Informed Consent

[scodina]

We are in the process of reviewing the informed consent process at our hospital. During my review, I noted that the AABB Primer of Blood Administration says that hospitals are required to obtain informed consent prior to administering blood components and plasma products to include Factor concentrates (Factor VIII, Factor IX, etc). Recombinent Factor VII is specifically excluded and it is listed as a "pharmaceutical related to blood products."

I have always thought of Factors as a pharmaceutical vs. a blood product, because I have never worked in a blood bank that actually dispenses these. However, I have learned that we currently do not obtain informed consent from the recipient prior to administering these products.

I am wondering how other facilities are handling this. I think there is probably room for interpretation in the standard, but the Primer is very clear.

[tbostock]

We (unfortunately) carry all clotting factors as well as albumin in the Blood Bank. I've tried for years, but Pharmacy won't take them. We obtain an informed consent for all blood products/derivatives. So whether they get red cells, albumin, RhoGam, or Factor VIII, they fill out the same consent form. Just makes it easier for us to get one for everything...not to mention, there are risks to these products, so I don't think it's a bad idea to let the patient know about them. Novoseven (factor VIIa) in my opinion especially should have a consent form because of the warnings that have been sent out by the FDA about using this product off-label.

[Lynn FrazerDowns]

Do other hospital require "ordering physician" signatures on your informed consent for blood products,ect...?

[cn1018]

The NovoSeven may be under "pharmaceutical related to blood products."

, because FactorViia is always recombinant, whereas FVIII's, FIX's, and von Willebrand's Factor are not always recombinant (monoclonal, plasma derived, or recombinant)

[adiescast]

Do other hospital require "ordering physician" signatures on your informed consent for blood products,ect...?

We have a place for the physician's signature. Our medical staff policies clearly state that it is ultimately the physician's responsibility to make sure the patient is informed and gives consent. Needless to say, it is still usually the nurses who have to not only confirm that the patient has been informed and but also make sure that both the patient and the physician sign the form!

[lalamb]

Do other hospital require "ordering physician" signatures on your informed consent for blood products,ect...?

As a result of our inspection a year ago, nursing now has to bring down the signed (by pt and dr) consent form, along w/ a hospital sticker, that has the pt's name, med rec number and DOB. Before, it was only the sticker.

So now, nursing puts the sticker on the consent form, it stays in the chart, and they bring it down for every unit. The signed form is considered good for the "admitted event". If the patient is discharged and comes back 2 days later, there is a new form and a new billing # and a new sticker.

We (lab) have refused to issue blood if the RN didn't bring it down. We apologize profuseley and send them back to floor to get it, or to track down a Dr to sign it! (Exceptions are ER, OR and emergencies). It's more of a habit now for the RN;s so we aren't dealing w/refuseles so much.