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Based on document review, medical record review, and interview, the Medical Staff failed to ensure resident physicians were privileged or signed off by their supervising physician to perform the procedures they were performing. These failure were identified in 4 of 4 credential files.

Findings include:

-- In 6 of 19 medical records reviewed, the resident physicians who performed procedures were not privileged to do so.

Please see Tag A-0339.

Based on document review, medical record review, and interview, the Medical Staff failed to ensure surgical resident physicians were privileged / signed off to perform the procedures they were performing. Specifically, 1) 5 of 16 surgical resident physicians, Staff A, Staff B, Staff C, Staff D, and Staff E, performing invasive procedures were not privileged to do so. 2) In 6 of 19 medical records reviewed, (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6) of patients who had an invasive procedure performed, they were performed by a surgical resident physician that was not credentialed to do so.

Findings include:

-- Review of the Medical Staff bylaws dated 6/25/2020, under section titled Special Conditions for Residents or Fellows in Training, it states, "Residents or fellows in training in the Hospital shall not normally hold membership on the Medical Staff and shall not normally be granted specific clinical privileges. Rather, they shall be permitted to function clinically only in accordance with the written training protocols developed by the residency program directors in conjunction with the residency training program. The protocols must delineate the roles, responsibilities, and patient care activities of residents and fellows including which types of residents may write patient care orders, under what circumstances they may do so, and what entries a supervising physician must countersign. The protocol must also describe the mechanisms through which resident directors and supervisors make decisions about a resident's progressive involvement and independence in delivering patient care and how these decisions will be communicated to appropriate Medical Staff and Hospital leaders."

-- Reivew of policy and procedure titled "Supervision for Residents," last revised 8/30/2024, "The supervising physician may be an attending, faculty, chief, senior or junior resident. ... All residents must report to the charge nurse prior to starting any procedure to verify their credentialing status. The resident is considered credentialed for a procedure if credentialed is listed next to the procedure name in New Innovations. ... Urgent patient care issues should be discussed immediately with the attending/faculty. Consultation should be used frequently within the chain of command, as this is optimal for learning, teaching, and patient care."

--Review of email dated 6/6/2024, from Staff F, Graduate Medical Education Department Manager, "Resident Supervision / Procedure Privileging: ... Staff G, Physician Director Graduate Medical Education met with the residents to review elements of the programs updated Supervision Policy. .... The final policy will be released in Policy Stat once finalized: Procedure list and required numbers: To be credentialed for the following procedures every resident (regardless of post graduate year) must hand in 10 fully completed procedures cards with at least 3 with the competency level of Proficient. The following are bedside procedures: Central Venous Insertion, Arterial Cannulation, Chest Tube, Bronchoscopy, Repair of skin / soft tissue lacerations and surgical incisions, excision of lesions under the skin and subcutaneous tissue, and Tube Thoracostomy.

MR Reviews
-- Review of Patient #1's medical record revealed, they presented to the emergency department (ED) on 12/29/2023 at 1:10 pm, with a chief complaint of rib injury following an recent assault. The patient had a chest x-ray performed 2 days later (at another location). The results, that had just become available, revealed a right sided pneumothorax (a collapsed lung). Patient #1 complained of right-sided chest pain worse with breathing. Denied any shortness of breath and did not appear to be in any acute distress. They were hemodynamically stable. Case was discussed with general surgery resident. Patient #1 was admitted to their service. Treatment plan included the placement of a chest tube. The consent was obtained by Staff A, Surgical Resident Physician on 12/29/2023 at 6:35 pm for insertion of a ride sided pigtail catheter (type of chest tube). Staff A inserted the chest tube at 9:26 pm. Minimal amount of serosanguineous fluid was evacuated. Post procedure chest x-ray was pending. The patient tolerated the procedure well without any complication. The chest tube came out during the night. Documentation by the attending physician on 12/30/2023 at 2:04 pm indicated, they were available. (Not directly supervising the resident physician.)

Review of Staff A's personnel file revealed that they were not credentialed to perform the chest tube placement procedure.

