(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 title (relating to Minimum Standards for All Home and
Community Support Services Agencies) and §97.401 of this title (relating
to Standards Specific to Licensed Home Health Services) except for §97.401(b)(2)(A)
and (B) of this title (relating to Standards Specific to Licensed Home Health
Services). If there is a conflict between the standards specified in this
section and those specified in Subchapter C of this title (relating to Minimum
Standards for All Home and Community Support Services Agencies) §97.401
of this title (relating to Standards Specific to Licensed Home Health Services),
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 director.
(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 or program.
(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 techniques;
(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) A registered nurse (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 registered nurse.
(B) Dialysis services must be supervised by an RN who meets
the qualifications for a supervising nurse as set out in §97.244(b)(3)
of this title (relating to Staffing Qualifications).
(C) Dialysis services must be provided by a qualified licensed
nurse who:
(i) is licensed as a registered or licensed vocational nurse
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 §97.2 of this title (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 renal
disease;
(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, if applicable;
(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 client;
(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 blood glucose);
(Q) the theory of blood products and blood administration;
and
(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 Department
of Human Services, 701 W. 51st Street, Austin, Texas 78751-2321, 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 a registered
nurse qualified under subsection (e)(1) of this section to supervise the provision
of dialysis services by a licensed nurse.
Cont'd... |