From: LindaB@psbc.org Sent: Friday, June 21, 2002 1:09 PM To: fdadockets@oc.fda.gov Subject: Docket [02D-0080] Comments June 21, 2002 Puget Sound Blood Center and Program 921 Terry Avenue Seattle, WA 98104 FDA Dockets Management Branch Via E-Mail: http://www.fda.gov/dockets/ecomments Re: [Docket No. 02D-0080] Comments on draft FDA Guidance: "Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires" To Whom It May Concern: The Puget Sound Blood Center applauds the FDA's forthright acknowledgement that the donor interview process should be streamlined. This is particularly true in light of additional questions introduced to protect against emerging infections. We are pleased that the FDA has formally modified its position that the HIV/behavioral risk questions require direct questioning. We understand from the content of the draft guidance that the FDA 1) perceives certain practices to be more appropriate and effective than others, 2) considers that the donor screening performed in accordance with the guidance will result in increased efficiencies, and 3) believes this guidance to be helpful and constructive in affording blood establishments opportunities to realize these efficiencies. Yet, as a blood establishment with over 50 years' experience screening donors of nearly every category, we are concerned that the FDA has not fully considered the consequences that the draft guidance would impose if adopted as written. We are also troubled by the apparent presumption that existing practices are essentially flawed. One cannot read the draft guidance without surmising that blood establishments must be unaware or ignorant of appropriate measures to obtain health histories using available media; thus, the necessity of promulgating such a far-reaching and particular opinion. We have substantial reservations about the overall effect of the draft guidance. Rather than achieve the advertised claim of streamlining, it is our view that the draft guidance instead greatly complicates and prolongs the screening process (particularly for the vast majority of blood centers without computer-assisted systems), hobbles attempts to introduce efficiencies appropriate to the particular establishment and donor clientele, re-engineers systems that have functioned as effectively and efficiently as possible for decades, and advocates definitively, from singular references, approaches that even objective experts in the Blood Products Advisory Committee have been reticent to promote or have not been given the opportunity to weigh. The Blood Products Advisory Committee has received and deliberated numerous presentations regarding donor suitability determination, the wording of questions to be posed, and how to interview prospective donors. Additionally, the FDA has committed personnel to the multi-organizational task force committed to creating a self-administered Uniform Donor History Questionnaire. The FDA also has at its disposal years' of data regarding post-donation information and error reports revealing information about the flaws, and likewise the successes, in obtaining medical histories. None of the above are cited or recognized. Instead, this guidance obviates the above sources and promotes an inflexible donor screening approach without supporting evidence or measure. It is our request and expectation that the FDA use its expert committees, promote consensus building by partnering with industry task forces, conduct or promote pilot studies, and utilize existing national data to generate recommendations that could be used to enhance any establishment's screening technique. Rather than narrowly defining a method with increased layers of requirements depending on the media used, the FDA is situated to advise establishments on what they have found effective based on studies appropriate to blood donors, to cite objective data and evidence and to access industry experiences and expert opinions. Licensed establishments have for years submitted their questionnaires to the FDA for approval, provided their screening procedures for review, solicited advice from the Agency, and requested that FDA staff participate in joint committees. In turn, the agency has approved myriad donor records utilizing varied interview techniques and strategies. To now invalidate these approvals warrants some form of justification or rationale beyond what was represented in the guidance. It is also for this reason that FDA should work actively with industry to allow for flexibility in the application of different techniques while establishing appropriate controls. We also encourage the FDA to realize that there must be a balance between what is perfect and what is practical. There are many good ideas, some of which are expressed in the draft guidance. However, not all good ideas are practical. Blood centers may screen hundreds of donors a day in a variety of environments. There may be two hundred donors at a high school drive in a gym. Even a donor screening technique that has been shown to be marginally superior will not be appropriate under these circumstances if it is also complicated and/or excessively time consuming. Marginal improvements also may not be appropriate if excessive resources are required for implementation. Specific comments on the draft guidance: Issue: Intent of the guidance is ambiguous: Statement: "...this guidance document describes how you may change your current pre-donation donor screening interview procedure to a self-administered format in your blood establishment." Problem: Most establishments already use a self-administered format and have done so for over 20 years. This is usually a hybrid where direct questioning is employed for HIV behavioral risk questions to comply with the April 23, 1992 Guidance. Is it intended for establishments using self-administered questionnaires to "invalidate" the existing approach and prepare a BLA Supplement? Resolution: Establish the intent of