Transitions to Surveys with Transitions to Surveys with New ESRD RegulationsNew ESRD Regulations

What does the future hold?What does the future hold?

Conditions of CoverageConditions of CoverageWater StandardsWater Standards

What are some of the What are some of the major changes?major changes?

Reasons for ChangeReasons for Change

• Changes in technologyChanges in technology

- Water treatment: more complexWater treatment: more complex

- Changes in dialysis equipmentChanges in dialysis equipment

• Changes in staffing, practice, Changes in staffing, practice, equipment & training needs.equipment & training needs.

Implementation for FacilitiesImplementation for Facilities

• Understand the new regulations.Understand the new regulations.

• Identify the changes required in policy and Identify the changes required in policy and procedures to satisfy the intent of the new procedures to satisfy the intent of the new regulations.regulations.

• Ensure the implementation of new Ensure the implementation of new regulations by monitoring staff practice regulations by monitoring staff practice and other audit tools.and other audit tools.

• Identify the areas in need for staff training.Identify the areas in need for staff training.

Water and DialysateWater and Dialysate

• Adoption of AAMI RD52:2004 for Adoption of AAMI RD52:2004 for water treatment system.water treatment system.

• Strict requirements for labeling and Strict requirements for labeling and monitoring the water treatment monitoring the water treatment system, dialysate preparation and system, dialysate preparation and distribution.distribution.

Water and Dialysate Water and Dialysate (continued…)(continued…)

• Association for the Advancement of Association for the Advancement of Medical Instrumentation (AAMI) has set Medical Instrumentation (AAMI) has set the standards for the quality of water the standards for the quality of water used in the preparation of dialysate.used in the preparation of dialysate.

• Environmental Protection Association Environmental Protection Association (EPA) has set the standard for levels of (EPA) has set the standard for levels of chemical contamination in safe chemical contamination in safe drinking water. drinking water.

Water Purification Storage Water Purification Storage SystemSystem• The layout of the water purification system must The layout of the water purification system must

provide easy access to all components of the provide easy access to all components of the system including all pressure gauges, flow meters system including all pressure gauges, flow meters and sampling ports.and sampling ports.

• User must label major water system components User must label major water system components in a manner that identifies the device, its function, in a manner that identifies the device, its function, verification of performance and the action taken in verification of performance and the action taken in the event of an unacceptable range. the event of an unacceptable range.

• Critical alarms associated with the ionizer Critical alarms associated with the ionizer exhaustion or low water levels in a storage tank exhaustion or low water levels in a storage tank must be configured to sound an alarm in the water must be configured to sound an alarm in the water treatment room as well as patient treatment area. treatment room as well as patient treatment area.

Feed Water ComponentsFeed Water Components

• Back flow preventer deviceBack flow preventer device• Temperature blending valveTemperature blending valve- Mixes the cold city water with the heated Mixes the cold city water with the heated

water and must be maintained at the water and must be maintained at the temperature between 77 & 80 degrees temperature between 77 & 80 degrees Fahrenheit to prevent the damage to Fahrenheit to prevent the damage to Reverse Osmosis system (RO) Reverse Osmosis system (RO) membranes.membranes.

• Booster pumpBooster pump- Maintain pressure and flow of water into - Maintain pressure and flow of water into

the water treatment system.the water treatment system.

Water Treatment SystemWater Treatment System

• Main components of water treatment Main components of water treatment systemsystem

- Sediment Filter (multi-media)Sediment Filter (multi-media)

- Softener Softener

- Primary and Secondary carbon tanksPrimary and Secondary carbon tanks

- Reverse Osmosis systemReverse Osmosis system

- Deionizer tanks Deionizer tanks

Sediment Filter Sediment Filter

• Multimedia filter commonly selected Multimedia filter commonly selected as sediment filters.as sediment filters.

• Located at or near the beginning of Located at or near the beginning of hemodialysis systemhemodialysis system

• Intended to remove relatively coarse Intended to remove relatively coarse particulate materials from particulate materials from incomming water. incomming water.

