subchapter C, Minimum Standards for All Home and Community Support Services Agencies

Subchapter D, Additional Standards Specific to License Category and Specific to Special Services

Subchapter E, Licensure Surveys

Subchapter F, Enforcement

Subchapter G, Home Health Aides

Subchapter H, Standards Specific to Agencies Licensed to Provide Hospice Services

Title 26, Part 1, concerning day activity and health services requirements.

Chapter 559, Day Activity and Health Services Requirements

Subchapter A, Introduction

Subchapter B, Application Procedures

Subchapter C, Facility Construction Procedures

Subchapter D, Licensure and Program Requirements

Subchapter E, Inspections, Surveys, and Visits

Subchapter F, Abuse, Neglect, And Exploitation: Complaint and Incident Reports and Investigations

Subchapter G, Enforcement

In Addition Re:

Public Notice – Texas State Plan Amendment 22-0021

OVERVIEW

The Texas Health and Human Services Commission (HHSC) announces its intent to submit amendments to the Texas State Plan for Medical Assistance, under Title XIX of the Social Security Act.

The purpose of the amendment is to change the minimum qualification for service coordinators to match proposed revisions recommended to state rule. HHSC is amending the minimum hiring qualifications for service coordinators that work for LIDDAs throughout Texas. As well, in accordance with House Bill (H.B.) 4 (87th Legislature, Regular Session, 2021), the amendment will permit targeted case managers to conduct comprehensive encounters and follow-up encounters for individuals with intellectual disabilities via synchronous audio-only or synchronous audio-visual technology. The proposed amendments are effective November 1, 2022.

The proposed amendments are estimated to have no fiscal impact, as they are not expected to affect Medicaid utilization or cost.

Texas State Board of Pharmacy

Adopted Rules Re:

Amending 22 TAC §283.4 concerning hours credited from a college or a school of pharmacy.

CHAPTER 283. LICENSING REQUIREMENTS FOR PHARMACISTS
22 TAC §283.4

OVERVIEW

The Texas State Board of Pharmacy adopts amendments to §283.4, concerning Internship Requirements. These amendments are adopted without changes to the proposed text as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3625). The rule will not be republished.

The amendments clarify that a person graduating from a college/school of pharmacy shall only be credited the number of hours obtained and reported by the program.

Amending 22 TAC §291.33 to update a term, correct a citation reference, and remove the requirement for oral patients counseling on a new prescription.

CHAPTER 291. PHARMACIES
SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)
22 TAC §291.33

OVERVIEW

The Texas State Board of Pharmacy adopts amendments to §291.33, concerning Operational Standards. These amendments are adopted without changes to the proposed text as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3628). The rule will not be republished.

The amendments update a term, correct a citation reference, and remove the requirement for oral patient counseling on a new prescription to be provided in person, a requirement which has been temporarily suspended by the Office of the Governor until September 30, 2022 or until the March 13, 2020 disaster declaration is lifted or expires.

Amending 22 TAC §291.104 to clarify that a Class E Pharmacies may outsource prescription drug order dispensing to a central fill pharmacy.

CHAPTER 291. PHARMACIES
SUBCHAPTER F. NON-RESIDENT PHARMACY (CLASS E)
22 TAC §291.104

The Texas State Board of Pharmacy adopts amendments to §291.104, concerning Operational Standards. These amendments are adopted without changes to the proposed text as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3639). The rule will not be republished.

The amendments clarify that a Class E Pharmacy may outsource prescription drug order dispensing to a central fill pharmacy.

Amending 22 TAC §291.125 to clarify that a Class E pharmacy may outsource prescription drug orders dispensing to a central fill pharmacy.

CHAPTER 291. PHARMACIES
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.125

OVERVIEW

The Texas State Board of Pharmacy adopts amendments to §291.125, concerning Centralized Prescription Dispensing. These amendments are adopted without changes to the proposed text as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3643). The rule will not be republished.

The amendments clarify that a Class E pharmacy may outsource prescription drug order dispensing to a central fill pharmacy.

Amending 22 TAC §291.131 to add definitions and clarify training requirements for all personnel involved in non-sterile compounding.

CHAPTER 291. PHARMACIES
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.131

OVERVIEW

The Texas State Board of Pharmacy adopts amendments to §291.131, concerning Pharmacies Compounding Non-Sterile Preparations. These amendments are adopted with changes to the proposed text as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3645). The rule will be republished.

The amendments add definitions of “cleaning” and “sanitizing”, clarify the training requirements for all personnel involved in non-sterile compounding, and update environmental, equipment, and compounding process requirements for non-sterile compounding.

