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Red Blood Cells

Secondary Bacterial Testing for Platelets

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5 hours ago, Smarty pants said:

I think Verax is the only one available.

Yup, Verax is the only one that is FDA approved so far.

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It's not a regulation yet. It is just a recommendation right now. The key word though is yet.

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22 hours ago, Red Blood Cells said:

if our blood supplier uses the pathogen reduction system we (blood transfusion service) will not be required to do secondary bacterial testing?

That's my understanding.

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23 hours ago, Red Blood Cells said:

So, if our blood supplier uses the pathogen reduction system we (blood transfusion service) will not be required to do secondary bacterial testing?

As I understand it, you would only need to perform secondary bacterial testing if you plan to extend the life of your platelets. In that case, you would also need to register with the FDA, if you have not already done so.

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On 3/19/2017 at 10:10 AM, Eagle Eye said:

Is this a regulation now and do we require to do this on day 4 and day 5?

There was a comment period for this about a year ago.  Still under FDA consideration as far as I know

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My blood supplier was anticipating that the comment period would end and that the FDA would move forward with this by the end of last year, early this year. Obviously that hasn't happened yet, but sloooooow is how they work.

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There is an even more insidious regulation on hold at this time.  It relates to lab developed testing.  For the blood bank it has been determined that apparently anything besides serum and cells is a LDT - LISS, enzyme, PEG, etc.  All labs would be required to submit their implementation of such enhancements within a specified time frame.  After that the $250,000 fee for an LDT would begin to apply.  AS of last June this policy was put on hold . . .  this came out at the TAC meeting I attended in Austin.  Just to make your day . . . :)

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On 3/29/2017 at 9:00 AM, David Saikin said:

There is an even more insidious regulation on hold at this time.  It relates to lab developed testing.  For the blood bank it has been determined that apparently anything besides serum and cells is a LDT - LISS, enzyme, PEG, etc.  All labs would be required to submit their implementation of such enhancements within a specified time frame.  After that the $250,000 fee for an LDT would begin to apply.  AS of last June this policy was put on hold . . .  this came out at the TAC meeting I attended in Austin.  Just to make your day . . . :)

Well, that would make my decision to retire very very easy!

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