Transitions to Surveys with
New ESRD Regulations
What does the future hold?
Conditions of Coverage
Water Standards
What are some of the major
changes?
Reasons for Change
• Changes in technology
- Water treatment: more complex
- Changes in dialysis equipment
• Changes in staffing, practice, equipment &
training needs.
Implementation for Facilities
• Understand the new regulations.
• Identify the changes required in policy and
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procedures to satisfy the intent of the new
regulations.
Ensure the implementation of new regulations
by monitoring staff practice and other audit
tools.
Identify the areas in need for staff training.
Water and Dialysate
• Adoption of AAMI RD52:2004 for water
treatment system.
• Strict requirements for labeling and
monitoring the water treatment system,
dialysate preparation and distribution.
Water and Dialysate (continued…)
• Association for the Advancement of
Medical Instrumentation (AAMI) has set
the standards for the quality of water used
in the preparation of dialysate.
• Environmental Protection Association
(EPA) has set the standard for levels of
chemical contamination in safe drinking
water.
Water Purification Storage System
• The layout of the water purification system must provide
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easy access to all components of the system including all
pressure gauges, flow meters and sampling ports.
User must label major water system components in a
manner that identifies the device, its function,
verification of performance and the action taken in the
event of an unacceptable range.
Critical alarms associated with the ionizer exhaustion or
low water levels in a storage tank must be configured to
sound an alarm in the water treatment room as well as
patient treatment area.
Feed Water Components
• Back flow preventer device
• Temperature blending valve
- Mixes the cold city water with the heated water
and must be maintained at the temperature
between 77 & 80 degrees Fahrenheit to prevent
the damage to Reverse Osmosis system (RO)
membranes.
• Booster pump
- Maintain pressure and flow of water into the
water treatment system.
Water Treatment System
• Main components of water treatment
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system
Sediment Filter (multi-media)
Softener
Primary and Secondary carbon tanks
Reverse Osmosis system
Deionizer tanks
Sediment Filter
• Multimedia filter commonly selected as
sediment filters.
• Located at or near the beginning of
hemodialysis system
• Intended to remove relatively coarse
particulate materials from incomming
water.
• Cleaned by periodic backwashing
Softeners
• Softener is a cylinder containing insoluble beads called
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resin.
Prevent hot water deposits from damaging sensitive
reverse osmosis membranes.
During operation exchange between calcium and
magnesium ions from hard water and sodium ions in the
resin occur.
Replacement of sodium ions occur by a process known
as regeneration which involves the exposure of the resin
beads to a saturated sodium chloride solution.
Softeners that automatically regenerate include a brine
tank from which saturated sodium chloride solution is
drawn into the tank during regeneration through a
control valve.
Carbon Tanks
• Two carbon tanks must be installed in series with a
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sample port following the first bed and the second bed.
Principle means of removing both free chlorine and
chloramine.
Removal of free chlorine to a maximum level of 0.5 mg/L
and chloramine maximum level of 0.1 mg/L.
Carbon tanks contain granular activated carbon with a
minimum iodine number of 900.
Each carbon bed shall have a minimum empty bed
contact time of 5 minutes at the maximum flow rate
through the bed.
Chemical Injection System
• May be used in the pre-treatment section to
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supplement physical purification of water.
Consists of a reservoir filled with chemical to be
injected, a metering pump and a mixing
chamber located in the main water line.
Must also include a means of verifying the
concentration of any residuals arising from the
addition of chemicals to the water are reduced
to safe levels at the point of use.
Reverse Osmosis System
• Consists of a series of semi permeable membranes, a pump, and
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various flow pressure controls.
Reverse osmosis system removes dissolved inorganic solutes as well
as bacteria and bacterial endotoxins.
Must be operated within its designed parameters and directions for
use set by the manufacturer.
Conductivity or total dissolved solids (TDS) must be monitored in
the feed water and product water streams to ensure the membranes
ability to remove dissolved inorganic solutes.
Flow meters are used in the product water and reject water streams
to monitor the output of the RO system.
Pressure gauges are installed to monitor the pressure at various
points in the system.
Deionization
• An exchange process that removes both an-ions (negatively charged
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ions) and cat-ions (positively charged ions) from water.
This process does not remove bacteria or bacterial endotoxins.
