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Potential Disease Transmission Post‐Transplant (2.14)

Potential Disease Transmission Post‐Transplant (2.14) - Policies, Clinical, UWHC Clinical, Department Specific, UW Organ and Tissue Donation

2.14



POLICY
Established Date: December 2010
Effective Date: January 2018
Title: Potential Disease Transmission Post-
Recovery
Policy Number: 2.14

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 outline the steps University of Wisconsin Organ and Tissue Donation (UW
OTD) will take when a potential donor-derived disease transmission may have occurred post-recovery
between a UW OTD organ donor and an organ recipient. UW OTD will follow all applicable regulatory
requirements including United Network for Organ Sharing (UNOS) policies.

FORMS

UNOS Potential Disease Transmission Report Form

POLICY

Initial Notification
A. Initial notification of a potential disease transmission may come to UW OTD from various
sources such as: Donor hospitals, Centers for Disease Control and Prevention (CDC), Wisconsin
Department of Health Services (DHS), transplant centers, a review of post recovery or other
donor follow-up activities, or patient families.
1. This includes results that indicate the patient had a pathogen of special interest or
malignancy or other findings highly suggestive of malignancy recognized post-recovery
per UW OTD policy 2.08.
2. UNOS will maintain the list of pathogens of special interest that is available online.
B. Per UNOS policy, the UW OTD patient safety contact (PSC) will be notified of any potential
disease transmissions that involve a UW OTD organ donor. A database of PSC contacts for every
organ procurement organization and transplant center is maintained by UNOS and is available
online.
C. If an outside agency identifies a potential disease transmission:
1. The UW OTD PSC will receive notification from the outside agency.
2. If the outside agency contacts a staff member that is not the PSC, the staff member will
direct the person reporting to contact the appropriate PSC per UNOS policy.
3. The PSC will also receive notification from the UNOS Improving Patient Safety portal.
D. If UW OTD identifies a potential disease transmission:
1. Staff will contact the PSC as soon as possible.



POLICY
Established Date: December 2010
Effective Date: January 2018
Title: Potential Disease Transmission Post-
Recovery
Policy Number: 2.14

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


Page 2 of 3
2. The PSC will submit notification of the event to the UNOS Improving Safety Portal as
soon as possible but no later than 24 hours after receipt of the information.
3. The PSC will complete and submit the UNOS Potential Disease Transmission Report no
later than 24 hours after reporting the event through the portal.

Investigation
E. The UW OTD PSC or designee will be the primary contact for the event and will ensure accurate
and timely execution of the investigation until it is resolved.
F. The PSC or designee will request all donor and/or affected recipient test results and diagnostic
documentation that may be relevant to acute patient care of the affected recipient(s) to assist
with the investigation.
G. The investigation will include, but not be limited to the following steps to be completed as soon
as possible and no more than 24 hours after initial notification:
1. Identify the disposition of each organ.
2. Determine if tissues and/or eyes were recovered.
3. Determine if vessels were recovered and the disposition of each vessel. The disposition
of vessels that were sent to the University of Wisconsin (UW) Transplant Program will be
identified by calling the University of Wisconsin Hospital and Clinics (UWHC) Blood Bank.
4. Determine if the donor blood sample used for serology testing was obtained pre or post
transfusion. If the sample was obtained post transfusion, review the hemodilution
calculations performed and note if the blood was hemodiluted.
5. Determine if serum from the donor was archived. If serum was archived, determine the
amount of serum and the type of blood tube.
6. Determine if an autopsy was performed on the donor. If an autopsy was performed,
obtain a copy of the report.

Communication and Documentation
H. The following agencies will be contacted by the PSC or designee as soon as possible after the
investigation and no more than 24 hours after the initial notification:
1. All transplant center PSCs and tissue and eye banks that received an organ, vessel, or
tissues from the donor.
2. The PSC or designee will share all relevant details, including test results that were not
available at the time of recovery or were performed after recovery.



POLICY
Established Date: December 2010
Effective Date: January 2018
Title: Potential Disease Transmission Post-
Recovery
Policy Number: 2.14

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


Page 3 of 3
3. The PSC or designee will document the communication to the transplant center PSCs and
tissue and eye banks in the UW OTD donor record as required per UNOS policy.
I. The UW OTD medical director and leadership team will be made aware of any potential disease
transmission events.
J. The PSC or designee will determine if UWHC public affairs will be notified to plan for media
inquiries.
K. The PSC or designee may notify the CDC and DHS if the disease meets the criteria for notification
as outlined on the CDC website.
L. The PSC or designee will cooperate fully with all agencies involved to provide information upon
request.
M. The PSC or designee will contact UNOS or the UWHC Infection Control Department with any
questions.
N. Per request, the PSC or designee will participate in any follow up reviews of the event, provide
additional related information or specimens, and provide copies of any supporting
documentation.
O. Any new diagnostic information identified about a UW OTD donor will be recorded in the UW
OTD donor record by the PSC or designee.
P. If the PSC is required to complete a UNOS Potential Disease Transmission Report form, this will
be completed and returned to UNOS within 24 hours after receiving it.
Q. The PSC or designee will provide the completed UNOS Potential Disease Transmission Report
form and other relevant documentation to the UW OTD regulatory and quality systems
specialist or designee to maintain.
R. UW OTD will comply with all current and relevant UNOS Potential Disease Transmission
regulations and requests for communication.

REFERENCES
UW OTD Policy 2.08
UNOS List of Pathogens of Special Interest
CDC Guidelines for Reportable Diseases:
http://www.cdc.gov/osels/ph_surveillance/nndss/phs/infdis2011.htm