DHQ Flowcharts v2.0

Question: 1. Are you feeling healthy and well today?
Donor Eligibility: A person should be free of infectious diseases, including colds, on the day of
donation. A person who is not in good health should not donate until it is determined that the
underlying condition is not cause for deferral.
Question #1
Are you feeling healthy Yes

and well today?
No
Determine the reason the

donor is not feeling well
and healthy today.
Consult SOP for deferral
criteria.
Is reason cause for No Accept donor

deferral?
Yes
Defer donor Next question

per SOP
DHQ Flowcharts v2.0 eff. February 2016

Question: 2. Are you currently taking an antibiotic?
Donor Eligibility: The reason the antibiotic was prescribed must be evaluated to determine if
the person has a bacterial infection that could be transmissible by blood. A person with an
infection should not donate.
Question #2
No
Are you currently taking
an antibiotic?
Yes
Consult SOP for

deferral criteria.
Determine why the
antibiotic(s) was
prescribed.
.
No
Is diagnosis cause for Accept donor
deferral?
Yes
Defer donor
per SOP Next question

Question: 3. Are you currently taking any other medication for an infection?
Donor Eligibility: The reason for use of any medication for an infection must be evaluated to
determine if the person has a viral, fungal, parasitic or other infection transmissible by blood. A
person with an infection should not donate.
Question #3
Are you currently No

taking any other
medication for an
infection?
Yes
Consult SOP for

deferral criteria.
Determine why the
medication(s) was
prescribed.
Is diagnosis cause No
Accept donor
for deferral?
Yes
Defer donor
Next question
per SOP

Question: 4. Have you taken any medications on the Medication Deferral List in the time frames
indicated? (Review the Medication Deferral List.)
Donor Eligibility: A person taking medications listed on the Medication Deferral List anytime in
the timeframes indicated is deferred for the appropriate period of time.
Question #4
Medication Deferral List

provided to donor.
Have you
taken any medications on No
the Medication Deferral List in Accept donor
the time frames indicated?
Yes
Refer to Medication Deferral List

to determine which of the
medication(s) were taken during
the time frames indicated.
Determine the date of last dose.
Qualify or defer donor per SOP. Next question

Question: 5. Have you read the educational materials today?
Donor Eligibility: Donors must read the educational materials prior to donating.
Question #5
Have you read the Yes

educational materials Next question
today?
No
The donor must read the

educational materials to
proceed if he/she has not
done so.

Question: 6. In the past 48 hours, have you taken aspirin or anything that has aspirin in it?
Donor Eligibility: Aspirin irreversibly inactivates platelet function. A person taking aspirin or any
medication containing aspirin should not be the sole source of platelets.
Question #6
In the past 48 hours, have No

you taken aspirin or anything Accept donor
that has aspirin in it?
Yes
Determine
donation type.
Consult SOP.
Qualify or defer Next question

donor per SOP

Question: 7. In the past 8 weeks, have you donated blood, platelets or plasma?
Donor Eligibility: A whole blood donor may donate no more frequently than every 8 weeks.
Donors of plasma, platelets or leukocytes by apheresis may donate no more frequently than
every 2 days.
Question #7
In the past 8 weeks,

No
have you donated blood,
platelets or plasma?
Yes
Determine date and type of

donation(s).
Consult SOP for donor
eligibility.
Is donor eligible Yes

based on Accept donor
donation date and
type?
No
Defer donor per SOP Next question

Question: 8. In the past 8 weeks, have you had any vaccinations or other shots?
Donor Eligibility: Certain vaccinations may contain live infectious agents. A person who has
been exposed to a live infectious agent in a vaccination should not donate for a specified period
of time.
Note on 8alt flowchart: Some blood centers may choose to use a simpler but stricter deferral
scheme in which all donors who received the smallpox vaccination are deferred for a minimum of
56 days, regardless of when the scab fell off. Blood centers using these criteria should use
alternative Flowchart 8alt.
Question #8
In the past 8
weeks, have you had No
Accept donor
any vaccinations or
other shots?
Yes
Determine details of shots

and vaccinations.
No Qualify or defer donor per
Was the vaccination
for smallpox? SOP.
Next question
Yes
More than 21
When were you days ago? Continue this question
vaccinated for on next page
smallpox?
Fewer than 21
days ago?
Defer donor until 21

days after the Next question
vaccination date.

