Twice daily for our standard in date panel.

ad hoc, when we use them, for expired panels.

:(:(

Malcolm,

So you do perform QC on your indated panels also? And you may have said this before, is that a UK thing? I have never heard of any regulation in the U.S. requiring us to perform QC on indated panels, and no definitive instructions to do so on outdated panels.

Also, unless I missed something, I still have not seen the reference from the person who said CAP requires this QC??

Brenda Hutson, CLS(ASCP)SBB

Malcolm,

So you do perform QC on your indated panels also? And you may have said this before, is that a UK thing? I have never heard of any regulation in the U.S. requiring us to perform QC on indated panels, and no definitive instructions to do so on outdated panels.

Also, unless I missed something, I still have not seen the reference from the person who said CAP requires this QC??

Brenda Hutson, CLS(ASCP)SBB

Hi Brenda,

It is not only a UK thing, but it is, as far as I know, an NHSBT thing (which means it only applies to the Blood Service in England); not the hospitals and not the Welsh, Scottish and Northern Irish Blood Services.

I did not write the SOP (if you see what I mean)!!!!!!!

Expired panels are QCed as we use them, rather than twice a day, but when used have to be QCed.

:(:(

Hi Brenda,

It is not only a UK thing, but it is, as far as I know, an NHSBT thing (which means it only applies to the Blood Service in England); not the hospitals and not the Welsh, Scottish and Northern Irish Blood Services.

I did not write the SOP (if you see what I mean)!!!!!!!

Expired panels are QCed as we use them, rather than twice a day, but when used have to be QCed.

:(:(

But you are saying you QC Indated panels also, correct?

Brenda

But you are saying you QC Indated panels also, correct?

Brenda

That is exactly what I mean.

i know, I know!!!!!!!!!!

:(:(

Wow,

Glad you didn't let me come work for you Malcolm! That sounds insane!

Malcolm,

Does that QC protocol apply to all BB's in England or just to reference labs there? The reason I am asking is because the frequency of QC may have to do with use. I can not see the logic behind QC'ing the panel cells twice a day in a small hospital setting.

Malcolm,

Does that QC protocol apply to all BB's in England or just to reference labs there? The reason I am asking is because the frequency of QC may have to do with use. I can not see the logic behind QC'ing the panel cells twice a day in a small hospital setting.

And again, I have not seen a requirement from any of the regulatory agencies (in the U.S.) that stipulates we must QC Antibody Panels.

Brenda Hutson

Maybe some of you missed the point of Malcolm saying "He didn't write the SOP".

But, for those using expired panels un-Qc'd in any fashion. How would the legal legs stand under that if there were an adverse reaction in a patient in whom and antibody was undiagnosed? We all know that a lot of testing is litigation driven - right? (I know we could get into years of discussion of the make-up of ID panels, but we had best avoid that).

Cheers

Eoin

Maybe some of you missed the point of Malcolm saying "He didn't write the SOP".

But, for those using expired panels un-Qc'd in any fashion. How would the legal legs stand under that if there were an adverse reaction in a patient in whom and antibody was undiagnosed? We all know that a lot of testing is litigation driven - right? (I know we could get into years of discussion of the make-up of ID panels, but we had best avoid that).

Cheers

Eoin

I did not miss that he did not write the Policy (and does not necessarily agree with it). I just wanted to clarify what he was saying.

Also, I certainly never said we should not QC Expired Panels; in fact, I belive that was the title of this Thread. I do QC expired panels; but it was interesting to see different ways people accomplished that (in that since I have yet to hear the reference stipulating it must be done), in that there is no documented method to perform that QC.

Thanks,

Brenda Hutson, CLS(ASCP)SBB

Hi Brenda,

Sorry, I wasn't referring to your post and I agree with you totally - maybe there should be a protocol. I am going to raise it with our local Expert User Group as a recommendation, because it is clear there are varied ways of doing it - if we adhere to a recognised "Standard or Rcommendation " then there is some legal comfort as well.

Cheers

Eoin

Wow,

Glad you didn't let me come work for you Malcolm! That sounds insane!

Aw come on; I did say that I didn't write the SOP. I just have to follow it!!!!!!!!!!!

:(:(

Malcolm,

Does that QC protocol apply to all BB's in England or just to reference labs there? The reason I am asking is because the frequency of QC may have to do with use. I can not see the logic behind QC'ing the panel cells twice a day in a small hospital setting.

Just Reference Laboratories (where, of course, most of our samples contain antibodies anyway - so we know they are working)!!!!!!!!!!!!!!!

:(:(:(

Aw come on; I did say that I didn't write the SOP. I just have to follow it!!!!!!!!!!!

:(:(

I suspect she was referring more to your situation (i.e. the rules you have to live under) rather than to you personally, although I hate to speak for others who are perfectly capable of speaking for themselves!

I suspect she was referring more to your situation (i.e. the rules you have to live under) rather than to you personally, although I hate to speak for others who are perfectly capable of speaking for themselves!

Fair comment!

:D:D:D:D

For those of you who are performing QC on panel cells, how often are you performing QC on panel cells, expired? or indate lots? Upon Receipt, daily, day of use?

Thank you in advance for your response,

DMR

What does your package insert require. You must adhere first to manufacturer's insert. I believe Ortho requires QC upon receipt.

If you deviate from CGMP i.e. using expired panel cells there should be a policy in place and quality control performed to assure reactivity etc....

Call your manufacturer, they should know the regulations more than anybody.

here's part of....

Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components

TESTING:

Testing events include those that occur during testing, which you did not discover until after you distributed the product. This includes testing that was not performed or was performed incorrectly. It includes situations where there is no record of testing and the safety, purity, or potency of the product may be affected. This also includes testing performed using incorrect or inappropriate (e.g., expired) samples, reagents, or media.

Under 21 CFR 600.14(, you must submit a report when there is an event (a deviation or unexpected or unforeseeable event) during testing that may affect the safety, purity, or potency of a licensed product you distributed. Examples of reportable events during testing may include:

• Safety, purity, potency, sterility, identity, or stability testing was
  
  • Not performed or not performed at required interval; or
    
  • Performed incorrectly.
    

  [*]There was no documentation of testing performed.