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Kidney Machine Perfusion and Cold Storage (3.08)

Kidney Machine Perfusion and Cold Storage (3.08) - Policies, Clinical, UWHC Clinical, Department Specific, UW Organ and Tissue Donation

3.08



POLICY
Established Date: September 2005
Effective Date: January 2018
Title: Kidney Machine Perfusion and Cold Storage Policy Number: 3.08

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 1 of 5
PURPOSE

The purpose of this policy is to standardize the process for machine perfusion or cold storage of a kidney
for transplantation by University of Wisconsin Organ and Tissue Donation (UW OTD) staff, to outline the
procedure for setting up the LifePort
TM
Kidney Transporter machine, and outline the procedure to clean the
perfusion machines. UW OTD will use the LifePort™ Kidney Transporter machine for the purpose of
preserving kidneys for use in transplantation at the direction of the transplant surgeon or his/her designee.

FORMS

LifePort Kidney Transporter Quarterly Inspection Form
UNOS Approved Internal and External Kidney Specific Organ Labels

POLICY

Kidney Machine Perfusion and Cold Storage Criteria
A. A UW OTD surgical recovery coordinator (SRC) will call the attending transplant surgeon on
service when a kidney arrives at the UW OTD lab and the transplant surgeon will determine if
the kidney will be machine perfusioned or cold stored.
B. Each transplant surgeon or designee will use his/her discretion in determining whether a kidney
will be machine perfusioned or cold stored.
C. If a kidney will be exported, the kidney will be cold stored unless instructed otherwise by the
UW OTD medical director on-call (MOC) or his/her designee.
D. The LifePort
TM
Kidney Transporter will be the primary kidney perfusion machines used by UW
OTD.
1. For an adult kidney (19 years old or older) 30 mmHG pressure will be used. Variations to
this pressure will be communicated to the attending transplant surgeon.
2. The pressure setting for a pediatric kidney will be determined by the attending
transplant surgeon or his/her designee.
Cold Storage
E. The definition of cold storage is to place the organ that has been packaged and labeled per
Organ Procurement and Transplantation Network (OPTN) Policy 16 (Organ and Vessel
Packaging, Labeling, Shipping, and Storage) in a UNOS approved organ container that contains
sufficient ice to maintain a temperature between 2-8 degree celsius.



POLICY
Established Date: September 2005
Effective Date: January 2018
Title: Kidney Machine Perfusion and Cold Storage Policy Number: 3.08

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 2 of 5
F. The following staff will be trained to cold store organs:
1. All SRC staff
2. UW OTD surgical recovery specialists (SRS) and advanced practice donation specialists
(APDS) staff
3. University of Wisconsin (UW) Transplant Program surgeon faculty and fellows.
G. The following materials will be used to cold store an organ:
1. UNOS approved storage container (insulated cooler or box)
2. Three sterile isolation bags
3. One sterile rigid container, if applicable.
4. Preservation solution
5. UNOS approved organ specific and laterality internal and external packaging labels
H. Cold storage may occur in the donor hospital operating room, a transplant center, or the UW
OTD laboratory.

Kidney Machine Perfusion Set-Up
I. The following staff will be trained to use the LifePortTM Kidney Transporter machine based on
their role:
1. All SRC staff
2. UW OTD SRS and APDS staff
3. UW Health Transplant Center surgeon faculty and fellows.
J. The following sterile materials will be provided by Organ Recovery Systems
1. Perfusion circuit
2. Cannula
3. Sterile drape.
K. The kidney perfusion machine will be set up in the following areas:
1. University of Wisconsin Hospital and Clinical (UWHC) in-patient operating room
2. American Family Children’s Hospital in-patient operating room
3. UW OTD lab in the area of the lab between the open shelves and the door of the walk-in
cooler and the surrounding counter space.

Placement of a Kidney in the Perfusion Machine
L. The preparation and placement of a kidney in the perfusion machine will occur in the following
areas:
1. In the operating room of a donor hospital



POLICY
Established Date: September 2005
Effective Date: January 2018
Title: Kidney Machine Perfusion and Cold Storage Policy Number: 3.08

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 3 of 5
2. In the UW OTD lab in the area between the open shelves and the door of the walk-in
cooler and the surrounding counter space
3. In the UWHC in-patient operating room.
4. American Family Children’s Hospital in-patient operating room

M. These areas are controlled environments per the applicable donor hospital, UW OTD, and UWHC
procedures.
N. Staff will follow aseptic techniques, use sterile instruments, and wear the appropriate personal
protective equipment while placing a kidney in the perfusion machine.

