Or. Admin. R. 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.
Notes
Statutory/Other
Statutes/Other Implemented: ORS 441.025
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