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Based on review of facility policy, medical record review, facility documentation review, and interviews the facility's Quality Assurance Performance Improvement (QAPI) failed to ensure an ongoing quality assessment and performance program related to surgical services and physician supervision of unlicensed and certified surgery team members in the Operating Room (OR) for 1 orthopedic surgical patient (Patient #2) of 4 orthopedic surgical patients reviewed.

The findings include:

Patient #2 was admitted to the facility on 5/23/2023 for Left Total Hip Arthroplasty Revision (previously implanted hip-joint is replaced with a new artificial hip-joint). During the procedure on 5/24/2023, the surgeon left the OR area while the First Assist Certified Surgical Technician (CST-assist the surgeon with tasks such as selecting equipment, holding open incisions, stopping bleeding, closing the incision, among many other tasks) was closing the surgical incision, left a physician assistant (PA) student unsupervised in the OR, and physically left the facility prior to closure of the incision. The First Assist CST stopped closing the incision when she became aware the surgeon was not in the OR area and coached the PA student to complete the incision closure. The facility's QAPI committee implemented new interventions but failed to implement monitoring to ensure no future occurrences and compliance with supervision of students and staff. The facility's failure to conduct ongoing monitoring of physician compliance regarding supervision of unlicensed and certified surgery team members during incision closure placed all surgical patients at risk.

Refer to A-0286.

Based on review of facility policy, medical record review, facility documentation review, and interviews the facility failed to systematically monitor processes to ensure physician supervision of unlicensed and certified surgical team members in the Operating Room (OR) during incision closure for 1 orthopedic surgery patient (Patient #2) of 4 orthopedic surgical patients reviewed.

The findings include:

Review of Facility A's "Nurse Anesthetist, Physician Assistant, and Nurse Practitioner Students Application Packet" undated showed "...Nurse Anesthetist, Physician Assistant [PA], and Nurse Practitioner [NP] Students (collectively referred to as Students), refer to practitioners who are currently enrolled in an educational program...The Students must be sponsored by a physician(s) having Active staff privileges at the Hospital(s) and who accepts full responsibility for supervision of the Students at all times...Students shall have no independent patient care responsibilities and may not practice independently of an attending physician and/or CRNA preceptor. A Student may only render medical services to patients for whom the Student's supervising physician is the attending physician and only when accompanied by and under the direct and immediate supervision of the attending physician and/or CRNA [Certified Registered Nurse Anesthetist] preceptor. The extent of direct supervision to be exercised by the sponsoring physician and/or CRNA preceptor will be outlined in an accompanying letter with this application..."

Review of Facility A's policy "Advanced Practice Provider Students-Medical Staff/Credentialing" revised 3/2012 showed "...This policy includes, but is not limited to, Nurse Anesthetist, Nurse Practitioner and Physician Assistant Students (collectively referred to as Advanced Practice Students) who are currently enrolled in an educational program...Purpose: To define the Medical Staff Office process for any [named corporation] facility to permit Advanced Practice Provider Students to participate in supervised training at such facility...The Advanced Practice Student must be sponsored by a physician(s) having Active staff privileges at the [named corporation] facility and who accepts full responsibility for supervision of the Advanced Practice Student at all times...Advanced Practice Students shall have no independent patient care responsibilities and may not practice independently of a sponsoring physician and/or CRNA preceptor. An Advanced Practice Student may only render medical services to patients for who the Student's supervising physician is the Attending physician and only when accompanied by and under the direct and immediate supervision of the Attending physician and/or CRNA preceptor who will be specified in a letter to accompany the application...Students shall be responsible and accountable at all times to their supervising physician...

