1. (a) A facility that provides home dialysis training, and support shall ensure through its interdisciplinary team that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable licensure rules.

2. (b) A facility shall provide a separate room for home dialysis services, as defined in §507.2 of this chapter (relating to Definitions).

   1. (1) The room shall include a handwashing sink with water and soap available to facilitate handwashing. Sink faucets shall have a hands-free operation to activate the water flow, which may include a single-lever, wrist blade lever, electronic sensor faucet, or an elbow or wrist action faucet. Provisions for hand drying shall be included at each handwashing sink.
   2. (2) The facility shall clearly designate clean areas for preparing, handling, and storing medications and unused supplies and equipment. Facility staff shall not handle or store medications or clean supplies in the same or an immediately adjacent area where facility staff handle used supplies, equipment, or blood samples.
   3. (3) The facility shall have a designated area with a separate sink for disposal of blood or body fluids. The facility shall clearly designate contaminated areas where staff handle used supplies, equipment, or blood samples.
3. (c) Patients may receive Training (Patient), as defined in §507.2 of this chapter (relating to Definitions), individually or in a small group setting. A facility must offer patients a choice of an individual or small group training setting and ensure the facility meets each patient's preferences and individual needs. Patient training must take place in person.
4. (d) When a patient completes home dialysis training, the facility shall assign each individual home dialysis patient, regardless of modality, one machine for the patient's exclusive use in the home. A facility shall not assign multiple home dialysis patients to the same machine.
5. (e) For home dialysis patients, including all modalities, a facility shall maintain a staffing level of one full-time equivalent registered nurse for every group of 25 patients. For 21 - 25 patients, the facility shall assign a licensed vocational nurse or a dialysis technician to assist the registered nurse.

6. (f) A registered nurse shall conduct home dialysis training. Before permitting a registered nurse to provide home dialysis training to a patient and a patient's caregiver, the facility shall:

   1. (1) verify the registered nurse has:

      1. (A) at least 12 months clinical nursing experience; and
      2. (B) a minimum of three months experience, occurring within the last 24 months, in the specific modality with the responsibility for training the patient and the patient's caregiver;
   2. (2) evaluate and document the nurse's ability to independently provide home dialysis training;
   3. (3) document the nurse's competency to provide home dialysis training three months after passing the initial competency exam; and
   4. (4) ensure all competency evaluations administered under this subsection contain the facility staff's signature evaluating the nurse's competency to provide home dialysis training.

7. (g) A facility's medical director shall develop and approve the home dialysis training curriculum. The home dialysis training curriculum shall comply with the following requirements.

   1. (1) Training for each home dialysis patient shall address the patient's specific needs in the nature and management of end stage renal disease in a manner that complies with all patient privacy and infection control requirements.
   2. (2) Training shall include the full range of techniques associated with the treatment modality selected, including the effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription.

   3. (3) Training of the patient and caregiver, as applicable, shall include:

      1. (A) effective and safe administration of erythropoiesis-stimulating agents (if prescribed) to achieve and maintain a target level hemoglobin, hematocrit, and blood pressure levels, or hematocrit, as written in the patient's plan of care;
      2. (B) how to detect, report, and manage potential dialysis complications, including water treatment problems;
      3. (C) availability of support resources and how to access and use resources;
      4. (D) how to self-monitor health status and record and report health status information;
      5. (E) how to handle medical and nonmedical emergencies;
      6. (F) infection control precautions;
      7. (G) proper waste storage and disposal procedures;
      8. (H) how to order supplies on an ongoing basis;
      9. (I) not using non-medical electrical equipment within six feet of the home hemodialysis machine; and
      10. (J) notifying the facility of any change in machinery used in home dialysis.
   4. (4) Staff shall include documentation in the clinical record that the patient, the caregiver, or both, received and demonstrated adequate comprehension of the training.
8. (h) The interdisciplinary team shall oversee training of a home dialysis patient and the designated caregiver before the initiation of home dialysis, and when the home dialysis caregiver or home dialysis modality changes.
9. (i) A home dialysis training facility shall retrieve and review complete self-monitoring data and other information from the home dialysis self-care patient, or their designated caregiver, at least every two months, and maintain this information in the patient's clinical record in the facility.
10. (j) If a facility is unable to obtain a patient's self-monitoring data after an appropriate number of attempts, the physician must refer the case to the medical director for a determination about a potential modality change for the patient.
11. (k) A home dialysis training facility shall furnish home dialysis support services, regardless of whether dialysis supplies may be provided by the dialysis facility or a durable medical equipment company.

12. (l) A home dialysis training facility shall provide services as follows.

    1. (1) The facility shall complete an initial monitoring visit of the patient's home adaptation by facility personnel (including the registered nurse responsible for training the patient in the chosen modality and technical staff as appropriate) in accordance with the patient's plan of care, before the patient begins training for the selected home modality, and periodically thereafter.

    2. (2) The facility must make a monitoring visit to the patient's home in case of:

       1. (A) patient's change of address,
       2. (B) change in the patient's primary caregiver,
       3. (C) disaster that impacts the patient's home,
       4. (D) major renovation, or
       5. (E) any other event that may impact the patient's care.
    3. (3) A physician, an advanced practice registered nurse, or a physician assistant shall see a home dialysis patient in accordance with §507.52(b)(4) of this subchapter (relating to Medical Services).
    4. (4) The interdisciplinary team shall develop and periodically review an individualized and comprehensive plan of care for the patient. The plan of care shall specify the services necessary to address the patient's needs and meet the measurable and expected outcomes, which meet a hemodialysis Kt/Vurea (Kt/V) of at least 1.2 (three times a week), or standard Kt/V of 2.0 (four to six times a week), or a peritoneal dialysis weekly Kt/V of at least 1.7, or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
    5. (5) The facility shall provide patient consultation with interdisciplinary team members as needed.

