Transcript Title of Presentation Myriad Pro, Bold, Shadow, 28pt

Investigation Framework for Transplant and
Transfusion Related Disease Transmissions
Susan N. Hocevar, MD
Medical Officer
Office of Blood, Organ, and Other Tissue Safety
Division of Healthcare Quality and Promotion
National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
Background

28,662 organ transplants in 2010 1
 Transmission reported in only 0.96% of deceased donor donations
overall 2
 Substantial morbidity and mortality
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2,000,000 tissues distributed
 Risk of transmission depends on tissue type and organism
 Recent Investigations: HCV, Clostridium sordellii , WNV

30 million blood components transfused each year3
 Estimates of disease transmission vary based on component and
disease
 HIV and HCV about 1 in 1.5 million donations 4
1OPTN /
SRTR 2010 Annual Data Report. HHS/HRSA/HSB/DOT
M. G., et. al. (2009), Donor-Derived Disease Transmission Events in the United States
3 http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics
4 Dodd, R. Y. (2004). "Current safety of the blood supply in the United States."
2 Ison,
Background
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Oversight / regulation of blood, organs, and tissues
vary
Multiple agencies and organizations involved in each
investigation
Organ
 Health Resources and Services Administration (HRSA)

Blood
 US Federal Drug Administration (US FDA)
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Tissue
 US FDA
Organ Oversight in the US:
Who are the Players?
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HRSA contracts with the United Network for Organ
Sharing (UNOS) to administer the Organ Procurement
and Transplantation Network (OPTN)
OPTN oversees organ transplant in the US
In order to do transplants or procure organs, must be a
member of OPTN in good standing
Follow policies including reporting of potential donor
derived diseases to UNOS patient safety
Organ Oversight in the US:
Who are the Players?

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Organ Procurement Organizations (OPO) evaluate and
test potential organ donors
Transplant centers review donor testing and history
prior to acceptance of organs via the OPO’s report
Both the OPO and the transplant center can report
potential disease transmissions to UNOS patient safety
http://optn.transplant.hrsa.gov/members/directory.asp
Investigation Overview

CDC is notified of potential transmissions in several
ways
 Notification directly from United Network for Organ Sharing via an
agreement with HRSA (organ)
 Health Department calls (blood, organ, tissue)
 US FDA fatality reports (Blood)
 Specimens sent to CDC for testing or consultation on treatment
recognized as belonging to an organ recipient (blood, organ,
tissue)
CDC and HRSA Agreement
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Transplant centers and OPOs are required to report
potential donor derived disease transmissions to UNOS
patient safety
UNOS sends CDC these notifications and pertinent
contact information for:
 Nationally notifiable diseases
 Disease reports involving >1 recipient (cluster)

Per the agreement, health departments should be
notified as well
Example of Health Department Notifications
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Report of Brucella in a Kidney recipient noted by state
health department with notation that other recipients
were ill….
Microspordia identified on kidney biopsy sent to CDC
3 recipients all with confirmed disease
 One death with disseminated microsporidiosis
 Two treated with improvement
Health Department
High Index of Suspicion

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Often such reports turn into clusters of donor-derived
illness
Many recipients have been successfully provided care
or prophylaxis through coordinated efforts of local and
state health departments, CDC, OPOs, and transplant
physicians
They may have never been recognized or reported if
not for the health department
Consider the potential for donor derived disease in
transplant recipients and transfusion recipients
Transplant Investigation Steps
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Obtain UNOS Donor ID from transplant center / OPO
Recommend that the center / OPO report to UNOS
Patient Safety
Contact the OPO to obtain:
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Transplant center for all other organ recipients
Tissue / eye procurement status and tissue/ eye bank contact
Donor chart
Status of remaining donor specimens
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Serum (stored for 10 years)
Cultures
Tissue biopsy
HLA typing tissue (lymph node, spleen)
Autopsy specimens if applicable
Transplant Investigation Steps
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Contact the transplant centers and other health
departments
 Ensure that the center is aware and has followed up with their
recipients
 Arrange specialized testing if needed
 Provide consultation for treatment
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Contact the tissue banks
 Notify of potential disease
 Request that the bank begin compiling a list of all tissues released
with contact information for follow up
 Begin contacting hospitals that received tissue
Transplant Investigation Steps
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Donor investigation
 Will depend on suspected disease
 The OPO can coordinate contact with the donor’s surviving
relatives
 Risk factor evaluation in the donor (consider transfusion)
 Disease activity in donor’s county of residency
Tissue and Blood Oversight in the US
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US FDA regulates tissue:
 Rules for testing
 Tracking tissue to the ‘hospital door’
 Mandatory reporting of adverse reactions involving
communicable diseases

US FDA regulates blood:
 Rules for testing
 Tracking throughout healthcare system (donor to each recipient)
 Only serious reactions or errors in manufacturing/handling require
mandatory reporting (fatalities, biologic product deviations)
• Infection transmission not required to be reported
Issues with Tissues
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Delays in notifications to the tissue bank and hospitals
with stored tissue can lead to preventable
transmissions
Hospital systems are variable for tracking to individual
recipients
There have been incidences where a hospital can not
determine where a particular tissue went (or delays of
weeks in determining this)
Public health often calls each hospital and physician to
locate tissues and recipients for follow up
Transfusion Confusion
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Transfusion associated diseases can involve:
 Blood product recipients alone
 Organ donors
 Organ recipients
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During transplant investigations consider the
possibility of transmission via transfusion
Time consuming process and can be incomplete
Transfusion Investigation Steps
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Contact the hospital blood bank to notify of the need
for a trace back investigation
The hospital blood bank will contact the blood
collection agency (ex. Red Cross) and provide the blood
product unit numbers for all products given
 This number is unique and links the product to the donor
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The blood collection agency will begin quarantine (of
remaining products), trace back of donors, testing of
retained segments
Your role may vary as the blood collection agency may
handle the investigation completely
Conclusion
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CDC can assist in any step in the Investigation process
These investigations can be complex and involve many
partners
Health departments play an integral role in identifying
potential transmission and leading or participating in
investigations
Toolkits in development : general transfusion and
general transplant
Thank You
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: [email protected]
Web: www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
National Center for Emerging and Zoonotic Infectious Diseases
Place Descriptor Here
There’s a Report involving a transplant case
I’m Considering it…Now what?
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Obtain the UNOS Donor ID from the transplant center
or OPO reporting the case to public health
Recommend that the center / OPO report to UNOS
patient safety
 This will trigger notification of other transplant centers
 UNOS will generate a report and upload donor information

Request information from the OPO on other recipient
status and location
 OPO can follow up on other recipients and report back
 Inquire about tissue status and tissue bank notification
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CDC can aid in these steps as one transplant may
involve several states
Report Information
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Organ Procurement Organization contact information
If applicable, reporting transplant center contact
Brief donor history and history of reported illness in
the recipient or finding in the donor
Organs transplanted
Occasionally information on if tissues / eyes were
procured
Organ ,Tissue, and Blood Oversight and Testing
Organs
Tissues
Blood
Regulation /
Oversight
Organ
Procurement and
Transplantation
Network (OPTN)
US Food and Drug US Food and Drug
Administration
Administration
(US FDA)
Screening
Assessment
Organ
Procurement
Organization
Tissue Bank
Blood Bank
Timeframe
Immediate usage
Prolonged
storage potential
Prolonged
storage potential
Link between
Donor and
recipient
UNOS Donor
identification
number
Tissue linked to
facility only
Barcode links
product to donor
and all recipients
Testing Required
Antibody
Screening
Nucleic Acid
Testing
Nucleic Acid
Testing