Secondary Bacterial Testing for Platelets

[Red Blood Cells 0]

What test is your transfusion service going to do for the secondary bacterial testing that is being required by the FDA?

[Smarty pants 31]

I think Verax is the only one available.

[Dan87 18]

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.

[MaryPDX 39]

Wonder what will be required for PAS platelets? Verax can't be used on PAS platelets, so we avoid getting those when possible. 

[Eagle Eye 203]

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

[pinktoptube 45]

I didn't think it was a regulation yet...

[Gkloc 72]

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

[kate murphy ★ 176]

We have implemented Verax testing - only used for 6 and 7-day extension at present.  If/when we are required, we can expand to 4 and 6-day platelets. 

[lehooke1 3]

We will not be using the Verax point of issue testing. Our blood supplier will be going to the FDA approved pathogen reduction system, INTERCEPT, by CERUS.

[Red Blood Cells 0]

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

[mollyredone 318]

 

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.

[lehooke1 3]

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.

[David Saikin 1,359]

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

[AMcCord 1,229]

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.

[David Saikin 1,359]

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 . . .

[kate murphy ★ 176]

The hell you say!  Why even bother with FDA approved reagents?!?! 

[AMcCord 1,229]

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!

[mollyredone 318]

On 3/31/2017 at 5:20 AM, AMcCord said:

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

Mine too!

[Eagle Eye 203]

PAS ---we do not need to do testing ...but can not be extended to 7 days..

I thought there was a limitation that supplier could not collect 3 bags?