26 TAC ch. 558

Licensing Standards for Home and Community Support Services Agencies

This chapter establishes minimum licensing standards for Home and Community Support Services Agencies (HCSSAs) in Texas, implementing Texas Health and Safety Code Chapter 142. It requires any person providing home health, hospice, or personal assistance services for pay to obtain an HCSSA license from HHSC for each place of business. The chapter covers purpose and scope, key definitions applicable throughout the chapter, and license fee schedules for parent agencies, branch offices, and alternate delivery sites.

[§558.1 Purpose and Scope]
(a) Purpose.

(1) The purpose of this chapter is to implement Texas Health and Safety Code, Chapter 142, which requires the Texas Health and Human Services Commission (HHSC) to adopt minimum standards that a person must meet in order to be licensed as a home and community support services agency (HCSSA) and also to qualify to provide certified home health services. The requirements serve as a basis for licensure and survey activities.

(2) Except as provided by Texas Health and Safety Code §142.003 (relating to Exemptions from Licensing Requirement), a person, including a health care facility licensed under the Texas Health and Safety Code, may not engage in the business of providing home health, hospice, or personal assistance services (PAS), or represent to the public that the person is a provider of home health, hospice, or PAS for pay without a HCSSA license authorizing the person to perform those services issued by HHSC for each place of business from which home health, hospice, or PAS is directed. A certified HCSSA must have a license to provide certified home health services.

(b) Scope. This chapter establishes the minimum standards for acceptable quality of care. A violation of a minimum standard established by Texas Health and Safety Code Chapter 142, or by a rule adopted under that chapter, is a violation of law. The rules in this chapter are adopted to protect clients of HCSSAs by establishing minimum standards relating to quality of care and quality of life.

(c) Limitations. Requirements established by private or public funding sources such as health maintenance organizations or other private third-party insurance, Medicaid (42 United States Code (USC) Chapter 7, Subchapter XIX), Medicare (42 USC Chapter 7, Subchapter XVIII), or state-sponsored funding programs are separate and apart from the requirements in this chapter for agencies. No matter what funding sources or requirements apply to an agency, the agency must still comply with the applicable provisions in the Statute and this chapter. The agency is responsible for researching availability of any funding source to cover a service provided by the agency.
Source Note: The provisions of this §558.1 adopted to be effective June 1, 1994, 19 TexReg 2915; amended to be effective July 21, 1997, 22 TexReg 6573; amended to be effective March 2, 1998, 23 TexReg 1958; transferred effective September 1, 1999, as published in the August 6, 1999 issue of the Texas Register, 24 TexReg 6099; amended to be effective June 15, 2000, 25 TexReg 5929; amended to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 1, 2006, 31 TexReg 1455; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

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

(1) Accessible and flexible services--Services that are delivered in the least intrusive manner possible and are provided in all settings where individuals live, work, and recreate.

(2) Accreditation organization--The Joint Commission, Community Health Accreditation Partner, Accreditation Commission for Health Care, Inc., or another accrediting entity approved by HHSC that demonstrates it meets or exceeds applicable rule requirements of this chapter. The entity reviews HCSSAs for compliance with standards for accreditation by the organization that apply to a HCSSA's licensed category of service.

(3) Administration of medication--The direct application of any medication by injection, inhalation, ingestion, or any other means to the body of a client. The preparation of medication is part of the administration of medication and is the act or process of making ready a medication for administration, including the calculation of a client's medication dosage; altering the form of the medication by crushing, dissolving, or any other method; reconstitution of an injectable medication; drawing an injectable medication into a syringe; preparing an intravenous admixture; or any other act required to render the medication ready for administration.

(4) Administrative support site--A facility or site where an agency performs administrative and other support functions but does not provide direct home health, hospice, or personal assistance services. This site does not require an agency license.

(5) Administrator--The person who is responsible for implementing and supervising the administrative polices and operations of a home and community support services agency and for administratively supervising the provision of all services to agency clients on a day-to-day basis.

(6) ADS--Alternate delivery site. A facility or site, including a residential unit or an inpatient unit:

(A) that is owned or operated by an agency providing hospice services;

(B) that is not the hospice's parent agency;

(C) that is located in the geographical area served by the hospice; and

(D) from which the hospice provides hospice services.

(7) Advanced practice nurse--An advanced practice registered nurse.

(8) Advanced practice registered nurse--A person licensed by the Texas Board of Nursing as an advanced practice registered nurse. The term is synonymous with "advanced practice nurse."

(9) Advisory committee--A committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup, established for the purpose of obtaining advice or recommendations on issues or policies that are within the scope of a person's responsibility.

(10) Affiliate--With respect to an applicant or license holder that is:

(A) a corporation--means each officer, director, and stockholder with direct ownership of at least 5.0 percent, subsidiary, and parent company;

(B) a limited liability company--means each officer, member, and parent company;

(C) an individual--means:

(i) the individual's spouse;

(ii) each partnership and each partner thereof of which the individual or any affiliate of the individual is a partner; and

(iii) each corporation in which the individual is an officer, director, or stockholder with a direct ownership or disclosable interest of at least 5.0 percent.

(D) a partnership--means each partner and any parent company; and

(E) a group of co-owners under any other business arrangement--means each officer, director, or the equivalent under the specific business arrangement and each parent company.

(11) Agency-- A HCSSA.

(12) Applicant--The owner of an agency that is applying for a license under the Statute. This is the person in whose name the license will be issued.

(13) Assistance with self-administration of medication--Any needed ancillary aid provided to a client in the client's self-administered medication or treatment regimen, such as reminding a client to take a medication at the prescribed time, opening and closing a medication container, pouring a predetermined quantity of liquid to be ingested, returning a medication to the proper storage area, and assisting in reordering medications from a pharmacy. Such ancillary aid includes administration of any medication when the client has the cognitive ability to direct the administration of their medication and would self-administer if not for a functional limitation.

(14) Association--A partnership, limited liability company, or other business entity that is not a corporation.

(15) Audiologist--A person who is currently licensed under the Texas Occupations Code, Chapter 401, as an audiologist.

(16) Bereavement--The process by which a survivor of a deceased person mourns and experiences grief.

(17) Bereavement services--Support services offered to a family during bereavement. Services may be provided to persons other than family members, including residents of a skilled nursing facility, nursing facility, or intermediate care facility for individuals with an intellectual disability or related conditions, when appropriate and identified in a bereavement plan of care.

(18) Biologicals--A medicinal preparation made from living organisms and their products, including serums, vaccines, antigens, and antitoxins.

(19) Boarding home facility--An establishment defined in Texas Health and Safety Code §260.001(2).

(20) Branch office--A facility or site in the service area of a parent agency from which home health or personal assistance services are delivered or where active client records are maintained. This does not include inactive records that are stored at an unlicensed site.

(21) Care plan--

(A) a written plan prepared by the appropriate health care professional for a client of the home and community support services agency; or

(B) for home dialysis designation, a written plan developed by the physician, registered nurse, dietitian, and qualified social worker to personalize the care for the client and enable long- and short-term goals to be met.

(22) Case conference--A conference among personnel furnishing services to the client to ensure that their efforts are coordinated effectively and support the objectives outlined in the plan of care or care plan.

(23) Certified agency--A home and community support services agency, or portion of the agency, that:

(A) provides a home health service; and

(B) is certified by an official of the U.S. Department of Health and Human Services as in compliance with Medicare conditions of participation in 42 USC Chapter 7, Subchapter XVIII.

(24) Certified home health services--Home health services that are provided by a certified agency.

(25) CFR--Code of Federal Regulations. The regulations and rules promulgated by agencies of the Federal government that address a broad range of subjects, including hospice care and home health services.

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

(27) Chief financial officer--An individual who is responsible for supervising and managing all financial activities for a home and community support services agency.

(28) Client--An individual receiving home health, hospice, or personal assistance services from a licensed home and community support services agency. This term includes each member of the primary client's family if the member is receiving ongoing services. This term does not include the spouse, significant other, or other family member living with the client who receives a one-time service (for example, vaccination) if the spouse, significant other, or other family member receives the service in connection with the care of a client.

(29) Clinical note--A dated and signed written notation by agency personnel of a contact with a client containing a description of signs and symptoms; treatment and medication given; the client's reaction; other health services provided; and any changes in physical and emotional condition.

(30) CMS--Centers for Medicare & Medicaid Services. The federal agency that administers the Medicare program and works in partnership with the states to administer Medicaid.

(31) Complaint--An allegation against an agency regulated by HHSC or against an employee of an agency regulated by HHSC that involves a violation of this chapter or the Statute.

(32) Community disaster resources--A local, statewide, or nationwide emergency system that provides information and resources during a disaster, including weather information, transportation, evacuation, and shelter information, disaster assistance and recovery efforts, evacuee and disaster victim resources, and resources for locating evacuated friends and relatives.

(33) Controlled substance--Has the meaning assigned in Texas Health and Safety Code Chapter 481, Subchapter A.

(34) 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 an agency or other person.

(A) A controlling person includes:

(i) a management company or other business entity that operates or contracts with others for the operation of an agency;

(ii) a person who is a controlling person of a management company or other business entity that operates an agency or that contracts with another person for the operation of an agency; and

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

(B) A controlling person, as described by subparagraph (A)(iii) of this paragraph, does not include an employee, lender, secured creditor, or other person who does not exercise formal or actual influence or control over the operation of an agency.

(35) Conviction--An adjudication of guilt based on a finding of guilt, a plea of guilty, or a plea of nolo contendere.

(36) Counselor--An individual qualified under Medicare standards to provide counseling services, including bereavement, dietary, spiritual, and other counseling services to both the client and the family.

(37) Day--Any reference to a day means a calendar day, unless otherwise specified in the text. A calendar day includes weekends and holidays.

(38) Deficiency--A finding of noncompliance with federal requirements resulting from a survey.

(39) Designated survey office--An HHSC HCSSA Program office located in an agency's geographic region.

(40) Dialysis treatment record--For home dialysis designation, a dated and signed written notation by the person providing dialysis treatment, which contains a description of signs and symptoms, machine parameters and pressure settings, type of dialyzer and dialysate, actual pre- and post-treatment weight, medications administered as part of the treatment, and the client's response to treatment.

(41) Dietitian--A person who is currently licensed under the laws of the State of Texas to use the title of licensed dietitian or provisional licensed dietitian, or who is a registered dietitian.

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

(43) Disaster--The occurrence or imminent threat of widespread or severe damage, injury, or loss of life or property resulting from a natural or man-made cause, such as fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, epidemic, air contamination, infestation, explosion, riot, hostile military or paramilitary action, or energy emergency. In a hospice inpatient unit, a disaster also includes failure of the heating or cooling system, power outage, explosion, and bomb threat.

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

(45) ESRD--End stage renal disease. For home dialysis designation, the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life.

(46) Functional need--Needs of the individual that require services without regard to diagnosis or label.

(47) Habilitation--Habilitation services, as defined by Texas Government Code §534.001, provided by an agency licensed under this chapter.

(48) HCSSA--Home and community support services agency. A person who provides home health, hospice, or personal assistance services for pay or other consideration in a client's residence, an independent living environment, or another appropriate location.

(49) Health assessment--A determination of a client's physical and mental status through inventory of systems.

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

(51) Home health aide--An individual working for an agency who meets at least one of the requirements for home health aides as described in §558.701 of this chapter (relating to Home Health Aides).

(52) Home health medication aide--An unlicensed person issued a permit by HHSC to administer medication to a client under Texas Health and Safety Code Chapter 142, Subchapter B.

(53) Home health service--The provision of one or more of the following health services required by an individual in a residence or independent living environment:

(A) nursing, including blood pressure monitoring and diabetes treatment;

(B) physical, occupational, speech, or respiratory therapy;

(C) medical social service;

(D) intravenous therapy;

(E) dialysis;

(F) service provided by unlicensed personnel under the delegation or supervision of a licensed health professional;

(G) the furnishing of medical equipment and supplies, excluding drugs and medicines; or

(H) nutritional counseling.

(54) Hospice--A person licensed under this chapter to provide hospice services, including a person who owns or operates a residential unit or an inpatient unit.

(55) Hospice aide--A person working for an agency licensed to provide hospice services who meets the qualifications for a hospice aide as described in §558.843 of this chapter (relating to Hospice Aide Qualifications).

(56) Hospice homemaker--A person working for an agency licensed to provide hospice services who meets the qualifications described in §558.845 of this chapter (relating to Hospice Homemaker Qualifications).

(57) Hospice services--Services, including services provided by unlicensed personnel under the delegation of a registered nurse or physical therapist, provided to a client or a client's family as part of a coordinated program consistent with the standards and rules adopted under this chapter. These services include physical care and support services to optimize quality of life for terminally ill clients and their families that:

(A) are available 24 hours a day, seven days a week, during the last stages of illness, death, and bereavement;

(B) are provided by a medically directed interdisciplinary team; and

(C) may be provided in a home, nursing facility, residential unit, inpatient unit, or other residence according to need. These services do not include inpatient care normally provided in a licensed hospital to a terminally ill person who has not elected to be a hospice client.

(58) IDR--Informal dispute resolution. An informal process that allows an agency to refute a violation or condition-level deficiency cited during a survey.

(59) Independent living environment--A client's residence, which may include a group home, foster home, or boarding home facility, or other settings where a client participates in activities, including school, work, or church.

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

(61) Individual and family choice and control--Individuals and families who express preferences and make choices about how their support service needs are met.

(62) Individualized service plan--A written plan prepared by the appropriate health care personnel for a client of a home and community support services agency licensed to provide personal assistance services.

(63) Inpatient unit--A facility, also referred to as a hospice freestanding inpatient facility, that provides a continuum of medical or nursing care and other hospice services to clients admitted into the unit and that is in compliance with:

(A) the Medicare conditions of participation for inpatient units adopted under 42 USC Chapter 7, Subchapter XVIII; and

(B) standards adopted under this chapter.

