Adopted Rules Title 26

TITLE 26. HEALTH AND HUMAN SERVICES

PART 1. HEALTH AND HUMAN SERVICES COMMISSION

CHAPTER 553. LICENSING STANDARDS FOR ASSISTED LIVING FACILITIES

SUBCHAPTER A. INTRODUCTION

The Texas Health and Human Services Commission (HHSC) adopts in Texas Administrative Code (TAC) Title 26, Part 1, Chapter 553, Licensing Standards for Assisted Living Facilities, amendments to §553.3, relating to Definitions; §553.17, relating to Criteria for Licensing; §553.103, relating to Site and Location for all Assisted Living Facilities; §553.257, relating to Human Resources; and §553.259, relating to Admission Policies and Procedures.

The amendments to §§553.3, 553.17, 553.103, and 553.257 are adopted with changes to the proposed text as published in the August 5, 2022, issue of the Texas Register (47 TexReg 4633). These rules will be republished.

The amendments to §553.259 are adopted without changes to the proposed text as published in the August 5, 2022, issue of the Texas Register (47 TexReg 4633). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the amendments to §553.17 and §553.103 is to implement House Bill (H.B.) 1681, 87th Legislature, Regular Session, 2021. H.B. 1681 prohibits new construction of assisted living facilities (ALFs) in a 100-year flood plain in counties of more than 3.3 million residents. The amendments also update outdated procedural information related to the licensing process.

The purpose of the amendments to §553.257 is to implement Senate Bill (S.B.) 271, 87th Legislature, Regular Session, 2021. S.B. 271 requires ALFs to obtain a signed disclosure, on an HHSC prescribed form, from applicants for employment regarding out-of-state criminal convictions and to perform a name-based criminal history check in any state the applicant has lived in during the previous five years.

The purpose of the amendments to §553.3 and §553.259 is to implement S.B. 383, 87th Legislature, Regular Session, 2021. S.B. 383 requires an ALF that advertises, markets, or otherwise promotes that it provides memory care services to provide an additional HHSC-prescribed memory care disclosure statement to each resident.

The amendments also update rule references that became outdated as a result of the administrative transfer of rules from 40 TAC Chapter 92 to 26 TAC Chapter 553, reflect the transfer of functions from the Texas Department of Human Services or the Texas Department of Aging and Disability Services to HHSC, update terminology, and remove outdated references and requirements.

COMMENTS

The 31-day comment period ended September 6, 2022.

During this period, HHSC received comments regarding the proposed rules from three commenters: Texas Assisted Living Association, Office of the State Long-term Care Ombudsman, and Texas Healthcare Association. A summary of comments relating to the rules and HHSC's responses follows.

Comment: A commenter suggested moving the date of implementation for the requirement prohibiting a newly constructed ALF from being built in a 100-year flood plain if the facility is located in a county of more than 3.3 million residents. The commenter also recommended that HHSC accept Federal Emergency Management Agency (FEMA) documentation in addition to the FEMA flood maps. The proposed rules at §553.103 implemented this rule beginning November 1, 2022. This date was chosen to coincide with the effective date of the rule. The commenter suggested changing the date to January 1, 2023, and to have the date apply to the submission of construction documents for architectural review by HHSC.

Response: HHSC declined to make the requested change to the rule implementation date but did change the date to match the rule effective date. HHSC will provide clarifying policy guidance about when the requirement will begin being enforced after the rule becomes effective. HHSC will also include in the policy guidance that FEMA documentation will be accepted by HHSC in addition to the FEMA flood maps.

Comment: A commenter recommended adding language to §553.257 to clarify that an employee may be hired by a facility pending the out of state background checks but must not hold a position that has direct contact with residents until the background checks have cleared.

Response: HHSC agreed with the commenter and revised the rule as suggested.

Comment: Multiple commenters expressed concern over an additional memory care disclosure statement required by §553.259. Commenters stated that multiple disclosure statements may be confusing to prospective or new residents. One commenter stated that the definition of "Memory care services" at §553.3(52) may confuse people by using the term "memory care impairment."

Response: HHSC declined to remove the additional memory care disclosure statement from rule as it is required by S.B. 383. HHSC agreed with the commenter regarding the definition of "Memory care services" and made clarifying changes in §553.3(52).

HHSC made a change to §553.3(10) to clarify the definition of the "Assisted Living Facility Memory Care Disclosure Statement."

HHSC edited the date in §553.17 and §553.103 to December 6, 2022. This date will coincide with the effective date of the rule.

HHSC made a change to §553.257(b)(4) to reflect the new TAC reference for the employee misconduct registry.

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; and Texas Health and Safety Code §247.025 and §247.026, which provide that the Executive Commissioner of HHSC shall adopt rules necessary to implement Chapter 247 and to ensure the quality of care and protection of assisted living facility residents' health and safety, respectively

§553.3.Definitions.

The following words and terms, when used in this chapter, have the following meaning, unless the context clearly indicates otherwise.

(1) Abuse--

(A) For a person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes, the term has the meaning in Texas Family Code §261.001(1), which is an intentional, knowing, or reckless act or omission by an employee, volunteer, or other individual working under the auspices of a facility or program that causes or may cause emotional harm or physical injury to, or the death of, a child served by the facility or program, as further described by rule or policy; and

(B) For a person other than one described in subparagraph (A) of this paragraph, the term has the meaning in Texas Health and Safety Code §260A.001(1), which is:

(i) the negligent or willful infliction of injury, unreasonable confinement, intimidation, or cruel punishment with resulting physical or emotional harm or pain to a resident by the resident's caregiver, family member, or other individual who has an ongoing relationship with the resident; or

(ii) sexual abuse of a resident, including any involuntary or nonconsensual sexual conduct that would constitute an offense under Texas Penal Code §21.08 (relating to Indecent Exposure), or Texas Penal Code, Chapter 22 (relating to Assaultive Offenses), committed by the resident's caregiver, family member, or other individual who has an ongoing relationship with the resident.

(2) Accreditation commission--Has the meaning given in Texas Health and Safety Code §247.032.

(3) Actual harm--A negative outcome that compromises a resident's physical, mental, or emotional well-being.

(4) Advance directive--Has the meaning given in Texas Health and Safety Code §166.002.

(5) Affiliate--With respect to:

(A) a partnership, each partner thereof;

(B) a corporation, each officer, director, principal stockholder, subsidiary, or person with a disclosable interest, as the term is defined in this section; and

(i) said person's spouse;

(ii) each partnership and each partner thereof, of which said person or any affiliate of said person is a partner; and

(iii) each corporation in which said person is an officer, director, principal stockholder, or person with a disclosable interest.

(6) Alzheimer's Assisted Living Disclosure Statement form--The HHSC-prescribed form a facility uses to describe the nature of care or treatment of residents with Alzheimer's disease and related disorders.

(7) Alzheimer's disease and related disorders--Alzheimer's disease and any other irreversible dementia described by the Centers for Disease Control and Prevention (CDC), or the most current edition of the Diagnostic and Statistical Manual of Mental Disorders.

(8) Alzheimer's facility--A Type B facility that is certified to provide specialized services to residents with Alzheimer's disease or a related condition.

(9) Applicant--A person applying for a license to operate an assisted living facility under Texas Health and Safety Code, Chapter 247.

(10) Assisted Living Facility Memory Care Disclosure Statement form--The HHSC-prescribed form that a facility uses when the facility advertises, markets, or otherwise promotes that it provides memory care services to residents with Alzheimer's disease and related disorders.

(11) Attendant--A facility employee who provides direct care to residents. This employee may serve other functions, including cook, janitor, porter, maid, laundry worker, security personnel, bookkeeper, activity director, and manager.

(12) Authorized electronic monitoring (AEM)--The placement of an electronic monitoring device in a resident's room and using the device to make tapes or recordings after making a request to the facility to allow electronic monitoring.

(13) Behavioral emergency--Has the meaning given in §553.261(g)(2) of this chapter (relating to Coordination of Care).

(14) Certified ombudsman--Has the meaning given in §88.2 of this title (relating to Definitions).

(15) CFR--Code of Federal Regulations.

(16) Change of ownership--An event that results in a change to the federal taxpayer identification number of the license holder of a facility. The substitution of a personal representative for a deceased license holder is not a change of ownership.

(17) Commingles--The laundering of apparel or linens of two or more individuals together.

(18) Controlling person--A person with the ability, acting alone or with others, to directly or indirectly influence, direct, or cause the direction of the management, expenditure of money, or policies of a facility or other person. A controlling person includes:

(A) a management company, landlord, or other business entity that operates or contracts with others for the operation of a facility;

(B) any person who is a controlling person of a management company or other business entity that operates a facility or that contracts with another person for the operation of an assisted living facility;

(C) an officer or director of a publicly traded corporation that is, or that controls, a facility, management company, or other business entity described in subparagraph (A) of this paragraph but does not include a shareholder or lender of the publicly traded corporation; and

(D) any other individual who, because of a personal, familial, or other relationship with the owner, manager, landlord, tenant, or provider of a facility, is in a position of actual control or authority with respect to the facility, without regard to whether the individual is formally named as an owner, manager, director, officer, provider, consultant, contractor, or employee of the facility, except an employee, lender, secured creditor, landlord, or other person who does not exercise formal or actual influence or control over the operation of a facility.

(19) Covert electronic monitoring--The placement and use of an electronic monitoring device that is not open and obvious, and about which the facility and HHSC have not been informed by the resident, by the person who placed the device in the room, or by a person who uses the device.

(20) Delegation--In the assisted living facility context, written authorization by a registered nurse (RN) acting on behalf of the facility for personal care staff to perform tasks of nursing care in selected situations, where delegation criteria are met for the task. The delegation process includes nursing assessment of a resident in a specific situation, evaluation of the ability of the personal care staff, teaching the task to the personal care staff, ensuring supervision of the personal care staff in performing a delegated task, and re-evaluating the task at regular intervals.

(21) Dietitian--A person who currently holds a license or provisional license issued by the Texas Department of Licensing and Regulation.

(22) Direct ownership interest--Ownership of equity in the capital, stock, or profits of, or a membership interest in, an applicant or license holder.

(23) Disclosable interest--Five percent or more direct or indirect ownership interest in an applicant or license holder.

(24) Disclosure statement--An HHSC form for prospective residents or their legally authorized representatives that a facility must complete. The form contains information regarding the preadmission, admission, and discharge process; resident assessment and service plans; staffing patterns; the physical environment of the facility; resident activities; and facility services.

(25) Electronic monitoring device--Video surveillance cameras and audio devices installed in a resident's room, designed to acquire communications or other sounds that occur in the room. An electronic, mechanical, or other device used specifically for the nonconsensual interception of wire or electronic communication is excluded from this definition.

(26) Exploitation--

(A) For a person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes, the term has the meaning in Texas Family Code §261.001(3), which is the illegal or improper use of a child or of the resources of a child for monetary or personal benefit, profit, or gain by an employee, volunteer, or other individual working under the auspices of a facility or program as further described by rule or policy; and

(B) For a person other than one described in subparagraph (A) of this paragraph, the term has the meaning in Texas Health and Safety Code §260A.001(4), which is the illegal or improper act or process of a caregiver, family member, or other individual who has an ongoing relationship with the resident using the resources of a resident for monetary or personal benefit, profit, or gain without the informed consent of the resident.

(27) Facility--An entity required to be licensed under the Assisted Living Facility Licensing Act, Texas Health and Safety Code, Chapter 247.

(28) Fire suppression authority--The paid or volunteer fire-fighting organization or tactical unit that is responsible for fire suppression operations and related duties once a fire incident occurs within its jurisdiction.

(29) Flame spread--The rate of fire travel along the surface of a material. This is different than other requirements for time-rated "burn through" resistance ratings, such as one-hour rated. Flame spread ratings are Class A (0-25), Class B (26-75), and Class C (76-200).

(30) Functional disability--A mental, cognitive, or physical disability that precludes the physical performance of self-care tasks, including health maintenance activities and personal care.

(31) Governmental unit--The state or any county, municipality, or other political subdivision, or any department, division, board, or other agency of any of the foregoing.

(32) Health care professional--An individual licensed, certified, or otherwise authorized to administer health care, for profit or otherwise, in the ordinary course of business or professional practice. The term includes a physician, registered nurse, licensed vocational nurse, licensed dietitian, physical therapist, and occupational therapist.

(33) Health maintenance activity (HMA)--Consistent with 22 TAC §225.4 (relating to Definitions), a task that:

(A) may be exempt from delegation based on an RN's assessment in accordance with §553.263(c) of this chapter (relating to Health Maintenance Activities); and

(B) requires a higher level of skill to perform than personal care services and, in the context of an ALF, excludes the following tasks:

(i) intermittent catheterization; and

(ii) subcutaneous, nasal, or insulin pump administration of insulin or other injectable medications prescribed in the treatment of diabetes mellitus.

(34) HHSC--The Texas Health and Human Services Commission.

(35) Immediate threat to the health or safety of a resident--A situation that causes, or is likely to cause, serious injury, harm, or impairment to or the death of a resident.

(36) Immediately available--The capacity of facility staff to immediately respond to an emergency after being notified through a communication or alarm system. The staff are to be no more than 600 feet from the farthest resident and in the facility while on duty.

(37) Indirect ownership interest--Any ownership or membership interest in a person that has a direct ownership interest in an applicant or license holder.

(38) Isolated--A very limited number of residents are affected, and a very limited number of staff are involved, or the situation has occurred only occasionally.

(39) Key infectious agents--Bacteria, viruses, and other microorganisms which cause the most common infections and infectious diseases in long-term care facilities, and can be mitigated by establishing, implementing, maintaining, and enforcing proper infection, prevention, and control policies and procedures.

(40) Large facility--A facility licensed for 17 or more residents.

(41) Legally authorized representative--A person authorized by law to act on behalf of a person with regard to a matter described in this chapter, and may include a parent, guardian, or managing conservator of a minor, or the guardian of an adult.

(42) License holder--A person that holds a license to operate a facility.

(43) Listed--Equipment, materials, or services included in a list published by an organization concerned with evaluation of products or services, that maintains periodic inspection of production of listed equipment or materials or periodic evaluation of services, and whose listing states that either the equipment, material, or service meets appropriate designated standards or has been tested and found suitable for a specified purpose. The listing organization must be acceptable to the authority having jurisdiction, including HHSC or any other state, federal, or local authority.

(44) Local code--A model building code adopted by the local building authority where the facility is constructed or located.

(45) Management services--Services provided under contract between the owner of a facility and a person to provide for the operation of a facility, including administration, staffing, maintenance, or delivery of resident services. Management services do not include contracts solely for maintenance, laundry, transportation, or food services.

(46) Manager--The individual in charge of the day-to-day operation of the facility.

(47) Managing local ombudsman--Has the meaning given in §88.2 of this title.

(48) Medication--

(A) Medication is any substance:

(i) recognized as a drug in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Texas Drug Code Index or official National Formulary, or any supplement to any of these official documents;

(ii) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;

(iii) other than food intended to affect the structure or any function of the body; and

(iv) intended for use as a component of any substance specified in this definition.

(B) Medication includes both prescription and over-the-counter medication, unless otherwise specified.

