Dialysis Water Training Class - FMQAI

Dialysis Water Training ClassJim Curtis, CHTJim Curtis & Associates, LLC

Water Basics‣ Water is the Universal Solvent• It will change almost anything it comes incontact with• It will Be changed by almost anything intouches‣ Water affects EVERY dialysis treatment

Water Basics‣ There are Four primary categories ofcontaminates found in Water• Particulate• Inorganics• Organics• Microbiological

Water Basics‣ Particulate Matter Includes:• Sediment• Suspended Solids• Grit• Sand

Water Basics‣ Inorganic Material is the IonicConcentration found in water• Dissolved Salts• Other dissolved solids• Hardness‣ Common Inorganic material found in water• Calcium, Magnesium, Sodium, Potassium,Zinc, Nitrates, Lead, Copper, Aluminum, etc.

Water Basics‣ Organic Material often come in morecomplex chemical compounds.‣ Examples include chloramines, pesticides,insecticides, tannins‣ Can be a result of either natural or man-made causes.

Water Basics‣ Microbiological Contaminates include:• Bacteria and Bacterial Endotoxin• Viruses• Cysts• Protozoan's‣ These substances vary greatly in size andshape‣ Different problems are encountered witheach

Water Terms You Should Know‣ Source Water: Where the water originallycomes from. Generally the two sources areGround Water that comes from wells, andSurface Water which comes from lakes andrivers.‣ Feed Water: This is the water “feeding” yourtreatment system, and is often treated by themunicipality before it gets to you.

Water Terms You Should Know‣ Pre-Treatment:Treatment: These are the devices thatyou yse to treat the water prior to the ReverseOsmosis or DI device.‣ Reverse Osmosis: This is a process wherehydraulic pressure is used to overcome theosmotic pressure and cause water to move fromareas of high solute concentration to areas ofLow solute concentration.Permeate: Water that has passed through theRO membrane- “Product” water‣ Permeate:

Water Terms You Should Know‣ Concentrate: This is the waste water from theRO, which now has a higher concentration ofsolutes that the feed water did.‣ Filtration (or Depth Filtration): Removal ofsuspended particles by mechanically trappingthem in a filter media.• Submicron Filtration: Removing particles lessthan1microninsize.in • Ultrafiltration: Removing particles from .002 to.1 microns.

Water Terms You Should Know‣ Ion Exchange: Exchange of one ionic particle foranother• Cation: Positively Charged particle• Anion: Negatively charged particle• Deionization: Removal of charged particles fromwater by means of ion exchange.Chloramines: Chemical used to disinfectmunicipal i water supplies. They are formed bycombining chlorine and ammonia.‣ Chloramines:

Water Terms You Should Know‣ Hardness: Refers to the sum of calciumand magnesium in the water• Expresses in Grains per Gallon of CalciumCarbonate (1 GPG = 17.1 mEq/L)• Primary source of scaling that fouls ROmembranes.

Water Terms You Should Know‣ pH: Potential of Hydrogen‣ Quantitative measurement of the acidity oralkalinity on a logarithmic scale from 1 to14• pH > 7 = Alkaline (base)• pH = 7 = Neutral• pH < 7 = Acidic

Water Terms You Should Know‣ Microorganism: Small living organismssuch as Bacteria, Virus or Ptotozoan.‣ Colony Forming Units (CFU): Themeasurement of viable colonies ofbacteria in a culture sample‣ Biofilm: A gelatinous material secreted bycertain bacteria that can adhere to thewalls of piping and forms a protectivecoating

Water Terms You Should Know‣ Endotoxin: A lipopolysaccoride that is partof cell walls of gram negative bacteria‣ LAL: Limulus Amebocyte Lysate, a test forbacterial endotoxin derived from intestinalfluid of horseshoe crabs.‣ Endotoxin Units (EU): Quantitativemeasurement of the amount of Endotoxincontamination in a solution.