(64) Joint training--Training provided by HHSC at least semi-annually for home and community support services agencies and HHSC surveyors on subjects that address the 10 most commonly cited violations of federal or state law by home and community support services agencies as published in HHSC annual reports.

(65) LAR--Legally authorized representative. A person authorized by law to act on behalf of a client regarding a matter described in this chapter, and may include a parent of a minor, guardian of an adult or minor, managing conservator of a minor, agent under a medical power of attorney, or surrogate decision-maker under Texas Health and Safety Code §313.004.

(66) License holder--A person that holds a license to operate an agency.

(67) Life Safety Code (also referred to as NFPA 101)--The Code for Safety to Life from Fire in Buildings and Structures, Standard 101, of the National Fire Protection Association (NFPA).

(68) Local emergency management agencies--The local emergency management coordinator, fire, police, and emergency medical services.

(69) Local emergency management coordinator--The person identified as the emergency management coordinator by the mayor or county judge in an agency's service area.

(70) LVN--Licensed vocational nurse. A person who is currently licensed under Texas Occupations Code Chapter 301, as a licensed vocational nurse.

(71) Manager--An employee or independent contractor responsible for providing management services to a home and community support services agency for the overall operation of a home and community support services agency including administration, staffing, or delivery of services. Examples of contracts for services that will not be considered contracts for management services include contracts solely for maintenance, laundry, or food services.

(72) Medication administration record--A record used to document the administration of a client's medications.

(73) Medication list--A list that includes all prescription and over-the-counter medication that a client is currently taking, including the dosage, the frequency, and the method of administration.

(74) Mitigation--An action taken to eliminate or reduce the probability of a disaster or reduce a disaster's severity or consequences.

(75) Multiple location--A Medicare-approved ADS that meets the definition in 42 CFR §418.3.

(76) Notarized copy--A sworn affidavit stating that attached copies are true and correct copies of the original documents.

(77) Nursing facility--An institution licensed as a nursing home under Texas Health and Safety Code, Chapter 242.

(78) Nutritional counseling--Advising and assisting individuals or families on appropriate nutritional intake by integrating information from the nutrition assessment with information on food and other sources of nutrients and meal preparation consistent with cultural background and socioeconomic status, with the goal being health promotion, disease prevention, and nutrition education. Nutritional counseling may include the following:

(A) dialogue with the client to discuss current eating habits, exercise habits, food budget, and problems with food preparation;

(B) discussion of dietary needs to help the client understand why certain foods should be included or excluded from the client's diet and to help with adjustment to the new or revised or existing diet plan;

(C) a personalized written diet plan as ordered by the client's physician or practitioner, to include instructions for implementation;

(D) providing the client with motivation to help the client understand and appreciate the importance of the diet plan in getting and staying healthy; or

(E) working with the client or the client's family members by recommending ideas for meal planning, food budget planning, and appropriate food gifts.

(79) Occupational therapist--A person who is currently licensed under the Texas Occupations Code Chapter 454, as an occupational therapist.

(80) Online portal--A secure portal provided on the HHSC website for licensure activities, including for a HCSSA applicant to submit licensure applications and information.

(81) Operating hours--The days of the week and the hours of day an agency's place of business is open as identified in an agency's written policy as required by §558.210 of this chapter (relating to Agency Operating Hours).

(82) Original active client record--A record composed first-hand for a client currently receiving services.

(83) Palliative--Ameliorating the symptoms associated with serious illness without the primary goal of curing an underlying condition.

(84) Parent agency--An agency's principal place of business; the location where an agency develops and maintains administrative controls and provides supervision of branch offices and ADSs.

(85) Parent company--A person, other than an individual, who has a direct 100 percent ownership interest in the owner of an agency.

(86) Person--An individual, corporation, or association.

(87) Personal assistance services--Routine ongoing care or services required by an individual in a residence or independent living environment that enable the individual to engage in the activities of daily living or to perform the physical functions required for independent living, including respite services. The term includes:

(A) personal care;

(B) health-related services performed under circumstances that are defined as not constituting the practice of professional nursing by the Texas Board of Nursing; and

(C) health-related tasks provided by unlicensed personnel under the delegation of a registered nurse or that a registered nurse determines do not require delegation.

(88) Personal care--The provision of one or more of the following services required by an individual in a residence or independent living environment:

(A) bathing;

(B) dressing;

(C) grooming;

(D) feeding;

(E) exercising;

(F) toileting;

(G) positioning;

(H) assisting with self-administered medications;

(I) routine hair and skin care; and

(J) transfer or ambulation.

(89) Pharmacist--A person who is licensed to practice pharmacy under Texas Occupations Code Chapter 558.

(90) Pharmacy--A facility defined in Texas Occupations Code §551.003(31), at which a prescription drug or medication order is received, processed, or dispensed, and which holds a pharmacy license issued under Texas Occupations Code Title 3, Subtitle J.

(91) Physical therapist--A person who is currently licensed under Texas Occupations Code Chapter 453, as a physical therapist.

(92) Physician--This term includes a person who is:

(A) licensed in Texas to practice medicine or osteopathy in accordance with Texas Occupations Code Chapter 155;

(B) licensed in Arkansas, Louisiana, New Mexico, or Oklahoma to practice medicine, who is the treating physician of a client and orders home health or hospice services for the client, in accordance with Texas Occupations Code §151.056(b)(4); or

(C) a commissioned or contract physician or surgeon who serves in the United States uniformed services or Public Health Service, if the person is not engaged in private practice, in accordance with the Texas Occupations Code §151.052(a)(8).

(93) Physician assistant--A person who is licensed under Texas Occupations Code Chapter 204, as a physician assistant.

(94) Physician-delegated task--A task performed in accordance with Texas Occupations Code Chapter 157, including orders signed by a physician that specify the delegated task, individual to whom the task is delegated, and client's name.

(95) Place of business--An office of a home and community support services agency that maintains client records or directs home health, hospice, or personal assistance services. This term includes a parent agency, a branch office, and an ADS. The term does not include an administrative support site.

(96) Plan of care--The written orders of a practitioner for a client who requires skilled services.

(97) Practitioner--A person who is currently licensed in a state in which the person practices as a physician, dentist, podiatrist, or a physician assistant, or a person who is an RN registered with the Texas Board of Nursing as an advanced practice nurse.

(98) Preparedness--Actions taken in anticipation of a disaster.

(99) Presurvey training--A computer-based training provided by HHSC for the applicant or the applicant's representatives to review licensure standards and survey documents, and to provide information regarding the survey process.

(100) Progress note--A dated and signed written notation by agency personnel summarizing facts about care and the client's response during a given period of time.

(101) Psychoactive treatment--The provision of a skilled nursing visit to a client with a psychiatric diagnosis under the direction of a physician that includes one or more of the following:

(A) assessment of alterations in mental status or evidence of suicide ideation or tendencies;

(B) teaching coping mechanisms or skills;

(C) counseling activities; or

(D) evaluation of the plan of care.

(102) Recovery--Activities implemented during and after a disaster response designed to return an agency to its normal operations as quickly as possible.

(103) Registered nurse delegation--Delegation by a registered nurse in accordance with:

(A) 22 TAC Chapter 224 (concerning Delegation of Nursing Tasks by Registered Professional Nurses to Unlicensed Personnel for Clients with Acute Conditions or in Acute Care Environments); and

(B) 22 TAC Chapter 225 (relating to RN Delegation to Unlicensed Personnel and Tasks Not Requiring Delegation in Independent Living Environments for Clients with Stable and Predictable Conditions).

(104) Residence--A place where a person resides, including a home, a nursing facility, a convalescent home, or a residential unit.

(105) Residential unit--A facility that provides living quarters and hospice services to clients admitted into the unit and that is in compliance with standards adopted under Texas Health and Safety Code Chapter 142.

(106) Respiratory therapist--A person who is currently licensed under Texas Occupations Code Chapter 604, as a respiratory care practitioner.

(107) Respite services--Support options that are provided temporarily for the purpose of relief for a primary caregiver in providing care to individuals of all ages with disabilities or at risk of abuse or neglect.

(108) Response--Actions taken immediately before an impending disaster or during and after a disaster to address the immediate and short-term effects of the disaster.

(109) Restraint--A restraint is:

(A) a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a client in a hospice inpatient unit to move his or her arms, legs, body, or head freely, but does not include a device, such as an orthopedically prescribed device, a surgical dressing or bandage, a protective helmet, or other method that involves the physical holding of the client for the purpose of:

(i) conducting a routine physical examination or test;

(ii) protecting the client from falling out of bed; or

(iii) permitting the client to participate in activities without the risk of physical harm, not including a physical escort; or

(B) a drug or medication when used as a restriction to manage a client's behavior or restrict the client's freedom of movement in a hospice inpatient unit, but not as a standard treatment or medication dosage for the client's condition.

(110) RN--Registered nurse. A person who is currently licensed under the Nursing Practice Act, Texas Occupations Code Chapter 301, as a registered nurse.

(111) Seclusion--The involuntary confinement of a client alone in a room or an area in a hospice inpatient unit from which the client is physically prevented from leaving.

(112) Section--A reference to a specific rule in this chapter.

(113) Service area--A geographic area established by an agency in which all or some of the agency's services are available.

(114) Skilled services--Services in accordance with a plan of care that require the skills of:

(A) an RN;

(B) an LVN;

(C) a physical therapist;

(D) an occupational therapist;

(E) a respiratory therapist;

(F) a speech-language pathologist;

(G) an audiologist;

(H) a social worker; or

(I) a dietitian.

(115) Social worker--A person who is currently licensed as a social worker under Texas Occupations Code Chapter 505.

(116) Speech-language pathologist--A person who is currently licensed as a speech-language pathologist under Texas Occupations Code Chapter 401.

(117) Statute--Texas Health and Safety Code Chapter 142.

(118) Substantial compliance--A finding in which an agency receives no recommendation for enforcement action after a survey.

(119) Supervised practical training--Hospice aide training that is conducted in a laboratory or other setting in which the trainee demonstrates knowledge while performing tasks on an individual. The training is supervised by an RN or by an LVN who works under the direction of a registered nurse.

(120) Supervising nurse--The person responsible for supervising skilled services provided by an agency and who has the qualifications described in §558.244(c) of this chapter (relating to Administrator Qualifications and Conditions and Supervising Nurse Qualifications). This person may also be known as the director of nursing or similar title.

(121) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

(122) Supportive palliative care--Physician-directed interdisciplinary patient and family-centered care provided to a patient with a serious illness without regard to the patient's age or terminal prognosis that:

(A) may be provided concurrently with methods of treatment or therapies that seek to cure or minimize the effects of the patient's illness; and

(B) seek to optimize the quality of life for a patient with a life-threatening or life-limiting illness and the patient's family through various methods, including methods that seek to:

(i) anticipate, prevent, and treat the patient's total suffering related to the patient's physical, emotional, social, and spiritual condition;

(ii) address the physical, intellectual, emotional, cultural, social, and spiritual needs of the patient; and

(iii) facilitate for the patient, regarding treatment options, education, informed consent, and expression of desires.

(123) Support services--Social, spiritual, and emotional care provided to a client and a client's family by a hospice.

(124) Survey--An on-site inspection or complaint investigation conducted by an HHSC representative to determine if an agency is in compliance with the Statute and this chapter or in compliance with applicable federal requirements or both.

(125) TAC--Texas Administrative Code.

(126) Terminal illness--An illness for which there is a limited prognosis if the illness runs its usual course.

(127) Unlicensed person--A person not licensed as a health care provider. The term includes home health aides, hospice aides, hospice homemakers, medication aides permitted by HHSC, and other unlicensed individuals providing personal care or assistance in health services.

(128) Unsatisfied judgments--A failure to fully carry out the terms or meet the obligation of a court's final disposition on the matters before it in a suit regarding the operation of an agency.

(129) Violation--A finding of noncompliance with this chapter or the Statute resulting from a survey.

(130) Volunteer--An individual who provides assistance to a home and community support services agency without compensation other than reimbursement for actual expenses.

(131) Working day--Any day except Saturday, Sunday, a state holiday, or a federal holiday.
Source Note: The provisions of this §558.2 adopted to be effective June 1, 1994, 19 TexReg 2915; amended to be effective July 21, 1997, 22 TexReg 6573; amended to be effective June 7, 1998, 23 TexReg 5694; transferred effective September 1, 1999, as published in the August 6, 1999 issue of the Texas Register, 24 TexReg 6099; amended to be effective June 15, 2000, 25 TexReg 5929; amended to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 29, 2003, 28 TexReg 4931; amended to be effective October 15, 2003, 28 TexReg 8955; amended to be effective June 1, 2006, 31 TexReg 1455; amended to be effectiveDecember 1, 2006, 31 TexReg 9620; amended to be effective May 1, 2008, 33 TexReg 1136; amended to be effective September 1, 2009, 34 TexReg 5139; amended to be effective July 1, 2012, 37 TexReg 4613; amended to be effective October 1, 2013, 38 TexReg 6628; amended to be effective September 1, 2016, 41 TexReg 6501; amended to be effective October 5, 2016, 41 TexReg 7717; amended to be effective October 11, 2017, 42 TexReg 5514; amended to be effective January 17, 2018, 43 TexReg 238; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.3 License Fees]
(a) The schedule of fees for licensure of an agency authorized to provide one or more services is as follows:

(1) initial (includes change of ownership) license fee--$2,625;

(2) renewal license fee for a three-year license--$2,625;

(3) renewal license fee for a two-year license--$1,750;

(4) initial (includes change of ownership) branch office license fee--$2,625;

(5) renewal branch office license fee for a three-year license--$2,625;

(6) renewal branch office license fee for a two-year license--$1,750;

(7) initial (includes change of ownership) ADS license fee--$1,000;

(8) renewal ADS license fee for a three-year license--$900; and

(9) renewal ADS license fee for a two-year license--$600.

(b) Separate fees for branch office and ADS licenses and renewals are required for each physical address. To renew a branch office or ADS license, the licensee must submit the renewal application and payment in full, of all applicable licensing fees, for each branch office and ADS sought to be renewed, at the same time as the parent agency submission for renewal.

