Johns Hopkins Bayview Medical Center

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 40926 Based on a review of medical records, hospital policies and procedures, and staff interviews, it was determined that the hospital failed to identify medications as chemical restraints for Patient #2 (P2) and Patient #8 (P8) when administered to restrict the patients’ freedom of movement during an emergency safety intervention. Findings include: Surveyors reviewed the hospital’s policy titled “Restraint and/or Seclusion for the Patient with Violent/Self-Destructive Behavior,” effective 06/01/2024. Under the section IV. Definitions, a “Chemical (Medication) Restraint” is defined as “ a drug or medication used as a restriction to manage the patient’s behavior, restrict a patient’s freedom of movement, and is not a standard treatment or dosage for the patient’s condition. The expectation that the standard use of medications to treat the patient’s condition enables the patient to move more effectively and appropriately function in the world around them.” Additionally, the policy above defines “Violent/Self-destructive behavior” as “patient’s behavior which becomes aggressive or threatening, presenting an immediate, serious danger to the patient’s safety or that of others.” P2 was a 50+ year old patient who was brought to the emergency department (ED) by law enforcement for a psychiatric evaluation after exhibiting behaviors consistent with psychosis. P2 was evaluated by an ED physician who ordered bloodwork and a psychiatric consult. The ED physician also ordered psychiatric medications to be given as needed (PRN) for severe aggression and agitation. The medications were to be administered intramuscularly (IM). P2 was noted as refusing all medications, bloodwork, and would not provide a urine sample. Approximately six hours after being brought to the ED, P2 was documented as verbally aggressive, intermittently yelling and pacing. At that time, nursing staff documented IM administration of the PRN anti-psychotic medication, a sedative medication that slows brain activity, and an antihistamine that is known to cause drowsiness. P2 was documented as ‘sleeping’ for the next six hours. P8 was a 60+ year old patient who was brought to the ED by law enforcement after making threats of violence in a public area. P8 was evaluated in the ED, and the ED physician’s assessment included orders for “PRN psychiatric medications.” The PRN medications included anti-psychotic medication, a sedative medication that slows brain activity, and an antihistamine that is known to cause drowsiness. The order frequency was listed as ‘once as needed PRN.’ Approximately 30 minutes later, an emergency response was called, which included clinical staff and security staff members. P8 was exhibiting aggressive behaviors, including verbal threats towards staff. At that time, P8 was physically held, administered a chemical restraint (medications ordered above), and placed in seclusion. P8 was documented as asleep for the next few hours. No documentation was found to support that the medications administered were considered a chemical restraint. The administration of these combined medications, given for aggressive behaviors that restricted the patient’s freedom of movement, was considered a chemical restraint. No evidence was found to support that the staff identified or documented this as a chemical restraint. Additionally, no physician face-to-face was conducted within one hour of the administration of the chemical restraint to evaluate P2’s or P8’s response to the intervention. Cross reference Tag A-0178.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(6) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN). This Standard is not met as evidenced by: 40926 Based on a review of medical records, hospital policies and procedures, and other pertinent documents, it was determined that the hospital ordered chemical restraints on an as needed (PRN) basis for Patient #2 (P2), Patient #7 (P7), Patient #8 (P8), Patient #9 (P9), and Patient #14 (P14). Findings include: Surveyors reviewed the hospital’s policy titled “Restraint and/or Seclusion for the Patient with Violent/Self-Destructive Behavior,” effective 06/01/2024. Under section III Policy, it states that “standing or PRN restraint and/or seclusion orders are not to be used”. Under section VI Process, subsection B, restraint and/or seclusion initiation, it states that “restraints and/or seclusion shall be initiated upon the order of an authorized prescriber responsible for the patient, or by a registered nurse when they determine it is necessary to protect the patient”. In addition, “initiation of restraints and/or seclusion for the patient with violent/self-destructive behaviors is based on when the patient’s behavior threatens the physical safety of the patient, staff, or others”. P2 was a 50+ year old patient who was brought to the emergency department (ED) by law enforcement for a psychiatric evaluation after exhibiting behaviors consistent with psychosis. P2 was evaluated by an ED physician who ordered bloodwork and a psychiatric consult. The ED physician also ordered psychiatric medications to be administered intramuscularly (IM) as needed (PRN) for severe aggression and agitation. Approximately six hours after being brought to the ED, P2 was documented as verbally aggressive, intermittently yelling and pacing. At that time, nursing staff documented IM administration of an anti-psychotic medication, a sedative medication that slows brain activity, and an antihistamine that generally causes drowsiness, based on the physician order mentioned above. P2 was documented as ‘sleeping’ for the next six hours. P7 was a 60+ year old patient who was transported to the ED by ambulance for evaluation of abdominal pain. P7 agreed to an inpatient admission for further evaluation and treatment for a chronic condition that was diagnosed on a