Hilo Benioff Medical Center

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 17281”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 39853 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.”

“MEDICAL RECORD SERVICES CFR(s): 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. This Condition is not met as evidenced by: 39853 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.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 39853 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.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 39853 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.”

“ELIGIBILITY & PROCESS FOR APPT TO MED STAFF CFR(s): 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope of practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body. This Standard is not met as evidenced by: 39853 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.”

“CONTENT OF RECORD CFR(s): 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services. This Standard is not met as evidenced by: 39853 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.”

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 39853 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.”

“PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES CFR(s): 482.13(a)(2)(ii) At a minimum: The grievance process must specify time frames for review of the grievance and the provision of a response. This Standard is not met as evidenced by: 39853 Based on record review (RR), document review and interviews, the facility failed to acknowledge, investigate and resolve one patient’s (P)1 family members (FM)1 grievance of a sample size of three. The day before P1’s discharge, Social Worker (SW)1 spoke with FM1 on the phone when FM1 verbalized being upset regarding P1’s care. SW1 was not able to resolve the concerns on the phone call, but did not identify the conversation as a grievance and process it appropriately. As a result of this deficiency, FM1’s complicated ongoing concerns, they were not all acknowledged, reviewed, investigated or resolved in a timely manner. Findings include: 1) P1 was a 62 year old female had a history of advanced COPD (chronic obstructive pulmonary disease/pulmonary fibrosis ) chronic respiratory failure, anxiety disorder, chronic pain syndrome, suspected lung cancer, and severe malnutrition. She had a Stage III Pressure Ulcer (PU) and was on home oxygen and BiPAP (breathing device that delivers air pressure when you breath in and out). P1 has had multiple Emergency Department (ED) visits and hospital admissions due to her chronic condition. On 04/04/2024, she presented to the ED for shortness of breath and was admitted for further care. P1’s hospitalization was complicated by a fall on 04/07/2024 resulting in a fracture of the left hip that required surgical repair. In addition, P1 was diagnosed positive with a Hospital Acquired COVID infection on a specimen collected 05/06/2024, 32 days after admission. She was discharged home on 05/23/2024 with Home Health Referrals. 2) Review of Nursing Progress Notes revealed the following entries: 04/29/2024 03:14 PM Medical Unit Registered Nurse (RN)1 note: “family concerns patient (P)1 was speaking with Family Members (FM1 and FM2) on the phone and asked to speak with this RN. FM1 asked if oxygen was being monitored and titrated as needed. I explained to FM’s that P1’s oxygen was monitored. FM1 then asked how often, explained with vitals every 4 hours and when RT (respiratory therapy) assesses and administer treatments. FM1 then started getting upset and stated that told all the doctors that he wants continuous Telemetry and oxygen monitoring of P1. ...FM1 said he has been taking care of P1 for “years” and that she is on continuous heart and oxygen monitoring at home at all time [sic]. Explained to FM1 I would give Provider (MD)1 the message to call back. ...When asked FM1 did not know that the patient was downgraded to team W (medical unit) and that they did not want this for the patient. When they were asked, who did they speak to with all these concerns ..., they stated that they spoke with everyone that took care of the patient. ...MD1 in to talk with patient and MD1 did call family back.” Review of Social Services notes revealed the following entry: 05/22/2024 at 11:06 AM: “This SW (Social Worker)1 met with pt at bedside to discuss DC (discharge) planning and provide psychosocial support. ...This SW shortly after received a call from FM1 and discussed home health vs SNF (skilled nursing facility). ...FM1 with multiple complaints regarding pt’s care at facility, this SW offered phone number for patient advocate office, FM1 