HospitalInspections.org

Based on interview and record review, the hospital failed to ensure there was an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients as evidenced by:

The facility failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients when a medical student (Med Student 1) was assisting in and performing surgical services in the operating room (OR) without authorization and was not under the direct supervision of a physician which was not in accordance with hospital policy (Refer to A-0049 and A-0347).

The cummulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.

Based on interview and record review, the facility failed to ensure patients or their representative, were informed of their rights when:

1. Patients 4, 12, 13, 14, and 21 were not informed in advance of their rights to appeal discharge (Refer to A-0117);

2. For Patient 8, a medical student (Med Student 1) performed a surgical procedure without supervision (Refer to A-0131); and

3. For 238 patients, the facility failed to protect patient private health information when a medical student (Med Student 1), who was not authorized to access patients' records, had accessed the facility's Electronic Health Record System and the patients files (Refer to A-0144).

These cummulative failures had the potential to result in the patients' rights to be violated and for patients to not be able to make informed decisions about their care.

Based on interview and record review the facility failed to ensure accountability of the medical staff when a medical student (Med Student) 1 performed surgical procedures in the operating room (OR) without authorization and without the direct supervision of a physician (Refer A-0347)

The cumulative effect of this systemic problem resulted in the facility failure to ensure patient safety was maintained in the OR had the potential to affect the quality of care provided to the patients.

Based on interview and record review the facility failed to ensure case management evaluation and reassessment were completed for patients during hospitalization, for six of 32 sampled patients (Patients 3, 6, 13, 18, 20, and 22) (Refer to A-0805). In addition, the facility failed to ensure the transfer to an acute care facility was appropriate, for one of 32 sampled patients (Patient 9) (Refer to A-0813).

The cumulative effect of these systemic problems had the potential for the patients' needs to not be met after they are discharged from the facility which may result to delay in recovery and to rehospitalization.

Based on interview and record review, the facility failed to ensure, for three of 32 sampled patients (Patients 2, 3, and 8),

1. Only authorized practitioner assist in and/or perform surgical procedures when a medical student (Med Student 1) was permitted to assist and perform surgical procedures in the operating room (OR) without authorization and direct supervision of a physician (Refer to A 0945);

2. Documents in the patients' records were filled appropriately:

a. For Patient 2, the facility failed to ensure the date and time when the document was signed were indicated on the consent for surgery (Refer to A-0955);

b. For Patient 3, the facility failed to ensure the date and time when the document was signed were indicated on the consent for anesthesia (Refer to A-0955); and

3. For Patient 8, the operative report was documented accurately (Refer to A-0959).

The cumulative effect of these systemic problems resulted in the facility's failure to ensure surgical services were provided by authorized providers only, and had the potential for patients to not receive information about their surgery and to not give their informed consent prior to the surgery/procedure which may result in substandard care provided to patients.

Based on interview and record review, the governing body failed to ensure accountability of the medical staff when a medical student (Med Student 1) was assisting in and performing surgical procedures in the operating room (OR) without authorization and direct supervision of a physician.

This failure had the potential to result in harm to patients undergoing surgery.

Findings:

On May 15, 2024, an unannounced visit was conducted at the facility to investigate a complaint. On May 15, 2024, at 10:57 a.m., an interview with the Director of Surgery was conducted. The Director of Surgery stated Med Student 1 was coming to the OR until mid-February of 2024. The Director of Surgery stated Med Student 1 was previously a medical student at the facility and did not have full privileges at the facility. The Director of Surgery stated Med Student 1 would come into the OR to observe and assist the surgeons after her authorized rotation at the facility. The Director of Surgery stated as a medical student, Med Student 1 would not have been allowed unsupervised in the OR and should have always been supervised by a surgeon.

On May 15, 2024, at 10:15 a.m., an interview with the Chief Nursing Officer (CNO) was conducted. The CNO stated Med Student 1 was observing and assisting with surgeries in the OR until possibly January or February 2024.

On May 15, 2024, at 11:35 a.m., an interview with OR Nurse 1 was conducted. OR Nurse 1 stated they are familiar with Med Student 1 being in the OR, and Med Student 1 was there until February 2024, and came and assisted the surgeons. OR Nurse 1 stated the operative reports listed who is in the room, such as the surgeon, who is assisting, and other OR staff.

On May 15, 2024, at 11:40 a.m., an interview with OR Tech 1 was conducted. OR Tech 1 stated Med Student 1 was a medical student in the OR until February 2024. OR Tech 1 stated Med Student 1 assisted the surgeons and sometimes helped with surgical wound dressings after.

On May 15, 2024, at 1:46 p.m., a review of Med Student 1's OR rotation documentation and a concurrent interview with the CNO was conducted. The CNO stated, when medical students are expected to be at the facility, an email was sent out from the Graduate Medical Education (GME) Program regarding the incoming medical students. The CNO stated the only information available at this time is the email which included Med Student 1. The email was reviewed with the CNO and indicated Med student 1 was incoming for a medical student rotation from September 25, 2023, through October 22, 2023. The CNO stated there is no documentation available to indicate Med Student 1 was still a medical student at the facility after October 2023. The CNO stated operative reports reviewed in February indicated Med Student 1 was in the OR as of February 2024.

On May 17, 2024, at 9:57 a.m., an interview with the Anesthesiologist was conducted. The Anesthesiologist stated she is familiar with Med Student 1. The Anesthesiologist stated Med Student 1 was coming into the OR from around September 2023 until February 2024. The Anesthesiologist stated Med Student 1 was a medical student doing her rotation at the facility until October 2023, and after that was not on rotation. The Anesthesiologist stated she witnessed Med Student 1 being left unsupervised by the surgeon, who left her "to close [performing stitches on an open surgical wound to close the surgical cut]" on a patient in February 2024, and the surgeon who was supervising left the room completely and was not supervising Med Student 1. The Anesthesiologist stated Med Student 1 was present in the OR almost daily, other than on the weekends. The Anesthesiologist stated Med Student 1 was in the OR with Surgeon Group 1 thru December 2023, and after about January 2024, was present with different surgeons outside of Surgeon Group 1.

On May 17, 2024, at 12:20 p.m., an interview was conducted with the Director of Surgery. The Director of Surgery stated that there is usually a list posted in the OR of current medical students on rotation. The Director of Surgery stated there was no list posted of current medical students in February 2024.

On May 17, 2024, at 12:25 p.m., a review of the facility document titled, "Application for Medical/Clinical Student Rotation," dated March 22, 2023, signed by Med Student 1, and email correspondence documents between Med Student 1, General Surgery Residency program manager, and executive assistant to the chief academic officer and GME program, dated May 17, 2024, was conducted with the CNO. The facility document titled, "Application for Medical/Clinical Student Rotation," indicated Med Student 1 applied for emergency medicine rotation from May 1, 2023, to June 2, 2023. The email correspondence documents indicated, "...Here is the email communication between the student, GS [General Surgery Program Manager, and myself regarding the confirmation and approval of students rotation for her last roll over rotation at [name of facility] in GS on 9/25-10/22/23 [September 25 to October 22, 2023] ..." The email correspondence titled, "Anticipated Medical Students Rotating Sept. [September] 2023," sent by the Executive Assistant of the Chief Academic Officer and GME program indicated, "...Please see added student "[Name of University]: [Name of Med Student 1] General surgery/[Name of Facility], 9/25-10/22/23..." An undated document titled, "Peri-op Case Attendees," was reviewed. The document indicated Med Student 1 was present for 100 cases in the OR between October 2023 and March 1, 2024.

There was no documented evidence Med Student 1 was authorized for a medical student rotation at the facility after October 23, 2023.

