Children’s National Hospital

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 43420 Based on medical record review, staff interview, and policy review, the medical staff failed to complete an outpatient medical visit note for one (1) of eleven patients (Patient #38). Findings include : A review of the hospital’s “ Bylaws of the Medical Staff” revised 08/07/2020 showed “ Article XI: Policies of The Medical Staff Part A. Purpose of Policies Medical Staff policies and procedures as may be necessary to implement the general principles of conduct found in these Bylaws more specifically shall be adopted in accordance with this Article. Policies and Procedures shall set standards of practice that are to be required of each individual exercising clinical privileges in the Hospital and shall act as an aid to evaluating performance under, and compliance with, these standards. Policies and Procedures shall have the same force and effect as the Bylaws...” Review of the hospital’s policy titled “Medical Staff Policies and Procedures” revised 09/13/2017 showed “Chapter 6: Medical Records ...A. General Rules; An adequate medical record shall be maintained for each patient who is evaluated and/or treated at this Hospital as an inpatient or ambulatory patient ... I. Ambulatory Medical Records; A medical record shall be maintained for every patient receiving ambulatory care services within the Hospital, Primary Care Centers, Regional Outpatient Centers or other satellite facilities or from a [Hospital Named]-employed licensed independent practitioner providing consultative services at another facility. The ambulatory record shall contain sufficient information to document the care given, procedures performed and level of services rendered to the patient. The ambulatory medical record shall contain, where appropriate:...2. date of ambulatory care and discharge;3. relevant history of the illness or injury and physical findings;4. diagnostic and therapeutic orders; 5. clinical observations, including results of treatment, where appropriate; 6. reports of procedures, test and results, where appropriate; 7. diagnostic impressions;8. patient disposition and any pertinent instructions given to the patient or the patient’s parent(s) or legal guardian for follow-up care; 9. immunization history, where appropriate; 10. allergy history, including drug allergy, if any; 11. adverse drug reactions, if any; 12. medication reconciliation;13. pain assessment;14. safety assessment;15. informed consent, where appropriate; 16. growth chart, where appropriate;17. consultation reports, where appropriate;18. referral information to and from outside agencies as appropriate; and19. patient summary list. At the time of each ambulatory care visit, the licensed independent practitioner shall record on the ambulatory treatment record pertinent clinical observations, relevant patient history, treatment rendered, and follow-up care recommended ...Transcribed documents or reports of an ambulatory encounter shall be completed and authenticated within 30 days of the encounter. The surveyor reviewed the medical record for Patient #38 on 06/26/2024 at approximately 11:00 AM with Employee # 31, Gastroenterology, Hepatology and Nutrition Outpatient Clinic Manager. According to the medical record Patient #38 arrived at their scheduled appointment on 03/21/2024 at approximately 2:10 PM. However, the record lacked documentation of the ambulatory care and discharge follow up, per hospital policy. The surveyor conducted an interview with Employee #31 on 06/26/2024 at approximately 11:30 AM. Employee #31 confirmed Patient #38 was seen by a physician on 03/21/2024 however there was no documentation of the encounter.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 47548 Based on medical record review, policy and procedures review, video footage review, and staff interviews, the nursing staff failed to clarify and maintain Continuous Pulse Oximetry for one (1) of 11 patients sampled (Patient #1). Findings Included: A review of the “Cardiac/Respiratory and Pulse Oximetry Monitoring on Acute Care Units” Policy last updated 04/01/2016 shows under policy statement: “The physician or licensed independent practitioner is required to write an order for patient monitoring which must include: the type of monitoring (cardiac/respiratory and/or pulse oximetry), rationale/ risk for placement on monitor, and frequency of use (i.e.continuous or intermittent, pulse ox checks with vital signs), circumstances under which patient can be temporarily off the monitor ...” Further review under Procedure showed Guidelines for Patients Requiring Cardiac, Respiratory, and/or Pulse Oximetry Monitoring as: “7. Patients on supplemental oxygen if their condition warrants monitoring. 8. Patients at risk for decreased oxygen saturation, arrhythmia, or hemodynamic instability.” Further review under Procedure showed Orders for monitors must include: “1. Type of monitoring and 3. Frequency of monitoring (i.e.continuous, continuous during sleep, etc.) and circumstances under which patient can temporarily be taken off the monitor.” According to the History and Physical dated 12/05/2023, at 22:17 (10:17 PM) Patient #1 was a 7 (seven) month old infant who presented to the emergency department with cough and fevers x (times) 2 (two) days. The Patient was admitted to a short-stay observation unit with diagnoses of Acute Hypoxic Respiratory Failure and Bronchiolitis related to RSV (Respiratory Syncytial Virus) and RLL (right lower lobe) Pneumonia. The assessment/plan showed the patient was “clinically stable on 2 Liters Nasal Cannula.” The patient requires admission for supplemental oxygen and antibiotics to maintain Sp02 > 92%...” The patient was also on maintenance intravenous fluid (mIVF) and Continuous Pulse Oximetry monitoring. According to the physician’s orders dated 12/04/2023 at 21:30 (9:30 PM) Patient #1 was ordered to “Monitor Pulse Oximetry Continuous (Continuous Pulse Ox) and Provide supplemental oxygen via nasal cannula if pulse Ox < = 92% STAT [immediate].” No documentation of circumstances under which the patient can temporarily be taken off the monitor. Additionally, there was no documentation of nursing staff notifying the physician for clarification of orders. A review of the Vital Sign Flowsheet dated 12/05/2023 showed between the hours of 11:58 (11:58 AM) to 18:11 (6:11 PM) there are no documented vital signs or pulse oximetry noted on the flowsheet. During a review of the Video footage from the 4 Main Observation unit on 12/12/2023 at 11:35 AM the surveyor observed on l2/05/2023 at 1:54 PM that Mother and Patient #1 were viewed walking off 4 Main unit. The Pulse Ox leads are seen dangling and not connected to a monitor. Mother and Patient #1 returned to 4 Main from FIC (Financial Information Center) at 2:45 PM. Patient #1 was off Continuous Pulse Oximetry monitoring for 50 minutes. At 3:25 PM, Mother and Patient #1 are observed leaving 4 Main with Pulse Oximetry leads dangling and not connected to a monitor, got on the elevator, headed to the 1st (first) floor east lobby then exited the building and entered a car at 3:42 PM. Before leaving the facility Patient #1 was off continuous monitoring for approximately 2 hours and 45 minutes. On 12/12/2023 at approximately 1:30 PM, the surveyors conducted a TEAMS (Microsoft application used to communicate using, chat, video, and screen sharing) interview with Employee #27 Acute Care Float Pool RN. Employee #27 was confirmed as being the primary bedside nurse for Patient #1 on 12/05/2023 from the hours of 7:00 AM to 7:00 PM. The surveyor was queried related to the Continuous Pulse Oximetry order for Patient #1. Employee #27 acknowledged the order for Continuous Pulse Oximetry and stated, “the baby [Patient #1] was not on Continuous Pulse Oximetry, it was discussed during rounds that the baby was stable and wasn’t connected to anything.” The surveyor queried if a discontinuation order was placed for the Continuous Pulse Oximetry. Employee #27 confirmed no new order was placed. The surveyor asked Employee #27 if Patient #1 should have been able to leave the unit. Employee #27 replied, “no that’s why I stayed with the baby while mom went down to FIC with the Social Worker (SW).” On 12/13/2023 at approximately 10:40 AM the surveyors conducted a face-to-face interview with Employee #7 Executive Nursing Director of 4 Main Medical/Surgical Nursing Unit. Employee #7 confirmed the physician orders showed the following: “Continuous Pulse Oximetry 12/04/2023 at 21:30 (9:30 PM) to 12/06/2023 at 18:13 (6:13 PM).””

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 49189 Based on hospital policy reviews, medical record reviews, supporting documentation reviews, and interviews, the facility failed to meet the Condition of Participation (CoP) for Patient Rights by failing to protect and promote each patient’s rights as evidenced by the following: 1. The facility failed to protect one patient from physical abuse by a hospital employee (2) did not remove the employee who abused a patient from direct care duties, and (3) delayed reporting an instance of physical abuse that occurred to a patient as required for Mandated Reporters who witnessed it to Child Protective Services for one (1) out of 11 patients sampled. See Tag 145. 2. The facility’s nursing staff failed to adhere to the recommended agitation behavior treatment plan and implemented a violent restraint before exhausting all other alternative measures for one (1) out of 11 patients sampled. See Tag 164. 3. The facility’s medical staff failed to order the use of a violent physical restraint for one (1) out of 11 patients sampled. See Tag 168. 4. The facility’s medical staff failed to update violent restraints every 4 hours per policy for one (1) out of 11 patients sampled. See Tag 171. 5. The facility’s nursing staff failed to release violent restraints at the earliest sign of improved behavior/ ending of a dangerous event requiring restraint for one (1) out of 11 patients sampled. See Tag 174.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 49189 Based on hospital policy reviews, medical record reviews, supporting documentation reviews, and interviews, the facility failed to (1) protect one patient from physical abuse by an employee, (2) remove the employee who abused a patient from direct care duties on the same medical unit, and (3) delayed reporting an instance of physical abuse that occurred to a patient as required for Mandated Reporters who witnessed it for one (1) out of 11 patients sampled (Patient #1). The Findings Include: 1. Findings related to failure to protect one patient from physical abuse by an employee: A review of the facility’s “Informing Patients/Parents of Their Rights” policy, last updated 03/31/2017, revealed: “We [facility] want you to know that each patient at [facility’s name] has these rights: to receive care in a safe setting and be free from all forms of abuse or harassment.” A review of the facility’s “Continuous Therapeutic Observation and Monitoring” policy, last updated 04/05/2021, revealed under Roles and Responsibilities: “Nursing- After utilizing the aforementioned techniques for prevention of patient self-harm, the Registered Nurse (RN) caring for the patient is responsible for: Re-evaluating the need for continuous therapeutic observation based on current patient behaviors and safety concerns