(c) A late fee assessed under Subchapter B of this chapter (relating to Criteria and Eligibility, Application Procedures, and Issuance of a License) is one-half the amount of the required renewal license fee established in subsection (a) of this section. If HHSC assesses a late fee described in this subsection, the applicant must pay the applicable renewal application fee in full plus the late fee described in this section. HHSC may assess a separate late fee for each parent agency, branch office, and ADS renewal application.

(d) If an applicant for an initial license based on a change of ownership submits a late application for a license to HHSC, as described in §558.25 of this chapter (relating to Requirements for Change of Ownership), the applicant must pay the required initial license fee, as set out in subsection (a) of this section, plus a late fee of $250.

(e) HHSC does not review an application until the applicant submits the application and the online portal reflects a status of payment received.

(f) A fee paid to HHSC is not refundable but may be reimbursed under the circumstances and conditions described in §558.31 of this chapter (relating to Time Frames for Processing and Issuing a License).

(g) HHSC accepts payment of required fees made in accordance with options made available through the online portal.
Source Note: The provisions of this §558.3 adopted to be effective June 1, 1994, 19 TexReg 2915; amended to be effective June 7, 1998, 23 TexReg 5694; transferred effective September 1, 1999, as published in the August 6, 1999 issue of the Texas Register, 24 TexReg 6099; amended to be effective June 15, 2000, 25 TexReg 5929; amended to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 1, 2006, 31 TexReg 1455; amended to be effective September 1, 2008, 33 TexReg 1149; amended to be effective January 15, 2009, 34 TexReg 252; amended to be effective July 1, 2012, 37 TexReg 4613; transferred effectiveMay 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.11 Criteria and Eligibility for Licensing]
(a) An applicant for a license must not admit a client or initiate services until the applicant completes the application process and receives an initial license.

(b) A first-time application for a license is an application for an initial license.

(c) An application for a license when there is a change of ownership is an application for an initial license.

(d) A separate license is required for each place of business as defined in §558.2 of this chapter (relating to Definitions).

(e) An agency's place of business must be located in and have an address in Texas. An agency located in another state must receive a license as a parent agency in Texas to operate as an agency in Texas.

(f) An applicant must be at least 18 years of age.

(g) Before issuing a license, HHSC considers the background of:

(1) the applicant;

(2) a controlling person of the applicant;

(3) a person with a disclosable interest;

(4) an affiliate of the applicant; and

(5) the chief financial officer.

(h) Before issuing a license, HHSC considers the background and qualifications of the administrator and alternate administrator in accordance with §558.244 of this chapter (relating Administrator Qualifications and Conditions and Supervising Nurse Qualifications).

(i) HHSC may deny an application for an initial license or for renewal of a license if a person described in subsection (g) or (h) of this section:

(1) on the date of the application:

(A) 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;

(B) has an unsatisfied final judgment in any state or other jurisdiction; or

(C) is delinquent on child support obligations (Texas Family Code Chapter 232);

(2) for two years preceding the date of the application, has a history in any state or other jurisdiction of any of the following:

(A) an unresolved federal or state tax lien;

(B) an eviction involving any property or space used as an inpatient hospice agency; or

(C) an unresolved final Medicare or Medicaid audit exception; or

(3) for 12 months preceding the date of the application, has a history in any state or other jurisdiction of any of the following:

(A) denial, suspension, or revocation of an agency license or a license for a health care facility;

(B) surrendering a license before expiration or allowing a license to expire instead of the licensing authority proceeding with enforcement action;

(C) a Medicaid or Medicare sanction or penalty relating to the operation of an agency or a health care facility;

(D) operating an agency that has been decertified in any state under Medicare or Medicaid; or

(E) debarment, exclusion, or involuntary contract cancellation in any state from Medicare or Medicaid.
Source Note: The provisions of this §558.11 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective December 1, 2006, 31 TexReg 9620; amended to be effective September 1, 2009, 34 TexReg 5139; amended to be effective January 18, 2012, 37 TexReg 127; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.12 General Application]
(a) An applicant must submit an application on the forms prescribed by HHSC through the online portal.

(b) An applicant must complete and furnish all documents and information that HHSC requests in accordance with instructions provided with the application. All uploaded documents an applicant submits must be complete and accurate. If an applicant provides incorrect or false information, or withholds information, on an application, HHSC may:

(1) deny the application; or

(2) assess an administrative penalty, as described in §558.602(e)(5) of this chapter (relating to Administrative Penalties).

(c) When an applicant submits an application through the online portal with full payment of applicable license fees, HHSC reviews the application and supporting documents to determine if it is complete and accurate. A complete and accurate application includes all documents and information that HHSC requests as part of the application process.

(1) HHSC processes the application in accordance with time frames established in §558.31 of this subchapter (relating to Time Frames for Processing and Issuing a License).

(2) If an applicant decides not to continue the application process for a license after submitting the application and license fee, the applicant must submit a written request to HHSC to withdraw the application. HHSC does not refund the license fee.

(d) If an application is not complete and accurate, HHSC provides the applicant with electronic notice through the online portal, that the application is incomplete and specifies the information required to complete the application.

(1) The applicant must submit to HHSC, through the online portal, the additional information requested to complete the application by no later than 30 days after the date of the notice. HHSC sends only one electronic notice through the online portal of the information needed to complete the application.

(2) If an applicant fails to submit the required information to complete the application within 30 days after HHSC provides electronic notice through the online portal, HHSC considers the application incomplete and may deny the application. If HHSC denies the application, HHSC does not refund the license fee.

(3) HHSC, at its discretion, may accept information later than 30 days based on extenuating circumstances. HHSC may assess the late fee authorized in §558.3(c) and set out in §558.3(d) of this chapter (relating to License Fees) for the parent agency and any applicable branch offices or ADSs for failure to comply with paragraph (1) of this subsection.

(e) HHSC may deny issuance of a license for any of the reasons specified in §558.21 of this subchapter (relating to Denial of an Application or a License).
Source Note: The provisions of this §558.12 adopted to be effective April 25, 2021, 46 TexReg 2427.

[§558.13 Obtaining an Initial License]
(a) The following staff must complete the Presurvey Training before submitting an application for a license:

(1) the administrator and alternate administrator; and

(2) the supervising nurse and alternate supervising nurse of an agency that provides licensed home health services with or without home dialysis designation, licensed and certified home health services with or without home dialysis designation, or hospice services.

(b) An applicant may request to be licensed in one or more of the following categories:

(1) licensed and certified home health services;

(2) licensed and certified home health services with home dialysis designation;

(3) licensed home health services;

(4) licensed home health services with home dialysis designation;

(5) hospice services; or

(6) personal assistance services.

(c) HHSC does not require an agency to be licensed in more than one category if the category for which the agency is licensed includes the services the agency provides.

(d) An applicant who has requested the category of licensed and certified home health services on the initial license application must also apply to CMS for certification as a Medicare-certified agency under the 42 United States Code Chapter 7, Subchapter XVIII.

(1) While the applicant is waiting for CMS to certify it as a Medicare-certified agency:

(A) HHSC issues an initial license reflecting the category of licensed home health services if the applicant meets the criteria for the license; and

(B) the applicant must comply with the Medicare conditions of participation for home health agencies in 42 CFR Part 484, as if the applicant were dually certified.

(2) If CMS certifies an agency to participate in the Medicare program during the initial license period, HHSC sends a notice to the agency that the category of licensed and certified home health services has been added to the license. If the agency wants to remove the licensed home health services category from the agency's license after the category of licensed and certified home health services has been added, the agency must submit to HHSC an application through the online portal to remove that category from the agency's license.

(3) If CMS denies certification to an agency or an agency withdraws the application for participation in the Medicare program, the agency may retain the category of licensed home health services on its license.

(e) An applicant for an initial license must comply with §558.30 of this subchapter (relating to Operation of an Inpatient Unit at a Parent Agency) to operate an inpatient unit at the applicant's parent agency.
Source Note: The provisions of this §558.13 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective January 17, 2018, 43 TexReg 238; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.15 Issuance of an Initial License]
(a) HHSC issues an initial license when HHSC determines:

(1) the application, including supporting documents, submitted are complete and accurate;

(2) HHSC has received funds constituting full payment of all applicable license fees, including late fees; and

(3) an applicant meets the criteria for a license as described in §558.11 of this subchapter (relating to Criteria and Eligibility for Licensing) and §558.13 of this subchapter (relating to Obtaining an Initial License).

(b) An initial license is valid for three years from the date of issuance.

(c) HHSC may deny an application to renew an initial license, or revoke or suspend an initial license, if an agency fails to:

(1) meet the requirements for an initial survey as specified in Subchapter E of this chapter (relating to Licensure Surveys); or

(2) maintain compliance with the Statute and this chapter for the services authorized under the license.

(d) HHSC may deny an application for an initial license for any of the reasons specified in §558.21 of this chapter (relating to Denial of an Application or a License).

(e) A license designates an agency's place of business from which services are to be provided and designates an agency's authorized category or categories of service.
Source Note: The provisions of this §558.15 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective September 1, 2008, 33 TexReg 1149; amended to be effective July 1, 2012, 37 TexReg 4613; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.17 Application Procedures for a Renewal License]
(a) To renew its license, an agency must submit a renewal application through the online portal.

(b) An agency must submit its renewal application in accordance with §558.12 of this subchapter (relating to General Application) when submitting a renewal application through the online portal.

(c) For each license period, an agency must provide services to at least one client to be eligible to renew its license.

(d) HHSC does not require an agency to admit a client under each category of service authorized under the license to be eligible to renew its license.

(e) With each renewal application, an agency accredited by an accreditation organization referenced in §558.503 of this chapter (relating to Exemption from Survey) must submit to HHSC through the online portal a copy of the accreditation documentation that the agency receives from the accreditation organization.

(f) At least 120 days before the expiration date of a license, HHSC makes the renewal application and instructions available through the online portal. HHSC notifies the agency with electronic notice that the application and instructions to renew the license are made available through the online portal.

(1) If the renewal application is not made available by HHSC in accordance with this subsection, the agency must, at least 90 days before the expiration date of a license, notify HHSC in writing that it has not received notice of expiration and request that HHSC make a renewal application available.

(2) To avoid a late fee, an agency must submit to HHSC a complete and accurate renewal application, as described in §558.12(c) of this subchapter, with full payment of all required license fees as specified in §558.3 of this chapter (relating to License Fees), no later than the 45th day before the expiration date of the license.

(3) If an agency submits a renewal application after the 45th day before the expiration date of a license, but before the expiration date of the license, HHSC assesses the late fee set out in §558.3(c) of this chapter for failure to comply with paragraph (2) of this subsection.

(g) If an agency submits a renewal application to HHSC after the expiration date of the license, HHSC denies the renewal application and does not refund the renewal license fee. The agency is not eligible to renew the license and must cease operation on the date the license expires. An agency whose license expires must apply for an initial license in accordance with §558.13 of this subchapter (relating to Obtaining an Initial License).

(h) If an agency submits a renewal application before the expiration date of the license in accordance with this subsection, the license does not expire until HHSC has made a final determination on the application.

(1) If an enforcement action is pending at the time the renewal applicant submits a renewal application, the agency's license does not expire and the agency may continue to operate until HHSC had made a final determination on the application, concurrent with the agency's opportunity for a formal hearing as described in §558.601 of this chapter (relating to Enforcement Actions).

(2) A license expires if the license holder fails to submit a renewal application in accordance with the subsection before the expiration date.

(i) If a license holder fails to submit a renewal application in accordance with subsection (h) of this section because the license holder is or was on active duty with the armed forces of the United States of America outside the State of Texas, the license holder may renew the license pursuant to this subsection.

(1) An individual having power of attorney from the license holder or other authority to act on behalf of the license holder may request renewal of the license. The renewal application must include a current address and telephone number for the individual requesting the renewal.

(2) An agency may submit a request for a renewal application through the online portal before or after the expiration of the license.

(3) A copy of the official orders or other official military documentation showing that the license holder is or was on active military duty serving outside the State of Texas must be submitted to HHSC with the renewal application.

(4) A copy of the power of attorney from the license holder or other authority to act on behalf of the license holder must be submitted to HHSC with the renewal application.

(5) A license holder applying to renew a license under this subsection must pay the required renewal fee in full.

(6) A license holder may not operate the agency for which the license was obtained after the expiration of the license unless and until HHSC renews the license.

(7) This subsection applies to a license holder who is an individual or a partnership comprised of individuals, all of whom are or were on active duty with the armed forces of the United States of America serving outside the State of Texas.

(j) An applicant for a renewal license must comply with §558.30 of this subchapter (relating to Operation of an Inpatient Unit at a Parent Agency) to operate an inpatient unit at the applicant's parent agency.
Source Note: The provisions of this §558.17 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective September 1, 2008, 33 TexReg 1149; amended to be effective January 15, 2009, 34 TexReg 252; amended to be effective July 1, 2012, 37 TexReg 4613; amended to be effective January 17, 2018, 43 TexReg 238; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.19 Issuance of a Renewal License]
(a) A license issued under this chapter expires three years after the date HHSC issues it, except as provided in subsections (e)(1) and (f)(1) of this section.

(b) Except as specified in §558.503 of this chapter (relating to Exemption From a Survey), HHSC may not renew an initial license unless HHSC conducts an initial survey of the agency. For renewal of an initial license, an agency must:

(1) meet the requirements for an initial survey as specified in Subchapter E of this chapter (relating to Licensure Surveys);

(2) demonstrate substantial compliance with the Statute and this chapter for the services authorized under the license as confirmed by an initial survey; and

(3) apply for renewal of the license in accordance with §558.17 of this subchapter (relating to Application Procedures for a Renewal License).

(c) For renewal of a license other than an initial license, an agency must:

(1) maintain substantial compliance with the Statute and this chapter for the services authorized under the license; and

(2) apply for renewal of the license in accordance with §558.17 of this subchapter.

