Unitypoint Health - Des Moines Iowa Methodist Medi

“CODING AND INDEXING OF MEDICAL RECORDS CFR(s): 482.24(b)(2) The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies. This Standard is not met as evidenced by: 49842 Based on document review, medical record review, and interviews with staff, the Acute Care Hospital (ACH)’s administrative staff failed to ensure that its medical record system was properly indexed to allow for accurate identification and timely retrieval of patient records, including the tracking of admissions and discharges for 1 of 10 patients reviewed (Patient #4). Failure to ensure all patients were included in the ACH’s list of admissions and discharges could hinder the hospital’s ability to appropriately track the status of patients and the care provided to said patients. This failure could result in discontinuity of care, thereby increasing patients’ risk of adverse health outcomes. Findings include: 1. Review of the policy titled “Record Control Procedure” dated 8/2023, revealed in part: a. “... [The ACH] shall define the record control system and assign responsibilities for the identification, storage, protection, retrieval, retention time, disposition, and destruction of [hospital] records. This system is established and maintained to provide evidence that the creation, maintenance, retention, and destruction of records conforms to all relevant Iowa and federal laws and regulations and to the requirements of the ISO Quality Management System (QMS).” 2. Review of the “Quality Assurance and Performance Improvement Plan,” last updated 1/2025, revealed in part: a. “... Operations Quality Control: Activities that monitor improvement goals and targets to ensure adoption and effectiveness. (Monitor-Sustain phase). Quality control includes methods to abstract/collect, submit, visualize, and analyze performance data to determine whether performance is stable (e.g., within control limits), whether a performance shift (favorable or unfavorable) is detected, and whether performance falls within a desirable range. Quality control activities inform quality planning activities.” b. “... Quality Operations: Data is collected, analyzed, and distributed to manage clinical and operational performance and to meet regulatory standards. These may include: i. “Data abstracted from the medical record and other key systems (e.g., quality software system, safety event reporting system, patient surveys and grievances, employee engagement surveys, accreditation surveys), which are submitted, as appropriate, to oversight bodies per specifications.” ii. “Data collected for management of clinical operations and medical staff performance per Standard Requirements of accreditation organizations.” iii. “Data collected to monitor clinical performance within value-based contractual agreements and to administer the value-based performance plan for employed providers.” 3. Medical record review for Patient #4 (P4) revealed the following: a. P4 arrived at the emergency department (ED) by ambulance on 02/24/2026 at 7:45 AM with complaints of dizziness, lightheadedness, nausea, and headache. The primary care physician (PCP) had advised ED evaluation due to dangerously low sodium levels. At 10:02 PM, providers changed P4’s disposition to ED admission. At 1:22 PM on 02/24/2026, staff transferred P4 to observation status, and later moved the patient to the inpatient floor with a primary diagnosis of symptomatic hyponatremia. b. At 6:55 AM on 02/25/2026, providers changed P4’s status to inpatient admission in the same unit. During the inpatient stay, the care team treated P4’s decreased sodium levels through saline hydration, increasing the patient’s blood sodium from 123 millimoles per liter (mmol/L) at admission to 134 mmol/L. The provider discharged P4 to home on 02/25/2026 at 1:18 PM in stable condition. 4. During an interview on 4/9/26 at 1:00 PM, Staff A, Executive Director of Quality Excellence, reported the following information: Staff A described a system-level role within the QAPI program, focused on ensuring data quality, standardization, and performance improvement across system, market, and local levels. Reports generated from the electronic health records (EHR) system rely on the appropriate use of filters. At the same time, system- and market-level data remain standardized to ensure consistency, while local-level users may apply more specific filters, such as discharge status, procedures, or unit. Incomplete or missing patients in reports are considered rare and typically attributed to data entry or workflow errors rather than system limitations. The failure of a specific patient to appear on multiple standard reports would be highly unusual and likely indicate a workflow deviation that requires further investigation. 5. During an interview on 4/9/26 at 2:00 PM, Staff B, Director of Health Information Management, reported the following: Staff B reported that accurate inclusion of patients in admission and discharge reports depends on correct registration and status updates within the EHR; if a patient is not formally admitted as an inpatient or their status is not updated appropriately, they will not appear in reports. Report accuracy also relies on correct data entry and the use of defined report parameters. The failure of a specific patient to appear on multiple reports was described as highly unusual and unprecedented, with the most likely explanations involving workflow or registration issues, or potentially a technical problem. 6. During an interview on 4/13/26 at 8:50 AM, Staff D, Clinical Nurse Informaticist, reported the following information: Staff D reported that they typically generate reports for survey teams, but were unavailable when the requested reports were run. They indicated that the staff member who completed the task was relatively new and may have missed selecting the required report criteria. Accurate report generation depends on applying multiple criteria correctly to capture data across both ED and inpatient settings. The interviewee suggested that the omission of a specific patient was likely due to a missed selection or parameter error and offered to rerun the report for the requested time period to verify whether the patient would appear. 7. During an interview on 4/13/26 at 9:30 AM, Staff D, Clinical Nurse Informaticist, reported the following information: Staff D indicated that a subsequent report, generated on the same date and for the identical time frame requested by the survey team, included a substantial number of patients who were missing from the original report. According to Staff D, the initial requested report of patient admissions did not fully incorporate all necessary criteria to appropriately index Emergency Department (ED) and Observation Status patients, including their respective dates of admission, resulting in an inaccurate and incomplete report of patients admitted to the facility within the specified timeframe. The ACH failed to ensure that medical records were properly indexed, allowing for the timely retrieval and tracking of patient admissions and discharges.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 50212 Based on medical record review, policy review, and interviews with hospital staff and patient family members, the Acute Care Hospital (ACH) ’ s administrative staff failed to protect and promote the rights of 1 of 11 sampled patients (Patient #9[P9]). Failure to preserve the rights of all patients resulted in the following: 1) hospital staff failed to ensure all patients received care in a safe setting (A-0144); 2) hospital staff failed to implement restraints in accordance with safe and appropriate restraint techniques (see A-0167); 3) hospital staff failed to utilize restraints in accordance with the order of a physician or other licensed practitioner (see A-0168); 4) hospital staff failed to consult the attending physician as soon as possible upon the application of restraints not ordered by a physician (see A-0170); and 5) hospital staff failed to impose restraints only to ensure the immediate safety of patients, and staff failed to discontinue restraints at the earliest possible time (see A-0154); The cumulative effect of these systemic failures and deficient practices resulted in the inability of the ACH’s administrative staff to ensure hospital staff implemented and maintained appropriate safety measures to preserve the health, dignity, and wellness of all patients. The ACH ’ s administrative staff identified an average of 9 new admissions to the Geropsychiatry Unit per month and an average daily census of 12 patients admitted to the unit.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH’s (Acute Care Hospital) administrative staff failed to ensure hospital staff provided care in an environment in which a reasonable person would consider to be safe from physical and emotional harm for 1 of 11 sampled patients (Patient #9 [P9]). Findings include: 1. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy . . . Each patient has the right to receive care in a safe setting. The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ Patient rights, dignity and well-being are protected during restraint or seclusion use and the following will be assured . . . Safety and cleanliness of the patient ’ s environment . . . [and] concern for the patient ’ s perspective related to the experience of being secluded or restrained. Restraints will not be used for patient coercion, discipline, convenience, corporal punishment, or staff retaliation. “ d. “ Based upon individual patient assessments, [the ACH] takes precautions to: Provide alternatives/interventions to promote optimal patient safety and protection; protect patients ’ rights, dignity and well-being; provide care in an environment which promotes optimum healing and functioning; prevent harm to patients, hospital personnel and others . . . “ e. “ VIII. For Violent or Self-Destructive Behavior including Physical Holds . . . 2. The licensed independent practitioner or a registered nurse . . . will conduct a face-to-face in-person evaluation of the restrained/secluded patient within one hour of the initiation of a seclusion/restraint incident . . . [To] evaluate the patient ’ s reaction to the intervention; Determine whether restraint or seclusion should be continued . . . Make any necessary revision to the treatment plan; [and] supply an additional order if necessary. “ f. “ The one-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient ’ s medical condition would include a complete review of systems assessment, behavioral assessment, review and assessment of the patient ’ s history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient ’ s condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient ’ s violent or self-destructive behavior. “ g. “ 3. If a patient ’ s violent or self-destructive behavior resolves and the restraint or seclusion intervention is discontinued before the practitioner conducts the one-hour, face-to-face evaluation, licensed independent practitioner or a registered nurse who has met the training requirements is still required to see the patient face-to-face and conduct the evaluation within one hour after the initiation of this intervention. The fact that the patient ’ s behavior warranted the use of a restraint or seclusion indicates a serious medical or psychological need for prompt evaluation of the patient behavior that led to the intervention. The evaluation would also determine whether there is a continued need for the intervention, factors that may have contributed to the violent or self-destructive behavior, and whether the intervention was appropriate to address the violent or self-destructive behavior. “ 2. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient’s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer ’ s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff with no documentation of the use of mechanical restraint devices (e.g., wrist or ankle restraint cuffs). 3. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient’s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient’s ability to move due to the patient’s history of wandering and going into other patients’ rooms. 4. During an interview on 5/15/25 at 12:25 PM, Staff H (Advanced Registered Nurse Practitioner (ARNP) reported P9’s condition did not necessitate the implementation of measures to prevent the patient from leaving their recliner. Staff H noted the patient could walk steadily and had been permitted by staff to wander around the unit. 5. During an interview on 5/19/25 at 11:30 AM, Staff N (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of P9’s recliner to limit the patient ’ s movement. Staff N acknowledged, “ That’s not supposed to happen. “ 6. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients’ recliners on a number of previous occasions. 7. During an interview on 5/19/25 at 12:30 PM, Staff E (Manager of Inpatient Psychiatric Unit) acknowledged, “ [The practice of placing a chair underneath a patient’s recliner to restrict their movement] isn’t what staff are trained to do, nor should they ever be doing that . . . [Staff] should not be propping anything under the recliner to keep it propped up. “”

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. 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: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH’s administrative staff failed to ensure hospital staff imposed restraints exclusively for the purpose of ensuring the immediate physical safety of the restrained patient for 1 of 11 sampled patients (Patient #9[P9]). Additionally, staff failed to discontinue restraints for said patient at the earliest possible time at which doing so would be safe for the patient and others. Findings include: 1. Review of the 06/2024 policy “ Patient Rights and Responsibilities “ revealed in part: “ Restraint or seclusion may only be imposed (used) by trained team members to ensure the immediate physical safety of the patient, our team members, or others and must be discontinued (stopped) at the earliest possible time. “ 2. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy: [the ACH’s] philosophy is to strive toward a restraint and seclusion-free environment through effective preventative strategies and the use of alternatives for patient safety. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. The use of restraint or seclusion is not based on the patient ’ s history of seclusion or restraint use or solely on a history of dangerous behavior. “ d. “ Restraints will only be applied . . . after a comprehensive assessment demonstrates restraint or seclusion is clinically indicated and other interventions are ineffective or not viable. “ e. “ Episodes of seclusion or restraint must be discontinued as soon as possible, when the patient is able to control behaviors which led to the episodes. “ f. “ Restraints will not be used for patient coercion, discipline, convenience, corporal punishment, or staff retaliation. “ g. “ II. Alternatives/Interventions to Restraint or Seclusion. Based upon individual patient assessments, [the ACH] takes precautions to: Provide alternatives/interventions to promote optimal patient safety and protection . . . restraints are considered after exhausting all reasonable alternatives/interventions. “ h. “ V. Patient Care. A. Initial Assessment: Use of restraint and seclusion are based on patient needs as identified in the initial comprehensive assessment or by qualified staff in emergent situations when the patient poses the risk of injury to self or others. The comprehensive assessment should include physical, environmental, psychological, patho-physiological assessment to identify possible underlying causes for patient ’ s behavior. “ i. “ The registered nurse validates that restraints are appropriate after alternatives/intervention strategies have been considered and interventions and reasonable alternatives have been exhausted and the patient continues to demonstrate behaviors that could lead to harm to self or others. “ j. “ F. Discontinuation of Restraint or Seclusion. 1. The RN in consultation with the licensed independent practitioner will re-evaluate the efficacy of the patient ’ s treatment plan and work with the patient to identify ways to help him/her regain control. The restraint or seclusion use will be discontinued when the patient meets the behavior criteria for their discontinuation. “ 3. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient’s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer ’ s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff with no documentation of the use of mechanical restraint devices (e.g., wrist or ankle restraint cuffs) or additional incidents in which such would be necessary or appropriate to maintain patient and staff safety. 4. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient’s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient’s ability to move due to the patient’s history of wandering and going into other patients’ rooms. 5. During an interview on 5/15/25 at 12:25 PM, Staff H (Advanced Registered Nurse Practitioner (ARNP) reported P9’s condition did not necessitate the implementation of measures to prevent the patient from leaving their recliner. Staff H noted the patient could walk steadily and had been permitted by staff to wander around the unit. 6. During an interview on 5/19/25 at 11:30 AM, Staff N (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of P9’s recliner to limit the patient ’ s movement. Staff N acknowledged, “ That’s not supposed to happen. “ 7. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients’ recliners on a number of previous occasions. 8. During an interview on 5/19/25 at 12:30 PM, Staff E (Manager of Inpatient Psychiatric Unit) acknowledged, “ [The practice of placing a chair underneath a patient ’ s recliner to restrict their movement] isn’t what staff are trained to do, nor should they ever be doing that . . . [Staff] should not be propping anything under the recliner to keep it propped up. “ Failure to ensure hospital staff implemented and discontinued restraints at appropriate times-only as deemed necessary to preserve the safety of the patient and others-could result in an increased risk of adverse physical and mental health outcomes up to and including death or disability.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH ’ s administrative staff failed to ensure hospital staff implemented restraints in accordance with safe and appropriate restraint techniques-as determined by hospital policy and in accordance with State law-for 1 of 11 sampled patients (Patient #9[P9]). Findings include: 1. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy . . . The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ Restraints will only be applied by competent healthcare providers after a comprehensive assessment demonstrates restraint or seclusion is clinically indicated and other interventions are ineffective or not viable. “ 2. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient ’ s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer ’ s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff with no documentation of the use of mechanical restraint devices (e.g., wrist or ankle restraint cuffs). 3. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient’s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient’s ability to move due to the patient’s history of wandering and going into other patients’ rooms. 4. During an interview on 5/19/25 at 10:00 AM, Staff K (Psychiatric Registered Nurse (RN)) reported observing instances in which P9’s recliner had been positioned “ back far enough “ such that the patient would have a harder time wandering around. 5. During an interview on 5/19/25 at 11:30 AM, Staff N (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of Patient #9 ’ s recliner to limit the patient ’ s movement. Staff N acknowledged, “ That’s not supposed to happen, “ and they reported instructing the staff member not to employ this technique of inappropriately restricting patient movement. 6. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients’ recliners on a number of previous occasions. 7. During an interview on 5/19/25 at 12:30 PM, Staff E (Manager of Inpatient Psychiatric Unit) acknowledged, “ [The practice of placing a chair underneath a patient ’ s recliner to restrict their movement] isn’t what staff are trained to do, nor should they ever be doing that . . . [Staff] should not be propping anything under the recliner to keep it propped up. “ Given the inherent risks to restricting an individual’s ability to move freely and independently, failure to ensure hospital staff implemented restraints in accordance with safe and appropriate restraint techniques could result in serious physiological adverse health outcomes up to and including death and disability.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH ’ s administrative staff failed to ensure hospital staff utilized restraints in accordance with the order of a physician or other licensed practitioner responsible for the care of the patient for 1 of 11 sampled patients (Patient #9[P9]). Findings include: 1. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy . . . All usage of restraints or seclusion requires an order by a licensed independent practitioner. This policy prohibits standing orders or orders on an as-needed basis (PRN) for restraint or seclusion. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ Licensed independent practitioner (LIP): Any individual permitted . . . to write orders including restraint orders and provide care and services for patients within the scope of the individual ’ s license and consistent with hospital policy . . . The [ACH ’ s] LIP category does not include independent allied health practitioners . . . or dependent allied health practitioners which includes P.A. (physician assistant), R.N. (registered nurse) . . . “ d. “ VI. Licensed Independent Practitioner Responsibility, Licensed Independent Practitioner Orders . . . The licensed independent practitioner is required to give an order at least every calendar day. “ e. “ A written order is entered in the medical record and needs to be authenticated by an appropriate LIP within 24 hours of initiation of restraint. If the restraint was ordered by someone other than the attending physician, the attending physician is notified during the next patient rounding. “ f. “ 3. Re-application: If a patient was recently released from restraint and exhibits behavior that can only be handled by the reapplication of restraint, a new order is required. Staff cannot discontinue an order and then re-start it under the same order because that would constitute a PRN order. “ g. “ 5. Emergency usage situations: In some situations, the need for restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to application of restraint or seclusion. In these emergency application situations, a verbal order must be obtained from the licensed independent practitioner during the application or within one hour after the patient is stabilized. “ h. “ VIII. For Violent or Self-Destructive Behavior including Physical Holds . . . 1. Each order for restraint or seclusion use for the management of violent or self-destructive behavior . . . Must include the reason for restraint or seclusion [and] must include the type of restraint to be used . . . “ 2. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient ’ s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer ’ s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff with no documentation of the use of mechanical restraint devices (e.g., wrist or ankle restraint cuffs) or appropriate corresponding orders by a provider. 3. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient ’ s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient ’ s ability to move due to the patient ’ s history of wandering and going into other patients’ rooms. 4. During an interview on 5/15/25 at 12:25 PM, Staff H (Advanced Registered Nurse Practitioner (ARNP) reported they were not aware of the use of physical restraints on P9. 