Vitalant adheres to all federal and state laws regarding the collection or testing of blood components and we follow the guidance and regulations of the following organizations in addition to similar applicable state regulations:

  • FDA (Food & Drug Administration)
  • CBER (Center for Biologics Evaluation and Research)
  • CLIA (Clinical Laboratory Improvement Amendments)
  • OSHA (Occupational Safety and Health Administration)

Current good manufacturing practices (cGMPs) for blood establishments, defined in the Code of Federal Regulations (CFR), apply not only to blood centers and hospital based blood centers, but to hospital transfusion services that may not be registered or licensed by FDA.

Post Donation Information

There are times when the blood center receives potentially deferring information after the donor has already donated (post-donation information). In this instance, the blood center may need to contact the hospital/consignee regarding in-date components from prior affected donations. The hospital notification is typically made by telephone, but may come as a fax or notification letter. The correspondence will identify the action to be taken along with a brief description as to why this process has been initiated for the component(s). The most common causes of post-donation notification are:

  • Donor received a tattoo in a non-approved state less than 1 year prior to the affected donation and did not reveal this information at the time of donation.
  • Donor traveled to malaria risk area and did not reveal this information at the time of donation.
  • Donor recently diagnosed with a deferring condition not known at the time of the prior donation.
  • Donor gives an unacceptable response to a health history or high risk question on current donation attempt that was not given at the time of the previous donation(s).
  • Eligibility requirements change causing previous donors to now be deferred. One example of this is the vCJD deferrals for military personnel and their dependents stationed in Europe from 1980-1996.

The hospital/consignee should have policies in place that identify how to handle this type of notification.

Quality Assurance Notification

Vitalant is a leader in quality management and process improvement. The manufacturing processes are continuously audited and improved in order to provide safe, high quality products to the customers we serve.

There are rare occasions when the blood center may initiate a voluntary market withdrawal for components when deviations are identified through quality assessment. If at any time, through review of current records or processes or through quality assurance audits from either internal or external inspectors, the integrity of the component(s) cannot be verified, the hospital/consignee will be notified. This notification may be via telephone, fax or letter and will contain information about the withdrawal as well as instructions on what to do with the component(s).

The hospital/consignee should have policies in place that identify how to handle this type of notification.

Hospital Reporting of Fatalities

In rare instances, death in patients can occur as a result of complications in blood collection or transfusion. According to 21 CFR 606.170(b), the Center for Biologics Evaluation and Research (CBER) must be notified as soon as possible. This notification can be made via telephone, fax, e-mail or express mail followed by a written report within 7 days of the fatality. If the fatality occurred during a transfusion, it is the hospital’s responsibility to notify the appropriate agency. In some instances, a joint report between the blood center and the transfusion facility may be indicated.

For detailed information on how to report fatalities to CBER along with contact information, click here.