Three reportable scenarios, can anyone explain?

[anonimmuno]

Hi, I am researching case studies and I came across three that I wanted some opinions on:

1) Type and screen testing was performed with expired A1 and B cells. A unit of blood was crossmatched with this type and screen and issued for a patient's transfusion. Is this reportable? Or are expired typing reagent errors reportable for blood donor centers only? The patient had a previous history with the transfusion service and the blood type from the expired reagents matched the patient's history.

2) An antibody patient required Jk(a) negative units. The technologist phenotyped two units for transfusion but did not document the lot #, manufacturer or expiration date of the typing sera. The products were labeled, crossmatched and issued for transfusion. Is this reportable? Would this be considered a minor clerical error?

3) A transfusion service has a sickle cell patient policy where they all receive Rh/Kell matched Hgb S-negative units. A patient comes in through the ED but the transfusion service is never notified that the patient has a history of Sickle Cell disease. The patient receives a blood product from the general population which is later found to be antigen positive. Is this reportable to the FDA?

If any of these are reportable, why? Thank you for your help !!!

[SMW]

The following algorithm is used to determine if something is FDA reportable (by both blood centers and transfusion services). An incident is reportable if all 3 conditions are met:

1. Either

i. Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or

ii. Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and

2. Occurs in your facility or a facility under contract with you; and

3. Involves a distributed blood or blood component.

So for the 3 examples you described:

1. Reportable. Use of expired reagents represents a deviation from good manufacturing practice, etc., occurred in your facility and product was distributed.

2. Reportable. No documentation represents a deviation from current good manufacturing practice, etc., occurred in your facility and product was distributed.

3. Not reportable. Condition 1 not met since sickle cell history not provided/received. If information had been provided and policy was not followed, then it would have been reportable since conditions 1i, 2 and 3 would have been met.

NOTE: Manufacturing includes testing, processing, packing, labeling, or storage, or with the holding or distribution of blood or a blood component.

[anonimmuno]

I'm familiar with the algorithm, seems like so many things can be interpreted a dozen different ways. Wouldn't the 3rd scenario fall under the "unexpected or unforseeable" event side seeing that it was something unforseeable that may have affected the safety purity or potency of the product?

[David Saikin]

I agree with SMW

[SMW]

I'm familiar with the algorithm, seems like so many things can be interpreted a dozen different ways. Wouldn't the 3rd scenario fall under the "unexpected or unforseeable" event side seeing that it was something unforseeable that may have affected the safety purity or potency of the product?

Just as inappropriate adminstration practices by hospital staff are not reportable, I believe inappropriate ordering practices by hospital staff are not reportable either. The information was not within the control of the blood bank/transfusion service.

[anonimmuno]

Just as inappropriate adminstration practices by hospital staff are not reportable, I believe inappropriate ordering practices by hospital staff are not reportable either. The information was not within the control of the blood bank/transfusion service.

Yes but debating with you in that vein, if you crossmatch and issue a unit based on a mislabeled specimen and find out about it later on, that is reportable. The information that it was a mislabel was not within the control of the blood bank/transfusion service at the time of issue, but it falls under the unexpected events side.

Are there any other viewpoints out there? Ironically others have looked at the first two as questionably/doubtfully reportable and the third case as reportable.

[SMW]

Yes but debating with you in that vein, if you crossmatch and issue a unit based on a mislabeled specimen and find out about it later on, that is reportable. The information that it was a mislabel was not within the control of the blood bank/transfusion service at the time of issue, but it falls under the unexpected events side.

Biological Product Deviation reporting is required for product deviations in manufacturing (21 CFR 606.171). Labeling is considered part of the manufacturing process so is reportable. Product odering is a practice of medicine and not manufacturing so is not covered by the rule and therefore is not reportable. Blood administration is also not part of manufacturing hence is not covered by the rule and therefore is not reportable.

Are there any other viewpoints out there? Ironically others have looked at the first two as questionably/doubtfully reportable and the third case as reportable.

Based on the rules for reporting, what is the rationale of those that feel the first two are questionable/doubtful? From what you described, they seem very straight forward in meeting the three requirements for reporting since they 1. represented cGMP deviations, 2. they occurred in your facility and 3. the product was issued.

[AMcCord]

Based on the rules for reporting, what is the rationale of those that feel the first two are questionable/doubtful? From what you described, they seem very straight forward in meeting the three requirements for reporting since they 1. represented cGMP deviations, 2. they occurred in your facility and 3. the product was issued.

I agree.

[anonimmuno]

Thanks everyone for posting your perspectives! I discussed these cases with the people at my blood bank and found the deeper meaning of why they didn't really see the first two situations as reportable. If the second situation was discovered at your hospital (no record of phenotyping info for units transfused to antibody patient) would you actually report it? Or would there be a brief counseling, correction of information, maybe a process change (different method of documentation, review all problem patients full record before issue, etc) and call it a day? Is reporting something like this being unreasonable/nitpicky?

[Eman]

Thanks everyone for posting your perspectives! I discussed these cases with the people at my blood bank and found the deeper meaning of why they didn't really see the first two situations as reportable. If the second situation was discovered at your hospital (no record of phenotyping info for units transfused to antibody patient) would you actually report it? Or would there be a brief counseling, correction of information, maybe a process change (different method of documentation, review all problem patients full record before issue, etc) and call it a day? Is reporting something like this being unreasonable/nitpicky?

FDA doesn't really have an exception that allows you to not report things that you feel are unreasonable/nitpicky. If you're aware of a reportable event and choose not to report you should have thorough documentation as to your reasoning behind the decision. And you could still get a 483 if they don't agree.