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

1. (1) Action level--The point at which end stage renal disease (ESRD) facility staff shall take steps to interrupt the trend towards unacceptable levels.
2. (2) Administrator--An individual responsible for implementation and proper application of policies, programs, and services established for the ESRD facility.
3. (3) Advanced practice registered nurse (APRN)--A registered nurse authorized by the Texas Board of Nursing to practice as an advanced practice registered nurse in Texas. The term includes a nurse practitioner and clinical nurse specialist. The term is synonymous with "advanced nurse practitioner" and "advanced practice nurse."
4. (4) Adverse event--An event that results in unintended harm to the patient because of an act of commission or omission by the ESRD facility or ESRD facility staff rather than by the patient's underlying disease or condition or those events affecting patient's family members, visitors, or staff.
5. (5) Applicant--The person who seeks an ESRD facility license from the Texas Health and Human Services Commission (HHSC) and is legally responsible for the ESRD facility's operation, whether by lease or ownership.
6. (6) Architectural inspection--An inspection HHSC conducts to ensure compliance with all applicable federal and state regulations relating to the ESRD facility physical plant and to verify project construction aligns with submitted contract construction documents.
7. (7) Audio-only telecommunication--An interactive, two-way audio communication that uses only sound and that meets the privacy requirements of the federal Health Insurance Portability and Accountability Act. Audio-only includes the use of telephonic communication.
8. (8) Biofilm--A coating on surfaces consisting of microcolonies of bacteria embedded in a protective extracellular matrix. The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and disinfectants.
9. (9) Business day--Any weekday from Monday through Friday that is not a state or national holiday listed in Texas Government Code §662.003.
10. (10) Calendar day--All days, including weekends and holidays.
11. (11) Caregiver--A person trained, qualified, and competent in using a device for the selected modality prescribed to the patient.
12. (12) Charge nurse--A practicing licensed registered nurse in accordance with applicable provisions of law who is responsible for making daily staff assignments based on patient needs, providing immediate supervision and support of patient care, monitoring patients for changes in condition, and communicating with the physician, dietitian, and social worker regarding patient needs.
13. (13) Closed system--A dialysis system for hemodialysis or peritoneal dialysis, that uses sterile manufactured bagged dialysate or dialysate solution.
14. (14) CMS--Centers for Medicare and Medicaid Services.
15. (15) Competency--Demonstrated ability to carry out specified tasks or activities with reasonable skill and safety that adheres to the prevailing standard of practice.
16. (16) Conditions for Coverage (CfCs)--The minimum health and safety rules that all Medicare and Medicaid participating ESRD facilities must meet. The basic health and safety requirements that an ESRD facility must meet to receive payment from the Medicare program.
17. (17) Conventional dialysis system--The ESRD facility's water treatment components and single pass dialysis machines.
18. (18) Core staff members--The ESRD facility's medical director, supervising nurse, dietitian, social worker, administrator, and approved biomedical representative.
19. (19) Corrective action plan--An alternative to enforcement action, as outlined in Texas Health and Safety Code §251.061 (relating to Corrective Action Plan).
20. (20) Delegation--Transfer of the authority to perform a selected task or activity in a selected situation to a qualified and properly trained individual.
21. (21) Dialysate--An aqueous fluid made from water and concentrate, containing electrolytes and usually dextrose that exchanges solutes with blood during hemodialysis that is delivered to the dialyzer by the dialysate supply system. This term does not include peritoneal dialysis fluid.
22. (22) Dialysate supply system--Devices that prepare dialysate on line from water and concentrates, or store and distribute premixed dialysate; circulate the dialysate through the dialyzer; monitor the dialysate for temperature, conductivity, pressure, flow, and blood leaks; and prevent dialysis during disinfection or cleaning modes. The term "devices" as used in this definition includes reservoirs; conduits; proportioning devices for the dialysate; monitors and associated alarms; and controls assembled as a dialysate supply system. The dialysate supply system is often an integral part of single patient dialysis machines.
23. (23) Dialysis--A process to remove dissolved substances from a patient's body by diffusion, osmosis, and convection (ultrafiltration) from one fluid compartment to another across a semipermeable membrane.
24. (24) Dialysis technician--An individual who is not a registered nurse or physician and provides dialysis care under the supervision of a registered nurse or physician. This individual may also be known as a Patient Care Technician (PCT) or Certified Clinical Hemodialysis Technician (CCHT).