• Cleaned by periodic backwashingCleaned by periodic backwashing

SoftenersSofteners

• Softener is a cylinder containing insoluble beads called Softener is a cylinder containing insoluble beads called resin. resin.

• Prevent hot water deposits from damaging sensitive Prevent hot water deposits from damaging sensitive reverse osmosis membranes.reverse osmosis membranes.

• During operation exchange between calcium and During operation exchange between calcium and magnesium ions from hard water and sodium ions in magnesium ions from hard water and sodium ions in the resin occur.the resin occur.

• Replacement of sodium ions occur by a process known Replacement of sodium ions occur by a process known as regeneration which involves the exposure of the as regeneration which involves the exposure of the resin beads to a saturated sodium chloride solution. resin beads to a saturated sodium chloride solution.

• Softeners that automatically regenerate include a Softeners that automatically regenerate include a brine tank from which saturated sodium chloride brine tank from which saturated sodium chloride solution is drawn into the tank during regeneration solution is drawn into the tank during regeneration through a control valve.through a control valve.

Carbon TanksCarbon Tanks

• Two carbon tanks must be installed in series with Two carbon tanks must be installed in series with a sample port following the first bed and the a sample port following the first bed and the second bed.second bed.

• Principle means of removing both free chlorine Principle means of removing both free chlorine and chloramine. and chloramine.

• Removal of free chlorine to a maximum level of Removal of free chlorine to a maximum level of 0.5 mg/L and chloramine maximum level of 0.1 0.5 mg/L and chloramine maximum level of 0.1 mg/L.mg/L.

• Carbon tanks contain granular activated carbon Carbon tanks contain granular activated carbon with a minimum iodine number of 900.with a minimum iodine number of 900.

• Each carbon bed shall have a minimum empty Each carbon bed shall have a minimum empty bed contact time of 5 minutes at the maximum bed contact time of 5 minutes at the maximum flow rate through the bed.flow rate through the bed.

Chemical Injection SystemChemical Injection System

• May be used in the pre-treatment section to May be used in the pre-treatment section to supplement physical purification of water.supplement physical purification of water.

• Consists of a reservoir filled with chemical to Consists of a reservoir filled with chemical to be injected, a metering pump and a mixing be injected, a metering pump and a mixing chamber located in the main water line.chamber located in the main water line.

• Must also include a means of verifying the Must also include a means of verifying the concentration of any residuals arising from concentration of any residuals arising from the addition of chemicals to the water are the addition of chemicals to the water are reduced to safe levels at the point of use. reduced to safe levels at the point of use.

Reverse Osmosis SystemReverse Osmosis System

• Consists of a series of semi permeable membranes, a Consists of a series of semi permeable membranes, a pump, and various flow pressure controls. pump, and various flow pressure controls.

• Reverse osmosis system removes dissolved inorganic Reverse osmosis system removes dissolved inorganic solutes as well as bacteria and bacterial endotoxins.solutes as well as bacteria and bacterial endotoxins.

• Must be operated within its designed parameters and Must be operated within its designed parameters and directions for use set by the manufacturer. directions for use set by the manufacturer.

• Conductivity or total dissolved solids (TDS) must be Conductivity or total dissolved solids (TDS) must be monitored in the feed water and product water streams to monitored in the feed water and product water streams to ensure the membranes ability to remove dissolved ensure the membranes ability to remove dissolved inorganic solutes.inorganic solutes.

• Flow meters are used in the product water and reject water Flow meters are used in the product water and reject water streams to monitor the output of the RO system.streams to monitor the output of the RO system.

• Pressure gauges are installed to monitor the pressure at Pressure gauges are installed to monitor the pressure at various points in the system. various points in the system.

DeionizationDeionization

• An exchange process that removes both an-ions (negatively An exchange process that removes both an-ions (negatively charged ions) and cat-ions (positively charged ions) from water.charged ions) and cat-ions (positively charged ions) from water.

