Coalinga Regional Medical Center

“PATIENT CARE POLICIES CFR(s): (1) The CAH’s health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the staff failed to follow hospital policies and procedures when: 1. The temperature for the blanket warmer found in the clean utility room of the Swing Unit was not monitored for three of 14 days in accordance with hospital policy and procedure (P&P), titled, “Warmer Temperature Check”. This failure had the potential for the warmer to overheat and become a fire hazard. 2. Two of two Registered Nurses (RN 3 and RN 4) initial orientation on hiring was not completed in accordance with hospital P&P. These failures resulted in the potential harm to patients related to nurses not being fully capable of providing nursing care in accordance with professional standards of practice. 3. Clean supplies were stored under the sink in the Nutrition room and did not follow the Centers for Disease Control and Prevention’s (CDC) standards of practice for infection control and the hospital document, “Registered Nurse (Acute) Job Description”. This failure had the potential for cross contamination to patients and staff to biohazard waste (any biological or chemical substance that is dangerous to humans, animals, or the environment. This can include body fluids, human tissue and blood) which can lead to infection and diseases. 4. A provider did not document the follow up consultation for one of eight sample patients, Patient (Pt) 20, in accordance with the hospitals P&P titled, “Discharge Planning and Transfers”. This failure had the potential for a patient not receiving continuity of care for his medical problems. 5. The medical/surgical unit’s crash cart (a mobile, wheeled cart used in medical emergencies to provide immediate access to life-saving equipment and medications) was not checked for readiness (lock on medications intact, oxygen tank full, portable suction and equipment available) for the day shift on 11/10/25 and 11/11/25, every 12 hours in accordance with hospital P&P titled, “CRASH CART - MED/SURGERY DEPARTMENT”. This failure had the potential to result in delays in a life-threatening emergency due to missing or non-functioning equipment or expired medications. Findings: 1. During a concurrent observation, interview and record review on 11/12/25 at 10:10 a.m. with the Registered Nurse (RN 3), on the swing unit, in the Clean Room, the blanket warmer “Temperature Documentation Log”, dated 11/25, was observed. RN 3 stated, the log showed three days missing (November 3, 9, and 11). RN 3 stated, the temperature should be recorded daily and documented on the record. RN 3 stated, it was important to check the blanket warmer was working and adjust the temperature if needed. RN 3 stated, this was done to prevent the blankets from being too hot for the patients. During an interview on 11/14/25 at 1:30 p.m., with the Director of Nursing (DON), with the Chief Executive Officer (CEO) present, the DON stated, it was important to check the Blanket warmer to ensure it was working properly and does not harm patients. DON stated, she expected the staff to follow hospital policies. During a review of the hospital’s document titled, “Warmer Temperature Check” dated September 2023, indicated, “ ... Unit clerk and House supervisor will be responsible for checking the temperature of the warmers on a daily basis. A log will be kept on the warmer to record the daily temperature (Attachment A). The log will record the date the temperature was taken, the temperature of the warmer, and the initials of the person recording the temperature. If the warmer temperature does not maintain a temperature, the thermostat will be adjusted to correct the temperature. The House supervisor and DON will monitor the log to ensure compliance with the established procedure. ... “ During a review of the hospital’s document titled, “Registered Nurse (Acute) Job Description” dated 2/9/24, indicated, “ ... Provides for personal and environmental safety in accordance with hospital and nursing policies and procedures ... Abides by all safety, infection control, and other guidelines as required. ... Routine assessment of the environment for high risks with immediate correction (look for dangerous things and fix them; identify high risk issues and fix them) ... “ 2. During a concurrent interview and record review on 11/14/25 at 10:17 a.m., with the Human Resource Specialist (HRS), the personnel files for RN 3 and RN 4 were reviewed. HRS stated RN 3 was hired in May 2024 but no documentation for new employee orientation and orientation to the job was in the file. HRS stated, RN 4 was hired April 2024 but documentation for new employee orientation and orientation to the job was not in the file. HRS stated, all new employees go through initial orientation as per the hospital’s policy and the documentation should be present in the employees’ file. HRS stated, he was unsure what happened to the documentation as he was new to his current position. During an interview on 11/14/25 at 1:30 p.m., with the CEO, with the DON present, the CEO stated it was important for orientation to be done, and he would make sure it would get done. The CEO stated the process should be in place to ensure employees were oriented to the hospital and the documentation was available. During a review of the hospital P&P titled, “General Orientation”, dated 10/2025, the P&P indicated, “ ... All new employees are required to attend the [HOSPITAL NAME]’s formal New Hire Orientation program, sponsored by the Human Resources Department. ... New Hire Orientation will include, but not be limited to: Infection Control, Mission, OSHA Standards, Fire Safety, Right to Know, Patient’s Bill of Rights, Incident Reporting, Risk Management, Security, A tour of the hospital, Employee Rights and Responsibilities, Benefits, Compensation, Abuse Awareness and Basic Quality Improvement Theory, Electrical Safety, Information Management and Confidentiality, and Sexual Harassment ...” 3. During a concurrent observation and interview on 11/12/25 at 10:00 a.m. with the Registered Nurse (RN 3), on the swing unit, in the Nutrition Room, the cabinet under the sink was observed with plastic containers, normally used to store food. RN 3 stated clean supplies should not be stored under the sink. RN 3 stated the plastic containers should not be under the sink. RN 3 stated under the sink was not considered “clean” and cross contamination could occur. During an interview on 11/14/25 at 1:30 p.m., with the Director of Nursing (DON) and Chief Executive Officer (CEO), the DON stated nothing should be stored under the sink and the cabinet under the sink should be clean. DON stated we should not store anything under the sink so as to prevent cross contamination. During a review of the hospital’s document titled, “Registered Nurse (Acute) Job Description” dated 2/9/24, indicated, “ ... Provides for personal and environmental safety in accordance with hospital and nursing policies and procedures ... Abides by all safety, infection control, and other guidelines as required. ... Routine assessment of the environment for high risks with immediate correction (look for dangerous things and fix them; identify high risk issues and fix them) ... “ During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, “Guidelines for Environmental Infection Control in Health-Care Facilities,” dated 7/2019, the professional reference indicated, “ ... Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations...” 4. During a concurrent interview and record review on 11/12/25 at 1:34 p.m. with the Director of Clinical Operations (DCO), Pt 20’s “History and Physical (H&P)”, dated 11/6/25 at 2:52 p.m., Pt 20’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), and Pt 20’s “electronic health records (EHR)” were reviewed for Pt 20’s admission dated 11/6/25. The “H&P” indicated, Pt 20 had a past medical history of encephalopathy (a disease or damage that affects the brain’s function), seizures, chronic kidney disease with dialysis (artificial machine that filters and removes waste from the blood), congestive heart failure (when the heart backs up with fluid), artificial feeding, and admitted to a swing bed for rehabilitation. The DCO stated that the H&P indicated Pt 20 had been readmitted to the hospital after being seen at another hospital for seizures that occurred during dialysis. DCO stated, Pt 20 had a CT (computed tomography - a medical imaging procedure that creates detailed images of the inside of the body) scan of the head and medication was added to prevent further seizures. DCO stated, there were no notes for follow up of the seizures and new medication by a neurologist. During a concurrent interview and record review on 11/13/25 at 9:50 a.m., with Nurse Practitioner (NP) 1, Pt 20’s H&P, dated 11/6/25 at 2:52 p.m., Pt 20’s “Face sheet” and Pt 20’s “electronic health records” (EHR), were reviewed. NP 1 stated the provider should document the follow-up with Neurology about the new seizures, even though they were being treated. NP 1 stated he knew there was an appointment in a month with the neurology, but it was not documented by the other provider. NP 1 stated the documentation should be accurate in order to communicate to everyone on the team about the care of the patient. During a concurrent interview and record review on 11/13/25 at 10:36 a.m., with Case Manager (CM), Pt 20’s H&P, dated 11/6/25 at 2:52 p.m., Pt 20’s “Face sheet” and Pt 20’s “electronic health records” (EHR), were reviewed. CM stated, Pt 20 had been readmitted after having seizures and was aware of the need for follow-up care. CM stated the order from the provider needed to be in the chart and communicated to everyone on the team. During an interview with the CEO, with the DON present, on 11/14/25 at 1:30 p.m., the CEO stated that we should make sure that staff document what follow ups were needed for the patient and ensure the patients were receiving quality of care. CEO stated the staff needed to follow the policies about documenting and following up on the care of the patient. During a review of the hospital P&P titled, “Discharge Planning and Transfers”, dated 5/1/2020, the P&P indicated, “ ... PURPOSE: To ensure a plan is in place to meet the patient’s continuing healthcare needs post-hospitalization. ... Discharge Planning - A process that involves determining the appropriate post-hospital discharge destination for a patient; identifying what the patient requires for a smooth and safe transition from the hospital to his/her discharge destination; and beginning the process of meeting the patient’s identified post-discharge needs ... Each discipline shall assess and reassess needs for after-care as part of the ongoing assessment and reassessment processes. ... Discharge planning needs shall be based on the patient’s plan of care. ... The discharge planning process shall be documented by all disciplines according to the protocols outlined in the hospital’s documentation standards. ...” 5. During a concurrent interview and record review on 11/12/25 at 10:05 a.m. on the medical/surgical unit with the DON, the 11/2025 Crash Cart check list was reviewed. The DON stated day shift boxes for the initials of the nurse checking the crash cart on 11/10/25 and 11/11/25 were blank and therefore were not checked on those dates. The DON stated the crash cart was to be checked once every 24 hours. During an interview on 11/12/25 at 10:10 a.m. with RN 1, RN 1 stated the crash cart was to be checked every 12-hour shift. During an interview on 11/14/25 at 3:50 p.m. with the DON, the DON stated she was mistaken about the crash cart check frequency every 24 hours and the crash cart should be checked every 12-hour shift. During a review of the hospital P&P titled, “CRASH CART - MED/SURGERY DEPARTMENT”, dated 5/1/20, the P&P indicated, “ ... PURPOSE & SCOPE ... To ensure Crash Cart is always stocked and ready for use ... POILICY ... Crash Cart will be checked every 12 hours by licensed personnel ...””

“GRIEVANCES CFR(s): § 485.614(a)(2) Grievances The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization. At a minimum: This Standard is not met as evidenced by: 51620 Based on interview and record review, the hospital failed to have a grievance process that clearly tracked and monitored the progress of resolving grievances submitted by patients and family in accordance with the hospital policy and procedure when there was no system in place to log, track, monitor, and respond, in writing to grievances submitted by patients, families or concerned individuals for five out of five patient grievances sampled (Patient [Pt] 1, Pt 2, Pt 3, Pt 4, Pt 5). These failures had the potential of not ensuring all patients’ the right to prompt resolution of grievances and could negatively affect the quality of care to patients due to not thoroughly investigating quality of care concerns. Findings: During an interview and record review on 11/14/25 at 11:55 a.m. with the Director of Nurses (DON) and the Director of Clinical Operations (DCO), the complaint/grievance log, dated 3/2025 - 10/2025, was reviewed. There was a total of five grievances on the log. The DCO stated that only formal grievances (a written or verbal complaint made by a patient, or someone speaking for them, about something serious that happened in the hospital), were placed on the grievance log and complaints were not being tracked or logged. The DCO stated that the Patient’s Rights poster does not contain the same time-frame as indicated in the facility’s policy and procedure (P&P) titled, “Patient Grievances,” dated 8/25. The DCO stated that grievances should be resolved within seven calendar days of receipt per their policy and the poster indicated 15 days. The DCO stated on the Patient’s Rights handout provided to patients the time-frame is blank; the name, address and phone number of the hospital is blank; and the local phone number and address of CDPH is blank. During a review of five grievances, the DCO stated no one is following up on the grievances and there have been no resolution letters (a written response that the hospital gives to a patient (or their representative) after the patient has made a formal complaint or grievance; hospitals are required by law to respond to grievances in writing) sent out. The DON verified there were no resolution letters sent as a response to the grievances. The DCO stated that she should have followed up on the grievances as it was important for the one lodging the complaint to have a response and not providing a response was not following their policy. During a review of the Patient Grievances, P&P, the policy indicated, “ ... All grievances should be resolved within seven (7) calendar days of receipt ... The written response must include the name and title of the [hospital name] contact person, summary of the actions taken to investigate the concern, findings and results of the investigation, date of completion or anticipated resolution date ...”. The DCO stated that they do not report complaints or grievances up to the Quality Assessment and Performance Improvement committee (a group in the hospital that works to make sure patients get the best care possible. They look at how the hospital is doing and find ways to make it better) and because they do not follow-up on grievances, the DCO stated no trends are noted. The DON stated that they do not provide education to staff on Patient’s Rights, which includes exercising the rights to file a grievance. During a professional reference review of Managing patient complaints and grievances, dated 2016, the article indicated, “ ... Patients have the right to file complaints and grievances when dissatisfied with care and that healthcare organizations are obligated to respond in a timely and structured manner. Unresolved grievances are linked to: clinical complications, an increased risk of malpractice litigation, and missed opportunities for quality improvement ... ... with online reviews and social medial platforms, it is important to be transparent and failure to address grievances can damage public trust and institutional credibility ...”.”

“EXERCISE OF RIGHTS CFR(s): The patient or their representative (as allowed under state law) has the right to make informed decisions regarding their care. The patient’s rights include being informed of their 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: 45929 Based on interview and record review, the hospital failed to promote a patient’s right to request or refuse treatment when Patient (Pt) 9’s “Conditions for Admission/Consent for Treatment (COA, a document confirming understanding of treatment plan, authorizing the hospital to treat the patient and signed by the patient/patient representative)” was not completed by Pt 9’s representative, physician, and appropriate staff from admission on 10/14/25 until discharge on 11/13/25. This failure resulted in restriction of Pt 9’s right to execute consent to or refusal of treatment. Findings: During a review of Pt 9’s H&P, dated 10/14/25, the H&P indicated Pt 9 came to the hospital with the complaint of left sided chest discomfort, had a history of methamphetamine (powerful synthetic stimulant drug) dependence, uncontrolled diabetes (chronic disease where the body does not produce or cannot effectively use the hormone insulin, leading to high blood glucose levels), chronic kidney disease (a long-term condition where the kidneys lose their function of filtering the blood). The H&P indicated Pt 9 was admitted for sepsis (a life-threatening medical emergency where the body has an overwhelming response to an infection, leading to widespread inflammation and organ damage) and acute myocardial infarction (MI, heart attack). During a review of Pt 9’s Face Sheet (FS, a document providing demographics of the patient, name, date of birth, admission date, chief complaint), dated 10/17/25, the FS indicated, “ ... Notify in Case of Emergency ...” which list Pt 9’s daughter and her phone number. During a review of Pt 9’s “Progress Note (PN)”, dated 11/12/25, the PN indicated Pt 9 has episodes of agitation and intermittent verbal/physical abuse to staff on 10/21/25, 10/22/25 and 10/28/25, indicating haloperidol (an antipsychotic medication used to treat a variety of illnesses and agitation) was ordered o 10/21/25 and 10/28/25. The PN indicated on 11/7/25, “ ... patient continues stable pending placement [to a skilled nursing facility or shelter] ...”. During a concurrent interview and record review on 11/12/25 at 2:25 p.m. with the Director of Nursing (DON), Pt 9’s electronic medical record (EMR). The EMR indicated Pt 9 was admitted to the hospital on 10/14/25. The DON stated she could not locate Pt 9’s COA and would contact Medical Records Department to attempt to locate. During an interview on 11/13/25 at 10:00 a.m. with the DON, the DON stated Medical Records reported finding Pt 9’s COA on 11/13/25, but it had not been scanned into the EMR. During a concurrent interview and record review on 11/13/25 at 10:10 a.m. with the DON, Pt 9’s COA was reviewed. The DON stated the COA was signed by Pt 9 on 11/13/25 at 7:30 a.m. and Pt 9 was discharged this morning. During an interview on 11/14/25 at 1:34 p.m. with the DON, the DON stated the COA should be signed prior to any treatment except in an emergency. The DON stated the COA should be signed as soon as possible or the next of kin should be contacted to sign. The DON stated signing the COA should not take a month. During a review of the hospital policy & procedure (P&P) titled, “REGISTRATION FORMS AND SIGNATURES”, dated 5/1/20, the P&P indicated, “ ... PURPOSE & SCOPE ... ensure compliance with State and Federal regulations regarding patient notification of ... Conditions of Admissions ...upon registration for both Inpatient and Outpatient services/procedures ... POLICY ... each time a patient registers for outpatient or inpatient services regardless of what service or procedure that a Conditions of Admission (COA) document be signed ... PROCEDURE ... 2. Every patient who is admitted to [hospital name] must sign a Conditions of Admission form granting consent for hospital services prior to medical treatment except in the event of an emergency ... b. Every patient has a legal right to decide upon the medical treatment he/she is to be given. c. In the event that the patient’s medical/mental condition does not allow the patient to sign the patient’s legal representative may sign. d. If the patient cannot sign the Conditions of Admissions, and does not have a legal representative, the staff member registering the patient should write ‘patient unable to sign due to ___________” on the signature line. The condition which prohibits obtaining the signature will be inserted into the underlined space. The Registrar must witness and date the appropriate space, and attached a label [example provided] ... The label alerts the physician that he/she needs to document that immediate treatment is necessary. If the patient is capable of providing oral consent, the oral consent will be documented and witnessed by two hospital employees ...”.”

“ORGANIZATIONAL STRUCTURE CFR(s): Organizational Structure This Condition is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to meet the requirements at CFR 485.627, Organizational Structure, when: 1.a. The GB was aware of the hospital practice of patients being admitted by allied health professionals (NPs and PAs) without the oversight of physicians with admitting privileges and not in accordance with hospital policies; b. The GB did not ensure Bylaws were kept current and revised in accordance with Medical Staff and GB bylaws; c. The GB reappointment of physicians and AHPs was not in accordance with medical staff bylaws. (Refer to C-0962, finding 1a. and 1b and 1c and C-1014) Because of the serious actual harm to Pt 1 and the serious potential harm to all inpatients due to not developing, implementing, and following policies and procedures to ensure an appropriately qualified and privileged physician, nurse practitioner or physician assistant was on-call and available to come into the hospital to address a patient change of condition in accordance with their bylaws, rules and regulationss and contracts, to ensure all patients who are being admitted to the hospital have an accepting physician who assessed the appropriateness of the admission considering the needs of the patient and the services provided by the hospital, and to ensure all patients admitted to the hospital are under the care of a physician, an immediate jeopardy (IJ) situation was called under under CFR 485.635(a)(3), C1014, on 3/20/25 at 1:35 p.m. with the Administrator (ADM), Director of Nursing (DON), Director of Quality (QD), Emergency Department Manager (EDM), Medical Director (MD 1), Director of Medical Staff and Medical Records (DMSMR), and Director of Clinical Operations (DCO). The IJ template was provided to the hospital. The hospital submitted an IJ Plan of Removal (Version One) on 3/21/25 at 3:48 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 3/25/25 at 8:08 p.m., it was reviewed and accepted at 8:46 p.m. by email. On 3/26/25 and 3/27/25 the team validated arrangements had been made to ensure a qualified physician was available onsite 24 hours a day, seven days a week to address a patient change of condition, that a process was in place for physician review of potential patient admissions to evaluate appropriateness of the admission considering the needs of the patient and the services the hospital provides, that a process was in place to ensure the medical records were periodically reviewed and signed by a physician and current medical record review verified a medical plan of care had been documented and approved by a physician. On 3/27/25 at 4:35 p.m. the IJ was removed with the DON, QD, EDM, DMSMR, DCO and Respiratory Care Manager in attendance. Following removal of the IJ, the hospital remained in condition level non-compliance. 2. Hospital services provided through contracts/agreements were not assessed to ensure the needs of the patient and/or hospital were met, services were not evaluated for compliance with terms of the contract or hospital policy. The terms of the contracts were not reviewed to ensure compliance with Medical Staff Bylaws and Rules and Regulations. (Refer to C-0962 finding 2) The cumulative effect of these systemic failures resulted in the hospital’s inability to provide quality healthcare in a safe setting.”

“STAFFING AND STAFF RESPONSIBILITIES CFR(s): §485.631 Condition of Participation: Staffing and Staff Responsibilities This Condition is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to meet the requirements at CFR 485.631, provisions for Staff and Staffing Responsibilities, when: 1. Physicians did not periodically review and sign patient records for seven of seven patients, Patients 1, 5, 6, 7, 8, 9 and 10. The hospital failed to have a system to ensure physicians periodically reviewed and signed records for inpatients cared for by physician assistants or nurse practitioners. (Refer to C-0986) 2. A physician was not notified of patients admitted to the hospital by a nurse practitioner or physician assistant for seven of seven patients, (Patients 1, 5, 6, 7, 8, 9 and 10). The hospital did not have a system in place to ensure patients admitted to the hospital was under the care of a physician privileged to admit and manage inpatients in accordance with Medical Staff Bylaws, Rules and Regulations. (Refer to C-0998) 3. The medical director failed to evaluate the performance of the nurse practitioners (NP) responsible for on-call coverage of the medical-surgical/swing bed patients, and failed to ensure the physician assistant (PA) had the credentials and was proctored for the privileges granted. The hospital failed to ensure the evaluation method was appropriate for the evaluation of Allied Health Professionals (AHP- PA and NP). (Refer to C-0999) The cumulative effect of these systemic failures resulted in the hospital’s inability to ensure quality healthcare in a safe setting.”

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure the requirements for CFR 485.635 Provision of Services were met when: 1. The hospital did not develop, implement, and/or follow policies and procedures to have an appropriately qualified and privileged physician, nurse practitioner or physician assistant on-call and available to come into the hospital to address a patient change of condition in accordance with their bylaws, rules and regulations and contracts. Instead, patients were discharged to the Emergency Department (ED) from the inpatient/swing bed for the ED physician to evaluate the patient. The ED physician was not privileged to admit or manage inpatients, and the ED privileges exclude the privilege to treat long term care patients such as swing bed patients. The hospital did not follow their policies for hospital admission, physician assessment of patients, and physician documentation. Patient (Pt) 1 was admitted to the hospital which did not provide the services, either in hospital or contracted, recommended by the transferring physician and/or needed to address the patient’s known chronic conditions. Pt 1 did not receive inpatient care directed by a physician in accordance with the needs of the patient, professional standards of practice and medical staff bylaws. These failures resulted in the urgent transfer of Pt 1 to other hospitals for anticipated procedures such as paracentesis and thoracentesis; and failure to have care directed by a physician contributed to the Pt 1’s death. (Refer to C-1014) Because of the serious actual harm to Pt 1 and the serious potential harm to all inpatients due to not developing, implementing, and following policies and procedures to ensure an appropriately qualified and privileged physician, nurse practitioner or physician assistant was on-call and available to come into the hospital to address a patient change of condition in accordance with their bylaws, rules and regulations and contracts, to ensure all patients who are being admitted to the hospital have an accepting physician who assessed the appropriateness of the admission considering the needs of the patient and the services provided by the hospital, and to ensure all patients admitted to the hospital are under the care of a physician, an immediate jeopardy (IJ) situation was called under under CFR 485.635(a)(3), C1014, on 3/20/25 at 1:35 p.m. with the Administrator (ADM), Director of Nursing (DON), Director of Quality (QD), Emergency Department Manager (EDM), Medical Director (MD 1), Director of Medical Staff and Medical Records (DMSMR), and Director of Clinical Operations (DCO). The IJ template was provided to the hospital. The hospital submitted an IJ Plan of Removal (Version One) on 3/21/25 at 3:48 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 3/25/25 at 8:08 p.m., it was reviewed and accepted at 8:46 p.m. by email. On 3/26/25 and 3/27/25 the team validated arrangements had been made to ensure a qualified physician was available onsite 24 hours a day, seven days a week to address a patient change of condition, that a process was in place for physician review of potential patient admissions to evaluate appropriateness of the admission considering the needs of the patient and the services the hospital provides, that a process was in place to ensure the medical records were periodically reviewed and signed by a physician and current medical record review verified a medical plan of care had been documented and approved by a physician. On 3/27/25 at 4:35 p.m. the IJ was removed with the DON, QD, EDM, DMSMR, DCO and Respiratory Care Manager in attendance. Following removal of the IJ, the hospital remained in condition level non-compliance. (refer to C-1014, IJ Statement) 2. The hospital failed to ensure staff implemented policies and procedures (“Medication Administration” and “Medication Errors”) meant to administer drugs and biologicals in a safe manner to avoid medication error for five of five patients (Patients (Pt) 12, Pt 13. Pt 14, Pt 15 and Pt 18). Staff did not inform the prescribing physician and the affected patient of the medication error in accordance with hospital policies and procedures. The hospital failed to conduct a look-back review of each medication error to determine factors that led to the medication error to avoid future occurrence in accordance with professional standards of practice. The hospital did not review the system for storage, handling, dispensation, and administration once aware of the medication errors in order to avoid future occurrence in accordance with professional standards of practice. (Refer to C-1016) 3. The hospital failed to ensure registry (contracted service) registered nurses (RNs) and licensed vocational nurse assigned to care for patients were evaluated for competency for two of four sampled RNs (RN 1 and RN 4) and one of one LVN (LVN 2) when RN 1, RN 2 and LVN 1 were assigned to care for patients in the hospital and the emergency department (ED) and were not evaluated in accordance with the hospital policy and procedure “Registry Evaluation - Emergency Department”. (Refer to C-1046) 4. The hospital failed to follow their policy for “Medication Administration” for one of seven sampled patients (Patient 7) when nurses did not clarify an order of “prn” for a medication used for pain. (Refer to C-1049) 5. The hospital failed to ensure nursing staff developed and kept current a nursing care plan; Licensed Nurses (LNs) did not assess and develop a complete care plan for six of six patients sampled (Patients 5, 6, 7, 8, 9, and 10) in accordance with hospital policy and procedure (P&P) titled, “Patient Plan of Care” and the hospital “Registered Nurse Job Description”. (Refer to C-1050) The cumulative effect of these systemic failures resulted in the hospital’s inability to ensure quality healthcare in a safe setting.”

“QAPI CFR(s): Condition of Participation: Quality Assessment and Performance Improvement Program The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program. The CAH must maintain and demonstrate evidence of the effectiveness of its QAPI program. (a) Definitions. For the purposes of this section- Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. Error means the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems; and Medical error means an error that occurs in the delivery of healthcare services. This Condition is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to have a CAH-wide, data driven Quality Assessment and Performance Improvement (QAPI) Program when: 1. Data regarding computerized tomography (CT) scan usage in the Emergency Department was not collected, monitored and analyzed for frequency of orders in relationship to number of emergency department (ED) visits for the department and by individual physician; and the indications for the scans were not evaluated for appropriateness in accordance with nationally accepted evidence-based guidelines. This resulted in a missed opportunity to identify trends and develop and implement strategies to reduce patient exposure to radiation. (Refer to C-1306, finding 1) 2. Services provided by contracts were not monitored for compliance with contract terms, hospital policy, or bylaws, and were not evaluated to ensure the needs of the patients were being met. This resulted in non-compliance with requirements for physician oversight of care provided to inpatients, and documentation of therapy services provided. (Refer to C-1306, finding 2) 3. Quality indicators were not identified and monitored for Therapy Services (physical therapy, occupational therapy, and speech therapy) provided to inpatients. This resulted in a missed opportunity to identify areas for improvement and/or to demonstrate effectiveness of the therapy program in improving patient’s functional status. (Refer to C-1306, finding 3) 4. Data in high-risk, high-volume and problem-prone areas such as the Emergency Department (ED) and Medical-Surgical units was not used to identify opportunities for improvement and implement changes that will lead to improvement. This failure resulted in a delay in implementing improvement measures that could affect health outcomes and patient safety. (Refer to C-1306, finding 4) The cumulative effect of these systemic failures resulted in the hospital’s inability to ensure quality healthcare in a safe setting.”

