APIC IC Challenges in Dialysis
APIC IC Challenges in Dialysis
Danilo B. Concepcion,CBNT, CCHT-A
Operations Manager, Renal Service
The views and opinions are those of the author and does not reflect those of St.
Joseph Hospital or any other organization.
*Infections: A Major Patient Safety Problem in Dialysis – 2nd Leading Cause Of Death
17.0%
48.0%5.0%
4.0%
26.0%
InfectionCardiacCerebrovascular DiseaseMalignant DiseaseAll Other
2
UM-KECC, 2009
Approximately 15,000 dialysis patients die annually due to infections
DIFFUSION IN THE DIALYZER•Dissolved particles can move
either way across the membrane.- From blood to the dialysate.- From dialysate to the blood.
•They will move from area of higher to lower concentration.
•Very important that precise electrolyte level of dialysate is known. - This will determine what is
removed or given to the patient.
MMWR Vol. 50/No.RR-5, page 23 “Hemodialysis in Acute-Care Settings” states: For patients with acute renal failure who receive hemodialysis in acute-care settings, Standard Precautions as applied in all health-care settings are sufficient to prevent transmission of bloodborne viruses. However, when chronic hemodialysis patients receive maintenance hemodialysis while hospitalized, infection control precautions specifically designed for chronic hemodialysis units should be applied to these patients. If both acute and chronic renal failure patients receive hemodialysis in the same unit, these infection control precautions should be applied to all patients
Why Is Infection Prevention Such a Challenge in
Dialysis?
High risk for spread of blood-borne and
other pathogens
Staff caring for multiple
patients w/short “changeover”
times
No physical separation of
individual treatment stations
Lots of potential
blood exposure
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immunosuppressed dialysis patients
The in-center hemodialysis patient treatment reality:
compounded by…
Recent Studies Illustrate How the Dialysis Facility Can Become a “Box of Bugs”
Organisms remain viable on surfaces for prolonged periods
Hepatitis B >1 weekInfluenza 1-2 daysMRSA 7 days to 7
monthsVRE 5 days to 4
monthsC. difficile spore 5 monthsKramer A, Schwebke I, Kampf G. BMC Infect Dis 6:130, 2006
Healthcare workers touch as many as 7 surfaces after touching a contaminated
one!McLaughlin AC, Walsh F. Am J Infect Control 39(6):456-463, 201114
How Are Infections Spread in Dialysis?
Five main sources of pathogen transmission:
1. On the hands of staff going between patients & between common areas and patients
2. From ineffectively disinfected equipment & environmental surfaces
3. From contaminated supplies & medications
4. From inadequate vascular access care
5. From virulent pathogens (e.g. hepatitis B) 15
Dialysis Patient Infections Can Be Prevented by:
Following good infection prevention and control practices
The Centers for Disease Control and Prevention (CDC) has guidelines for these practices in
dialysis facilities
16
The CDC Guidelines
*Address general practices (wash hands, clean & disinfect equipment, etc.)
*Do not include details for application of the guidelines (what parts of the equipment need to be disinfected, etc.)
Remember the lesson from the Patient Safety Movement…
Staff need clear directions in what is expected of them in their duties… 17
NOTICE!National Opportunity To
Improve Infection Control In ESRD
The NOTICE Initiative is funded by the
Department of Health and Human Services
to support the renal community inimproving infection control
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Infection Control Checklists for Dialysis
*Initiation of Dialysis with CVC
*CVC Exit Site Care
*Discontinuation of Dialysis and Post Care of CVC
*Initiation of Dialysis with AVF/G
*Discontinuation of Dialysis and Post Care of AVF/G
*Parenteral Medication Preparation/Administration
*Cleaning & Disinfection of the Dialysis Station
*Supply Management & Contamination Prevention
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Note: It is not required that the patient has vacated the dialysis station before disinfection and preparation of the machine can be conducted.
If the patient remains in the chair during disinfection, strictly adhere to separation b/t the patient and the disinfected/prepared machine.
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V128 Isolation of HBV+ Patients
*Separate isolation room
*February 9, 2009 all new facilities must have a separate isolation room (waiver)…
*Separate isolation area
*If there are current HBV+ patients on census, the isolation area/room can not be used for HBV- patients on other shifts or days due to the risk of cross-contamination.
