Current through Reg. 49, No. 38; September 20, 2024
(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.
(14) Deionization systems, if used, shall be
monitored continuously to produce water of one megohm-centimeter (cm) or
greater specific resistivity (or conductivity of one microsiemen/cm or less) at
25 degrees Centigrade. An audible and visual alarm shall be activated when the
product water resistivity falls below this level and the product water stream
shall be prevented from reaching any point of use.
(15) Patients shall not be dialyzed on
deionized water with a resistivity less than 1.0 megohm-cm measured at the
output of the deionizer.
(16) A
minimum of two DI tanks in series shall be used with resistivity monitors
including audible and visual alarms placed pre and post the final DI tank in
the system. The alarms must be audible in the patient care area.
(17) Feed water for deionization systems
shall be pretreated with activated carbon adsorption, or a comparable
alternative, to prevent nitrosamine formation.
(18) If a deionization system is the last
process in a water treatment system, it shall be followed by an ultrafilter or
other bacteria and endotoxin reducing device.
(19) The carbon tanks must contain acid
washed carbon, 30-mesh or smaller with a minimum iodine number of
900.
(20) A minimum of two carbon
adsorption beds shall be installed in a series configuration.
(21) The total empty bed contact time (EBCT)
shall be at least 10 minutes, with the final tank providing at least five
minutes EBCT. Carbon adsorption systems used to prepare water for portable
dialysis systems are exempt from the requirement for the second carbon and a
10-minute EBCT if removal of chloramines to below 0.1 milligram (mg)/1 is
verified before each treatment.
(22) A means shall be provided to sample the
product water immediately prior to the final bed(s). Water from this port(s)
must be tested for chlorine/chloramine levels immediately prior to each patient
shift.
(23) All samples for
chlorine/chloramine testing must be drawn when the water treatment system has
been operating for at least 15 minutes.
(24) Tests for total chlorine, which include
both free and combined forms of chlorine, may be used as a single analysis with
the maximum allowable concentration of 0.1 mg/liter (L). Test results of
greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine
from the port between the initial tank(s) and final tank(s) shall require
testing to be performed at the final exit and replacement of the initial
tank(s).
(25) In a system without a
holding tank, if test results at the exit of the final tank(s) are greater than
the parameters for chlorine or chloramine described in this subclause, dialysis
treatment shall be immediately terminated to protect patients from exposure to
chlorine/chloramine and the medical director shall be notified. In systems with
holding tanks, if the holding tank tests <1 mg/L for total chlorine, the RO
may be turned off and the product water in the holding tank may be used to
finish treatments in process. The medical director shall be notified.
(26) If means other than granulated carbon
are used to remove chlorine/chloramine, the facility's governing body must
approve such use, in writing, after review of the safety of the intended method
for use in hemodialysis applications. If such methods include the use of
additives, there must be evidence the product water does not contain unsafe
levels of these additives.
(27)
Water softeners, if used, shall be tested at the end of the treatment day to
verify their capacity to treat a sufficient volume of water to supply the
facility for the entire treatment day and shall be fitted with a mechanism to
prevent water containing the high concentrations of sodium chloride used during
regeneration from entering the product water line during
regeneration.
(28) If used, the
face(s) of timer(s) used to control any component of the water treatment or
dialysate delivery system shall be visible to the operator at all times.
Written evidence that timers are checked for operation and accuracy each day of
operation must be maintained.
(29)
Filter housings, if used during disinfectant procedures, shall include a means
to clear the lower portion of the housing of the disinfecting agents. Filter
housings shall be opaque.
(30)
Ultrafilters, or other bacterial reducing filters, if used, shall be fitted
with pressure gauges on the inlet and outlet water lines to monitor the
pressure drop across the membrane. Ultrafilters shall be included in routine
disinfection procedures.
(31) If
used, storage tanks shall have a conical or bowl-shaped base and shall drain
from the lowest point of the base. Storage tanks shall have a tight-fitting lid
and be vented through a hydrophobic 0.2 micron air filter. Means shall be
provided to effectively disinfect any storage tank installed in a water
distribution system.
(32)
Ultraviolet (UV) lights, if used, shall be monitored at the frequency
recommended by the manufacturer. A log sheet shall be used to record
monitoring.
(33) Water treatment
system piping shall be labeled to indicate the contents of the pipe and
direction of flow.
