- Recommendations for All Self-Administered Procedures
- You must describe the self-administered procedures in your written standard operating procedures (SOPs) (§ 606.100(b)). You must adequately train your personnel in these procedures (§ 600.10(b) and 606.20(b)).
- The donor must complete the self-administered questionnaire on the day of donation (§§ 640.3(a) and 640.63(a)) before blood collection at the donation site.
- You must provide an appropriate environment for individuals to complete their donor questionnaire in a private setting (§ 606.40(a)(1)). You should ensure that the donor is answering the questions in a confidential setting.
- You should have a method at each donation to ensure that the donor understands the questions (e.g., additional verbal or written questions). This should include an evaluation of the donor's ability to read and understand the language of the self-administered questionnaire, regardless of its medium (written, audio, or visual). Published studies have shown that individuals with low medical literacy may not reliably complete self-administered questionnaires (Ref. 5). You must defer donors who do not appear to be providing reliable answers to the questions (§ 640.63(d)).
- You should provide options for donors who prefer direct oral questioning or who would like or need assistance in completing the questionnaire.
- You should provide the donor with written or verbal instructions on how to properly complete the questionnaire, including how to request assistance, if needed. The instructions and questionnaire should be in a language that the donor readily understands. You should instruct the donor to read and/or listen to the full question before answering and leave the answer blank if he or she does not understand a question. Your personnel should be available to answer questions.
- The donor should answer all applicable questions on the questionnaire, as defined by your SOP. The donor does not need to complete the questionnaire if he or she is deferred early in the questioning process.
- You should have a method to review the questionnaire for completeness and accuracy before allowing the donor to donate and to question the donor further, when necessary to determine the donor's suitability. If you modify answers or document the donor's answer to blank questions after clarification from the donor, you should annotate the entries (e.g., reviewer's initials, further explanation of comments). If there are multiple reasons to defer the donor, you must document all reasons for deferral on the donor record (§ 606.160(b)(1)(ii)).
- If you revise your questionnaire to include new or modified questions, you should highlight, or otherwise draw attention to, the new or modified questions for one year so that all donors (new donors and donors who have previously donated at your facility) will be aware of the change. You should have a method to ensure consistent implementation of revised questionnaires.
- You should monitor the effectiveness of the self-administered questionnaire in identifying unsuitable donors (e.g., by evaluating post-donation information reports, infectious disease marker rates, specific deferral trends, biological product deviation reports, post-transfusion infectious disease reports).
- Additional Recommendations for the Use of Audio/Visual Tools
Current audio/visual (AV) technology may encompass electronic media such as audiocassette tapes and compact discs, videotape (e.g., VHS), digital videodisks, and digitized recordings played on a computer. You may use these media to present the medical/health history and/or high-risk behavior questions as well as AIDS/HIV educational materials to the donors. The donors may play these recordings and document their answers to the questions.
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In addition to the recommendations in section III.A, you should consider the following item when implementing the self-administered questionnaire using audio and visual media:
- Before implementation and periodically thereafter, you should verify and document that the audio portion is understandable, in accordance with a written SOP. You should have a written SOP for administering the questionnaire when the audio/visual tools are not available.
- The content of the audio recording should match the information displayed in the video. When you revise your written materials or questionnaire, you should also change the video and audio recording to match the written materials. If you provide the donor with written AIDS/HIV educational materials, they should correlate with the video and/or audio recording.
- If more than one donor will be listening to the audio and/or watching the audio/visual display at one time, your SOP should include provisions regarding the appropriate number of donors for joint listening or viewing to ensure privacy when answering the questions.
- Additional Recommendations for Computer-Assisted Interactive Procedures
In the self-administered computer-assisted interactive interview procedure, the donor reviews the questions on a computer screen and enters the answers electronically into the software program managing the interview process. The computer software may or may not make decisions on the suitability of the donors depending on the responses to the questions. Under Section 510 of the Federal Food, Drug, and Cosmetic Act, your computer system's functionality may require 510(k) clearance
(Ref. 6).
The computer system used in the computer-assisted interactive interview procedure includes any hardware and software needed to perform the process. It may be a stand-alone system, used solely to conduct the donor interview, or it may interface with other computer systems at the same or other locations. It may be a desktop or laptop computer or a handheld device. The software may have data storage capabilities or may send data to a printer for hardcopy printout. In addition, the computer system may be accessible from a remote location. The user interface may present both video and audio data to the user via monitors, headphones, etc. Donors and collection personnel may input data or responses via keyboard, microphone, or a pointing device such as a mouse, touch screen, or stylus. The system may use pictures or drawings to illustrate the topic of the displayed questions.
In addition to the recommendations in sections III.A and III.B, you should consider the following items when implementing the self-administered computer-assisted interactive questionnaire:
- You should validate all aspects of your computer system for its intended use. You should perform this validation consistent with the provisions contained in FDA guidance documents (Refs. 7-8) and in § 820.100.
- The computer system record keeping functions, including electronic signatures and records, must comply with the requirements in Part 11 (Refs. 9-10).
- You should have a written SOP for administering the questionnaire when your computer system is not available.