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Based on document review and interviews, the facility failed to ensure:

A.chemical restraints/emergency behavioral medications (EBM) administered Intramuscular (IM) or Intravenous (IV) for behavioral emergencies were identified and monitored as a restraint in 2 (Patient's #6 and #5) of 2 medical records reviewed.

B. the policy and procedure titled "Patient Seclusion and Restraint" gave clear instructions for the assessment and reassessment of a patient after the administration of a chemical restraint/EBM in 2 (Patient's #6 and #5) of 2 medical records reviewed.

C. the policy and procedures for "Patient Restraint and Seclusion" were followed to prevent a restraint from being ordered as a PRN or as-needed order.

D. chemical restraints/EBM's were not identified in the facility's restraints report for 2 (Patient's #6 and #5) of 2 medical records reviewed.

E. that all staff received appropriate training for the use, administration, and assessment of all patients receiving chemical restraints/EBM.

Findings included:

A review of the facility's Restraints Report from 4/8/25 thru 5/5/25 did not identify any use of Chemical Restraints/EBM's being administered for behavioral emergencies.

Patient #6

A review of patient # 6's medical record revealed the patient was brought to the Emergency Room (ER) on 4/25/25 at 1632. A review of the ER physician notes revealed patient #6 was 58 years old with a diagnosis of dementia and was having outbursts of yelling, confusion, and aggressive behavior.

A review of the nurse's notes dated 4/25/25 at 2044 stated, "Pt (patient) began yelling and throwing sheets off of self when this RN (Registered Nurse) heard the occurrence." The nurse notified the provider and charge nurse. The nurse documented that a sitter was ordered at 2107. There was no documentation of any de-escalation or interventions before a chemical restraint/EBM was ordered and administered.

A review of patient #6's ER record revealed the following physician orders (PO): "4/25/25 at 2047 Haldol (antipsychotic) 5 mg IV once." There was not a diagnosis indicated or the reason for a chemical restraint/EBM on the physicians order. Haldol was documented as administered at 2053 in the left hand. There was no documentation of the medication's effectiveness or the patient's behaviors after the chemical restraint/EBM.

The nurse documented vital signs at 2101. Patient #6's blood pressure was elevated at 147/105 and a pulse of 119. The next set of vital signs was taken one hour later at 2201. Patient #6's blood pressure was still elevated at 160/94 and a pulse of 100. There was no documentation that the physician was aware of the patients vitals.

There was no further documentation of whether the physician was aware of the patient's behavioral and medical status, or whether further care was given.

A review of patient #6's ER record revealed that on 4/25/25 at 2221, the nurse documented, "Pt began yelling and having similar outbursts to before, notified the provider and charge nurse." There was no documented information from the provider at this time. There were no documented interventions by the nursing staff.

A review of patient #6's ER record revealed the following physician orders: "4/25/25 at 2221 Ativan (sedative) 2 mg IV once." There was not a diagnosis indicated or the reason for a chemical restraint/EBM on the physician order. Ativan was documented as administered at 2227 in the left hand. Vital signs were documented at 2330. There was no documentation of the medication's effectiveness or whether the medication was effective.

A review of patient #6's medical record revealed she was admitted to the hospital on 4/26/25 at 1427 for a Urinary Tract Infection and Aggressive behavior.

A review of patient #6's record revealed the following physician orders: 4/26/25 at 1517 Haldol 5 mg IV every 6 Hours as needed/PRN for Agitation/Anxiety. Haldol was documented as administered at 1517 in the left antecubital.

A review of the facility's policy and procedure "Patient Restraint/Seclusion" last revised 04/2025 indicated, in part; "Order for a Restraint or Seclusion; 1. An order for restraint or seclusion may not be written as a standing order, protocol, or as a PRN or 'as needed' order."

According to the FDA.gov, "While Haloperidol injection is FDA-approved for intramuscular (IM) use, its IV use is considered 'off-label' in the United States. This means the FDA has not specifically approved it for this route of administration, but it is a practice supported by clinical experience and evidence.