“PATIENTS RIGHTS CFR(s): A CAH must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45977 Based on observation, interview and record review, the hospital failed to promote and protect each patient’s rights when: 1. Two of six patients (Patient 5 and Patient 8) did not receive Notice of Patients Rights as a Condition of Admission and hospital policy and procedure. (refer to C-2502) 2. The hospital did not have a system in place to log, track and monitor grievances submitted by patients, families or concerned individuals. (Refer to CA-2505) 3. Nursing staff did not ensure patients were free from restraints and/or released at the soonest opportunity and/or assessed every two hours for one of two patients, Patient 11. (Refer to C-2540) The cumulative effect of these systemic failures resulted in the hospital’s inability to ensure quality healthcare in a safe setting. 51620”

“GOVERNING BODY OR RESPONSIBLE INDIVIDUAL CFR(s): The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH’S total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital’s governing body (GB) failed to take full responsibility for the operation of the hospital when: 1.a. The GB was aware of the hospital practice of patients being admitted by allied health professionals (NPs and PAs) without the oversight of physicians with admitting privileges and not in accordance with hosptial policies; b. The GB did not ensure Bylaws were kept current and revised in accordance with Medical Staff and GB bylaws. c. The GB reappointment of physicians and AHPs was not in accordance with medical staff bylaws. 2. Hospital services provided through contracts/agreements were not assessed to ensure the needs of the patient and/or hospital were met, services were not evaluated for compliance with terms of the contract or hospital policy. The terms of the contracts were not reviewed to ensure compliance with Medical Staff Bylaws and Rules and Regulations. These failures resulted in the hospital’s inability to ensure patient care was provided in a safe environment. Findings: 1.a. During a review of the daily inpatient census reports for 3/11/24- 3/21/24, the reports indicated each day there were between sixteen and eighteen inpatients on the med-surg/swing bed unit. The report indicated the physician (a medical doctor [M.D.] or Doctor of Osteopathic Medicine [D.O] issued a license to practice medicine) for each patient was not a physician but rather a physician assistant (PA) or a nurse practitioner (NP). During an interview on 3/26/25 at 11:05 a.m. with Physician Assistant (PA) 1, PA 1 stated the inpatients were admitted by a PA or NP. During a review of Hospital A’s Medical Staff Bylaws, revised 4/18/23, Page 2 of the Bylaws indicated, “AHPs are not eligible for Medical Staff Membership.” Section 5.4-1 Admitting Privileges- The following categories of licensees are eligible to independently admit patients to the hospital: Physicians (MDs or DOs). Additionally, AHPs with admitting privileges may admit patients upon order of a member of the Medical Staff who has admitting privileges and who maintains responsibility for the overall care of the patient.” (Cross reference C-998) b. During a concurrent interview and record review on 3/14/25 at 2:35 p.m. with the DMSMR, the Medical Staff Bylaws (Bylaws) dated 4/18/25, were reviewed. The DMSMR stated this is the most recent version of the Bylaws. The Bylaws had an approval page dated 4/18/23 with signatures of the Chief Executive Officer (CEO), the Medical Director, and Governing Board member indicating Governing Board of [Hospital A] approval. The first page of the Bylaws indicated “Revised May 2023.” Following Page 4, there was a three page Table of Contents which indicated “Bylaws ...Revised 5/1/20,” and following that there were six different Page 7s, which indicated, “Bylaws ...Revised 5/2022,” followed by Page 12 which indicated “Bylaws ...Revised 5/1/20. The last section of the Bylaws “Adoption and Amendment of Bylaws,” indicated, “The Medical Staff Bylaws may be adopted, amended, or repealed by the following combined actions: The affirmative vote of the majority of the medical staff members by secret ballot, provided at least fourteen days advance written notice accompanied by the proposed Bylaws and/or alterations, has been given; and the approval of the Governing Body ...” The DMSMR stated the Bylaws should reflect the same date of revision which should coincide with the governing body approval. The DMSMR stated the governing body approval would be captured in the meeting minutes, however the DMSMR stated there had not been a medical staff vote as described in the Bylaws for any revisions or amendments. c. During a concurrent interview and record review on 3/14/25 at 2:45 p.m. with the DMSMR, MD 3’s credential file was reviewed. The DMSMR stated MD 3 was appointed to the medical staff in 2020 and was reappointed in 2023. The DMSMR stated the medical staff and allied health professional staff are reappointed every three years. The DMSMR stated the [Hospital A] changed the reappointment from every two years to every three years a couple years ago. The DMSMR stated she thought the frequency of reappointment of the Medical Staff and AHP staff was changed from every two years to every three years in the latest revision of the Bylaws dated 4/18/23. The DMSMR was unable to find any reference to the frequency of reappointment of the medical staff in the Bylaws. Review of Article 4. Titled “Appointment and Reappointment,” indicated, “4.2 Overview of the Process-The following chart depicts the basic steps of the appointment, reappointment, and temporary privileges processes. Details of each step are described in the Rules 2.2-2.9 [refers to the Medical Staff Rules and Regulations].” During a concurrent interview and record review on 3/18/25 at 3:15 p.m., with the DMSMR, the Medical Staff Rules and Regulations (R&R), dated 5/1/20, indicated, “RULE 2 Appointment and Reappointment ...Rule 2.8 Duration of Appointment ...2.8-2 Reappointment of any staff category other than Provisional [which is a twelve month period] shall be for a maximum period of two years ...” The DMSMR stated the R&R did not reflect a change from two to three years for the reappointment period. During a concurrent interview and record review on 3/18/25 at 3:20 p.m., with the DMSMR, the Medical Staff Bylaws (Bylaws) dated 4/18/23, were reviewed. The Bylaws indicated, “ ...Article 6 Allied Health Professionals [AHP] ...6.1 AHPs are not eligible for Medical Staff membership. They may be granted practice privileges ...6.3-2 An AHP must apply and qualify for practice privileges ... Applications for initial granting of practice privileges and biennial [every two years] renewal thereof shall be submitted and processed in a similar manner to that provided to practitioners [any currently licensed physician, dentist, clinical psychologist, or podiatrist (Bylaws definition)] ...” The DMSMR stated she thought the renewal period had been changed from two years to three years in this most recent version of the Bylaws. During a concurrent interview and record review on 3/18/25 at 3:25 p.m., with the DMSMR, the Medical Staff Rules and Regulations (R&R), dated 5/1/20, indicated, “ ...RULE 7 Credentialing of Allied Health Professionals-[AHP] ...RULE 7-3 All new Allied Health Professionals shall be subject to a one-year period of formal proctoring. Upon successful completion of the proctoring period, the credentials of each AHP practicing in the hospital shall be reviewed at least every two years ...” The DMSMR confirmed the R&R indicated the two year review period for AHPs had not been changed to three years. 2. During a concurrent interview and record review on 3/19/24 at 3:55 p.m. with the Director of Nursing (DON), Pt 1’s electronic medical record dated 10/29/24- 12/16/24 was reviewed. Review of the Interdisciplinary Team (IDT) meeting notes dated 10/30/24 were reviewed. The meeting notes indicated the Physician Assistant (PA), the charge nurse, DON, activities coordinator, and the respiratory therapist were present. The meeting notes included the respiratory status and oxygen needs, the activity plans, nursing input regarding wounds, wandering risk, the medications list, and patient’s discharge goal of going home to his family. The section in the notes for the Therapy Plan and goals from physical therapy (PT), occupational therapy (OT), and speech therapy (ST) was blank. During a concurrent interview and record review on 3/19/24 at 4 p.m. with the DON, the IDT meeting notes dated 12/10/24 were reviewed. The notes indicated the PA, the case manager, and the respiratory therapist were present. The meeting notes included patient’s discharge goal and referral needs, respiratory care needs, nutrition assessment and plan, wound care, participation in activities, and the medication list. The section of the notes for the Therapy Plan and progress was blank. The DON stated he has asked the lead physical therapist to update the IDT notes for the meetings. The DON attempted to find the PT/OT notes in the medical record. The record indicated there were PT and OT orders for the duration of Pt 1’s hospital stay. The DON contacted medical records for assistance. The DON stated therapy drives the swing bed program and it is important to have the therapy plan and notes accessible to the patient care team, including the PA, NP, and physician staff, and no one has access to the PT/OT records. The DON stated this has been an ongoing problem and several other people have spoken to the lead PT about this, and nothing has changed. The DON stated the Director of Quality, and the Chief Executive Officer (CEO) are aware of this ongoing issue. During an interview on 3/19/24 at 4:10 p.m. with the Director of Medical Staff and Medical Records (DMSMR), the DMSMR stated therapy was a contracted service and the therapists are documenting the PT/OT services in their own system that does not interface with the one used at [Hospital A]. The DMSMR stated the therapists can either print their notes each time and provide them to the medical records department to be scanned into the patient’s hospital record or they can give the medical records staff access to their system. The DMSMR stated since Pt 1 was discharged on 12/16/24, this was a closed record and any paper documents from Pt 1’s hospital stays would have already been scanned into this record. The DMSMR stated the therapy notes not being in the patient’s medical record is not just a problem for the patient care team, it is a significant issue in terms of the legal medical record being incomplete, especially if a record had been requested and provided without being complete. During an interview on 3/26/25 at 11:05 a.m. with Physician Assistant (PA) 1, PA 1 stated he was not able to check on the progress of any of the rehabilitation services by reviewing the electronic health record. PA 1 stated, he has to request the records, and the department will drop them off for him to review. PA stated, they are supposed to be fixing the issue to allow their software to connect with the electronic record. Review of the document titled, “Therapy Services Agreement,” dated 1/26/21, indicated, “Provider is a therapy company licensed to provide physical, speech, and/or occupational therapy services in the State of California and qualified to provide services to Facility [Hospital A] and Facility residents. Facility is licensed to provide skilled nursing and/or long term care services ...1. DUTIES AND OBLIGATIONS OF PROVIDER ...1.1 Provider shall provide, or cause to be provided by duly licensed therapists, physical, speech, and/or occupational therapy services to residents of Facility pursuant to the order of a duly licensed physician. Provider shall also assist Facility in devising and implementing policies and procedures for such therapy, in devising care plans and discharge plans and in coordinating and supervising and evaluating the need for such therapy services. Services will be performed in accordance with a treatment plan either established by the physician responsible for the patient’s care with input from the therapist, or by the therapist in consult with the physician ...1.2 Facility’s sole interest and responsibility shall be to assure that such services are rendered in a competent, efficient, and satisfactory manner ...1.3 Documentation- In accordance with Facility’s policies and procedures, therapist shall document in the resident’s medical record all services rendered to residents in a timely, accurate, and legible manner. All resident medical records are and shall remain the property of the Facility ...” During a concurrent interview and record review on 3/14/25 at 11:45 a.m. with the Director of Medical Staff Services and Medical Records (DMSMR), Hospital A’s list of Medical Staff members (physicians) and Allied Health Professional staff (AHP- Physician Assistant [PA], Nurse Practitioner [NP]) indicated there was one physician assistant (PA 1) with internal medicine privileges, and eight nurse practitioners with internal medicine privileges. The DMSMR stated six of the eight NPs with internal medicine privileges do not work in person at Hospital A but are scheduled at night on call for the inpatient unit. The DMSMR stated there were no physicians with internal medicine privileges on Hospital A’s list of medical staff members. Review of the monthly Hospitalist (a clinician whose primary focus is the general medical care of hospitalized patients) schedules for January 2025, February 2025, and March 2025 for the inpatient unit (med-surg and swing bed) indicated there was a physician’s assistant or a nurse practitioner onsite every day for twelve hours and at night there was a nurse practitioner on call. The DMSMR stated the six NPs who cover the night shift on-call are not available to come in since they are hours away from Hospital A. The DMSMR stated there were no physicians on the Hospitalist schedule for day shift or for on-call coverage during the night, and no on-call physician, NP, or PA available to come into the hospital within 35 minutes of notification. During a concurrent interview and record review on 3/14/24 at 4 p.m. with the DMSMR, MD 1’s credential file was reviewed. The DMSMR stated MD 1 was an emergency medicine physician and was also the Hospitalist Medical Director. (MD 1) and the supervising physician for the PA and NPs who were onsite and on-call for the med-surg/swing bed patients. Review of MD 1’s credential file indicated MD 1 applied for and was granted privileges in Emergency Medicine, and was appointed to the Medical Staff on 1/5/23. The Emergency Medicine privilege request form was reviewed and indicated, “ ...Privileges do not include long-term care of patients on an inpatient basis, or admitting ...” The DMSMR confirmed this was the current form and stated she was not aware of that statement on the form. The DMSMR stated the ED physicians privileges do not include admission and management of patients (for acute care or swing bed) on the inpatient unit, those privileges were Internal Medicine privileges. The DMSMR stated MD 1 did not have Internal Medicine privileges. During a concurrent interview and record review on 3/24/25 at 12:05 p.m. with the Director of Medical Staff and Medical Records (DMSMR), MD 1’s contract titled “Professional Physician Independent Contractor Agreement,” dated 7/1/23, was reviewed. The contract indicated, “ ...PHYSICIAN OBLIGATIONS. 1.1 Professional Services. Physician shall provide professional hospitalist physician services to patients including acute, swing, and skilled nursing facility patients within the hospital [Hospital A]. (a) Physician shall be available to provide hospitalist patient care to hospital patients during independent scheduled 12-hour day shifts. Physician shall also be responsible for 12-hour nights on-call following the scheduled day shift ...(c) Hospitalist Medical Director (MD 1) shall perform on-site rounds with Hospitalist Mid-Level Providers (NP or PA) 1-2 days per week and be available to hospitalist midlevels for telephone calls and any time through the week. Hospitalist Medical Director will provide oversight and management of the clinical aspects of acute/swing bed hospitalist program at [Hospital A]. responsibilities include but may not be limited to: Supervision, Education & Evaluation of midlevel provider clinical activities ...Review and update policies and procedures as appropriate ...” The DMSMR stated MD 1 does not schedule twelve hour days shifts as a hospitalist, and he is not on the on-call Hospitalist schedule. During a concurrent interview and record review on 3/24/25 at 12:15 p.m. with the Director of Medical Staff and Medical Records (DMSMR), the “Hospitalist Services Agreement, dated 12/1/20, indicated, “ ...Hospital Program Coverage- Providers will remain in communication with Hospital [A] staff and be available to return to Hospital [A] within 35 minutes of receiving notification to do so ...” During a concurrent interview and record review on 3/24/25 at 12:30 p.m., with the Chief Executive Officer (CEO), the Hospitalist Medical Director agreement terms were discussed. Reviewed discrepancies between the agreement, the policies, and the current practice as it relates to medical record documentation of patient rounds, scheduling day shifts working as a hospitalist or nights on call, swing bed admit orders and treatment plan not signed by the physician. The CEO stated the contract will be revised. During a record review on 3/27/25, the Medical Director monthly invoice/timesheet for 1/25 and 2/25, indicated the dates of the patient rounds performed, which were paid a set amount for each occurrence per the contract, and also indicated a flat monthly amount to be paid which was the maximum amount allowed per the contract. There were no duties listed as performed each month for the compensation, other than the separately paid patient rounds. Review of the policy and procedure (P&P) titled,” Swing Bed Medical Staff Assessment,” dated 4/18/23, indicated, “ ...POLICY: The physician documentation will be timely and provide information to the interdisciplinary team to assist in developing and implementing a comprehensive plan of care for the patient. PROCEDURE: B. Physician’s orders on admission must include orders for medications and treatments. All orders from an acute care admission are discontinued, and new orders written for Swing Bed ...C. The physician will visit the patient twice per week and document in the progress notes ...D. Progress notes will document visits. Content of the progress notes should include: 1. Evaluation of progress 2. Care Objectives 3. Anticipated length of stay ...” Review of the P&P titled, “Swing Bed Admission Criteria,” effective date 3/2022, reviewed 2/2024, the P&P indicated, “ ...PROCEDURE: A. Admission Criteria a. The patient must have a need for post hospital extended care services requiring the skills of technical or professional personnel to furnish or supervise activities on a daily basis that facilitate recovery and stability or when a patient continues to need skilled healthcare services for a condition for which the patient was admitted to inpatient acute care or for a condition which arose while receiving inpatient care or specialized rehabilitative services ... c. Services must be needed daily ... f. Services are ordered by a physician and related to an active written treatment plan signed by the physician ...k. Once a patient reaches their maximum functional potential, discharge is expected ...” During a concurrent interview and record review on 3/24/25 at 2:40 p.m. with the DMSMR, MD 5’s credential file was reviewed. The file indicated MD 5 applied for and was granted Emergency Medicine privileges and appointed to the medical staff on 1/14/22. The DMSMR stated MD 5 is also the Medical Director of Respiratory Care and the Emergency Department stated the work history available in MD 5’s file did not show previous experience as the medical director of respiratory care services. During a record review on 3/24/25, the document titled, “EMERGENCY DEPARTMENT INDEPENDENT CONTRACTOR AGREEMENT,” dated 12/1/22, indicated, “ ...1.1 Professional Services. Physician [MD 5] is duly licensed and authorized to practice medicine under the laws of the State of California and specializes in the practice of emergency medicine. Physician shall provide services to patients in Hospital’s [Hospital A’s] emergency department [ED], and provide rapid response and code response services for any inpatient/medical-surgical patients. Rapid and code response services provided during Physician’s scheduled ED shifts. 1.2 Director of Emergency Department and Respiratory Department: Department quality management, compliance and survey activities, and policy and procedure development ...” The agreement did not include any qualifications specific to the medical director role for respiratory care services, or specific duties to be carried out by the medical director of respiratory care services. Information was requested from the hospital and was provided on 3/27/25. During a concurrent interview and record review on 3/26/25 at 3 p.m. with the Lead Respiratory Therapist (LRT), the LRT stated her responsibilities included working as a respiratory therapist covering the inpatient unit and the ED, and supervisory duties such as writing the monthly RT schedules, reviewing and updating policies and procedures, educating nurses on trach care, coordinating completion of the annual RT staff competencies, and annual RT evaluations. The LRT stated for the initial and annual competencies, she signed off the other RTs, and one of those RTs signed her off. The LRT stated she completed the annual evaluations for the RTs. The LRT stated she reported to the Chief Executive Officer (CEO) and he completed the LRT’s annual evaluations. The LRT was asked in what situations had she contacted the Medical Director of Respiratory Care (MD 5) in the past two years. The LRT could not provide an example of any clinical practice issues discussed, or staff meetings held. The LRT stated the only time she could remember contacting MD 5 was when RT staff wanted to schedule vacation time and that left one week of the monthly schedule without coverage. The LRT stated since MD 5 was an ED physician and the ED would be most affected by the lack of RT support, she asked MD 5 for assistance to cover those vacation days. The LRT stated MD 5 was able to get staff from another hospital to cover the week. During a record review on 3/27/25, the document titled, “Medical Director of Respiratory Therapy Duties,” indicated the duties to be performed by the medical director included, “ ...Oversee the Respiratory Therapy department to ensure high standards of care, regulatory compliance, and patient safety in accordance with California state and federal regulations. Act as a key point of contact for respiratory therapy-related issues, including ventilator management, respiratory assessments, airway management, and related interventions ...Provide oversight and input into the performance reviews of respiratory therapy staff, including feedback on training, development, and professional growth ... Assist with training and mentoring respiratory therapists, ensuring that staff maintain knowledge in line with hospital policies ...Ensure compliance with federal and state regulations, including those related to patient rights, documentation standards, and licensing requirements. Collaborate with the hospital’s Quality Improvement and department managers to monitor adherence to clinical protocols and maintain quality standards across respiratory care services ... Facilitate and attend respiratory therapy department meetings, including staff meetings, quality reviews, and continuing education sessions ...” During a record review on 3/27/25, the Medical Director (ED and Respiratory Care) monthly timesheet/invoice for 1/25 and 2/25, indicated the total amount paid for each month was the maximum amount allowed each month. The timesheet/invoice did not indicate what duties, if any, were performed by the medical director for the compensation paid. Review of the Bylaws of the Governing Board of [Hospital A], dated 1/23/20, indicated, “ ...Purpose and Activities- The Governing Board may engage in any lawful activity, including but not limited to, operating the health care facilities of [Hospital A], including all related departments and activities associated therewith. These activities shall include, but are not limited to : (a) approve hospital policies and procedures, (b) operate a quality assessment/performance improvement (QAPI) program, (c) approve the Medical Staff Bylaws and other Medical Staff Rules and Regulations, (d) ensure the medical staff requirements of the hospital are met and, (e) appoint members of the medical staff after considering the recommendations of the existing members of the medical staff ...””

“PATIENT CARE SERVICES CFR(s): [The doctor of medicine or osteopathy-] (iv) Periodically reviews and signs the records of all inpatients cared for by nurse practitioners, clinical nurse specialists, or physician assistants. (v) Periodically reviews and signs a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants only to the extent required under State law where State law requires record reviews or co signatures, or both, by a collaborating physician. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure physicians periodically reviewed and signed patient records for seven of seven patients, Patients 1, 5, 6, 7, 8, 9 and 10. . The hospital failed to have a system to ensure physicians periodically reviewed and signed records for inpatients cared for by physician assistants or nurse practitioners. These failures resulted in not providing the benefit of physician oversight of the care of patients and had the potential to lead to negative health outcomes. Findings: During a concurrent interview and record review on 3/12/25 at 10:47 a.m. with the Director of Nursing (DON), Pt 6’s medical record was reviewed. The medical record indicated Pt 6 was a current patient at Hospital A, and was admitted on 2/6/25 to a swing bed for rehabilitation. The DON stated there are no orders or progress notes from a physician. The DON stated only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/12/25 at 10:50 a.m. with the DON, Pt 5’s medical record was reviewed. The record indicated Pt 5 was admitted on 3/11/25. The DON stated there are no orders or progress notes from a physician. The DON stated only the physician assistant and/or nurse practitioners have written orders or progress notes during the hospital admission. During a concurrent interview and record review on 3/12/25 at 11:35 a.m. with the DON, Pt 8’s medical record was reviewed. The record indicated Pt 8 was admitted on 3/11/25. The DON stated there are no orders or progress notes from a physician. The DON stated only the physician assistant and/or nurse practitioners have written orders or progress notes during the hospital admission. During a concurrent interview and record review on 3/12/25 at 2:00 p.m. with the DON, Pt 9’s medical record was reviewed. The record indicated Pt 9 was currently an inpatient at Hospital A and was admitted on 12/20/24 to a swing bed for management of medical conditions. The DON stated there are no orders or progress notes from a physician. The DON stated only the physician assistant and/or nurse practitioners have written orders or progress notes during the hospital admission. During a concurrent interview and record review on 3/12/25 at 2:18 p.m. with the DON, Pt 10’s medical record was reviewed. The record indicated Pt 10 was currently an inpatient at Hospital A and was admitted on 1/10/25 to a swing bed for management of medical conditions. The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders or progress notes during the hospital admission. During a concurrent interview and record review on 3/13/25 at 11:20 a.m. with the DON, Pt 7’s medical record was reviewed. The record indicated Pt 7 was currently an inpatient at Hospital A and was admitted on 2/12/25 to a swing bed and was admitted to treat an infected Stage III sacral decubitus ulcer (wound on buttocks). The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders or progress notes during the hospital admission. During a concurrent interview and record review on 3/19/25 at 3:05 p.m. with the DON, Pt 1’s medical record was reviewed. The record indicated Pt 1 was admitted to a swing bed for rehab and management of medical conditions on 10/28/24 and discharged to the emergency department (ED) on 11/5/24, readmitted on 11/12/24 and discharged to the ED on 11/26/24, and readmitted 11/29/24 and discharged to the ED on 12/16/24 where he died. The DON stated from 10/28/24 until 12/14/24 all orders for admission and during the inpatient stays were written by a physician assistant or nurse practitioner. The DON stated there were no physician notes written during any of Pt 1’s inpatient stays at Hospital A. The only physician notes in the medical record were from the ED visits. During an interview on 3/24/25 at 11:50 a.m. with the Director of Medical Staff and Medical Records (DMSMR), the DMSMR stated staff in the medical records department do audit the medical records for the presence of documents such as admission history and physical, orders, and progress notes but they do not check the content within the documents or whether they were written by a physician. The DMSMR stated audits did not include checking for evidence a physician had reviewed and signed the medical records. The DMSMR stated she was not aware of the requirement. Review of the policy and procedure (P&P) titled,” Swing Bed Medical Staff Assessment,” dated 4/18/23, indicated, “ ...POLICY: The physician documentation will be timely and provide information to the interdisciplinary team to assist in developing and implementing a comprehensive plan of care for the patient. PROCEDURE: B. Physician’s orders on admission must include orders for medications and treatments. All orders from an acute care admission are discontinued, and new orders written for Swing Bed ...C. The physician will visit the patient twice per week and document in the progress notes ...D. Progress notes will document visits. Content of the progress notes should include: 1. Evaluation of progress 2. Care Objectives 3. Anticipated length of stay ...” Review of the P&P titled, “Swing Bed Admission Criteria,” effective date 3/2022, reviewed 2/2024, the P&P indicated, “ ...PROCEDURE: A. Admission Criteria a. The patient must have a need for post hospital extended care services requiring the skills of technical or professional personnel to furnish or supervise activities on a daily basis that facilitate recovery and stability or when a patient continues to need skilled healthcare services for a condition for which the patient was admitted to inpatient acute care or for a condition which arose while receiving inpatient care or specialized rehabilitative services ... c. Services must be needed daily ... f. Services are ordered by a physician and related to an active written treatment plan signed by the physician ...k. Once a patient reaches their maximum functional potential, discharge is expected ...””

“PA, NP, & CLINICAL SPEC RESPONSIBILITIES CFR(s): Whenever a patient is admitted to the CAH by a nurse practitioner, physician assistant, or clinical nurse specialist, a doctor of medicine or osteopathy on the staff of the CAH is notified of the admission. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure a physician was notified of patients admitted to the hospital by a nurse practitioner or physician assistant for seven of seven patients, (Patients 1, 5, 6, 7, 8, 9 and 10). The hospital did not have a system in place to ensure patients admitted to the hospital was under the care of a physician privileged to admit and manage inpatients in accordance with Medical Staff Bylaws, Rules and Regulations. These failures resulted in all patients admitted to the hospital not having the benefit of physician oversight and responsibility of care and could lead to negative health outcomes. Findings: During a review of the daily inpatient census reports for 3/11/24- 3/21/24, the reports indicated each day there were between sixteen and eighteen inpatients on the med-surg/swing bed unit. The report indicated the physician (a medical doctor [M.D.] or Doctor of Osteopathic Medicine [D.O] issued a license to practice medicine) for each patient was not a physician but rather a physician assistant (PA) or a nurse practitioner (NP). During a review of Hospital A’s Medical Staff Bylaws, revised 4/18/23, Page 2 of the Bylaws indicated, “AHPs are not eligible for Medical Staff Membership.” Section 5.4-1 Admitting Privileges- The following categories of licensees are eligible to independently admit patients to the hospital: Physicians (MDs or DOs). Additionally, AHPs with admitting privileges may admit patients upon order of a member of the Medical Staff who has admitting privileges and who maintains responsibility for the overall care of the patient.” During a concurrent interview and record review on 3/12/25 at 10:47 a.m. with the Director of Nursing (DON), Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 2/6/25 at 9:31 a.m., Pt 6’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), and Pt 6’s “electronic health records” (EHR), were reviewed for Pt 6’s admission dated 2/6/2025. The “H&P” indicated Pt 6 had a past medical history of high blood pressure, atrial fibrillation (an irregular heartbeat), chronic kidney disease, congestive heart failure (when the heart backs up with fluid), and admitted to a swing bed for rehabilitation. The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/12/25 at 10:50 a.m. with the DON, Pt 5’s “History & Physical”, dated 3/11/25 at 10:50 a.m., Pt 5’s “Face sheet”, and Pt 5’s “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 3/11/2025. The “H&P” indicated Pt 5 had a past medical history of seizures, high blood pressure and chief complaint of aspiration pneumonia (lung infection that occurs when a foreign substance is inhaled into the lungs). The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/12/25 at 11:35 a.m. with the DON, Pt 8’s “History & Physical”, dated 3/12/25 at 9:11 a.m., Pt 8’s “Face sheet”, and Pt 8’s “electronic health records” (EHR), were reviewed for Pt 8’s admission dated 3/11/2025. The “H&P” indicated Pt 8 had a past medical history diabetes mellitus (a disorder where the body does not control the amount of glucose in the blood), high blood pressure, coronary artery disease (were the arteries that supply blood to the heart become narrowed or blocked), chronic kidney disease), and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/12/25 at 2:00 p.m. with the DON, Pt 9’s “History & Physical”, dated 12/18/24 at 9:43 a.m., Pt 9’s “Face sheet”, and Pt 9’s “electronic health records” (EHR), were reviewed for Pt 9’s admission dated 12/20/2024. The “H&P” indicated Pt 9 had a past high blood pressure, coronary artery disease, pneumonia, coronary artery bypass grafting (open heart surgery to increase blood flow to the heart) of 12/3/24, atrial fibrillation, chronic kidney disease, and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/12/25 at 2:18 p.m. with the DON, Pt 10’s “History & Physical”, dated 1/10/25 at 3:57 p.m., Pt 10’s “Face sheet”, and Pt 10’s “electronic health records” (EHR), were reviewed for Pt 10’s admission dated 1/10/2025. The “H&P” indicated Pt 10 had a past medical history of infection related to COVID, dementia, and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/13/25 at 11:20 a.m. with the DON, Pt 7’s “History & Physical”, dated 2/13/25 at 7:00 a.m., Pt 7’s “Face sheet”, and Pt 7’s “electronic health records” (EHR), were reviewed for Pt 7’s admission dated 2/12/2025. The “H&P” indicated Pt 7 had a past medical history of diabetes, obesity, chronic venous ulcers (wounds that form on the legs due to poor blood circulation) left above knee amputation, bedbound, and was admitted to treat an infected Stage III sacral decubitus ulcer (wound on buttocks). The DON stated, there are no orders or progress notes from a physician. The DON stated, only the physician assistant and/or nurse practitioners have written orders during the hospital admission. During a concurrent interview and record review on 3/14/25 at 11:45 a.m. with the Director of Medical Staff Services and Medical Records (DMSMR) Hospital A’s list of Medical Staff members (physicians) and Allied Health Professional staff (AHP- Physician Assistant [PA], Nurse Practitioner [NP]) was reviewed. The list indicated there were thirteen physicians on Hospital A’s medical staff, six physicians with privileges in emergency medicine and seven physicians with teleradiology privileges. The Emergency Medicine privilege request form was reviewed and indicated, “ ...Privileges do not include long-term care of patients on an inpatient basis, or admitting ...” The DMSMR confirmed this was the current form and stated she was not aware of that statement on the form. The DMSMR stated the ED physicians privileges do not include admission and management of patients (for acute care or swing bed) on the inpatient unit. During a concurrent interview and record review on 3/19/25 at 3:05 p.m. with the DON, Pt 1’s medical record was reviewed. The record indicated Pt 1 was admitted to a swing bed for rehab and management of medical conditions on 10/29/24 and discharged to the emergency department (ED) on 11/5/24, readmitted on 11/12/24 and discharged to the ED on 11/26/24, and readmitted 11/29/24 and discharged to the ED on 12/16/24 where he died. The DON stated from 10/29/24 until 12/14/24 all orders for admission and during the inpatient stays were written by a physician assistant or nurse practitioner. The DON stated there were no physician notes written during any of Pt 1’s inpatient stays at Hospital A. The only physician notes in the medical record were from the ED visits. The DON stated requests for swing bed admission to the hospital from another hospital are reviewed by a nurse practitioner offsite and then an email is sent to the DON and the NP or PA on duty at Hospital A informing them of the planned admit. The DON stated the staff at Hospital A are not involved in the process of determining if a patient will be admitted from another hospital. During an interview on 3/20/25 at 2:15 p.m. with Emergency Department Manager (EDM), the EDM stated, only potential patient admissions to the medical-surgical unit for acute care were discussed with the Medical Director (MD 4), not admissions to swing beds. During an interview on 3/26/25 at 11:05 a.m. with Physician Assistant (PA) 1, PA 1 stated the inpatients were admitted by a PA or NP. Review of the policy and procedure (P&P) titled,” Swing Bed Medical Staff Assessment,” dated 4/18/23, indicated, “ ...POLICY: The physician documentation will be timely and provide information to the interdisciplinary team to assist in developing and implementing a comprehensive plan of care for the patient. PROCEDURE: B. Physician’s orders on admission must include orders for medications and treatments. All orders from an acute care admission are discontinued, and new orders written for Swing Bed ...C. The physician will visit the patient twice per week and document in the progress notes ...D. Progress notes will document visits. Content of the progress notes should include: 1. Evaluation of progress 2. Care Objectives 3. Anticipated length of stay ...” Review of the P&P titled, “Swing Bed Admission Criteria,” effective date 3/2022, reviewed 2/2024, the P&P indicated, “ ...PROCEDURE: A. Admission Criteria a. The patient must have a need for post hospital extended care services requiring the skills of technical or professional personnel to furnish or supervise activities on a daily basis that facilitate recovery and stability or when a patient continues to need skilled healthcare services for a condition for which the patient was admitted to inpatient acute care or for a condition which arose while receiving inpatient care or specialized rehabilitative services ... c. Services must be needed daily ... f. Services are ordered by a physician and related to an active written treatment plan signed by the physician ...k. Once a patient reaches their maximum functional potential, discharge is expected ...””