the guidance. Establishments already using a self-administered format that has been cleared by the FDA should not be required to resubmit. Therefore, this guidance should only apply to establishments modifying their method. Issue: Streamlining is not achieved. Statement: "Blood establishments are concerned that the current donor questionnaire process is burdensome for the following reasons: a) the donor questionnaire is complicated; b) the donor interview process makes increasing demands upon limited resources at the blood collection facilities (e.g., time and personnel); and c) many donors are concerned about answering personal questions in front of a stranger." Problem: The draft guidance fails to effectively ameliorate any of these stated concerns. Instead, the guidance greatly complicates the screening process by requiring different interactions for different sets of donors. To keep track of which donor has seen which version of a particular screening question will be next to impossible in the absence of computerized screening. It also greatly increases the demands on the resources of the collection facilities. Activities such as direct questioning for all questions for new or lapsed donors, targeted direct questioning for donors who have not yet seen the latest version of some questions, and monitoring the attentiveness of donors will all require larger staffs and more complicated procedures. Finally, the direct questioning recommended for new donors directly contradicts the concern in item c). Resolution: Promote and allow establishments to utilize process improvement techniques to effectively. Placing further restriction on an already burdensome process does not address the problem. The freedom that this draft Guidance did introduce was the allowance to self-administer the high-risk questions, but only in certain very restricted circumstances. Issue: The requirement for an audio component for an automated donor interview. Statement: "Studies have shown that visual-based systems accompanied by an audio component provide the most accurate collection of sensitive data." Problem: According to the draft guidance, new donors are allowed to self-administer the donor questionnaire only if a computer-assisted procedure with an audio component is employed. The justification for this restriction is that "Studies have shown that visual-based systems accompanied by an audio component provide the most accurate collection of sensitive data. These conclusions cannot be drawn from the reference cited (Turner et al; Science 1998; 280:867). In this study, although the computer-assisted procedure employed happened to include an audio component, there was no attempt to compare the technique to a system without an audio component. The authors made no claim that the audio component was essential. Also, the circumstances of the study and the postulated reasons for the superiority of the computer-assisted approach make it highly unlikely that the results are applicable to blood donor screening. The study purported to be an anonymous survey where the ability to link the respondent's answer to the respondent might be threatening. The authors postulated that the subjects might have been more confident that the computer-assisted method better protected their identity. This circumstance does not apply to blood donation where, no matter what the form of the questionnaire, the donor knows that his answers will be linked to his identity. Second, the authors suggest that literacy may be more of a problem with a paper self-administered test. There is no reason to suppose that the literacy levels of the typical blood donor are the same as that of the adolescent males who participated in the study. Third, it was felt that the computer-assisted procedure better allowed the subject to understand complex branching questions. No such questions should exist in the typical blood screening questionnaire. In short, to prohibit manual self-administration of the donor questionnaire by new donors cannot be justified by the results of a study that was conducted under very different circumstances and had nothing to do with blood donation. Resolution: Provide objective evidence or data that may be appropriately correlated to the blood donor interview. Once the new donor demonstrates literacy, comprehension and understanding, there should not be any requirement that whatever screening process is used is methodically altered. Issue: The requirement to assess literacy, comprehension and understanding. Statement: "You should have a method at each donation to assure the donor understands the questions" and "fully educate the new donor about their responsibilities in donating blood products and help ensure that barriers of limited literacy, attention, and comprehension do not compromise the donor qualification process" Problem: Literacy, comprehension and understanding are nearly impossible to objectively assess. As with informed consent, it is a process and not simplified to a singular test or interaction. In addition, once it is determined that a donor is literate, there seems little reason to have to reassess literacy on subsequent donation. Resolution: Recommend methods for assessing literacy, comprehension and understanding or require that establishments identify how it is that this is achieved in whatever interview process is applied. In either case, if the new donor demonstrates literacy, comprehension and understanding, there should not be any requirement that the screening process be methodically altered. Issue: The requirement to assess the donor for all facets of suitability even if deferred Statement: "The donor should answer all applicable questions on the questionnaire" Problem: This section cites 21 CFR 616.160(b)(1)(iii) erroneously. The citation should be 21 CFR 616.160(b)(1)(ii) which requires that a record of deferrals be maintained. There is no CFR requirement that a donor be fully