• This process does not remove bacteria or bacterial endotoxins. This process does not remove bacteria or bacterial endotoxins. • Must be used along with carbon tanks and an ultra filter must be Must be used along with carbon tanks and an ultra filter must be

placed downstream of the deionizer tanks. placed downstream of the deionizer tanks. • Can be used as the primary means of purification in the event of Can be used as the primary means of purification in the event of

RO failure or as a polisher following reverse osmosis system.RO failure or as a polisher following reverse osmosis system.• The quality of water product from DI is monitored by resistivity The quality of water product from DI is monitored by resistivity

monitors (minimum resistivity of 1 megohm – cm or greater).monitors (minimum resistivity of 1 megohm – cm or greater).• Resistivity monitor following the final deionizer bed must be Resistivity monitor following the final deionizer bed must be

connected to an audible and visible alarm in the dialysis connected to an audible and visible alarm in the dialysis treatment. treatment.

• DI system must divert low quality water to drain when the final DI system must divert low quality water to drain when the final bed has a resistivity below 1 megohm-cm.bed has a resistivity below 1 megohm-cm.

Water Storage & Water Storage & DistributionDistribution• Two types of water distribution systems:Two types of water distribution systems:- Direct feed systems Direct feed systems - Indirect feed systemsIndirect feed systems• Materials used in the product water Materials used in the product water

distribution system must provide the distribution system must provide the least favorable environment for least favorable environment for bacterial proliferation and prevent bacterial proliferation and prevent leaching of dangerous chemicals into leaching of dangerous chemicals into the water. the water.

Water Storage & Distribution Water Storage & Distribution (continued…)(continued…)

• Direct feed:Direct feed:- Water flows directly from the last stage Water flows directly from the last stage

of purification system to the point of of purification system to the point of use. use.

- Offers the least favorable environment Offers the least favorable environment for bacterial proliferation. for bacterial proliferation.

• Indirect feed:Indirect feed:- Water flows from the end of purification - Water flows from the end of purification

system to a storage tank.system to a storage tank.

Storage TankStorage Tank

• Must have a conical or bow shaped baseMust have a conical or bow shaped base

• Should drain from the lowest point of the Should drain from the lowest point of the basebase

• Should have a tight fitting lid and be vented Should have a tight fitting lid and be vented through a hydrophobic 0.2 micron air filterthrough a hydrophobic 0.2 micron air filter

• Must be installed with internal spray Must be installed with internal spray mechanism to facilitate effective mechanism to facilitate effective disinfections and rinsing of the storage tank.disinfections and rinsing of the storage tank.

Bicarbonate Mixing & Storage Bicarbonate Mixing & Storage SystemsSystems• Bicarbonate delivery pipe should be color coated blue at the Bicarbonate delivery pipe should be color coated blue at the

point of use. point of use. • Storage times for bicarbonate concentrate should be Storage times for bicarbonate concentrate should be

minimized minimized • Procedures should be developed and demonstrated to ensure Procedures should be developed and demonstrated to ensure

proper mixing of the concentrate.proper mixing of the concentrate.• Bicarbonate concentrates may be tested by using Bicarbonate concentrates may be tested by using

conductivity or by using a hydrometer.conductivity or by using a hydrometer.• Mixing of fresh bicarbonate concentrate with unused portions Mixing of fresh bicarbonate concentrate with unused portions

of concentrate from a pervious batch is not recommendedof concentrate from a pervious batch is not recommended• Bicarbonate concentrate delivery system must be rinsed Bicarbonate concentrate delivery system must be rinsed

clean at the end of treatment and disinfected at least weekly.clean at the end of treatment and disinfected at least weekly.• Bicarbonate concentrate jugs must be rinsed with treated Bicarbonate concentrate jugs must be rinsed with treated

water and stored inverted at the end of each treatment daywater and stored inverted at the end of each treatment day• Reusable concentrate jugs must be disinfected at least weekly Reusable concentrate jugs must be disinfected at least weekly

Acid Concentrate Distribution Acid Concentrate Distribution SystemsSystems

• Delivery piping should be labeled and color Delivery piping should be labeled and color coated red at the point of use.coated red at the point of use.