(d) If HHSC grants the renewal application, it issues a renewal license effective on the day after the previous license expires.

(e) If HHSC renews a license that expires after December 31, 2020, and before January 1, 2022, HHSC:

(1) issues a license that is valid for two years, if the license is for an agency with a license number that ends in 0-3 or 7-9; and

(2) issues a license that is valid for three years, if the license is for an agency with a license number that ends in 4-6.

(f) If HHSC renews a license that expires after December 31, 2020, and before January 1, 2023, HHSC:

(1) issues a license that is valid for two years, if the license is for an agency with a license number that ends in 4-6; and

(2) issues a license that is valid for three years, if the license is for an agency with a license number that ends in 0-3 or 7-9.

(g) HHSC may deny a renewal application:

(1) if an agency fails to meet the eligibility criteria in §558.11 of this subchapter (relating to Criteria and Eligibility for Licensing);

(2) if the agency fails to meet the requirements for renewal of a license as specified in this subchapter; or

(3) for any of the reasons specified in §558.21 of this subchapter (relating to Denial of an Application or a License).

(h) A renewal license designates an agency's place of business from which services are to be provided or directed and designates an agency's authorized category or categories of service.
Source Note: The provisions of this §558.19 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective December 1, 2006, 31 TexReg 9620; amended to be effective September 1, 2008, 33 TexReg 1149; amended to be effective July 1, 2012, 37 TexReg 4613; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.21 Denial of an Application or a License]
(a) HHSC may deny an application for a license on any ground described in this chapter, or if any person described in §558.11(g) or (h) of this subchapter (relating to Criteria and Eligibility for Licensing):

(1) fails to comply with the Statute;

(2) fails to comply with this chapter;

(3) knowingly aids, abets, or permits another person to violate the Statute or this chapter;

(4) fails to meet the criteria for a license established in §558.11 of this subchapter; or

(5) violates Texas Occupations Code §102.001.

(b) If HHSC denies an application for a license, the applicant or agency may request an administrative hearing in accordance with §558.601 of this chapter (relating to Enforcement Actions).
Source Note: The provisions of this §558.21 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective September 1, 2009, 34 TexReg 5139; amended to be effective July 1, 2012, 37 TexReg 4613; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.23 Change of Ownership]
(a) A license holder may not transfer its license. If there is a change of ownership, the license holder's license becomes invalid on the date of the licensure change of ownership. The prospective license holder must apply for a license in accordance with §558.12 of this subchapter (relating to General Application) and §558.13 of this subchapter (relating to Obtaining an Initial License).

(b) If HHSC grants the application for an initial change of ownership license and allows an initial change of ownership application to occur without a gap in the agency's licensed status, the license holder at the time of the application must maintain an active and valid license until HHSC grants and issues an initial license to the change of ownership applicant.

(c) A change of ownership for a parent agency is a change of ownership for the parent agency's branch office or ADS and requires the submittal of an application and license fee for each branch office and ADS at the same time as the parent agency application and fee.

(d) HHSC conducts an on-site health inspection to verify compliance with the licensure requirements after issuing a license as a result of a change of ownership. HHSC may conduct a desk review instead of an on-site health inspection after issuing a license as a result of a change of ownership if:

(1) less than 50 percent of the direct or indirect ownership interest in the former license holder changed, when compared to the new license holder; or

(2) every owner with a disclosable interest in the new license holder had a disclosable interest in the former license holder.

(e) For an agency licensed to provide licensed and certified home health services or certified, as well as licensed, to provide hospice services, applicable federal laws and regulations relating to change of ownership or control apply in addition to the requirements of this section.
Source Note: The provisions of this §558.23 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective October 11, 2017, 42 TexReg 5514; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.25 Requirements for Change of Ownership]
To apply for an initial change of ownership license, a prospective new owner must submit an initial license application to HHSC through the online portal in accordance with paragraph (2) of this subsection. The application must be complete and accurate, as described in §558.12(c) of this subchapter (relating to General Application), and the applicant must submit the appropriate license fee with the application.

(1) The change of ownership applicant must submit the complete and accurate initial application with full payment of required license fees at least 30 days before the anticipated date of sale or other transfer of ownership and before the expiration date of the license.

(A) HHSC may accept a change of ownership application less than 30 days before the effective date.

(B) HHSC may assess a late fee set out in §558.3(d) of this chapter (relating to License Fees).

(2) The change of ownership applicant must apply for the initial license in accordance with §558.23(a) of this subchapter (relating to Change of Ownership) and meet the criteria for a license as described in §558.11 of this subchapter (relating to Criteria and Eligibility for Licensing) and §558.13 of this subchapter (relating to Obtaining an Initial License).

(3) If an applicant submits a complete and accurate application through the online portal, has met all the criteria for a license, and HHSC has received funds constituting full payment of all required license fee HHSC issues the change of ownership applicant an initial license. The effective date of the license constitutes the licensure change of ownership date.

(4) The initial license issued to the new owner is valid for three years from the date of issuance.
Source Note: The provisions of this §558.25 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective September 1, 2008, 33 TexReg 1149; amended to be effective January 15, 2009, 34 TexReg 252; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.27 Application and Issuance of an Initial Branch Office License]
(a) An agency with a current license to provide licensed home health services, licensed and certified home health services, or personal assistance services may qualify for a branch office license, if the parent agency:

(1) is found to be in substantial compliance with the Statute and this chapter;

(2) has no enforcement action pending against the license; and

(3) meets its initial survey requirements before HHSC approves a branch office license.

(b) To apply for a branch office license, an agency must submit an application for the license to HHSC through the online portal, in accordance with §558.12 of this subchapter (relating to General Application).

(c) A designated survey office conducts a review of an agency's request to establish a branch office. The survey office makes a recommendation to approve or disapprove the branch office request.

(d) HHSC approves or denies the application for a branch office license after considering the designated survey office's recommendation. If HHSC denies the application, HHSC sends the agency a written notice:

(1) of its decision; and

(2) the agency's opportunity to appeal its decision through a formal hearing process as described in §558.601 of this chapter (relating to Enforcement Actions).

(e) CMS approves or denies the branch location if an agency is licensed to provide licensed and certified home health services.

(f) A branch office license expires on the same expiration date as the parent agency's license. To renew a branch office license, the license holder must submit, to HHSC through the online portal, a complete and accurate renewal application and all required fees for the branch office license application, and the agency may renew it with the parent agency's license.

(g) If HHSC grants a branch office license, it provides the branch office license to the license holder for the parent agency and branch office. The branch office must post the license in a conspicuous place on the licensed branch office premises.

(h) A branch office must comply with §558.321 of this title (relating to Standards for Branch Offices) and the additional standards that relate to the agency's authorized categories under the license.

(i) Unless an agency is exempt from the survey, as specified in §558.503 of this chapter (relating to Exemption From a Survey), HHSC does not renew a branch office license if it has not conducted a health survey of a branch office after issuance of the license to verify compliance with the Statute and this chapter.
Source Note: The provisions of this §558.27 adopted to be effective June 1, 2006, 31 TexReg 1455; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.29 Application and Issuance of an Alternate Delivery Site License]
(a) An agency with a license to provide hospice services may qualify for an ADS license if the parent agency:

(1) is in substantial compliance with the Statute and this chapter; and

(2) has no enforcement action pending against its license.

(b) To apply for an ADS license, an agency must submit an ADS application to HHSC through the online portal, in accordance with §558.12 of this subchapter (relating to General Application).

(1) In the application, an agency may request to operate an inpatient unit at the ADS location.

(2) To add an inpatient unit to a licensed ADS, an agency must submit a change of service category application through the online portal according to the instructions for requesting HHSC approval, and otherwise comply with requirements of this section.

(c) After an agency submits an application for an ADS with an inpatient unit, the agency must contact the HHSC Architectural Unit to request a Life Safety Code survey. Before HHSC considers whether the application is complete, HHSC determines an agency's compliance with the Life Safety Code requirements §558.871 of this chapter (relating to Physical Environment in a Hospice Inpatient Unit).

(d) A designated survey office reviews an agency's application for an ADS license and makes a recommendation to the HHSC HCSSA licensing unit whether to approve or deny the application. The HCSSA licensing unit approves or denies the agency's application.

(e) If HHSC denies an agency's application, HHSC sends the agency a written notice:

(1) informing the agency of its decision; and

(2) providing the agency with an opportunity to appeal its decision through a formal hearing process as described in §558.601 of this chapter (relating to Enforcement Actions).

(f) Except as provided in subsection (g) of this section, after HHSC issues a license for an ADS with an inpatient unit, the agency must, after providing inpatient services to a client, submit the Notification of Readiness for a Health Survey of a Hospice Inpatient Unit (HHSC Form 2020-A), to the designated survey office. HHSC conducts an initial licensure health survey to review the requirements in §558.871 of this chapter specified in Subchapter H, Division 7 of this chapter (relating to Hospice Inpatient Units) that an HHSC Life Safety Code surveyor did not review during the initial Life Safety Code survey.

(g) An agency is not required to request an initial licensure health survey of an ADS with an inpatient unit if the agency is exempt from the health survey as specified in §558.503 of this chapter (relating to Exemption From a Survey). To demonstrate that it is exempt, the agency must send the accreditation documentation from the accreditation organization to the HHSC designated survey office within seven days after the agency receives the accreditation documentation.

(h) If an agency receives accreditation documentation from the accreditation organization after the agency submits a written request to HHSC for an initial licensure health survey, the agency may demonstrate that it is exempt from the survey by sending the accreditation documentation to the HHSC designated survey office before HHSC arrives at the agency to conduct an initial health survey.

(i) A Medicare-certified hospice agency must also submit a request to CMS for approval of an ADS, including an ADS with an inpatient unit. CMS approves or denies the request.

(j) An ADS license expires on the same date the parent agency's license expires. To renew an ADS license, the license holder must submit to HHSC through the online portal a renewal application and all required fees for the ADS license when submitting a renewal application for the parent agency's license.

(k) If HHSC grants an ADS license, it will provide the license to the parent agency. The agency must post the ADS license in a conspicuous place on the licensed ADS premises.

(l) An ADS must comply with the Statute and this chapter, including the applicable additional standards for hospice agencies in Subchapter H of this chapter (relating to Standards Specific to Agencies Licensed to Provide Hospice Services) and §558.322 of this chapter (relating to Standards for Alternate Delivery Sites). A Medicare-certified hospice agency's ADS must also comply with the applicable federal rules and regulations for hospice agencies in 42 CFR Part 418.
Source Note: The provisions of this §558.29 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective October 1, 2013, 38 TexReg 6628; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893 amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.30 Operation of an Inpatient Unit at a Parent Agency]
(a) To operate an inpatient unit at a parent agency, the license holder for the parent agency or an applicant for an initial license to provide hospice services must:

(1) submit an initial parent application through the online portal according to applicable instructions for requesting HHSC approval to operate an inpatient unit at the parent agency;

(2) send written notice to HHSC that it is ready for a Life Safety Code inspection through the online portal;

(3) allow HHSC to conduct an on-site Life Safety Code inspection to determine if the inpatient unit is in compliance with §558.871 of this chapter (relating to Physical Environment in a Hospice Inpatient Unit);

(4) obtain verification from HHSC that the inpatient unit is in compliance with Subchapter H, Division 7 of this chapter (relating to Hospice Inpatient Units) before admitting a client to the inpatient unit;

(5) after HHSC issues a license authorizing the inpatient unit, admit and provide hospice services to a client in the inpatient unit; and

(6) except as provided in subsection (c) of this section:

(A) submit the Notification of Readiness for a Health Survey of a Hospice Inpatient Unit (HHSC Form 2020-A) to HHSC after admitting and providing services to at least one client in the inpatient unit; and

(B) be determined by HHSC to be in substantial compliance with the Statute and this chapter, including Subchapter H of this chapter (relating to Standards Specific to Agencies Licensed to Provide Hospice Services).

(b) If the applicant is currently licensed at the time an agency notifies HHSC in accordance with subsection (a)(1) of this section, the agency must not have enforcement action pending against the license under which the agency would operate the inpatient unit.

(c) An agency that provides hospice services is not required to submit the Notification of Readiness for a Health Survey of a Hospice Inpatient Unit (HHSC Form 2020-A) in accordance with subsection (a)(6)(A) of this section if the agency demonstrates that it is exempt from a health survey, as described in §558.503 of this chapter (relating to Exemption From a Survey). The agency may demonstrate that it is exempt from the initial health survey described in §558.521 of this chapter (relating to Requirements for an Initial Survey) by submitting the accreditation documentation from an approved accreditation organization referenced in §558.503 of this chapter to the designated HHSC survey office within seven days after the agency receives the accreditation documentation.

(d) If HHSC grants an application for an initial parent agency license with an inpatient unit or to add an inpatient unit to a licensed parent agency, the licensed agency and the license holder must comply with the Statute and this chapter, including Subchapter H of this chapter.
Source Note: The provisions of this §558.30 adopted to be effective January 17, 2018, 43 TexReg 238; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.31 Time Frames for Processing and Issuing a License]
(a) General.

(1) In this section, the date of an application is the date an applicant successfully submits an application to HHSC through the online portal as described in subsection (b)(1) of this section.

(2) HHSC considers an application complete for purposes of this section when it is complete and accurate as described in §558.12 of this subchapter (relating to General Applications), and the applicant has met all requirements for licensure, including applicable background and survey standards before HHSC issues a license.

(b) Time frames. HHSC processes an application in accordance with the following time frames.

(1) The first time frame begins on the date the applicant successfully submits an application through the online portal and the online portal reflects a status of "payment received" for applicable license fees, including late fees, and ends on the date HHSC determines the submission is complete and accurate, as described in §558.12 of this subchapter (relating to General Applications). If HHSC receives an incomplete application, the first time frame ends on the date HHSC sends an electronic notice, through the online portal, to the agency that the application is incomplete. The electronic notice specifies the information that the applicant must submit to complete the application. The first time frame is no longer than 45 days.

