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CLEVELAND CLINIC HOSPITAL 3100 WESTON RD WESTON, FL 33331 June 11, 2013
VIOLATION: INFORMED CONSENT Tag No: A0955
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, clinical record review, review of the facilities policies and procedures and review of the material risks inherent to the specific procedure; the facility failed to ensure a properly executed consent form for 1 or 10 surgical patients (#1) records reviewed. The facility failed to ensure the information provided by the responsible practitioner included material risks with a low degree of likelihood but a high degree of severity were addressed prior to the signing of the informed consent for 1 of 10 (#1) surgical records reviewed.

Findings include:

A review of the clinical record for Patient #1 revealed the patient was admitted on [DATE] for a planned surgical procedure.

Review of the completed Informed Consent signed by Patient #1 and the physician/ surgeon on 04/15/2013 prior to undergoing the planned procedure, disclosed, " Risks, benefits, alternatives, and personnel discussed with patient who consents to proceed." Upon request documentation provided by the facility related to the Informed Consent includes physician office notes dated 02/25/2013, which state the following; "Verbal Informed Consent was obtained for .............., ....... and possible thermal ablation. Risks, benefits, personnel involved and alternatives were discussed and questions answered and she agrees to proceed. Inparticular, possible complications, including damage to the bladder, bowel and /or major blood vessels, were discussed." There was no documentation/evidence found in the review of the clinical record and associated physician office notes indicating the risk of thermal injury (burn) was discussed with the patient.

On 06/11/2013 at 12:45 PM, interview was conducted with the physician/surgeon who performed the procedure on Patient #1 on 04/15/2013. The surgeon acknowledged that she had not discussed the risk possibility of a burn with the patient, and stated it was not something which she had experienced or anticipated. The surgeon stated,"Going forward, knowing what I learned from this experience, I will inform patients of the possibility of a burn during this procedure."

Review of the manufacturer's literature related to the Hudro Thermablator Ablation (HTA) system used during the surgical procedure on patient #1 revealed burn from leakage of fluid is a known potential outcome. The following information is documented:
"POTENTIAL ADVERSE EFFECTS that may occur include pain, cramping, nausea, vomiting, bleeding, infection, laceration, Endometriosis, thermal injury to adjacent tissue including cervix, vagina, vulva, and/or perineum, heated saline escaping from the device system into the vascular spaces, hemorrhage, perforation of uterus, complications with pregnancy. "

A review of the facility's policy and procedure,"Informed Consent" most recently reviewed and revised on August 2012 revealed the following:
"The purpose of the Informed Consent policy is to provide an environment in which patients have an opportunity to accept or reject medical, surgical and allied health interventions and services in an informed and involuntary manner. Cleveland Clinic, Florida recognizes that a patient has the right to consent or refuse consent to a proposed medical or surgical procedure or treatment, or the intervention and services offered by allied health professionals. The patient has the right to be advised of the material risks inherent and incidental to the proposed treatment, the benefits or expected results of consenting to the treatment. Prior to performing any operative or invasive procedure, the physician is responsible for obtaining the patient's informed consent. Patients must by given sufficient information concerning the proposed intervention to exercise their rights to choose the proposed intervention, an alternate intervention or reject the invention altogether. The informed consent process generally includes a discussion of medically significant benefits and material risks, dangers or side effect inherently and potentially involved with respect to the proposed therapy."