Review of Facility A's policy "System Improvement Report" (SIR) revised 12/2017 showed "...[named corporation] has adopted an incident reporting system to enable the organization to carry out its responsibility for the provision and continuous improvement of quality of care in a safe environment...Department Manager Follow-Up: When an SIR is submitted, the Manager of the area where the event occurred is electronically notified. The Department Manager or his/her designee has the responsibility to investigate the occurrence immediately and complete the Manager response section of the SIR...The Department Manager section of the SIR includes the following categories: Treatment Intervention Results...Assessment of Injury...Assessment of process...P&P [policy and procedure] Followed...P&P Not Followed...Communication Failure...Education Needed...Personnel Related...Manager Performance Improvement Action/Remarks...List the details of actions being taken to prevent the occurrence from happening again in the future...Data Aggregation, Analysis and Reporting: SIR data is aggregated, analyzed, and reported Senior Leadership at each facility. Specific information obtained from the SIR system may be presented at various facility Quality Improvement Committees as appropriate as part of the ongoing evaluation of quality, process, and safety. Ad Hoc reports may also be generated as needed to aid in tracking, trending, and other quality or performance improvement activities..."

Review of Facility A's Job Description for "Surgical First Assistant" revised 12/22/2021 showed "...With directed delegation, assists the surgeon throughout the entire surgical procedure. The surgeon may allow the surgical first assistant to tie or cauterize vessels, muscle, or fat under their immediate direction or observation: the surgical first assistant may close the skin with suture or staples and place dressings. It is the surgeon's responsibility to verify the acceptability and appropriateness of the closure..."

Review of a named university's Physician Assistant Program Clinical Preceptor (provides instruction/training) Manual for 2022-2023 showed "...Students must work under the direct supervision of a licensed PA, physician...PAs [Physician Assistant student] must be supervised by a licensed physician...Students must always work under the direct supervision of a preceptor (assigned preceptor or alternate). Students are at no time allowed to be in charge of a patient's care. Students are not allowed to provide any services without consultation and supervision of the preceptor..."

Review of the facility's Quality, Patient Safety and Performance Improvement Plan for 2023-2024 showed "...This [named corporation] Quality, Patient Safety, & [and] Performance Improvement Plan...is aligned with the strategic plan and commitment to patient safety and continuous quality improvement. The goal is to provide the highest level of healthcare and service through the use of evidence-based practices, policies, and processes...The [named corporation] Performance Improvement Council...is a multidisciplinary body that serves to oversee, coordinate, and direct organizational performance improvement activities...Department leaders are accountable to administration, affiliate Quality Committees, and the Board of Directors for the quality, performance improvement, and ongoing safety of services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the care provided in their departments ensuring alignment of efforts with this plan...Employees collect, organize, and analyze data necessary to determine root causes, contributing factors, track performance, and benchmark..."

Medical record review of a History and Physical showed Patient #2 was transferred to the facility from another acute care hospital for left hip pain on 5/23/2023. Patient #2 underwent a Left Hip Percutaneous Screw Fixation (procedure for a hip fracture) on 1/15/2023 and a Total Hip Arthroplasty (hip replacement) was performed for the patient on 4/3/2023. Patient #2 reported that her hip kept popping out of socket since the surgery on 4/3/2023. Patient #2 was admitted to the facility's medical/surgical unit with diagnoses including Pain of Left Hip, Chronic Obstructive Pulmonary Disease (disease which causes difficulty breathing), and Type 2 Diabetes Mellitus.

Medical record review of an OR Intraoperative (during surgery) record dated 5/24/2023 showed Patient #2 arrived in the OR at 4:15 PM; surgery start time was 4:41 PM; and surgery stop time was 6:25 PM. Patient #2 was transferred to the Post Anesthesia Care Unit (PACU) at 6:34 PM. The following staff were documented as present during the procedure: surgeon, Certified Registered Nurse Anesthetist (CRNA), 1 Registered Nurse (RN) Circulator (responsible for coordinating the nursing care and safety needs of the patient in the operating room), 3 scrub technicians (set out necessary instruments, ensure they're sterilized, position the patient on the operating table, and arrange sterile drapes ensuring the surgical field is exposed), and 1 PA student. Documentation showed the PA student was present in the OR from 4:15 PM-6:34 PM (entire procedure).

