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Jorge Martinez
Manager
Bloodless Medicine and Surgery Program
Sharp Chula Vista Medical Center
Chula Vista, CA
Toll free - 866-USE NO BLOOD (866-873-6625)
619-482-4037

That is an interesting point. We don't normally have a consent for
the cell saver. Just the DPA saying they will accept it. Are you looking
at something similar to the Consent for Blood Tranfusions that release liability if they get hepatitis? Is this something we should consider mentioning in
our DPA lectures? and is this going to "frighten" people from accepting it? What about those who don't know if they have cancer or if it (a tumor etc.) is benign? Interesting!
Jan

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Jan Graziani - LVN
Chicago, IL USA

Interesting that you are being asked to do this. My former experience was that not only would the patient who is refusing blood products for religious reasons specify this on his Durable Power of Attorney for Healthcare, but each institution should also have a separate release of liability form. These are usually designed by the blood conservation program and mention not only the different components that the patient is willing or not willing to except, but also the different recirculating or recycling devices that they are, or are not, willing to accept. This form then is approved and tweaked by your legal department. The form that I am referring to would be unique to the blood conservation / bloodless community. Regarding the subject of cell salvage in the use of cancer, is a whole other can of worms that gets into much legal, ethical, and good practice issues, that you would not want to necessarily get involved with. That should be a choice between the perfusionists, the surgeons, anesthesiologists and hospital policy. If it is a person who is opposed to blood transfusions, or blood conservation methods and is coming through your program, then of course it comes into your own realm as mentioned above. I don't know if this is clear,,,,hopefully so.

Jorge - this is an interesting topic to discuss. However, I agree w/ Trudy. The Durable Power of Attorney for Healthcare and the Release of Liability should completely free the healthcare provider of liability for untoward outcome from using cell salvage. It is possible for us to analyze liability issues so severely that physicians who have become willing to treat and proficient in treating blood conservation/bloodless patients will become unwilling to do so.

My answer to any physicians who question using cell salvage in the presence of cancer cells, would be to provide them copies of clinical articles for their review - and leave the decision up to each surgeon, anethesiologist, perfusionist, etc. With this knowledge the surgeon, anesthesiologist and perfusionist can then discuss options with the patient. If the patient accepts cell salvage - he accepts cell salvage in the presence of cancer cells. If he does not accept cell salvage - then that preference is respected too.

I agree with your Medical Director and encourage him to provide appropriate review articles to the physicians. Then discuss with them the value of existing documents and patient interviews.

Please let us know the outcome.

Debbie A.

Is this for any patient using the cell saver or only Bloodless? The posting by John Viney on 9-18-03 using irradiated blood would be a consideration - however some may not permit this. Is that what you want the release for?

The Release of Liability is a general release that some facilities require in addition to the release of liability statement included in the Durable Power of Attorney for Healthcare. It states that the patient and their representatives release the facility, physician, nurses and others involved in their treatment from any liability that may result from the patient's decision to refuse blood transfusion. This release is not specific to salvaged blood.

Thanks.
Deb A.

This is an interesting thread. I interpret the issue here as informed consent.
The DPA does not discuss the risks and benefits nor does the release of liability my hospital uses. Food for thought: is it necessary to develop a separate consent form? There are risks to cardiopulmonary bypass but patients do not sign a separate consent.


Debbie Tolich, RN
Regional Center for
Blood Conservation
St. Vincent Charity Hospital
Cleveland, OH
216-363-3353

I have to agree with Deborah. We do all kinds of things in the medical field that carry risks and the physician should inform the patient about the risks. There are other serious risks associated with the cellsaver that we do not have a separate consent for. Physicians do many things as an "off label use". As long as they inform the patient then that is all that is needed. If we try to make a consent form for every possible risk then there are going to be consent forms for everything.
We do most of our kidney cancer surgeries on veno-veno bypass because it reduces the blood loss by 50%. When you do surgery on a patient that has a tumor in their atrium or anywhere in the heart you have to put that patient on bypass. The blood is circulating so you would have the same argument. That is a "theoretical" risk of the surgery and we have never had a recurrence of cancer due to recirculating the blood. Some would say it only takes one cell but obviously that is not true.
Elora Thorpe RN
Coordinator
St. Luke's Hospital of Kansas City

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Elora Thorpe RN BSN
Coordinator
Blood Conservation Program
St. Luke's Hospital of Kansas City
Kansas City, MO. 64111
816-932-6183

Thanks to everyone for their valuable input. At the crux of the matter is that the hospital's policy precludes the use of the Cell-Saver in cancer patients. Thus, our Bloodless Program patients would be an exception to the rule. Also, the doctors want to be sure that the patient be informed about the theoretical risk before consenting to its use. I can see that this could potentially start a wave of form production but I do not believe that is the case here. Risk management is not yet involved because as you know that would probably only complicate matters. I will keep you abreast of my progress.

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Jorge Martinez
Manager
Bloodless Medicine and Surgery Program
Sharp Chula Vista Medical Center
Chula Vista, CA
Toll free - 866-USE NO BLOOD (866-873-6625)
619-482-4037

I have had several major operations here in TX both in the Civilian hospitals and the Large Veterans hospital and in every case I have had to sign a consent form stating that I was aware of what the operation was for and the possible side effects from the procedure. Is this not a standard uniform medical procedure?