During a concurrent interview, the CNO stated she spoke with the program director who stated the process they use for notifying hospital of medical students is through email. The CNO stated the email records indicated Med Student 1 was approved as a medical student on rotation at the facility from September through October 22, 2023. The CNO stated after October 22, 2023, Med Student 1 did not have approval as a medical student to rotate at the facility. The CNO stated Med Student 1 completed her medical student application for a rotation at the facility in March of 2023, and there were no applications submitted since then. The CNO stated she found out about the issue with Med Student 1 and escalated it up the chain of command. The CNO stated when she escalated it, she spoke with the Chief of staff and was told it was already being addressed. The CNO stated there has been disconnect between the medical staff, Med Student 1, and the facility since the issue was identified. The CNO stated the issue could have occurred with any medical student. The CNO stated the process used for medical students was not as structured as it should have been. The CNO stated Med Student 1's rotation ended on October 22, 2023, and there is no evidence she was authorized to be at the facility as a medical student after October 22, 2023. The CNO stated Med Student 1 came to the hospital and still had a badge and access to the OR and the surgeons after her authorized rotation at the facility. The CNO stated it was a failure between the supervising surgeons, Med Student 1, and the facility. The CNO stated based on facility's policy, medical students should be under constant direct supervision while assisting in the OR.

On May 20, 2024, an interview was conducted with Medical Doctor 1 (MD 1). MD 1 stated the OR staff thought that Med Student 1 was a medical student, and at one point Med Student 1 told the OR staff that she was a resident (a medical school graduate and physician in training). MD 1 stated staff do not want to admit to what happened for fear of losing their jobs. MD 1 stated the Quality Department was forwarded the information and no response was given. MD 1 stated this was a big concern for patient safety. MD 1 stated they got confirmation that Med Student 1 had not been a medical student with the facility since October 22, 2023. MD 1 stated Med Student 1 was pulled from the OR and was interviewed on March 1, 2024. MD 1 stated Med Student 1 admitted she had her badge and access and would come to the hospital and pick the surgical procedures to assist in. MD 1 stated Med Student 1 admitted the facility's Chief Executive Officer was aware she was coming to the hospital. MD 1 further stated Med Student 1 admitted that she had posed as a medical student and as a resident, and that surgeons had stepped out of the operating room many times during the surgeries she assisted in. MD 1 stated the Medical Executive Committee (MEC) was involved. MD 1 stated the MEC has a list of approximately 100 cases that Med Student 1 was involved in.

A review of facility policy and procedure (P&P) titled, "Graduate Medical Education and Trainees," revised December 2021 was conducted. The P&P indicated, "...Ultimately, the management of each patient's care, treatment, and services is a responsibility of a licensed independent practitioner with appropriate clinical privileges...Medical students are not members of the Medical staff and are not entitled to the procedural rights provided in the Medical Staff Bylaws...Medical Students are not eligible for clinical privileges...they cannot manage patients independently and only function under the direct supervision of a Medical Staff Member...With respect to procedures performed...the Medical Staff Member must be physically present at the time of performance...Supervision of Medical Students...At all times, each Trainee Staff member remains under the supervision of the Faculty Attending Medical Staff Member to whom the Trainee is assigned...Procedures/Surgery..."physically present" means that the Faculty Attending Physician is located in the same room...as the patient...Medical students may assist in surgical procedures, but only under the direct and continuous supervision of the faculty attending physician or the resident or fellow (who is appropriately supervised as well) for the entire duration of the procedure..."

Based on interview and record review, the facility failed to ensure patients or their representatives were informed in advance of their rights to appeal discharge, for five of 32 sampled patients (Patient 4, 12, 13, 14, and 21 ).

These failures had the potential for patients to not be able to appeal their discharge.

Findings:

1. On July 17, 2024, at 10:15 a.m., a concurrent interview and review of Patient 4's record were conducted with the Manager of Medical Surgical Telemetry (MST) and Infection Prevention Coordinator (IPC) 2. A facility document titled, "History and Physical [H&P]," dated July 13, 2024, at 5:12 p.m., indicated Patient 4 was admitted to the facility for 5150 hold (an involuntarily detention for 72 hours for being a danger to self or others) for visual hallucinations (an apparent perception of something not present).

There was no documented evidence the document titled, "An Important Message from Medicare [IMM, a document indicating the patient's right to appeal his discharge]," was given to Patient 4 when Patient 4 was admitted to the facility.

An interview was conducted with the Regional Director of Patient Access (RPDA) on July 17, 2024, at 10:28 a.m. The RPDA stated Patient 4 was uncooperative and agitated and would not sign documents. She stated they should have attempted to get the IMM document signed. The RPDA stated she did not see any notes in the Patient 4's record the staff attempted to get the IMM document signed by the patient. She further stated if it was not documented, it was not done.

2. On July 16, 2024, at 10:50 a.m., a review of Patient 12's record was conducted with the Infection Prevention Coordinator (IPC) and the Clinical System Analyst (CSA). The "H&P," dated December 7, 2023, at 3:45 p.m., indicated Patient 12 was admitted to the facility for Covid (a highly contagious disease caused by a virus) pneumonia (infection in the lungs).

The facility document titled, "Order," dated December 7, 2023, at 3:44 p.m., indicated, "...Admit to Inpatient...Hypoxia [not enough oxygen to the tissues]..."

The facility document titled, "Discharge Request," dated December 27, 2023, at 11:56 a.m., indicated, "...Discharge to SNF [Skilled Nursing Facility]..."

There was no documented evidence an IMM document was given to Patient 12 when Patient 12 was admitted to the facility and 48 hours prior to discharge.

An interview was conducted with the RDPA on July 16, 2024, at 2:23 p.m. The RDPA stated once an order for admission is given, a Patient Access Representative should have given the IMM document for the patient to sign. The RDPA stated she was unable to find documentation an IMM document was given to Patient 12 on admission. She further stated the facility's process was not followed.

An interview was conducted with Case Manager (CM) 1 on July 16, 2024, at 2:26 p.m. CM 1 stated Patient 12 was not given the IMM document 48 hours before discharge and the facility's policy was not followed.

3. On July 17, 2024, at 10:12 a.m., a review of Patient 13's record was conducted with the IPC and the CSA. The "H&P," dated October 1, 2023, at 2:11 p.m., indicated Patient 13 was admitted to the facility for attempted suicide and was placed on a 5150 hold.

The facility document titled, "Order," dated September 30, 2023, at 8:05 p.m., indicated, "...Admit as Inpatient...vomiting/suicidal ideation [thoughts of committing suicide]..."

There was no documented evidence an IMM document was given to Patient 13 when Patient 13 was admitted to the facility.

An interview was conducted with the RDPA on July 17, 2024, at 10:29 a.m. The RDPA stated there was no copy of the IMM document in Patient 13's record and a copy of the IMM document should have been given to the patient once an admission order was given. The RDPA further stated the facility's process was not followed.

An interview was conducted with the CSA on July 17, 2024, at 10:31 a.m. The CSA stated she cannot find a copy of the IMM document in Patient 13's record.

4. On July 18, 2024, at 9:14 a.m., a review of Patient 14's record was conducted with the IPC and the CSA. The "H&P," dated February 13, 2024, at 9:06 a.m., indicated Patient 14 was admitted for anemia (a condition in which the blood doesn't have enough healthy red blood cells) and chest pain.

The facility document titled, "Order," dated February 13, 2024, at 5:15 p.m., indicated, "...Admit to Inpatient...chest pain..."

There was no documented evidence an IMM document was given to Patient 14 when Patient 14 was admitted to the facility.

An interview was conducted with the CSA on July 18, 2024, at 9:28 a.m. The CSA stated she cannot find a copy of the IMM document in Patient 14's record.

An interview was conducted with the RDPA on July 18, 2024, at 9:41 a.m. The RDPA stated there was no IMM document in Patient 14's record and a copy should have been given to the patient once an admission order was given. The RDPA further stated the facility's process was not followed.