Yes Defer donor for 21 days after
Is the scab still on? vaccination date or until scab
spontaneously falls off,
whichever is later.
No
Did the scab(s) No Defer donor 56 days after

fall off by itself? vaccination date.
Yes
Did you have any Yes Defer until 14 days after

illness or complications due
symptoms resolve.
to the vaccination?
No
Accept donor Next question

Question: 8alt. In the past 8 weeks, have you had any vaccinations or other shots?
been exposed to a live infectious agent in a vaccination should not donate for a specified period
of time.
Question #8alt.

No Accept donor
have you had any
vaccinations or
other shots?
Yes
Determine details of shots

Was the vaccination for No and vaccinations.
smallpox?
Qualify or defer donor per
SOP.
Yes
Continue this question

on next page
Next question

Fewer than
When were you 56 days ago Defer donor for
vaccinated? 56 days after
vaccination date.
56 days ago
or more
more
Did you have any Yes Defer donor for

illness or complications due 14 days after
to the vaccination? symptoms resolve.
No

Question: 9. In the past 8 weeks, have you had contact with someone who was vaccinated for
smallpox in the past 8 weeks?
had close contact with the vaccination site, bandages covering the vaccination site, or materials
that might have come into contact with an unbandaged vaccination site, including clothing, may
be exposed to the live infectious agents and should not donate for a specified period of time
following the contact. See User Brochure Glossary for specifics.
Note on 9alt Flowchart: Some blood centers may choose to use a simpler but stricter deferral
scheme in which all donors who have been in contact with a person who received the smallpox
vaccination are deferred for 56 days if they developed any subsequent complication, skin rash or
sore, regardless of when the rash or sore resolved. Blood centers using these criteria should use
alternative Flowchart 9alt.
Question #9
In the past 8 Have you Yes

weeks, have you had Yes No
had any new skin Did your
contact with someone who was rash or skin sore since scab(s) fall off
vaccinated for smallpox in the time of by itself?
the past 8 weeks? contact?
No
Yes Defer for 3 months
after the date of
Have you the contact’s
No had any severe vaccination;
complication* since if date is not
the time of known, defer for 2
contact? months from
today’s date.
Yes
Has it been 14
Yes
days or more since the
symptoms went
away?
No
Defer for 14 days after

symptoms resolve.
*Severe complications include the following: rash (resembling blisters) covering a small or large area of the body; necrosis (tissue
death) in the area of exposure; encephalitis (inflammation of the brain); infection of the cornea (eye); and localized or systemic skin
reaction in someone with eczema or other chronic skin condition.

Question: 9alt. In the past 8 weeks, have you had contact with someone who was vaccinated for
smallpox in the past 8 weeks?
had close contact with the vaccination site, bandages covering the vaccination site or materials
that might have come into contact with an unbandaged vaccination site, including clothing, may
be exposed to the live infectious agent and should not donate for a specified period of time
following the contact. See User Brochure Glossary for specifics.
Question #9alt.

have you had contact with No
someone who was vaccinated
for smallpox in the past 8
weeks?
Yes
Have you had any skin No

sore, rash or any severe Accept donor
complication* since the
time of contact?
Yes
Defer for 56 days from current

date or 14 days from resolution of Next question
complications, whichever is later.
*Severe complications include the following: rash (resembling blisters) covering a small or large area of the body;
necrosis (tissue death) in the area of exposure; encephalitis (inflammation of the brain); infection of the cornea (eye);
and localized or systemic skin reaction in someone with eczema or other chronic skin condition.