Medical record review of an Orthopedic Operative Note dated 5/24/2023 at 5:36 PM showed a "...Revision left total hip arthroplasty...[previously implanted hip-joint is replaced with a new artificial hip-joint]..." was performed for Patient #2. The superficial (top layer) of skin was closed with the assistance of the First Assist Certified Scrub Technician (CST-assist the surgeon with tasks such as selecting equipment, holding open incisions, stopping bleeding, closing the incision, among many other tasks). Patient #2 "...was awakened and taken to the PACU in good condition..." The surgeon electronically signed the Operative Note on 5/24/2023 at 5:40 PM (45 minutes before documented surgery stop time and 54 minutes before patient taken to PACU).

Facility A's Senior Risk Manager reviewed Patient #2's medical record and video footage for 5/24/2023 and documented the following timeline.
*2:44 PM-Patient #2 was in Pre-Operative area.
*4:15 PM-Patient #2 was transported into the OR
*5:35 PM-Physician #1 to OR desk-dictation of operative note
*5:40 PM-Patient #2's Operative note was time stamped by the physician
(medical record review)
*5:43 PM-Physician #1 to staff breakroom near PACU doors
*5:45 PM-Physician #1 exited the breakroom through back door into hallway near
the elevator
*5:50 PM-Physician #1 left surgery unit and exited 2 south/IMC (Intermediate
Care Unit) stairwell
*5:50 PM-Physician #1 exited the building through physician parking lot entrance
near physician's lounge and left in white Toyota SUV
*6:25 PM-Documented surgery stop time for Patient #2
*6:33 PM-Patient #2 transported from OR to PACU
*7:00 PM-Patient #2 was transported from PACU to 306

Review of documentation from a system improvement report for Facility A showed on 5/24/2023 at 5:34 PM, the physician (unnamed) left the OR suite to dictate his operative note, leaving the First Assist CST and PA student to close the incision. After completing the operative note at 5:40 PM, the physician exited the premises, unknown to staff and without checking on the closing progress. At 6:00 PM, the circulator received a call to say that the physician's car had left the parking lot and he was no longer on the premises. The First Assist CST began teaching the PA student how to suture because it was understood to her that she could not close without the physician's presence in the room. The surgical site was closed, and the procedure stopped at 6:25 PM, approximately 50 minutes after the surgeon had left the room. The operative note states that the First Assist assisted him with closure and the patient was taken to PACU in good condition. He (physician) was not present for these events, as witnessed by all surgical staff in the room.

Review of Facility A's investigation documentation showed the following:
*5/24/2023-Physician #1 began closing the patient's wound with the physician's
assistant student. The physician left the room and the physician's assistant
student completed the closure. The physician did not tell the team where he was
going.
*5/24/2023-Verbal and written statements were taken from OR staff who were
scrubbed in for the procedure. The witness accounts revealed the surgeon left
the OR area and the First Assist CST coached the PA student while the PA
student closed the incision.

Medical record review of a discharge summary showed Patient #2 was discharged from Facility A to home on 5/25/2023 in stable condition, with self-care and follow-up as an outpatient.

Medical record review showed Patient #2 presented to Facility A's Emergency Department (ED) on 5/27/2023 with onset of increased left hip pain and bleeding. The ED physician spoke with Physician #1 who advised that she could remain at Facility A, and he would remove the artificial joint components, or the patient could be transferred to Facility B. The ED physician spoke with Patient #2 who preferred to be transferred to Facility B.

Review of Facility B's medical record showed Patient #2 was transferred to Facility B's ED on 5/27/2023 and was admitted to the facility. The patient underwent removal of the artificial components, the hip joint was cleaned and washed out, and antibiotic spacers (device that releases antibiotic in joint space) were placed on 6/2/2023. Patient #2 received intravenous (IV) antibiotics until she was discharged on 7/14/2023.

During an interview on 9/5/2023 at 10:39 AM, in the conference room, the OR Director stated PA students fall under the direct supervision of the physician. The physician must be present in the OR if the PA student performed the incision closure. The OR Director stated the First Assist CST could close the incision, if the surgeon was available, or close by within the OR area. The First Assist CST spoke with the OR Director the following morning, and reported she did not close Patient #2's incision, but she had coached the PA student to make sure it was done properly.