(2) The second time frame begins on the date that the application is complete, as described for the purpose of this section, in subsection (a)(2) of this section, and ends on the date the license is issued. The second time frame is no longer than 45 days.

(3) If an agency is subject to a proposed or pending enforcement action on its license, on or within 45 days before the expiration date of the license, HHSC may postpone decision on a renewal application while the action is pending.

(c) Reimbursement of fees.

(1) If HHSC does not process the application in the time frames stated in subsection (b) of this section, the applicant has the right to request that HHSC reimburse the license fee. If HHSC does not agree that the established time frames have been violated or finds that good cause existed for exceeding the established time frames, HHSC denies the request.

(2) HHSC considers that good cause for exceeding the established time frames exists if:

(A) the number of applications to be processed exceeds by 15 percent or more the number of applications processed in the same quarter for the preceding year;

(B) another public or private entity used in the application process caused the delay; or

(C) other conditions existed giving good cause for exceeding the established time frames.

(d) Appeal. If HHSC denies the request for reimbursement of the license fee, as authorized by subsection (c) of this section, the applicant may appeal the denial. In order to appeal, the applicant must send a written request for reimbursement of the license fee to the HHSC executive commissioner. The request must include that the application was not processed within the established time frame. The HHSC HCSSA licensing unit provides the HHSC executive commissioner with a written report of the facts related to the processing of the application and good cause for exceeding the established time frame. The HHSC executive commissioner makes the final decision and provides written notification of the decision to the applicant and the HHSC HCSSA licensing unit.
Source Note: The provisions of this §558.31 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective January 15, 2009, 34 TexReg 252; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.401 Standards Specific to Licensed Home Health Services]
(a) In addition to the standards in Subchapter C of this chapter (relating to Minimum Standards for All Home and Community Support Services Agencies), an agency providing licensed home health services must also meet the standards of this section.

(b) The agency must accept a client for home health services based on a reasonable expectation that the client's medical, nursing, and social needs can be met adequately in the client's residence. An agency has made a reasonable expectation that it can meet a client's needs if, at the time of the agency's acceptance of the client, the client and the agency have agreed as to what needs the agency would meet; for instance, the agency and the client could agree that some needs would be met but not necessarily all needs.

(1) The agency must start providing licensed home health services to a client within a reasonable time after acceptance of the client and according to the agency's policy. The initiation of licensed home health services must be based on the client's health service needs.

(2) An initial health assessment must be performed in the client's residence by the appropriate health care professional prior to or at the time that licensed home health services are initially provided to the client. The assessment must determine whether the agency can provide the necessary services.

(A) If a practitioner has not ordered skilled care for a client, then the appropriate health care professional must prepare a care plan. The care plan must be developed after consultation with the client and the client's family and must include services to be rendered, the frequency of visits or hours of service, identified problems, method of intervention, and projected date of resolution. The care plan must be reviewed and updated by all appropriate staff members involved in client care at least annually, or more often as necessary to meet the needs of the client.

(B) If a practitioner orders skilled treatment, then the appropriate health care professional must prepare a plan of care. The plan of care must be signed and approved by a practitioner in a timely manner. The plan of care must be developed in conjunction with agency staff and must cover all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits at the time of admission, prognoses, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, and any other appropriate items. The appropriate health care personnel must perform services as specified in the plan of care. The plan of care must be revised as necessary, but it must be reviewed and updated at least every six months.

(c) Agency staff must provide at least one home health service.

(d) All services must be provided and supervised by qualified personnel. The appropriate licensed health care professional must be available to supervise as needed, when services are provided. If medical social service is provided, the social worker must be licensed in the State of Texas to provide social work services.

(e) All staff providing services, delegation, and supervision must be employed by or be under contract with the agency.

(f) An agency is not required to employ home health aides. If an agency employs home health aides, the agency must comply with §558.701 of this chapter (relating to Home Health Aides).

(g) Unlicensed personnel employed by an agency to provide licensed home health services must:

(1) have demonstrated competency in the task assigned when competency cannot be determined through education and experience; and

(2) be at least 18 years of age or, if under 18 years of age, be a high school graduate or enrolled in a vocational education program.
Source Note: The provisions of this §558.401 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective April 1, 2004, 29 TexReg 2383; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.402 Standards Specific to Licensed and Certified Home Health Services]
(a) In addition to the standards in Subchapter C of this chapter (relating to Minimum Standards for All Home and Community Support Services Agencies), an agency providing licensed and certified home health services must comply with applicable requirements of 42 United States Code Chapter 7, Subchapter XVII and the regulations in 42 CFR Part 484.

(b) An agency providing licensed and certified home health services that plans to implement a home health aide training and competency evaluation program must meet the requirements in §558.701(d)-(f) of this chapter (relating to Home Health Aides).

(c) An agency providing licensed and certified home health services that plans to implement a competency evaluation program must comply with §558.701(f) of this chapter.

(d) An agency providing licensed and certified home health services may not use an individual as a home health aide unless:

(1) the individual has met the federal requirements under subsection (a) of this section;

(2) the individual qualifies as a home health aide based on a:

(A) training and competency evaluation program, and the program meets the requirements of subsection (b) of this section; or

(B) competency evaluation program, and the program meets the requirements of subsection (c) of this section; or

(3) the individual is a licensed health care provider.

(e) Since the individual's most recent completion of a training and competency evaluation program, or a competency evaluation program, if there has been a period of 24 consecutive months during which the individual has not furnished home health services, the individual will not be considered as having completed a training and competency evaluation program or a competency evaluation program.
Source Note: The provisions of this §558.402 adopted to be effective February 1, 2002, 26 TexReg 9159; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.404 Standards Specific to Agencies Licensed to Provide Personal Assistance Services]
(a) In addition to meeting the standards in Subchapter C of this chapter (relating to Minimum Standards for All Home and Community Support Services Agencies), an agency holding a license with the category of personal assistance services must meet the standards of this section.

(b) A person who is not licensed to provide personal assistance services under this chapter may not indicate or imply that the person is licensed to provide personal assistance services by using the words "personal assistance services" or in any other manner.

(c) Personal assistance services, as defined in §558.2 of this chapter (relating to Definitions), may be performed by an unlicensed person who is at least 18 years of age and has demonstrated competency, when competency cannot be determined through education and experience, to perform the tasks assigned by the supervisor. An unlicensed person who is under 18 years of age, is a high school graduate or is enrolled in a vocational educational program, and has demonstrated competency to perform the tasks assigned by the supervisor, may perform personal assistance services.

(d) The following tasks may be performed under a personal assistance services category:

(1) personal care as defined in §558.2 of this chapter;

(2) health-related tasks provided by unlicensed personnel that may be delegated by an RN, or that an RN determines do not require delegation, in accordance with the agency's written policy adopted, implemented, and enforced to ensure compliance with the rules adopted by the Texas Board of Nursing in 22 TAC Chapter 225 (relating to RN Delegation to Unlicensed Personnel and Tasks Not Requiring Delegation in Independent Living Environments for Clients with Stable and Predictable Conditions);

(3) health-related tasks that are not the practice of professional nursing under the memorandum of understanding between HHSC and the Texas Board of Nursing; and

(4) health-related tasks that are delegated by a physician under the Texas Occupations Code Chapter 157.

(e) The agency must ensure that when developing its operational policies, the policies are considerate of principles of individual and family choice and control, functional need, and accessible and flexible services.

(f) In addition to the client record requirements in §558.301(a)(9) of this chapter (relating to Client Records), the client file must include the following:

(1) documentation of determination of services based on an on-site visit by the supervisor where services will be primarily delivered and records of supervisory visits, if applicable;

(2) individualized service plan developed, agreed upon, and signed by the client or family and the agency. The individualized service plan must include:

(A) types of services, supplies, and equipment to be provided;

(B) locations of services;

(C) frequency and duration of services;

(D) planned date of service initiation;

(E) charges for services rendered if the charges will be paid in full or in part by the client or significant other(s), or on request; and

(F) plan of supervision; and

(3) documentation that the services have been provided according to the individualized service plan.

(g) In addition to the written policies required by §558.245 of this chapter (relating to Staffing Policies) the agency must adopt and enforce a written policy addressing the supervision of personnel with input from the client or family on the frequency of supervision.

(1) Supervision of personnel must be in accordance with the agency's policies and applicable State laws and rules, including rules adopted by the Texas Board of Nursing in 22 TAC Chapter 225.

(2) A supervisor must be a licensed nurse or have completed two years of full-time study at an accredited college or university. An individual with a high school diploma or general equivalence diploma (GED) may substitute one year of full-time employment in a supervisory capacity in a health care facility, agency, or community-based agency for each required year of college.

(3) The client in a client managed attendant care program funded by HHSC or the Department of Assistive and Rehabilitative Services is not required to meet the standard in paragraph (2) of this subsection.

(h) Tube feedings and medication administration through a permanently placed gastrostomy tube (g-tube) in accordance with subsection (d)(3) of this section may be performed by an unlicensed person only after successful completion of the training and competency program and procedures described in paragraphs (1) - (5) of this subsection.

(1) The training and competency program for the performance of g-tube feedings by an unlicensed person must be taught by an RN, physician, physician assistant (PA), or qualified trainer. A qualified trainer must:

(A) have successfully completed the training and competency program described in paragraphs (2) and (3) of this subsection taught by an RN, physician, or PA;

(B) have demonstrated upon return demonstration to an RN, physician, or PA the performance of the task and the ability to teach the task; and

(C) have been deemed competent by an RN, physician, or PA, to train unlicensed personnel in these procedures. Documentation of competency to perform, train, and teach must be maintained in the employee's or contractor's file. Competency must be evaluated and documented annually by an RN, physician, or PA.

(2) The minimum training program must include:

(A) a description of the g-tube placement, including its purpose;

(B) infection control procedures and universal precautions to be used when performing g-tube feedings or medication administration through a g-tube;

(C) a description of conditions that must be reported to the client or the primary caregiver, or in the absence of the primary caregiver, to the agency administrator, supervisor, or the client's physician. The description of conditions must include a plan to be effected if the g-tube comes out or is not positioned correctly to ensure medical attention is provided within one hour;

(D) review of a written procedure for g-tube feeding or medication administration through a g-tube. The written procedure must be equivalent to current acceptable nursing standards of practice, including addressing the crushing of medications;

(E) conditions under which g-tube feeding or medication administration must not be performed; and

(F) demonstration of a g-tube feeding and medication administration to a client. If the trainee will become a qualified trainer, the demonstration must be done by the RN, PA, or physician. If the trainee will not become a qualified trainer, the demonstration may be done by an RN, PA, physician, or qualified trainer.

(3) The minimum competency evaluation must be documented and maintained in the employee's file and must include:

(A) a score of 100 percent on a written multiple-choice test that consists of situational questions to include the criteria in paragraph (2)(A) - (E) of this subsection and an evaluation of the trainee's judgment and understanding of the essential skills, risks, and possible complications of a g-tube feeding or medication administration through a g-tube;

(B) a skills checklist demonstrating that the trainee has successfully completed the necessary skills for a g-tube feeding and medication administration via g-tube, and if the trainee will become a qualified trainer, the skills checklist must also demonstrate the ability to teach another person to perform the task. The skills checklist must be completed by an RN, physician, or PA, if the trainee will become a qualified trainer. The skills checklist for a trainee who will not become a qualified trainer may be completed by an RN, physician, PA, or qualified trainer; and

(C) documentation of an accurate demonstration of the g-tube feeding and medication administration performed by the trainee as required by paragraph (2)(F) of this subsection. If the trainee will become a qualified trainer, documentation of competency to teach this task must be maintained in the file of the qualified trainer. The person responsible for the training of the trainee must document the successful demonstration of the g-tube feeding and medication administration via g-tube by the trainee and the trainee's competency to perform this task in the trainee's file.

(4) The client or primary caregiver must provide information on the client's g-tube feeding or medication administration to the agency supervisor. If the client is not capable of directing his or her own care, the client's primary caregiver must be present to instruct and orient the supervisor regarding the client's g-tube feeding and medication regime. A copy of the current regime including unique conditions specific to the client must be placed in the client's file by the agency supervisor and provided to the respite caregiver. The respite caregiver must be oriented by the client, the client's primary caregiver, or the agency supervisor. The supervisor of the delivery of these services must have successfully completed a training and competency program outlined in paragraphs (2) and (3) of this subsection or be a qualified trainer.

(5) Legend medications that are to be administered must be in a legally labeled container from a pharmacy that contains the name of the client. Instructions for dosages according to weight or age for over-the-counter drugs commonly given the client must be furnished by the primary caregiver to the respite caregiver performing the tube feeding or medication administration.
Source Note: The provisions of this §558.404 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 29, 2003, 28 TexReg 4931; amended to be effective October 15, 2003, 28 TexReg 8955; amended to be effective May 1, 2008, 33 TexReg 1136; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.405 Standards Specific to Agencies Licensed to Provide Home Dialysis Services]
(a) License designation. An agency may not provide peritoneal dialysis or hemodialysis services in a client's residence, independent living environment, or other appropriate location unless the agency holds a license to provide licensed home health or licensed and certified home health services and designated to provide home dialysis services. In order to receive a home dialysis designation, the agency must meet the licensing standards specified in this section and the standards for home health services in accordance with Subchapter C of this chapter (relating to Minimum Standards for All Home and Community Support Services Agencies) and §558.401 of this subchapter (relating to Standards Specific to Licensed Home Health Services), except for §558.401(b)(2)(A) and (B) of this subchapter. If there is a conflict between the standards specified in this section and those specified in Subchapter C of this chapter and §558.401 of this subchapter, the standards specified in this section will apply to the home dialysis services.

(b) Governing body. An agency must have a governing body. The governing body must appoint a medical director and the physicians who are on the agency's medical staff. The governing body must annually approve the medical staff policies and procedures. The governing body on a biannual basis must review and consider for approval continuing privileges of the agency's medical staff. The minutes from the governing body of the agency must be on file in the agency office.