Importance of Monitoring‣ Increases Patient Safety‣ Maintain Regulatory Compliance‣ Assures Proper Functioning i of WaterTreatment System

Water for Hemodialysis is aPrescription‣ More than 95% of the dialysate is water‣ The Doctor makes the ultimate decisionregarding water quality???‣ Water treatment systems for dialysispurposes are considered d a Class IIMedical Device by the FDA

Exposure to Water andContaminants‣ Average Population• Drinks approximately14 L/week (2 L/day)• Able to excrete toxicsubstances in urine• Contaminantsselectively absorbed inGI system, indirectlyexposed to blood‣ Hemodialysis Patients• Exposed toapproximately 360 L/week (120L/treatment)• Kidneys unable toexcrete toxicsubstances• Contaminants directlyexposed to blood viadialyzer membrane

Weekly Water Exposure

Water SystemComponents

DustGasesDustImpuritiesPumping StationMinerals & ImpuritiesWellMineralsRiverMinerals & ImpuritiesLake, Stream, PondHardnessImpuritiesMineralsWaterTable

SurfaceWaterGround Water‣ Higher in organicmaterial, silt, andbacterial levels‣ Industrial wastes,automotive by-products,run off or dumping‣ Rural area water is alsoaffected by animalwastes, fertilizers andpesticides‣ Higher in inorganicmaterial and lower inorganic material‣ Calcium, magnesium,iron, zinc, copper,sodium, aluminum‣ Any mineral the watercomes in contact withwill change it.‣ Level of mineral may bespecific c to an area

Municipal SystemTreats available water to meet the Nation Drinking Water Standards.Quality of municipal water dictates what is needed as pretreatmentfor the RO system.• Communication with water supplier (name, phone number,alternate t contact)t)• Get annual water reports and updates sent to you• Can have high chlorine/chloramine levels (minimum of .1PPM)• High pH (8.5 and higher with chloramine is problem)• High fluoride levels or spikes• Overdosing or normal dosing polymers or flocculent l cancause membrane problems• Alum (aluminum sulfate) is commonly used• Water quality can change after natural disasters• Emergency (disaster) or temporary water supplies

Complete System

Complete SystemFeed Water‣ Backflow Preventers‣ TemperatureBlending Valves‣ Feed Water BoosterPumps‣ Bladder Tanks‣ Electrical ca Outlets

BackflowPreventer

Backflow Preventer‣Prevents reverse flow ofwater and or contaminantsthrough the valve, whichwould contaminate thepotable drinking watersupply.‣Installed, tested by licensedplumber

Monitoring theBackflow Prevention Device‣ Monitor: PressureDrop across thedevice‣ Look For: A change of10 PSI from baseline

Temperature Blending ValveHot WaterDischargeCold Water• Increases the incomingwater temperature toapproximately 77degrees F, “ideal”membrane operatingtemperature.• Membrane productwater production isbased in part on watertemperature.• Production decreases1.5% per F, 3% per C.

Temperature Blending Valve• Considerations/Concerns• Pipe size of valve normally small• High pressure losses through valve isnormal (20 - 45 PSI)• Inlet screens can get clogged• Personnel adjusting valve too hot or cold

Monitoring theTemperature Blending Valve‣ Monitor: Temperatureon a Daily Basis postblending valve‣ Look For: Appropriatewater temperature,minimal temperaturefluxuation

BoosterPumps

Booster PumpsUsed to increase and maintainfeed water pressure to adesired level for systemoperation

Booster Pumps‣Considerations/Concerns• Does not make water, only boosts available waterpressure• Pump sizing considerations: flows and pressuresneeded for equipment, supplied pressure, pipesize, electrical l needs.• Intermittent low pressure problems• Pump operation is controlled by a pressureswitch• Tend to be noisy

Booster Pump Monitoring‣ Maintains Adequatewater flow andpressure‣ Monitor: WaterPressure‣ Look For: Pumpturning on and off atappropriate pressures

Bladder TankAir Bladder orDiaphragm• Provides additionalvolume of water forchanging flowrequirementsTo PT & RO

Bladder Tank‣Concerns/Considerations• Normally installed with booster pump asbuffer• Can be used without a pump• Bacteria problems if used with non-chlorinated water• Loss of air charge• Never use post RO unit• It is a large dead end and will trap disinfectantswith no way to ensure a negative level

Bladder Tank‣MonitoringPump turns on and off at preset•pressures

Complete SystemPretreatment‣ Chemical FeedPumps‣ Multi-Media Media Filters‣ Softener Tanks‣ Carbon Tanks

Chemical Feed Pumps/ pH ControlAcid tankPumpUsed to adjust pHto a desired levelby metering insmall amounts ofchemical intofeed water.

