The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.
  (1) Action level--The point at which steps shall be taken to interrupt the trend towards unacceptable levels.
  (2) Administrator--A person who is delegated the responsibility for the implementation and proper application of policies, programs, and services established for the end stage renal disease facility.
  (3) Advanced practice registered nurse (APRN)--A registered nurse who is currently licensed and authorized by the Texas Board of Nursing to practice.
  (4) Adverse event--An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient or those events affecting patient's family members, visitors, or staff.
  (5) Affiliate--An applicant or owner which is:
    (A) a corporation--includes each officer, consultant, stockholder with a direct ownership of at least 5.0%, subsidiary, and parent company;
    (B) a limited liability company--includes each officer, member, and parent company;
    (C) an individual--includes:
      (i) an individual;
      (ii) an individual's spouse if the spouse is actively involved in the management of the facility;
      (iii) each partnership and each partner thereof of which the individual or any affiliate of the individual is a partner; and
      (iv) each corporation in which the individual is an officer, consultant, or stockholder with direct ownership of at least 5.0%.
    (D) a partnership--includes each partner and any parent company; and
    (E) a group of co-owners under any other business arrangement--includes each officer, consultant, or the equivalent under the specific business arrangement and each parent company.
  (6) Applicant--The owner of an end stage renal disease facility which is applying for a license under the statute. This is the person in whose name the license is issued.
  (7) 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.
  (8) Caregiver--A person trained, qualified, and competent in the use of a device for the selected modality prescribed by the physician.
  (9) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership and the tax identification number of the partnership changes; or a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility's ownership to another person or persons and the tax identification number of the corporation changes.
  (10) Charge nurse--A registered nurse practicing nursing in accordance with applicable provisions of law who is responsible for making daily staff assignments based on patient needs, providing immediate supervision of patient care, monitoring patients for changes in condition, and communicating with the physician, dietician, and social worker regarding patient needs.
  (11) Closed system--A dialysis system, hemodialysis or peritoneal dialysis, which uses sterile manufactured bagged dialysate, or dialysate solution.
  (12) CMS--Centers for Medicare and Medicaid Services.
  (13) Commissioner--The commissioner of the Department of State Health Services.
  (14) Competency--The demonstrated ability to carry out specified tasks or activities with reasonable skill and safety that adheres to the prevailing standard of practice.
  (15) Conventional dialysis system--The facility's water treatment components and single pass dialysis machines.
  (16) Core staff members--The facility's medical director, supervising nurse, dietitian, social worker, administrator, and chief technician.
  (17) Corrective action plan--A written strategy for correcting a licensing violation. The corrective action plan is developed by the facility and addresses the system(s) operation(s) of the facility as the system(s) operation(s) applies to the deficiency.
  (18) Delegation--The transfer to a qualified and properly trained individual of the authority to perform a selected task or activity in a selected situation.
  (19) Department--The Department of State Health Services.
  (20) Dialysate--An aqueous fluid containing electrolytes and usually dextrose, which is intended to exchange solutes with blood during hemodialysis. The word "dialysate" is used throughout this document to mean the fluid made from water and concentrate which is delivered to the dialyzer by the dialysate supply system. Such phrases as "dialyzing fluid" or "dialysis solution" may be used in place of dialysate. It does not include peritoneal dialysis fluid.
  (21) 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 includes reservoirs; conduits; proportioning devices for the dialysate; and monitors, associated alarms, and controls assembled as a system for the characteristics listed above. The dialysate supply system is often an integral part of single-patient dialysis machines.
  (22) Dialysis--A process by which dissolved substances are removed from a patient's body by diffusion, osmosis, and convection (ultrafiltration) from one fluid compartment to another across a semipermeable membrane.
  (23) Dialysis technician--An individual who provides hands on dialysis care to specifically assigned patients during their dialysis treatment under the direct supervision of a registered nurse. If unlicensed, this individual may also be known as a patient care technician.
  (24) Dietitian--A person who is currently licensed under the laws of this state to use the title of licensed dietitian, is a registered dietitian, and has one year of experience in clinical dietetics after becoming a registered dietitian.
