| (E) training of the patient, and/or caregiver how to detect, report, and manage potential dialysis complications, including water treatment problems; (F) training of the patient, and/or caregiver regarding the availability of support resources and how to access and use resources; (G) training of the patient, and/or caregiver how to self-monitor health status and record and report health status information; (H) training of the patient, and/or caregiver how to handle medical and nonmedical emergencies; (I) training of the patient, and/or caregiver regarding infection control precautions; (J) training of the patient, and/or caregiver regarding proper waste storage and disposal procedures; (K) training of the patient, and/or caregiver how to order supplies on an ongoing basis; (L) training of the patient, and/or caregiver that non-medical electrical equipment shall not be used within 6 feet of the home hemodialysis machine; and (M) maintain the documentation in the clinical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training. (6) The interdisciplinary team shall oversee training of the home dialysis patient and the designated caregiver before the initiation of home dialysis, and when the home dialysis caregiver or home dialysis modality changes. (7) The dialysis facility shall retrieve and review complete self-monitoring data and other information from the home dialysis self-patient or their designated caregiver(s) at least every two months, and maintain this information in the patient's clinical record in the facility. (8) A home dialysis 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. (9) Services include, but are not limited to, the following: (A) initial monitoring visit of the patient's home adaptation, including visits to the patient's home by facility personnel (including, but not limited to, 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, and no less than annually thereafter. The initial home visit shall be completed prior to the patient beginning training for the selected home modality. (B) The patient shall be seen by the prescribing physician, advanced practice registered nurse, or physician's assistant no less than one time a month. The prescribing physician shall see the patient at least one time every three months, if an advanced practice registered nurse, or physician's assistant sees the patient on a monthly basis. This visit may be conducted in the dialysis facility, at the physician's office, or in the patient's home. (C) The development and periodic review of the patient's individualized comprehensive plan of care that specifies the services necessary to address the patient's needs and meets the measurable and expected outcomes, which meet a hemodialysis Kt/V of at least 1.2 (3 times a week), or standard Kt/V of 2.0 (4-6 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. (D) The facility shall provide patient consultation with members of the interdisciplinary team, as needed. (10) A home dialysis facility shall monitor the quality of water and dialysate used by a home hemodialysis patient including an on-site evaluation and testing of the water and dialysate system initially, and any time repairs or exchanges of the water treatment equipment are made. (A) An AAMI analysis of the product water used for dialysate preparation shall be performed annually. (B) The water and dialysate system shall be tested in accordance with the manufacturer's direction for use. (C) The water and dialysate system shall be tested in accordance with the system's Food and Drug Administration (FDA) approved labeling, for integrated dialysis system designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramines testing) water and dialysate. The facility shall meet testing and other requirements of AAMI RD 52:2004, when using an integrated water and dialysate system, which is designed and validated to meet AAMI quality. (D) The bacteriological and endotoxin testing of water used for dialysate preparation and dialysate shall be performed monthly until results do not exceed 200 CFU/ml and an endotoxin concentration less than 2 EU/ml are obtained for three consecutive months and quarterly thereafter, on a more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits. (11) 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 problem is corrected if: (A) an analysis of the water and dialysate quality indicates contamination; or (B) if the home hemodialysis patient demonstrates clinical symptoms associated with water and dialysate contamination. (12) The dialysis facility shall be responsible for the purchase, lease, or rent, and delivery, installation, repair, and shall maintain medically necessary home dialysis 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 that the equipment is installed, repaired and maintained in accordance with the manufacturer's directions for use.) (13) The dialysis facility shall identify a plan and arrange for emergency backup dialysis services when needed. (14) The dialysis facility shall maintain a record keeping system that ensures continuity of care and patient privacy. (15) Hemodialysis machines of home patients shall be cultured and measured for colony forming units and endotoxins prior to disinfection, if the machine is to be disinfected. (16) All dialysis machines and dialysis equipment shall have maintenance logs maintained at the dialysis facility. (17) The electrical connection for the home hemodialysis machines shall be connected to a GFCI receptacle in accordance with §117.102(i)(8)(F) of this title (relating to Construction Requirements for a New End Stage Renal Disease Facility). (18) Equipment for home hemodialysis includes the conventional (single pass) dialysis machine, the integrated dialysis system, the dialysis system which uses manufactured bagged dialysate, the peritoneal dialysis system which uses manufactured bagged dialysis solution, and the sorbent regeneration system. (A) The conventional (single pass) dialysis machine shall comply with the requirements at §117.31 of this title (relating to Equipment), and §117.32 of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse). The facility shall ensure that the water pressure in the patient's home meets the minimum requirement specified by the manufacturer of the water treatment system. (B) Integrated dialysis system. (i) The facility shall perform an analysis of 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. (ii) The chemical quality of the product water shall be obtained every six months prior to a replacement of the water purification disposable component, or when any modifications are made to the integrated dialysis system to ensure that the product water meets the primary standards of AAMI RD 52:2004. (iii) A means shall be provided to sample the product water to test for chlorine/chloramines levels immediately prior to using the dialysate. Chlorine/chloramines level shall be less that 0.1 mg/L, and the results shall be documented. (iv) The microbiological quality of the dialysate shall be obtained at the end of a prepared dialysate bag, with the requirements at §117.32 of this title. (C) The dialysis system, which uses sterile manufactured bagged dialysate, in its existing form, shall be used according to manufacturer's directions for use. (D) The peritoneal dialysis system, which uses manufactured bagged dialysis solution, shall be used according to manufacturer's directions for use. (E) When sorbent technology is used, the quantity of water used shall not exceed six liters per treatment; and testing for chlorine/chloramines is not required. Prior to each treatment the sorbent regeneration dialysis system (machine) shall be tested through the manufacturer's self-test method, and the evidence of the self-test shall be documented. The facility shall perform an analysis of 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. Cont'd... |
