I think it is reportable

[Deny Morlino]

If a patient is transfused with Dextrose 5% piggybacked with PRBC's :eek: vs normal saline, would this be a FDA reportable event? My thought is yes. Please chime in an let me know your thoughts.

[L106]

I don't think it is reportable. From our experience, FDA wants Blood Bank errors & deviations. They don't seem to want to know about problems that are due to or involve nursing errors. (Go figure!!!)

Example: Our nursing personnel wanted a blood product for a patient ("Pt # 1"), but ordered it using the account # of a different patient ("Pt # 2") who had a similar-sounding name. So Blood Bank issued a blood product of the wrong type to Pt #1. FDA did not want to hear about this error/problem! (Doesn't make sense to me.......I think this is a more important patient care problem than something like issuing a unit without using the computer.)

[SMW]

Not reportable. According to the FDA, the transfusion itself is not considered "manufacturing" so no FDA error or deviation occurred related to manufacturing. Similar scenario: Group A unit labled and issued according to blood bank/hospital protocol for patient Mary Jones but nursing transfuses to group O patient John Doe--not reportable to FDA (unless there is fatality associated with transfusion).

[L106]

SMW - I agree with your interpretation of this scenario. (P.S. Nice explanation! Thanks!)

Donna

[Deny Morlino]

Thanks folks! I guess I was expecting the worst on this. My instincts said FDA reportable (makes sense to me anyway). I see some changes coming down the pike to the point of examining the floors to see how these products are stored (i.e. next to each other perhaps) and see if any recommendation for change is mandated. Patient was an 88 yo female with some reduction in renal function. Lab results subsequent to the event looked OK and patient is still doing well. This occurred back in May and blood bank was not included in the loop until now . That oversight has been corrected already . Nursing policy related to transfusion has been updated to add a check of the entire IV setup by two nurses prior to initiating infusion. At least nursing is taking this event seriously.

[tbostock]

We had the same exact scenario at another hospital many years ago; the patient expired because of it, so the FDA came to visit...not a good day.

[Bill]

I don't like to disagree with my learned members, but the dextrose is probably in Y-tubing mixing with the blood prior to entering the patient. This, to me, comes under the realm of manufacturing and since the dextrose will hemolyze the blood (making it useless), it does affect purity etc which makes it reportable. My understanding is that the FDA wants actions reported that make the product unhealthy --this action makes the blood unhealthy

[tbostock]

I agree with Bill 100%, it affects the purity by hemolyzing the cells.

[BSIPHERD]

I don't like to disagree with my learned members, but the dextrose is probably in Y-tubing mixing with the blood prior to entering the patient. This, to me, comes under the realm of manufacturing and since the dextrose will hemolyze the blood (making it useless), it does affect purity etc which makes it reportable. My understanding is that the FDA wants actions reported that make the product unhealthy --this action makes the blood unhealthy

I think this would be "post manufacturing" and not part of the process overseen by the FDA. I don't think anyone disagrees that this is bad and adversely affects the safety and purity of the blood - but it happened after the process controlled by the FDA is complete, so unless it kills the patient, it would not be FDA reportable. The incident certainly deserves follow up and root cause analysis, but as part of the "practice of medicine error" rather than as an FDA Reportable event.

[SMW]

This is not reportable. Below is from the FDA guidance document for BPD reporting.

1. A Transfusion Service is NOT required to report to us if the event occurs during transfusion or administration procedures, after the blood product has left the control of the transfusion service. For example, a report is not required:
   
   • If the transfusion service issued a product from the laboratory to the nursing floor, operating room, emergency room, etc., for transfusion and the product was not held at the appropriate temperature outside of the transfusion service prior to transfusion. However, the transfusion service is required to report if the product was returned and the transfusion service determined it to be unsuitable, but contrary to CGMP, applicable regulations, applicable standards, or established specifications, reissued the product.
     
   • If the hospital staff, outside of the blood bank, transfused the wrong patient or transfused a patient with the wrong unit, provided the unit was labeled appropriately and the transfusion service conducted compatibility testing properly. If a complication of a transfusion was confirmed to be fatal, the facility that performed the compatibility testing must submit a fatality report to us in accordance with 21 CFR 606.170(.
     
   • If the transfusion service issued a filter with the product and the hospital staff did not use the filter at the bedside.
     
   • If the patient has a transfusion reaction that is not related to an event in manufacturing. Fatalities due to Transfusion Related Acute Lung Injury (TRALI) or other transfusion complications must be reported to CBER in accordance with 21 CFR 606.170(. We also accept voluntary reports of non-fatal TRALI as a serious adverse reaction to transfusions. Such voluntary reports can be submitted via MedWatch by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by US mail at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852, or by email at http://www.fda.gov/medwatch. For additional information, see the "Dear Colleague" letter published October 19, 2001 at http://www.fda.gov/cber/ltr/trali101901.htm.
     

[LaraT23]

I think after reading this and other threads it might be a good idea for annual meetings to have either a presentation or round table discussion featuring an FDA representative or quality expert to help give us some guidance about these things. what does everyone else think?

