If a hospital contracts with an outside service for operating the cell saver in the OR, what are their responsibilities as far as CAP or TJC for quality assurance and making sure regulations are being followed? 

This is a bit of an old post: Great question, I've never seen that setup.  If you happened to find an answer, would you mind posting a followup just for educational purposes @ffriesen?

Get a disclaimer from your administration that you are not responsible for cell saver operations.  Your Medical Director should offer advice on what is acceptable practice even if you get the disclaimer.  You don't want to be responsible if you are not the responsible party operating the device(s).

Unfortunately, the JC standards put cell saver under the QSA for Blood Bank. I'm not sure a disclaimer would help, though I like that idea! We have a contracted perfusion service that runs our cell savers in the OR, and I still oversee it. They must follow our processes, use our forms, etc. I get a copy of their annual training/competency from the perfusion company to prove they are capable. As far as QC/QA for the cell saver instruments, the OR and I have joint oversight of that, and we log every time the cell savers are used and document the QC for it. 

I do have a disclaimer for the cell saver because an outside company operates the unit during procedures, and I have never been questioned about the cell saver by  CAP or JC,

I also have a policy in my policy and procedures stating the same and also stating that the blood bank is not responsible, but the medical director is available for consultation.

On 6/2/2022 at 6:18 PM, jshepherd said:

Unfortunately, the JC standards put cell saver under the QSA for Blood Bank. I'm not sure a disclaimer would help, though I like that idea! We have a contracted perfusion service that runs our cell savers in the OR, and I still oversee it. They must follow our processes, use our forms, etc. I get a copy of their annual training/competency from the perfusion company to prove they are capable. As far as QC/QA for the cell saver instruments, the OR and I have joint oversight of that, and we log every time the cell savers are used and document the QC for it. 

May I ask - What QC do you do when the cell saver is used?

Our cell saver machines have an in-line optical Hct sensor. So we record that on our forms for documentation. There is a "line in" and "line out", so we get a good read on the low Hct coming in, and the high crit of the processed blood on the way out. If this is not recorded, or unable to be read, the perfusionists are supposed to collect a purple top for H/H determination in the lab. Once 10 units have been processed for the patient (this has never happened), they should be collecting a heparin level on the patient to ensure adequate washing of the processed blood. That is a manufacturer recommended QC step.