|(a) License designation. An agency may not provide
peritoneal dialysis or hemodialysis services in a client's residence,
independent living environment, or other appropriate location unless
the agency holds a license to provide licensed home health or licensed
and certified home health services and designated to provide home
dialysis services. In order to receive a home dialysis designation,
the agency must meet the licensing standards specified in this section
and the standards for home health services in accordance with Subchapter
C of this chapter (relating to Minimum Standards for All Home and
Community Support Services Agencies) and §558.401 of this subchapter
(relating to Standards Specific to Licensed Home Health Services),
except for §558.401(b)(2)(A) and (B) of this subchapter. If there
is a conflict between the standards specified in this section and
those specified in Subchapter C of this chapter and §558.401
of this subchapter, the standards specified in this section will apply
to the home dialysis services.
(b) Governing body. An agency must have a governing
body. The governing body must appoint a medical director and the physicians
who are on the agency's medical staff. The governing body must annually
approve the medical staff policies and procedures. The governing body
on a biannual basis must review and consider for approval continuing
privileges of the agency's medical staff. The minutes from the governing
body of the agency must be on file in the agency office.
(c) Qualifications and responsibilities of the medical
(1) Qualifications. The medical director must be a
physician licensed in the State of Texas who:
(A) is eligible for certification or is certified in
nephrology or pediatric nephrology by a professional board; or
(B) during the five-year period prior to September
1, 1996, served at least 12 months as director of a dialysis facility
(2) Responsibilities. The medical director must:
(A) participate in the selection of a suitable treatment
modality for all clients;
(B) assure adequate training of nurses in dialysis
(C) assure adequate monitoring of the client and the
dialysis process; and
(D) assure the development and availability of a client
care policy and procedures manual and its implementation.
(d) Personnel files. An agency must have individual
personnel files on all physicians, including the medical director.
The file must include the following:
(1) a curriculum vitae which documents undergraduate,
medical school, and all pertinent post graduate training; and
(2) evidence of current licensure, and evidence of
current United States Drug Enforcement Administration certification,
Texas Department of Public Safety registration, and the board eligibility
or certification, or the experience or training described in subsection
(c)(1) of this section.
(e) Provision of services. An agency that provides
home staff-assisted dialysis must, at a minimum, provide nursing services,
nutritional counseling, and medical social service. These services
must be provided as necessary and as appropriate at the client's home,
by telephone, or by a client's visit to a licensed ESRD facility in
accordance with this subsection. The use of dialysis technicians in
home dialysis is prohibited.
(1) Nursing services.
(A) An RN, licensed by the State of Texas, who has
at least 18 months experience in hemodialysis obtained within the
last 24 months and has successfully completed the orientation and
skills education described in subsection (f) of this section, must
be available whenever dialysis treatments are in progress in a client's
home. The agency administrator must designate a qualified alternate
to this RN.
(B) Dialysis services must be supervised by an RN who
meets the qualifications for a supervising nurse as set out in §558.244(c)(2)
of this chapter (relating to Administrator Qualifications and Conditions
and Supervising Nurse Qualifications).
(C) Dialysis services must be provided by a qualified
licensed nurse who:
(i) is licensed as an RN or LVN by the State of Texas;
(ii) has at least 18 months experience in hemodialysis
obtained within the last 24 months; and
(iii) has successfully completed the orientation and
skills education described in subsection (f) of this section.
(2) Nutritional counseling. A dietitian who meets the
qualifications of this paragraph must be employed by or under contract
with the agency to provide services. A qualified dietitian must meet
the definition of dietitian in §558.2 of this chapter (relating
to Definitions) and have at least one year of experience in clinical
nutrition after obtaining eligibility for registration by the American
Dietetic Association, Commission on Dietetic Registration.
(3) Medical social services. A social worker who meets
the qualifications established in this paragraph must be employed
by or be under contract with the agency to provide services. A qualified
social worker is a person who:
(A) is currently licensed under the laws of the State
of Texas as a social worker and has a master's degree in social work
from a graduate school of social work accredited by the Council on
Social Work Education; or
(B) has served for at least two years as a social worker,
one year of which was in a dialysis facility or program prior to September
1, 1976, and has established a consultative relationship with a licensed
master social worker.
(f) Orientation, skills education, and evaluation.
(1) All personnel providing dialysis in the home must
receive orientation and skills education and demonstrate knowledge
of the following:
(A) anatomy and physiology of the normal kidney;
(B) fluid, electrolyte, and acid-base balance;
(C) pathophysiology of renal disease;
(D) acceptable laboratory values for the client with
(E) theoretical aspects of dialysis;
(F) vascular access and maintenance of blood flow;
(G) technical aspects of dialysis;
(H) peritoneal dialysis catheter, testing for peritoneal
membrane equilibration, and peritoneal dialysis adequacy clearance,
(I) the monitoring of clients during treatment, beginning
with treatment initiation through termination;
(J) the recognition of dialysis complications, emergency
conditions, and institution of the appropriate corrective action.
This includes training agency personnel in emergency procedures and
how to use emergency equipment;
(K) psychological, social, financial, and physical
complications of chronic dialysis;
(L) care of the client with chronic renal failure;
(M) dietary modifications and medications for the uremic
(N) alternative forms of treatment for ESRD;
(O) the role of renal health team members (physician,
nurse, social worker, and dietitian);
(P) performance of laboratory tests (hematocrit and
(Q) the theory of blood products and blood administration;
(R) water treatment to include:
(i) standards for treatment of water used for dialysis
as described in §3.2.1 (Hemodialysis Systems) and §3.2.2
(Maximum Level of Chemical Contaminants) of the American National
Standard, Hemodialysis Systems, March 1992 Edition, published by the
Association for the Advancement of Medical Instrumentation (AAMI),
3330 Washington Boulevard, Suite 500, Arlington, Virginia 22201. Copies
of the standards are indexed and filed in the Texas Health and Human
Services Commission, 701 W. 51st Street, Austin, Texas 78751, and
are available for public inspection during regular working hours;
(ii) systems and devices;
(iii) monitoring; and
(iv) risks to clients of unsafe water.
(2) The requirements for the orientation and skills
education period for licensed nurses are as follows.
(A) The agency must develop an 80-hour written orientation
program that includes classroom theory and direct observation of the
licensed nurse performing procedures on a client in the home.
(i) The orientation program must be provided by an
RN qualified under subsection (e)(1) of this section to supervise
the provision of dialysis services by a licensed nurse.
(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
(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
(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
(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
(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.