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Based on interviews, document and record review, the hospital medical staff failed to ensure there was an organized program for the physician supervision of the Interventional Radiology (IR) Allied Advance Practice Professional (APP1). There was lack of evidence the physician supervision met the requirements as outlined in the Hawaii State Statute. In addition, the investigation revealed lack of adequate supervision of the care provided to one patient (P)1, that APP1 attempted placement of a bedside gastrostomy tube (G-tube/provides nutrition through a tube inserted through the abdomen). The cumulative effect of the deficiencies, resulted in a condition level deficiency.

Findings include:

1) The hospital is part of a Health Systems Corporation, and delivers a full range of services, including interventional radiology (IR- interventional radiologist uses CT scan, MRI or ultrasound to get direct access to part of the body) The Medical Staff is comprised of community physicians, physician assistants and Advanced Practice Registered Nurses. The interventional radiology medical staff included two physicians (MD1 and MD2), and one Allied Advance Practice Professional (Certified Physician's Assistant (PA)), licensed in Hawaii. At the time of survey the APP1 and MD1 were no longer working at the facility. A new interventional radiology APP, was expected to start in the near future.

2) The Statutes that define the Physician Assistant Scope of practice, supervision required and licensure are the "Hawaii Administrative Rules Chapter 85 Medical Examiners, Subchapter 6 Certifying Physician Assistants," and "Chapter 453 Medicine and Surgery."

Hawaii Administrative Rules Chapter 85 Medical Examiners, Subchapter 6 Certifying Physician Assistants includes:
16-85-44.5 Definition.
"Physician assistant" means an individual who had been certified by the board to practice medicine with physician supervision. A physician assistant may perform those duties and responsibilities delegated by the physician assistant's
supervising physician."
"Supervising physician" means a physician or group of physicians ...licensed to practice in this State who accepts the responsibility for the supervision of services rendered by physician assistants. The supervising physician shall direct and exercise supervision at all times."
"Supervision" means overseeing the activities of, and accepting responsibilities for, the medical services rendered by a physician assistant. Supervision shall be continuous but shall not be construed as necessarily requiring the physical presence of the supervising physician at the time and place the services are rendered."

16-85-49 "Degree of Supervision. (a) The supervising physician shall:"
"(2) Submit a statement that the supervising physician will direct and exercise supervision over any subordinate physician assistant in accordance with this subchapter ...."
"(5) Personally review the records of each patient seen by the physician assistant within seven working days;"
"(6) Designate an alternate supervising physician in the physician's absence;"

16-85-49.1 "Scope of practice. (a) A physician assistant shall be considered the agents of the physician assistant's supervising physician in the performance of all practice-related activities as established in writing by the employer."

Chapter 453 Medicine and Surgery include:
453-5.3 Physician assistant
(g) For medical records of patients seen by physician assistants:
(1) Each physician assistant and supervising physician ...or group of physicians shall establish written guidelines for the review of medical records as appropriate to the specific practice.. These guidelines shall be kept in the office of the practice setting ...
(2) The supervising physician, ....or group of physicians shall review medical records as required by this subsection; provided that ...(B) When supervising a physician assistant with more than one year of practice experience as a licensed physician assistant, the supervising physician ....shall (i) Establish a process for the regular review of a sample of medical records of patients seen by the physician assistant; and (ii) For at least thirty minutes each month, perform an audit and review the medical records; ..."

3) Reviewed the "East Hawaii Region Hawaii Health Services Corporation Unified Medical Bylaws with approved date 07/19/2025. The preamble of the Bylaws included "...This Medical Staff organization has the authority and responsibility to ensure the quality of the professional services provided by the privileged providers, including ...directing the structure and quality of clinical services, and providing quality improvement, conflict resolution, and self-regulation. ...These bylaws are adopted to define the organization of the Medical Staff of the Region and to provide a framework for self-governance through which the Medical Staff can fulfill its responsibilities to meet high standards for ethical patient care and medical excellence."