and notifying the Provider of any recommendations and Reviewing the patient’s plan of care, expectations for communication and escalation and precautionary interventions with the Direct Observer.” Further review under Roles and Responsibilities revealed: “Direct Observer- Reinforce positive behaviors and maintain a calm environment.” A review of the facility’s “Management of Child/Adolescent Maltreatment” policy, last updated 11/14/2023, revealed under definitions: “Physical Abuse - A type of maltreatment that refers to physical acts that caused or could have caused physical injury to a child.” Further review revealed under procedure: “Any suspicion for child maltreatment should be reported to the child protective service agency in the appropriate jurisdiction.” Review of the facility’s Code of Conduct, last updated 11/2023, revealed under expectations: “Follow the letter and spirit of legal requirements and our written standards, including our policies, procedures, and this Code and Disclose all suspected illegal or unethical conduct to the appropriate person, and All workforce members must act in a manner that supports and promotes the reputation of [Facility’s name] and reflect high ethical standards that are consistent with all applicable local and federal laws and regulations.” Further review under Personal Obligation to raise suspected violations revealed: “Each of us has an obligation to our patients, our community, and each other to report suspected ethical or legal violations in good faith to the appropriate person.” A review of Patient #1’s medical record from 11/07/2023-11/15/2023 revealed that Patient #1 was 12 years old and presented to the facility’s Emergency Department for evaluation of Suicidal Ideation and Fever. A review of History and Physical from 11/07/2023 revealed: “Patient was undergoing HD (hemodialysis) yesterday 11/6 when he began pulling at his HD catheter, endorsed SI (suicidal ideation), also has been recently becoming physically aggressive w/ [with] his parents and siblings.” Patient #1 was admitted to the facility’s medical unit on 11/7/2023. A review of Patient #1’s Medical Provider’s Note on 11/14/2023 revealed: “[Patient #1] became agitated around 2230 [10:30 PM] 11/13/23, per a verbal report from RNs (Registered Nurses) [Patient #1] did not want to take his medications. Resident [physician] on standby in case the situation escalated. Security was called and standing at the room door. The Resident was personally observed from the doorway. [Patient #1] yelling and being held by nurse trying to calm him down. Sitter [Employee #13, Unit Support Associate] was standing in front of [Patient #1]. [Patient #1] was yelling at sitter and tried to hit the sitter. Sitter was yelling back and grabbed [Patient #1]’s face. At that point Charge RN and Resident entered the room. The sitter was asked to step outside. After the sitter left, [Patient #1] was able to be calmed down by verbal de-escalation. [Patient #1] was calming sitting back on his bed with bedside RN and second RN [Bedside RN and Charge RN] at his side.” On 12/01/2023 at approximately 9:30 AM, the surveyors conducted a face-to-face interview with Employee #10 Registered Nurse. Employee #10 confirmed being the bedside nurse responsible for the care of Patient #1 on the night shift [7:00 PM to 7:00 AM] of 11/13/2023. Regarding the events of 11/13/2023, Employee #10 reported, “I went into the room to administer medications through his [Patient #1’s] G-tube (Gastrostomy tube). He doesn’t like to keep the extender in, so you have to put it in. I told him I was going to put in his extension for the meds and he refused. Then he was getting more agitated kicking and swinging, moving his arms all around. As I went to put in the extension, he bit my hand. The direct observer [Employee #13] yelled at him. At that point, he got out of bed, and I was trying to redirect him. I wrapped my arms around him to comfort him and he struck me and the direct observer. At that time the commotion was heard, and the Resident and Charge [Charge nurse] came into the room. After he [Patient #1] hit the observer, the observer hit him in the face.” The surveyor inquired about after-action for Patient #1 being slapped. Employee #10 confirmed that they witnessed the slap, assessed the patient afterward, stayed with the patient while a new direct observer was called for, and calmed the patient down. Employee #10 confirmed that they did not contact Child Protective Services as it is not the protocol of the hospital to have bedside nursing contact them. Employee #10 did acknowledge their responsibility as a Mandated Reporter in the District of Columbia. 2. Findings related to failure to remove the employee who abused a patient from direct care duties on the same medical unit: A review of Employee #13’s timecard for 11/13/2023 revealed that Employee #13 punched in for work at 6:54 PM and punched out at 7:29 AM on 11/14/23. A review of Employee #13’s Termination Letter, dated 11/27/2023, revealed: “[Employee #13] On 11/13/2023, you assisted in de-escalating a patient where you made physical contact with a patient by slapping them across the face.” On 12/01/2023 at approximately 11:06 AM, the surveyors conducted a telephone interview with Employee #12 Shift Coordinator. Employee #12 confirmed being the Charge Nurse of the nursing unit that Patient #1 was on during night shift of 11/13/2023. Regarding the events of 11/13/2023, Employee #12 stated: “When it was starting, I was in another room talking to a patient’s parent. I received a call from another nurse to go to the patient’s room immediately. I left and as I was getting to the room, I saw a couple of security guards outside