Infection Control in the Dialysis Infection Control in the Dialysis Setting – Part 1 of 4Setting – Part 1 of 4

Danilo B. Concepcion CCHT, CHTDanilo B. Concepcion CCHT, CHTManager, Renal Technology ServicesManager, Renal Technology Services

Email: danilo.concepcion@stjoe.orgPhone: 714.771.8944

The findings and conclusions in this presentation are those of the authorand do not necessarily represent the views of St. Joseph Hospital

ObjectivesObjectives

• Discuss the new AAMI RD52:2004 – Discuss the new AAMI RD52:2004 – Dialysate for hemodialysis Dialysate for hemodialysis recommendationsrecommendations

• Discuss the buttonhole technique of Discuss the buttonhole technique of cannulationcannulation

• Discuss infection control concerns in Discuss infection control concerns in hemodialysis hemodialysis

Growing Dialysis PopulationGrowing Dialysis Population

USRDS 2005 Annual Data Report

In 2003, > 450,000 ESRD patients, > 300,000 receiving hemodialysis

Why Change the Standards?Why Change the Standards?• Increasing data that shows microbial Increasing data that shows microbial

quality of dialysis fluids is importantquality of dialysis fluids is important• Chronic inflammatory response syndromeChronic inflammatory response syndrome

– Amyloid diseaseAmyloid disease– CarpalCarpal– Cardiovascular diseaseCardiovascular disease

• Endotoxin/Pyrogens and EPO resistanceEndotoxin/Pyrogens and EPO resistance

Microbial Quality of Water and DialysateMicrobial Quality of Water and Dialysate

MCLMCLCFU/mlCFU/ml

Action Action limitlimit

CFU/mlCFU/mlMCLMCLEU/mlEU/ml

Action Action limit limit

EU/mlEU/ml

WaterWater 200200 5050 22 11

DialysateDialysate 200200 5050 22 11

Ultra-pureUltra-puredialysatedialysate

0.10.1 0.030.03

Dialysate for infusionDialysate for infusion 1010-6-6 0.030.03

Microbes Associated with Water and Microbes Associated with Water and Dialysate Dialysate-Bacteria--Bacteria-

• Bacteria can be broken down into 2 main Bacteria can be broken down into 2 main groups based on the characteristics of their groups based on the characteristics of their cell wallcell wall– Gram PositiveGram Positive– Gram NegativeGram Negative

• They can also be further grouped by their They can also be further grouped by their shape:shape:– Cocci (round shaped)Cocci (round shaped)– Bacilli (rod shaped)Bacilli (rod shaped)– Spirilla (curved, helical, cork screw) Spirilla (curved, helical, cork screw)

Bacteria Commonly Found in Water for Bacteria Commonly Found in Water for DialysisDialysis

• Primarily gram negative bacilli:Primarily gram negative bacilli:– Pseudomonas aeruginosa, Burkholderia cepacia complex, Pseudomonas aeruginosa, Burkholderia cepacia complex,

Ralstonia pickettii, Stenotrophomonas maltophilia, Ralstonia pickettii, Stenotrophomonas maltophilia, Methylobacterium mesophilicum, M. extorquens, Cuprividae Methylobacterium mesophilicum, M. extorquens, Cuprividae comamonascomamonas

– Enterobacter cloacae, Klebsiella pneumoniaeEnterobacter cloacae, Klebsiella pneumoniae• Occasionally mycobacteria:Occasionally mycobacteria:

– Mycobacterium abscessus, M. chelonae, M. fortuitum, M. Mycobacterium abscessus, M. chelonae, M. fortuitum, M. mucogenicummucogenicum

• Other organisms: Other organisms: Corynebacterium aquaticum, Oeskovia Corynebacterium aquaticum, Oeskovia spp, Bacillus spp.spp, Bacillus spp.

Bacteria Testing FrequencyBacteria Testing Frequency• Should be performed at minimum once a Should be performed at minimum once a

month for established systemsmonth for established systems• Collect samples as part of patient work up Collect samples as part of patient work up

for bacteremia or pyrogenic reactionfor bacteremia or pyrogenic reaction• After modification to the water After modification to the water

treatment systemtreatment system• At least weekly for new systemsAt least weekly for new systems

– Establish a pattern then can reduce frequencyEstablish a pattern then can reduce frequency

Bacteria Sampling TechniquesBacteria Sampling Techniques

• Test worst case scenario Test worst case scenario – Right before disinfecting water systemRight before disinfecting water system– Outlets: first, last, reuse, bicarbOutlets: first, last, reuse, bicarb

• Sample all points of use (AAMI)Sample all points of use (AAMI)– Allow sample port to flush for 30-60 secondsAllow sample port to flush for 30-60 seconds– Do not use betadine or bleach to clean sampling portDo not use betadine or bleach to clean sampling port– Do not sample from tubing connected to portsDo not sample from tubing connected to ports

Bacteria Testing MethodsBacteria Testing Methods• Must be assayed within 1-2 hours of Must be assayed within 1-2 hours of

drawing or refrigerated at 4-6 degrees C not drawing or refrigerated at 4-6 degrees C not longer than 24 hours of collectionlonger than 24 hours of collection

• Use membrane filter technique (including Use membrane filter technique (including commercial devices) or spread plate methodcommercial devices) or spread plate method– Use pipette for accuracy Use pipette for accuracy – No “calibrated loop” methodsNo “calibrated loop” methods