All antipsychotic medications carry a black box warning due to the increased risk of death in elderly patients with dementia-related psychosis. This warning highlights that these drugs are not approved for treating behavioral symptoms in this specific patient population and carry a significant risk of death. The FDA issued the initial warning for atypical antipsychotics in 2005, and later extended it to all conventional antipsychotics in 2008. Patient Monitoring: If Haloperidol is administered IV, close monitoring of the patient's heart rhythm (ECG) is crucial to identify and manage any potential complications.

Risks and Benefits: The potential benefits of rapid calming and reduced agitation need to be weighed against the risks associated with IV administration, such as QT prolongation and the potential for a rare but serious heart rhythm disturbance called torsades de pointes." Haldol has black box warnings for the a life-threatening adverse event called catalepsy, which leaves patients in a trance-like state accompanied by rigid muscles and abnormal, uncontrollable movements. There is no antidote."

Patient # 5

A review of patient #5's medical record revealed he was a 75-year-old male who arrived as a walk-in to the ER on 4/25/25 at 2316. The patient had a ground-level fall, pt was hypotensive. A review of the physician notes dated 4/25/25 stated the patient had a history of dementia presenting for syncope and hypotension.

A review of the physician orders dated 4/26/25 at 0413 stated, "Haloperidol Lactate Inj (Haldol Injection) 2 mg IV."

Patient #5's Emergency Patient Record revealed Haldol Lactate 2 mg IV administered on 4/26/25 at 0426.

A review of the Emergency Provider Report, physician's notes dated 4/26/25 stated, "Patient did receive Haldol for an episode of sundowning at which time he was pulling out his IV and pulling off all of his monitoring."

https://pmc.ncbi.nlm.nih.gov. Sundowning is a syndrome recognized in patients with dementia or delirium who display symptoms of neuropsychiatric symptoms (NPS) in the late afternoon or early evening; agitation in particular, that may result in disruptive behaviors and psychological disturbances.

Further review of Patient #5's medical record revealed there were no nursing notes that described any unwanted behaviors or any pulling at lines. There was no documentation in the patient's record of any inappropriate behaviors or "sundowning" episodes. There was no documentation that interventions had been attempted before ordering and administering a chemical restraint/EBM. There was no documentation that interventions had been attempted before ordering and administering a chemical restraint. There were no nursing notes that stated the medication was administered, the effectiveness of the medication, or if the patient was reassessed after the medication was administered. At 0436 the nurse documented vital signs.

Interview on 5/7/25 at 3:05PM with Staff #26 stated in part when asked by surveyor, if there had been any restraint monitoring or documentation for Patient #5, responded, "No, I don't see any."

Review of the facility's Restraint/Seclusion Policy last revised 04/2025 indicated the following, in part;
"Policy: The facility will comply with state laws when initiating restraints to,
B. Ensure the least restrictive methods of intervention are used, and
C. Attempt alternatives whenever possible and only initiate restraint when those attempts are determined ineffective.

5. Order for Restraint
a. An order for restraint must be obtained from a physician who is responsible for the care of the patient prior to the application of restraint.
5. Describe the specific behaviors which constituted the behavioral emergency which resulted in the need for restraint or seclusion.

7. Monitoring the Patient in Restraints
a. Patients are assessed by an RN immediately after restraints are initiated to assure safe application/initiation of the restraint.
b. The assessment will include where appropriate:
1. Signs of injury associated with restraint, including circulation of affected extremities.
2. Respiratory, circulation, skin integrity and cardiac status
3. Psychological status including level of distress or agitation, mental status and cognitive functioning.
c. More frequent monitoring and notification of the ordering physician occurs when:
1. Patient's medical and emotional needs and health status change
2. The type and design of the device or intervention poses increased risk

9. Face-to-face assessment by a Physician or LIP:
a. A face-to-face assessment by a physician or LIP, physician assistant or a RN who is trained with demonstrated competence in assessing medical and psychiatric stability, other than the nurse who initiated the use of violent restraint or seclusion, shall conduct a face to face evaluation of the individual within one hour following the initiation of the restraint.