The bylaws included the following definitions:
"Advanced Practice Professional ("APP") means a licensed health care provider other than a physician, dentist, or podiatrist. Please refer to "Health Care Provider" for further clarification."
"Allied Advance Practice Professional ("Allied APP") means a licensed health care provider who must, under state statue, practice under the supervision of another licensed provider."
"Health Care Provider means a doctor of medicine, or osteopathy, ...psychologist, optometrist, nurse practitioner, nurse--midwife, or a clinical social worker who is authorized to practice by the State and performing within the scope of their practice as defined by state law."
"Independent Advanced Practice Professional means APP's who under state law may practice medicine independently within their scope of practice."

The bylaws address Allied Advanced Practice Professional in section 3.5, and included:
Requirements: "Allied APP are licensed health care professionals and recognized by the Professional and Vocational Licensing Division of the Hawaii State Department of Commerce and Consumer Affairs who are not permitted by statute to practice independently and who ...2. are "credentialed and privileged in their specialty or sub-specialty ..."
Prerogatives: "... Allied APP's are entitled to 1. provide care for patients in the hospital...within clearly defined delineation of privileges under the supervision of a member of the Medical Staff. Such privileges shall be stated on initial application and approved by the Governing Body and shall be subject to the rules and regulations of the division to which the practitioner is assigned, and to the authority of the Division Chair, Department Chief, or Chief of Staff, ..."

The bylaws addressed Privileges in Section 5, which included:
"5.3.3 Allied Advance Practice professionals. The Allied APP shall practice within their license, scope of practice, and clinical privileges as approved by the Board of Directors and be responsible for the care of patients within the areas the practitioner's current competence. Privileges granted to an Allied APP, described per Medical Staff policy, shall be based on training, experience, demonstrated current competence and judgment, and the privileges of the supervising physician. The scope and extent of clinical care and procedures that each APP may perform shall be specifically delineated and granted in the same manner as all other clinical privileges.
"5.5 Temporary Privileges. ... A practitioner who has been granted temporary privileges is not concurrently granted membership in the Medical Staff.

3) Reviewed the document titled "Allied Advance Practice Professional Supervising Physician Attestation," for APP1. The attestation was for the service line Interventional Radiology and included the statement: "As a sponsoring/supervising medical staff member, I support the request of the applicant (APP1), as delineated above and within the context of the applicant's employment by me/my group (MD1 and MD2), and/or my anticipated use of professional services of this individual. I accept full responsibility for the performance of the applicant in the East Hawaii Region facilities noted above with respect to patients under my care, for proper conduct and for observance of all Bylaws, Rules and policies of the facility and Medical Staff." The attestation was signed by MD1 on 07/10/2023.

4) P1 was a quadriplegic (paralysis that affects all four limbs) post stroke, non verbal and had a G-tube. Review of Emergency Physician records revealed on 06/28/2025, P1 was taken to the ER, after his G-tube fell out at home. The tube was reinserted, and he was discharged back home by ambulance at approximately 01:07 AM. The G-tube fell out again after getting home, and he returned back to the ER on 06/28/2025 at approximately 01:00 PM. At that time, the ER Physician was unable to pass the G-tube, because there was significant resistance. After consulting the on call general surgeon, it was recommended that P1 be admitted "until IR intervention on Monday (06/30/2025).

On 06/30/2025 at approximately 02:30 PM, the APP1 and a technician went to P1's room and attempted to reinsert the G-tube, which was unsuccessful.

Reviewed the Interventional Radiologist call schedule for the period from 06/02/2025 to 01/05/2026, which revealed the following:
- Week of 06/02/2025: "MD2"
- Week of 06/09/2025: "MD1 (last week)"
- Week of 06/16/2025: "MD2"
- Week of 06/30/2025: "MD3"

As noted above in APP1's privileges, the supervising physicians were MD1 and MD2. On 06/30/2025, MD1 was no longer working at the hospital and MD2 was not known to be available for communication as required. APP1 referred to MD3 as the "attending." MD3 was a Locum Tenen (temporary physician who fills in for another clinician while they are unavailable). MD3 was not identified on APP1's certificate with the DCCA (Department of Commerce and Consumer Affairs, Licensing Branch) that identified MD1 and MD2 as the group supervising APP1. In addition, MD3 had been given temporary status privileges, and it was his/her first day at the hospital.

