Can anyone explain these 2 FDA reportable scenarios?

[carolynn]

In the July, 2011 issue of Transfusion, was the study entitled "Knowledge of food and drug administration reportable deviations". A bunch of scenarios were presented, all of which were reportable, I think. Two cases I didn't understand why they were FDA reportable. I am a generalist, so I don't know the FDA regs in depth. But I do understand the gist: if a specimen/product isn't fully tested or properly labeled per SOP, and the product is issued, (even if it's returned), then the case is reportable. So what's the deal with these two:

Case 1: A patient is discharged from a hospital, but returns to the ER (same hospital) the next day wearing a blood bank armband. The specimen/band are from the previous admission and are not expired. A crossmatch was ordered, and the CLS used the old specimen to add on 2 units RBC.

(Based on this, I have had 2 patients rebanded: First, an oncology patient who was banded Friday for a transfusion on Monday, but who came into the ER over the weekend. Second, an ER patient who left AMA, but who came back to the ER the next day wearing the same band. I don't know if this was necessary or not!)

Case 2: (part of my copy got cut off, so I am missing the end) A patient's antibody screen was negative. The doctor ordered a DAT, which was positive. The CLS did not request a transfusion history because he thought all was fine with the negative screen. The patient had, in fact, been transfused at another hospital a few days earlier. An elution was not ordered by the doctor or the CLS. (This is where my copy ends. I think what happened next is that the patient was transfused.)

Can anyone explain why these are reportable? Sorry about missing info on case 2. I don't have access to the article and am going off of a powerpoint I found off the internet. Thanks!

[Bill]

Case #2 is reportable because the CLS did not catch a hemolytic reaction prior to further transfusions--if the CLS had inquired into the history and knew of the transfusion days earlier, the need for elution would have been clearer. Also, we do not know if a full IAG crossmatch was performed due to lack of info. That would complicate matter even more.

The only reason Case #1 might be reportable would be because of hospital "visit number" not matching--leaving a discrepency in demographics. Also, this would depend on hospital/blood bank policy about the "visit number."

[Mabel Adams]

I think case #1 is because it didn't follow that transfusion service's policies. Here, I will go look up the article.

• Case 7: A patient was discharged from a hospital, but he returned the next day to the emergency room of the same hospital. A type and cross was ordered. The technologist did an add-on two units of RBCs using an old blood bank specimen from the previous admission, which had not expired. The patient's blood bank armband from the previous visit was still on.
  
• Case 8: A patient's antibody screen was negative. The doctor ordered a direct antiglobulin test (DAT), which turned out to be positive. The technologist did not request a transfusion history because he thought everything was fine when the screen was negative. The patient, in fact, had been transfused a few days earlier at another hospital. An elution was not ordered by the doctor or the technologist. The doctor ordered a unit of blood the next day. The patient received the transfusion and had a transfusion reaction. An elution was ordered on the pretransfusion and posttransfusion specimens because both DATs were positive. Anti-Jka was detected in both eluates.
  Results:
  
  • Case 7: The BPD code should be QC9707: quality control and distribution; distribution procedure not performed in accordance with blood bank transfusion service's specifications; product released before obtaining current sample for ABO, Rh, antibody screen and/or compatibility testing.
    
  • Case 8: The deviation code should be QC9310: quality control and distribution; testing not performed, incompletely performed or not documented for antibody screen or identification.
    

Edited August 19, 2012 by Mabel Adams

[carolyn swickard]

If your internal policies allow it - can't you use the same armband within 72 hours even if the pt goes home. We do for Infusion Therapy all the time. The visit number remains the same for them. In the scenario #7, the visit number would change, but the pt's medical record number should still be the same. You can use that and the band number itself as 2 distinct identifiers, along with the pt's name, of course. QC9707 sounds more like releasing on history alone (definite no-no) and not having a current specimen. That's just my take on it - anyone else?

