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Talisman Limited develops medical self-interviewing systems that improve quality and timeliness of patient information. The company focuses on blood banking, having evolved its Quality Donor SystemTM (QDS) via more than 2,500,000 completed donor interviews (as of 12/2009) from eight organizations into a scientifically proven tool that reduces errors, increases donor and staff satisfaction and saves staff time. QDS is marketed and supported by Talisman Limited's sister company, Talisman Medical Systems (Talmed).

Our Mission
To design, develop and implement automated medical interviewing and closely related systems in order to provide better information for improvement in the quality of medical decisions and patient treatment.

History
Talisman Limited was founded in 1982 by Paul D. Cumming, Ph.D. Dr. Cumming is President of the company and serves as Principal Investigator on the Small Business Innovation Research grants awarded the company by the National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). The original purpose of the company was to provide corporate means for completing a NHLBI sponsored study of the Impact of Adenine on Blood Banking at the time when Dr. Cumming was changing employment from Science Applications International Corporation to the American National Red Cross (ANRC). When Dr. Cumming left the ANRC in 1989, he transformed Talisman Ltd. into a systems consulting firm engaged in support work related to litigation, regulatory compliance, blood donor history screening, transmissible disease testing, statistical consulting and database integration.

In the early 1990's, at the suggestion of Ronald Franzmeier of the Milwaukee blood center, Dr. Cumming started designing an automated blood and plasma donor screening system for the purpose of improving the quality of donor interviewing. The development of Talisman systems in this area evolved gradually, since implementations were delayed by the FDA Center for Biologics Evaluation & Research's (CBER) 1993 classification of blood software as a medical device.

In December 1997 Talisman secured FDA agreement that Talisman's blood donor screening technology was not subject to medical device regulations. At this point Talisman applied for and received a Small Business Innovation Research (SBIR) Phase I grant from NHLBI which was followed by a Phase II grant in 2000. (For more detail on results of these research studies see Grants & Research and Reference.) As part of the SBIR Phase II studies, in April 2000 Talisman entered into agreements with the  Mississippi Valley Regional Blood Center / Louis M. Katz, MD (Davenport, IA) and the Center for Management Systems, Inc. / Edward L. Wallace, PhD (Naples. FL) to develop, install and research a standardized version of QDS using Web browser technology. The resultant system, QDS Version 18, was deployed at MVRBC in Spring 2001. QDS V18 used the American Association of Blood Banks (AABB) Uniform Donor History Questionnaire (UDHQ) as updated to meet year 2002 CBER CJD/vCJD requirements. Initial performance data on the Mississippi Valley installation was presented at the AABB meetings in October 2001 and have been presented elsewhere as detailed at Reference.

In 2003, 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) premarket clearance in order for blood centers to use interstate wide area networks.

During 2004, Talisman developed an application for a 510(k) clearance for QDS 2004, which clearance was granted by CBER/FDA in October 2004. LifeShare Blood Centers (Shreveport, LA) and Dartmouth-Hitchcock Medical Center (Lebanon, NH) began implementation of QDS in 2004. QDS was updated to include the new Uniform Donor History Questionnaire developed by AABB and approved by CBER.

In 2006, Talisman developed the Talisman Phlebotomy System (TPS) and submitted a 510(k) application to CBER. The 510(k) clearance for TPS was granted May 2006. Also in 2006, Virginia Blood Services (Richmond, VA) contracted with Talisman. Their implementation of QDS was completed in November 2007.

During 2007, two more blood customers began using QDS. Rock River Valley Blood Center (Rockford, IL) and Exempla Healthcare (Denver, CO). Exempla was the second hospital-based blood collection service to use Talisman software.

Talisman initiated the idea of allowing donors to complete the health history interview remotely over the Internet and presented it to FDA in 2003. At that time, FDA was unreceptive to an Internet interview. After ongoing dialog Talisman resubmitted an application for 510(k) clearance for an Internet interview. QDS Release 2.1, which includes the Internet interview, was cleared by FDA in July 2007.

 

 
 

 

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Talisman Limited 501 Church Street NE, Suite 305 Vienna, Virginia 22180

Document last updated 12 February 2010