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THOREK MEMORIAL HOSPITAL 850 W IRVING PARK RD CHICAGO, IL 60613 July 11, 2013
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on document review and interview, it was determined that for 1 of 1 patient (Pt. #1) who underwent a sternotomy, the Hospital failed to ensure staff were trained in the surgical procedure, and failed to have specific emergency cardiac defibrillation equipment available prior to the start of the surgical procedure. This placed Pt. #1 at risk for potential harm on 07/05/13. As a result, it was determined that the Condition of Surgical Services was not in compliance.

1. The Hospital failed to ensure staff were trained in a sternotomy procedure. Refer to A 951.

2. The Hospital performed an open chest procedure (sternotomy) with the knowledge that necessary emergency equipment was not available. Refer to A 956.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on document review and interview, it was determined for 2 of 2 surgical employees (E#4 and E#6), the hospital failed to ensure staff were trained in sternotomy procedures.

Findings include:

1. The personnel file for E#4 (RN circulating nurse) was reviewed on 07/10/13. E #4, surgery date of hire 10/01/09, failed to include experience in sternotomy procedures. The OR skills checklist dated 10/01/09 did not include experience in sternotomy procedures. E#4 was interviewed on 07/11/13 at approximately 9 AM. E#4 stated this hospital has never had a sternotomy case or any open heart surgeries. E#4 stated she was part of the surgical team on 07/05/13 during Pt. #1's sternotomy.

2. The personnel file for E#6 (RN operating room nurse) was reviewed on 07/10/13. E#6, surgery date of hire 10/01/09 failed to include experience in sternotomy procedures. The OR skills check list dated 10/01/09 did not include experience in sternotomy procedures. E#6 was interviewed on 07/11/13 at approximately 9:15 AM. E#6 stated,"I have no open heart surgery experience." E#6 was in charge during a sternotomy procedure on 07/05/13.

3. On 07/10/13 the hospital's root cause analysis was reviewed. The hospital identified staff were qualified to perform in the operating room, but needed competency in regards to sternotomy cases.

4. The findings were verified with the administrative staff during the exit interview on 07/11/13 at 4:30PM.
VIOLATION: REQUIRED OPERATING ROOM EQUIPMENT Tag No: A0956
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on document review and interview, it was determined that for 1 of 1 patient (Pt. #1) who underwent a sternotomy, it was determined that the hospital knowingly failed to have necessary emergency equipment available prior to the start of the surgical procedure.

Finding include:

1. The clinical record for Pt. #1 was reviewed on 07/10/13. Pt. #1, a [AGE] year old female, was admitted for a sternotomy and removal of sternal mass on 07/05/13. The surgery began at approximately 10:35 AM on 07/05/13. According to the anesthesia record at approximately 10:51 AM, Pt. #1 sustained ventricular fibrillation which required several external shocks and direct cardiac massage until Pt. #1's heart was restored to a normal sinus rhythm at 12:05 PM. The last set of vital signs as documented by anesthesia at 1:45 PM were: heart rate 96, intubated and blood pressure(B/P) 100/40. Pt. #1 was transferred in critical condition to intensive care unit (ICU) on 07/05/13 with blood pressure medication and antiarrhythmic medication infusing. Vital signs at 2:45 PM, the approximate time of ICU admission, were: temp 97.6, pulse 87, ventilator rate 20, and B/P 104/61 with a pulse oximetry of 100%.

2. The Hospital's root cause analysis dated 07/05/13 identified essential equipment (internal defibrillator) was not on hand and should have been available.

3. E#5 (Surgical technologist) was interviewed on 07/10/13. E#5 stated she has thoracic training and stated,"when you crack a chest you always need to have internal defibrillator paddles available." E#5 stated she and E#4 informed MD #1 on Tuesday (07/02/13) the hospital did not have the paddles. The case was scheduled for 07/05/13. On 07/05/13, the day of surgery and before Pt. #1 was in the operating room, MD #1 was informed again that there were no internal paddles. MD#1 stated,"That is OK. She is [AGE] years old and healthy. The case will only take 15 minutes." The surgery proceeded without the necessary equipment.

4. E# 4 (RN circulating nurse) was interviewed on 07/11/13 in the surgical department. E#4 stated Pt. #1's case was scheduled on 7/1/13. E#4 told a scheduler, MD#1 did not have a sternotomy preference card and internal paddles were needed. E#4 stated she knew internal paddles were needed because she observed open heart surgery while working at another hospital. E#4 stated she thought the scheduler informed E#3 to order the paddles. On the day of surgery E#4 informed MD#1 there were no internal defibrillator paddles available. MD #1 stated,"That is OK the patient is young " E#4 could not recall the rest of the conversation and the surgery proceeded.

5. MD#1 was interviewed by telephone on 07/10/13. MD#1 stated Pt. #1 had a pre-surgical echocardiogram which was normal. Approximately 30 minutes into the surgery, Pt#1 went into a ventricular fibrillation. A code was called and direct cardiac massage was initiated. MD#1 stated internal defibrillator paddles would have been "helpful " but not necessary. When asked if staff informed him prior to the surgical procedure and on the day of surgery the paddles were not available, MD#1 stated he did not recall being informed. MD #1 stated in the future he will have the internal defibrillator paddles as part of his case card for sternotomy. The hospital did not have a reference or policy that required the necessity for internal defibrillator paddles for sternotomy cases.

6. MD#3 (cardiologist) was interviewed on 07/11/13. MD #3 stated he received a call from Thorek hospital requesting him to come to the hospital to assist in a code situation. Upon arrival to the OR, staff were performing external shocks and internal cardiac massage. MD#3 was trying to figure out why the external shocks were not converting the heart to normal sinus rhythm. MD #3 stated more electricity was needed because conduction is difficult with an open chest wound and when the Pt. is obese. MD#3 shocked Pt. #1 using several sets of pads and a defibrillator with more electrical power. Pt #1 then converted to normal sinus rhythm.

7. The findings were discussed with administrative staff during the survey exit on 07/11/13 at 4:30PM.