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1-CBC-0103-2020-Website-Updates-V01-DF

Changes in Blood Donor Eligibility Rules Now in Effect

By Dr. Laurie Sutor, Vice President of Medical and Technical Services | 0 comment | General, Time Sensitive | 28 July, 2020

Effective Tuesday, July 28, 2020 Carter BloodCare will be able to accept individuals as blood donors who were previously deferred by Food and Drug Administration (FDA) guidelines that regulate the blood industry. The FDA announced the revised guidelines in April, but Carter BloodCare needed time to modify computer systems, write procedures and train our staff on how to implement these changes safely. Thank you for your patience. HOWEVER, if you tried to donate with us in the past and were deferred in our computer system, you will need to be re-entered into the active database again before you can donate (see “Re-entry Process” below).

We are excited about these changes and have highlighted a few of them here.

Examples of the changes (in the words of this author, not the FDA) include:

No deferral time now (eligible to donate again):

  • Individuals who were stationed with the military or lived on a base in Europe from 1980 to 1996; the previous deferral was because of risk of variant Creutzfeldt-Jakob disease (vCJD or mad cow disease).
  • Individuals who lived in Europe for five years or more from 1980 to the present; the deferral was because of risk of vCJD or mad cow disease. There are two exceptions: An indefinite deferral will remain for those who lived in Ireland or France for 5 years or more cumulatively in the period from 1980 to 2001. An indefinite deferral also remains for persons who lived in the United Kingdom for three months or more cumulatively in the period from 1980 to 1996.
  • Individuals who used bovine insulin for diabetes; it was also considered a risk for vCJD/ mad cow disease.

Deferral times now reduced to three months (previously were one year):

  • After travel to a malarial endemic area (as long as you were not a resident of a malarial endemic country).
  • After any possible blood exposure including, but not limited to, tattoo or piercing in an unlicensed facility; needle stick exposure; blood transfusion; organ transplant; skin or bone graft.
  • After male-male sexual contact.
  • After sexual contact with a high risk individual

There are other changes that are not listed in the interest of space.

Re-entry Process.

If you gave blood with Carter BloodCare, or with our organization under a previous brand name (Carter Blood Center, BloodCare of Dallas, Wadley, Stewart Regional Blood Center in East Texas), and you were “indefinitely deferred” in our system, please complete this Request For Information form. This will allow us to get you entered into the system before you make a trip to our donor centers or a blood drive. You may also call 817-412-5603 to the Donor Notification Department with any questions about your eligibility.

If you have never donated with us, the form is not required. We look forward to welcoming you as a blood donor with us. Visit carterbloodcare.org to make an appointment. You can also text or call 800-366-2834 and let us help you.

Note: These changes were made after careful study of risks and benefits to the blood supply by panels of experts in our field. The panel evaluated a great deal of scientific evidence as well as the experiences in other countries with these criteria in place. 
The public should not be concerned about these changes endangering the safety of our blood supply. The FDA does not make changes lightly and only with great deliberation.

The documents can be reviewed at:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/revised-recommendations-reducing-risk-human-immunodeficiency-virus-transmission-blood-and-blood

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reduce-possible-risk-transmission-creutzfeldt-jakob-disease-and-variant-creutzfeldt

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/revised-recommendations-reduce-risk-transfusion-transmitted-malaria

Request for Information

  • Your records are confidential. MOST information CANNOT be given over the phone.
  • The review of your donor history can take several weeks to complete. Because each case is individual, some reviews may take longer than others. You will receive a letter to let you know the reason for your deferral, and any changes to your donor status.

If Carter BloodCare personnel have informed you that you are classified as a deferred donor, we will provide you with written confirmation of the reason for this classification, or of changes made to your eligibility. Blood center or mobile blood drive staff does NOT have access to your confidential records.

A complete review of your donation history will be performed. However, to determine if you meet current eligibility standards, we may need to contact you before the review is complete. Please ensure there is a phone number/email address listed below that we can use to reach you. If we are unable to contact you, we may not be able to properly process your review.

We appreciate your patience during this process. Thank you for your willingness to be a blood donor.
This form contains health information that is privileged and confidential, the disclosure of which is governed by federal and state laws. If you are not authorized to use or disclose this information, you are hereby notified that any use, dissemination, distribution or copying of this information is STRICTLY PROHIBITED. If you have additional questions, please contact Carter BloodCare’s Donor Notification Department at (817) 412-5603.