(c) Qualifications and responsibilities of the medical director.

(1) Qualifications. The medical director must be a physician licensed in the State of Texas who:

(A) is eligible for certification or is certified in nephrology or pediatric nephrology by a professional board; or

(B) during the five-year period prior to September 1, 1996, served at least 12 months as director of a dialysis facility or program.

(2) Responsibilities. The medical director must:

(A) participate in the selection of a suitable treatment modality for all clients;

(B) assure adequate training of nurses in dialysis techniques;

(C) assure adequate monitoring of the client and the dialysis process; and

(D) assure the development and availability of a client care policy and procedures manual and its implementation.

(d) Personnel files. An agency must have individual personnel files on all physicians, including the medical director. The file must include the following:

(1) a curriculum vitae which documents undergraduate, medical school, and all pertinent post graduate training; and

(2) evidence of current licensure, and evidence of current United States Drug Enforcement Administration certification, Texas Department of Public Safety registration, and the board eligibility or certification, or the experience or training described in subsection (c)(1) of this section.

(e) Provision of services. An agency that provides home staff-assisted dialysis must, at a minimum, provide nursing services, nutritional counseling, and medical social service. These services must be provided as necessary and as appropriate at the client's home, by telephone, or by a client's visit to a licensed ESRD facility in accordance with this subsection. The use of dialysis technicians in home dialysis is prohibited.

(1) Nursing services.

(A) An RN, licensed by the State of Texas, who has at least 18 months experience in hemodialysis obtained within the last 24 months and has successfully completed the orientation and skills education described in subsection (f) of this section, must be available whenever dialysis treatments are in progress in a client's home. The agency administrator must designate a qualified alternate to this RN.

(B) Dialysis services must be supervised by an RN who meets the qualifications for a supervising nurse as set out in §558.244(c)(2) of this chapter (relating to Administrator Qualifications and Conditions and Supervising Nurse Qualifications).

(C) Dialysis services must be provided by a qualified licensed nurse who:

(i) is licensed as an RN or LVN by the State of Texas;

(ii) has at least 18 months experience in hemodialysis obtained within the last 24 months; and

(iii) has successfully completed the orientation and skills education described in subsection (f) of this section.

(2) Nutritional counseling. A dietitian who meets the qualifications of this paragraph must be employed by or under contract with the agency to provide services. A qualified dietitian must meet the definition of dietitian in §558.2 of this chapter (relating to Definitions) and have at least one year of experience in clinical nutrition after obtaining eligibility for registration by the American Dietetic Association, Commission on Dietetic Registration.

(3) Medical social services. A social worker who meets the qualifications established in this paragraph must be employed by or be under contract with the agency to provide services. A qualified social worker is a person who:

(A) is currently licensed under the laws of the State of Texas as a social worker and has a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education; or

(B) has served for at least two years as a social worker, one year of which was in a dialysis facility or program prior to September 1, 1976, and has established a consultative relationship with a licensed master social worker.

(f) Orientation, skills education, and evaluation.

(1) All personnel providing dialysis in the home must receive orientation and skills education and demonstrate knowledge of the following:

(A) anatomy and physiology of the normal kidney;

(B) fluid, electrolyte, and acid-base balance;

(C) pathophysiology of renal disease;

(D) acceptable laboratory values for the client with renal disease;

(E) theoretical aspects of dialysis;

(F) vascular access and maintenance of blood flow;

(G) technical aspects of dialysis;

(H) peritoneal dialysis catheter, testing for peritoneal membrane equilibration, and peritoneal dialysis adequacy clearance, if applicable;

(I) the monitoring of clients during treatment, beginning with treatment initiation through termination;

(J) the recognition of dialysis complications, emergency conditions, and institution of the appropriate corrective action. This includes training agency personnel in emergency procedures and how to use emergency equipment;

(K) psychological, social, financial, and physical complications of chronic dialysis;

(L) care of the client with chronic renal failure;

(M) dietary modifications and medications for the uremic client;

(N) alternative forms of treatment for ESRD;

(O) the role of renal health team members (physician, nurse, social worker, and dietitian);

(P) performance of laboratory tests (hematocrit and blood glucose);

(Q) the theory of blood products and blood administration; and

(R) water treatment to include:

(i) standards for treatment of water used for dialysis as described in §3.2.1 (Hemodialysis Systems) and §3.2.2 (Maximum Level of Chemical Contaminants) of the American National Standard, Hemodialysis Systems, March 1992 Edition, published by the Association for the Advancement of Medical Instrumentation (AAMI), 3330 Washington Boulevard, Suite 500, Arlington, Virginia 22201. Copies of the standards are indexed and filed in the Texas Health and Human Services Commission, 701 W. 51st Street, Austin, Texas 78751, and are available for public inspection during regular working hours;

(ii) systems and devices;

(iii) monitoring; and

(iv) risks to clients of unsafe water.

(2) The requirements for the orientation and skills education period for licensed nurses are as follows.

(A) The agency must develop an 80-hour written orientation program that includes classroom theory and direct observation of the licensed nurse performing procedures on a client in the home.

(i) The orientation program must be provided by an RN qualified under subsection (e)(1) of this section to supervise the provision of dialysis services by a licensed nurse.

(ii) The licensed nurse must pass a written skills examination or competency evaluation at the conclusion of the orientation program and prior to the time the licensed nurse delivers independent client care.

(B) The licensed nurse must complete the required classroom component as described in paragraph (1)(A) - (E), (K) - (O), (Q) and (R) of this subsection and satisfactorily demonstrate the skills described in paragraph (1)(F) - (J) and (P) of this subsection. The orientation program may be waived by successful completion of the written examination as described in subparagraph (A)(ii) of this paragraph.

(C) The supervising nurse or qualified designee must complete an orientation competency skills checklist for each licensed nurse to reflect the progression of learned skills, as described in subsection (f)(1) of this section.

(D) Prior to the delivery of independent client care, the supervising nurse or qualified designee must directly supervise the licensed nurse for a minimum of three dialysis treatments and ensure satisfactory performance. Dependent upon the trainee's experience and accomplishments on the skills checklist, additional supervised dialysis treatments may be required.

(E) Continuing education for employees must be provided quarterly.

(F) Performance evaluations must be done annually.

(G) The supervising nurse or qualified designee must provide direct supervision to the licensed nurse providing dialysis services monthly, or more often if necessary. Direct supervision means that the supervising nurse is on the premises but not necessarily immediately present where dialysis services are being provided.

(g) Hospital transfer procedure. An agency must establish an effective procedure for the immediate transfer to a local Medicare-certified hospital for clients requiring emergency medical care. The agency must have a written transfer agreement with such a hospital, or all physician members of the agency's medical staff must have admitting privileges at such a hospital.

(h) Backup dialysis services. An agency that supplies home staff-assisted dialysis must have an agreement with a licensed ESRD facility to provide backup outpatient dialysis services.

(i) Coordination of medical and other information. An agency must provide for the exchange of medical and other information necessary or useful in the care and treatment of clients transferred between treating facilities. This provision must also include the transfer of the client care plan, hepatitis B status, and long-term program.

(j) Transplant recipient registry program. An agency must ensure that the names of clients awaiting cadaveric donor transplantation are entered in a recipient registry program.

(k) Testing for hepatitis B. An agency must conduct routine testing of home dialysis clients and agency employees to ensure detection of hepatitis B in employees and clients.

(1) An agency must offer hepatitis B vaccination to previously unvaccinated, susceptible new staff members in accordance with 29 CFR §1910.1030(f)(1) - (2) (Bloodborne Pathogens).

(A) Staff vaccination records must be maintained in each staff member's personnel file.

(B) New staff members providing home dialysis care must be screened for hepatitis B surface antigen (HBsAg) and the results reviewed prior to the staff providing client care, unless the new staff member provides the agency documentation of positive serologic response to hepatitis B vaccine.

(C) An agency must establish, implement, and enforce a policy for repeated serologic screening of staff. The repeated serologic screening must be based on each staff member's HBsAg/antibody to HBsAg (anti-HBs) and must be congruent with Appendices i and ii of the National Surveillance of Dialysis Associated Disease in the United States, 1993, published by the United States Department of Health and Human Services (USDHHS).

(2) With the advice and consent of a client's nephrologist or attending physician, an agency must make the hepatitis B vaccine available to a client who is susceptible to hepatitis B, provided that the client has coverage or is willing to pay for vaccination.

(A) An agency must make available to clients literature describing the risks and benefits of the hepatitis B vaccination.

(B) Candidates for home dialysis must be screened for HBsAg within one month before or at the time of admission to the agency.

(C) Repeated serologic screening must be based on the antigen or antibody status of the client.

(D) Monthly screening for HBsAg is required for clients whose previous test results are negative for HBsAg.

(E) Screening of HbsAg-positive or anti-HbsAg-positive clients may be performed on a less frequent basis, provided that the agency's policy on this subject remains congruent with Appendices i and ii of the National Surveillance of Dialysis Associated Diseases in the United States, 1993, published by the USDHHS.

(l) CPR certification. All direct client care employees must have current CPR certification.

(m) Initial admission assessment. Assessment of the client's residence must be made to ensure a safe physical environment for the performance of dialysis. The initial admission assessment must be performed by a qualified RN who meets the qualifications under subsection (e)(1)(A) of this section.

(n) Client long-term program. The agency must develop a long-term program for each client admitted to home dialysis. Criteria must be defined in writing and must provide guidance to the agency in the selection of clients suitable for home staff-assisted dialysis and in noting changes in a client's condition that would require discharge from the program. For the purposes of this subsection, Long-term program means the written documentation of the selection of a suitable treatment modality and dialysis setting, which has been selected by the client and the interdisciplinary team.

(o) Client history and physical. The agency must ensure that the history and physical is conducted upon the client's admission, or no more than six months prior to the date of admission, then annually after the date of admission.

(p) Physician orders. If home staff-assisted dialysis is selected, the physician must prepare orders outlining specifics of prescribed treatment.

(1) If these physician's orders are received verbally, they must be confirmed in writing within a reasonable time frame. An agency must adopt and enforce a policy on the time frame for the countersignature of a physician's verbal orders. Medical orders for home staff-assisted dialysis must be revised as necessary but reviewed and updated at least every six months.

(2) The initial orders for home staff-assisted dialysis must be received prior to the first treatment and must cover all pertinent diagnoses, including mental status, prognosis, functional limitations, activities permitted, nutritional requirements, medications and treatments, and any safety measures to protect against injury. Orders for home staff-assisted dialysis must include frequency and length of treatment, target weight, type of dialyzer, dialysate, dialysate flow rate, heparin dosage, and blood flow rate, and must specify the level of preparation required for the caregiver, such as an LVN or RN.

(q) Client care plan. The client care plan must be developed after consultation with the client and the client's family by the interdisciplinary team. The interdisciplinary team must include the physician, the RN, the dietitian, and the qualified social worker responsible for planning the care delivered to the home staff-assisted dialysis patient.

(1) The initial client care plan must be completed by the interdisciplinary team within 10 calendar days after the first home dialysis treatment.

(2) The client care plan must implement the medical orders and must include services to be rendered, such as the identification of problems, methods of intervention, and the assignment of health care personnel.

(3) The client care plan must be in writing, be personalized for the individual, and reflect the ongoing medical, psychological, social, nutritional, and functional needs of the client, including treatment goals.

(4) The client care plan must include written evidence of coordination with other service providers, such as dialysis facilities or transportation providers, as needed to assure the provision of safe care.

(5) The client care plan must include written evidence of the client's or client's legal representative's input and participation, unless they refuse to participate. At a minimum, the client care plan must demonstrate that the content was shared with the client or the client's legal representative.

(6) For non-stabilized clients, where there is a change in modality, unacceptable laboratory work, uncontrolled weight changes, infections, or a change in family status, the client care plan must be reviewed at least monthly by the interdisciplinary team. Evidence of the review of the client care plan with the client and the interdisciplinary team to evaluate the client's progress or lack of progress toward the goals of the care plan, and interventions taken when progress toward stabilization or the goals are not achieved, must be documented and included in the client record.

(7) For a stable client, the client care plan must be reviewed and updated as indicated by any change in the client's medical, nutritional, or psychosocial condition or at least every six months. The long-term program must be revised as needed and reviewed annually. Evidence of the review of the client care plan with the client and the interdisciplinary team to evaluate the client's progress or lack of progress toward the goals of the care plan, and interventions taken when the goals are not achieved, must be documented and included in the client record.

(r) Medication administration. Medications must be administered only by licensed personnel.

(s) Client records. In addition to the applicable information described in §558.301(a)(9) of this chapter (relating to Client Records), records of home staff assisted dialysis clients must include the following:

(1) a medical history and physical;

(2) clinical progress notes by the physician, qualified licensed nurse, qualified dietitian, and qualified social worker;

(3) dialysis treatment records;

(4) laboratory reports;

(5) a client care plan;

(6) a long-term program; and

(7) documentation of supervisory visits.

(t) Water treatment.

(1) Water used for dialysis purposes must be analyzed for chemical contaminants every six months. Additional chemical analysis must be conducted if test results exceed the maximum levels of chemical contaminants listed in §3.2.2 (Maximum Level of Chemical Contaminants) of the American National Standards for Hemodialysis Systems, March 1992 Edition, published by the AAMI. Copies of the standards are indexed and filed in the Texas Health and Human Services Commission, 701 W. 51st Street, Austin, Texas 78751, and are available for public inspection during regular working hours.

(2) Water used for dialysis must be treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques.

(3) Water used to prepare dialysate must meet the requirements set forth in §3.2.1 (Hemodialysis Systems) and §3.2.2 (Maximum Level of Chemical Contaminants), March 1992 Edition, published by the AAMI. Copies of the standards are indexed and filed in the Texas Health and Human Services Commission 701 W. 51st Street, Austin, Texas 78751, and are available for public inspection during regular working hours.

