HospitalInspections.org

Based on a review of facility policy, a review of medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure that a properly executed informed consent form for invasive procedures was present in the medical record for 15 of 15 medical records related to informed consents events reviewed (MR 1 - MR15)

Findings include:

A review conducted on October 14, 2010, of facility Patient Services policy 4.21 "Informed Consent" last revised February 2010, revealed "...IV. Documenting Consent ... B. Consent form ... 3. A consent form must be completed and properly signed prior to any operation or invasive procedure... 4. A consent form must list the exact procedure(s) to be performed, and mus distinguish between the right and left side when appropriate... 9. All completed consents must be filed in the patient's medical record."

1) A review conducted on October 14-15, 2010, of the facility's event report log from March 1, 2010, through September 30, 2010, for informed consent events revealed that there were 13 events related to informed consents. Further review of the events revealed that all of the events met the criteria for an Infrastructure Failure.

An interview conducted on October 15, 2010, at 1:00 PM with EMP1, EMP2 and EMP3 confirmed that there were 13 events related to informed consents and that all of the events met the criteria for an Infrastructure Failure but were not reported to the Department as such.

2) A review was conducted on October 15, 2010, of two medical records (MR) randomly chosen from the event report list. The review revealed the following:

The event report for MR3 revealed: "Pt. arrived from ICU via bed without RN. Operative consent "witnessed" but not signed. Consent for treatment/admission unsigned. Called ICU. Nurse ... states pt. gave verbal permission to perform cysto. No documentation on chart. ... said admission consent not signed because pt. refused. No documentation in chart. Informed Dr. ... Pt. unresponsive to questions about permission but responsive to other questions. Pt. taken to procedure room, pt. did not refuse cysto."

The event report for MR6 revealed: "Patient was brought to surgery and under anesthesia before it was discovered that no surgical consent was signed by patient or surgeon. Dr. ... was notified. ... stated that ... had obtained verbal consent, as did anesthesia and nurse in room. Dr. ... stated ...would continue with surgery "

2) An interview conducted on October 15, 2010, at 1:00 PM with EMP1 confirmed that the above statements were written on the event reports.