the room. I saw [Employee #10] sitting in a chair holding [Patient #1]’s shoulders trying to calm him down. I saw the sitter [Employee #13] in front of the patient holding both of their arms. It looked like the patient was trying to lunge to bite either of them. That’s when I saw the sitter slap the patient. I told the sitter to leave the room and made sure the patient had no injuries. The child then began to calm down and I sent security away.” The surveyor inquired about whether a report was made to Child Protective Services by Employee #12 as witnessing physical child abuse. Employee #12 confirmed that they did not make a report. Employee #12 acknowledged their responsibility as a Mandated Reporter in the District of Columbia. The surveyor then inquired about protective measures to ensure continued safety of the unit and notification to hospital leadership. Employee #12 confirmed that Employee #13 who slapped Patient #1 was removed from their assignment and placed on a different patient’s assignment [Patient #2] on the same Medical Unit. Employee #12 also confirmed that the hospital’s Administrative Manager (Nursing Supervisor) was not notified that Patient #1 was slapped by an employee. On 12/01/2023 at approximately 11:30 AM the surveyor conducted a face-to-face interview with Employee #5 Director of Nursing who confirmed that the Administrative Manager should have been called as they start a notification process to hospital leadership on call and would remove the employee from care areas. 3. Findings related to delay in reporting an instance of physical child abuse to Child Protective Services: A review of Patient #1’s Progress Note-Social Work from 11/17/2023 at 10:03 AM revealed, “SW (Social Worker) reported 11/13/2023 incident involving [Facility’s name] staff slapping [Patient #1] in response to behavioral problems in the room. CFSA (Child and Family Services Agency) notified. CFSA stated that MPD (Metropolitan Police Department) will be notified and will be the agency to respond.” On 12/01/2023 at approximately 10:10 AM, the surveyors conducted a telephone interview with Employee #11 Resident Physician. Employee #11 was confirmed as being covering the resident on the evening of 11/13/2023. Regarding the events, Employee #11 reported that “As I was approaching the fishbowl [central area of the medical unit where nursing and residents are] I heard yelling as the patient did not want to take his medications or go into his room. The yelling got louder, and I stood outside the room observing the nurse holding down the patient with the sitter standing in front of them yelling at the patient. The patient freed his arm from the nurse’s restraint and either did or tried to hit the sitter. After that, the sitter either grabbed or hit the patient’s face. Once that happened the Charge nurse and myself went into the room and sent the sitter out. The patient was crying after the event.” The surveyor inquired about the care of Patient #1 after the physical abuse. Employee #11 reported that they did not contact Child Protective Services that the abuse occurred. Employee #11 acknowledged their responsibility as a Mandated Reporter in the District of Columbia. An Immediate Jeopardy (IJ) was identified on 12/04/2023 and presented to the facility’s leadership on 12/04/2023 at 11:52 AM. The facility submitted a plan of removal on 12/04/2023 at approximately 8:02 PM that included the following: 1. A nursing stand-down meeting was conducted on 12/04/2023 to review action items with all unit leadership to ensure they are aware of expectations for escalation of events. 2. A review of training and competencies for all direct care & support staff regarding patient rights will be ongoing. This refresher will be included & tracked for all incoming direct observers, clinical instructors, and charge nurses. 3. Nursing Administrators will communicate the expectations outlined above to charge nurses, shift coordinators, and direct observers via rounds tonight beginning with 7pm-7am shift & ongoing since the issuance of the Immediate Jeopardy. 3A. Communication to all the shift coordinators and charge nurses will include how to escalate issues with patients immediately. This will be communicated tonight and on an ongoing basis. 3B. Refresher tonight to direct observers will include: all patients are free from abuse by hospital staff. Hospital staff must be able to de-escalate patients while remaining calm. 3C. This education will be completed & tracked for all incoming Charge Nurses, Shift Coordinators, and Direct Observers tonight and upon return to the hospital since the issuance of the Immediate Jeopardy. 4. Nursing Administrators will communicate any and all patient-related events to the Nursing Leadership, when it occurs off-shift, as indicated. The survey team returned on 12/05/2023 to validate the facility’s plan and the Immediate Jeopardy was lifted on 12/05/2023 at 4:55 PM.