(49) Medication administration--The direct application of a medication or drug to the body of a resident by an individual legally allowed to administer medication in the state of Texas.

(50) Medication assistance or supervision--The assistance or supervision of the medication regimen by facility staff. Refer to §553.261(a) of this chapter.

(51) Medication (self- or self-administration of)--The capability of a resident to administer the resident's own medication or treatments without assistance from the facility staff.

(52) Memory care services--Services provided by an assisted living facility to meet the needs of residents with a diagnosis of Alzheimer's disease or related disorders or a diagnosis of dementia.

(53) Multidrug-resistant organisms--Bacteria and other microorganisms that have developed resistance to multiple types of medicine used to act against the microorganism.

(54) Neglect--

(A) For a person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes, the term has the meaning in Texas Family Code §261.001(4), which is a negligent act or omission by an employee, volunteer, or other individual working under the auspices of a facility or program, including failure to comply with an individual treatment plan, plan of care, or individualized service plan, that causes or may cause substantial emotional harm or physical injury to, or the death of, a child served by the facility or program as further described by rule or policy; and

(B) For a person other than one described in subparagraph (A) of this paragraph, the term has the meaning in Texas Health and Safety Code §260A.001(6), which is the failure to provide for oneself the goods or services, including medical services, which are necessary to avoid physical or emotional harm or pain or the failure of a caregiver to provide such goods or services.

(55) NFPA 101--The 2012 publication titled NFPA 101 Life Safety Code published by the National Fire Protection Association, Inc., 1 Batterymarch Park, Quincy, Massachusetts 02169.

(56) Ombudsman intern--Has the meaning given in §88.2 of this title.

(57) Ombudsman program--Has the meaning given in §88.2 of this title.

(58) Online portal--A secure portal provided on the HHSC website for licensure activities, including for an assisted living facility applicant to submit licensure applications and information.

(59) Pattern of violation--Repeated, but not widespread in scope, failures of a facility to comply with this chapter or a rule, standard, or order adopted under Texas Health and Safety Code, Chapter 247 that:

(A) result in a violation; and

(B) are found throughout the services provided by the facility or that affect or involve the same residents or facility employees.

(60) Person--Any individual, firm, partnership, corporation, association, or joint stock association, and the legal successor thereof.

(61) Personal care services--Assistance with feeding, dressing, moving, bathing, or other personal needs or maintenance; or general supervision or oversight of the physical and mental well-being of a person who needs assistance to maintain a private and independent residence in the facility or who needs assistance to manage his or her personal life, regardless of whether a guardian has been appointed for the person.

(62) Personal care staff--An attendant whose primary employment function is to provide personal care services.

(63) Physician--A practitioner licensed by the Texas Medical Board.

(64) Potential for minimal harm--A violation that has the potential for causing no more than a minor negative impact on a resident.

(65) Practitioner--An individual who is currently licensed in a state in which the individual practices as a physician, dentist, podiatrist, or a physician assistant; or a registered nurse approved by the Texas Board of Nursing to practice as an advanced practice registered nurse.

(66) Private and unimpeded access--Access to enter a facility or communicate with a resident outside of the hearing and view of others, without interference or obstruction from facility employees, volunteers, or contractors.

(67) Qualified medical personnel--An individual who is licensed, certified, or otherwise authorized to administer health care. The term includes a physician, registered nurse, and licensed vocational nurse.

(68) Rapid influenza diagnostic test--A test administered to a person with flu-like symptoms that can detect the influenza viral nucleoprotein antigen.

(69) Resident--An individual accepted for care in a facility.

(70) Respite--The provision by a facility of room, board, and care at the level ordinarily provided for permanent residents of the facility to a person for not more than 60 days for each stay in the facility.

(71) Restraint hold--

(A) A manual method, except for physical guidance or prompting of brief duration, used to restrict:

(i) free movement or normal functioning of all or a portion of a resident's body; or

(ii) normal access by a resident to a portion of the resident's body.

(B) Physical guidance or prompting of brief duration becomes a restraint if the resident resists the guidance or prompting.

(72) Restraints--Chemical restraints are psychoactive drugs administered for the purposes of discipline or convenience and are not required to treat the resident's medical symptoms. Physical restraints are any manual method, or physical or mechanical device, material, or equipment attached or adjacent to the resident that restricts freedom of movement. Physical restraints include restraint holds.

(73) RN (registered nurse)--A person who holds a current and active license from the Texas Board of Nursing to practice professional nursing, as defined in Texas Occupations Code §301.002(2).

(74) Safety--Protection from injury or loss of life due to such conditions as fire, electrical hazard, unsafe building or site conditions, and the hazardous presence of toxic fumes and materials.

(75) Seclusion--The involuntary separation of a resident from other residents and the placement of the resident alone in an area from which the resident is prevented from leaving.

(76) Service plan--A written description of the medical care, supervision, or nonmedical care needed by a resident.

(77) Short-term acute episode--An illness of less than 30 days' duration.

(78) Small facility--A facility licensed for 16 or fewer residents.

(79) Stable and predictable--A phrase describing the clinical and behavioral status of a resident that is non-fluctuating and consistent and does not require the regular presence of a registered or licensed vocational nurse.

(A) The phrase does not include within its meaning a description of the clinical and behavioral status of a resident that is expected to change rapidly or needs continuous or continual nursing assessment and evaluation.

(B) The phrase does include within its meaning a description of the condition of a resident receiving hospice care within a facility where deterioration is predictable.

(80) Staff--Employees of an assisted living facility.

(81) Standards--The minimum conditions, requirements, and criteria established in this chapter with which a facility must comply to be licensed under this chapter.

(82) State Ombudsman--Has the meaning given in §88.2 of this title.

(83) Terminal condition--A medical diagnosis, certified by a physician, of an illness that will result in death in six months or less.

(84) Universal precautions--An approach to infection control in which blood, any body fluids visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids are treated as if known to be infectious for HIV, hepatitis B, and other blood-borne pathogens.

(85) Vaccine Preventable Diseases--The diseases included in the most current recommendations of the Advisory Committee on Immunization Practices of the CDC.

(86) Widespread in scope--A violation of Texas Health and Safety Code, Chapter 247 or a rule, standard, or order adopted under Chapter 247 that:

(A) is pervasive throughout the services provided by the facility; or

(B) represents a systemic failure by the facility that affects or has the potential to affect a large portion of or all of the residents of the facility.

(87) Willfully interfere--To act or not act to intentionally prevent, interfere with, impeded, or to attempt to intentionally prevent, interfere with, or impede.

(88) Working day--Any 24-hour period, Monday through Friday, excluding state and federal holidays.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204423

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER B. LICENSING

26 TAC §553.17

STATUTORY AUTHORITY

§553.17.Criteria for Licensing.

(a) A person must be licensed to establish or operate an assisted living facility in Texas.

(1) HHSC considers one or more facilities to be part of the same establishment and, therefore, subject to licensure as an assisted living facility, based on the following factors:

(A) common ownership;

(B) physical proximity;

(D) any public appearance of joint operations or of a relationship between the facilities.

(2) The presence or absence of any one factor in paragraph (1) of this subsection is not conclusive.

(b) To obtain a license, a person must follow the application requirements in this subchapter and meet the criteria for a license.

(c) An applicant must affirmatively show that the applicant, license holder, controlling person, and any person required to submit background and qualification information meet the criteria and eligibility for licensing, in accordance with this section, and:

(1) the building in which the facility is housed:

(A) meets local fire ordinances;

(B) is approved by the local fire authority;

(C) meets HHSC licensing standards in accordance with Subchapter D of this chapter (relating to Facility Construction) based on an on-site inspection by HHSC; and

(D) if located in a county of more than 3.3 million residents for initial license applications submitted or issued on or after December 6, 2022, is not located in a 100-year floodplain; and

(2) operation of the facility meets HHSC licensing standards based on an on-site health inspection by HHSC, which must include observation of the care of a resident; or

(3) the facility meets the standards for accreditation based on an on-site accreditation survey by the accreditation commission.

(d) An applicant who chooses the option authorized in subsection (c)(3) of this section must contact HHSC to determine which accreditation commissions are available to meet the requirements of that subsection. If a license holder uses an on-site accreditation survey by an accreditation commission, as provided in this subsection and §553.33(i) of this subchapter (relating to Renewal Procedures and Qualifications), the license holder must:

(1) provide written notification to HHSC by submitting an updated application in the licensing system within five working days after the license holder receives a notice of change in accreditation status from the accreditation commission; and

(2) include a copy of the notice of change with its written notification to HHSC.

(e) HHSC issues a license to a facility meeting all requirements of this chapter. The facility must not exceed the maximum allowable number of residents specified on the license.

(f) HHSC denies an application for an initial license or a renewal of a license if:

(1) the applicant, license holder, controlling person, or any person required to be disclosed on the application for licensure has been debarred or excluded from the Medicare or Medicaid programs by the federal government or a state;

(2) a court has issued an injunction prohibiting the applicant, license holder, controlling person, or any person required to be disclosed on the application for licensure from operating a facility; or

(3) during the five years preceding the date of the application, a license to operate a health care facility, long-term care facility, assisted living facility, or similar facility in any state held by the applicant, license holder, controlling person, or any person required to be disclosed on the application for licensure has been revoked.

(g) A license holder or controlling person who operates a nursing facility or an assisted living facility for which a trustee was appointed and for which emergency assistance funds, other than funds to pay the expenses of the trustee, were used is subject to exclusion from eligibility for:

(1) the issuance of an initial license for a facility for which the person has not previously held a license; and

(2) the renewal of the license of the facility for which the trustee was appointed.

(h) HHSC may deny an application for an initial license or refuse to renew a license if an applicant, license holder, controlling person, or any person required to be disclosed on the application for licensure:

(1) violates Texas Health and Safety Code, Chapter 247; a section, standard, or order adopted under Chapter 247; or a license issued under Chapter 247 in either a repeated or substantial manner;

(2) commits an act described in §553.751(a)(2) - (9) of this chapter (relating to Administrative Penalties);

(3) aids, abets, or permits a substantial violation described in paragraph (1) or (2) of this subsection about which the person had or should have had knowledge;

(4) fails to provide the required information, facts, or references;

(5) engages in the following:

(A) knowingly submits false or intentionally misleading statements to HHSC;

(B) uses subterfuge or other evasive means of filing an application for licensure;

(D) knowingly conceals a material fact related to licensure; or

(E) is responsible for fraud;

(6) fails to pay the following fees, taxes, and assessments when due:

(A) license fees, as described in §553.47 of this subchapter (relating to License Fees); or

(B) franchise taxes, if applicable;

(7) during the five years preceding the date of the application, has a history in any state or other jurisdiction of any of the following:

(A) operation of a facility that has been decertified or has had its contract canceled under the Medicare or Medicaid program;

(B) federal or state long-term care facility, assisted living facility, or similar facility sanctions or penalties, including monetary penalties, involuntary downgrading of the status of a facility license, proposals to decertify, directed plans of correction, or the denial of payment for new Medicaid admissions;

(C) unsatisfied final judgments, excluding judgments wholly unrelated to the provision of care rendered in long-term care facilities;

(D) eviction involving any property or space used as a facility; or

(E) suspension of a license to operate a health care facility, long-term care facility, assisted living facility, or a similar facility;

(8) violates Texas Health and Safety Code §247.021 by operating a facility without a license; or

(9) is subject to denial or refusal as described in Chapter 560 of this title (relating to Denial or Refusal of License) during the time frames described in that chapter.

(i) Without limitation, HHSC reviews all information provided by an applicant, a license holder, a person required to be disclosed on the application for licensure, or a manager when considering grounds for denial of an initial license application or a renewal application in accordance with subsection (h) of this section. HHSC may grant a license if HHSC finds the applicant, license holder, person required to be disclosed on the application for licensure, affiliate, or manager is able to comply with the rules in this chapter.

(j) HHSC reviews final actions when considering the grounds for denial of an initial license application or renewal application in accordance with subsections (f) and (h) of this section. An action is final when routine administrative and judicial remedies are exhausted. An applicant must disclose all actions, whether pending or final.

(k) If an applicant owns multiple facilities, HHSC examines the overall record of compliance in all of the applicant's facilities. An overall record poor enough to deny issuance of a new license does not preclude the renewal of a license of a facility with a satisfactory record.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204424

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER D. FACILITY CONSTRUCTION

DIVISION 2. PROVISIONS APPLICABLE TO ALL FACILITIES

26 TAC §553.103

STATUTORY AUTHORITY

§553.103.Site and Location for all Assisted Living Facilities.

(a) Firefighting unit. An assisted living facility must be served by a professional or volunteer firefighting unit and must have a water supply that meets the firefighting unit's requirements and approval.

(b) Correction of hazards. An assisted living facility must correct a site or building condition that HHSC staff identifies to be a fire, health, or physical hazard.

(1) An assisted living facility must provide or arrange for nearby parking spaces for the private vehicles of residents and visitors.

(2) An assisted living facility must provide a minimum of one parking space for every four residents in its licensed capacity, and for any fraction thereof, or per local requirements, whichever is more stringent.

(d) Ramps.

(1) An assisted living facility must ensure a ramp, walk, or step is of slip-resistive texture and is uniform, without irregularities.

(2) An assisted living facility must ensure a ramp does not exceed a slope of one foot in 12 feet.

(3) An assisted living facility must ensure any new ramp has a clear width of at least 36 inches. A new ramp is one that was installed or constructed on or after August 31, 2021.

(e) Site conditions. An assisted living facility must provide a guardrail, fence, or handrail where a grade makes an abrupt change in level.

(f) Outside grounds. An assisted living facility must ensure that each outside area, grounds, and any adjacent buildings are maintained in good condition and kept free of rubbish, garbage, and untended growth that may constitute a fire or health hazard.

(g) Drainage. An assisted living facility must ensure site grades provide for water drainage away from structures to prevent ponding or standing water at or near a building, unless the ponding or standing water is part of an approved drainage system intended to hold water for a period of time.

(h) 100-year Floodplain. An assisted living facility that applies for an initial license or is initially licensed on or after December 6, 2022, must not be located in a 100-year floodplain, if the facility is located in a county of more than 3.3 million residents.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204426

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER E. STANDARDS FOR LICENSURE

26 TAC §553.257, §553.259

STATUTORY AUTHORITY

The amendments are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; and Texas Health and Safety Code §247.025 and §247.026, which provide that the Executive Commissioner of HHSC shall adopt rules necessary to implement Chapter 247 and to ensure the quality of care and protection of assisted living facility residents' health and safety, respectively

§553.257.Human Resources.

(a) Personnel records. A facility must keep current and complete personnel records on a facility employee for review by HHSC staff including:

(1) documentation that the facility performed a criminal history check;

(2) an annual employee misconduct registry check;

(3) an annual nurse aide registry check;

(4) documentation of initial tuberculosis screenings referenced in §553.261(f) of this subchapter (relating to Coordination of Care);

(5) documentation of the employee's compliance with or exemption from the facility vaccination policy referenced in §553.261(f) of this subchapter;

(6) the signed statement from the employee referenced in §553.273 of this subchapter (relating to Abuse, Neglect, or Exploitation Reportable to HHSC by Facilities), acknowledging that the employee may be criminally liable for the failure to report abuse, neglect, and exploitation; and

(7) a signed disclosure statement, indicating whether the employee:

(A) has been convicted of an offense described in Texas Health and Safety Code §250.006; and

(B) has lived in a state other than Texas within the past five years.

