HCV Lookback

[flaminredfirebird]

We recently received notification from our blood supplier that a donor of a blood product we transfused tested positive for Anti-HCV EIA, Intermediate RIBA 3.0, Negative NAT. The patient that received the blood has deceased. According to AABB Technical Manual 16th addition - "In case of HIV and HCV, notification of relatives or legal representatives is mandatory if the recipient is deceased or judged incompetent". Our Medical Director is just wanting to send a letter to the deceased patient's physician. Is this acceptable? Does this count as the legal representative? Also, I have tried to 'google' for an answer and it looks like the FDA may have done away with this policy on the deceased anyway but I can't find anything that clearly says so. I am finding a lot where they have "proposed" to do away with it. We have not received our 17th addition tech manual yet, does anyone know if they have done away with it in there? Any help is appreciated!

[SMW]

The FDA guidance document which contains flow charts is attached. Regardless of what's in the Technical Manual, it will be the FDA guidance you will need to follow.

[JMunden]

If your RIBA 3.0 is "Indeterminant" and NAT is nonreactive the transfusion service notification is not required. Follow Figure1 or Table 1 in the aforementioned PDF FDA Recommendations submitted by SMW.

[carolyn swickard]

I checked with the AABB about that "family notification" for HCV and was told that it was an error - you only have to notify family in the case of HIV if the patient is deceased. This has been corrected in the new 17th edition (just received!!) and now references the actual CFRs too.