Docket Management
Docket: 03D-0163 - Guide-Recommend-Assess-Blood Donor Suitability/Safety-Severe Acute Respiratory Syndrome (SARS)
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Ms. Kathleen Wilson Date/Time 2003-05-01 17:39:13
Organization Mississippi Valley Regional Blood Center
Category Company

Comments for FDA General
1. General Comments A1. In the past 28 days, have you been ill with SARS or suspected SARS? Asking additional screening questions about SARS is unnecessary based on lack of scientific data when current screening questions for general health would capture and defer these donors. Addition of this question could be revisited in the future when additional data supports we have additional data to support its benefit. A3. To ensure that the questions used remain consistent with updated case definitions and the list of geographic areas affected by SARS, we recommend that you routinely and periodically refer to the CDC website to obtain the updated information. Requiring daily check of the CDC website for potential changes in deferral criteria increases the chance for errors. Continuous changes to the list of countries requires changes in SOPs, changes in documentation, changes in training of staff, etc. C3. Post-Donation Information and Look-back Investigation We consider that the establishments consider notifying the treating physician of those recipients about the post donation information, including whether the donor developed suspected SARS. Post-donation information and look-back investigations would be handled per the blood center's established procedures. It is not the role of blood center to notify physicians. C4. Notification of State or Local Public Health Departments CDC has asked blood establishments to contact the CDC Division of Viral and Rickettsial Diseases, to determine if retrieved units should be sent to CDC for laboratory studies, under quarantine and specially labeled as indicated above. This would involve shipment of potentially infectious units to the CDC. It would be more appropriate to work through the local public health departments. V. Implementation We recommend that you implement the recommendations in this guidance as soon as feasible, but not later than 30 deays after the guidance issue date. The rapid implementation of the final guidance places an undue burden on blood centers and takes the focus away from other important issues with a greater impact on the blood supply, such as bacterial detection. It also increases the chance of working outside cGMPs.

EC -3