Bacteria Testing MethodsBacteria Testing Methods

• Culture media should be trypticase soy agar (TSA) Culture media should be trypticase soy agar (TSA) or equivalentor equivalent – No blood or chocolate agarNo blood or chocolate agar

• Incubate at 35-37Incubate at 35-37oo C for 48 hours C for 48 hours– May want to go to 72 hoursMay want to go to 72 hours

• Count colonies with a magnifying deviceCount colonies with a magnifying device– Shall not exceed 200 cfu/mlShall not exceed 200 cfu/ml / 50 cfu action level / 50 cfu action level

Bacteriology of the DialysateBacteriology of the Dialysate• Collected during or at the termination of Collected during or at the termination of

dialysis at or beyond the point where the dialysis at or beyond the point where the dialysate leaves the hemodialyzer.dialysate leaves the hemodialyzer.

• AAMI: Two machines per monthAAMI: Two machines per month– Each machine at least once annuallyEach machine at least once annually

• The total viable bacteria count shall not exceed The total viable bacteria count shall not exceed 200 cfu/ml.200 cfu/ml.

Bacteria Reporting/RecordingBacteria Reporting/Recording• Do not accept “positive” or “negative” as a Do not accept “positive” or “negative” as a

resultresult– Want a full count of every viable colonyWant a full count of every viable colony

• Watch for results that consistently have zeroes Watch for results that consistently have zeroes (e.g. 200 cfu, etc.)(e.g. 200 cfu, etc.)– This may indicate the lab is using a This may indicate the lab is using a

calibrated loopcalibrated loop• Be suspicious of many “no growth” resultsBe suspicious of many “no growth” results• Do Trend Analysis Do Trend Analysis

– Can see problems arisingCan see problems arising

EndotoxinsEndotoxins• By-products of water-borne gram negative By-products of water-borne gram negative

bacteriabacteria• Reside in the cell wallReside in the cell wall• Released when the bacteria diesReleased when the bacteria dies• Enter bloodstreamEnter bloodstream

– Build-up in Reprocessed HemodialyzersBuild-up in Reprocessed Hemodialyzers– Back Diffusion*Back Diffusion*– Back Filtration*Back Filtration*– Sense Bacteria/EndotoxinSense Bacteria/Endotoxin

Limulus Limulus Amebocyte Lysate Amebocyte Lysate (LAL) Assay(LAL) Assay

• Do disinfect the ports with LAL testingDo disinfect the ports with LAL testing• <2 EU <2 EU

– > 1EU action level> 1EU action level• Current testing can be done in-centerCurrent testing can be done in-center

– Perform a control with each batch of testsPerform a control with each batch of tests– Outside labs usually require freezing or refrigerated specimen Outside labs usually require freezing or refrigerated specimen

and have better sensitivitiesand have better sensitivities• FrequencyFrequency

– monthlymonthly– If suspected endotoxin reactionIf suspected endotoxin reaction

Pyrogenic (Endotoxin) Pyrogenic (Endotoxin) Reaction Reaction

Occurs 1 hour to half-way into the Occurs 1 hour to half-way into the treatmenttreatmentSeverity of reaction is directly Severity of reaction is directly proportional to amount of endotoxin proportional to amount of endotoxin exposureexposureSymptomsSymptoms

Uncontrollable shaking, chills, Uncontrollable shaking, chills, temperature spikestemperature spikesNausea and vomitingNausea and vomitingMyalgiaMyalgiaHypotensionHypotension

EndotoxinEndotoxin• Predominant cause of acute patient reactionsPredominant cause of acute patient reactions

– Pyrogenic Reactions (PR): onset of objective chills Pyrogenic Reactions (PR): onset of objective chills (rigors) and/or fever (oral temp (rigors) and/or fever (oral temp 37.8°C) in a patient 37.8°C) in a patient who was afebrile and had no signs or symptoms of who was afebrile and had no signs or symptoms of infection before dialysis treatment.infection before dialysis treatment.

• In the United States, approximately 20% of all In the United States, approximately 20% of all hemodialysis centers report having hemodialysis centers report having 1 PR only 1.7% 1 PR only 1.7% of these centers report PR in clustersof these centers report PR in clusters

• From CDC investigations of outbreaks most PR clusters From CDC investigations of outbreaks most PR clusters are associated with errors in dialyzer reprocessingare associated with errors in dialyzer reprocessing

Causes That Contribute to Growth Causes That Contribute to Growth

• Improper water treatment system designImproper water treatment system design– LoopLoop– Holding tanksHolding tanks– UV/UltrafiltersUV/Ultrafilters

• Improper maintenance of water treatment system Improper maintenance of water treatment system and delivery system (dialysis machine)and delivery system (dialysis machine)– Disinfection scheduleDisinfection schedule– Improper disinfectantImproper disinfectant

DisinfectionDisinfection

A key concept in ensuring compliance with theA key concept in ensuring compliance with thebacteriological control requirements is thatbacteriological control requirements is thatdisinfection schedules should be designed todisinfection schedules should be designed toprevent bacterial proliferation, rather thanprevent bacterial proliferation, rather thanbeing designed to eliminate bacteria once theybeing designed to eliminate bacteria once theyhave proliferated to an unacceptable level. have proliferated to an unacceptable level.