Current through Reg. 49, No. 38; September 20, 2024
(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 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) 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 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 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 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 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.
(6)
For non-stabilized clients, where there is a change in modality, unacceptable
laboratory work, uncontrolled weight changes, infections, or a change in family
status, the client care plan must be reviewed at least monthly by the
interdisciplinary team. Evidence of the review of the client care plan with the
client and the interdisciplinary team to evaluate the client's progress or lack
of progress toward the goals of the care plan, and interventions taken when
progress toward stabilization or the goals are not achieved, must be documented
and included in the client record.
(7) For a stable client, the client care plan
must be reviewed and updated as indicated by any change in the client's
medical, nutritional, or psychosocial condition or at least every six months.
The long-term program must be revised as needed and reviewed annually. Evidence
of the review of the client care plan with the client and the interdisciplinary
team to evaluate the client's progress or lack of progress toward the goals of
the care plan, and interventions taken when the goals are not achieved, must be
documented and included in the client record.
(r) Medication administration. Medications
must be administered only by licensed personnel.
(s) Client records. In addition to the
applicable information described in § 558.301(a)(9) of this chapter
(relating to Client Records), records of home staff assisted dialysis clients
must include the following:
(1) a medical
history and physical;
(2) clinical
progress notes by the physician, qualified licensed nurse, qualified dietitian,
and qualified social worker;
(3)
dialysis treatment records;
(4)
laboratory reports;
(5) a client
care plan;
(6) a long-term program;
and
(7) documentation of
supervisory visits.
(t)
Water treatment.
(1) Water used for dialysis
purposes must be analyzed for chemical contaminants every six months.
Additional chemical analysis must be conducted if test results exceed the
maximum levels of chemical contaminants listed in §3.2.2 (Maximum Level of
Chemical Contaminants) of the American National Standards for Hemodialysis
Systems, March 1992 Edition, published by the AAMI. 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.
(2)
Water used for dialysis must be treated as necessary to maintain a continuous
water supply that is biologically and chemically compatible with acceptable
dialysis techniques.
(3) Water used
to prepare dialysate must meet the requirements set forth in §3.2.1
(Hemodialysis Systems) and §3.2.2 (Maximum Level of Chemical
Contaminants), March 1992 Edition, published by the AAMI. 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.
(4) Records of test results and equipment
maintenance must be maintained at the agency.
(u) Equipment testing. An agency must adopt
and enforce a policy to describe how the nurse will check the machine for
conductivity, temperature, and pH prior to treatment, and describe the
equipment required for these tests. The equipment must be available for use
prior to each treatment. This policy must reflect current standards.
(v) Preventive maintenance for equipment. An
agency must develop and enforce a written preventive maintenance program to
ensure client care related equipment receives electrical safety inspections, if
appropriate, and maintenance at least annually or more frequently if
recommended by the manufacturer. The preventive maintenance may be provided by
agency or contract staff qualified by training or experience in the maintenance
of dialysis equipment.
(1) All equipment used
by a client in home dialysis must be maintained free of defects, which could be
a potential hazard to clients, the client's family, or agency personnel.
(A) Agency staff must be able to identify
malfunctioning equipment and report such equipment to the appropriate agency
staff. Malfunctioning equipment must be immediately removed from use.
(B) Written evidence of all preventive
maintenance and equipment repairs must be maintained.
(C) After repairs or alterations are made to
any equipment, the equipment must be thoroughly tested for proper operation
before returning to service.
(D) An
agency must comply with the federal Food, Drug, and Cosmetic Act, 21 United
States Code (USC) §360i(b), concerning reporting when a medical device, as
defined in
21 USC §
321(h), has or may have
caused or contributed to the injury or death of an agency
client.
(2) In the event
that the water used for dialysis purposes or home dialysis equipment is found
not to meet safe operating parameters, and corrections cannot be effected to
ensure safe care promptly, the client must be transferred to a licensed
hospital (if inpatient care is required) or licensed ESRD facility until such
time as the water or equipment is found to be operating within safe
parameters.
(w) Reuse or
reprocessing of medical devices. Reuse or reprocessing of disposable medical
devices, including but not limited to, dialyzers, end-caps, and blood lines
must be in accordance with this subsection.