5. On July 16, 2024, at 2:44 p.m., a review of Patient 21's record was conducted with the Director of Medical Surgical Telemetry (DMST). The "H&P," dated July 10, 2024, at 1:51 p.m., indicated Patient 21 was admitted to the facility on July 10, 2024.

A facility document titled, "Discharge Request," dated July 15, 2024, at 12:58 p.m., indicated, "...Discharge to Skilled Nursing Facility..."

A facility document titled, "Important Message from Medicare," dated July 15, 2024, at 1:55 p.m., was reviewed. The document indicated the patient or representative signed the IMM document on July 15, 2024, at 1:55 p.m..

A facility document titled, "Discharge Summary," indicated Patient 21 was discharged from the facility on July 15, 2024, at 6:45 p.m. (four hours and 50 minutes after receiving the IMM document).

There was no documented evidence an IMM document was given to Patient 21 when Patient 21 was admitted to the facility and in two calendar days before discharge.

On July 16, 2024, at 3:05 p.m., an interview with the DMST was conducted. The DMST stated Patient 21 was not given the IMM document on admission. She stated the IMM document was given to the patient four hours before discharge.

A review of the facility's policy and procedure (P&P) titled, "Important Message from Medicare," dated April 2024, was conducted. The P&P indicated, "...All inpatients within 2 [two] calendar days of admission and no more than 7 [seven] days prior to an elective admission. A copy of the IMM must also be provided to each beneficiary within a maximum of 2 [two] calendar days and a minimum of 4 [four] hours prior to discharge. The IM must be signed by all Medicare, Medicare Advantage and Senior HMO (Health Maintenance Organization) patients or the patient's representative to indicate receipt and understanding of the notice..."

Based on interview and record review, the facility failed to ensure a patient, Patient 8, was informed a medical student (Med Student 1) would perform/assist with a surgical procedure.

These failures caused the patient to not make an informed decision and could possibly cause harm to Patient 8.

Findings

On July 17, 2024, at 1:20 p.m., an interview was conducted with Anonymous Staff (U) 1. U1 stated medical students signed a separate consent form each time they needed to observe a procedure and are required to ask for consent from the patient prior to observing the procedure.

On July 17, 2024, at 1:45 p.m., an interview was conducted with Physician 2. Physician 2 stated medical students are supposed to obtain a signed consent from the patient to be an observer during a surgical procedure. Physician 2 stated it was common for the medical student to participate by holding the retractors. She stated the student consent form was a separate consent form the surgical consent.

On July 18, 2024, at 10:20 a.m., an interview and review of Patient 8's record were conducted with the Manager of Medical Surgical Telemetry (MST) and Infection Prevention Coordinator (IPC) 2. A facility document titled, "History and Physical (H&P)," dated February 23, 2024, at 12:32 p.m., indicated Patient 8 was admitted to the facility for altered mental status after surgery.

There was no documented evidence the patient consent form titled, "Medical Student Presence or Participation in Surgical Procedures (Exhibit D)," was signed by the patient.

The MST stated the patient consent titled, "Medical Student Presence or Participation in Surgical Procedures (Exhibit D)," was not found in Patient 8's record.

On July 18, 2024, at 11:23 a.m., an interview was conducted with the CNO. The CNO stated the document "Medical Student Presence or Participation in Surgical Procedures (Exhibit D)" was common practice and not the policy of the facility. She further stated there was no written policy about the student consent form.

A facility document titled, "Medical and Clinical Student Rotations Requiring a Physician Preceptor," dated October 9, 2017, was reviewed. The document indicated, "...A current clinical affiliation agreement between the Hospital and the Education Institution must be in place...Hospital retains ultimate responsibility for the care of its patients...Education institution Responsibilities...Students be fully knowledgeable and proficient in the areas of patients' rights, HIPPA compliance...Preceptor Responsibilities...Any patient evaluated or treated by physician preceptor during a student rotation must be informed of the rotating student's presence and activities...Preceptor is responsible for informing the patient...Preceptor must obtain a signed Patient Consent, Medical Student Presence or Participation in Surgical Procedures (Exhibit D)...Medical Staff Office...Ensure a clinical affiliation agreement is current..."

A facility document titled, "Graduate Medical Education and Trainees," dated May 2024, was reviewed. The document indicated, "...Medical Students...Medical students are not members of the medical staff and are not entitled to the procedural rights provided in the Medical Staff Bylaws...Medical Students must first be properly introduced to the patient and the patient's consent to their presence..."

Based on interview and record review, the facility failed to ensure the patients' private health information were protected when an unauthorized medical student (Med Student 1) accessed the records of 238 patient.

These failures resulted in a breach of 238 patients' private health information.

Findings:

On July 17, 2024, at 2:14 p.m., an interview was conducted with Anonymous Staff (U) 2. U2 stated she followed up with the Director of Quality (DQ) multiple times by email questioning the possible breach of patients' private health information. U2 further stated the DQ told her there was nothing to report.

On July 17, 2024, at 3:30 p.m., an interview was conducted with Graduate Medical Education (GME) 1. GME 1 stated once a medical student finished her rotation at the facility, she is no longer authorized to be in the facility and should no longer have access to the private health information. GME 1 further stated if the medical student did not follow protocol she would be in violation of HIPAA (Health Insurance Portability and Accountability Act, a privacy law).

On July 17, 2024, at 3:45 p.m., an interview was conducted with the DQ. The DQ stated no one reached out to quality and asked for this to be reported as a possible HIPAA violation. She stated a discussion about the risk of the patients was never brought up and the focus was on the process. The DQ further stated, "unfortunately we just messed up."

On July 17, 2024, at 4:20 p.m., an interview was conducted with the Systems Director HIM (SDHIM). The SDHIM stated she just found out about the situation and the possible reportable breach fifteen minutes before the interview.

On July 18, 2024, at 11:23 a.m., an interview and concurrent record review was conducted with the Chief Nursing Officer (CNO). An audit of Med Student 1's accessed records from October 23, 2023, to March 1, 2024, were reviewed. The documents indicated Med Student 1 had accessed around 238 patient records. A review of Med Student 1's OR rotation documentation was conducted with the CNO. The CNO stated Med Student 1 accessed around 238 patient records and she shouldnt have. The CNO stated, when medical students are expected to be at the facility, an email was sent out from the Graduate Medical Education (GME) Program regarding the incoming medical students. The CNO stated the only information available at this time was the email which included Med Student 1. The email was reviewed with the CNO and indicated Med student 1 was incoming for a medical student rotation from September 25, 2023, through October 22, 2023. The review of the email indicated only two persons received the email, and this was the disconnect. The CNO stated there was no documentation available to indicate Med Student 1 was still a medical student at the facility after October 2023. The CNO stated operative reports reviewed indicated Med Student 1 participated in surgeries from October 25, 2023, to March 1, 2024.

A review of a facility policy and procedure (P&P) titled, "Patients' Rights Under HIPPA Privacy Rule," dated May 15, 2024, was reviewed. The document indicated, "...Patients have the right to request that a Facility restrict the use or disclose of PHI of treatment, payment or health care operations: the disclosure to persons involved in their health care...Notification of Breach of Unsecured PHI...Patients are entitled to notification of a breach of their unsecured PHI in accordance with UHS Privacy 2.0 Breach Notifications..."

A review of a facility P&P titled, "Patient's Rights and responsibilities-1501," dated September 2022, was reviewed. The document indicated, "...Patient's rights include...Informed participation in decisions...Personal privacy and confidentiality information...Patient has the right to full consideration of privacy concerning the medical care...right to be advised as to the reason for the presence of any individual...will be conducted discreetly and individuals not directly involved in the care will not be present without permission...medical records...kept confidential...by individuals directly involved in the treatment...Staff Identity...the patient has the right to know the identity and professional relationship of all individuals providing service...are required to wear name badges
identifying..."

