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CLEVELAND CLINIC 9500 EUCLID AVENUE CLEVELAND, OH 44195 Dec. 22, 2016
VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, policy review and interviews, the facility failed to ensure operative reports contained a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner for three (Patients #1, #6 and Patient #9) of 10 medical records reviewed. The facility failed to ensure operative reports and brief operative notes contained end times for two (Patient #8 and #11) of ten medical records reviewed.

Findings include:

The facility's "Medical Records- Operative/Procedure Documentation Policy" was reviewed. The policy stated the primary surgeon is responsible for complete and accurate operative/procedure documentation. An Operative Report must be initiated within 24 hours or less. The report must be signed/dated/timed within 30 days of the discharge date and must contain the following elements:
Patient name
Medical record number
Date and times of surgery
Name(s) of primary and other surgeon(s) and assistant(s) or other practitioners who performed significant surgical tasks (even when performing those tasks under supervision)
Preoperative diagnosis
Postoperative diagnosis
Name of specific surgical procedure(s) performed
Type of anesthesia administered
Complications, if any
Estimated blood loss
Specimen(s) removed
Descriptions of procedures, including techniques, findings, and tissues removed or altered
Surgeon's or practitioner's name(s) and a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner (significant surgical procedures include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues)
Prosthetic devices, grafts, tissues, transplants, or devices implanted, if any

1. The medical records of Patient #9 and Patient #6 were reviewed. The records contained operative reports from 11/21/16. Staff X was the primary physician for both surgeries.

The operative report for Patient #9 stated the primary physician performed the entire procedure with assistance from two residents, Staff Y and Staff Z. The surgery Start Time was listed as 9:13 AM and the Incision Close/Procedure End Time was listed as 12:21 PM. The Operative Report for Patient #6 listed the Start Time as 12:14 PM, seven minutes prior to the procedure ended for Patient #9. The Operative Report for Patient #9 did not specify who performed the closure.

The above findings were shared with Staff W on 12/22/16 at 12:52 and confirmed.





2. On 12/19/16 an electronic medical record review was conducted for Patient #1 with the assistance of Staff T, M, and O. The record review revealed on 09/20/16 the patient had a surgical Robotic-assisted Laproscopic Retropubic Radical Prostatectomy with nerve sparing. The patient had a diagnosis of [DIAGNOSES REDACTED]. The report was co-signed by the surgeon on 09/20/16 at 5:49 PM.

The operative report contained the following documentation: The primary surgeon/proceduralist performed all critical portions of the procedure with assistance with exception of port placement and fascial and skin closure which were performed with him immediately available.

The operative report listed the primary surgeon, and three residents assisting with the procedure. According to review of their job descriptions, two Residents (Staff R and Staff J2) were PGY6 level Residents and required oversite to conduct the port placement, and robot docking which was a part of the procedure. The third Resident (Staff S) was a PGY1 level Resident who required oversite by the surgeon for A-line and Foley placement, and direct supervision for other procedures. When performing an ultrasound procedure, Staff S required indirect supervision.

This operative report lacked specific documentation for what portions of the surgical procedure were performed by Staff R, Staff J2, and Staff S.

This finding was confirmed with the aforementioned staff who assisted with the electronic record review.

3. The medical record of Patient #8 was reviewed. The record contained an Operative Report from 12/09/16. The Operative Report listed an Incision/Procedure Start Time. The Operative Report did not contain an Incision Close/Procedure End Time.

The findings were shared with Staff A on 12/20/16 at 10:23 AM and confirmed.

4. On 12/21/16, a medical record review was conducted for Patient #11. This review revealed the patient had the following surgical procedure on 12/21/16: Valvuloplasty Mitral with ring and bypass, TVR Valvuloplasty tricuspid valve with ring insertion, and full maze done with valve repair with CP-Bypass under general anesthesia.

The brief operative report authored by Staff P (physician) on 12/20/16 at 6:10 PM lacked an incision Close/Procedure end time. On 12/21/16 at 2:35 PM, Staff A confirmed the lack of procedure end time on the operative report.