Cleaning, Disinfection, and Sterilization Perfusion Machines and Cold Storage Coolers
O. All perfusion machines will be cleaned and disinfected after each use of perfusing a kidney.
After a kidney is placed in the machine, the machine will need to be cleaned.
P. All cleaning procedures including disposal of the cassette and all fluids used in the machine will
be completed by UWHC central services reprocessing personnel in the reprocessing area. UW
OTD staff will not complete any cleaning tasks or any disposal of the cassette or fluids in the
UW OTD lab when the perfusion machine was used to perfuse a kidney.
Q. If a perfusion machine was set up but a kidney was not placed, the machine will be considered
clean and will not need to be cleaned by UWHC central services reprocessing.
R. For kidneys transplanted at UWHC, the kidney will be transported to the UWHC operating room
in the perfusion machine. At that time, the perfusion machine will be in the custody of UWHC
Transplant staff. UWHC operating room staff will send the perfusion machine to UWHC central
services reprocessing for cleaning.
S. For kidneys that are machine perfused and exported to another transplant center or discarded,
UW OTD staff will send the perfusion machine to UWHC central services reprocessing for
cleaning.
T. For kidneys that are cold stored and not placed on a perfusion machine and transplanted at
UWHC, the kidney will be transported to the UWHC operating room in the cooler containing
wet ice. At that time, the cooler and its contents will be in the custody of UWHC Transplant
staff. UWHC operating room staff will send the cooler to UWHC central services reprocessing
for cleaning.
U. For kidneys that are cold stored and exported to another transplant center or discarded, UW
OTD staff will send the cooler to UWHC central services reprocessing for cleaning.



POLICY
Established Date: September 2005
Effective Date: January 2018
Title: Kidney Machine Perfusion and Cold Storage Policy Number: 3.08

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 4 of 5
V. UWHC central services reprocessing personnel will complete all cleaning tasks for perfusion
machines and coolers as outlined in UWHC infection control policy 4.1.7.
W. UWHC central services reprocessing personnel will identify each perfusion machine and cooler
using a barcode and will document the date and time the cleaning is completed.
X. UW OTD staff will pick up the cleaned perfusion machines and coolers from the UWHC central
services reprocessing area and will return the machines and coolers to the UW OTD lab.

Quality Control Checks
Y. The recovery team will perform a visual inspection of the machine prior to each use.
Z. The machine contains a factory calibrated and quality checked pressure sensor.
1. When the machine is powered on, it will perform an automatic power-on self-test
(POST).
2. When the pressure, flow, resistance and temperature parameters fall within operational
ranges, the machine will display the message “READY” signifying all checks have passed.
3. If any parameter is out of range, an error message will appear. Staff will not proceed
until the error is corrected.
AA. A UW OTD trained individual will perform a detailed user inspection quarterly per the
manufacturer standards. These inspection records will be recorded on the LifePort Kidney
Transporter Quarterly Inspection Form and maintained by UW OTD.

Continuous Monitoring During Perfusion
BB. Kidneys will be continuously remotely monitored while being machine perfused through an
electronic alarm notification system that is facilitated by the UWHC paging office.
CC. When an alarm is triggered on the machine, the SRC on-call will determine the appropriate
response and complete any necessary interventions.
DD. The SRC will share with the attending transplant surgeon as appropriate the pump report and
reason for the pump faulting. The SRC will report the variance per UW OTD policy 1.08.

Labeling of the Kidney Perfusion Machine and Cooler
EE. The kidney perfusion machine and cooler will be labeled using the UNOS approved internal and
external labels.
1. The internal, laterality specific label will be attached to the kidney cassette using a zip tie
or string to an area that will not impede on the function of the cassette. For cold storage
the internal, laterality specific label will be affixed to the outer barrier.



POLICY
Established Date: September 2005
Effective Date: January 2018
Title: Kidney Machine Perfusion and Cold Storage Policy Number: 3.08

Electronically Approved By: Michael E. Anderson, PA-C Anthony M. D’Alessandro, M.D.
Executive Director Medical Director


Page 5 of 5
2. The external, laterality specific label will be placed in the plastic sleeve that is affixed to
the base of the machine. For cold storage, the external label will be affixed to the outer
surface of the cooler or placed in the sleeve.
3. 3. When machine is powered on and in wash mode, UNOS ID, Laterality, Blood Type,
Cross Clamp Date/Time, Timezone will be entered electronically by the staff setting up
the machine for kidney perfusion. This will be verified by the external label that was
affixed to the shipping container the kidney arrived in. Once the machine is in infuse
mode, no changes are allowed to be made to this information.

4.

REFERENCES

OPTN Policy 16
UWHC Policy 13.20
UW OTD Policy 1.08