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Packaging, Labeling, and Storage of Organs and Tissue Typing Materials (3.04)

Packaging, Labeling, and Storage of Organs and Tissue Typing Materials (3.04) - Policies, Clinical, UWHC Clinical, Department Specific, UW Organ and Tissue Donation

3.04



POLICY
Established Date: November 2006
Effective Date: January 2018
Title: Packaging, Labeling, and Storage of Organs
and Tissue Typing Materials
Policy Number: 3.04

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


Page 1 of 3
PURPOSE

The purpose of this policy is to establish standardization of practice and compliance with applicable
regulatory requirements regarding the packaging, labeling, and storage of organs and tissue typing
materials by University of Wisconsin Organ and Tissue Donation (UW OTD) staff. UW OTD will adhere to all
applicable regulatory requirements including United Network for Organ Sharing (UNOS), Association of
Organ Procurement Organizations (AOPO), and Centers for Medicare and Medicaid Services (CMS)
requirements. UW OTD staff will send the required tissue typing materials, ABO confirmation materials, and
necessary documents with all organs in accordance with regulatory requirements.

FORMS

Verification for Accuracy of Documentation and Packaging of Transplantable Organs


POLICY
Organ Preservation and Storage
A. Abdominal organs and hearts will be preserved in Static Preservation Solution (SPS-1), Belzer
UW Cold Storage Solution or Food and Drug Administration (FDA) and United Network for Organ
Sharing (UNOS) approved solutions.
B. Kidneys that will be mechanically perfused will be preserved in Kidney Preservation Solution
(KPS) or Machine Perfusion Solution (MPS), FDA and UNOS approved solutions.
C. Lungs will be preserved in Perfadex, a FDA and UNOS approved solutions.
D. Tissue typing materials such as spleen and lymph nodes will be preserved in Roswell Park
Memorial Institution (RPMI) solution, a UNOS approved solution.

Packaging and Labeling an Organ for Return to the University of Wisconsin (UW) Transplant Program
E. The organ will be packaged according to OPTN Policy 16.
F. All organs, vessels, blood and tissue typing material returning to the University of Wisconsin
Transplant program will be packaged in one shipping container.
G. The internal organ label will be attached to the outer-most sterile bowel bag.
H. If multiple organs are packaged together, an internal label for each individual organ will be
attached. For example, if en-bloc lungs are packaged together in one triple sterile barrier, a
label for “Right Lung” and a label for “Left Lung” will both be attached or if a liver and pancreas



POLICY
Established Date: November 2006
Effective Date: January 2018
Title: Packaging, Labeling, and Storage of Organs
and Tissue Typing Materials
Policy Number: 3.04

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


Page 2 of 3
are packaged together, a “Liver” label and a “Pancreas” label will both be attached.
I. Tissue typing materials and blood samples will be packaged.
J. The external organ label will be attached to the shipping container. If multiple organs are
packaged together, the external label will document the presence of each individual organ.
K. The UW OTD staff member who performed the packaging and labeling tasks and a different
person approved to complete the second verification (see section below) will complete the
Verification for Accuracy of Documentation and Packaging of Transplantable Organs form.
L. The completed form will be maintained in the UW OTD patient record.

Packaging and Labeling an Organ for Shipment to an External Transplant Center (Export)
M. The organ will be packaged according to OPTN Policy 16.
N. The UW OTD staff member who performed the packaging and labeling tasks and a different
person approved to complete the second verification (see section below) will complete the
Verification for Accuracy of Documentation and Packaging of Transplantable Organs form.
O. The completed form will be maintained in the UW OTD patient record.

Packaging and Labeling an Organ from a Living Donor for the UW Transplant Program
P. UW OTD staff may be requested to package, label, and store a living donor organ by the UW
Health Transplant Program.
Q. This is a service provided to the transplant center and will be completed under the direction and
oversight of transplant center staff per any transplant regulatory requirements.

Repackaging an Organ
R. If an organ is required to be repackaged for transplantation, UW OTD staff will repackage and
label the organ appropriately as previously described.
S. The organ may be repackaged in a donor hospital, a transplant center, or in the UW OTD lab.
These repackaging areas will be controlled environments per the specific procedures provided
by the host location.
T. Staff will follow aseptic techniques, use sterile instruments, and wear the appropriate personal
protective equipment when repackaging an organ.
U. The UW OTD staff member who performed the re-packaging tasks and a different person
approved to complete the second verification (see section below) will complete the Verification
for Accuracy of Documentation and Packaging of Transplantable Organs form.
V. The completed form will be maintained in the UW OTD patient record.



POLICY
Established Date: November 2006
Effective Date: January 2018
Title: Packaging, Labeling, and Storage of Organs
and Tissue Typing Materials
Policy Number: 3.04

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


Page 3 of 3


Staff Members Approved to Perform the Second Verification of Organ Packaging and Labeling (in
preference order):
W. UW OTD or UW Transplant Program staff readily available on-site.
X. UW Transplant Program fellow readily available on-site.
Y. UW OTD organ procurement coordinator (OPC) on-call.
Z. A University of Wisconsin Hospital and Clinics (UWHC) surgical assistant.

The use of TransNet and Downtime
AA. UW OTD uses TransNet, an OPTN-approved packaging and labeling software.
BB. If TransNet is down due to a systems or device issue or failure, UW OTD staff will complete the
packaging and labeling process manually, which may include the need to hand write vital data.
CC. Prior approval by the administrator on call (AOC) or the manager of surgical recovery must be
done so to capture the occurrence and to provide guidence