IDM Accent Header
A quarterly newsletter published by Information Data Management
Volume 1 Issue 1 Winter 2005

In This Issue

IDM Welcomes Five New Customers for Prelude

Benefits of the Self-Administered Donor Interview

Is Your Centers Donor Data Safe? Data Encryption

FDA Accepts Digitized Signatures

2005 IDM User Conference

IDM Surround User Advisory Committee Meeting - February 2006

News You Can Use


 
Prelude

IDM welcomes Blood Systems, Inc., Dayton Community Blood Center, The Blood Connection, Inc., Lifeshare, Inc., and Blood Center of the Ozarks as new customers of Prelude. Customers share their comments about their selection.

“Of the systems we reviewed, Prelude met our requirements and was already submitted to the FDA for 510K clearance. The combination of these two items will allow us to start using the system sooner than others evaluated,” said Dennis Harpool, Vice President Procedures Development and Training of Blood Systems, Inc.

“Our center wanted a product that would be fully integrated with our current donor system,” said Don Thomson, Chief Operating Officer of Blood Center of the Ozarks. “IDM has provided our center with great customer service over the years.”

“We believe IDM is a company that is forward thinking, looking at the future of what centers and donors need,” said Jodi Minneman, Chief Operating Officer of Community Blood Center, Dayton, Ohio. “We saw this as a first step to IDM’s new suite of products and a way for us to be positioned as a blood center of the future.”

 “Prelude will truly revolutionize our collection process,” said Brian Madden, Vice President of Operations of The Blood Connection.  “Our staff could not say enough about the level of professionalism and customer service delivered by this company.”

IDM looks forward to its new partnerships and believes they will pave the way for using cutting- edge technology to positively impact the donor room registration process.

 

Press release...


Welcome to IDM Accent, a new quarterly newsletter aimed at sharing pertinent blood banking industry information, as well as updating IDM customers on current events and products.

This first edition of IDM Accent looks at how computerized self-administered donor interviews can improve the donation process, and how donor identity information and other data on PCs can be protected from theft or misuse through the use of data encryption. In this edition we also look back at our annual users conference, held in September, welcome new customers of our Prelude system, and more.

  • Benefits of the Self-Administered Donor Interview
  • Prelude Interview

    Donor satisfaction, improved accuracy, and a more efficient and cost effective record-management system are just a few of the reasons driving blood centers around the world to consider purchasing computerized self-administered donor interview systems.

    Jodi Minneman, Chief Operating Officer of Community Blood Center, Dayton, Ohio, said about the benefits of a computerized self-administered donor interview, “It creates a more pleasant experience for our donors and gives them more privacy in answering questions.” She added, “It streamlines the process and allows us to become more efficient, because we are not having to spend time interviewing the donor.”

    A computerized self-administered donor interview system uses visual and audio prompts on a workstation to ask the donor a series of health history questions.  The donor responds to the questions by entering the answers via the keyboard or touch screen capabilities.  The system records the answers and attaches the information to the donor identity record.

    As it relates to donor satisfaction, a self-administered process provides the donor privacy to respond at a personalized pace, increasing the chances that the donor will return to donate again.  “It puts the donor in charge of their own interview process.  We believe the process will reduce waiting time and ultimately result in a more satisfying donation experience,” said Dennis Harpool, Vice President Procedures and Training of Blood Systems Inc.

    Also, using a computerized questionnaire easily allows the questionnaire to be presented in multiple languages, assisting centers to reach out to non-English speaking donor populations.

    From an accuracy standpoint, the computerized self-administered donor interview eliminates the chance for transcription errors as well as omissions of essential data. There is no transcribing of information from a document into the donor management system. The donors’ answers are reviewed online and stored with their records.

    “Many studies have been conducted supporting the finding that a computerized method is able to reduce psychological barriers linked to the collection of sensitive health-related information, thereby increasing its reliability,” according to an abstract published by Simoes AM, Bastos FI, at the National Library of Medicine.  One of those studies, conducted at the Canadian Red Cross Society (CRCS), found that a self-administered computerized questionnaire may increase reporting of high-risk activities by blood donors.  To read more about the CRCS study visit BioMed Central.

    Lastly, a significant productivity improvement can be made in the amount of time that is spent in record management and retention.  Imagine a paperless process that eliminates the need to review, collate, copy and archive the donor health history form.  “Anytime you can reduce paper it is a plus,” said Harpool.

    The benefits of a computerized self-administered questionnaire are clear and that is why more and more blood centers are choosing to automate this process.  IDM has responded to this trend by including a fully automated, comprehensive, self-administered donor history questionnaire in Prelude, IDM’s donor room management system.

    The FDA has also responded to this interest and has established a guideline for self-administered questionnaires titled “Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires.” If your center is considering implementing a computerized questionnaire, the guidelines as it pertains to Computer-Assisted Interactive Procedures can be found at www.fda.gov.donorsaq.htm.

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  • Is Your Centers Donor Data Safe? Data Encryption
  • The need for data encryption has grown significantly during the past two years as state and federal privacy laws take effect and enterprises take stronger measures to protect their data following database intrusions across the globe.

    Many blood centers are downloading donor information onto portable PCs to execute some sort of donor lookup and/or registration at a donation site. Is the data on these PCs safe?

    There have been cases where the actual portable PC containing critical donor identity data was either stolen or lost, according to a FBI May 2005 report, titled "U.S. Blood Banks: Targets for Identity Theft".  One way to protect sensitive donor information in this type of situation is to use data encryption.