assessed for future suitability if found to be unsuitable on the day of donation. In other words, the requirement to ask all questions is not based on the CFR citation. The purpose of donor screening is to determine the donor's suitability to donate on that particular day. As such, most blood collection facilities will not continue to question the donor once it has been determined that the donor is deferred. To do so would be a waste of time, it would unnecessarily consume additional resources, and the donor would likely interpret it as excessively intrusive and time consuming. Resolution: Require that records of deferral be maintained. It is reasonable to require that all known reasons for deferral be documented. The ideal of fully screening each deferred donor should not be required and does not result in any form of streamlining. Issue: The ideal of notifying the donor of changes Statement: "...you should administer the new or modified questions to all donors by direct oral questioning or provide all donors with a detailed description of the changes." Problem: While conceptually pleasing, the belief that a change history could be maintained for revisions between each and every donor's visit is impractical. Providing educational resources at the time of a revision is a good practice. Requiring that each donor be notified of interim changes to the record is not. Resolution: Suggest that education materials about the background of key questions or material changes but do not require that a change history be presented to the donor. Issue: Monitoring the donor throughout the interview process Statement: "You should monitor the donor's attentiveness and be ready to intervene if the donor appears confused or inattentive." Problem: Besides sounding patronizing, is there an objective method of assessing attentiveness or confusion? This is an issue of customer service not regulatory compliance. Resolution: Measures should be established to assure that the donor comprehends the questions and assures that help available. Issue: Signing the questionnaire Statement: "You should also instruct the donor not to sign the questionnaire until your personnel have reviewed it." Problem: There is no requirement to sign the questionnaire. The draft guidance already stipulates that it is not addressing issues of informed consent. It has been a common practice for a signature to acknowledge the risks of the procedure, testing to be performed and disclosure of information. A signature is a way of achieving this but not the only way. Resolution: Delete the statement. Issue: The questionnaire must be printed and signed Statement: "Personnel print the electronically captured answers and review them with the donor." Problem: This requirement is overly restrictive and actually inhibits streamlining. The future is paperless systems. There is no reason that computer-assisted interviews cannot be adequately reviewed without being printed. Signatures, if required, can be digital or electronic. Resolution: Discontinue the requirement to maintain a printed record. Issue: The draft Guidance provides disincentive to introduce measures that have been found to aid in comprehension Statement: "In addition to the recommendations described...you should consider the following items when implementing the self-administered questionnaire using audio and visual media" Problem: These materials are usually adjunct to a self-administered questionnaire where the questions are still written out in full detail. The requirements to have the materials correlate exactly to the question, monitor attentiveness, include a "pause" or "replay" option, disallowing any discussion of the questions in entirely too restrictive for an ancillary aid. Resolution: These requirements should only apply if the donor is not provided a written questionnaire or if literacy is impaired. Issue: General submission information Statement: "PAS: Computer-assisted interactive procedures where any of the following are true." Problem: It is not apparent why a PAS is required for a computer interview but a facility can introduce an entirely new computerized system in an annual report. The disparity in FDA's reasoning is not at all clear. Additionally, the terminology used in this section of the guidance is not consistent with other FDA documents on electronic records and open to substantial interpretation (e.g., "accessed from remote locations" vs. 21CFR11 which uses "open" or "closed" systems). The term "user" is confusing. Typically, this means the blood establishment. Is this intended to mean the "donor" who is actually using the interview software? Resolution: Computerized donor interviews should be subject to reporting only as stringent as is required for computerizing the entire establishment (Changes to an Approved Application, July, 2001). For clarity, FDA's specific concern should be cited or existing regulation referenced. We look forward to the FDA actively working with blood establishments to address these, and other issues, such as an abbreviated donor history questionnaire. We recommend that this guidance and assembled comments be refined through the Uniform Donor History Questionnaire Task Force or a subcommittee thereof. Additionally, the revisions to this guidance should be reviewed at a future BPAC meeting to assure a consistent philosophy is applied to future interview recommendations and to allow for expert evaluation. The objective of streamlining the donor interview is entirely too important to advance without adequate examination, dialog and the development of objective, science-based evidence. Thank you for the opportunity to comment. Sincerely, Thomas H. Price, MD Linda S. Barnes, RAC Medical Director, Vice President Director, Quality Assurance/Regulatory Affairs *** IMPORTANT NOTICE *** This e-mail message, including any attachment, has been scanned for viruses. 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