5. During an interview on 5/15/25 at 2:00 PM, Staff J (ARNP) reported hospital policy required nursing staff to have or obtain an order from a provider for the use of any patient restraints. 6. During an interview on 5/19/25 at 11:30 AM, Staff N (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of P9’s recliner to limit the patient’s movement. Staff N acknowledged, “ That’s not supposed to happen “ in the absence of a provider order to restrain the patient. 7. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients’ recliners on a number of previous occasions. Failure to ensure hospital staff utilized restraints in accordance with appropriate orders by a physician or other licensed practitioner could compromise the safety and autonomy of patients and could result in increased risk of disability or death, among other adverse health outcomes.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(7) The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. This Standard is not met as evidenced by: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH ’ s administrative staff failed to ensure hospital staff consulted the attending physician of 1 of 11 sampled patients (Patient #9[P9]) as soon as possible following the implementation of restraints not ordered by the physician. Findings include: 1. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy . . . The use of restraint or seclusion intervention is a collaborative function of the nursing and medical staff in response to an assessed patient need. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ A written order is entered in the medical record and needs to be authenticated by an appropriate [Licensed Independent Practitioner (LIP)] within 24 hours of initiation of restraint. If the restraint was ordered by someone other than the attending physician, the attending physician is notified during the next patient rounding. “ d. “ VIII. For Violent or Self-Destructive Behavior including Physical Holds . . . The licensed independent practitioner or a registered nurse who has met the training requirements will conduct a face-to-face in-person evaluation of the restrained/secluded patient within one hour of the initiation of a seclusion/restraint incident. If the one-hour, face-to-face evaluation is conducted by a trained RN, the registered nurse consults with the licensed independent practitioner who is responsible for the care of the patient within one hour after the patient is stabilized. The purpose of face-to-face evaluation is to: Observe and review with staff the immediate medical and behavioral condition of the patient; Evaluate the patient ’ s reaction to the intervention; Determine whether restraint or seclusion should be continued; Work with the patient and staff to identify ways to help the patient regain control; Make any necessary revision to the treatment plan; [and] supply an additional order if necessary. “ e. “ F. Discontinuation of Restraint or Seclusion. 1. The RN in consultation with the licensed independent practitioner will re-evaluate the efficacy of the patient ’ s treatment plan and work with the patient to identify ways to help him/her regain control. “ 2. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient’s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer’s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff with no documentation of the use of mechanical restraint devices (e.g., wrist or ankle restraint cuffs) or corresponding consultations with a provider as appropriate. 3. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient ’ s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient ’ s ability to move due to the patient ’ s history of wandering and going into other patients ’ rooms. 4. During an interview on 5/15/25 at 12:25 PM, Staff H (Advanced Registered Nurse Practitioner (ARNP) reported they were not aware of the use of physical restraints on Patient #9. 5. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients’ recliners on a number of previous occasions. Failure to ensure hospital staff consulted with the attending physician of patients as soon as feasible following the implementation of restraints could hinder the ability of the physician and care team to maintain the safety and efficacy of the patient ’ s care and could thereby result in serious harm to the patient-up to and including death or disability.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 50212 Based on policy review, medical record review, and interviews with hospital staff and patient family members, the ACH ’ s administrative staff failed to ensure licensed nursing staff adhered to applicable nursing policies and procedures regarding the use of restraints for 1 of 11 sampled patients (Patient #9[P9]). Findings include: 1. Review of the 01/2024 policy “ Restraint and Seclusion Use “ revealed in part: a. “ Policy: [the ACH ’ s] philosophy is to strive toward a restraint and seclusion-free environment through effective preventative strategies and the use of alternatives for patient safety. Each patient has the right to receive care in a safe setting. The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. “ b. “ Physical Restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely . . . Physical Hold: Holding a patient in a manner that restricts their movement against the patient ’ s will is considered a restraint. This includes holding a patient for a medication against their will or moving a patient from one location to another against their will . . . Violent and self-destructive behaviors: A situation in which a patient is in immediate danger of physically harming himself/herself, staff, or others and less restrictive interventions have been determined to be ineffective. “ c. “ The use of restraint or seclusion is not based on the patient ’ s history of seclusion or restraint use or solely on a history of dangerous behavior. The use of restraint or seclusion intervention is a collaborative function of the nursing and medical staff in response to an assessed patient need. “ d. “ All usage of restraints or seclusion requires an order by a licensed independent practitioner. “ e. “ Restraints will only be applied . . . after a comprehensive assessment demonstrates restraint or seclusion is clinically indicated and other interventions are ineffective or not viable. “ f. “ Episodes of seclusion or restraint must be discontinued as soon as possible, when the patient is able to control behaviors which led to the episodes. “ g. “ Patient rights, dignity and well-being are protected during restraint or seclusion use and the following will be assured . . . Safety and cleanliness of the patient ’ s environment . . . [and] concern for the patient ’ s perspective related to the experience of being secluded or restrained. Restraints will not be used for patient coercion, discipline, convenience, corporal punishment, or staff retaliation. “ h. “ II. Alternatives/Interventions to Restraint or Seclusion. Based upon individual patient assessments, [the ACH] takes precautions to: Provide alternatives/interventions to promote optimal patient safety and protection; protect patients ’ rights, dignity and well-being; provide care in an environment which promotes optimum healing and functioning; prevent harm to patients, hospital personnel and others; restraints are considered after exhausting all reasonable alternatives/interventions. “ i. “ Licensed independent practitioner (LIP): Any individual permitted by a federal law, Iowa law and either [the ACH ’ s] Medical Staff hospital policy or the [ACH ’ s] Graduate Medical Education Committee Policy on Rsident and Medical Student Supervision to write orders including restraint orders and provide care and services for patients within the scope of the individual ’ s license and consistent with hospital policy. For purpose of this policy, LIP includes M.D. (physician/resident physician), D.O. (physician/resident physician . . . and ARNP (advanced registered nurse practitioner). The [ACH ’ s] LIP category does not include independent allied health practitioners. . . or dependent allied health practitioners which includes P.A. (physician assistant), R.N. (registered nurse) . . . “ j. “ V. Patient Care. A. Initial Assessment: Use of restraint and seclusion are based on patient needs as identified in the initial comprehensive assessment or by qualified staff in emergent situations when the patient poses the risk of injury to self or others. The comprehensive assessment should include physical, environmental, psychological, patho-physiological assessment to identify possible underlying causes for patient ’ s behavior. “ k. “ The registered nurse validates that restraints are appropriate after alternatives/intervention strategies have been considered and interventions and reasonable alternatives have been exhausted and the patient continues to demonstrate behaviors that could lead to harm to self or others. “ l. “ VI. Licensed Independent Practitioner Responsibility, Licensed Independent Practitioner Orders . . . The licensed independent practitioner is required to give an order at least every calendar day. “ m. “ A written order is entered in the medical record and needs to be authenticated by an appropriate LIP within 24 hours of initiation of restraint. If the restraint was ordered by someone other than the attending physician, the attending physician is notified during the next patient rounding. “ n. “ 3. Re-application: If a patient was recently released from restraint and exhibits behavior that can only be handled by the reapplication of restraint, a new order is required. Staff cannot discontinue an order and then re-start it under the same order because that would constitute a PRN order. “ o. “ 5. Emergency usage situations: In some situations, the need for restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to application of restraint or seclusion. In these emergency application situations, a verbal order must be obtained from the licensed independent practitioner during the application or within one hour after the patient is stabilized. “ p. “ VIII. For Violent or Self-Destructive Behavior including Physical Holds . . . 1. Each order for restraint or seclusion use for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of patient, staff or others is written with the following limits: 4 hours for adults . . . Must include the reason for restraint or seclusion. Must include the type of restraint to be used . . . 2. The licensed independent practitioner or a registered nurse who has met the training requirements will conduct a face-to-face in-person evaluation of the restrained/secluded patient within one hour of the initiation of a seclusion/restraint incident. If the one-hour, face-to-face evaluation is conducted by a trained RN, the registered nurse consults with the licensed independent practitioner who is responsible for the care of the patient within one hour after the patient is stabilized. The purpose of face-to-face evaluation is to: Observe and review with staff the immediate medical and behavioral condition of the patient; Evaluate the patient ’ s reaction to the intervention; Determine whether restraint or seclusion should be continued; Work with the patient and staff to identify ways to help the patient regain control; Make any necessary revision to the treatment plan; Supply an additional order if necessary. “ q. “ The one-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient ’ s medical condition would include a complete review of systems assessment, behavioral assessment, review and assessment of the patient ’ s history drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient ’ s condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient ’ s violent or self-destructive behavior. “ r. “ 3. If a patient ’ s violent or self-destructive behavior resolves and the restraint or seclusion intervention is discontinued before the practitioner conducts the one-hour, face-to-face evaluation, licensed independent practitioner or a registered nurse who has met the training requirements is still required to see the patient face-to-face and conduct the evaluation within one hour after the initiation of this intervention. The fact that the patient ’ s behavior warranted the use of a restraint or seclusion indicates a serious medical or psychological need for prompt evaluation of the patient behavior that led to the intervention. The evaluation would also determine whether there is a continued need for the intervention, factors that may have contributed to the violent or self-destructive behavior, and whether the intervention was appropriate to address the violent or self-destructive behavior. “ s. “ F. Discontinuation of Restraint or Seclusion. 1. The RN in consultation with the licensed independent practitioner will re-evaluate the efficacy of the patient ’ s treatment plan and work with the patient to identify ways to help him/her regain control. The restraint or seclusion use will be discontinued when the patient meets the behavior criteria for their discontinuation. “ 2. Review of the 06/2024 policy “ Patient Rights and Responsibilities “ revealed in part: “ Restraint or seclusion may only be imposed (used) by trained team members to ensure the immediate physical safety of the patient, our team members, or others and must be discontinued (stopped) at the earliest possible time. 3. Review of P9’s 3/21/25 medical records revealed the following: a. On 3/21/25 at 7:10 PM, the patient presented to the Emergency Department (ED) with behavioral health concerns following a reported altercation between the patient and another resident of the patient’s assisted living facility (ALF). On 3/24/25 at 2:01 PM, hospital staff admitted the patient to the Geropsychiatry Unit for inpatient management of Alzheimer’s dementia with agitation. b. From 4/6/25 to 5/4/25, hospital staff documented eight separate restraint applications due to the patient exhibiting aggressive behaviors, which included attempting to punch or bite staff. Each documented restraint included a brief physical hold by staff. The medical record did not include documentation of additional incidents in which the application of mechanical restraint devices (e.g., wrist or ankle restraint cuffs) had been necessary or appropriate to maintain the safety of patients and staff, nor did the record include appropriate corresponding orders by a provider or consultations with an appropriate provider regarding the use of said restraints. 4. During an interview on 5/13/25 at 12:45 PM, a member of P9’s family reported hospital staff placed a chair underneath the leg rest of the patient ’ s recliner. The staff reportedly indicated they placed the chair in this position to restrict the patient ’ s ability to move due to the patient ’ s history of wandering and going into other patients ’ rooms. 5. During an interview on 5/15/25 at 2:00 PM, Staff J (ARNP) reported hospital policy required nursing staff to have or obtain an order from a provider for the use of any patient restraints. 6. During an interview on 5/19/25 at 11:30 AM, Staff N (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of P9’s recliner to limit the patient ’ s movement. Staff N acknowledged, “ That’s not supposed to happen, “ per hospital policy regarding the use of restraints. 7. During an interview on 5/19/25 at 3:50 PM, Staff M (Psychiatric RN) reported observing staff placing a chair underneath the leg rest of patients ’ recliners on a number of previous occasions. Failure to ensure licensed nursing staff adhered to applicable nursing policies and procedures regarding the safe and appropriate use of restraints could compromise the safety and efficacy of patient care and result in serious injury or harm to patients, including disability or death.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 48530 Based on medical record review, review of hospital policy, observations, staff interviews, and family interviews the Hospital’s staff failed to ensure all licensed nurses who provide services in the hospital adhered to the policies and procedures of the hospital (see A0398). The cumulative effect of this systemic failure and deficient practice resulted in the Hospital’s administrative staff’s inability to ensure that patients received adequate nursing services to meet the care needs of all patients.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 48530 Based on document review, staff interviews, and observations, the hospital nursing staff failed to follow policy and procedure in relation to wound assessment and wound care interventions for 1 of 11 sampled patients (Patient #2) with wounds severe enough to require a wound department consult. Failure to provide wound assessment and wound care interventions per hospital policy resulted in the worsening of patient wounds. Findings include: 1. Review of the policy “Adult Pressure Ulcer Prevention and Maintenance of Skin Integrity”, review date 2/2024 revealed in part, “... Report any breakdown to physician provider ... When to contact a WOC Nurse: For any pressure ulcer that has occurred. For any pressure ulcer prevention challenges ...” 2. Review of the medical record for Patient #2 from Hospital A revealed: a. On 10/9/24 at 1:19 AM, Emergency Department (ED) Physician H documented Patient #2 presented to the ED with a chief complaint of atrial fibrillation (type of abnormal heart rate) and chest pain. Physician H assessed the patient’s skin to be warm and dry and negative for any concerns. b. On 10/9/24 at 4:47 PM, nursing staff completed a skin assessment which included a Braden scale of 12 (type of risk assessment for skin breakdown, with 12 being a moderate risk). c. On 10/9/24 at 6:40 PM, Physician I documented Patient #2 was admitted to the Medical Surgical unit for further treatment of pneumonia, anemia and diverticulosis (condition of multiple pouches in the intestines without inflammation). d. On 10/10/24 at 1:38 PM, Physician I documented Patient #2 had an episode of decreased blood pressure, decreased oxygen saturation level and high heart rate. Due to the patient’s deterioration and history of heart failure Patient #2 was transferred to the Cardiac Intensive Care Unit (CICU). e. A skin assessment, dated 10/10/24 at 4:37 PM, completed by RN B, included documentation that the Patient #2’s skin had erythema (reddened area) on the coccyx (buttocks) and bilateral heels. The patient’s ability to self-reposition was limited due to general weakness. RN B initiated Patient #2’s Care Plan including a specialty mattress, repositioning schedule every two hours, minimized layers beneath the patient and applied a sacral (upper buttock area) preventative foam dressing. e. On 10/12/24 at 10:22 PM RN C initiated additional Care Plan interventions for Patient #2 including lowering the head of the bed at 30 degrees or less and applying protective moisture barrier ointment. f. On 10/14/24 at 8:59 PM RN K initiated additional Care Plan interventions for Patient #2 including the Turning and Positioning System (TAPS) which includes a turn sheet with handles and two wedges that were specifically positioned under the turn sheet. g. On 10/15/24 at 12:23 AM RN K initiated additional Care Plan interventions for Patient #2 including bilateral padded heel protectors. h. On 10/18/24 at 3:54 AM, RN L uploaded a wound picture labeled coccyx, with no further documentation. Review of the wound picture taken 10/18/24 revealed a red discolored, open area on coccyx. The medical record lacked evidence of a completed skin assessment on 10/18/24. The medical record lacked evidence nursing staff assessed the patient’s wound, including a description of the wound and wound measurements. The medical record lacked evidence nursing staff notified the physician of the patient’s change in condition in relation to the wound and lacked evidence of a wound nurse consultation order. i. On 11/1/24 at 3:13 AM RN L uploaded a wound picture labeled coccyx, with no further documentation. Review of the wound picture taken 11/1/24 revealed a red/purple open area on coccyx which increased in size when compared to the wound picture taken on 10/18/24. The medical record lacked evidence nursing staff assessed the patient ’ s wound, including a description of the wound and wound measurements. The medical record lacked evidence nursing staff notified the physician of the patient’s change in condition in relation to the wound and lacked evidence of a wound nurse consultation order. j. On 11/4/24 at 2:28 PM, Physician N documented the following Discharge Summary, “Skin: Venous stasis dermatitis in the lower extremities”. Physician N documented Patient #2 was stable on pressure support ventilation, PEG tube feedings, and was transferred to a long-term care facility (the physician’s discharge summary lacked any mention of the patient’s coccyx wound). 3. Review of the medical record for Patient #2 from Hospital B revealed: The Initial Integumentary Assessment on 11/4/24 at 4:23 PM, completed by RN S, included documentation that the Patient #2’s coccyx had a pink dermal tissue Stage 2 wound area that measured 5 cm (cetimeters) length, 3 cm width, 0.2 cm depth. 4. On 12/23/24 at 1:05 PM, during an interview, Staff D Wound Nurse revealed moisture breakdown treatment was nurse driven by following guidelines in the Adult Pressure Ulcer Prevention and Maintenance of Skin Integrity policy. The wound team would expect a wound consultation order to be placed by a nurse if they observed an open pressure wound. Staff D confirmed no wound consultation order was placed for Patient #2, and after review of the patient’s medical record, explained that they would have expected to be consulted. 5. On 12/23/24 at 3:21 PM, during an interview, Staff L RN revealed they did not recall Patient #2 nor did they recall that they uploaded photographs of the coccyx wound. Staff L explained when they cared for an intubated patient, they repositioned them every two hours with the TAPS wedges. If a patient had an open wound, they ordered a wound nurse consultation. 6. On 12/23/24 at 9:20 AM, during an interview, the CICU Manager explained all nurses were educated that anyone could have placed an order for the wound team consultation if they had concerns for a patient’s skin condition. The CICU Manager confirmed nursing staff had not placed a wound consultation order for Patient #2. Review of Patient #2’s medical record from Hospital A revealed no documentation by a nurse or physician of an open coccyx wound other than the wound pictures. Review of Patient #2’s medical record from Hospital B revealed the patient was admitted with an existing Stage two wound on the coccyx area.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47335 Based on medical record review, review of hospital policy, and staff interview, the Acute Care Hospital’s (ACH) administrative staff failed to follow their policies for care of patients during admission to the inpatient (IP) child/adolescent behavioral health unit (BHU) to ensure staff followed hospital policy to protect and promote each patient’s rights. Failure to follow their policies for patient care resulted in the following: 1. A patient being admitted to the inpatient unit without an appropriate safety check for contraband (see A0144); and, 2. A patient being able to cause significant injury to them self while receiving care in the IP setting (see A0144). The cumulative effect of this systemic failure and deficient practice resulted in the ACH’s administrative staff’s inability to ensure the patient rights were maintained and were adequate to meet patient care needs.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 49848 Based on hospital policy, medical record review, family interview and staff interview, hospital administrative staff failed to ensure hospital staff followed hospital policies for the care of patients in their emergency department (ED) due to inadequate staff available to meet the emergency needs of patients. Failure to follow the hospital’s policies in the ED resulted in: 1) a failure of ED staff to complete timely assessment and treatment of patients (see A1112); and, 2) a failure of ED staff to report changes in condition of patients in a timely manner to an ED provider (see A1112). The cumulative effect of this deficient practice resulted in the failure of a patient experiencing stroke symptoms and a pediatric patient experiencing complications from a tonsillectomy, including low blood volume, not receiving timely assessment and treatment by a medical provider.