Chemical Feed Pumps/ pH Control• Concerns/Considerations• Municipalities increasing pH to complywith lead and copper rule• Commonly used acids are Hydrochloric(HCL)(Muriatic) ) and Sulfuric (H2SO4)• Settings need to be monitored• Automatic controls and monitors canget out of calibration• Can lose prime on acid line to pump• All of the safety precautions needed d forchemicals

Acid Feed Pump Monitoring‣ Monitor: pH post feedpump‣ Look For: pH shouldbe between 7.0 and8.0

Multi-media (Depth) FiltersUsed to filter outparticulates 10 micronsand larger by depthfiltration• Contains multiplelayers of varioussized rocks andsand

Multi-media Filters• Multiple layers of various sizedgravel, sand, anthracite- selected for specific density-re-stratifies after back washends• Water pressure/flow must beadequate to backwash properly- HIGH flow requirement

Multi-media Filters, cont.• Media bed can become overloaded & unableto backwash• Sized in-flow rate ( gallons) per square footof cross-sectional sectional area• Test with Silt Density Index (SDI) kit- measures ‘plugging’ rate

Multi-Media Media Filter Monitoring‣ Monitor: Pressuredrop across thedevice‣ Look For: A change of10 PSI or more frombaseline

Softeners & Exchange TanksFor theremoval ofwaterhardness(calcium,magnesium)in exchangefor sodiumNaClsolution

Cation Exchange ProcessSoftenerResin BeadNa+Na+Na+Na+Na+Na+N+ Na+2Na+Cl-Cl-2Na+Ca++Ca++ Na+ Ca++ Ca+2Na+ Cl- Cl-2Na+Na+ 2Na+2Na+

Softener Considerations andConcerns• Rated in grains of hardness removalcapacity• 30,000 or 30K grain is 1 cu. ft. of resin.• 15 Lbs. of salt saturated water neededto completely recharge 30K or 1 cu. ft.• Softener Resin• Iron fouling of resin effects exchangeperformance• Chlorine exposure damages resin• Age of resin (diminished i i d regeneration)

Softeners Concerns andConsiderations (cont.)• Dirt in salt clogs brine valve• Salt bridge can form in brine tank• Testing incorrectly• Potassium chloride not recommendedto regenerate softeners used forDialysis

Water Softener‣ Monitor:• Post softener hardness,• amount of salt in the brinetank,• “salt bridge” in the brinetank,• pressure drop across thedevice,• settings on regenerationtimer.

Water Softener slide 2‣ Look For:• Hardness notexceeding 10 PPM• Adequate amount ofsalt with no salt bridge• Pressure drop changefrom baseline of 10PSI or more• Timer set to activatewhen facility is not inoperation

Carbon TanksUsed toremovechlorine andchloraminesharmful to ROmembranesand patients

Carbon Tanks• Carbon commonly referred to as GAC (GranularActivated dCarbon)• Made from organic materials exposed to hightemperatures• Bituminous coal, peach pits, coconut shells• Extremely porous• 1 teaspoon of GAC has the surface area of footballfield.• Mesh size of 12 x 40 microns or smaller• Iodine number of 900 or higher• Acid washing removes manufacturing debris

Carbon Tanks• Tanks are sized for Empty Bed Contact Time(EBCT).• 10 minutes EBCT required by AAMI standards• Two tanks in series for total EBCT, worker andpolisher, each with an EBCT of 5 minutes• Chlorine testing is done from a sample port afterthe first tank, and before the second

Carbon Tank Concerns• High levels of chlorine and chloramines can shorten the life ofcarbon• Color blind tester• Automatic testing equipment is available• Bacteria growth will happen in and after carbon• Channeling or compaction of bed• Bypass valves on carbon tanks are a hazard• Testing should not take place sooner than 15 minutes fromstartup, and at the end of the tank fill cycle in an indirectsystem

Carbon Tank Monitoring‣ Monitor:• Chlorine andchloramine levels afterthe worker tank beforeeach patient shift• pressure drop acrosseach tank• Back-flush timer• EBCT calculated andat least 10 minutes forboth tanks

Carbon Tanks slide 2‣ Look for:• Chlorine levels withinAAMI standards (0.5PPM free chlorine, 0.1PPM chloramine)• Pressure drop changeof 10 PSI or greater• Back-flush timer set toactivate when facility isnot in operation.