(34) The water
treatment system must be continuously monitored during patient treatment and be
guarded by audible and visual alarms that can be seen and heard in the dialysis
treatment area should water quality drop below specific parameters. Quality
monitor sensing cells shall be located as the last component of the water
treatment system and at the beginning of the distribution system. No water
treatment components that could affect the quality of the product water as
measured by this device shall be located after the sensing cell.
(35) When deionization tanks do not follow an
RO system, parameters for the rejection rate of the membranes must assure that
the lowest rate accepted would provide product water in compliance with
§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 AAMI.
(36) An LSRH shall maintain written logs of
the operation of the water treatment system for each treatment day. The log
book shall include each component's operating parameter and the action taken
when a component is not within the facility's set parameters.
(37) Microbiological testing of product water
shall be conducted.
(A) Microbiological
testing shall be conducted monthly and following any repair or change to the
water treatment system. For a newly installed water distribution system, or
when a change has been made to an existing system, weekly testing shall be
conducted for one month to verify that bacteria and endotoxin levels are
consistently within the allowed limits.
(B) At a minimum, sample sites chosen for the
testing shall include the beginning of the distribution piping, at any site of
dialysate mixing, and the end of the distribution piping.
(C) Samples shall be collected immediately
before sanitization/disinfection of the water treatment system and dialysis
machines. Water testing results shall be routinely trended and reviewed by the
medical director in order to determine if results seem questionable or if there
is an opportunity for improvement. The medical director shall determine if
there is a need for retesting. Repeated results of "no growth" shall be
validated via an outside laboratory. A calibrated loop may not be used in
microbiological testing of water samples. Colonies shall be counted using a
magnifying device.
(38)
Product water used to prepare dialysate, concentrates from powder, or to
reprocess dialyzers for multiple use, shall contain a total viable microbial
count less than 200 colony forming units (CFU)/millimeter (ml) and an endotoxin
concentration less than 2 endotoxin units (EU)/ml. The action level for the
total viable microbial count in the product water shall be 50 CFU/ml and the
action level for the endotoxin concentration shall be 1 EU/ml.
(39) Required action for unacceptable
results. If the action levels described at paragraph (6) of this subsection are
observed in the product water, corrective measures shall be taken promptly to
reduce the levels into an acceptable range.
(40) All bacteria and endotoxin results shall
be recorded on a log sheet in order to identify trends that may indicate the
need for corrective action.
(41) If
ozone generators are used to disinfect any portion of the water or dialysate
delivery system, testing based on the manufacturer's direction shall be used to
measure the ozone concentration each time disinfection is performed, to include
testing for safe levels of residual ozone at the end of the disinfection cycle.
Testing for ozone in the ambient air shall be conducted on a periodic basis as
recommended by the manufacturer. Records of all testing must be maintained in a
log.
(42) If used, hot water
disinfection systems shall be monitored for temperature and time of exposure to
hot water as specified by the manufacturer. Temperature of the water shall be
recorded at a point furthest from the water heater, where the lowest water
temperature is likely to occur. The water temperature shall be measured each
time a disinfection cycle is performed. A record that verifies successful
completion of the heat disinfection shall be maintained.
(43) After chemical disinfection, means shall
be provided to restore the equipment and the system in which it is installed to
a safe condition relative to residual disinfectant prior to the product water
being used for dialysis applications.
(44) Samples of product water must be
submitted for chemical analysis every six months and must demonstrate that the
quality of the product water used to prepare dialysate or concentrates from
powder, meets §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 AAMI.
(45) Samples for chemical analysis shall be
collected at the end of the water treatment components and at the most distal
point in each water distribution loop, if applicable. All other outlets from
the distribution loops shall be inspected to ensure that the outlets are
fabricated from compatible materials. Appropriate containers and pH adjustments
shall be used to ensure accurate determinations. New LSRHs or LSRHs that add or
change the configuration of the water distribution system must draw samples at
the most distal point for each water distribution loop, if applicable, on a one
time basis.
(46) Additional
chemical analysis shall be submitted if substantial changes are made to the
water treatment system or if the percent rejection of an RO system decreased
5.0% or more from the percent rejection measured at the time the water sample
for the preceding chemical analysis was taken.
(47) LSRH records must include all test
results and evidence that the medical director has reviewed the results of the
water quality testing and directed corrective action when indicated.
(48) Only persons qualified by the education
or experience may operate, repair, or replace components of the water treatment
system.
(49) Quality control
procedures shall be established to ensure ongoing conformance to policies and
procedures regarding dialysate quality.