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm. This Standard is not met as evidenced by: 49189 Based on hospital policy review, medical record review, and interviews, the facility nursing staff failed to adhere to the recommended agitation behavior treatment plan and implemented a violent restraint before exhausting all other alternative measures for one (1) out of 11 patients sampled (Patient #1). The Findings Include: A review of facility’s “Restraint and Seclusion” policy, last updated 06/16/2023, revealed the definition of a restraint as “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.” Further review defines Restraint use for violent/self-destructive behavior as: “the physical restriction (manual or mechanical) of a person’s freedom of movement, physical activity, or normal access to his or her body, for the protection from physical activity that intends to cause harm to self or others.” Further review defines Physical Hold as “the holding of a patient in a manner that restricts the patient’s movement against the patient’s will is considered restraint.” Further review under Essential Elements in Use of Violent/Self Destructive Restraints/Seclusions revealed: “Each use of violent restraint/seclusion: c. is the least restrictive method when all other alternatives to restraint/seclusion have been considered.” Further review under Orders for Violent/Self-Destructive Restraints and Seclusion revealed: “15. Physical holds that meet restraint criterion require an order and must meet restraint order requirements.” A review of Patient #1’s medical record from 11/07/2023-11/15/2023 revealed that Patient #1 was 12 years old and presented to the facility’s Emergency Department for evaluation of Suicidal Ideation and Fever. A review of History and Physical from 11/07/2023 revealed: “Patient was undergoing HD (hemodialysis) yesterday 11/6 when he began pulling at his HD catheter, endorsed SI (Suicidal Ideation), also has been recently becoming physically aggressive w/ [with] his parents and siblings.” A review of Initial Psychiatric Evaluation note from 11/07/2023 revealed that Patient #1 had feelings of abandonment and isolation and history of child abuse. Patient #1 was admitted to the facility’s medical unit on 11/07/2023. A review of Psychology Consult Note from 11/13/2023 revealed “Patient would likely benefit from inpatient psychiatric hospitalization, however at this time due to medical complexity ...will continue admission on medical floor at this time with ongoing discussions/reassessment.” A review of Progress note from 11/13/2023 revealed under Plan: “Agitation Recommendations: 1st line: we recommend behavioral redirection and de-escalation whenever possible. Please call nephrology SW [Social Work]. 2nd line: Should patient be unable to be redirected or pose an acute risk to themselves or others, give Aripiprazole 2.5mg PO PRN q30 [oral, as needed, every 30 minutes], max dose 10mg/day [milligrams per day]. 3rd line: If patient remains agitated after 30 minutes following administration of first line medication, we recommend olanzapine 2.5mg IM Q30 minutes [2.5 milligrams intramuscular every 30 minutes]. Max dose 10mg in 24 hours.” A review of Patient #1’s Medical Provider’s Note on 11/14/2023 revealed: “[Patient #1] became agitated around 2230 [10:30 PM] 11/13/23, per a verbal report from RNs [Registered Nurses] [Patient #1] did not want to take his medications. Resident [physician] on standby in case the situation escalated. Security was called and standing at the room door. The Resident was personally observed from the doorway [Patient #1] yelling and being held by nurse trying to calm him down. Sitter [Employee #13, Unit Support Associate] was standing in front of [Patient #1]. [Patient #1] was yelling at sitter and tried to hit the sitter. Sitter was yelling back and grabbed [Patient #1]’s face. At that point Charge RN and Resident entered the room. The sitter was asked to step outside. After the sitter left, [Patient #1] was able to be calmed down by verbal de-escalation. [Patient #1] was calming sitting back on his bed with bedside RN and second RN [Bedside RN and Charge RN] at his side.” A review of Patient #1’s Medication Administration Record (MAR) from 11/13/2023 revealed no documentation of administration of as-needed (PRN) psychiatric medications. Review did show active orders for olanzapine 2.5milligrams intramuscular. A review of Patient #1’s Nursing Assessments from 11/13/2023 revealed documentation that Patient #1 was “Playing/ Appropriate sleep pattern” under behavior. There is no further nursing documentation of Patient #1 showing signs of aggression before the utilization of the violent restraint. Further review of nursing documentation shows no documentation for restraint application, assessment, duration, or patient response to application of the violent restraint. A review of facility’s “Security Shift Report 2nd Shift” from 11/13/2023 revealed under noteworthy events: “4. At 10:33PM, Stat call Room [Room Number]. Patient, [Patient #1] refused to take his medication and became agitated. Nursing staff did not want security to intervene due to risk of escalating the patient. Nothing further to report.” On 12/01/2023 at approximately 9:30 AM, the surveyors conducted a face to face interview with Employee #10 Registered Nurse. Employee #10 confirmed as being the bedside nurse responsible for the care of Patient #1 on the night shift of 11/13/2023. Regarding the events of 11/13/2023, Employee #10 reported “I went into the room to admin meds through G-tube. He doesn’t like to keep the extender in so you have to put it in. I told him I was going to put in his extension for the meds and he refused. Then he was getting more agitated kicking and swinging, moving his arms all around. As I went to put in the extension he bit my hand. The direct observer yelled at him. At that point he got out of bed and I was trying to redirect him. I wrapped my arms around him to comfort him and he struck me and the direct observer. At that time the commotion was heard and the nurse and charge came into the room. After he struck the observer the observer hit him in the face.” The surveyor inquired about the technique and aims of the hold Employee #10 used on Patient #1. Employee #10 confirmed that they wrapped their arms around the patient and that the rationale for using the hold was to “protect him [Patient #1] and us [care team].” The surveyor inquired about the rationale for not