Chlorine Test‣ Test for• “Free chlorine”• “Total chlorine”‣ Difference between “free chlorine” and “totalchlorine” equals the chloramine level‣ Always test for “total chlorine” and never “freechlorine” alone‣ Perform on fresh water‣ Test Between Working Tank and PolisherPerform on fresh water after fifteen minutes

Chlorine Test‣ Allowable Limits:Free • Chlorine 0.5 ppm• Chloramines 0.1 ppm‣ Use Accurate Measurement Tools• DPD Testing Method• Chlorine Specific Test Strips

PrefiltersHeadFlowOutletO-ringFilterCartridgeFlowFinal Barrieragainst particlesor debris thatcan damage ROpumps andmembranesShell

Prefilters• Considerations/Concerns• Disposable cartridge with a 1 micron filtersize• Change prefilter when• 8-10 PSI higher than clean pressure loss• Or on a routine schedule• Disinfect bowl and head to remove biofilm• AAMI standards require housing to beopaque to prevent algae growth

Complete SystemRO Unit‣ RO Pumps‣ Membranes‣ Disinfection‣ Gauges and Flowmeters‣ Monitors and Controls

RO PumpsHousingPumpOutletVentBoosts feedwater up tomembraneoperatingpressuresMotorInlet

RO Pumps• Two common types of pumps• Rotary vane positive displacement• multi-stage centrifugal• Considerations/concerns• Operated without adequate water supply, run dry, orgrit in water is damaging to pumps• Material of construction is important• Stainless steel and inert plastics• Some motors are noisy

Spiral Wound MembraneElementPermeate FlowConcentratePermeateFeedSolutionCollection Tube

RO Membrane SectionRO MembraneOuterMeshInner Mesh

Outer Mesh

Outer Membrane at 10X

Inner Membrane at 200X(Torn edge)

Inner Mesh at 60X

Inner Mesh at 200X

Spiral Wound MembraneElementThe heart of water treatment process• Will remove on an average 96-99% 99% of all incomingsolute. This includes dissolved inorganic, largeorganic (>200 molecular weight), endotoxins, viruses,and bacteria• Thin Film Composite (TFC) and Cellulose acetate(CA) are most commonly used membranes in dialysistoday• Service life is 1 to 5 years or greater

Monitoring Reverse OsmosisDevice (Operating Parameters)‣ Monitor: Waterpressure and flow atvarious locationsthroughout thesystem.

Monitoring RO Device slide 2(Operating parameters)‣ Look For: Changes inthe water pressureand flow at variouslocations throughoutthe system.

RO Water Quality Monitoring 1‣ Monitor Chemical Analysisof Raw and RO Productwater; Compare Results toAAMI Standards. Must beAnalyzed Annually(Quarterly Recommended)d)

RO Water Quality Monitoring 2‣ Continuous Monitoring byIndirect Method Required‣ Percent Rejection and/orTDS Monitor‣ Alarm Set to Divert toDrain if Quality BelowStandards.

RO Water Quality Monitoring 3‣ Conductivity Is MeasuredBoth Pre and Post ROMembrane‣ Is An Indication Of TotalDissolved Solids In Water‣ Percent Rejection IsCalculated From Pre and PostConductivity i Measurements• {(Input-Product)/Input}*100 = %Rejection

Complete System‣ Storage Tanks andPumps‣ DI Tanks and Monitors‣ UV Lamps‣ Ultra Filters andSubmicron Filters‣ Drains‣ Piping LoopsDelivery

Storage TankCollects andrecirculates ROwater to meet peakusage demands

Storage Tanks• Shape and design of tank is important• Conical shaped bottom, completely sealed, sprayheads, vent filter, and check valve overflows• 30Ft/ 3.0 Ft./sec. velocity at peak kd demand d at returnloop• Volume of tank needs to be small enough notto allow water to stand dormant• Level controls start and stop RO unit• Bacteria growth in a storage tank canhappen• Frequent bacteria/LAL testing recommended

Deionization (DI) TankRemovespositively andnegativelycharged ionsfrom the water

DI Tank MonitorsMeasures Resistivity to indicate DI water quality• Must be temperature compensated with audible andvisual alarms after last tank• Single light monitors can be used on all tanks before lasttank•