  (25) 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).
  (26) Director--The director of the Patient Quality Care Unit of the department or his or her designee.
  (27) 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 xV)/Q where V is the volume of particles in the bed (feet3 ), Q is the flow rate of the water through the bed (gallon/minute), and 7.48 is the conversion factor for gallons to feet3 .
  (28) End stage renal disease (ESRD)--That 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).
  (29) End stage renal disease facility--A facility that provides dialysis treatment or dialysis training and support to individuals with end stage renal disease.
  (30) 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.
  (31) Endotoxin-retentive filter--Membrane filter specifically proven to remove bacteria and endotoxins.
  (32) EOC--Emergency Operations Center in local jurisdictions.
  (33) Full-time--The time period established by a facility as a full working week, as defined and specified in the facility's policies and procedures.
  (34) Full-time equivalent--Work time equivalent to 2,080 hours per 12 consecutive months.
  (35) Governing body--An identified group, which includes the medical director and a representative(s) of the owner of the facility, with full legal authority and responsibility for the governance and operation of the facility.
  (36) Ground fault circuit interrupters (GFCI)--GFCI receptacles shall be provided for all general use receptacles located within three feet of a wash basin or sink. When GFCI receptacles are used, they shall be connected to not affect other devices connected to the circuit in the event of a trip. Receptacles connected to the critical branch that may be used for equipment that should not be interrupted do not have to be GFCI protected. Receptacles in wet locations, as defined by National Fire Protection Association (NFPA) 70, §517.20 and $517.21, shall be GFCI protected regardless of the branch of the electrical system serving the receptacle.
Cont'd...
(37) 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.
  (38) 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 §117.45(j) of this title (relating to Provision and Coordination of Treatment and Services).
  (39) Hospital--A facility that is licensed under the Texas Hospital Licensing Law, Health and Safety Code, Chapter 241, or if 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.).
  (40) Incident--Death of a dialysis patient, which occurs in the facility, at home, or in a hospital; hospital transfers; conversion of staff or a patient to hepatitis B surface antigen (HbsAg) positive; involuntary transfer or discharge of a patient; and a fire in the ESRD facility.
  (41) Inspection--An investigation or survey conducted by a representative of the department to determine if an applicant or licensee is in compliance with this chapter.
  (42) Integrated dialysis system--A preconfigured system which incorporates water treatment and dialysis preparation and delivery into one system.
  (43) Interdisciplinary team (IDT)--A group composed of the primary dialysis physician, the registered nurse, the dietitian, and the social worker who are responsible for planning care for the patient.
  (44) Intermediate-level disinfection--A surface treatment using chemical germicides or disinfectants which are capable of inactivating various classes of microorganisms including, but not limited to, 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% ethanol or isopropanol, and certain phenolic or iodophor preparations.
  (45) Licensed nurse--A registered nurse or licensed vocational nurse.
  (46) Licensed vocational nurse (LVN)--A person who is currently licensed under the Nursing Practice Act 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, and who may provide dialysis treatment after meeting the competency requirements specified for dialysis technicians.
  (47) Manager--An individual approved or selected by the department who assumes overall management of an end stage renal disease facility to ensure adequate and safe services are provided to patients.
  (48) Medical director--A physician who:
    (A) is board certified in internal medicine by the American Board of Internal Medicine or 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
    (B) is board certified in nephrology or pediatric nephrology and has at least 12 months of experience providing care to patients receiving dialysis.
  (49) Medical review board (MRB)--A medical review board that is appointed by a renal disease network organization which includes this state, with the network having a contract with the Centers for Medicare and Medicaid Services of the United States Department of Health and Human Services under 42 United States Code §1395rr.
  (50) Modality--Different treatment options and settings for patients with end stage renal disease, for example, in-center dialysis, home hemodialysis, peritoneal dialysis, self-care dialysis, nocturnal dialysis, and transplantation.
  (51) Monitor--An individual approved or selected by the department who observes, supervises, consults, and educates a facility to correct identified violations of the statute or this chapter.