(b) Investigation of facility employees.

(1) A facility must comply with the provisions of Texas Health and Safety Code, Chapter 250.

(2) Before a facility hires an employee, the facility must search the employee misconduct registry (EMR) established under §253.007, Texas Health and Safety Code, and the HHSC nurse aide registry (NAR) to determine if the individual is designated in either registry as unemployable based on employee misconduct. Both registries can be accessed on the HHSC Internet website.

(3) A facility is prohibited from hiring or continuing to employ a person who is listed in the EMR or NAR as unemployable or who has been convicted of an offense listed in §250.006 as a bar to employment or is a contraindication to employment with the facility.

(4) A facility must provide notification about the EMR to an employee in accordance with 26 TAC §711.1413 (relating to Employment and Registry Information).

(5) In addition to the initial search of the NAR and the EMR, a facility must conduct a search of the NAR and the EMR to determine if the employee is designated in either registry as unemployable at least every 12 months.

(6) A facility must keep a copy of the results of the initial and annual searches of the NAR and EMR in the employee's personnel file.

(7) If an applicant for employment indicates on the disclosure statement that they have lived in another state within the past five years, the facility must conduct a name-based criminal history check in each state in which the applicant previously resided within the five-year period. A facility may hire the applicant pending the results of the name-based criminal history check in each state, but the employee must not be in a position that has direct contact with residents.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204427

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

CHAPTER 554. NURSING FACILITY REQUIREMENTS FOR LICENSURE AND MEDICAID CERTIFICATION

The Texas Health and Human Services Commission (HHSC) adopts in Texas Administrative Code (TAC) Title 26, Part 1, Chapter 554, Licensing Standards for Licensure and Medicaid Certification, amendments to §554.101, relating to Definitions; §554.204, relating to Application Requirements; §554.403, relating to Notice of Rights and Services; §554.1921, relating to General Requirements for a Nursing Facility; §554.1935, relating to Automated External Defibrillators; §554.2002, relating to Procedural Requirements--Licensure Inspections and Surveys; §554.2326, relating to Medicaid Swing Bed Program for Rural Hospitals; and the repeal of §554.1913, relating to Clinical Records Service Supervisor.

The amendments to §§554.101, 554.403, 554.1921 and §554.2326 are adopted with changes to the proposed text as published in the August 5, 2022, issue of the Texas Register (47 TexReg 4645). These rules will be republished.

The amendments to §§554.204, 554.1935, and 554.2002, and the repeal of §554.1913 are adopted without changes to the proposed text as published in the August 5, 2022, issue of the Texas Register (47 TexReg 4645). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the amendments to §§554.101, 554.204, 554.403, and 554.1921 is to implement Senate Bill (S.B.) 383, 87th Legislature, Regular Session, 2021. S.B. 383 requires a nursing facility (NF) that advertises, markets, or otherwise promotes that it provides memory care services to provide an additional HHSC prescribed memory care disclosure statement to each resident or resident representative and to each person applying for services from the facility or that person's next of kin or guardian.

The purpose of the repeal of §554.1913 and amendments to §554.2326 is to remove the requirement for a NF to employ a clinical records supervisor or other medical records keeper.

The purpose of the amendments to §554.1935 is to implement S.B. 199, 87th Legislature, Regular Session, 2021. S.B. 199 requires a NF to conduct monthly inspections of its automated external defibrillator.

The purpose of the amendment to §554.2002 is to implement House Bill (H.B.) 1423, 87th Legislature, Regular Session, 2021. H.B. 1423 increases the survey frequency of required unannounced NF inspections from two per three-year licensing period to one annually. H.B. 1423 also allows HHSC to conduct a follow-up inspection for evaluation and monitoring purposes to ensure HHSC is citing deficiencies consistently.

The amendments also update rule references that became outdated as a result of the administrative transfer of rules from 40 TAC Chapter 19 to 26 TAC Chapter 554, reflect the transfer of functions from the Texas Department of Human Services or the Texas Department of Aging and Disability Services to HHSC, update terminology, and remove outdated references and requirements.

COMMENTS

The 31-day comment period ended September 6, 2022.

During this period, HHSC received comments regarding the proposed rules from two commenters: the Office of the State Long-term Care Ombudsman and Texas Healthcare Association. A summary of comments relating to the rules and HHSC's responses follows.

Comment: The commenters expressed concern over an additional memory care disclosure statement required by §554.403(n)(1). Commenters stated that multiple disclosure statements may be confusing to prospective or new residents. One commenter was concerned that memory care services may not be clearly distinguished from an Alzheimer's certified facility's services and recommended changes to language at §554.403(n)(1)(B). Another commenter recommended allowing more time to notify the residents of a change to the disclosure statement as required by §554.403(o).

Response: HHSC declined to remove the additional memory care disclosure statement in §554.403(n)(1) as it is required by S.B. 383. HHSC agreed with the concerns that memory care services may not be clearly distinguished from Alzheimer's and revised the definition of "Memory care services" at §554.101(82) and revised language at §554.403(n)(1)(B). HHSC declined to increase the time frame in §554.403(o) to allow for more than 30-days' notice to residents and families before a change to the disclosure statement. HHSC will take this recommendation into consideration during a future rule project.

HHSC made a change to §554.1921(e)(12) to comply with changes to Government Code §411.204 and remove the word "concealed" when referencing handguns.

HHSC made a change to §554.2326(e) to remove the swing bed NF applicability reference requirements as they are informational only and are found in the requirements for hospitals. There is no additional benefit to having the rule references in the NF rules.

SUBCHAPTER B. DEFINITIONS

26 TAC §554.101

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

§554.101.Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Abuse--Negligent or willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical or emotional harm or pain to a resident; or sexual abuse, including involuntary or nonconsensual sexual conduct that would constitute an offense under Texas Penal Code §21.08 (indecent exposure) or Texas Penal Code Chapter 22 (assaultive offenses), sexual harassment, sexual coercion, or sexual assault.

(2) Act--Chapter 242 of the Texas Health and SafetyCode.

(3) Activities assessment--See Comprehensive Assessment and Comprehensive Care Plan.

(4) Activity director--The qualified individual appointed by the facility to direct the activities program as described in §554.702 of this chapter (relating to Activities).

(5) Addition--The addition of floor space to an institution.

(6) Administrator--A person currently licensed in accordance with 26 TAC Chapter 555 (relating to Nursing Facility Administrators).

(7) Admission MDS assessment--An MDS assessment that determines a recipient's initial determination of eligibility for medical necessity for admission into the Texas Medicaid Nursing Facility Program.

(8) Advanced practice registered nurse--A person licensed as a registered nurse and approved to practice as an advanced practice registered nurse by the Texas Board of Nursing.

(9) Adverse event--An untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk of death or serious injury.

(10) Alzheimer's Disclosure Statement for Nursing Facilities--The HHSC-prescribed form a facility uses to describe the nature of care or treatment of residents with Alzheimer's disease and related disorders.

(11) Alzheimer's disease and related disorders--Alzheimer's disease and any other irreversible dementia described by the Centers for Disease Control and Prevention or the most current edition of the Diagnostic and Statistical Manual of Mental Disorders.

(12) Applicant--A person or governmental unit, as those terms are defined in the Texas Health and Safety Code, Chapter 242, applying for a license under that chapter.

(13) Attending physician--A physician, currently licensed by the Texas Medical Board, who is designated by the resident or resident representative as having primary responsibility for the treatment and care of the resident.

(14) Authorized electronic monitoring--The placement of an electronic monitoring device in a resident's room and using the device to make tapes or recordings after making a request to the facility to allow electronic monitoring.

(15) Barrier precautions--Precautions including the use of gloves, masks, gowns, resuscitation equipment, eye protectors, aprons, face shields, and protective clothing for purposes of infection control.

(16) Care and treatment--Services required to maximize resident independence, personal choice, participation, health, self-care, psychosocial functioning, and reasonable safety, all consistent with the preferences of the resident.

(17) Certification--The determination by HHSC that a nursing facility meets all the requirements of the Medicaid or Medicare programs.

(18) Certified facility--A facility that meets the requirements of the Medicare program, the Medicaid program, or both.

(19) Certified Ombudsman--Has the meaning given in §88.2 of this title (relating to Definitions).

(20) CFR--Code of Federal Regulations.

(21) Change of ownership-- An event that results in a change to the federal taxpayer identification number of the license holder of a facility. The substitution of a personal representative for a deceased license holder is not a change of ownership.

(22) Chemical restraints--Any drug administered for the purpose of discipline or convenience, and not required to treat the resident's medical symptoms.

(23) CMS--Centers for Medicare & Medicaid Services.

(24) Complaint--Any allegation received by HHSC other than an incident reported by the facility. Such allegations include, but are not limited to, abuse, neglect, exploitation, or violation of state or federal standards.

(25) Completion date--The date an RN assessment coordinator signs an MDS assessment as complete.

(26) Comprehensive assessment--An interdisciplinary description of a resident's needs and capabilities including daily life functions and significant impairments of functional capacity, as described in §554.801(2) of this chapter (relating to Resident Assessment).

(27) Comprehensive care plan--A plan of care prepared by an interdisciplinary team that includes measurable short-term and long-term objectives and timetables to meet the resident's needs developed for each resident after admission. The plan addresses at least the following needs: medical, nursing, rehabilitative, psychosocial, dietary, activity, and resident's rights. The plan includes strategies developed by the team, as described in §554.802(c)(2) of this chapter (relating to Comprehensive Person-Centered Care Planning), consistent with the physician's prescribed plan of care, to assist the resident in eliminating, managing, or alleviating health or psychosocial problems identified through assessment. Planning includes:

(A) goal setting;

(B) establishing priorities for management of care;

(D) assisting in the development of appropriate coping mechanisms.

(28) Controlling person--A person with the ability, acting alone or in concert with others, to directly or indirectly, influence, direct, or cause the direction of the management, expenditure of money, or policies of a nursing facility or other person. A controlling person does not include a person, such as an employee, lender, secured creditor, or landlord, who does not exercise any influence or control, whether formal or actual, over the operation of a facility. A controlling person includes:

(A) a management company, landlord, or other business entity that operates or contracts with others for the operation of a nursing facility;

(B) any person who is a controlling person of a management company or other business entity that operates a nursing facility or that contracts with another person for the operation of a nursing facility;

(D) any other individual who, because of a personal, familial, or other relationship with the owner, manager, landlord, tenant, or provider of a nursing facility, is in a position of actual control or authority with respect to the nursing facility, without regard to whether the individual is formally named as an owner, manager, director, officer, provider, consultant, contractor, or employee of the facility.

(29) Covert electronic monitoring--The placement and use of an electronic monitoring device that is not open and obvious, and the facility and HHSC have not been informed about the device by the resident, by a person who placed the device in the room, or by a person who uses the device.

(30) DADS--The term referred to the Department of Aging and Disability Services; it now refers to HHSC.

(31) Dentist--A practitioner licensed to practice dentistry by the Texas State Board of Dental Examiners.

(32) DHS--This term referred to the Texas Department of Human Services; it now refers to HHSC.

(33) Dietitian--A qualified dietitian is one who is qualified based upon either:

(A) registration by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics; or

(B) licensure, or provisional licensure, as a dietitian under Texas Occupations Code, Chapter 701 and one year of supervisory experience in dietetic service of a health care facility.

(34) Direct ownership interest--Ownership of equity in the capital, stock, or profits of, or a membership interest in, an applicant or license holder.

(35) Disclosable interest--Five percent or more direct or indirect ownership interest in an applicant or license holder.

(36) Distinct part--That portion of a facility certified to participate in the Medicaid Nursing Facility program or as a SNF in the Medicare program.

(37) Drug (also referred to as medication)--Any of the following:

(A) any substance recognized as a drug in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;

(B) any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans;

(D) any substance intended for use as a component of any substance specified in subparagraphs (A) - (C) of this paragraph. It does not include devices or their components, parts, or accessories.

(38) Electronic monitoring device--Video surveillance cameras and audio devices installed in a resident's room, designed to acquire communications or other sounds that occur in the room. An electronic, mechanical, or other device used specifically for the nonconsensual interception of wire or electronic communication is excluded from this definition.

(39) Emergency--A sudden change in a resident's condition requiring immediate medical intervention.

(40) Essential Caregiver--A family member, friend, guardian, volunteer, or other person designated for in-person visits by an individual, resident, or client or the individual's, resident's, or client's guardian or legally authorized representative (LAR) during a public health emergency or disaster. In case of conflict between an individual's, resident's, or client's selection and a guardian's selection on behalf of the individual, resident, or client, the guardian's selection prevails, in accordance with the terms of the guardianship. If an individual, resident, or client has no guardian and is unable to select an essential caregiver, the individual's, resident's, or client's LAR may select the essential caregiver.

(41) Executive Commissioner--The executive commissioner of the Health and Human Services Commission.

(42) Exploitation--The illegal or improper act or process of a caregiver, family member, or other individual who has an ongoing relationship with a resident using the resources of the resident for monetary or personal benefit, profit, or gain without the informed consent of the resident.

(43) Facility--Unless otherwise indicated, a facility is an institution that provides organized and structured nursing care and service and is subject to licensure under Texas Health and Safety Code, Chapter 242.

(A) For Medicaid, a facility is a nursing facility which meets the requirements of §1919(a) - (d) of the Social Security Act (42 U.S.C. §1396r(a) - (d)). A facility may not include any institution that is for the care and treatment of mental diseases except for services furnished to individuals age 65 and over and who are eligible as defined in Chapter 303 of this title (relating to Preadmission Screening and Resident Review (PASRR)).

(B) For Medicare and Medicaid purposes (including eligibility, coverage, certification, and payment), the "facility" is always the entity which participates in the program, whether that entity is comprised of all of, or a distinct part of, a larger institution.

(C) "Facility" is also referred to as a nursing home or nursing facility. Depending on context, these terms are used to represent the management, administrator, or other persons or groups involved in the provision of care of the resident; or to represent the physical building, which may consist of one or more floors or one or more units, or which may be a distinct part of a licensed hospital.

(44) Family council--A group of family members, friends, or legal guardians of residents, who organize and meet privately or openly.

(45) Family representative--An individual appointed by the resident to represent the resident and other family members, by formal or informal arrangement.

(46) Fiduciary agent--An individual who holds in trust another's monies.

(47) Goals--Long-term: general statements of desired outcomes. Short-term: measurable time-limited, expected results that provide the means to evaluate the resident's progress toward achieving long-term goals.

(48) Governmental unit--A state or a political subdivision of the state, including a county or municipality.

(49) Health care provider--An individual, including a physician, or facility licensed, certified, or otherwise authorized to administer health care, in the ordinary course of business or professional practice.

(50) Hearing--A contested case hearing held in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001, and the formal hearing procedures in 1 TAC Chapter 357, Subchapter I (relating to Hearings Under the Administrative Procedure Act) and 40 TAC Chapter 91 (relating to Hearings Under the Administrative Procedure Act).

(51) HHSC--The Texas Health and Human Services Commission.