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47335 Based on medical record review, review of hospital policy, and staff interview the Acute Care Hospital’s (ACH) administrative staff failed to ensure hospital staff provided care in a safe setting to 1 of 10 patients reviewed (Patient #1). The effects of the failures and deficient practices resulted in hospital staff missing contraband during Patient #1’s body search, allowing a razor blade to be snuck into the inpatient (IP) child/adolescent behavioral health unit (BHU), and causing self-harm injuries. The effects of these failures and deficient practice could have also resulted in injuries to other patients and/or staff, or death of Patient #1. The ACH’s administration identified an average daily census of 11 patients treated on the IP child/adolescent BHU. Findings include: 1. Review of the policy “Inpatient Behavioral Health Policy to Screen Patients,” Last Revised 5/24, revealed in part: a. “Purpose: ...committed to providing a safe environment for patients, visitors and colleagues. For this reason, no weapons or other items deemed as potentially dangerous are allowed in any inpatient behavioral health unit ... This search will include the use of a security wand, a hand-held metal detecting device, to assist in providing a safe environment for the patients, team members and visitors... The handheld security wand is utilized to deter and prevent the bringing of weapons or other dangerous items into the behavioral health programs, thereby reducing the potential for violent incidents.” b. “Any patient who is being admitted to an inpatient behavioral health unit will be scanned with a security wand prior to entry and while still in triage ... They will be required to change into scrubs prior to entering the unit ...” c. “ ...Upon admission patient and patients ’ belongings will be screened by use of a metal detecting wand ...” 2. Review of the policy “Acuity Precautions- Behavioral Health,” Last Revised 2/29/24, revealed in part: a. “ ...The goal is to establish a safe environment and practice to support patients. When assessed as self-injurious or as having suicidal ideation, additional safety precautions and assessments may occur to keep patients safe and engage resources as needed ...” b. “ ...Any patient indicating an inability to remain safe in the hospital and/or displaying behaviors and/or statements that will indicate immediate risk will be placed under 1:1 supervision ...” c. “ ...A body search will be completed prior to entering the behavioral health unit ... to remove any potentially dangerous items from patient’s belongings. The body search and any contraband found will be documented on the body check/belongings sheet ... Public safety shall be notified if any weapons or contraband are found ...” d. “ ...General Safety Precautions ... All personal hygiene products will be kept in the nurse’s station and/or in locked closets. When patients utilize the products, they will be returned and accounted for following use ...” e. “ ...Acuity Level: ... Level Red. These patients may not leave the unit except for medical procedures ... Two team members must accompany the patient to the procedure ... Patients on this level are NOT eligible for off unit activities ... Room search will be performed daily ... Two team members will be present to complete the room search ... All room items, including bathrooms and mattresses, should be checked and anything identified as a risk will be addressed at the time of the search ...” 3. Review of Patient #1’s medical record revealed: a. On 4/15/24 at 3:13 PM, Patient #1 presented to UnityPoint Health (UPH), Des Moines Methodist (DMM) Blank Children’s Hospital ED with their mother for multiple left arm lacerations due to self-harm using a razor blade to cut. Patient #1 had a diagnosis of severe major depressive disorder (MDD), generalized anxiety with panic attacks, and depressive type psychosis (serious mental illness with loss of contact with reality). b. On 4/15/24 at 3:29 PM, Patient #1’s had a Columbia Suicide Screening completed with a suicide risk level of high. Patient #1 identified thoughts of killing them self by cutting. ED staff placed Patient #1 on suicide and safety checks, assigned them a sitter for continuous 1:1 visual checks, and Patient #1’s belongings were placed at the nurse’s station. c. On 4/15/24 at 3:34 PM, the ED provider evaluated Patient #1, and recommended IP BHU due to the severity of their lacerations and acute change. d. On 4/15/24 at 4:59 PM, Social Worker (SW) RR assessed Patient #1, and noted Patient #1 was evasive and denied knowing where the razor blade went after they used it to cut them self. Patient #1 told SW RR, they considered telling SW RR something, but wasn’t sure if they wanted to. SW RR followed up with Patient #1, and Patient #1 verbalized they didn’t know why they struggled with suicidal ideation (SI) (thoughts). SW RR recommended Patient #1 be admitted to an IP BHU due to the severity of cutting to their arm requiring 53 sutures, report of feeling they wanted to die, and not knowing if they could be safe at home. e. On 4/15/24 at 5:57 PM, patient history, exam, and ED course were discussed with MD SS, inpatient psychiatry, who agreed to accept Patient #1 to UnityPoint Health’s (UPH) IP child/adolescent BHU due to their suicidal ideation and significant injury. f. On 4/15/24 at 7:20 PM, the ED provider repaired Patient #1’s lacerations. Patient #1 had a post-procedure diagnosis of deliberate self-cutting with left forearm lacerations. Patient#1 had two very shallow vertical lacerations, 8 centimeters (cm) each to the right forearm, and eight horizontal gaping lacerations to the left forearm, three of the lacerations measured 3.5 cm with exposed subcutaneous (found under the skin) fat, and one significant 9 cm x 2 cm and 0.5 cm deep gaping laceration went vertically down the forearm with exposed fat and muscle. The ED provider repaired the lacerations with 53 sutures. Patient #1 had a depressed mood and withdrawn behavior. Patient #1 had multiple prior admissions to different BHU’s, and stayed in a long-term BH facility in Illinois at the end of 2023. g. On 4/15/24 at 8:26 PM, ED staff gave a handoff report on Patient #1 to an IP BHU nurse. h. On 4/15/24 at 9:07 PM, Patient #1 departed from the ED to the IP child/adolescent BHU. i. On 4/15/24 at 9:35 PM, Patient #1 admitted to the IP Child/Adolescent BHU due to extremity (limb) laceration, multiple lacerations by self-harm with a razor blade, and self-mutilating behavior. Patient #1 was placed on elopement (run away), safety, and suicide precautions, and every 15-minute rounding (visual checks). Patient #1 was placed on acuity level red. j. On 4/15/24 at 10:07 PM, Staff searched Patient #1’s room. k. On 4/15/24 at 10:19 Patient #1 had a Columbia Suicide Screening completed by RN VV, and remained at a risk level of high, and noted Patient #1’s reason for admission as suicide attempt by trying to cut an artery. l. On 4/15/24 at 11:12 PM, RN OO and BH Counselor (BHC) K completed Patient #1 skin assessment and body search, and signed by MD SS. m. On 4/16/24 at 1:15 PM, BHC M noted Patient #1 wrote on their white board in their room “How did I end up here again?” “Am I done for?” and “I can’t keep doing this I just want to die?” BHC M tried to speak to Patient #1 about the comments, and told Patient #1 it needed to be erased. n. On 4/16/2024 at 4:42 AM, MD SS completed Patient #21’s history and physical assessment. MD SS noted Patient #21 denied knowing what they did with the razor blade after they used it to cut them self, reported they often felt hopeless, and had increased SI on a daily basis. MD SS noted Patient #21’s mood as incongruent (emotional state or reaction seems to conflict with the situation they are in), with a near constant, small smile not reflective of their mood, poor judgment, and psychomotor retardation (slowed thoughts and physical movement). o. On 4/16/2024 at 6:54 PM, Patient #1 had new self-harm bruising to their forehead not present at admission, and Patient #1 reported hitting their head on the wall. p. On 4/18/24 at 2:20 AM, staff completed a room check. q. On 4/18/24 at 10:45 AM, a family medicine resident evaluated Patient #1 for nursing concerns of Patient #1 pulled out some of their sutures, and had multiple sutures pulled out. r. On 4/18/24 at 1:00 PM, staff completed a room check. s. On 4/18/24 at approximately 6:40 PM, BHC B met with Patient #1 in their room for a 1:1 visit. Patient #1 smiled, told BHC B they had to tell BHC B something, and admitted to having something on them, but refused to disclose it while continuing to smile. Patient #1 refused to give the item to BHC B, so BHC B instructed Patient #1 to accompany them to the common area to their assigned nurse. Patient #1 refused, and went into their bathroom. BHC B immediately took Patient #1’s toiletries from the bathroom, and blocked the door from closing. BHC B yelled out for help, RN A came to Patient #1’s room, and both staff opened the bathroom door. Staff observed Patient #1 cut their right arm with a razor blade. Patient #1 then attempted to hide the razor blade behind their back, and refused to give it to staff. Two public safety officers (PSO) arrived to assist staff. BHC B asked Patient #1 to hand over the razor blade, and Patient #1 used the razor blade to cut their right arm two additional times. Patient #1 was placed in a physical hold by a PSO, and the razor blade was secured in a specimen cup. t. On 4/18/24 at 7:10 PM, RN A completed a face to face assessment, and noted RN A and BHC B discovered while Patient #1 was in their bathroom, they made numerous deep cuts on their right forearm with a razor blade they reported having hidden in their bra since admission to the hospital. RN A and BHC B entered Patient #1’s bathroom, and RN A applied pressure to the wounds. After Patient #1 made two additional cuts to their right arm, a physical hold was initiated by a PSO to Patient #1’s left wrist in order to prevent Patient #1 from further harming them self. The physical hold was maintained until Patient #1 verbalized they would stop attempting to harm self. Patient #1 had seven new lacerations on their right forearm. After the physical hold ended, Patient #1 agreed to allow a family medicine resident to assess the lacerations. u. On 4/18/24 at 6:45 PM, staff completed a room check. v. On 4/18/24 at 7:50 PM, RN A made Patient #1 a 1:1 supervision while awake, placed them in a safety gown, and RN A and RN OO removed all Patient #1’s jewelry, which included two earrings, and one nose ring. w. On 4/18/24 at 8:23 PM, five of the seven new lacerations to Patient #1’s right arm were sutured by a family medicine resident, for a total of 14 new sutures. x. On 4/18/24 at 10:10 PM, Patient #1 spoke to BHC J, and reported their goal with the razor blade was to do enough to cause pain, but not enough to kill them self. Patient #1 also commented about planning to use the razor blade on their thigh, so no staff saw it, or just hit an artery. y. On 4/18/24 at 10:39 PM, RN A attempted to contact Patient #1’s mother, to inform them of Patient #1’s new self-harm incident. RN A left a voice message requesting a return call. RN A reported the incident to the house supervisor, BHU supervisor, and the on-call psychiatrist. z. On 4/19/24 at 5:05 AM, MD SS completed an assessment on Patient #1, and based on the severity of Patient #1’s self-harm, acting out, manipulative behavior, and lack of insight, they remained a 1:1 supervision, level red acuity level, continued wearing the safety gown, and continued with their current programming. MD SS instructed Patient #1 to make a list of all hidden items in their home, and their parents would search their entire home. aa. On 4/20/24 at 4:55 AM, MD SS completed an assessment on Patient #1. Patient #1 continued with 1:1 supervision while awake, but MD SS allowed Patient #1 to wear scrubs, and be out of the safety gown. Patient #1 continued as an acuity risk level of red. bb. On 4/22/24 at 7:23 AM, MD SS discontinued Patient #1’s 1:1 supervision. cc. During the remainder of Patient #1’s hospitalization they were caught continuing self-harming behaviors such as continuing to pick at their sutures, making their previous lacerations bleed, and had an incident where they broke off a medal clip from a pen and attempted to hide it in their waistband, but was observed by a PSO. dd. Hospital staff failed to wand Patient #1 for metal contraband, and failed to conduct a thorough body search at the time of their admission. Hospital staff failed to have Patient #1 remove their bra to search it for contraband, and only had Patient #1 pull the bra bands away from their body to shake it, to see if anything fell out. Hospital staff allowed Patient #1’s toiletries to remain in their bathroom between use, and continue wearing jewelry after admission that could have been used to self-harm. Hospital staff failed to use their panic button (device worn by all staff) to call for staff assist when Patient #1 went into their bathroom. Hospital staff were aware of Patient #1 self-harming behaviors, and Patient #1 had self-harming behaviors throughout their hospitalization such as picking and pulling out old sutures, causing themselves to bleed, and hitting their head. 4. During an interview on 5/7/24 at 8:55 AM, Patient #1’s family member reported not understanding how Patient #1 was able to sneak a razor blade through two hospitals. 5. During an interview on 5/13/24 at 9:30 AM, RN Q reported doing a modified body search in the pediatric ED on BH patients, and explained they don’t put hands on the patient. RN Q reported behavioral health patients remove their clothing, and change into hospital safety scrubs. RN Q reported patients wearing bras with underwire are required to remove their bra, otherwise the patient is allowed to wear their bra. RN Q reported they don’t use a metal detector in the ED, and patients place their belongings in a belonging bag with a patient label, and place it in a secure file cabinet. RN Q recalled Patient #1 came into the ED with a large cut on their left forearm with multiple little cuts. RN Q reported they removed all safety risk items from Patient #1’s ED room, placed them in safety scrubs, and assigned a sitter who stayed with Patient #1 for 1:1 supervision. RN Q denied searching Patient #1 for contraband. 6. During an interview on 5/13/24 at 9:00 AM, SW RR recalled Patient #1 came into the ED with a severe self-injury cut on their left arm with several smaller less severe cuts on the same arm. SW RR reported Patient #1 attempted to take their own live, which resulted in Patient #1’s admission to UPH’s IP Child/Adolescent BHU. SW RR recalled recommending Patient #1 needed IP BHU. SW RR denied any involvement in searching Patient #1 for contraband, and recalled being called to the ED after Patient #1 had been changed into scrubs. SW RR reported when a patient is a risk for self-harm, they are stripped down, placed into hospital scrubs, and assigned a sitter while in the ED. SW RR reported they would have recommended IP BHU staff continue the same safety precautions for Patient #1, such as having a sitter at all times. 7. During an interview on 5/13/24 at 4:00 PM, RN OO recalled Patient #1’s admission process, and reported having Patient #1 remove their top, but not their bra. RN OO had Patient #1 shake their bra while wearing it. RN OO recalled Patient #1 telling them after cutting them self, they held onto the razor blade while shaking their bra at admission. RN OO acknowledged they failed to use the metal detector wand on Patient #1 during their admission process. RN OO reported working on the day Patient #1 used the razor blade to cut them self. RN OO recalled holding pressure to Patient #1’s arm while RN A contacted family medicine, BHC B went to get a specimen cup, and PSOs were present. RN OO reported Patient #1 made seven cuts to their right arm before staff physically restrained them, and removed the razor blade. 8. During an interview on 5/13/24 at 10:30 AM, BHC K acknowledged assisting the RN during Patient #1’s admission, and body search. BHC K recalled having Patient #1 shake their bra, and run their fingers along the edges of the bra, but they didn’t remove the bra. BHC K acknowledged they didn’t follow policy during Patient #1’s admission, as they failed to use the metal detector wand to search Patient #1 for contraband. BHC K recalled Patient #1 being on the same safety precautions as most of the other patients on the unit, and Patient #1 stayed on acuity level red their entire hospitalization. BHC K reported Patient #1 required daily room searches. 9. During an interview on 5/9/24 at 8:30 AM, MD SS recalled Patient #1 being involved in serious self-harm behavior, and caused significant lacerations to them self requiring over 50 sutures. MD SS reported Patient #1 had chronic self-harm and suicidal thoughts, and required treatment. MD SS reported Patient #1 had a pocket in their bra where they hid the razor blade during admission to the hospital. MD SS reported feeling the incident with Patient #1 having the razor blade could have been prevented, only if the ACH changed the way they do things on admission. 10. During an interview on 5/9/24 at 9:00 AM, Licensed Mental Health Counselor (LMHC) O recalled Patient #1, and reported they also worked with Patient #1 during previous hospitalizations. LMHC O reported Patient #1 focused on self-harm injuries and SI. LMHC O reported developing individual programming for Patient #1, and explained patients are typically programmed for group therapy, but Patient #1 had individualized programming due to staff ‘s familiarity with Patient #1’s needs. LMHC O reported Patient #1 being programmed to be out of their room from 8:00 AM to 8:00 PM to be engaged in their programming after their cutting incident on the unit. 11. During an interview on 5/9/24 at 12:00 PM, BHC B reported on 4/18/24 while in the day area, Patient #1 asked to talk to them, and Patient #1 told BHC B they needed to tell them something. BHC B reported going to Patient #1’s room with Patient #1, they sat down on seperate beds, across from one another, and Patient #1 started out the conversation telling BHC B their frustration with their mother. BHC B reported Patient #1 hesitated about telling them what they wanted to tell BHC B, but Patient #1 did finally say they had something on them from home. Patient #1 refused to disclose to BHC B what they had, so BHC B told Patient #1 they needed to talk to their nurse. BHC B recalled as they walked to the door of the room, Patient #1 went into the bathroom, BHC B grabbed the toiletries from the bathroom, and blocked Patient #1 from closing the bathroom door. BHC B yelled out into the hallway for a nurse, while trying to get Patient #1 to come out of the bathroom. BHC B reported another patient heard them yell for help, and went to get a nurse. BHC B reported RN A came to Patient #1’s room, and they opened the bathroom door. BHC B reported Patient #1 had new cuts present to their right arm. RN A quickly put pressure on the cuts, and when staff asked Patient #1 to hand over the razor blade from behind their back, they immediately made two more cuts to her right arm, and the PSO initiated a physical hold on Patient #1. BHC B reported obtaining the razor blade from Patient #1, and placed it in a specimen cup. BHC B acknowledged they failed to push their panic button to alert staff of their need for assistance. 12. During an interview on 5/15/24 at 2:30 PM, RN A recalled Patient #1, and reported they had a hard time keeping them self safe. RN A reported Patient #1 came to the BHU for significant cuts to their left arm, and after being admitted to the BHU, they kept trying to pull their sutures out and self-harm. RN A reported Patient #1 needed 1:1 supervision at times due to their continued self-harming behavior, such as picking at their sutures. 13. During an interview on 5/15/24 at 11:00 AM, PSO ZZ reported working on the BHU when Patient #1 used a razor blade to self-harm, and recalled a BHC ran in and out of Patient #1’s room, so PSO ZZ asked if they needed anything. PSO ZZ reported seeing staff gripping Patient #1’s arm with blood running down, and PSO ZZ called for other officers’ assistance. 14. During an interview on 5/15/24 at 3:10 PM, MD TT reported Patient #1 being able to sneak the razor blade onto the BHU is concerning, the ACH learned from the incident, and staff have taken appropriate steps to try and prevent something like this from happening again. MD TT reported Patient #1 had a rigorous individualized plan based on their injuries and history, and hospital staff were very aware and paying close attention to them. 15. During an interview on 5/13/24 at 3:30 PM, BHC F recalled Patient #1, and reported Patient #1 didn’t see the point in trying anymore, voiced SI and self-harm thoughts, and had severe self-harm tendencies. 16. During an interview on 5/9/24 at 9:30 AM, RN N recalled Patient #1 had no interest in getting better, and they had individualized programming to focus on safety planning. RN N reported Patient #1 would pick at their sutures and try to pull them out. RN N explained that any time a patient is able to sneak contraband into the BHU, they should learn from it, and make changes. 17. During an interview on 5/13/24 at 1:00 PM, RN I recalled Patient #1 hid things in their sweatshirt sleeves, and required staff to keep a close watch on them. RN I reported any patient admitted to the BHU has the potential for self-harming behaviors, and staff are monitoring for cues as well as changes in mood and behaviors. 18. During an interview on 5/15/24 at 3:30 PM, BHU Manager reported feeling the BHU is appropriately staffed. BHU Manager reported 1:1 supervision can be implemented at any time depending on a patient’s presenting symptoms, behaviors, and safety risks, but explained that a doctor’s order must be obtained after a 1:1 has been implemented and/or to be discontinued. BNU Manager reported a patient has never been denied a 1:1 supervision due to staffing issues, but explained they try other interventions prior to using 1:1 supervision. BHU Manager reported they don’t currently do audits to ensure room checks are being completed appropriately. BHU Manager reported they found that staff weren’t doing complete body searches on all patients being admitted to the BHU, and weren’t having patients remove all their clothing completely, but this process has been standardized and guidelines made clear after Patient #1 snuck the razor blade onto the unit. BHU Manager explained patients now remove all clothing including undergarments on admission for the body search. BHU Manager acknowledged BHC B failed to press their panic button when Patient #1 went into their bathroom and used a razor blade to cut them self. BHU Manager explained an individual plan is developed for patients who come in with complex diagnoses, and are frequently admitted to the BHU. The therapists develop plans particular to that patient instead of as a group with the other patients on the unit, and the patient is placed at a separate desk away from other patients. 19. During an interview on 5/15/24 at 4:15 PM, BHU Director reported the wording in the policy for doing body searches on admission wasn’t clear on what clothing should be removed. BHU Director acknowledged BHU staff failed to use the metal detector wand to search Patient #1 on admission, and failed to remove all Patient #1’s clothing including their undergarments during the body search which resulted in Patient #1 being able to sneak a razor blade onto the BHU. BHU Director also acknowledged that BHU staff failed to press their panic button worn when working on the unit to alert other staff of their need for assistance, and staff failed to remove the weapon from Patient #1’s hand immediately when they realized they had it.”

