FDA reportable

[nickels24]

I recently had a webinar in which someone stated that not issuing a unit in the computer was an FDA reportable error. This happens occaisionally, though, we've never reported to the FDA. Anyone have an ideas if this is something that should be reported?

[David Saikin]

Does not issuing it in the computer affect purity, potency, effectiveness of the product? I think not. However, if you have special instructions and did not follow them and discovered them "after the fact" when finally using the computer THAT would be a reportable biologic product deviation. Years ago I was performing an AABB inspection at a facility which had a BBIS but issued the units manually and then back entered them in their system. When we got to the patient care area to observe the transfusion, the unit had to be returned because it was supposed to be irradiated (and was not). If you have a BBIS you should be using it; it is foolish to use both paper and the BBIS. Is it in your policy to sign out product on paper and then back enter? If so you should amend it. If it is not, the computer should be used as defined in the policy. If you have staff that cannot use it they should either be retrained or offered employment elsewhere.

[nickels24]

We have a BBIS and only use the paper system when our computers are down. We don't typically have a problem with units not being issued in the computer. It happens only rarely and usually when multiple units of red cells and plasma are being issued to the OR and the tech accidentially misses scanning one unit. We catch it the following day when the inventory doesn't match and post issue it in our computer. I know that if we miss a special need that is FDA reportable. We have Horizon Blood Bank and are looking to upgrade to 3.5, and one of the improvements is that there will be a window that pops up after hitting OK that tells you the units was successfully issued. Someone else in the webinar was really excited about this because she said not issuing in the computer is an FDA reportable error. I just wanted to know if someone had any knowledge of this because if there weren't any problems or special needs not met, we have not been reporting these.

[SMW]

It is reportable. SOP was not followed and it has the potential to affect safety, purity potency of product, e.g., wrong unit, wrong type, wrong attributes, unit in quarantine/hold. Whether in the particular situation it actually affected safety, etc. does not come into the decision tree...it's if it might have (MAY).

From the FDA guidance document for what is to be reported:

1. Either:

a. 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

YES

b. 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; YES and

3. Involves a distributed blood or blood component. YES

[Lori McClintock]

We were just inspected by the FDA in January. We did report to the FDA when a product wasn't issued in the computer, and she agreed that we should. The reason being, at the time of issue, we document in the computer that the visual inspection at that time is "ok". By forgetting to issue it in the computer, we were not documenting the final visual inspection when the unit left the blood bank, so it was reportable.

This occured only on units we had to deliver to the OR or the ER. We would just pull part of the unit tag and document where the unit went, date, time and who delivered. Now we add "ok" for visual inspection.

[adiescast]

I was also told by FDA that it is a reportable error if you have computer based issuing and fail to complete and save the process at the time of issue. It is not reportable if you are deliberately on "downtime" and follow your downtime procedure, which should include the visual inspection before release.

[Eagle Eye]

We have a BBIS and only use the paper system when our computers are down. We don't ... because if there weren't any problems or special needs not met, we have not been reporting these.

we used to have lots of errors where tech forgot to issue unit in BBIS but physically unit was issued. we kept documenting occurances and made a change in our process where we print transfusion slip at the time of dispensing and the slip has computer generated date and time. Also you must scan the unit barcode before dispensing. SO there is no room for an error.

we have a zero tolerance for such occurances now since we changed whole process to make system fool proof.

[Lcsmrz]

Since going live on the online Transfusion Administration Record, the only way to issue a unit is in the computer. No form is generated or physically signed, and all nursing info is entered at a bedside terminal.

It would be FDA-reportable at our site if the unit left the Blood Bank without being issued in the computer.

[Eagle Eye]

when we are talking about reporting to FDA(particularly in this case), is this for licensed and registered facility or for everyone????

[Lcsmrz]

All transfusion services are required to report Blood Product Deviations.

There is always a discussion over what is considered a reportable event ...

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129716.htm

[Antrita]

I have a question. Do you have to report a blood type computer entry error when the test is not connected to a transfusion. A sister hospital asked me and I said no but now I'm not sure. It was an out-patient order just for a blood type. The error was caught the next day and corrected.