Must be used along with carbon tanks and an ultra filter must be
placed downstream of the deionizer tanks.
Can be used as the primary means of purification in the event of RO
failure or as a polisher following reverse osmosis system.
The quality of water product from DI is monitored by resistivity
monitors (minimum resistivity of 1 megohm – cm or greater).
Resistivity monitor following the final deionizer bed must be
connected to an audible and visible alarm in the dialysis treatment.
DI system must divert low quality water to drain when the final bed
has a resistivity below 1 megohm-cm.
Water Storage & Distribution
• Two types of water distribution systems:
- Direct feed systems
- Indirect feed systems
• Materials used in the product water
distribution system must provide the least
favorable environment for bacterial
proliferation and prevent leaching of
dangerous chemicals into the water.
Water Storage & Distribution
(continued…)
• Direct feed:
- Water flows directly from the last stage of
purification system to the point of use.
- Offers the least favorable environment for
bacterial proliferation.
• Indirect feed:
- Water flows from the end of purification
system to a storage tank.
Storage Tank
• Must have a conical or bow shaped base
• Should drain from the lowest point of the base
• Should have a tight fitting lid and be vented
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through a hydrophobic 0.2 micron air filter
Must be installed with internal spray mechanism
to facilitate effective disinfections and rinsing of
the storage tank.
Bicarbonate Mixing & Storage
Systems
• Bicarbonate delivery pipe should be color coated blue at the point of
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use.
Storage times for bicarbonate concentrate should be minimized
Procedures should be developed and demonstrated to ensure proper
mixing of the concentrate.
Bicarbonate concentrates may be tested by using conductivity or by
using a hydrometer.
Mixing of fresh bicarbonate concentrate with unused portions of
concentrate from a pervious batch is not recommended
Bicarbonate concentrate delivery system must be rinsed clean at the
end of treatment and disinfected at least weekly.
Bicarbonate concentrate jugs must be rinsed with treated water and
stored inverted at the end of each treatment day
Reusable concentrate jugs must be disinfected at least weekly
Acid Concentrate Distribution
Systems
• Delivery piping should be labeled and color
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coated red at the point of use.
Delivery piping must indicate the type of acid
concentrate it delivers at the point of use.
System must be closed to prevent non bacterial
contamination and evaporation.
Reusable acid concentrate jugs must be clearly
labeled with the type of acid it contains.
Bacteriology of Water and Dialysate
• Water samples for bacteriology testing must be
collected directly from outlets taps located in
different parts of the water distribution system
on a monthly basis.
• Disinfection of sample taps not recommended.
• Dialysate samples must be collected from at
least 2 dialysis machines monthly and from
enough machines so that each machine is tested
at least once per year.
- Sample must be collected from a dialysate port
of the dialyzer, if possible.
Recommended AAMI limits
• AAMI maximum acceptable limit:
- 200 colony forming units
- 2 endotoxin units
• AAMI action levels:
- 50 colony forming units
- 1 endotoxin unit
Maximum Level of Contaminants
• The water used to prepare the dialysate is
analyzed for the levels of chemical
contaminants.
• Water analysis report must be within
normal range according to the standards
set forth by AAMI recommendations.
Personnel
• Patient Care Techinician
- High school diploma or equivalency
- Certification from a state or national program.
• New employees to be certified within 18 months of hire (as of
10/14/08).
• Existing employees to be certified within 24 months starting
4/4/08.
• Complete any required additional training (approved by the
Medical Director and Governing Body) specific to the assigned
job responsibilities, which may include monitoring the water
treatment system and preparation of dialysate.
• Undergo vision testing for color blindness if the job responsibility
involves testing for chlorine/ chloramine in water using color
comparisons.
Personnel (continued…)
• Chief Technician
- Currently no certification required.
- Must be certified by the manufacturer of the
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dialysis machines to be able to maintain them.
Must have training (approved by the Medical
Director and Governing Body) to monitor and
maintain the water treatment system.
Responsibilities of Medical Director
• Ensure that all staff adhere to policy and
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procedures.
Ensure that the water treatment system is
monitored and maintained in a manner to
provide safe patient care.
Ensure that personnel responsible for the
monitoring and maintenance of water treatment
system are adequately trained to carry out their
assigned duties.