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 49848 Based on hospital policy, medical record review, family interview and staff interview, hospital administrative staff failed to ensure hospital staff followed hospital policies for the care of patients in their emergency department (ED) due to inadequate staff available to meet the emergency needs of patients for 2 of 21 (Patient #17 and #37) sample patients that presented to the ED requesting medical care. Failure to ensure adequate ED staff were available to meet the emergency needs of patients resulted in a patient experiencing stroke symptoms and a pediatric patient experiencing complications from a tonsillectomy, including low blood volume, not receiving timely assessment and treatment by a medical provider. Hospital Capabilities: The acute care hospital had three campuses (Iowa Methodist “Downtown,” Methodist West, and Iowa Lutheran). Between the three campuses, the hospital had a Dedicated ED (DED) on each campus. The Methodist West campus had 15 emergency department rooms. The Iowa Methodist “Downtown” campus had 26 emergency department rooms, plus 12 additional pediatric emergency department rooms in a separate emergency department area. The Methodist West and Iowa Lutheran campuses had Level III Trauma designations, while Iowa Methodist Medical Center “Downtown” had a Level I Trauma center designation. The Iowa Methodist Medical Center “Downtown” Emergency Department had a dedicated pediatrics DED (and associated children’s hospital) known as “Blank Children’s Hospital (under the same CCN).” Each DED was staffed with at least a physician as the provider on duty, along with a mix of additional physician assistants and nurse practitioners providing coverage to each department. The Iowa Methodist “Downtown” campus offered a 23 hour observation unit, which was considered part of the Emergency Department, and was staffed by mid-level providers, who are also scheduled on different shifts at the Iowa Methodist Emergency Departments. The Methodist West campus DED saw an average of 287 ED visits per month. The Iowa Methodist “Downtown” campus DED saw an average of 3628 ED visits per month.The hospital, across all campuses, had a total of 758 licensed beds, 29 operating rooms, 8 endoscopy rooms, and 7 cardiac catheterization procedure rooms. 24 Hour on-call, specialist and surgeons. The Methodist West campus had 15 Emergency Department beds and was staffed at all times with an emergency department dedicated physician. The Emergency Department also had mid-level coverage, in addition to the physician coverage, during the peak hours. The DED was staffed with a variety of nurse and patient care technicians. The hospital staffed a Patient Access (registration) individual dedicated to the Emergency Department. The ED staff had access to a wide variety of specialties and subspecialties on-call including neurologists, surgeons and pediatricians. Findings include: 1. Review of policy, “Use of Triage Protocol Order Sets in The Emergency Department,” last revised 12/21, revealed in part: a. “ ...Purpose: To provide for timely care of patients presenting to the emergency department who meet specified criteria; and to allow for rapid diagnostics and appropriate treatment of those patients.” b. “...Policy Statement: Nursing-initiated triage order sets are intended to enhance rapid diagnostics and treatment to ED patients. They do not delay a MSE... After a patient has undergone ED triage and while awaiting a MSE a registered nurse (RN) initiates an approved ED Triage Protocol Order Set in EPIC based upon the criteria in the following procedures ...Widely recognized standards and/or evidence-based guidelines are used to develop triage order sets which are regularly reviewed (at least every three years) by the UnityPoint Health Emergency Medicine Clinical Service Group. Current order sets are found by searching “ED Triage Protocol” in the EPIC order sets ....” c. “...Procedure: The nurse may initiate an ED Triage Protocol order set following the triage assessment. Criteria for when a specific ED Triage Protocol may be initiated are recorded at the top of each protocol set in EPIC... Each patient condition is unique and there may be a need due to the patient’s clinical condition to modify these procedures. The nurse and physician collaborate to manage the patient’s condition on a case-by-case basis, and the rationale for any changes is documented in the patient’s medical record ....” 2. Review of policy, “Transfer and Emergency Examination-EMTALA,” last revised 9/21, revealed in part: a. “ ...Medical Screening Procedure- Initial Assessment When an individual requests examination or treatment, the patient registrar will notify an Emergency Department nurse of the individual’s arrival and will inform such nurse of the individual’s complaints and symptoms, as well as any observations made by the registrar. Individuals who arrive at Unity Point Hospital Des Moines (UPHDM) by either ground or air ambulance will be examined by a nurse upon arrival ....” b. “ ...Medical Screening Procedure-Examination -The individual shall be examined according to Emergency Department protocol and procedures. The Medical Screening Examination provided shall be within the Capability and Capacity of the UPHDM hospital’s Emergency Department (including ancillary services routinely available to the emergency department). The Medical Screening Examination shall be recorded in the individual’s medical record ....” c. “ ... Stabilize-To 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 a facility; or with respect to a woman in Labor, to deliver (including the placenta)” ... “...Medical Screening Examination in Emergency Department ...” 3. Review of Policy “Emergency Department Standards of Practice Guidelines,” last revised 7/7/2023, revealed in part: a. “Policy Statement: Health care consumers presenting to the emergency departments ... will receive nursing care consistent with the Emergency Nursing Scope and Standards of Practice outlined in the Emergency Nursing Association (ENA), Third Edition (2023) ...” b. “...Responsibilities... It is the responsibility of the ED RN to complete and accurately document nursing care provided ...It is the responsibility of the ED Patient Care Technician (PCT) to complete and accurately document any patient care provided by the PCT ....” c. “...Standards of Practice and Documentation Guidelines ... ... ENA Standard of Practice: Assessment: The emergency nurse collects pertinent data and information relative to the patient’s health or information ....” “...Primary Assessment - All patients regardless of chief complaint or triage acuity level will have a primary assessment Circulation, Airway, Breathing and Disability (CABD) completed by the triage RN, primary RN, or ED paramedic ....” “...Secondary Assessment(s) - All patients will have at least one secondary assessment related to the body system of the patient’s chief complaint ....” “...Alerts - The following alerts should be initiated by calling 777, requesting the type of alert and location of the patient ....”... Cardiac Alert - segment elevation myocardial infarction (STEMI) on electrocardiogram (EKG) or at provider direction ... “... Stroke Alert - Stroke-like symptoms within 24 hours of last known well (LKW) or at provider direction...” “...Trauma Alert - Level 1 or Level 2 based on trauma criteria or at provider direction. Level 3 at IMMC only...” d. “...Additional Guidelines, Reassessment of primary and secondary assessments should occur as needed throughout the ED visit depending on clinical judgment and change in patient condition ...” “...PCT’s may obtain and document vital signs. PCT’s should report vital signs to the primary RN ....” e. “...Assessment and Reassessment .......Reassessment, Vitals and Monitoring ....” Vitals must include: heart rate, respiratory rate, blood pressure, and oxygen saturation. A temperature should be obtained on arrival and reassessed as needed. “...Clinical Situation/VITALS REASSESSMENT GUIDELINES ...” “ ...Patient’s assigned Emergency Services Indicator (ESI 1 level), Vitals assessed every 5-15 minutes until stable then every hour as needed. ESI 2 level, Vitals assessed every 15 minutes until stable then every hour and as needed. ESI 3 level, Vitals assessed every 2 hours and as needed (PRN). Monitoring according to patient needs and nursing judgment. ESI 4 level and 5 Vitals upon arrival, at discharge and PRN. ESI levels 3, 4 and 5: Re-assessment and vital signs will occur as needed with changes in patient condition, before and after titration of medications, or other conditions as clinically indicated. Abnormal vital signs require physician notification and repeat vital signs prior to patient discharge, admission, or transfer...” “ ...Additional Guidance: Communicate change in patient condition, abnormal vital signs, and critical values to the ED provider, or, if the patient is a boarder, should communicate with the admitting provider. For inpatient borders, vitals should follow “Routine Vital Signs for Adult Inpatients on Medical Surgical Units” from time of bed request or per physician order. Critical care patients should have vitals at least every 1 hour or per order. Abnormal Vitals to be reported to ED provider: Systolic BP: > 180 or < 90 millimeters of mercury (mmHg); Diastolic BP: > 110 mmHg; Heart Rate: > 130 beats per minute; Respiratory Rate: < 8 or > 30 breaths per minute: O2 Saturation: < 90%; Temp: < 96 F (35.6 C) or > 100.4 F (38 C); Acute mental status changes ...” 4. Patient #17 medical record review, family and staff interviews revealed the following: a. On 6/3/24 at 1:00 PM, during an interview, a family member reported the patient complained of weakness and an inability to lift themselves out of the bathtub. Family called 911, and emergency medical services (EMS) took the patient to the hospital’s downtown campus ED. Family reported they arrived at the hospital at 1:00 PM; they found the patient sitting unaccompanied, in a wheelchair in the ED waiting room. Per family interview, Patient #17 appeared lethargic, a little sleepy, slightly disoriented, sitting hunched over and the patient’s head was down. The family member recalled the patient told them that the patient’s left side was losing more sensation 15-20 minutes after the family member’s arrival at the ED. The family reported that there were approximately 25-35 additional people in the ED waiting area. A hospital staff (Patient Care Technician-PCT) came out and took the patients’ blood pressure two or three times while the patient was in the ED waiting room. The family member reported that the first time the PCT took the patient’s blood pressure, the patient told the PCT that they could not feel their left side. The PCT stated she would mention the concern to staff. The family member reported “a gal” came out to take the patient to get some blood work completed between 3-5 PM. The patient told the female staff person that got the patient for blood work about not being able to feel the left side. The PCT came and took VS again and patient #17 again stated that the patient could not feel the left side and felt worse. The family member reported that at about 7:00 PM that night, hospital staff wheeled the patient into an exam room. Fairly soon after the patient got into the exam room, hospital staff took the patient for a CT scan. b. On 6/3/24 at 3:00 PM, during an interview, another family member explained the following: “ ED felt very compartmentalized and not clear who was in charge, and what were the next steps for orders and patient care.” Felt like no one was on site taking care of patient in the ED, no one in control of the situation, making decisions and ordering testing. c. On 1/8/24 at 11:57 AM, Patient #17 arrived at the hospital ED by ambulance emergency medical services (EMS) with a complaint of syncope (brief loss of consciousness). The EMS trip report indicated the patient had the following abnormally high blood pressures (BPs) : 176 (systolic)/72 (diastolic) at 11:22 AM; 167/86 at 11:30 AM; 203/148 at 11:40 AM; 185/149 at 11:47 AM; and 169/64 at 11:53 AM. d. On 1/8/2024 at 12:17 PM, Staff W ED RN initiated triage. At 12:19 PM, Staff W ED RN documented, vital signs (VS) as follows: temperature 36.4 degrees Celsius (C), 97.5degrees Fahrenheit (F); heart rate 67 beats per minute (BPM); respiratory rate (RR) 16 breaths per minute; oxygen saturation (O2 Sat) 98% on room air; blood pressure (BP) 138/109 millimeters of mercury (mmHg). Patient #17 denied any pain. e. During an interview, on 5/8/24 at 2:30 PM, Staff W ED RN explained the different levels of triage, noting patients were given a triage level 1-5, 1 being the highest acuity level and 5 being minor. Staff W ED RN, recalled triaging Patient #17 and determined an acuity level 3, due to weakness. Patient #17 was returned to the waiting room following triage. Patient #17 should have had the patient’s vital signs checked every two hours based on the identified acuity level 3. f. On 1/8/2024 at 4:03 PM Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70 BPM; O2 sat 99% on room air; BP 152/80. Record review of Patient #17’s medical chart on 5/7/2024 failed to reveal the evidence of rounding notes completed while Patient#17 remained in the ED waiting area, as indicated by nursing staff during interviews. Review of the record revealed an approximately 3.5-hour void in documentation of VS on Patient #17 (between 12:19 PM and 4:03 PM). g. On 5/7/2024 at 11:00 AM Staff JJ Clinical Informatics after review of the record, confirmed the staff failed to include rounding notes completed by nursing staff. h. During an interview on 5/8/24 at 9:30 AM Staff S ED PCT explained patients were assigned an acuity level following triage. Patient’s assigned a level 3 acuity and sent to the waiting room required vitals completed every two hours. Staff S/ED PCT, further explained if the ED was busy with 30 or more patients, staff prioritized by acuity level and completed higher levels first. If extremely busy, staff should call back to the shift lead to request help to ensure everyone received appropriate care and vital signs. If a patient had a different or additional complaint VS should be taken and reported to the triage nurse. Staff S ED PCT denied remembering Patient #17 and denied remembering any of the events that occurred in the ED waiting room on 1/8/24. A review of daily patient census and staffing schedule revealed the total patient census for the ED on 1/8/24 was 118 patients. Patients arrived in th ED on 1/8/24 as follows: 16 patients arrived between 9:00 AM and 11:00 AM; 20 patients arrived between 11:00 AM and 1:00PM with 15 patients arriving by ambulance; 7 patients arrived between 1:00 PM and 3:00 PM; 6 patients arrived between 3:00 PM and 5:00 PM; 18 patients arrived between 5PM-7PM. Patients arriving between 11AM-1PM consisted of stroke, overdose, unresponsive, chest pain, and loss of consciousness. While Patient #17 waited in the ED waiting area, 51 patients arrived. During this time, 11 RNs and 4 PCTs worked in the ED. Physicians and mid level providers scheduled between the hours of 11:00 AM to 7:00 PM included 2 physicians and 1 ARNP during day shift and 2 physicians and 1 ARNP during evening and night shift. i. On 5/7/24 at 10:41 AM, during an interview, Staff V ED RN Nurse Manger reported the average wait time for a patient to be seen in the ED was 30 to 40 minutes for triage and 45 minutes from triage until the patient was placed in an ED room. In a later interview on 6/5/24 at 9:30AM, Staff V ED RN Nurse Manger explained hospital administrative staff used a staffing matrix to meet staffing needs; they did not have staff on call for busy time periods to address surge and patients with higher acuity needs. They staffed 11 nurses and 4 PCT’s from 7:00 AM to 7:00 PM, and added 2 more nurses between the hours of 11:00 AM to 11:00 PM. Staff V, recalled if a PCT needs assistance in the ED waiting area, the PCT was supposed to call the shift leader to request additional staffing. If there were any staff available, they would send them to the waiting area to assist with rounding. j. On 1/8/2024 at 6:25 PM, Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70; RR 16; O2 sat 97% on room air; BP 180/106 mmHg. Staff S ED PCT documented she notified the triage nurse of Patient #17’s elevated BP reading. Documentation showed Staff S ED PCT reported the elevated BP to the triage nurse. k. On 1/8/24 at 6:54 PM, Staff Y ED RN documented they placed Patient #17 in a fast track (FT). ED staff ordered labs including complete blood count (CBC) with differential, complete metabolic panel (CMP), urinalysis (UA), respiratory film array panel and Covid testing. l. On 1/8/24 at 6:56 PM, Staff Y ED RN documented a neurological assessment and determined the patient was displaying stroke-like symptoms including arm drifting, slurred or inappropriate words; talking like the patient’s mouth was full of food, left hand grip weak, left foot dorsiflexion and plantar flexion weak and decreased left lower extremity sensation (symptoms indicative of a stroke). Staff Y ED RN documented the patient failed the stroke screening assessment and the nurse ordered the patient to be nothing by mouth (NPO) and ordered a bed-side swallow study. m. On 1/8/2024 at 7:00 PM, Staff Y ED RN, documented VS, HR 68 bpm, RR 16, BP 182/98 elevated O2 Sat 98%. n. On 1/8/2024 at 7:20 PM, Staff T ED ARNP and documented that around 11:00 AM today (1/8/24) the patient noticed weakness in left arm and leg. The patient’s family member said the patient was quite a bit worse than over the past several weeks. The patient stated the patient could not make a fist or lift the patient’s left leg; the left leg felt heavy. o. On 1/8/24 at 7:40 PM, Staff T, ED ARNP completed the stroke scale and placed orders for chest x ray CT head with contrast stroke alert only, CT angiography of the head. CT of head and CT angiography were completed on 1/8/24 at 7:51 PM. p. During an interview, on 5/14/24 at 10:00 AM, Staff Y ED RN recalled staff brought Patient #17 to Fast Track (FT) bed. Staff Y reported they noted changes with Patient #17’s VS, specifically elevated BP and neurological assessment for stroke symptoms. Staff Y ED EN informed Staff T ED ARNP of the concerns. Staff Y ED RN, recalled they took Patient #17 to obtain a CT, and the CT was positive. Staff T ED ARNP, then called the stroke alert. Patient #17 was outside of the window to receive Thrombolytics (TPA) therapy. Staff Y ED RN, stated “Patient #17 then moved to a room for higher acuity level of care.” q. During an interview on 5/7/24 at 11:30 AM Staff T ED ARNP recalled examining Patient #17 in a FT room and asking Staff U ED DO, to further evaluate the patient. Patient #17 was moved to a room for higher acuity level of care in the ED. Staff T ED ARNP and Staff U ED DO, called the stroke alert at 7:42 PM, and Staff U ED DO, became the primary physician, implementing stroke protocol. Patient #17’s care was turned over to internal medicine, as the patient was admitted to the hospital. r. On 1/9/24 at 7:57 AM, Staff X Hospitalist documented Patient #17’s history (hx) of diabetes mellitus type 2 (DM 2), obstructive sleep apnea (OSA), gastroesophageal reflux disorder (GERD), hypertension (HTN), cerebral vascular accident (CVA), anxiety/depression, benign prostatic hypertrophy (BPH) and noted Patient #17 admission on 1/8/24 with bilateral strokes. They further noted Patient #17 presented following four weeks of weakness with acute worsening of left-sided weakness. A head computed tomography (CT) was unremarkable. Computed tomography angiography (CTA) of the head and neck showed no large vessel occlusion (LVO) but noted multifocal areas of mild to moderate arterial narrowing of the posterior circulation. A magnetic resonance imaging (MRI) showed infarct (stroke) of the right pons, left posterior limb of the internal capsule/left anterior thalamus, left temporal periventricular parenchyma. Patient was on Plavix prior to arrival; Aspirin was added to the regimen. s. On 1/9/24 at 3:06 PM, Staff HH Neurologist documented Patient # 17’s history of a right corona radiata ischemic stroke, memory problems, under control diabetes, hypertension and hyperlipidemia. Staff HH Neurologist noted Patient #17 presented to the ED for evaluation of left-sided weakness. The patient’s last well known normal was 11:00 AM on 1/8/2024. Staff HH Neurologist documented Patient #17 was out of the window for thrombolytics. A CTA (scan) of the head and neck showed no evidence of LVO (large vessel occlusion). An MRI showed Patient #17’s brain demonstrated acute to subacute infarct in right pons, left posterior limb of internal capsule/anterior thalamus and left temporal periventricular parenchymal. Staff HH Neurologist noted Patient #17 scored 10 on the National Institute of Health Stroke Scale (NIHSS)(subtle left facial droop, left arm and leg drift, sensory changes). Patient #17 took Plavix prior to admission. Staff HH Neurologist, ordered the following: - P2Y12 platelet function assay and Transesophageal Echocardiogram (TEE) for further evaluation - Continued dual antiplatelet therapy (DAPT) for the time - Continued Atrovastatin (medication to lower blood cholesterol levels) 80 mg orally nightly - Follow-up P2Y12 results - Allowed permissive hypertension with goal LDL (type of blood cholesterol level)<70 and HbA1c (type of blood test related to blood sugar levels)<7 - Physical therapy (PT), occupational therapy (OT) and speech therapy (ST) -Stroke education He further noted Patient #17 likely needed a 30-day cardiac event monitor at discharge and follow up with Neurology would occur the next day. t. During an interview, on 5/8/24 at 8:10 AM, Staff X Physician recalled they saw patient #17 the second day. They explained standing orders for a typical stroke protocol included imaging, management of BP, platelet therapy, and anticoagulation therapy. Patient #17 had Bilateral strokes during inpatient admission, while waiting for rehab therapy recommendations and admission. A bed request was put in at the time of admission, but they could not recall if the patient had left the ED yet. Staff X Physician, could not confirm the patient boarded in the ED while waiting for a bed to become available in therapy and a rehab admission. u. During an interview, on 5/14/24 at 3:00 PM, Staff HH Neurologist recalled they saw Patient #17 and, as a supervising physician, also oversaw resident notes. Staff HH Neurologist recalled confusion amongst the staff and physicians regarding exact time of onset of Patient #17’s symptoms of dizziness and confusion. Patient #17 arrived at the ED reporting symptoms had been on-going for days to weeks prior. Staff HH Neurologist explained TPA therapy should be initiated within a 4.5 hour time frame, unless the exact time of symptom onset was known. Due to ongoing weakness and not knowing the actual onset of symptoms, the decision to initiate TPA therapy was difficult. The patient’s report of four weeks of symptoms put Patient #17 outside the TPA therapy window. According to the ED staffing matrix, the ED was appropriately staffed on 1/8/24. However, hospital staff could not provide evidence to explain why Patient #17 had to wait almost 7 hours in the ED waiting room and over 7 hours to be assessed by a provider in the ED. ED staff could not explain why Patient #7 failed to be assessed every 2 hours at a minimum and why none of the staff responded with any urgency to the Patient’s complaints of weakness, increased feeling of unwellness, and loss of sensation on the left side of the patient’s body. 5. Review of Patient #37, a pediatric patient, medical record revealed the following: a. On 5/1/24 at 9:30 PM, Staff CC ED RN and Staff BB ED RN documented the following: “Arrive to Methodist West ED via private vehicle...chief complaint post-op problem (Patient #37) underwent a tonsillectomy and adenoidectomy (T&A) on 4/22/24 by pediatric Ear Nose and Throat (ENT) physician...Patient woke up covered in blood on 4/30 (4/30/24) and the ENT physician told them if the bleeding stops that is okay, but if reoccurred to come to the ED. Patient woke up again tonight (5/1/24) covered in blood. Bleeding from the throat has stopped since the patient arrived in the ED. Family reports no new spitting up of blood.” b. On 5/1/24 at 9:46 PM, Staff CC ED RN and Staff BB ED RN documented a triage assessment on Patient #37 as follows: vital signs (VS) were heart rate (HR) 142 beats per minute (bpm- elevated), respirations 22 per minute, BP- 99/58, oxygen saturation level of 100%, wt (weight)-25 lbs (pounds), temp 98.6 (degrees Fahrenheit). c. On 5/1/24 10:56 PM, ED staff documented, “Family signed Refusal of Medical Screening Exam; “too long of wait for treatment”. d. On 5/8/24 at 4:00 PM, during an interview, a family member reported they asked a person at the front desk how long of a wait it would be, and the front desk told the family member there was a 3 to 4 hour wait for a bed (exam room). The family member asked a nurse if they should take the patient to another hospital, as they had been told by the ENT surgeon that the patient needed to be seen immediately. The nurse (identified as Staff BB ED Triage Nurse) informed the family that they could not tell the family member to take the patient to another hospital, encouraged them to stay, but expressed her understanding that a 3 to 4 hour wait was too long for a child. The family member confirmed they signed a form to refuse treatment. e. A review of daily patient census revealed the following: a total patient census for the ED on 5/1/24 was 71 patients; 62 patients arrived between 7:00 AM and 11:00 AM; 19 patients arrived between 11AM and 3:00 PM; 32 patients arrived between 3:00 PM and 7:00 PM; 28 patients arrived between 7:00 PM and 11:00 PM; 24 patients arrived between 11:00 PM and 3:00 AM. Review of the ED staffing schedule revealed the ED had 1 physician and 1 mid-level working at all times and 5 nurses and 1 to 2 PCTs working at all times during the 24 hour shift. f. On 5/1/24 11:26 PM Patient #37 arrived at a second hospital ED, Hospital SS via private vehicle. On 5/1/24 at 11:30 PM, Staff RR, ED RN, Triage Note-“(Patient #37) had tonsillectomy/adenoidectomy and tubes placed 4/22/24 with pediatric ENT Staff PP. Last night, the patient had a little bleeding but stopped, tonight the patient had another episode of bleeding that was worse.” g. On 5/2/24 at 12:48 AM, Staff QQ ED Physician documented the following: “(Patient #37) presented after tonsils and adenoids removed on 4/22/24, late last night (Patient #37) had a small amount of post tonsillar bleeding, resolved spontaneously, seems to be doing fine, tolerating P.O. (by mouth) today, took Ibuprofen, however this evening woke after another episode of bleeding, blood in the naris (nose), large blood clot was spit out of the mouth, however bleeding is now stopped, recommended to go to the emergency department by Ear Nose and Throat (ENT) for evaluation and potentially IV fluids. Previous treatment: outpatient surgery. Post op course: Fluctuating. Incision complaints: moderate Bleeding. Risk factors consist of age. Therapy today: none. MSE completed.” PLAN: “(Patient #37) with post tonsillar bleed, appears not to be bleeding currently, will keep an eye on (Patient #37) in the ED, patient appears pale, recommendation from ENT to get IV(intravenous) fluids, will place IV, do screening blood work (complete metabolic profile (CMP), complete blood count (CBC) with differential) and give Dextrose 5% and Sodium Chloride 0.9% with Potassium Chloride 20 milliequivalents per liter (mEq/L) per 1000 mL(milliliters)- 250 cc(cubic centimeters) bolus.” h. On 5/2/24 4:15 AM Staff QQ ED Physician documented Physician Notes as follows: “Patient with no further bleeding in the emergency department however is profoundly anemic with hemoglobin 7.3 (normal 11.5-13.5; indicative of anemia or low blood volume), discussed with ENT and will admit to PEDS (pediatric) Hospitalist, type and screen pending, ENT will see in the a.m. and reevaluate.” i. On 5/2/24 at 4:28 AM, Staff PP ENT documented the following progress notes: “(Patient #37) was admitted earlier this morning with a postoperative bleed. We are evaluating Patient #37 today to assess how they have done over the course of the day. Patient #37 has been doing quite well and has had no further bleeding. There have been no concerns regarding their airway since admission. I spoke to the family a couple of nights ago and noted that Patient #37 had a brief bleed at that time, but we had followed up that morning and they had no further issues. It was only in the middle of the night that they began bleeding again at which time the family brought them in. Again, the last 12 hours have been uneventful. Patient 37 has had no further bleeding or concerns. Patient #37 is feeding and doing quite well. We will monitor them overnight and see how Patient #37 does. If there is no further bleeding tomorrow depending on how they are feeling and the family is comfortable, we will start considering discharge home. Order for Pediatric Admission placed.” j. During an interview, on 5/9/24 at 8:10 AM, Staff BB ED RN (West campus ED triage nurse), recalled the patient. Staff BB reported they recalled that “it was a very busy evening” and they believed “the wait times were getting to be long”. Staff BB reported the patient had a little bit of blood on their pajamas or in their hair. Family said the bleeding had stopped. Staff BB did not remember seeing the patient bleeding. The family never asked for a tissue or notified staff that the bleeding had started again. Staff BB explained that if the patient’s condition worsened, she would have called the charge nurse to direct Staff BB to get the patient seen immediately by a provider. Staff BB, did ask the charge nurse what acuity level the patient should be, and Staff BB reported the charge nurse told her a Level 3. Level 3 would be brought back before a Level 4 patient. Since the waiting room was busy there was a PCT rounding for the patient’s vitals. The PCT documents those vitals in the patients’ electronic records. When asked if they explained to the family that the patient had a possible EMC and should stay and let the patient to be seen, Staff BB responded that they encouraged them to stay to see a provider. When the family asked how long it would be before the patient could be seen, Staff BB reported they told the family that wait times were always changing and they could not provide that information. Staff BB reported they explained the Refusal of Medical Treatment form and had a family member sign it. k. During an interview, on 5/9/24 at 8:40 AM, Staff CC ED RN (West Campus ED Triage nurse), recalled Patient #37 and recalled that night (5/1/24) being horribly busy. Staff CC ED RN explained there were a lot of patients boarding (in the ED) and no beds were opening up. Staff CC ED RN recalled the family came up to the desk voicing their frustration, because their provider told them to rush the child in and then they had to wait for their child to be seen. The family said they were going to take the patient to a different ED. Staff CC ED RN reported that Staff BB explained that Patient #37 needed to be seen, but if they were leaving they could sign the Refusal of Medical Exam form. The family did sign the form. Staff CC ED RN did not recall staff stating a time frame for the wait to be seen by a provider. Staff usually state that they cannot give an estimate of the time frame, and patient were taken into the ED rooms according to their acuity level. Per the hospital’s staffing matrix, the hospital ED was adequately staffed on 5/1/24 (when Patient #37) was in the ED; however, ED staff reported the ED was busy with long wait times for medical assessment by a provider. The hospital’s ED failed to have enough physicians/mid-level providers to meet the emergency needs of patients and provide timely assessment and treatment.”