Based on interview and record review, the facility failed to ensure a medical student (Med Student 1) was authorized to assist during surgical procedures and was directly supervised by a physician while assisting in and performing surgical procedures in the operating room (OR).

This failure had the potential to result in harm to patients undergoing surgery.

Findings:

On May 15, 2024, an unannounced visit was conducted at the facility to investigate a complaint. On May 15, 2024, at 10:57 a.m., an interview with the Director of Surgery was conducted. The Director of Surgery stated Med Student 1 was coming to the OR until mid-February of 2024. The Director of Surgery stated Med Student 1 was previously a medical student at the facility and did not have full privileges at the facility. The Director of Surgery stated Med Student 1 would come into the OR to observe and assist the surgeons. The Director of surgery stated as a medical student, Med Student 1 would not have been allowed unsupervised in the OR and should have always been supervised by a surgeon.

On May 15, 2024, at 10:15 a.m., an interview with the Chief Nursing Officer (CNO) was conducted. The CNO stated Med Student 1 was observing and assisting with surgeries in the OR until possibly January or February 2024.

On May 15, 2024, at 11:35 a.m., an interview with OR Nurse 1 was conducted. OR Nurse 1 stated they are familiar with Med Student 1 being in the OR, and Med Student 1 was there until February 2024, and came and assisted the surgeons. OR Nurse 1 stated the operative reports listed who is in the room, such as the surgeon, who is assisting, and other OR staff.

On May 15, 2024, at 11:40 a.m., an interview with OR Tech 1 was conducted. OR Tech 1 stated Med Student 1 was a medical student in the OR until February 2024. OR Tech 1 stated Med Student 1 assisted the surgeons and sometimes helped with surgical wound dressings after.

On May 15, 2024, at 1:46 p.m., a review of Med Student 1's OR rotation documentation and a concurrent interview with the CNO was conducted. The CNO stated, when medical students are expected to be at the facility, an email was sent out from the Graduate Medical Education (GME) Program regarding the incoming medical students. The CNO stated the only information available at this time is the email which included Med Student 1. The email was reviewed with the CNO and indicated Med student 1 was incoming for a medical student rotation from September 25, 2023, through October 22, 2023. The CNO stated there is no documentation available to indicate Med Student 1 was still a medical student at the facility after October 2023. The CNO stated operative reports reviewed in February indicated Med Student 1 was in the OR as of February 2024.

On May 17, 2024, at 9:57 a.m., an interview with the Anesthesiologist was conducted. The Anesthesiologist stated she is familiar with Med Student 1. The Anesthesiologist stated Med Student 1 was coming into the OR from around September 2023 until February 2024. The Anesthesiologist stated Med Student 1 was a medical student doing her rotation at the facility until October 2023, and after that was not on rotation. The Anesthesiologist stated she witnessed Med Student 1 being left unsupervised by the surgeon, who left her "to close [performing stitches on an open surgical wound to close the surgical cut]" on a patient in February 2024, and the surgeon who was supervising left the room completely and was not supervising Med Student 1. The Anesthesiologist stated Med Student 1 was present in the OR almost daily, other than on the weekends. The Anesthesiologist stated Med Student 1 was in the OR with Surgeon Group 1 thru December 2023, and after about January 2024, was present with different surgeons outside of Surgeon Group 1.

On May 17, 2024, at 12:20 p.m., an interview was conducted with the Director of Surgery. The Director of Surgery stated that there is usually a list posted in the OR of current medical students on rotation. The Director of Surgery stated there was no list posted of current medical students in February 2024.

On May 17, 2024, at 12:25 p.m., a review of the facility document titled, "Application for Medical/Clinical Student Rotation," dated March 22, 2023, signed by Med Student 1, and email correspondence documents between Med Student 1, General Surgery Residency program manager, and executive assistant to the chief academic officer and GME program, dated May 17, 2024, was conducted with the CNO. The facility document titled, "Application for Medical/Clinical Student Rotation," indicated Med Student 1 applied for emergency medicine rotation from May 1, 2023, to June 2, 2023. The email correspondence documents indicated, "...Here is the email communication between the student, GS [General Surgery Program Manager, and myself regarding the confirmation and approval of students rotation for her last roll over rotation at [name of facility] in GS on 9/25-10/22/23 [September 25 to October 22, 2023] ..." The email correspondence titled, "Anticipated Medical Students Rotating Sept. [September] 2023," sent by the Executive Assistant of the Chief Academic Officer and GME program indicated, "...Please see added student "[Name of University]: [Name of Med Student 1] General surgery/[Name of Facility], 9/25-10/22/23..." An undated document titled, "Peri-op Case Attendees," was reviewed. The document indicated Med Student 1 was present for 100 cases in the OR between October 2023 and March 1, 2024.

There was no documented evidence Med Student 1 was authorized for a medical student rotation at the facility after October 23, 2023.

During a concurrent interview, the CNO stated she spoke with the program director who stated the process they use for notifying hospital of medical students is through email. The CNO stated the email records indicated Med Student 1 was approved as a medical student on rotation at the facility from September through October 22, 2023. The CNO stated after October 22, 2023, Med Student 1 did not have approval as a medical student to rotate at the facility. The CNO stated Med Student 1 completed her medical student application for a rotation at the facility in March of 2023, and there were no applications submitted since then. The CNO stated she found out about the issue with Med Student 1 and escalated it up the chain of command. The CNO stated when she escalated it, she spoke with the Chief of staff and was told it was already being addressed. The CNO stated there has been disconnect between the medical staff, Med Student 1, and the facility since the issue was identified. The CNO stated the issue could have occurred with any medical student. The CNO stated the process used for medical students was not as structured as it should have been. The CNO stated Med Student 1's rotation ended on October 22, 2023, and there is no evidence she was authorized to be at the facility as a medical student after October 22, 2023. The CNO stated Med Student 1 came to the hospital and still had a badge and access to the OR and the surgeons after her authorized rotation at the facility. The CNO stated it was a failure between the supervising surgeons, Med Student 1, and the facility. The CNO stated based on facility's policy, medical students should be under constant direct supervision while assisting in the OR.

On May 20, 2024, at 12:04 p.m., an interview was conducted with Medical Doctor 1 (MD 1). MD 1 stated the OR staff thought that Med Student 1 was a medical student, and at one point Med Student 1 told the OR staff that she was a resident (a medical school graduate and physician in training). MD 1 stated staff do not want to admit to what happened for fear of losing their jobs. MD 1 stated the Quality Department was forwarded the information and no response was given. MD 1 stated this was a big concern for patient safety. MD 1 stated they got confirmation that Med Student 1 had not been a medical student with the facility since October 22, 2023. MD 1 stated Med Student 1 was pulled from the OR and was interviewed on March 1, 2024. MD 1 stated Med Student 1 admitted she had her badge and access and would come to the hospital and pick the surgical procedures to assist in. MD 1 stated Med Student 1 admitted the facility's Chief Executive Officer was aware she was coming to the hospital. MD 1 further stated Med Student 1 admitted that she had posed as a medical student and as a resident, and that surgeons had stepped out of the operating room many times during the surgeries she assisted in. MD 1 stated the Medical Executive Committee (MEC) was involved. MD 1 stated the MEC has a list of approximately 100 cases that Med Student 1 was involved in.

A review of facility policy and procedure (P&P) titled, "Graduate Medical Education and Trainees," revised December 2021 was conducted. The P&P indicated, "...Ultimately, the management of each patient's care, treatment, and services is a responsibility of a licensed independent practitioner with appropriate clinical privileges...Medical students are not members of the Medical staff and are not entitled to the procedural rights provided in the Medical Staff Bylaws...Medical Students are not eligible for clinical privileges...they cannot manage patients independently and only function under the direct supervision of a Medical Staff Member...With respect to procedures performed...the Medical Staff Member must be physically present at the time of performance...Supervision of Medical Students...At all times, each Trainee Staff member remains under the supervision of the Faculty Attending Medical Staff Member to whom the Trainee is assigned...Procedures/Surgery..."physically present" means that the Faculty Attending Physician is located in the same room...as the patient...Medical students may assist in surgical procedures, but only under the direct and continuous supervision of the faculty attending physician or the resident or fellow (who is appropriately supervised as well) for the entire duration of the procedure..."

