| (a) A limited services rural hospital (LSRH) may provide
dialysis services as a patient medical service in an emergency or
to stabilize a patient without an additional license under Texas Health
and Safety Code (HSC) Chapter 251. An LSRH may not provide outpatient
dialysis services or seek licensure under HSC Chapter 251 except if
providing services during a state of disaster as allowed by HSC §251.012(2)(B)
(relating to Exemptions from Licensing Requirement) and subsection
(b) of this section.
(b) An LSRH may provide outpatient dialysis services
when the governor declares a state of disaster or the president of
the United States declares a federal disaster in this state or another
state. The LSRH may provide outpatient dialysis only during the term
of the disaster declaration.
(c) All equipment used in the process for providing
dialysis, including backup equipment, shall be operated within manufacturer's
specifications, and maintained free of defects that could be a potential
hazard to patients, staff, or visitors. Maintenance and repair of
all equipment shall be performed by qualified staff or contract personnel.
(d) Staff shall be able to identify malfunctioning
equipment used in the process for providing dialysis and report such
equipment to the appropriate staff for immediate repair.
(e) Medical equipment used in the process for providing
dialysis that malfunctions must be clearly labeled and immediately
removed from service until the malfunction is identified and corrected.
Written evidence of all maintenance and repairs shall be maintained.
(f) After repairs or alterations are made to any equipment
or system used in the process for providing dialysis, the equipment
or system shall be thoroughly tested for proper operation before returning
to service. This testing must be documented.
(g) An LSRH shall comply with the federal Food, Drug,
and Cosmetic Act, 21 United States Code (USC), §360i(b), relating
to 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 a
patient of the facility.
(h) An LSRH shall develop, implement, and enforce a
written preventive maintenance program to ensure patient care related
equipment used in a facility receives electrical safety inspections,
if appropriate, and maintenance at least annually or more frequently
as recommended by the manufacturer. The preventive maintenance may
be provided by LSRH staff or by contract.
(i) At least one complete dialysis machine shall be
available on site as backup for every 10 dialysis machines in use.
At least one of these backup machines must be completely operational
during hours of treatment. Machines not in use during a patient shift
may be counted as backup except at the time of an initial or an expansion
survey.
(j) An LSRH shall have emergency equipment and supplies
immediately accessible in the treatment area. The emergency equipment
and supplies shall include at least the following:
(1) oxygen;
(2) mechanical ventilatory assistance equipment, to
include airways, manual breathing bag, and mask;
(3) suction equipment;
(4) supplies specified by the medical director;
(5) electrocardiograph; and
(6) automated external defibrillator or defibrillator.
(k) If pediatric patients are treated, the LSRH shall
have the appropriate type and size emergency equipment and supplies
listed in subsection (j) of this section for this special population.
(l) If pediatric patients are treated, an LSRH shall
use equipment and supplies, to include blood pressure cuffs, dialyzers,
and blood tubing, appropriate for this special population.
(m) An LSRH shall establish, implement, and enforce
a policy for the periodic testing and maintenance of the emergency
equipment. Staff shall properly maintain and test the emergency equipment
and supplies and document the testing and maintenance.
(n) A transducer protector shall be replaced when wetted
during a dialysis treatment and shall be used for one treatment only.
(o) Water treatment and dialysate supply systems shall
meet the requirements of this subsection. An LSRH may follow more
stringent requirements than the standards required by this subsection.
(1) The LSRH administrator and medical director shall
each demonstrate responsibility for the water treatment and dialysate
supply systems to protect hemodialysis patients from adverse effects
arising from known chemical and microbial contaminates that may be
found in improperly prepared dialysate, to ensure that the dialysate
is correctly formulated and meets the requirements of all applicable
quality standards.
(2) The LSRH administrator and medical director must
assure that policies and procedures related to water treatment and
dialysate are understandable and accessible to the operator and that
the training program includes quality testing, risks and hazards of
improperly prepared concentrate and bacterial issues.
(3) The LSRH administrator and medical director must
be informed before any alteration of, or any device being added to,
the water system.
(4) These requirements apply to water intended for
use in the delivery of hemodialysis, including the preparation of
concentrates from powder at a dialysis facility and dialysate.
(5) The design for the water treatment system in an
LSRH shall be based on considerations of the source water for the
LSRH and designed by a water quality professional with education,
training, or experience in dialysis system design.
(6) When an LSRH does not use a public water system
supply, the LSRH shall test the source water at monthly intervals
in the same manner as a public water system as described in Texas
Administrative Code Title 30 §290.104 (relating to Summary of
Maximum Contaminant Levels, Maximum Residual Disinfectant Levels,
Treatment Techniques, and Action Levels), and §290.109 (relating
to Microbial Contaminants) as adopted by the Texas Commission on Environmental
Quality (TCEQ).
(7) The physical space in which the water treatment
system is located must be adequate to allow for maintenance, testing,
and repair of equipment. If mixing of dialysate is performed in the
same area, the physical space must also be adequate to house and allow
for the maintenance, testing, and repair of the mixing equipment and
for performing the mixing procedure.
(8) The water treatment system components shall be
arranged and maintained so that bacterial and chemical contaminant
levels in the product water do not exceed the standards for hemodialysis
water quality described in §4.2.1 (relating to Water Bacteriology)
and §4.2.2 (relating to Maximum Level of Chemical Contaminants)
of the American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition, published by the Association for
the Advancement of Medical Instrumentation (AAMI).
(9) Written policies and procedures for the operation
of the water treatment system must be developed and implemented. Parameters
for the operation of each component of the water treatment system
must be developed, in writing, and known to the operator. Each major
water system component shall be labeled in a manner that identifies
the device, describes its function, how performance is verified and
actions to take in the event performance is not within an acceptable
range.
(10) The materials of any components of water treatment
systems (including piping, storage, filters and distribution systems)
that contact the purified water shall not interact chemically or physically
so as to affect the purity or quality of the product water adversely.
Such components shall be fabricated from unreactive materials (e.g.,
plastics) or appropriate stainless steel. The use of materials that
are known to cause toxicity in hemodialysis, such as copper, brass,
galvanized material, or aluminum, is prohibited.
(11) Chemicals infused into the water such as iodine,
acid, flocculants, and complexing agents shall be shown to be nondialyzable
or shall be adequately removed from product water. Monitors or specific
test procedures to verify removal of additives shall be provided and
documented.
(12) Each water treatment system shall include reverse
osmosis (RO) membranes or deionization (DI) tanks and a minimum of
two carbon tanks in series. If the source water is from a private
supply that does not use chlorine/chloramine, the water treatment
system shall include RO membranes or deionization tanks and a minimum
of one carbon tank.
(13) Reverse osmosis membranes, if used, shall meet
the standards in §4.3.7 (relating to Reverse Osmosis) of the
American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition, published by the AAMI.
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