“PERIODIC REVIEW OF CLINICAL PRIVILEGES CFR(s): §485.631(d) Standard: Periodic review of clinical privileges and performance. The CAH requires that- (1) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialist, and physician assistants at the CAH are evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH. (2) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH are evaluated by- (i) One hospital that is a member of the network, when applicable; (ii) One Quality Improvement Organization (QIO) or equivalent entity; (iii) One other appropriate and qualified entity identified in the State rural health care plan; (iv) In the case of distant-site physicians and practitioners providing telemedicine services to the CAH’s patient under an agreement between the CAH and a distant-site hospital, the distant-site hospital; or (v) In the case of distant-site physicians and practitioners providing telemedicine services to the CAH’s patients under a written agreement between the CAH and a distant-site telemedicine entity, one of the entities listed in paragraphs (d)(2)(i) through (iii) of this section. (3) The CAH staff consider the findings of the evaluation and make the necessary changes as specified in paragraphs (b) through (d) of this section. This Standard is not met as evidenced by: 37529 Based on interview and records review, the medical director failed to evaluate the performance of the nurse practitioners (NP) responsible for on-call coverage of the medical-surgical/swing bed patients, and failed to ensure the physician assistant (PA) had the credentials and was proctored for the privileges granted. The hospital failed to ensure the evaluation method was appropriate for the evaluation of Allied Health Professionals (AHP- PA and NP). These failures resulted in the nurse practitioners’ privileges being renewed without having first been evaluated, and the physician assistant being granted privileges for procedures he did not have the documented competency to perform, which had the potential to result in patient harm. Findings: During a concurrent interview and record review on 3/14/25 at 11:45 a.m. with the Director of Medical Staff Services and Medical Records (DMSMR), Hospital A’s list of Medical Staff members (physicians) and Allied Health Professional staff (AHP- Physician Assistant [PA], Nurse Practitioner [NP]) indicated there were six physicians with privileges for emergency medicine, seven physicians with teleradiology privileges, one physician assistant (PA 1) with internal medicine privileges, and two nurse practitioners with internal medicine privileges. There were also six nurse practitioners with internal medicine privileges on the list with the word “NOC” next to their names. The DMSMR stated those are the NPs who are on call at night for the inpatient unit. The DMSMR stated the “NOC” NPs do not work on site at Hospital A and they are not available to come in since they are hours away from Hospital A. Review of the monthly ED physician schedules indicated there was twenty-four hour physician coverage onsite in the ED every day. Review of the monthly schedule for the inpatient unit (med-surg and swing bed) indicated there was a physician’s assistant or a nurse practitioner onsite every day for twelve hours and at night there was a nurse practitioner on call. During a concurrent interview and record review on 3/18/25 at 4 p.m., with the DMSMR, PA 1’s credential file was reviewed. The file indicated PA 1 had a Practice Agreement to provide medical services in Internal Medicine at [Hospital A]. The Practice Agreement indicated PA 1’s supervising physician was the Hospitalist Medical Director, (MD 1). The DMSMR stated the MD 1 is responsible for the ongoing evaluation of the AHPs. Review of PA 1’s credential file indicated he had been appointed to the AHP staff in 2022 as a hospitalist working the twelve hour day shifts, and had education and training and experience appropriate for a PA hospitalist role. The DMSMR stated PA 1 also had been granted privileges in Emergency Medicine in 8/24. Review of the privilege form indicated PA 1 had requested and was granted privileges using the same Emergency Medicine privilege form as used for physicians applying for privileges. The privilege form indicated, “Privileges specifically include incision and drainage, excision of lesions, excision of thrombosed hemorrhoid, wound closure, treatment of burns, intravenous cutdown, split thickness skin graft, thoracotomy, tracheostomy, tube thoracostomy, lumbar puncture, thoracentesis, paracentesis, emergency pacemaker placement, removal of foreign bodies including the cornea ...” and many more. PA 1’s credential file did not indicate he had training or experience in emergency medicine, and the DMSMR stated there is no evidence PA 1 was proctored for the procedural privileges he had been granted. The DMSMR stated she thought the privileges were granted so PA 1 could help out in the ED. The DMSMR stated she does not have any information regarding how many shifts if any, PA 1 worked in the ED and/or if he performed any procedures. The DMSMR stated PA 1 should have been proctored for any new procedures he requested. The DMSMR stated a separate privilege request form needed to be developed for a PA for emergency medicine. When asked, the DMSMR stated Hospital A does not have an Intradisciplinary Practice Committee responsible for the development of policies, procedures and protocols and Ongoing Professional Practice Evaluation and Focused Professional Practice Evaluation (OPPE/FPPE) for AHPs. The evaluation of PA 1’s performance by MD 1 used at the time of renewal of appointment to the AHP staff was requested. The DMSMR stated they did not have a summary document evaluating overall performance, with the recommendation for reappointment. The DMSMR stated the Hospitalist Medical Director or designee completed six retrospective medical record reviews for each AHP to assess the quality of the care provided by the PA and the NPs. Review of the form completed for each record was titled “Medical Record Review for Consultative Services,” and was for the evaluation of a consulting physician. The form indicated “Six (6) charts that received consultative services will be reviewed ...Data will be compiled and utilized by the Medical Director, Medical Executive Committee and Governing Board to determine appropriateness of appointment/reappointment to the medical staff.” The form consisted of a list of fifteen questions to be answered Yes or No by the reviewer for each record reviewed such as, “The consulting physician arrived to see the patient within 24 hours of consult?, The consulting physician examined the patient for the purpose of the consult?, The consulting physician wrote a thorough progress note in regard to the consult?” The reviewer answered Yes despite the questions not applying to the PA. The DMSMR was asked how the decision was made to use this form which was designed for the review of a physician consultant to use in part to determine appropriateness of reappointment, and the PA (or NP) is not a consultant or a physician, or a member of the medical staff. The DMSMR stated there was not a different form available, and agreed one needs to be developed because this one does not serve the intended purpose. During a concurrent interview and record review on 3/24/25 at 12:30 p.m., with the DMSMR, NP 4’s credential file was reviewed. The DMSMR stated NP 4 does not work on site at [Hospital A] but is one of the NP hospitalists who is on-call at night for the med-surg/swing bed unit. The DMSMR stated the Hospitalist Medical Director (MD 1) was responsible for evaluating the performance of NP 4. The DMSMR stated six retrospective medical record reviews are required for reappointment. The DMSMR was able to find medical record reviews completed prior to NP 4’s completion of proctoring on 10/24/23, but none since that time. The DMSMR stated their process was to give the medical director or designee the records to review spread throughout the appointment period, so she expected there to be others. Review of the reviews prior to 10/24/23 indicated they were completed using the “Medical Record Review for Consultative Services,” which was designed to be an evaluation of the care provided by a physician consultant. MD 1 completed the forms and answered Yes to “The consulting physician arrived to see the patient within 24 hours of consult? and The consulting physician examined the patient for the purpose of the consult?” The DMSMR did not have an explanation for the reviewing physician answering Yes to these questions when the NP being evaluated does not physically come in to [Hospital A] so she could not have arrived to see the patient, or examined the patient. The DMSMR verified the patients reviewed were patients of [Hospital A] and that NP 4 was on-call at night. The NPs that cover the night shift call do not come in as they are hours away from [Hospital A]. The DMSMR stated the evaluation of the on-call NP should not be the same as for the NP who is working in the hospital seeing the patients. The DMSMR stated this form should not be used for this reason in addition to the fact that this form is for the evaluation of a physician consultant, not an on-call NP. The DMSMR stated this incorrect form was the one used to evaluate the performance of the six night shift on call NPs, and the day shift on-site NP and PA. Review of the Medical Staff Bylaws, dated 4/18/23, indicated, “Allied Health Professionals (AHP) are not eligible for Medical Staff Membership. They may be granted practice privileges if they hold a license, certificate, or other credentials in a category of AHPs eligible to apply for practice privileges, and only if the AHPs are professionally competent and continuously meet the qualifications, standards and requirements set forth in the Medical Staff Bylaws and Rules ...Article V Privileges The Medical Staff will be responsible for developing criteria for granting setting-specific privileges. These criteria shall address the hospital’s general competencies and assure uniform quality of patient care, treatment, and services. Insofar as feasible, affected categories of AHPs shall participate in developing the criteria ...The medical staff shall assess all practitioners current proficiency in the hospital’s general competencies which shall be established by the medical staff and shall include assessment of patient care, medical/clinical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, and system based practice. Article VII Bylaws Articles IV and V require the Medical staff develop ongoing performance evaluation and monitoring activities to ensure the decisions regarding appointment and granting or renewing of privileges are detailed, current, accurate, objective, and evidence based. Article XIII The medical staff is responsible to oversee the quality of medical care, treatment, and services delivered in the hospital, An important component of that responsibility is the oversight of care rendered by members and AHPs practicing in the hospital ... All initial appointees and all members granted new privileges shall be subject to a period of focused professional practice evaluation (FPPE)-proctoring ...” Review of the article titled, “Credentialing and Privileging Provider Profiling,” dated 2/29/24, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK603712/ indicated, “ ...Profiling for the Ongoing Professional Practice Evaluation (OPPE). Healthcare institutions and the medical staff use Ongoing Professional Practice Evaluation (OPPE) to monitor providers’ continuing performance and competency. Reporting and evaluation intervals for OPPE reports should be more than once every 12 months, with cycle length determined by the institution. The OPPE data for each practitioner should be specific to their specialty, relevant, and valid. It should encompass critical metrics to facilitate ongoing quality improvement for the individual practitioner and the broader department and institution. Measurements of OPPE data can also include periodic chart reviews or audits, direct observation, proctoring, 360° evaluations, simulation, and external peer review ...Both the OPPE and the FPPE processes must be uniform, data-driven, consistent, free from bias, and fairly applied to every provider of every specialty, including physicians, advanced practice providers such as physician assistants and advanced practice registered nurses, midwives, dentists, chiropractors, podiatrists, psychologists, and others ...””

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iii) Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the CAH. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital did not develop, implement, and/or follow policies and procedures to have an appropriately qualified and privileged physician, nurse practitioner or physician assistant on-call and available to come into the hospital to address a patient change of condition in accordance with their bylaws, rules and regs and contracts. Instead, patients were discharged to the Emergency Department (ED) from the inpatient/swing bed for the ED physician to evaluate the patient. The ED physician was not privileged to admit or manage inpatients, and the ED privileges exclude the privilege to treat long term care patients such as swing bed patients. The hospital did not follow their policies for hospital admission, physician assessment of patients, and physician documentation. Patient (Pt) 1 was admitted to the hospital which did not provide the services, either in hospital or contracted, recommended by the transferring physician and/or needed to address the patient’s known chronic conditions. Pt 1 did not receive inpatient care directed by a physician in accordance with the needs of the patient, professional standards of practice and medical staff bylaws. These failures resulted in the need for urgent or emergent transfer of Pt 1 to other hospitals in unstable condition three times, twice for anticipated procedures such as paracentesis and thoracentesis, and once for an ongoing gastrointestinal bleed; and failure to have care directed by a physician contributed to Pt 1’s death in the Emergency Department while waiting for transfer. These failures resulted in the potential harm to all patients admitted to the hospital. Because of the serious actual harm to Pt 1 and the serious potential harm to all inpatients due to not developing, implementing, and following policies and procedures to ensure an appropriately qualified and privileged physician, nurse practitioner or physician assistant was on-call and available to come into the hospital to address a patient change of condition in accordance with their bylaws, rules and regulations, contracts, to ensure all patients who are being admitted to the hospital have an accepting physician who assessed the appropriateness of the admission considering the needs of the patient and the services provided by the hospital, and to ensure all patients admitted to the hospital are under the care of a physician, an immediate jeopardy (IJ) situation was called under CFR 485.635(a)(3), C1014, on 3/20/25 at 1:35 p.m. with the Administrator (ADM), Director of Nursing (DON), Director of Quality (QD), Emergency Department Manager (EDM), Medical Director (MD 1), Director of Medical Staff and Medical Records (DMSMR), and Director of Clinical Operations (DCO). The IJ template was provided to the hospital. The hospital submitted an IJ Plan of Removal (Version One) on 3/21/25 at 3:48 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 3/25/25 at 8:08 p.m., it was reviewed and accepted at 8:46 p.m. by email. On 3/26/25 and 3/27/25 the team validated arrangements had been made to ensure a qualified physician was available onsite 24 hours a day, seven days a week to address a patient change of condition, that a process was in place for physician review of potential patient admissions to evaluate appropriateness of the admission considering the needs of the patient and the services the hospital provides, that a process was in place to ensure the medical records were periodically reviewed and signed by a physician and current medical record review verified a medical plan of care had been documented and approved by a physician. On 3/27/25 at 4:35 p.m. the IJ was removed with the DON, QD, EDM, DMSMR, DCO and Respiratory Care Manager in attendance. Following removal of the IJ, the hospital remained in condition level non-compliance. Findings: Review of the monthly ED physician schedules indicated there was twenty-four hour physician coverage onsite in the ED every day. Review of the monthly schedule for the inpatient unit (med-surg and swing bed) indicated there was a physician’s assistant or a nurse practitioner onsite every day for twelve hours and at night there was a nurse practitioner on call; there were no physicians on the inpatient unit schedule or on call schedule. During a concurrent interview and record review on 3/14/25 at 11:45 a.m. with the Director of Medical Staff Services and Medical Records (DMSMR), The Hospital’s list of Medical Staff members (physicians) and Allied Health Professional staff (AHP- Physician Assistant [PA], Nurse Practitioner [NP]) indicated there were six physicians with privileges for emergency medicine, seven physicians with teleradiology privileges, one physician assistant with internal medicine privileges, and two nurse practitioners with internal medicine privileges. There were also six nurse practitioners with internal medicine privileges on the list with the word “NOC” next to their names. The DMSMR stated “NOC” designated the NPs who are on call at night for the inpatient unit. The DMSMR stated the “NOC” NPs do not work on site at the hospital and they are not available to come in since they are hours away from Hospital A. The DMSMR stated the were no physicians with internal medicine privileges on the medical staff list for the hospital. The Emergency Medicine privilege request form was reviewed and indicated, “ ...Privileges do not include long-term care of patients on an inpatient basis, or admitting ...” The DMSMR confirmed this was the current form and stated she was not aware of that statement on the form. The DMSMR stated the ED physicians’ privileges do not include admission and management of patients (for acute care or swing bed) on the inpatient unit. During a concurrent interview and record review on 3/19/25 at 11:05 a.m. with the Director of Nursing (DON), Pt 1’s electronic medical record was reviewed. The DON stated according to the visit history, Pt 1 was admitted on 10/29/24 to the hospital’s swing bed program (refers to the hospital’s ability to use its beds for acute care or for skilled nursing facility [SNF]-level care) from Hospital B (a long term acute care hospital located several hours distance from Hospital A) and was discharged to the emergency department (ED) on 11/5/24, and then transferred on 11/6/24 from the ED to another hospital for a higher level of care. The DON stated Pt 1 was readmitted to Hospital A on 11/12/24 and was discharged to the ED on 11/26/24 and was transferred to another hospital that same day for a higher level of care. Pt 1 was readmitted to Hospital A on 11/29/24 and was discharged to the ED on 12/16/24 and died the same day while awaiting transfer to another hospital for a higher level of care. Review of the handwritten “Transfer Form” indicated “Physician Orders” and the printed name of the sending physician from Hospital B, the code status “Full Code,” and orders for oxygen, physical and occupational therapy (PT and OT), diet orders, and wound care orders. The transfer form also indicated Pt 1 was alert and oriented and required moderate to maximum assistance with activities of daily living (ADL- basic daily self-care tasks such as eating, bathing, dressing, using the toilet, walking). The sending physician’s name was hand-printed with no signature and was dated 10/23/24. The line indicating the name of the receiving physician was blank, and the transfer date consisted of the month and year, with the day left blank. The medication report accompanying the records from Hospital B was dated 10/22/24. A review of the admission orders indicated on 10/24/24 the physician assistant (PA 1) initiated admission orders and on 10/29/24 admission orders were initiated by NP 2. Review of the physician’s progress notes from Hospital B, dated 10/28/24 at 11:06 a.m., indicated, “Disposition: Transitional care [moving to a different care setting] to be looked into when practical and safe. Presently patient meets medical necessity for LTAC [Long Term Acute Care, Long Term Care Hospital (LTCH)-refers to acute-care hospitals that focus on patients with complex medical problems who, on average stay more than 25 days] ...” Review of Pt 1’s Discharge Summary from Hospital B dated 10/28/24 at 3:26 p.m., indicated it was written by the same physician who wrote the progress notes at 11:06 a.m. The discharge summary included the same list of medical problems and specialty service needed as in the progress notes on 10/28/24 including, GI, pulmonology, nephrology, outpatient hematology, methadone clinic, nutrition, a list of the medications given during the stay and lab work from the past week. There was no plan or disposition. There was no indication from the discharge summary that Pt 1 was to be discharged from Hospital B and admitted to the hospital, or that anything had changed from his 11:06 a.m. progress note which indicated the need for acute care. Review of the admission history and physical by nurse practitioner (NP) 1, dated 10/29/24, indicated the date of admission was 10/29/24. Pt 1 was a 50 year-old man with a medical history of end stage renal disease (ESRD- the final stage of chronic kidney disease, where the kidneys can no longer function on their own) on dialysis (a treatment to remove extra fluid and waste when kidneys fail) three times per week, cirrhosis of the liver (permanent scarring that causes liver damage and can lead to liver failure), right pleural effusion (buildup of fluid around the lung) requiring thoracentesis (a procedure to drain the fluid from around the lung) three times prior to admission, ascites (abnormal buildup of fluid in the abdomen) requiring paracentesis (a procedure to remove the abdominal fluid) three times prior to admission, low blood pressure, anemia, thrombocytopenia (a low level of platelets [tiny cells that form clots to stop bleeding] in the blood), had muscle wasting and weakness in his legs and required continuous oxygen at 3 liters per minute (L/min). The H&P indicated Pt 1’s code status was Do Not Resuscitate/Do Not Intubate (DNR/DNI) in one part of the H&P, and also a Full Code in another part. The H&P also indicated Pt 1 was a high risk of gastrointestinal bleeding due to low platelets, esophageal varices and liver and kidney disease, and medication for prevention of deep venous thrombosis (DVT-a blot clot forms in a deep vein) was contraindicated. Review of the medication orders indicated heparin (a medication used to prevent blood clots) 5000 units was ordered to be given every twelve hours. On 10/30/24, the NP’s progress note indicated Pt 1 wanted to go home and missed his family. A review of the admission orders from indicated on 10/24/24 the physician assistant (PA 1) initiated admission orders and on 10/29/24 admission orders were initiated by NP 2 and NP 3. The DON stated Pt 1 was admitted on 10/29/24 from Hospital B, not on 10/24/24. Pt 1 lived twenty minutes from Hospital B, and two hours from the hospital. The DON was asked how patients are evaluated for admission from an outside hospital to determine whether they meet swing bed criteria and whether the needs of the patient can be met by the hospital, considering the hospital does not have any specialty physicians on staff in the hospital or available on call, to perform procedures. The DON stated requests for swing bed admission to the hospital from another hospital are reviewed by a nurse practitioner offsite and then an email is sent to the DON and the NP or PA on duty at the hospital informing them of the planned admit. The DON stated the staff at the hospital are not involved in the process of determining if a patient will be admitted from another hospital. The DON stated if a patient needs services that cannot be provided at the hospital they have to be transferred out to another hospital. The DON stated they would not perform thoracentesis or paracentesis at the hospital because they need interventional radiologist (IR- minimally invasive, image-guided treatment of medical conditions) to perform those procedures safely. During a concurrent interview and record review on 3/19/25 at 3:05 p.m. with the DON, Pt 1’s medical record was reviewed. The order report indicated all orders for admission and during the inpatient stays were written by a physician assistant (PA) or nurse practitioner (NP). The only orders from a physician from 10/29/24 until 12/14/24 were those written when Pt 1 was in the emergency department after being discharged from the inpatient swing bed. The DON stated there were no physician notes written during any of Pt 1’s inpatient stays at the Hospital, from 10/29/24-11/5/24, 11/12/24-11/26/24, and 11/29/24-12/16/24, which totaled 38 days. The only physician notes in the medical record were from the ED visits on 11/5/24-11/6/24, 11/26/24, and 12/16/24. Review of the physician assistant’s discharge summary dated 11/5/24, indicated, “Discharge Disposition: Guarded. Discharged from swing bed to ED for further evaluation and higher level of care due to change in mental status and vomiting. Hyperammonemia [high levels of ammonia in the blood] ...” Review of the lab results indicated Pt 1’s ammonia level was 170 umol/L (range 11-32 umol/L). Review of the orders and lab results from 10/29/24 until 11/5/24 indicated Pt 1 had an ammonia level checked on the day of admission on 10/29/24 which was 72 umol/L (up from 39 umol/L on 10/28/24), and the next time it was checked was seven days later on 11/5/24 at 1 p.m. Review of the ED physician’s note dated 11/5/24 at 5:14 p.m. indicated, “Profound nausea end-stage liver disease end-stage kidney disease from the floor to the ED for further observation resuscitation and management ... According to the midlevel who was caring for the patient, the patient was satting only in the mid-80s on the floor which was concerning issues reported staff on the floor and the fact that the patient was profoundly nauseated and elevated ammonia of 174. After I was contacted shortly prior to arrival I requested the patient to be transferred to the ED for further workup ...” Imaging revealed large right pleural effusion and small left pleural effusion and large abdominopelvic ascites. Review of ED physician note, dated 11/6/24, indicated, “Patient’s medical condition has been treated with the previous emergency room physician, but his medical condition has not been stabilized since we do not have the specialty care that the patient needs ...Plan: Transfer for higher level of care ...” 11/6/24- Review of nurses notes dated 11/6/24 indicated Pt 1 was transferred to Hospital C for a higher level of care at 2:20 p.m. in unstable condition. 11/12/24- Pt 1 was readmitted to swing bed with admission diagnosis of ESRD. Review of the orders indicated the admission orders, and all inpatient orders were initiated by an NP or PA. The record indicated during Pt 1’s hospital stay from 11/6/24 to 11/12/24, Pt 1 underwent a paracentesis for symptomatic ascites with 6850 milliliters (ml) of fluid removed, and a thoracentesis for pleural effusion with 1500 ml fluid removed. Palliative care consult was completed at Hospital C and Pt 1 agreed to DNR/DNI. Review of PA notes from 11/18/24-11/24/24 indicated “ ...Should have another talk in regard to future plan of care such as palliative care vs hospice. Pt not ready for hospice from our last conversation ...” There is no indication of when that last conversation occurred, what was discussed, what resources were provided. Review of the NP’s progress notes dated 11/26/24, indicated, “ ...patient stated he is having difficulty breathing and chest pain also. Looked for orders to the IR [refers to interventional radiology] could not find and placed new orders for GI and IR referral. Pt is having the desaturation on nasal cannula patient is around 80s and then on mask patient not able to maintain saturation is high 80s. Patient started on 100% oxygen via mask. Patient transferred to ED for further management ...” Review of the ED physician’s note dated 11/26/24 indicated, “Patient was transferred from the Swing Unit to the ED because of progressive SOB [shortness of breath] and generalized weakness ... Plan: will need to transfer to higher level of care ...” Review of nurses notes dated 11/26/24 indicated at 5:43 p.m. Pt 1 was transferred to Hospital D in unstable condition for a higher level of care. On 11/29/24 Pt 1 was readmitted to swing bed status. Code status: DNR/DNI. Review of the PA’s progress notes dated 12/2/24-12/8/24, indicated, “Will plan to revisit possible referral to hospice palliative care services if patient is open to it.” The record did not reflect the status of that referral, if or when the PA had this discussion with Pt 1, options offered, involvement of family. Review of the NP progress notes dated 12/12/24, indicated Pt 1 was anxious and depressed and wanted to go home. NP indicated they are working on a plan to get him home before 12/25/24 and referrals needed for pulmonary and GI. Review of the nurses notes dated 12/13/24 at 6:53 a.m., indicated Pt 1 had vomited bright red blood. Patient had tarry stools during the day. Review of the nurses notes dated 12/14/24 at 6:35 a.m., indicated Pt 1 had vomited blood twice. A rapid response call was initiated, the ED physician responded, and a blood transfusion was ordered. Oxygen at 10L/min by mask. Notes also indicated Pt 1’s abdomen was firm, distended and tender and Pt 1 was having black tarry stools. There was not a physician progress note or assessment. On 12/14/24 NP progress note indicated, Pt 1 was transfused with two units of blood and four units of platelets. Refusing medications. Potassium and white blood cell count elevated. On oxygen 10L/min. The NP’s note does not describe the vomiting of blood or awareness of the tarry stools. NP indicated Pt did not want to be transferred to another hospital. The record does not reflect a current discussion with Pt 1 and/or with family regarding comfort care, end of life options considering he already has a DNR/DNI order, and his condition was deteriorating, and he was in pain. Review of nurses notes dated 12/15/24 indicated Pt 1’s abdomen was hard and tender, Pt 1 was in pain, drowsy, pale and had several episodes of anxiety. On 12/15/24, NP progress note indicated Pt 1 was confused, had an elevated ammonia level and was refusing medication to lower it; the blood pressure was low. The progress note indicated Pt 1 “still wants to go home before Christmas,” plan is to send home with oxygen and home health on 12/23/24. The record did not reflect tarry stools. There was no record of a discussion about making Pt 1 more comfortable, providing end of life care, discussions with family, spiritual care. Review of Pt 1’s discharge summary by the PA from the inpatient unit dated 12/16/24, indicated, “ ...Vital signs demonstrate chronic hypoxia, now at 5L nasal cannula, patient is in dire need of urgent thoracocentesis (an emergency procedure to relieve tension pneumothorax by inserting a needle to allow air to escape) ...Patient will have dialysis today, however, will re-evaluate once he comes back from dialysis. If patient requires higher supplemental oxygen, and respirations continue elevated will plan to dc to ER for full evaluation and potential transfer for urgent thoracocentesis. Patient will no longer be able to have hemodialysis done if he requires greater than 5L/min of oxygen ...” On 12/16/24 at 2:30 p.m., Pt 1 was transported by wheelchair outside by staff to the dialysis center located in a building past the end of the hospital’s parking lot. At 5:08 p.m. the dialysis center notified the nursing unit that Pt 1 requested to get off dialysis early due to abdominal pain and shortness of breath. Pt brought back to his hospital room. Oxygen saturation in the 80s, 15 L/min oxygen per non-rebreather mask. Pt 1 transferred to the ED per charge nurse. Review of the ED Physician’s note dated 12/16/24 at 5:09 p.m., indicated, “ ...This patient is known to me. I was made aware of his deteriorating status at the 10 a.m. rounds. He at that time was DNR/DNI. His respiratory rate is approximately 40 [breaths per minute] with EXTREME Difficulty breathing at 15L oxygen, vomiting blood. I explained to him that he must be intubated to survive ...The patient changed his code status and agrees to intubation ...” Pt 1 was intubated and placed on a ventilator. Pressors given for low blood pressure. Attempted to transfer patient via air transport, systolic blood pressures 55-65 mmHg. Blood given. After 9 p.m., air transport arrived, however before Pt 1 could be moved to transport gurney he suffered a cardiac arrest. After CPR and medications produced no response and pupils were fixed, Pt 1 was pronounced dead at 9:23 p.m. Discharge diagnoses included “Massive GI bleed.” During an interview on 3/20/25 at 2:15 p.m. with Emergency Department Manager (EDM), the EDM stated only potential patient admissions to the medical-surgical unit for acute care are discussed with the Medical Director (MD 4), not admissions to swing beds. During a review of the daily inpatient census reports for 3/11/24- 3/21/24, the reports indicated each day there were between sixteen and eighteen inpatients on the med-surg/swing bed unit. The report indicated the physician (a medical doctor [M.D.] or Doctor of Osteopathic Medicine [D.O] issued a license to practice medicine) for each patient was not a physician but rather a physician assistant (PA) or a nurse practitioner (NP). During a concurrent interview and record review on 3/25/25 at 1:10 p.m. with Case Manager (CM), Pt 1’s medical record was reviewed. The CM stated, she had started in December 2024 and no other referrals had been set up for Pt 1. The CM stated she worked with the family to have follow up appointments with him (Pt 1) in [HOME CITY] so that he could be home with his wife for Christmas. The CM stated, she had set up a gastroenterology (providers who specialize in liver and digestion diseases) appointment for 1/22/25, a pulmonary (providers who specialize in lung disease) appointment for 1/9/25. The CM stated she made referrals for home oxygen setup up and home health nursing assistance on 12/9/24 and 12/10/24 in preparation for discharge. During a concurrent interview and record review on 3/26/25 at 11:05 a.m. with Physician Assistant (PA), Pt 1’s medical record was reviewed. The PA stated, there were no orders or progress notes from the physician. The PA stated, he did discuss Pt 1’s care and medical issues with the Medical Director (MD 1) but he did not document those discussions in his notes. The PA stated admissions are done by the NPs and PA. During a review of Hospital A’s Medical Staff Bylaws, revised 4/18/23, Page 2 of the Bylaws indicated, “Allied Health Professionals (AHP- PA or NP) are not eligible for Medical Staff Membership. Section 5.4-1 Admitting Privileges- The following categories of licensees are eligible to independently admit patients to the hospital: Physicians (MDs or DOs). Additionally, AHPs with admitting privileges may admit patients upon order of a member of the Medical Staff who has admitting privileges and who maintains responsibility for the overall care of the patient ...” Review of the policy and procedure (P&P) titled,” Swing Bed Medical Staff Assessment,” dated 4/18/23, indicated, “ ...POLICY: The physician documentation will be timely and provide information to the interdisciplinary team to assist in developing and implementing a comprehensive plan of care for the patient. PROCEDURE: B. Physician’s orders on admission must include orders for medications and treatments. All orders from an acute care admission are discontinued, and new orders written for Swing Bed ...C. The physician will visit the patient twice per week and document in the progress notes ...D. Progress notes will document visits. Content of the progress notes should include: 1. Evaluation of progress 2. Care Objectives 3. Anticipated length of stay ...” Review of the P&P titled, “Swing Bed Admission Criteria,” effective date 3/2022, reviewed 2/2024, the P&P indicated, “ ...PROCEDURE: A. Admission Criteria a. The patient must have a need for post hospital extended care services requiring the skills of technical or professional personnel to furnish or supervise activities on a daily basis that facilitate recovery and stability or when a patient continues to need skilled healthcare services for a condition for which the patient was admitted to inpatient acute care or for a condition which arose while receiving inpatient care or specialized rehabilitative services ... c. Services must be needed daily ... f. Services are ordered by a physician and related to an active written treatment plan signed by the physician ...k. Once a patient reaches their maximum functional potential, discharge is expected ...” Review of the P&P titled, “Transfer of a Patient,” effective date 5/1/20, reviewed 2/1/24, indicated the policy applied to the department of Med-Surg. The P&P indicated, “ ...I. PURPOSE AND SCOPE: a. To provide guidance for the transfer of a patient between units and to outside sources ...b. PROCEDURE: 1. The transfer will be completed upon the order of the attending physician. a. The physician will perform an assessment of medical need, and request transfer for a higher level of care. b. The physician will make arrangements for the continuation of patient care in the receiving unit or outside service ...””

