Susan N. Hocevar, MD

Medical OfficerOffice of Blood, Organ, and Other Tissue SafetyDivision of Healthcare Quality and Promotion

Investigation Framework for Transplant and Transfusion Related Disease

Transmissions

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 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/DOT2 Ison, M. G., et. al. (2009), Donor-Derived Disease Transmission Events in the United States3 http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics4 Dodd, R. Y. (2004). "Current safety of the blood supply in the United States."

Background

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)

Tissue US FDA

Organ Oversight in the US:Who are the Players?

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?

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

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

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 DepartmentHigh Index of Suspicion

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 Obtain UNOS Donor ID from transplant center /

OPO Recommend that the center / OPO report to

UNOS Patient Safety Contact the OPO to obtain:

Transplant center for all other organ recipients Tissue / eye procurement status and tissue/ eye bank

contact Donor chart Status of remaining donor specimens

• Serum (stored for 10 years)• Cultures• Tissue biopsy • HLA typing tissue (lymph node, spleen)• Autopsy specimens if applicable

Transplant Investigation Steps 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

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

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

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 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

Transfusion associated diseases can involve: Blood product recipients alone Organ donors Organ recipients

During transplant investigations consider the possibility of transmission via transfusion

Time consuming process and can be incomplete

Transfusion Investigation Steps 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

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

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

For more information please contact Centers for Disease Control and Prevention1600 Clifton Road NE, Atlanta, GA 30333Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov 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.

Thank You

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?

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

CDC can aid in these steps as one transplant may involve several states

Report Information

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 Administration(US FDA)

US Food and Drug Administration

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