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Based on documentation review the Hospital failed to ensure that the Surgeon properly executed an informed consent for 1 patient (Patient #34).

Findings included:

The Hospital ' s Policy/Procedure titled Informed Consent for Medical, Surgical, and Diagnostic Procedures indicated that the provider performing the service will disclose in a reasonable manner all pertinent medical information for the patient to make an informed decision including the risks, benefits, and reasonable alternatives to the proposed procedure.

Review of the medical record for Patient #34, conducted on 5/26/10 at 3:15 P.M., indicated that Patient #34 was admitted to the Hospital on 5/24/10 for elective knee surgery. Patient #34 was alert and oriented.

Review of the Consent for Medical, Surgical and Diagnostic Procedures, dated 5/17/10, indicated that Patient #34 consented to a total knee replacement of the left knee. The area designated for documentation of the discussion of risks, benefits, and alternatives to treatment was blank.

Review of physician progress notes, dated 5/24/10, did not evidence the discussion.

Patient #34 was interviewed on 5/26/10 at 3:30 P.M. Patient #34 said this was the second knee replacement and when the impending surgery was discussed the Surgeon described at length the risks, benefits, complications, and alternatives to treatment. Patient #34 reported having multiple questions and was provided the Surgeon's personal telephone number to call if additional questions arose.

Although the Surgeon verbally reviewed the risks, benefits, and alternatives to treatment; the Surgeon did not document the discussion on the Consent form or in the medical record.

Based on interviews and documentation review the Hospital failed to ensure that: 1). the Surgical Safety Checklist was completed for 3 patients (Patient #16, Patient #17, and Patient #19) who had cardiac catheterizations, and 2). a Universal Protocol Invasive Bedside Procedure Checklist was properly executed for 1 patient (Patient #19) for a bedside procedure.

Findings included:

1). Review of the Hospital ' s Policy/Procedure titled Surgical/Procedural Safety Protocol and the Surgical Safety Checklist indicated that the steps to ensuring surgical or invasive procedure safety protocols were followed was through completion of the appropriate Surgical Safety Checklist. A final Time-Out was performed in the procedural area and a post-procedure verification was completed prior to the patient leaving the procedure area. The final Time-Out and the post-procedure verification were documented on the Surgical Safety Checklist.

Review of Patient #16 ' s medical record documentation indicated that on 5/24/10 a cardiac catheterization was performed. The electronic documentation of the procedure indicated that at 8:03 A.M. a final Time-Out was performed by the Attending Physician and all staff participating in the procedure.

Review of the Surgical Safety Checklist, dated 5/24/10, indicated that the sections for final Time-Out and post-procedure verification were not completed.

The registered nurse assigned to Patient #16 ' s cardiac catheterization (RN #2) was interviewed on 5/26/10 at 9:50 A.M. RN # said a final Time-Out was performed and RN #2 was responsible for completion of the Surgical Safety Checklist. RN #2 said RN #2 was recently provided with education related to Time-Out and implementation of the newly revised Surgical Safety Checklist.

Review of Patient #17 ' s medical record documentation indicated that on 5/25/10 a cardiac catheterization was performed. The electronic documentation of the procedure indicated that at 10:55 A.M. a final Time-Out was performed by the Attending Physician and the staff participating in the procedure.

Review of the Surgical Safety Checklist, dated 5/25/10, indicated that the sections for final Time-Out and post-procedure verification were not completed.

Review of Patient #19 ' s medical record documentation, conducted on 5/26/10 at 11:00 A.M., indicated that on 5/10/10 a cardiac catheterization was performed. The electronic documentation of the procedure indicated that at 1:08 P.M. a final Time-Out was performed by the Attending Physician and the staff participating in the procedure.

Review of the Surgical Safety Checklist, dated 5/10/10, indicated that the sections for final Time-Out and post-procedure verification were not completed.

The registered nurse assigned to Patient #19 ' s cardiac catheterization (RN #3) was interviewed on 5/26/10 at 11:25 A.M. RN # said a final Time-Out was performed and RN #3 was responsible for completion of the Surgical Safety Checklist. RN # said RN #3 was recently provided with education related to Time-Out and implementation of the newly revised Surgical Safety Checklist.

The Cardiac Catheter Lab Staff Meeting Minutes, reviewed on 6/3/10 at 10:35 A.M., indicated that Universal Protocol and audit results were reviewed.

The Cardiac Catheter Lab audit tools for the period of 4/1/10 to 5/26/10 were reviewed on 6/3/10 at 10:35 A.M. and evidenced that the Time-Out process and documentation was being audited and addressed as needed.

Although the electronic documentation for Patients #16, #17, and #19 indicated that a final Time-Out was performed at the site of the procedure and just prior to the start of the procedure, the final Time-Out was not documented on the Surgical Safety Checklist. The post-procedure area of the Checklists were not completed as well.


2). Review of the Operative Note, conducted on 5/26/10 at 11:00 A.M. indicated that on 5/12/10 Physician #1 performed a bedside thoracentesis on Patient# 19.

Review of Patient #19 ' s medical record documentation, conducted on 5/26/10 at 11:00 A.M., indicated that there was no evidence that a Universal Protocol Invasive Bedside Procedure Checklist was completed.

Physician #1 was interviewed on 5/26/10 at 10:45 A.M. Physician #1 said a Time-Out was performed but a Universal Protocol Invasive Bedside Procedure Checklist was not completed. Physician #1 said the importance of the Time-Out process was recently discussed at a monthly meeting.

The registered nurse assigned to Patient #19 at the time the thoracentesis was performed (RN #9) was interviewed on 5/26/10 at 3:40 P.M. RN #9 reported being present for the thoracentesis and although a Checklist was not completed a Time-Out was performed. RN #9 acknowledged attending recent education regarding Universal Protocol and the Time-Out process and knew the Checklist should have been completed.