In the revised CAP checklist dated 06/15/09, TRM42300 on Therapuetic Phlebotomy requirements, there is now listed the need for informed consent. We are trying to develop a specific consent form for this procedure as we are a small rural hospital and this is the only donation procedure we do in our phlebotomy department. Would any of you have Consent Forms you could share to give me some ideas to go on? Thank you

Our facility currently documents donor consent (with donor signature) on our therapeutic plebotomy form. This is the statement we use "I consent to the withdrawal, as directed by my physician, of approximately 500 mL of my blood. I consent to the use or disposal of my blood in any manner deemed appropriate by my physician or the physician in the blood bank." Guess we will re-examine if this statement is adequate in light of new requirement.

We currently have a similar statement of consent on our therapeutic phlebotomy form. By saying informed consent, I wonder if CAP means that the patient has had the reason for the procedure and possible risks explained to him. If they want the benefits and risks explained, then is it for every phlebotomy or just the first one of a series? Who should obtain the consent, the pathologist or the phlebotomist? Unfortunately there is no guidance on the checklist so my Medical Director has suggested a call to CAP for clarification.

We also obtain the consent on the Therapeutic Blood Donation Record. Our consent reads, " The therapeutic process has been explained to me. All of my questions have been answered to my satisfaction. I have answered all questions truthfully and to the best of my knowledge. I understand that my blood will be disposed of in accordance with the blood center policies and procedures. I have read and understand the "Blood Donor Educational Material" and the "Privacy Notice."

One significant difference from your situation of course, is that we are a community blood center and a good bit of the information that we tell the donor is in the educational material we provide to each donor; allogenic, auto and therapeutic. From the donor's side of it, we require a prescription from the physician, our medical director approves the procedure and the prescription has to be renewed every 6 months. Hope this helps. Happy New Year to all of ya'll.

Here is our consent - a little long winded but seems to cover everything. They get it from the referring Physician.

I consent to the procedure known as Therapeutic Phlebotomy for the treatment of a condition explained to me as _________________________ by Dr. __________________, who also explained the benefits and alternative treatments.

I understand that in the phlebotomy procedure one pint (or less) of blood is removed as directed by Dr. __________________. I understand that I may have pain, discomfort, bruising, clotting and rarely infection at the site of the blood drawing. Symptoms such as sweating, nausea, or even fainting may sometimes occur. In addition, there may be unforeseen risks. However, I still willing to accept responsibility of these.

I understand that if I have any questions regarding the purpose of the phlebotomy procedure and its usefulness, the hazards involved in it, or any related questions, I am free to ask them at any time and have them answered to my full and complete satisfaction.

Print Name_______________ Signgnature__________________

Witness______________ Date______________

Thank yoy all for your responses. I called CAP today to clarify the issue. Susan at CAP Accreditdation said the is was up to the Transfusion Director to decide what consituted informed consent and what form this would take based on good medicall practices and patient saftey. I would think all your responces would be OK.

Here is ours:

"I am voluntarily and knowingly requesting and consenting to a therapeutic phlebotomy as ordered by my physician due to a medical condition. I understand that a sterile needle will be placed in my arm and a unit (approximately 500 mL) of blood will be collected. Side effects seldom occur, however I may experience discomfort and/or bruising at the needle site, nerve damage, dizziness, nausea, fainting, or involuntary muscle contractions. I understand that XXXX assumes no financial responsibility for medical or other expenses that may arise as a result of this therapeutic procedure."

Then there is some language that we use because we are a donor center that wouldn't apply to you...and finally,

"I have been informed of the nature of therapeutic phlebotomy and understand the risks listed above. I understand that I am free to ask questions and that I may withdraw from the procedure at any time. I have read and understand the above information and am voluntarily consenting to therapeutic phlebotomy."

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