“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: 49848 Based on patient, family and staff interviews, ED log, medical record and policy review, it was determined that the hospital failed to ensure that Patients # 16, 17, and 37 (of 21 sampled patients who presented to the emergency department seeking care) received an appropriate medical screening examination (MSE) that made use of the hospital’s capabilities; failed to ensure that Patients # 17 and 37 received further medical evaluation and treatment as required to stabilize their emergency medical condition; and failed to ensure that Patient # 44 did not experience a delay in medical examination and treatment in order to inquire about payment. These failures resulted in Patient #16 leaving the hospital ’ s off-campus emergency department and traveling 9.5 miles (16 minutes) to the main campus to receive examination and treatment; a delay in activation of the Stroke Protocol preventing Patient # 17 from receiving thrombolytic medication to treat an acute stroke; Patient # 37 leaving the ED to go to another hospital to receive a rapid assessment for the presence and severity of post-tonsillectomy bleeding (a high risk condition that can be life threatening); Patient # 44 coreced into making a payment to prevent care from being stopped; and placed all patients at risk for deterioration of their health and wellbeing as a result of an undetected or untreated emergency medical condition.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 49848 Based on patient interview, staff interviews, and the hospital’s emergency department (ED) log/Obstetrics Department (OB) log, the hospital’s administrative staff failed to ensure hospital ED staff maintained a complete ED log for 1 of 21 patients reviewed (Patient #16) who presented to the ED seeking medical care on 5/2/24. Failure to maintain a complete log resulted in the possibility of the hospital staff inability to track the care provided to each individual who comes to the hospital seeking care for a potential emergency medical condition (EMC). Findings include: 1. Review of Policy “Triage of OB Patient in the Emergency Department,” last revised 5/23 revealed in part: a. “< (less than) 20 Weeks gestation with any chief complaint: Registered to the Emergency Department (ED) and triaged according to the ED Policy and Procedure...” b. “ > (greater than) 20 Weeks gestation with OB related chief complaint: OB related chief complaints may include: Abdominal cramps/pain, contractions, vaginal bleeding, leaking fluid, decreased fetal movement, headache with hypertension, epigastric pain, hypertension (SBP > 140 and/or DBP > 90)...Patients will be triaged to labor and delivery...The main ED will notify the OB charge RN or RN in the OB ED and provide patient name, care provider’s name (if available), due date/weeks’ gestation, and chief complaint.” 2. On 5/8/24 at 9:00 AM, during an interview, Patient #16 reported the patient went to hospital’s West campus ED on 3/31/24 (sometime before 5:00 PM) with a complaint of back pain and the patient was also 7 months pregnant. The patient explained the patient went to an urgent care clinic to be seen initially. The provider at the clinic reportedly told the patient that the patient could be in labor and to go to the hospital’s West campus to be seen. Patient #16 arrived at the ED, the patient approached the receptionist. The receptionist retrieved a wheelchair for the patient to sit and the receptionist told the patient they would call up to the OB department. The receptionist placed a call, spoke with someone, and then advised the patient that OB staff were in the middle of a delivery and it would be a few minutes for someone to come retrieve the patient. Patient #16 waited in the ED lobby with family. The receptionist informed the patient that staff called from the OB floor and advised the patient to go to the hospital’s downtown campus (approximately 20 minute drive) to be seen. When the patient arrived at the hospital’s downtown campus, the ED staff reported the patient could have been seen at the West campus ED and they were not sure of the reason why the patient was sent downtown. 3. Review of the West campus hospital ED and OB logs, dated 3/31/24, revealed Patient #16 was not identified in the logs. 4. On 5/7/24 at 1:30 PM, during an interview, Staff L Patient Access Associate (PAA-ED registration staff at the West campus) recalled Patient #16 presented to the ED triage desk stating they had back pain and needed to be seen. Staff L PAA explained Patient #16 reported being sent to the ED by the patient’s provider. Staff called upstairs to the OB department inquiring about the patient needing to be seen. OB staff reported they were in the middle of a delivery and it would be a few minutes. Staff L PAA reported, a few minutes later, staff from the OB department called back to the ED triage desk and told staff to send Patient #16 to the main (downtown) campus. Staff L PAA explained that patients that OB staff registered patients that went to the OB department. Hospital staff do not register OB patients in the ED area unless they were treated in the ED for unrelated OB issues. 5. On 5/7/24 at 4:00 PM, during an interview, Staff K ED RN (triage nurse at the West campus) reported Patient #16 presented to registration and asked to be seen. Registration staff came to the door and asked Staff K what they should do with the OB patient. Staff K ED Triage Nurse advised registration staff to call the OB department if the patient was more than 20 weeks pregnant. Staff K ED Triage Nurse reported they heard registration staff place the call the OB Department. Staff K ED Triage Nurse explained when they later asked registration staff what happened to Patient #16, registration staff reported that OB staff called down and told the patient to go to Methodist downtown. Staff K ED Triage Nurse reported that if an OB patient needed to be seen upstairs in the OB department, the OB staff registered the patient in their log.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 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: 49848 Based on medical record review, hospital policy review, patient interview, family interview and staff interviews, the Acute Care Hospital’s administrative staff failed to ensure the Emergency Department (ED) staff provided, within the hospital’s capabilities, a timely and appropriate medical screening examination (MSE) to 3 of 21 sampled patients (Patient #16, #17 and #37) seeking emergency medical treatment at one of the hospital’s 3 campuses. Failure to provide an appropriate and timely MSE to all patients presenting to the ED seeking medical care placed patients at risk for an undetected emergency medical condition. Hospital Capabilities: The acute care hospital had three campuses (Iowa Methodist “Downtown,” Methodist West, and Iowa Lutheran). Between the three campuses, the hospital had a Dedicated ED (DED) on each campus. The Methodist West campus had 15 emergency department exam rooms. The Iowa Methodist “Downtown” campus had 26 emergency department exams rooms, plus 12 additional pediatric emergency department exam rooms in a separate emergency department area. The Methodist West and Iowa Lutheran campuses had Level III Trauma designations, while Iowa Methodist Medical Center “Downtown” had a Level I Trauma center designation. The Iowa Methodist Medical Center “Downtown” Emergency Department had a dedicated pediatrics DED (and associated children’s hospital) known as “Blank Children’s Hospital (under the same CCN).” Each DED was staffed with at least a physician as the provider on duty, along with a mix of additional physician assistants and nurse practitioners providing coverage to each department. The hospital, across all campuses, had 24 hour on-call, specialists and surgeons, and imagery testing (CT, MRI scans). The Methodist West location offered OB services and the Iowa Methodist “Downtown” Blank hospital offered Level IV OB and Neonatal nursery level care. The Iowa Methodist “Downtown” campus had 45 Labor & Delivery rooms. The Methodist West campus had 24 obstetrical rooms. Findings include: 1. Review of policy, “Transfer and Emergency Examination-EMTALA,” last revised 9/21, revealed in part: a. “ ...Medical Screening Examination-The process required to reach, with reasonable clinical confidence, the point at which it can be determined whether an individual who has come to the Dedicated Emergency Department, has or does not have an Emergency Medical Condition ...” b “ ...Medical Screening Procedure- Initial Assessment When an individual requests examination or treatment, the patient registrar will notify an Emergency Department nurse of the individual’s arrival and will inform such nurse of the individual’s complaints and symptoms, as well as any observations made by the registrar. Individuals who arrive at Unity Point Hospital Des Moines (UPHDM) by either ground or air ambulance will be examined by a nurse upon arrival ....” c. “ ...Medical Screening Procedure-Examination -The individual shall be examined according to Emergency Department protocol and procedures. The Medical Screening Examination provided shall be within the Capability and Capacity of the UPHDM hospital’s Emergency Department (including ancillary services routinely available to the emergency department). The Medical Screening Examination shall be recorded in the individual’s medical record ....” 2. Patient #17 medical record review and family interview revealed the following: a. On 6/3/24 at 1:00 PM, during an interview, a family member reported the patient complained of weakness and an inability to lift themselves out of the bathtub. Family called 911, and emergency medical services (EMS) took the patient to the hospital’s downtown campus ED. Family reported they arrived at the hospital at 1:00 PM; they found the patient sitting unaccompanied, in a wheelchair in the ED waiting room. Per family interview, Patient #17 appeared lethargic, a little sleepy, slightly disoriented, sitting hunched over and the patient’s head was down. The family member recalled the patient told them that the patient’s left side was losing more sensation 15-20 minutes after the family member’s arrival at the ED. The family reported that there were approximately 25-35 additional people in the ED waiting area. A hospital staff (Patient Care Technician-PCT) came out and took the patients’ blood pressure two or three times while the patient was in the ED waiting room. The family member reported that the first time the PCT took the patient’s blood pressure, the patient told the PCT that they could not feel their left side. The PCT stated she would mention the concern to staff. The family member reported “a gal” came out to take the patient to get some blood work completed between 3-5 PM. The patient told the female staff person that got the patient for blood work about not being able to feel the left side. The PCT came and took VS again and patient #17 again stated that the patient could not feel the left side and felt worse. The family member reported that at about 7:00 PM that night, hospital staff wheeled the patient into an exam room. Fairly soon after the patient got into the exam room, hospital staff took the patient for a CT scan. b. On 1/8/24 at 11:57 AM, Patient #17 arrived at the hospital ED by ambulance emergency medical services (EMS) with a complaint of syncope (brief loss of consciousness). The EMS trip report indicated the patient had the following abnormally high blood pressures (BPs) : 176 (systolic)/72 (diastolic) at 11:22 AM; 167/86 at 11:30 AM; 203/148 at 11:40 AM; 185/149 at 11:47 AM; and 169/64 at 11:53 AM. c. On 1/8/2024 at 12:17 PM, Staff W ED RN initiated triage. At 12:19 PM, Staff W ED RN documented, vital signs (VS) as follows: temperature 36.4 degrees Celsius (C), 97.5 degrees Fahrenheit (F); heart rate 67 beats per minute (bmp); respiratory rate (RR) 16 breaths per minute; oxygen saturation (O2 Sat) 98% on room air; blood pressure (BP) 138/109 millimeters of mercury (mmHg). Patient #17 denied any pain. d. On 1/8/24 at 12:19 PM Staff W ED RN documented Patient #17 reported to have been sick for the past four weeks and today was too weak to get out of bed to go to a doctor appointment. Patient #17 reported being unable to eat much, or at all, and thought they lost quite a bit of weight. e. On 1/8/2024 at 4:03 PM Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70 pm; O2 sat 99% on room air; BP 152/80. f. On 1/8/2024 at 6:25 PM, Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70; RR 16; O2 sat 97% on room air; BP 180/106 mmHg. Staff S ED PCT noted she notified the triage nurse of Patient #17’s elevated BP reading, 180/106. g. On 1/8/24 at 6:54 PM, Staff Y ED RN documented they placed Patient #17 in a fast track (FT) room. ED staff ordered labs including complete blood count (CBC) with differential, complete metabolic panel (CMP), urinalysis (UA), respiratory film array panel and Covid testing. h. On 1/8/24 at 6:56 PM, Staff Y ED RN documented a neurological assessment and determined the patient was displaying stroke-like symptoms including arm drifting, slurred or inappropriate words; talking like the patient’s mouth was full of food, left hand grip weak, left foot dorsiflexion and plantar flexion weak and decreased left lower extremity sensation (symptoms indicative of a stroke). Staff Y ED RN documented the patient failed the stroke screening assessment and the nurse ordered the patient to be nothing by mouth (NPO) and ordered a bed-side swallow study. i. On 1/8/2024 at 7:00 PM, Staff Y ED RN documented vital signs which included an elevated blood pressure of 182/98. j. On 1/8/2024 at 7:20 PM, Staff T ED ARNP and documented that around 11:00 AM today (1/8/24) the patient noticed weakness in left arm and leg. The patient’s family member said the patient was quite a bit worse than over the past several weeks. The patient stated the patient could not make a fist or lift the patient’s left leg; the left leg felt heavy. k. On 1/8/24 at 7:40 PM, Staff T ED ARNP completed the stroke scale and placed orders for chest x ray and computed tomography (CT) of the head with contrast, stroke alert only, CT angiography of the head. l. At 7:42 PM Staff Y ED RN documented Stroke Activation by Staff T ED ARNP. m. On 1/8/24 at 7:51 PM, hospital staff completed the CT of head and CT angiography. n. On 1/9/24 at 7:57 AM, Staff X Hospitalist documented Patient #17’s history (hx) of diabetes mellitus type 2 (DM 2), obstructive sleep apnea (OSA), gastroesophageal reflux disorder (GERD), hypertension (HTN), cerebral vascular accident (CVA), anxiety/depression, benign prostatic hypertrophy (BPH) and noted Patient #17 admission on 1/8/24 with bilateral strokes. They further noted Patient #17 presented following four weeks of weakness with acute worsening of left-sided weakness. A head computed tomography (CT) was unremarkable. Computed tomography angiography (CTA) of the head and neck showed no large vessel occlusion (LVO) but noted multifocal areas of mild to moderate arterial narrowing of the posterior circulation. A magnetic resonance imaging (MRI) showed infarct (stroke) of the right pons, left posterior limb of the internal capsule/left anterior thalamus, left temporal periventricular parenchyma. Patient was on Plavix prior to arrival; Aspirin was added to the regimen. o. On 1/9/24 at 3:06 PM, Staff HH Neurologist documented Patient # 17’s history of a right corona radiata ischemic stroke, memory problems, under control diabetes, hypertension and hyperlipidemia. Staff HH Neurologist noted Patient #17 presented to the ED for evaluation of left-sided weakness. The patient’s last well known normal was 11:00 AM on 1/8/2024. Staff HH Neurologist documented Patient #17 was out of the window for thrombolytics. A CTA (scan) of the head and neck showed no evidence of LVO (large vessel occlusion). An MRI showed Patient #17’s brain demonstrated acute to subacute infarct in right pons, left posterior limb of internal capsule/anterior thalamus and left temporal periventricular parenchymal. Staff HH Neurologist noted Patient #17 scored 10 on the National Institute of Health Stroke Scale (NIHSS)(subtle left facial droop, left arm and leg drift, sensory changes). Patient #17 took Plavix prior to admission. Staff HH Neurologist, ordered the following: - P2Y12 platelet function assay and Transesophageal Echocardiogram (TEE) for further evaluation - Continued dual antiplatelet therapy (DAPT) for the time - Continued Atrovastatin (medication to lower blood cholesterol levels) 80 mg orally nightly - Follow-up P2Y12 results - Allowed permissive hypertension with goal LDL (type of blood cholesterol level)<70 and HbA1c (type of blood test related to blood sugar levels)<7 - Physical therapy (PT), occupational therapy (OT) and speech therapy (ST) -Stroke education He further noted Patient #17 likely needed a 30-day cardiac event monitor at discharge and follow up with Neurology would occur the next day. 3. During an interview, on 5/8/24 at 2:30 PM, Staff W ED RN explained the different levels of triage, noting patients were given a triage level 1-5, 1 being the highest acuity level and 5 being minor. Staff W/ED RN, recalled triaging Patient #17 and determined an acuity level 3 due to weakness. Patient #17 was returned to the waiting room following triage. ED staff should have checked Patient #17’s VS every two hours based on the identified acuity level 3 per Staff W. 4. During an interview, on 5/8/24 at 9:30 AM, Staff S ED PCT explained patients were assigned an acuity level following triage. Patient’s assigned a level 3 acuity and sent to the waiting room required vitals completed every two hours. Staff S/ED PCT, further explained if the ED was busy with 30 or more patients, staff prioritized by acuity level and completed higher levels first. If extremely busy, staff should call back to the shift lead to request help to ensure everyone received appropriate care and vital signs. If a patient had a different or additional complaint VS should be taken and reported to the triage nurse. A review of daily patient census and staffing schedule revealed the total patient census for the ED on 1/8/24 was 118 patients. From 11:00 AM until 4:00 PM, while Patient #17 waited in the ED, 20 patients arrived. Review of Patient #17’s medical record, dated 1/8/24, revealed an approximately 3.5 hour void in documentation of VS on Patient #17. 5. During an interview, on 5/14/24 at 10:00 AM, Staff Y ED RN recalled staff brought Patient #17 to a Fast Track (FT) bed. Staff Y reported they noted changes with Patient #17’s VS, specifically elevated BP and neurological assessment for stroke symptoms. Staff Y ED PCT informed Staff T ED ARNP of the concerns. Staff Y ED RN, recalled they took Patient #17 to obtain a CT, and the CT was positive. Staff T ED ARNP, then called the stroke alert. Patient #17 was outside of the window to receive Thrombolytics (TPA) therapy. Staff Y ED RN, stated “Patient #17 then moved to a room for higher acuity level of care.” 6. During an interview, on 5/7/24 at 11:30 AM, Staff T ED ARNP recalled examining Patient #17 in a FT bed and asking Staff U ED Physician, to further evaluate the patient. Patient #17 was moved to a room for higher acuity level of care in the ED. Staff T ED ARNP and Staff U ED Physician, called the stroke alert at 7:42 PM, and Staff U ED Physician, became the primary physician, implementing stroke protocol. Patient #17’s care was turned over to internal medicine, as the patient was admitted to the hospital. 7. During an interview, on 5/7/24 at 1:05 PM, Staff U ED Physician recalled being asked to verify findings on Patient #17 and speak with the patient and family. Staff U ED Physician became involved in Patient #17’s care and moved the patient into a room around 7:00 PM, due to his higher acuity level. 8. During an interview, on 5/8/24 at 8:10 AM, Staff X Physician of Internal Medicine recalled they saw patient #17 the second day, following Staff P admitted the patient. They explained standing orders for a typical stroke protocol included imaging, management of BP, platelet therapy, and anticoagulation therapy. Patient #17 had Bilateral strokes during inpatient admission, while waiting for rehab therapy recommendations and admission. A bed request was put in at the time of admission, but they could not recall if the patient had left the ED yet. Staff X Physician, could not confirm the patient boarded in the ED while waiting for a bed to become available in therapy and a rehab admission. 9. During an interview, 5/14/24 at 3:00 PM, Staff HH Neurologist recalled they saw Patient #17 and, as a supervising physician, also oversaw resident notes. Staff HH Neurologist, further recalled confusion amongst the staff and physicians regarding exact time of onset Patient #17’s symptoms of dizziness and confusion. Patient #17 arrived at the ED reporting symptoms had been on-going for days to weeks prior. Staff HH Neurologist, explained TPA therapy should be initiated within a 4.5 hours’ time frame, unless the exact time of symptom onset was known. Due to ongoing weakness and not knowing the actual onset of symptoms, the decision to initiate TPA therapy was difficult. The patient’s report of four weeks of symptoms put Patient #17 outside the TPA therapy window. 10. Review of Policy “Triage of OB Patient in the Emergency Department,” last revised 5/23 revealed in part: a. ...”Policy Statement: Obstetric patients presenting to the main Emergency Department (ED) will be screened and referred or treated with the appropriate interventions as early as possible ...” b. > 20 Weeks gestation with OB related chief complaint: c. OB related chief complaints may include: Abdominal cramps/pain, contractions, vaginal bleeding, leaking fluid, decreased fetal movement, headache with hypertension, epigastric pain, hypertension (SBP > 140 and/or DBP > 90). d. Patients will be triaged to labor and delivery at Methodist West (MWH) or the Obstetric Emergency Department (OBED) at Iowa Methodist Medical Center (IMMC). c. The main ED will notify the OB charge RN at MWH or the RN in the OBED at IMMC and provide patient name, care provider’s name (if available), due date/weeks’ gestation, and chief complaint. d.. If a patient presents to the Iowa Lutheran Hospital (ILH) ED the OB stat RN and their primary OB provider should be notified to determine appropriate plan of care/disposition. e. If the patient does not have an established OB provider, and presents to the ILH ED, the East Des Moines Family Medicine resident should be consulted ...” 