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Packaging and Labeling of Organ Donor Vessels (3.09)

Packaging and Labeling of Organ Donor Vessels (3.09) - Policies, Clinical, UWHC Clinical, Department Specific, UW Organ and Tissue Donation

3.09



POLICY
Established Date: July 2006
Effective Date: January 2018
Title: Packaging and Labeling of Organ Donor
Vessels
Policy Number: 3.09

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 for University of Wisconsin Organ and Tissue Donation (UW OTD) regarding the
packaging and labeling of organ donor vessels intended for transplantation in a manner which ensures safe
arrival to the transplant center. UW OTD staff that will perform packaging and labeling procedures for
organ donor vessels intended for transplantation will adhere to all applicable United Network for Organ
Sharing (UNOS) policies and other applicable regulatory requirements.

FORMS

UW Transplant Vessel Verification Form
UWHC Tissue Request Form 170301

ASSOCIATED POLICIES

Transfusion Services: 1566.5.20 Receipt, Storage, Dispensing and tracking of Vessels
University of Wisconsin Transplant Program: 3.52 Donor Vessel Recovery, Transplant and Storage

POLICY

Vessel Recovery
A. Vessels will be recovered and separated (i.e. left and right iliac artery and left and right iliac vein,
carotid artery, etc at the discretion of the transplanting surgeon or their designee.
B. HIV I/II and HIV NAT positive donor vessels will not be recovered according to UNOS policy.

Packaging, Labeling and Shipping Vessels
C. Vessels will be packaged and labeled according to UNOS policy 16.0
D. The vessels will be stored in a Food and Drug Administration (FDA) approved preservation
storage solution.
E. The type of vessel(s) recovered at the time of donation will be documented in the donor record
and will be reported to the UW Transplant Program on an ongoing basis.
F. Each vessel recovered will be packaged individually in a triple sterile barrier, one of which will be
a rigid container, at the donor hospital.



POLICY
Established Date: July 2006
Effective Date: January 2018
Title: Packaging and Labeling of Organ Donor
Vessels
Policy Number: 3.09

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


Page 2 of 3
G. Each vessel container will be labeled with two completed UNOS approved standardized vessel
labels. The sterile label will be attached to the sterile rigid container and second label completed
using the OPTN organ tracking system will be attached to the outermost sterile barrier.
H. The sterile container label will include:
1. Donor ID
2. Donor blood type
3. Donor blood subtype, if used for allocation
4. Recovery date
5. Description of the container contents
6. Indication the vessels will be used for organ transplant only
7. Indication the vessels are from a donor with a positive result (including NAT) for Human
Immunodeficiency Virus (HIV), Hepatitis C virus (HCV), or Hepatitis B Virus (HBsAg),
and/or Hepatitis B Virus (HBcAb)
8. Indication the vessels are from a donor that meets the increased risk for disease
transmission criteria.
I. The outermost barrier label will be completed using the OPTN organ tracking system:
1. Donor ID
2. Donor ABO. Donor blood subtype, if used for allocation
3. Recovery date
4. Originating organ procurement organization (OPO) identification
5. Telephone number of host OPO
6. All infectious disease testing results
7. Indication the vessels are from a donor that meets the increased risk for disease
transmission criteria.
8. The statement “For Use in Organ Transplant Only”
9. A reference to the appropriate UNOS policy.
J. On the back of the non- sterile UNOS approved internal vessel label, a completed vessel sticker
with the vessel type and donor age will be placed.
K. UW OTD staff will complete the UW Transplant Vessel Verification form.
L. After vessels are packaged in a triple sterile barrier and labeled, the each vessel container will be
placed in a biohazard bag along with the completed vessel verification form.
M. The vessels will be packaged using OPTN organ tracking system according to UNOS policy 16.0.
N. An OPTN external label completed using the OPTN organ tracking system will be affixed to the
outside of the transport container.



POLICY
Established Date: July 2006
Effective Date: January 2018
Title: Packaging and Labeling of Organ Donor
Vessels
Policy Number: 3.09

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


Page 3 of 3
O. Upon returning to the UW Transplant center, the vessels will be handed over to UW Transfusion
Services Department for storage and distribution to UW Transplant. The vessels will be available
to the UW Transplant Program for use in transplant recipients only.
P. UWHC Transfusion Services will be responsible for the storage, disposal, tracking, and dispensing
of vessels in a manner consistent with meeting all UNOS policies and other regulatory
requirements.

Import Donor Vessels
Q. UW OTD staff will place a label with the donor’s age on the back of the UNOS approved internal
vessel label. UW OTD staff will complete the UW Transplant Vessel Verification form
R. UW OTD staff will transport vessel(s) and forms to UW Transfusion services for storage and
distribution to UW Transplant program.

Packaging and Labeling of Donor Vessels for Shipment to an External Transplant Center (export)

S. Donor vessels may be requested by a transplant center other than the UW Transplant Program.
T. The accepting transplant center will provide UW OTD a written request for vessels.
U. The UW OTD medical director or his/her designee will approve the release of the vessels from
UWHC Transfusion Services.
V. If the request for exporting the vessels is approved, the vessels will be packaged according to
UNOS policy 16.0.
W. The transportation arrangements and cost associated with exporting the vessels will be
negotiated between the accepting transplant center and UW OTD.
X. The vessels that were exported and the receiving transplant center identification will be
documented in the donor record.
Y. The written request for the vessels will be filed in the donor record.

REFERENCES

UW OTD Policy 3.03
OPTN Policy 16.0, Organ and Vessel Recovery, Storage and Transplant