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Based on policy review, document review, medical record review, and interview the facility did not ensure there was a properly executed informed consent form prior to the surgical procedure in the medical record for three of twenty surgical patients (Patient #15, #16 and #19). Failure to obtain informed consent has the potential for an adverse patient event.

Findings Include:

Review of policy "Informed Consent Policy," last revised 05/10/22 indicates that each patient or the patient ' s authorized representative will be provided with the information they need to enable them to make informed treatment decisions. Informed consent must be documented, in writing, prior to performance of all invasive medical and surgical procedures except in cases of emergency when informed consent cannot be reasonably obtained. The discussion with the patient or the patient's authorized representative, and their consent to the treatment or procedure, must be documented in the patient's medical record. All paper documented informed consents will be scanned into and become part of the permanent medical record. Consent documentation must include a signature/date/time by the patient, family, guardian, health care agent and a practitioner/provider or another designated physician member of the surgical/procedural team.

Review of policy "Informed Consent Form Guidelines," (no date) revealed there is one "Consent for Medical or Surgical Procedure" form approved for use at Strong Memorial Hospital practice sites.

Review of the "Consent for Medical or Surgical Procedure-SH 419 MR" form, (no date) revealed this informed consent form is to be used by staff that includes risks, benefits, alternatives, surgical procedure being performed, and the provider (s) performing the surgical procedure. The form has a space required for the patient signature, the date and time acknowledging they have been informed of the above (risks, benefits, alternatives, the surgical procedure being performed, and the provider (s) performing the surgical procedure). Additionally, there is a "Care provider ' s statement " section requiring provider signature, the date and time acknowledging that the patient has been informed of the risks, benefits, alternatives, and the surgical procedure being performed.

Review on 10/18/23 of the medical record for Patient #15 revealed they presented to the facility on 08/15/23 for a robot assisted Sacro colpopexy (surgery to treat pelvic organ prolapse), removal of an IUD (intrauterine device-contraceptive device), supracervical hysterectomy (removal of uterus-female pelvic organ for nourishing developing fetus), and cystoscopy (procedure using a tube to examine the bladder and urethra). The medical record did not include the "Consent for Medical or Surgical Procedure SH 419 MR" form.

Review on 10/18/23 of the medical record for Patient #16 revealed they presented to the facility on 08/23/23 for surgical removal of the prostate (small reproductive organ in males) and removal of lymph nodes. The "Consent for Medical or Surgical Procedure SH 419 MR" form lacked the signature of Patient #16.

Review on 10/18/23 of the medical record for patient #19 revealed they presented to the facility on 09/21/23 for robot assisted lysis of adhesions (removal of scar tissue) with possible bowel resection (removal of portion of the intestine), and possible temporary ostomy (a portion of the intestine is diverted to an artificial opening in the abdominal wall to allow passage of stool). The "Consent for Medical or Surgical Procedure SH 419 MR" lacked the signature of Patient #19.

Interview on 10/18/23 at 10:00 AM with Staff (G), Operating Room Assistant Director of Nursing revealed that informed consent should include both the provider and patient and/or responsible party signature, and the date/time that the informed consent was obtained.

Interview on 10/18/23 at 01:28 PM with Staff (CC), Assistant Quality Officer, verified these findings.