declined and continued to say that he is very upset and frustrated with pt’s care and this SW ended call d/t (due to) FM1 yelling at this SW.” 3) Reviewed a facility incident number #HL2024-000857 regarding P1 initiated on 04/29/2024, documented as “Event Code: Grievance.” The reports included: 04/29/2024 at 03:55, initiated by Medical Unit RN: “family concerns patient (P)1 was speaking with FM’s on the phone and asked to speak with this RN. FM1 asked if oxygen was being monitored and titrated as needed . I explained to FM’s that P1’s her oxygen was monitored FM1 then asked how often, explained with vitals every 4 hours and when RT (respiratory therapy) assess and administer treatments FM1 then started getting upset and stated that told all the doctors that he wants continuous Telemetry and oxygenation of P1. ...” This is the same nursing note listed above in RR. 04/30/2024 09:15 AM. Addendum by MD1: “I called and spoke to FM1 for 50 minutes after receiving message from RN. We discussed patient’s downgrade status, current treatment plan, and discharge planning. I advised that there is specific criteria which needs to be met for telemetry and continuous pulse oximetry as we have limited units. We could justify placing her back on this temporarily since we just started digoxin (heart medication). FM1 was grateful and very pleasant throughout conversation. FM1 did not mention any disagreements with nursing or with current care plan. Spoke to patient prior to calling FM1 and she had no complaints and is also happy with her current care plan. ...FM1 advised that Team W has high patient census and we are unable to contact family members daily for updates. Recommend that FM1 contact nursing or patient’s CM (Case Manager) when he would like updates or to discuss concerns and they will be happy to relay message to us. FM1 satisfied with this and grateful for time spent on call.” 05/01/2024 01:18 PM. Addendum by Patient Advocate (PA): “FM1 called today to voice his concerns-I can see the unit and MD1 have spent an extensive amount of time speaking with FM1 and FM2. I asked FM1 if his questions had been answered and his concerns resolved-he did not provide direct answers, but rather responded with statements of staff is not taking proper care of P1. I asked for specific issues QM (quality management/RM (Risk Management) can look into for him. Per FM1: - “P1 is on bipap at home and should be on bipap at hospital, instead her level of care was downgraded and she is now given CPAP (CPAP provides a constant air pressure to keep airways open, BiPAP offers two pressure levels, one for inhalation and and one for exhalation.). Medical Unit staff has explained to FM1 that they don’t do Bipap, only CPAP-which FM1 feels is not appropriate.” - “FM1 feels P1 should be on telemetry-but needs higher level of care to receive. He states her saturation levels dropped to 50%.” -“FM1 is concerned about pressure injury-says the surgeon is also worried saying her PU could be causing her back pain. FM1 feels wound care is not properly cared for the wound and noone else seems to be worried about it, but he is worried.” -“FM1 feels there is an issue with the dehumidifier, the air is not going through.” -“FM1 made aware that analyst is looking into his concerns and will update him. ...” 05/01/2024 02:07 PM: Addendum by Wound Nurse: “Wound team saw P1 yesterday with FM1 at bedside. Her wound looks good, clean. It is more open than it was when she was admitted. ...We amended wound care orders and he is happy with that. ...” 05/03/2024 01:44 PM. Addendum by PA: “FM1 called with several concerns-reviewed with NM2 on steps taken the last two days to address FM1’s concerns. ...Today’s concerns: -P1 is not on pulse ox, ... -P1 is not being changed quickly enough after having a bowel movement, he believes her PI (pressure injury) now has an infection. ... -Noise outside of window is to much, P2 has a headache. Additionally, transfer order to PCU has been placed. ... FM1 has been called and updated, thankful for the information. ...” 05/03/2024 02:24 PM. Addendum by NM2: “I spoke with FM1 on the phone 5.02.2024 and let him know Physician (MD2) would be reviewing the list he gave to PA. He said he would be coming to the hospital later that day, and I suggested he connect with the nurse and dr. [sic] regarding plan going forward. He agreed.” 05/07/2025 08:45 AM: Addendum by PA: “P1 has been transferred to PCU- FM1 not pleased P1 is not on continuous pulse/ox (oxygen level monitoring) but rather bedside and being checked every 2 hr. I contacted ..., who confirmed spoke with FM1, explained level of care PCU provides. ... Discussed with MD3, FM1 in agreement that new saturation levels can range from 86-94% vs previous 88-92%. FM1 questioned if the unit has appropriate staffing-we assured him PCU is adequately staffed for PCU staff to patient ratio, but not 1:1, this would be ICU. ...” 