Reviewed the Hospital "Provider Onboarding Guide,"used to orient new Providers to the facility. The guide did not include any information regarding assuming the responsibility and oversight of a Physician's Assistant, and what that may entail. There was no evidence MD3 (Locum) had knowledge and accepted this responsibility.

On 08/08/2025 at 09:20 AM, during an interview with the Credentialing Coordinator (CC), we reviewed APP1's delineation of privileges. At that time she confirmed APP1 was signed off as being able to remove a G-tube independently on 01/23/2024. In addition, the CC confirmed MD3's start date was 06/30/2025 and at that time had temporary privileges.

5) Cross Reference A0131 Patient Rights: Informed Consent.
The APP1 did not document any discussion with P1 regarding the procedure he/she was going to perform on him, and did not determine his ability to understand any information provided. In addition, there was no documentation of attempts to reach P1's caregiver or surrogate regarding the plan to reinsert the G-tube at bedside.

Cross reference A- 0339 Eligibility & Process for Appt to Med Staff
The facility failed to ensure there were written practice-related activities defining the APP's scope of practice. There was not an effective framework in place to ensure that the "Allied Advance Practice Practitioner (APP), as defined in the "Unified Medical Bylaws," in this specific case, Interventional Radiology Physician's Assistant's scope and extent of clinical care was consistent with Hawaii State Law.

Cross reference A0449 Content of Record.
The APP1 failed to initiate a timely note of the encounter he/she had on 06/30/2025 with P1, when a consult was done, an assessment, and unsuccessfull attempted to reinsert a G-tube at bedside. APP1 initiated an incomplete note on 07/07/2025, after a recommendation was made to document the encounter. In addition, the note was not countersigned according to the facility's policy.

Based on interviews, record review (RR), and document review, the facility failed to have processes in place to ensure the Advanced Practice Professional (APP)1's records were initiated in a timely manner, accurate and complete. The facility had no written guidelines or process for auditing the APP1's records to ensure they were complete. In addition, one patient's (P)1 consult note was formatted in such a manner it could be misinterpreted and inaccurate. The cumulative effect resulted in a Condition level deficiency.

Findings include:

Cross Reference A-0338- Medical Staff
The facility failed to provide evidence that the group of physicians that supervised APP1, met the Hawaii Statute requirements for record review. The group had not established written guidelines for review of medical records as appropriate to the specific practice of Interventional Radiology.

Cross Reference A-0449-Content of Record
APP1 failed to initiate a note of an encounter on 06/30/2025 with P1. The APP1 conducted an assessment, and unsuccessfully attempted to insert a G-tube at bedside. He/she generated a late entry note on 07/07/2025, after recommended to document the encounter, which was found to be incomplete. In addition, the note was not countersigned according to the facility's policy.

Cross Reference A-0450-Medical Record Service
The Individual entries P1's medical record related to the procedure of replacing his gastrostomy tube (long term tube inserted in the stomach through the abdomen, for nutrition) could be misinterpreted. Specifically, the "Imaging Consult Report" is formatted and documented to read as if the procedure was performed in Interventional Radiology under conscious sedation at a different time, which would be inaccurate.

Based on interviews, record review and document review, the facility failed to provide evidence that they took reasonable steps to provide information and obtain consent for a procedure, from one patient (P)1/representative of a sample of four. On 06/30/2025, an Allied Advance Practice Professional (APP1 [Physician Assistant]), attempted to reinsert a gastrostomy tube (G-tube, a tube inserted through the abdominal wall into the stomach, used to provide nutrition) at bedside. APP1 did not make an attempt to contact the caregiver, who was waiting for surrogate paperwork, being processed by Social Services and did not document he/she attempted to provide information to the patient or determine his ability to understand and make health care decisions.

Findings include:

1) P1 was a quadriplegic (paralysis that affects all four limbs) post stroke, non verbal and had a G-tube. He lived at home and had a full time caregiver. P1 does not have a Power of Attorney for Healthcare decisions, but had not been able to make his own decisions. The previous time he was hospitalized at the same facility, Social Services worked with his family, who designated the caregiver as his surrogate, to make health-care decisions for him.