previous visit. On this visit, P7 was diagnosed with an electrolyte imbalance. Later that evening/early morning, P7 was documented as agitated, confused and pulling out their intravenous catheter and wandering. P7 was held by security staff, medicated and placed in 4-point restraints (both wrists and both ankles attached to the bed). A few minutes later, the ED physician certified P7 as not capable of making their own decisions. P7 was transferred to a medical intensive care unit (MICU) six hours later and according to a note from the physician, the 4-point restraints were removed upon transfer. The MICU physician also documented that the following “Emergency PRN’s” would be needed which included an IM anti-psychotic combined with an IM sedating medication. The indication for administration was noted as “[for] moderate to severe psychiatric distress including acts of violence, threats of violence or posturing.” P8 was a 60+ year old patient who was brought to the ED by law enforcement after making threats of violence in a public area. P8 was evaluated in the ED and the ED physician assessment included orders for “PRN psychiatric medications.” The PRN medications included anti-psychotic medication, a sedative medications that slows brain activity, and an antihistamine that is known to cause drowsiness. The order frequency was listed as ‘once as need PRN.’ Approximately 30 minutes later, an emergency response was called which included clinical staff and security staff members. P8 was exhibiting aggressive behaviors including verbal threats towards staff. At that time, P8 was physically held, administered a chemical restraint (medications ordered above) and placed in seclusion. P9 was a 30+ year old patient who presented to the ED for a psychiatric evaluation due to feelings of increased anxiety and depression. An ED provider evaluated P9 and ordered bloodwork and a psychiatric consultation. The ED provider also ordered an anti-psychotic medication to be given once PRN for severe psychiatric distress and another medication (depressant that produces sedation) once PRN for severe agitation, intoxication, or undifferentiated distress. Both medications were to be administered intramuscularly (IM). On the following day, the physician discontinued the above medication order. The same physician wrote a medication order for an antipsychotic medication to be given once PRN for threats, threatening behavior, or acts of aggression, and an antihistamine for EPS (extrapyramidal symptoms), which are a group of side effects that can occur due to the use of antipsychotic medications. Both medications were to be administered IM. P14 was a 20+ year old patient who was brought to the ED by ambulance with law enforcement for a psychiatric evaluation for reported suicidal thoughts and self-harm. An ED provider evaluated P14 and ordered bloodwork and a psychiatric consultation. The ED provider also ordered an anti-psychotic medication to be given once PRN for severe psychiatric distress, another medication (depressant that produces sedation) as once PRN for severe agitation, intoxication, or undifferentiated distress, and an antihistamine (known to cause drowsiness) every six hours PRN. All three medications were to be administered IM. Each of the medications administered were ordered ‘as needed/PRN’; however, they were administered or intended to be administered as a chemical restraint for violent and aggressive behaviors during an emergency intervention that restricted the patient’s freedom of movement and therefore required an order at the time of the intervention.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed practitioner; or - Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 40926 Based on a review of medical records, hospital policies and procedures, and staff interviews, it was determined that the hospital failed to perform a 1-hour face-to-face assessment for Patient #2 (P2) and Patient #8 (P8) following a chemical restraint episode. Findings include: Surveyors reviewed the hospital’s policy titled “Restraint and/or Seclusion for the Patient with Violent/Self-Destructive Behavior,” effective 06/01/2024. Under the section IV. Definitions, a “Chemical (Medication) Restraint” is defined as: “ a drug or medication used as a restriction to manage the patient’s behavior, restrict a patient’s freedom of movement, and is not a standard treatment or dosage for the patient’s condition. The expectation that the standard use of medications to treat the patient’s condition enables the patient to move more effectively and appropriately function in the world around them.” Additionally, under section V. Responsibility, the above-mentioned policy states, “B. Authorized prescribers shall: 4. Conduct an in-person (face-to-face) evaluation of patients ordered for Restraint and/or seclusion as described in the appropriate state/jurisdictional appendix. A. Appendix B.” Appendix B describes the requirement as “within one hour of initiation of physical hold, restraint or seclusion.” P2 was a 50+ year old patient who was brought to the emergency department (ED) by law enforcement for a psychiatric evaluation after exhibiting behaviors consistent with psychosis. P2 was evaluated by an ED physician who ordered bloodwork and a psychiatric consult. The ED physician also ordered psychiatric medications to be given as needed (PRN) for severe aggression and agitation. The medications were to be administered intramuscularly (IM). P2 was noted as refusing all medications, bloodwork, and would not provide a urine sample. Approximately six hours after being brought to the ED, P2 was documented as verbally aggressive, intermittently yelling and pacing. At that time, nursing staff documented IM administration of the PRN anti-psychotic medication, a sedative medication that slows brain activity, and an antihistamine that is known to cause drowsiness, based on the physician order mentioned