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Computer Assisted Self Interview (CASI) Donor Questionnaires. Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009. Outline. CASI Software Applications Overview Web-based systems Non-web-based systems SOP content Submissions: Information to include

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Computer assisted self interview casi donor questionnaires l.jpg

Computer Assisted Self Interview (CASI) Donor Questionnaires

Michael Gorman, BA, MT(ASCP)SBB

Consumer Safety Officer, CBER, OBRR, DBA

September 15, 2009


Outline l.jpg
Outline

  • CASI Software Applications Overview

    • Web-based systems

    • Non-web-based systems

  • SOP content

  • Submissions: Information to include

  • Submissions: Documents to include

  • Submissions: Print Screens

  • Submissions: Reporting categories

  • References


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CASI Software Applications Overview

  • Donors review questions via a computer and respond electronically

    • Medical/health history questions

    • High-risk behavior questions

  • Non-web-based Applications:

  • Accessed on-site (fixed locations & mobiles)

  • Web-based Applications:

  • Remote donor access via the Internet


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SOP Content: Web-based & Non-web-based CASI

  • Steps describing the self-administered questionnaire process including use of the software program [21 CFR 606.100(b)]

  • Donor must complete questionnaire on the day of donation [21 CFR 640.3]

    • Web-based: How to determine if questionnaire was completed on day of donation

    • Web-based: What actions to take if donor appears the day after


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SOP Content: Web-based & Non-web-based CASI(cont.)

  • Non-web-based: Describe how donor privacy is assured at fixed locations and mobile sites, when applicable [21 CFR 606.40(a)(1)]

  • Web-based: Describe steps for determining if questionnaire was completed in a private setting [21 CFR 606.40(a)(1)]


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SOP Content:Web-based & Non-web-based CASI (cont.)

Additionally we recommend you include:

  • How donor comprehension of questions is assessed and documented

  • Alternate procedures if computer system is unavailable

  • Alternative methods for donor screening

    • Donor does not wish to use CASI

    • Donor unable to use CASI


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SOP Content:Web-based & Non-web-based CASI (cont.)

  • Additionally we recommend you include (cont.):

  • Availability of staff to respond to a user’s questions

  • How changes to donor responses or interviewer’s comments are documented

  • How questionnaire revisions are managed

    • Revisions should be made obvious to donors in some manner for at least one year


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Additional SOP Content: Web-based CASI

  • How donor identity is confirmed upon arrival at center [21 CFR 640.3]

  • How donor responses are documented when donor is at the center (electronic or hard copy) [21 CFR 606.160]



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Submission: Information to Include

  • Software manufacturer’s name

  • Software name

  • Software version or release number

  • Software capabilities and functions

  • 510(k) number

  • Who can modify the software


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Submission: Information to Include (cont.)

  • Usage on mobile operations, if applicable

  • CASI wireless connectivity on mobile operations, if applicable

    • Is wireless functionality 510(k) cleared?

  • Software interfaces with other regulated devices such as BECS, if applicable

  • List of fixed locations with addresses where software will be used/installed


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Submission: Information to Include (cont.)

  • Does system interface with other locations where program is installed or is it stand-alone (independent)

  • Who can modify the donor health history questionnaire (DHQ)

  • Are medical history and/or AIDS high risk questions computer administered


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Submission: Information to Include (cont.)

  • Are donor suitability decisions made by the software and/or center personnel


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Submission: Additional Information Typically Requested

  • Who is authorized to access the system and enter or change data

    • Example: changing software applied donor suitability decisions, if applicable

  • How system access is managed

    • Authorization and deauthorization


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Submission: Documents to Include

  • SOPs

  • Donor instructions for completing the questionnaire

  • Copy of DHQ

  • Validation protocol

    • Pre-defined written plan that was used for on-site validation prior to implementation

    • Do not include actual validation data

  • Print screens


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Submission: Documents to Include Print Screens

All print screens

  • New non-web-based CASI

  • New DHQ used with CASI not previously:

    • Approved by FDA, or

    • Accepted by FDA in a guidance document

  • New web-based CASI: non-web-based CASI not previously approved


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Submission: Documents to Include Print Screens (cont.)

Only print screens for web-based CASI

  • New web-based CASI: non-web-based CASI previously approved


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Submission Reporting Categories

  • CBE-30 – Web-based CASI if already approved for non-web-based CASI

  • CBE-30 – CASI or web-based CASI – firm’s DHQ previously approved by FDA

  • CBE-30 – CASI or web-based CASI- DHQ has been accepted by FDA in a guidance document

  • PAS – CASI or web-based CASI - new DHQnot previously approved or accepted by FDA


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References

  • 21 CFR 601.12

  • Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (7/3/2003)

  • Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components  (10/27/2006) 


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References (cont.)

  • Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (8/07/2001)

  • Guidance Link: FDA website A to Z Subject Index - G Page; Click Guidance Documents – Biologics: http://www.fda.gov/SiteIndex/ucm148505.htm


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