(ii) The licensed nurse must pass a written skills
examination or competency evaluation at the conclusion of the orientation
program and prior to the time the licensed nurse delivers independent
client care.
(B) The licensed nurse must complete the required classroom
component as described in paragraph (1)(A) - (E), (K) - (O), (Q) and
(R) of this subsection and satisfactorily demonstrate the skills described
in paragraph (1)(F) - (J) and (P) of this subsection. The orientation
program may be waived by successful completion of the written examination
as described in subparagraph (A)(ii) of this paragraph.
(C) The supervising nurse or qualified designee must
complete an orientation competency skills checklist for each licensed
nurse to reflect the progression of learned skills, as described in
subsection (f)(1) of this section.
(D) Prior to the delivery of independent client care,
the supervising nurse or qualified designee must directly supervise
the licensed nurse for a minimum of three dialysis treatments and
ensure satisfactory performance. Dependent upon the trainee's experience
and accomplishments on the skills checklist, additional supervised
dialysis treatments may be required.
(E) Continuing education for employees must be provided
quarterly.
(F) Performance evaluations must be done annually.
(G) The supervising nurse or qualified designee must
provide direct supervision to the licensed nurse providing dialysis
services monthly, or more often if necessary. Direct supervision means
that the supervising nurse is on the premises but not necessarily
immediately present where dialysis services are being provided.
(g) Hospital transfer procedure. An agency must establish
an effective procedure for the immediate transfer to a local Medicare-certified
hospital for clients requiring emergency medical care. The agency
must have a written transfer agreement with such a hospital, or all
physician members of the agency's medical staff must have admitting
privileges at such a hospital.
(h) Backup dialysis services. An agency that supplies
home staff-assisted dialysis must have an agreement with a licensed
ESRD facility to provide backup outpatient dialysis services.
(i) Coordination of medical and other information.
An agency must provide for the exchange of medical and other information
necessary or useful in the care and treatment of clients transferred
between treating facilities. This provision must also include the
transfer of the client care plan, hepatitis B status, and long-term
program.
(j) Transplant recipient registry program. An agency
must ensure that the names of clients awaiting cadaveric donor transplantation
are entered in a recipient registry program.
(k) Testing for hepatitis B. An agency must conduct
routine testing of home dialysis clients and agency employees to ensure
detection of hepatitis B in employees and clients.
(1) An agency must offer hepatitis B vaccination to
previously unvaccinated, susceptible new staff members in accordance
with 29 CFR §1910.1030(f)(1) - (2) (Bloodborne Pathogens).
(A) Staff vaccination records must be maintained in
each staff member's personnel file.
(B) New staff members providing home dialysis care
must be screened for hepatitis B surface antigen (HBsAg) and the results
reviewed prior to the staff providing client care, unless the new
staff member provides the agency documentation of positive serologic
response to hepatitis B vaccine.
(C) An agency must establish, implement, and enforce
a policy for repeated serologic screening of staff. The repeated serologic
screening must be based on each staff member's HBsAg/antibody to HBsAg
(anti-HBs) and must be congruent with Appendices i and ii of the National
Surveillance of Dialysis Associated Disease in the United States,
1993, published by the United States Department of Health and Human
Services (USDHHS).
(2) With the advice and consent of a client's nephrologist
or attending physician, an agency must make the hepatitis B vaccine
available to a client who is susceptible to hepatitis B, provided
that the client has coverage or is willing to pay for vaccination.
(A) An agency must make available to clients literature
describing the risks and benefits of the hepatitis B vaccination.
(B) Candidates for home dialysis must be screened for
HBsAg within one month before or at the time of admission to the agency.
(C) Repeated serologic screening must be based on the
antigen or antibody status of the client.
(D) Monthly screening for HBsAg is required for clients
whose previous test results are negative for HBsAg.
(E) Screening of HbsAg-positive or anti-HbsAg-positive
clients may be performed on a less frequent basis, provided that the
agency's policy on this subject remains congruent with Appendices
i and ii of the National Surveillance of Dialysis Associated Diseases
in the United States, 1993, published by the USDHHS.
(l) CPR certification. All direct client care employees
must have current CPR certification.
(m) Initial admission assessment. Assessment of the
client's residence must be made to ensure a safe physical environment
for the performance of dialysis. The initial admission assessment
must be performed by a qualified RN who meets the qualifications under
subsection (e)(1)(A) of this section.
(n) Client long-term program. The agency must develop
a long-term program for each client admitted to home dialysis. Criteria
must be defined in writing and must provide guidance to the agency
in the selection of clients suitable for home staff-assisted dialysis
and in noting changes in a client's condition that would require discharge
from the program. For the purposes of this subsection, Long-term program
means the written documentation of the selection of a suitable treatment
modality and dialysis setting, which has been selected by the client
and the interdisciplinary team.
(o) Client history and physical. The agency must ensure
that the history and physical is conducted upon the client's admission,
or no more than six months prior to the date of admission, then annually
after the date of admission.
(p) Physician orders. If home staff-assisted dialysis
is selected, the physician must prepare orders outlining specifics
of prescribed treatment.
(1) If these physician's orders are received verbally,
they must be confirmed in writing within a reasonable time frame.
An agency must adopt and enforce a policy on the time frame for the
countersignature of a physician's verbal orders. Medical orders for
home staff-assisted dialysis must be revised as necessary but reviewed
and updated at least every six months.
(2) The initial orders for home staff-assisted dialysis
must be received prior to the first treatment and must cover all pertinent
diagnoses, including mental status, prognosis, functional limitations,
activities permitted, nutritional requirements, medications and treatments,
and any safety measures to protect against injury. Orders for home
staff-assisted dialysis must include frequency and length of treatment,
target weight, type of dialyzer, dialysate, dialysate flow rate, heparin
dosage, and blood flow rate, and must specify the level of preparation
required for the caregiver, such as an LVN or RN.
(q) Client care plan. The client care plan must be
developed after consultation with the client and the client's family
by the interdisciplinary team. The interdisciplinary team must include
the physician, the RN, the dietitian, and the qualified social worker
responsible for planning the care delivered to the home staff-assisted
dialysis patient.
(1) The initial client care plan must be completed
by the interdisciplinary team within 10 calendar days after the first
home dialysis treatment.
(2) The client care plan must implement the medical
orders and must include services to be rendered, such as the identification
of problems, methods of intervention, and the assignment of health
care personnel.
(3) The client care plan must be in writing, be personalized
for the individual, and reflect the ongoing medical, psychological,
social, nutritional, and functional needs of the client, including
treatment goals.
(4) The client care plan must include written evidence
of coordination with other service providers, such as dialysis facilities
or transportation providers, as needed to assure the provision of
safe care.
(5) The client care plan must include written evidence
of the client's or client's legal representative's input and participation,
unless they refuse to participate. At a minimum, the client care plan
must demonstrate that the content was shared with the client or the
client's legal representative.
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