FDA reportable or not?

[bmarotto]

A patient who receives irradiated blood has an unexpected massive bleed. Ten units of uncrossmatched blood are requested emergently. Blood Bank Director makes a medical decision to not irradiate the units. This is documented on our internal deviation from SOP. Is it FDA reportable?

[SMW]

No. If the occurence was a "planned" event with appropriate documentation according to your policies and procedures, there was no deviation or error so nothing to report (or correct). On the other hand, if the products were inadvertently issued without irradiation and the medical director subsequently evaluated and documented the occurence, then it would be reportable.

[David Saikin]

I concur

[Likewine99]

SMW is absolutely correct

[Malcolm Needs ☆]

Being from the UK, I don't know what or what is not reportable to the FDA, but I would be amazed if our equivalent (the MHRA) would require notification under the circumstances (well, maybe not amazed, but at least mildly surprised)!!!!!!!!!!!!!!!!!!!!!!

:rolleyes::rolleyes:

[bmarotto]

That is what I was hoping. We decided not to report. I am glad everyone concurs. Thank you everyone.

[conwaysbb]

Just to play devil's advocate here...Just because a Medical Director documents it is his/her medical decision not to irradiate the blood due to the emergent situation of the patient, does not make the decison correct or not reportable, especially if he/she did not consult the transfusing/ordering physician before making his decision.

As this is a documented event, the QA unit must determine whether (A) there was a consultation between the ordering physician and the medical director and if so did the ordering physician concur with that decision. Accordingly, If the ordering physician has a standing order that the patient only recieve irradiated products and still insisted that the patient receive these products even in the emergent situation, then the medical director would have to document it was impossible to irradiate any of the blood in the available time required to get all 10 units to the patient. ( Whether there is a exisiting policy in place that has been approved by the Transfusion/Blood Utilization committee for for these types of situations (example automatically switching from RH Neg RBCs to RH Pos RBCs); © whether the facility has access to an in-house blood irradiator and what the irradiation time is to determine whether you can iirradiate any and/or all of the units being given in the available timeframe.

While I am sure most medical directors are competent in making these types of decision, I have met a medical director or two, who have made hasty decisions, which upon investigation of the event(s) were determined to be the wrong decision.

[adiescast]

I think that you would have to report if your situation shows that the medical director made the "wrong" decision (anyone can make a wrong decision). Bmarotto's case as given does not give any indication that this fits.

I definitely agree that the decision must be made in consultation with the treating physician (who, by the way, is also capable of making the "wrong" decision).

It sounds like you have some horror stories to tell, conwaysbb!

[bmarotto]

In this case the requesting physician was a surgeon who did not know (or care) that the patient receives irradiated blood. The surgeon wanted blood in the room immediately. Trying to hunt down the hematolgist for consultation would have taken as much time as irradiating the units. It was clear from speaking to the surgeon that a delay was not in the best interest of the patient. This event happened several hours before a scheduled transfusion committee meeting. Everyone at the meeting concurred that the right decision was made.

[tricore]

This was medical decision not a reportable incident. FDA tends not to interfere with medical decisions. Would it have been better to let the patient bleed with the resulting modbidity (or mortality)? However, if the patient develops GVHD from the nonirradiated transfusions would you then report it?

[L106]

My three cents:

A agree with conwaysbb that the decision to go with nonirradiated blood products should primarily be the decision of the physician who ordered the blood. (I would call and tell him "Dr. So-and-so requested only irradiated products for this patient. Do you want to wait 2 hours for irradiated products, or do you want regular units now?")

If it was a surgeon, so be it. If his decision contradicts the original gameplan of the patient's oncologist, then that's between the two of them. I would accept the order from the physician currently dealing with the patient (unless I felt that it clearly was not in the patient's best interest, at which point I would drag the Pathologist into the situation.) If the surgeon's decision was evaluated and supported by the Pathologist and/or hospital's Transfusion Committee, great! (Document that.)

No, it is not an event that must be reported to the FDA. The physician ordered regular donor units; they were not accidently issued by the BB tech as a mistake.

[vilma_mt]

I would not consider releasing non-irradiated products during an emergency situation a reportable event provided it was considered an 'emergency release' with the approval and signature of the patient's physician. Red Cross in our area do not even provide irradiated products STAT. It is necessary to inform the patient's physician so that he can take the necessary measures to prevent the disease, there are some drugs used for GVHD prophylaxis. It may not be a reportable event but physician notification is essential even if it's your Medical Director's decision to switch to non-irradiated products.

[barobinson]

I can tell you that at our large university medical center we would not report this one to FDA as long as our Medical Director completed our deviation from standard SOP form. We do report a lot of things to the FDA so I fell we would be okay not reporting this. Do you report units not issued in the computer prior to release? If so, how many do you have a month.

[adiescast]

I can tell you that at our large university medical center we would not report this one to FDA as long as our Medical Director completed our deviation from standard SOP form. We do report a lot of things to the FDA so I fell we would be okay not reporting this. Do you report units not issued in the computer prior to release? If so, how many do you have a month.

FDA includes units not documented as issued in their requirements for reporting. We have had one or two a year. Usually it is when things get really busy and someone forgets to hit accept or save and the computer times out without recording the issue.

[Eagle Eye]

I agree with the fact that this is not FDA reportable as long as your Medical Director aprroved to give non-irradiated product and pt's clinician agreed to accept the non-irradited products due to emergency.

[Trish Beckjord]

I am curious, after having read this posting trail, as to whether anyone would try to get the surgeon's signature (or at least the anesthesiologist) documented for the file as being aware of the deviation and approving of it...

