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201708227

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UWHC,UWMF,

Policies,Clinical,UWHC Clinical,Department Specific,Hemodialysis

Corrective Action Plan in the event of Positive Water Cultures/Endotoxins (2.3)

Corrective Action Plan in the event of Positive Water Cultures/Endotoxins (2.3) - Policies, Clinical, UWHC Clinical, Department Specific, Hemodialysis

2.3

University of Wisconsin Hospital and Clinics
Inpatient Hemodialysis
Department 55400

TITLE: Corrective Action Plan in the
event of Positive Water
Cultures/Endotoxins

POLICY #:2.3
REVISED: May 1, 2013
Page 1 of 3
Nurse Manager: Joan Watson, MS, RN
Director: Ann Malec, DNP, RN, NEA-BC
Medical Director: Alex Yevzlin, MD


I. PURPOSE

To provide guidance for evaluating and addressing Colony Counts (CFU/mL) and
Endotoxin levels (EU/mL) test that meet or exceed standards established by the
Association for the Advancement of Medical Instrumentation (AAMI) for treated water
used to prepare dialysate.

II. POLICIES

A. Colony Counts (CFU/mL) and Endotoxin levels (EU/mL) test results will be reviewed
and signed off by the Chief Biomed Technician, Medical Director, and Nurse Manager
monthly. These results will also be reviewed by an Infection Control Practitioner and a
summary of these results will be presented at the UWHC Infection Control Committee
and shared with the VA Contract Office monthly.
B. There are three action levels that determine the response necessary for each Colony
Counts (CFU/mL) and Endotoxin levels (EU/mL) test results. Responses are detailed in
Section IV: Implementation of this policy.
C. If high counts of bacteria or the presence of other microbes (i.e. fungi), which are
believed to represent an imminent threat to the health of dialyzed patients are detected,
these results will be immediately reported to the Nurse Manager of the Hemodialysis
Unit and the Medical Director will be notified. Decisions to stop dialyzing patients,
remove the water distribution system from service, or otherwise remediate the problem
will be made by the Medical director in consultation with the UWHC Infection Control
Department.

III. GENERAL INFORMATION

A. AAMI recommends that the level of microbial content of treated water used to prepare
dialysate should not exceed 200 CFU/mL with an action level of 50 CFU/ml.
B. Endotoxin content of treated water should not exceed 2.0 EU/mL with an action level of
1.0 EU/mL.
C. Water samples for Colony Counts and Endotoxin are obtained monthly from
Hemodialysis equipment and/or various locations within the In-center Hemodialysis Unit.
For detail regarding sampling procedures and routines see policy entitled Water Analysis
Testing and Sampling procedure for product water Colony Count and Endotoxin levels.

Page 2 of 3
IV. IMPLEMENTATION

A. In-center RO Water Distribution System
Level CFU/mL EU/mL Action
I 0-49 0-1 No action required, may be used.

II 50-199 1-2 Action is necessary.
Call Dialysis Solutions. Re-sample within 24
hours. May continue to use until test results are
confirmed.
III 200+ 2+ Action is necessary. Call Dialysis Solutions.
Disinfect and then Re-sample within 24 hours.
Do Not Use until test results within normal
operating parameters.
See Policy X: Reverse Osmosis (RO) In-center
Loop Contingency Plan

B. Hemodialysis Machine
Level CFU/mL EU/mL Action
I 0-49 0-1 No Action required, may be used.
II 50-199 1-2 Action is necessary.
Call Dialysis Solutions. Re-sample machine within
24 hours.
Perform chemical disinfect.
May continue to use until test results are
confirmed.
III 200+ 2+ Action is necessary.
Call Dialysis Solutions. Re-culture and remain out
of service until test results are normal.
Perform chemical disinfect.
Do Not Use until test results within normal
operating parameters.

C. Portable RO
Level CFU/mL EU/mL Action
I 0-49 0-1 No Action required, may be used.
II 50-199 1-2 Action is necessary.
Call Dialysis Solutions. Re-culture within 24
hours. May continue to use until test results are
confirmed.
III 200+ 2+ Action is necessary.
Call Dialysis Solutions. Re-culture and remain out
of service until test results are normal. Perform
chemical disinfect.
Do Not Use until test results within normal
operating parameters.

Page 3 of 3

VI. DOCUMENTATION

A. Microbiology reports will be filed in the water culture logbook.
B. The Chief Technician, Nurse Manager, Infection Control Practitioner and Medical
Director for the Hemodialysis unit will sign test results resulting from a corrective action
plan.
C. The Infection Control Practitioner for the Hemodialysis unit will give final approval to
return equipment into service.

VII. RESOURCES

o Association for the Advancements of Medical Instrumentation (AAMI), Dialysate
for Hemodialysis, ANSI/AAMI RD52:2004.
o Association for the Advancements of Medical Instrumentation (AAMI), Water
Treatment Equipment for Hemodialysis Applications, ANSI/AAMI RD62:2006
o Centers for Medicare and Medicaid Services. Conditions for Coverage for End-
Stage Renal Disease Facilities Interpretive Guidance, 2008.


REVIEWED: 12/1/2016
JMW6/1/13