25. (25) Dietitian--An individual who:

    1. (A) is currently licensed by the Texas Department of Licensing and Regulation under the laws of this state as a licensed dietitian;
    2. (B) is a registered dietitian; and
    3. (C) has one year of experience in clinical dietetics after becoming a registered dietitian.
26. (26) Direct care staff--Staff who provide hands-on dialysis care to specifically assigned patients during their dialysis treatment (e.g., registered nurse, licensed vocational nurse, patient care technician). These staff members fulfill the patient to staff ratio requirement.
27. (27) Education--Presenting and teaching informative materials, including to licensed ESRD facility's patients, about treatment modalities, options, and overall health literacy. An ESRD facility may conduct education individually or in a group setting.
28. (28) Empty bed contact time (EBCT)--A measure of how much contact occurs between particles, such as activated carbon, and water as the water flows through a bed of the particles. EBCT = (7.48 x V)/Q where V is the volume of particles in the bed (feet), Q is the flow rate of the water through the bed (gallon/minute), and 7.48 is the conversion factor for gallons to feet.
29. (29) End stage renal disease--The stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life (also known as chronic kidney disease stage V).
30. (30) End stage renal disease (ESRD) facility--A facility that provides dialysis treatment or dialysis training and support to individuals with end stage renal disease.
31. (31) ESRD Network--An organization consisting of all Medicare-approved ESRD facilities in the designated geographic area specified by CMS. The network is operated by a corporation that functions under a federal government contract. The network organization is the administrative governing body to the network and acts as a liaison to the Federal government. The network helps ensure quality of care and coordinated delivery of end stage renal disease services.
32. (32) Endotoxin--Lipopolysaccharides consisting of a polysaccharide chain covalently bound to lipid A and the major component of the outer cell wall of gram-negative bacteria.
33. (33) Endotoxin-retentive filter--Membrane filter specifically proven to remove bacteria and endotoxins.
34. (34) Executive commissioner--The executive commissioner of the Texas Health and Human Services Commission.
35. (35) Facility--A contiguous, identifiable location HHSC approved for use as a licensed ESRD facility that is either a freestanding building or a single, distinct, contiguous space in a multi-tenant building.
36. (36) Full-time--The time period established by an ESRD facility as a full working week, as defined and specified in the facility's policies and procedures.
37. (37) Full-time equivalent--Work time equivalent to 2,080 hours per 12 consecutive months.
38. (38) Governing body--The governing authority of a licensed ESRD facility responsible for organization, management, control, operation, and appointment of medical staff. The governing body includes the medical director and representatives of the ESRD facility's owner. The governing body has the overall legal responsibility for the ESRD facility's governance and operation.
39. (39) Health care facility--Any type of facility or home and community support services agency licensed to provide health care in any state or certified for Medicare (Title XVIII) or Medicaid (Title XIX) participation in any state.
40. (40) Home dialysis service--Dialysis performed at home by an end stage renal disease patient or caregiver who has completed an appropriate course of training, as described in §507.53 of this chapter (relating to Home Dialysis Service).
41. (41) Hospital--A entity licensed under Texas Health and Safety Code Chapter 241 (relating to Hospitals), or when exempt from licensure, certified by the United States Department of Health and Human Services as in compliance with conditions of participation for hospitals in Title XVIII, Social Security Act (42 United States Code §1395 et seq.).
42. (42) In-center dialysis--Dialysis provided within the ESRD facility's licensed patient care area.
43. (43) Inspection--A survey conducted by a representative of HHSC to determine whether an applicant or licensee is in compliance with this chapter and Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities).
44. (44) Integrated hemodialysis system--A preconfigured hemodialysis system, as designated by the United States Food and Drug Administration (FDA), in which dialysis-quality water and concentrate is prepared and used at the patient's station in the approved and licensed dialysis unit. In licensed facilities that use this modality of delivery of dialysis services, the conventional water distribution system may not be necessary, as each unit contains its own water purification system, produces dialysate, and makes individualized adjustments as needed.
45. (45) Interdisciplinary team (IDT)--A group composed of the primary dialysis physician, registered nurse, dietitian, and social worker who are responsible for planning care for the patient.
46. (46) Intermediate-level disinfection--A surface treatment using chemical germicides or disinfectants that are capable of inactivating various classes of microorganisms including viruses (primarily medium to large viruses and lipid-containing viruses), fungi, and actively growing bacteria (including tubercle bacteria) when such chemical germicides or disinfectants are used in accordance with the manufacturer's directions for use or per established guidelines. Intermediate-level disinfection is generally not effective in inactivating or eliminating bacterial endospores. Examples of intermediate-level disinfectants include bleach, 70 - 90 percent ethanol or isopropanol, and certain phenolic or iodophor preparations.
47. (47) Licensed nurse--A registered nurse or licensed vocational nurse.
48. (48) Licensed vocational nurse (LVN)--An individual who is currently licensed under Texas Occupations Code Chapter 301 (relating to Nurses) by the Texas Board of Nursing as a licensed vocational nurse, or who holds a valid vocational nursing license with multi-state licensure privilege from another compact state. An LVN may act in the capacity of a dialysis technician after meeting the competency requirements specified in §507.48(o) of this chapter (relating to Nursing Services).

