(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.
Cont'd... |