As a small community hospital, we get 100% of our blood products from a Community Blood Bank. I was just sent a consignee notification form from our blood supplier with "Lookback" (vs. Market Withdrawal) checked for a unit we received 4 years ago from donor who just now disclosed "jaundice at age 11; cause unknown and not disclosed at previous donations."

I was under the impression that the FDA "Lookback" procedures were only indicated for confirmed positive tests for HIV &/or Hepatitis (and recommended for Chagas as well).

Of course our own Lookback policy/procedure does not reference "jaundice of unknown origin" so I'm wondering if I need to edit our procedure and/or perform a true lookback and recipient notification for this one? What would you do?

Thanks for any input!

At two of three institutions where I was on Transfusion Committee, we wrote the procedure to state "any lookback notice from our supplier" would be handled the same way. The Blood Bank Director just changed the letter that accompanied the form to include the disease or condition of the donor to be appropriate for the situation. According to the procedure, the Director also had authority to NOT to send letter if it is not mandated by regulation (as the Director sees fit) but all notices from supplier were reported to committee for review.

I was considering having my Medical Director note that the lookback wasn't required for this one...but then I was afraid that as confusing as the FDA guidances are on this that maybe I had missed something. Thanks for your input Bill!

At our last DNV inspection we were given a web site to obtain a form to fill out for lookbacks. We have been able to get the forms from the web page until a few weeks ago. We were told we could not store forms and had to obtain a "fresh" copy each time a form is needed.

Does anyone have some he?!

Thanks,

John

You are correct, a lookback as defined by the FDA is from a confirmed positive test and they require recipient notification. Post-donation information recalls are really common and blood suppliers handle them differently, but the FDA usually requires that the blood supplier only recall any in-date transfusable product. I have my medical director review any recalls that we receive from our blood supplier, but we very rarely notify the recipients, except in the case of true "lookbacks".

At your facilities, who is responsible for notifying the recipient of a blood product now involved in a lookback? The blood bank director or the physician that ordered the transfusion?

Once our pathologist reviews the lookback he/she notified the patient's physician for the actual patient contact.

The patient's physician. They have the option of refusing the responsibility of notification at our facility at which point the notification is made by the blood bank. Can say I have not ever had a physician refuse the duty.

Hi Deny,

I can agree - we also have never had a patient's physician refuse to make contact with a patient.

John

Does anyone have a copy of a lookback letter or form that they send to the physician that they could share? I need to rewrite ours and could use some best practices.

The patient's physician. They have the option of refusing the responsibility of notification at our facility at which point the notification is made by the blood bank. Can say I have not ever had a physician refuse the duty.

I have, what a mess.