| (i) Orders for hemodialysis treatment shall include
length of treatment, dialyzer, blood flow rate, dialysate composition,
target weight, medications including heparin, and, as needed, specific
infection control measures.
(ii) Orders for peritoneal dialysis treatment shall
include fill volume(s), number of exchanges, dialysate concentrations,
catheter care, medications, and, as needed, specific infection control
measures.
(3) Physician Extenders. If advanced practice registered
nurses or physician assistants are utilized:
(A) there shall be evidence of communication with the
treating physician whenever the advanced practice registered nurse
or physician assistant changes treatment orders;
(B) the advanced practice registered nurse or physician
assistant may not replace the physician in participating in patient
care planning or in QAPI activities;
(C) the advanced practice registered nurse or physician
assistant may not replace the physician for the every two week evaluation
of the in-center dialysis patient;
(D) the advanced practice registered nurse or physician
assistant shall notify the treating physician of patient medical emergencies;
(E) if an advanced practice registered nurse or physician
assistant is utilized, such individuals shall meet the requirements
established by the Texas Board of Nursing (for an advanced practice
registered nurse) or the Texas Medical Board (for a physician assistant);
and
(F) if an advanced practice registered nurse or a physician
assistant is utilized such individuals shall utilize mechanisms which
provide authority for that care. These mechanisms shall include, but
are not limited to protocols or other written authorization. The protocols
or other written authorization shall be jointly developed by the practitioner
and the appropriate physician(s), be signed by both the practitioner
and the physician(s), be reviewed and re-signed at least annually,
be maintained in the practice setting of the practitioner, and be
made available as necessary to the department to verify authority
to provide medical aspects of care.
(j) Home dialysis service.
(1) A dialysis facility that provides home dialysis
training and support shall be approved to provide home dialysis services,
and 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) A facility shall provide a separate room for home
dialysis services.
(A) The room shall include a hand washing sink with
hands-free operable controls, warm water, and soap to facilitate hand
washing. Provisions for hand drying shall be included at each hand
washing sink.
(B) Clean areas shall be clearly designated for the
preparation, handling, and storage of medications and unused supplies
and equipment. Medications or clean supplies shall not be handled
and stored in the same or an immediately adjacent area to that where
used supplies, equipment, or blood samples are handled.
(C) There shall be a designated area in the facility
with a separate sink for the disposal of blood or body fluids. Contaminated
areas where used supplies, equipment, or blood samples are handled
shall be clearly designated.
(3) On completion of training, each individual home
dialysis patient, regardless of modality, shall be assigned one machine
for the patient's exclusive use in the home.
(4) The staffing level for home dialysis patients,
including all modalities, shall be one full-time equivalent registered
nurse per 20 patients, or portion thereof.
(5) The training curriculum for the facility that provides
home dialysis training and support shall be developed and approved
by the medical director of the facility and include, but not be limited
to, the following:
(A) be conducted by a registered nurse with at least
12 months clinical experience and six months experience in the specific
modality with the responsibility for training the patient, and the
patient's caregiver;
(B) be conducted for each home dialysis patient and
address the specific needs of the patient, in the nature and management
of end stage renal disease;
(C) include the full range of techniques associated
with the treatment modality selected, including effective use of dialysis
supplies and equipment in achieving and delivering the physician's
prescription;
(D) training of the patient, and/or caregiver regarding
the effective, and safe administration of erythropoiesis-stimulating
agent(s) (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;
(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.
Cont'd... |
