(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 §97.301(a)(9) of this title (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 Department of Human
Services, 701 W. 51st Street, Austin, Texas 78751-2321, 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 Department of Human Services,
701 W. 51st Street, Austin, Texas 78751-2321, 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 DHS 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 Clinical Laboratory Improvement
Amendments of 1988, 42 United States Code, §263a, Certification of Laboratories
(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 §97.284 of this title (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.
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