• Delivery piping must indicate the type of acid Delivery piping must indicate the type of acid concentrate it delivers at the point of use. concentrate it delivers at the point of use.

• System must be closed to prevent non System must be closed to prevent non bacterial contamination and evaporation.bacterial contamination and evaporation.

• Reusable acid concentrate jugs must be Reusable acid concentrate jugs must be clearly labeled with the type of acid it clearly labeled with the type of acid it contains.contains.

Bacteriology of Water and Bacteriology of Water and DialysateDialysate• Water samples for bacteriology testing must Water samples for bacteriology testing must

be collected directly from outlets taps be collected directly from outlets taps located in different parts of the water located in different parts of the water distribution system on a monthly basis.distribution system on a monthly basis.

• Disinfection of sample taps not Disinfection of sample taps not recommended. recommended.

• Dialysate samples must be collected from at Dialysate samples must be collected from at least 2 dialysis machines monthly and from least 2 dialysis machines monthly and from enough machines so that each machine is enough machines so that each machine is tested at least once per year. tested at least once per year.

- Sample must be collected from a dialysate - Sample must be collected from a dialysate port of the dialyzer, if possible.port of the dialyzer, if possible.

Recommended AAMI limitsRecommended AAMI limits

• AAMI maximum acceptable limit: AAMI maximum acceptable limit:

- 200 colony forming units200 colony forming units

- 2 endotoxin units2 endotoxin units

• AAMI action levels:AAMI action levels:

- 50 colony forming units50 colony forming units

- 1 endotoxin unit1 endotoxin unit

Maximum Level of Maximum Level of ContaminantsContaminants

• The water used to prepare the The water used to prepare the dialysate is analyzed for the levels of dialysate is analyzed for the levels of chemical contaminants. chemical contaminants.

• Water analysis report must be within Water analysis report must be within normal range according to the normal range according to the standards set forth by AAMI standards set forth by AAMI recommendations.recommendations.

PersonnelPersonnel

• Patient Care TechinicianPatient Care Techinician- High school diploma or equivalencyHigh school diploma or equivalency- Certification from a state or national program.Certification from a state or national program.

• New employees to be certified within 18 months of hire New employees to be certified within 18 months of hire (as of 10/14/08).(as of 10/14/08).

• Existing employees to be certified within 24 months Existing employees to be certified within 24 months starting 4/4/08. starting 4/4/08.

• Complete any required additional training (approved by Complete any required additional training (approved by the Medical Director and Governing Body) specific to the the Medical Director and Governing Body) specific to the assigned job responsibilities, which may include assigned job responsibilities, which may include monitoring the water treatment system and preparation monitoring the water treatment system and preparation of dialysate.of dialysate.

• Undergo vision testing for color blindness if the job Undergo vision testing for color blindness if the job responsibility involves testing for chlorine/ chloramine in responsibility involves testing for chlorine/ chloramine in water using color comparisons.water using color comparisons.

Personnel (continued…)Personnel (continued…)

• Chief TechnicianChief Technician

- Currently no certification required. Currently no certification required.

- Must be certified by the manufacturer of Must be certified by the manufacturer of the dialysis machines to be able to the dialysis machines to be able to maintain them. maintain them.

- Must have training (approved by the Must have training (approved by the Medical Director and Governing Body) to Medical Director and Governing Body) to monitor and maintain the water treatment monitor and maintain the water treatment system.system.

Responsibilities of Medical Responsibilities of Medical DirectorDirector

• Ensure that all staff adhere to policy and Ensure that all staff adhere to policy and procedures.procedures.

• Ensure that the water treatment system is Ensure that the water treatment system is monitored and maintained in a manner to monitored and maintained in a manner to provide safe patient care.provide safe patient care.

• Ensure that personnel responsible for the Ensure that personnel responsible for the monitoring and maintenance of water monitoring and maintenance of water treatment system are adequately trained treatment system are adequately trained to carry out their assigned duties.to carry out their assigned duties.