APIC IC Challenges in Dialysis

APIC IC Challenges in Dialysis

Danilo B. Concepcion,CBNT, CCHT-A

Operations Manager, Renal Service

danilo.concepcion@stjoe.org714-771-8944

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

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UM-KECC, 2009

Approximately 15,000 dialysis patients die annually due to infections

IC Challenges in Dialysis

*Temporal and spatial issues

*Water and dialysate

*Staffing matrix

HOLLOW FIBERSHollow fiber

Fiber wall

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

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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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20

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25

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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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The Infection Control Checklists Don’t Address

Everything on How to Protect Patients from HAI…

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V120Blood

Contaminating a

Pressure Transducer

Filter

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

Disinfection

A key concept in ensuring compliance with the

bacteriological control requirements is that

disinfection schedules should be designed to

prevent bacterial proliferation, rather than

being designed to eliminate bacteria once they

have proliferated to an unacceptable level.