(52) HIV--Human Immunodeficiency Virus.

(53) Incident--An abnormal event, including accidents or injury to staff or residents, which is documented in facility reports. An occurrence in which a resident may have been subject to abuse, neglect, or exploitation must also be reported to HHSC.

(54) Indirect ownership interest--Any ownership or membership interest in a person that has a direct ownership interest in an applicant or license holder.

(55) Infection control--A program designed to prevent the transmission of disease and infection in order to provide a safe and sanitary environment.

(56) Inspection--Any on-site visit to or survey of an institution by HHSC for the purpose of licensing, monitoring, complaint investigation, architectural review, or similar purpose.

(57) Involuntary seclusion--Separation of a resident from others or from the resident's room or confinement to the resident's room, against the resident's will or the will of a person who is legally authorized to act on behalf of the resident. Monitored separation from other residents is not involuntary seclusion if the separation is a therapeutic intervention that uses the least restrictive approach for the minimum amount of time, not to exceed 24 hours, until professional staff can develop a care plan to meet the resident's needs.

(58) IV--Intravenous.

(59) Legend drug or prescription drug--Any drug that requires a written or telephonic order of a practitioner before it may be dispensed by a pharmacist, or that may be delivered to a particular resident by a practitioner in the course of the practitioner's practice.

(60) License holder--A person that holds a license to operate a facility.

(61) Licensed health professional--A physician; physician assistant; advanced practice registered nurse; physical, speech, or occupational therapist; pharmacist; physical therapist assistant occupational therapy assistant; registered professional nurse; licensed vocational nurse; licensed dietitian; licensed social worker; or certified respiratory care practitioner.

(62) Licensed vocational nurse (LVN)--A nurse who is currently licensed by the Texas Board of Nursing as a licensed vocational nurse.

(63) Life Safety Code--NFPA 101.

(64) Life safety features--Fire safety components required by NFPA 101, including building construction, fire alarm systems, smoke detection systems, interior finishes, sizes and thicknesses of doors, exits, emergency electrical systems, and sprinkler systems.

(65) Life support--Use of any technique, therapy, or device to assist in sustaining life. (See §554.419 of this chapter (relating to Advance Directives)).

(66) Local authorities--Persons, including, but not limited to, local health authority, fire marshal, and building inspector, who may be authorized by state law, county order, or municipal ordinance to perform certain inspections or certifications.

(67) Local health authority--The physician appointed by the governing body of a municipality or the commissioner's court of the county to administer state and local laws relating to public health in the municipality's or county's jurisdiction as defined in Texas Health and Safety Code, §121.021.

(68) Long-term care-regulatory--HHSC Regulatory Services Division, which is responsible for surveying nursing facilities to determine compliance with regulations for licensure and certification for Medicaid participation.

(69) Major injury--An injury that qualifies as a major injury under NFPA 99.

(70) Management services--Services provided under contract between the owner of a facility and a person to provide for the operation of a facility, including administration, staffing, maintenance, or delivery of resident services. Management services do not include contracts solely for maintenance, laundry, or food service.

(71) Manager--A person, other than a licensed nursing home administrator, having a contractual relationship to provide management services to a facility.

(72) Managing local ombudsman--Has the meaning given in §88.2 of this title.

(73) MDS--Minimum data set. See RAI.

(74) MDS nurse reviewer--A registered nurse employed by HHSC to monitor the accuracy of the MDS assessment submitted by a Medicaid-certified nursing facility.

(75) Medicaid applicant--A person who requests the determination of eligibility to become a Medicaid recipient.

(76) Medicaid nursing facility vendor payment system--Electronic billing and payment system for reimbursement to nursing facilities for services provided to eligible Medicaid recipients.

(77) Medicaid recipient--A person who meets the eligibility requirements of the Title XIX Medicaid program, is eligible for nursing facility services, and resides in a Medicaid-participating facility.

(78) Medical director--A physician licensed by the Texas Medical Board, who is engaged by the nursing home to assist in and advise regarding the provision of nursing and health care.

(79) Medical power of attorney--The legal document that designates an agent to make treatment decisions if the individual designator becomes incapable.

(80) Medication aide--A person who holds a current permit issued under the Medication Aide Training Program as described in Chapter 557 of this title (relating to Medication Aides--Program Requirements) and acts under the authority of a person who holds a current license under state law which authorizes the licensee to administer medication.

(81) Memory Care Disclosure Statement for Nursing Facilities--The HHSC-prescribed form a facility uses when the facility advertises, markets, or otherwise promotes that it provides services to residents with Alzheimer's disease and related disorders.

(82) Memory care services--Services provided by a nursing facility that meet the needs of residents with a diagnosis of Alzheimer's disease or related disorders or a diagnosis of dementia.

(83) Misappropriation--The taking, secretion, misapplication, deprivation, transfer, or attempted transfer to any person not entitled to receive any property, real or personal, or anything of value belonging to or under the legal control of a resident without the effective consent of the resident or other appropriate legal authority, or the taking of any action contrary to any duty imposed by federal or state law prescribing conduct relating to the custody or disposition of property of a resident.

(84) MN--Medical necessity. A determination, made by physicians and registered nurses who are employed by or contract with the state Medicaid claims administrator, that a recipient requires the services of a licensed nurse in an institutional setting to carry out a physician's planned regimen for total care. A recipient's need for custodial care in a 24-hour institutional setting does not constitute medical necessity.

(85) Neglect--The failure to provide goods or services, including medical services that are necessary to avoid physical or emotional harm, pain, or mental illness.

(86) NFPA--National Fire Protection Association.

(87) NFPA 99--NFPA 99, Health Care Facilities Code, 2012 Edition.

(88) NFPA 101--NFPA 101, Life Safety Code, 2012 Edition.

(89) Nurse aide--An individual who provides nursing or nursing-related services to residents in a facility under the supervision of a licensed nurse. This term may include an individual who provides these services through an agency or under a contract with the facility. This definition does not include an individual who is a licensed health professional, a registered dietitian, or someone who volunteers such services without pay. A nurse aide is not authorized to provide nursing or nursing-related services for which a license or registration is required under state law. Nurse aides do not include those individuals who furnish services to residents only as paid feeding assistants.

(90) Nurse practitioner--An advanced practice registered nurse licensed by the Texas Board of Nursing in the role of Nurse Practitioner.

(91) Nurses' station--A nurses' station is an area designated as the focal point on all shifts for the administration and supervision of resident-care activities for a designated number of resident bedrooms.

(92) Nursing care--Services provided by nursing personnel which include, but are not limited to, observation; promotion and maintenance of health; prevention of illness and disability; management of health care during acute and chronic phases of illness; guidance and counseling of individuals and families; and referral to physicians, other health care providers, and community resources when appropriate.

(93) Nursing facility or nursing home--See definition of "facility."

(94) Nursing personnel--Persons assigned to give direct personal and nursing services to residents, including registered nurses, licensed vocational nurses, nurse aides, and medication aides. Unlicensed personnel function under the authority of licensed personnel.

(95) Objectives--See definition of "goals."

(96) OBRA--Omnibus Budget Reconciliation Act of 1987, which includes provisions relating to nursing home reform.

(97) Ombudsman intern--Has the meaning given in §88.2 of this title.

(98) Ombudsman Program--Has the meaning given in §88.2 of this title.

(99) Paid feeding assistant--An individual who meets the requirements of §554.1113 of this chapter (relating to Paid Feeding Assistants) and who is paid to feed residents by a facility or who is used under an arrangement with another agency or organization.

(100) Palliative Plan of Care--Appropriate medical and nursing care for residents with advanced and progressive diseases for whom the focus of care is controlling pain and symptoms while maintaining optimum quality of life.

(101) PASARR or PASRR--Preadmission Screening and Resident Review.

(102) Patient care-related electrical appliance--An electrical appliance that is intended to be used for diagnostic, therapeutic, or monitoring purposes in a patient care area, as defined in Standard 99 of the National Fire Protection Association.

(103) Person--An individual, firm, partnership, corporation, association, joint stock company, limited partnership, limited liability company, or any other legal entity, including a legal successor of those entities.

(104) Person-centered care--To focus on the resident as the locus of control, and to support the resident in making choices and having control over the resident's daily life.

(105) Pharmacist--An individual, licensed by the Texas State Board of Pharmacy to practice pharmacy, who prepares and dispenses medications prescribed by a practitioner.

(106) Physical restraint--Any manual method, or physical or mechanical device, material or equipment attached, or adjacent to the resident's body, that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. The term includes a restraint hold.

(107) Physician--A doctor of medicine or osteopathy currently licensed by the Texas Medical Board to practice medicine.

(108) Physician assistant (PA)--An individual who is licensed as a physician assistant under Texas Occupations Code, Chapter 204.

(109) Podiatrist--A practitioner whose profession encompasses the care and treatment of feet who is licensed to practice podiatry by the Texas State Board of Podiatric Medical Examiners.

(110) Poison--Any substance that federal or state regulations require the manufacturer to label as a poison and is to be used externally by the consumer from the original manufacturer's container. Drugs to be taken internally that contain the manufacturer's poison label, but are dispensed by a pharmacist only by or on the prescription order of a practitioner, are not considered a poison, unless regulations specifically require poison labeling by the pharmacist.

(111) Practitioner--A physician, podiatrist, dentist, or an advanced practice registered nurse or physician assistant to whom a physician has delegated authority to sign a prescription order, when relating to pharmacy services.

(112) Private and unimpeded access--Access to enter a facility, or communicate with a resident outside of the hearing or view of others, without interference or obstruction from facility employees, volunteers, or contractors.

(113) PRN (pro re nata)--As needed.

(114) Provider--The individual or legal business entity that is contractually responsible for providing Medicaid services under an agreement with HHSC.

(115) Qualified mental health professional - community services--Has the meaning given in §301.303 of this title (relating to Definitions).

(116) Qualified surveyor--An employee of HHSC who has completed state and federal training on the survey process and passed a federal standardized exam.

(117) Quality assessment and assurance committee--A group of health care professionals in a facility who develop and implement appropriate action to identify and rectify substandard care and deficient facility practice.

(118) Quality measure report--A report that provides information derived from an MDS that provides a numeric value to quality indicators. This data is available to the public as part of the Nursing Home Quality Initiative (NHQI), and is intended to provide objective measures for consumers to make informed decisions about the quality of care in a nursing facility.

(119) Quality-of-care monitor--A registered nurse, pharmacist, or dietitian employed by HHSC who is trained and experienced in long-term care facility regulation, standards of practice in long-term care, and evaluation of resident care, and functions independently of HHSC Regulatory Services Division.

(120) RAI--Resident Assessment Instrument. An assessment tool used to conduct comprehensive, accurate, standardized, and reproducible assessments of each resident's functional capacity as specified by the Secretary of the U. S. Department of Health and Human Services. At a minimum, this instrument must consist of the MDS core elements as specified by CMS; utilization guidelines; and Care Area Assessment process.

(121) Recipient--Any individual residing in a Medicaid certified facility or a Medicaid certified distinct part of a facility whose daily vendor rate is paid by Medicaid.

(122) Rehabilitative services--Rehabilitative therapies and devices provided to help a person regain, maintain, or prevent deterioration of a skill or function that has been acquired but then lost or impaired due to illness, injury, or disabling condition. The term includes physical and occupational therapy, speech-language pathology, and psychiatric rehabilitation services.

(123) Representative payee--A person designated by the Social Security Administration to receive and disburse benefits, act in the best interest of the beneficiary, and ensure that benefits will be used according to the beneficiary's needs.

(124) Resident--Any individual residing in a nursing facility.

(125) Resident group--A group or council of residents who meet regularly.

(126) Resident representative--

(A) Any of the following:

(i) an individual chosen by the resident to act on behalf of the resident in order to support the resident in decision-making; access medical, social, or other personal information of the resident; manage financial matters; or receive notifications;

(ii) a person authorized by state or federal law (including agents under power of attorney, representative payees, and other fiduciaries) to act on behalf of the resident in order to support the resident in decision-making; access medical, social, or other personal information of the resident; manage financial matters; or receive notifications;

(iii) legal representative, as used in Section 712 of the Older Americans Act (40 U.S.C. §3058g); or

(iv) the court-appointed guardian of a resident.

(B) This definition is not intended to expand the scope of authority of any resident representative beyond that authority specifically authorized by the resident, state or federal law, or a court of competent jurisdiction.

(127) Responsible party--An individual authorized by the resident to act for him as an official delegate or agent. Responsible party is usually a family member or relative, but may be a legal guardian or other individual. Authorization may be in writing or may be given orally.

(128) Restraint--A chemical or physical restraint.

(129) Restraint hold--

(A) A manual method, except for physical guidance or prompting of brief duration, used to restrict:

(i) free movement or normal functioning of all or a portion of a resident's body; or

(ii) normal access by a resident to a portion of the resident's body.

(B) Physical guidance or prompting of brief duration becomes a restraint if the resident resists the guidance or prompting.

(130) RN--Registered nurse. An individual currently licensed by the Texas Board of Nursing as a registered nurse.

(131) RN assessment coordinator--A registered nurse who signs and certifies a comprehensive assessment of a resident's needs, using the RAI, including the MDS, as specified by HHSC.

(132) RUG--Resource Utilization Group. A categorization method, consisting of 34 categories based on the MDS, that is used to determine a recipient's service and care requirements and to determine the daily rate HHSC pays a nursing facility for services provided to the recipient.

(133) Secretary--Secretary of the U.S. Department of Health and Human Services.

(134) Services required on a regular basis--Services which are provided at fixed or recurring intervals and are needed so frequently that it would be impractical to provide the services in a home or family setting. Services required on a regular basis include continuous or periodic nursing observation, assessment, and intervention in all areas of resident care.

(135) SNF--A skilled nursing facility or distinct part of a facility that participates in the Medicare program. SNF requirements apply when a certified facility is billing Medicare for a resident's per diem rate.

(136) Social Security Administration--Federal agency for administration of social security benefits. Local social security administration offices take applications for Medicare, assist beneficiaries file claims, and provide information about the Medicare program.

(137) Social worker--A qualified social worker is an individual who is licensed, or provisionally licensed, by the Texas State Board of Social Work Examiners as prescribed by the Texas Occupations Code, Chapter 505, and who has at least:

(A) a bachelor's degree in social work; or

(B) similar professional qualifications, which include a minimum educational requirement of a bachelor's degree and one year experience met by supervised employment providing social services in a health care setting.

(138) Standards--The minimum conditions, requirements, and criteria established in this chapter with which an institution must comply to be licensed under this chapter.

(139) State Medicaid claims administrator--The entity under contract with HHSC to process Medicaid claims in Texas.

(140) State Ombudsman--Has the meaning given in §88.2 of this title.

(141) State plan--A formal plan for the medical assistance program, submitted to CMS, in which the State of Texas agrees to administer the program in accordance with the provisions of the State Plan, the requirements of Titles XVIII and XIX, and all applicable federal regulations and other official issuances of the U.S. Department of Health and Human Services.

(142) Stay agreement--An agreement between a license holder and the executive commissioner that sets forth all requirements necessary to lift a stay and rescind a license revocation proposed under §554.2107 of this chapter (relating to Revocation of a License by the HHSC Executive Commissioner).

