2006 Tibbetts Award Winner

Talisman Limited received the 2006 Tibbetts Award in September 2006. Named for Roland Tibbetts — the person acknowledged as the father of the Small Business Innovation Research (SBIR) program — these prestigious, national awards are made periodically to those small firms, projects, organizations and individuals judged to exemplify the very best in SBIR achievement by the Small Business Technology Council.

Talisman Limited is one of 55 companies in the U.S. to receive the Tibbetts Award from among an estimated 4000 to 5000 projects. The complete list of winners can be found at www.tibbettsawards.org .

Talisman Limited was founded in 1982 by Paul D. Cumming, PhD. Early work in automated medical interview software began in 1993. The company received its first SBIR Phase I grant from National Heart Lung and Blood Institute in 1998 to prototype a system for automated blood donor interviewing. Phase II of that grant led to field testing of the system in 1999 in a blood community blood center, with positive results. The system was further developed using web technology. QDS went operational in a blood center in the spring of 2001. The company applied for and received a fast-track grant in 2003 to develop the self-interviewing technology further and to deploy it in multiple blood centers. In 2005, Talisman was awarded a 3-year competing continuation grant for FDA-regulated SBIR projects, entitled “Paperless Quality Donor System with Decision Making”, to carry on its development and commercialization of its systems. All of the SBIR grants support the company’s mission to improve the safety and availability of the US blood supply using information technology (IT).

The Talisman Quality Donor System™ (QDS) is an audiovisual touch-screen computer-assisted self-interview system (AVT-CASI) used for the health history interview to qualify blood donors. The system also collects vital signs information from the physical exam. An additional new system collects data from the phlebotomy of blood donors. QDS has been installed at 5 blood centers ranging from a university hospital to a large independent community blood center. Over 800,000 donor interviews have been performed successfully using QDS, in settings ranging from fixed sites to all types of bloodmobiles.

Talisman’s leadership work has been recognized in peer reviewed scientific publications in 2001 and 2005 and another article is near publication. This latest article rather clearly demonstrates that Talisman is alone in researching, implementing and publishing performance measures on this scientifically superior technology.

Because of its application to blood, Talisman’s software is considered to be a medical device by the US Food and Drug Administration (FDA). Consequently the company had to apply for and obtain FDA 510(k) clearance to market its product legally. Today the Talisman QDS is cleared by FDA to be marketed in the United States. The requirement to satisfy regulatory mandates, while onerous for a small business, has also helped to create a competitive barrier to entry that has longer term business value.

Talisman Limited has grown from a home business to an independent company employing 6 highly skilled professionals as well as contractors. Its location in Vienna, VA near Washington, DC has facilitated relationships with FDA and National Institutes of Health. Through its scientific publications and participation in professional meetings, the company has become recognized as an authority in the field of automated interviewing using AVT-CASI technology.

Unlike other health care areas, blood services have a standardized mandatory error reporting system regulated by the FDA known as Biological Product Deviation Reports (BPDRs). This system shows that 75% of all avoidable blood center errors occur during the donor history interview. QDS, once fully developed and implemented, will help blood centers avoid over 90% of these errors, with the current release (R2.03) expected to achieve much of this improvement.

QDS has had a profound impact on the blood centers which have installed it. These centers have reduced FDA-reportable errors by over 60% compared to experience prior to QDS. This translates into lower QA costs and into significantly less blood recalled and discarded. The system has been installed by minimally IT trained typical blood center staff and functioned perfectly. No donor training is required and only 2 to 3 staff hours are needed. No donor refusal to use QDS has been reported. No software bugs have been reported for years. QDS has been shown to reduce staff time required to complete donor interviews, allowing staff to provide additional services to their volunteer donors. Our studies demonstrate dramatically higher donor and staff satisfaction with QDS compared to previous methods, leading potentially to greater rates of repeat donations. Finally, QDS interviewees admit to risky behavior at a rate of 2 to 9 times more than with face-to-face interviewing with a concomitant improvement in blood safety.

Thanks to its SBIR grants, Talisman has been able to refine the QDS system as well as develop complementary products. A unique aspect of the company’s approach is to conduct scientifically valid studies of its products, a novel approach for health-related software. Products being developed under the grants include the Talisman Phlebotomy System™, currently being 510(k) reviewed by FDA, an Internet version of QDS that allows donors to complete the interview at home before going to a blood drive, and the Survey Research System, which is generalized multimedia software for constructing and administering questionnaires using AVT-CASI.

The company has recently begun concerted efforts toward broader commercialization with the hiring of a full-time person dedicated to these efforts. The company now actively participates in regional and national professional meetings and has begun an advertising and promotion program with the goal of tripling the number of annual interviews to 1,000,000. Talisman continues to support its existing users, including the ability to respond to FDA-mandated changes in less than 1 week. Finally, we are exploring other applications and markets for computer self-interviews using our unique AVT-CASI technology, including health history taking in medical practices, informed consent administration and use in emergency rooms.

Talisman believes this project exemplifies the type of action recommended by the Institute of Medicine (IOM) to the Department of Health and Human Services (HHS) in its reports of 2000, To Err Is Human, Building a Safer Health System and 2004, Patient Safety: Achieving a New Standard of Care. These are the reports that led to Presidential Executive Order 13335, April 2004 directing the Secretary of HHS to "provide leadership for the development and nationwide implementation of an interoperable health information technology (IT) infrastructure to improve the quality and efficiency of health care." It is with this conviction in mind, as well as the spirit of the SBIR program, that Talisman has brought to the blood collection market a commercial product that serves its needs. And as the title of its SBIR grant implies -- Paperless Quality Donor System with Decision Making – future developments will make the QDS even more useful. Moreover, Talisman’s QDS ultimately serves the larger community by assisting to keep the nation’s blood supply safe thus helping to ensure any prospective blood product recipient the safest possible product. Slight variations of QDS also have substantial potential for applications to other areas of health care with benefits similar to blood such as error reduction. What is more common to health care and more error prone than a patient interview?

Document last updated 12 December 2006