Background Document - Screening Donors for Risk of EVD 10-28-14

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Screening Donors for Risk Associated with Ebola Virus Disease (EVD)
Background Document
The following notes were produced from two, one-hour meetings of AATB’s Tissue Transmitted
Diseases Advisory Group (TTDAG), a subgroup of the Physicians’ Council, and comments received
from members of the DRAI Stakeholder Review Group during late October.

Additional screening measures should be implemented as soon as possible to enhance
ability to identify a donor at increased risk for Ebola Virus disease (EVD). This is based upon
recognition of the following:
o Risk of EVD transmission via transplantation is unstudied.
o The Center for Disease Control & Prevention (CDC) recommends early recognition is
critical.
o Human error can occur leading to misdiagnosis of an infected person, or a missed
determination that a person is at risk after exposure.
o When the disease is fatal, the dead body remains contagious.
o A donor may be at risk if a sexual partner is at risk for EVD.
o A child donor may be at risk if breastfed by a mother at risk for EVD.
o As events occur in our homeland, citizens can be identified as “at risk” due to
exposure and may be notified by health authorities or by airline companies.
o Death can occur outside of a hospital and not all death referrals for donation
originate from a hospital or from a medical examiner’s office. Where it's developed,
death referrals can be received from law enforcement, emergency medical services,
an extended care facility, and from a funeral home.
o Death referrals from funeral homes are common for whole body donation (for nontransplant anatomical donation for education).
o During this heightened awareness, the cause of death should be clear.
o US tissue banks distribute processed tissue allografts for transplant to other
countries. International expectations for screening donors for risk associated with
EVD should be honored or stricter policies by US tissue banks can be established.
o The protection of personnel involved with procurement of organs or recovery of
tissues is a consideration. If “donor risk information is pending” and procurement
or recovery proceeds, this can create a risk scenario that could have been avoided.
o Reproductive tissue donors of semen can be at risk for several weeks after recovery
from an Ebola Virus infection. Additionally, already approved semen donors who
are actively donating require rescreening for communicable disease risks but the
usual 6-month interval for screening donors may need to be shortened to every
donation event.

An adjustment to the Uniform Donor Risk Assessment Interview (DRAI) process is indicated
but should be kept to a minimum. Interview fatigue is a concern but relevant information,
when known by the interviewee, should be sought. This can be addressed by providing an
appropriate “addendum” that can be used for the Adult Donor form, the Child Donor form,
or the Birth Mother form. An addendum provides the opportunity to discontinue use if
screening for EVD risk changes and is determined to no longer be relevant. Additionally,
this is an acceptable method when adding questions to a Uniform DRAI form (i.e., adding
new questions after the last numbered question). Refer to the AOPO-EBAA-AATB
Implementation Guidance Document issued 9-10-14. A flowchart for each addendum
question should be developed.