Review of Emergency Room (ER) Physician records revealed on 06/28/2025, P1 was taken to the ER, after his G-tube fell out at home. The tube was reinserted, and he was discharged back home by ambulance at approximately 01:07 AM. The G-tube fell out again after getting home, and he returned back to the ER on 06/28/2025 at approximately 01:00 PM. At that time, the ER Physician was unable to pass the G-tube, because there was significant resistance. After consulting the on call general surgeon, it was recommended that P1 be admitted "until IR (Interventional Radiology, a specialty that performs procedures using imaging guidance) on Monday (06/30/2025).

On 06/30/2025, sometime prior to 09:30 AM, (Caregiver (CG) arrived), the APP1 and a technician went to P1's room and attempted to reinsert the G-tube, which was unsuccessful. The exact time is unknown, as there was no documentation regarding the attempt on that day, and the nursing staff had not been notified or involved.

Reviewed the Hospitalist History and Physical dated 06/28/2025, which revealed the following entries:
"Reliability: The patient cannot participate in History ...due to the following (nonverbal at baseline)"
"Is the patient able to give informed consent?: No"

2) Cross Reference A 0338 Content of Record:
The APP1 did not document the encounter on 06/30/2025 when she attempted to reinsert the G-tube. There was a late record made on 07/07/2025 at 02:10 PM. This record did not contain any documentation of attempts to inform P1 of what was being done, or if he understood, and did not include attempts to determine who his surrogate was.

3) On 08/07/2025 at 10:05 AM, interviewed the IR technician (IRT), and the Director of Imaging. The IRT said he accompanied the APP1 to P1's room on 06/30/2025 and was present when he/she attempted to insert the G-tube. He said the APP1 explained the procedure to P1, and attempted to insert the tube "a couple of times." When asked if P1 appeared to understand what was being said, the IRT replied "Not sure if he was mentally altered, as he was not responding."

The APP1 no longer works at the facility and was unavailable for interview.

4) Reviewed the facility policy titled "Informed Consent," last revised 01/2023. The policy included:
"I. Purpose: A. To establish guidelines to ensure that patients receive and understand information needed to evaluate treatment options, risk, benefits, treatment alternatives ..." B. To define the performance expectations of Medical Staff for informed consent."
'II. Definitions: A. Informed consent: Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment. B. Invasive Procedure: The puncture or incision of the skin, insertion of an instrument, or foreign material into the body for diagnostic or treatment-related purposes. ..."
"III. A. Every patient (or personal representative) has the right to participate in an informed consent discussion. ...The conversation should be documented in the patient's medical record. ...D8. An informed consent for non-surgical invasive procedures do not require an informed consent form, rather a completely documented attestation statement is acceptable; ...a. A properly completed consent attestation statement documented prior to the procedure includes: The discussion, understanding, and agreement, or declination to; All risks, benefits, side effects of the procedure/treatment; The risk, benefits, side effects of the alternatives, including the not receiving the proposed care; The right to decline treatment."

Reviewed the facility policy titled "Surrogate Designation & Surrogate Decision Making'" last revised 01/2023. The policy included:
"Purpose: To provide for the appointment of a legal surrogate to make health care decisions for the patient/resident."
"Surrogate" means an individual (other than a court-appointed guardian or an agent appointed under a health care power of attorney) who had been designated by a patient ... or who has been selected by interested persons (non-designated surrogate) to make health care decisions for a patient has been determined to lack capacity to provide informed consent to or refusal of medical treatment."
"Responsibilities of Legal Surrogate are to:"
"Make day to day health care decision during the period of incapacity ..."
"Provide decisions based on informed consent"
"Provide written consent whenever such consent is required ..."

5) Reviewed the Document titled "Declaration of Authority as Surrogate for a Patient Appointed "Non-Designated" Surrogate". The document was completed on 06/30/2025 at 10:24 AM, and declared P1's Surrogate to be the Caregiver.

Based on interviews, observation, record and document review, the facility failed to identify a situation as an adverse event that should have been analyzed in a timely manner, to identify any opportunities for improvement and to decrease the risk of a similar event happening to others. Specifically, on 02/28/2025, P2 was found in respiratory distress, when her BIPAP (non-invasive oxygen ventilation therapy) tubing became disconnected. The staff did not complete an incident report to promptly notify the respiratory therapy (RT) manager, or risk management. In addition, the equipment was not saved so it could be inspected for any malfunction, and staff were not interviewed.