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to ensure staff implemented policies and procedures (“Medication Administration” and “Medication Errors”) meant to administer drugs and biologicals in a safe manner to avoid medication error for five of five patients (Patients (Pt) 12, Pt 13. Pt 14, Pt 15 and Pt 18). Staff did not inform the prescribing physician and the affected patient of the medication error in accordance with hospital policies and procedures. The hospital failed to conduct a look-back review of each medication error to determine factors that led to the medication error to avoid future occurrence in accordance with professional standards of practice. The hospital did not review the system for storage, handling, dispensation, and administration once aware of the medication errors in order to avoid future occurrence in accordance with professional standards of practice. These failures resulted in the unsafe administration of medications and possible negative outcome for each patient that experienced a medication error. These failures resulted in the potential harm for all patients in the hospital administered medications. Findings: During a concurrent interview and record review on 3/14/25, at 10:45 a.m., with the Emergency Department Nurse Manager (EDM), Pt 12’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Hemodynamics Monitoring Flowsheet [HMF]”, “Medication Administration Record [MAR]”, “Medication Error Report”, dated 12/24 and 1/25, and “electronic health records” (EHR), were reviewed for Pt 12’s admission on 1/2/2025. The EDM stated, Pt 12 had been admitted for not feeling well after a cat bite and left arm infection. EDM stated, Pt 12 had been administered Dextrose 5% 1000 ml (milliliter) intravenously (a fluid with sugar that is administered through the vein) instead of Normal Saline (0.9% Sodium Chloride) 1000 ml intravenously in the Emergency room prior to being admitted. The EHR indicated, the provider had ordered, “Ordered Medication Sodium Chloride 0.9 % ... Start Date/Time 01/02/2025 ... Dosage 100 ml/hr [hour] ... Route intravenous ... Cont IV [Continuous infusion] ... “ The EDM stated, the medication error was discovered by Pharmacy as they reconciled the automatic dispensing machine (a computerized system used for storing, dispensing, and tracking medications at the point of care in healthcare settings) inventory. reported on 1/20/25 at 7:49 a.m. The EDM stated, the DON was notified about the medication error, who counseled the nurse involved, and Risk Management was notified. The EDM stated, the provider nor Pt 12 were notified about the wrong medication being given. The EDM stated, Pt 12 eventually was admitted and the serum (blood) glucoses remained stable throughout the stay and Pt 12 was discharged. The EDM stated, the provider and Pt 12 should have been notified about the medication error. The EDM stated, the provider should be notified in order to mitigate the error and correctly treat the patient. During a concurrent interview and record review on 3/14/25, at 10:50 a.m., with the EDM, Pt 14’s “Face sheet”, “[HMF]”, “[MAR]”, “Medication Error Report”, dated 12/24 and 1/25, and “EHR”, were reviewed for Pt 14’s Emergency room visit of 12/27/2024 at 4:07 p.m. The EDM stated, Pt 14 was admitted for nausea and vomiting and tremors related to binge drinking. EDM stated, Pt 14 had been brought to the ED by ambulance for evaluation as his heart rate was elevated. EDM stated, Pt 14 was supposed to receive 260 mg (4 vials) of phenobarbital (anti-seizure medication) intravenously. EDM stated, Pt 14 received one vial (65 mg) at 4:34 p.m. instead, with a decrease in heart rate. EDM stated, Pt 14 left the Emergency room 7:50 p.m. against medical advice after feeling better. The EHR indicated, the provider had ordered, “Ordered Medication Phenobarbital Sodium Inject ... Start Date/Time 12/27/2024 ... Dosage 100 ml/hr ... Comments: 4 vials =260 mg ... Route intravenous ... IVPB [Intravenous piggyback] ... “. The EDM stated, the medication error was discovered by Pharmacy as they reconciled the automatic dispensing machine inventory and reported on 12/27/24 after the patient had left the hospital. The EDM stated, the DON was notified about the medication error, who counseled the nurse involved, and Risk Management was notified. EDM stated, the nurse did not document that the provider had been notified nor that Pt 14 had been notified about the medication error. During a concurrent interview and record review on 3/14/25, at 11:01 a.m., with the EDM, Pt 13’s “Face sheet”, “[HMF]”, “[MAR]”, “Medication Error Report”, dated 12/24 and 1/25, and “EHR”, were reviewed for Pt 13’s admission dated 11/12/2024. The EDM stated, Pt 13 had been admitted after a prolonged acute hospitalization to the swing beds for close management and monitoring of chronic conditions. The EDM stated, on 12/15/24 at 6:47 a.m., Pt 13 received clonidine (a medication used to treat high blood pressure) 0.1mg (milligrams) by mouth and levothyroxine (a medication used to treat low thyroid hormone) 112 mcg (micrograms) by mouth that had been prescribed for a different patient. The EDM stated, the provider was notified about wrong medications and the provider ordered monitoring of the patient’s blood pressure for a low blood pressure. The EDM stated, a nurse had discovered the medication error discussion the patient with the nurse coming off shift. The EDM stated, the DON was notified about the medication error, who counseled the nurse involved, and Risk Management was notified. The EDM stated, the patient was never notified per the record. The EDM reviewed the chart and noted no other issues were noted with Pt 13 being discharged on 12/21/24. During a concurrent interview and record review on 3/14/25, at 11:09 a.m., with the EDM, Pt 15’s “Face sheet”, “[HMF]”, “[MAR]”, “Medication Error Report”, dated 12/24 and 1/25, and “EHR”, were reviewed for Pt 15’s Emergency room visit on 1/1/2025. The EDM stated, Pt 15 was a homeless patient who had been bitten by a dog on the left arm. EDM stated, Pt 15 was treated for right thigh and left arm lacerations. EDM stated, Pt 15 had rabies immunoglobulin (medication that vaccinates against rabies) 1910 units (7 vials) injection intravascular (into the muscle) ordered. EDM stated, Pt 15 was erroneously given 1800 units (6 vials). The EHR indicated, the provider had ordered, “Ordered Rabies Vaccine ... Start Date/Time 01/01/2025 at 1700 [5 p.m.] ... Dosage 1910 Units ... Route IM [Intramuscular (shot in the muscle)] ls =260 mg ... Frequency X1 [one time] ... “. The EDM stated, the medication error was discovered by Pharmacy as they reconciled the automatic dispensing machine inventory and reported on 1/1/25 after the patient had left the hospital. EDM stated, Pt 15 returned 1/7/25 and 1/13/25 for follow up care of the lacerations. EDM stated, the provider nor Pt 15 were notified about the medication error and documented in the record. During a concurrent interview and record review on 3/18/25, at 9:30 a.m., with the EDM, Pt 18’s “Face sheet”, “[HMF]”, “[MAR]”, “Medication Error Report”, dated 12/24 and 1/25, and “EHR”, were reviewed for Pt 18’s Emergency room visit on 1/20/2025 at 6:40 a.m. The EDM stated, Pt 18 came to the Emergency room via ambulance and had a history of seizures. EDM stated, Pt 18 had seizure on arrival and Levetiracetam (anti-seizure medication) 500 mg intravenously was ordered. EDM stated, the medication error was noted by pharmacy as they noted the discrepancy in the count of the unit dose dispensing machine and Linezolid (an antibiotic -- medication used to treat infections) 600 mg intravenously was given at 6:53 a.m. The EHR indicated, the provider had ordered, “Ordered Levetiracetam 500mg/100ml ... Start Date/Time 01/20/2025 at 6:40 [a.m.] ... IV PIGGY [Intravenous infusion] ... Frequency X1 [one time] ... “. The EDM stated, the medication error was discovered by Pharmacy as they reconciled the automatic dispensing machine inventory and reported it to the EDM. EDM stated, Pt 18 was also given lorazepam (anti-seizure medication). EDM stated, Pt 18 was discharged stable at 2:08 p.m. The EDM stated, she personally knew about this case and that the provider had been notified about the wrong medication error. EDM stated, the nurse did not notify Pt 18 of the medication error and document in the record about notifying the provider or the patient. During a concurrent interview and record review on 3/18/25, at 11:13 a.m., with the Director of Nursing (DON) and the Director of Pharmacy (PDR), the hospital’s policy and procedure (P&P). “Medication Error Reduction Plan [MERP]”, dated 1/09/2025, and “Medication Error Report”, dated 12/24 and 1/25, were reviewed. The PDR read the policy out loud for the section, under “B. Medication Errors, ... iii. When a medication error has occurred, the nurse or pharmacist will communicate with the patient’s physician, patient and/or patient’s agent that a medication error has occurred.” The PDR stated, when the MERP looked at the medication errors, only six elements were analyzed when running the report from the ADM, which were “Wrong Controlled Substance Waste, Wrong Controlled Substance Documentation/Discrepancy, Wrong Medication, Wrong Dose, Wrong Route of Administration, Other Medication Errors (didn’t reach patient) ... “. The PDR stated, she did discuss the medication errors with the DON and they felt the medication errors occurred due registry (a company that connects temporary nurses with hospitals) nurses not being familiar with the hospital’s process for administering medications. The DON stated he had talked to the individual nurses in each case. The PDR stated, Risk Management Department was also notified through the computer system to track medical errors. The PDR stated, the patient and the provider should be notified when a medication error occurs. The DON stated, the provider needs to know about the medication error as it guides how he is treating the patient. The DON stated, if the information is not documented in the chart, then it did not occur. The DON stated, he expects nurses to follow the policies when medication errors occur. During a review of the hospital’s P&P titled, “[MERP]”, dated 1/9/2025, was reviewed. The P&P indicated, “ ... The primary goal of the MERP program is to promote safe and effective medication use through reduction of preventable medication related errors and adverse events ... MERP shall involve a multidisciplinary process, including professionals responsible for pharmaceuticals, nursing, medical, and administration, to regularly analyze all identified actual or potential medication-related errors and describe how the analysis will be utilized to change current procedures and systems to reduce medication-related errors. ... Eleven (11) methodologies below will be evaluated and assessed as it pertains to the medication error and any weaknesses or deficiencies will be identified that could contribute to errors in the administration of medication. A. Prescribing. B. Prescribing order communications C. Product labeling D. Packaging and nomenclature E. Compounding F. Dispensing G. Distribution H. Administration I. Education J. Monitoring K. Use ... Trends will be identified to help analyze and correct any systemic weaknesses or deficiencies. ... When a medication error has occurred, the nurse or pharmacist will communicate with the patient’s physician, patient and/or patient’s agent that a medication error has occurred. Pharmacy will investigate and conduct the root cause analysis to avoid injury or mitigate the errors. ... iv. The record for medication error review includes: A. Date, location, and participants in the review ... B. Pertinent data and other information related to the medication error reviewed ... C. Findings and determinations ... D. Recommended changes to avoid or mitigate errors ... “ During a review of the hospital’s P&P titled, “Medication Administration Standards”, dated 2/1/24, was reviewed. The P&P indicated, “ ... 16. Medication errors will be reported on a Quality Review Form. The error will be reflected in the Medication Administration Record (MAR). ... “ “ During a review of a professional reference titled “Lippincott Manual of Nursing Practice (11th ed.),” dated 2018, indicated, “Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record, administer medications as ordered, and follow physician’s orders that should have been questioned or not followed, such as orders containing medication dosage errors.” During a professional reference review retrieved from https://www.ncbi.nlm.nih.gov/books/NBK519065/, titled, “Medication Dispensing Errors and Prevention,” dated 2/2024, the professional reference indicated, “ ... Medication errors rank as the most frequent and avoidable source of patient harm. They can manifest at various points in the healthcare process, ranging from prescribing to actual drug administration. Medication errors can occur at any time during the treatment process. Various healthcare professionals must go through multiple steps when a patient is prescribed a medication. The following steps outline potential places where medication errors may occur. ... Ordering and prescribing ... Documenting ... Transcribing ... Dispensing ... Administering ... Monitoring ... Preventing medication errors requires an understanding of the causes and types of medication errors as well as when during the prescribing process mistakes can occur. ... System Failures ... Inaccurate order transcription ... Drug knowledge dissemination ... Failing to obtain an allergy history ... Incomplete order checking ... Mistakes in the tracking of the medication orders ... Poor interprofessional communication ... Unavailable or inaccurate patient information ...According to the World Health Organization’s publication titled “Medication Errors: Technical Series on Safer Primary Care,” the following factors have been associated with an increased risk of medication errors in the primary care setting: Lack of therapeutic training or inadequate knowledge ... Poor communication with patients ... A language barrier between healthcare professionals and patients ... Increased workload ... Interruptions and distractions ... Lack of accuracy of patient records and a poor interface between prescriber and electronic health records ... Lack of protocols and standardized procedures in the work environment ... Inadequate naming, labeling, and packaging of medicines ... Poor communication with secondary care providers ... Medical Error Disclosure ... Creating an environment that focuses on the healthcare team’s respect and compassion for patients, along with dedication to providing high-quality care and ensuring patient safety, requires prompt and full disclosure of a medication error once identified. ... The patient and family should understand what happened and the harm caused and receive an explanation of the measures taken to minimize the harm, if possible. The interaction should also allow the patient and their family to ask questions. ... Disclosure of medication errors should also include disclosure to regulatory agencies and institutional committees so that implementation of organizational changes can prevent such errors in the future. ... Care must be taken to avoid individual blame ... “.”

“NURSING SERVICES CFR(s): Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient’s needs and the specialized qualifications and competence of the staff available. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to ensure registry (contracted service) registered nurses (RNs) and licensed vocational nurse assigned to care for patients were evaluated for competency for two of four sampled RNs (RN 1 and RN 4) and one of one LVN (LVN 2) when RN 1, RN 2 and LVN 1 were assigned to care for patients in the hospital and the emergency department (ED) and were not evaluated in accordance with the hospital policy and procedure “Registry Evaluation - Emergency Department”. This failure had the potential for allowing incompetent Licensed Nurses (LN) to be provide nursing care and had the potential to result in patient harm due to lack of oversight in the management of patients. Findings: During a concurrent interview and record review on 3/25/24, at 11:30 a.m., with Human Resource Specialist (HRS), Registered Nurse (RN) 1’s, RN 4’s and Licensed Vocational Nurse (LVN) 2’s personnel files were reviewed. RN 1 was hired on May 31, 2024 from a registry and had been oriented to the current position in the Emergency Room May 2024. RN 4 was hired on March 5, 2024 from a registry and had been oriented to the current position in the Emergency Room March 2024. LVN 2 was hired on November 5, 2024 from a registry from had been oriented to the current position in the Emergency Room November 2024. HRS stated, the “Registry personnel evaluation” forms were missing for RN 1, RN 4 and LVN 2. HRS stated, the forms should have been completed by the DON and returned to Human Resources to be put in their file. HRS stated, this is an area we need to improve. During a review of ED’s schedule for assignments, documents titled, “Nursing Department Daily Staffing” dated 3/12/25, 3/14/25, 3/18/25, 3/19,25, 3/24/25, 3/25/25 and 3/27/25, RN 1 was assigned on each of those days to a team of patients in the hospital. During a review of ED’s schedule for assignments, documents titled, “Nursing Department Daily Staffing” dated, 3/14/2025, 3/18/25, and 3/25/25, RN 4 was assigned on each of those days to a team of patients in the hospital. During a review of ED’s schedule for assignments, documents titled, “Nursing Department Daily Staffing” dated 3/14/25, 3/18/25, 3/19/25, 3/20/25, 3/21/25, 3/24/25, 3/25/25, 3/26/25 and 3/27/25, LVN 2 was assigned on each of those days to a team of patients in ED. During an interview on 3/27/25 at 9:20 a.m., with the Director of Nursing (DON), the DON stated, registry staff should have evaluations done after their first shift and the forms should be filled out. The DON stated, it is something we need to improve on. During a review of the hospital’s policy and procedure (P&P) titled, “Registry Evaluation - Emergency Department”, dated 5/1/2020, the P&P indicated, ... “ ... i. Upon completion of three consecutive shifts, the registry personnel evaluation form will be completed if indicated by the Director of Nursing ; ii. If the nurse’s performance meets performance requirements, he/she may return to [HOSPITAL NAME] to work additional shifts without evaluation, unless determined by the Director of Nursing. If the nurse’s performance does not consistently meet performance requirements, the referring registry agency will be notified that the nurse is a “Do Not Return”; iii. The completed evaluation form will be returned to the referring Nurse Registry; iv. A copy of the Registry personnel evaluation form will be placed in the nurse’s employee file. ... “”

“NURSING SERVICES CFR(s): §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. This Standard is not met as evidenced by: 45977 Based on interview and record review the hospital failed to follow their policy for “Medication Administration” for one of seven sampled patients (Patient (Pt) 7) when nurses did not clarify an order of “prn” for a medication used for pain. This failure had the potential to leave patients with under or overmedicated. Findings: During a review of Pt 7’s,”History and Physical [H&P],” dated 2/13/25, the “H&P” indicated, Pt 7 was admitted on 2/12/25. Pt 7 was a 70 year old with DM (diabetes mellitus - a disorder where the body does not control the amount of glucose in the blood), obesity, chronic venous ulcers (wounds that form on the legs due to poor blood circulation) left above knee amputation, bedbound, and infected Stage III sacral decubitus ulcer (wound on buttocks). During a concurrent interview and record review on 3/13/25, at 11:20 a.m., with the Director of Nursing (DON), Pt 7’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Hemodynamics Monitoring Flowsheet [HMF]”, “Medication Administration Record”, dated 2/14/25 to 3/12/25 and “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 2/12/2024. The DON stated, Pt 7 had an order on 2/13/25 at 5:07 p.m. for “oxycodone HCL (medication used for pain) ... 5 mg (milligrams) ... by mouth ... every four hours ... PRN [when needed] ...”. DON stated, the nurse who verified the order should have asked a clarified with the provider the indication or reason for the medication as per policy. DON stated, the order was not clear for every nurse or clinician working with the patient. DON stated, the medication was used for pain and should also have a pain level indication score. During a concurrent interview and record review on 3/13/25, at 12:46 p.m., with Registered Nurse (RN) 2, Pt 7’s “Face sheet”, “Hemodynamics Monitoring Flowsheet [HMF]”, “Medication Administration Record”, dated 2/14/2025 to 3/12/25, and “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 2/12/2024. RN 2 stated, Pt 7 had an order on 2/13/25 at 5:07 p.m. for “oxycodone HCL (medication used for pain) ... 5 mg (milligrams) ... by mouth ... every four hours ... PRN [when needed] ...”. RN 2 stated, the order on indication “prn” needs to be clarified as there is no reason for the medication. RN 2 stated, the nurse should have called the provider and clarified the order with specific parameters and indication. RN 2 stated, the medication has been given for wound dressing changes. During an interview on 3/13/25, at 1:45 p.m., with the Director of Pharmacy (PDR), the PDR stated, the pharmacist should have clarified the medication order and asked the doctor for an indication for the medication. The PDR stated, the orders should follow the policy on medication administration so that all the nurses and providers are doing the same thing. During a review of the facility’s policy and procedure (P&P) titled, “Medication Administration Standards”, dated 2/1/24, was reviewed. The P&P indicated, “ ... To ensure safety and accuracy in the administration and documentation of medications in all clinical areas of [HOSPITAL NAME] by Physicians, RN’ s, L VN’ s and Respiratory Therapists. ... Administration of Medications: ... a) Check order for Medication, on the EMAR [Electronic Medication Administration Record] ... (1) If any questions exist, or the order is unclear, check with the Provider for clarification. ... “”

“NURSING SERVICES CFR(s): A nursing care plan must be developed and kept current for each inpatient. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to ensure nursing staff developed and kept current a nursing care plan when Licensed Nurses (LNs) did not assess and develop a complete care plan for six of six patients sampled (Patients (Pt) 5, 6, 7, 8, 9, and 10) in accordance with hospital policy and procedure (P&P) titled, “Patient Plan of Care” and the hospital “Registered Nurse Job Description”. These failures had the potential to result in patient’s needs going unmet and could lead to a decline in health status. Findings: During a concurrent interview and record review on 3/12/25 at 10:47 a.m. with the Director of Nursing (DON), Pt 6’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 2/6/25 at 9:31 a.m., Pt 6’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), and Pt 6’s “electronic health records” (EHR), were reviewed for Pt 6’s admission dated 2/6/2025. The “H&P” indicated Pt 6 had a past medical history of high blood pressure, atrial fibrillation (an irregular heartbeat), chronic kidney disease, congestive heart failure (when the heart backs up with fluid), and admitted to a swing bed for rehabilitation. The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During a concurrent interview and record review on 3/12/25 at 10:50 a.m. with the DON, Pt 5’s “History & Physical”, dated 3/11/25 at 10:50 a.m., Pt 5’s “Face sheet”, and Pt 5’s “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 3/11/2025. The “H&P” indicated Pt 5 had a past medical history of seizures, high blood pressure and chief complaint of aspiration pneumonia (lung infection that occurs when a foreign substance is inhaled into the lungs). The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During a concurrent interview and record review on 3/12/25 at 11:35 a.m. with the DON, Pt 8’s “History & Physical”, dated 3/12/25 at 9:11 a.m., Pt 8’s “Face sheet”, and Pt 8’s “electronic health records” (EHR), were reviewed for Pt 8’s admission dated 3/11/2025. The “H&P” indicated Pt 8 had a past medical history diabetes mellitus (a disorder where the body does not control the amount of glucose in the blood), high blood pressure, coronary artery disease (were the arteries that supply blood to the heart become narrowed or blocked), chronic kidney disease,), and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During a concurrent interview and record review on 3/12/25 at 2:00 p.m. with the DON, Pt 9’s “History & Physical”, dated 12/18/24 at 9:43 a.m., Pt 9’s “Face sheet”, and Pt 9’s “electronic health records” (EHR), were reviewed for Pt 9’s admission dated 12/20/2024. The “H&P” indicated Pt 9 had a past high blood pressure, coronary artery disease, pneumonia, coronary artery bypass grafting (open heart surgery to increase blood flow to the heart) of 12/3/24, atrial fibrillation, chronic kidney disease, and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During a concurrent interview and record review on 3/12/25 at 2:18 p.m. with the DON, Pt 10’s “History & Physical”, dated 1/10/25 at 3:57 p.m., Pt 10’s “Face sheet”, and Pt 10’s “electronic health records” (EHR), were reviewed for Pt 10’s admission dated 1/10/2025. The “H&P” indicated Pt 10 had a past medical history of infection related to COVID, dementia, and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During a concurrent interview and record review on 3/13/25 at 9:55 a.m. with Registered Nurse (RN) 3, Pt 10’s “History & Physical”, dated 1/10/25 at 3:57 p.m., Pt 10’s “Face sheet”, and Pt 10’s “electronic health records” (EHR), were reviewed for Pt 10’s admission dated 1/10/2025. RN 3 stated, she could not find any documentation of nursing interventions in the care plan as she looked in the record from 2/7/24 to 3/13/24. RN 3 stated, she was able to locate the different nursing diagnoses and problems and the related goals for prevention of falls, impaired skin integrity, risk for aspiration, pain, risk for elopement and self-care deficit but no associated nursing interventions. RN 3 stated, the nursing care plan is important as it guides the overall care of the patient and we use it as a map to the care of the patient. During a concurrent interview and record review on 3/13/25 at 11:20 a.m. with the DON, Pt 7’s “History & Physical”, dated 2/13/25 at 7:00 a.m., Pt 7’s “Face sheet”, and Pt 7’s “electronic health records” (EHR), were reviewed for Pt 7’s admission dated 2/12/2025. The “H&P” indicated Pt 7 had a past medical history of diabetes, obesity, chronic venous ulcers (wounds that form on the legs due to poor blood circulation) left above knee amputation, bedbound, and was admitted to treat an infected Stage III sacral decubitus ulcer (wound on buttocks). The DON stated, the nursing care plan had the problem foci and the goals but the interventions were not developed or updated in the medical record. During an interview with the DON on 3/13/25, at 5:15 p.m., the DON stated, nursing care plans are important for the care of the patient. The DON stated, LNs were expected to follow hospital policy and procedure to develop, document and update the care plan to meet the patients’ care needs. During a review of the facility P&P titled, “Patient Plan of Care”, dated 10/19/23, the P&P indicated, “ ... The plan of care will be individualized to the patient’s condition or needs and will be developed with the patient, significant others and other members of the Health Care team, as appropriate. d. The plan of care will be based upon problems/potential problems derived from the assessment data collected on admission. e. The plan of care will include the interventions necessary to achieve the expected outcome. f. The plan of care and the patient’s progress toward the attainment of the outcome is systematic and ongoing. ... Desired patient outcomes will be specified on the plan of care. 5. Nursing actions will be specified to reach desired patient outcome. 6. At time of patient’s admission, discharge goals will be identified and incorporated into the plan of care. ... 8. During the course of hospitalization, the nursing care plan will be reviewed each shift with additional documentation, updates added by appropriate licensed personnel, RN, LVN or other members of the interdisciplinary team. 9. Patient problems or nursing actions that are resolved and deemed no longer necessary will be marked resolved in the EMR documenting the date and time the goal was obtained.10. As new problems and/or nursing actions are identified during the patient’s hospitalization, they will be added to the care plan. The EMR timestamp of each entry will give a clear outline of progress. ... “ During a review of the hospital’s document titled, “ Registered Nurse (Acute) Job Description” dated 2/9/24, indicated, “ ... Nursing Service maintains the delivery of quality care by assuring the nursing care plan is followed. In collaboration with the provider, the RN assures implementation of the assessment plan, evaluation, and follows up the plan of care for the patient population. ... Interprets assessment data and information to develop a nursing care plan which contains problem identification, nursing diagnosis, nursing orders, approaches, interventions, short/long term goals, and discharge planning. ... a) Develops nursing care plan utilizing nursing diagnosis ... “. The “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ ...Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...””

“INFECTION PREVENT SURVEIL & CONTROL OF HAIs CFR(s): The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection according to hospital’s policy and procedures, and the Center’s for Disease Control and Prevention’s (CDC) standards of practice for infection when: 1.In one of three sampled Clean Storage Rooms, clean patient care supplies were found on shelves in proximity to the floor; the bottom shelf of the storage cabinet did not have a solid base. 2.One of one sampled prefilled medical oxygen humidifier (a device that adds moisture to supplemental oxygen, preventing dryness and irritation of the respiratory passages, especially during oxygen therapy) was hanging three days past the date it should be discarded and the connected oxygen tubing had no date and not in accordance with hospital policy, “Oxygen Therapy - Respiratory Therapy Department.” These failures placed all patients and staff at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Findings: 1. During a concurrent observation and interview, on 3/11/25, at 11:25 p.m., with the Director of Quality (QD), in the clean utility room for clean supplies, the bottom shelf of a wire shelving unit for clean medical supplies was observed to be without a solid base. A cardboard box with clean supplies was noted on the bottom shelf. The QD stated, a mop could fit under the shelving unit to clean underneath and dirty water could touch the boxes. The QD stated, the floors should be swept and mopped daily and as needed, including under the shelving units. During an interview, on 3/11/24, at 11:55 a.m., with the QD, the QD stated, he is the Infection Control Manager for the hospital. The QD stated, the bottom shelf should have a solid base to prevent contaminated water from contacting clean supplies. The QD stated, the bottom shelfs should consistently have a plastic bin or sold bottom for the clean supplies to prevent cross contamination. 2. During a concurrent observation and interview, on 3/13/25, at 10:14 p.m., with the QD and Licensed vocational nurse (LVN) 1, in the room of Patient 11, an opened prefilled medical oxygen humidifier was connected to oxygen tubing. The equipment had a sticker indicating, “opened 3/3/25”. The oxygen tubing had no sticker and date. The QD stated, he does not know when the humidifier should be discarded and replaced. Licensed Vocational Nurse (LVN) 1 stated, she did not know when the humidifier is changed and the respiratory department is responsible to date and change. During a concurrent interview and record review on 3/14/25 at 12:45 p.m. with the QD, the hospitals policy and procedure (P&P) titled, “Oxygen Therapy - Respiratory Therapy Department”, dated 5/1/20, was reviewed. The QD stated, the policy had a blank number for when the oxygen humidifier should be changed. The QD stated, the policy will be revised to indicate seven days the humidifier should be changed. During an interview, on 3/26/25, at 2:45 p.m., with the Respiratory Care Manager (RCM), the RCM stated, “we change them [oxygen humidifier] when the water is used up.” The RCM stated, the bottle was labeled because that is what the nurse did at her previous employment. The RCM stated, we do not usually date the humidifiers. The RCM stated, we try to change the oxygen tubing once a week or if it is dirty. The RCM stated, we do not date the tubing and would not know if it had been changed if not date is present. The RCM stated, there is not policy about dating the oxygen tubing. During a review of the hospital’s P&P titled, “Oxygen Therapy - Respiratory Therapy Department”, dated 5/1/20, the policy indicated, “ ... To provide and establish guidelines for the use of oxygen therapy oxygen ... Fill the humidifier with sterile water (if required) ... The set-up and operation of the oxygen will be the responsibility of Respiratory Care Practitioners and Licensed Nursing Personnel ...Steps ... 3. Date the humidifier bottle. ... Ensure that humidifiers are changed [sic] [blank] every days or when the fluid falls below the minimum fill line ...” During a review of the facility’s policy and procedure titled, “Infection Control Plan”, dated 1/2025, the policy indicated, “... The goal of the Infection Control Program is to reduce the risk of acquisition and transmission of healthcare associated infections. ... Prevention: Implementation of methods to prevent transmission of infectious agents and to reduce risks for device-related and procedure-related infections ... Utilizing sound epidemiologic principles and HAI research from recognized authoritative agencies. ... PROGRAM ELEMENTS: ... Healthcare workers in-service education related to infection control practices, to ensure a safe environment for patients and healthcare workers. ...” During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, “Guidelines for Environmental Infection Control in Health-Care Facilities,” dated 7/2019, the professional reference indicated, “ ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations...”.”