Repealing 22 TAC §305.1 to remove practice degree program standards that are redundant.

CHAPTER 305. EDUCATIONAL REQUIREMENTS
22 TAC §305.1

OVERVIEW

The Texas State Board of Pharmacy adopts the repeal of §305.1, concerning Pharmacy Education Requirements. This repeal is adopted without changes to the proposed repeal as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3652). The rule will not be republished.

The repeal of §305.1 removes professional practice degree program standards that are redundant with standards specified elsewhere in Board rules.

Repealing 22 TAC §305.2 to eliminate standards for pharmacy technician training programs that are not required or that are outside the resources of the Board.

CHAPTER 305. EDUCATIONAL REQUIREMENTS
22 TAC §305.2

The Texas State Board of Pharmacy adopts the repeal of §305.2, concerning Pharmacy Technician Training Programs. This repeal is adopted without changes to the proposed repeal as published in the June 24, 2022, issue of the Texas Register (47 TexReg 3652). The rule will not be republished.

The repeal of §305.2 removes standards for pharmacy technician training programs that are not required to be specified in Board rule and other requirements that are outside the resources of the Board to perform.

Texas Department of State Health Services

Adopted Rules Re:

Amending 25 TAC §181.28 to update instructions and requirements for issuance of certified copies of vital records.

CHAPTER 181. VITAL STATISTICS
SUBCHAPTER B. VITAL RECORDS
25 TAC §181.28

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §181.28, concerning Instructions and Requirements for Issuance of Certified Copies of Vital Records by the State Registrar, Local Registrar, or County Clerk.

The amendment to §181.28 is adopted without changes to the proposed text as published in the June 17, 2022, issue of the Texas Register (47 TexReg 3525). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment to §181.28 amends the list of security features in the rule. This change allows DSHS to increase the security of vital statistics paper by removing detailed information on security features from public access. The amendment also increases DSHS’s flexibility to address changes in security technology and ensures a steady supply of security paper from qualified vendors.

Proposed Rule Reviews Re:

Title 25, Part 1, Chapter 229, concerning Food and Drug.

The Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes to review and consider for readoption, revision, or repeal the chapter listed below, in its entirety, contained in Title 25, Part 1 of the Texas Administrative Code:

Chapter 229, Food and Drug

Subchapter A, Prescription Drug Price Disclosure

Subchapter B, Donation of Unused Drugs

Subchapter C, Purchase of Domestic Beef

Subchapter D, Regulation of Cosmetics

Subchapter F, Production, Processing, and Distribution of Bottled and Vended Drinking Water

Subchapter G, Manufacture, Storage, and Distribution of Ice Sold for Human Consumption, Including Ice Produced at Point of Use

Subchapter J, Minimum Standards for Narcotic Treatment Programs

Subchapter K, Texas Food Establishments

Subchapter L, Licensure of Food Manufacturers, Food Wholesalers, and Warehouse Operators

Subchapter N, Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food

Subchapter O, Licensing of Wholesale Distributors of Nonprescription Drugs–Including Good Manufacturing Practices

Subchapter P, Assessment of Administrative Penalties

Subchapter Q, License/Permit Applications

Subchapter R, Issuance of Certificates of Free Sale and Sanitation and/or Certificates of Origin and Sanitation

Subchapter S, Pesticides in Food

Subchapter T, Licensure of Tanning Facilities

Subchapter U, Permitting Retail Food Establishments

Subchapter V, Minimum Standards for Licensure of Tattoo and Certain Body Piercing Studios

Subchapter W, Licensing of Wholesale Distributors of Prescription Drugs–Including Good Manufacturing Practices

Subchapter X, Licensing of Device Distributors and Manufacturers

Subchapter Y, Regulations to Prohibit the Sale of Dietary Supplements Containing Ephedrine Group Alkaloids; and to Restrict the Sale and Distribution of Certain Products Containing Ephedrine

Subchapter Z, Inspection Fees for Retail Food Establishments

Subchapter AA, Regulation of Food Salvage Establishments and Brokers

Subchapter BB, Regulation of Drug Salvage Establishments and Brokers

Subchapter CC, Regulation of Device Salvage Establishments and Brokers

Subchapter DD, Regulation of Cosmetic Salvage Establishments and Brokers

Subchapter EE, Cottage Food Production Operations

Subchapter FF, Farmers’ Markets

Subchapter GG, Sanitary Transportation of Human Foods

This review is conducted pursuant to the requirements of the Texas Government Code §2001.039, which requires state agencies, every four years, to assess whether the initial reasons for adopting a rule continue to exist. After reviewing its rules, the agency will consider whether these rules should be repealed, readopted, or readopted with amendments.