(4) Records of test results and equipment maintenance must be maintained at the agency.

(u) Equipment testing. An agency must adopt and enforce a policy to describe how the nurse will check the machine for conductivity, temperature, and pH prior to treatment, and describe the equipment required for these tests. The equipment must be available for use prior to each treatment. This policy must reflect current standards.

(v) Preventive maintenance for equipment. An agency must develop and enforce a written preventive maintenance program to ensure client care related equipment receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently if recommended by the manufacturer. The preventive maintenance may be provided by agency or contract staff qualified by training or experience in the maintenance of dialysis equipment.

(1) All equipment used by a client in home dialysis must be maintained free of defects, which could be a potential hazard to clients, the client's family, or agency personnel.

(A) Agency staff must be able to identify malfunctioning equipment and report such equipment to the appropriate agency staff. Malfunctioning equipment must be immediately removed from use.

(B) Written evidence of all preventive maintenance and equipment repairs must be maintained.

(C) After repairs or alterations are made to any equipment, the equipment must be thoroughly tested for proper operation before returning to service.

(D) An agency must comply with the federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §360i(b), concerning reporting when a medical device, as defined in 21 USC §321(h), has or may have caused or contributed to the injury or death of an agency client.

(2) In the event that the water used for dialysis purposes or home dialysis equipment is found not to meet safe operating parameters, and corrections cannot be effected to ensure safe care promptly, the client must be transferred to a licensed hospital (if inpatient care is required) or licensed ESRD facility until such time as the water or equipment is found to be operating within safe parameters.

(w) Reuse or reprocessing of medical devices. Reuse or reprocessing of disposable medical devices, including but not limited to, dialyzers, end-caps, and blood lines must be in accordance with this subsection.

(1) An agency's reuse practice must comply with the American National Standard, Reuse of Hemodialyzers, 1993 Edition, published by the AAMI. An agency must adopt and enforce a policy for dialyzer reuse criteria (including any agency-set number of reuses allowed) which is included in client education materials.

(2) A transducer protector must be replaced when wetted during a dialysis treatment and must be used for one treatment only.

(3) Arterial lines may be reused only when the arterial lines are labeled to allow for reuse by the manufacturer and the manufacturer-established protocols for the specific line have been approved by the United States Food and Drug Administration.

(4) An agency must consider and address the health and safety of clients sensitive to disinfectant solution residuals.

(5) An agency must provide each client and the client's family or legal representative with information regarding the reuse practices of the agency, the opportunity to tour the reuse facility used by the agency, and the opportunity to have questions answered.

(6) An agency practicing reuse of dialyzers must:

(A) ensure that dialyzers are reprocessed via automated reprocessing equipment in a licensed ESRD facility or a centralized reprocessing facility;

(B) maintain responsibility and accountability for the entire reuse process;

(C) adopt and enforce policies to ensure that the transfer and transport of used and reprocessed dialyzers to and from the client's home does not increase contamination of the dialyzers, staff, or the environment; and

(D) ensure that HHSC staff has access to the reprocessing facility as part of an agency inspection.

(x) Laboratory services. Provision of laboratory services must be as follows.

(1) All laboratory services ordered for the client by a physician must be performed by a laboratory which meets the applicable requirements of 42 United States Code (USC) §263a, concerning certification and certificates of waiver of a clinical laboratory (CLIA 1988) and in accordance with a written arrangement or agreement with the agency. CLIA 1988 applies to all agencies with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(2) Copies of all laboratory reports must be maintained in the client's medical record.

(3) Hematocrit and blood glucose tests may be performed at the client's home in accordance with §558.284 of this chapter (relating to Laboratory Services). Results of these tests must be recorded in the client's medical record and signed by the qualified licensed nurse providing the treatment. Maintenance, calibration, and quality control studies must be performed according to the equipment manufacturer's suggestions, and the results must be maintained at the agency.

(4) Blood and blood products must only be administered to dialysis clients in their homes by a licensed nurse or physician.

(y) Home dialysis supplies. Supplies for home dialysis must meet the following requirements.

(1) All drugs, biologicals, and legend medical devices must be obtained for each client pursuant to a physician's prescription in accordance with applicable rules of the Texas State Board of Pharmacy.

(2) In conjunction with the client's attending physician, the agency must ensure that there are sufficient supplies maintained in the client's home to perform the scheduled dialysis treatments and to provide a reasonable number of backup items for replacements, if needed, due to breakage, contamination, or defective products. All dialysis supplies, including medications, must be delivered directly to the client's home by a vendor of such products. However, agency personnel may transport prescription items from a vendor's place of business to the client's home for the client's convenience, so long as the item is properly labeled with the client's name and direction for use. Agency personnel may transport medical devices for reuse.

(z) Emergency procedures. The agency must adopt and enforce policies and procedures for medical emergencies and emergencies resulting from a disaster.

(1) Procedures must be individualized for each client to include the appropriate evacuation from the home and emergency telephone numbers. Emergency telephone numbers must be posted at each client's home and must include 911, if available, the number of the physician, the ambulance, the qualified RN on call for home dialysis, and any other phone number deemed as an emergency number.

(2) The agency must ensure that the client and the client's family know the agency's procedures for medical emergencies and emergencies resulting from a disaster.

(3) The agency must ensure that the client and the client's family know the procedure for disconnecting the dialysis equipment.

(4) The agency must ensure that the client and the client's family know emergency call procedures.

(5) A working telephone must be available during the dialysis procedure.

(6) Depending on the kinds of medications administered, an agency must have available emergency drugs as specified by the medical director.

(7) In the event of a medical emergency or an emergency resulting from a disaster requiring transport to a hospital for care, the agency must assure the following:

(A) the receiving hospital is given advance notice of the client's arrival;

(B) the receiving hospital is given a description of the client's health status; and

(C) the selection of personnel, vehicle, and equipment are appropriate to effect a safe transfer.
Source Note: The provisions of this §558.405 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective May 1, 2008, 33 TexReg 1136; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.406 Standards for Agencies Providing Psychoactive Services]
An agency that provides skilled nursing psychoactive treatments must comply with the requirements of this section.

(1) An agency must adopt and enforce a written policy relating to the provision of psychoactive treatments consistent with this section.

(2) Skilled nursing psychoactive treatments must be under the direction of a physician. Psychoactive treatments may only be provided by a physician or an RN.

(3) An RN providing skilled nursing psychoactive treatments must have one of the following qualifications:

(A) a master's degree in psychiatric or mental health nursing;

(B) a bachelor's degree in nursing with one year of full-time experience in an active treatment unit in a mental health facility or outpatient clinic;

(C) a diploma or associate degree with two years of full-time experience in an active treatment unit in a mental health facility or outpatient clinic; or

(D) for an RN for Medicare certified agencies, as allowed by the fiscal intermediary for Texas contracting with the United States Department of Health and Human Services (USDHHS) CMS.

(4) An agency must have written documentation that an RN providing skilled nursing psychoactive treatments is qualified under paragraph (3) of this section.

(5) The initial health assessment of a client receiving skilled nursing psychoactive treatments must include:

(A) mental status including psychological and behavioral status;

(B) sensory and motor function;

(C) cranial nerve function;

(D) language function; and

(E) any other criteria established by an agency's policy.
Source Note: The provisions of this §558.406 adopted to be effective February 1, 2002, 26 TexReg 9159; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.407 Standards for Agencies Providing Home Intravenous Therapy]
An agency furnishing intravenous therapy directly or under arrangement must comply with the following standards of care.

(1) A physician's order must be written specifically for intravenous therapy.

(2) Intravenous therapy must be provided by a licensed nurse.

(3) To ensure that prescribed care is administered safely, a licensed nurse must have the knowledge and documented competency to interpret and implement the written order.

(4) Written policies and procedures regarding the agency's provision of intravenous therapy must include, but are not limited to, addressing initiation, medication administration, monitoring, and discontinuation. Responsibilities of the licensed nurse must be clearly delineated in written policies and procedures.

(5) An RN must be available 24 hours a day.

(6) The client and caregiver must be assessed for the ability to safely administer the prescribed intravenous therapy, as per agency written criteria.

(7) If the client or caregiver is willing and able to safely administer the prescribed intravenous therapy, the agency must offer to teach the client or caregiver such administration. The teaching process is based on the client and caregiver needs and may include written instructions, verbal explanations, demonstrations, evaluation and documentation of competency, proficiency in performing intravenous therapy, scope of physical activities, and safe disposal of equipment.

(8) Actions must be implemented prior to and during all intravenous therapy to minimize the risk of anaphylaxis or other adverse reactions, as stated in the agency's written policy.

(9) An ongoing assessment of client and caregiver compliance in performing intravenous therapy related procedures must be done at periodic intervals.

(10) Care coordination must be provided to ensure continuity of care.

(11) The client and caregiver must be provided with 24-hour access to appropriate health care professionals employed by or having a contract with the agency.
Source Note: The provisions of this §558.407 adopted to be effective February 1, 2002, 26 TexReg 9159; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.601 Enforcement Actions]
(a) Enforcement actions. HHSC may take the following enforcement actions against an agency:

(1) license suspension;

(2) immediate license suspension;

(3) license revocation;

(4) immediate license revocation;

(5) administrative penalties; and

(6) denial of license application.

(b) Denial of license application. HHSC may deny a license application for the reasons set out in §558.21 of this chapter (relating to Denial of an Application or a License).

(c) Suspension or revocation.

(1) HHSC may suspend or revoke an agency's license if the license holder, the controlling person, the affiliate, the administrator, or the alternate administrator:

(A) fails to comply with this chapter;

(B) fails to comply with the Statute; or

(C) violates Texas Occupations Code §102.001 (relating to Soliciting Patients; Offense) and §102.006 (relating to Failure to Disclose; Offense).

(2) HHSC may suspend or revoke an agency's license to provide licensed and certified home health services if the agency fails to maintain its certification qualifying the agency as a certified agency, as referenced in Texas Health and Safety Code §142.011(c).

(d) Administrative penalties.

(1) HHSC may assess an administrative penalty against an agency in accordance with §558.602 of this subchapter (relating to Administrative Penalties).

(2) HHSC may consider the assessment of past administrative penalties when considering another enforcement action against an agency.

(e) Immediate licensure suspension or revocation. HHSC may immediately suspend or revoke an agency's license when the health and safety of persons are threatened.

(1) If HHSC issues an order for immediate suspension or revocation of the agency's license, HHSC provides immediate notice to the controlling person, administrator, or alternate administrator of the agency by fax and either by certified mail with return receipt requested or hand-delivery. The notice includes:

(A) the action taken;

(B) legal grounds for the action;

(C) the procedure governing appeal of the action; and

(D) the effective date of the order.

(2) An order for immediate suspension or revocation goes into effect immediately.

(3) An agency is entitled to a formal administrative hearing not later than seven days after the effective date of the order for immediate suspension or revocation.

(4) If an agency requests a formal administrative hearing, the hearing is held in accordance with the Texas Government Code Chapter 2001, and with 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).

(f) Opportunity to show compliance.

(1) Before revocation or suspension of an agency's license or denial of an application for the renewal of an agency's license, HHSC gives the license holder:

(A) a notice by personal service or by registered or certified mail of the facts or conduct alleged to warrant the proposed action, with a copy sent to the agency; and

(B) an opportunity to show compliance with all requirements of law for the retention of the license by sending HHSC Regulatory Services office a written request. The request must:

(i) be postmarked within 10 days after the date of HHSC notice and be received in HHSC Regulatory Services office within 10 days after the date of the postmark; and

(ii) contain specific documentation refuting HHSC allegations.

(2) HHSC limits its review to the documentation submitted by the license holder and information HHSC used as the basis for its proposed action. An agency may not attend HHSC meeting to review the opportunity to show compliance. HHSC gives a license holder a written affirmation or reversal of the proposed action.

(3) After an opportunity to show compliance, HHSC sends a license holder a written notice that:

(A) informs the license holder of HHSC decision; and

(B) provides the agency with an opportunity to appeal HHSC decision through a formal hearing process.

(g) Notice of denial of application for license or renewal of a license, suspension or revocation of license. HHSC sends an applicant or license holder notice by fax and either by certified mail with return receipt requested or hand-delivery of HHSC denial of an application for an initial license or renewal of a license, suspension of a license or revocation of a license.

(h) Formal appeal. An applicant or license holder has the right to make a formal appeal after receipt of HHSC notification of denial of an application for an initial license or renewal of a license and suspension or revocation of a license.

(1) An agency must request a formal administrative hearing within 20 days of receipt of HHSC notice of denial of an application for an initial license or renewal of a license, suspension of a license, or revocation of a license. To make a formal appeal, the applicant or agency must comply with the formal hearing procedures in 1 TAC Chapter 357, Subchapter I and 40 TAC Chapter 91.

(2) HHSC presumes receipt of HHSC notice to occur on the 10th day after the notice is mailed to the last known address, unless another date is reflected on the return receipt.

(3) If an agency does not meet the deadline for requesting a formal hearing, the agency has lost its opportunity for a formal hearing, and HHSC takes the proposed action.

(4) A formal administrative hearing is held in accordance with Government Code, Chapter 2001, and the formal hearing procedures in 1 TAC Chapter 357, Subchapter I and 40 TAC Chapter 91.

(5) Except for the denial of an application for an initial license, if an agency appeals, the license remains valid until all appeals are final, unless the license expires without a timely application for renewal submitted to HHSC. The agency must continue to submit a renewal application in accordance with §558.17 of this chapter (relating to Application Procedures for a Renewal License) until the action to revoke, suspend, or deny renewal of the license is completed. However, HHSC does not renew the license until it determines the reason for the proposed action no longer exists.

(6) If an agency appeals, the enforcement action will take effect when all appeals are final, and the proposed enforcement action is upheld. If the agency wins the appeal, the proposed action does not happen.

(7) If HHSC suspends a license, the suspension remains in effect until HHSC determines that the reason for suspension no longer exists. A suspension may last no longer than the term of the license. HHSC conducts a survey of the agency before making a determination to recommend cancellation of a suspension.

