From: Rivermyst [rivrmyst@muscanet.com]
Sent: Friday, May 24, 2002 3:48 AM
To: fdadockets@oc.fda.gov
Subject: Comments on "Streamlining the Donor Interview Process", Docket #02D-0080

To Whom It May Concern:

These comments are in response to your request for comments on Draft "Guidance for Industry:  Streamlining the Donor Interview Process:  Recommendations for Self-Administered Questionnaires", Docket #02D-0080.  These comments reflect the opinions of the medical and management staff in the DeGowin Blood Center at University of Iowa Hospitals & Clinics.  Some of the comments are minor points, but hopefully they will serve as suggestions to improve the document overall.

Under "Recommendations for Manual Procedures"
  a.. Does use of the word "should" throughout this section indicate that the step is mandated or is recommended to be performed as described? 
  b.. Item #4 indicates that new donors should not be allowed to self-administer the donor questionnaire.  Does this mean that with a new donor all questions should be asked orally or can some variation to this occur, such as the interviewer reads the question but the donor marks his/her answer on the questionnaire? 
  c.. Item #5 suggests that a facility have a method to ensure the donor understands the questions.  Can this be accomplished by asking the donor if he/she has any questions?  Can this accomplished by reviewing several of the questions with the donor, looking for understanding and comprehension of the question? 
  d.. Item #9 explains that when the questionnaire contains new or modified questions, questions must be read orally to all donors OR a detailed description of changes provided.  For what period of time should this occur - the first time donation after the new-revised question was added?  Or would this need to occur for a specified period of time?
Thank you for the opportunity to comment on this proposed document.  We hope these remarks will be helpful to you as you develop the final rule.

Sincerely,

Deborah Greene
Manager - Quality, Accreditation and Compliance
DeGowin Blood Center
University of Iowa Hospitals and Clinics
Iowa City, IA.
deborah-greene@uiowa.edu