Based on observation, interview, and record review, the facility failed to ensure the facility's policy and procedures (P&P) were implemented, for five of 32 sampled patients (Patient 1, 6, 13, 14, and 24), when:

1. For Patient 1, pain assessment was not conducted prior to the administration of pain medication;

2. For Patient 6, the DNR (Do Not Resuscitate) form was not signed by the patient and the facility staff;

3. For Patient 13, pain reassessment was not performed after pain medication was administered;

4. For Patient 14, pain medication was not administered timely for pain assessed at a seven (pain scale 1-10, with 10 being the worst pain); and

5. For Patient 24, the heart rate was not assessed prior to medication administration in accordance with the physician's order.

These failures had the potential to cause a delay in care and may affect the quality of care delivered to the patients.

Findings:

1. On July 16, 2024, at 10:30 a.m., a review of Patient 1's record was conducted with the Manager of Medical Surgical Telemetry (MST) and Infection Prevention Coordinator (IPC) 2. A facility document titled, "History and Physical (H&P)," dated July 10, 2024, at 12:07 p.m., indicated Patient 1 was admitted to the facility for acute colitis (infection of the bowels).

A facility document titled, "Vital Sign flow sheet," indicated, "...12:55 p.m...pain...0/10...1 p.m...pain...6/10...2 p.m...pain...0/10..."

A facility document titled, "Medication Administration Record," indicated, "...hydrocodone-acetaminophen [a pain medication]...1Tabs [tablets], Tab, Oral, q [every] 4hrs, PRN [as needed]...Pain 4-6 (Moderate)..." The document further indicated, "...Hydromorphone (Dilaudid) [a pain medication] 1 mg [milligram, unit of measurement] = 1 mL [milliliter, unit of measurement], Injection, IV [intravenous, administered through the vein]...push, q4hrs...PRN Pain 7-10...(Severe)..7.14.24 (July 14, 2024)...12:41 p.m...1 mg given..."

On July 16, 2024, at 10:45 a.m., an interview was conducted with the MST. The MST stated there should have been a pre-medication assessment completed prior to giving the Dilaudid 1 mg. The MST stated Patient 1's pain was assessed at 6/10, and the pain medication which should have been administered was the hydrocodone-acetaminophen 1 tab which was ordered for pain 4-6. The MST stated the Dilaudid was ordered for pain 7-10.

A review of the facility P&P titled, "Physician's Orders 1400," dated August 2023, was conducted. The P&P indicated, "...Physician's orders are carried out until canceled..."

A review of a facility P&P titled, "Medication Administration and Monitoring Policy-MM 0809," dated April 2024, was conducted. The P&P indicated, "...Before administration, the individual administering the medication will confirm the following...verify that the medication selected matches the medication order...Medications will be administered on the established scheduled times or based on patient needs as specified by the ordering LIP [Licensed Independent Practitioner]..."

A review of a facility P&P titled, "Pain Assessment and Management for the Hospital Patient," dated April 2024, was conducted. The P&P indicated, "...Moderate pain...pain score within the range of 4 to 6...Severe pain...score...range...7-10 on scale...care giver will assess the patient's pain level...pain will be reassessed after each pain management intervention...expectation is that the reassessment will be completed and documented within 120 min of pain management intervention...Pain assessment/re-assessment will be documented in EMR [Electronic Medical Record]..."

2. On July 17, 2024, at 11:11 a.m., a review of Patient 6's record was conducted with the MST and the IPC 2. A facility document titled, "H&P," dated October 5, 2023, at 6:10 p.m., indicated Patient 6 was admitted to the facility for dislodged cholecystostomy tube (tube to drain the gallbladder).

A facility document titled, "(Name of Facility) PREFERRED INTENSITY OF CARE," indicated, the sections for the date and time the document was signed by the Physician, the registered nurse, and the patient were blank.

On July 17, 2024, at 11:14 a.m., an interview was conducted with the MST. The MST stated the DNR form should have been timed and dated. She stated the date and time would attest to when the discussion and decision occurred.

On July 17, 2024, at 11:50 a.m., an interview was conducted with the Chief Nursing Officer (CNO). The CNO stated all forms should be dated and timed. She further stated it was a documentation expectation that all the forms were completed.

A review of the facility's P&P titled, "Medical Record E-201," dated April 2022, was conducted. The P&P indicated, "...Guidelines for Documenting in the Medical Record...All entries are signed and dated..."

3. On July 17, 2024, at 10:27 a.m., a review of Patient 13's record was conducted with IPC 1 and the Clinical System Analyst (CSA). The "H&P," dated October 1, 2023, at 2:11 p.m., indicated Patient 13 was admitted to the facility for attempted suicide and was placed on a 5150 hold (an involuntarily detention for 72 hours for being a danger to self or others).

A facility document titled, "Pain and Comfort," indicated, "...October 1, 2023...Numeric Pain Scale...9...5:36 p.m...October 1, 2023...Numeric Scale...9...10:54 p.m..."

A facility document titled, "Medications," indicated, "...hydrocodone - acetaminophen...1 Tabs, Tab, Oral, q4H Pain 7-10...October 1, 2023...5:36 p.m...1 tabs...October 1, 2023...10:55 p.m...1 tabs..."

There was no documented evidence that pain was reassessed after hydrocodone-acetaminophen was administered on October 1, 2023, at 5:36 p.m and 10:55 p.m.

On July 17, 2024, at 10:47 a.m., an interview was conducted with the CSA. The CSA stated pain should have been reassessed within 120 minutes of pain management intervention. The CSA further stated the policy was not followed on October 1, 2023, for both medication administrations. The CSA stated there is no reassessment documented on Patient 13's record.

A review of the facility's P&P titled, "Pain Assessment and Management for Hospital Patient," dated April 2024, was conducted. The P&P indicated, "...The expectation is that the reassessment will be completed and documented within 120 minutes of pain management intervention..."

4. On July 17, 2024, at 11:32 a.m., a review of Patient 14's record was conducted with IPC 1 and CSA.

A facility's document titled, "H&P," dated February 13, 2024, at 9:06 a.m., indicated Patient 14 was admitted for anemia (low red blood cell count) and chest pain.

An untitled facility document, dated February 13, 2024, indicated, "...12:38 a.m...Numeric...7...2 a.m...Numeric 5...4 a.m...Numeric 5...4:46 a.m...Numeric 7..."

A facility's document titled, "Medications," dated February 13, 2024, at 4:47 a.m., indicated, "...morphine [a pain medication] 4mg = 1 ml, injection, IV push, Once, First Dose: Now, start date: February 13, 2024 at 4:33..."

There was no documented evidence pain medication was administered when Patient 14 complained of pain from 12:38 a.m. to 4:46 a.m. (for 4 hours and 8 minutes).

On July 17, 2024, at 10:47 a.m., an interview was conducted with the CSA. The CSA stated there is no documentation the nurse addressed Patient 14's pain for the above times on February 13, 2024. The CSA further stated pain should have been addressed and the policy was not followed.

A review of the facility's P&P titled, "Pain Assessment and Management for Hospital Patient," dated April 2024, was conducted. The P&P indicated, "...In the ED, a timely screening for pain is one (1) hour or less after treatment begins...The hospital will treat a patient's pain and refer the patient for treatment consistent with the patient's care and treatment needs. Treatment strategies should include non-pharmacologic, pharmacologic, or a combination of approaches..."