(143) Substandard quality of care violation--A violation of §554.401(a) or (b); §554.402(b), (c), or (m); §554.406(d) - (h); §554.417(a), (b), or (d); §554.425(b)(1); §554.504(a); §554.601; §554.602; §554.701; §554.703; §554.706(a), (c), (d)(1) - (5), or (e)(7); §554.801; §554.901; §554.904(2) or (4); §554.1501(5), (6), or (7); or §554.1601(e)(2) of this chapter (relating to Resident Rights) that constitutes:

(A) an immediate threat to resident health or safety;

(B) a pattern of or actual harm that is not an immediate threat; or

(144) Supervision--General supervision, unless otherwise identified.

(145) Supervision (direct)--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity within the qualified person's sphere of competence. If the person being supervised does not meet assistant-level qualifications specified in this chapter and in federal regulations, the supervisor must be on the premises and directly supervising.

(146) Supervision (general)--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity within the qualified person's sphere of competence. The person being supervised must have access to the qualified person providing the supervision.

(147) Survey agency--HHSC is the agency that, through contractual agreement with CMS, is responsible for Title XIX (Medicaid) survey and certification of nursing facilities.

(148) Texas Register--A publication of the Texas Register Publications Section of the Office of the Secretary of State that contains emergency, proposed, withdrawn, and adopted rules issued by Texas state agencies.

(149) Therapeutic diet--A diet ordered by a physician as part of treatment for a disease or clinical condition, in order to eliminate, decrease, or increase certain substances in the diet or to provide food which has been altered to make it easier for the resident to eat.

(150) Threatened violation--A situation that, unless immediate steps are taken to correct, may cause injury or harm to a resident's health and safety.

(151) Title II--Federal Old-Age, Survivors, and Disability Insurance Benefits of the Social Security Act (42 U.S.C. §§401 - 434).

(152) Title XVI--Supplemental Security Income (SSI) of the Social Security Act (42 U.S.C. §§1381 - 1385).

(153) Title XVIII--Medicare provisions of the Social Security Act (42 U.S.C. §§1390 - 1395lll).

(154) Title XIX--Medicaid provisions of the Social Security Act (42 U.S.C. §§1396 - 1396w-5).

(155) Total health status--Includes functional status, medical care, nursing care, nutritional status, rehabilitation and restorative potential, activities potential, cognitive status, oral health status, psychosocial status, and sensory and physical impairments.

(156) Universal precautions--The use of barrier precautions and other precautions to prevent the spread of blood-borne diseases.

(157) Unreasonable confinement--Involuntary seclusion.

(158) Vaccine preventable diseases--The diseases included in the most current recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

(159) Vendor payment--Payment made by HHSC on a daily-rate basis for services delivered to recipients in Medicaid-certified nursing facilities. Vendor payment is based on the nursing facility's approved-to-pay claim processed by the state Medicaid claims administrator. The Nursing Facility Billing Statement, subject to adjustments and corrections, is prepared from information submitted by the nursing facility, which is currently on file in the computer system as of the billing date. Vendor payment is made at periodic intervals, but not less than once per month for services rendered during the previous billing cycle.

(160) Widespread--When the problem causing a violation is pervasive in a facility or represents systemic failure that affected or has the potential to affect a large portion or all of a facility's residents.

(161) Willfully interfere--To act or not act to intentionally prevent, interfere with, or impede or to attempt to intentionally prevent, interfere with, or impede.

(162) Working day--Any 24-hour period, Monday through Friday, excluding state and federal holidays.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204428

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER C. NURSING FACILITY LICENSURE APPLICATION PROCESS

26 TAC §554.204

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204429

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER E. RESIDENT RIGHTS

26 TAC §554.403

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

§554.403.Notice of Rights and Services.

(a) The facility must inform the resident, both orally and in writing, in a language that the resident understands, of the resident's rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility. This notification must be made prior to or upon admission and during the resident's stay if changed.

(b) The facility must also inform the resident, upon admission and during the stay, in a language the resident understands, of the following:

(1) facility admission policies;

(2) a description of the protection of personal funds as described in §554.404 of this subchapter (relating to Protection of Resident Funds);

(3) the Texas Human Resources Code, Title 6, Chapter 102; or a written list of the rights and responsibilities contained in the Texas Human Resources Code, Title 6, Chapter 102;

(4) a written description of the services available through the Ombudsman Program. This information must be made available to each facility by the ombudsman program. Facilities are responsible for reproducing this information and making it available to residents, their families, and resident representatives;

(5) a written statement to the resident, the resident's next of kin, or guardian describing the facility's policy for:

(A) the drug testing of employees who have direct contact with residents; and

(B) the criminal history checks of employees and applicants for employment;

(6) HHSC rules and the facility's policies related to the use of restraint and involuntary seclusion. This information must also be given to the resident's legally authorized representative, if the resident has one; and

(7) facility essential caregiver policies and procedures during a public health emergency or disaster, and this information must also be given to the resident’s legally authorized representative, if the resident has one.

(1) provide written information to the resident's family representative, in a language the representative understands, of the right to form a family council; or

(2) inform the resident's family representative, in writing, if a family council exists, of the council's meeting time, date, location and contact person.

(d) Receipt of information in subsections (b) - (d) of this section, and any amendments to it, must be acknowledged in writing by all parties receiving the information.

(e) The facility must post a copy of the documents specified in subsections (a) and (b) of this section in a conspicuous location.

(f) The resident or the resident's legal representative has the following rights:

(1) upon an oral or written request to the facility, to access all records pertaining to the resident, including clinical records, within 24 hours (excluding weekends and holidays); and

(2) to purchase photocopies of all or any portion of the records upon request and two workdays advance notice to the facility.

(g) The resident has the right to be fully informed in language the resident understands of the resident's total health status, including the resident's medical condition.

(h) The resident has the right to refuse treatment, to formulate an advance directive (as specified in §554.419 of this subchapter (relating to Advance Directives), and to refuse to participate in experimental research.

(1) If the resident refuses treatment, the resident must be informed of the possible consequences.

(2) If the resident chooses to participate in experimental research, the resident must be fully notified of the research and possible effects of the research. The research may be carried on only with the full written consent of the resident's physician, and the resident.

(3) Experimental research must comply with Federal Drug Administration regulations on human research as found in 45 CFR, Part 46.

(i) The facility must inform a resident before, or at the time of admission, and periodically during the resident's stay (if there are any changes), of services available in the facility and of charges for those services, including any charges for services not covered under Medicare or by the facility's per diem rate.

(j) The facility must provide a written description of a resident's legal rights, which includes:

(1) a description of the manner of protecting personal funds, described in §554.404 of this subchapter;

(2) a posting of names, addresses, and telephone numbers of all pertinent state client advocacy groups such as HHSC, the Ombudsman Program, the protection and advocacy network, and, in Medicaid-certified facilities, the Medicaid fraud control unit; and

(3) a statement that the resident may file a complaint with HHSC concerning resident abuse, neglect, and misappropriation of resident property in the facility.

(k) The facility must inform a resident of the name, specialty, and way of contacting the physician responsible for the resident's care.

(l) Notification of changes.

(1) A facility must immediately inform the resident; consult with the resident's physician; and notify, consistent with the representative's authority, the resident representative when there is:

(A) an accident involving the resident that results in injury and has the potential for requiring physician intervention;

(B) a significant change in the resident's physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications);

(C) a need to alter treatment significantly (that is, a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); or

(D) a decision to transfer or discharge the resident from the facility.

(2) The facility also must promptly notify the resident and the resident representative, if any, when there is:

(A) a change in room or roommate assignment with the reason for the change provided in writing; or

(B) a change in resident rights under federal or state law or regulations as described in subsection (b) of this section.

(3) The facility must record and periodically update the address and phone number of the resident.

(m) Additional requirements for Medicaid-certified facilities. Medicaid-certified facilities must:

(1) provide the resident with the state-developed notice of rights under §1919(e)(6) of the Social Security Act (42 U.S.C. §1396r(e)(6));

(2) inform a resident who is entitled to Medicaid benefits, in writing, at the time of admission to the nursing facility or, when the resident becomes eligible for Medicaid of:

(A) the items and services that are included in nursing facility services provided under the State Plan and for which the resident may not be charged;

(B) those other items and services that the facility offers and for which the resident may be charged, and the amount of charges for those services;

(3) inform each resident when changes are made to the items and services specified in paragraph (2)(A) and (B) of this subsection;

(4) provide a written description of the requirements and procedures for establishing eligibility for Medicaid, including the right to request an assessment under §1924(c) of the Social Security Act (42 U.S.C. §1396r-5(c)), which:

(A) is used to determine the extent of a couple's nonexempt resources at the time of institutionalization; and

(B) attributes to the community spouse an equitable share of resources that cannot be considered available for payment toward the cost of the institutionalized spouse's medical care in the process of spending down to Medicaid eligibility levels; and

(5) prominently display in the facility written information, and provide to residents and potential residents oral and written information about how to apply for and use Medicare and Medicaid benefits, and how to receive refunds for previous payments covered by such benefits.

(n) Additional requirements for certain facilities related to memory care and Alzheimer’s disease and related disorders. Facilities must provide the following HHSC forms:

(1) for a facility that advertises, markets, or otherwise promotes that it provides memory care services to residents, the Memory Care Disclosure Statement for Nursing Facilities, to each resident, disclosing as required by the Texas Health and Safety Code §242.0405 whether the facility is certified to provide specialized care and treatment for a resident with Alzheimer's disease and related disorders, to:

(A) each resident or resident representative; and

(B) each person seeking information about the facility's care and treatment of residents with Alzheimer's disease or related disorders or dementia; or

(2) for a facility that advertises, markets, or otherwise promotes that it provides services to residents with Alzheimer's disease and related disorders, HHSC Form 3641-A, Alzheimer's Disclosure Statement for Nursing Facilities, disclosing as required by the Texas Health and Safety Code §242.202 whether the facility is certified to provide specialized care and treatment for a resident with Alzheimer's disease and related disorders to:

(A) each resident or resident representative;

(B) each person seeking to become a resident of the facility or that person’s representative; and

(C) a person seeking information about the facility's care and treatment of residents with Alzheimer's disease and related disorders.

(o) Amended disclosure statement. A facility must provide an amended disclosure statement required by subsection (n)(1) and (2) of this section, to a resident, responsible party, or legal guardian at least 30 days before the change in the operation of the facility reflected in the amended disclosure statement is effective.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204430

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER T. ADMINISTRATION

26 TAC §554.1913

STATUTORY AUTHORITY

The repeal is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204432

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

26 TAC §554.1921, §554.1935

STATUTORY AUTHORITY

The amendments are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

§554.1921.General Requirements for a Nursing Facility.

(a) The facility must admit and retain only residents whose needs can be met through service from the facility staff, or in cooperation with community resources or other providers under contract.

(b) Individuals who have met the requirements of Chapter 17 of this title (relating to Preadmission Screening and Resident Review (PASRR) and have mental or physical diseases, or both, that endanger other residents may be admitted or retained if adequate rooms and care are provided to protect the other residents.

(c) The term "hospital" may not be used as part of the name of a nursing facility unless it has been classified and duly licensed as a hospital by the appropriate state agency.

(d) A facility that ceases operation, temporarily or permanently, voluntarily or involuntarily, must provide notice to the residents and residents' relatives or responsible parties of closure. See §554.2310 of this chapter (relating to Nursing Facility Ceases to Participate) for additional notice requirements that apply to a Medicaid or Medicare certified facility.

(1) If the closure is voluntary, within one week after the date on which the decision to close is made, the facility must send written notice to residents' relatives or responsible parties stating that the closure will occur no earlier than 60 days after receipt of the notice.

(2) If the closure is involuntary, the facility must make the notification, whether orally or in writing, immediately on receiving notice of the closure.

(e) Each licensed facility must conspicuously and prominently post the information listed in paragraphs (1) - (13) of this subsection in an area of the facility that is readily available to residents, employees, and visitors. The posting must be in a manner that each item of information is directly visible at a single time. In the case of a licensed section that is part of a larger building or complex, the posting must be in the licensed section or public way leading to it. Any exceptions must be approved by HHSC. The following items must be posted:

(1) the facility license;

(2) a complaint sign provided by HHSC giving the toll-free telephone number;

(3) a notice in a form prescribed by HHSC that inspection and related reports are available at the facility for public inspection;

(4) a concise summary prepared by HHSC of the most recent inspection report;

(5) a notice of HHSC toll-free telephone number 1-800-458-9858 to request summary reports relating to the quality of care, recent investigations, litigation or other aspects of the operation of the facility that are available to the public;

(6) a notice that HHSC can provide information about the nursing facility administrator at (512) 438-2015;

(7) if a facility has been ordered to suspend admissions, a notice of the suspension, which must be posted also on all doors providing public ingress to and egress from the facility;

(8) the statement of resident rights provided in §554.401 of this chapter (relating to Introduction) and any additional facility requirements involving resident rights and responsibilities;

(9) a notice that employees, other staff, residents, volunteers, and family members and guardians of residents are protected from discrimination or retaliation as provided by the Texas Health and Safety Code, §260A.014 and §260A.015; and that the facility has available for public inspection a copy of the Texas Health and Safety Code, Chapter 260A;

(10) a prominent and conspicuous sign for display in a public area of the facility that is readily available to the residents, employees, and visitors and that includes the statement: CASES OF SUSPECTED ABUSE, NEGLECT, OR EXPLOITATION SHALL BE REPORTED TO HHSC BY CALLING 1-800-458-9858;

(11) for a facility that advertises, markets, or otherwise promotes that it provides services to residents with Alzheimer's disease and related disorders, a disclosure statement describing the nature of its care or treatment of residents with Alzheimer's disease and related disorders in accordance with §554.403(n)(2) of this chapter (relating to Notice of Rights and Services);

(12) at each entrance to the facility, a sign that states that a person may not enter the premises with a handgun and that complies with Government Code §411.204; and

(13) daily for each shift, the current number of licensed and unlicensed nursing staff directly responsible for resident care in the facility. In addition, the nursing facility must make the information required to be posted available to the public upon request.

(f) The reports referenced in subsection (e)(3) of this section must be maintained in a well-lighted, accessible location and must include:

(1) a statement of the facility's compliance record that is updated at least bi-monthly and reflects at least one year's compliance record, in a form required by HHSC; and

(2) if a facility has been cited for a violation of residents' rights, a copy of the citation, which must remain in the reports until any regulatory action with respect to the violation is complete and HHSC has determined that the facility is in full compliance with the applicable requirement.

(g) The facility must inform the resident or responsible party or both upon the resident's admission that the inspection reports referenced in subsection (e)(3) of this section are available for review.

(h) A facility must provide the telephone number for reporting cases of suspected abuse, neglect, or exploitation to an immediate family member of a resident of the facility upon the resident's admission to the facility.

(i) A copy of the Texas Health and Safety Code, Chapters 242 and 260A, must be available for public inspection at the facility.