(8) If HHSC revokes or does not renew a license and one year has passed following the effective date of revocation or denial of licensure renewal, a person may reapply for a license by complying with the requirements and procedures in §558.13 of this chapter (relating to Obtaining an Initial License). HHSC does not issue a license if the reason for revocation or nonrenewal continues to exist.

(i) Agency dissolution. Upon suspension, revocation, or nonrenewal of a license, the license holder must:

(1) return the original license to HHSC; and

(2) implement its written plan required in §558.291 of this chapter (relating to Agency Dissolution).
Source Note: The provisions of this §558.601 adopted to be effective June 1, 2006, 31 TexReg 1455; amended to be effective July 1, 2012, 37 TexReg 4613; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.602 Administrative Penalties]
(a) Assessing penalties. HHSC may assess an administrative penalty against a person who violates:

(1) the Statute;

(2) a provision in this chapter for which a penalty may be assessed; or

(3) Texas Occupations Code §102.001 (relating to Soliciting Patients; Offense) or §102.006 (relating to Failure to Disclose; Offense), if related to the provision of home health, hospice, or personal assistance services.

(b) Criteria for assessing penalties. HHSC assesses administrative penalties in accordance with the schedule of appropriate and graduated penalties established in this section.

(1) The schedule of appropriate and graduated penalties for each violation is based on the following criteria:

(A) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation and the hazard of the violation to the health or safety of clients;

(B) the history of previous violations by a person or a controlling person with respect to that person;

(C) whether the affected agency identified the violation as part of its internal quality assurance process and made a good faith, substantial effort to correct the violation in a timely manner;

(D) the amount necessary to deter future violations;

(E) efforts made to correct the violation; and

(F) any other matters that justice may require.

(2) In determining which violation warrants a penalty, HHSC considers:

(A) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation and the hazard of the violation to the health or safety of clients; and

(B) whether the affected agency identified the violation as part of its internal quality assurance program and made a good faith, substantial effort to correct the violation in a timely manner.

(c) Opportunity to correct. Except as provided in subsections (e) and (f) of this section, HHSC provides an agency with an opportunity to correct a violation in accordance with the time frames established in §558.527(g)(2) of this chapter (relating to Post-Survey Procedures) before assessing an administrative penalty if a plan of correction has been implemented.

(d) Minor violations.

(1) HHSC may not assess an administrative penalty for a minor violation unless the violation is of a continuing nature or is not corrected in accordance with an accepted plan of correction.

(2) HHSC may assess an administrative penalty for a subsequent occurrence of a minor violation when cited within three years from the date the agency first received written notice of the violation.

(3) HHSC does not assess an administrative penalty for a subsequent occurrence of a minor violation when cited more than three years from the date the agency first received written notice of the violation.

(e) No opportunity to correct. HHSC may assess an administrative penalty without providing an agency with an opportunity to correct a violation if HHSC determines that the violation:

(1) results in serious harm to or death of a client;

(2) constitutes a serious threat to the health or safety of a client;

(3) substantially limits the agency's capacity to provide care;

(4) involves the provisions of Texas Human Resources Code Chapter 102, Rights of the Elderly;

(5) is a violation in which a person:

(A) makes a false statement, that the person knows or should know is false of a material fact:

(i) on an application for issuance or renewal of a license or in an attachment to the application; or

(ii) with respect to a matter under investigation by HHSC;

(B) refuses to allow a representative of HHSC to inspect a book, record, or file required to be maintained by an agency;

(C) willfully interferes with the work of a representative of HHSC or the enforcement of this chapter;

(D) willfully interferes with a representative of HHSC preserving evidence of a violation of this chapter or a rule, standard, or order adopted, or license issued under this chapter;

(E) fails to pay a penalty assessed by HHSC under this chapter within 10 days after the date the assessment of the penalty becomes final; or

(F) fails to submit:

(i) a plan of correction within 10 days after the date the person receives a statement of licensing violations; or

(ii) an acceptable plan of correction within 30 days after the date the person receives notification from HHSC that the previously submitted plan of correction is not acceptable.

(f) Violations relating to Advance Directives. As provided in Texas Health and Safety Code §142.0145, HHSC assesses an administrative penalty of $500 for a violation of §558.283 of this chapter (relating to Advance Directives) without providing an agency with an opportunity to correct the violation.

(g) Penalty calculation and assessment.

(1) Each day that a violation occurs before the date on which the person receives written notice of the violation is considered one violation.

(2) Each day that a violation occurs after the date on which an agency receives written notice of the violation constitutes a separate violation.

(h) Schedule of appropriate and graduated penalties.

(1) If two or more rules listed in paragraphs (2) and (3) of this subsection relate to the same or similar matter, one administrative penalty may be assessed at the higher severity level violation.

(2) Severity Level A violations.

(A) The penalty range for a Severity Level A violation is $100 - $250 per violation.

(B) A Severity Level A violation is a violation that has or has had minor or no client health or safety significance.

(C) HHSC assesses a penalty for a Severity Level A violation only if the violation is of a continuing nature or was not corrected in accordance with an accepted plan of correction.

(D) HHSC may assess a separate Severity Level A administrative penalty for each of the rules listed in the following table.

Attached Graphic

(3) Severity Level B violations.

(A) The penalty range for a Severity Level B violation is $500-$1,000 per violation.

(B) A Severity Level B violation is a violation that:

(i) results in serious harm to or death of a client;

(ii) constitutes an actual serious threat to the health or safety of a client; or

(iii) substantially limits the agency's capacity to provide care.

(C) The penalty for a Severity Level B violation that:

(i) results in serious harm to or death of a client is $1,000;

(ii) constitutes an actual serious threat to the health or safety of a client is $500 - $1,000; and

(iii) substantially limits the agency's capacity to provide care is $500 - $750.

(D) As provided in subsection (e) of this section, a Severity Level B violation is a violation for which HHSC may assess an administrative penalty without providing an agency with an opportunity to correct the violation.

(E) HHSC may assess a separate Severity Level B administrative penalty for each of the rules listed in the following table.

Attached Graphic

(i) Violations for which HHSC may assess an administrative penalty of $500.

(1) HHSC may assess an administrative penalty of $500 for each of the violations listed in subsection (e)(4) and (5) of this section, without providing an agency with an opportunity to correct the violation.

(2) A separate penalty may be assessed for each of these violations.

(j) Proposal of administrative penalties.

(1) If HHSC assesses an administrative penalty, HHSC provides a written notice of violation letter to an agency. The notice includes:

(A) a summary of the violation;

(B) the amount of the proposed penalty; and

(C) a statement of the agency's right to a formal administrative hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(2) An agency may accept HHSC determination within 20 days after the date on which the agency receives the notice of violation letter, including the proposed penalty, or may make a written request for a formal administrative hearing on the determination.

(A) If an agency notified of a violation accepts HHSC determination, the HHSC executive commissioner or the HHSC executive commissioner's designee issues an order approving the determination and ordering that the agency pay the proposed penalty.

(B) If an agency notified of a violation does not accept HHSC determination, the agency must submit to the Health and Human Services Commission a written request for a formal administrative hearing on the determination and must not pay the proposed penalty. Remittance of the penalty to HHSC is deemed acceptance by the agency of HHSC determination, is final, and waives the agency's right to a formal administrative hearing.

(C) If an agency notified of a violation fails to respond to the notice of violation letter within the required time frame, the HHSC executive commissioner or the HHSC executive commissioner's designee issues an order approving the determination and ordering that the agency pay the proposed penalty.

(D) If an agency requests a formal administrative hearing, the hearing is held in accordance with the Statute §142.0172, §142.0173, 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).
Source Note: The provisions of this §558.602 adopted to be effective January 15, 2009, 34 TexReg 254; amended to be effective September 1, 2010, 35 TexReg 7879; amended to be effective August 1, 2011, 36 TexReg 4673; amended to be effective July 1, 2012, 37 TexReg 4613; amended to be effective October 1, 2013, 38 TexReg 6628; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.603 Court Action]
(a) If a person operates an agency without a license issued under this chapter, the person is liable for a civil penalty of not less than $1,000 or more than $2,500 for each day of violation.

(b) If a person violates the licensing requirements of the Statute, HHSC may petition the district court to restrain the person from continuing the violation.
Source Note: The provisions of this §558.603 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 1, 2006, 31 TexReg 1455; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.604 Surrender or Expiration of a License]
(a) After a survey in which a surveyor cited deficiencies, an agency may surrender its license or allow its license to expire to avoid enforcement action by HHSC.

(b) If an agency surrenders its license before the expiration date, the agency must return its original license and provide the following information to HHSC:

(1) the effective date of closure;

(2) the location of client records;

(3) the name and address of the client record custodian;

(4) a statement signed and dated by the license holder agreeing to the surrender of the license; and

(5) the disposition of active clients at the time of closure.

(c) If an agency surrenders its license or allows its license to expire, HHSC denies an application for license by the agency, its license holder, and its affiliate for one year after the date of the surrender or expiration.
Source Note: The provisions of this §558.604 adopted to be effective June 1, 2006, 31 TexReg 1455; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.

[§558.701 Home Health Aides]
(a) A home health aide may be used by an agency providing licensed home health services if the aide meets one of the following requirements:

(1) a minimum of one year of full-time experience in direct client care in an institutional setting (hospital or nursing facility);

(2) one year of full-time experience within the last five years in direct client care in an agency setting;

(3) satisfactorily completed a training and competency evaluation program that complies with the requirements of this section;

(4) satisfactorily completed a competency evaluation program that complies with the requirements of this section;

(5) submitted to the agency documentation from the director of programs or the dean of a school of nursing that states that the individual is a nursing student who has demonstrated competency in providing basic nursing skills in accordance with the school's curriculum; or

(6) listed on the HHSC nurse aide registry (NAR) with no finding against the aide relating to client abuse or neglect or misappropriation of client property.

(b) A home health aide must have provided home health services within the previous 24 months to qualify under subsection (a)(3) or (4) of this section.

(c) Assignment, delegation, and supervision of services provided by home health aides must be performed in accordance with rules in this chapter governing the agency's license category.

(d) The training portion of a training and competency evaluation program for home health aides must be conducted by or under the general supervision of an RN who possesses a minimum of two years of nursing experience, at least one year of which must be in the provision of home health care. The training program may contain other aspects of learning, but must contain the following:

(1) a minimum of 75 hours as follows:

(A) an appropriate number of hours of classroom instruction; and

(B) a minimum of 16 hours of clinical experience, which will include in-home training and must be conducted in a home, hospital, nursing home, or laboratory;

(2) completion of at least 16 hours of classroom training before a home health aide begins clinical experience working directly with clients under the supervision of qualified instructors;

(3) if LVN instructors are used for the training portion of the program, the following qualifications and supervisory requirements apply:

(A) an LVN may provide the home health aide classroom training under the supervision of an RN who has two years of nursing experience, at least one year of which must be in the provision of home health care;

(B) LVNs, as well as RNs, may supervise home health aide candidates in the course of the clinical experience; and

(C) an RN must maintain overall responsibility for the training and supervision of all home health aide training students; and

(4) an assessment that the student knows how to read and write English and carry out directions.

(e) The classroom instruction and clinical experience content of the training portion of a training and competency evaluation program must include, but is not limited to:

(1) communication skills;

(2) observation, reporting, and documentation of a client's status and the care or service furnished;

(3) reading and recording temperature, pulse, and respiration;

(4) basic infection control procedures and instruction on universal precautions;

(5) basic elements of body functioning and changes in body function that must be reported to an aide's supervisor;

(6) maintenance of a clean, safe, and healthy environment;

(7) recognizing emergencies and knowledge of emergency procedures;

(8) the physical, emotional, and developmental needs of and ways to work with the populations served by the agency including the need for respect for the client and his or her privacy and property;

(9) appropriate and safe techniques in personal hygiene and grooming that include:

(A) bed bath;

(B) sponge, tub, or shower bath;

(C) shampoo, sink, tub, or bed;

(D) nail and skin care;

(E) oral hygiene; and

(F) toileting and elimination;

(10) safe transfer techniques and ambulation;

(11) normal range of motion and positioning;

(12) adequate nutrition and fluid intake;

(13) any other task the agency may choose to have the home health aide perform in accordance with §558.298 of this chapter (relating to Delegation of Nursing Tasks by Registered Professional Nurses to Unlicensed Personnel and Tasks Not Requiring Delegation); and

(14) the rights of the elderly.

(f) This section addresses the requirements for the competency evaluation program or the competency evaluation portion of a training and competency evaluation program.

(1) The competency evaluation must be performed by an RN.

(2) The competency evaluation must address each of the subjects listed in subsection (e)(2) - (13) of this section.

(3) Each of the areas described in subsection (e)(3) and (9) - (11) of this section must be evaluated by observation of the home health aide's performance of the task with a client or person.

(4) Each of the areas described in subsection (e)(2), (4) - (8), (12), and (13) of this section may be evaluated through written examination, oral examination, or by observation of a home health aide with a client.

(5) A home health aide is not considered to have successfully completed a competency evaluation if the aide has an unsatisfactory rating in more than one of the areas described in subsection (e)(2) - (13) of this section.

(6) If an aide receives an unsatisfactory rating, the aide must not perform that task without direct supervision by an RN or LVN, until the aide receives training in the task for which he or she was evaluated as unsatisfactory and successfully completes a subsequent competency evaluation with a satisfactory rating on the task.

(7) If an individual fails to complete the competency evaluation satisfactorily, the individual must be advised of the areas in which he or she is inadequate.

(g) If a person, who is not an agency licensed under this section, desires to implement a home health aide training and competency evaluation program or a competency evaluation program, the person must meet the requirements of this section in the same manner as set forth for an agency.
Source Note: The provisions of this §558.701 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective June 29, 2003, 28 TexReg 4931; amended to be effective April 1, 2004, 29 TexReg 2383; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427.