above. P2 was documented as ‘sleeping’ for the next six hours. P8 was a 60+ year old patient who was brought to the ED by law enforcement after making threats of violence in a public area. P8 was evaluated in the ED, and the ED physician’s assessment included orders for “PRN psychiatric medications.” The PRN medications included anti-psychotic medication, a sedative medication that slows brain activity, and an antihistamine that is known to cause drowsiness. Approximately 30 minutes later, an emergency response was called, which included clinical staff and security staff members. P8 was exhibiting aggressive behaviors, including verbal threats towards staff. At that time, P8 was physically held, administered a chemical restraint (medications ordered above), and placed in seclusion. P8 was documented as asleep for the next few hours. The administration of these combined medications, given for aggressive behaviors that restricted the patient’s freedom of movement, was considered a chemical restraint. Therefore, a physician face-to-face assessment was required to be conducted within one hour of the administration of the chemical restraint to evaluate P2’s or P8’s response to the intervention. No evidence was found to support that a face-to-face with the required components was completed for P2 or P8. Cross reference Tag A-0160”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(2)(iv) [The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] (iv) The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia). This Standard is not met as evidenced by: 40926 Based on a review of medical records, hospital policies and procedures, the hospital’s restraint training and staff interviews, it was determined that the hospital failed to identify and include education related to chemical restraints within their staff restraint and seclusion training materials or their restraint policy. Without the appropriate training related to chemical restraint use, staff are not educated on monitoring patients after administration of sedative medications. Additionally, other components of restraint use such as physician’s conducting a face-to-face assessment within one hour of the use of chemical restraints are not being completed. Findings include: Surveyors reviewed the hospital policy titled “Restraint and/or Seclusion for the Patient with Violent/Self-Destructive Behavior.” effective 06/01/2024. Under Section IV. Definitions, a clear regulatory definition is listed for a Chemical (Medication) Restraint; however, after a review of the entire policy including attachments, no documentation was found to support educational guidance for that term or other information related to the administration of Chemical Restraints. Surveyors reviewed clinical staff training related to the appropriate use of restraints/seclusion. On review of “Caring for Patients Needing Restraints and/or Seclusion” training slides, it was noted that the only definitions listed were for manual restraints, physical holds, and seclusion. Additionally, the quiz presented at the end for staff to complete only listed physical restraint, seclusion, and short-term hold as options for the scenarios. Surveyors reviewed JHHS Clinical Staff Annual Update Issue 2025. Staff education was centered on physical 4-point restraints, physical holds, and seclusion. No references were found related to the use of chemical restraints. Furthermore, in review of additional restraint/seclusion training material, the only information found related to chemical restraints read in part ..., “medications given for violent behavior are not automatically considered a chemical restraint. Avoid using language in the medical record such as ‘chemical restraint used.’ Surveyors reviewed five restraint and/or seclusion medical records (Patient #2 [P2], Patient #7 [P7], Patient #8 [P8], Patient #9 [P9], Patient #14 [P14]) . For all five of these medical records, it was noted that the same three medications, an antipsychotic, along with a fast-acting benzodiazepine (that increased the calming chemicals in the brain) and an antihistamine with sedative properties, were ordered “as needed PRN.” According to the American College of Emergency Physicians (ACEP), antipsychotic and benzodiazepine medications when combined are widely recognized and used as a chemical restraint in the agitated, violent patient due to their quick onset and sedative properties. Chemical Restraints in the ED (2012). American College of Emergency Physicians. ACEP Now. Retrieved from: https://www.acepnow.com/article/chemical-restraint-ed/ For P2, P7 and P8, these medications, although ordered as ‘PRN’, were used as chemical restraints in emergency situations with psychiatric patients. For P9 and P14, the same medications were ordered, however, they were not administered as the patients did not have any documented emergency safety interventions. On September 18, 2025 at 1:05 pm, an interview was conducted with the Clinical Director (CD) of the Emergency Department (ED). When discussing the chemical restraint medications ordered as PRN use, it was expressed by the CD that the medications are ordered for the safety of the staff and not considered chemical restraint in that setting. Surveyors conveyed that in three of the medical record reviews, these medications were combined and administered to psychiatric patients during an emergency safety intervention for violent and aggressive behaviors. The CD responded that the medications that are ordered for psychiatric patients and are to be used for the safety of staff as part of the patient’s treatment. Surveyors explained to the CD that the medications ordered and used for emergency safety interventions that decrease the patient’s awareness and ability to actively participate in their treatment plan are considered chemical restraints and need to be ordered at the time of the intervention only and cannot be written as PRN/as needed.”