05/07/2024 08:49 AM: “Final disposition: Closed, Corrective Action Completed.” FM1’s grievance had not been resolved as noted in the conversation with SW1 on 05/22/2024. 4) Reviewed the facility policy titled “Patient Complaint and Grievance Policy” last revised 05/2022. The policy included the following: “Purpose: To establish a process for prompt response and resolution of patient complaints and grievances consistent with Federal Centers for Medicare and Medicaid Services.” Definitions: A. Complaint: Concern raised by the patient or his/her legal representative (hereafter referred to as “patient”) about the quality of care or services provided by staff, practitioners, or contracted agents of the organization that is addressed or resolved promptly by staff (generally within 24 hours), while the patient is in our facility and services are being provided. ...A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf. B. Grievance: According to the Interpretive Guidelines for CMS Hospital Conditions of Participation, “A ‘patient grievance’ is a written or verbal complaint (when the verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient, or the patient’s representative, regarding the patient’s care...” Procedure Addressing and Resolving Grievances: “C All patient complaints that are unable to be resolved at the point of service, either by unit staff, or department management, will be referred to the Patient Advocate by staff through prompt entry of the incident in the incident reporting system. ...1. The investigation of the grievance shall be conducted by the manager(s) of the areas involved. Managers should respond to grievances promptly... 4. All grievances will have a prompt written response, within 7 business days if possible, depending on the nature of the grievance. 5. If the grievance is unable to be resolved within 7 business days, the grievance will receive a final written response stating the organization is working to resolve the grievance and a final written response within 30 days will be provided. ...” Reviewed the policy titled “Patient Rights & Responsibilities” last revised 03/2022. The policy included “B. Grievance Process. A clearly explained grievance process shall be implemented which specifies the time frames for review of and response to the grievance. C. Notice of Grievance Results. The response to the grievance shall be communicated to the patient in writing with the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the process and the date of completion.” Reviewed the Patient Handbook provided to all admission. The handbook included a section titled “Your Rights,” which included “Concerns and complaints-You have the right to make a complaint without fear of retribution. Reasonable attempts will be made to resolve the complaint to your satisfaction. If a resolution cannot be achieved, the complaint will be handled as a grievance and you will receive a response in writing. ...” 5) On 06/20/2024 at 01:50 PM, during an interview with the PA, she said P1 lived with FM1 and FM2, and FM1 has been caring for her for several years. FM1 is very concerned about her oxygen levels and likes her to have more care. Has had complaints about not titrating the oxygen properly to 88-92% and lower level of care on medical unit and wants her on telemetry monitoring. P1 has had several admissions and FM1’s “common concerns are about her pressure injury and O2 saturation. He feels staff are not monitoring the oxygen levels enough.” PA said she is responsible for coordinating the follow up on the grievances. Inquired why FM1’s grievance was not listed on the grievance log and she said she had considered them complaints because she felt they had been resolved. 6/20/2024 at 02:45 PM, during an interview with NM1, she said P1 was left on telemetry (PCU) due to family concerns of monitoring. NM1 said P1 was very labile and desaturates (oxygen level drops) quickly when eating or any type of exertion. If you put her back on BiPaP, her oxygen saturation level comes right back up. She went on to say there hadn’t been issues when P1 was on PCU recently, but when changed units (medical), FM1 was upset. Inquired if there had been a care conference with the family and NM1 replied no. NM1 confirmed P1 had a fall, resulting in a fractured hip while in PCU. 6/21/24 at 09:11 AM, during interview with the Director Patient Services (Case Managers, Socials Services), reviewed the progress note entered by SW1 on 05/22/2024, when FM1 expressed frustration and concerns regarding P1’s care. At that time she said although FM1 declined taking the number for the Patient Advocate, an incident report should have been made per hospital policy so follow up could have been done.