Question: 10. In the past 16 weeks, have you donated a double unit of red cells using an
apheresis machine?
Donor Eligibility: A donor should not donate double red cells by apheresis more frequently
than every 16 weeks.
Question #10
In the past 16 weeks, No

have you donated a double unit Accept donor
of red cells using an apheresis
machine?
Yes

Question: 11. In the past 12 months, have you had a blood transfusion?
Donor Eligibility: A person who has received an allogeneic transfusion of blood, platelets,
plasma or other blood component is at increased risk for transmitting infectious diseases, and is
deferred for 12 months following the transfusion.
Question #11
In the past 12 months, No

have you had a blood transfusion? Accept donor
Yes
Determine if the donor

received an allogeneic
transfusion.
Qualify or defer
Next question
donor per SOP

Question: 12. In the past 12 months, have you had a transplant such as organ, tissue, or bone
marrow?
Donor Eligibility: A person who has been exposed to allogeneic tissues through transplant
should not donate blood for 12 months following exposure due to increased risk for transmitting
infectious diseases.
Question #12
In the past 12 months, have No

you had a transplant such as organ,
tissue, or bone marrow?
Yes
No
Determine if the transplant
was an allogeneic donation.
Yes
Accept donor
Defer donor per Next question

SOP

Question: 13. In the past 12 months, have you had a graft such as bone or skin?
Donor Eligibility: A person who has been exposed to allogeneic tissues through grafting should
not donate blood for 12 months following exposure due to increased risk for transmitting
infectious diseases.
Question #13

have you had a graft such as
bone or skin?
Yes
Determine if the graft was

an allogeneic donation. No
Accept donor
Yes

Question: 14. In the past 12 months, have you come into contact with someone else's blood?
Donor Eligibility: A person who has had one of the following in the past 12 months: 1) contact
with an open wound, non-intact skin or mucous membrane with the blood of a person, or 2) a
needle-stick or other sharps injury from an instrument that has been used on a person, is at
increased risk for transmitting infectious diseases, and is deferred for 12 months from the date of
exposure.
Question #14

have you come into contact Accept donor
with someone else's
blood?
Yes

Question: 15. In the past 12 months, have you had an accidental needle-stick?
Donor Eligibility: A person who has been exposed to someone else's blood through a needle-
stick is at increased risk for transmitting infectious diseases, and is deferred for 12 months
following the date of exposure.
Question #15

have you had an accidental
needle-stick?
Yes
Were you exposed to No

someone else's blood through Accept donor
the needle-stick?
Yes or
don't know

Question: 16. In the past 12 months, have you had sexual contact with anyone who has
HIV/AIDS or has had a positive test for the HIV/AIDS virus?
Donor Eligibility: A person who has had sexual contact with a person with clinical or laboratory
evidence of HIV infection is at increased risk for transmitting HIV and other infectious diseases,
and is deferred for 12 months from the date of last sexual contact. HIV may be transmitted
through sexual contact with an infected person.
Note: Not all donors define "sex" or "sexual contact" in the same way. The donor must have read
the Blood Donor Educational Material provided.
Question #16
In the past 12 months,

have you had sexual contact No
with anyone who has HIV/AIDS or Accept donor
has had a positive test for the
HIV/AIDS virus?
Yes

Question: 17. In the past 12 months, have you had sexual contact with a prostitute or anyone
else who takes money or drugs or other payment for sex?
Donor Eligibility: A person who has taken money, drugs, or other payment in exchange for sex
is at increased risk for transmitting HIV and other infectious diseases. The sexual contacts of this
person are also at increased risk for transmitting HIV and other infectious diseases, and are
deferred for 12 months from the date of the last sexual contact. HIV and other diseases may be
transmitted through sexual contact.
Question #17

with a prostitute or anyone else Accept donor
who takes money or drugs or
other payment for
sex?
Yes

Question: 18. In the past 12 months, have you had sexual contact with anyone who has ever
used needles to take drugs or steroids, or anything not prescribed by their doctor?
Donor Eligibility: A person who has used needles, in the past or present, to take drugs,
steroids, or anything not prescribed by their doctor is at increased risk for transmitting HIV and
other infectious diseases. The sexual contacts of this person are also at increased risk for
transmitting HIV and other infectious diseases and are deferred for 12 months from the date of
the last sexual contact. HIV and other diseases may be transmitted through sexual contact.
Note: The phrase "used needles" includes intravenous use, "skin popping" (injection under the
skin), "mainlining" (arterial injection) and any other use of a needle to administer drugs, steroids
or anything else not prescribed by their doctor for intravenous use.
Question #18

with anyone who has ever used needles to
Accept donor
take drugs or steroids, or anything not
prescribed by their doctor?
Yes