49. (49) Medical director--A physician who:

    1. (A) is board certified in internal medicine by the American Board of Internal Medicine or in pediatrics by the American Board of Pediatrics; has completed a board-approved training program in nephrology; and has at least 12 months of experience providing care to patients receiving dialysis; or
    2. (B) is board certified in nephrology or pediatric nephrology and has at least 12 months of experience providing care to patients receiving dialysis.
50. (50) Medical review board--A review board appointed by the ESRD Network that has a contract with CMS.
51. (51) Modality--A particular treatment option and settings for a patient with end stage renal disease, for example, in-center hemodialysis, home hemodialysis, home peritoneal dialysis, self-care dialysis, nocturnal dialysis, or transplantation.
52. (52) Owner--The legal or governmental entity that holds or will hold a license issued under this chapter and Texas Health and Safety Code Chapter 251.
53. (53) Patient--An individual receiving dialysis treatment or training from an ESRD facility.
54. (54) Patient plan of care--Documentation of the interactive process by which the interdisciplinary team and the patient and family members or guardian develop and implement a plan, based on the assessments performed by the interdisciplinary team members, to assist the end stage renal disease patient in managing the disease and its complications.
55. (55) Pediatric patient--An individual under 18 years of age.
56. (56) Person--An individual, corporation, or other legal entity.
57. (57) Physician--An individual who is licensed by the Texas Medical Board to practice medicine under Texas Occupations Code, Subtitle B, Title 3.
58. (58) Physician assistant--An individual licensed as a physician assistant by the Texas Physician Assistant Board.
59. (59) Plan of Correction (POC)--A written plan developed by the ESRD facility that lists specific actions the ESRD facility will take to correct specific deficiencies of state licensing regulations.
60. (60) Prelicensure conference--A meeting between HHSC staff and the administrator or licensed professional listed on the license application to review licensure standards and provide consultation before HHSC issues a license. The prelicensure conference is not an architectural review feasibility conference.
61. (61) Product water--Water produced by a water treatment system or by an individual component of a system.
62. (62) Progress note--A physical or electronic record of an event dated and signed by facility staff, which summarizes facts about the patient's care and the patient's response during a given time period.
63. (63) Pyrogen--A fever producing substance. Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin.
64. (64) Quality assessment and performance improvement (QAPI)--An ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes. The program implements improvement plans and evaluates the implementation until resolution is achieved.
65. (65) Registered nurse (RN)--An individual currently licensed by the Texas Board of Nursing as a registered nurse, or who holds a valid registered nursing license with multi-state licensure privilege from another compact state.
66. (66) Second-chance patient--A patient voluntarily or involuntarily discharged from a facility, or pending involuntary discharge due to behavioral or compliance issues, chosen by the ESRD Network to participate in the second chance program set forth by the ESRD Network who agrees to receive treatment at another licensed ESRD facility. The patient will have specific behavioral expectations compliance expectations, or both, that shall be achieved and maintained to successfully participate in the second chance program and remain a patient at the accepting facility.
67. (67) Self-care patient--An in-center patient who performs all or part of their dialysis treatment, including, at a minimum, set up and tear down of machinery, holding their own site at termination of treatment, and taking and recording their own vital signs.
68. (68) Self-care service--A service where patients participate in their self-care with supervision by a qualified registered nurse as approved and delegated by the medical director.
69. (69) Single patient device--A dialysis machine, as designated by the FDA, assigned to a patient for individual use at home.

