Informed Consent

[Jane]

Do any of your facilities' informed consent forms require that the physician sign them? Ours currently does and administration is wanting to remove it to end a compliance problem (forms don't end up getting signed). I know that it is not a direct requirement by anyone that we have this. One of the docs wanted me to get a feel for what others do.

Thanks for your help!

Jane

[Karen Olsen]

Jane,

I am in this same process. Our Administration is considering changing from a physician presented and signed informed consent to having nurses perform this task. Our PI department states that according to national law an informed consent must be presented and signed by the physician, whereas a general consent form can be performed by a non-physician. I have contacted all of our governing agencies and read and re-read all the standards involved. I am still not convinced either way. CAP states that they don't care whether a physician or nurse presents the information as long as each aspect stated gets presented and that the Medical Director is involved in the P&P process. AABB states that even though it isnt stated in their standard it is assumed that an informed consent is required and that if the patient has the opportunity to ask questions wouldn't the physician have to be there. JCAHO states that there are no national regulations on this matter and that they have moved the standard out of the laboratory section and into the general section. They leave it up to each facility to decide which procedures require an informed consent and which ones a general consent.

If anyone has any additional discussion on this I would appreciate it as we will need to make a decision soon.

I can understand why the physician compliance is poor at best when you think of all of the chonically transfused patients.

Thanks for your help!

Karen

[David]

Several years ago when we struggled with this issue, Dr. Kathleen Sazama was extremely helpful. Her credentials as a transfusion medicine MD, and JD gave her advice a lot of weight with many disciplines. If she can be reached or if she monitors this site her input would be very helpful to you.