11. Patient #16 medical record review, patient and staff interviews revealed the following: a. On 5/8/24 at 9:00 AM, during an interview, Patient #16 reported the patient went to hospital’s West campus ED on 3/31/24 (sometime before 5:00 PM) with a complaint of back pain and the patient was also 7 months pregnant. The patient explained the patient went to an urgent care clinic to be seen initially. The provider at the clinic reportedly told the patient that the patient could be in labor and to go to the hospital’s West campus to be seen. Patient #16 arrived at the ED, the patient approached the receptionist. The receptionist retrieved a wheelchair for the patient to sit and the receptionist told the patient they would call up to the OB department. The receptionist placed a call, spoke with someone, and then advised the patient that OB staff were in the middle of a delivery and it would be a few minutes for someone to come retrieve the patient. Patient #16 waited in the ED lobby with family. The receptionist informed the patient that staff called from the OB floor and advised the patient to go to the hospital’s downtown campus (approximately 20 minute drive) to be seen. When the patient arrived at the hospital’s downtown campus, the ED staff reported the patient could have been seen at the West campus ED and they were not sure of the reason why the patient was sent downtown. b. On 5/7/24 at 1:30 PM, during an interview, Staff L Patient Access Associate (PAA-ED registration staff at the West campus) recalled Patient #16 presented to the ED triage desk stating they had back pain and needed to be seen. Staff L PAA explained Patient #16 reported being sent to the ED by the patient’s provider. Staff called upstairs to the OB department inquiring about the patient needing to be seen. OB staff reported they were in the middle of a delivery and it would be a few minutes. Staff L PAA reported, a few minutes later, staff from the OB department called back to the ED triage desk and told staff to send Patient #16 to the main (downtown) campus. Staff L PAA explained that patients that OB staff registered patients that went to the OB department. Hospital staff do not register OB patients in the ED area unless they were treated in the ED for unrelated OB issues. c. On 3/31/24 5:00 PM- Patient #16 arrived at Iowa Methodist Downtown, ED, by private car and went directly to the OB Department. d. On 3/31/24 6:00 PM, Staff N, Certified Nurse Midwife (CNM) ARNP, documented the following assessment of Patient #16: “...28 weeks pregnant with estimated delivery date of 6/23/24. History of polycystic ovarian syndrome, postpartum depression, migraines, IVF (in vitro fertilization). Assessed the patient in OB ED Triage... (Patient #16) presented today for evaluation of back pain. Pain started worsening last week, did not improve with chiropractor, stretching or yoga. “(Patient #16) has a hx (history) of back pain due to injury at the age of 13 but today she is having a hard time with movement, rating pain 8/10. Pain is across the lower back and radiates over to the right side. Denies any obstetrical complaints. The patient states that the baby moves as usual. She denies contractions. Denies vaginal bleeding or loss of fluid. No dysuria (difficulty with urination). BP 121/74 (within normal limits).” e. On 3/31/24 7:32 PM, documentation noted, Staff O RN provided discharge education to Patient #16. f. On 3/31/24 7:32 PM Staff N CNM, ARNP- documented “Discharge Note- Treatment- Fetal Non-Stress Test obtained- reactive (Fetal Heart Rate 125 bpm, no uterine contractions, no accelerations, no decelerations), UA within normal limits, Flexeril (muscle relaxant medication) given, 2 Norco (pain medication) given. Plan- Pt (patient) was given an additional Norco Rx (prescription) to take tonight, physical therapy consulted and education given to follow up, the patient is to call the OB office in the morning, stay hydrated, rest, and use a heat pack as needed...” 12. Review of Patient #37, a pediatric patient, medical record revealed the following: a. On 5/1/24 at 9:30 PM, Staff CC ED RN and Staff BB ED RN documented the following: “Arrive to Methodist West ED via private vehicle...chief complaint post-op problem (Patient #37) underwent a tonsillectomy and adenoidectomy (T&A) on 4/22/24 by pediatric Ear Nose and Throat (ENT) physician...Patient woke up covered in blood on 4/30 (4/30/24) and the ENT physician told them if the bleeding stops that is okay, but if reoccurred to come to the ED. Patient woke up again tonight (5/1/24) covered in blood. Bleeding from the throat has stopped since the patient arrived in the ED. Family reports no new spitting up of blood.” b. On 5/1/24 at 9:46 PM, Staff CC ED RN and Staff BB ED RN documented a triage assessment on Patient #37 as follows: vital signs (VS) were heart rate (HR) 142 beats per minute (bpm- elevated), respirations 22 per minute, BP- 99/58, oxygen saturation level of 100%, wt (weight)-25 lbs (pounds), temp 98.6 (degrees Fahrenheit). c. On 5/1/24 10:56 PM, ED staff documented, “Family signed Refusal of Medical Screening Exam; “too long of wait for treatment”. d. On 5/8/24 at 4:00 PM, during an interview, a family member reported they asked a person at the front desk how long of a wait it would be, and the front desk told the family member there was a 3 to 4 hour wait for a bed (exam room). The family member asked a nurse if they should take the patient to another hospital, as they had been told by the ENT surgeon that the patient needed to be seen immediately. The nurse (identified as Staff BB ED Triage Nurse) informed the family that they could not tell the family member to take the patient to another hospital, encouraged them to stay, but expressed her understanding that a 3 to 4 hour wait was too long for a child. The family member confirmed they signed a form to refuse treatment. e. On 5/1/24 11:26 PM Patient #37 arrived at a second hospital ED, Hospital SS via private vehicle. f. On 5/1/24 at 11:30 PM, Staff RR, ED RN, Triage Note-“(Patient #37) had tonsillectomy/adenoidectomy and tubes placed 4/22/24 with pediatric ENT Staff PP. Last night, the patient had a little bleeding but stopped, tonight the patient had another episode of bleeding that was worse.” g. On 5/2/24 at 12:48 AM, Staff QQ ED Physician documented the following: “(Patient #37) presented after tonsils and adenoids removed on 4/22/24, late last night (Patient #37) had a small amount of post tonsillar bleeding, resolved spontaneously, seems to be doing fine, tolerating P.O. (by mouth) today, took Ibuprofen, however this evening woke after another episode of bleeding, blood in the naris (nose), large blood clot was spit out of the mouth, however bleeding is now stopped, recommended to go to the emergency department by Ear Nose and Throat (ENT) for evaluation and potentially IV fluids. Previous treatment: outpatient surgery. Post op course: Fluctuating. Incision complaints: moderate Bleeding. Risk factors consist of age. Therapy today: none. MSE completed.” PLAN: “(Patient #37) with post tonsillar bleed, appears not to be bleeding currently, will keep an eye on (Patient #37) in the ED, patient appears pale, recommendation from ENT to get IV(intravenous) fluids, will place IV, do screening blood work (complete metabolic profile (CMP), complete blood count (CBC) with differential) and give Dextrose 5% and Sodium Chloride 0.9% with Potassium Chloride 20 milliequivalents per liter (mEq/L) per 1000 mL(milliliters)- 250 cc(cubic centimeters) bolus.” h. On 5/2/24 4:15 AM Staff QQ ED Physician documented Physician Notes as follows: “Patient with no further bleeding in the emergency department however is profoundly anemic with hemoglobin 7.3 (normal 11.5-13.5; indicative of anemia or low blood volume), discussed with ENT and will admit to PEDS (pediatric) Hospitalist, type and screen pending, ENT will see in the a.m. and reevaluate.” i. On 5/2/24 at 4:28 AM, Staff PP ENT documented the following progress notes: “(Patient #37) was admitted earlier this morning with a postoperative bleed. We are evaluating Patient #37 today to assess how they have done over the course of the day. Patient #37 has been doing quite well and has had no further bleeding. There have been no concerns regarding their airway since admission. I spoke to the family a couple of nights ago and noted that Patient #37 had a brief bleed at that time, but we had followed up that morning and they had no further issues. It was only in the middle of the night that they began bleeding again at which time the family brought them in. Again, the last 12 hours have been uneventful. Patient 37 has had no further bleeding or concerns. Patient #37 is feeding and doing quite well. We will monitor them overnight and see how Patient #37 does. If there is no further bleeding tomorrow depending on how they are feeling and the family is comfortable, we will start considering discharge home. Order for Pediatric Admission placed.” 13. During an interview, on 5/9/24 at 8:10 AM, Staff BB ED RN (West campus ED triage nurse), recalled the patient. Staff BB reported they recalled that “it was a very busy evening” and they believed “the wait times were getting to be long”. Staff BB reported the patient had a little bit of blood on their pajamas or in their hair. Family said the bleeding had stopped. Staff BB did not remember seeing the patient bleeding. The family never asked for a tissue or notified staff that the bleeding had started again. Staff BB explained that if the patient’s condition worsened, she would have called the charge nurse to direct Staff BB to get the patient seen immediately by a provider. Staff BB, did ask the charge nurse what acuity level the patient should be, and Staff BB reported the charge nurse told her a Level 3. Level 3 would be brought back before a Level 4 patient. Since the waiting room was busy there was a PCT rounding for the patient’s vitals. The PCT documents those vitals in the patients’ electronic records. When asked if they explained to the family that the patient had a possible EMC and should stay and let the patient to be seen, Staff BB responded that they encouraged them to stay to see a provider. When the family asked how long it would be before the patient could be seen, Staff BB reported they told the family that wait times were always changing and they could not provide that information. Staff BB reported they explained the Refusal of Medical Treatment form and had a family member sign it. 14. During an interview, on 5/9/24 at 8:40 AM, Staff CC ED RN (West Campus ED Triage nurse), recalled Patient #37 and recalled that night (5/1/24) being horribly busy. Staff CC ED RN explained there were a lot of patients boarding (in the ED) and no beds were opening up. Staff CC ED RN recalled the family came up to the desk voicing their frustration, because their provider told them to rush the child in and then they had to wait for their child to be seen. The family said they were going to take the patient to a different ED. Staff CC ED RN reported that Staff BB explained that Patient #37 needed to be seen, but if they were leaving they could sign the Refusal of Medical Exam form. The family did sign the form. Staff CC ED RN did not recall staff stating a time frame for the wait to be seen by a provider. Staff usually state that they cannot give an estimate of the time frame, and patient were taken into the ED rooms according to their acuity level. The Hospital failed to provide Patient #16, #17 and #37 with a timely and appropriate MSE. Patient #16, a pregnant patient, presented to the ED on 3/31/24 with back pain. Patient #16 was sent to another ED location on the hospital’s campus without a triage and screening exam. Patient #17 presented to the ED on 11/24/2023 with weakness and stroke symptoms. Hospital ED staff sent Patient #17 to the ED waiting area while the patient’s symptoms got increasingly worse. Patient #17 remained in the ED waiting area for 7 hours, and did not receive an examination by a healthcare provider until more than 7 hours after arriving at the ED. Patient #37, a pediatric patient, presented to the ED with family on 5/1/24 with post surgical bleeding. The family left with Patient #37 without being seen by a provider due to long wait times and fear for their child’s imminent health.”

“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: 49848 Based on medical record review, hospital policy review, family and staff interviews, the Hospital’s administrative staff failed to ensure emergency department (ED) staff provided appropriate and timely stabilizing treatment for 2 of 21 sample patients (Patient #17 and Patient #37) that had an emergency medical condition (EMC) and presented to the ED seeking medical care from 12/1/23 to 5/1/24. Failure to provide all patients with the appropriate and timely stabilizing treatment placed patients at risk for a worsening emergency medical condition and at a potential risk for death. Findings include: 1. Review of policy, “Transfer and Emergency Examination-EMTALA,” last revised 9/21, revealed in part: . “ ... Stabilize-To 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 a facility; or with respect to a woman in Labor, to deliver (including the placenta)” ... “...Medical Screening Examination in Emergency Department ...” 2. Patient #17 medical record review and family interview revealed the following: a. On 6/3/24 at 1:00 PM, during an interview, a family member reported the patient complained of weakness and an inability to lift themselves out of the bathtub. Family called 911, and emergency medical services (EMS) took the patient to the hospital’s downtown campus ED. Family reported they arrived at the hospital at 1:00 PM; they found the patient sitting unaccompanied, in a wheelchair in the ED waiting room. Per family interview, Patient #17 appeared lethargic, a little sleepy, slightly disoriented, sitting hunched over and the patient’s head was down. The family member recalled the patient told them that the patient’s left side was losing more sensation 15-20 minutes after the family member’s arrival at the ED. The family reported that there were approximately 25-35 additional people in the ED waiting area. A hospital staff (Patient Care Technician-PCT) came out and took the patients’ blood pressure two or three times while the patient was in the ED waiting room. The family member reported that the first time the PCT took the patient’s blood pressure, the patient told the PCT that they could not feel their left side. The PCT stated she would mention the concern to staff. The family member reported “a gal” came out to take the patient to get some blood work completed between 3-5 PM. The patient told the female staff person that got the patient for blood work about not being able to feel the left side. The PCT came and took VS again and patient #17 again stated that the patient could not feel the left side and felt worse. The family member reported that at about 7:00 PM that night, hospital staff wheeled the patient into an exam room. Fairly soon after the patient got into the exam room, hospital staff took the patient for a CT scan. b. On 1/8/24 at 11:57 AM, Patient #17 arrived at the hospital ED by ambulance emergency medical services (EMS) with a complaint of syncope (brief loss of consciousness). The EMS trip report indicated the patient had the following abnormally high blood pressures (BPs) : 176 (systolic)/72 (diastolic) at 11:22 AM; 167/86 at 11:30 AM; 203/148 at 11:40 AM; 185/149 at 11:47 AM; and 169/64 at 11:53 AM. c. On 1/8/2024 at 12:17 PM, Staff W ED RN initiated triage. At 12:19 PM, Staff W ED RN documented, vital signs (VS) as follows: temperature 36.4 degrees Celsius (C), 97.5 degrees Fahrenheit (F); heart rate 67 beats per minute (bmp); respiratory rate (RR) 16 breaths per minute; oxygen saturation (O2 Sat) 98% on room air; blood pressure (BP) 138/109 millimeters of mercury (mmHg). Patient #17 denied any pain. d. On 1/8/24 at 12:19 PM Staff W ED RN documented Patient #17 reported to have been sick for the past four weeks and today was too weak to get out of bed to go to a doctor appointment. Patient #17 reported being unable to eat much, or at all, and thought they lost quite a bit of weight. e. On 1/8/2024 at 4:03 PM Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70 pm; O2 sat 99% on room air; BP 152/80. f. On 1/8/2024 at 6:25 PM, Staff S ED PCT documented the following VS: temperature 36.3 degrees C, 97.4 degrees F; HR 70; RR 16; O2 sat 97% on room air; BP 180/106 mmHg. Staff S ED PCT noted she notified the triage nurse of Patient #17’s elevated BP reading, 180/106. g. On 1/8/24 at 6:54 PM, Staff Y ED RN documented they placed Patient #17 in a fast track (FT) room. ED staff ordered labs including complete blood count (CBC) with differential, complete metabolic panel (CMP), urinalysis (UA), respiratory film array panel and Covid testing. h. On 1/8/24 at 6:56 PM, Staff Y ED RN documented a neurological assessment and determined the patient was displaying stroke-like symptoms including arm drifting, slurred or inappropriate words; talking like the patient’s mouth was full of food, left hand grip weak, left foot dorsiflexion and plantar flexion weak and decreased left lower extremity sensation (symptoms indicative of a stroke). Staff Y ED RN documented the patient failed the stroke screening assessment and the nurse ordered the patient to be nothing by mouth (NPO) and ordered a bed-side swallow study. i. On 1/8/2024 at 7:00 PM, Staff Y ED RN documented vital signs which included an elevated blood pressure of 182/98. j. On 1/8/2024 at 7:20 PM, Staff T ED ARNP and documented that around 11:00 AM today (1/8/24) the patient noticed weakness in left arm and leg. The patient’s family member said the patient was quite a bit worse than over the past several weeks. The patient stated the patient could not make a fist or lift the patient’s left leg; the left leg felt heavy. k. On 1/8/24 at 7:40 PM, Staff T ED ARNP completed the stroke scale and placed orders for chest x ray and computed tomography (CT) of the head with contrast, stroke alert only, CT angiography of the head. l. At 7:42 PM Staff Y ED RN documented Stroke Activation by Staff T ED ARNP. m. On 1/8/24 at 7:51 PM, hospital staff completed the CT of head and CT angiography. n. On 1/9/24 at 7:57 AM, Staff X Hospitalist documented Patient #17’s history (hx) of diabetes mellitus type 2 (DM 2), obstructive sleep apnea (OSA), gastroesophageal reflux disorder (GERD), hypertension (HTN), cerebral vascular accident (CVA), anxiety/depression, benign prostatic hypertrophy (BPH) and noted Patient #17 admission on 1/8/24 with bilateral strokes. They further noted Patient #17 presented following four weeks of weakness with acute worsening of left-sided weakness. A head computed tomography (CT) was unremarkable. Computed tomography angiography (CTA) of the head and neck showed no large vessel occlusion (LVO) but noted multifocal areas of mild to moderate arterial narrowing of the posterior circulation. A magnetic resonance imaging (MRI) showed infarct (stroke) of the right pons, left posterior limb of the internal capsule/left anterior thalamus, left temporal periventricular parenchyma. Patient was on Plavix prior to arrival; Aspirin was added to the regimen. o. On 1/9/24 at 3:06 PM, Staff HH Neurologist documented Patient # 17’s history of a right corona radiata ischemic stroke, memory problems, under control diabetes, hypertension and hyperlipidemia. Staff HH Neurologist noted Patient #17 presented to the ED for evaluation of left-sided weakness. The patient’s last well known normal was 11:00 AM on 1/8/2024. Staff HH Neurologist documented Patient #17 was out of the window for thrombolytics. A CTA (scan) of the head and neck showed no evidence of LVO (large vessel occlusion). An MRI showed Patient #17’s brain demonstrated acute to subacute infarct in right pons, left posterior limb of internal capsule/anterior thalamus and left temporal periventricular parenchymal. Staff HH Neurologist noted Patient #17 scored 10 on the National Institute of Health Stroke Scale (NIHSS)(subtle left facial droop, left arm and leg drift, sensory changes). Patient #17 took Plavix prior to admission. Staff HH Neurologist, ordered the following: - P2Y12 platelet function assay and Transesophageal Echocardiogram (TEE) for further evaluation - Continued dual antiplatelet therapy (DAPT) for the time - Continued Atrovastatin (medication to lower blood cholesterol levels) 80 mg orally nightly - Follow-up P2Y12 results - Allowed permissive hypertension with goal LDL (type of blood cholesterol level)<70 and HbA1c (type of blood test related to blood sugar levels)<7 - Physical therapy (PT), occupational therapy (OT) and speech therapy (ST) -Stroke education He further noted Patient #17 likely needed a 30-day cardiac event monitor at discharge and follow up with Neurology would occur the next day. 3. During an interview, on 5/8/24 at 2:30 PM, Staff W ED RN explained the different levels of triage, noting patients were given a triage level 1-5, 1 being the highest acuity level and 5 being minor. Staff W/ED RN, recalled triaging Patient #17 and determined an acuity level 3 due to weakness. Patient #17 was returned to the waiting room following triage. ED staff should have checked Patient #17’s VS every two hours based on the identified acuity level 3 per Staff W. 4. During an interview, on 5/8/24 at 9:30 AM, Staff S ED PCT explained patients were assigned an acuity level following triage. Patient’s assigned a level 3 acuity and sent to the waiting room required vitals completed every two hours. Staff S/ED PCT, further explained if the ED was busy with 30 or more patients, staff prioritized by acuity level and completed higher levels first. If extremely busy, staff should call back to the shift lead to request help to ensure everyone received appropriate care and vital signs. If a patient had a different or additional complaint VS should be taken and reported to the triage nurse. 5. A review of daily patient census and staffing schedule revealed the total patient census for the ED on 1/8/24 was 118 patients. From 11:00 AM until 4:00 PM, while Patient #17 waited in the ED, 20 patients arrived. Review of Patient #17’s medical record, dated 1/8/24, revealed an approximately 3.5 hour void in documentation of VS on Patient #17. 6. During an interview, on 5/14/24 at 10:00 AM, Staff Y ED RN recalled staff brought Patient #17 to a Fast Track (FT) bed. Staff Y reported they noted changes with Patient #17’s VS, specifically elevated BP and neurological assessment for stroke symptoms. Staff Y ED PCT informed Staff T ED ARNP of the concerns. Staff Y ED RN, recalled they took Patient #17 to obtain a CT, and the CT was positive. Staff T ED ARNP, then called the stroke alert. Patient #17 was outside of the window to receive Thrombolytics (TPA) therapy. Staff Y ED RN, stated “Patient #17 then moved to a room for higher acuity level of care.” 7. During an interview, on 5/7/24 at 11:30 AM, Staff T ED ARNP recalled examining Patient #17 in a FT bed and asking Staff U ED Physician, to further evaluate the patient. Patient #17 was moved to a room for higher acuity level of care in the ED. Staff T ED ARNP and Staff U ED Physician, called the stroke alert at 7:42 PM, and Staff U ED Physician, became the primary physician, implementing stroke protocol. Patient #17’s care was turned over to internal medicine, as the patient was admitted to the hospital. 8. During an interview, on 5/7/24 at 1:05 PM, Staff U ED Physician recalled being asked to verify findings on Patient #17 and speak with the patient and family. Staff U ED Physician became involved in Patient #17’s care and moved the patient into a room around 7:00 PM, due to his higher acuity level. 9. During an interview, on 5/8/24 at 8:10 AM, Staff X Physician of Internal Medicine recalled they saw patient #17 the second day, following Staff P admitted the patient. They explained standing orders for a typical stroke protocol included imaging, management of BP, platelet therapy, and anticoagulation therapy. Patient #17 had Bilateral strokes during inpatient admission, while waiting for rehab therapy recommendations and admission. A bed request was put in at the time of admission, but they could not recall if the patient had left the ED yet. Staff X Physician, could not confirm the patient boarded in the ED while waiting for a bed to become available in therapy and a rehab admission. 10. During an interview, 5/14/24 at 3:00 PM, Staff HH Neurologist recalled they saw Patient #17 and, as a supervising physician, also oversaw resident notes. Staff HH Neurologist, further recalled confusion amongst the staff and physicians regarding exact time of onset Patient #17’s symptoms of dizziness and confusion. Patient #17 arrived at the ED reporting symptoms had been on-going for days to weeks prior. Staff HH Neurologist, explained TPA therapy should be initiated within a 4.5 hours’ time frame, unless the exact time of symptom onset was known. Due to ongoing weakness and not knowing the actual onset of symptoms, the decision to initiate TPA therapy was difficult. The patient’s report of four weeks of symptoms put Patient #17 outside the TPA therapy window. 