“QAPI CFR(s): (b) Standard: QAPI Program Design and scope. The CAH’s QAPI program must: (2) Be ongoing and comprehensive. (3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement). This Standard is not met as evidenced by: 37529 Based on interview and record review the hospital failed to develop and maintain a quality assessment and performance improvement (QAPI) program which included all departments and services when: 1. Data regarding CT scan usage in the Emergency Department was not collected, monitored and analyzed for frequency of orders in relationship to number of emergency department (ED) visits for the department and by individual physician; and the indications for the scans were not evaluated for appropriateness in accordance with nationally accepted evidence-based guidelines. This resulted in a missed opportunity to identify trends and develop and implement strategies to reduce patient exposure to radiation. 2. Services provided by contracts were not monitored for compliance with contract terms, hospital policy, or bylaws, and were not evaluated to ensure the needs of the patients were being met. This resulted in non-compliance with requirements for physician oversight of care provided to inpatients, and documentation of therapy services provided. 3. Quality indicators were not identified and monitored for Therapy Services (physical therapy, occupational therapy, and speech therapy) provided to inpatients. This resulted in a missed opportunity to identify areas for improvement and/or to demonstrate effectiveness of the therapy program in improving patient’s functional status. 4. Data in high-risk, high-volume and problem-prone areas such as the Emergency Department (ED) and Medical-Surgical units was not used to identify opportunities for improvement and implement changes that will lead to improvement. This failure resulted in a delay in implementing improvement measures that could affect health outcomes and patient safety. Findings: 1. During a concurrent interview and record review, on 3/18/25, at 4:40 p.m., with the radiology department manager (MRD), the Radiology Quality Assessment Performance Improvement (QAPI) Plan was reviewed. The QAPI plan included Emergency Department (ED) data regarding the number of CT scans, x-rays, and ultrasounds performed each month, starting in 10/2024. The 2024 data indicated there were 354 CT scans performed in 10/2024, 571 in 11/2024, and 355 in 12/2024. The data report indicated, “CT exams have increased from 866 in quarter (Q)1 to 1280 in Q 4.” The “Plan” was “Track number of exams” and “See if there are trends.” In 2025, the monthly CT, x-ray, and ultrasound data was further divided by ordering physician, and a separate category of CT scans on pediatric patients (under 15 years old) without trauma was reported by month and by ordering physician. The “Plan” for the pediatric category was “Try and reduce radiation to pediatric patients without trauma” and “track progression and trends.” The plan also indicated “correlate with radiologist if need be and possible alternate orders per symptoms with radiologist.” The MRD stated he doesn’t have information regarding how many CT scans are performed each month or each quarter compared to how many patients there were during that same time period, and the same applied to the usage of ultrasound and x-ray. The MRD stated he did not have information regarding how many scans each physician ordered compared to how many patients each physician saw in the ED, in order to have some context in which to interpret the data. The MRD stated the same is true as far as CT scans for pediatric patients, the data reported is simply the number of the tests ordered by each physician. The MRD stated he does not have a benchmark for comparison, such as the average CT scan usage per patient across the state or country, in order to help identify if the usage is significant or not. The MRD stated they had not evaluated the indications for the CT scans or compared the indications to evidence based guidelines such as the American College of Radiology (ACR- a professional medical society) Appropriateness Criteria (AC- comprehensive evidence-based guidelines for diagnostic imaging and image guided interventional procedures for numerous clinical conditions). Review of the professional reference from the American Academy of Pediatrics journal article titled, “Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department,” PEDIATRICS Volume 154, number 1, July 2024, the reference indicated, “ ...Diagnostic imaging is an important tool frequently used in the emergency department (ED), and 1 out of every 4 children evaluated in the ED receives some type of imaging. Imaging for children evaluated in the ED has increased over time without improvements in patient outcomes. These patterns have called into question the appropriateness of use of imaging, and many studies have demonstrated that much of the advanced imaging performed in EDs in children is low value, with the risks outweighing the net patient benefit. Risks specific to imaging include those from radiation exposure, false-positive and incidental findings and the downstream testing that may result, increases in ED length of stay, sedation, transport away from the ED, and overall health care costs ... There are different imaging strategies for common pediatric conditions, and optimizing imaging for children is an important consideration as part of overall emergency care. Such optimization includes use of evidence-based guidelines, including those embedded as part of clinical decision support, to minimize low-value studies in patients who can be safely observed; reducing radiation exposure by using pediatric-specific dosing protocols for CT; providing alternatives to CT, specifically ultrasonography ...” Review of the journal Current Problems in Diagnostic Radiology article titled, “Appropriateness of Computed Tomography [CT] and Ultrasound [US] for Abdominal Complaints in the Emergency Department,” dated 11/2021, the article indicated orders for CT and US were reviewed for appropriateness using evidence-based recommendations by the American College of Radiology. “ ...The rate of inappropriate orders was 36.3% for CT and 84.4% for US. The final report of appropriate orders was significantly more likely to demonstrate findings compatible with the initial diagnosis for both CT and US. Inappropriately ordered CT scans were more likely to show no abnormalities. An additional imaging order with a secondary modality was requested in 20% of the inappropriate US orders, and 8.2% of the inappropriate CT orders ...” 2. During a concurrent interview and record review, on 3/18/25, at 2:15 p.m., the QD was unable to provide evidence that the services provided to the hospital by contract or agreement were evaluated as part of the QAPI plan activities. Review of the “Quality Committee Minutes” dated 6/28/24, 11/27/2024, 12/20/24 and 1/30/25, and quality dashboards, did not indicate the contracted services: Therapy, Hospitalist Services, Medical Director of ED and Respiratory Care, Hospitalist Medical Director, Nutrition Services, Linen, Emergency Department Physicians, Nurse Practitioner Hospitalists, Physician Assistant Hospitalist, (Tele)Radiology and Radiology Services, Medical Waste, Medical Gas, and Medical Equipment Maintenance were evaluated. 3. During a concurrent interview and record review on 3/18/25 at 3 p.m. with the QD, the QD stated the physical therapy department was trying to getting the rehabilitation notes to the nurses and providers and had developed a plan. Review of the dashboard data indicated the quantity of patients seen by rehabilitation services were reported each month, and not data related to improvement in communication or access to the therapy notes. The “Quality Committee Minutes” dated 6/28/24, 11/27/2024, 12/20/24 and 1/30/25, indicated there were no other QAPI activities which reflected Therapy department monitoring or outcomes. 4. During concurrent interview and record review on 3/18/25, at 2:15 p.m., with the Director of Quality (QD), the following hospital policies and Procedures (P&P), “Quality Management Plan”, dated 1/2025, and “Conducting Root Cause Analysis [RCA]”, dated 5/24, and the “Quality Committee Minutes” dated, 6/28/24, 11/27/2024, 12/20/24 and 1/30/25, and “Dashboards”, 2024 and 2025, were reviewed: a. There was no interdisciplinary annual evaluation of distinct quality management projects. The QD stated, the different departments decide on what they will report to the Quality Committee and the Quality Committee reports the information to the Governing Body. The QD stated, the Governing Body did not provide any projects for the Quality Committee to work on. The QD stated, the “Quality Management Plan” was the policy that was revised every year for the annual review. The QD stated, PDCA [Plan-Do-Check-Act] was used to develop improvement plans for the hospital and guided each departments improvement plan. The QD stated the Governing Body reviews the minutes and approves what the committee does. The QD did not provide evidence this had occurred. b. The Safety/Environment of Care Committee did not identify a high-risk safety process for proactive risk assessment. The QD stated, “I can only think of the new cardiac telemetry system was upgraded because the equipment needed to be replaced but it was not part of Quality Management Committee.” c. He is also the Risk Manager for the hospital. The QD stated, no RCA’s had been conducted in the last two years. The QD stated, he could not provide any reports of RCA’s that had been conducted. The QD stated, he has not been told about any RCAs. d. He is also the Infection Prevention Practitioner. The “Dashboards”, dated 2024 and 2025, indicated for Infection Prevention, compliance with hand hygiene policy was being monitored. Review of the monthly results for all of 2024 indicated for each month there was 100% compliance, and for January and February 2025 there was 100% compliance each month. The QD stated he asked a nurse leader to do observations of staff and return the results to him. The QD could not provide the numerator or dominator for the number of observations. The QD stated, he does not understand the term “interrater reliability” and assumed the instructions were self-explanatory for the nurse leader to understand. The QD stated, he trusted the data. The QD stated, he did not understand the term “benchmark” and had no data to compare to the hospital’s data. The QD stated he felt since the organization was doing so well he wished they would not have to track the data anymore. e. The hospital had 3 cases of patients with Clostridioides Difficile infection (C-diff, an infection of the colon that leads to diarrhea and inflammation of the colon) for 2024. The “Dashboards”, dated 2024 and 2025, indicated, “Infection Prevention ... C.diff ...January 0 ... February 2 ... March 0 ... April 0 ... May 0 ... June 0 ... July 0 ... August 0 ... September 0 ... October 0 ... November 0 ... December 1 ... 2025 ... January 0 ... February 0 ... “. The QD stated, he felt they were doing very good in this area. The QD stated, he did not understand the term “rate” or by expressing the cases by number of total patient days. The QD stated, he does not have a comparison number to determine how the hospital is performing. f. He is in charge of Patient Grievances/Complaints. The QD only provided one grievance for December 31, 2024. The QD stated he has no other complaints tracked and monitored and this was something they will have to work on. The “Dashboards” dated, 2024 and 2025, indicated, Patient Satisfaction: ...The QD stated nurse leaders do patient rounding and ask a set of five questions and record the responses. The five questions were: Were you treated with respect?, Did a Staff member attend you at least once?, Did Staff attend your call light very quickly?, Do the nurses tell you what medication you will be given and what are the uses? Review of the results by month for 2024 for each of the five questions indicated seven of the twelve months in 2024 were 100%, and five of the months in 2024 were BLANK. For 2025, January 2025 was 100% for all five questions, and February 2025 was blank. The QD stated sometime last year the leadership team was looking into obtaining a contract with a third party for patient satisfaction and that is why the data was not collected for the fourth quarter of 2024. The “Quality Committee Minutes”, dated 1/30/25, indicated “ ... Patient satisfaction: Still doing, good Q2 still going a hundred percent. No date on Q3 and Q4 but it does not [define] we are doing bad it’s just new process will be implemented. Overall we are a 100% ...” The QD could not provide the number of patients that have been sampled or asked the questions. The QD stated he does not understand the term “interrater reliability” and assumed the instructions were self-explanatory for the nurse leader to understand. The QD stated he had no data to compare to the hospital’s data. The QD stated, no one was concerned about no data being reported for the six of the fourteen months. During a review of the hospital documents titled, the “Quality Committee Minutes” 6/28/24, 11/27/24, 12/20/24 and 1/30/25, the meeting minutes did not identify any Root Cause Analysis’s (RCA) or other Performance Improvement (PI) projects for addressing ongoing problems related to medication errors, patient satisfaction, and rehabilitation documentation. During a record review of the hospital document titled, “Quality Management Plan”, dated 1/2025, the plan indicated, “ ...PURPOSE: ... [Name] shall ensure that the Governing Body, medical staff and professional service staff demonstrate a consistent endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk... The organizational program, established by the medical staff and interdisciplinary Quality management Committee, with support and approval from the Governing Body, shall have the responsibility for monitoring every aspect of patient care and service (including contracted services), from the time the patient enters the hospital through diagnosis, treatment, recovery and discharge in order to identify and resolve any breakdowns that may result in suboptimal patient care and safety, while striving to continuously improve and facilitate positive patient outcomes...Track the status of identified problems and action plans to assure improvement or problem resolution... Detect trends, patterns of performance or potential problems that affect more than one ... department/service using information from departments/services and the findings of discrete quality management activities and adverse patient events... These indicators shall be objective, measurable, based on current knowledge and experience and shall be structured to produce statistically valid, data driven, performance measures of care provided. This mechanism shall also provide for evaluation of improvements and the stability of the improvement over time...The Governing Body shall require the detail and frequency of data collection for all indicators and performance processes as outlined in this plan (i.e., reporting of all patient care and service indicators to the Patient Safety Committee on a monthly basis). As outlined in this plan, the Governing Body shall further delegate the authority for data analysis, evaluation, action determination, implementation and outcome evaluation to the individuals, departments and committees listed in this plan...The Governing Body shall provide for resources and support systems for the quality management system functions and risk management functions related to patient care and safety... The Governing Body shall have a responsibility to evaluate the effectiveness of the quality management activities performed throughout the hospital and the organizational quality management program as a whole... With designated responsibility from the Quality Management Committee, the Safety/Environment of Care Committee shall operate as an independent committee dedicated to implementation and monitoring of the effectiveness of the Patient Safety Program. The scope of the Patient Safety Program shall include an ongoing assessment, using internal and external knowledge and experience, to prevent error occurrence, maintain and improve patient safety. Patient safety occurrence information from aggregated data reports and individual occurrence reports shall be reviewed by the Safety/Environment of Care Committee to prioritize organizational patient safety activity efforts. Included in the duties of the Safety/ Environment of Care Committee shall be a review of these data reports1 and through use of the quality management priority criteria grid, the committee shall select at least one (1) high-risk safety process for proactive risk assessment annually. ... Benchmarks or thresholds that trigger intensive assessment and evaluation shall be established. Undesirable patterns or trends in performance shall be analyzed for all of the above; however, an in-depth analysis shall be conducted for the following when the levels of performance, patterns or trends vary substantially from those expected ... Check:... Assess care when benchmarks or thresholds are reached in order to identify opportunities to improve performance or resolve problem areas... ANNUAL EVALUATION AND APPROVAL: ...To assure that the appropriate approach to planning processes of improvement; setting priorities for improvement; assessing performance systematically; implementing improvement activities on the basis of assessment; and maintaining achieved improvements, the organizational quality management program shall be evaluated for effectiveness at least annually, including the identification of the number of distinct quality management projects, and revised as necessary...” A review of the National Institute of Health, “Methods of Quality Assessment and Assurance” located at https://www.ncbi.nlm.nih.gov/books/NBK235459/, indicated, “... A quality assurance program can have several purposes, each of which may be emphasized to varying degrees. In working toward its goals, a quality assurance program can try to prevent problems from occurring, detect and correct those problems that do occur, and encourage higher standards of care. It can attempt to remove or rehabilitate poor practitioners and providers, improve the average level of practice, reward excellence, or use some combination of those goals. The methods used in a quality assurance program may be as sharply focused as finding and reacting to isolated events involving a single patient and practitioner, such as a surgical mishap. They may be as broad as conducting continuing education, disseminating practice guidelines, initiating institution-wide “continuous improvement,” designing management information systems with uniform clinical data elements, and conducting research on effectiveness at a national level. Ideally, the choice of methods for a strategy for Medicare quality review and assurance should be based on an assessment of the burdens of harm from different quality problems,... an understanding of important features of health delivery systems that affect our current ability to measure care and effect change... the strengths and limitations of major methods of quality assessment...” A review of the U.S. Department of Veteran Affairs, VHA National Center for Patient Safety, “Root Cause Analysis,” located at https://www.patientsafety.va.gov/professionals/onthejob/rca.asp, indicated “... a multi-disciplinary team approach, known as Root Cause Analysis - RCA - to study health care-related adverse events and close calls. The goal of the RCA process is to find out what happened, why it happened, and how to prevent it from happening again... RCA teams investigate how well patient care systems function. We focus on the “how” and the “why”? not on the “who”. Through the application of Human Factors Engineering (HFE) approaches, we aim to support human performance... The goal of an RCA is to find out: What happened...Why did it happen...How to prevent it from happening again...The RCA process is: Inter-disciplinary, involving experts from the frontline services...Involving of those who are the most familiar with the situation...Continually digging deeper by asking why, why, why at each level of cause and effect...A process that identifies changes that need to be made to systems...A process that is as impartial as possible ...” A review of the Agency for Healthcare Research and Quality -Patient Safety Network, “Patient Safety 101 - Root Cause Analysis”, located https://psnet.ahrq.gov/primer/root-cause-analysis indicated, “... Root cause analysis (RCA) is a structured method used to analyze serious adverse events. Initially developed to analyze industrial accidents, RCA is now widely deployed as an error analysis tool in health care. A central tenet of RCA is to identify underlying problems that increase the likelihood of errors while avoiding the trap of focusing on mistakes by individuals. RCA thus uses the systems approach to identify both active errors (errors occurring at the point of interface between humans and a complex system) and latent errors (the hidden problems within health care systems that contribute to adverse events). It is one of the most widely used retrospective methods for detecting safety hazards... RCAs should generally follow a prespecified protocol that begins with data collection and reconstruction of the event in question through record review and participant interviews. A multidisciplinary team should then analyze the sequence of events leading to the error, with the goals of identifying how the event occurred (through identification of active errors) and why the event occurred (through systematic identification and analysis of latent errors)...The ultimate goal of RCA, of course, is to prevent future harm by eliminating the latent errors that so often underlie adverse events ...””

“NOTICE OF RIGHTS CFR(s): A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under state law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to ensure patients were informed of the patient’s rights when the hospital did not inform two of six patients sampled (Patient (Pt) 5 and Pt 8) of their rights in accordance with hospital policy and procedure (P&P) titled, “Patient Rights and Responsibilities”. These failures had the potential to result in patients not exercising their rights, (i.e. patient rights include the right to respectful care, right to communicate with providers about the plan of care, informed consent, privacy, visitation, access to medical records, the right to refuse treatment, to be free from discrimination, and right to complain about care received) their needs going unmet and could possibly lead to a decline in health status Findings: During a concurrent interview and record review on 3/12/25 at 10:50 a.m. with the DON, Pt 5’s “History & Physical”, dated 3/11/25 at 10:50 a.m., Pt 5’s “Face sheet”, “Consent for Admission/Consent for Treatment [COA]” dated 3/11/25 and Pt 5’s “electronic health records” (EHR), were reviewed for Pt 5’s admission dated 3/11/2025. The “H&P” indicated Pt 5 had a past medical history of seizures, high blood pressure and chief complaint of aspiration pneumonia (lung infection that occurs when a foreign substance is inhaled into the lungs). The DON stated, the COA did not indicate that the patient was informed of their rights when they were admitted for an acute admission. The DON stated, no other place in the medical record is their documentation the patient was informed of their rights. During a concurrent interview and record review on 3/12/25 at 11:35 a.m. with the DON, Pt 8’s “History & Physical”, dated 3/12/25 at 9:11 a.m., Pt 8’s “Face sheet”, “[COA]” dated 3/7/25 and Pt 8’s “electronic health records” (EHR), were reviewed for Pt 8’s admission dated 3/11/2025. The “H&P” indicated Pt 8 had a past medical history diabetes mellitus (a disorder where the body does not control the amount of glucose in the blood), high blood pressure, coronary artery disease (were the arteries that supply blood to the heart become narrowed or blocked), chronic kidney disease,), and was admitted to a swing bed admission for close monitoring and management of medical conditions. The DON stated, the COA did not indicate that the patient was informed of their rights when they were admitted for an acute admission. The DON stated, no other place in the medical record is their documentation the patient was informed of their rights. During a concurrent interview and record review on 3/12/25 at 11:35 a.m. with the Admission’s Specialist (AS), a blank “[COA]”, not dated, and “Patient Rights”, dated 3/17, were reviewed. The AS stated, we give the “Patient Rights” document to the patients but noted that the “[COA]” does not indicate that this action was done. The AS stated, she would immediately work to correct the form to indicate what actually occurs. During a review of the facility P&P titled, “Patient Rights and Responsibilities,” dated 5/1/20, the P&P indicated, “ ... [HOSPITAL NAME] respects the rights of the patient, recognizes that each patient is an individual with unique health care needs and because of the importance of respecting each patient’s personal dignity, provides considerate, respectful care focused upon the patient’s individual needs. ... [HOSPITAL NAME] affirms the patient’s right to make decisions regarding his/her medical care, ... [HOSPITAL NAME] will assist the patient in the exercise of his/her rights and informs the patient of any responsibilities incumbent upon him/her in the exercise of those rights. including the decision to discontinue treatment, the extent permitted by law. ... “ During a professional reference review retrieved from https://www.americanpatient.org/aha-patients-bill-of-rights/ titled, “AHA [American Hospital Association Patient’s Bill of Rights,” dated 7/2019, the professional reference indicated, “ ... AHA Patient’s Bill of Rights ... These rights can be exercised on the patient’s behalf by a designated surrogate or proxy decision-maker if the patient lacks decision-making capacity, is legally incompetent, or is a minor. ... 1. The patient has the right to considerate and respectful care. ... 2. The patient has the right to and is encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information concerning diagnosis, treatment, and prognosis. ... 3. Except in emergencies when the patient lacks decision-making capacity and the need for treatment is urgent, the patient is entitled to the opportunity to discuss and request information related to the specific procedures and/or treatments, the risks involved, the possible length of recuperation, and the medically reasonable alternatives and their accompanying risks and benefits. ... 4. Patients have the right to know the identity of physicians, nurses, and others involved in their care, as well as when those involved are students, residents, or other trainees. ... 5. The patient also has the right to know the immediate and long-term financial implications of treatment choices, insofar as they are known. ... 6. The patient has the right to make decisions about the plan of care prior to and during the course of treatment and to refuse a recommended treatment or plan of care to the extent permitted by law and hospital policy and to be informed of the medical consequences of this action. In case of such refusal, the patient is entitled to other appropriate care and services that the hospital provides or transfer to another hospital. The hospital should notify patients of any policy that might affect patient choices within the institution. ... 7. The patient has the right to have an advance directive (such as a living will, health care proxy, or durable power of attorney for health care) concerning treatment or designating a surrogate decision-maker with the expectation that the hospital will honor the intent of that directive to the extent permitted by law and hospital policy. Health care institutions must advise patients of their rights under state law and hospital policy to make informed medical choices, ask if the patient has an advance directive, and include that information in patient records. The patient has the right to timely information about hospital policy that may limit its ability to implement fully a legally valid advance directive. ... 8. The patient has the right to every consideration of privacy. Case discussion, consultation, examination, and treatment should be conducted so as to protect each patient’s privacy. ... 9. The patient has the right to expect that all communications and records pertaining to his/her care will be treated as confidential by the hospital, except in cases such as suspected abuse and public health hazards when reporting is permitted or required by law. The patient has he right to expect that the hospital will emphasize the confidentiality of this information when it releases it to any other parties entitled to review information in these records. ... 10. The patient has the right to review the records pertaining to his/her medical care and to have the information explained or interpreted as necessary, except when restricted by law. ... 11. The patient has the right to expect that, within its capacity and policies, a hospital will make reasonable response to the request of a patient for appropriate and medically indicated care and services. The hospital must provide evaluation, service, and/or referral as indicated by the urgency of the case. When medically appropriate and legally permissible, or when a patient has so requested, a patient may be transferred to another facility. The institution to which the patient is to be transferred must first have accepted the patient for transfer. The patient must also have the benefit of complete information and explanation concerning the need for, risks, benefits, and alternatives to such a transfer. ... 12. The patient has the right to ask and be informed of the existence of business relationships among the hospital, educational institutions, other health care providers, or payers that may influence the patient’s treatment and care. ... 13. The patient has the right to consent to or decline to participate in proposed research studies or human experimentation affecting care and treatment or requiring direct patient involvement and to have those studies fully explained prior to consent. A patient who declines to participate in research or experimentation is entitled to the most effective care that the hospital can otherwise provide. ... 14. The patient has the right to expect reasonable continuity of care when appropriate and to be informed by physicians and other caregivers of available and realistic patient care options when hospital care is no longer appropriate. 15. The patient has the right to be informed of hospital policies and practices that relate to patient care, treatment, and responsibilities. The patient has the right to be informed of available resources for resolving disputes, grievances, and conflicts, such as ethics committees, patient representatives, or other mechanisms available in the institution. The patient has the right to be informed of the hospital’s charges for services and available payment methods. ... “”

“GRIEVANCES CFR(s): The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to have a grievance process that clearly tracked and monitored the progress of resolving grievances submitted by patients and family in accordance with the hospital policy and procedure. These failures resulted in not ensuring all patients’ right to prompt resolution of grievances and could negatively affect the quality of care to patients due to not thoroughly investigating quality of care concerns. Findings: During a concurrent interview and record review on 3/12/25, at 10:00 a.m., with the Director of Quality (DQ), the complaint/grievance log for the last six months was reviewed. Only one grievance was listed for December 31, 2024 about Pt 17. The DQ stated, only formal grievances were being tracked and complaints were not being tracked or logged. The DQ stated, all other complaints were resolved on the spot or immediately by the person the patient may have complained to and are not logged. The DQ stated, they are not tracking the complaints that are resolved. The DQ stated, he has not received patient complaints from the staff. The DQ stated, the hospital’s policy and procedure, “Patient complaint and grievance process”, outlines that staff or patients can submit a complaint to him via email or verbally tell him. During a concurrent interview and record review on 3/18/25, at 10:16 a.m., with the DQ, the hospital’s policy and procedure, “Patient complaint and grievance process”, dated 1/2025, was reviewed. The DQ stated, since no data is collected as per policy, it is hard to determine what we need to improve. During an interview on 3/18/25 at 11:25 a.m. with the Director of Nursing (DON), the DON stated, issues about complaints and grievances have been reported to him and he will resolve them. The DON stated, he does not report patient complaints to DQ to allow the information to be tracked and monitored. During a review of the hospital’s policy and procedure, “Patient complaint and grievance process”, dated 1/2025, the record indicated, “ ...Complaint: Concern raised by the patient about the quality of care or services provided by staff, practitioners or contracted agents of the organization. ... Grievance: 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, abuse or neglect, issues related to the hospital’s compliance with the CMS Hospital Conditions of Participation (CoP) or accrediting organization standards, or a Medicare beneficiary billing complaint related to rights and limitations. ... Patient complaint files shall be securely stored and maintained by administration. All complaint information shall be documented on the Patient Complaint Form and retained for a period of not less than seven (7) years. Complaints shall be aggregated and reported to the Quality Committee at least quarterly. The Quality Committee shall evaluate trends and recommend actions to eliminate root causes of dissatisfaction. Quality Committee shall also monitor the timeliness of the complaint process. ... “”

