Infection Control in the Dialysis Setting – Part 1 of 4

1. Infection Control in the Dialysis Setting – Part 1 of 4 Danilo B. Concepcion CCHT, CHT Manager, Renal Technology Services Email: danilo.concepcion@stjoe.org Phone: 714.771.8944 The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of St. Joseph Hospital

2. Objectives • Discuss the new AAMI RD52:2004 – Dialysate for hemodialysis recommendations • Discuss the buttonhole technique of cannulation • Discuss infection control concerns in hemodialysis

3. Growing Dialysis Population In 2003, > 450,000 ESRD patients, > 300,000 receiving hemodialysis USRDS 2005 Annual Data Report

4. Why Change the Standards? • Increasing data that shows microbial quality of dialysis fluids is important • Chronic inflammatory response syndrome • Amyloid disease • Carpal • Cardiovascular disease • Endotoxin/Pyrogens and EPO resistance

5. Microbial Quality of Water and Dialysate

6. Microbes Associated with Water and Dialysate-Bacteria- • Bacteria can be broken down into 2 main groups based on the characteristics of their cell wall • Gram Positive • Gram Negative • They can also be further grouped by their shape: • Cocci (round shaped) • Bacilli (rod shaped) • Spirilla (curved, helical, cork screw)

7. Bacteria Commonly Found in Water for Dialysis • Primarily gram negative bacilli: • Pseudomonas aeruginosa, Burkholderia cepacia complex, Ralstonia pickettii, Stenotrophomonas maltophilia, Methylobacterium mesophilicum, M. extorquens, Cuprividae comamonas • Enterobacter cloacae, Klebsiella pneumoniae • Occasionally mycobacteria: • Mycobacterium abscessus, M. chelonae, M. fortuitum, M. mucogenicum • Other organisms: Corynebacterium aquaticum, Oeskovia spp, Bacillus spp.

8. Bacteria Testing Frequency • Should be performed at minimum once a month for established systems • Collect samples as part of patient work up for bacteremia or pyrogenic reaction • After modification to the water treatment system • At least weekly for new systems • Establish a pattern then can reduce frequency

9. Bacteria Sampling Techniques • Test worst case scenario • Right before disinfecting water system • Outlets: first, last, reuse, bicarb • Sample all points of use (AAMI) • Allow sample port to flush for 30-60 seconds • Do not use betadine or bleach to clean sampling port • Do not sample from tubing connected to ports

10. Bacteria Testing Methods • Must be assayed within 1-2 hours of drawing or refrigerated at 4-6 degrees C not longer than 24 hours of collection • Use membrane filter technique (including commercial devices) or spread plate method • Use pipette for accuracy • No “calibrated loop” methods

11. 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

12. 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.

13. Bacteria Reporting/Recording • Do not accept “positive” or “negative” as a result • Want a full count of every viable colony • Watch for results that consistently have zeroes (e.g. 200 cfu, etc.) • This may indicate the lab is using a calibrated loop • Be suspicious of many “no growth” results • Do Trend Analysis • Can see problems arising

14. 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

15. 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

16. Pyrogenic (Endotoxin) Reaction • Occurs 1 hour to half-way into the treatment • Severity of reaction is directly proportional to amount of endotoxin exposure • Symptoms • Uncontrollable shaking, chills, temperature spikes • Nausea and vomiting • Myalgia • Hypotension

17. Endotoxin • Predominant cause of acute patient reactions • Pyrogenic Reactions (PR): onset of objective chills (rigors) and/or fever (oral temp  37.8°C) in a patient who was afebrile and had no signs or symptoms of infection before dialysis treatment. • In the United States, approximately 20% of all hemodialysis centers report having  1 PR only 1.7% of these centers report PR in clusters • From CDC investigations of outbreaks most PR clusters are associated with errors in dialyzer reprocessing

18. 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

19. 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.