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Statement Before the Blood Products Advisory Committee

Blood Donor Written Statement of Understanding

29 April 2011

M. Allene Carr-Greer, Director, Regulatory Affairs

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

Thank you for the opportunity to provide information for your discussion of this important issue today. I will briefly summarize the current requirements of AABB Standards relating to donor information, consents and notification and bring to your attention comments previously submitted by AABB on the 2007 proposed rule on Human Blood and Blood Components for Transfusion and Further Manufacturing Use.

Section 5.2 of AABB Standards for Blood Banks and Transfusion Services (27th ed) provides the framework for educational material, consents and notification policies that must be developed and implemented by member blood establishments. These requirements parallel the elements that FDA has proposed to be contained in the written statement of understanding.

5.2.1 Donor Education
The blood bank shall have procedures to ensure that the following requirements are met for all prospective donors:

  1. Donors are given educational materials regarding infectious diseases transmitted by blood transfusion.
  2. Donors are informed of the signs and symptoms of AIDS.
  3. **Donors acknowledge that the educational materials have been read.
  4. Donors are informed of the importance of providing accurate information.
  5. Donors are informed of the importance of withdrawing themselves from the donation process if they believe that their blood is not suitable for transfusion.

5.2.2 **When parental permission is required, the collection facility shall have a process to provide information concerning the donation process to parents or the legally authorized representative of the donor.

5.2.3 **Donor Consent
The consent of all donors shall be obtained on the day of donation and before collection. Elements of the donation procedure shall be explained to the prospective donor in understandable terms. The explanation shall include information about risks of the procedure, tests performed to reduce the risks of transmission of infectious diseases to the allogeneic recipient, and requirements to report donor information, including test results, to state or local health departments. The donor shall have an opportunity to ask questions and have them answered and to give or refuse consent for donation. In the case of a minor or a legally incompetent adult, consent shall be addressed in accordance with applicable law. A prospective donor shall be informed that there are circumstances in which infectious disease tests are not performed. Confidential Unit Exclusion
If an opportunity is provided to the donor at the time of donation to indicate that blood collected should not be used for transfusion, the donor shall be informed that the blood will be subjected to testing and that there will be notification of any positive infectious disease test results. Standard applies.

5.2.4 **Donor Notification of Abnormal Findings and Test Results
The medical director shall establish the means to notify all donors (including autologous donors) of any medically significant abnormality detected during the predonation evaluation or as a result of laboratory testing or recipient follow-up. In the case of autologous donors, the referring physician shall also be notified. Appropriate education, counseling, and referral shall be offered.

**Indicates a record requirement

The 2007 proposed rule also solicited comments on how comprehensive the educational material should be and the format or style in which it is to be presented. (The AABB Donor History Task Force developed the Donor Educational Materials, appended to the Issue Summary, as part of the materials to accompany the AABB Donor History Questionnaire). The work group convened by AABB to review and develop responses to the 2007 proposed rule provided the following comments:

"We do not agree with the proposed requirement that signs and symptoms of relevant transfusion-transmitted infections (RTTIs) be included in the education materials. The signs, symptoms and risk factors for HIV infection already appear in the AABB DHQ Educational Materials and all other FDA approved donor history materials. Many of the risk factors adequately cover risks for other RTTIs including hepatitis B and C. We do not consider it appropriate to add additional items to this section. In fact, we question the value of including a signs and symptoms section in the current DHQ materials. Most of the signs and symptoms are decidedly non-specific and can be found in numerous other medical conditions. For example, a woman having night sweats could simply be menopausal. Further one would expect the other items would be picked up by the routine donor questions, beginning with, "Are you feeling well and healthy today?" This question would capture swollen lymph nodes, sores in mouth, cough, shortness of breath or diarrhea that won't go away. Coughs and shortness of breath would also be identified by the question regarding problems the donor has with his lungs. Fevers would be identified when a donor has their temperature taken during the mini-physical. In addition, issues such as mouth sores, blue or purple spots on mouth or skin, etc are indicative of well established AIDS. It is highly unlikely that persons who are already ill with HIV infection would be coming to donate blood. The AABB Donor History Task Force recommended the removal of this list of signs and symptoms at the time the uniform DHQ was developed due to the non-specific nature of the list… Further it was noted that in the absence of very specific and unique signs/symptoms it is better to keep the Educational Materials as simple as possible to enable the donor to focus on the more specific questions."

With respect to Question 2 regarding a need for minimum standards for the explanation of the risks and hazards of blood donation, AABB supports the development of an evidence-based statement by the community that can be used with locally developed materials to explain the risks and hazards of Whole Blood donation to the donor. AABB believes this type of statement would provide greater benefit than a standardized statement developed through guidance or rulemaking, as it could be written in language more easily understood by donors.

Question 3 is concerned with acceptable methods for presenting the statement of understanding to the donor and how the donor should acknowledge receipt of the statement. As noted above, AABB Standards require that the establishment have a framework of procedures to ensure that all donors are provided with the appropriate information/elements prior to donation. In addition, there are recordkeeping requirements associated with these activities. An additional proposal by FDA in the 2007 proposed rule would require that the donor sign a written statement of understanding. The AABB work group commented that any FDA requirements in this context should accommodate the use of electronic technology and noted that some FDA cleared computer systems for donor screening do not require actual or electronic donor signatures. AABB Standards allow electronic acknowledgements and we reiterate today our position that a donor's actual signature on a statement of understanding should not be required.

With respect to Question 4 on when establishments should administer the statement of understanding, AABB believes this decision should be made by the collecting establishment, provided it is administered prior to phlebotomy. Donor flow through facilities, and particularly at mobile sites, is not uniform and is often dictated by location constraints, as well as the specific medium used to administer educational materials. Imposing a specific order to the process, other than requiring that consent be obtained prior to phlebotomy, adds a level of complexity that will not necessarily improve donor or recipient safety. In addition, we note that there is no regulatory or standards requirement that questions be asked before examinations or vice versa.

AABB Standards require that the steps referred to in the written statement of understanding be performed at each donation, prior to collection.