(1) An agency's reuse practice must comply
with the American National Standard, Reuse of Hemodialyzers, 1993 Edition,
published by the AAMI. An agency must adopt and enforce a policy for dialyzer
reuse criteria (including any agency-set number of reuses allowed) which is
included in client education materials.
(2) A transducer protector must be replaced
when wetted during a dialysis treatment and must be used for one treatment
only.
(3) Arterial lines may be
reused only when the arterial lines are labeled to allow for reuse by the
manufacturer and the manufacturer-established protocols for the specific line
have been approved by the United States Food and Drug Administration.
(4) An agency must consider and address the
health and safety of clients sensitive to disinfectant solution
residuals.
(5) An agency must
provide each client and the client's family or legal representative with
information regarding the reuse practices of the agency, the opportunity to
tour the reuse facility used by the agency, and the opportunity to have
questions answered.
(6) An agency
practicing reuse of dialyzers must:
(A)
ensure that dialyzers are reprocessed via automated reprocessing equipment in a
licensed ESRD facility or a centralized reprocessing facility;
(B) maintain responsibility and
accountability for the entire reuse process;
(C) adopt and enforce policies to ensure that
the transfer and transport of used and reprocessed dialyzers to and from the
client's home does not increase contamination of the dialyzers, staff, or the
environment; and
(D) ensure that
HHSC staff has access to the reprocessing facility as part of an agency
inspection.
(x)
Laboratory services. Provision of laboratory services must be as follows.
(1) All laboratory services ordered for the
client by a physician must be performed by a laboratory which meets the
applicable requirements of 42 United States Code (USC) §263a, concerning
certification and certificates of waiver of a clinical laboratory (CLIA 1988)
and in accordance with a written arrangement or agreement with the agency. CLIA
1988 applies to all agencies with laboratories that examine human specimens for
the diagnosis, prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings.
(2) Copies of all laboratory reports must be
maintained in the client's medical record.
(3) Hematocrit and blood glucose tests may be
performed at the client's home in accordance with § 558.284 of this
chapter (relating to Laboratory Services). Results of these tests must be
recorded in the client's medical record and signed by the qualified licensed
nurse providing the treatment. Maintenance, calibration, and quality control
studies must be performed according to the equipment manufacturer's
suggestions, and the results must be maintained at the agency.
(4) Blood and blood products must only be
administered to dialysis clients in their homes by a licensed nurse or
physician.
(y) Home
dialysis supplies. Supplies for home dialysis must meet the following
requirements.
(1) All drugs, biologicals, and
legend medical devices must be obtained for each client pursuant to a
physician's prescription in accordance with applicable rules of the Texas State
Board of Pharmacy.
(2) In
conjunction with the client's attending physician, the agency must ensure that
there are sufficient supplies maintained in the client's home to perform the
scheduled dialysis treatments and to provide a reasonable number of backup
items for replacements, if needed, due to breakage, contamination, or defective
products. All dialysis supplies, including medications, must be delivered
directly to the client's home by a vendor of such products. However, agency
personnel may transport prescription items from a vendor's place of business to
the client's home for the client's convenience, so long as the item is properly
labeled with the client's name and direction for use. Agency personnel may
transport medical devices for reuse.
(z) Emergency procedures. The agency must
adopt and enforce policies and procedures for medical emergencies and
emergencies resulting from a disaster.
(1)
Procedures must be individualized for each client to include the appropriate
evacuation from the home and emergency telephone numbers. Emergency telephone
numbers must be posted at each client's home and must include 911, if
available, the number of the physician, the ambulance, the qualified RN on call
for home dialysis, and any other phone number deemed as an emergency
number.
(2) The agency must ensure
that the client and the client's family know the agency's procedures for
medical emergencies and emergencies resulting from a disaster.
(3) The agency must ensure that the client
and the client's family know the procedure for disconnecting the dialysis
equipment.
(4) The agency must
ensure that the client and the client's family know emergency call
procedures.
(5) A working telephone
must be available during the dialysis procedure.
(6) Depending on the kinds of medications
administered, an agency must have available emergency drugs as specified by the
medical director.
(7) In the event
of a medical emergency or an emergency resulting from a disaster requiring
transport to a hospital for care, the agency must assure the following:
(A) the receiving hospital is given advance
notice of the client's arrival;
(B)
the receiving hospital is given a description of the client's health status;
and
(C) the selection of personnel,
vehicle, and equipment are appropriate to effect a safe transfer.