  (52) Owner--One of the following which holds or will hold a license issued under the statute in the person's name or the person's assumed name:
    (A) a corporation;
    (B) a limited liability company;
    (C) an individual;
    (D) a partnership if a partnership name is stated in a written partnership agreement or an assumed name certificate;
    (E) all partners in a partnership if a partnership name is not stated in a written partnership agreement or an assumed name certificate; or
    (F) all co-owners under any other business arrangement.
  (53) Patient--An individual receiving dialysis treatment or training from an end stage renal disease facility.
  (54) Patient plan of care--Documentation of the interactive process whereby the interdisciplinary team and the patient and/or family member or guardian develop and implement a plan, based on the assessments preformed by the interdisciplinary team members, to assist the end stage renal disease patient in managing the disease and its complications.
  (55) Pediatric patient--An individual from birth and continuing through 18 years of age.
  (56) Person--An individual, corporation, or other legal entity.
  (57) Physician--A physician licensed by the Texas Medical Board.
  (58) Physician assistant--A person licensed as a physician assistant by the Texas Medical Board.
  (59) Physician extender--A health care provider (advanced practice registered nurse or physician assistant) who is not a physician but who performs medical activities typically performed by a physician.
  (60) Presurvey conference--A conference held with department staff and the applicant or his or her representatives to review licensure standards and survey documents and provide consultation prior to the issuance of the license. The applicant's representatives shall include an individual who will be responsible for the day-to-day supervision of care by the facility.
  (61) Product water--Water produced by a water treatment system or by an individual component of a system.
  (62) Progress note--A 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 period of time.
  (63) Pyrogen--A fever producing substance. Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin.
  (64) Quality assessment and performance improvement (QAPI)--An ongoing program which measures, analyzes, and tracks quality indicators related to improve health outcomes. The program implements improvement plans and evaluates the implementation until resolution is achieved.
  (65) Registered nurse (RN)--A person who is 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) Self-care patients--In-center patients who perform all or part of their dialysis treatments.
  (67) Social worker--A person who:
    (A) is currently licensed as a social worker under the Occupations Code, Chapter 505, and holds a master's degree from a graduate school of social work accredited by the Council on Social Work Education; or
    (B) has worked for at least two years as a social worker, one year of which was in a dialysis facility or transplantation program prior to 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.
  (68) 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.
  (69) Station--An area in the facility in which a patient receives in-center dialysis treatment, or dialysis instruction, (i.e., home hemodialysis training, or peritoneal dialysis training).
  (70) Statute--The Health and Safety Code, Chapter 251.
  (71) Supervising nurse (also may be known as the director of nursing)--A registered nurse who:
    (A) has at least 18 months experience as an RN, which includes at least 12 months experience in dialysis which has been obtained within the last 24 months; or
Cont'd...
(B) has at least 18 months experience as an RN, and holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis.
  (72) 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. Immediate supervision means the supervisor is actually observing the task or activity as it is performed. Direct supervision means the supervisor is on the premises but not necessarily immediately physically present where the task or activity is being performed. Indirect supervision means the supervisor is not on the premises but is accessible by two-way communication and able to respond to an inquiry when made, and is readily available for consultation.
  (73) Technical supervisor--The supervisor of the facility's mechanical, reuse and water treatment systems.
  (74) Training--The learning of tasks through on-the-job experience or instruction by an individual who has the capacity through education or experience to perform the task or activity to be delegated.
  (75) Ultrafilter--A membrane filter with a pore size in the range 0.001 to 0.05 micron (µm). 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% rejection. Ultrafilters with a nominal MWCO of 20,000 or less are generally adequate for endotoxin removal.
  (76) Water distribution systems--Components to include any 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.
  (77) Water treatment system--A collection of water purification devices and associated piping, pumps, valves, gauges, etc., that together produce purified water for hemodialysis applications and deliver it to the point of use.
  (78) Working day--Any day of the calendar week excluding Saturday or Sunday or holidays.

Source Note: The provisions of this §117.2 adopted to be effective July 6, 2010, 35 TexReg 5835