Patient Informed Consent and Zika Virus

[AMcCord]

For those of you who are NOT in an area where mosquito populations can carry the Zika virus.......I just got an email from our blood supplier regarding donor testing for Zika. In nine selected tests investigational testing will begin for the virus. The units screened will be labeled as such. We are not one of the states listed for donor testing for Zika, however we have, in the past, received products collected in a couple of those states. People also travel and they forget they have traveled or don't think it matters and don't self-defer for all kinds of other things - that's why we get 'look backs' and recalls'.

In the letter is the following exactly quoted statement "With the distribution of labeled product, the FDA has also recommended that an approriate acknowledgement or consent be obtained prior to transfusion of high-risk recipients (e.g., a fetus in utero or pregnant woman)."

Here's the question. Have any of you altered your informed consent for Zika? Is anyone thinking about altering your informed consent for Zika?

[Eman]

Very interesting scenario, back when NAT for WNV was new it was also done under IND, and blood donors signed a consent about that testing, but I did not ever hear that patients had to have an updated consent or additional acknowledement about that testing. I'm curious who your provider is and where that comment about the FDA recommendation came from.

[David Saikin]

We received notice of zika testing but not the FDA comment.  When I left NH we had just started receiving all babesia tested units (under an unlilcensed test).  This comment was added to the bag label.  We did not require any additional consent statement.  This testing was entirely voluntary on the hospital's part.  It was not blanket testing by the supplier (Red Cross).

[Eman]

Good point, this is analogous to babesia testing. Red Cross supplies 25% of our products, and they are doing some babesia testing, like you've seen they state the test as an additional item on the label. Asking around a bit no one can recall having to consent recipients when we were consenting donors for the WNV NAT when it was IND.

[Marianne]

For those receiving the Babesia tested products, what do you do about product modification and ISBT labeling?  Or are they so few, you can avoid using them?  Our LIS will not print any of the new testing results.

I also received the same blood supplier notice and would like to hear how others will be approaching the patient consent issure.  We did not require consent for WNV back in the day either, so this is new territory.

[AMcCord]

Our supplier is the Red Cross. The bags of tested donors will be marked, but the likelihood of receiving tested donors here is small - for now. (We haven't received units tested for babesia. Again, out of our area - for now.)

I suppose this is 'different' because of the risk of transmission to the fetus and the potential for such severe birth defects. Once there is an FDA approved test rolled out and data to show that the test is effective, the consent scenario could change.

[Auntie-D]

I've looked into this as the UK imports some of its Frozen Products for the US - as the virus is lipid encapsulated methylene blue should deactivate it, so there shouldn't be any worries with FFP/cryo/Octoplas etc.

1. Remington KM, Trejo SR, Buczynski G, Li H, Osheroff WP, Brown JP, Renfrow H, Reynolds R, Pifat DY. Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sang. 2004 Jul;87(1):10-8

[Johnv]

What a great question to present to "Ask the FDA" at AABB in Orlando.  Unfortunately the meeting is months away. Why is this different than the other tests conducted under an IND, such as WNV?  

[pinktoptube]

This is an FDA recommendation and not a mandate so you do not "have" get consent, correct?

[AMcCord]

11 hours ago, pinktoptube said:

This is an FDA recommendation and not a mandate so you do not "have" get consent, correct?

I'm going to run this one by the facility safety officer and the quality people to see what they think. They can think about the legal and safety implications. I'm also waiting for a reply to a list of questions that have been sent to the assistant medical director of our blood supplier. I'll let you know if I get any interesting info.

[DebbieL]

I am far from an expert on consents.... That being said, I wouldn't think the consent should list the things they could contract from blood products, because something new could immerge (like Zika) and we couldn't get the consent changed in time to meet the need. It takes an act of congress to change any form at my place and it has to be blessed by everyone that has anything to do with the form. Months!

I think it should be somewhat vague so that the hospital is covered. "you could be exposed to viruses or other infectious agents" Zike would be included in that part. My 2 cents

[AMcCord]

OK...just got some info from my blood supplier (ARC).

Why is Zika provisional testing being treated differently than West Nile provisional testing (recommendation of specific consent).

Answer: "Since Zika has significant risk for birth defects the CDC and FDA have issued the additional guidance that was not recommended for West Nile."

I asked for specific information on what we should tell our high risk patients.

Answer: "...at this time the FDA has not provided additional information or clarification regarding this recommendation. We recommend that you consult the CDC website when determining what to tell your high-risk patients about Zika virus transmission. AABB will offer more clarity on "Labeling and Recipient Consent Issues Related to Zika Virus tested Blood Components" in the weekly report expected 7/29/2016."

My medical director and I have been mulling over the consent issue and we feel that additional information specific to Zika probably should be given to women of childbearing potential because of the risk of birth defects. We do not transfuse a lot of patients in this category thankfully. Because of all the attention its getting in the media, patients are going to be very aware of it - who hasn't seen pictures of babies affected by it? Its only natural that a pregnant woman would be concerned. Looking at it from a purely business angle, if by some misfortune you have a patient where something goes wrong and you have not provided that information in spite of the FDA/CDC recommendation, it could leave your facility in a very shaky legal position in the event of a law suit by either mother or on behalf of the affected child.

We're going to let risk management decide how they want to handle it. Our current consent is very generic and yes, it took months to be approved when it was implemented in the first place.

 

[pinktoptube]

Thank you AMcCord for the follow-up. I still haven't heard a response from my Medical Director on how they want to handle this, but you brought up very important points that I will take to them to help them in their decision.

[tbostock]

We received the same memo from our blood supplier.  We will be discussing at our Transfusion Committee tomorrow.  I don't believe we will change our consent specifically, but alert OB and ED physicians about the increased risk for pregnant females.

[Ann in CA]

Hi, did anyone catch this in the AABB weekly report on 8/5/2016?

FDA Updates Labeling Requirements for Test-Negative Blood Screened for ZIKV Under IND

FDA updated the labeling requirements for test-negative blood screened for ZIKV under an IND. The update comes after FDA announced new labeling requirements for such blood last week, as reported in last Friday’s issue of Weekly Report. In the updated requirements, FDA has removed its earlier recommendation to obtain “appropriate acknowledgement or consent” prior to transfusing the unit to a high-risk recipient. In addition, the updated labeling requirements declare that test-negative blood components screened for ZIKV by NAT must be labeled as “negative for Zika virus by an investigational test.” This phrase must be added to each test-negative blood product label (i.e., ISBT 128 or equivalent label). FDA has also recommended additional labeling (via a labeling supplement or modification of the Circular of Information) to state “Units labeled as negative for Zika virus RNA were tested with an investigational nucleic acid test (NAT) and found to be nonreactive.”

 

I can't find the FDA source for this and the blood suppliers haven't passed on this information to us either!

 

We are overjoyed at this development as this was going to be an operational nightmare!

 

Ann in CA

 

[tbostock]

I was also very happy to hear this.  My legal department was struggling over this.  So now we are just going to send a more general memo to all of our physicians about Zika and the increased risk in transfusing pregnant women.

[AMcCord]

11 hours ago, tbostock said:

I was also very happy to hear this.  My legal department was struggling over this.  So now we are just going to send a more general memo to all of our physicians about Zika and the increased risk in transfusing pregnant women.

Me, too! Quite an abrupt reversal - I wonder what the story was behind that? I think the memo is probably how we'll handle this now. Much less alarming.