70. (70) Social worker--An individual who:

    1. (A) is currently licensed by the Texas Behavioral Health Executive Council as a social worker under Texas Occupations Code Chapter 505 (relating to Social Workers), and holds a master's degree from a graduate school of social work accredited by the Council on Social Work Education; or
    2. (B) has at least two years of work experience as a social worker, one year of which was in a dialysis facility or transplantation program before September 1, 1976, and has established a consultative relationship with a social worker who has a master's degree from a graduate school of social work accredited by the Council on Social Work Education.
71. (71) Sorbent regeneration system--A system that regenerates dialysate by passing the dialysate through substances that restore the dialysate to a condition comparable to fresh dialysate.
72. (72) Station--An area in the ESRD facility in which a patient receives in-center hemodialysis treatment, or dialysis instruction, such as home hemodialysis training or home peritoneal dialysis training.

73. (73) Supervising nurse (Director of Nursing)--A registered nurse who has:

    1. (A) clinical experience including:

       1. (i) at least 12 months of clinical nursing experience as an RN, and
       2. (ii) an additional 6 months of experience in dialysis obtained within the last 24 months, or
    2. (B) at least 18 months experience as an RN and holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis.

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

    1. (A) Immediate supervision--The supervisor is observing the task or activity as it is performed.
    2. (B) Direct supervision--The supervisor is at the licensed ESRD facility site but not necessarily immediately physically present where the task or activity is being performed.
    3. (C) Indirect supervision--The supervisor is not at the licensed ESRD facility site but is accessible by two-way communication, able to respond to an inquiry when made, and readily available for consultation.
75. (75) Technical supervisor--The supervisor of the ESRD facility's mechanical, reuse, and water treatment systems.
76. (76) Telehealth or telehealth service--A health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state and acting within the scope of the health professional's license, certification, or entitlement to a patient at a different physical location than the health professional using telecommunications or information technology, in accordance with Texas Occupations Code Chapter 111 (relating to Telemedicine, Teledentistry, and Telehealth).
77. (77) Telemedicine or telemedicine medical service--A health care service delivered by a physician licensed in this state, or a health professional acting under the delegation and supervision of a physician licensed in this state, and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or information technology, in accordance with Texas Occupations Code Chapter 111.
78. (78) Training (Patient)--The process of developing, practicing, and maintaining specific skills of an individual patient related to the patient's home dialysis treatment modality, including self-care, home hemodialysis, peritoneal dialysis, and other modalities. Patient training must meet the requirements in §507.53 of this chapter.
79. (79) Training (Staff)--The process of teaching tasks through on-the-job experience or instruction from an individual who has the capacity through education or experience to perform the delegated task or activity.
80. (80) Transitional care--Services to transition a patient from a current modality to a self-care modality in-center or at home.
81. (81) Transitional services--In-center dialysis intended to transition a patient from a current modality to a self-care modality whether in-center or at home.
82. (82) Ultrafilter--A membrane filter with a pore size in the range of 0.001 to 0.05 micrometer. Performance is usually rated in terms of a nominal molecular weight cut off (MWCO), which is defined as the smallest molecular weight species for which the filter membrane has more than 90 percent rejection.
83. (83) Water distribution system--Storage tanks and piping used to distribute the product water from the purification cascade to or from its point of use, including individual hemodialysis machines, dialyzer reprocessing equipment, and dialysate concentrate preparation systems.
84. (84) Water treatment system--A collection of water purification devices and associated piping, pumps, valves, gauges, and other related components that together produce purified water for hemodialysis applications and deliver it to the point of use.

Source Note:The provisions of this §507.2 adopted to be effective December 23, 2025, 50 TexReg 8289.