Recipient notification

[SRMC BB]

We had a donor that was reactive for HBc and was reactive again after the 8 week deferral for HBc reentry. We had indefinetely deferred him from future donations and the donor has been notified. While doing the "Look-back" of recipients, I traced back one year prior to his last nagative donation and found 3 recipients of 4 components. My question is this....are these recipients supposed to be notified? The medical director thinks this may cause more harm than good to notify these recipients since there is no confirmatory test. I can only find in the CFR's where it states to notify those that were HIV & HCV confirmed positive, and no other infectious disease guidelines. And again, I'm wondering what is the point of a look-back when there are no notification guidlelines (except HIV & HCV). Any help and references will be greatly appreciated.

Thanks!

Natalie

[Malcolm Needs ☆]

I thought that there was a confirmatory test now involving PCR.

As I am completely and utterly useless at Transfusion Microbiology, I could well be wrong!!!!!!!!!!!!!!!!!!!!!!

My wife, who is a Medical Laboratory Assistant in Microbiology at our local hospital has just confirmed that I am correct. You can look for HCV RNA in the recipient.

Edited March 30, 2011 by Malcolm Needs
Asked my wife!!!!!!!!!!!!!!

[SRMC BB]

We do the confirmatory for HCV. I'm looking for information about HBc (Core). Thanks

[Malcolm Needs ☆]

I'll have another go at my wife's grey matter!!!!!!!!!!!!

She says that you can look for HCV core IgG or HCV total IgG (apparently it has different names!).

The other thing you could do is contact Harvey Alter - he's the world expert and a simply fantastic lecturer.

Edited March 30, 2011 by Malcolm Needs
I asked my wife again!!!!!! She's very useful!!!!!!!

[David Saikin]

There is no confirmatory for HepBCore antibody (anti-HBc). What does your donor policy say regarding notifications? I think you need to notify your pt's physicians and let them determine if there is need for f/u. The FDA will want to see that there were no untoward effects on pts who rec'd blood from this donor . . . how will you demonstrate that to THEM?

[SRMC BB]

I have it in my policy to notify the recipient. The problem is, the lab manager and Medical director want the reference and the only references I can find relate to look back notification for HCV and HIV. Nothing on Core, HBsAg, HTLV, etc. This is (thankfully) the first time this has come up for us. The AABB standards say to identify the recipients, (7.4.6.2.1) and then notify if appropriate (7.4.6.2.2) and this standard references 21 CFR 610.46-48 and 42 CFR 482.27 ©. Both CFR's deal with HCV and HIV.

I don't see why we have to look-back if we don't have to notify them:confused::confused:

[Malcolm Needs ☆]

Yes, David. After my post, my wife said that she was thinking about hep B core. Sorry about that.

I have started divorce proceedings!!!!!!!!!!!!!!!

[Bill]

David is correct--for our lookback program for any infectious disease, we notify the recipient's physician with a request to return information about any additional medical history that may be related to the transfusion. It is up to the physician to notify the recipient if he/she thinks it is necessary; we do enclose a letter from our Medical Director to the recipient if the physician wishes to use it.

[Deny Morlino]

We are in the process of revising the lookback policy. The revision is going to address any sort of lookback since Red Cross notifies us of any subsequently discovered reason for deferral. I agree with David . . . you will want to be able to demonstrate the effects for the regulatory agencies.

[carolyn swickard]

We are in the process of revising this policy too - maybe we could post a few of them and compare. We have a graded policy at this time. The miscellaneous stuff our distributor sends us is graded Level 1 and the Medical Director and I decide whether to notify or not and if we notify, it is one notification to the (closest possible) attending physician and we allow the physician to decide whether to notify the patient. All exposures to infectious diseases (except HIV or HCV) are Level 2. We notify on most of them (unless the chance of exposure is really low to non-existent). We notify once and allow the physician to make the decision to contact. All HCV and/or HIV notifications or any really good chance of exposure to an infectious disease notice is a Level 3 and follows all FDA regulations for notifications. We will try to work through the physician first with notices, education material and testing offers. If the physician will not or can not participate, we attempt to notify the patient ourselves (3 tries mandatory before failure). Gives us some latitude in dealing with the distributor notices which are sometimes very weird.

[Deb]

Back to the original question. There are no requirements for recipient notification if a donor is reactive in HBcore only. The purpose of lookback is to quarantine any in-date units that might still be in inventory somewhere (i.e., a frozen plasma from a previous donation would be one example).

[SRMC BB]

Could I see a copy of your graded policy? I think this might work well for us. I will mention the "grading" to our medical director and see if he likes the idea. Hopefully, we could just notify the recipient's MD's and they will handle it since I don't believe there is any reason to alarm the recipients.

Thanks!!

Natalie

My email is nlamb@sampsonrmc.org if you will send the "grading" guidelines to me.

[Mabel Adams]

Or post the "grading" criteria here as an attachment if you don't want to be inundated with email requests and don't mind sharing them with all of us.

[carolyn swickard]

Hi - would have done it to begin with but am computer challenged most of the time - nice FAQ helped me out so here goes a try -

this is our SOP for responding to most of the lookbacks/recalls/withdrawals that our blood distributor sends our way -

92-Notification of Transfusion Recipients.doc

[SMW]

You may want to take a look at an article by Glenn Ramsey, Managing Recalls and Withdrawals of Blood Components, Transfusion Medicine Reviews, Vol. 18, No.1 (January), 2004: p36-45.

Although some of the references and guidelines have been updated since 2004, the overall concept of having a local policy and determining who notifies who of what may be helpful as you develop your own policies.

[snilon]

cswickard-I liked your SOP! Were did you get the HIV/HCV lookback packets that you mentioned in your attachments section?

I am looking for basic information to send along with my notification letters and can't seem to come up with anything simple for the general public to understand. Did you get it from UBS?

[hunb]

As a transfusion service we notify all potential recipients with exposure to Hepatitis B , Hep. C, and HIV. Even if they receive no follow-up testing for viral markers their physician has implicit knowledge of the risks the patient has going forward. I for one would want to be notified if there were a potential problem regarding transmissable viruses. Look backs have decidely declined since the advent of the HCV and HIV PCR testing. I have only had one lookback in nine years for a Hepatitis B donor (HBsAg+) whose products were transfused at our facility. Good luck with the Medical director

[carolyn swickard]

cswickard-I liked your SOP! Were did you get the HIV/HCV lookback packets that you mentioned in your attachments section?

I am looking for basic information to send along with my notification letters and can't seem to come up with anything simple for the general public to understand. Did you get it from UBS?

Yes they came from United Blood Services - they would come as part of any lookback notice for HCV or HIV, but if you call the Arizona Lookback coordinators, they could probably send you a set of the current letters. They have changed a little over time to reflect advances, but are designed for the general public - make that one scared recipient! hope they can help.

[David Saikin]

Just as an aside to all of this "notification" info . . . we found it prudent when notifying donors to give a "heads up" call to them prior to mailing a letter of their reactivity (for whatever moiety). Our experience was that they would receive a letter saying that they were reactive AND they never got any further than that - - - they knew they had AIDS and were going to die . . . our Medical Director would contact everyone who was receiving a letter explaining what they were positive for and its impact.