“RESTRAINT AND SECLUSION CFR(s): All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 45977 Based on observation, interview and record review, the hospital failed to ensure patients were free from restraints and to ensure restraints were discontinued at the earliest possible time when Licensed Nurses (LN) did not implement every two-hour monitoring for one of two patients (Pt 11) to determine if the restraints could be released in accordance with hospital policy and procedure (P&P). These failures allowed Pt 11 to go unmonitored, which could have caused injury from restraints and violated Pt 11’s right to be free of restraint use and to be released from restraints at the earliest possible time in the event restraints are needed for care Findings: During a concurrent observation and interview on 3/13/25, at 10:14 a.m., with Pt 11 and LVN 1, Pt 11 was observed lying in bed and watching television. Pt 11 was not in distress and had mitten restraints applied to both hands. Pt 11 did not respond to staff. Pt 11 had a foley catheter and PEG tube in place. Pt 11 had dressing to his neck. LVN 1 stated she checks the restraints every two hours and documents that circulation is not compromised to the patient’s hands. During a concurrent interview and record review on 3/12/25 at 2:35 p.m. with the Director of Nursing (DON), Pt 11’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 1/2/25 at 2:00 p.m. and Pt 11’s “Progress note”, dated 3/11/25 at 2:05 p.m. were reviewed. The “H&P” indicated Pt 11 had a past medical history of cerebrovascular accident (stroke or parts of the brain cells had died), chronic respiratory failure, a tracheostomy (an opening in the windpipe to allow air to enter the lungs) tube, percutaneous endoscopic gastrostomy tube (PEG - a feeding tube inserted into the stomach through the abdominal wall), chronic foley catheter (a tube inserted into the bladder to allow for drainage of urine) and multiple other medical conditions. The “Progress note” indicated Pt 11 was nonverbal, not able to follow commands, pulls at his tracheostomy tube, had a history of pulling out his tracheostomy tube, and had mitten restraints placed to prevent pulling at medical devices. During a concurrent interview and record review on 3/12/25 at 10:05 a.m. with the DON, Pt 11’s “Restraint Monitoring Flowsheet (RMF),” dated 3/10/25 to 3/11/25 were reviewed. The “RMF” indicated Pt 11 was on two-point (a mechanical restraint that restricts a patient’s wrist movement) soft limb (soft materials for arm or leg) restraints that had continued from a previous shift. DON stated LNs documented monitoring assessments of Pt 11 every two hours on 3/10/26. DON stated Pt 11’s “RMF” indicated on 3/10/25 at 8:00 a.m. LNs documented Pt 11’s restraints were continued. Pt 11’s “RMF” indicated on 3/10/25 at 3 p.m. Pt 11 had two-point (restraining both wrists) soft limb restraints applied, and LNs completed the two-hour monitoring documentation until 6 p.m. DON stated Pt 11’s “RMF” indicated LNs did not document the two-hour assessment on 3/10/26 at 6 p.m. until 3/11/25 at 8 a.m. DON stated hospital expectation and physician orders for non-violent restraint monitoring were for LNs to complete a patient assessment at least every two hours. DON stated monitoring patients on restraints at least every two hours was important because the patients are “tied down”. DON stated assessing patient’s every two hours also allows LNs to determine if the patient needed to remain restrained. The DON stated if LNs did not monitor patients on restraints there was an increased risk of harm to the patient. The DON stated his expectation was for LNs to follow the hospital P&P and monitor and document assessments for patients on restraints. During a concurrent interview and record review on 3/13/25 at 10:05 a.m. with Licensed vocational nurse (LVN) 1, Pt 11’s “Electronic Medical Record [EMR- a digital version of a patient’s medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans]” was reviewed. LVN 1 stated Pt 11’s “EMR” nursing notes indicated Pt 11 was confused, climbing out of bed, kicking at staff, and pulling out his tubes. Pt 11 was on restraints due to interfering with medical devices. During a review of the hospital’s P&P titled, “Restraints: Types and Uses ...” dated 3/5/24, indicated, “ ... The Medical and Nursing Staff of [HOSPITAL NAME] recognizes the right of patients to be free of restraint and provide the following guidelines to be used throughout all patient care areas of the [HOSPITAL NAME] acute care facility ... i. Each patient in behavioral modification restraints shall be assessed and evaluated by an appropriate clinical staff member at least every two (2) hours. j. At the time of the patient’s assessment and evaluation, the clinical staff member shall comment on the patient’s clinical condition, circulation, condition of limbs, and attention given to the patient’s needs, including nutrition, hydration and elimination. k. A record of the staff evaluation of the patient will be recorded on a restraint flow sheet. l. All restraints will be attempted to be released at least every two (2) hours for a minimum of five (5) minutes. Release one extremity at a time if patient’s behavior contraindicated removing all extremities from restraints simultaneously. ... “ During a review of professional reference titled, Patient Restraint and Seclusion,” dated 11/14/22, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK565873/ f (nih.gov) indicated, “ ... Healthcare workers should know that restraint and seclusion can have significant adverse implications on patients and should be deemed a last resort. Healthcare professionals must follow the 4 basic ethical healthcare principles: autonomy [make decisions and act independently without interference from others], justice, beneficence [the doing of good, promoting the well-being of others], and non-maleficence [doing no harm]. Per beneficence - the act of doing good - and non-maleficence - do no harm; healthcare providers must ensure the administration of restraint is implemented as a last resort ... Healthcare workers must also be sure to appropriately monitor the patient following restraint and seclusion to avoid deleterious [causing harm] effects such as pressure ulcers [localized area of damaged skin or tissue that occurs when pressure is applied to skin for a long time], skin breakdown, abrasions [scraping or wearing away] , asphyxia [body deprived of oxygen, suffocation], strangulation, incontinence [involuntary loss of bladder control], depression, social isolation, and drug overdose or interaction ...Document appropriate clinical indications and prepare a standardized checklist for staff to monitor and supply patient needs effectively. Numerous deaths and adverse patient outcomes have been reported due to inappropriate restraint placement and negligent [failing to take proper care] monitoring. After restraint placement, patients should be reevaluated every hour and moved regularly ... Once it is safe, the patient should also be evaluated for medical causes of agitation ...”.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for three of 20 patients, Patients (Pts) 21, 22, and 3, when: 1. Pt 21 presented to the Emergency Department (ED) with complaints of abdominal pain lasting one day, pain level 8, and nausea and vomiting, with decreased output from his colostomy. A CT scan was completed and before the results were available Pt 21 was discharged home. The results of the CT scan indicated Pt 21 had a small bowel obstruction (a blockage in the small intestine, an emergency medical condition) and the hospital did not contact Pt 21 to inform him, ask him to return to the hospital, or instruct him not to eat or drink. Pt 21 returned to the ED in severe pain nine hours after he was discharged and was transferred to a higher level of care for further treatment. (Refer to C-2407) 2. Pt 22 presented to the ED by ambulance with a chief complaint of 5150 hold (an involuntary psychiatric hold for up to 72 hours for the purpose of assessment, evaluation, and crisis intervention or placement for evaluation and treatment) for being a danger to self (DTS) and gravely disabled (GD- as a result of a mental disorder, severe substance use disorder or both, is unable to provide for his or her basic personal needs). Pt 22 was confused and unsteady on her feet. When a medical cause for Pt 22 symptoms was ruled out Pt 22 was to be transferred to a facility capable of providing a mental health evaluation, however the hospital did not transfer Pt 22 to another facility prior to the expiration of the 5150 hold. Pt 22 was discharged without receiving stabilizing measures in the form of mental health evaluation and treatment to address the emergency medical condition. (Refer to C-2407) 3 Pt 3 presented to the ED at 35 weeks pregnant complaining of lower abdominal pain and a headache, pain level 8. Pt 3 also had discomfort with urination. A urinalysis was ordered, and the results indicated a culture was needed to rule out a urinary tract infection. The physician and nurses did not obtain Pt 3’s pregnancy history, did not monitor pt 3’s unborn baby or assess the baby’s heart rate. The physician discharged Pt 3 less than an hour after she arrived without addressing Pt 3’s abdominal pain, headache, or discomfort with urination and without assessing the well-being of Pt 3’s unborn baby. (refer to C-2406) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to provide an appropriate medical screening examination (MSE, an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether or not an emergency medical condition [EMC] exists) within the capability of the hospital’s Emergency Department (ED) for one of 20 patients (Patient 3) when: Patient (Pt) 3 came to the ED on 10/26/24 at 12:05 p.m. at 35 weeks pregnant with a chief complaint of lower abdominal pain and a headache for one day, pain level 8 (on a scale of 0 [no pain] to 10 [worst possible pain], 8 is severe pain). Pt 3 also had discomfort with urination. Vital signs were within normal limits except for Pt 3 ’ s heart rate which was 104 beats per minute (bpm- normal is 60-100). The QMP saw Pt 3 and ordered tests for COVID, influenza and a urinalysis at 12:30 p.m. The urinalysis indicated a need for culture which was sent, and the COVID and influenza tests were negative. At 12:58 p.m. the QMP indicated Pt 3 would be discharged with a diagnosis of headache and abdominal pain of unknown cause, and Pt 3 left the hospital at 2:20 p.m. with a discharge pain level of 8. The QMP and the nursing staff did not obtain any information from Pt 3 about her obstetric history, how many pregnancies and births, history of preterm labor, her prenatal care, or the presence of complications in this pregnancy; and the QMP incorrectly indicated Pt 3 was in her second trimester of pregnancy. The QMP and the nursing staff did not assess the fetal heart rate or inquire about whether there was active fetal movement present. The QMP did not address the discomfort with urination or discuss fluid intake and did not address Pt 3 ’ s headache. These failures resulted in Pt 3 and her unborn baby being discharged without having an appropriate MSE and had the potential to result in harm if an emergency medical condition existed. Findings: During a concurrent interview and record review on 12/18/24 at 12:15 p.m. with the ED manager (EDM), Pt 3 ’ s medical record dated 10/26/24 was reviewed. The record indicated Pt 3 came to the ED on 10/26/24 at 12:05 p.m. at 35 weeks pregnant with a chief complaint of lower abdominal pain and a headache for one day. The triage note indicated at 12:16 p.m. Pt 3 had pain in her left and right lower quadrants of her abdomen and a headache on the top and temple areas. Pt 3 ’ s, pain level was 8. The note indicated Pt 3 ’ s last menstrual period was 2/27/24 and the gestational age was 35 weeks by dates. Vital signs were within normal limits except for Pt 3 ’ s heart rate was 104 bpm. Pt 3 also indicated she had discomfort with urination. The EDM stated Pt 3 ’ s triage was completed, and Pt 3 was moved to an ED room at 12:30 p.m. Review of the orders indicated orders were placed at 12:32 p.m. for COVID and influenza tests and a urinalysis. The EDM stated it is not clear in the ED Note what time the ED physician (MD 3) initiated the MSE. Review of MD 3 ’ s ED Note dated 10/26/24, indicated, “ ...CHIEF COMPLAINT: Lower abdominal pain starting this morning. HISTORY OF PRESENT ILLNESS [HPI]: 25 year-old female reports some pressure in her lower abdomen with some discomfort with urination. No vaginal bleeding, but patient reports she is in her second trimester pregnancy without any vomiting or diarrhea. No fever or problems breathing without any shortness of breath or cough. PHYSICAL EXAMINATION: ...ABDOMEN: soft fundal height is consistent with dates and patient reports having some tenderness in the suprapubic area without tenderness in the right lower quadrant or the right upper quadrant ...DIAGNOSTICS: [blank] IMAGING: None. Lab Results This Visit: COVID Negative, INFLUENZA A and B Negative. URINALYSIS/CULTURE: Collected ... DIFFERENTIAL DIAGNOSIS/CLINICAL COURSE/ MEDICAL DECISION MAKING: Differential diagnosis- COVID test were unremarkable, and urinalysis was noted. CONDITION: Improved. ASSESSMENT: Diagnoses headache, abdominal pain in second trimester pregnancy of unknown etiology. PLAN: Discharge ... “ The ED Note was signed by MD 3 at 12:58 p.m. The EDM stated the urinalysis was positive for leukocyte esterase (an enzyme present in white blood cells. The presence of white blood cells in urine may indicate a urinary tract infection [UTI]) and bacteria which indicated the need for a culture, and it was sent to the lab. The EDM was asked if there is documentation indicating the nurse or the physician obtained information regarding Pt 3 ’ s obstetric history such as the gravida (total number of confirmed pregnancies a woman has had, including the current pregnancy) and para (number of births a woman has had after 20 weeks of gestation), history of preterm labor/delivery, complications with previous or current pregnancy like gestational diabetes or high blood pressure, whether she has regular prenatal care and when her last appointment was. The EDM stated there is no indication that any of that information was obtained. The EDM was asked if there was an assessment by the physician or the nursing staff of the fetal heart rate and whether there was active fetal movement present. The EDM stated there is no documentation related to the baby. The EDM stated they have a doppler in the ED and do not need an order to obtain the fetal heart rate, however it would depend on the experience of the ED nurse whether or not they would think to do that, or ask questions related to the pregnancy. The EDM stated they do not have protocol or standards of practice to guide their assessment of patients who are pregnant. Review of the discharge documentation indicated at discharge Pt 3 ’ s heart rate was still elevated at 101 bpm, and Pt 3 ’ s pain level was 8, the same as it was when she was triaged. Pt 3 received no medications, no fluids either oral or intravenous, and had no imaging or blood tests. There was also no indication in the record that Pt 3 ’ s headache or discomfort with urination were addressed. The EDM stated MD 3 ’ s note does not have much information or detail. Review of the discharge instructions given to Pt 3 dated 10/26/24 at 2:13 p.m. indicated, “Diagnosis: Abdominal pain in second trimester pregnancy of unclear etiology. Problems addressed today: No Problems Available. Plan: Discharge Medication given this visit: [blank]. Discharge Medications: No Discharge Medications Available. Follow up with your health care provider in two days. During a review of the professional reference, American College of Obstetricians and Gynecologists ’ Committee on Obstetric Practice, Committee Opinion Number 667, July 2016 (Reaffirmed 2023), “ Hospital-Based Triage of Obstetric Patient, “ the reference indicated, “ ...Pregnant patients could present for care to any institution providing urgent or emergent care ...The federal Emergency Medical Treatment and Labor Act (EMTALA) requires an initial medical screening examination to determine if a medical emergency exists; in the case of a pregnant woman, this includes evaluation of the woman and the fetus ...To be considered an appropriate location to care for and evaluate pregnant patients, the unit should have the ability to perform basic ultrasonography and fetal monitoring ... “ During a review of the professional reference American College of Obstetricians and Gynecologists ’ Clinical Consensus Number 4, “ Urinary Tract Infections in Pregnant Individuals, “ dated 8/23, the reference indicated, “ ...Urinary tract infection (UTI) is one of the more common perinatal complications, affecting approximately 8% of pregnancies. The presence of UTIs has been associated with adverse pregnancy outcomes, including increased rates of preterm delivery and low birth weight. Furthermore, serious maternal complications of pyelonephritis include sepsis, disseminated intravascular coagulation, and acute respiratory distress syndrome (ARDS) ...The ability to recognize, diagnose, and treat them is essential for those providing care to pregnant individuals. Urinalysis is a useful tool for triage of UTI symptoms. Pyuria, defined as more than 5 white blood cells/high-power field or presence of leukocyte esterase, has up to 97% sensitivity for UTI ... “ During a review of the Patient Safety Advisory article titled, “ Triage of the Obstetrics Patient in the Emergency Department: Is There Only One Patient?, “ dated 9/08, the article indicated, “ When a pregnant patient arrives at the emergency department, there are really two patients. Risk reduction strategies include having policy and procedures in place that ensure a systematic approach to the triage and initial assessment of the pregnant patient ...There are two patients that need care ... “”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to provide stabilizing measures for identified emergency medical conditions (EMC) within the capability and capacity of the hospital for two of 20 patients, Patient (Pt) 21 and Pt 22 when: 1. Pt 21 came to the Emergency Department (ED) on 11/15/24 at 8:32 p.m. with complaints of abdominal pain lasting one day and nausea, with decreased output from his colostomy (an opening [stoma] that connects the large intestine to the surface of the abdomen creating a path for stool to leave the body). A Computed Tomography (CT- diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce images of the inside of the body) scan of the abdomen pelvis was performed at 10:42 p.m. and sent to the radiologist for interpretation. At 1:37 a.m. before the radiologist had completed his review of the CT scan, Pt 21 was sent home with a diagnosis of abdominal pain with relative constipation and instructions to increase oral fluids, increase fruits and vegetables in diet, and follow-up with his (Pt 21 ’ s) doctor in three days. The radiologist ’ s report indicating Pt 21 had a small bowel obstruction (a blockage in the small intestine, an emergency medical condition) was available at 3:44 a.m., and the hospital did not contact Pt 21 to inform him, ask him to return to the hospital, or instruct him not to eat or drink. These failures resulted in Pt 21 being discharged without the emergency medical condition being stabilized and led to Pt 21 experiencing increased pain and worsening symptoms of a small bowel obstruction. Pt 21 returned to the ED nine hours later with severe abdominal pain and imaging confirmed a worsening small bowel obstruction. Pt 21 was transferred to a higher level of care for further treatment on 11/16/24. 2. Patient (Pt) 22 came to the ED by ambulance on 10/8/24 at 6:20 p.m. after a police officer placed Pt 22 on a 5150 hold (an involuntary psychiatric hold for up to 72 hours for the purpose of assessment, evaluation, and crisis intervention or placement for evaluation and treatment) for being a danger to self (DTS) and gravely disabled (GD- as a result of a mental disorder, severe substance use disorder or both, is unable to provide for his or her basic personal needs). Pt 22 was confused, unsteady on her feet and smelled of alcohol. Pt 22 was evaluated, lab tests and imaging were negative, there was no evidence of drugs or alcohol in Pt 22 ’ s system. Pt 22was medically cleared on 10/9/24 at 12:40 a.m. Pt 22 was not evaluated by a mental health professional in order to address the reason for the altered mental status leading to the 5150 and the hospital did not transfer Pt 22 to another facility for a mental health evaluation prior to the expiration of the 5150 hold. These failures resulted in Pt 22 not receiving stabilizing measures in the form of mental health evaluation to address the emergency mental health condition and had the potential to result in harm. Findings: 1. During a review of the ED readmission log (A report of ED patients who were discharged and returned to the ED within 48 hours), the log indicated Pt 21 had an ED visit on 11/15/24 from 8:37 p.m. until 11/16/24 at 1:46 a.m., and then returned to the ED less than nine hours later on 11/16/24 at 10:32 a.m. Review of the transfer log indicated Pt 21 was transferred to Hospital B on 11/16/24 at 6:51 p.m. During a concurrent interview and record review on 12/17/24 at 2:15 p.m. with the emergency department manager (EDM), Pt 21 ’ s medical record was reviewed. The triage notes dated 11/15/24, indicated Pt 21 was a 79 year-old Spanish-speaking male who came to the ED accompanied by his son on 11/15/24 at 8:37 p.m. with a chief complaint of cramping abdominal pain in the umbilical region (the belly button area) lasting one day, pain level 8 (on a scale of 0 [no pain] to 10 [worst possible pain]). The triage notes indicated Pt 21 had a permanent colostomy (an opening [stoma] that connects the large intestine to the surface of the abdomen creating a path for stool to leave the body) located in the left lower quadrant of his abdomen. The EDM stated triage was completed at 8:42 p.m. and then Pt 21 was taken to an ED room to wait for the medical screening exam (MSE). Review of the ED nurses notes dated 11/15/24 at 9:09 p.m. indicated Pt 21 ’ s vital signs were stable, and Pt 21 had “ ...Rebound tenderness (more pain when pressure on the tender area is released) and guarding (contraction of the abdominal wall muscles to avoid pain) ... “ Review of the the ED physician ’ s note indicated MD 1 saw Pt 21 on 11/15/24 at 9:29 p.m.. The note indicated, “ ...History of Present Illness [HPI]: ...History of colon cancer, underwent a permanent diverting colostomy for upper sigmoid adenocarcinoma several years ago, presents with decreased colostomy output for the last several hours and crampy abdominal pain. Patient [Pt 21] is burping, has crampy belly pain, he usually has 3-4 colostomy bowel movements daily and today has had only a couple ...no vomiting ...slight nausea ...no fever ...Physical Exam: ... ABDOMEN: Bowel sounds present throughout abdomen, slightly distended, non-tender, no guarding, no rebound ...soft formed stool within the [colostomy] bag ...ED Course: Computed tomography [CT- diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce images of the inside of the body] scan of the abdomen pelvis will be performed. Intravenous [IV- into a vein] fluids will be administered. IV Toradol [pain medication] will be provided ... “ Review of the ED nurses notes dated 11/15/24 at 9:35 p.m. indicated, Pt 21 complained of cramping abdominal pain in the epigastric region (the upper middle part of the abdomen), level 8/10, was moaning, grimacing and restless and had nausea and emesis (vomit). The note indicated Pt 21 ’ s abdomen was taut (tight) with normal bowel sounds, and Pt 21 ’ s last bowel movement (BM) was “ abnormal, constipation, no BM. “ Review of the nurses notes dated 11/15/24 at 9:50 p.m. indicated an IV was started, labs were drawn, and IV pain medication was given for pain level 8/10. A normal saline fluid bolus was initiated at approximately 10:15 p.m. At 10:30 p.m. Pt 21 complained of nausea and had yellowish colored emesis, and orders were obtained for Zofran 4 milligrams (mg) IV which was administered. The EDM stated the CT scan was completed at 10:42 p.m., and the record indicated at 11 p.m. Pt 21 was resting in bed, pain level 0/10. Pain reassessed at 11:30 p.m. and was 5/10. Review of the ED physician ’ s note indicated, “Medical Decision Making: Laboratory evaluations are reassuring this evening. Complete Blood Count [CBC] normal, chemistries are normal with a creatinine of 1.13. COVID and Influenza A and B are negative. CT scan of the abdomen pelvis demonstrates no evidence of bowel obstruction. There is copious stool throughout the colon, no air-fluid levels are observed however. Assessment: Abdominal pain with obstipation [a severe form of constipation that results in a person being unable to have a bowel movement]. Plan: Push fluids, increase fruits and vegetables in diet, see your doctor for recheck on Monday [11/18/24]. Disposition: The patient appears comfortable and without distress upon final reevaluation following completion of the clinical evaluation shortly before dismissal ... “ The note was signed by MD 1 on 11/16/24 at 12:51 a.m. The EDM stated the ED physician completes the discharge instruction note and the RN reviews the instructions with the patient/family and has the patient sign that they have received the instructions. Review of the Pt 21 ’ s ED discharge instructions indicated, “ Diagnosis Today: Abdominal pain with relative constipation. Diet: Resume normal diet. Additional Instructions: Push fluids, increase fruits and vegetables in diet. See your doctor for follow up on Monday [11/18/24]. Activity: Return to School/Work in 3 days. Follow up with: Your Primary Care Provider in 3 days for recheck. “ The record indicated Pt 21 was discharged from the hospital on 11/16/24 at 1:37 a.m. Pain level 2/10. Review of the “ Radiology Report “ dated 11/16/24 at 3:44 a.m., indicated Pt 21 had a CT Abdomen and Pelvis without contrast on 11/15/24 and the images were received by the teleradiologist for review on 11/15/24 at 11:30 p.m. The report of the findings was available on 11/16/24 at 3:44 a.m. The report indicated, “ Findings: ...Multiple loops of mid small bowel show moderate diffuse distention with a probable caliber change in the anterior mid lower abdomen ...IMPRESSION: Mid small bowel obstruction ... “ Review of Pt 21 ’ s medical record dated 11/16/24 at 10:32 a.m., indicated Pt 21 returned to the ED at 10:30 a.m. with complaints of severe abdominal pain with a pain level 10/10, nausea and vomiting. Pt 21 reported no stool or gas from colostomy since the morning of 11/15/24. Pt 21 had an abdominal x-ray at 11:40 a.m., was given IV fluids and had a CT of the abdomen with contrast at 1:50 p.m. Review of the “ Radiology Report “ dated 11/16/24 at 2:07 p.m., indicated, “ ...Findings- GI Tract/abdominal wall: Again seen is postsurgical changes of abdominal perineal resection with lower left quadrant ostomy. There are postsurgical changes in the anterior abdominal wall. There is atrophy of the abdominal wall muscles with eventration of the abdominal contents. Increased air and fluid filled distention of small bowel in the anterior abdomen up to 4.8 centimeters [cm] in maximum distention with transition point in the left lower quadrant and collapsed bowel distally compatible with ongoing small bowel obstruction. IMPRESSION: Interval worsening of small bowel obstruction with transition point in the left lower quadrant ... “ Pt 21 was given IV antibiotics and medication for pain and nausea and was later transferred to a higher level of care (Hospital B) on 11/16/24 at 6:51 p.m. During a concurrent interview and record review on 12/17/2024 at 2:25 p.m., the EDM stated she was aware of this patient because they review the records of patients who have a return visit and then get transferred. The EDM stated MD 1 discharged Pt 21 before the teleradiologist had finished his report of the CT scan findings. The EDM stated the report was not completed until 3:44 a.m. by the radiologist and Pt 21 left the hospital at 1:37 a.m. There was no indication in the record that results of that CT scan were still pending at the time Pt 21 was discharged, and no indication that Pt 21 wanted to leave or requested to be discharged. The EDM was asked about MD 1 ’ s note signed on 11/16/24 at 12:51 a.m. which indicated the CT scan “ demonstrates no evidence of bowel obstruction. “ The EDM stated that MD 1 reviewed the imaging, “ but he is not a radiologist. “ The EDM stated she does not know of a policy for follow up with a patient a radiology report indicated abnormal findings and the patient had already been discharged. The EDM stated the report comes by fax to the ED and she does not know if the report was received and/or reviewed by anyone during the night. During an interview on 12/18/24 at 11:30 a.m. with the radiology department manager (RDM), the RDM stated the imaging performed at the hospital is interpreted by the teleradiologists twenty-four hours a day. The radiology techs are at the hospital during the day and are on call at night. The radiology tech will complete the imaging and it will be received by the teleradiologist who will interpret the imaging and prepare the report which gets automatically faxed to the ED unit clerk and also to a fax machine in the radiology department. There are not staff in the radiology department who are waiting for the fax to come. The RDM stated the turnaround time from the time of the order to the time the test is performed depends on the radiology tech ’ s workload at the time meaning the number of imaging tests being ordered. The turnaround time from the time the image is performed by the radiology tech to the time the report is available would likely depend on the workload of the teleradiologists. During the night, it may take longer than during the day. The RDM stated in this case the turnaround time from when the images were received by the teleradiologist and the report from the teleradiologist being available was approximately four hours and fifteen minutes which would not be considered to be too long. The RDM stated once the radiology tech has completed the imaging it is automatically in the Picture Archiving and Communication System (PACS- a medical imaging technology used to store and digitally transmit electronic images) and the teleradiologist accesses the images remotely from wherever they are. The RDM stated the physicians on site at the hospital can access the imaging as well but do not review the imaging for the purpose of formal interpretation of the scan, that is only done by the radiologists. The RDM stated the radiology department does not have a policy for follow up with patients if a report indicated abnormal findings, they would not be aware of the results. The report that is sent to their fax machine in radiology is not for the purpose of someone receiving it and reviewing the results. When the report is completed with the interpretation by the radiologist it is sent by the system to the ED where the patient is. Review of the journal article in Radiology: Volume 275: Number 2-May 2015 titled, “ Review of Small-Bowel Obstruction: The Diagnosis and When to Worry, “ the article indicated, “ Small-bowel obstruction (SBO) is a substantial cause of morbidity and mortality, accounting for up to 16% of hospital admissions for acute abdominal pain in the United States. Most patients with SBO are treated successfully with nasogastric tube decompression. However, the mortality of SBO ranges from 2% to 8% and may increase to as high as 25% if bowel ischemia is present and there is a delay in surgical management ...Clinical presentation, physical examination findings, and laboratory tests are neither sufficiently sensitive nor specific to determine which patients with SBO have coexistent strangulation or ischemia. This uncertainty has led to the widespread use of imaging to not only diagnose SBO but to detect complications that require prompt surgery ...CT has been proven to be the single best imaging tool for evaluating patients suspected of having SBO, with sensitivity and specificity of 95%; it is also highly accurate in detecting the complications of SBO. The job of the radiologist is to diagnose the suspected SBO, determine its site and cause, and determine the presence or absence of complications such as ischemia or perforation ... “ During a review of the journal article in American Family Physician Volume 98, Number 6, titled, “ Intestinal Obstruction: Evaluation and Management, “ dated 9/15/18, the article indicated, “ ...The hallmarks of intestinal obstruction include colicky abdominal pain, nausea, vomiting, abdominal distension, and cessation of flatus and bowel movements ...As soon as acute intestinal obstruction is suspected, intravenous isotonic fluid should be started, and oral intake should be restricted. Nasogastric intubation should be performed for decompression in most patients ... “ During a review of the article titled, “ Small Bowel Obstruction, “ dated 12/2/24, retrieved from <https://emedicine.medscape.com/article/774140-overview>, the article indicated, “ ...Emergency Department Care- Initial emergency department (ED) treatment of small-bowel obstruction (SBO) consists of aggressive fluid resuscitation, bowel decompression, administration of analgesia and antiemetic as indicated clinically, early surgical consultation, and administration of antibiotics ... “ During a review of the journal article from Clinics in Colon and Rectal Surgery Vol. 34 No. 4/2021, titled, “ Imaging Modalities for Evaluation of Intestinal Obstruction, “ the article indicated, “ ...Diagnostic imaging is an essential aspect of the modern management of both LBO and SBO. While history and physical exam remain the backbone of evaluation, clinical assessment alone lacks accuracy for bowel obstruction diagnosis and guidance of management ...Computed tomography is usually the most appropriate and accurate diagnostic imaging modality for most suspected bowel obstructions. Regardless of the imaging modality used, interpretation of imaging should involve a systematic, methodological approach to ensure diagnostic accuracy ... “ 2. During an interview on 12/13/24 at 1:30 p.m., with ED physician (MD 1), MD 1 stated the hospital does not have a process in place to provide a mental health evaluation or treatment to patients who are brought to the hospital under a 5150 hold. MD 1 stated the hospital also does not have a process to get a 5150 hold lifted prior to 72 hours when the hold expires. MD 1 stated police officers place the patient on the hold, but they do not come back to reevaluate whether the hold should remain, and the police officers do not lift the holds. MD 1 stated the physicians working in the ED are not authorized by the county to either place or lift a 5150 hold. MD 1 stated after a police officer puts the patient on a hold, the patient is brought to the ED and then ED physician sees the patient only for the purpose of medically clearing the patient for transfer to a facility that provides evaluation and treatment for mental health disorders, the physician does not perform a mental health evaluation. MD 1 stated after the patient is medically cleared, the hospital starts the process for initiating the transfer. MD 1 stated the problem they run into is when they are unable to arrange the transfer within the 72 hours and the hold expires. MD 1 stated the hospital does not contract with a telepsychiatry provider. During a concurrent interview and record review on 12/17/24 at 2 p.m. with the EDM, Pt 22 ’ s medical record was reviewed. The record indicated Pt 22 was brought to the ED by ambulance on 10/8/24 at 6:20 p.m. with a chief complaint of 5150 hold placed by law enforcement due to Pt 22 being a DTS, and GD. Review of the Patient Care Record (PCR- a record completed by EMS personnel documenting the prehospital care of a patient) indicated Pt 22 was observed by law enforcement officers to be standing in a gas station/convenience store staring at the ceiling and then walked outside and attempted to walk into traffic. The PCR indicated at 6:05 p.m., Pt 2 had altered mental status with a Glasgow Coma Scale score of 14 (GCS- a tool used to assess a patient ’ s level of consciousness; scores range from 3 [worst] to 15 [alert and oriented]- Pt 22 ’ s score of 14 was due to confused verbal responses), was unsteady on her feet and smelled of alcohol. The PCR indicated, Pt 22 ’ s current medications were Zyprexa (a medication given to treat schizophrenia and bipolar disorder) and Depakote (a medications used to treat bipolar disorder). Review of the triage notes dated 10/8/24 at 6:30 p.m. indicated Pt 22 ’ s “ speech is significantly slurred; she is cooperative however noted to be lethargic. Denies suicidal ideation [SI]/ homicidal ideation [HI] ...Unsteady on feet unable to get standing scale weight ... “ The triage note indicated Pt 22 did not have a primary care provider (PCP). At 6:30 p.m., Pt 22 ’ s GCS was 12. Triage was completed and Pt 22 was assigned an Emergency Severity Index level 3 (ESI- a 5-level acuity scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, in order