Findings include:

1) P2 was a 62 year old female who had a history of lung issues that included: COVID-19, Congestive Heart Failure, Severe Pulmonary Hypertension (serious condition characterized by high blood pressure in the arteries of the lungs), Pulmonary Fibrosis (lung condition that makes them stiff and scarred making it hard to breath), and hypoxia (low levels of oxygen in body's tissues). P2 also had hypertension and Coronary Artery Disease. She was on high flow (flow rates that exceed conventional oxygen delivery systems)/BIPAP, and at 50% SpO2 (percent of oxygen in the blood) at baseline without supplemental oxygen. She is alert and oriented and able to follow commands.

On 02/28/2025 at approximately 08:50 AM, the Certified Nurse Assistant (CNA) responded to P2's call light and found her in respiratory distress. At that time she noted the BIPAP tubing had become disconnected.

2) Reviewed the document titled "Resuscitation Event Documentation." There was a comment entry at 08:50 AM that read "BIPAP disconnected, SpO2 19%." Additional documentation included:
-09:01:36 AM SpO2 89%
-09:01:44 AM SpO2 94%
"Outcome: Patient Resuscitated"

3) On 03/04/2025, an incident report was generated by the Risk Manager after she received a call from a family member regarding a rapid response call on P2. Review of the Report revealed the following documentation:
- Respiratory Therapy Manager: "...Upon review of the medical record, I was unable to verify the reason for the rapid response. The patient no longer has that adaptor (MDI connector) on the machine she is using. I checked a similar connection using the same type of tubing and mask and it was tight as designed by manufacturer." This entry was not dated or timed.
- Risk Management: "...The family member (FM) said it was caused (respiratory distress) by a loose connection on the Bipap machine where the MDI (meter-dose inhaler, an adaptor that delivers aerosol medication) was placed. He stated that he had spoken to respiratory therapists about this. ..."
- Nurse Manger: "...03/10/2025 ...There was a disconnect in the BIPAP tubing that was reported when aide entered room. RN notified and RRT (rapid response team) called. Unsure where the disconnect was. Staff reported main "tubing" not where MDI placed so unclear. ..."

4) Reviewed the facility policy title "Incident (Event ) Reporting," last revised 07/2024. The policy included the following:
- "Purpose: A. To provide guidelines for all staff members ...in reporting all unforeseen events ...occurring in and around the facility ...C. To provide a systematic process of collecting incident data for improving patient outcomes, patient safety and staff performance. ...E. To ensure a safe environment for patients/residents by preventing re-occurrence of incident ..."
- "Policy: A. All incident [sic] shall be reported promptly to Risk Management by completing an Incident Report as soon as possible following the event. ...B. An incident is an occurrence that is not consistent with routine patient/resident care ...H. Any serious injury that is a result of malfunctioning equipment, care for the patient first, however, do not dispose of the equipment or alter it in anyway. ..sequester the equipment in the original location and contact the supervisor, risk manager ..."

5) On 08/07/2025 at 08:42 AM, interviewed the Respiratory Therapy Manager (RT). He said he was very familiar with P2 and her family. The RT said P2 could not tolerate being off the BIPAP for any length of time because of her end stage chronic obstructive pulmonary disease. He was not aware of the incident until a FM called him the next day, or a few days later. He went on to say FM was upset that the MDI adaptor was being left on the BIPAP tubing after the medication was administered. The RT said that was the first time he was made aware of his concern, but apparently the FM had mentioned it to the staff. He said there are multiple connection points on the BIPAP that could have come disconnected, so after he became aware of the incident, he took some BIPAP tubing, and a MDI connector from stock, and checked to see if there were any issues with the equipment. The RT said the equipment P2 had the day of the event, had not been kept, so it could not be inspected. He said the practice of leaving the MDI on or off was not consistent among staff, and there currently was not a policy. When inquired if he had done any interviews with the staff, or knew who reconnected the tubing, he said, he should have conducted interviews, but did not. The RT agreed an incident report should have been made immediately after the incident. He said he did not know what the equipment manufacturer recommended for leaving the MDI connector in place, but said he would investigate. Request was made to look at the equipment.