-- Review of Patient #2's medical record revealed, they presented to ED on 5/20/2024 at 9:36 am from a facility after being found confused with altered mental status. There was a concern of seizures. Patient with a history of tobacco abuse and drug abuse. In the ED Patient #2 was very agitated and was having difficulty breathing. Patient #2 was tachycardic (rapid heart rate) and tachypneic (rapid respirations). Patient was intubated for airway protection and sedated. Chest x-ray showed signs of aspiration pneumonitis. Intravenous antibiotics were initiated. Urine drug screen test was negative. It was suspected that patient could have consumed synthetic drug.

5/22/2024
Patient #2 continued to decline and developed multisystem failure. Hemodialysis (HD) was ordered by nephrology.

At 3:25 am, Staff B, Surgical Resident Physician documented the insertion of a right femoral HD catheter via ultrasound. Dialysis was initiated at 7:30 am and stopped at 8:00 am due to the catheter not functioning. Surgery was notified of need for new catheter.

At 10:26 am, Staff A documented the insertion a hemodialysis catheter in right internal jugular via ultrasound. The patient tolerated the procedure well and there were no complications. Chest x-ray was performed post procedure, resident informed dialysis nurse of correct placement. Dialysis was resumed.

At 11:05 am, X-ray notified nurse of critical result of chest x-ray, regarding new HD catheter placement, possibly in aorta rather than the superior vena cava. General surgery notified dialysis stopped. At 11:30 am, providers at bedside, updated.

At 1:05 pm, nursing documented, Patient #2 received 1 hour of HD, no fluid removal. blood pressure remained stable. During treatment, Staff H, Physician entered the room and determined the right jugular catheter placed this morning for HD was not appropriate for use at this time. Patient to go to OR (operating room) or IR (interventional radiology) to receive new catheter.

At 2:11 pm, computed tomography (CT) of the chest confirmed catheter on the right inserted into the right brachiocephalic artery with its tip in the ascending aorta.

At 4:20 pm, insertion of right groin hemodialysis catheter (revision of surgically placed temporary HD catheter) by interventional radiology.

5/23/2024
At 8:28 am, Staff H, Physician documented, they were "notified after the placement of this line that there was a complication with the placement. The resident is credentialed to perform central line/temporary HD catheter placement, and I was immediately available if needed and was here for indirect supervision of the resident. I was however not aware that this procedure was taking place or officially consulted for this malfunctioning catheter / catheter placement. I was made aware after the fact that confirmation X-ray for line placement indicated catheter in artery and computed tomography angiography (CTA) indicated location at junction of right innominate/subclavian artery. I discussed this with Staff I, Vascular Surgeon and I have arranged for transfer to another medical center after discussing with cardiothoracic (CT) surgeon at that facility via transfer center, as CT surgery is not available at Wynn hospital and will be needed for catheter removal and likely artery repair."

-- Review of Staff A's personnel file revealed that they were not credentialed to perform the central line/hemodialysis catheter placement procedure.

-- Review of Patient #3's medical record revealed, they presented to the ED from another facility on 10/28/2023 at 2:35 pm with diagnosis of an unwitnessed fall. Patient sustained a laceration to the forehead. The CT of the head was abnormal and therefore further studies were requested. No acute infarct was noted, unfortunately suboptimal study. Patient noted to have a leukocytosis (high white blood cell count). Patient did just finish course of antibiotics for a urinary tract infection and vancomycin for Clostridium difficile. They complained of a headache and generalized weakness.

Staff C, Surgical Resident Physician inserted an arterial line in the right femoral artery on 10/30/2023 at 11:30 pm for hemodynamic monitoring.

Staff H, Physician documented on 10/31/2023 at 5:11 pm (under procedure note), they were available.(not directly supervising).

-- Review of Staff C's personnel file revealed that they were not credentialed to perform the arterial line catheter placement procedure.

-- Review of Patient #4's medical record revealed, they presented to ED on 11/11/2023 at 11:08 pm after an urgent care visit where he was found to have a spontaneous pneumothorax. Pneumothorax was confirmed by imaging in the ED. It was discussed with the patient that due to the size of his pneumothorax he would need a pigtail chest tube placed and to be admitted for monitoring.

