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Water Analysis Testing and Sampling procedure for product water Colony Count and Endotoxin levels (2.1)

Water Analysis Testing and Sampling procedure for product water Colony Count and Endotoxin levels (2.1) - Policies, Clinical, UWHC Clinical, Department Specific, Hemodialysis

2.1

University of Wisconsin Hospital and Clinics
Inpatient Hemodialysis
Department 55400
TITLE: Water Analysis Testing and
Sampling procedure for product water
Colony Count and Endotoxin levels
POLICY #:2.1
REVISED: October 2016
Page 1 of 4
Nurse Manager: Joan Watson, MS, RN
Director: Ann Malec, DNP, RN, NEA-BC
Medical Director: Alex Yevzlin, MD
I. PURPOSE
Water used for Hemodialysis must meet standards for Water Quality (free of contaminants) as
endorsed by the Association for the Advancement of Medical Instrumentation (AAMI). The
microbial content of treated water used for dialysis must meet minimum standards for Colony
Forming Units (CFU/mL) and Endotoxin Units (EU/mL) as recommended by the Association for
the Advancement of Medical Instrumentation (AAMI).
II. POLICIES
A. The Chief Dialysis Technician will obtain water samples for AAMI water quality
annually. Water samples for Colony Counts and Endotoxin will be obtained monthly
from the following equipment/sample valve (SV) locations: Main RO Water System
(SV6), Pre UF (SV7), End Loop (SV10), and Portable RO Systems. Hemodialysis
machines will be sampled at a rate of two per month and all machines will be samples at
least once per year.
B. If positive cultures are obtained from the Main Water Loops, portable RO equipment,
Hemodialysis machines and associated Unit Wall stations see Departmental Policy
Corrective Action Plan in the event of Positive Water Cultures/Endotoxins.
III. GENERAL INFORMATION
A. Madison city water is obtained from a ground water source which is currently treated
with chlorine gas.
B. Supply of water at the dialysis unit is treated with submicron filters, reverse osmosis and
ultraviolet light to control bacterial growth.
C. Supply water for portable dialysis is treated with the Gambro WRO300 portable RO
system in addition the Fresenius hemodialysis machines use a DiasafeĀ® Plus filter.
D. 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. Endotoxin
content of treated water should not exceed 2.0 EU/mL with an action level of 1.0 EU/mL.
E. Acceptable limits for AAMI water quality standards for Hemodialysis are included in the
annual sampling report.

Page 2 of 4
IV. EQUIPMENT
Gloves
Mask
Sterile Collection Cup
Lab Tubes
V. PROCEDURE
A. RO loop sample valves, Bicarb Feed and portable RO product sampling procedure
1. Don gloves.
2. Attach adapter to RO outlet or Bicarb Feed outlet if needed, to allow for fluid to
run freely.
3. Do not touch the inside of adapter or the inside of the outlet.
4. Allow water to run for at least 2 minutes. (Allow water to run into 5 gallon bucket
in water room.
5. Open appropriate sterile specimen container. Maintain sterility of container by
not touching the inside of the container or lid with anything.
6. Fill container with sample. Cover tightly.
7. Label the specimen as instructed in section V. Procedure, C. Specimen Handling.
B. Hemodialysis Machine Dialysate Sampling:
1. Machine must be up in conductivity before taking sample.
2. Hand sanitizes then put glove on, open specimen container as described above,
maintaining sterility.
3. Detach Hansen connector from machine or dialyzer.
4. Allow dialysate to run freely into waste basket for 30 seconds.
5. Fill specimen container. Cover tightly.
C. Specimen Handling:
1. Specify the site of collection, the date, the time, and the machine number on
specimen container.
2. Prepare specimen for shipment to the lab. Specimen should be refrigerated and
shipped on ice.
VI. DOCUMENTATION
A. Microbiology reports will be filed in the water culture logbook.
B. Results will be reviewed and signed off by the Chief Biomed Technician, Medical
Director, and Nurse Manager monthly.
C. An electronic copy of these results will be reviewed by the Infection Control Practitioner
for Hemodialysis and a summary of these results will be presented at the UWHC
Infection Control Committee and shared with the VA Contract Office monthly.
D. Results that do not meet AAMI standards will be reported to the Nurse Manager, Medical
Director, and Infection Control Practitioner of the Hemodialysis unit and a corrective
action plan will be implemented. For detail see Departmental Policy 2.3: Corrective
Action Plan in the event of Positive Water Cultures/Endotoxins

Page 3 of 4
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.
o Attachment A: Monthly Labs Schedule at UW Health Dialysis
REVIEWED: 12/1/2016
Jmw10/3/16

Page 4 of 4
Attachment A:
Monthly Labs Schedule at UW Health Dialysis


All AAMI Testing in JANUARY

Main Water System
Main RO Monthly LAL and Colony Count
End of Loop Monthly LAL and Colony Count

Portable RO Systems

6854 Monthly LAL and Colony Count
6587 Monthly LAL and Colony Count
6849 Monthly LAL and Colony Count
6609 Monthly LAL and Colony Count
6850 Monthly LAL and Colony Count
6853 Monthly LAL and Colony Count

Dialysis Machines

Fresenius 11 JAN LAL and Colony Count
Fresenius 12 JAN LAL and Colony Count
Fresenius 16 FEB LAL and Colony Count
Fresenius 17 FEB LAL and Colony Count
Fresenius 18 MARCH LAL and Colony Count
Fresenius 19 MARCH LAL and Colony Count
Gambro 1 APRIL LAL and Colony Count
Gambro 2 APRIL LAL and Colony Count
Fresenius 12 MAY LAL and Colony Count
Fresenius 16 MAY LAL and Colony Count
Fresenius 17 JUNE LAL and Colony Count
Fresenius 18 JUNE LAL and Colony Count
Fresenius 19 JULY LAL and Colony Count
Gambro 1 JULY LAL and Colony Count
Gambro 2 AUG LAL and Colony Count
Gambro 3 AUG LAL and Colony Count
Gambro 4 SEPT LAL and Colony Count
Gambro 5 SEPT LAL and Colony Count
Gambro 6 OCT LAL and Colony Count
Gambro 7 OCT LAL and Colony Count
Gambro 8 NOV LAL and Colony Count
Gambro 9 NOV LAL and Colony Count
Gambro 10 DEC LAL and Colony Count
Fresenius 10 DEC LAL and Colony Count