(p) Each LSRH shall set all hemodialysis
machines to use only one family of concentrates. When new machines are put into
service or the concentrate family or concentrate manufacturer is changed,
samples shall be sent to a laboratory for verification.
(q) Prior to each patient treatment, LSRH
staff shall verify the dialysate conductivity and pH of each machine with an
independent device.
(r) The LSRH
shall conduct bacteriological testing.
(s) Responsible LSRH staff shall develop a
schedule to ensure each hemodialysis machine is tested quarterly for bacterial
growth and the presence of endotoxins. Hemodialysis machines of home patients
shall be cultured monthly until results not exceeding 200 CFU/ml are obtained
for three consecutive months, then quarterly samples shall be
cultured.
(t) Dialysate shall
contain less than 200 CFU/ml and an endotoxin concentration of less than 2
EU/ml. The action level for total viable microbial count shall be 50 CFU/ml and
the action level for endotoxin concentration shall be 1 EU/ml.
(u) Disinfection and retesting shall be done
when bacterial or endotoxin counts exceed the action levels. Additional samples
shall be collected when there is a clinical indication of a pyrogenic reaction
and/or septicemia.
(v) Only a
licensed nurse may use an additive to increase concentrations of specific
electrolytes in the acid concentrate. Mixing procedures shall be followed as
specified by the additive manufacturer. When additives are prescribed for a
specific patient, the container holding the prescribed acid concentrate shall
be labeled with the name of the patient, the final concentration of the added
electrolyte, the date the prescribed concentrate was made, and the name of the
person who mixed the additive.
(w)
All components used in concentrate preparation systems (including mixing and
storage tanks, pumps, valves, and piping) shall be fabricated from materials
(e.g., plastics or appropriate stainless steel) that do not interact chemically
or physically with the concentrate so as to affect its purity, or with the
germicides used to disinfect the equipment. The use of materials that are known
to cause toxicity in hemodialysis such as copper, brass, galvanized material,
and aluminum is prohibited.
(x)
LSRH policies shall address means to protect stored acid concentrates from
tampering or from degeneration due to exposure to extreme heat or
cold.
(y) Procedures to control the
transfer of acid concentrates from the delivery container to the storage tank
and prevent the inadvertent mixing of different concentrate formulations shall
be developed, implemented, and enforced. The storage tanks shall be clearly
labeled.
(z) Concentrate mixing
systems shall include a purified water source, a suitable drain, and a ground
fault-protected electrical outlet.
(aa) Operators of mixing systems shall use
personal protective equipment as specified by the manufacturer during all
mixing processes.
(bb) The
manufacturer's instructions for use of a concentrate mixing system shall be
followed, including instructions for mixing the powder with the correct amount
of water. The number of bags or weight of powder added shall be determined and
recorded.
(1) The mixing tank shall be clearly
labeled to indicate the fill and final volumes required to correctly dilute the
powder.
(2) Systems for preparing
either bicarbonate or acid concentrate from powder shall be monitored according
to the manufacturer's instructions.
(3) Concentrates shall not be used, or
transferred to holding tanks or distribution systems, until all tests are
completed.
(4) If an LSRH designs
its own system for mixing concentrates, procedures shall be developed and
validated using an independent laboratory to ensure proper mixing.
(5) Acid concentrate mixing tanks shall be
designed to allow the inside of the tank to be rinsed when changing concentrate
formulas.
(6) Acid mixing systems
shall be designed and maintained to prevent rust and corrosion.
(7) Acid concentrate mixing tanks shall be
emptied completely and rinsed with product water before mixing another batch of
concentrate to prevent cross contamination between different batches.
(8) Acid concentrate mixing equipment shall
be disinfected as specified by the equipment manufacturer or in the case where
no specifications are given, as defined by LSRH policy.
(9) Records of disinfection and rinsing of
disinfectants to safe residual levels shall be maintained.
(10) Bicarbonate concentrate mixing tanks
shall have conical or bowl-shaped bottoms and shall drain from the lowest point
of the base. The tank design shall allow all internal surfaces to be
disinfected and rinsed.
(11)
Bicarbonate concentrate mixing tanks shall not be prefilled the night before
use.
(12) If disinfectant remains
in the mixing tank overnight, this solution must be completely drained and the
tank must be rinsed and tested for residual disinfectant prior to preparing the
first batch of that day of bicarbonate concentrate.
(13) Unused portions of bicarbonate
concentrate shall not be mixed with fresh concentrate.