Guidelines issued by authorities and professional donation associations should be used to
develop screening steps and to establish policies. These authorities and associations
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Screening Donors for Risk Associated with Ebola Virus Disease (EVD)
Background Document
include the following and their websites should be monitored for updates, which can
occur at any time:
o OPTN/UNOS Guidance for OPOs and for organ transplant centers that reference
information published by the CDC;
o CDC information regarding the case definition for EVD and maps that identify
countries involved in the Ebola Outbreak in West Africa.
o European CDC’s (ECDC) Public Health Emergency Technical Document covering the
risk of transmission of Ebola virus via donors of “substances of human origin
(SoHO)” which includes blood, blood components, cells, tissues, and organs. There
is another map of EVD-affected countries on the ECDC website and it can differ from
CDC’s.
o AABB’s Association Bulletin #14-08 “Deferral for Blood Donation of Persons Under
Public Health Surveillance for Possible Exposure to Ebola Virus” contains a
consideration for screening based on an epidemiologic risk factor.
o Recently, another advisory group issued recommendations for screening donors of
SoHO for risk of Ebola Virus Disease. Refer to the report from the Advisory
Committee on the Safety of Blood, Tissues, and Organs (SaBTO). This report
supports the ECDC document.
o The World Health Organization (WHO) also provides a Global Alert and Response
webpage that provides updates on Ebola Virus.
o Specific guidance for screening organ, tissue or eye donors has not yet been
published by the CDC’s Office of Blood, Organs, and Other Tissues, or by FDA/CBER
for donors of human cells, tissues, and cellular and tissue–based products. These
entities encourage establishments to pursue appropriate steps by following
published guidelines and their updates.
o In recognition of published advisories the following information should be obtained
during the DRAI process:
1) travel history involving an EVD-affected country,
2) clinical criteria such as a current or past diagnosis of infection with Ebola Virus
or recent symptoms related to possible infection with Ebola Virus, and
3) epidemiologic risk factors such as a person who was notified by a public
health authority they were exposed to someone infected with Ebola Virus, and
were monitored.
Considerations: Addendum to the Uniform DRAI Forms & for Establishing Eligibility Policies

Travel history involving an EVD-affected country
o No change is necessary to the Uniform DRAI forms issued on 9-10-14 (or the Child
Donor form updated on 10-20-14). They already have the ability to collect relevant
information to identify travel risk associated with EVD-affected countries. See Q#26
on the Adult Donor form; Q#18 on the Child Donor form; and, Q#19 on the Birth
Mother form. The filter question and sub-questions are formatted as follows:
 xx. Did she/he* (you) EVER travel or live outside of the United States or
Canada?
If yes,
xxa. Where?
xxb. When and for how long?
If an establishment is not using the Uniform DRAI forms, creation of a similar
question and sub-questions should be developed immediately and used.
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Screening Donors for Risk Associated with Ebola Virus Disease (EVD)
Background Document
Eligibility Policies
Policies regarding donor assessment for EVD risk and eligibility related to travel
history should be based upon the CDC’s map of countries involved in the Ebola
Outbreak in West Africa and the ECDC’s map of EVD-affected countries. These maps
must be accessed to determine relevance of any travel. Be aware these maps can
differ slightly.
The ECDC advises asymptomatic travellers returning from an Ebola affected area
should be ruled ineligible for donation of cells and tissues for two months after
return. At this writing, qualifiers exist for organ donation, however current
guidelines should be sought.
Current EVD guidance should be assessed before recovery of cells/tissues or
procurement of organs occurs.

