(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 end stage renal
disease (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 Code of
Federal Regulations, §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). This document may
be obtained by writing the Home and Community Support Services Program, Texas
Department of Human Services, 701 W. 51st Street, Austin, Texas 78751-2321
or calling 438-3011 or writing the United States Department of Health and
Human Services at the Public Health Service, Centers for Disease Control and
Prevention, National Center for Infectious Diseases, Hospital Infection Program,
Mail Stop C01, Atlanta, Georgia 30333, or calling 404-639-2318.
(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
registered nurse 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 a licensed vocational
nurse or registered nurse.
(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 registered
nurse, 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 ten 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.
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