13. (m) A home dialysis training facility shall monitor the quality of water and dialysate used by a home hemodialysis patient, including an initial on-site evaluation and testing of the water and dialysate system, and any time facility staff repairs or exchanges the water treatment equipment.

    1. (1) A home dialysis training facility shall annually analyze the product water used for dialysate preparation to ensure the water meets the standards listed in §507.30 of this chapter (relating to Technical Standards).
    2. (2) A home dialysis training facility shall test the water and dialysate system in accordance with the manufacturer's direction for use.
    3. (3) A home dialysis training facility shall test the water and dialysate system in accordance with the system's United States Food and Drug Administration (FDA) approved labeling, for integrated hemodialysis system designed, tested, and validated to meet the quality (including standards for chemical and total chlorine testing) water and dialysate required by standards listed in §507.30 of this chapter. The facility shall meet testing and other requirements of the standards listed in §507.30 of this chapter, when using an integrated water and dialysate system, which is designed and validated to meet the standards listed in §507.30 of this chapter.
    4. (4) A home dialysis training facility shall perform bacteriological and endotoxin testing of water used for dialysate preparation and dialysate monthly and ensure the results are within the limits allowed by the standards listed in §507.30 of this chapter.

14. (n) The dialysis facility shall correct any water and dialysate quality problem for the home hemodialysis patient, and if necessary, arrange for backup dialysis until the facility corrects the problem if:

    1. (1) an analysis of the water and dialysate quality indicates contamination; or
    2. (2) the home hemodialysis patient demonstrates clinical symptoms associated with water and dialysate contamination.
15. (o) The dialysis facility shall be responsible for arranging the purchase, lease, or rental of medically necessary home dialysis supplies and equipment, and the delivery, installation, repair, and maintenance of these supplies and equipment (including supportive equipment), as prescribed by the attending physician. If the patient purchases, leases or rents dialysis equipment, the facility shall ensure the equipment's installation, repair, and maintenance in accordance with the manufacturer's directions for use.
16. (p) The dialysis facility shall identify a plan and arrange for emergency backup dialysis services when needed.
17. (q) The dialysis facility shall maintain a recordkeeping system that ensures continuity of care and patient privacy.
18. (r) The dialysis facility, or the patient or patient's caregiver with facility oversight, shall culture and measure the hemodialysis machines of home patients for colony forming units and endotoxins before disinfection, at least quarterly or more frequently, as needed, or required by the standards listed in §507.30 of this chapter. The facility shall follow the manufacturer's recommendations regarding the proper procedure for disinfection. For integrated hemodialysis system devices, facility staff shall follow the device's FDA labeling and manufacturer's recommendations.
19. (s) As applicable, the facility shall maintain maintenance records for all dialysis machines and dialysis equipment at the licensed facility site.
20. (t) If required, the electrical connection for the home hemodialysis machines shall be connected to a ground-fault circuit interrupter (GFCI) receptacle in accordance with Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements).

21. (u) The dialysis machine shall comply with the requirements of §507.33 of this chapter (relating to Water Treatment). The facility shall ensure that the water pressure in the patient's home meets the minimum requirement specified by the water treatment system's manufacturer.

    1. (1) The facility shall meet the following requirements for an integrated hemodialysis system.

       1. (A) The facility shall analyze the source water used for dialysate annually or if there is a change in the source water, to ensure the water quality meets the manufacturer's guidelines for source water purity.
       2. (B) The facility shall obtain the product water chemical quality every six months before replacing the water purification disposable component, or when any modifications are made to the integrated hemodialysis system to ensure that the product water meets the current CMS guidelines.
       3. (C) The facility shall provide a means for the patient or patient's caregiver to sample the product water to test for total chlorine levels immediately before using the dialysate. The total chlorine level shall comply with the standards listed in §507.30 of this chapter, and the results shall be documented by the patient or the patient's caregiver.
       4. (D) If applicable, the facility, or the patient or patient's caregiver with facility oversight, shall obtain the microbiological quality of the dialysate at the end of a prepared dialysate bag, with the requirements at §507.33 of this chapter and §507.34 of this chapter (relating to Dialysate).
    2. (2) If using a dialysis system that uses manufactured dialysate solution in its existing form, the facility shall use the system according to manufacturer's directions. The facility shall ensure patients receive necessary training and can demonstrate competencies to follow the manufacturer's directions for use.
    3. (3) If using a peritoneal dialysis system that uses manufactured dialysis solution the facility shall use the system according to manufacturer's directions. The facility shall ensure that patients are trained and can demonstrate competencies to follow the manufacturer's directions for use.
    4. (4) If using sorbent technology, the patient or facility staff shall test the sorbent regeneration dialysis system (machine) before each treatment with the manufacturer's self-test method, and the patient or facility staff shall document evidence of the self-test. The facility shall analyze the source water used for dialysate to ensure the water quality meets the manufacturer's guidelines for source water purity annually or if there is a change in the source water.

Source Note:The provisions of this §507.53 adopted to be effective December 23, 2025, 50 TexReg 8289.