5. On July 17, 2024, at 11 a.m., a review of Patient 24's record was conducted with the Director of Medical Surgical Telemetry (DMST). A facility document titled, "H&P" indicated, Patient 24 was admitted to the facility on June 17, 2024, for "abdominal distention since 5/24 [May 2024]."

A facility document titled, "Medications," indicated, "...Carvedilol (Coreg) [medication for high blood pressure]...3.125 mg = 1 tabs...Oral, BID [twice a day] With meals...Start date 06/18/2024 [June 18, 2024] 11:04 [a.m.]...Hold for HR [heart rate] < [less than] 55..."

An untitled document indicated, "...Carvedilol..." and the portion for "Systolic Blood Pressure, Diastolic Blood Pressure, and peripheral Pulse Rate" were not filled on June 18, 2024, at 11:12 a.m., on June 18, 2024, at 6:12 p.m., and on June 19, 2024, at 9:02 a.m.

There was no documented evidence Patient 24's heart rate was monitored prior to the administration of the medication, in accordance with the physician's order..

A review of the facility's P&P, dated August 2023, indicated, "...To provide guidelines so that medications will be administered in safe, accurate, and consistent manner...Patients will be monitored based on parameters specified in the medication order..."

Based on interview and record review, the facility failed to ensure a patient was transferred appropriately to an acute care facility, in accordance with the facility's policy and procedure (P&P), for one of 32 sampled patients (Patient 9).

This failure had the potential to cause harm and delay care to Patient 9 and to the patients who would be transferred to another facility.

Findings:

On July 15, 2024, at 2:02 p.m., an interview and review of Patient 9's record were conducted with the Director of Behavior Health (DBH). A facility document titled, "Initial Evaluation Note," indicated Patient 9 was admitted to the facility on September 20, 2023, for assistance with medical management and was already placed on a 5150 hold (an involuntarily detention for 72 hours for being a danger to self or others) by a police officer for being a danger to others.

A facility document titled, "Lab Review," dated September 22, 2023, at 1:46 p.m., indicated, "...SARS-CoV-2 Ag [A rapid test to detect Covid, a higly contagious disease caused by a virus]...Positive..."

A facility document titled, "BH [Behavioral Health] progress note-Nurse," dated September 22, 2023, at 8:40 p.m., indicated, "...[Name of Physician 1] notified about patients positive Covid result, DR: gave orders to have the patient sign voluntary status and transfer patient to [Name of acute care facility Patient 9 was transferred to]..."

There was no documented evidence an inter-facility transfer form titled, "Patient Transfer and Referral Record," was completed for Patient 9.

There was no documented evidence of an accepting physician for Patient 9 at the receiving facility.

There was no documented evidence a complete patient report was given by the nurse assigned to Patient 9 directly to the nurse at the receiving facility.

On July 15, 2024, at 2:24 p.m., an interview and record review were conducted with the DBH. The DBH stated the facility had to transfer the patient out due to a positive COVID result. The DBH further stated there was no transfer form nor accepting physician documented in the chart. The DBH stated the facility's process was not followed.

On July 16, 2024, at 10:38 a.m., an interview and record review were conducted with the Chief Nursing Officer (CNO). The CNO stated it was an inappropriate/incomplete transfer. The CNO further stated there was no documentation a transfer form was filled out and a physician accepted the patient. She stated the facility's policy for transferring a patient was not followed.

The facility P&P titled, "Interfacility and interhospital Transfer," dated November 2023, was reviewed. The policy indicated, "...All transfers require an accepting physician and report from the sending physician to the accepting physician...When the patient has been accepted by the receiving hospital and the receiving physician and nursing unit have been assigned, the transfer of clinical information will take place as follows...will assist with obtain the names and telephone numbers of both the accepting physician and the nursing unit if not already provided by the receiving hospital...nurse assigned to the patient will speak directly with the receiving RN or unit charge nurse, providing a complete patient report...An inter-facility transfer form, "Patient Transfer and Referral Record," is completed..."

Based on interview and record review, the facility failed to ensure only authorized practitioner assist in and/or perform surgical procedures when a medical student (Med Student 1) was assisting in and performing surgical procedures in the operating room (OR) without authorization and direct supervision of a physician.

This failure had the potential to result in harm to patients undergoing surgery.

Findings:

On May 15, 2024, an unannounced visit was conducted at the facility to investigate a complaint. On May 15, 2024, at 10:57 a.m., an interview with the Director of Surgery was conducted. The Director of Surgery stated Med Student 1 was coming to the OR until mid-February of 2024. The Director of Surgery stated Med Student 1 was previously a medical student at the facility and did not have full privileges at the facility. The Director of Surgery stated Med Student 1 would come into the OR to observe and assist the surgeons after her authorized rotation at the facility. The Director of Surgery stated as a medical student, Med Student 1 would not have been allowed unsupervised in the OR and should have always been supervised by a surgeon.

On May 15, 2024, at 10:15 a.m., an interview with the Chief Nursing Officer (CNO) was conducted. The CNO stated Med Student 1 was observing and assisting with surgeries in the OR until possibly January or February 2024.

On May 15, 2024, at 11:35 a.m., an interview with OR Nurse 1 was conducted. OR Nurse 1 stated they are familiar with Med Student 1 being in the OR, and Med Student 1 was there until February 2024, and came and assisted the surgeons. OR Nurse 1 stated the operative reports listed who is in the room, such as the surgeon, who is assisting, and other OR staff.

On May 15, 2024, at 11:40 a.m., an interview with OR Tech 1 was conducted. OR Tech 1 stated Med Student 1 was a medical student in the OR until February 2024. OR Tech 1 stated Med Student 1 assisted the surgeons and sometimes helped with surgical wound dressings after.

On May 15, 2024, at 1:46 p.m., a review of Med Student 1's OR rotation documentation and a concurrent interview with the CNO was conducted. The CNO stated, when medical students are expected to be at the facility, an email was sent out from the Graduate Medical Education (GME) Program regarding the incoming medical students. The CNO stated the only information available at this time is the email which included Med Student 1. The email was reviewed with the CNO and indicated Med student 1 was incoming for a medical student rotation from September 25, 2023, through October 22, 2023. The CNO stated there is no documentation available to indicate Med Student 1 was still a medical student at the facility after October 2023. The CNO stated operative reports reviewed in February indicated Med Student 1 was in the OR as of February 2024.

On May 17, 2024, at 9:57 a.m., an interview with the Anesthesiologist was conducted. The Anesthesiologist stated she is familiar with Med Student 1. The Anesthesiologist stated Med Student 1 was coming into the OR from around September 2023 until February 2024. The Anesthesiologist stated Med Student 1 was a medical student doing her rotation at the facility until October 2023, and after that was not on rotation. The Anesthesiologist stated she witnessed Med Student 1 being left unsupervised by the surgeon, who left her "to close [performing stitches on an open surgical wound to close the surgical cut]" on a patient in February 2024, and the surgeon who was supervising left the room completely and was not supervising Med Student 1. The Anesthesiologist stated Med Student 1 was present in the OR almost daily, other than on the weekends. The Anesthesiologist stated Med Student 1 was in the OR with Surgeon Group 1 thru December 2023, and after about January 2024, was present with different surgeons outside of Surgeon Group 1.

On May 17, 2024, at 12:20 p.m., an interview was conducted with the Director of Surgery. The Director of Surgery stated that there is usually a list posted in the OR of current medical students on rotation. The Director of Surgery stated there was no list posted of current medical students in February 2024.