Question: 19. Male Donors: In the past 12 months, have you had sexual contact with another
male?
Donor Eligibility: A male who has had sexual contact with another male is at increased risk for
transmitting HIV and other infectious diseases, and is deferred for 12 months from the date of the
last sexual contact with a male. HIV and other diseases may be transmitted through sexual
contact.
Question #19
(Male Donors) In the past 12 months, No

have you had sexual contact with another Accept donor
male?
Yes

Question: 20. Female donors: In the past 12 months, have you had sexual contact with a male
who had sexual contact with another male in the past 12 months?
Donor Eligibility: A male who had sexual contact with another male is at increased risk for
transmitting HIV and other infectious diseases. The sexual contacts of the male are also at
increased risk for transmitting HIV and other infectious diseases, and are deferred for 12 months
from the date of the last sexual contact. HIV and other diseases may be transmitted through
sexual contact.
Question #20
(Female donors) In the

past 12 months, have you had sexual No
contact with a male who had sexual Accept donor
contact with another male in the past
12 months?
Yes
Defer donor
Next question

Question: 21. In the past 12 months, have you had sexual contact with a person who has
hepatitis?
Donor Eligibility: A person who has had sexual contact with a person who has viral hepatitis
may be at increased risk for transmitting infection, and is deferred for 12 months from the date of
last contact. Hepatitis, particularly hepatitis B, may be spread through sexual contact.
Question #21

with a person who
has hepatitis?
Yes
Determine type Non-viral

of hepatitis
viral
asymptomatic hepatitis C
Determine type
Accept donor
of viral hepatitis
hepatitis B,
symptomatic hepatitis C,
or unknown

Question: 22. In the past 12 months, have you lived with a person who has hepatitis?
Donor Eligibility: In certain cases, a person living with someone who has viral hepatitis is at
increased risk for acquiring viral hepatitis as well. A person who is living with a person with viral
hepatitis is deferred for 12 months following the date of the last contact. See User Brochure
Glossary.
Question #22

have you lived with a person
who has hepatitis?
Yes
Determine type Non-viral

of hepatitis
Viral
asymptomatic hepatitis C
Determine type
Accept donor
of viral hepatitis
hepatitis B,
symptomatic hepatitis C, or
unknown

Question: 23. In the past 12 months, have you had a tattoo?
Donor Eligibility: A person who has had a tattoo in the past 12 months is deferred for 12
months from the date of the tattoo application, unless applied by a state regulated entity with
sterile needles and non-reused ink. There may be a risk of transmission of infectious diseases
when tattoos have been applied using non-sterile needles and/or reused ink.
Note: Tattoos include tattoo "touch ups", tattoos applied by oneself, and those applied by others.
Question #23

Accept donor
have you had a tattoo?
Yes
Qualify or defer
Next question
donor per SOP

Question: 24. In the past 12 months, have you had ear or body piercing?
Donor Eligibility: A person who has had ear or body piercing during the past 12 months is at
increased risk for transmitting HIV and other infectious diseases, and is deferred for 12 months
from the date of procedure, unless ear or body piercing has been done using single-use
equipment. There is an increased risk for transmitting HIV and other diseases if the equipment is
re-used.
Question #24

have you had ear or
body piercing?
Yes
Determine if single Yes

use equipment was Accept donor
used.
No
Defer donor per Next question

SOP

Question: 25. In the past 12 months, have you had or been treated for syphilis or gonorrhea?
Donor Eligibility: A person who has had syphilis or gonorrhea, treatment for either, or a
confirmed reactive screening test for syphilis is at increased risk for transmitting disease, and is
deferred for 12 months after the date treatment is completed.
Question #25

No
have you had or been treated
for syphilis or gonorrhea?
Yes
Determine date treatment

was completed.
Yes
Was treatment completed 12 Accept donor
months ago?
No
Defer donor for

12 months after
treatment is Next question
completed.

