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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 Transfusion, December 2001. (See also Dr. Zuck's presentation (with audio) to the American Association of Blood Banks in late 1999)

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 [1] developed  an architectural design for an integrated system that included vital signs and phlebotomy, wide area networks, bar coding and archiving; [2] prototyped and tested a vital signs module; [3] prototyped and tested electronic data transfer with other blood center systems; [4] demonstrated feasibility of developing decision aids to support staff decision-making; [5] 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 guidance.

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 networks.

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.

 

 
 

 

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Document last updated 9 January 2009