14. Documentation Requirements:
The medical record contains documentation of:
a. Assessment for risk for restraint
b. Restraint or seclusion alternatives employed
d. Second tier review of need for restraint
j. Assessment of the patient in restraint
k. Monitoring of the patient in restraint

Appendix A: Training Requirements

B. Staff who conduct the one hour face-to-face evaluation
The purpose of the 1-hour face-to-face evaluation is to complete a comprehensive review of
the patient's condition and 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.
Training for the RN or PA who conduct the 1-hour face-to-face will include:
1. Application of restraints.
2. Implementation of seclusion.
3. Monitoring, assessment and providing care for a patient in restraint or seclusion,
including:
a. The patient's immediate situation
b. The patient's reaction to the intervention
c. The patient's medical and behavioral condition

Appendix D:
Definitions, C. Drugs as restraints: 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 is considered a restraint. A medication that is not being used as a standard treatment or in a dosage for the patient's medical or psychiatric condition and that results in controlling the patient's behavior and/or in restricting his or her freedom would be a drug used as a restraint.

e. "Chemical restraint" is defined as the use of any chemical, including pharmaceuticals, through topical application, oral administration, injection, or other means, for purposes of restraining an individual and which is not standard treatment for the individual's medical or psychiatric conditions."

Further review of the policy and procedure Patient Restraint/Seclusion revealed there was no direction on how soon, how frequently, and for how long the patient should be assessed after the administration of a chemical restraint/EBM.

An interview with staff #2 on 5/7/25 at 2:00 PM revealed that there were no specific time frames listed in the policy for the assessment of a patient after the administration of a chemical restraint/EBM. Staff #2 confirmed there were no patients listed on the restraint log that had received a chemical restraint/EBM. Staff #2 confirmed that there were only mechanical/physical restraints listed.

An interview was conducted on 5/5/25 at 7:30 PM with RN staff #18 and RN staff #19. RN Staff #18 was asked if she could define a chemical restraint, when it should be administered, and how she would assess the patient afterward. Staff #18 stated that a chemical restraint was "a bunch of medications all mixed together or anything that would calm a patient down like Ativan or Haldol." Staff #18 stated that she was not aware of any specific time frames for the reassessment following administration of a chemical restraint/EBM. Staff #18 stated that she reassessed the patient every 5 minutes until she thought the patient was safe. Staff #18 was asked if there was an antidote for psychotropic meds, and she stated she was not aware. She also stated that she was not aware that the medications had black box warnings. Staff #18 stated that she had chemical restraint training recently, but she was not sure she understood the training. Staff #18 stated that there was no post-test to validate the training comprehension.

Staff #19 stated that when she had a psychiatric patient who needed a chemical restraint, she would ask the doctor for something like Ativan IV or IM. Patient #19 stated that she was not sure of any antidotes for psychotropic medications or that any of these medications had black box warnings for administration. Staff #19 stated that she was not aware of any policy or process that gave information on how to assess and reassess a patient after the administration of a chemical restraint/EBM. Staff #19 stated that she would stay with her patient and check vitals every five minutes. Staff #19 stated that she would continue until the patient was stable but was not able to give a time frame or her definition of "stable". Staff #19 stated that she had some recent training on restraints but was told that they do not give chemical restraints or emergency behavioral medications, and it was not part of the training. Staff #18 stated that she was taught how to de-escalate and hold the patient, but not how to assess patients after chemical restraints/EBM.

