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Trm.30950


bevydawn

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Can anyone please tell me their interpretation on this question concerning a small hospital blood bank that doesn't "manufacture" any products. My medical director and I are having a slight disagreement on the interpretation. Thank you!

**NEW** 10/31/2006

TRM.30950 Phase I N/A YES NO

Is there a policy requiring notification of the Centers for Biologics Evaluation and Research according to U.S. federal regulations when a biological product deviation occurs?

NOTE: A manufacturer is required to report to the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) as soon as possible, but not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred. In accordance with 21 CFR 606.171, transfusion facilities that are not licensed or registered with FDA are required to report to FDA any deviations or unexpected events associated with manufacturing that may affect the safety, purity or potency of a distributed product. Manufacturing in a transfusion service may include compatibility testing, component preparation, labeling, storage, and distribution of units for transfusion. A BPDR is reportable to CBER if the transfusion service releases a blood product from its control and the error has the potential to effect the safety, potency or purity of the product, even if it is not administered to a patient.

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BPDR applies to all testing done by transfusion services, as well as the blood center that draws the donor: all testing for types, screens, antibody identification, etc to get blood products ready for transfusion, the QC on the reagents you use, tagging the products, issuing the products, etc etc etc. So, short answer... it does definitely apply to a small transfusion service.

Here's the web site for BPDR. It explains what must be reported (and that is one huge list of possible errors and omissions!) as well as how to report. http://www.fda.gov/cber/reading.htm

We submit our reports on-line. The report part is pretty easy - just fill out their form with the requested information. The tricky part can sometimes be deciding what code to enter to identify your deviation. If you get it wrong, they will email and let you know what code you should have used. If you catch the error/omission prior to issue, it is not reportable. If you catch it after issue, even if not transfused, it IS reportable. If you submit a report and it wasn't really a reportable event, they will let you know that, too. It really is not that big of a burden once you figure out the process. A small facility should not have very many reports in a years time.

Edited by AMcCord
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The short answer is that everyone is required to comply with this. Even if all you do is store and crossmatch, you have to report blood product deviations that occur in your facility (Manufacturing in a transfusion service may include compatibility testing, component preparation, labeling, storage, and distribution of units for transfusion.)

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BPD need to be reported whenever something happens not in keeping with your hospital/BB policies. This includes errors made by nursing/anesthia staff - i.e. in the event the appropriate double checks are not performed at bedside.

We have questioned the FDA and were told that anytime a component is not in the BB's control (issued to a nursing unit) and anything is wrong (switched tags, labeling issues, nursing issues), that is reportable. So if you mis-tag a unit in the BB, but internal double checks catch it before you issue it, that's okay; but if you do issue it to the floor, that's reportable.

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Just to clarify Kate's reply: if the actual error is made by nursing *after* the unit has left your control, you do not have to report it as a BPD from your lab. Any error you make that gets out of your lab in the form of a product issued is reportable as a BPD. If the BPD error is not made in your institution, but you discover it, report it to the institution that made the error. They are obligated to report the BPD.

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I have a question for adiescast regarding this possible scenario:

Let's say the nursing unit requests a unit of blood on Ann Smith, the Blood Bank issues a unit for Ann Smith, and the nurse goes into the wrong room and transfuses the blood to Amy Smith. (Let's assume no fatal harm is done.)

Are you saying that this transfusion error does not need to be reported as a BPD?

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I have a question for adiescast regarding this possible scenario:

Let's say the nursing unit requests a unit of blood on Ann Smith, the Blood Bank issues a unit for Ann Smith, and the nurse goes into the wrong room and transfuses the blood to Amy Smith. (Let's assume no fatal harm is done.)

Are you saying that this transfusion error does not need to be reported as a BPD?

That is correct. Unless it is fatal, that error would not be considered a BPD by FDA. It would however, make a whole lot of other accreditation agencies nervous!
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  • 3 months later...

This has nothing to do with manufacturing a product. If you issue a product that does not meet the requirements it should have for the patient (ie. pt needed CMV- and you issued a non CMV_ unit) this is a BPDR. If you have a policy for a second check and a product was issued before the second check was done- this is a BPDR.

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  • 5 months later...
  • 1 month later...

So how would this apply if the lab were not informed by the clinical staff of any special requirements for a patient and issued non-irradiated etc components to someone who needed this? Who would thissituaton be reported to ?

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If it is stated in standard that certain population need this special requirement and if lab was informed of pt's diagnosis and lab fail to issue component as recomended by standard...you need to report to your STATE...atleast we do...I do not know about FDA???

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At our facility, Blood Bank SOP defines which diagnosis or patient population requires irradiated or leukopoor or CMV negative, HbS negative etc. Also SOP requires to view patient order or diagnosis in HIS when processing specimen or transfusion order.

So if we issue product that does not meet SOP criteria and information was available in HIS, we do report BPDR to FDA.

So it comes down to one's SOP how it is written.

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You may not manufacture anything, but you still have to report incidents where inappropriate blood is issued. We asked and were told to report an incident where a patient had a reaction to a unit due to anti-Wr(a). The screen was negative, IS crossmatch fine, but we happened to unfortunately give out a Wr(a+) unit. We didn't do anything "wrong" according to P&P, but they wanted it reported. It's easy to do on line, as is contacting them to see if an incident should be reported or not.

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  • 3 months later...

On my last inspection in 2007 I marked this one N/A because we are a smaller hospital that does not manufacture. I received a Phase I for it because things like transposing numbers and forgetting a Date/Time Thawed Plasma sticker are reportable according to my last AABB inspector.

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Your AABB assessor was correct, those things are reportable. Also, as I pointed out earlier, anyone who performs compatibility testing is required to report. You do not have to report errors that do not originate in your transfusion service and you do not have to report errors that do not affect the quality of the product. An example of the latter would be that you give a product a shorter outdate than necessary (like making your thawed ffp expire in 6 hours instead of 24). Switching tags on two red cell units going to the same patient, however, is reportable.

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If you go the CBER website you can see all the requirements for BPD reporting. If you are a transfusion service you are required to do this no matter who accredits you. This is one of the means the FDA is using to gain access to all transfusion services. I would beg to differ with some of the comments, esp reagarding "special" products. We do not have access to patient diagnoses and/or if we do, many times the diagnosis on file for the current admission does not implicate a condition which might require a special product. You need to review the CBER website . . . . this became a Federal regualtion in the late 19990's/early 2000's. I am surprised it took so long for your assessments to discover its absence in your protocols.

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