On 08/07/2025, at 11:45 AM, the RT brought equipment to the office, and demonstrated how the MDI was connected to the tubing. Observed the different areas that could become disconnected, and tested the equipment which had tight fittings. He had checked with the manufacturer, and found that the MDI adaptor was designed to stay in the circuit for up to 29 days.

On 08/07/2025 at 12:30 PM, interviewed the CNA assigned to P2 the day of the event. She said she was caring for another patient when P2's call light was alarming. CNA said she responded as soon as she could, and when entered the room, the ventilator bedside alarm was going off. She went on to say "P2 was not getting any air. I saw it was disconnected, and she was trying to connect it herself, so I connected it, and called for help." When inquired if anyone had interviewed her or asked her specifics about the equipment, she said no. At approximately 12:40 PM, requested RT to meet with CNA and bring BIPAP tubing and a connector. Asked CNA if she could recall exactly where the tubing got disconnected, but she could not remember because it happened so long ago.

On 08/07/2025 at 01:00 PM, interviewed Registered Nurse (RN)1, who was the chair of the Code Blue Committee. She said this committee looks at all resuscitation events, that includes Rapid Responses. RN1 said assigned individuals audit and review the events for documentation and any opportunities for improvement. She said the rapid response document does not go directly into the medical record, as it is a third party vendor and does have some delay. The 02/28/2025 event was reviewed and RN1 agreed there should have been an event report, and the audit process should have identified the tubing disconnection as a concern, so it would have a thorough analysis.

Based on interviews, document and record review, the hospital Medical Staff failed to have an effective structure, written guidelines and processes in place, to ensure that one "Allied Advance Practice Practitioner (APP)1," as defined in the "Unified Medical Bylaws," extent of clinical practice was consistent with Hawaii State Law, and approved hospital delineation of privileges. During the survey, one patient (P)3, was identified to have x-ray interpretations by APP1, which had not been approved to be within his/her scope of practice.

Findings include:

1) Cross Reference A-0338
The hospital Medical Staff failed to have an effective structure, written guidelines and processes in place, to ensure that one "Allied Advance Practice Practitioner (APP)1," as defined in the "Unified Medical Bylaws," had consistent physician supervision of his/her clinical practice and met all the requirements and was consistent with Hawaii State Law..

2) Reviewed the "Delineation of Privileges APP EHI Interventional Radiology Service Line Privileges" form, which included the "Interventional Radiology Service Line Core Privileges. The core privileges included:
- Performance and documentation of history and physical examination
- Rounds/inpatient and outpatient evaluation and management services
- Request consultations from other medical services
- Ordering laboratory tests and imaging studies
- Communicate with referring services
- Provide patient education
- Established patient follow up/evaluation.
The form included multiple Procedures and Vascular Access. Each procedure privilege granted was based on documented training / experience.

3) P3 was a 64 year old male who had a left hemothorax (accumulation of blood within the pleural cavity), which was first treated with the insertion of a chest tube that drains the blood and air from the chest cavity on 02/21/2025. He was seen by APP1, for follow up. Review of APP1's "Interv (Interventional) Rad (Radiology) Notes" included, but limited to the following:

03/03/2025, 08:48 AM: " ...new left side chest tube on 3/1/25. ...Chest x-ray this morning reviewed and interpreted by myself demonstrates left chest tube in good position, still a moderate sized pleural effusion. ...The patient states his breathing is still shallow and he is having left sided chest pain. ...

03/04/2025, 09:39 AM: "...Patient had 1 dose of TPA (Alteplase, clot busting medication) through the chest tube yesterday with increased output ... Chest x-ray this morning reviewed and interpreted by myself essentially unchanged from yesterday. ..."

03/06/2025, 09:18 AM: " ...Chest x-ray this morning reviewed and interpreted by myself shows a small stable left pleural effusion (accumulation of fluid in the pleural space). Patient states his breathing is still somewhat labored but improved since admission, and his chest pain is much more tolerable. ...at this point reached maximum benefit from the chest tube and we feel it can be removed today. ...Chest tube was removed at the bedside without complication . ..."