Question: 26. In the past 12 months, have you been in juvenile detention, lockup, jail, or prison
for more than 72 consecutive hours?
Donor Eligibility: A person who has been detained or incarcerated in a facility (juvenile
detention, lockup, jail, or prison) for more than 72 consecutive hours (3 days) is at increased risk
for transmitting HIV and other transmissible diseases, and is deferred for 12 months from the last
date of incarceration.
Note: The reason for incarceration (e.g. white-collar crimes, child support) does not change the
deferral
Question #26

No
have you been in juvenile detention,
lockup, jail, or prison
for more than 72 consecutive
hours?
Yes
Determine if the period of No

incarceration was 72 Accept donor
consecutive hours
Yes

Question: 27. In the past 3 years, have you been outside the United States or Canada?
Donor Eligibility: Malaria is a transfusion-transmitted disease; eligibility to donate is not

mitigated by use of malaria chemoprophylaxis when traveling.
* In general, residents of a malaria-endemic country will be deferred for 3 years after departure
from the country of residence if they remain free from unexplained symptoms suggestive of
malaria. Prior residents of malaria-endemic countries who live in non-endemic countries for 3
consecutive years without travelling to a malaria-endemic area, will then be deferred for 12
months after subsequent travel to a malaria-endemic area. Prior residents of malaria-endemic
countries who have not lived in non-endemic countries for 3 consecutive years, and then travel to
a malaria-endemic area will be deferred for 3 years after the recent travel to a malaria-endemic
area.
A person who is not a prior resident of malaria-endemic countries and travels to a malaria-
endemic area is deferred for 12 months after departure from that area.
* Note: Use of the definitions (excerpts are provided below) provided in the August 2014 FDA
“Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product
Management to Reduce the Risk of Transfusion-Transmitted Malaria” are necessary in order to
use the flowchart properly.
The guidance can be found by date and title on the FDA website at the following link:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidanc
es/Blood/default.htm
Definitions
Malaria-endemic area - Any areas with malaria where CDC recommends anti-malarial
chemoprophylaxis in travelers in the most current version of the CDC Health Information
for International Travel (commonly known as The Yellow Book) at the time the donor is
screened.
Malaria-endemic country - Any country having an area or areas with malaria where
CDC recommends anti-malarial chemoprophylaxis in travelers in The Yellow Book at the
time the donor is screened. A country that has any malaria-endemic areas should be
considered to be malaria-endemic in its entirety.
Residence in a malaria-endemic country - Residence is defined as a continuous stay

of longer than 5 years in a country or countries having any malaria-endemic area. In
determining residence, consideration is by malaria-endemic country and not by malaria-
endemic area since the geographic distribution of malaria-endemic areas may change
during the period of residence, or the resident may have traveled from a non-endemic
area to an endemic area in the country during his or her stay.
Travel to a malaria-endemic area - Any travel to or through a malaria-endemic area or

areas, as identified by CDC. The duration of travel to a malaria-endemic area is defined
as more than 24 hours to less than 5 years. Note that a passage greater than 24 hours
through a malaria-endemic area while on route to a malaria-free area is considered a
sufficient possible exposure to trigger donor deferral.

Question #27
In the past 3 years,

No
have you been
outside the United
States or Canada?
Yes
Only non-endemic
Determine if donor
country(ies)
was in any malaria-
endemic
country(ies)
Malaria-endemic
country(ies)
Only non-
Determine length of ≤5yrs Determine if donor endemic area(s)
stay in malaria- was in any malaria-
endemic country(ies) endemic area(s)
Malaria-endemic
>5 years, area(s)
continuously
Determine donor’s ≤24 hours

length of stay in Accept donor
malaria-endemic
area(s)
>24 hours
Continue this question Continue this question Next question

on next page on next page

Was donor EVER a resident
(lived for >5 years, No
continuously) in malaria-
endemic country(ies) prior to
this recent travel?
Yes
Subsequent to this residency

did donor ever have a 3 year
Yes
period in which they
remained in non-endemic
country(ies) without travel to
malaria-endemic area(s)?
No
Has donor traveled

