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Antigen Tested Units


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Hello All,

I am trying to revise our Blood bank policies and wanted to make some desirable changes in practice. We have been ordering " Antigen Tested Units " from our Blood supplier and have been repeating antigen testing in house to confirm them. I am not sure if we are required to repeat the testing because of regulations? I do not want my staff to repeat the testing. Can someone please enlighten me with details? Thanks in advance for your time.

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2 hours ago, Kathyang said:

When we order antigen testing, we don't re-test the unit. We do order historically tested units from our blood supplier and then we test it.

That's what we do as well.  If the unit comes from the supplier with an antigen test result on a separate tag, we do not retype it.  We also get a historical database from our supplier to test our own units.

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There are two types of "antigen negative" units we can get from our supplier here in Michigan.  One is "historically negative" -- those have to be retested when they arrive.  The other type is "confirmed" -- those units have been confirmed negative for a particular antigen at the supplier and do not need to be retested here.

Scott

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48 minutes ago, SMILLER said:

There are two types of "antigen negative" units we can get from our supplier here in Michigan.  One is "historically negative" -- those have to be retested when they arrive.  The other type is "confirmed" -- those units have been confirmed negative for a particular antigen at the supplier and do not need to be retested here.

Scott

Our policy as well.  

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3 hours ago, SMILLER said:

There are two types of "antigen negative" units we can get from our supplier here in Michigan.  One is "historically negative" -- those have to be retested when they arrive.  The other type is "confirmed" -- those units have been confirmed negative for a particular antigen at the supplier and do not need to be retested here.

Scott

This is our policy as well.

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On 11/9/2017 at 7:36 AM, SMILLER said:

There are two types of "antigen negative" units we can get from our supplier here in Michigan.  One is "historically negative" -- those have to be retested when they arrive.  The other type is "confirmed" -- those units have been confirmed negative for a particular antigen at the supplier and do not need to be retested here.

Scott

We do it this way also. 

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AABB standard 5.13 states

5.13 Serologic Confirmation of Donor Blood Red Cell Antigen Other Than ABO/Rh

Red Blood Cells products labelled as negative for red blood cell antigens other than ABO and RhD do not require repeat testing for the labeled antigens

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10 minutes ago, Marianne said:

AABB standard 5.13 states

5.13 Serologic Confirmation of Donor Blood Red Cell Antigen Other Than ABO/Rh

Red Blood Cells products labelled as negative for red blood cell antigens other than ABO and RhD do not require repeat testing for the labeled antigens

The above is interesting, and it is found under Transfusion Services standards.  Under collection facility standards, 5.8.4 says that untested units for "other" antigens may be labeled negative only if units from two previous donations were tested  by the collection facility.  Does anyone get this kind of information from their blood supplier?  We just either get a "confirmed negative" or a "historical negative" label, with the historical label specifically stating that confirmatory testing must  be done.  So I guess we are stuck with that.  Not really much of an issue here though!

Scott

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14 minutes ago, SMILLER said:

The above is interesting, and it is found under Transfusion Services standards.  Under collection facility standards, 5.8.4 says that untested units for "other" antigens may be labeled negative only if units from two previous donations were tested  by the collection facility.  Does anyone get this kind of information from their blood supplier?  We just either get a "confirmed negative" or a "historical negative" label, with the historical label specifically stating that confirmatory testing must  be done.  So I guess we are stuck with that.  Not really much of an issue here though!

Scott

Is that collection facility standard referring to the actual product label, and not a hang tag or other type of tag?

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We do the antigen testing for units ordered from our blood service.  We have found units that were supposedly negative for an antigen but actually positive.  We also are required by our computer system to enter the antigen testing results for a unit before it will allow the selection of that unit to a patient with the corresponding antibody.  

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19 hours ago, BldBnker said:

We do the antigen testing for units ordered from our blood service.  We have found units that were supposedly negative for an antigen but actually positive.  We also are required by our computer system to enter the antigen testing results for a unit before it will allow the selection of that unit to a patient with the corresponding antibody.  

How do you handle those that you don't have antisera for - like Vel for example?

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On 11/14/2017 at 9:17 AM, Marianne said:

AABB standard 5.13 states

5.13 Serologic Confirmation of Donor Blood Red Cell Antigen Other Than ABO/Rh

Red Blood Cells products labelled as negative for red blood cell antigens other than ABO and RhD do not require repeat testing for the labeled antigens

Based on these standard we stoped retyping the units but we have internal process to check the clerical entry by our staff.

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On 11/14/2017 at 9:34 AM, SMILLER said:

The above is interesting, and it is found under Transfusion Services standards.  Under collection facility standards, 5.8.4 says that untested units for "other" antigens may be labeled negative only if units from two previous donations were tested  by the collection facility.  Does anyone get this kind of information from their blood supplier?  We just either get a "confirmed negative" or a "historical negative" label, with the historical label specifically stating that confirmatory testing must  be done.  So I guess we are stuck with that.  Not really much of an issue here though!

Scott

This standard is for collection facility and based on these standard BBTS standard was updated and stated that we do not need to retype the unit...

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Right.  But please look at AABB standard 5.8.4.  As I mentioned above, the donor processing facility can only label a unit as tested negative (far a particular antigen) if that has been done on two separate occasions.  In that case, or if the unit in question was tested by the donor facility, the donor facility could indeed label the unit as "negative for RBC antigens".  Otherwise, it would have to be tested, either by the donor facility or when it reaches your blood bank.

After all, every donation by a donor is typed twice for ABO before a patient gets it.

Scott

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  • 3 weeks later...
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  • 4 weeks later...
On ‎11‎/‎10‎/‎2017 at 12:38 PM, Malcolm Needs said:

That is terrible - absolutely unacceptable.

Yes terrible.  I am hoping this was reported by the FDA by the blood supplier.  Scary.  @Baby Banker This should never happen ever.

Edited by Gnapplec
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