using medications specified in Patient #1’s agitation treatment plan. Employee #10 responded that they did not feel Patient #1 was at a point needing them and that injectable medications are a last resort. On 12/01/2023 at approximately 10:10 AM, the surveyors conducted a telephone interview with Employee #11 Resident Physician. Employee #11 was confirmed as being covering resident on the evening of 11/13/2023. Regarding the events, Employee #11 reported that “As I was approaching the fishbowl [central area of the unit where nursing and residents are] I heard yelling as the patient did not want to take his medications or go into his room. The yelling got louder and I stood outside the room observing the nurse holding down the patient with the sitter standing in front of them yelling at the patient. The patient freed his arm from the nurse’s restraint and either did or tried to hit the sitter. After that, the sitter either grabbed or hit the patient’s face. Once that happened the Charge nurse and myself went into the room and sent the sitter out. The patient was crying after the event.” The surveyor inquired about the hold technique that Employee #11 witnessed being used on Patient #1. Employee #11 confirmed that the nurse restrained the patient by laying them sideways on their lap and had their arms around the patient’s legs and arms to keep them from moving.”

“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: 49189 Based on hospital policy review, medical record review, and interviews, the facility’s medical staff failed to order the use of a violent physical restraint for one (1) out of 11 patients sampled (Patient #1). The Findings Include: Review of the facility’s “Restraint and Seclusion” policy, last updated 06/16/2023, revealed the definition of a restraint as “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.” Further review defines Restraint use for violent/self-destructive behavior as: “the physical restriction (manual or mechanical) of a person’s freedom of movement, physical activity, or normal access to his or her body, for the protection from physical activity that intends to cause harm to self or others.” Further review defines Physical Hold as “the holding of a patient in a manner that restricts the patient’s movement against the patient’s will is considered restraint.” Further review under Orders for Violent/Self-Destructive Restraints and Seclusion revealed: “1. An order must be obtained from an authorized LP (Licensed Provider) by the hospital prior to the application of the restraint or seclusion. 2. In an emergency situation (when the need for restraint or seclusion occurs so quickly that an order cannot be obtained prior to the application), a RN (registered nurse) may initiate the emergency restraint application. The LP order must be obtained immediately or as soon as possible after the restraint or seclusion application. 7. Orders for restraint or seclusion must never be written as a standing order or on an as needed basis (PRN) order.” A review of Patient #1’s medical record from 11/07/2023-11/15/2023 revealed that Patient #1 was 12 years old and presented to the facility’s Emergency Department for evaluation of Suicidal Ideation and fever. A review of History and Physical from 11/07/2023 revealed: “Patient was undergoing HD [hemodialysis] yesterday 11/6 when he began pulling at his HD catheter, endorsed SI, also has been recently becoming physically aggressive w/ his parents and siblings.” Patient #1 was admitted to the facility’s medical unit on 11/07/2023. A review of Patient #1’s Medical Provider’s Note on 11/14/2023 revealed: “[Patient #1] became agitated around 2230 [10:30 PM] 11/13/23, per a verbal report from RNs [Registered Nurses] [Patient #1] did not want to take his medications. Resident [physician] on standby in case the situation escalated. Security was called and standing at the room door. The Resident was personally observed from the doorway [Patient #1] yelling and being held by nurse trying to calm him down. Sitter [Employee #13, Unit Support Associate] was standing in front of [Patient #1]. [Patient #1] was yelling at sitter and tried to hit the sitter. Sitter was yelling back and grabbed [Patient #1]’s face. At that point Charge RN and Resident entered the room. The sitter was asked to step outside. After the sitter left, [Patient #1] was able to be calmed down by verbal de-escalation. [Patient #1] was calming sitting back on his bed with bedside RN and second RN [Bedside RN and Charge RN] at his side.” A review of Patient #1’s Orders from 11/13/2023 revealed no orders for the application of a violent restraint. On 12/01/2023 at approximately 10:10 AM, the surveyors conducted a telephone interview with Employee #11 Resident Physician. Employee #11 was confirmed as being covering resident on the evening of 11/13/2023. Regarding the events, Employee #11 reported that “As I was approaching the fishbowl [central area of the unit where nursing and residents are] I heard yelling as the patient did not want to take his medications or go into his room. The yelling got louder, and I stood outside the room observing the nurse holding down the patient with the sitter standing in front of them yelling at the patient. The patient freed his arm from the nurse’s restraint and either did or tried to hit the sitter. After that the sitter either grabbed or hit the patient’s face. Once that happened the Charge nurse and myself went into the room and sent the sitter out. The patient was crying after the event.” The surveyor inquired on if an order for a violent restraint was placed by Employee #11. Employee #11 confirmed that they did not place a violent restraint order but was unsure if Psychiatry had placed an “As Needed” PRN order for restraints. On 12/01/2023 at 11:50 AM, the surveyor conducted a face-to-face interview with Employee #15 Division Chief of Psychiatry. Employee #15 confirmed that orders for restraints are never placed as standing or As Needed/PRN. Employee #15 continued that if a provider determines that a patient requires restraints, it is the provider’s responsibility to order them.