Clinical criteria such as a current or past diagnosis of infection with Ebola Virus or recent
symptoms related to possible infection with Ebola Virus
o The Uniform DRAI forms include questions related to Ebola-related symptoms such
as recent fever, headache, or diarrhea, which are commonly encountered with EVD.
However, a few (possible) symptoms are not included in the questions that cover
recent health history. These include: muscle pain, weakness, vomiting,
abdominal(stomach) pain, and unexplained hemorrhage or bruising.
 Continue with current diligence to look for an active infection. Follow usual
practice to locate relevant medical records. Information collected during the
DRAI process should be used in conjunction with available relevant medical
records when such records exist. Records should be sought and used to look
for clinical symptoms and patient test results that can indicate an active
infection (any infection).
Eligibility Policies
Caution is advised when evaluating additional information such as:
 An older person, or a person otherwise immune deficient, may not present
with fever but could be infected.
 Reliance entirely on symptoms reported by an interviewee may be
problematic; lessons were learned when “fever with a headache” did not
assist with identifying an active infection with West Nile Virus, and that
correlation fell out of favor and is no longer used.
 If any referral includes having had a fever or other symptoms and the death
was considered unexpected and/or sudden (soon after onset of symptoms),
this can be a trigger requiring increased scrutiny regarding donor eligibility.
o
DRAI questions should elicit information regarding any diagnosis of EVD and, if
applicable, when recovery from the infection occurred.
If such a diagnosis occurred, information could be sought from the healthcare
professional involved to get details (i.e., confirmation of diagnosis, date of
recovery/considered cured, etc.).
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Screening Donors for Risk Associated with Ebola Virus Disease (EVD)
Background Document
Currently in the United States, a test for Ebola Virus that can be used for donor
screening is not available and diagnostic tests are not accessible for this purpose. If
considering testing a donor for Ebola Virus, test sensitivity and qualifications of the
testing laboratory should be evaluated, however, at this time, testing is not
recommended.
Eligibility Policies
Policies regarding donor assessment for Ebola Virus Disease risk should be
established using current guidance. Active infection is a rule out. If a person
survived a previous infection, organ donor eligibility should be based on current
guidance from the Organ Procurement and Transplantation Network (OPTN)
(http://transplantpro.org/guidance-regarding-ebola-virus-disease-evd/) and from
published advisories from public health authorities. Consultation with infectious
disease experts is also advised. Knowledge of when the potential donor was
diagnosed can be useful. Until more is known about testing capabilities, as well as
Ebola infection, recovery, viral clearance, and antibody response, donation of
cells/tissues should not be considered. At this time, testing for Ebola Virus is not
recommended. Information collected via the DRAI could be verified by contacting
the healthcare professional(s) involved. Current EVD guidance should be assessed
before procurement of organs occurs. A documented, risk-based assessment is
expected if a donor presents with a past history of Ebola Virus infection and is
considered for donation.

Epidemiologic risk factors such as a person who was notified by a public health authority
they were exposed to someone infected with Ebola Virus, and were monitored.
o A person that was notified they were exposed, or possibly exposed, is usually
monitored for changes in health, and relatives could be aware of such a history. If
such an exposure occurred, information could be sought from the public health
authority involved to get details (i.e., confirmation of exposure, date monitoring
began, etc.). A donor may be at risk if any of these individuals were notified and
monitored:
 a member of their household,
 any sexual partner,
 a caretaker, or
 a mother who breastfed the child donor during the monitoring period.
o
Currently in the United States, a test for Ebola Virus that can be used for donor
screening is not available and diagnostic tests are not accessible for this purpose. If
considering testing a donor for Ebola Virus, the test’s sensitivity and qualifications
of the testing laboratory should be evaluated, however, at this time, testing is not
recommended.
Eligibility Policies
Policies regarding donor assessment for Ebola Virus Disease risk should be
established using current guidance. Knowledge of exposure, or possible exposure, to
an EVD-infected person should be queried during risk periods. Organ donor
eligibility should be based on current guidance from the Organ Procurement and
Transplantation Network (OPTN) (http://transplantpro.org/guidance-regardingebola-virus-disease-evd/) and from published advisories from public health
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Screening Donors for Risk Associated with Ebola Virus Disease (EVD)
Background Document
authorities. Consultation with infectious disease experts is also advised. For
cell/tissue donation, a person with an exposure history should be excluded
from donation for two months from the beginning of the monitoring period.
Current EVD guidance should be assessed before recovery of cells/tissues or
procurement of organs occurs. Information collected via the DRAI can be verified by
contacting the public health authority involved. At this time, testing for Ebola Virus
is not recommended.
Applicability
A donor of reproductive tissue should be initially screened for risk associated with EVD and rescreened upon each subsequent donation event without regard to a time period between donations.
The Uniform DRAI Addendum for Ebola Virus Disease, associated flowcharts, and this background
document should be useful to the following institutions when screening donors with authorization
or informed consent not only for transplantation, implantation, infusion or transfer, but also when
donation is for research and/or education:





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Eye Banks,
Tissue Banks,
Reproductive Tissue Banks,
Organ Procurement Organizations,
Non-transplant Anatomical Donation Organizations,
Bioskills Laboratories,
In vitro Fertilization Clinics, and
Biospecimen Repositories.
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