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Logan51

Cell-Salvage Regulations

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Hello,

I would like to ask for any advice about the minimal QC requirements for cell-salvage devices.   Both myself and my Medical Director are fairly new to our roles here and Intraoperative Cell Salvage is not something that either of us has much experience with. 

Our facility utilizes Cell-Savers and historically we have received about 4 QC samples/year which we have performed and reported a Hct on.  I have recently noted that we have not received any QC samples in more than six months and reached out to the head of our Anesthesia, whom is ultimately responsible for the devices.  He has reported to me that they only periodically use the Cell Savers and doesn't feel that QC is worth-while any longer.  My initial response is that as a CAP Laboratory we need to ensure the safety and efficacy of the recovered blood components (TRM.41550); and recommended that they should at least perform QC on the day of use.  However, I am wondering what, if any, other regulations we are subject to?  I see that AABB has Standards for Perioperative Collection and Administration which states that a QC program should be in place but we are not accredited in any way by AABB.  I'm sure the manufacturer publishes an Instructions for Use, do these typically include requirements for QC? (for which I'm sure FDA and JCAHO would require us to follow).  I wasn't involved in the implementation of these devices and I don't even know how we decided upon the plan for the quarterly Hct so any insight will be very much appreciated.

Thanks

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I have a letter exculping us from responsibility for the use of cell savers (moot point now since we no longer have one).

This always satisfied AABB and CAP.  The Medical Director was involved in the setting up of the device and would make suggestions on QC.  It's been quite a while since we used these.

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Hi Logan,

I am an AABB perioperative assessor  (and laboratory manager :) )that  works at a facility in Boston MA that uses cell salvage on over 3,000 cases annually. We have 11 machines, and although we are not (yet) accredited by AABB, with the work we have done with our program, we are hoping to be accredited for periop by our next BB inspection.

I got involved in this because our SVP for surgical services asked me, as the resident AABB SME, LOL, to evaluate effectiveness of cell salvage at our facility. She wanted us to adhere to the AABB standards and thought I was their best candidate to lead the effort. 6 years later, the past practice is truly history.

To answer your question, we do QC quarterly on each machine that we have in use--- Hgb and Albumin. AABB allows you to decide what and how much is needed, but for quality purposes, you really do need something to make sure your equipment (and operator) is obtaining the best possible product for the patient in between PM's. If you would like more information on our approach, I am happy to share what we do, just message me and I will give you my work contact information.

Between Cell Salvage and other specific PBM strategies, we have reduced our organization-wide transfusion ratio per adjusted patient discharge, from 0.78 to 0.17, in ~5 years time. ( Caveat: The cell salvage program overhaul took some time and was truly implemented last).  I actually like to think it is because Blood Bank is involved, but honestly, it takes a village and I had to build influence up with the surgical services team and make really good use of my role as Transfusion Committee Facilitator to make things happen.

Best,

Linda

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23 hours ago, Linda0623 said:

Hi Logan,

I got involved in this because our SVP for surgical services asked me, as the resident AABB SME, LOL, to evaluate effectiveness of cell salvage at our facility. She wanted us to adhere to the AABB standards and thought I was their best candidate to lead the effort. 6 years later, the past practice is truly history.

Linda

The key here is they came to Linda and asked for help!  :coffeecup:

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