(>24 hours) in malaria- Defer for 3 years from Defer for 12 months
Yes
endemic area(s) after most recent date of from most recent date of
leaving malaria- departure from malaria- departure from malaria-
endemic country(ies) of endemic area endemic area
residence?
No
Defer for 3 years from date

of departure from malaria- Next question
endemic country of
residence

Question: 28. From 1980 through 1996, did you spend time that adds up to 3 months or more in
the United Kingdom? (Review list of countries in the UK.*)
Donor Eligibility: A person who has spent time that adds up to 3 months or more in the United
Kingdom from 1980 through 1996 is indefinitely deferred. Donors may be at risk of developing
vCJD from eating beef from the United Kingdom are indefinitely deferred. There may be a risk of
transmitting vCJD through blood transfusion.
Question #28
From 1980 through 1996, did

you spend time that adds up to 3 No
months or more in the United Kingdom? Accept donor
(Review list of countries
in the UK.*)
Yes
Defer donor
indefinitely Next question
*See the January 2016 FDA guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products: Guidance for
Industry.”
The guidance can also be found by date and title on the FDA website at the following link:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm

Question: 29. From 1980 through 1996, were you a member of the U.S. military, a civilian
military employee, or a dependent of a member of the U.S. military?
Donor Eligibility: Members of the U.S. military, a civilian military employee, or a dependent of a
member of the U.S. military are indefinitely deferred if they spent a total of 6 months or more
associated with a military base in any of the following countries: From 1980 through 1990 in
Belgium, the Netherlands, or Germany; From 1980 through 1996 in Spain, Portugal, Turkey, Italy
or Greece. These donors may be at risk of developing vCJD from eating beef from the UK and
are indefinitely deferred. There may be a risk of transmitting vCJD through blood transfusion.
Question #29
From 1980 through 1996, were

you a member of the U.S. military, a No
civilian military employee or a dependent
of a member of the U.S. military?
Yes
Did you
spend a total time of 6
months or more associated
with a military base in any of the
following countries: No
·From 1980 through 1990 in Belgium, the Accept donor
Netherlands, or Germany;
·From 1980 through 1996 in Spain,
Portugal,
Turkey, Italy or Greece?
Yes

indefinitely

Question: 30. From 1980 to the present, did you spend time that adds up to 5 years or more in
Europe? (Review list of countries in Europe.*)
Donor Eligibility: A person who spent time that adds up to 5 years or more in Europe from
1980 to the present may be at risk of developing vCJD from eating beef in Europe and is
indefinitely deferred. There may be a risk of transmitting vCJD through blood transfusion.
Question #30
From 1980 to the present,

did you spend time that adds No
up to 5 years or more in Europe? Accept donor
(Review list of countries
in Europe.*)
Yes
Defer donor
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products: Guidance for Industry.”

Question: 31. From 1980 to the present, did you receive a blood transfusion in the United
Kingdom or France? (Review country lists.*)
Donor Eligibility: A person who received a transfusion of blood, platelets, plasma,

cryoprecipitate, or granulocytes in the UK or France from 1980 to the present may be at risk of
developing vCJD through transfusion, and is indefinitely deferred. There may be a risk of
transmitting vCJD through blood transfusion.
Question #31
From 1980 to the present,

did you receive a blood transfusion in No
the United Kingdom or France? Accept donor
(Review country lists.*)
Yes
Defer donor
Next question
indefinitely
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products: Guidance for Industry.”

Question: 32. Female donors: Have you ever been pregnant or are you pregnant now?
Donor Eligibility: A female who is pregnant now or was pregnant in the past 6 weeks is
deferred for the safety of the donor. Previous pregnancies are associated with developing
antibodies that can cause TRALI, a serious transfusion complication. Blood centers have SOPs
for donor qualification and testing to reduce this risk of TRALI.
Question #32
(Female donors)
Have
No
you ever been pregnant or are Accept donor
you pregnant now?
Yes Next question
Qualify or defer
Pregnant now or in past 6 No
donor per
weeks? TRALI SOP
Yes
Defer donor