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 39853 Based on interviews, record review (RR) and document review, the hospital did not update one Patient’s (P2) Care Plan (CP) out of a sample size of four. When nursing staff reassessed P2 throughout his inpatient stay, they identified new skin problems that required treatment to promote healing and strategies to prevent further injury. P2’s CP was not revised to include the skin integrity problem to reflect his needs and goals. Findings include: 1) P1 was a 64 year old male transferred to the Hospital (H)1 from another Emergency Department for a higher level of care on 09/24/2023. He had renal failure and had been on dialysis. P2’s medical history included congestive heart failure, chronic bilateral pleural effusions (collection of fluid around lungs) with episodes of respiratory distress. P2 was admitted to the Intensive Care Unit (ICU) for acute on chronic hypoxic (low oxygen level) and hypercapneic respiratory failure (too much carbon in your blood). He remained in ICU until he was discharged on 10/03/2023. 2) Review of P2’s medical records revealed the following entries. 09/25/23 at 10:30 AM: Initial Nursing Assessment in ICU documented “Skin Condition WNL (within normal limits).” Review of P2’s Nursing Wound Assessments included but not limited to: 09/25/2023 at 09:00 PM: Skin tear identified on Left Lower Arm, treated with adaptic and kerlix dressing. 09/26/2023 at 09:00 AM: New skin issue identified. “Location: Medial Distal Sacrum, Skin type injury: shear, ...Dressing Status Dry and intact. 09/28/2024 at 09:00 AM: Description of Sacrum wound: Covered, Reddened, Draining, Partial Thickness, Blister, Errythema (redness), Friable Skin, Peeling skin, Edematous, with drainage. 09/29/2023 at 09:00 AM: “Stage of Pressure Injury (sacrum) 2-Partial Thickness. ...Comment: Previous shear/blister wound on sacrum, but now wound is open and appears to be a partial thickness injury.” 09/29/2023 at 03:14 PM, Wound Care (Registered Nurse) consult: “he (P1) has the following pressure injuries: - sacrum sDTI (Suspected Deep Tissue Injury)-wound with full and partial thickness skin loss. Wound bed dark purple/red with minimal serosang drainage. - Lateral heel sDTI- skin intact, wound dark red/purple. - nasal bridge st 2 (stage 2) PI (pressure injury) 2/2 biPap usage (due to pressure from mask over the nose). - He has a skin tear to his L FA (Left forearm) ...” Recommendations for treatment included: - “Phytoplex zinc oxide paste BID (twice a day) and PRN (as needed) to the sacral wound.” - “mepilex q3D (every three days) and PRN to L FA skin tear” 10/02/2023 09:00 AM: Wound locations: - Left hand skin tear, Covered, bleeding bandaid applied - Right forearm skin tear, dressing covered - Left lower arm skin tear, dressing covered - Sacrum, “drainage minimal ...covered” Reviewed P2’s orders, which included the following: 09/29/2023 at 03:21 PM: “Wound Skin Protection Measure Q (every)Shift.” Intervention: “zinc oxide paste BID and PRN to sacrum.” 09/29/2023 at 03:21 PM: “L FA skin tear-cleanse with NS (normal saline), Mepilex q3D and prn if soiled.” Review of P2’s active CP revealed it was initiated on 09/24/2023 at 10:30 AM. The nursing staff failed to identify he was a high risk for pressure ulcer, and did not include interventions in the initial CP. In addition, the CP was not revised to when P2’s skin problems were identified. 3) Reviewed the hospital policy titled “Interdisciplinary Patient Care Plan” last revised 01/2023. The policy included: Policy: “A. Each patinet admitted into the acute section ...will have a Plan of Care (Care Plan/CP) in the Patient EMR (Electronic Medical Record) , based on his/her individualized needs. ...D. The Plan of Care will be periodically evaluated and revised according to the patient’s progress.” Procedure: “...D. If a problem is identified, it will be indicated on the Plan of Care. ...E. As the patient’s progress is periodically evaluated, changes in patient needs and goals will be reflected in the Plan of Care. 4) On 06/20/2024 at 10:45 AM, during an interview and concurrent RR with the ICU Nurse Manager (NM)3, she confirmed P2’s initial assessment did not identify any skin issues, but they were found later during routine reassessments. NM3 said the new skin problems should have added to the CP when they were identified.”

