Grants and Research
First SBIR Grant - Computerized
Blood Donor Processing System (HL61111)
In December 1997 Talisman secured FDA agreement that Talisman's
blood donor screening technology was not subject to medical device
regulations. At that point Talisman applied for a SBIR-I grant from
the NHLBI. The grant was awarded in August 1998 with Thomas F. Zuck,
MD, former CBER head and Chief Executive of the University of Cincinnati's
Hoxworth Blood Center as co-investigator. The original Windows 3.1
technology used in the earlier version of the donor self-interviewing
system was updated for Windows 9x compatibility, customized to Hoxworth's
requirements and implemented as a single workstation at the Hoxworth
main center in Cincinnati, OH in February of 1999. The system was custom tailored using Hoxworth's donor history interview and became known as the Hoxworth Quality Donor System™ (HQDS). HQDS software performed as expected and data collected during the pilot study showed that donors had very favorable responses to the system.
Research studies conducted on the HQDS system provided evidence
that donors who have a preference for one system or the other clearly
preferred QDS to the traditional staff administered health history
interview, believed the system provided more privacy and said with
the system they would be more honest and donate more frequently.
The system standardizes the interview process and reduces or eliminates
human errors such as typographical, transposition, incompleteness,
illegibility, and illiteracy.
Results of the pilot study have been published in the
also Dr. Zuck's
audio) to the American Association of Blood Banks in late
In April 2000 Talisman received a Phase II (SBIR-II) two-year grant
to develop a more robust, networked, web-compatible version of QDS
capable of ultimate expansion into a fully automated blood donor
data collection and processing system.
In 2000 agreement was reached with Mississippi Valley
Regional Blood Center, Davenport, IA (MVRBC) for installation of a standardized version of QDS based on
the American Association of Blood Banks (AABB) Uniform Donor History
Questionnaire (UDHQ). In spring 2001 NHLBI provided additional
support and assistance to Talisman in working with FDA/CBER to permit
implementation of the standalone and LAN versions of QDS as a Changes
Being Effected in 30 Days (CBE-30) procedure. QDS implementation
began in May 2001 at Mississippi Valley.
Initial data from the MVRBC installation have confirmed, strengthened
and extended the findings of the Hoxworth study. Over 1000 MVRBC completed
donor and staff surveys showed extremely strong donor and staff
support for QDS. For example, compared to traditional donor-staff
interviews, donors with preferences preferred QDS by factors of four
or more for clarity, privacy, truthfulness, time satisfaction,
understanding and likelihood of donation again. Staff surveys showed
that among staff with an opinion the minimum strength of preference
is a factor of three compared to traditional face-to-face interviews
on faster for staff, more honest donor responses, more accurate
donor responses, more confidential donor answers, fewer staff
errors, and personal satisfaction. MVRBC studies also show
errors/omissions to be reduced by more than 60%. These SBIR-II study
findings were first presented at the AABB meeting in October 2001
and have since been expanded and presented elsewhere as detailed at References. In May 2002 QDS was updated to incorporate the
CBER mandated CJD/vCJD questions.
Second SBIR Grant - Paperless
Quality Donor Systemô with Decision Making (HL072635)
Talisman won a second SBIR grant to develop a Paperless QDS with
Decision Making in January 2003. This grant was awarded under the
Fast Track program, in which the Phase I and Phase II grants are
approved at the same time. Phase II began in mid-2003 upon
completion of the Phase I work.
In Phase I, Talisman  developed an architectural design
for an integrated system that included vital signs and phlebotomy,
wide area networks, bar coding and archiving;  prototyped and
tested a vital signs module;  prototyped and tested electronic
data transfer with other blood center systems;  demonstrated
feasibility of developing decision aids to support staff
decision-making;  on an emergency basis developed two updates to
QDS to respond to FDA added requirements for questions regarding smallpox
vaccinations, SARS and West Nile Virus.
Talisman updated QDS well
within the FDA time requirements, and consistently faster than blood
centers were able to update their own procedures. The WNV changes
were accomplished in less than a week from issuance of the FDA
During 2003, two more blood centers began to implement
QDS: West Tennessee Regional Blood Center (Jackson, TN) and
Lifeblood/Mid-South Blood Center (Memphis, TN). Late in 2003, CBER
advised Talisman that it must apply for a 510(k) marketing
clearance in order for blood centers to use interstate wide area
Talisman made substantial improvements in QDS to support larger
network configurations for efficiently. A subsystem was developed to
collect vital signs and phlebotomy information, the latter using
wireless handheld computers. This system was demonstrated at the
AABB Annual Meeting in November 2004. Also during this period, QDS
was extended to include a Spanish interview as well as English.
During 2004, Talisman developed an application for an FDA 510(k)
clearance for the QDS 2004 system, which clearance was granted by CBER/FDA in
October 2004. The company also developed a version of QDS that can
administer the donor health history interview over the Internet.
This capability is of interest to many employers that host blood
drives, on the expectation that employees can minimize time away
from their workstations by going to
the blood drive with the interview already completed. This Internet
interview capability has not been cleared by CBER. Finally, QDS was
updated to include the new Uniform Donor History Questionnaire
developed by AABB and approved by CBER, including supplemental
material and staff procedural flowcharts.
LifeShare Blood Centers (Shreveport, LA) and Dartmouth-Hitchcock
Medical Center (Lebanon, NH) began implementation of QDS in 2004.
Additional donor and staff satisfaction studies were conducted at
three blood centers. The results of these studies corroborated the
2001-2002 MVRBC data showing overwhelming donor and staff preference
for QDS on multiple dimensions.
In February 2005, a second article was published in
Transfusion describing the first 2 years of QDS use (2001-2002) at
Mississippi Valley Regional Blood Center. Further, two blood centers (MVRBC and West TN RBC) upgraded to
the new UDHQ early in the year. Other centers plan to upgrade during
the summer. Current work includes developing the Survey Research
System, a general system that allows easy development and deployment
of QDS-type AVT-CASI surveys on any subject.