11. Review of Patient #37, a pediatric patient, medical record revealed the following: a. On 5/1/24 at 9:30 PM, Staff CC ED RN and Staff BB ED RN documented the following: “Arrive to Methodist West ED via private vehicle...chief complaint post-op problem (Patient #37) underwent a tonsillectomy and adenoidectomy (T&A) on 4/22/24 by pediatric Ear Nose and Throat (ENT) physician...Patient woke up covered in blood on 4/30 (4/30/24) and the ENT physician told them if the bleeding stops that is okay, but if reoccurred to come to the ED. Patient woke up again tonight (5/1/24) covered in blood. Bleeding from the throat has stopped since the patient arrived in the ED. Family reports no new spitting up of blood.” b. On 5/1/24 at 9:46 PM, Staff CC ED RN and Staff BB ED RN documented a triage assessment on Patient #37 as follows: vital signs (VS) were heart rate (HR) 142 beats per minute (bpm- elevated), respirations 22 per minute, BP- 99/58, oxygen saturation level of 100%, wt (weight)-25 lbs (pounds), temp 98.6 (degrees Fahrenheit). c. On 5/1/24 10:56 PM, ED staff documented, “Family signed Refusal of Medical Screening Exam; “too long of wait for treatment”. d. On 5/8/24 at 4:00 PM, during an interview, a family member reported they asked a person at the front desk how long of a wait it would be, and the front desk told the family member there was a 3 to 4 hour wait for a bed (exam room). The family member asked a nurse if they should take the patient to another hospital, as they had been told by the ENT surgeon that the patient needed to be seen immediately. The nurse (identified as Staff BB ED Triage Nurse) informed the family that they could not tell the family member to take the patient to another hospital, encouraged them to stay, but expressed her understanding that a 3 to 4 hour wait was too long for a child. The family member confirmed they signed a form to refuse treatment. e. On 5/1/24 11:26 PM Patient #37 arrived at a second hospital ED, Hospital SS via private vehicle. f. On 5/1/24 at 11:30 PM, Staff RR, ED RN, Triage Note-“(Patient #37) had tonsillectomy/adenoidectomy and tubes placed 4/22/24 with pediatric ENT Staff PP. Last night, the patient had a little bleeding but stopped, tonight the patient had another episode of bleeding that was worse.” g. On 5/2/24 at 12:48 AM, Staff QQ ED Physician documented the following: “(Patient #37) presented after tonsils and adenoids removed on 4/22/24, late last night (Patient #37) had a small amount of post tonsillar bleeding, resolved spontaneously, seems to be doing fine, tolerating P.O. (by mouth) today, took Ibuprofen, however this evening woke after another episode of bleeding, blood in the naris (nose), large blood clot was spit out of the mouth, however bleeding is now stopped, recommended to go to the emergency department by Ear Nose and Throat (ENT) for evaluation and potentially IV fluids. Previous treatment: outpatient surgery. Post op course: Fluctuating. Incision complaints: moderate Bleeding. Risk factors consist of age. Therapy today: none. MSE completed.” PLAN: “(Patient #37) with post tonsillar bleed, appears not to be bleeding currently, will keep an eye on (Patient #37) in the ED, patient appears pale, recommendation from ENT to get IV(intravenous) fluids, will place IV, do screening blood work (complete metabolic profile (CMP), complete blood count (CBC) with differential) and give Dextrose 5% and Sodium Chloride 0.9% with Potassium Chloride 20 milliequivalents per liter (mEq/L) per 1000 mL(milliliters)- 250 cc(cubic centimeters) bolus.” h. On 5/2/24 4:15 AM Staff QQ ED Physician documented Physician Notes as follows: “Patient with no further bleeding in the emergency department however is profoundly anemic with hemoglobin 7.3 (normal 11.5-13.5; indicative of anemia or low blood volume), discussed with ENT and will admit to PEDS (pediatric) Hospitalist, type and screen pending, ENT will see in the a.m. and reevaluate.” i. On 5/2/24 at 4:28 AM, Staff PP ENT documented the following progress notes: “(Patient #37) was admitted earlier this morning with a postoperative bleed. We are evaluating Patient #37 today to assess how they have done over the course of the day. Patient #37 has been doing quite well and has had no further bleeding. There have been no concerns regarding their airway since admission. I spoke to the family a couple of nights ago and noted that Patient #37 had a brief bleed at that time, but we had followed up that morning and they had no further issues. It was only in the middle of the night that they began bleeding again at which time the family brought them in. Again, the last 12 hours have been uneventful. Patient 37 has had no further bleeding or concerns. Patient #37 is feeding and doing quite well. We will monitor them overnight and see how Patient #37 does. If there is no further bleeding tomorrow depending on how they are feeling and the family is comfortable, we will start considering discharge home. Order for Pediatric Admission placed.” 12. During an interview, on 5/9/24 at 8:10 AM, Staff BB ED RN (West campus ED triage nurse), recalled the patient. Staff BB reported they recalled that “it was a very busy evening” and they believed “the wait times were getting to be long”. Staff BB reported the patient had a little bit of blood on their pajamas or in their hair. Family said the bleeding had stopped. Staff BB did not remember seeing the patient bleeding. The family never asked for a tissue or notified staff that the bleeding had started again. Staff BB explained that if the patient’s condition worsened, she would have called the charge nurse to direct Staff BB to get the patient seen immediately by a provider. Staff BB, did ask the charge nurse what acuity level the patient should be, and Staff BB reported the charge nurse told her a Level 3. Level 3 would be brought back before a Level 4 patient. Since the waiting room was busy there was a PCT rounding for the patient’s vitals. The PCT documents those vitals in the patients’ electronic records. When asked if they explained to the family that the patient had a possible EMC and should stay and let the patient to be seen, Staff BB responded that they encouraged them to stay to see a provider. When the family asked how long it would be before the patient could be seen, Staff BB reported they told the family that wait times were always changing and they could not provide that information. Staff BB reported they explained the Refusal of Medical Treatment form and had a family member sign it. 13. During an interview, on 5/9/24 at 8:40 AM, Staff CC ED RN (West Campus ED Triage nurse), recalled Patient #37 and recalled that night (5/1/24) being horribly busy. Staff CC ED RN explained there were a lot of patients boarding (in the ED) and no beds were opening up. Staff CC ED RN recalled the family came up to the desk voicing their frustration, because their provider told them to rush the child in and then they had to wait for their child to be seen. The family said they were going to take the patient to a different ED. Staff CC ED RN reported that Staff BB explained that Patient #37 needed to be seen, but if they were leaving they could sign the Refusal of Medical Exam form. The family did sign the form. Staff CC ED RN did not recall staff stating a time frame for the wait to be seen by a provider. Staff usually state that they cannot give an estimate of the time frame, and patient were taken into the ED rooms according to their acuity level. The Hospital failed to provide Patient #17 and #37 with the appropriate stabilizing treatment. Patient #17 presented to the ED on 11/24/2023 with weakness and stroke symptoms. Hospital ED staff sent Patient #17 to the ED waiting area while the patient’s symptoms got increasingly worse. Patient #17 remained in the ED waiting area for 7 hours, and did not receive an examination by a healthcare provider until more than 7 hours after arriving at the ED; this resulted in a delay in stabilizing treatment for the patient’s EMC. Patient #37, a pediatric patient, presented to the ED with family on 5/1/24 with post surgical bleeding. The family left with Patient #37 without being seen by a provider due to long wait times and fear for their child’s imminent health.”

“DELAY IN EXAMINATION OR TREATMENT CFR(s): 489.24(d)(4-5) (4) Delay in treatment. (i) A participating hospital may not delay providing an appropriate medical screening examination required under paragraph (a) of this section or further medical examination and treatment required under paragraph (d)(1) of this section in order to inquire about the individual’s method of payment or insurance status. (ii)A participating hospital may not seek, or direct an individual to seek, authorization from the individual’s insurance company for screening or stabilization services to be furnished by a hospital, physician, or nonphysician practitioner to an individual until after the hospital has provided the appropriate medical screening examination required under paragraph (a) of this section, and initiated any further medical examination and treatment that may be required to stabilize the emergency medical condition under paragraph (d)(1) of this section. (iii) An emergency physician or nonphysician practitioner is not precluded from contacting the individual’s physician at any time to seek advice regarding the individual’s medical history and needs that may be relevant to the medical treatment and screening of the patient, as long as this consultation does not inappropriately delay services required under paragraph (a) or paragraphs (d)(1) and (d)(2) of this section. Hospitals may follow reasonable registration processes for individuals for whom examination or treatment is required by this section, including asking whether an individual is insured and, if so, what that insurance is, as long as that inquiry does not delay screening or treatment. Reasonable registration processes may not unduly discourage individuals from remaining for further evaluation. A hospital meets the requirements of paragraph (d)(1)(ii) of this section with respect to an individual if the hospital offers to transfer the individual to another medical facility in accordance with paragraph (e) of this section and informs the individual (or a person acting on his or her behalf) of the risks and benefits to the individual of the transfer, but the individual (or a person acting on the individual’s behalf) does not consent to the transfer. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of a person acting on his or her behalf). The written document must indicate the person has been informed of the risks and benefits of the transfer and state the reasons for the individual’s refusal. The medical record must contain a description of the proposed transfer that was refused by or on behalf of the individual. This Standard is not met as evidenced by: 27303 Based on document review, policy review and staff interview, the acute care hospital emergency department staff failed to ensure that 1 of 21 patients who presented for emergency medical care (Patient # 44) did not experience a delay in medical examination and treatment in order to inquire about payment and failed to ensure the patient was not unduly discouraged from remaining for further evaluation during the registration process. Failure to delay requesting payment for the medical care until after the patient had received stabilizing treatment could potentially result in the patient deciding to discontinue receiving stabilizing treatment due to concerns regarding the cost of their medical care. The hospital’s administrative staff identified that an average of 287 patients presented to the emergency department each month and requested an emergency medical screening examination and stabilizing treatment. Findings include: Review of the policy titled “Transfer and Emergency Examination - EMTALA,” revised 9/2021, revealed in part, “Prohibitions on actions discouraging examination or treatment. Hospital and hospital staff will not discourage individuals presenting to the hospital’s Dedicated Emergency Department from seeking emergency care or treatment. Hospital staff will not request or demand that Dedicated Emergency Department (DED) patients pay co-pays or any monies prior to receiving screening or treatment for an Emergency Medical Conditions [sic]. Hospital will not allow any debt collection activities either directly by hospital staff or through contracted debt collection entities that would interfere with the provision of any emergency medical care without discrimination. 1. Review of Patient #44’s medical record revealed the following on 2/5/24: a. at 10:04 AM, Patient #44 presented to the hospital’s Dedicated Emergency Department (DED) complaining right sided abdominal pain. b. at 10:05 AM, Registered Nurse (RN) WW began triaging Patient #44 and documented that Patient #44 was complaining of 8 out of 10 (with 10 being the worst pain imaginable) pain in Patient #44’s right side. c. at 10:30 AM, RN XX took Patient #44 to ED Room #4 and continued assessing Patient #44. RN XX documented that Patient #44 had a personal history of kidney stones and was complaining of pain starting on the right side of their back and the pain radiated around towards the front of Patient #44’s body. d. at 10:32 AM, Physician’s Assistant (PA) YY assessed Patient #44 and ordered an abdominal/pelvis CT scan and laboratory testing on Patient #44. PA YY also ordered Patient #44 to receive 1,000 ml of intravenous fluids and 15 mg of toradol (a non-steriodal anti-inflammatory pain medication similar to ibuprofen). e. at 10:45 AM, RN ZZ started an intravenous (IV) line and administered the IV fluids and toradol to Patient #44. f. at 10:47 AM, Patient #44’s medical record indicated that the hospital staff began the registration process. g. at 11:25 AM, Patient #44 underwent the CT scan. Radiologist AAA (a physician with specialized training to interpret radiology tests) diagnosed Patient #44 with a 3 mm kidney stone in their right ureter (a small tube between the kidney and bladder). Patient #44 also had several other kidney stones in both kidneys. h. at 11:37 AM, PA YY ordered Patient #44 to receive 50 micrograms of fentanyl (a opioid pain medication) once, 4 mg of ondansetron (a medication to relieve nausea), and an additional 1,000 ml of intravenous fluids. PA YY also ordered that Patient #44 could receive an additional 25 micrograms of fentanyl every hour, as needed, for pain control. i. at 11:40 AM, RN ZZ administered the ordered medications to Patient #44. j. at 11:53 AM, Radiologist AAA completed the documentation for Patient #44’s CT scan and transmitted the results to PA YY. k. at 12:41 PM, Patient #44’s medical record indicated that the hospital staff completed the registration process. l. at 1:49 PM, PA YY ordered RN ZZ to administer tamsulosin (a medication to help pass kidney stones) to Patient #44. m. at 1:53 PM, RN ZZ documented they administered the tamsulosin to Patient #44. n. at 1:53 PM, the laboratory staff transmitted the results from Patient #44’s urinalysis to PA YY. o. at 1:58 PM, RN ZZ documented that Patient #44’s pain had decreased from 8 out of 10 to 4 out of 10, but also documented Patient #44’s pain as “High.” p. at 2:14 PM, PA YY ordered the emergency department staff to discharge Patient #44 home. q. at 2:16 PM, Patient #44’s discharge instructions included that PA YY had prescribed Hydrocodone to Patient #44 and that Patient #44 received fentanyl (an opiod pain medication). The discharge instructions contained information on “Opioids Discharge Instructions” that included “Opioids or other medications that contain them include: ... Hydrocone (Norco)...” The Opioids Discharge Instructions indicated that Patient #44 should “Be Cautious. Opioids may affect your judgement and decision making. Do not drive or operate heavy machinery while you take them.” r. at 2:21 PM, RN ZZ administered an additional 25 micrograms of fentanyl, as needed, to Patient #44. RN ZZ discharged Patient #44 home 4 minutes later. RN ZZ did not document Patient #44’s pain prior to administering the 25 micrograms of fentanyl, nor did RN ZZ document Patient #44’s pain after receiving the fentanyl. 2. During an interview on 5/20/2024 at 12:00 PM, Patient #44 revealed that they presented to the hospital complaining of severe right sided abdominal pain, with their family member. The nursing staff and physician’s assistant assessed Patient #44 and ordered medication to relieve Patient #44’s pain. After the physician’s assistant had evaluated Patient #44, and after the nurse had administered fentanyl to Patient #44, a Patient Access Representative (PAR) came into Patient #44’s emergency department room and began asking questions. After the PAR updated Patient #44’s insurance information, the patient stated,”the patient access person said that I needed to pay $340. I think I said “what?” They said that I needed to pay them $340...I was thinking the ED copay was $50. They kept saying that I needed to pay $340 and that payment needs to be made or care could be stopped. the patient access person said that I needed to pay $340. I think I said “what?” They said that I needed to pay them $340. Since I have had the same insurance for 20 years, I was thinking the ED copay was $50. They kept saying that I needed to pay $340 and that payment needs to be made or care could be stopped. Eventually I paid them the $50 copay I thought I owed. I felt intimidated because they said that they could stop my care.” Then, a nurse came into Patient #44’s room. The nurse asked if there was a problem and Patient #44 told the nurse that the PAR staff member insisted that Patient #44 had to pay something. The nurse then said, “welcome to American healthcare. Everyone wants to get paid. The insurance company wants to get paid, the doctor wants to get paid, and the hospital wants to get paid.” Patient #44 stated, “She was very bullying. It was nuts... I felt threatened and it wasn ’ t appropriate.” 3. During an interview on 5/20/24 at 3:25 PM, Patient #44’s Family Member, a healthcare professional, revealed that they accompanied Patient #44 to the hospital, as they believed Patient #44 had a kidney stone. After Patient #44 received the first dose of fentanyl, a Patient Access Registration (PAR) staff member knocked on Patient #44’s emergency room door. Initially, the system indicated that Patient #44’s insurance had expired, but Patient #44’s Family Member found an updated insurance card in Patient #44’s wallet. Once the PAR entered the updated information in the system, the Family Member reported the hospital’s system indicated that Patient #44 “owed an odd amount, like $267.00.” The PAR explained that since Patient #44 had testing and other procedures, Patient #44 would owe more than Patient #44 thought. The PAR informed Patient #44 and Patient #44’s Family Member that, unless Patient #44 paid at least 10 percent of what the system thought Patient #44 owed, Patient #44’s care could be stopped. Patient #44’s nurse came in after the PAR left the room. When Patient #44’s Family Member informed the nurse that the PAR demanded payment, the nurse responded, “welcome to American healthcare. Everyone wants paid. The insurance wants paid and the doctor wants paid.” 4. Review of Patient #44’s “Account History Report,” printed on 5/21/24 and provided by the hospital staff, revealed the following information: a. at 12:56 PM, Patient Access Representative (PAR) UU documented “[Patient’s family member] was upset that I asked for signature and payment she said we shouldn’t ask for it and paid $50 down towards but I need to bring RN to explain to them process because they were so unhappy about the payment.” b. at 1:09 PM, PAR UU documented that RN ZZ assisted PAR UU with explaining the financial situation to Patient #44 and their family member. 5. Review of the undated presentation slide titled “EMTALA Cornerstone Training Slide” revealed the following, “... providers and staff will not discourage individuals presenting to the hospital’s dedicated emergency department from seeking emergency care or treatment. Further review of the document revealed, “Hospital staff will not demand that dedicated emergency department patients pay copays or any monies prior to receiving screening or treatment for emergency medical conditions. Hospital will not allow any debt collection activities either directly by hospital staff, ... that would interfere with the provision of any emergency medical care ...” 6. Review of the undated presentation “Point of Service Collection Training” slides revealed the following, a. “Collection Opportunities ... Past Balances ... Take this opportunity to educate the patient about their past balances. Ask them what they would like to pay towards the balance.” b. if the patient requested the hospital staff “just bill me,” the staff are instructed “Take this opportunity to negotiate if needed.” The slide provides the suggested response, “We do require payment on date of service. What can you pay towards the visit today?” c. if the patient had a past due balance, the staff are instructed to indicate “You have an outstanding balance of ... We accept cash, checks, and all major credit cards.” d. if the patient indicated that they can not pay the full amount the system indicates they need to pay, the staff are instructed to negotiate with the patient, including asking if the patient can pay 50 percent of the amount due. If the patient, the staff are instructed to see if the patient can pay 25 percent of the amount due. If the patient can’t pay that amount, the staff are instructed to offer the patient other payment options, including asking “what can you pay towards your visit today?” e. if the patient indicated they did not have insurance, the staff are instructed to say “the estimate of today’s visit will be ... With the same day 20 percent discount, your estimate updates to ... How would you like to take care of that today?” 7. During an interview on 5/20/24 at 4:15 PM, Patient Access Representative (PAR) UU revealed that they registered Patient #44 after PA YY examined Patient #44. During the registration process, PAR UU obtained Patient #44’s insurance information and entered it into the hospital’s computer system. The hospital’s computer system provided an estimate of Patient #44’s out of pocket deductible, how much of the deductible Patient #44 had met, and how much Patient #44 still had to pay that year. The system also showed if Patient #44 owed a copay for the emergency department visit. PAR UU explained that all patients are required to pay the copayment amount for an emergency department visit. PAR UU is required to ask all patients for their copayment amount, explain why the patients owe their copayment, and ask if the patient can make the copayment. 8. During an interview on 5/22/24 at 3:25 PM, Patient Access Manager (PAM) M revealed that PAR UU called PAM M after PAR UU registered Patient #44 and indicated that Patient #44’s Family Member was upset that PAR UU had asked Patient #44 to make a payment while Patient #44 was still being treated in the emergency department. PAM M explained that while registering a patient in the emergency department, the Patient Access staff access the patient’s insurance information and create an estimate of how much the patient will need to pay for the emergency department visit, including how much the patient will owe. The Patient Access staff are required to ask the patients for payment of their emergency department visit copayment and any deductibles (amount of money the patient must pay out of their pocket before their health insurance starts paying) during the registration process. After providing the patient with an estimate of the costs from their emergency department visit (while the patient is still in the emergency department room), the Patient Accesses staff are required to ask how the patients would like to pay the anticipated out of pocket costs (which can exceed several hundred dollars). 9. During an interview on 5/22/24 at 3:40 PM, Patient Access Supervisor (PAS) VV revealed that when PAR UU registered Patient #44, PAR UU was required to create an estimate of Patient #44’s expected out of pocket costs (which can exceed several hundred dollars) for the emergency department visit and required to ask Patient #44 how Patient #44 wanted to pay the out of pocket costs. The PAR staff received training on scripting how they ask patients for money by asking how the patient would like to pay the estimated amount owed to the hospital or how can the patient take care of the amount owed to the hospital. PAS VV indicated they train the PAR staff to collect money in the emergency department, because the Patient Access group is part of the revenue cycle team, and thus, responsible for helping to collect money owed to the hospital.”