4) On 08/08/2025 at 09:20 AM, during an interview with the Credentialing Coordinator (CC), reviewed APP1's delineation of privileges. At that time, she confirmed that x-ray interpreting was not included in the core privileges. The facility did not provide evidence that APP1 demonstrated competency in x-ray interpretation. CC confirmed APP1 had been approved to independently remove a chest tube on 10/06/2023.

Based on interviews, and record review, the medical record of one patient (P)1 was found to be incomplete. Specifically, an Allied Advanced Practice Professional (APP1/Physician Assistant) failed to initiate a timely note of an encounter on 06/30/2025 with P1. The APP1 conducted an assessment, and unsuccessfully attempted to insert a gastrostomy tube (long term tube in stomach through the abdomen for nutrition) at bedside. As a result of this deficient practice, this information was not available to other care providers. The APP1 generated an incomplete note on 07/07/2025, after recommended to document the encounter. In addition, the note was not countersigned according the facility's policy.

Findings include:

1) P1 is a quadriplegic (paralysis that affects all four limbs) post stroke, non verbal and had a G-tube. On 06/28/2025, P1 was taken to the ER, twice after his G-tube fell out at home. The first time, the tube was reinserted, and he was discharged back home. The G-tube fell out again after getting home, and he had to return to the ER on at approximately 01:00 PM. At that time, the ER Physician was unable to pass the G-tube, because there was significant resistance. After consulting the on call general surgeon, it was recommended that P1 be admitted "until IR intervention on Monday (06/30/2025).

2) P1's Caregiver (CG) notified the facility of a grievance on 06/30/2025 regarding the unsuccessful bedside attempt to reinsert P1's G-tube on 06/28/2025. When the facility conducted their investigation of the CG's concerns, they noted that there was no documentation from APP1. The Risk Manager documented on the grievance form APP1 was contacted via phone, and said "he/she doesn't document typically these things if nothing is done. ..." At that time, the APP1 was advised to do a late entry and document the encounter.

3) Review of P1's medical record, revealed a "Miscellaneous Note" was initiated by APP1 on 07/07/2025 at 01:36 PM. The note included the following:
" Late documentation: Date of Service, consultation and patient encounter 6/30/25. "
" IR was consulted due to dislodged gastrostomy tube. Per the standard of care a bedside attempt was made. I assessed the gastrostomy tube stoma at bedside. There was dried blood covering the stoma. Chlorhexidene scrub was used to clean the area. I then attempted to pass the 14 Fr (french) Kangaroo gastrostomy tube (type of tube) through the existing stoma with the addition of lubricated jelly, this attempt was unsuccessful. Recommend fluoroscopic guided gastrostomy tube placement."
It is unknown what time this encounter occurred, as it was not documented.

4) On 08/07/2025 at 10:05 AM, interviewed the Interventional Radiology technician (IRT), who was present in the room when the APP1 attempted the bedside insertion of the G-tube on P1 on 06/30/2025. He said APP1 tried to put in the tube "a couple of times," and that P1"was trying to move around and not sure if he was in pain, or just moving. The IRT confirmed P1 was nonverbal.

5) Reviewed the facility policy titled "Medical Record Documentation," effective date of 02/2022. The policy included the following:
"1.C. The Medical Record documents the patient's medical evaluation, treatment, ....during the hospital inpatient stay, ..."
"1.D. The Medical Record provides an insight as to what the patient's condition was at a specific time."
Definition of Counter-authentication: "All entries by Allied Health Professional including Physician's Assistants, Nurse Practitioners, ...will be promptly countersigned by the responsible staff physician."
Medical Record Content: ..."2. Documentation and content: The medical record must support the diagnosis, justify the treatment and document the course and results of treatment and facilitate the continuity of care."
"6. Entries in the medical record shall be: ...B. Timely. Record significant information at the time of the event, as delays result in inaccurate or incomplete information. ... D. Specific. Concise and descriptive. The medical record is a clinical communication tool and record entries should be detailed (not generalized), brief and meaningful without sacrificing essential facts, and thoroughly describe observations and other pertinent information. ...F. Comprehensive. Record significant information relative to a client's condition and course of treatment. Documentation should reflect pertinent findings, services rendered, changes in the condition and the response to treatment. Information in the record should include justification for the initial need for services and continued treatment needs. ..."
"Informed consent: It is the responsibility of the physician performing the procedure/ordering the treatment to discuss risks, benefits, potential complications, and alternatives with the patient/family prior to obtaining informed consent."

