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H LEE MOFFITT CANCER CENTER & RESEARCH INSTITUTE I 12902 MAGNOLIA DR TAMPA, FL Aug. 6, 2019
VIOLATION: MEDICAL STAFF CREDENTIALING Tag No: A0341
Based on policy review, document review, medical record review, and staff interview, it was determined the facility failed to enforce the Medical Staff the Bylaws requirement for appointment of surgical privileges based on current competency related to vascular surgery privileges for four (#A, #B, #D, and #H) of ten credential files reviewed.

Findings included:

A review of the Medical Staff Bylaws, approved June 12, 2018, revised March 27, 2019 showed privileging and credentialing of Licensed Independent Practitioners (LIP's), under Section 5, page 9:
- Credentialing and re-credentialing appointment, reappointment, change in staff category, and the renewal or revision of clinical privileges, shall be based on the factors and procedure set forth in the Medical Staff
- Credentialing policies, which shall be consistent with the Bylaws
- Each LIP appointed to the Medical Staff must have his/her category of clinical privileges clearly delineated and determined on an individual basis commensurate with the Licensed Independent Practitioner (LIP's) education, training, experience and demonstrated current competency.

A review of the Medical Staff Credentialing policies and procedures (P&P) adopted by the Board of Directors on March 27, 2019 and Medical Staff on February 20, 2019, under section 2., A, page 1, showed Application for Appointment, Reappointment or Change in Staff Category or Privileges shall be made based on the following, as applicable:
- Compliance with the Medical Staff Bylaws, Rules and Regulation, and P&P ...
- Continuing training, education, experience and current competence qualifying the Medical staff appointee for the Privileges ...
- Membership shall contain a request for the specific privileges desired by the applicant and such other information and documentation as is prescribed by the Hospital in accordance with the criteria set forth in the Medical Staff Bylaws and in these P&P's ...
- Each LIP appointed to the Medical Staff must have his/her category of clinical privileges clearly delineated in accordance and delineation of privileges shall be determined on an individual basis and shall be commensurate with the applicant's education, training, experience, and demonstrated current competency.
- Each Member shall be entitled to exercise only those clinical privileges specifically granted to him/her by the Board of Directors.

An interview with the Chief of Surgery, Surgeon #B, on 08/02/19 at 4:47 PM, revealed the facility recently set up a team of surgeons that are on-call to respond to a catastrophic injury intra-operatively. The facility surgeons have the skill to repair vascular damage until the vascular surgeon can get to the facility. Surgeon #B confirmed there were no vascular surgeons on the team emergency catastrophic team. Surgeon #B stated that surgeons, by default, receive vascular training when they go to school. They must be able to repair vascular injuries as part of their core training. Surgeon #B stated, moving forward, the facility could add vascular privileges to their surgeon's set of privileges if needed. Surgeon #B stated vascular surgeons should arrive within 30 minutes after being called.

An interview with the facility senior legal counsel on 08/05/19 at 9:50 AM, revealed that all general surgeons are qualified to perform vascular surgery because they are board certified by the American Board of Surgery (ABS). In response to why the facility would even need a vascular surgery contract if their ABS certified surgeons can perform vascular surgery, the senior legal counsel stated, "they are an extra set of hands."

A review of A review of Patient #1's history and physical (H&P) physician documentation dated 01/17/19 showed the patient was scheduled and consented for elective surgery (non-emergency) to be performed by Surgeon #A (Thoracic Surgeon) and Co-Surgeon #H (Thoracic Surgeon).

A review of Patient #1's operative report documentation by Surgeon #A dated 01/17/19 showed that vessels were notably friable due to prior radiation and oozing noted from the hiatus. The area was packed ...oozing was again noted, packing removed and significant bleeding noted and patient packed. There was a drop in Blood Pressure. Anesthesia aware and addressed, mass transfusion protocol (MTP) was started and the thoracic surgeon called to assist. Exposure pursued and bleeding continued. Left thoracotomy, left lung deflated, aorta seen and appeared to be avulsed off the left portion of the intercostal artery, a branch off the thoracic aorta in the hiatus. The vascular injury was noted and appropriately repaired with a 2-0 pledgeted proline suture. The repair was hemostatic. This allowed time for anesthesia to stabilize and resuscitate the patient. The planned procedure was aborted and gastric vessels checked and intact. Peak in blood pressure noted, then very sudden bleed again from aorta. The skeletonized area of the vessel was stitched again, but other areas of aorta started to bleed, vessel wall was fragile and falling apart. Pressure and cardiac massage started. Code team called. General surgeon called to assist. The aorta was clamped. The patient was unable to be resuscitated and expired.

The review of the credentialing file for Surgeon #A (Thoracic Surgeon) for the period of 04/01/2019 through 03/31/2021, failed to show privileges for vascular surgery to include: arterial surgery, aneurysm resection or repair, arterial reconstructive operations, aortic arterial graft thrombectomy or embolectomy, or visceral arterial reconstruction.

The review of the credentialing file for Surgeon #H (Thoracic Surgeon) for the period of 11/01/2018 through 01/31/2020, failed to show privileges for vascular surgery to include: arterial surgery, aneurysm resection or repair, arterial reconstructive operations, aortic arterial graft thrombectomy or embolectomy, or visceral arterial reconstruction.

The review of the credentialing file for Surgeon #B (General Surgeon) for the period of 03/01/2019 through 02/28/2021, failed to show privileges for vascular surgery to include: arterial surgery, aneurysm resection or repair, arterial reconstructive operations, aortic arterial graft thrombectomy or embolectomy, or visceral arterial reconstruction.

An interview with the facility legal counsel on 08/05/19 at 8:50 AM, confirmed that none of the surgeons that provided care to Patient #1 had privileges for vascular surgery. Additionally, a vascular surgeon was not called to assist with Patient #1's damaged aorta.

A review of Patient #2's H&P physician documentation, dated 04/11/19, showed the patient was scheduled for a surgical procedure. A review of Patient #2's surgical consent confirmed the patient signed the consent for the procedure on 04/11/19 to be performed by Surgeon #D (Urology Surgeon).

A review of Patient #2's operative report documentation by Surgeon #D dated 04/11/19 showed: "once both the renal artery and renal vein were identified, a vascular stapler was then placed across the vein and artery and fired. The area was inspected, and within about 3 seconds there was a significant welling up of blood in retroperitoneum. It was difficult to identify the location of the bleeding. I initially placed my finger on the hilum for pressure then we called for help. Massive transfusion protocol (MTP) was then initiated ...we help pressure for approximately 20 minutes while the anesthesiology team initiated the MTP..we continued to code for approximately 1 hour ...We called the code at 10:30 AM. The report showed Patient #2 had an estimated blood loss (EBL) of 8 liters ...it appeared the patient had a cardiogenic event during the acute blood loss."

The review of the credentialing file for Surgeon #D (Urology Surgeon) for the period of 11/01/2018 through 10/31/2020, failed to show privileges for vascular surgery to include: arterial surgery, aneurysm resection or repair, arterial reconstructive operations, aortic arterial graft thrombectomy or embolectomy, or visceral arterial reconstruction.

Patient #2's intra-operative record showed Surgeon #D called for help, however, the record failed to show a vascular surgeon or a surgeon with vascular surgery privileges was called to assist in controlling the hemorrhage of blood. The only surgeon called to assist with the artery repair was also a urology surgeon and not a vascular surgeon.