[cthherbal ☆]

If your internal policies allow it - can't you use the same armband within 72 hours even if the pt goes home. We do for Infusion Therapy all the time. The visit number remains the same for them. In the scenario #7, the visit number would change, but the pt's medical record number should still be the same. You can use that and the band number itself as 2 distinct identifiers, along with the pt's name, of course. QC9707 sounds more like releasing on history alone (definite no-no) and not having a current specimen. That's just my take on it - anyone else?

cswickard: I agree with you. We would do a deviation from policy to allow an in-date specimen to be used in another location (ex: patient in infusion center today, then comes to ER tomorrow) IF patient already had two independent blood types on record, (including current specimen), AND patient is wearing original Blood ID band, which at our hospital is separate from the hospital armband.

[Mabel Adams]

I agree that case 7 is allowed if your policy doesn't disallow it and your identifiers are still in place. If you use a visit number for ID and that changes, then you probably have a problem. As stated above that could be managed with documenting a deviation.

[tbostock]

I'm going to disagree that these should be reportable. Case 7, even if it was a variance because policy was not followed, there was no patient safety issue (band was still on), and the unit of blood was not in any way compromised. Just more of a clerical/billing issue really. And Case 8, yes, that positive DAT should have been followed through, but we don't always have info about patients being transfused elsewhere. I don't know of any regulation that requires you to do obtain a history on every positive DAT....good practice, yes, but...

[goodchild]

I'm going to disagree that these should be reportable. Case 7, even if it was a variance because policy was not followed, there was no patient safety issue (band was still on), and the unit of blood was not in any way compromised. Just more of a clerical/billing issue really. And Case 8, yes, that positive DAT should have been followed through, but we don't always have info about patients being transfused elsewhere. I don't know of any regulation that requires you to do obtain a history on every positive DAT....good practice, yes, but...

If you violate your own internal policies when it relates to "manufacturing" (i.e. testing/etc) and the product is distributed, it becomes reportable. At my institution both of these would be reportable events. Our internal policies say that if someone leaves and comes back the next day we need a new sample with only few exceptions. We also don't require doctors to specifically order an elution. If a DAT is positive, an elution is automatically performed prior to the release of any blood products.

[jeanne.wall]

If you violate your own internal policies when it relates to "manufacturing" (i.e. testing/etc) and the product is distributed, it becomes reportable. At my institution both of these would be reportable events. Our internal policies say that if someone leaves and comes back the next day we need a new sample with only few exceptions. We also don't require doctors to specifically order an elution. If a DAT is positive, an elution is automatically performed prior to the release of any blood products.

I agree - it becomes reportable as soon as you violate the procedure, it doesn't matter if patient safety was actually at risk or not.

[carolyn swickard]

"Our internal policies say that if someone leaves and comes back the next day we need a new sample with only few exceptions." - quote from Goodchild -

If you don't mind sharing - what are your exceptions? Why do you have exceptions?

[phan,binh]

If you violate your own internal policies when it relates to "manufacturing" (i.e. testing/etc) and the product is distributed, it becomes reportable. At my institution both of these would be reportable events. Our internal policies say that if someone leaves and comes back the next day we need a new sample with only few exceptions. We also don't require doctors to specifically order an elution. If a DAT is positive, an elution is automatically performed prior to the release of any blood products.

i am not knowledgeable about FDA reportable but i have this happened to me:

1/ i have a patient with a negative antibody screen; the DAT was accidentally performed that day and was positive.When i asked the referral lab wether to send the sample for an elution, they told me ,'there's no need, why did you do the DAT"?.i am confused but i did what they told me ..

2/ for Ag type unit: if we use the 0.8% cell suspension for doing qc (pos and neg) instead of the 3% cell susp (the unit has been dispensed), is it an FDA reportable? (Next day, the qc has been redone with the 3% and it was the same) . There was no any harm /effect or change on the unit.

Any explanation would be appreciated.

thanks

[jeanne.wall]

i am not knowledgeable about FDA reportable but i have this happened to me:

1/ i have a patient with a negative antibody screen; the DAT was accidentally performed that day and was positive.When i asked the referral lab wether to send the sample for an elution, they told me ,'there's no need, why did you do the DAT"?.i am confused but i did what they told me ..