At 5:02 am, Staff D, Surgical Resident Physician placed a pigtail chest tube into the right chest. Post procedure chest x-ray confirmed placement. Staff A, was present during entire procedure.

On 11/12/2023 at 9:23 am, Staff H, Physician documented "I was not present for the entirety of the procedure(s), but I was readily available for direct supervision."

-- Review of Staff D's personnel file revealed that they were not credentialed to perform the chest tube placement procedure.

-- Review of Staff A's personnel file revealed that they were not credentialed to perform the chest tube placement procedure.

-- Review of Patient #5's medical record revealed, they presented to the ED on 11/23/2023 at 8:23 pm via ambulance after being hit by a car. The patient had multiple contusions and laceration to the scalp. X-rays were completed and revealed the following: closed nondisplaced fracture of proximal end of left humerus, fracture of sacrum, closed fracture of left inferior pubic ramus, closed fracture of superior ramus of left pubis.

Staff E, Surgical Resident Physician, documented on 11/24/2023 at 1:29 am the repair of a right upper frontal bone laceration.

-- Review of Staff E's personnel file revealed that they were not credentialed to perform the repair of skin laceration procedure.

-- Review of Patient #6's medical record revealed, they presented to the ED on 11/3/2023 at 8:02 pm, via ambulance from a nursing home after being found on the floor. When emergency medical services arrived the patient was receiving cardio pulmonary resuscitation (CPR) by staff. Patient was intubated on arrival, required a chest tube for right sided pneumothorax.

On 11/4/2023 at 2:04 am - Staff A placed a 36 french chest tube into the right 4th rib.

-- Review of Staff A's personnel file revealed that they were not credentialed to perform the chest tube placement procedure.

Staff Interviews
-- Per interview of Staff J, Senior Director of Quality Management Systems & Regulatory Affairs and Staff K, Manager, Quality Management, on 10/21/2024 at 12:00 pm, they have heard of issues regarding the residency programs, including surgical residents. There have been quality concerns and concerns regarding the oversight of residents brought to Staff J and Staff K's by various staff members. There have been MIDAS (online occurrence reporting system) reports generated about surgical residents and adverse events involving surgical residents. If there was an issue with a residents case, the quality department would look at the case and decide what needs to be written up for a report and then send it over to the resident program. If there are issues with a particular resident, those concerns would be brought to the supervising physician. The quality department does not get any follow up to resident concerns.

-- Per interview of Staff G, Physician Director Graduate Medical Education, on 10/21/2024 at 2:00 pm, residents are required to have 10 procedure cards turned in for invasive procedures, with 3 indicating they are proficient at performing the procedure before being able to perform the procedure on their own. A senior resident can oversee a junior resident as long as the senior resident is credentialed to perform the procedure. This does not require the attending to be present during the procedure. In an emergency, an uncredentialed resident can perform a bedside procedure. In non-emergent cases, uncredentialed residents that perform bedside procedures without a supervising provider, would require a root cause analysis. The charge nurse has access to the online list of credentialed residents. The nurse has a right to say no to the resident if they are not credentialed

-- Per interview of Staff L on 10/22/2024 at 2:22 pm, attending physicians are not around during the day and residents are not supervised. The attending will say there is a senior resident around who can watch patients. There is a weekly Morbidity & Mortality Meeting to discuss complications with residents. Chest tubes are an issue, they have had difficulty inserting. One resident inserted a chest tube and left a foreign body but there were no repercussions. In the intensive care unit (ICU), a resident placed a chest tube and left and it was not working. The resident then returned to put in a second chest tube. Because there is no supervision, they do what they want to. That incident was reported through the Midas system. The bedside nurses in ICU complain about the residents and the lack of supervision. Some providers are immediately available and others are not. Residents are not honest with their concerns for fear of backlash.