to prioritize care). Pt 22 was taken to an ED room and a staff member was assigned to provide one to one observation. Review of the ED Physician ’ s Note dated 10/8/24, untimed, indicated the MSE was initiated by MD 2. The EDM stated the physician would need to indicate on the note what time an entry was made, the electronic record does not do that. The electronic record does automatically record what time the note is completed and signed. The note indicated, “ HISTORY OF PRESENT ILLNESS [HPI] 43 y/o female was found disoriented staring up at the sky and police involved placed a 5150. Patient has not been able to give any specific statements reports of harm fall or injury. No prehospital reports of pinpoint pupils /intentional harm or pill ingestion was reported without anybody able to coordinate patient ‘s care prior to arrival here by ambulance ...SOCIAL HISTORY: Denies using alcohol or tobacco ...REVIEW OF SYSTEMS [ROS] ...Psychiatric: Pt denies mental health issues although patient has poor thought process ...ROS limited from the patient is 5150 with patient not able to give much history about how she ended up arriving here. PHYSICAL EXAMINATION: ...Psychiatric: Good eye contact but patient has blank stare with patient not making any spontaneous speech or answering to confirm a congruent thought process. Flat affect ... “ The note indicated the results of the lab tests including a complete blood count (CBC), Complete Metabolic Panel (CMP) were within normal limits, and the tests for drugs and alcohol were negative. The note indicated, “ ...DIFFERENTIAL DIAGNOSIS/ CLINICAL COURSE/ MEDICAL DECISION MAKING: Differential [BLANK]. CONDITION: Improved. ASSESSMENT: Diagnosis: 5150 placement PLAN: Patient was medically clear to continue psychiatric care and evaluation of the 5150 after patient was medically cleared/ care signed out to the next emergency room physician [MD 3] ... “ The EDM stated medical clearance was on 10/9/24 at 12:40 a.m. The EDM stated the physicians work 24 hour shifts from 8 a.m. to 8 a.m. so the handoff to the next physician was at 8 a.m. on 10/9/24. Review of MD 3 ’ s ED Note dated 10/9/24 at 10:25 a.m. indicated, “ Pt care was assumed from MD 2 at 8 a.m. on 10/9/2024 (Change of Shift). Patient on 5150 apparently noted by PD to be confused and disoriented and staring at the sky and placed patient on 5150. Patient is poor historian drug screen negative ... “ The rest of MD 3 ’ s ED note consisted of a table with the results of all of the lab tests previously reported, and the vital signs ending at 10/9/24 at 9:45 a.m. Review of the orders report dated 10/8/24 through 10/11/24 indicated on 10/9/24 at 8:50 p.m. Zyprexa 10 milligrams and Depakote 500 mg were ordered and given on 10/9/24, 10/10/24, and 10/11/24. The order report also indicated a CT scan of the brain was ordered on 10/10/24 at 9:21 a.m. and the results were negative. Review of MD 2 ’ s ED Note dated 10/10/24, indicated, “ Care continued on 10/10/24 ...Patient continues to demonstrate hemodynamic stability and she has a flat affect with patient cooperative with care with patient medically clear for psychiatric evaluation. Patient was not found to have any evidence of a substance abuse disorder with the patient having medical clearance given without any organ disfunction to determine ... ROS: Psychiatric: Poorly defined mental health issues. DIFFERENTIAL DIAGNOSIS/ CLINICAL COURSE/ MEDICAL DECISION MAKING: Differential [BLANK] ...There is no medical cause of the patient ’ s change in mental status that caused the need for the 5150. Patient continued to have a very flat affect with poor insight ...remaining essentially nonverbal ... Patient is medically clear to receive further psychiatric assessment which is beyond the capabilities of our facility. We do not have an online service or any remote telemedicine ability to perform psychiatric evaluation which she is being on the spectrum of her care at our emergency department ... Patient has had a 5150 placed on her and patient is medically clear. The patient needs to have further psychiatric evaluation of this beyond the capabilities of our facility. Transfer center is reaching out to a facility that has psychiatric services where the patient can go for complete evaluation of the patient ’ s medical condition. ASSESSMENT: Diagnosis: 5150 placement. Patient continues to be medically cleared today and will need to have further psychiatric assessment. Transfer center is involved in this higher level of care transfer ... “ The EDM stated they did not have a transfer center. As soon as the patient was medically cleared the ED staff (unit clerk or charge nurse) were the ones who will initiate the transfer process to a facility that provides evaluation and treatment for mental health disorders. The EDM stated for all patient transfers, a log is maintained to document the date and time and name of all of the facilities contacted, their response, and when patient information was faxed to the facility. The log with the record of the efforts made by the hospital to transfer Pt 22 was requested. The hospital was unable to locate a log and could only provide evidence that one facility was faxed Pt 22 ’ s information on 10/9/24 at 5:36 a.m. The EDM was unable to find any documentation of a discussion by the staff with the physician regarding progress with the transfer request and there is no way to know if any other facilities were contacted and/or why they were not, or if the request was escalated due to difficulty with the transfer. The EDM stated the log of the transfer requests should have been maintained and it was not. The EDM provided a piece of paper with handwriting from an unknown person indicating the name of a physician and an appointment date 10/17/24 at 9:30 a.m. The person who wrote the note was not identified. There was no patient name or other patient identifier on the piece of paper, and no indication who or what the appointment was for. The EDM stated the hospital does not employ any social workers or mental health workers to assist with the transfer process, perform mental health evaluations, provide crisis intervention, or reevaluate a patient on a hold to assess whether it is still needed. Review of the nurses notes dated 10/11/24 at 12:15 p.m. indicated, “ ...Mother called who is her caregiver and is aware her 72 hour hold is up at 6:01 p.m. as long as [Pt 22] is not a threat to herself or others ... “ The record indicated Pt 22 was screened for suicide risk and no risk was identified, however the 5150 hold was not placed for suicidal ideation or homicidal ideation. The EDM stated Pt 22 did not receive a mental health evaluation. Review of the “ ED Discharge Instructions, “ indicated the note was completed by MD 1 on 10/11/24 at 5:42 p.m. The note indicated, “ Reason for Visit: Chief Complaint- 5150. Diagnosis Today: 5150 Hold Expired. Diet: Resume normal diet. Additional Instructions: See your mental health provider 5-7 days. Resume current medications. Return for any further problems. For any new problems please reach out to your crisis hotline or return to the emergency department. “ The EDM stated this is the only note from MD 1, there is not a discharge assessment and there is not a discharge order. The EDM stated if a patient is on a hold and does not get transferred within 72 hours, the hold expires. There was no documentation in the record regarding Pt 22 ’ s mental health history, no documentation of a discussion with anyone regarding Pt 22 ’ s disposition. and Pt 22 did not have a primary care physician. During a review of the hospital ’ s Policy and Procedure (P&P) titled, “ Scope of Services, “ dated 12/19/23, The P&P indicated, “ ...Scope and Complexity of Patient Care Needs: All patients that present to [Hospital A] premises for a non-scheduled visit and are seeking care shall receive a medical screening exam by an Emergency Department Physician that includes providing all necessary testing and on-call services within the capability of [Hospital A] to reach a diagnosis. Support services including, but not limited to, clinical laboratory studies and x-rays will be provided to the patient in a timely manner. All necessary definitive treatment will be given to the patient within the hospital ’ s capabilities. Emergency Department patients are then evaluated for response to treatment and are admitted, transferred for further treatment not provided by [Hospital A], or discharged with follow-up instructions as appropriate ... “ Review of the document “ County of Fresno Department of Behavioral Health 2023-2024 Annual 5150 Re-Certification Training, “ the document indicated, “ ...The danger to self or others does not have to be an “ active “ danger, the person doesn ’ t need to be actively suicidal or making threats, threatening or physically injuring another party. Danger can come in many forms, including “ passive “ danger such as endangering one ’ s child or own health and safety through behaviors caused by untreated symptoms of mental illness. Such “ passive “ danger could include, not taking needed medication for a serious medical condition or exposing oneself to violent elements on the streets. The governing rule becomes whether this “ passive “ danger is the result of a mental disorder ... “ The document indicated when placing a person on a 5150 hold, the following Detainment Advisement (part of the Application for up to 72-Hour Assessment, Evaluation, and Crisis Intervention or Placement for Evaluation and Treatment form) must be given orally to the person, “ I am a peace officer/mental health professional with [name of agency]. You are not under arrest, but I am taking you for examination by mental health professionals at [name of facility] You will be told your rights by the mental health staff. “ During a review of the emDocs article titled, “ Medical Clearance of Psychiatric Patients: Pearls & Pitfalls, “ dated 5/28/15, retrieved from <https://www.emdocs.net/medical-clearance-of-psychiatric-patients-pearls-pitfalls/>, the article indicated, “ ...Medical Clearance is a term commonly used for the initial medical evaluation or focused medical assessment performed in the ED prior to transfer to a psychiatric facility. The term “ medical clearance “ can be problematic because there is no singular accepted standard definition or process among EPs or psychiatrists. Medical clearance is not a term to represent the absence of medical issues, but rather the absence of medical instability or a medical condition causing or contributing to the psychiatric presentation. Determining medical causation for psychiatric disease is the most essential reason for the medical evaluation in the ED prior to psychiatric placement. There are numerous conditions that can cause psychiatric symptomatology including medication side effects, drug and alcohol abuse and withdrawal, infections, central nervous system disease, metabolic/endocrine conditions, and cardiopulmonary disease. If an underlying medical condition is found to be causing or exacerbating the psychiatric complaint, treatment in the ED or in a medical hospital is indicated ... “ During a review of the Western Journal of Emergency Medicine Volume 18, no. 4, article titled, “ American Association for Emergency Psychiatry Task Force on Medical Clearance of Adults, “ dated 6/2017, the article indicated, “ The goal of medical assessment of psychiatric patients in an ED is to identify potential causative factors for a patient ’ s presenting complaint (i.e., medical mimics) as well as medical problems that will need ongoing care but do not contribute directly to the presenting psychiatric complaint ... Medically clear A term meaning that, in the opinion of the examining provider, the patient does not have any medical condition which merits further treatment or concern ... “”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 45580 Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for five of 20 patients, Patients (Pts) 1, 2, 5, 6, and 7, when: 1. Based on interview and record review, the hospital failed to comply with regulatory requirements for EMTALA when Patient (Pt) 1 was brought in by an ambulance to the Emergency Department (ED) on 6/19/24 when the hospital was on diversion for the lack of radiology services, with a chief complaint of shortness of breath (SOB-difficulty breathing) and the Charge Nurse (CN) walked out of the ED and informed the Fire Fighter Medic (FFM) the hospital was in diversion. The FFM was given the impression Hospital A would not accept Pt 1 and Pt 1 was diverted to Hospital B which was over 40 miles away. Pt 1 was not evaluated by the CN and was not provided a Medical Screening Exam (MSE) for the purpose of identifying an emergency medical condition (EMC-a medical condition that requires immediate medical attention to prevent serious harm or death). (Refer to C2406) 2. Patient 2 was brought in by ambulance on 11/28/23 at 3:58 p.m. with a chief complaint of 5150 Danger to Others (the number of the section of the Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily [something is done without choice] detained for a 72-hour psychiatric hospitalization when evaluated to be a danger to others, or to himself or herself, or gravely disabled [an inability to provider for their basic needs due to a mental illness]) and while in the emergency department (ED), Patient 2 did not receive a mental health evaluation (a test that assesses a person’s mental health and well-being) to address her emergency medical condition (EMC-an illness, injury, symptom or condition so serious that a reasonable person would seek care right away to avoid severe harm), there was no indication there were attempts to transfer Patient 2 to another hospital for a mental health evaluation and Patient 2 was discharged after her 5150 expired. While in the ED there was no suicide risk screening assessment (identifies individuals that require further mental health/suicide safety assessment) or documentation Patient 2 was not a danger to others. (Refer to C2407) 3. Patient 5 presented to the ED on 6/19/24 at 3:06 p.m. with a chief complaint of lower back pain after a fall. Patient 5’s pain was not addressed while in the ED, the ED did not have radiology services due to lack of staffing therefore Patient 5 was told to come back in a couple days for an x-ray and was discharged with a prescription for pain medication. Patient 5’s vital signs (measurements of body’s most basic functions, such as temperature, pulse, breathing rate and blood pressure) and pain were not reassessed at discharge. (Refer to C2407) 4. Patient 6 presented to the ED with his mother on 8/9/24 at 11:37 p.m. with a chief complaint of fever and ear pain. Patient 6 had a fever on arrival to the ED, there was no indication fever reducing medication was administered to Patient 6 prior to arrival to the ED and the ED physician did not order any fever reducing medications while Patient 6 was in the ED. Patient 6 was tested for covid 19 (a nasal swab that checks for the Covid 19 virus), influenza (test used to determine if someone has the flu), and respiratory syncytial virus (RSV-checks a fluid sample from your nose to see if the RSV virus is causing symptoms of a respiratory infection) which were all negative. Patient 6 was eventually discharged home with acetaminophen (fever reducing medication) and amoxicillin (medication used to treat a wide range of germs) and Patient 6’s temperature to include vital signs were not reassessed at discharge. (Refer to C2407) 5. Patient 7 was brought in by ambulance on 6/19/24 at 11:18 p.m. with a chief complaint of right shoulder injury. Patient 7’s pain was not addressed while in the ED, there was no indication pain medications were ordered or administered. Patient 7was eventually discharged and told to go to Hospital B for x-rays due to the lack of a radiology tech. (Refer to C2407) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to comply with regulatory requirements for EMTALA when Patient (Pt) 1 was brought in by an ambulance to the Emergency Department (ED) on 6/19/24 when the hospital was on diversion for the lack of radiology services, with a chief complaint of shortness of breath (SOB-difficulty breathing) and the Charge Nurse (CN) walked out of the ED and informed the Fire Fighter Medic (FFM) the hospital was in diversion. The FFM was given the impression Hospital A would not accept Pt 1 and Pt 1 was diverted to Hospital B which was over 40 miles away. Pt 1 was not evaluated by the CN and was not provided a Medical Screening Exam (MSE) for the purpose of identifying an emergency medical condition (EMC-a medical condition that requires immediate medical attention to prevent serious harm or death). This failure resulted in Pt 1 not being provided the benefit of a timely MSE and stabilization of a potential emergency medical condition to the capabilities of the hospital. Findings: During a review of Pt 1’s “Patient Care Record (PCR) ,” dated 6/19/24, the PCR indicated, “ ...[Pt 1] ...Male ...66 [years] ...Signs & Symptoms ...Shortness of breath ...Cough ...Fatigue ...Fever ...On scene found 66 [year old] male patient laying semi Fowler’s on a bed ...in mild distress [chief complaint] of body pain. [Patient] stated that he was having all over body pain rating it at 4/10. Further information from Wife stated that he has had a cough [times] 1 week and had a fever of 103 last night. Vitals assessed on scene vitals [within normal limits]. [Patient] Denied any [nausea, vomiting, diarrhea]. [History] of diabetes [a disease that occurs when the body’s blood sugar levels are too high], a triple bypass [a type of heart surgery that reroutes blood around three blocked arteries]. [No known drug allergies]. [Patient] Moved to gurney with help of engine crew using a mega mover. [Patient] Transported priority 2 to Coalinga originally but at destination we were advised that Coalinga was on diversion ...rerouted to [name of Hospital B]. During transport [patient] Complained of some SOB along with cough [Patient] Had audible wheezing [a high-pitched whistling sound made while breathing], 2.5 [milligrams (mg)-unit of measure] of albuterol [medication used to relax and open-air passages to the lungs to make breathing easier] breathing treatment given with improvement to patient breathing. No other interventions during transport. Vitals remained [within normal limits]. At destination, handoff report given to RN and care transferred to [registered nurse] ...” During a review of Pt 1’s “Emergency Department Physician Notes (Note ),” dated 6/19/24 from Hospital B, the Note indicated, “Chief Complaint ...[Brought in by ambulance] for cough and wheezing [times] 1 [week], started with a fever yesterday and generalized body pain today ...Orders ...DuoNeb, 6 [milliliter-unit of measure], Chest radiograph ...No acute disease of the chest ...I was able to speak with the patient’s wife and understand her concerns. She states that he had a documented elevated temperature yesterday however, the patient has not been febrile here today. She says that he has had a cough which has resolved by today as the patient has not been coughing at the bedside. He did receive a breathing treatment upon arrival and has since been feeling well ...Otherwise, the patient has had normal oxygen saturations on room air. Patient is having oxygenation at 96% on room air ...Patient already has home health at home ...The patient is stable and does not have any complaints here ...I was not able to visualize or appreciate pneumonia on his chest x-ray ...However, he may have an atypical pneumonia and so I placed him on azithromycin for the next 5 days. His wife will have him follow-up with a primary care physician or with his home health care and return here if there is any persistent or worsening symptoms ...Condition ...Stable ...Disposition ...Discharge to home ...” During an interview on 8/21/24 at 11:06 a.m. with the Unit Clerk (UC), the UC stated on 6/19/24 the hospital was on diversion. The UC stated she called the dispatch for emergency medical services (EMS) and informed the dispatcher the hospital was on diversion for inability to staff a radiology technician (a healthcare professional who uses imaging equipment to create images of the human body). The UC stated diversion was when the hospital did not have a service and when EMS was informed of the diversion, the EMS staff decided which hospital to take the patient based on their symptoms. The UC stated the Director of Nursing (DON) and Emergency Department Manager (EDM) notified her when the hospital was on diversion. The UC stated on 6/19/24, an ambulance drove up to the emergency department (ED), she notified the Charge Nurse (CN) and he went outside to talk to the FFM. During an interview on 8/21/24 at 11:19 a.m. with the CN, the CN stated a patient was considered a patient of the ED when they walked in through the door or pulled up in their vehicles. The CN stated on 6/19/24 the hospital was on diversion at 9:50 a.m. due to not having a radiology technician. The CN stated a call came in from EMS and a registered nurse (RN) picked up the call and informed him they had a 35-year-old female with shortness of breath (difficulty breathing) and no other information was obtained during the call. The CN stated he had the UC redial the number that just called so he could inform the FFM the hospital was in diversion and had no radiology services so they should proceed to the nearest hospital. The CN stated he thought the ambulance was proceeding the nearest hospital but the next thing he knew the ambulance was backing up in the EMS bay. The CN stated the FFM asked if the ED was closed, and the CN informed the FFM the ED was not closed. The CN stated the FFM asked if patients were accepted on a case-by-case basis and the CN stated yes. The CN stated he began walking back inside the ED and the ambulance drove off. The CN stated Pt 1 was not triaged and when the ambulance pulled up to the ED, he did not see Pt 1. During an interview on 8/21/24 at 1:41 p.m. with the CN, the CN stated during his conversation with the FFM, there was no mention that the ED could not accept Pt 1 and the FFM did not ask if the ED would accept Pt 1. The CN stated he was not sure if Pt 1 should have been triaged, Pt 1 was on their property, but she was still under the FFM’s care. The CN stated the importance of triage was to categorize how critical the patients were and if there was one bed available and many patients, they could prioritize which patient was more critical by their triage. The CN stated if patients were not triaged timely, the patient could deteriorate. During an interview on 8/21/24 at 4:55 p.m. with the Director of Nursing (DON), the DON stated he had always given instructions to the ED staff regarding EMTALA. The DON stated regardless of whether they were on diversion, when an ambulance did not get the message and they pulled up to the ED, the hospital staff were to see the patient. The DON stated the patient should be triaged even if they have to transfer the patient out 15 minutes after arriving. The DON stated he had never educated staff to turn away patients and had continued to remind staff of the need to accept patients when they arrived at the ED . During a concurrent interview and record review on 8/22/24 at 1:47 p.m. with the Communications Supervisor (CSR), the document titled, “Facility Status Audit Report (Report),” dated 8/22/24 was reviewed. The CSR stated a diversion occurred when the hospital could not take any patients. The CSR stated a diversion could occur at any time depending on what was happening at the hospital. The CSR stated the Report indicated, Hospital A had 10 episodes of diversion from 6/19/24 to 8/22/24. The CSR stated when they were informed a hospital was on diversion, they entered the diversion into their computer aided design (the program used by dispatch). The CSR stated if the EMS units had the need to transport a patient to that hospital, a diversion caution note would remind the dispatcher. The CSR stated the dispatcher would advise the unit of the diversion so they could make the appropriate change to either continue to the hospital or divert to a different hospital. The CSR stated the patient would be sent to another hospital depending on the patient’s symptoms and possible need for radiology services. The CSR stated the most appropriate hospital for the patient’s condition was decided by the medic, however a patient could also make a request for which hospital they preferred. During an interview on 8/23/24 at 11 a.m. with the FFM, the FFM stated on 6/19/24 Pt 1 presented with cough for one week and a fever of 103 degrees Fahrenheit. The FFM stated he informed Hospital A he was bringing a patient to their ED and was not aware Hospital A was on diversion until they were already backing up to the ED EMS entrance. The FFM stated when they got to the ED EMS entrance one of their charge nurses (CN) came outside and told them the hospital was on diversion for not having radiology services available. The FFM stated once he was informed of the diversion by the CN, he contacted Hospital B and alerted Hospital B to what was going on. The FFM stated the CN said based on Pt 1’s signs and symptoms, they were not going to accept Pt 1. The FFM stated he did not make face to face contact with the ED physician, and he assumed the ED physician told the CN which patients they could accept. The FFM stated if the CN did not come out of the ED to inform them of the diversion, they would have unloaded the patient and taken the patient into the ED. The FFM stated the ED physician did not see Pt 1. The FFM stated Pt 1 was taken to Hospital B which was about 42 miles away and it took about 45 minutes to get there. The FFM stated Hospital A has been on diversion on and off and the main reason was due to the lack of radiology services. During an interview on 8/23/24 at 4:10 p.m. with Medical Doctor (MD) 1, MD 1 stated he did not recall the incident on 6/19/24 which involved Pt 1. MD 1 stated a patient was considered a patient of the ED when they entered the hospital’s property. MD 1 stated the ED should have taken Pt 1 in if they did not. During an interview on 8/26/24 at 1:48 p.m. with the Director of Nursing (DON), the DON stated he was made aware of the incident that occurred on 6/19/24 the following day when he reviewed his email. The DON stated with the information provided to him, he let the CN know that anytime an ambulance presents whether they were on diversion or not, that it was their patient. The DON stated the CN was somewhat confused about what happened, and the CN reiterated (repeated) that he did not turn the ambulance away. The DON stated he informed the CN that the CN should have informed the FFM to bring Pt 1 into the ED. The DON stated there had not been any formal education about the incident with Pt 1, but he had been talking to staff and discussed it daily when he went to the ED. The DON stated he was irritated about the incident from the beginning because anytime a patient came to the ED, the patient should be evaluated by the ED physician. The DON stated EMTALA protected patients and was the emergency medical treatment act and labor act, which ensured every person who came within 250 yards of the hospital were seen, no matter what their race, ethnic background, or ability to pay. The DON stated the patients should be treated to determine if there was an EMC and if the ED was able to stabilize the patient. The DON stated the patient should be cared for there at the hospital and if transfer was required, the patient was transferred to another facility. During an interview on 8/26/24 at 3:39 p.m. with the EDM, the EMD stated she was aware of the incident on 6/19/24 after it occurred when the CN informed her about what happened. The EDM stated she asked the CN what occurred, and they discussed the situation and the EDM wanted to make sure they were able to account for Patient 1, so they created an EMS log to log all the EMS calls that came into their ED. The EDM stated this was the first time they were unable to log the situation where the patient did not come inside the ED. The EDM stated there was no education provided to ED staff regarding the incident with Patient 1. The EDM stated she had one to one conversation with the CN about what happened, went over diversion, EMTALA, and ED protocols and the CN understood. The EDM stated she was not sure how many times the ED had to go on diversion since 6/19/24. During an interview on 8/26/24 at 3:55 p.m. with the Compliance/Infection Preventionist (CIP), the CIP stated the EDM notified him about the incident involving Pt 1 on 6/19/24 when the EDM was notified by the CN. The CIP stated once he was notified, the CIP asked around to see what happened, notified the Administrator (ADM), and decided to self-report (report the incident to the California Department of Public Health (CDPH). The CIP stated the self-report was emailed on 6/19/24. The CIP stated they discussed the situation with Pt 1 during huddles, on the spot education, and updated their leaders in the ED to ensure this incident did not happen again. During an interview on 8/27/24 at 10:08 a.m. with MD 2, MD 2 stated he was aware of the incident that occurred on 6/19/24 which involved Pt 1. MD 2 stated he was told Pt 1 did not enter the ED and he was not sure if Pt 1 was triaged. MD 2 stated he was aware the ED was on diversion for the past couple of months due to radiology staffing. MD 2 stated hospitals were allowed to self-divert and the only reason the hospital self-diverted was due to the lack of radiology services. MD 2 stated a patient was considered a patient of the ED when the patient was registered. MD 2 stated when a patient was in the EMS entrance and up to 200 feet from the hospital, the patient should be seen in the ED. During a concurrent interview and record review on 8/28/24 at 3:05 p.m. with the DON, the hospital’s policy and procedure (P&P) titled, “Saturation-Emergency Department,” dated 8/2/21 was reviewed. The P&P indicated, “ ...The Administrator or Chief Nursing Officer has the responsibility of reporting any incidents of “diversion” to the California Department of Public Health within 24 hours by phone or fax ...” The DON stated the incidences of diversion was not reported to CDPH and it was not their policy to report incidences of diversion to CDPH unless the diversion was going to last longer than 24 hours. During a concurrent interview and record review on 8/28/24 at 3:15 p.m. with the ADM, the hospital’s P&P titled, “Saturation-Emergency Department,” dated 8/2/21 was reviewed. The ADM stated anytime there were any issues whether its equipment failure or staffing in the ED, he was notified of the issues. The P&P indicated, “ ...The Administrator or Chief Nursing Officer has the responsibility of reporting any incidents of “diversion” to the California Department of Public Health within 24 hours by phone or fax ...” The ADM stated the information was not accurate, all their P&P needed to be reviewed and revised for best practices. The ADM stated if the hospital did not have radiology services, the EMS needed to be aware so as to not delay patient care. During a review of the hospital’s P&P titled, “Saturation-Emergency Department,” dated 8/2/21, the P&P indicated, “ ...To establish criteria on when the Emergency Department may declare saturation ...ED diversion is only determined as a last resort when the ED cannot safely care for incoming patients ...Other internal incidents that may trigger the ED to go on “diversion” from EMS calls include inability to perform CT or diagnostic x-rays for a period greater than 4 hours, loss of laboratory function and inability to send lab to nearby facilities for resulting, anything that may result in the ED having the capability to sustain the appropriate level of care necessary. Prior to the Emergency Department going on “diversion” for any reason, the charge nurse and the ED physician shall immediately notify the Chief Nursing Officer or the Administrator (Admin on call if previous unavailable) of the facility occurrence ...The Administrator or Chief Nursing Officer has the responsibility of reporting any incidents of “diversion” to the California Department of Public Health within 24 hours by phone or fax ...” During a review of the hospital’s P&P titled, “Compliance with Emergency Medical Treatment,” dated 2/10/24, the P&P indicated, “ ...It is the policy of the Hospital to comply with the EMTALA obligations. These policies are mandated by Section 1867 of the Social Security Act, as amended, and regulations adopted by the Centers for Medicare Services (CMS), and applicable state laws governing the provision of emergency services and care ...Failure to comply with EMTALA may result in termination by CMS of the hospital’s participation in the Medicare and Medicaid programs, as well as civil monetary penalties impose by the OIG for both the Hospital and Physicians of up to $50,000 and possible exclusion from Medicare/Medicaid. Failure to comply with the state laws on emergency services is subject to a licensing enforcement action. A violation of EMTALA is also subject to civil lawsuits for damages ...Comes to the Emergency Department means an individual who ...Is in a ground or air ambulance owned and operated by the Hospital for the purposes of examination or treatment for a medical condition at the hospital’s dedicated emergency department, unless the ambulance is operated (i) under community EMS protocols that direct the ambulance to transport the individual to another facility ...or ...at the direction of a physician is not employed or affiliated with the Hospital ...Is in a non-Hospital owned ground or air ambulance that is on Hospital property for presentation for examination or treatment for a medical condition at the Hospital’s dedicated emergency department ...Hospital Property means the entire main Hospital campus, including ...Areas and structures that are located within 250 yards of the main building, and any other areas determined on an individual case basis by the CMS regional office, to be part of the main Hospital’s campus. Hospital property includes the parking lots, sidewalks, and driveways on the main Hospital campus ...” During a professional review of an article from the National Library of Medicine titled, “EMS Emergency Department Diversion,” dated 2/24/24, the Article indicated, “Emergency medical services (EMS) are an essential healthcare component in the United States. EMS provides skilled acute car and timely access to definitive care for critically ill or injured patients. Situations like epidemics may overwhelm a medical facility’s capabilities, affecting patient care quality or availability. EMS diversion occurs when emergency departments (EDs) temporarily close to incoming ambulance traffic. When an ED assumes a diversion status, EMS must bypass that hospital and proceed to the closest facility with availability. Diversion may affect all ambulance traffic or limit admissions to certain patient types, such as trauma services, OB care, or advanced cardiac care ...EMS diversion was initially intended to combat the growing issue of ED crowding. Facilities previously experienced rising ED wait times due to increasing patient volume. The perceived solution to this problem was to disperse incoming volume to less crowded facilities. However, EMS diversion has been shown recently to not only perpetuate the ED crowding issue but also to incite new problems. Understanding the difficulties, initiatives, and proposed plans to tackle EMS diversion and its effects on healthcare is crucial for safeguarding patient safety, optimizing resource allocation, enhancing system efficiency, protecting public health, informing policy and planning decisions, managing costs, and maintaining care standards within healthcare systems ...Ambulance diversion is undesirable yet unavoidable in the face of severe ED crowding and facility limitations. EMS and ED directors and hospital system administrators should collaborate to decrease ED crowding and EMS diversion hours. EMS plays a critical role in enabling patients to access the healthcare system. Patients may receive improved care by reducing diversion and subsequent offload delays. Ambulances can return to service quicker, enhancing efficiency and patient outcomes ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to ensure stabilizing measures were provided for four of 20 patients (Patient 2, Patient 5, Patient 6, and Patient 7) when: 1. Patient 2 was brought in by ambulance on 11/28/23 at 3:58 p.m. with a chief complaint of 5150 Danger to Others (the number of the section of the Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily [something is done without choice] detained for a 72-hour psychiatric hospitalization when evaluated to be a danger to others, or to himself or herself, or gravely disabled [an inability to provider for their basic needs due to a mental illness]) and while in the emergency department (ED), Patient 2 did not receive a mental health evaluation (a test that assesses a person’s mental health and well-being) to address her emergency medical condition (EMC-an illness, injury, symptom or condition so serious that a reasonable person would seek care right away to avoid severe harm), there was no indication there were attempts to transfer Patient 2 to another hospital for a mental health evaluation and Patient 2 was discharged after her 5150 expired. While in the ED there was no suicide risk screening assessment (identifies individuals that require further mental health/suicide safety assessment) or documentation Patient 2 was not a danger to others. This failure resulted in Patient 2’s emergent psychiatric problem not to be stabilized and had the potential to worsen, lead to injury, harm, or death for Patient 2 and others who have a psychiatric emergency. 