V130
*Separate dedicated supplies and equipment, including blood glucose monitors.
*Labeled “isolation”
*Concentrate containers
V131
*Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another (e.g., during the same shift or during patient change-over).*If a staff member assigned to care for an HVB+ patient must concurrently care for someone other than another HBV+ patient, the additional patient must be HBV immune
Dialysate is the largest contact material a
patient’s blood touches
The more pure and endotoxin free the water and dialysate, the fewer Chronic Inflammatory Disease (CID) processes seen in patients over time
Fluid Bacteria (CFU/ml)
Endotoxin (EU/ml)
Water used for dialysate, reprocessing of hemodialyzers, germicide production
200 / 50 action level
2 / 1 action level
Dialysate 200 / 50 action level
2 / 1 action level
Minimum Frequency Monthly Monthly
Reference Allowable water TVC Action level water TVC
Allowable Level water EU
Action Level water EU
RD52:2004 <200 <2 2 1
ANSI/AAMI/ISO 13959
<100 50 <0.25 0.125
ANSI/AAMI/ISO 23500
<100 50 <0.25 0.125
ANSI/AAMI/ISO 11663
<100 50 <0.25 0.125
Ultrapure
<0.1 <0.03
Infusable (Sterile)Not listed in the
standards
Reference Allowable dialysate TVC
Action level dialysate TVC
Allowable Level dialysate EU
Action Level dialysate EU
RD52:2004 <200 <2 50 1
ANSI/AAMI/ISO 13959
<100 50 <0.5 0.25
ANSI/AAMI/ISO 23500
<100 50 <0.5 0.25
ANSI/AAMI/ISO 11663
<100 50 <0.5 0.25
Ultrapure
<0.1 <0.03
Infusable (Sterile) 10-6 <0.03
Chemical Contaminant maximum allowable levels equal in all references.
Definitions of Quality for Dialysis
Disinfection Frequency
*Distribution/Loop System*Central systems at
least once a month
*Disinfects water inlet line to hemodialysis machines
*Portables
*Dialysis Machines*Daily OP
*Acute setting
*Bicarbonate mixing systems *daily rinse
*Weekly disinfect
*Individual bicarbonate concentrate containers *should rinsed and
inverted to drain at end of each day
*disinfected weekly
Bacteria Testing Methods
*Culture media should be trypticase soy agar (TSA) or equivalent *No blood or chocolate agar
*Incubate at 35-37o C for 48 hours*May want to go to 72 hours
*Count colonies with a magnifying device*Shall not exceed 200 cfu/ml / 50 cfu action level
Bacteriology of the Dialysate
*Collected during or at the termination of dialysis at or beyond the point where the dialysate leaves the hemodialyzer.
*AAMI: Two machines per month
*Each machine at least once annually
*The total viable bacteria count shall not exceed 200
cfu/ml.
Bacteriology of water
*V178 IG: the final decision of whether to discontinue dialysis rests with the medical director of a facility.
*V179 IG: “Promptly” would be met if action is taken within 48 hours of receiving the results of testing.”
Endotoxins
*By-products of water-borne gram negative bacteria*Reside in the cell wall*Released when the bacteria dies*Enter bloodstream*Build-up in Reprocessed Hemodialyzers
*Back Diffusion*
*Back Filtration*
*Sense Bacteria/Endotoxin
Limulus Amebocyte Lysate (LAL) Assay
*Do disinfect the ports with LAL testing*<2 EU *> 1EU action level
*Current testing can be done in-center*Perform a control with each batch of tests
*Outside labs usually require freezing or refrigerated specimen and have better sensitivities
*Frequency*monthly
*If suspected endotoxin reaction
Long-term Effects Attributed to Chronic Micro-
Inflammation*Malnutrition
*Low albumin
*Muscle protein wasting
*Protein catabolism
*Increased CRP
*Atherosclerosis
*Low cholesterol synthesis
*Increased ferritinlevels
*Resistance to EPO therapy
*Bone disease, cysts, fractures
*Sleep disorders
*Anti-endotoxinantibodies
Causes That Contribute to Growth
*Improper water treatment system design*Loop
*Holding tanks
*UV/Ultrafilters
*Improper maintenance of water treatment system and delivery system (dialysis machine)*Disinfection schedule
*Improper disinfectant
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