Safest Set-up for DI‣ Two tanks in a series• One as worker, one as back-up‣ Audible and visual, temperaturecompensated alarms• On last tank at least‣ Designated resins for medical applications‣ UF post DI

De-ionization DeviceMonitoring (Operating Parameters)DIExchangeProcessH+H+H+Hydrogen IonsH+Na+ Cl-Na+ Cl-Cl-Na+Na+Cl-Na+Cl-H+ Na+Cl- OH-OH-H+H+OH-H+‣ Monitor: Pressurebefore and after eachtank‣ Look For: A change inpressure of 10 psi ormore from baselineOH- OH-OH-OH-H+OH-Hydroxyl IonsH+ H+OH- OH-OH-H+OH-H+ OH-Cation Resin BeadH 2 OAnion Resin Bead

DI Water Quality Monitoring‣ Monitoring is the same as forRO except:‣ Continuous Monitoring isdone by Resistivity instead ofConductivity‣ Resistivity Must Always BeGreater Than 1 MegaOhm

Ultraviolet Irradiator‣UV is a mercury vapor lamp enclosed in afused quartz sleeve• Endotoxins may be produced as it killsbacteria• Ultrafilter recommended after UV forendotoxin control• UF may be placed at points of use• Check LAL• Unit lamp sleeve not routinely cleaned and willaffect efficiencyi• Lamp should have a monitor built in to device• With or Without monitor, replace lamp once per year

Ultra and Submicron FiltersFor the removal of bacteriaand endotoxins

Ultra and Submicron Filters• UF filters rated by yppore size• generally .01 through 0.1 microns)• Sub micron filter• 0.1 through 1.0 microns• Grow bacteria if not disinfected or replacedroutinely• Low flows and high pressure loss throughfilters• Record pressure pre and post filter• >8 PSI, action taken

Product Distribution SystemsPiping i loop capable of delivering i water to allequipment and patient needs• Material and construction is very important• No branch lines or dead ends• Loop pressures can be very high when water consumptionis low in piping• Velocity greater than 3 feet per second (FPS) at peakdemand• Loop sections repaired or additions with incorrectmaterials• Hoses and valves can cause positive bacteria results

Microbiological Monitoring

Microbiological Standards for WaterUsed to Prepare Dialysis Fluid andReprocess Hemodialyzers‣ Bacteria: Less than 200 CFU/mLwith anaction level of 50 CFU/mL‣ Endotoxin: Less than 2 EU/mLwith anaction level of 1 EU/mL

Sample Collection Sites‣ Water leaving the RO or DI system‣ Water leaving a holding tank‣ Water returning at the end of the loop‣ Water entering the reprocessingequipment‣ Water entering any concentrate mixingequipment‣ Water entering the dialysis machines

Backup Water Plan‣ If your facility uses a back up water planthat uses anything other than areplacement RO, this water should bemonitored for microbiologicalcontamination as well.‣ If you perform LAL’s on site, it isrecommended that you test the waterbefore dialysis is initiated in the facility

Bacteria Testing Methods‣ Must be assayed within 1-2 hours of drawing orrefrigerated at 5 degrees C not longer than 24 hours ofcollection‣ Use membrane filter technique (including commercialdevices) or spread plate method• Use pipette for accuracy• No “calibrated loop” methods‣ Culture media should be trypticase soy agar (TSA) orequivalent• No blood or chocolate agar‣ Incubate at 35-3737 degrees C for 48 hours‣ Count viable colonies with a magnifying device• Shall not exceed 200 cfu/ml

If Results Exceed Action Level‣ Disinfect RO• Reculture‣ If still above 50 cfu/ml• Check all previous sample sites• All patient stations• Storage tanks• Water to mix dialysate• Final component of water treatment system• All dialysis machines

Monitoring Flow Rates‣ Flow velocity indistribution loop shouldbe at least 3 feet persecond‣ Monitor the flow rate atthe end of the loop‣ Calculate the velocityfrom the flow rate andpipe size‣ V = Q/A

Documentation‣ “If it isn’t written down, it didn’t happen”‣ Documentation of technical parametersmust meet the same stringent standardsas patient care documentation. After all,IT IS patient documentation!