During an interview on 9/5/2023 at 11:53 AM, in the conference room, RN #1 stated there was a student and a First Assist CST in the room when Physician #1 said he was going to dictate the patient's (Patient #2) operative report. The physician had been out of the room for quite a while, and he didn't return. RN #1 stated she received a phone call from the PACU nurse who reported the physician's car was gone. The First Assist CST was closing the incision when they became aware the physician was no longer in the facility. RN #1 reported the First Assist CST stopped closing the incision because according to policy the First Assist could not close without the physician being on the premises. At that point, the First Assist CST coached the PA student through closing the surgical incision. During a second interview (telephone) on 9/7/2023 at 1:09 PM, the surveyor asked RN #1 if she attempted to call Physician #1 to ask him to return to the OR and RN #1 stated she did not recall calling the physician.

During an interview on 9/5/2023 at 12:07 PM, in the conference room CRNA #1 confirmed the surgeon was not in the OR room while the First Assist CST was helping the PA student close the surgical incision. CRNA #1 stated the surgeon was nowhere to be found afterwards.

During an interview on 9/6/2023 at 11:56 AM, in the conference room, RN #2 stated she received a message asking why a First Assist CST and a PA student were closing on a case. RN #2 stated she went to the OR to see what was going on. RN #2 stated she did not see the physician at the desk or in the department. "...I knew medical students could not be left alone to close..." RN #2 stated she saw the physician leave the OR area through the PACU, but she did not see him leave the premises. RN #2 stated she saw the student and First Assist CST at the patient's bedside closing after the case. RN #2 confirmed the physician was not in the OR with the student. During a second interview (telephone) on 9/7/2023 at 1:14 PM, the surveyor asked RN #2 if she attempted to contact Physician #1 to return to the OR and RN #2 stated she did not attempt to call Physician #1.

During a telephone interview on 9/6/2023 at 12:06 PM, Physician #1 stated Patient #2 was transferred to the facility from another hospital. When the surveyor asked the physician to describe the events of Patient #2's surgical procedure on 5/24/2023 the physician stated "...I closed the deep and some of the superficial tissue...I said okay guys, you got it from here? I thanked them...went out and dictated...changed out of scrubs and left...found out I'm not allowed to leave the arena while a scrub tech was closing..." Physician #1 stated one week after the surgery the First Assist CST told him PA students were not allowed to close the wound after he left the room. Physician #1 stated "...I told [OR Director] I didn't ask my PA student to close..." Physician #1 then stated the OR Director informed him that he had to remain in the OR suite when the First Assist CST was closing, and he had to stay with the student. Physician #1 stated "...I got a letter that I had egregious behavior, and I may not have privileges at the hospital. That was over a month ago..." Physician #1 stated he presented his case to the peer review committee. He was told they were still investigating.

During an interview on 9/7/2023 at 4:15 PM, in the conference room, the OR Director confirmed the facility was not monitoring to ensure the surgeon remained with advanced practice students in the OR and were not monitoring to ensure the surgeon remained within the surgical theatre while the First Assist CST closed the incision.

During an interview on 9/8/2023 at 9:24 AM, in the conference room, the Senior Risk Manager stated she was made aware of the incident surrounding Patient #2's surgical procedure on 5/25/2023. The Senior Risk Manager reviewed the patient's medical record and made notes of time stamps. She then reviewed the video surveillance footage. The Senior Risk Manager stated the physician was seen going to the desk and sitting in front of the computer; he was then seen walking to the break room near the PACU; exited through the PACU doors; and went to the Intermediate Care Unit/2 South stairwell. He then exited out the door near the physician's parking lot. The Senior Risk Manager created a timeline which showed the physician left the facility prior to completion of the patient's surgical procedure, according to time stamps in Patient #2's medical record. The Senior Risk Manager stated she was not involved in any other part of the investigation.

During an interview on 9/8/2023 at 9:35 AM, in the conference room, the OR Nurse Manager stated she had made a few modification to her daily chart audits to include surgeon in and out of room times since the event with Patient #2. The OR Nurse Manager stated she was not documenting, tracking, or trending information collected during the chart audits.

