Perioperative Cell Salvage QA/QC/Consent

[dbrown]

Hello All,

I am writing today to see what types of QC are performed on Peri-operative cell salvages. I recently found out that we (our OR) is not runnging QC. This lead to finding and reading standards. I am wondering if anyone is willing to share information regarding their program and SOPs, QC, QA, Maintenance, Consent, etc.

I have the feeling that I should in the Transfusion Service have information regarding these procedures and how they are handled in our facility, even though we contract the services to a third party. This party seems to have very minimal requirements and documentation may be sketchy from a blood bankers view.

Do organizations allow "units" to leave the OR for transfusion on the nursing unit. And if you do how do you document according to the standards. I have been told that the unit here sometimes is infused by nursing, but we have no bedside check documentation etc. This process (lack of)makes me very nervous.

Thanks Deanna

A Transfusion Service Section Head.

150 bed organization

[SMILLER]

I would check your regs.  In the US, that would be the FDA and whoever else inspects the facility (the hospital system inspection agency - not just the Lab!).  Then you should let your director know your concerns.

 

I do not know all the details here, but I know that OR periodically sends a form with blood specimens on a regular basis for all of our "cell-savers".  We run and document the Hct, and later the results of a culture.

 

Scott

[cthherbal]

We contract with an outside service which does quarterly QC. We get quarterly usage/QC reports and review them at our Transfusion Committee meetings.

[ltechlin]

I would check your regs.  In the US, that would be the FDA and whoever else inspects the facility (the hospital system inspection agency - not just the Lab!).  Then you should let your director know your concerns.

 

I do not know all the details here, but I know that OR periodically sends a form with blood specimens on a regular basis for all of our "cell-savers".  We run and document the Hct, and later the results of a culture.

 

Scott

I work at the same facility as Scott.  To expand on his answer, when we set up QC for our cell savers we also consulted the equipment's manual to see what requirements the manufacturer had.  We check that the hematocrit is greater than 50% to verify that the blood collected is washed correctly before reinfusion.  We also have surgery draw two sets of pediatric blood cultures.  One from the patient (maybe they are septic!) and a second one from the salvaged blood prior to reinfusion.  The cell saver sample should have no growth unless 1) the patient already had septicemia 2) there was a skin contaminant (staph) or 3) a problem in surgery (such as the bowel being nicked).  In the case of #2, the surgical staff assures me that a skin contaminant is an acceptable part of the process and TJC/FDA has never questioned this.  In the case of #3, this should never/rarely happen.  The surgical staff tells me that if something happens in surgery where there is question of serious contamination of the salvaged blood, they shut down the process and discard it.  In the past 5 years of reviewing these QC samples, I think I have only seen one bowel related contamination. 

 

When we set this up, we initially did QC monthly.  Once the lab and surgery had a good handle on the process and results were acceptable repeatedly, we changed to QC quarterly for each cell saver in surgery.  Our hospital associates handle the cell savers in surgery, not a 3rd party.  Although surgery is responsible for running this equipment, it falls on the blood banks shoulders to monitor the QC process.  We also monitor competency with hospital education in the form of competency module on-line annually for the surgical associates.

 

Off the top of my head, I believe that salvaged blood may continue to be reinfused to the patient while in the recovery room, but typically it is completed before the patient would head back to his room.  Again, without rereading our policy (I am at home) the units are labeled with the typical patient demographics/ID and with a bright green sticker that states it is an autologous product (purchased from Shamrock).

[carolyn swickard]

Third party providers can be notoriously difficult to get information from - at least ours is.  At a minimun, if you hospital Lab is Joint Commission accredited, they will want to see documentation that your Medical Director is aware of and has reviewed all the policies and procedures of the perfusionist service doing the work on cell savers for you.  Documentation of QC/QA and competency will probably be along shortly, if they do not already do that part when they inspect the hospital (again, if your hospital is Joint accredited).

The accreditation agencies do seem to want the Blood Bank to be responsible for this stuff, but it can be very difficult to get unless you have the power and authority of hospital administration behind you.  Good luck.