“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: 39445 Based on medical record review, hospital policy review and staff interviews, the hospital’s administrative staff failed to ensure the hospital’s emergency department (ED) staff followed hospital policies, ensuring 1 of 19 patients (Patient #10) selected for review, who presented to the hospital for emergency care from 4/1/23 through 10/22/23, received all appropriate stabilizing treatment. Failure to provide all appropriate stabilizing treatment at the ED resulted in Patient #10 eloping from the ED, which may have resulted in suicidal attempts, injury, or death. The hospital’s administrative staff identified an average of 1,973 patients per month who presented to the hospital’s dedicated emergency department and requested emergency medical care. Findings include: 1. Review of policy “TRANSFER AND EMERGENCY EXAMINATION - EMTALA”, dated 9/21, revealed in part, “... Individuals exhibiting signs and symptoms of a psychiatric condition...should be provided a Medical Screening Examination including a mental health screening exam and further treatment within the Capability and Capacity of the Emergency Department...” 2. Review of policy “MISSING OR WANDERING PATIENT-ADULT”, dated 6/22, revealed in part, “...Definitions At-Risk Patient...at-risk for harm to themselves...if not found and returned to a safe treatment environment if they were to...go missing from a care setting...Lack cognitive ability..(either permanently or temporarily) to make relevant decisions(e.g. ...intoxication)...Elopement:...leaves the department unauthorized before treatment is complete...”At-Risk” assessment is positive, patient will be placed under precautions and interventions initiated...patient changed into...pale green scrubs...for ED behavioral health patients so that all staff can easily identify a patient at risk...for leaving...Store “Triggers” such as clothing, shoes,...out of sight of the patient...Communicate with the entire care team on the unit that the patient is on precautions and at shift change that the patient is “At-Risk”...” 3. See A2407 The lack of hospital staff communication regarding the need to obtain a 48 hour hold should Patient # 10 attempt to leave the hospital, Patient #10’s assessable clothing, and shoes resulted in hospital staff allowing Patient #10 to leave the hospital prior to receiving a psychiatric re-assessment, completed medical screening exam, and all stabilizing treatment.”

“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: 39445 Based on document review and staff interviews, the hospital’s administrative staff failed to ensure 1 of 19 patients (Patient #10) selected for review, who presented to the hospital for emergency care from 4/1/23 through 10/22/23, received all appropriate stabilizing treatment. Failure to provide all appropriate stabilizing treatment at the Emergency Department (ED) resulted in Patient #10 eloping from the ED, which may have resulted in significant injury or death. The hospital’s administrative staff identified an average of 1973 patients per month who presented to the hospital’s dedicated emergency department and requested emergency medical care. Findings include: 1. See 2400 #1 and #2 2. Review of Patient #10’s medical record revealed: a. On 9/11/23 at 5:57 PM Patient # 10 presented to the ED intoxicated and with suicidal ideation. Police reported Patient #10 had called the police because they wanted to kill themselves and wanted treatment. b. On 9/11/23 at 6:03 PM Triage RN Q completed a Columbia Suicide Risk assessment that place Patient #10 at high risk for suicide. Patient #10 was subsequently moved to ED Room 11, placed on suicide precautions with 1:1 observation, assigned a sitter, and changed into hospital scrubs. c. On 9/11/23 at 6:08 PM Physician Assistant-Certified (PA-C) I medically evaluated Patient #10 and noted suicidal ideation (SI) with a plan to hang themselves under a bridge. Patient #10 reported intake of greater than 1000 milliliters (ml) of vodka and verbalized daily alcohol intake for more than 20 years. PA-C I documented Patient #10’s affect as labile, speech slurred, thought content without suicidal content or plan. PA-C I ordered screening lab work including a drug screen, ethanol level, inpatient consult to psychiatry, and a bed request. The drug screen returned positive for cannabinoids, ethanol level 0.45%. (legal limit for driving 0.08%). d. On 9/11/23 at 8:14 PM Psychiatric Resident Dr. M evaluated Patient #10 and documented, “unable to participate in safety planning due intoxicated state. Presented with symptoms of suicidal ideation in the context of recent alcohol use. Vital signs and lab findings are not concerning for acute life/limb threatening pathology. Acute concern for suicide, baseline/chronic risk for harm to self is elevated. Admit to psychiatry, recommend a 48 hour hold if patient attempts to leave AMA, while in ED recommend 1:1 Sitter for safety risk as well as acute intoxication.” e. Patient #10 slept throughout the night and remained on suicide precautions with 1:1 sitter observation. Patient #10 awakened at approximately 8:00 AM. f. On 9/12/23 at approximately 10:00 AM RN J documented patient #10 began to put on their clothes and stated they were leaving. RN J asked Patient #10 to stay due to the suicidal statements made. Patient #10 stated that the patient was not suicidal and the patient was leaving. RN J documented security and ED Dr. D notified. Patient #10 left the hospital. RN J also documented per Psychiatric Resident Dr. M’s note a 48 hold is recommended if patient attempted to leave facility. RN J documented that staff notified the local police department and the hospital Social Worker (SW) was obtaining as 48 hour hold. g. 9/12/23 at 10:15 AM ED Charge RN G documented “Pt becoming escalated d/t (due to) waiting in ED - in nurse’s station yelling that (the patient) wants to leave. ED staff and PSO (Patient Safety Officer) to bedside. Pt ran past staff and eloped from ED. (Local police department) notified and court order placed, awaiting pt return. ED leadership notified.” h. 9/12/23 at 10:04 AM ED DR. D documented, “ Patient #10 was signed out to him by ED Dr. F. The patient is awaiting placement/psychiatric evaluation. BP 117/73 | Pulse 76 | Temp 36.1 °C (96.9 °F) | Resp 16 | Ht 190.5 cm (6’ 3”) | Wt 81.6 kg (180 lb) | SpO2 97%...Patient became agitated and eloped. Declined SI to nurse prior to elopement. Police contacted by nursing. Court hold placed per psych recommendations.” 3. Review of “Incident Report” dated 9/12/23, completed by Public Safety Officer R, revealed in part, “...Incident Occurred Date 9/12/2023 at 1005...Incident Occurred End Date 9/12/2023 at 1006...Incident Discovered/Called in 9/12/2023 1004...Specific Location ER 11 WENT AMA LAST SEEN THRU PKG LOT WEST ON U... Report Synopsis/Overview AGAINST MEDICAL ADVICE RM 11, LATER DISCOVERED TO HAVE 48 HOUR COURT HOLD...while in are dealing with an unrelated event...heard yelling coming from ER 11...flagged down by nurse...needed help with patient in ER 11 who was trying to leave against medical advice...yelling “don’t [profanity] touch me”...I observed [Officer S] walking behind [Patient #10]...followed patient as...went north through the ER, onto the outer hallway and finally leaving the hospital through the ER entrance/exit. [Patient #10] was not detained... because we were informed there was no court order...hold...and was free to leave...After [Patient #10] had left the hospital, it was discovered that the doctor notes...recommended that a court order/hold should be obtained if [Patient #10] attempted to leave before being seen by a psychiatrist ...(the local) police were contacted and given...last direction of travel for an attempt to locate...” 4. During an interview on 10/31/23 at 12:00 PM, Triage RN Q reported they completed a Columbia Suicide Screening that placed Patient #10 at high risk for suicide. Patient #10 placed in ED room #11 and handed off care to RN H. 5. During an interview on 10/26/23 at 9:16 AM, RN H reported they assisted with triage of Patient #10 in room 11 and assigned a Patient Care Tech (PCT) for 1:1 observation suicide precautions. Patient #10 denied suicidal ideation at that time. 6. During an interview on 10/26/23 at 9:30 AM, PA-C I reported Patient #10 had come in with the police and the police told them Patient #10 wanted to hang themselves as an art demonstration under the bridge. Patient #10 denied suicidal ideation at the time of PA-C’s medical screening examination. PA-C I verbalized they didn’t feel comfortable that Patient #10 was not suicidal and that Patient #10 was pretty intoxicated. PA-C I ordered a psychiatric consult. A psychiatry resident did the psychiatric assessment. They recommended admission, so the patient had to sit in the ER until a bed is available. PA-C I acknowledged they read the psych consult note and talked with Psychiatric Resident Dr. M. If the patient attempted to leave, staff were to obtain a 48 hour hold; no hold was needed at the time of the consult. PA-C verbalized they verbally reported off to ED Dr. F at the end of their shift. PA-C I described the half page hand-off sheets utilized to relay patient information to the next provider. PA-C I reported they would have written 48 hour hold if patient tried to leave, but then stated they were not confident that information was documented or relayed to Dr. F. The report slips of paper are not kept. 7. During an interview on 10/31/23 at 9:25 AM, ED Dr. F reported they do not remember this patient at all as Patient #10 was asleep when they got them and Patient #10 was asleep when they left. ED Dr. F verbalized they had no recall of the hand off content. Hand off slips with pertinent patient information are utilized for report but these are not kept. Dr. F handed off to Dr D at change of shift, approximately 6 AM. 8. During an interview on 10/26/23 at 12:30 AM, Psychiatric Resident Dr. M reported they received the psychiatric consult for Patient #10 and attempted to complete the psychiatric evaluation. Dr. M acknowledged they read Patient #10’s medical record and attempted to talk with Patient #10. Patient #10 was unable to participate due to acute intoxication, the uncompleted assessment to be repeated the following day by another psychiatric provider. Dr. M verified they believed Patient #10 needed to be admitted due their back ground and desire to hang themselves while intoxicated. Admission orders placed, signed and held for later release, a bed request placed, if a bed is available they would go there. Dr. M recommended a 48 hour hold be obtained if Patient #10 attempted to leave prior to completion of a follow up psychiatric evaluation. Psychiatric Resident Dr. M placed the psychiatric recommendations in the medical record and attempted verbal communication with the provider. Dr. M reported they could not recall if they actually spoke with the provider in this case. 9. During an interview on 10/30/23 at 11:50 AM, PCT T reported they were told Patient #10 was on suicide precautions, fall risk, and elopement precautions but no court hold. Patient #10 was wide awake for a few hours then slept the whole night. PCT escorted Patient #10 to the bathroom in the hall by the nurses station once. PCT T verified that Patient #10 was in hospital scrubs but could not recall where Patient #10’s clothes were located, but added they were usually kept in a box just outside the of the room or with the nurse. 10. During an interview on 10/30/23 at 4:00 PM, RN P reported Patient #10 was pleasant and cooperative and had no problems during the night. 11. During an interview on 10/26/23 at 11:00 AM, Patient Care Technician (PCT) L reported they started their shift at approximately 7 AM and had received in report from PCT T that Patient #10 was on suicide precautions and had been intoxicated. Patient #10 had been very pleasant and cooperative that morning. Patient #10 requested to go to the bathroom so PCT L escorted Patient #10 to the bathroom in the hall by the nurses’ station. Upon return to ED room 11, Patient #10 reached down into the box outside ED room 11 door, where Patient #10’s clothes were kept, and stated they wanted to get their socks. PCT L replied no. Patient #10 responded yes, grabbed their bag of clothes and got dressed. RN J walked by and attempted to dissuade Patient #10 from leaving until seen by the provider. Patient #10 was adamant they were leaving. Security was called, it all happened quickly, not even 5 minutes and Patient #10 was gone. PCT L reported they did not know staff was to obtain a 48 hour hold if Patient #10 attempted to leave AMA. 12. During an interview on 10/26/23 at 10:00 AM, RN J reported they remembered Patient #10 coming out of their room that morning saying I am leaving, I am not suicidal, you can’t hold me. RN J claimed the interaction lasted about 5 seconds. RN J notified Dr. D and the public safety officer that Patient #10 was leaving the ED. RN J reported they were not aware of the psychiatric recommendation that a 48 hour hold be obtained if Patient #10 attempted to leave. RN J replied they were told in report that Patient #10 was intoxicated and they had come to the ED voluntarily. RN J verified Patient #10 had a 1:1 sitter continuously, and that RN J themselves did a suicide safety check at 7:15 AM and 8:00 AM, and provided medications at 8:52 AM and 8:53 AM. Patient #10 gave no indication they wanted to leave the ED prior 10:00 AM. RN J verified Patient #10’s clothes were in a green bag right outside ED room 11, visible to Patient #10 when they ambulated in and out of the ED room, such as when they went to the bathroom. 13. During an interview on 10/31/23 at 9:30 AM, Public Safety Officer (PSO) S reported they were at the Behavioral Health Access Center in the ED when he heard a bunch of yelling, cussing, and screaming. PSO walked over to the hallway area in front of ED room 11 to see what was going on and to make sure everyone was safe. The Patient #10 wanted to leave, was dressed in their clothes, and refused to listen to attempts to de-escalate and encouragement to stay until a provider could see them. PSO S verbalized they heard Dr. D say the patient could leave, so PSO S watched Patient #10 as they walked out the door. Shortly after Patient #10 walked out the door, they found what was documented in the chart. Dr. D asked PSO S to stop patient #10 as Dr .D was ordering a 48 hour hold for Patient #10, but it was too late. PSO S acknowledged if Dr. D had said earlier, stop Patient #10, I am getting a 48 hour hold, we would have stopped them as they are focused on keeping the staff and the patient safe. Patient #10 refused to take no for an answer, was upset, and just wanted to leave. 14. During an interview on 10/31/23 at 10:00 AM, PSO R reported they were in the ED at the time of the elopement dealing with an unrelated event. They heard yelling, so walked over to ED room 11 area to see what was going on. PSO R witnessed Patient #10 yelling profanity and telling staff don’t touch me. PSO R watched Patient #10 as they walked down the hall and out the main ER entrance as there was no hold order. PSO R followed at a distance. The ED staff looked at Patient #10’s medical record and discovered a note that they should have gotten a hold order if Patient #10 tried to leave, but at the time no one, not even the nurse, knew about that. The PSO’s looked for Patient #10, but the PSO staffed outside the hospital reported Patient #10 had already exited the hospital campus. Hospital staff notified the local police department to locate Patient #10 and return them to the ED. PSO R acknowledged there should be a better way for staff to know when a patient needs a court hold as once the doctor says we are going to get a hold, that is legal grounds to hold a person. 15. During an interview on 10/26/23 at 10:30 AM ED Charge RN G reported the Behavioral Health area of the ED was full so Patient #10 was held in ED room 11, the main area of the ED. About 10:00 AM Patient #10 exited their room and entered the hallway with the sitter, RN, and public safety officer. RN J attempted to de-escalate telling Patient #10 psych would be there shortly and hopefully they would be cleared to go home, noting the psych RN was on the unit. Charge RN G reported Dr. D and RN J searched Patient #10’s medical record for the psychiatric recommendations to determine if Patient #10 could leave. It all happened so quickly, public safety officers don’t want to get their hands on a patient unless we have a court hold or it is determined we need to get a court hold. By the time it was identified a court hold was needed Patient #10 was out the door. 16. During an interview on 10/30/23 at 8:30 PM, ED Dr. D reported they had assumed care of Patient #10 from Dr. F. Hand off relayed Patient #10 was suicidal due to substance abuse, recommended patient stay and psychiatry was going to re-eval in the AM when Patient #10 sobered up. RN J approached Dr. D that morning and told them Patient #10 had recanted and said the patient was no longer suicidal and the patient was going to leave. “We needed to look at the psych note and see what was recommended before we held Patient #10 against their will. That information usually gets passed on. We had 14 or 16 psych holds that morning, it is difficult to keep them all straight when there were so many ...we needed to check the record.” Recalled Dr. F reported this might be more of a substance abuse issue and if the patient was no longer suicidal when sober Patient #10 could probably be discharged. Dr. D acknowledged they had not been in to see Patient#10 yet and did not think the psych nurse had been in when the RN told them the patient wanted to leave. Dr. D verbalized they were looking in Patient #10’s record when Patient #10 left. Dr. D requested a 48 hour hold and hospital staff notified the police of the hold and to bring Patient #10 back to the ED. 17. During an interview on 10/30/23 at 11:00 AM ED Nurse Manager RN U acknowledged ED Staff discuss patients on a hold or needing a hold in the morning during a staff huddle. ED Manager RN R could not explain why staff were not aware of the need for a 48 hour hold if Patient #10 attempted to leave, and had staff known, they could have prevented the elopement of Patient #10. ED Nurse Manager RN U reported the mental health patient is placed in safety scrubs and the patient’s clothes are placed outside the room in storage tubs when patients are housed in the main ED area. These tubs are out of sight as patients are encouraged to use a urinal or commode instead of the restroom. Nurse Manager U lacked awareness that staff utilized the hall bathroom in the staff/nurse hallway rather than a urinal or commode. 18. During an interview on 10/31/23 at 2:00 PM, ED Medical Director acknowledged the RN and ED Provider should have been aware of the psychiatric recommendation for a 48 hour hold for Patient #10, if the patient attempted to leave. The rapid elopement of Patient #10 could have been prevented with good hand-off communication between providers and nurses.”