Based on review of facility policy, medical record review, facility documentation review, and interviews the facility failed to provide organized surgical services in accordance with acceptable standards of practice for 1 orthopedic surgical patient (Patient #2) of 4 orthopedic surgical patients reviewed.

The findings include:

Patient #2 was admitted to the facility on 5/23/2023 for Left Total Hip Arthroplasty Revision (previously implanted hip-joint is replaced with a new artificial hip-joint). During the procedure on 5/24/2023, the surgeon left the OR area while the First Assist Certified Surgical Technician (CST-assist the surgeon with tasks such as selecting equipment, holding open incisions, stopping bleeding, closing the incision, among many other tasks) was closing the surgical incision, left a physician assistant (PA) student unsupervised in the OR, and physically left the facility prior to closure of the incision. The First Assist CST stopped closing the incision when she became aware the surgeon was not in the OR area and coached the PA student to complete the incision closure. The facility failed to ensure supervision of unlicensed and certified surgery team members by a physician through completion of a surgical procedure. The facility's failure to ensure physician supervision of unlicensed and certified surgery team members through completion of a surgical procedure placed all surgical patients at risk.

Refer to A-0942.

Based on review of facility policy, medical record review, facility documentation review, and interviews the facility failed to ensure supervision of unlicensed and certified surgery team members by a physician through completion of a surgical procedure for 1 orthopedic surgical patient (Patient #2) of 4 orthopedic surgical patients reviewed.

The findings include:

Review of Facility A's "Nurse Anesthetist, Physician Assistant, and Nurse Practitioner Students Application Packet" undated showed "...Nurse Anesthetist, Physician Assistant [PA], and Nurse Practitioner [NP] Students (collectively referred to as Students), refer to practitioners who are currently enrolled in an educational program...The Students must be sponsored by a physician(s) having Active staff privileges at the Hospital(s) and who accepts full responsibility for supervision of the Students at all times...Students shall have no independent patient care responsibilities and may not practice independently of an attending physician and/or CRNA preceptor. A Student may only render medical services to patients for whom the Student's supervising physician is the attending physician and only when accompanied by and under the direct and immediate supervision of the attending physician and/or CRNA [Certified Registered Nurse Anesthetist] preceptor. The extent of direct supervision to be exercised by the sponsoring physician and/or CRNA preceptor will be outlined in an accompanying letter with this application..."

Review of Facility A's policy "Advanced Practice Provider Students-Medical Staff/Credentialing" revised 3/2012 showed "...This policy includes, but is not limited to, Nurse Anesthetist, Nurse Practitioner and Physician Assistant Students (collectively referred to as Advanced Practice Students) who are currently enrolled in an educational program...Purpose: To define the Medical Staff Office process for any [named corporation] facility to permit Advanced Practice Provider Students to participate in supervised training at such facility...The Advanced Practice Student must be sponsored by a physician(s) having Active staff privileges at the [named corporation] facility and who accepts full responsibility for supervision of the Advanced Practice Student at all times...Advanced Practice Students shall have no independent patient care responsibilities and may not practice independently of a sponsoring physician and/or CRNA preceptor. An Advanced Practice Student may only render medical services to patients for who the Student's supervising physician is the Attending physician and only when accompanied by and under the direct and immediate supervision of the Attending physician and/or CRNA preceptor who will be specified in a letter to accompany the application...Students shall be responsible and accountable at all times to their supervising physician...

Review of Facility A's Job Description for "Surgical First Assistant" revised 12/22/2021 showed "...With directed delegation, assists the surgeon throughout the entire surgical procedure. The surgeon may allow the surgical first assistant to tie or cauterize vessels, muscle, or fat under their immediate direction or observation: the surgical first assistant may close the skin with suture or staples and place dressings. It is the surgeon's responsibility to verify the acceptability and appropriateness of the closure..."