2. Patient 5 presented to the ED on 6/19/24 at 3:06 p.m. with a chief complaint of lower back pain after a fall. Patient 5’s pain was not addressed while in the ED, the ED did not have radiology services due to lack of staffing therefore Patient 5 was told to come back in a couple days for an x-ray and was discharged with a prescription for pain medication. Patient 5’s vital signs (measurements of body’s most basic functions, such as temperature, pulse, breathing rate and blood pressure) and pain were not reassessed at discharge. This failure resulted in Patient 5 being discharged home without her EMC being appropriately addressed and had the potential for her back pain to worsen, and cause possible long-term damages and continued pain. 3. Patient 6 presented to the ED with his mother on 8/9/24 at 11:37 p.m. with a chief complaint of fever and ear pain. Patient 6 had a fever on arrival to the ED, there was no indication fever reducing medication was administered to Patient 6 prior to arrival to the ED and the ED physician did not order any fever reducing medications while Patient 6 was in the ED. Patient 6 was tested for covid 19 (a nasal swab that checks for the Covid 19 virus), influenza (test used to determine if someone has the flu), and respiratory syncytial virus (RSV-checks a fluid sample from your nose to see if the RSV virus is causing symptoms of a respiratory infection) which were all negative. Patient 6 was eventually discharged home with acetaminophen (fever reducing medication) and amoxicillin (medication used to treat a wide range of germs) and Patient 6’s temperature to include vital signs were not reassessed at discharge. This failure had the potential for Patient 6 to continue to have unrelieved fever and worsening symptoms due to the lack of addressing Patient 6’s fever while in the ED. 4. Patient 7 was brought in by ambulance on 6/19/24 at 11:18 p.m. with a chief complaint of right shoulder injury. Patient 7’s pain was not addressed while in the ED, there was no indication pain medications were ordered or administered. Patient 7 was eventually discharged and told to go to Hospital B for x-rays due to the lack of a radiology tech. This failure resulted in delayed pain control and care for Patient 7 when he was discharged and had to be driven to Hospital B which was 42 miles away for treatment to resolve his EMC. Findings: 1. During a review of Patient 2’s “Electronic Health Record (EHR-an electronic version of a patient’s medical history),” dated 11/27/23, the EHR indicated, “68-year-old female brought in by ambulance on law enforcement 5150 hold after she was found setting fires in a creek bed. EMS reports that the patient was agitated [very worried or upset] and aggressive [likely to attack other people or behave violently] during transport, attempting to assault [hit] them; patient was given [midazolam-an injection that helps you relax or sleep] 4 mg (milligram-unit of measurement) which resulted in diminished [decreased] aggression. She was initially noted to have [Glasgow coma scale-GCS-a tool used to measure a patient’s level of consciousness] of 13, but has increased to 15 as the [midazolam] wore off. Multiple attempts to obtain a history from the patient have proven successful as she is verbally aggressive, challenging, demanding, and uncooperative ...Past Medical History: methamphetamine abuse [a highly addictive drug], homelessness ...Thin, disheveled [in a state of disorder] female, poor hygiene, intermittently agitated ...ordered an [electrocardiogram-EKG-a simple, painless test that records electrical activity of the heart to assess its function] ...Interpretation ...Abnormal ... Imaging ...[anteroposterior-AP-a type of chest x-ray that examines the lungs, heart, and other structures of the chest] view of the chest ...Impression: No focal airspace consolidation [normal finding] ...Clinical Course/Medical Decision Making: Anemia [a condition that develops when your blood produces a lower than normal amount of healthy red blood cells] ...Hypokalemia [a condition where the level of potassium (electrolyte) in your blood is lower than normal] ...Hypoalbuminemia [a condition in which the body has low levels of albumin(a protein that helps keep fluid in blood vessels)] ...Hypocalcemia [a condition in which the body has too little calcium in the blood] ...Condition: unchanged ...Continue with 72 hour hold ...” During a review of Patient 2’s “EHR,” dated 11/29/23, the EHR indicated, “ ...Test ...Potassium ...3.4 ...Ordered medication ...11/27/23 ...sodium chloride [a source of electrolytes and water for hydration] 0.9% 1000 ml [millimeter-unit of measurement] bag ...potassium chloride premix [intravenous (IV) solution used to treat hypokalemia] 10MEQ/100ML ...potassium chloride tab [oral tablet used to treat hypokalemia] 20MEQ ...11/28/23 ...diphenhydramine injection [used as a sedative for mental health patients] 50mg/ml ...haloperidol [medication used to manage symptoms including hallucinations [false perceptions of sensory experiences] and delusions [a false belief that is fixed and persists] 5mg/1ml ...lorazepam [medication used to relieve anxiety] injection solution 2mg/1ml ...sodium chloride 0.9% 1000ml bag ...potassium chloride tab 20 [milliequivalent (MEQ-a unit of measurement)] ...potassium chloride premix 10 MEQ/100ml ...potassium chloride tab 20 MEQ ...hydroxyzine pamoate oral [used to treat anxiety (a feeling of fear or dread)] capsule 25 mg ...nitrofuran mono [commonly used to treat bladder infections] cap 100mg ...Clinical Course ...Patient remain stable. Occasional episodes of agitation managed with hydroxyzine. Largely cooperative ...Assessment ...5150 ...Hypokalemia ...methamphetamine positive toxicology screen ...urinary tract infection [UTI-an infection of the urinary tract] ...Plan: Start [nitrofurantoin100mg, 1 tab by mouth twice a day ...5150 expires tomorrow ...In past patient has been discharged to the care of her daughter who lives in town ...” During a review of Patient 2’s “EHR,” dated 11/30/23, the EHR indicated, “ ...GCS 15 ...Some anxiety persists-she is indeed quite anxious about “getting out”-her 5150 is over 3 PM today. We have contacted a “friend” by telephone who states he might be able to pick her up-we are to contact him again ...[Patient 2] has no physical complaints; tolerates her diet well; has no auditory nor visual hallucinations ...Psychiatric: GCS 15. The patient is oriented [times] 4. Mood and affect are appropriate ...ED Course ...Examined and Evaluated in ER. Did well under current regimen. Discussed all aspects with patient. Appears will be stable for discharge off of 5150 at 3PM today. Was a bit somnolent during the day after earlier sedation; however did well. Patient appears to be a safe discharge 5:20PM ...Reeval: Improved clinical status on repeated examinations and evaluations ...Diagnostic Impression: (1). 5150 Hold-Release (2). Anemia (3). Hypothyroid (4). Hypokalemia-Treated (5). UTI-Treated (6). Amphetamine [stimulant drug] Intoxication [a temporary condition that affects the central nervous system (CNS-the brain and spinal cord which work together to process and respond to sensory information, and control nearly all of the body’s functions)]-Resolved ...Disposition/Plan: (1). Discharge Home (2). Follow up with [primary medical doctor] /Rural Clinic in 1-2 days (3). Return to ER if symptoms persist or worsen in any way. (4). Review Discharge Instructions given to you prior to discharge ...Condition: Stable ...Disposition: Home ...” During a review of Patient 2’s “Nursing Note (NN),” dated 12/1/23, the NN indicated, “ ...[Patient] given clothes, jeans, jacket, and socks, has been discharged since yesterday when her 5150 expired at 1457. At this time [patient] got up from bed, put on her clothes that were given to her, and stated she wanted to leave. [Patient] walked out the front of the hospital and said that she would be leaving at this time ...” During a concurrent interview and record review on 8/22/24 at 3:15 p.m. with the EDM, Patient 2’s “EHR,” dated 11/27/23 was reviewed. The EDM stated the EHR indicated Patient 2’s Suicide Risk assessment and documentation of whether Patient 2 was a danger to others was not documented. The EDM stated the suicide risk assessment should be assessed at triage for all patients and when Patient 2 was cognitively available to complete the assessment the nurse should have assessed Patient 2’s suicide risk. The EDM stated Patient 2 was never medically cleared by the time her hold was up, they were not able to get Patient 2 a mental health evaluation. The EDM stated unless there was a medical reason to transfer Patient 2 or once Patient 2 was medically cleared, the ED physician should have transferred Patient 2 to a hospital for a higher level of care or to another hospital for a mental health evaluation. The EDM stated the hospital did not have mental health evaluators and patients who required a mental health evaluation should be transferred to another hospital that had those services. The EDM stated the importance of a mental health evaluation was to make sure the patient received the necessary care and resources. During a concurrent telephone interview and record review on 8/27/24 at 11:15 a.m. with MD 2, Patient 2’s “EHR,” dated 11/27/23 was reviewed. MD 2 stated 5150 patients are usually brought in custody or in the presence of law enforcement. MD 2 stated the patient could be a danger to self or others or gravely disabled. MD 2 stated the patient was kept under constant observation with a sitter MD 2 stated when patients are under constant observation their personal belongings are taken and put in a secure area and the patient was asked to change into a pair of green paper jump suit. MD 2 stated he would order labs,urinalysis and if the patient’s mental status was questionable, he could order imaging. MD 2 stated he would collect information such as the patient’s past medical history and assess the patient. MD 2 stated once all the labs, imaging or urinalysis results are back he was able to determine if the patient was medically cleared and the transfer requests were initiated. MD 2 stated transfer requests for mental health evaluations had been unsuccessful and the hospital did not have a dedicated tele psychiatry (a type of telemedicine that uses technology to provider psychiatric care remotely) to assess patients who required a mental health evaluation. MD 2 stated after the 5150 expired, if the patient was medically stable, and they were not suicidal (marked by an impulse to end one’s life) or homicidal (having tendencies towards the killing of another person)they are usually discharged to family or friends. MD 2 stated occasionally they had to get the police department to extend a patient’s 5150 especially when they found a hospital who accepted the patient. MD 2 stated due to transportation delays the patient’s 5150 expired so they would have to extend the 5150 in order for the hospital to accept the patient. MD 2 stated the EHR indicated, “ ...[Patient] given clothes, jeans, jacket, and socks, has been discharged since yesterday when her 5150 expired at 1457. At this time [patient] got up from bed, put on her clothes that were given to her, and stated she wanted to leave. [Patient] walked out the front of the hospital and said that she would be leaving at this time ...” MD 2 stated there was no indication Patient 2 left with a family member or friend and there was no documented indication whether Patient 2 was a danger to others during her ED stay or prior to discharge. MD 2 stated ideally a patient on a 5150 should have a mental health evaluation. MD 2 stated the importance of a mental health evaluation was to ensure the patient’s care was addressed. During an interview on 8/27/24 at 1:35 p.m. with the Registered Nurse (RN), the RN stated when a patient arrived in the ED, the patient was registered and then the patient was called back to triage. The RN stated the patient was called to triage within 10-15 minutes, their vital signs were taken, the patient was triaged and assigned an emergency severity index (ESI-a tool used in the emergency department triage) level of 1-5. The RN stated level 1 was death, CPR in progress; level 2 acute respiratory distress, life or limb; level 3 required two or more interventions; 4 and 5 required lesser resources. The RN stated a patient on a 5150 should have an ESI of 2. RN stated an ESI of 2 is determined by assessing if patient had an active plan to hurt themselves. Interventions put into place were a one to one sitter, the patient was asked to change into paper scrubs and personal clothing was secured in a locked area due to the fact that the patient could use their clothing to hurt themselves. The RN stated the abuse and suicide risk screening was completed at triage. The RN stated the ED did not have a licensed mental health evaluator so during the 72 hour period, the ED staff were actively trying to transfer the patient to a mental health facility in the area to get assessed. The RN stated sometimes there could be up to three patients in the ED on 5150’s and the ED staff may have a hard time to find accepting facilities, if they were unable to find a facility within 72 hours, the police department could reassess the patient and reissue the 72 hour hold. The RN stated the importance of a mental health evaluation was to ensure the patient’s care needs were met. During an interview on 8/27/24 at 3:10 p.m. with the Director of Nursing (DON), the DON stated his expectations of 5150 patients was, these patients should be assessed by an ED physician, if the patient had an emergency or medical condition, their needs should be addressed and once medically cleared, start the transfer process. The DON stated the transfer process should be documented on the Transfer Call Log. The DON stated if the patient was suicidal, the patient required a one-to-one sitter who would monitor and document the patient’s behavior every 15 minutes. The DON stated the importance of a mental health evaluation was very important so the patients could receive the help they needed . The DON stated unfortunately due to the hospital location and the availability of beds for patients who required mental health evaluations, sometimes the facility was unable to transfer these patients and once their hold expired, they were free to leave as they could not hold these patients. The DON stated the nurses were responsible to document each patient’s suicide risk screening and this screening should be completed on all patients during triage. The DON stated the suicide risk screening for 5150 patients should be completed initially at triage and then on an ongoing basis. During a concurrent interview and record review on 8/27/24 at 3:15 p.m. with the DON, the hospital’s policy and procedure (P&P) titled, “Patient Awaiting Psychiatric Evaluation,” dated 2/2/24 was reviewed. The P&P indicated “ ...For those who are brought for suicidal ideation, A Suicidal Screening must be completed by the RN/LVN each shift and any time the patient expresses suicidal ideation or makes self-harming gestures ...Observation of signs and symptoms of mental, emotional, behavioral or suspected substance abuse ...Documentation of potential danger to self, staff, or others ...” The DON stated his expectations were nurses should follow all hospital P&P. During an interview on 8/27/24 at 4:26 p.m. with the CIP, the CIP stated there were no documented attempts to transfer Patient 2 to another hospital. During an interview on 8/28/24 at 3:05 p.m. with the DON, the DON stated the importance of nurses following P&P was to ensure everything was done correctly and should always be the same. During a review of the hospital’s P&P titled, “Compliance with Emergency Medical Treatment,” dated 2/10/24, the P&P indicated, “ ...To stabilize means with respect to an emergency medical condition, to ...either provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital or, in care of a woman in labor, that the woman has delivered the child and the placenta ...Stable for Discharge means a determination by the treating physician, within reasonable clinical confidence, that an individual has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could reasonably be performed as an outpatient or later as an inpatient, provide the individual is given a plan for appropriate follow-up care with the discharge instructions. For the purpose of discharging an individual with psychiatric condition(s), the individual is considered to be stable for discharge when he/she is no longer to be a threat to himself/herself or to other ...” 2. During a record review of Patient 5’s “EHR,” dated 6/19/24, the EHR indicated Patient 5 came to the ED with a chief complaint of 9/10 (pain scale usually 0-10 with 10 being the worst pain) lower back pain after a fall. The EHR indicated, “ ...32 year old female presents emergency room complaining of pain in the middle of her lumbar area. Patient fell on Saturday landing directly on the mid lumbar area. She has most of the tenderness is over the mid posterior spinous processes of the lumbar area with a little bit of tenderness in the paraspinous muscles adjacent to that. The patient is up and while ambulatory ...Examination shows tenderness over the posterior spinous processes of the mid lumbar area with some mild discomfort over the paraspinal muscles. Patient is fully ambulatory and does not seem to be having a lot of pain although she says the pain is 9 on a scale of 10 and she is able to walk without showing any evidence of discomfort. Unfortunately the [radiology] department is closed today because the [radiology] tech developed an acute illness. This morning and had to go home and there was not sufficient notice to get somebody else to pull the shift today. We will have an x-ray tech in the morning. Patient may return at that time and will be lumbar spine ...Plan: Return tomorrow for x-rays lumbar spine ...Norco 5/3/2025 1 every 4 hours #12 ...” The EHR indicated Patient 5 was not administered any pain medications while in the ED. The EHR indicated Patient 5 was discharged at 4:25 p.m. with a diagnosis of tenderness over lumbar spine, back pain and Patient 5’s vital signs and pain were not reassessed at discharge. During an interview on 8/21/24 at 2:25 p.m. with the EDM, the EDM stated, “The importance of vital signs if the patient’s chief complaint was pain, was their pain should be assessed to ensure the patient didn’t have any physiological issues before the patient was discharged.” The EDM stated pain was considered a vital sign as well and should be assessed with the vital signs. The EDM stated if Patient 5’s vital signs were not assessed prior to discharge, depending on what the patient presented with, the patient could have a form of distress and if they did not appear in distress, something could be missed. During a concurrent interview and record review on 8/23/24 at 4:10 p.m. with MD 1, Patient 5’s “EHR,” dated 6/19/24 was reviewed. The EHR indicated Patient 5 came to the ED for lower back pain after a fall with a 9/10 pain. MD 1 stated it was the ED physician’s judgement call, whether to transfer Patient 5 or if could wait to take x-rays. MD 1 stated the common practice is to discuss discharge with the patient and having the patient coming back for an x-ray. MD 1 state the option is also given to the patient to be transferred. The EHR indicated there was no indication MD 1 discussed a possible transfer for an x-ray with Patient 5. The EHR indicated while in the ED Patient 5 was not administered any pain medications or interventions to assist with Patient 5’s 9/10 pain. MD 1 stated the importance of pain interventions was to relieve the patient’s pain as much as they could, and he did not have any issues with ordering pain medications if it was in the patient’s best interest. MD 2 stated if the patient’s pain was not addressed, he was not sure what could happen to the patient. During a telephone interview on 8/26/24 at 4:46 p.m. with Patient 5, Patient 5 stated she was told her back pain was not that bad. Patient 5 stated the doctor gave her a prescription for pain medication and told her to go back to the ED in two to three days for an x-ray due to not having anyone available to take x-rays. Patient 5 stated the doctor did not offer to transfer her to another hospital for x-rays. Patient 5 stated she felt the ED did not address her back pain when she was in the ED. Patient 5 stated she did not return to the ED for x-rays due to having to go back to work and take care of her kids. During a concurrent interview and record review on 8/27/24 at 10:30 a.m. with MD 2, Patient 5’s “EHR,” dated 6/19/24 was reviewed. MD 2 stated he addressed his patient’s pain based on the patient’s self-report which was subjective and then he used the Baker-Wong pain assessment (pain assessment tool to help a person effectively communicate the severity of their physical pain) to determine what level of pain the patient really had. MD 2 stated the EHR indicated, “ ...Examination revealed a well-developed well-nourished female no acute distress ...Examination back shows tenderness over the posterior spinous processes of the mid lumbar area with some mild discomfort ...” MD 2 stated there was no documented Baker-Wong score by the ED physician. MD 2 stated the EHR indicated, “Clinical Observation of Pain: relaxed; calm expression ...Pain Level: 9 ...” MD 2 stated the EHR indicated, according to the nurse’s notes and ED physician assessment, the patient’s pain level based on Baker Wong was less than 5. MD 2 stated if Patient 5’s pain level was truly 9/10, the patient’s pain should have been addressed but the nurse’s notes and ED physician’s assessment indicated that was not the case. MD 2 stated when the ED did not have radiology services and a patient came in for abdominal or central or peripheral neurological issues, he would transfer these patients to another hospital. MD 2 stated if the examination of the patient’s abdomen and chest did not have any problems or the patient had a normal neurological examination or non-critical orthopedic problem then those patients would be discharged and told to come back to the ED. MD 2 stated the EHR indicated Patient 5’s pain was not addressed while in the ED but when Patient 5 was discharged MD 1 gave her a prescription for pain medication to address her pain. During a review of the hospital’s P&P titled, “Pain Assessment-Emergency Department,” dated 3/1/24, the P&P indicated, “ ...It is the policy of this organization to respect and support the patient’s right to optimal pain assessment and management. Pain is assessed in all patients in our organization. The organization will also address the appropriateness and effectiveness of pain management ...Effective pain assessment and management can remove the adverse psychological and physiological effects of unrelieved pain. Optimal management of the patient experiencing pain enhances healing and promotes both physical and psychological wellness. Patients need to be involved in all aspects of their care including pain management ...It is the responsibility of nursing staff to assess and periodically reassess the patient for pain and relief from pain and may include the intensity and quality ...and response to treatment ...At time of admission to the facility, the patient will be questioned regarding pain during the initial nursing assessment ...The patient will undergo reassessment of pain at least once per shift and after the administration of narcotic medication for pain control ...Any patient care provider, from any department, that has implemented a narcotic pain control medication will reassess the patient within one (1) hour to determine amount of pain control or relief achieved ...As part of the reassessment, the nurse shall assess and document the pain in terms of its duration numerical value and any use of analgesics. Also include other pain interventions, vital signs, the effectiveness of all interventions including non pharmacological if utilized and any side effects or adverse reactions. This ongoing reassessment should be done minimally once per shift while active and during the night time hours when pain often becomes more intense and the patient’s ability to sleep does not always mean that there is an absence of pain ...” During a review of the hospital’s P&P titled, “Compliance with Emergency Medical Treatment,” dated 2/10/24, the P&P indicated, “ ...To stabilize means with respect to an emergency medical condition, to ...either provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital or, in care of a woman in labor, that the woman has delivered the child and the placenta ...Stable for Discharge means a determination by the treating physician, within reasonable clinical confidence, that an individual has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could reasonably be performed as an outpatient or later as an inpatient, provide the individual is given a plan for appropriate follow-up care with the discharge instructions. For the purpose of discharging an individual with psychiatric condition(s), the individual is considered to be stable for discharge when he/she is no longer to be a threat to himself/herself or to other ...” 3. During a concurrent interview and record review on 8/23/24 at 4:30 p.m. with the EDM, Patient 6’s “EHR,” dated 8/9/24 was reviewed. The EHR indicated Patient 6 came into the ED for a chief complaint of fever and ear pain and a fever of 102.8 degrees Fahrenheit (Unit of measurement). The EDM stated the EHR indicated the ED physician ordered a covid 19, influenza, and RSV test which were all negative. The EDM stated the EHR indicated Patient 6 was not administered a fever reducing medication while in the ED and there was no indication from the ED physician’s note that Patient 6 was administered a fever reducing medication prior to the ED visit. The EDM stated the EHR indicated Patient 6 was discharged at 12:56 a.m. with a diagnosis of febrile (fever) illness and bilateral otitis media (middle ear inflammation). The EHR indicated Patient 6’s vital signs and pain were not assessed at discharge. The EDM stated Patient 6’s vital signs and pain should have been reassessed at discharge at least 30 minutes prior to discharge. The EDM stated the importance of reassessing a patient’s temperature was to ensure their fever was stabilized. The EDM stated if the patient’s temperature was not checked prior to discharge the patient’s condition could worsen or continue to have a fever. During an interview on 8/26/24 at 4:28 p.m. with the Family Member (FM), the FM stated Patient 6 had a fever and ear pain. The FM stated the doctor ordered a few tests and the results came back negative. The FM stated Patient 6 was discharged with acetaminophen (pain or fever mediation) and amoxicillin (antibiotic). The FM stated she did not remember if Patient 6’s temperature was reassessed prior to discharge. During a concurrent telephone interview and record review on 8/27/24 at 11 a.m. with MD 2, Patient 6’s “EHR,” dated 8/9/24 was reviewed. MD 2 stated the EHR indicated Patient 6 did have a fever and ideally he would have liked to see the fever come down prior to discharge. MD 2 stated the EHR indicated Patient 6 was not administered any fever reducing medications while in the ED. MD 2 stated Patient 6 was still febrile at discharge so his fever was not resolved prior to discharge. MD 2 stated if Patient 6 received instructions for acetaminophen and amoxicillin at discharge. MD 2 stated the importance of reassessing a patient’s vital signs and pain at discharge was to ensure the patient was stable for discharge. MD 2 stated patients should have had their vital signs and pain reassessed at least 30 minutes prior to discharge. During an interview on 8/27/24 at 3 p.m. with the DON, the DON stated his expectations of nurses was assessing and reassessing their patients’. The DON stated vital signs and should be completed at triage, at least once an hour after triage, at the time of discharge and if there were any pain interventions. The DON stated the importance of vital signs was to monitor the patient’s progress. The DON stated if a patient’s vital signs were not assessed or reassessed they could have a bad outcome. During a review of a professional resource titled, “Vital Signs Assessment,” dated January 2024 was reviewed, the Article indicated, “ ...Vital signs are an objective measurement of the essential physiological functions of a living organism. They have the name “vital” as their measurement and assessment is the critical first step for any clinical evaluation. The first set of clinical examination is an evaluation of the vital sings of the patient. Triage of patients in an urgent/prompt care or an emergency department is based on their vital signs as it tells the physician the degree of derangement that is happening from the baseline. Healthcare providers must understand the various physiologic and pathologic processes affecting these sets of measurements and their proper interpretation. If we use a triage method where we select patients without determining their vital signs, it may not give us a reflection of the urgency of the patient’s presentation ...The degree of vital signs abnormalities may also predict the long-term patient health outcomes, return emergency department visits, and frequency of readmission of hospitals, and utilization of healthcare resources ...Traditionally, the vital signs consist of temperature, pulse rate, blood pressure, and respiratory rate. Pulse oximetry sometimes helps to clarify the patient’s physiological functions, which would sometimes be unclear by checking just the traditional vital signs ...” During a review of the hospital’s P&P titled, “Compliance with Emergency Medical Treatment,” dated 2/10/24, the P&P indicated, “ ...To stabilize means with respect to an emergency medical condition, to ...either provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital or, in care of a woman in labor, that the woman has delivered the child and the placenta ...Stable for Discharge means a determination by the treating physician, within reasonable clinical confidence, that an individual has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could reasonably be performed as an outpatient or later as an inpatient, provide the individual is given a plan for appropriate follow-up care with the discharge instructions. For the purpose of discharging an individual with psychiatric condition(s), the individual is considered to be stable for discharge when he/she is no longer to be a threat to himself/herself or to other ...” 4. During a concurrent interview and record review on 8/22/24 at 11:45 a.m. with the EDM, Patient 7’s “EHR,” dated 6/19/24 was reviewed. The EHR indicated Patient 7 had a chief complaint of right shoulder injury. The EHR indicated, “26 year old male ...fell hitting his shoulder. He has soft tissue swelling and abrasions over the top of the shoulder and is reluctant to move it. Possibly could have a humeral fat fracture but no x-rays are available because x-ray tech became ill during this shift and we have no one to take the x-rays ...Soonest we will have x-ray tech is at 8:30 a.m. in the morning ...Will try to make an arrangement with [name of Hospital B] to take the x-rays at that facility ...Case discussed with [name of MD at Hospital B] who is graciously accepted the patient to be transferred by the prison guards to that facility for x-ray and further treatment. We will discharge the patient to the prison guards who will transport the patient over to [name of Hospital B] for x-rays and further evaluation ...” The EHR indicated Patient 7 was discharged at 12:15 a.m. with a diagnosis of unspecified injury to right shoulder and left upper arm. The EHR indicated Patient 7 did not have vital signs documented prior to discharge. The EDM stated, “Usually if the patient has an urgent or emergent situation, the patient was transferred via EMS but if the ED physician felt comfortable with discharging the patient to the officers to go by private vehicle, the patient could but this did not happen often.” During a concurrent interview and record review on 8/27/24 at 10:45 p.m. with MD 2, Patient 7’s “EHR,” dated 9/19/24 was reviewed. The EHR indicated the ED physician spoke to [name of physician from Hospital B] and the physician from Hospital B accepted the patient. MD 2 stated, “The transfer form should have been filled out because it sounded like there was an accepting physician.” MD 2 stated Patient 7 should have been transferred and the security officers could have transported the patient. The EHR indicated Patient 7’s vital signs were not reassessed at discharge. MD 2 stated ideally, the vital signs should be done at discharge but occasionally it did not happen. MD 2 stated the importance of vital signs at discharge was to ensure the patient was stable and important for compliance purposes . During a review of the hospital’s P&P titled, “Transfer of Patients to Another Facility,” dated 2/3/24, the P&P indicated, “ ...To establish guidelines based on COBRA and EMTALA standards to insure that adequate care is given to each patient; if unable to continue with care, offer specialty care or higher level of care, patient is to be transferred to an appropriate facility ...If the physician determines, through CRMC policy, tat the patient should be transferred to another facility for further care, COBRA standards must be followed ...The patient must ...Require a higher level of care ...Not be in imminent labor ...Require a service not provided here ...Be medically stable for transport ...Agree to the transfer unless physical condition inhibits consent ...Acceptance to the receiving facility must be made physician to physician with documentation of the receiving facility’s physician name ...Transfer papers will be completed ...i. Physician Authorization for Transfer form; ii. Patient Transfer Acceptance form; iii. Physician Medical Certification for Transfer form; iv. Transfer Summary form ...Copy of medical records, lab and x-rays, will accompany the patient ...Documentation shall include, but is not limited to ...i. Report given to transfer team; ii. Condition of the patient prior to transport; iii. Vital signs prior to transfer ...” During a professional reference review from the National Library of Medicine an article titled, “EMTALA and Patient Transfers,” dated 11/22/23, the Article indicated, “ ...The United States Congress passed the Emergency Medicine Treatment and Active Labor Act (EMTALA) in 1986. EMTALA was part of the Consolidated Omnibus Reconciliation Act (COBRA), which Congress enacted to address Medicare issues. The origine intent of the EMTALA law was to attempt to prevent discrimination against patients in the form of “patient dumping.” Patient dumping is the practice of involuntarily transferring uninsured patients from one hospital to another strictly for financial reasons ...The second legal requirement of EMTALA deals with patient stabilization and treatment. If the patient has been found to have an emergency medical condition, the hospital must treat and stabilize the patient. Hospitals cannot refuse emergency care to patients based on their inability to pay, age, color, disability, ethnicity, immigration status, lack of insurance coverage, lack of pre-authorization, or national origin ...The same medical screening procedures and stabilizing treatments must be used for all patients with comparable signs and symptoms regardless of their ability to pay, insurance coverage, or legal status. Clinical management decisions are not covered under EMTALA, but good clinical judgment and nationally recognized standards of care would still apply. Also, the same medical screening procedures and stabilizing treatments must be used for all patients with comparable signs and symptoms regardless of their ability to pay, insurance coverage, or legal status ...” During a review of the hospital’s P&P titled, “Compliance with Emergency Medical Treatment,” dated 2/10/24, the P&P indicated, “ ...To stabilize means with respect to an emergency medical condition, to ...either provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the Hospital or, in care of a woman in labor, that the woman has delivered the child and the placenta ...Stable for Discharge means a determination by the treating physician, within reasonable clinical confidence, that an individual has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could reasonably be performed as an outpatient or later as an inpatient, provide the individual is given a plan for appropriate follow-up care with the discharge instructions. For the purpose of discharging an individual with psychiatric condition(s), the individual is considered to be stable for discharge when he/she is no longer to be a threat to himself/herself or to other ...””