“DISCHARGE PLANNING - PT RE-EVALUATION CFR(s): The hospital’s discharge planning process must require regular re-evaluation of the patient’s condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes This Standard is not met as evidenced by: 39853 Based on interviews, record review and document review, the hospital failed to provide a comprehensive discharge instructions for one patient (P)2, out of a sample size of four. P2 developed skin wounds while hospitalized that required treatment and ongoing care post discharge. P2 and the designated Caregiver (Family Member(FM)3) were not provided education to immediately address the wound care needs on discharge. As a result of this deficiency, P2 was a higher risk of an adverse outcome related to his wounds. Findings include: 1) P2 was a 64 year old male transferred to Hospital (H)1 from another Emergency Department for a higher level of care on 09/24/2023. He lived with FM3 and FM4, who assisted with his activities of daily living. P2 had renal failure and had been on dialysis. His medical history included congestive heart failure, chronic bilateral pleural effusions (collection of fluid around lungs) with episodes of respiratory distress. He was admitted to the Intensive Care Unit (ICU) where he remained until discharged home with FM3 on 10/03/2023. 2) Reviewed P2’s medical records, which revealed he developed several skin problems while hospitalized. Entries included the following: 09/25/23 at 10:30 AM: Initial Nursing Assessment in ICU- “Skin Condition WNL (within normal limits)- Yes” 09/29/2023 03:14 PM: Wound Care Consult (Registered Nurse): “he (P2) has the following pressure injuries: - sacrum sDTI (Suspected Deep Tissue Injury)-wound with full and partial thickness skin loss. Wound bed dark purple/red with minimal serosang drainage. - Lateral heel sDTI- skin intact, wound dark red/purple. - nasal bridge st 2 (stage 2) PI (pressure injury) ... biPap usage (pressure from mask on bridge of nose). - He has a skin tear to his L FA (Left forearm) ...” Recommendations for treatment included: - “Phytoplex zinc oxide paste BID (twice a day) and PRN (as needed) to the sacral wound.” - “mepilex (absorbent dressing) q3D (every three days) and PRN to L FA skin tear” 10/02/2023 09:00 AM: Wound locations: - Left hand skin tear, Covered, bleeding bandaid applied - Right forearm skin tear, dressing covered - Left lower arm skin tear, dressing covered - Sacrum, “drainage minimal ...covered” 3) Reviewed the provider discharge summary dated 10/03/2023. The record included an entry on 09/29/2023 at 10:40 for wound care consult for pressure injury with notation to “Please indicate location of wound: Left heel DTI and sacral pressure injury.” The discharge summary section titled “Discharge Plan” included “Patient Instructions: Anemia of inflammation (anemia of chronic disease), Diastolic Heart Failure (CD), Chronic Kidney Disease (DC), General Emergency Department Discharge Instruction, SPEAK UP: Antibiotics. There were no other entries or reference to the wounds, or instructions for the care required post discharge. Reviewed the discharge instructions the ICU Registered Nurse provided to P2 and FM3 at the time of discharge. The information included: “Patient instructions: Received with this packet on 10/03/2023 at 06:09 PM. Anemia of inflammation (anemia of chronic disease) Chronic Kidney Disease Discharge Instructions Diastolic Heart Failure Discharge Instruction General Instruction SPEAK UP: Antibiotics (education about overuse of antibiotics)” FM3 was identified as the designated caregiver in the discharge instructions. Reviewed the “Nurse Note” entered on 10/03/2023 at 06:35 PM, which included: “Bipap (breathing device) and wheelchair delivered to room, RT (respiratory therapy) educated family member (FM)3 and pt (P2) on how to use bipap, they state they are comfortable. and competent. Discharge instruction provided with time for questions, pt IV’s (intravenous therapy) removed and pt taken to personal car ...” 3) Reviewed the policy titled “Discharge Policy and Procedure” last revised 01/2023. The policy included: - “1. Each patient shall have the opportunity to identity a designated Caregiver...” - “2. ...There are no specific requirements for the designated Caregiver expect that he or she be capable of performing the necessary care. Post-discharge assistance includes help with basic and instrumental activities of daily living and support tasks (e.g. wound care, medication administration, and medical equipment use) in accordance with the patient’s written discharge plan signed by the patient or his or her representative.” - “9. The Caregiver will be included in all phases of the discharge process including planning for follow-up and direct education and hands-on training, when necessary.” - “10. The patient will be provided with comprehensive discharge instructions at the time or discharge. These instructions shall include but not be limited to: ...c. wound care. ...” 4) On 06/20/2024 at 10:45 AM, during an interview with the ICU Nurse Manager (NM)3, she confirmed P2 was discharged home from the ICU. At that time a RR was done and she explained the discharge process. NM3 said the Provider documents the specific discharge instructions to be given to the patient. She went on to say the information populates into the discharge education documents provided to the patient and family. The RN who discharges the patient ensures all the handouts identified by the Provider are included and reviews the instructions with the patient and family. NM3 confirmed there was no documentation of wound care discharge instructions. The RN who discharged P2 was unavailable for interview. On 6/20/2024 at 01:00 PM, during an interview with the Case Manager (CM)1, she said P2’s discharge planning included a referral for home Physical Therapy, but there was not a referral for wound care. She said if the Caregiver would be doing the wound care, the RN that dicharges the patient would be responsible to educate the patient and caregiver.”