Review of a named university's Physician Assistant Program Clinical Preceptor (provides instruction/training) Manual for 2022-2023 showed "...Students must work under the direct supervision of a licensed PA, physician...PAs [Physician Assistant student] must be supervised by a licensed physician...Students must always work under the direct supervision of a preceptor (assigned preceptor or alternate). Students are at no time allowed to be in charge of a patient's care. Students are not allowed to provide any services without consultation and supervision of the preceptor..."

Medical record review of a History and Physical showed Patient #2 was transferred to the facility from another acute care hospital for left hip pain on 5/23/2023. Patient #2 underwent a Left Hip Percutaneous Screw Fixation (procedure for a hip fracture) on 1/15/2023 and a Total Hip Arthroplasty (hip replacement) was performed for the patient on 4/3/2023. Patient #2 reported that her hip kept popping out of socket since the surgery on 4/3/2023. Patient #2 was admitted to the facility's medical/surgical unit with diagnoses including Pain of Left Hip, Chronic Obstructive Pulmonary Disease (disease which causes difficulty breathing), and Type 2 Diabetes Mellitus.

Medical record review of an OR Intraoperative (during surgery) record dated 5/24/2023 showed Patient #2 arrived in the OR at 4:15 PM; surgery start time was 4:41 PM; and surgery stop time was 6:25 PM. Patient #2 was transferred to the Post Anesthesia Care Unit (PACU) at 6:34 PM. The following staff were documented as present during the procedure: surgeon, Certified Registered Nurse Anesthetist (CRNA), 1 Registered Nurse (RN) Circulator (responsible for coordinating the nursing care and safety needs of the patient in the operating room), 3 scrub technicians (set out necessary instruments, ensure they're sterilized, position the patient on the operating table, and arrange sterile drapes ensuring the surgical field is exposed), and 1 PA student. Documentation showed the PA student was present in the OR from 4:15 PM-6:34 PM (entire procedure).

Medical record review of an Orthopedic Operative Note dated 5/24/2023 at 5:36 PM showed a "...Revision left total hip arthroplasty...[previously implanted hip-joint is replaced with a new artificial hip-joint]..." was performed for Patient #2. The superficial (top layer) of skin was closed with the assistance of the First Assist Certified Scrub Technician (CST-assist the surgeon with tasks such as selecting equipment, holding open incisions, stopping bleeding, closing the incision, among many other tasks). Patient #2 "...was awakened and taken to the PACU in good condition..." The surgeon electronically signed the Operative Note on 5/24/2023 at 5:40 PM (45 minutes before documented surgery stop time and 54 minutes before patient taken to PACU).

Facility A's Senior Risk Manager reviewed Patient #2's medical record and video footage for 5/24/2023 and documented the following timeline.
*2:44 PM-Patient #2 was in Pre-Operative area.
*4:15 PM-Patient #2 was transported into the OR
*5:35 PM-Physician #1 to OR desk-dictation of operative note
*5:40 PM-Patient #2's Operative note was time stamped by the physician
(medical record review)
*5:43 PM-Physician #1 to staff breakroom near PACU doors
*5:45 PM-Physician #1 exited the breakroom through back door into hallway near
the elevator
*5:50 PM-Physician #1 left surgery unit and exited 2 south/IMC (Intermediate
Care Unit) stairwell
*5:50 PM-Physician #1 exited the building through physician parking lot entrance
near physician's lounge and left in white Toyota SUV
*6:25 PM-Documented surgery stop time for Patient #2
*6:33 PM-Patient #2 transported from OR to PACU
*7:00 PM-Patient #2 was transported from PACU to 306

Review of documentation from a system improvement report for Facility A showed on 5/24/2023 at 5:34 PM, the physician (unnamed) left the OR suite to dictate his operative note, leaving the First Assist CST and PA student to close the incision. After completing the operative note at 5:40 PM, the physician exited the premises, unknown to staff and without checking on the closing progress. At 6:00 PM, the circulator received a call to say that the physician's car had left the parking lot and he was no longer on the premises. The First Assist CST began teaching the PA student how to suture because it was understood to her that she could not close without the physician's presence in the room. The surgical site was closed, and the procedure stopped at 6:25 PM, approximately 50 minutes after the surgeon had left the room. The operative note states that the First Assist assisted him with closure and the patient was taken to PACU in good condition. He (physician) was not present for these events, as witnessed by all surgical staff in the room.