An interview was conducted with Pharmacist Staff # 12 and the Manager of Pharmacy, Staff #13 on 5/7/25 at 9:20 am. Staff #12 stated they do complete retrospective data collection on antipsychotic medications monthly that are provided to the hospital's patient safety and quality department but have not specifically been looking into reasons for ordering or appropriate use of the medications. Staff #12 and #13 confirmed that currently the pharmacy does not have a process for alerts or black box warnings for antipsychotic medications and have not been assessing or ensuring the PO's for appropriate use. Staff # 12 stated the ER department uses the Automated Medication Dispensing Unit (AMDU) which is accessible for any medication from the doctor's order due to the urgency in that unit. Staff #12 and #13 confirmed the pharmacy department has not been asked, nor has it attended any process improvement meetings related to medication restraints. Staff #12 was asked if they have screens in the electronic medical record or the AMDU that are specific to restraint medications the hospital uses and he stated no; that would have to be submitted to corporate level because they oversee the standard screens, and that process could take up to a year if approved.

A review of the education materials " Restraint Use" and "Welcome to Restraint Bootcamp" was developed and provided to staff during April of 2025. The training revealed education on definitions, examples, orders, monitoring, alternatives during de-escalation, and documentation of violent vs nonviolent restraints, seclusions, physical holds, mechanical restraints, and Emergency Behavioral Medications. However, there was no training or policy that directed the nurse on patient assessment after the administration of a chemical restraint.


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Interview on 5/5/25 at 5:37 PM with RN #22 stated he received restraint re-training within the last month including the types of restraints and their uses. RN #22 stated emergency medications used for restraint included Haldol, Ativan, and Zyprexa; but that Haldol was the "go to." RN #22 stated sometimes medications are used for "agitation" and trying to calm the patient down. RN #22 said their unit used the "RASS" (Richmond Agitation-Sedation Scale) score for agitation. [The RASS is a tool used to assess a patient's level of agitation and sedation by using a numerical score]. RN #22 stated there was an electronic policy and protocol for the use of violent restraints and medications used for restraints, but when asked to review the protocol, he was unable to locate it on the computer-based system the facility uses.

Interview on 5/5/25 at 6:08 PM with Staff #21 stated the restraints are audited by the charge nurse on every shift. The newly implemented process is for the unit directors to review the restraint documentation and process twice weekly. Staff #21 stated with this new process the biggest identified issue was the "documentation gaps; either in the orders or missing documentation."

Interview on 5/5/25 at 7:30 PM with Staff #23 said she conducts the restraint chart audits by checking the orders and identifying any "fall outs." Staff #23 stated as the process has progressed, they have identified issues to address and follow up with the staff, or for administration to explore how to remove the barriers to ensure compliance. Staff #23 said that sometimes it just the staff are "not picking the right choice" in the menu. Staff #23 stated there had been conversations about adapting the Electronic Medical Record (EMR) to ensure all areas for restraints are completed, as required. Staff #23 said a chemical restraint was if you "snow" [the slang term used when a patient is heavily or overly sedated in order to make them drowsy or unconscious] the patient, and an emergency medication restraint was "not to subdue" but to change their behavior, if given for anxiety," and not their normal medication regimen. Staff #23 said sometimes medications were given for "disruptive" behavior, but only if their safety was going to be affected.

Interview on 5/6/25 at 12:50 PM with RN Staff #24 stated she was not sure about the process for the use of chemical restraints when asked, and further stated, "restraints in PACU [Post-Anesthesia Care Unit] are covered under procedure orders."

Interview on 5/6/25 at 12:52 PM with RN Staff #25 when asked about violent restraints, stated violent restraints are not used in the PACU and there had only been one restraint in the past year, but she could not remember.

Interview on 5/6/25 at 1:50 PM with Staff #2 indicated the restraint reports are reviewed daily for a specific set of parameters from a work tool (spread sheet) we have developed. If there is a discrepancy, error, or omission is found they address it with that staff prior to the end of shift. There was training for the RN's in the ER department that included monitoring patients while restraints are used. Staff #2 stated the clinical documentation has improved after the training.