(j) Within 72 hours after admission, the facility must prepare a written inventory of the personal property a resident brings to the facility, such as furnishings, jewelry, televisions, radios, sewing machines, and medical equipment. The facility does not have to inventory the resident's clothing; however, the operating policies and procedures must provide for the management of resident clothing and other personal property to prevent loss or damage. The facility administrator or his or her designee must sign and retain the written inventory and must give a copy to the resident or the resident's responsible party or both. The facility must revise the written inventory to show if property is lost, destroyed, damaged, replaced, or supplemented. Upon discharge of the resident, the facility must document the disposition of personal effects by a dated receipt bearing the signature of the resident or the resident's responsible party or both. See §554.416 of this chapter (relating to Personal Property).

(k) Each facility must comply with the provisions of the Texas Health and Safety Code, Chapter 250 (relating to Nurse Aide Registry and Criminal History Checks of Employees and Applicants for Employment in Certain Facilities Serving the Elderly or Persons with Disabilities).

(l) Before a facility hires an unlicensed employee, the facility must search the employee misconduct registry (EMR) established under §253.007, Texas Health and Safety Code, and the HHSC nurse aide registry (NAR) to determine whether the individual is designated in either registry as unemployable. Both registries can be accessed on the HHSC Internet website.

(m) A facility is prohibited from hiring or continuing to employ a person who is listed in the EMR or NAR as unemployable.

(n) A facility must provide notification about the EMR to an employee in accordance with 40 TAC §93.3 (relating to Employment and Registry Information).

(o) In addition to the initial search of the EMR and NAR, a facility must:

(1) conduct a search of the NAR and EMR to determine if an employee of the facility is listed as unemployable in either registry as follows:

(A) for an employee most recently hired before September 1, 2009, by August 31, 2011, and at least every 12 months thereafter; and

(B) for an employee most recently hired on or after September 1, 2009, at least every twelve months; and

(2) keep a copy of the results of the initial and annual searches of the NAR and EMR in the employee's personnel file.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204436

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER U. INSPECTIONS, SURVEYS, AND VISITS

26 TAC §554.2002M

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204490

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

SUBCHAPTER X. REQUIREMENTS FOR MEDICAID-CERTIFIED FACILITIES

26 TAC §554.2326

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rule-making authority; Texas Health and Safety Code §242.001, which states that the goal of Chapter 242 is to ensure that nursing facilities in Texas deliver the highest possible quality of care and establish the minimum acceptable levels of care for individuals who are living in a nursing facility; and Texas Health and Safety Code §242.037, which requires the Executive Commissioner of HHSC to make and enforce rules prescribing the minimum standards relating to quality of life, quality of care, and resident rights for nursing facility residents.

§554.2326.Medicaid Swing Bed Program for Rural Hospitals.

(a) Program description. HHSC operates the Medicaid Swing Bed Program for rural hospitals located in counties with populations of 100,000 or less. The Medicaid Swing Bed Program is modeled on Medicare's Swing Bed Program. The Medicaid Swing Bed Program permits participating rural hospitals to use their beds interchangeably to furnish both acute hospital care and nursing facility care to Medicaid recipients, when no care beds are available in nursing facilities (NFs) in the area. When a participating rural hospital furnishes NF nursing care to Medicaid recipients, HHSC makes payment to the hospital using the same procedures and the same Resource Utilization Group daily rates that the Texas Health and Human Services Commission authorizes for reimbursing NFs participating in the Texas Medicaid Nursing Home Program.

(b) Application to participate. Rural hospitals apply to HHSC to participate in the Medicaid Swing Bed Program. Each applicant must be located in a county with a population of 100,000 or less and must meet the qualifying requirements of the Medicare Swing Bed Program. Hospitals approved for participation enter into swing bed provider agreements with HHSC.

(1) have a Medicare hospital provider agreement; and

(2) be Medicare-certified as a swing bed hospital in the Medicare Swing Bed Program.

(d) Applicability of Medicare requirements. Each participating rural hospital must satisfy all the requirements of the Medicare Swing Bed Program, except that Medicare's five-weekday transfer requirement and 15 percent payment limitation, as stated in 42 CFR §413.114(d)(2), do not apply for Medicaid reimbursement purposes.

(e) Applicability of NF requirements. From day one of the resident's stay, a rural hospital participating in the Medicaid Swing Bed Program must meet the requirements set forth in §554.2304(c) of this chapter (relating to Contract Requirements); §§554.2601 - 554.2608 and 554.2610 of this chapter (relating to Vendor Payment (Items and Services Included), Additional Charges (Items and Services Excluded from Vendor Payment), Therapeutic Home Visits Away from the Facility, Vendor Payment Information, Effective Date of Vendor Coverage, Supplementation of Vendor Payments, Penalties for Supplementation, Limitations on Provider Charges, and Medicare part A Skilled Nursing Facility Deductible and Coinsurance Payment); and Subchapter Y of this chapter (relating to Medical Necessity Determinations).

(f) Rural hospital (Medicaid swing bed facility) licensure and certification requirements. Pursuant to Texas Health and Safety Code §222.024 concerning the duplication of health care inspections and licensing, a rural hospital participating in the Medicaid Swing Bed Program satisfies licensure and certification requirements referenced in this section when it is currently licensed and certified as a hospital. However, in accordance with Texas Human Resources Code, §32.024, if the rural hospital's swing beds are used for more than one 30-day length of stay per year, per resident the hospital must comply with the full Nursing Facility Requirements.

(g) Rural hospital (Medicaid swing bed facility) administrator. The governing body of a rural hospital participating in the Medicaid Swing Bed Program satisfies the requirement to appoint a qualified full-time nursing facility administrator, found at §554.1902(b) of this chapter (relating to Governing Body), when it appoints a hospital administrator as its official representative and designates the administrator's responsibilities and authority, subject to the following exception. If the swing beds are used for more than one 30-day length of stay per year, per resident, the hospital's governing body must appoint a full-time licensed nursing facility administrator.

(h) Rural hospital (Medicaid swing bed facility) staff development requirements. A rural hospital participating in the Medicaid Swing Bed Program satisfies the staff development requirements found at §554.1929 of this chapter (relating to Staff Development) if the swing beds are used for no more than one 30-day length of stay per year, per resident.

(i) Rural hospital (Medicaid swing bed facility) transfer agreement. A rural hospital participating in the Medicaid Swing Bed Program is not required to have a transfer agreement with another hospital, as required by §554.1915 of this chapter (relating to Transfer Agreement).

(j) Rural hospital geographic region. The phrase "a participating rural hospital's geographic region" refers to an area that includes nursing facilities with which the hospital normally arranges transfers and all other nursing facilities in similar proximity to the hospital. If a hospital has no previous transfer practices on which to base a determination, the phrase "geographic region" refers to an area that includes all nursing facilities within 50 miles of the hospital except for facilities that the hospital demonstrates to be inaccessible to its patients.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204439

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: December 6, 2022

Proposal publication date: August 5, 2022

For further information, please call: (512) 438-3161

CHAPTER 745. LICENSING

The Texas Health and Human Services Commission (HHSC) adopts amendments to §§745.273, 745.275, 745.277, and 745.435 in Title 26, Texas Administrative Code, Chapter 745, Licensing.

Amendments to §745.435 are adopted with changes to the proposed text as published in the July 22, 2022, issue of the Texas Register (47 TexReg 4254). This rule will be republished.

Amendments to §§745.273, 745.275, and 745.277 are adopted without changes to the proposed text, as published in the July 22, 2022, issue of the Texas Register (47 TexReg 4254). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments are necessary to implement sections of statute that were amended by Senate Bill (S.B.) 225, 87th Texas Legislature, Regular Session, 2021.

S.B. 225, SECTIONS 5 and 9, amended Texas Human Resources Code (HRC) §42.048(e) and §42.048(e-3) to (1) delete the requirement that a license or certificate is automatically revoked when certain operations change location (although HRC §42.048 only explicitly applies to licensed operations, this provision also applies to certified operations by way of HRC §42.052(b)); (2) require the operation to inform HHSC Child Care Regulation (CCR) of the new location before moving there; and (3) allow the operation to operate at the new location after CCR approves the location as meeting all relevant requirements.

These changes to HRC §42.048 took effect on September 1, 2021, and apply to the following operation types that may now change location without their license or certification being automatically revoked: (1) school-age programs, regardless of when they operate; (2) before or after-school programs; (3) licensed child-care homes; (4) child-care centers; and (5) general residential operations (GROs). Child-placing agencies (CPAs) were already able to change location without these statutory changes. However, the bill repealed the subsection that explicitly addressed CPAs, so CCR is aligning requirements for CPAs with those for other licensed or certified operation types for consistency.

The amendments are also necessary to implement sections of statute added by S.B. 781, 86th Texas Legislature, Regular Session, 2019. This bill added HRC Chapter 42, Subchapter H, which includes requirements for GROs that provide treatment services to children with emotional disorders. CCR is clarifying in rule that if such an operation fails to comply with any applicable public notice and hearing requirements, CCR may deny the operation an amendment to provide treatment services to children with emotional disorders.

CCR conducted two work group meetings: one on November 15, 2021, which included 32 invited participants with day care experience, and one on November 18, 2021, which included 12 invited participants with residential care experience. The workgroups met to discuss rule changes needed to implement the legislation and provided feedback on the drafted rules.

COMMENTS

The 31-day formal comment period ended August 22, 2022. During this period, HHSC received five comments regarding the proposed rules from four commenters, which included the Texas Alliance of Child and Family Services, a licensed child-care center; one set of parents; and one member of the public. A summary of comments relating to the rules and HHSC CCR's responses follows.

Comment: Regarding the proposed rules in general, one commenter simply stated that SECTIONS 5 and 9 of S.B. 225 are very important and need to be implemented.

Response: HHSC appreciates the support for the rules.

Comment: Regarding the proposed rules in general, one commenter expressed appreciation for HHSC's work in implementing legislation and carrying out federal guidance.

Response: HHSC appreciates the support for the rules.

Comment: Regarding §745.273, one commenter asked for clarification regarding an operation moving to a location "in a different community," as that language may be interpreted in multiple ways. The same commenter also recommended that HHSC consider whether the rule changes are in keeping with the statutory language in HRC §42.0461, which refers to the issuance of a license or expansion of capacity, and HRC §42.255, which allows county commissioners to request a hearing if needed at the time of an operation's license renewal.

Response: HHSC disagrees with the commenter's recommendation to clarify "in a different community." Section 745.275 provides context for when a GRO would need to meet public hearing requirements related to a change in location within a county with a population of less than 300,000. Through its repeated reference to "the governing body of a community," §745.275 implicitly conveys that the GRO would have to meet public hearing requirements related to the new location if the new location is in a part of the county served by a governing body that does not serve the prior location. An obvious example is when the GRO relocates to a different city or town within the county; other examples include a different hospital district, housing authority, or special district. The bottom line is that HRC §42.0461 recognizes that a GRO located in a county with a population of under 300,000 could have a significant effect on the law enforcement, school district, and community resources of that county, and that persons have the right to weigh in on how the presence of a GRO may affect those resources. Allowing the GRO to change location to a part of the county with different resources without requiring the GRO to meet the public hearing requirement in relation to the new location would circumvent the purpose of the public hearing requirement. Accordingly, HHSC also disagrees with the commenter's implication that the rule changes are not in line with statutory language for when a public hearing is required. Regarding the commenter's mentioning of HRC §42.255, HHSC adopted §745.487 (relating to When is a public hearing required for the renewal of license?) in April 2021 to implement the statute and allow HHSC to hold a public hearing regarding the renewal of the license of a GRO that provides treatment services to children with emotional disorders, if requested by the commissioner's court in the county in which the operation is located. Lastly, if HHSC decides at some point to develop more specific criteria for what constitutes a "community," HHSC would seek input from providers, stakeholders, and the public during the rulemaking process.

Comment: Regarding §745.435, one commenter expressed support for the changes, which allow certain child-care operations to relocate without their licenses or certificates being automatically revoked.

Response: HHSC appreciates the support for the rule.

Comment: Regarding §745.435, one commenter expressed support for the changes, but recommended that language be added to ensure an operation's permit number does not change due to relocation.

Response: HHSC appreciates the support for the rule. HHSC agrees with the commenter's recommendation and revised the rule to include language indicating that an operation's amended permit will retain the same "permit number" that is on the original permit.

SUBCHAPTER D. APPLICATION PROCESS

DIVISION 4. PUBLIC NOTICE AND HEARING REQUIREMENTS FOR RESIDENTIAL CHILD-CARE OPERATIONS

26 TAC §§745.273, 745.275, 745.277

STATUTORY AUTHORITY

The amendments are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the GRO and provision of services by the health and human services agencies, and Texas Government Code §531.02011, which transferred the regulatory functions of the Texas Department of Family and Protective Services to HHSC. In addition, HRC §42.042(a) requires HHSC to adopt rules to carry out the requirements of HRC Chapter 42.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204352

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

DIVISION 10. RELOCATION OF OPERATION

26 TAC §745.435

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the GRO and provision of services by the health and human services agencies, and Texas Government Code §531.02011, which transferred the regulatory functions of the Texas Department of Family and Protective Services to HHSC. In addition, HRC §42.042(a) requires HHSC to adopt rules to carry out the requirements of HRC Chapter 42.

§745.435.What must I do if I relocate my operation after I receive my license or certification?

(a) If you are going to relocate your operation permanently to a new location, you must notify us as early as possible before the move and meet the notification requirements in the following table.

Figure: 26 TAC §745.435(a) (.pdf)

(b) If you fail to notify us before you relocate, we may deny you an amendment to your permit that would allow you to operate at the new location.

(c) You must notify us of the address of your new location by completing a form that we provide you. After we inspect your new location, we will amend your permit to reflect the new address if:

(1) The new location complies with the minimum standards; and

(2) You meet the requirements in Division 4 of this subchapter (relating to Public Notice and Hearing Requirements for Residential Child-Care Operations), if applicable.

(d) If we amend your permit to reflect a new address as described in subsection (c) of this section:

(1) The issuance date and permit number that is on your original permit will remain in effect; and

(2) There is no additional fee for your change in location.

(e) For temporary re-location of a residential child-care facility during a declared disaster, see §748.303(e)(3) of this title (relating to When must I report and document a serious incident?) and §749.503(e)(3) of this title (relating to When must I report and document a serious incident?).

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204353

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

CHAPTER 748. MINIMUM STANDARDS FOR GENERAL RESIDENTIAL OPERATIONS

The Texas Health and Human Services Commission (HHSC) adopts amendments to §748.153 and §748.303 in Title 26, Texas Administrative Code, Chapter 748, Minimum Standards for General Residential Operations.

Amendments to §748.153 and §748.303 are adopted without changes to the proposed text, as published in the July 22, 2022, issue of the Texas Register (47 TexReg 4257). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments are necessary to implement sections of statute that were amended by Senate Bill (S.B.) 225 and S.B. 863, 87th Texas Legislature, Regular Session, 2021.

S.B. 863 took effect on May 15, 2021. This bill amended HRC §42.048 by adding subsection (e-4), which allows CCR to comply with a local or state order during a declared disaster (as described in Texas Government Code Chapter 418) by authorizing a licensed or certified residential child-care facility to temporarily (1) move to a new location not on the facility’s license application; or (2) provide care for one or more children at an additional location that is not stated in the facility’s license application.