Review of Facility A's investigation documentation showed the following:
*5/24/2023-Physician #1 began closing the patient's wound with the physician's
assistant student. The physician left the room and the physician's assistant
student completed the closure. The physician did not tell the team where he was
going.
*5/24/2023-Verbal and written statements were taken from OR staff who were
scrubbed in for the procedure. The witness accounts revealed the surgeon left
the OR area and the First Assist CST coached the PA student while the PA
student closed the incision.

Medical record review of a discharge summary showed Patient #2 was discharged from Facility A to home on 5/25/2023 in stable condition, with self-care and follow-up as an outpatient.

Medical record review showed Patient #2 presented to Facility A's Emergency Department (ED) on 5/27/2023 with onset of increased left hip pain and bleeding. The ED physician spoke with Physician #1 who advised that she could remain at Facility A, and he would remove the artificial joint components, or the patient could be transferred to Facility B. The ED physician spoke with Patient #2 who preferred to be transferred to Facility B.

Review of Facility B's medical record showed Patient #2 was transferred to Facility B's ED on 5/27/2023 and was admitted to the facility. The patient underwent removal of the artificial components, the hip joint was cleaned and washed out, and antibiotic spacers (device that releases antibiotic in joint space) were placed on 6/2/2023. Patient #2 received intravenous (IV) antibiotics until she was discharged on 7/14/2023.

During an interview on 9/5/2023 at 10:39 AM, in the conference room, the OR Director stated PA students fall under the direct supervision of the physician. The physician must be present in the OR if the PA student performed the incision closure. The OR Director stated the First Assist CST could close the incision, if the surgeon was available, or close by within the OR area. The First Assist CST spoke with the OR Director the following morning, and reported she did not close Patient #2's incision, but she had coached the PA student to make sure it was done properly. The OR Director informed the First Assist CST that she should not be coaching the student and that she could close the incision only if the surgeon was in the OR area. The OR Director agreed the facility's policy related to physician supervision of PA students and First Assist CSTs was not followed.

During an interview on 9/5/2023 at 11:53 AM, in the conference room, RN #1 stated there was a student and a First Assist CST in the room when Physician #1 said he was going to dictate the patient's (Patient #2) operative report. The physician had been out of the room for quite a while, and he didn't return. RN #1 stated she received a phone call from the PACU nurse who reported the physician's car was gone. The First Assist CST was closing the incision when they became aware the physician was no longer in the facility. RN #1 reported the First Assist CST stopped closing the incision because according to policy the First Assist could not close without the physician being on the premises. At that point, the First Assist CST coached the PA student through closing the surgical incision. During a second interview (telephone) on 9/7/2023 at 1:09 PM, the surveyor asked RN #1 if she attempted to call Physician #1 to ask him to return to the OR and RN #1 stated she did not recall calling the physician.

During an interview on 9/5/2023 at 12:07 PM, in the conference room CRNA #1 confirmed the surgeon was not in the OR room while the First Assist CST was helping the PA student close the surgical incision. CRNA #1 stated the surgeon was nowhere to be found afterwards.

During an interview on 9/6/2023 at 11:56 AM, in the conference room, RN #2 stated she received a message asking why a First Assist CST and a PA student were closing on a case. RN #2 stated she went to the OR to see what was going on. RN #2 stated she did not see the physician at the desk or in the department. "...I knew medical students could not be left alone to close..." RN #2 stated she saw the physician leave the OR area through the PACU, but she did not see him leave the premises. RN #2 stated she saw the student and First Assist CST at the patient's bedside closing after the case. RN #2 confirmed the physician was not in the OR with the student. During a second interview (telephone) on 9/7/2023 at 1:14 PM, the surveyor asked RN #2 if she attempted to contact Physician #1 to return to the OR and RN #2 stated she did not attempt to call Physician #1.