[conwaysbb]

I actually sent a question to " BP_Deviations@fda.hhs.gov" in regards to this.

The contents of the e-mail were as follows:

To whom it may concern.

This scenario has come up as a question whether it would be reportable or not.

A request for 10 units of red blood cells comes in as a stat for a bleeding patient. The patient has special instructions to have all cellular products irradiated. The blood bank technologist calls the medical director of the blood bank and the medical director tells the blood bank technologist to release the blood without irradiating it and documents his decision to not irradiate the blood. The medical director however does not consult with any of the patient’s physicians that are treating the patient /requesting the 10 units of blood.

Is this reportable as a BPD?

Subsequent to the event, the physician in charge of the patient states, if he was informed of the special instructions that he would have wanted at least some of the units to be irradiated, if the blood bank could have provided irradiated blood in the time frame available, as he didn’t take all 10 units at once. Upon further review, the facility has an in-house blood irradiator and it was determined that based upon the time line presented 4 of the 10 units could have been irradiated, but as the physician in charge was not consulted this option was not presented.

Is this reportable as a BPD.

This question is being presented on a message board and there are many comments. I thought I would present it to you for your thoughts. Please reply at your convenience.

Thanking you in advance.

This morning I received a phone reply on this. The individual responding said that this e-mail was discussed with several inidviduals at the agency for some length and the following are their answers:

1) If the blood was released as emergency release and you have the requesting MDs signature than this is not reportable.

2) If the medical director consulted with the requesting MD and they both agreed that they could not provide irradiated RBCs in the time frame needed, this would not be reportable.

3) However, if the Medical Director did not discuss this with the requesting MD and it was not an emergency release, then they would want this reported, as this could effect the safety, purity or potency of the product to the patient.

Again, I do not know the situation of the patient, as the original post said the patitient needed 10 untis of blood in an "emergent" situation. Further information would be needed, such as: Was the blood to be released as emergency release blood? Was the requestiing MD called to see if they needed all 10 units at once or could they give some units immediately and have time to irradiate the other blood? Does the facility have an in-house blood irradiator and if so, how long does it take to irradaite one unit? multiple units? If not, how long would it take to get irradiated product in? Did the Medical DIrector consult the requestign MD prior to release of the blood?

As I said in my first response, I was playing the devil's advocate, as is my wont :-). However, managing blood banks in large institutions, primarily Trauma centers, we have come across these similiar situations, whether it was for a patient needing irrdaited blood, sickle blood, antigen negative blood and the first call is to the requesting MD to find out the situation of the patient, to see if they really need all 10 units right away and are they aware of the special requirements of the patient. The first call is not to the medical director. The medical director is usually called after speaking with the requesting MD to both notify him of the situation and/or to have the medical director consult the requesting MD

[L106]

Hey, conwaysbb, thank you for taking the time to pursue this topic with the FDA. (It sounds like you got ahold of some reasonable individuals!) Thanks for sharing this info with us.

Donna

[bmarotto]

Thanks for the information. In our case, the 10 units were requested to be sent to the operating room uncrossmatched and we do have the requesting physician's signature.

[MJDrew]

This is a medical decision, as the units were ordered uncrossmatched, presumably on an emergent basis. Medical decisions are not in the jurisdiction of the FDA in a situation where blood is emergently needed and there is no time to irradiate prior to release, regardless of whether it has been discussed with the attending MD. The key factor in answer 3 is "not discussed AND not emergency release". Technically, there is no difference in purity/potency based on a discussion or no discussion prior to transfusion, regardless of whether there is actually time to irradiate. The risk of TA-GVHD, while there, is miniscule with randomly selected, LR RBCs. If the patient is losing blood that fast, how long do those lymphocytes have in the circulation, anyway?

In my biased opinion, irradiation is a medical decision to begin with and individuals at the FDA who are not in possession of an MD degree have no business ruling on this one way or the other. Since I am not certain as to whether the FDA employee answering the query was an MD or not, I can't assess the validity of their answer, as it pertains only to procedural issues. I am assuming the respondent was not an MD. MJD

[L106]

Way to go, MJDrew!!!

[MJDrew]

I should have mentioned in my last rant (!) that we had actually approved this with our solid organ transplant docs as part of a tranfusion committee discussion, ie, when you order uncrossmatched on one of your patients who normally would have irradiated blood, it will be assumed to be an emergency and since each unit will take >3 minutes to irradiate, what you'll be getting won't be irradiated. This was written into the BB policies for massive txn, emergency txn, etc, as well, and these changes were published in our monthly lab newsletter, print & on intranet. If you have evidence these conversations/information were distributed, and there was opportunity for questions, this would at least help you "cover" for situations where there is not time to irradiate and staff may not be available for an approval of un-irradiated units. MJD

[tricore]

Here is another situation. Patient who requires irradiated products is in a motor vehicle accident. The ER to which he is taken has no way of knowing this (unless he/she has a med-alert bracelet, necklace, etc ) and transfuses non-irradiated products. It is later found out that the patient requires irradiated products. What do you do? Anything? Report it to FDA as a BPD? I wouldn't. Technically, irradiated products were not ordered for the patient in this facility. It is not an error.

[L106]

I agree, tricore. This would not be reportable. Goodness gracious.......How could anyone take special action in a situation in which there is absolutely no way to be aware of the patient's special cirmunstances???

[Eagle Eye]

Yes this is not reportable as blood bank didn't know the special requirement. Sometime this happens with sickler as they tend to go to different hospitals. If they go to new hospital first time, there is no way hospital BB will know that patient is sickle cell Disease patient as when they go to ER, many time ---altered mental status and sometime they are not good historian.