Question: 33. Have you ever had a positive test for the HIV/AIDS virus?
Donor Eligibility: A person with clinical or laboratory evidence of HIV/AIDS is at increased risk
for transmitting HIV and other infectious diseases, and is indefinitely deferred.
Question #33
Have you ever had a positive test for No

the HIV/AIDS virus? Accept donor
Yes

indefinitely

Question: 34. Have you ever used needles to take drugs, steroids, or anything not prescribed by
your doctor?
Donor Eligibility: A person who has used needles, in the past or present, to take drugs,
steroids, or anything not prescribed by their doctor is at increased risk for transmitting HIV and
other infectious diseases, and is indefinitely deferred.
Note: The phrase "used needles" includes intravenous use, "skin popping" (injection under the
skin), "mainlining" (arterial injection) and any other use of a needle to administer drugs, steroids
or anything else not prescribed by their doctor for intravenous use.
Question #34
Have you ever used needles to No

take drugs, steroids, or anything not Accept donor
prescribed by your doctor?
Yes
Defer donor
Next question
indefinitely

Question: 35. Have you ever received money, drugs, or other payment for sex?
Donor Eligibility: A person who has received money, drugs, or other payment for sex is at
increased risk for HIV and other infectious diseases, and is indefinitely deferred.
Question #35
Have you ever No

received money, drugs, or other payment Accept donor
for sex?
Yes
Defer donor
Next question
indefinitely

Question: 36. Have you ever had malaria?
\Donor Eligibility: A person who has had malaria and received an appropriate treatment is
deferred for three years after becoming asymptomatic while residing in a non-endemic country.
Malaria can be transmitted through blood transfusion.
Question #36
No
Have you ever had malaria?
Yes
Have you been

asymptomatic for more Yes
than 3 years while Accept donor
residing in a non-endemic
country?
No

Question: 37. Have you ever had Chagas disease?
Donor Eligibility: A person who has had Chagas disease is indefinitely deferred. Chagas disease can
be transmitted by blood.
Question #37
No
Have you ever had
Accept donor
Chagas disease?
Yes

Question: 38. Have you ever had babesiosis?
Donor Eligibility: A person who has had babesiosis is indefinitely deferred. Babesiosis can be
transmitted by blood.
Question #38
No
Have you ever had
Accept donor
babesiosis?
Yes

Question: 39. Have you ever received a dura mater (or brain covering) graft or xenotransplantation
product?
Donor Eligibility: A person who has received an allogeneic dura mater transplant or graft may be at risk
for Creutzfeldt-Jakob disease, and is permanently deferred. Autologous dura mater grafts are acceptable.
A person who has received a xenotransplantation product is indefinitely deferred. Xenotransplantation is

defined to include any procedure that involves the transplantation, implantation, or infusion into a human
recipient of either (a) live cells, tissues, or organs from a nonhuman animal source or (b) human body
fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or
organs. Xenotransplantation products include live cells, tissues or organs used in xenotransplantation.
*Xenotransplantation definitions are provided in the January 19, 2001 document “PHS Guideline on
Infectious Disease Issues in Xenotransplantation”. The guidance is available at www.fda.gov.
Note: Nonliving biological products or material from nonhuman animals, such as porcine heart valves
and porcine insulin, are not classified as xenotransplantation products for the purposes of this definition.
Question #39
Have you
ever received
a dura mater (or No
brain covering) graft
or
xenotransplantation
product?
Yes
Did you receive

only an Yes
Accept donor
autologous dura
mater graft?
No
Defer donor permanently for allogeneic dura

mater transplant/graft OR defer indefinitely Next question
for receiving a xenotransplantation product.