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 49189 Based on hospital policy review, medical record review, and interview the facility’s medical staff failed to update violent restraints every 4 hours per policy for one (1) out of 11 patients sampled (Patient #3). The Findings Include: A review of the facility’s “Restraint and Seclusion” policy, last updated 06/16/2023, revealed: “C. Orders for Violent/Self-Destructive Restraints and Seclusion: 8. Violent/Self-Destructive Restraint or Seclusion orders are time limited to reduce the amount of time a patient spends in restraint or seclusion as much as possible. a. Orders are time-limited to a maximum of i. Four hours for adolescents/young adults ages 18 and older. 9. If restraint or seclusion needs to continue beyond the expiration of the time-limited order, a new order must be obtained.” A review of Patient #3’s Medical Records from 09/22/2023 to 09/24/2023 revealed that Patient #3 is a 19 year old female with a history of Trisomy 21 and complete AVSD (Atrioventricular septal defect) that was repaired who presented to the facility for an episode of choking that led to possible loss of consciousness. Patient #3 was admitted to the facility for diuretic titration, observation, and hemodynamic monitoring. A review of Provider Restraint Documentation from 09/22/2023 at 5:54 PM revealed that Patient #3 was placed in restraints due to them being combative. A review of nursing restraint documentation from 09/22/2023 to 09/23/2023 revealed documentation of Patient #3 being in wrist and ankle restraints from 5:54 PM on 09/22/2023 to 8:15 AM on 09/23/2023. A review of Patient #3’s Restraint Orders from 09/22/2023 to 09/23/2023 revealed the following: Patient #3’s first restraint order was placed on 09/22/2023 at 5:43 PM. The stop time on the order is 09/22/2023 at 9:42 PM. Patient #3’s next restraint order was placed on 09/22/2023 at 11:08 PM. The stop time on the order is 09/23/2023 at 3:07 AM. There is no order to reflect the restraint times from 9:42 PM to 11:07 PM. Patient #3’s next restraint order was placed on 09/23/2023 at 6:49 AM. There is no order to reflect the restraint times from 3:07 AM to 6:48 AM. On 12/05/2023 at approximately 11:00 AM, the surveyors conducted a face-to-face interview with Employee #18 Attending Physician. Employee #18 confirmed that violent restraints require specific timed orders and that this is usually prompted by the nurse to get the renewal order. Employee #18 confirmed that the physician is responsible for ensuring that restraint orders do not expire if they’re still needed for patients.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 49189 Based on hospital policy review, medical record review, and interviews, the facility’s nursing staff failed to release violent restraints at the earliest sign of improved behavior/ ending of a dangerous event requiring restraint for one (1) out of 11 patients sampled (Patient #3). The Findings Include: A review of the facility’s “Restraint and Seclusion” policy, last updated 06/16/2023, revealed: “C. Orders for Violent/Self-Destructive Restraints and Seclusion: 11. The use of restraint or seclusion must be discontinued once the unsafe situation ends. 13. Patients should be continually assessed for opportunities to release and discontinue the violent/self-destructive restraint or seclusion at the earliest possible time.” A review of Patient #3’s Medical Records from 09/22/2023 to 09/24/2023 revealed that Patient #3 is a 19-year-old female with a history of Trisomy 21 and complete AVSD (Atrioventricular septal defect) that was repaired who presented to the facility for an episode of choking that let to possible loss of consciousness. Patient #3 was admitted to the facility for diuretic titration, observation, and hemodynamic monitoring. A review of Provider Restraint Documentation from 09/22/2023 at 5:54 PM revealed that Patient #3 was placed in restraints due to them being combative. A review of nursing restraint documentation from 09/22/2023 to 09/23/2023 revealed documentation of Patient #3 being in wrist and ankle restraints from 5:54 PM on 09/22/2023 to 8:15 AM on 09/23/2023. Further review of nursing restraint documentation revealed documentation that Patient #3 was asleep from 8:45 PM to 1:00 AM while in wrist and ankle violent restraints. Further review of nursing restraint documentation revealed documentation that Patient #3 was asleep from 1:45 AM to 5:45 AM while in wrist and ankle violent restraints. On 12/04/2023 at approximately 3:45 PM, the surveyors conducted a face-to-face interview with Employee #5 Director of Nursing. Employee #5 confirmed that nursing is expected to assess their restrained patients and determine the need to keep them on and remove them at the earliest possible moment.