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1 TAMPA GENERAL CIR

TAMPA, FL 33606

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on clinical record review and staff interview it was determined the medical staff failed to be accountable to the governing body for the quality of the medical care provided to the patients receiving anesthesia for 1 (#3) of ten records reviewed.

Findings include:

Patient #3 presented on 10/4/13 at 2:52 a.m. as a trauma alert. Review of Emergency Department physician and nursing documentation revealed the patient had multiple injuries and fluid resuscitation was initiated. Review of the physician's treatment plan indicated to proceed to surgery.

Review of anesthesia documentation by the anesthesiologist revealed a Central Venous Catheter was placed in the right subclavian via a percutaneous puncture. The guide wire was passed into the vein. The site was dilated with a skin incision and dilator. The first attempt after dilation to advance the catheter over the guide wire was unsuccessful. The second attempt from a different angle went without resistance. The catheter was passed and sutured. A chest x-ray (CXR) was ordered with a wet reading. Review of the record did not reveal evidence of the CXR being performed or documentation as to why the CXR was not performed.

Review of the operative note dated 10/4/14 by the surgeon revealed an Iatrogenic injury to the right subclavian vein from the subclavian catheter placement. The documentation noted the massive transfusion protocol was continued with a systolic blood pressure on the 90s. The patient was prepped and waited for anesthesia to achieve appropriate lines prior to beginning the procedure. The documentation noted the right chest was explored for the bleeding source. The patient's systolic blood pressure was dropping to the 40-50s. Upon entry into the right chest bleeding was encountered that could not be kept up with. Resuscitative efforts were not successful and the patient was pronounced.

The documentation of the post mortality maneuvers revealed the patient's rapid decline was surprising on how quickly he declined after the right thoracotomy. It was found the majority of the right subclavian catheter was in the right chest. It appeared the catheter had gone through the subclavian vein and into the chest. There was a second venotomy adjacent to the catheter. There were two large holes in the subclavian vein and a catheter protruding into the right chest. The documentation noted the rapid decline with the thoracotomy was probably due to the large subclavian vein injury caused by the catheter. The other venotomy was presumably due to a prior attempt at the line placement. The surgeon documented the true mortal source of the bleeding was the right chest. The bleeding in the right chest was initially due to the lung laceration. The uncontrollable and life threatening bleeding that lead to the cardiopulmonary arrest and left resuscitative thoracotomy probably came from the iatrogenic venotomies in the subclavian vein. Quick note dated 10/4/14 at 11:07 p.m. indicated anesthesia was aware of the findings.

Review of the Medical Examiner's report revealed the right subclavian vein had a catheter sutured in place. There was no mention of the two holes in the subclavian vein identified by the surgeon during the post mortality surgery.

Interview and record review with the Director of Surgery on 3/25/14 at 12:20 p.m. revealed the record had not been reviewed by him or his staff. He did not know if the record was reviewed by surgery or anesthesia. He was not informed if they did a review. He stated an event report should have been completed by the surgeon, anesthesia or coding. He stated he was unaware of the documentation by the surgeon until the date of survey on review of the record.

Interview with the Manager of Risk Management and the Risk Management Specialist, who did the death record review, on 3/25/14 at approximately 1:10 p.m. revealed an event report was filed as a death in the Operating Room (OR). They both stated this was the first they heard about the documentation of the catheter protruding from the subclavian vein. The Risk Management Manager stated there had been no peer review and no tracking or trending of similar situations. She stated there was no documentation of the case in surgical or anesthesia department meeting minutes.

Interview with the Risk Management Manager on 3/25/14 at approximately 2:24 p.m. revealed the Assistant Chief of Trauma indicated the case was reviewed by the Trauma Committee and referred for peer review. Per her, the Chief Medical Officer agreed to the peer reviewed but it had not been done. The Manager of Risk Management stated it was referred to peer review due to a death in the OR of a trauma patient not because of the subclavian event. She indicated she found out today the Chief of Anesthesia was the only one who knew about incident prior to today.

Interview with the Chief of Anesthesia on 3/25/14 at approximately 3:20 p.m. revealed he re-reviewed the record of the subject patient the day of survey. He had reviewed the record back in October, 2013. He stated the involved anesthesiologist had spoken to him directly concerning the surgeon's alluding to the cause of death being directly attributable to the perforation of the subclavian vein. The conversation occurred the day following the event in October, 2013. He indicated he had not discussed the concerns with the involved surgeon, but believed the involved anesthesiologist had discussed it with the surgeon directly. The Chief of Anesthesia stated he had not discussed the case with Risk Management before today.

The medical staff failed to involve administration and risk management in an event alleged by a physician leading to a cause of death and why a CXR was not performed as ordered from 10/4/13 to the date of survey.