-- Per interview of Staff H on 10/22/2024 at 2:35 pm, once residents are signed off on a procedure they can perform them independently. There have been discussions about what they are doing. Sometimes the paperwork doesn't get submitted for credentialing. There are not a lot of senior residents in the program for support. There has been discussion about chest tubes and the program has had a significant overhaul.

-- Per interview of Staff M on 10/22/24 at 3:55 pm, there is not a lot of supervision of the residents and the procedures they are performing. If they (residents) get into trouble they will call Staff N, Physician or Staff H equally, they do not call before they do procedures. If nursing staff reach out to the attending they just say "oh, ok." If nursing staff says something to a resident they respond "they are just going to Midas us anyway."

"One resident when drawing blood gases had multiple missed attempts, using the patient as a pin cushion." Staff M puts in a Midas report for more than 2 attempts. Another patient had to be transferred due to issues with a hemodialysis catheter placement by a resident. Staff N will have residents change ventilator settings after a blood gas is resulted. The residents will ask Staff M, what they should do? Staff M indicated that it is not nursing's role to make that decision.

-- Per interview of Staff O on 10/23/2024 at 10:05 am, there have been issues identified with chest tube insertions. One resident placed an central line into the aorta. There was also an issue with a first year resident, they were not able to reach an attending and proceeded to put chest tube in themselves. Recently, Staff O was consulted to go to the ED for a trauma case. The chest tube was already placed however, it was not in the lung it was exterior to the ribcage A thoracic surgeon was called and then they placed the chest tube. During this same case, 2 residents were not able to place a femoral line and the senior resident had to be notified. The residents procedure notes do not reflect any complications that occur during procedures.

-- Per interview of Staff P on 10/28/24 at 2:35 pm, residents do not always let the nurse know when they are doing a procedure, so nursing is unable to check if they are credentialed to perform a procedure..

-- During interview of Staff K on 10/28/2024 at 12:15 pm, they acknowledged the above findings.

Based on document review, medical record review, and interview in 4 of 31 medical records reviewed, Patient #2, Patient #4, Patient #7, and Patient #8, the facilty failed to ensure properly executed informed consent forms were completed. Specifically, surgical consents for procedures performed by surgical resident physicians were incomplete and/or incorrect. This could cause patients to be unaware of the procedure to be performed on them.

Findings include:

-- Review of the facility's policy and procedure titled, "Advance Directives, Consents and Medical Decisions Management Plan," revised 2/2024, indicated "an informed consent must contain the following ... name and description of the surgery in terms understandable by the patient. ... Name, signature, and date of the provider(s) performing the procedure ... Every blank should be filled in before the patient or responsible person signs and it is witnessed."

-- Review of Patient #2's medical record revealed the document titled, "Consent for Operative and/or Diagnostic Procedures and/or Treatment," dated 5/20/2024 at 5:23 pm, indicated it was for placement of an arterial line. The space for the provider name was left blank. Staff B, Surgical Resident Physician signed the consent electronically on 5/29/2024 (9 days after the procedure was performed).

A consent form dated 5/22/2024 at 1:43 am for placement of a hemodialysis catheter, the name of the procedure being performed was left blank.

A consent form dated 5/22/2024 at 9:10 am for placement of a hemodialysis catheter, the space for provider name was left blank. Staff A, Surgical Resident Physician electronically signed the consent on 5/29/2024 (7 days after the procedure was performed).

-- Review of Patient #4's medical record revealed the informed consent form was dated 11/23/2023 at 3:47 am, for the placement of a chest tube was signed by the emergency department (ED) physician. However a surgical resident physician inserted the chest tube. The residents name was not on the consent form.

-- Review of Patient #7's medical record revealed the informed consent form dated 8/3/2024 at 12:13 pm, lacked the name and signature of the provider performing the procedure.

-- Review of Patient #8's medical record revealed the informed consent dated 12/12/2023 at 3:20 pm, lacked the name and signature of the provider performing the procedure.

-- Per interview of Staff G, Physician Director Graduate Medical Education on 10/21/2024 at 2:00 pm, informed consent forms should contain the name of the resident performing the procedure.