My understanding of FDA requirements for HIV lookback is that family needs to be contacted if the patient has expired. However, if the patient shortly after transfusion and without being discharged, is it still necessary to contact the family. (It just seems cruel and unnecessary.)

I too have wondered this, but then considered two things.

First, what if... what if the donor had a cut and a family member wiped the blood up for them? What if they had "relations" with a family member (or someone else), what i someone was exposed in another way, what if...

Second, the rule doesn't distinguish, so we are obligated to notify.

I think it can be a "legal representative" but I suppose that would usually be the executor of the will so still likely to be someone grieving.

Below is from the transcript of the"Ask the FDA" session at the 2008 AABB Annual Meeting:

Question 2: A patient was transfused with a unit of packed cells in 2006. He died during the same admission, within 48 hours of the transfusion. In 2008 the hospital received an HIV lookback notice stating that the donor of that unit now tests positive for HIV. To notify the family two years after the patient's death when there was no risk of transmission even if the unit had been infected will only cause distress to them and serve no useful purpose. Is there any way that the requirement to notify a deceased patient's family can be waived in such a situation?

DR. MIED: In 610.46((3), the HIV lookback regulation says “when the supplemental test for HIV is positive, the consignee must notify transfusion recipients, or the recipient's physician of record, of the need for recipient HIV testing and counseling.” It also states “you must notify the recipient's physician of record or a legal representative or relative if the recipient is deceased.” So the consignee must notify the physician of record or a legal representative or a relative, in this case. We understand your concern about notifying the patient's family and causing distress to them in this situation, and the notification would appear to serve no useful purpose. The physician of record, at his or her medical discretion, may decline to notify the family in this case for the reasons that you have stated, and FDA would certainly grant a variance from the HIV lookback regulation in this situation.

[Paul Mied, PhD, Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER]

This is indeed interesting. So we can request a "variance" from the FDA from the notification requirement? This is a medical decision on the part of the physician not to notify the next of kin when it is clearly not needed. The FDA representative clearly stated this is a matter of medical discretion, which takes it OUT of the agency's purview.

Our responsibility is to notify the physician, point out that it need go no further if he/she feels it is not necessary, notify FDA that the contact has been made, and leave it at that. That is the requirement. Is the FDA policing the practice of medicine now? It certainly seems they are. It is none of the agency's business what happens with the notification once the appropriate, required contact has been made. You would never find me filing paperwork for a "variance". Why don't they just rewrite the regulation to allow for the medical discretion?

Our tax dollars at work! MJD

Wow. Dr. Drew, we haven't seen you on here in awhile have we? Welcome back.

I think the regs say that if the Doctor declines to notify the patient, we have to do it ourselves. How does that fit in with the practice of medicine?

Mabel, from the first answer at the FDA session and Dr. Drew's response, it sounds to me like we have to notify the doctor. I wouldn't ask if he is going to notify the family, since that is an obligation for him/her not us. We must notify the doctor or a representative of the family and if we notify the doctor that is doing our part.

And it's great to see Dr. Drew posting!!

TJC doesn't leave us much leeway per the standards below:

4 The laboratory’s human immunodeficiency virus (HIV) procedures require the transfusing facility to make several attempts to notify the blood recipient or, as needed, another authorized person, of the potential for HIV infection and to inform him or her of the need for HIV testing and counseling, if the physician is unavailable or declines to notify the recipient.

5 The laboratory’s human immunodeficiency virus (HIV) procedures require the transfusing facility to document the attempts to notify the blood recipient of the potential for HIV infection, including whether the recipient was located.

Note: Documentation of notification attempts are in accordance with federal guidelines.

And a recent CMS self-audit specifically mentions the need to notify the recipient's next of kin in HIV lookback. I have had FDA inspectors ask me about any notices we sent out but we had not sent any in recent years. I agree that it becomes a practice of medicine issue and should be changed in the regs.

21CFR610.46

You must notify the recipient's physician of record or a legal representative or relative if the recipient is a minor, deceased, adjudged incompetent by a State court, or, if the recipient is competent but State law permits a legal representative or relative to receive information on behalf of the recipient. You must make reasonable attempts to perform the notification within 12 weeks after receiving the supplemental (additional, more specific) test results... [Revised as of April 1, 2011]

This reference from the CFR seems to actually give more flexibility than I remember from the past or than CMS allows.

There is a practice of medicine issue here because the risk of infection in each case must be assessed. This assessment, whether on the part of the transfusing MD, or the blood bank physician, will determine how to frame the notification. If the transfusiing MD notifies, he or she must then inform the BB/transfusion service whether or not the recipient/representative was located. This is what is documented by the transfusion service. As the transfusion service MD, I was not the one who assessed the patient's need for the transfusion and ordered the transfusion be administered. This is the responsibility of the ordering MD who is caring for the patient. I do not have a strict "doctor/patient relationship" with the recipient.

This was an issue that I discussed with my physician staff at my last hospital post, and made it clear that, as the physician with the primary care relationship with the patient, they were expected to make this notification, or assess the need to notify, based on information I provided. This policy was approved by our medical staff council.

As far as risk of transfusion of units donated prior to the HIV+ unit, this depends upon the prior testing done on the donor; ie, how many years ago were prior donations made? If all previous testing was NAT tested negative, and there has been a gap of 6 months or more between the current, positive donation and the last negative donation, I feel confident in (confidentially) assuring the treating physician that the risk of HIV infection from prior units is very low. The longer the gap, in all likelihood, the lower the risk. Most of the very few HIV+ donors I see now in the blood center setting are either first time donors (no notification of recipients) or what we term "lapsed donors"--donors whose last donation was >2+ years ago. While the physician cannot share donor information, I provide this in confidence to assist the MD in making the decision how/whether to notifiy.

This to me constitutes a reasonable attempt to notify. I stand by my prior assertion that the physician's decision to notify or not notify patient family/representative is a medical decision and is not under the FDA's jurisdiction. When the treating physician is notified, the notification has been made.

We're all gonna bookmark this thread. Thanks Dr. Drew.