COMMENTS

The 31-day formal comment period ended August 22, 2022. During this period, HHSC received three comments regarding the proposed rules from two commenters: the Texas Alliance of Child and Family Services, a licensed child-care center, and one member of the public. A summary of comments relating to the rules and HHSC CCR’s responses follows.

Comment: Regarding the proposed rules in general, one commenter simply stated that SECTIONS 5 and 9 of S.B. 225 are very important and need to be implemented.

Response: HHSC appreciates the support for the rules.

Comment: Regarding the proposed rules in general, one commenter expressed appreciation for HHSC’s work in implementing legislation and carrying out federal guidance.

Response: HHSC appreciates the support for the rules.

Comment: Regarding §748.303, one commenter recommended that HHSC more comprehensively review the list of reporting requirements for serious incidents to determine if all the incidents truly need to be reported as soon as they are currently required to be. The commenter mentioned that there are 20 different categories listing various type of incidents that allow for 38 possible deficiencies with the standard’s subsections being weighted from medium-high to high. The commenter expressed concern for the "day-to-day compliance load for the regulated community." In addition, with regard to reporting as soon as possible but no later than 24 hours after relocating or providing care at a location not noted on the operation’s permit, the commenter recommended the reporting time frame be more lenient and that it begin "after the safety of the children...has been assured and the situation has stabilized such that the operation can reasonably be expected to have awareness of the relocation or additional child and the ability to make the report."

Response: HHSC disagrees with the commenter’s recommendations to revise the rule. HHSC recently evaluated the content and time frames for §748.303, during the comprehensive review of Chapter 748, and adopted rule changes resulting from that review took effect in April 2022. The reporting requirements and time frames that HHSC is currently adding to that rule implement HRC §42.048(e-4), which provides that CCR may authorize a residential child-care operation to temporarily relocate or care for any child at a different location so the operation can comply with a declared state of disaster. The time frame stated in the rules for reporting these serious incidents is "as soon as possible, but no later than 24 hours" after the occurrence of the relevant incident. This time frame for notifying CCR and parents is necessary to ensure that parents know the whereabouts of their children during a disaster. Further, this time frame is easily measurable when the date of relocation or provision of care at an alternate location is known. By comparison, the time frame and revisions suggested by the commenter would not provide clarity as to when the operation would have to make a report to CCR and parents; this lack of clarity could delay notifications to CCR and parents and result in inconsistent regulation.

SUBCHAPTER C. ORGANIZATION AND ADMINISTRATION

DIVISION 2. OPERATIONAL RESPONSIBILITIES AND NOTIFICATIONS

26 TAC §748.153

STATUTORY AUTHORITY

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204354

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

SUBCHAPTER D. REPORTS AND RECORD KEEPING

DIVISION 1. REPORTING SERIOUS INCIDENTS AND OTHER OCCURRENCES

26 TAC §748.303

STATUTORY AUTHORITY

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204356

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

CHAPTER 749. MINIMUM STANDARDS FOR CHILD-PLACING AGENCIES

The Texas Health and Human Services Commission (HHSC) adopts amendments to §§749.153, 749.503, and 749.2551 in Title 26, Texas Administrative Code, Chapter 749, Minimum Standards for Child-Placing Agencies.

Amendments to §749.2551 and §749.503 are adopted with changes to the proposed text as published in the July 22, 2022, issue of the Texas Register (47 TexReg 4259). These rules will be republished.

Amendments to §749.153 are adopted without changes to the proposed text, as published in the July 22, 2022, issue of the Texas Register (47 TexReg 4259). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments are necessary to implement sections of statute that were amended by Senate Bill (S.B.) 225 and S.B. 863, 87th Texas Legislature, Regular Session, 2021.

These changes to HRC §42.048 took effect on September 1, 2021, and apply to the following operation types that may now change location without their license or certification being automatically revoked: (1) school-age programs, regardless of when they operate; (2) before or after-school programs; (3) licensed child-care homes; (4) child-care centers; and (5) general residential operations (GROs). Child-placing agencies (CPAs) were already able to change location without to these statutory changes made. However, the bill repealed the subsection that explicitly addressed CPAs, so CCR is aligning requirements for CPAs with those for other licensed or certified operation types for consistency.

S.B. 863 amended HRC §42.048 by adding subsection (e-4), which allows CCR to comply with a local or state order during a declared disaster (as described in Texas Government Code Chapter 418) by authorizing a licensed or certified residential child-care facility to temporarily (1) move to a new location not on the facility's license application; or (2) provide care for one or more children at an additional location that is not stated in the facility's license application.

HRC §42.048(e-4) took effect on May 15, 2021, and applies to GROs and CPAs. The amendments in Chapter 749 address temporary relocation of children in foster homes to be consistent with the bill's requirements for CPAs, which are tasked with overseeing foster homes.

The amendments are also necessary to align foster home capacity requirements related to 42 United States Code (U.S.C.) §671(a), which includes requirements that a state must meet to have a federally approved IV-E plan.

COMMENTS

The 31-day formal comment period ended August 22, 2022. During this period, HHSC received four comments regarding the proposed rules from two commenters: the Texas Alliance of Child and Family Services, a licensed child-care center, and one member of the public. A summary of comments relating to the rules and HHSC CCR's responses follows.

Comment: Regarding the proposed rules in general, one commenter simply stated that SECTIONS 5 and 9 of S.B. 225 are very important and need to be implemented.

Response: HHSC appreciates the support for the rules.

Comment: Regarding the proposed rules in general, one commenter expressed appreciation for HHSC's work in implementing legislation and carrying out federal guidance.

Response: HHSC appreciates the support for the rules.

Comment: Regarding §749.503, one commenter recommended that HHSC more comprehensively review the list of reporting requirements for serious incidents to determine if all the incidents truly need to be reported as soon as they are currently required to be. The commenter mentioned that there are 20 different categories listing various type of incidents that allow for 38 possible deficiencies with the standard's subsections being weighted from medium-high to high. The commenter expressed concern for the "day-to-day compliance load for the regulated community." In addition, with regard to reporting as soon as possible but no later than 24 hours after relocating the CPA office or foster home or providing care at a location not noted on the foster home's verification, the commenter recommended the reporting time frame be more lenient and that it begin "after the safety of the children…has been assured and the situation has stabilized such that the operation can reasonably be expected to have awareness of the relocation or additional child and the ability to make the report."

Response: HHSC disagrees with the commenter's recommendations to revise the rule. HHSC recently evaluated the content and time frames for §749.503, during the comprehensive review of Chapter 749, and adopted rule changes resulting from that review took effect in April 2022. The reporting requirements and time frames that HHSC is currently adding to that rule implement HRC §42.048(e-4), which provides that CCR may authorize a residential child-care operation to temporarily relocate or care for any child at a different location so the operation can comply with a declared state of disaster. The time frame stated in the rules for reporting these serious incidents is "as soon as possible, but no later than 24 hours" after the occurrence of the relevant incident. This time frame for notifying CCR and parents is necessary to ensure that parents know the whereabouts of their children during a disaster. Further, this time frame is easily measurable when the date of relocation or provision of care at an alternate location is known. By comparison, the time frame and revisions suggested by the commenter would not provide clarity as to when the operation would have to make a report to CCR and parents; this lack of clarity could delay notifications to CCR and parents and result in inconsistent regulation.

Comment: Regarding §749.2551, one commenter recommended that HHSC not delete subsection (d) as proposed because the subsection allows a CPA to ask for a capacity exception for a foster home to care for seven or eight children. The commenter also recommended that HHSC consider including the additional exceptions permitted by 42 U.S.C. §672(c)(1)(B), particularly those allowing a parenting youth in care to remain with the parent's child and a family with special training or skills to provide care to a child with a severe disability.

Response: HHSC partially agrees with the commenter's recommendation to reconsider the deletion of subsection (d). Instead of deleting the entire subsection, HHSC will retain the first sentence of subsection (d) in the revised rule with a slight modification to correct the TAC title reference. The second sentence of subsection (d) will remain deleted because the language is superfluous and not integral to meeting the intent of the subsection. In addition, HHSC agrees with the commenter's recommendation to include all exceptions allowed by federal law and revised subsection (b) to allow a parenting youth in care to remain with the child of the parenting youth and to allow a family with special training or skills to provide care to a child with a severe disability. To ensure that HHSC only grants variances that are consistent with additional exceptions permitted by state and federal law, including federal law related to Title IV-E funding requirements, HHSC is adding language to subsection (d) highlighting that HHSC will consider any limitations in state or federal law. A separate rule project may also include a cross reference to this subsection in Chapter 745, Subchapter J (Waivers and Variances for Minimum Standards), to further ensure that Texas will meet Title IV-E funding requirements.

HHSC made a change to correct a reference in paragraph (9) in Figure: 26 TAC §749.503(e).

SUBCHAPTER C. ORGANIZATION AND ADMINISTRATION

DIVISION 2. OPERATIONAL RESPONSIBILITIES AND NOTIFICATIONS

26 TAC §749.153

STATUTORY AUTHORITY

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204357

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

SUBCHAPTER D. REPORTS AND RECORD KEEPING

DIVISION 1. REPORTING SERIOUS INCIDENTS AND OTHER OCCURRENCES

26 TAC §749.503

STATUTORY AUTHORITY

§749.503.When must I report and document a serious incident?

(a) You must report and document the following types of serious incidents involving a child in your care. The reports must be made to the following entities, and the reporting and documenting must be within the specified timeframes:

Figure: 26 TAC §749.503(a) (.pdf)

(b) If there is a medically pertinent incident that does not rise to the level of a serious incident, you do not have to report the incident but you must document the incident in the same manner as for a serious incident, as described in §749.511 of this division (relating to How must I document a serious incident?).

(c) If a child returns before the required reporting timeframe outlined in subsection (a)(8) - (10) of this section, you are not required to report the absence as a serious incident. Instead, you must document within 24 hours after you become aware of the unauthorized absence in the same manner as for a serious incident, as described in §749.511 of this division.

(d) If there is a serious incident involving an adult resident, you do not have to report the incident to Licensing, but you must document the incident in the same manner as a serious incident. You do have to report the incident to:

(1) Law enforcement, if there is a fatality;

(2) The parent, if the adult resident is not capable of making decisions about the resident's own care; and

(3) Adult Protective Services through the Texas Abuse and Neglect Hotline if there is reason to believe the adult resident has been abused, neglected or exploited.

(e) You must report and document the following types of serious incidents involving your agency, one of your foster homes, an employee, professional level service provider, contract staff, or a volunteer to the following entities within the specified timeframe:

Figure: 26 TAC §749.503(e) (.pdf)

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204358

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

SUBCHAPTER M. FOSTER HOMES: SCREENINGS AND VERIFICATIONS

DIVISION 5. CAPACITY AND CHILD/CAREGIVER RATIO

26 TAC §749.2551

STATUTORY AUTHORITY

§749.2551.What is the maximum number of children a foster family home may care for?

(a) A one-parent foster family home with one additional full-time, live-in caregiver or a two-parent foster family home may care for up to six children, except as noted in the chart below:

Figure: 26 TAC §749.2551(a) (.pdf)

(b) A one-parent foster family home with one additional full-time, live-in caregiver or a two-parent foster family home may care for seven or eight children if all of the following criteria are met:

(1) Each foster or adoptive child that you place in the home that expands the home's capacity to more than six children is placed in the home for the purpose of allowing:

(A) Siblings to remain together;

(B) A child with an established meaningful relationship with the foster family (including a relative or close family friend) to remain with the family;

(D) A family with special training or skills to provide care to a child who has a severe disability;

(2) The foster family home cares for a maximum of two infants and two more children less than six years old, unless the placement is necessary to maintain a sibling group of children;

(3) The foster family home cares for a maximum of three children with primary medical needs requiring total care, unless the placement is necessary to maintain a sibling group of children;

(4) You complete a Foster Family Home Capacity Exception Form with the appropriate signatures and place the form in the foster family home record; and

(5) After you complete the exception form, you lower the home's capacity each time a child listed on the form leaves the home until the home's capacity does not exceed six. This applies to both a foster child that leaves and a child who was placed in the home to be adopted leaves without the adoption being consummated.

(c) A one-parent foster family home or two-parent foster family home with one foster parent absent for extended periods of time (such as military service or out-of-town job assignments) may care for up to six children, except as noted in the chart below:

Figure: 26 TAC §749.2551(c) (.pdf)

(d) Notwithstanding subsections (a), (b), and (c) of this section, a child-placing agency may request an exception for a foster family home to care for seven or eight children by using the process for requesting a variance that is in 26 TAC Chapter 745, Subchapter J of this title (relating to Waivers and Variances for Minimum Standards) and meeting the requirements of that subchapter. When processing a request for a variance related to a foster home's capacity, we will consider any limitations in state or federal law.

(e) The maximum number of children that a foster family home may care for includes any biological and adopted children of the caregivers who live in the foster home, any children receiving foster or respite child-care, and any children for whom the family provides day care. All adults in care must also be counted in the capacity of the home as required by §749.2651(b) of this chapter (relating to May a foster home accept adults into the home for care?).

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 3, 2022.

TRD-202204359

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 23, 2022

Proposal publication date: July 22, 2022

For further information, please call: (512) 438-3269

CHAPTER 925. RESEARCH INVOLVING HEALTH AND HUMAN SERVICES COMMISSION SERVICES

26 TAC §§925.1 - 925.11

The Texas Health and Human Services Commission (HHSC) adopts in Texas Administrative Code (TAC) Title 1, Part 1, new Chapter 925, concerning Research Involving Health and Human Services Commission Services, consisting of §925.1, concerning Purpose; §925.2, concerning Application; §925.3, concerning Definitions; §925.4, concerning General Principles; §925.5, concerning Designated Institutional Review Board; §925.6, concerning Designated Institutional Review Board Functions and Operations; §925.7, concerning Review and Approval of Proposed Research; §925.8, concerning Informed Consent; §925.9, concerning Using and Disclosing Protected Health Information in Research; §925.10, concerning Investigation of Allegations of Misconduct in Science; and §925.11, concerning Responsibilities of the Institutional Review Board 2.

Sections 925.3, 925.6, 925.7, and 925.8 are adopted with changes to the proposed text as published in the July 8, 2022, issue of the Texas Register (47 TexReg 3917). These rules will be republished.

Sections 925.1, 925.2, 925.4, 925.5, 925.9, 925.10, and 925.11 are adopted without changes to the proposed text as published in the July 8, 2022, issue of the Texas Register (47 TexReg 3917). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the new rules is to move HHSC rules in 25 TAC Chapter 414, Subchapter P and 40 TAC Chapter 4, Subchapter P to 26 TAC Chapter 925 as part of consolidating HHSC rules. The adopted rules have up-to-date agency information, research protocols, population language, and includes plain language where possible. The adoption of repealed 25 TAC Chapter 414, Subchapter P, concerning Research in TDMHMR Facilities, and repealed 40 TAC Chapter 4, Subchapter P, concerning Research in State Facilities, are published simultaneously elsewhere in this issue of the Texas Register.

The adopted rules describe the components and use of an institutional review board for the review of research requests and activities pertaining to mental health, substance use, and intellectual or developmental disabilities services within HHSC, involving one or more of the following: HHSC in-patient or community-based mental health services; HHSC community-based substance use services; HHSC intellectual or developmental disabilities services; data owned or created regarding individuals receiving HHSC services; or related HHSC resources (e.g., employees, property, and non-public information).