Antrita

[KKidd]

Since no blood was issued to the patient, it is my understanding that the error would not be reported.

:cool::cool::cool:

[vilma_mt]

I have a question. Do you have to report a blood type computer entry error when the test is not connected to a transfusion. A sister hospital asked me and I said no but now I'm not sure. It was an out-patient order just for a blood type. The error was caught the next day and corrected.

Antrita

Not reportable since no blood was issued. Even if it was part of a crossmatch, if the error was caught and corrections made prior to issue of any unit... still not reportable error.

[rravkin@aol.com]

It seems that there are certain checks that the computer makes and the manual system does not. If the manual system were designed to make these same checks and held accountable, through a form that is part of your issueing proceedure, then would this system be FDA reportable? Do we not have manual issue systems in place when, as one poster pointed out, our computers are down? So it seems that if history and attribute checks are accountable manually the why would manual issue be a reportable event?

[Eagle Eye]

i believe if our computer is down and our SOP is defined that we will issue units manually and will complete transaction when computer system is available, then this case is not reportable.

But if the system is not down and someone forgets to issue the unit in computer...it is consider FDA reportable....THis is my understanding from all the above posts????

[jcdayaz]

I might get blasted here....but on rare occasion we will issue a unit and do the computer issue later. Rare occasion--Emergency release situations where you have no patient ID whatsoever, computer being down and having a critical patient anywhere in the hospital, etc. We are "paperless" but still have a printed transfusion form that is associated with each unit crossmatched. There is a place to note that the unit has been inspected and is suitable for transfusion on the form. We are an AABB certified Blood Bank and our procedure has never been questioned by AABB, FDA, CAP or JACHO.

[Dr. Pepper]

jcdayaz, we do the same thing for emergency release and downtime. We document on a downtime form that the unit appearence and check of patient/donor data and special requirements is OK and catch up in the computer later.

[heathervaught]

Yes, I think that it boils down to: was the unit issued in error?

If you are intentionally releasing a unit using a method that does not involve a computer, then you have built checks and balances into the manual system to ensure that the component is acceptable for release. In this case, you have not made an error.

If you fail to use the computer system when that is your primary method for issuing components, then you circumvent all of the checks and balances that are built into the system. I don't claim to be an expert on the FDA, but if the question is does this have the potential to harm the patient, you have to answer that it absolutely does.

[adiescast]

Heather is correct. The reportable issue is performance and documentation of the issue process. The reportable error occurs when units are issued without documentation of all the proper checks at the time of issue. Thus, it would also be reportable if you have a manual system in place and the unit is issued without documentation in your manual log (or form, or whatever your process is). Because, as everyone knows, "if it wasn't documented, it wasn't done."

[Ellen Zeigler]

This is reportable to the FDA. This issue is not purity, etc, but the ability to track a product years from now if there is a lookback, recall or market withdrawal. The code is QC-97-19

The best way to get an idea of what is and is not reportable, is to look at the coding scheme. Obviously a lot are collection related issues, but not exclusively. If your crossmatch tags that are attached to the product are wrong, or you send out the wrong product, or patient.

here's the link to the coding

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129721.htm

and the specifics for the failure to electronically release that is under QC and distribution:

QC-97-19 Product not documented or incorrectly documented as issued in the computer (computer documentation is final check of issue process)

[Antrita]

I have also e-mailed the FDA twice when I was not sure if something was reportable. I find their website a little

confusing. Both times they answered me within 24 hours.

Antrita

[barobinson]

We have been reporting all of ours except for trauma patients where we have units stored in the ED and OR refrigerator or if we never receive a sample and are just giving out O Neg uncrossmatched. The FDA document is pretty clear. In addition, since there are so many checks that occur for the electronic crossmatch at the issue step we feel we could really cause harm if somewhere up stream we had over looked a QA message. The issuing in the computer is the last step. Now obviously during computer down time we would not report those.