On May 17, 2024, at 12:25 p.m., a review of the facility document titled, "Application for Medical/Clinical Student Rotation," dated March 22, 2023, signed by Med Student 1, and email correspondence documents between Med Student 1, General Surgery Residency program manager, and executive assistant to the chief academic officer and GME program, dated May 17, 2024, was conducted with the CNO. The facility document titled, "Application for Medical/Clinical Student Rotation," indicated Med Student 1 applied for emergency medicine rotation from May 1, 2023, to June 2, 2023. The email correspondence documents indicated, "...Here is the email communication between the student, GS [General Surgery Program Manager, and myself regarding the confirmation and approval of students rotation for her last roll over rotation at [name of facility] in GS on 9/25-10/22/23 [September 25 to October 22, 2023] ..." The email correspondence titled, "Anticipated Medical Students Rotating Sept. [September] 2023," sent by the Executive Assistant of the Chief Academic Officer and GME program indicated, "...Please see added student "[Name of University]: [Name of Med Student 1] General surgery/[Name of Facility], 9/25-10/22/23..." An undated document titled, "Peri-op Case Attendees," was reviewed. The document indicated Med Student 1 was present for 100 cases in the OR between October 2023 and March 1, 2024.

There was no documented evidence Med Student 1 was authorized for a medical student rotation at the facility after October 23, 2023.

During a concurrent interview, the CNO stated she spoke with the program director who stated the process they use for notifying hospital of medical students is through email. The CNO stated the email records indicated Med Student 1 was approved as a medical student on rotation at the facility from September through October 22, 2023. The CNO stated after October 22, 2023, Med Student 1 did not have approval as a medical student to rotate at the facility. The CNO stated Med Student 1 completed her medical student application for a rotation at the facility in March of 2023, and there were no applications submitted since then. The CNO stated she found out about the issue with Med Student 1 and escalated it up the chain of command. The CNO stated when she escalated it, she spoke with the Chief of staff and was told it was already being addressed. The CNO stated there has been disconnect between the medical staff, Med Student 1, and the facility since the issue was identified. The CNO stated the issue could have occurred with any medical student. The CNO stated the process used for medical students was not as structured as it should have been. The CNO stated Med Student 1's rotation ended on October 22, 2023, and there is no evidence she was authorized to be at the facility as a medical student after October 22, 2023. The CNO stated Med Student 1 came to the hospital and still had a badge and access to the OR and the surgeons after her authorized rotation at the facility. The CNO stated it was a failure between the supervising surgeons, Med Student 1, and the facility. The CNO stated based on facility's policy, medical students should be under constant direct supervision while assisting in the OR.

On May 20, 2024, an interview was conducted with Medical Doctor 1 (MD 1). MD 1 stated the OR staff thought that Med Student 1 was a medical student, and at one point Med Student 1 told the OR staff that she was a resident (a medical school graduate and physician in training). MD 1 stated staff do not want to admit to what happened for fear of losing their jobs. MD 1 stated the Quality Department was forwarded the information and no response was given. MD 1 stated this was a big concern for patient safety. MD 1 stated they got confirmation that Med Student 1 had not been a medical student with the facility since October 22, 2023. MD 1 stated Med Student 1 was pulled from the OR and was interviewed on March 1, 2024. MD 1 stated Med Student 1 admitted she had her badge and access and would come to the hospital and pick the surgical procedures to assist in. MD 1 stated Med Student 1 admitted the facility's Chief Executive Officer was aware she was coming to the hospital. MD 1 further stated Med Student 1 admitted that she had posed as a medical student and as a resident, and that surgeons had stepped out of the operating room many times during the surgeries she assisted in. MD 1 stated the Medical Executive Committee (MEC) was involved. MD 1 stated the MEC has a list of approximately 100 cases that Med Student 1 was involved in.

A review of facility policy and procedure (P&P) titled, "Graduate Medical Education and Trainees," revised December 2021 was conducted. The P&P indicated, "...Ultimately, the management of each patient's care, treatment, and services is a responsibility of a licensed independent practitioner with appropriate clinical privileges...Medical students are not members of the Medical staff and are not entitled to the procedural rights provided in the Medical Staff Bylaws...Medical Students are not eligible for clinical privileges...they cannot manage patients independently and only function under the direct supervision of a Medical Staff Member...With respect to procedures performed...the Medical Staff Member must be physically present at the time of performance...Supervision of Medical Students...At all times, each Trainee Staff member remains under the supervision of the Faculty Attending Medical Staff Member to whom the Trainee is assigned...Procedures/Surgery..."physically present" means that the Faculty Attending Physician is located in the same room...as the patient...Medical students may assist in surgical procedures, but only under the direct and continuous supervision of the faculty attending physician or the resident or fellow (who is appropriately supervised as well) for the entire duration of the procedure..."

Based on interview and record review the facility failed to ensure the date and time were indicated on patient documents, for two of 32 sampled patients (Patient 2, and 3), when:

1. For Patient 2, the date and time the document was signed were not indicated on the consent for surgery; and

2. For Patient 3, the date and time the document was signed were not indicated on the consent for anesthesia.

These failures had the potential for patients to not receive information about their surgery and to not give their informed consent prior to the surgery/procedure.

Findings

1. On July 15, 2024, at 10:20 a.m., a concurrent interview and review of Paient 2's record were conducted with the Manager of Medical Surgical Telemetry (MST), Infection Prevention Coordinator (IPC) 2, and the Director of Education/Interim Director of the ICU (DOE).

A facility document titled, "History and Physical (H&P)," dated October 5, 2023, at 6:10 p.m., indicated Patient 2 was admitted to the facility for severe right flank (the areas on the back between the lower ribs and hips) pain.

A facility document titled, "Authorization For And Consent To Surgery Or Special Diagnostic Or Therapeutic Procedures," indicated, "...To: [Name of Patient]...Date: ____ Time: ___...Patient/Patient Representative Acknowledgement...Date: ____ Time: ____..." There were no entries for the sections for the date and time.

There was no documented evidence the dates and times were indicated on the facility document titled, "Authorization For And Consent To Surgery Or Special Diagnostic Or Therapeutic Procedures."

The DOE stated when the doctor signed and dated the consent, it was not necessary for the patient to date and time their signature. When asked if it was important for the patient to date and time the consent to indicate the signature happened before the surgery, the DOE agreed and stated the patient should have signed, dated, and timed. She further stated the staff should have indicated the date and time on page one of the consent when completing the form.

2. On July 15, 2024, at 10:35 a.m., a review of Patient 3's record review was conducted with the MST, IPC 2, and the CS. A facility document titled, "H&P," dated October 5, 2023, at 6:10 p.m., indicated Patient 3 was admitted to the facility for epigastric (upper abdominal region) abdominal pain.

A facility document titled, "ANESTHESIA CONSENT INFORMED CONSENT FOR ANESTHESIA SERVICES," were conducted. "...General Anesthesia...Major/Minor Nerve Block...Patient Signature...Date...Time..." There was no documented evidence the date and time when Patient 3 signed the consent was completed.

On July 15, 2024, at 10:43 a.m., an interview with the CS was conducted. The CS stated it was important to have the date and time to know when the patient signed the consent for surgery and discussed the risks and benefits with the doctor before the surgical procedure. The date and time was not placed on the document when the patient signed the consent.

Based on interview and record review, the facility failed to ensure the post operative note was completed accurately and in a timely manner, for one of 32 sampled patients (Patient 8), when the surgeon did not document who completed the closure of the surgical procedure.

These failures had the potential to delay patient care and may cause physical harm to the patient.

Findings:

On July 18, 2024, at 10:20 a.m., a review of Patient 8's record was conducted with the Manager of Medical Surgical Telemetry (MST), Infection Prevention Coordinator (IPC) 2, and the Director of Education/Interim Director of the ICU (DOE).

A facility document titled, "History and Physical (H&P)," dated February 23, 2024, at 12:32 p.m., indicated Patient 8 was admitted to the facility for altered mental status (confusion) after surgery.

