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Opinions:
Clarification of end date for malaria risk in all areas of Aceh province, Indonesia
following 12/26/04 tsunami: Response from CDC Malaria Branch
CreaTech submitted the following question to the CDC's Malaria Branch:
I have been trying to determine when the CDC's recommendation for malaria prophylaxis for travel to Aceh province
(following the tsunami) due to risk in all areas of the province was updated to the current recommendation that indicates risk is limited to
rural areas on Sumatra. Can anyone help me out by providing the date of this change?
The CDC's Response:
Thank you for your inquiry. Our current malaria prophylaxis recommendations for travel to Indonesia were
updated with the release of the new Yellow Book in May 2007.
Clarification of malaria risk areas in China: Response from CDC Malaria Branch
CreaTech submitted the following question to the CDC's Malaria Branch:
The interactive map application does not reflect the boundary between Sichuan
province and Chongqing municipality (created in 1997), should it therefore be assumed that malaria
risk in Chongqing is the same as for Sichuan?
The CDC's Response:
Thank you for your inquiry. Yes - malaria risk is the same for Chongqing as for Sichuan
province. The risk is in rural areas May-Dec.
Clarification of malaria risk areas in Botswana: Response from CDC Malaria Branch
CreaTech submitted the following question to the CDC's Malaria Branch:
It appears that the districts of Chobe and Ngamiland were merged in 2001 to form the North-West district in Botswana.
Is it reasonable to infer that malaria risk exists in the North-West district?
The CDC's Response:
Thank you for your inquiry. The North West province of Botswana consists of Ngamiland, Okavango and Chobe; all of which are malaria-risk areas.
CreaTech
Solutions' opinion on the CDC's Interactive Map
Here are the biggest concerns about
the CDC's interactive malaria risk map that we have heard from blood
bankers:
- The application has not been
validated
- There is no formal change control
process
- It is still a beta version
- Because it is web-based, it
cannot be accessed by all mobile operations
- Sometimes the application is down
or not functioning correctly when it is needed
- The pages can take a long time to
load
In CreaTech Solutions' opinion, all
of these concerns are valid. CreaTech Solutions does not use the CDC's
interactive map as a primary reference. We use the Yellow Book instead as
our primary reference because the information is version controlled. All
blood banks regardless of technology have access the Yellow Book,
therefore we consider the Yellow Book to be the universal standard for
dissemination of the CDC's malaria risk information.
That said, we do use the CDC's malaria risk map application as a
supplemental tool in order to verify information published in the Yellow
Book and for other research purposes.
CreaTech
Solutions' opinion on behavior-based HIV deferral policy
CreaTech Solutions finds the
current FDA policy requiring lifetime deferral from blood donation for
males that have had sex with another male even once since 1977 to
be a particularly unnecessary and cruel policy when applied to males who
have been victims of sexual assault or molestation by another male.
Research has established that the risk of acquiring a sexually transmitted
disease as the result of a one-time rape or molestation by a male is very
low, regardless of the gender of the victim. Therefore, there doesn't seem
to be a compelling reason that male victims should be permanently deferred
while the FDA recommends a 12 month deferral for female rape victims. We
believe that the permanent deferral of male victims of sexual assault or
molestation by another male amounts to an unfair and very personal
violation against individuals who instead deserve our empathy and
compassion.
CreaTech Solutions agrees with the
position of the AABB, America's Blood Centers (ABC), and the American Red
Cross (ARC) regarding deferral of male donors who have had sex with
another male. These organizations advocate a reduction in the deferral
period for male to male sex from a permanent deferral to a 12 month
deferral, based on current donor testing methods. Since the advent of
Nucleic Acid Testing (NAT) to screen blood donors for HIV, the
"window period" to reliably detect HIV infection using donor
screening tests has been reduced to well within one month from the date of
infection.
For more information on the FDA's current policy regarding deferral of
male donors who have had sex with another male, check out this link:
CreaTech
Solutions' opinion on HIV-1 group O donor screening
The uniform Donor History Questionnaire for blood donation, developed
under the leadership of the AABB and the Donor History Task Force has been
officially recognized by the FDA as meeting the requirements for donor
screening as described in CFR 640.3 and 640.63.
CreaTech Solutions has reviewed the
current Donor History Questionnaire materials and has concerns related to
the following instruction:
"Questions to detect
donors at risk for HIV Group O: The questions related to Africa
are recommended by FDA to identify donors who may be at risk for HIV group
O infections. Blood collection agencies utilizing an HIV test that has
been approved by FDA for blood screening to include a claim for detection
of group O viruses may delete these questions from their screening
questionnaire and may renumber the remainder of the questions (and related
documents such as flow charts). All other centers must continue to use
these questions as formatted."
We are concerned that removal of
one of the two questions designed to detect donors at risk for HIV-1 group
O may allow blood products to be collected from donors that have been
recently infected with HIV-1 group O and that these donations could yield
false negative donor screening test results for HIV-1 group O due to the
"window period" known to be associated with recent viral
exposure.
It is our opinion that with a donor
screening test in place for HIV-1 group O, the deletion of the question
regarding donor travel to Africa does not present a risk, since donors
that have been in a country with high risk of HIV-1 group O within the
past 12 months should be deferred for malaria risk (all HIV-1 group O risk
countries are also malaria risk countries). However, we believe that
deletion of the question regarding sexual contact with a person that was
born in or lived in Africa does present a risk, since a donor that has had
recent sexual contact with a person that was born in or lived in a country
associated with high risk of HIV-1 group O infection could fail to be
detected with an FDA approved screening test with a claim for detection of
HIV-1 group O.
For facilities that use an FDA-approved test for detection of HIV-1 group
O, we recommend that the question "Have you ever had sexual contact
with anyone who was born on or lived in Africa?" should either be
retained as is or revised to "In the past 12 months have you had
sexual contact with anyone who was born on or lived in Africa?". We
do not recommend that this question be completely deleted from the
questionnaire.
CreaTech
Solutions' opinion on biometric donor identification
CreaTech Solutions endorses the adoption of biometric donor identification
as an accurate and reliable method to positively identify donors
throughout the donor screening and blood collection process. According to
industry sources, current technology makes biometric identification using
fingerprint scanning more than 99% accurate.
Biometric identification is a
unique form of identification that cannot be borrowed, forged, or left at
home.
Incorporation of biometric donor
identification in the donor registration process makes the use and expense
of donor identification cards unnecessary. The superior accuracy of
biometric identification all but eliminates the inadvertent creation of
duplicate donor records, preventing donor deferrals and donation intervals
from being circumvented, and in turn prevents the collection and potential
release of blood from a deferred or ineligible donor. Preventing the
creation of duplicate donor records also eliminates the time-consuming and
inherently fallible process of identifying and resolving potential
duplicate donor records.
Incorporation of biometric donor
identification with donor screening and blood collection software systems
has the potential to greatly enhance the integrity of the donor screening
and collection processes by requiring biometric verification of the
donor's identity at critical "hand off" points in these
processes. The use of biometric donor identification in conjunction with
the electronic label verification of both blood bags and testing samples
has great potential to identify and prevent process errors and enhance
positive traceability of all components and samples to the donor.
Long story short, we think that biometric donor identification is a great
solution to a number of long-standing challenges that blood collection
programs have struggled with for a very long time. For more information on
biometric identification, check out the Bio-Key website:
http://www.bio-key.com/ID.asp
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