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 49189 Based on hospital policy review, adverse event review, supporting documentation review, and staff interviews the facility’s Quality Assurance Performance Improvement (QAPI) program failed to measure, analyze, and track quality indicators impacting patient safety related to the utilization of identified Violent Restraints for one (1) out of 11 patients sampled. (Patient #3). The Findings Include: A review of the facility’s “Restraint and Seclusion” policy, last updated 06/16/2023, revealed under Performance Improvement: “All opportunities to prevent, reduce, and eliminate the use of restraint will be identified through regular review of the medical record, risk management activities/monitoring, and other hospital-based reports. Data will be collected on all episodes of restraint use. Aggregate data will be reviewed and analyzed to identify opportunities to reduce the occurrence and/or improve the safety of restraint use.” A review of the adverse event log from 09/23/2023 revealed that Patient #3 had a Safety/Security event with the report stating: “S [Situation]-During the shift patient has become agitated, combative and has physically harmed multiple staff. B [Background]- 19 year old patient with trisomy 21 and repaired CHD (Congenital heart defect) admitted [s/p] for evaluation of a coughing episode with possible loss of consciousness. A [Assessment]- Security, social work, AODs, multiple nurses and sitters, and our residents and fellows have worked so patiently to try to calm her down, talk with her, and ultimately physically restrain her. We have used Ativan, Seroquel and reluctantly had to use 4 point restraints [wrist and ankle restraints]. R [Recommendation]- Patient kept on 4-point restraint w/ [with] 2 stters [s/p] in the room.” A review of Patient #3’s Medical Records from 09/22/2023 to 09/24/2023 revealed that Patient #3 is a 19-year-old female with a history of Trisomy 21 and complete AVSD (Atrioventricular septal defect) that was repaired who presented to the facility for an episode of choking that let to possible loss of consciousness. Patient #3 was admitted to the facility for diuretic titration, observation, and hemodynamic monitoring. A review of Provider Restraint Documentation from 09/22/2023 at 5:54 PM revealed that Patient #3 was placed in restraints due to them being combative. A review of nursing restraint documentation from 09/22/2023 to 09/23/2023 revealed documentation of Patient #3 being in wrist and ankle restraints from 5:54 PM on 09/22/2023 to 8:15 AM on 09/23/2023. A review of the facility’s Restraint Report from September 2023 to November 2023 revealed no listing of Patient #3’s restraint event in the log. On 12/05/2023 at approximately 3:45 PM, the surveyors conducted a face-to-face interview with Employee #17 Chief Nursing Informatic and Education Officer. Employee #17 acknowledged that Patient #3 had a restraint event at the facility but was unable to provide how it was reviewed or tracked for quality assurance. Employee #17 reported that the facility conducts a monthly prevalence study for skin issues related to medical devices, such as restraints. The prevalence study was conducted on September 13, 2023, and October 11, 2023. Employee #17 clarified that because Patient #3 was not an active patient on either of those dates, they would not have been identified for the study. The surveyor inquired if the facility performs a retrospective review focused solely on restraint utilization. Employee #17 confirmed that it is not done currently. Employee #17 confirmed that risk management does not report to QAPI that a restraint event has been identified from incident reports.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 17578 Based on medical record review, policy review and staff interview the nursing staff failed to consistently document the presence of a Continuous Therapeutic Observer and complete Hand Off procedures per hospital policy for one (1) out of 11 patients observed (Patient #2). The Findings Include: A review of the policy titled “Observation & Monitoring” dated April 2014, showed the unit nursing staff would assume responsibility and accountability for monitoring each patient based on their level of care within any 24-hour period. A review of the policy titled “Continuous Therapeutic Observation,” dated 04/05/2021, showed the purpose of the policy is to provide a therapeutic and physically safe environment for patients who require continuous therapeutic observation and monitoring (1:1 direct observation) ... The use of 1:1 continuous, direct observation is a nursing-driven intervention. “The Registered Nurse (RN) caring for the patient is responsible for reviewing the patient’s plan of care, expectations for communication and escalation, and precautionary intervention with the Director Observer. The Director Observer is under the direction of the Registered Nurse, the Director Observer will Follow Hand Off Procedures: Receive hand off prior to providing continuous therapeutic observations ...” A review of Patient #2’s medical record from 10/11/2023 showed the physician admitted the patient with diagnoses of Suicidal Ideations, Major Depression Disorder (MDD), and Oral Ingestion of Multiple Medications resulting in respiratory complications. Further review of Patient #2’s orders revealed the physician ordered Safety Continuous Therapeutic Observation Monitoring (SCTOM) on 11/13/2023 at 11:23 AM. The surveyor reviewed the medical record for the Safety Continuous Therapeutic Observation Monitoring from 11/14/2023 to 11/30/2023. Further review of the medical record showed the nursing staff failed to consistently document (once per 12 hour shift) the presence of the Director Observer for the Safety Continuous Therapeutic Observation Monitoring and the Hand Off of Care on both the day and night shift from 11/17/2023 to 11/24/2023. On 12/04/2023 at approximately 11:00 AM, the surveyor conducted a face-to-face interview with Employee #5, Director of Nursing, regarding the nursing staff’s failure to document the presence of the Continuous Observer. Employee #5 acknowledged the absence of nursing staff documentation.”