[tricore]

Excellent idea for regional meetings. They do have ask the FDA at the aaBB annual meeting and publish the transscript. It used to be more informal but guess some inappropriate anwers were given so now FDA has to have the questions beforehand so they can plot their answers.

About 11 or 12 years ago our local community college (TVI now CNM) had a presentation for small business. We had the District Director and 3 or 4 inspectors and several of us local people on the panel. It was excellent. This particular one was not just for blood bankers. Are you a member of SCABB? They may do it or you can suggest it. Would be excellent for the combined meeting CSBB/SCABB next year.

[LaraT23]

As a matter of fact I am on the technical/scientific commitee. I am going to suggest that as one of our speaker slots and then work to find someone qualified to come out.

[Eoin]

Hi Guys,

Sounds like here in the old days before the european directive Dir 2002-98-EC which became law and the setting up of a national haemovigilance network (which covers haemovigilance and traceability). The procedure specifically precludes anything being given / introduced into the giving set. Thus this would be a reportable Adverse Event and if there was lysed cells infused, would also cause some changes in the patient and thus would be an Adverse Reaction as well, either reportable to the National Haemovigilance Network, who would probably pass this on to the Irish Medicines Board (who are the licence regulators by law) - different body in the UK I know.

If you guys over there are interested, I could give a synopsis of the whole system (e.g. tracing from vein to vein - keeping records for 30 years, the haemovigilance and quality setups etc) and attach to a post in this forum.

Cheers Eoin

[adiescast]

Hi Guys,

Sounds like here in the old days before the european directive Dir 2002-98-EC which became law and the setting up of a national haemovigilance network (which covers haemovigilance and traceability). The procedure specifically precludes anything being given / introduced into the giving set. Thus this would be a reportable Adverse Event and if there was lysed cells infused, would also cause some changes in the patient and thus would be an Adverse Reaction as well, either reportable to the National Haemovigilance Network, who would probably pass this on to the Irish Medicines Board (who are the licence regulators by law) - different body in the UK I know.

If you guys over there are interested, I could give a synopsis of the whole system (e.g. tracing from vein to vein - keeping records for 30 years, the haemovigilance and quality setups etc) and attach to a post in this forum.

Cheers Eoin

Hi Eoin,

I think that would be very informative. One thing that has happened over here is that the steps have been spearated and certain portions receive intense scrutiny and other steps are ignored. I hope some day we will have a complete system that treats all of the steps equally. Right now a nurse can pick up a unit of blood with correct information, walk into the wrong room, and transfuse it and it would not be reportable to FDA (because it was post-issue). Joint Commision would expect this event to have been noted with root cause analysis and corrective and preventive action taken. Nursing boards recommend reporting of this type of event, but do not have a way to enforce it.

I know all of this because it has happened here and I was floored that it was handled in a rather carefree manner. I am not sure anyone even talked to the nurse about it. The Lab would never have stood for one of their employees making an error of this magnitude without some sort of action (depending on the reason for the error).

OK, enough soap box!

[L106]

adiescast - You are exactly correct, and I share you disgust with this inequity.

Donna

[Deny Morlino]

For what it is worth, this item was not swept under the rug. It has generated a host of sop changes along with several recommendations regarding storage of D5W and normal saline on the units. Patient is doing fine (thank goodness!). I am not looking for disciplinary actions, only process improvements. I consider myself lucky to be working with a PI coordinator, Risk management coordinator, and nursing management all open to suggestions with realistic unbiased (fairly) outlooks during the handling of this event. Hoping for good outcomes!

[adiescast]

Glad to hear the situation is being treated with the seriousness it deserves. Disciplinary action is not the goal, although it is appropriate with an employee who makes multiples of the same error or displays negligent behavior. The goal is to get everyone involved in the solution and make sure it works.

[Deny Morlino]

Thankfully that is the outlook almost all of the time here. A far cry different from the environment even 10 years ago when finger pointing was still the norm :mad:.

[Eoin]

Hi,

We run our Non-Conformance System as a "No-Blame" culture, but staff hate non-conformance letters or being recalled for re-education / re-competency testing, and despite many newsletters etc about the no-blame, we still get adverse comments in our user surveys. After all, they are accountable for thier practice. I read an article recently in an ASQ publication about a "Just Culture" which refers to three types of behavior -

Human Error - inadvertent action - a mistake

At-Risk Behavior - a choice that increases risk because it is not recognised (or outside SOP)

Reckless Behavior - a choice to consiously disregard a risk that is substantial and unjustifiable.

I think "Just Culture" may be a more acceptable approach, even though it is essentially the same described in a "Just" manner.

The non-conformances often identify process weaknesses and leads to improvement. If an adverse event happens it is not good, but it is unforgivable if the institution does not learn from it and put in better process descriptions.

Your hospital has done a good job in re-defining the process. Often things are not spelled completely out because they have not occured.

Well done Deny

Cheers

Eoin