333-700-0073 Outpatient Mobile Dialysis (1) A dialysis facility that provides staff assisted hemodialysis in a patient's home must: (a) Be licensed as an outpatient renal dialysis facility; and (b) Have a centralized, secure location, where the patient, water quality, equipment maintenance, quality assurance and other records are available for review by the Division. (2) A facility must obtain written approval from the Authority prior to implementation of the provision of outpatient mobile dialysis services. The Authority may conduct a survey to determine compliance with this rule. (3) Hemodialysis treatments must be performed by an individual currently licensed or certified in Oregon as a certified hemodialysis technician, registered nurse or licensed practical nurse who: (a) Has at least six months of experience in caring for hemodialysis patients; and (b) Has completed, prior to providing assisted hemodialysis treatments in a patient's home, a training program and skills checklist specific to care of hemodialysis patients in the patient’s home and management of complications. (4) The dialysis facility RN responsible for patient care shall ensure that individuals performing hemodialysis in a patient’s home meet the qualifications in section (3) of this rule and shall document such qualifications and provide the documentation to the Division upon request. (5) The facility must ensure that the water and dialysate testing and other requirements of American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) 13959:2014, Water for Hemodialysis and Related Therapies, and the ANSI/AAMI 26722:2014, Water Treatment Equipment for Hemodialysis and Related Therapies, adopted by reference, are met. In addition, bacteriological and endotoxin testing must be performed on a quarterly or more frequent basis as needed, to ensure that the quality of the water and dialysate meets these AAMI requirements. (6) The dialysis facility must correct any water and dialysate quality problems for the home hemodialysis patient. (a) A record of any preventive hemodialysis machine maintenance as required by the manufacturer's directions for use must be maintained and any breakdowns repaired; and (b) The facility must arrange for backup dialysis until water quality and mechanical problems are corrected. (7) If staff assisted outpatient mobile dialysis is provided in a health care facility providing 24/7 onsite nursing services the following additional requirement must be met: (a) The staffing ratio for staff assisted home dialysis must be one licensed nurse or CHDT per patient unless the following conditions are met: (A) The patients are located in one room in which they are visible from a central location within that room; and (B) There is a second staff member, who is a registered nurse, with at least six months dialysis experience. (b) Should the requirements in paragraphs (a)(A) and (B) of this section be met, the staffing ratio must be dependent on the acuity and needs of the patients as determined by the dialysis facility RN or the patient's nephrologist. In no case shall the staffing ratio be greater than three patients per one qualified staff member while patients are undergoing hemodialysis treatments. (c) There must be an agreement between the dialysis facility and the care facility specifying the expectations of each party, to ensure the coordination of individual patient care needs. (d) Policies and procedures regarding care of the hemodialysis patient must be in place for both the care facility and dialysis facility. (e) If the staff assisted hemodialysis is performed by a CHDT there must be an RN on duty, and accessible, in the care facility who has documented training in the care of hemodialysis patients including, but not limited to, common ESRD related medications, IV medications commonly given during dialysis, potential complications of hemodialysis, assessment of ESRD patients, and treatment of those complications. This training shall be updated annually. (f) There must be documentation reflecting that: (A) On the day of dialysis prior to the initiation of the hemodialysis treatment, the care facility RN has assessed the patient and consulted with the dialysis facility RN; and (B) The CHDT providing the hemodialysis treatment must consult with the care facility RN before and after the hemodialysis treatment. (g) The dialysis facility RN must be available at all times for consultation while the patient is undergoing hemodialysis treatment. Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 18-2019, amend filed 10/01/2019, effective 01/01/2020 PH 4-2012, f. 3-30-12, cert. ef. 4-1-12