(14) At a minimum, bicarbonate distribution
systems shall be disinfected weekly. More frequent disinfection shall be done
if required by the manufacturer, or if dialysate culture results are above the
action level.
(15) If jugs are
reused to deliver bicarbonate concentrate to individual hemodialysis machines:
(A) jugs shall be emptied of concentrate,
rinsed, and inverted to drain at the end of each treatment day;
(B) at a minimum, jugs shall be disinfected
weekly, and more frequent disinfection shall be considered by the medical
director if dialysate culture results are above the action level; and
(C) following disinfection, jugs shall be
drained, rinsed free of residual disinfectant, and inverted to dry. Testing for
residual disinfectant shall be done and documented.
(16) All mixing tanks, bulk storage tanks,
dispensing tanks, and containers for single hemodialysis treatments shall be
labeled as to the contents.
(17)
Prior to batch preparation, a label shall be affixed to the mixing tank that
includes the date of preparation and the chemical composition or formulation of
the concentrate being prepared. This labeling shall remain on the mixing tank
until the tank has been emptied.
(18) Mixing tanks shall be permanently
labeled to identify the chemical composition or formulation of their
contents.
(19) At a minimum, single
machine containers shall be labeled with sufficient information to
differentiate the contents from other concentrate formulations used in the LSRH
and permit positive identification by users of container contents.
(20) Permanent records of batches produced
shall be maintained to include the concentrate formula produced, the volume of
the batch, lot number(s) of powdered concentrate packages, the manufacturer of
the powdered concentrate, date and time of mixing, test results, person
performing mixing, and expiration date (if applicable).
(21) If dialysate concentrates are prepared
in the facility, the manufacturers' recommendations shall be followed regarding
any preventive maintenance. Records shall be maintained indicating the date,
time, person performing the procedure, and the results (if
applicable).
(cc) With
the advice and consent of a patient's attending nephrologist, facility staff
shall make the hepatitis B vaccine available to a patient who is susceptible to
hepatitis B, provided that the patient has coverage or is willing to pay for
vaccination.
(dd) The LSRH shall
make available to patients literature describing the risks and benefits of the
hepatitis B vaccination.
(ee) A
patient new to dialysis shall have been screened for hepatitis B surface
antigen (HBsAg) within one month before or at the time of admission to the
facility or have a known hepatitis B surface antibody (anti-HBs) status of at
least 10 milli-international units per milliliter no more than 12 months prior
to admission. The LSRH shall document how this screening requirement is met.
(1) Repeated serologic screening shall be
based on the antigen or antibody status of the patient.
(2) Monthly screening for HBsAg is required
for patients whose previous test results are negative for HBsAg.
(3) Screening of HBsAg-positive or
anti-HBs-positive patients may be performed on a less frequent basis, provided
that the LSRH's policy on this subject remains congruent with Appendices i and
ii of the National Surveillance of Dialysis Associated Disease in the United
States, 2000, published by the United States Department of Health and Human
Services.
(ff) The LSRH
shall treat patients positive for HBsAg in a segregated treatment area that
includes a hand washing sink, a work area, patient care supplies and equipment,
and sufficient space to prevent cross-contamination to other patients.
(1) A patient who tests positive for HBsAg
shall be dialyzed on equipment reserved and maintained for the HBsAg-positive
patient's use only.
(2) When a
caregiver is assigned to both HBsAg-negative and HBsAg-positive patients, the
HBsAg-negative patients assigned to this grouping must be hepatitis B antibody
positive. Hepatitis B antibody positive patients are to be seated at the
treatment stations nearest the isolation station and be assigned to the same
staff member who is caring for the HBsAg-positive patient.
(3) If an HBsAg-positive patient is
discharged, the equipment that had been reserved for that patient shall be
given intermediate level disinfection prior to use for a patient testing
negative for HBsAg.
(4) In the case
of patients new to dialysis, if these patients are admitted for treatment
before results of HBsAg or anti-HBs testing are known, these patients shall
undergo treatment as if the HBsAg test results were potentially positive,
except that they shall not be treated in the HBsAg isolation room, area, or
machine.
(A) The LSRH shall treat potentially
HBsAg-positive patients in a location in the treatment area that is outside of
traffic patterns until the HBsAg test results are known.
(B) The dialysis machine used by this patient
shall be given intermediate level disinfection prior to its use by another
patient.
(C) The LSRH shall obtain
HBsAg status results of the patient no later than three days from
admission.
