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SOUTHCOAST HOSPITALS GROUP 363 HIGHLAND AVENUE FALL RIVER, MA 02720 Sept. 13, 2011
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of documentation, the internal investigation file and interviews, the Hospital failed to complete an investigation in a timely manner.

Findings include:

1) The Hospital reported that Patient #1, with spinal stenosis and a compression fracture, had surgery on 6/23/11 for elective spinal surgery. During the procedure, cement injected into the vertebrae, leaked into the epidural space and was removed by the Neurosurgeon. Post-operatively, Patient #1 reported a new onset of significant lower extremity weakness. Diagnostic testing was performed and identified cement in the spinal canal. The next day, Patient #1 was brought back to surgery and the cement was removed, but post-operatively, Patient #1 continued with significant lower extremity weakness as well as bilateral painful paresthesias of both feet. Patient #1 was transferred to an acute inpatient rehabilitation for further care and treatment and developed a surgical wound infection requiring extended care. After 2 months, Patient #1 was discharged to a skilled nursing facility for continued care and treatment. On 6/28/11 Patient #1 was transferred to acute inpatient rehabilitation for further care and treatment and developed an infection of the surgical wound requiring extended care. On 8/24/11 Patient #1 was discharged to a skilled nursing facility for continued care and treatment without significant improvement in his/her mobility status.

2) Information provided by the Hospital indicated Neurosurgeons who performed surgeries requiring the use of a cement system, used the Stryker Cement Delivery System. The cement was delivered into the vertebra via a canister that was twisted to inject the cement. The amount of cement injected and the rapidity of delivery was controlled by the Neurosurgeon.

The Neurosurgeon was interviewed on 9/13/11 at 9:15 A.M. The Neurosurgeon said cement leakage was a known complication, but the leakage was usually small and not into the spinal canal. The Neurosurgeon said he became affiliated with the Hospital in August, 2010. The Neurosurgeon said that prior to coming to the Hospital, he had used the Kyphon Cement Delivery System which differed from the Stryker system. The Neurosurgeon said the injection method differed from the Stryker System, the amount of cement injected was controlled at very small increments and there was less cement leakage. The Neurosurgeon said that prior to using the Stryker system, he observed his partner using the System during several procedures. The Neurosurgeon said he then had the Stryker Representative present during surgeries requiring kyphoplasty cement. The Neurosurgeon said this was the first patient on his service that suffered such serious consequences as a result of the surgical procedure.

The Neurosurgeon said that prior to the procedure, the risks for the procedure were discussed with Patient #1.

Review of the Informed Consent for Medical, Surgical, and/or Diagnostic Procedures dated 6/16/11 indicated the risks of the procedure included infection, loss of sensation, loss of limb function and paralysis. The Consent form was signed by Patient #1 and the Neurosurgeon.

The Neurosurgeon said this was not an unusual type of surgery, but cement leakage was unpredictable and therefore it was his practice to use two C-Arms (a portable fluoroscopy unit that allows the surgeon to visual the surgical area) during the procedure. The Neurosurgeon said using two C-Arms allowed him to visualize the surgical area from several angles and to observe for cement leakage during injection. The Neurosurgeon said visualization was important because he was injecting the cement into bone which could have a crack. The Neurosurgeon said that during Patient #1's surgery, the amount of cement leakage that occurred was unusual. The Neurosurgeon said he cleaned out the excess cement and there were no other issues with the procedure. The Neurosurgeon said there were no contributing factors that could have affected the surgery such as staffing, delay of procedure, or problems with equipment and the surgery went smoothly. The Neurosurgeon said the Stryker Representative was not present for Patient #1's 6/23/11 surgery.

3) The First Assist Nurse, the Surgical Technician and the Team Leader assigned to Patient #1's 6/23/11 surgery or on duty at the time of the surgery were interviewed respectively on 9/13/11 at 1:30 P.M., 1:35 P.M. and 1:40 P.M. They said there was nothing unusual about the surgery and they had worked with the Neurosurgeon on other surgeries without any problems or complaints. They said there had been no previous problems with the Stryker cement system.

4) The Stryker Representative was interviewed on 9/13/11 at 2:00 P.M. The Representative said he had observed the Neurosurgeon on several occasions prior to the 6/23/11 surgery and there were no problems with the Neurosurgeon's use of the Stryker cement system. The Representative said the staff assigned to Patient #1's surgery on 6/23/11 were all competent with the system.

5) Review of the medical records for 8 patients who had surgeries requiring the use of the Stryker cement system from 3/28/11 to 6/21/11 and performed either by the Neurosurgeon or his partner, indicated that during the surgeries, there was a small amount of cement leakage, but there were no post-operative complications. On 6/24/11 the Neurosurgeon performed a surgical procedure requiring the use of the Stryker cement system on 6/24/11 without complications.

6) Review of the Surgical Incident Report Log dated 3/1/11 to 9/13/11 indicated there were no other incidents involving the use of a cement system.

7) Review of Patient #1's medical record documentation dated 6/24/11 to 8/24/11 indicated that following the 6/24/11 surgery to remove the remaining cement, there was no significant improvement in Patient #1/s medical condition. On 6/28/11, Patient #1 was transferred to the Hospital's acute rehabilitation unit where Patient #1 received therapies without significant improvement. Patient #1 developed several post-operative complications including an infection of the surgical wound requiring incision and drainage and use of a wound vacuum system to remove drainage. Patient #1 also experienced a urinary tract infection, congestive heart failure, and respiratory complications. On 8/24/11 Patient #1 was discharged to a skilled nursing facility for ongoing care treatment.

8) Risk Managers #1 and #2 and Quality Specialists #1 and #2 were interviewed together on 9/13/11 at 11:30 A.M. regarding the Hospital's Investigation of the incident. Interviews indicated that as of 9/13/11, the investigation was still in process. The investigation conducted thusfar consisted of a medical record review by a Quality Specialist (not available for an interview) on 8/12/11, followed by a review by a member of the Neurosurgery Division (date unknown).

The Chair of Surgery was interviewed on 9/13/11 at 8:50 A.M. The Chair said this was not an unusual type of surgery. The Chair of Surgery said the he had not yet reviewed the case, but he would be participating in a review scheduled for 9/14/11 by the Quality and Utilization Committee.

There were no investigative steps reported as taken prior to 8/12/11 or since the Neurosurgery review.

On 6/24/11 the Neurosurgeon requested that the Hospital make accommodations for use of the Kyphon Cement System which he has been using since.

As of the date of the survey, no corrective actions have been identified or taken other than the action taken by the Neurosurgeon.