COMMENTS

The 31-day comment period ended August 8, 2022.

During this period, HHSC received comments regarding the proposed rules from the Texas Medical Association (TMA). A summary of comments relating to the rules and HHSC's responses follow.

Comment: TMA requested clarification of the research review process when an external institutional review board (IRB) is the designated IRB. TMA recommended edits to the rules regarding which IRB or person has final approval or disapproval and the timing within the review process this decision occurs. Additionally, TMA recommended editing the rules to include the process for and steps following the determination by the IRB2 that an additional review is needed.

Response: HHSC agrees with the comment and added the following language to §925.7(e)(1)(D) for clarity, "Any approval by an external IRB is subject to HHSC policy requirements."

Comment: TMA recommended modifying §925.8(a)(2)(A) to include that the qualified professional determining whether an individual has capacity to consent to a research study is independent of the research study.

Response: HHSC disagrees and declines to revise the rule in response to this comment. A primary function of the IRB, which is an independent board, is to review the appropriateness of an investigator's informed consent process, which includes determining the capacity to consent by individuals who may participate in the research. The Code of Federal Regulations (CFR) Title 45, Section 46.116, governing IRB activities, sets forth requirements on how informed consent must be obtained and does not require the qualified professional to be independent of the research study. Section 925.8 requires an investigator to ensure compliance with 45 CFR §46.116.

Comment: TMA recommended adding language to §925.8(a)(7) to require that the preferred modes of communication for prospective human subjects receiving HHSC intellectual and developmental services are considered for purposes of assessing their capacity to consent or attempting to obtain their consent or assent to participation.

Response: HHSC agrees with the recommendation and modified §925.8(a)(7) to include, "The procedures must take into consideration a prospective human subject's preferred method of communication for consent or objection."

A minor editorial change to §925.3(12) was made to include a section symbol; and a minor editorial change was made to §925.6(a)(1) to correct a reference.

STATUTORY AUTHORITY

The new sections are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §574.154.

§925.3.Definitions.

The following words and terms have the following meanings when used in this chapter.

(1) Authorization--The written permission given by an individual who is participating in a research study or the individual's legally authorized representative to use or disclose certain protected health information related to the research study.

(2) Children--Consistent with 45 Code of Federal Regulations §46.402(a), individuals who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

(3) Code of Federal Regulations (CFR)--The codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government.

(4) Designated institutional review board--The institutional review board whose purpose is to review, approve, and monitor proposed research studies as well as oversee the conduct of approved research, which includes:

(A) an external institutional review board established and operated by a non-Texas Health and Human Services Commission organization with an active Federalwide Assurance (see, 48 C.F.R. Subpart §370.3 Acquisitions Involving Human Subjects) approved by the Office for Human Research Protection (OHRP); and

(B) IRB2.

(5) HHSC--Texas Health and Human Services Commission.

(6) HHSC services--Services provided by HHSC or an HHSC-contracted provider. For purposes of this chapter, HHSC services are:

(A) services delivered in state psychiatric hospitals;

(B) services delivered in state supported living centers;

(D) intellectual or developmental disabilities services;

(E) substance use prevention, intervention, and treatment services; and

(F) services delivered by other HHSC-contracted behavioral health providers required to submit data and information to HHSC.

(7) HHSC services authorized person--A person with the authority to allow research at the proposed research site where HHSC services are delivered (i.e., superintendent, director, or chief executive officer).

(8) Human subject--Consistent with 45 CFR §46.102(e)(1), a living individual about whom an investigator (whether professional or student) conducting research:

(A) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(B) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(9) Individual--A person who previously received, or is currently receiving, HHSC services.

(10) Informed consent--The knowing approval by an individual or an individual's legally authorized representative to participate in a research study, given under the individual's or legally authorized representative's decision without undue influence or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

(11) Institutional review board (IRB)--A board that reviews and approves proposed research, as well as oversees the conduct of approved research.

(12) Intellectual or developmental disability (IDD)--Intellectual disability consistent with Texas Health and Safety Code §591.003 or a disability that meets the criteria described in the definition of "persons with related conditions" in 42 CFR §435.1010.

(13) Investigational medication or device--Any drug, biological product, or medical device under investigation for human use that is not currently approved by the U.S. Food and Drug Administration for the indication being studied.

(14) Investigator--A principal investigator, a co-investigator, or a person who has direct and ongoing contact with human subjects participating in a research study or with prospective human subjects.

(15) IRB2--The Mental Health, Substance Use and Intellectual or Developmental Disabilities Institutional Review Board, which is established and operated by the Texas State Hospital Central Administration.

(16) Legally authorized representative (LAR)--Consistent with 45 CFR §46.102(i), an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure or procedures involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject's participation in the procedure or procedures involved in the research.

(17) Limited data set--Consistent with 45 CFR §164.514(e), protected health information of an individual or of relatives, employers, or household members of an individual that excludes the following direct identifiers:

(A) names;

(B) postal address information, other than town or city, state, and zip code;

(D) fax numbers;

(E) electronic mail addresses;

(F) social security numbers;

(G) medical record numbers;

(H) health plan beneficiary numbers;

(I) account numbers;

(J) certificate or license numbers;

(K) vehicle identifiers and serial numbers;

(L) device identifiers and serial numbers;

(M) Web universal resource locators (URLs);

(N) Internet protocol (IP) address numbers;

(O) biometric identifiers, including finger and voice prints; and

(P) full face photographic images and comparable images.

(18) Minimal risk--The probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

(19) Misconduct in science--The fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

(20) Notice of privacy practices--A written noticedescribing:

(A) the uses and disclosures of protected health information that may be made; and

(B) the individual's rights and the legal duties of the HHSC service with respect to protected health information.

(21) Office for Human Research Protection (OHRP)--The office that provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.

(22) Principal investigator--The investigator identified as responsible for conducting a research study.

(23) Privacy coordinator--An HHSC staff member who is responsible for working with the Texas Health and Human Services Privacy Division to implement the policies and procedures relating to state and federal privacy laws.

(24) Protected health information (PHI)--

(A) Any information that identifies or could be used to identify an individual, whether oral or recorded in any form, that relates to:

(i) the past, present, or future physical or mental health or condition of the individual;

(ii) the provision of health care to the individual; or

(iii) the payment for the provision of health care to the individual.

(B) The term includes:

(i) an individual's name, address, date of birth, or Social Security number;

(ii) an individual's medical record or case number;

(iii) a photograph or recording of an individual;

(iv) statements made by an individual, either orally or in writing, while seeking or receiving HHSC services;

(v) any acknowledgment that an individual is seeking or receiving or has sought or received HHSC services;

(vi) direct identifiers of relatives, employers, or household members of the individual; and

(vii) any information by which the identity of an individual can be determined either directly or by reference to other publicly available information.

(i) health information that has been de-identified in accordance with 45 CFR §164.514(b); and

(ii) employment records.

(25) Research--Consistent with 45 CFR §46.102(l), a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this chapter, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this chapter, the following activities are not deemed as research.

(A) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(B) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters).

(C) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(D) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

(26) Rights officer--A person who oversees the research site to protect and advocate for the rights of individuals receiving HHSC services.

(27) State Hospital Central Administration--The HHSC office that is responsible for the management and oversight of the state hospital system.

(28) Texas Health and Human Services Commission Privacy Division--The HHSC workforce responsible for creating and maintaining privacy policies and procedures and investigating potential unauthorized disclosures of protected health information, personally identifiable information, and sensitive personal information. The Privacy Division is responsible for declaring whether an incident is a breach of information and notifying or recommending notification to affected individuals. The Privacy Division acts as a resource and subject matter experts to HHSC.

§925.6.Designated Institutional Review Board Functions and Operations.

(a) Each designated institutional review board (IRB) shall:

(1) follow its written policies and procedures as described in §925.5(f) of this chapter (relating to Designated Institutional Review Board);

(2) function in accordance with 45 Code of Federal Regulations (CFR) §46.108;

(3) ensure proposed research is reviewed and approved in accordance with §925.7 of this chapter (relating to Review and Approval of Proposed Research);

(4) exercise appropriate oversight to ensure:

(A) its policies and procedures designed for protecting the rights, privacy, and welfare of human subjects are being applied; and

(B) research is being conducted in accordance with the approved protocol;

(5) maintain records of its operations in accordance with 45 CFR §46.115;

(6) maintain documentation of its continuing review of all approved and active research protocols; and

(7) maintain documentation of any unanticipated serious problems or events involving risks to the human subjects or others.

(b) Each designated IRB will suspend or terminate research that is not being conducted in accordance with the IRB's requirements or that has been associated with significant unexpected harm to human subjects. If an IRB suspends or terminates research, the IRB must promptly notify the following in writing of the suspension or termination and include a statement of the reasons for the IRB's action:

(1) the principal investigator;

(2) the appropriate HHSC services authorized person; and

(3) the IRB2.

(c) When IRB2 is not the designated IRB for a research protocol, a reliance agreement will be signed by the IRB2 chair outlining all oversight responsibilities and obligations in order to ensure the protection of human subjects.

§925.7.Review and Approval of Proposed Research.

(a) Proposed research must be submitted to the designated institutional review board (IRB) and contain written information for the IRB to determine whether the requirements described in 45 Code of Federal Regulations (CFR) §46.111 are satisfied.

(b) Each designated IRB shall review all proposed research in accordance with 45 CFR §46.109.

(c) Each designated IRB has the authority to approve, require modifications to, or disapprove any proposed research. Approval of proposed research shall be based on:

(1) consideration of the information described in 45 CFR §46.111;

(2) the designated IRB's verification that the requirements in 45 CFR §46.111, §925.4 of this chapter (relating to General Principles), and §925.8 of this chapter (relating to Informed Consent) are met; and

(3) the designated IRB's verification that procedures for obtaining and documenting authorization to use or disclose protected health information (PHI) meet the requirements in 45 CFR §164.508, unless:

(A) the designated IRB approves a waiver or alteration of the authorization requirement as permitted in §925.9(b) of this chapter (relating to Using and Disclosing Protected Health Information in Research); or

(B) the designated IRB determines and documents that:

(i) the data needed for the research is contained in a limited data set and the investigator will comply with the requirements in 45 CFR §164.514(e), including the execution of a data use agreement; or

(ii) the data needed for the research is limited to decedents' PHI and documentation submitted by the investigator meets the requirements in 45 CFR §164.512(i)(1).

(d) The designated IRB may take into consideration deliberations and reviews from another IRB that has approved the protocol for a specific research proposal, but the designated IRB is ultimately responsible for approval of the proposed research.

(e) Research review and documentation process.

(1) External IRB as the designated IRB. The research review and documentation process for research using an external IRB is generally as follows.

(A) The IRB2 screens the research proposal and, if determined appropriate for implementation, the investigator submits the research proposal to the external IRB for review.

(B) The external IRB reviews the research proposal.

(C) The investigator informs the IRB2 of the external IRB's approval or disapproval. The IRB2 informs the Texas Health and Human Services Commission (HHSC) services authorized person of the external IRB's approval or disapproval.

(D) Any approval by an external IRB is subject to HHSC policy requirements.

(2) IRB2 as the designated IRB. The research review and documentation process for research involving HHSC services using the IRB2 is generally as follows.

(A) The principal investigator submits the proposal to the IRB2.

(B) The IRB2 reviews the research proposal.

(C) The IRB2 informs the HHSC services authorized person of the IRB2's approval or disapproval and recommendations, if any.

(D) If the research proposal is approved by the IRB2, the HHSC services authorized person considers the IRB2's recommendations, if any, and either approves or disapproves the research proposal for implementation.

(f) In addition to approval by the designated IRB and HHSC services authorized person, review and approval by the chief medical officer or chief medical director of the state hospitals, state supported living centers, or other entity primarily responsible for the health and safety of the research subjects, as applicable, is required for any research proposal involving:

(1) a placebo as the primary medication therapy;

(2) medication or doses of medication as the primary medication therapy with an unknown effectiveness for the targeted disorder or condition; or

(3) an investigational medication or device.

(g) The review process for proposed research may require additional steps as necessary, (e.g., in the event a proposal is initially rejected).

(h) The HHSC services authorized person is responsible for ensuring that all investigators are qualified to perform any clinical duties assigned to them and are knowledgeable of HHSC's rules governing the care and protection of individuals as described in 25 TAC Chapter 404, Subchapter E (relating to Rights of Persons Receiving Mental Health Services) and 40 TAC Chapter 4, Subchapter C (relating to Rights of Individuals with an Intellectual Disability).

§925.8.Informed Consent.

Requirements for approval of proposed research. Investigators shall ensure:

(1) procedures for obtaining and documenting informed consent meet the requirements in 45 Code of Federal Regulations (CFR) §46.116 and 45 CFR §46.117 and address:

(A) any extension of the subject's length of stay because of participation in the research;

(B) the subject's ability to receive the medication or device after the research has concluded if the research involves an investigational medication or device;

(D) whether the research involves medication or doses of medication which are known to be ineffective for the targeted disorder or condition and the likelihood of assignment to such medication or doses of medication; and

(E) any risk of deterioration in the subject's condition and the potential consequences of such deterioration (e.g., an extension in the length of stay, or the use of interventions, such as restraint, seclusion, or emergency medications);

(2) there are procedures to ensure prospective human subjects are assessed for capacity to consent for research protocols that present greater than minimal risk, and:

(A) provide for a qualified professional to assess prospective human subjects for capacity to consent;

(B) identify and document who will conduct the assessments; and

(3) the requirements in 45 CFR §46.408 are met if children are the proposed human subjects;

(4) there are procedures that:

(A) each prospective human subject or the subject's legally authorized representative (LAR) understands the information provided before obtaining consent to research participation; and

(B) if consent is obtained from the subject's LAR, attempts are made, to the extent possible given the prospective subject's capacity, to obtain the human subject's assent to participation. Assent is an affirmative agreement of a prospective human subject to participate in research, which is obtained when the subject does not have the capacity or legal authority to consent;

(5) there are adequate safeguards to minimize the possibility of coercion or undue influence. For example, the possible advantages of the subject's participation in the research may not be so valuable as to impair the subject's ability to weigh the risks of the research against those advantages. Possible advantages within the limited choice environment may include enhancement of general living conditions, medical care, quality of food, or amenities; opportunity for earnings; or a change in commitment status;

(6) there are procedures for ensuring a prospective human subject's objection to enrollment in research or a human subject's objection to continued participation in a research protocol is heeded in all circumstances, regardless of whether the subject or the subject's LAR has given consent. Objection may be conveyed verbally, in writing, behaviorally, or by other indications or means; and

(7) procedures to ensure, throughout the course of the research study, human subjects' comprehension and capacity are assessed and enhanced since informed consent is an ongoing process. The procedures must take into consideration a prospective human subject's preferred method of communication for consent or objection.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on November 7, 2022.

TRD-202204443

Karen Ray

Chief Counsel

Health and Human Services Commission

Effective date: November 27, 2022

Proposal publication date: July 8, 2022

For further information, please call: (512) 438-3049