FAQs – New FDA Donor Eligibility Guidelines

Why did the Food and Drug Administration (FDA) make these changes?

The FDA made changes during a time that COVID-19 was stressing the adequacy of the blood supply, but not without evaluating scientific evidence on the safety of allowing donations from certain previously deferred donors.
With the onset of the coronavirus pandemic and the shelter-in-place orders, thousands of blood drives were cancelled locally and nationally, as schools, businesses, and houses of worship were closed.
Only 4% of people in the Carter BloodCare service area (north, central and east Texas) give blood. The new guidelines will allow thousands more people to donate blood who were previously deferred.

Am I at risk if I need a transfusion because some previously deferred individuals may now donate blood?

No. The FDA only changes the donor eligibility guidelines after careful study of available scientific evidence. They remain very conservative in their decision-making as to donor and recipient safety. They would not allow changes that compromise the safety of the blood. These guidelines are not unique to Carter BloodCare. All blood programs in the United States follow the same regulations.

If I lived overseas, may I now give blood?

For many years donors have been deferred because of living in Europe and/or the United Kingdom through identified years and for specific durations. The previous deferral was because of risk of variant Creutzfeldt-Jakob disease (vCJD or mad cow disease).
Now, you will only be deferred for this eligibility requirement if one or more of these exceptions are true for you:

If you spent three months or more, cumulatively, in the United Kingdom (U.K.) from 1980-1996, and/or

If you lived five years or more, cumulatively, in Ireland or France from 1980-2001, or

You received a blood transfusion in the U.K., Ireland or France from 1980 to the present

(NOTE: The U.K. includes England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar and the Falkland Islands.)

If you previously attempted to donate with Carter BloodCare or Stewart Regional Blood Center in Tyler and were deferred because of the above-mentioned criteria, you must be reinstated. Please follow the re-entry process on this page to change your status in our computer system before presenting to donate.

If you have never attempted to donate blood with Carter BloodCare or Stewart Regional Blood Center, you are welcome to make an appointment to give.

If I lived on an overseas U.S. military base, may I now donate blood?

Yes. Presently, residency on a U.S. military base in Europe is not a deferral.
If you previously attempted to donate with Carter BloodCare or Stewart Regional Blood Center in Tyler and were deferred for this eligibility requirement, you must be reinstated. Please follow the re-entry process on this page to change your status in our computer system before presenting to donate.
If you have never attempted to donate blood with Carter BloodCare or Stewart Regional Blood Center, you are welcome to make an appointment to give.

If I was previously deferred for my residency in Europe and I am now eligible, can I just make an appointment to donate?

If you have never donated blood with Carter BloodCare or Stewart Regional Blood Center and you are now eligible under these new criteria, you may make an appointment at a blood drive or donation center near you and give blood.
If you attempted to give blood with Carter BloodCare and were deferred because of the residency criteria above, you must follow the re-entry process on this page to change your status before showing up to donate.

I was deferred in the past for travel to malaria-endemic parts of the world. Has that deferral changed?

Yes. The deferral period is shortened from 12 months to three months after travel to a malaria-endemic country.

However, if you were a resident of a malaria-endemic country before making your residency in the United States, you must be in the U.S. continually for three years, before donating blood.

If you travel back to a malaria-endemic area before three years in the U.S. has passed, the three-year timeframe will start over. After three years in the U.S., you may attempt to donate blood.

Is there a change in the deferral period for male-to-male sexual contact?

Yes. The FDA has shortened the deferral period from 12 months to three months, for any male who answers ‘yes’ to the question, “In the past three months have you had sexual contact with another male?”
All U.S. blood centers, including Carter BloodCare, follow this guideline from the FDA because, as our regulatory agency, the FDA sets the blood donation eligibility criteria.
The question is not addressing one’s gender identity or sexual preference. The question is designed to assess human sexual contact and its associated risk with the spread of HIV.
There is also a three-month deferral for a female who has had sexual contact in the past three months with a male, who has had sexual contact with another male, in the past three months.
If you were deferred from donating with Carter BloodCare in the past and would like to be reinstated under the three-month guideline, please follow the re-entry process on this page to change your status.

No tags.

Dr. Laurie Sutor, Vice President of Medical and Technical Services

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