2/ for Ag type unit: if we use the 0.8% cell suspension for doing qc (pos and neg) instead of the 3% cell susp (the unit has been dispensed), is it an FDA reportable? (Next day, the qc has been redone with the 3% and it was the same) . There was no any harm /effect or change on the unit.

Any explanation would be appreciated.

thanks

I’ll try to help phan,binh. You can check out the actual CFR reference yourself, 21 CFR 606.171, but in brief, you report any deviation from cGMP, regulations, standards, established specification or unexpected event that may affect the safety, purity or potency of the product, and involves a distributed product, when the deviation has occurred in your facility or under your facility’s control.

1/ This one is dependent on what your procedures say, if you violated your standard operating procedures and you issued product to the patient then it would be reportable. In general, whether the test was ordered or not, once you know the result, it is considered known and should be managed, so I’d have worked it up. The discussion with your reference laboratory has no impact on whether the situation is FDA reportable or not.

2/ Since QC was not performed correctly (incorrect cell suspension used) it could be reportable if the antigen type was done as part of pre-transfusion testing (manufacturing according to the FDA definitions) and the product was issued to the patient.

[phan,binh]

i am not knowledgeable about FDA reportable but i have this happened to me:

1/ i have a patient with a negative antibody screen; the DAT was accidentally performed that day and was positive.When i asked the referral lab wether to send the sample for an elution, they told me ,'there's no need, why did you do the DAT"?.i am confused but i did what they told me ..

2/ for Ag type unit: if we use the 0.8% cell suspension for doing qc (pos and neg) instead of the 3% cell susp (the unit has been dispensed), is it an FDA reportable? (Next day, the qc has been redone with the 3% and it was the same) . There was no any harm /effect or change on the unit.

Any explanation would be appreciated.

thanks

thanks for the explanation.

[Brenda K Hutson]

Case #1: Not sure on this one....but don't think it is just because you violated your own policy. I do not see that listed anywhere in the list of BPDs! Plus, there are many ways (minor even) one could not follow their own SOPs and they certainly would not all be reportable. I know that sometimes they can be picky about people being discharged; then coming back (i.e. Neonates); and suggesting they be redrawn. But that also does not seem reportable in that it happens all the time with Pre-Op patients or Outpatients being drawn for future Outpatient Transfusion. There was nothing else in this scenario??

2. Case #2 is much more clear-cut. Without investigating the Positive DAT, the patient was potentially at risk. Anytime you do not complete required testing (which now that you know the results of the DAT, you become responsible); with the exception of Uncrossmatched Products, you are putting a patient at risk and it is that potential risk, and the fact the Blood Banker let the blood go out that made it reportable.

Along those lines (and I suspect some will disagree with me on this); if someone performs an Antibody ID and gives out crossmatched, Antigen Negative blood based on their interpretation.....but then say the next day, the BB Supervisor reviews the work-up and sees that the Tech. neglected to rule-out a clinically significant antibody (could be any of them; let' s just say they did not test any cells that were negative for the identified antibody but positive for Jka), that would be reportable; regardless of whether further testing "at that point" revealed that there was no Jka present. It has to do with "potential risk at the time the blood leaves your possession." And what you don't know, could have been a risk (it could have gone either way).

Brenda Hutson, CLS(ASCP)SBB

[carolynn]

Brenda, I think you are right about Case#1 not being about failure to follow SOP. The reason being that it was presented as part of a study (Case 7... see Mabel's post) to see what percentage of CLSs surveyed knew what was considered reportable. In my opinion, the study would be meaningless if the cases presented were dependent on individual institutions' SOPs. This is the abstract from the study:

[h=1]Knowledge of food and drug administration reportable deviations

[/h]

1. Rebecca Lam,
   
   
2. Barbara J. Bryant
   

BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations.

STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service.

RESULTS: There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization.

CONCLUSION: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.

"Less importance was attached to deviations involving...using a recent sample from a previous hospitalization." Is there a regulation that states that a patient's blood bank specimen must be from the same admit? That may explain how pre-ops and outpatients can be banded and go home.

Case #2(8 in the study) is pretty scary to me, because I can imagine the former me (before reading the study and joining this group) failing to interview the patient and send out the specimen for an elution.

Thanks everyone for all your responses!