Hi,

Happy Holidays to you all! Has anyone done a blood utilization survey required by FDA? My manager assigned me to do one for 2017. I have no idea what information is needed. I was wondering if you guys have any previous experience with it? Thanks for your time and attention.

Make sure you get yourself plenty of time to work on it - its a doozy. They want to know how many blood products you've transfused, what categories of patients have received what products (pediatrics, general surg, heme/onc, etc.), avg age of products when transfused, etc. etc. Past surveys have drilled pretty deep. If you have a good computer system, you should be able to pull nice reports. If you are on paper, like I am, you will pull your hair out. Good luck!

One presumes that the FDA know what they want you to do. Perhaps you should ask them......?

I know, my advice is not very enlightening, but second-guessing what hoops the regulatory agencies want you to jump through is an exercise in futility.

21 hours ago, exlimey said:

One presumes that the FDA know what they want you to do. Perhaps you should ask them......?

I know, my advice is not very enlightening, but second-guessing what hoops the regulatory agencies want you to jump through is an exercise in futility.

There will be full instructions on the survey paperwork. It changes from survey to survey - they ask for something new about every survey, nothing ever goes away.

29 minutes ago, AMcCord said:

There will be full instructions on the survey paperwork. It changes from survey to survey - they ask for something new about every survey, nothing ever goes away.

Why am I not surprised ?

On ‎12‎/‎25‎/‎2017 at 11:25 PM, Jane12 said:

Hi,

Happy Holidays to you all! Has anyone done a blood utilization survey required by FDA? My manager assigned me to do one for 2017. I have no idea what information is needed. I was wondering if you guys have any previous experience with it? Thanks for your time and attention.

Are you sure that the survey is required by the FDA?

 

I remember one from a few years ago and it was from the AABB and not required so I did not do it.

 

Edited December 28, 20177 yr by R1R2

If its the survey I'm thinking of, it is actually a biennial survey for HHS (I think) and yes, AABB sends it out/has a link for it. It is a voluntary survey to collect information on transfusion practices in the US. Its still a stinker .

On 12/27/2017 at 7:56 PM, R1R2 said:

Are you sure that the survey is required by the FDA?

I remember one from a few years ago and it was from the AABB and not required so I did not do it.

 

20 hours ago, AMcCord said:

If its the survey I'm thinking of, it is actually a biennial survey for HHS (I think) and yes, AABB sends it out/has a link for it. It is a voluntary survey to collect information on transfusion practices in the US. Its still a stinker .

Fascinating.....voluntary, but, it appears, strongly encouraged. I wonder in how many institutions this has been translated to "mandatory"?

I lean toward R1R2's position - don't do it, especially if it is indeed a "doozy" or a "stinker". We're all busy enough already. Unless the survey organizers (FDA) are going to provide funding for such an exercise......

I have always wondered what is done with the information from such surveys.  Are decisions made and action taken or simply are heads scratched and eyes rolled?  Are they undertaken simply for the "that's interesting" factor of the information?   

6 minutes ago, John C. Staley said:

I have always wondered what is done with the information from such surveys.  Are decisions made and action taken or simply are heads scratched and eyes rolled?  Are they undertaken simply for the "that's interesting" factor of the information?   

You cynic John - and I agree entirely with your cynicism!

27 minutes ago, John C. Staley said:

I have always wondered what is done with the information from such surveys.  Are decisions made and action taken or simply are heads scratched and eyes rolled?  Are they undertaken simply for the "that's interesting" factor of the information?   

I agree too.

I find it additionally perplexing that that information from these types of surveys usually takes a few years to be compiled and published. Not much use after the fact.

I was not going to say that I promptly threw it in the circular file because I was afraid of being "shamed" for doing so but I threw it in the circular file promptly.  

I have done one that is CDC/HHS with the following information at the prompting or request of my lab director:

"Your contribution is vital to this national effort to estimate and project future needs of blood collection and blood utilization in the United States.  For more information related to NBCUS, the findings of the 2015 survey were published in a June 2017 Transfusion supplement issue¹.

 

Jefferson Jones, MD MPH

Medical Officer

LCDR USPHS

Office of Blood, Organ, and Other Tissue Safety

Division of Healthcare Quality Promotion

Centers for Disease "

18 hours ago, bldbnkr said:

"Your contribution is vital to this national effort to estimate and project future needs of blood collection and blood utilization in the United States.  For more information related to NBCUS, the findings of the 2015 survey were published in a June 2017 Transfusion supplement issue¹."

Pretty sure that every blood supplier out there is already doing this both locally as well as nationally depending on the size and reach of the organization with plans of actually utilize the info for planning for the future.  The govt on the other hand.......... well, not so much.  Just keeping bureaucrats employed.  

You are right Malcolm, am very cynical as well as pessimistic.  The thing is, when I'm wrong it's a good thing!

Thanks for all the advice. I apologize, it is from CDC not from FDA. The email said that We are required to participate in the survey if our organization performed more than 1000 transfusions in an year. I do not think I have an option to opt out.

Just curious but did they indicate what the penalty would be for not complying?   

On 12/31/2017 at 8:50 AM, John C. Staley said:

Just curious but did they indicate what the penalty would be for not complying?   

A serious finger wagging ????? Twelve lashes with a wet noodle ????? A stern, disapproving look ?????

On 12/31/2017 at 12:09 AM, Jane12 said:

Thanks for all the advice. I apologize, it is from CDC not from FDA. The email said that We are required to participate in the survey if our organization performed more than 1000 transfusions in an year. I do not think I have an option to opt out.

I would check the regulations VERY carefully. I suspect it would be very difficult to make this kind of thing mandatory, especially if there is some arbitrary cutoff (transfusions/yr).

On the other hand, if your boss would LIKE you to participate, it might take some clever moves to convince them to decline. Good luck.