CONSENT FOR SURGERY OR OTHER INVASIVE PROCEDURAL TREATMENT PILOT VERSION 11
1. PROCEDURE: I

[Patient’s name], give consent to the following procedure(s):

[Description of procedure(s)].
My practitioner has discussed with me and I understand what will be involved with my procedure including the fact that
I may receive either anesthesia or sedation, or both. I understand my rights and responsibilities to make decisions about
my healthcare. I may have received additional education material. I have made my decision voluntarily and freely.

Day of Procedure
Verify patient consents
to the documented
procedure.

RN/Tech initials
Date
Time

2. RISKS: My practitioner has discussed with me specific risks associated with this procedure. These risks may require additional procedures. I
understand that the common risks with any procedure include: stroke, device failure, infection, nerve injury, blood clots, heart attack, allergic
reactions, respiratory failure, kidney failure, bleeding, and severe blood loss. These risks can be serious and possibly fatal. I understand and
freely assume these risks. Risks and side effects associated with anesthesia or sedation will be discussed with me before I have my procedure. I
may be asked to sign a separate consent regarding anesthesia or sedation prior to my procedure.
3. ALTERNATIVES: Reasonable alternative(s) to this procedure have been explained to me by my practitioner. He or she discussed the risks and
benefits of not having the procedure. Knowing this information, I choose to have the procedure(s) described on this form.
4. BENEFITS: My practitioner has discussed with me the possible benefits associated with this procedure. I understand that there is no certainty
that I will achieve these benefits. No guarantee(s) has/have been made to me regarding the outcome of this procedure.
5. CARE TEAM: I authorize my practitioner,
[Practitioner’s name], to perform this procedure.
I accept that he or she will be assisted by a care team which may include anesthesia providers, nurses, technicians, and medical device
specialists, and a surgical team. This team may include other attending surgeons, residents, fellows, medical students or other allied healthcare
professionals. I authorize such associates or assistants to perform portions of the operation or procedure under the direction of the physician
identified above. My practitioner or another qualified surgeon designated by my practitioner will be present for all key/critical parts of the
procedure/surgery, although other medical professionals may perform some aspects of the procedure, as my practitioner or another qualified
surgeon designated by my practitioner deems appropriate.
6. OVERLAPPING SURGERY or procedure: I understand that Doctor
will be present during the key/critical
portions of the surgery or procedure and that once those portions of the surgery are completed, he/she may leave the operating room. I also
understand that even if the Doctor listed above leaves the operating room where I am having my surgery, he/she at all times during my surgery
will be immediately available to assist with my surgery, if necessary, or will ensure another qualified surgeon is immediately available to assist
and/or supervise.
(Patient’s initials) I have been advised that my surgeon may be scheduled to perform surgery in two operating rooms at the same time.
N/A
7. OBSERVERS: My practitioner may allow observers during my procedure. They are not part of the care team and will not participate.
8. BLOOD TRANSFUSION: My practitioner has explained that blood or blood products may need to be used. I
understand the side effects and risks, including: allergic reactions, fever, hives, lung injury, and in rare cases, infectious
diseases, such as hepatitis and HIV/AIDS. My practitioner discussed with me strategies to reduce the need for blood
transfusion including anemia management and blood conservation techniques.
(Patient’s initials) **I DO NOT consent for blood transfusion. Requires signed documents.
9. PATHOLOGY: I accept that any specimens, such as tissue, blood, bodily fluids, etc. will be examined, disposed
of or stored for future use in medical studies or research. Any research involving specimens will be reviewed by an
appropriate review board. I understand that my tissue or other explanted material will not be returned to me. Requests
for exceptions will be reviewed on a case-by-case basis.

Day of Procedure
**Verify patient’s signed
documents are in the
medical record.

RN/Tech initials
Date
Time

10. VIDEO or PHOTOGRAPHY RECORD: I understand video or photography records made as part of my treatment and/or diagnosis may be useful
for clinical education or professional publications. If used in this way, I understand that my records will be edited so that I will not be identified
(referred to as “de-identified”). Video or photography records will not be used for any other purpose without my authorization.
(Patient’s initials) I DO NOT authorize my de-identified video or photography records to be used for clinical education or
professional publications.

Any questions I have had regarding this procedure have been answered to my satisfaction. By signing
below, I attest to my consent to this procedure.
DATE

TIME

Signature (Patient or Legal Representative)

Print Name

Relationship (If other than Patient)

PRACTITIONER’S STATEMENT
I have explained the contents of this document to the patient/legal representative and have answered all the
patient’s questions, and to the best of my knowledge, I feel this patient has been adequately informed and has
consented.
Practitioner’s Signature

Print Name

DATE

Consent Update
Patient consent
validation, if patient
signature date is greater
than 90 days prior to the
procedure date.

Practitioner
initials
Date
Time

TIME

Yes – Interpreter was used as part of this process.
PATIENT LABEL

SEATTLE, WASHINGTON
Form 396230 – Pilot Version 11

Stock Rev. 5/17

FV

CONSENT FOR SURGERY OR OTHER INVASIVE PROCEDURAL TREATMENT PILOT VERSION 11