Question: 40. Have you ever had any type of cancer, including leukemia?
Donor Eligibility: A person with a history of cancer must be evaluated to determine their eligibility to
donate.
Question #40
Have you ever had

No
any type of cancer, including
leukemia?
Yes
Consult SOP and assess

donor
Is history of No
cancer reason Accept donor
for deferral?
Yes

Question: 41. Have you ever had any problems with your heart or lungs?
Donor Eligibility: A person must be free of acute respiratory disease. A person with a history of
diseases of the heart and lungs, including acute lung diseases or colds, must be evaluated.
Question #41
Have you ever had

No
any problems with your heart
or lungs?
Yes
Consult SOP and assess

donor
Is history of heart or lung No

problems reason for Accept donor
deferral?
Yes

Question: 42. Have you ever had a bleeding condition or a blood disease?
Donor Eligibility: A person with hemophilia or related clotting disorder that requires treatment should be
deferred to prevent harm by the large bore needles used during the donation process.
Note: See the December 2015 FDA guidance, “Revised Recommendations for Reducing the Risk of
Human Immunodeficiency Virus Transmission by Blood and Blood Products.” The guidance can also be
found by date and title on the FDA website at the following link:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blo
od/default.htm
Question #42
Have you ever had a No

bleeding condition or a blood
disease?
Yes
Is it hemophilia No
or a related clotting disorder
Accept donor
that requires treatment?
Yes
Defer donor
Next question
Indefinitely

Question: 43. Have any of your relatives had Creutzfeldt-Jakob disease?
Donor Eligibility: A person with a blood relative with Creutzfeldt-Jakob disease is indefinitely deferred
due to the risk of transmission.
Note: If laboratory testing (gene sequencing) shows that the donor does not have a mutation associated
with familial CJD, the donor is eligible. Gene sequencing of the donor is not necessary to demonstrate
that the donor is not at risk for familial CJD. Sequencing of the family member with CJD or the appropriate
parent of the donor, if the CJD-affected family member was a second-degree relative, may be sufficient to
demonstrate that the donor does not have a mutation associated with familial CJD, as stated in the
January 2016 guidance* found on the FDA website under Blood guidances.
Question #43
Have any of your relatives No or don't know

had Creutzfeldt-Jakob
disease?
Yes
No, related by marriage

Was this person related by Accept donor
blood?
Yes
Defer donor
*See the January 2016 FDA guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission
of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products: Guidance for
Industry.” The guidance can also be found by date and title on the FDA website at the following link:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.
htm

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Question: 1. Are you feeling healthy and well today?

Are you feeling healthy Yes

Determine the reason the

Is reason cause for No Accept donor

Defer donor Next question

DHQ Flowcharts v2.0 eff. February 2016

Consult SOP for

DHQ Flowcharts v2.0 eff. February 2016

Are you currently No

Consult SOP for

DHQ Flowcharts v2.0 eff. February 2016

Medication Deferral List

Refer to Medication Deferral List

Qualify or defer donor per SOP. Next question

DHQ Flowcharts v2.0 eff. February 2016

Have you read the Yes

The donor must read the

DHQ Flowcharts v2.0 eff. February 2016

In the past 48 hours, have No

Qualify or defer Next question

DHQ Flowcharts v2.0 eff. February 2016

In the past 8 weeks,

Determine date and type of

Is donor eligible Yes

Defer donor per SOP Next question

DHQ Flowcharts v2.0 eff. February 2016

Determine details of shots

Defer donor until 21

DHQ Flowcharts v2.0 eff. February 2016

Did the scab(s) No Defer donor 56 days after

Did you have any Yes Defer until 14 days after

Accept donor Next question

DHQ Flowcharts v2.0 eff. February 2016

In the past 8 weeks,

Determine details of shots

Continue this question

DHQ Flowcharts v2.0 eff. February 2016

Did you have any Yes Defer donor for

Accept donor Next question

DHQ Flowcharts v2.0 eff. February 2016

In the past 8 Have you Yes

Defer for 14 days after

DHQ Flowcharts v2.0 eff. February 2016

In the past 8 weeks,

Have you had any skin No

Defer for 56 days from current

DHQ Flowcharts v2.0 eff. February 2016

In the past 16 weeks, No

Defer donor Next question

DHQ Flowcharts v2.0 eff. February 2016

In the past 12 months, No

Determine if the donor

DHQ Flowcharts v2.0 eff. February 2016

In the past 12 months, have No

Defer donor per Next question

DHQ Flowcharts v2.0 eff. February 2016

In the past 12 months, No

Determine if the graft was

Defer donor Next question