During a telephone interview on 9/6/2023 at 12:06 PM, Physician #1 stated Patient #2 was transferred to the facility from another hospital. When the surveyor asked the physician to describe the events of Patient #2's surgical procedure on 5/24/2023 the physician stated "...I closed the deep and some of the superficial tissue...I said okay guys, you got it from here? I thanked them...went out and dictated...changed out of scrubs and left...found out I'm not allowed to leave the arena while a scrub tech was closing..." Physician #1 stated one week after the surgery the First Assist CST told him PA students were not allowed to close the wound after he left the room. Physician #1 stated "...I told [OR Director] I didn't ask my PA student to close..." Physician #1 then stated the OR Director informed him that he had to remain in the OR suite when the First Assist CST was closing, and he had to stay with the student. Physician #1 stated "...I got a letter that I had egregious behavior, and I may not have privileges at the hospital. That was over a month ago..." Physician #1 stated he presented his case to the peer review committee. He was told they were still investigating.

During an interview on 9/7/2023 at 2:35PM, in the conference room, the Quality Manager stated Physician #1 contacted her on 6/5/2023 to discuss the event surrounding Patient #2's surgical procedure on 5/24/2023. The Quality Manager discussed with the physician that it was against facility policy for a PA student to be left alone and he needed further education on the policy. The Quality Manager agreed the facility policy for physician supervision of advanced practice students and First Assist CSTs were not followed.

During an interview on 9/8/2023 at 9:24 AM, in the conference room, the Senior Risk Manager stated she was made aware of the incident surrounding Patient #2's surgical procedure on 5/25/2023. The Senior Risk Manager reviewed the patient's medical record and made notes of time stamps. She then reviewed the video surveillance footage. The Senior Risk Manager stated the physician was seen going to the desk and sitting in front of the computer; he was then seen walking to the break room near the PACU; exited through the PACU doors; and went to the Intermediate Care Unit/2 South stairwell. He then exited out the door near the physician's parking lot. The Senior Risk Manager created a timeline which showed the physician left the facility prior to completion of the patient's surgical procedure, according to time stamps in Patient #2's medical record.

Based on review of facility policy, medical record review, and interview the facility failed to ensure informed consent was obtained for 1 surgical patient (Patient #1) of 4 surgical patients reviewed.

The findings include:

Review of the facility's policy "Special Consent to Operation or Other Procedure" revised 9/2021 showed "...Prior to any proposed medical treatment, confirmation of patient's written informed consent to medical treatment should be obtained...Written informed consent is required for, but not limited to, the following invasive procedures...Procedural Moderate Sedation and/or anesthesia administration (except for low risk local anesthesia)...Major and minor surgery that involves entry into the body no matter location of where the procedure is performed..."

Medical record review of a history and physical dated 6/2/2022 showed Patient #1 had a previous medical history of significant uncontrolled Type 2 Diabetes Mellitus and Bilateral (both) Lower Extremity non-healing wounds. The patient presented with worsening wounds on his feet with purulent (pus-sign of infection) drainage. Patient #1's x-rays of the right foot showed "...extensive soft tissue gas [may indicate infection], but no obvious evidence of osteomyelitis [bone infection]..." Patient #1 was admitted to the facility with diagnoses including Sepsis (infection) without Acute (sudden onset) Organ Dysfunction (failure), Bilateral Leg Ulcer (wound), Cellulitis (skin infection) of Left and Right Lower Extremity (legs or feet), Wound of Foot, and Diabetes.

Medical record review of an Orthopedic Operative note showed Patient #1 had a Right Below the Knee Amputation (leg removed below the knee) on 6/12/2022.

Medical record review showed a surgical consent for the Below the Knee Amputation performed for Patient #1 on 6/12/2022 was not in the patient's medical record.

During an interview on 9/6/2023 at 11:50 AM, in the conference room, the Chief Nursing Officer agreed a signed surgical consent for the surgical procedure performed for Patient #1 on 6/12/2022 was not in the patient's medical record and the facility did not follow the policy for obtaining consents.