    How does encryption work?  In this particular scenario, the entire disk of a portable PC containing donor data is encrypted.  Access to decrypt the data is strictly password protected.  Therefore, the extraction of donor identity information from a lost or stolen PC is prohibited.  

    IDM researched third party encryption tools and selected SafeGuard Easy by Utimaco to incorporate into Prelude, a recently released product designed for donor registration.   SafeGuard Easy was selected because of its effectiveness, ease of use, and performance.   

    SafeGuard Easy is seamless to the end user by managing the entire encryption process without user intervention.  SafeGuard Easy supports the sophisticated and efficient encryption algorithms: AES(256 and 128 bit), IDEA(128) and others. 

    Advanced Encryption Standard, AES was adapted by the National Institute of Standards and Technology (NIST) in November 2001.  AES has a fixed block size of 128 bits and a key size of 128, 192, or 256 bits.  The greater the bit size specified, the more difficult it is to break the encryption algorithm and therefore the more secure your data is. 

    Data security is a concern at the forefront of many blood centers and data encryption is yet another valuable tool to utilize to ensure the safety of donor data.

    To read more about data encryption technology visit www.utimaco.us\encryption\aes.html.

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  • FDA Accepts Digitized Signatures
  • signature pad

    The U.S. Food and Drug Administration has notified IDM that digitized signatures can be accepted as part of a paperless donation record system as long as the system meets guidelines set forth by the Code of Federal Regulations, 21CFR Part 11, relating to handwritten signatures and electronic records.

    Most people encounter digitized signatures when they use their credit cards in major stores and sign their name or legal mark to an electronic pad instead of a piece of paper. This signature is considered an electronic record of a signature and must be linked to the customer’s respective electronic records. These records must reside on a closed system to ensure the signatures cannot be copied or tampered with.

    Utilizing digitized signatures allows a center to have a paperless donation record system.  “A paperless system reduces omission errors, and gains efficiencies as it relates to paper storage and record retention and retrieval,” said Dennis Harpool, Vice President Procedures Development and Training of Blood Systems Inc. 

    IDM has incorporated a digitized signature system into Prelude, its recently released donor room management system, for use on blood donation records.

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  • 2005 IDM User Conference
  • Chicago Skyline

    Representatives of more than 25 blood organizations worldwide converged on Chicago in September for IDM’s 11th annual Users Conference.

    Users of IDM’s Surround laboratory system and Select Series donor/product management systems had the opportunity to gain a better understand of IDM’s philosophies and product direction, and to learn how they can maximize the benefits of IDM’s products and services.

    A feature of the conference that many users found refreshing was the open discussion for customers to communicate their concerns and requests and for IDM to respond to them.

    IDM updates
    Many topics were presented and discussed including; IDM’s Disaster Plan, Development Process and Customer Support Call data.  The attendees got a better understanding and appreciation of the experience and expertise required to deliver and support a FDA regulated software product for the Blood Banking industry. 


    Lab System Updates
    An update of the current laboratory system, Surround, was given.  IDM has released two new revisions of Surround this year with many requested changes including the interface to Immucor’s Galileo, automated shipping and tracking of sample tubes to the test site, and capabilities to streamline CMV and first time ABO/Rh testing.    IDM also announced its plans to release an exciting new revision of Surround in 2006, highlights to include the elimination of the
    SCO server, transferring only new test results to the host system, allowing data archiving of batch and sample results to a separate database partition, and an upgrade to the Oracle Database revision. 

     

    Donor System Updates
    The Select Series Users Conference included a presentation of IDM’s new innovative suite of products, called IDM Symphony.  A complete description of IDM Symphony can be found at www.idm.com.  Further discussions included regulatory affairs and customer services.  Open discussion was also conducted to gather information for future revisions of IDM products.  Once again, the customers provided valuable information as well as an opportunity for IDM to address their needs.

     

    Networking and Socialization
    The conference wasn’t all business. IDM hosted a night out on a cruise ship on Lake Michigan.  A good time was had by all while enjoying the Chicago skyline. “The night out was absolutely wonderful and the view was breathtaking.  Everybody had a great time and it was a good opportunity to meet other users of Surround and the IDM staff,” said Irma Villarreal, Technical Services Administrator of South Texas Blood and Tissue Center.

     

    Future Users Conferences
    The Users Conference is an annual IDM event, held every year in IDM’s hometown of Rosemont, Ill., conveniently located next to Chicago’s O’Hare International Airport. Look for information on IDM’s next conference in the Spring edition of the newsletter.

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  • IDM Surround User Advisory Committee Meeting - February 2006
  • In an effort to be proactive addressing user needs and industry trends IDM moderates a quarterly conference call with current Surround users.

    Topics are gathered through customer requests and approved by the Surround User Chairperson, Sharon Gordon, Executive Director Testing Laboratories of LifeSource Blood Services. Recent topics that have been discussed were instrument interfaces including the Ortho Tango and Bac-T Alert, update on the Abbott Prism, eliminating the SCO server and more. 

    The attendees of the meetings are Sharon Gordon; Steve Slaw, IDM Account Manager; Kyle Kruska, Surround Development Manager; and 12 users of IDM Surround.  IDM invites any interested user to join the committee.  If you would like to join, please contact Steve Slaw at sas@idm.com.

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  • News You Can Use
  • ISBT 128 Implementation - Here are some helpful links to stay up to date:

    On the Road to ISBT 128 - AABB Annual Meeting aabb.org

    What's New with ISBT 128? iccbba.com

    AABB ISBT Code 128 Implementation PlanStock# 043005, Cost $20.00 aabb.org

    Recent FDA Guidelines

    Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods - 9/30/2005

    Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV- 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry - 7/19/2005

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