A facility document titled, "[Name of Facility] Operative Reports Final Report," dated February 24, 2024, was reviewed. The document indicated, "...Surgeon: [Surgeon 1]...The wound was closed in 2 [two] layers. The deep layer was closed with 3-0 Vicryl (type of suture) running fashion. The skin was closed with 4-0 Monocryl (type of suture) in subcuticular fashion. Dermabond (strong bonding agent for skin) was placed over the skin this included the counter incision at the bicep (muscle in the arm)...signature line...Electronically signed by..." The document did not reflect Med Student 1 being part of or involved in Patient 8's surgical procedure.

On July 17, 2024, at 1:45 p.m., an interview and record review were conducted with the Anesthesiologist (Physician 2). Physician 2 stated she was in the Operating Room (OR) on February 24, 2024, during Patient 8's surgery. Physician 2 stated Surgeon (Surgeon 1) and Medical Student (Med Student 1) started the surgical procedure together. Physician 2 stated Surgeon 1 got up and walked out of the OR and did not return. She stated Surgeon 1 left Med student 1 to close the surgical incision unsupervised. Physican 2 stated Surgeon 1 did not return to the OR and Med Student 1 should have had direct supervision at all times.

On July 18, 2024, at 10:55 a.m., an interview and record review were conducted with the Interim Director of Medical Staff (IDMS). The IDMS stated, looking at this note (referring to the Operative Reports Final Report, dated February 24, 2024), one would assume Surgeon 1 was the person who closed the surgical wounds of Patient 8. After discussing Physician 2's statement about Surgeon 1 leaving Med Student 1 unsupervised to close Patient 8's surgical incision, the IDMS stated Surgeon 1 should not have left the operating room, leaving the student alone. She further stated the note would be considered falsified or inaccurate if Surgeon 1 did not perform the closure of the wound on Patient 8.

On July 18, 2024, at 11:23 a.m., an interview and record review were conducted with the Chief Nursing Officer (CNO). The CNO stated this note (referring to the Operative Reports Final Report, dated February 24, 2024) indicated Surgeon 1 closed the surgical wounds on Patient 8 and it did not mention the medical student (Med Student 1) in the note. The CNO further stated Med Student 1 should have ended her rotation and not been able to come back into the facility. The CNO stated Med Student 1 was left alone to complete the surgery when Surgeon 1 stepped out of the room and did not return.

A facility document titled, "Name of Facility General Rules and Regulations," dated October 2021 was reviewed. The document indicated, "...Operative reports will be completed immediately following surgery and a comprehensive operative note must be entered in to the progress note immediately after completion of surgery...The note shall contain a description...name of primary surgeon and any assistants..."

Based on interview and record review, the facility failed to ensure case management evaluation and reassessment were completed for patients during hospitalization, for five of 32 sampled patients (Patient 3, 6, 13, 20, and 22).

This failure had the potential to delay continuity of care and discharge planning in the facility.

Findings:

1. On July 16, 2024, at 1:55 p.m., a review of Patient 3's record was conducted with the Manager of Medical Surgical Telemetry (MST) and Infection Prevention Coordinator (IPC) 2. A facility document titled, "History and Physical (H&P)," dated July 12, 2024, at 4:31 p.m., indicated Patient 3 was admitted to the facility for epigastric (stomach) abdominal pain. The face sheet indicated Patient 3 was discharged on July 16, 2024, at 12:30 p.m.

There was no documented evidence a case manager completed an initial assessment and discharge planning within two days of admission for Patient 3.

On July 16, 2024, at 2:05 p.m., an interview was conducted with the MST. The MST stated there was no initial case management assessment conducted for Patient 13. She further stated there should have been an initial case management assessment completed on or before July 14, 2024.

On July 16, 2024, at 2:10 p.m., an interview was conducted with Case Manager (CM) 1. CM 1 stated she reviewed Patient 3's electronic file and did not see documentation an initial case management assessment was completed. She further stated the assessment should have been completed within two days of admission and the facility's policy was not followed.

2. On July 17, 2024, at 11:11 a.m., a review of Patient 6's record was conducted with the MST and the IPC 2. A facility document titled, "H&P," dated October 5, 2023, at 6:10 p.m., indicated Patient 6 was admitted to the facility for dislodged cholecystostomy tube (tube to drain the gallbladder). The face sheet indicated Patient 6 was discharged on October 14, 2023.

A facility document titled, "Discharge Planning Assessment," dated October 6, 2023, indicated discharge planning was conducted for Patient 6.

There was no documented evidence that a case manager completed a reassessment on Patient 6 on or before October 11, 2023 (five days after the initial assessment on October 6, 2023), in the EMR

An interview was conducted with the MST on July 17, 2024, at 11:25 a.m. The MST stated there was no reassessment completed by a case manager for Patient 6 on or before October 11, 2023.

An interview was conducted with CM 1 on July 17, 2024, at 11:40 a.m. CM 1 stated she reviewed Patient 6's record and did not find documentation a reassessment was completed per the facility's policy. She further stated the case management reassessment should have been completed on or before October 11, 2023. CM 1 stated the facility's policy was not followed.

3. On July 17, 2024, at 10:12 a.m., a review of Patient 13's record was conducted with Infection Prevention Coordinator (IPC) 1 and the Clinical System Analyst (CSA). The "H&P," dated October 1, 2023, at 2:11 p.m., indicated Patient 13 was admitted to the facility for attempted suicide and was placed on a 5150 hold (an involuntary 72 hold for person who are a danger to self or to others). The face sheet indicated Patient 13 was discharged on October 11, 2023.

There was no documented evidence a Case Manager completed an assessment for Patient 13.

On July 17, 2024, at 11:07 a.m., an interview and review of Patient 13's record were conducted with the CSA. The CSA stated there was no case Management evaluation found in the chart. The CSA stated the facility's process was not followed.

On July 17, 2024, at 11:21 a.m., an interview and review of Patient 13's record were conducted with CM 1. CM 1 stated she did not find documentation a case management evaluation was conducted. CM1 stated a case management evaluation was not done in accordance with the facility's policy.

4. On July 16, 2024, at 1:20 p.m., a review of Patient 20's record was conducted with the DMST. A facility document titled, "H&P," dated July 12, 2024, at 2:10 p.m. indicated Patient 20 was admitted to the facility for right upper quadrant [area of the abdomen] and epigastric abdominal pain. The document indicated Patient 20 had a past history of pre-diabetes [condition with abnormal blood sugar] and gall stones.

There was no documented evidence a case management assessment was completed for Patient 20. The DMST stated the case manager should have seen this patient within two days of admission. She stated when a patient was admitted, they should have been seen by case management for an evaluation in accordance with the facility's policy.

On July 16, 2024, at 2:30 p.m., an interview was conducted with CM 1. CM 1 stated a case management assessment was not done for Patient 20 and according to the facility policy, one should have been done within two days of admission. CM 1 stated the case management department did not have enough staff to complete one for each patient admitted and the department only prioritized the "neediest cases."

5. On July 17, 2024, at 10:14 a.m., a review of Patient 22's record was conducted with the DMST. Records for Patient 22 were reviewed. A facility document titled, "H&P," dated June 25, 2024, at 2:38 p.m., indicated Patient 22 was admitted to the facility for low back pain.

There was no documented evidence a case management assessment was completed for Patient 22. The DMST stated the case manager should have seen this patient within two days of admission. She stated when a patient was admitted, they should have been seen by case management for an evaluation.

A review of a facility policy and procedure (P&P) titled, "Discharge Planning and Social Service Needs- D01," dated April 2024, was conducted. The P&P indicated, "...All patients admitted to inpatient services will be evaluated by Case Management within one to two (1-2) working day of admission to determine continuum of care needs and availability of community resources...Patients are reassessed every five days for appropriateness of the discharge plan, further social service needs, after being ransferred to another unit, or when there is a change in condition."