6) The PA note above entered on 07/07/2025 was incomplete and did not provide an accurate presentation of P1 or the encounter on 06/30/2025. The late entry note did not include the following pertinent information:
- P1 was nonverbal and if he could understand the information he was given.
- P1's G-tube had fallen out twice on 08/28/2025, and had been seen in the ER both times. The first time the ER physician was able to reinsert the tube, but the second time he returned, the Physician was unsuccessful due to resistance. The G-tube had been out since 06/28/2025. This would mean the tube had been out approximately 48 hours, which would determine the standard of care.
- The justification for the bedside procedure should be detailed, and outline the indications and contraindications for bedside replacement.
- P1's response to the unsuccessful procedure.

Based on interview, record and document review, there were individual entries in the medical record related to one patient's (P)1's gastrostomy tube (long term tube in stomach through the abdomen for nutrition) replacement procedure, that could be misinterpreted. Specifically, on the consult report, due to the timing and authentication documented, "Imaging Consult Report" could be interpreted that the procedure was performed in Interventional Radiology under conscious sedation at a different time, which would be inaccurate.

Findings include:

1) P1 is a quadriplegic (paralysis that affects all four limbs) post stroke, non verbal and had a G-tube. On 06/28/2025, P1 was taken to the ER, twice after his G-tube fell out at home. The first time, the tube was reinserted, and he was discharged back home. The G-tube fell out again, and he had to return to the ER on at approximately 01:00 PM. At that time, the ER Physician was unable to pass the G-tube, because there was significant resistance. After consulting the on call general surgeon, it was recommended that P1 be admitted "until IR intervention on Monday (06/30/2025). On the morning of 06/30/2025, the Interventional Radiology Allied Advance Practice Practitioner (APP1/Physician Assistant) made an unsuccessful attempt to replace the G-tube at the beside. P1 went to interventional radiology later that day and had the G-tube successfully reinserted under conscious sedation (medical procedure to help manage pain).

2) Cross Reference, F0449-Content of Record
The APP1 failed to initiate a timely note of the encounter on 06/30/2025 with P1. He/she conducted an assessment, and unsuccessfully attempted to insert the G-tube at bedside. On 07/07/2025, after recommendation to document the encounter, the APP1 generated an incomplete note.

3) Reviewed the Record titled "Imaging Consult Report" for P1, Service Date of 06/30/2025, Service Time: 08:52 AM. The report revealed the following entries:
Exam: "Interventional Rad (Radiology) Consult"
"Reason for Consultation: G tube replacement"
"Procedure: Gastrostomy tube replacement"
"Procedure Advanced practice provider(s): None"
"Plan: May start using gastrostomy tube immediately."
"Procedure Summary/ Details: Informed consent for the procedure including risks, benefits and ....was obtained and time-out performed prior to the procedure. ...IV conscious sedation was provided...Contrast was instilled through the gastrostomy tube to confirm satisfactory position."
"This report was electronically signed by MD3 on 7/2/2025 5:19 PM."
The initial IR consult and unsuccessful attempt to place the G-tube was done in the morning of 06/30/2025 by APP1. MD3 was not present at that time. This documents reads as if the procedure occurred at the service time documented to be 08:52 AM, which is not correct.

Reviewed the document titled "Procedure Report" for P1's, dated 06/30/2025. The procedure was performed in interventional radiology. The record included:
Time: 03:41 PM: P1 arrived.
03:42 PM: Comment G-tube insertion.
03:52 PM: Team Time out preformed.
04:04 PM: "...Gastrostomy feeding tube advanced ...into position, positron confirmed with contrast injection."
04:10 PM: "Reviewed and Approved" by MD3. Electronically signed.