| (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.
|
| Source Note: The provisions of this §558.405 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective May 1, 2008, 33 TexReg 1136; transferred effective May 1, 2019, as published in the April 12, 2019 issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427 |
